Hiv & Aids - GL 6

Guidelines for Antiretroviral Therapy
& Management of Opportunistic Infections

for Children, Adolescents & Adults Living with HIV
July2022
National HIV/AIDS Programme

Department of Communicable Diseases
Ministry of Health
Democratic Republic of Timor-Leste
CONTENTS
Message from Hon’ble Minister of

Health……………………………………………………………………………….. .. $1
Message from WHO
Representative…………………………………………..…………………………………………..1
Acknowledgements ........................................................................................................ 1$
Acronyms and abbreviations ........................................................................................... 1$$
Chapter 1 ...................................................................................................... 1
Introduction ........................................................................................................ 1
International HIV/AIDS situation .......................................................................................................... 1
HIV/AIDS in Timor-Leste ....................................................................................................................... 2
Objectives of the guideline ................................................................................................................... 4
Chapter 2 ...................................................................................................... 5
HIV testing ........................................................................................................... 5
HIV testing service for OPDand IPD ...................................................................................................... 5
Chapter 3 ...................................................................................................... 8
Technical guidance on ART .................................................................................... 8
Objectives of ART .................................................................................................................................. 9
Principles of ART ................................................................................................................................. 10
ART regimens in Timor-Leste ............................................................................................................. 13
Introducing Dolutegravir .................................................................................................................... 16
Monitoring and changing the regimen of ART ................................................................................... 19
Starting of ART regimen...................................................................................................................... 23
ART education and adherence ........................................................................................................... 24
Chapter 4 .................................................................................................... 30
ART operational guidance: assessment of adolescents and adults with HIV infection 30
Initial HIV consultation ....................................................................................................................... 30
Initial laboratory investigation of PLHIVs .......................................................................................... 31
Tailored approach to care .................................................................................................................. 32
Monitoring ART during the first year .................................................................................................. 33
Follow-up of PLHIV beyond the first year of ART............................................................................... 35
Chapter 5 .................................................................................................... 38
ART operational guidance: standard package of care (SPC) for PLHIVs ..................... 38
ART ....................................................................................................................................................... 40
Positive health and GBV prevention .................................................................................................. 40
Screening and management for TB ................................................................................................... 41
Screening and management of other coinfections and OIs ............................................................. 42
Reproductive health services ............................................................................................................. 45
Sexually transmitted infections (STIs) ............................................................................................... 45
Chapter 6 .................................................................................................... 48
Management of opportunistic infections ............................................................... 48
Pneumocystis pneumonia .................................................................................................................. 48
Cryptococcal meningitis (CM) ............................................................................................................ 50
$
Prevention of other infections ........................................................................................................... 54
Oral lesions, odynophagia and dysphagia ........................................................................................ 58
Diarrhoea in HIV infection .................................................................................................................. 63
Skin lesions in HIV infection ............................................................................................................... 64
Management of neurological disorders in HIV infection ................................................................... 72
Palliative care ...................................................................................................................................... 74
Some special conditions in HIV management ......................................................... 77
Immune reconstitution inflammatory syndrome (IRIS).................................................................... 77
Chapter 7 .................................................................................................... 80
TB and HIV .......................................................................................................... 80
TB diagnosis and treatment ............................................................................................................... 80
Treatment for LTBI .............................................................................................................................. 86
Chapter 8 .................................................................................................... 89
Post-exposure prophylaxis (PEP) .......................................................................... 89
Management of exposure person ...................................................................................................... 91
Chapter 9 .................................................................................................... 94
HIV-Hepatitis coinfection ..................................................................................... 94
Evaluation of HIV and hepatitis B coinfected persons ...................................................................... 94
HIV and HCV coinfection ..................................................................................................................... 96
Chapter 10 .................................................................................................. 98
Other comorbidities in HIV and their management ................................................. 98
Screening and management for NCDs in PLHIVs .............................................................................. 98
CVDs ..................................................................................................................................................... 98
Diabetes ..............................................................................................................................................100
Chronic kidney disease (CKD)............................................................................................................101
Mental health screening and management ......................................................................................102
Nutritional assessment and counselling ..........................................................................................104
Annex 1: ‘Test and Treat’ protocol for Timor-Leste .............................................................. 108
Annex 2: HTS protocol ............................................................................................................ 111
Annex 3: Patient registration form ........................................................................................ 112
Annex 4: Patient monitoring form (Adult and paediatric) .................................................... 113
Annex 5:Monthlydata reporting form .................................................................................... 115
Annex 6: Appointment and tracing registers ........................................................................ 117
Annex 7: WHO clinical staging ................................................................................................ 118
Annex 8: Assessment of patient during the first visit to ART centre .................................... 121
Annex 9: National referral system.......................................................................................... 123
Annex 10: Management of chronic hepatitis B infection – WHO algorithm......................... 130
Annex 11: Standard precautions – WHO recommendations ................................................ 131
$$
Figures
Fig. 1.The 30 years of HIV/AIDS control effort, 1988--2018 ........................................................... 1
Fig. 2. Four opportunities for HIV prevention ............................................................................... 2
Fig. 3. HIV prevalence (%) in Timor-Leste, 2004---2019 ................................................................ 2
Fig. 4. HIV treatment cascade, 2020 (Cumulative data until December 2020) ............................ 4
Fig. 5. Diagnostic algorithm for HIV testing ................................................................................... 6
Fig. 6. HIV life cycle and classes of ART drugs ............................................................................. 10
Fig. 7. Algorithm for managing single drug substitution ............................................................ 21
Fig.8. Management algorithm for PLHIVs with suspected cryptococcosis ................................ 52
Fig. 9. Management of mouth pain in PLHIVs ............................................................................. 62
Fig. 10. Visual analogue scale with Wong-Baker faces for assessment of pain ......................... 75
Fig. 13. HIV-TB coinfection: algorithm for screening HIV positive individuals .......................... 82
Fig. 16. Stages of hypertension - WHO....................................................................................... 100
Fig. 17. Trends of malnutrition status of U5 children in Timor-Leste, 2009--2016 .................. 104
Tables
Table 1. Protocols to be followed for outcomes of an HIV test .................................................... 7
Table 2. Special consideration for initiation of ART ..................................................................... 9
Table 3. Characteristics of ART drugs available in Timor-Leste ................................................. 11
Table 4. Proposed first-line regimens for adults, adolescents, children and infants ............... 13
Table 5. Dosing of solid and liquid formulations for infants and children of four weeks of age
and older ....................................................................................................................................... 14
Table 6. Dosage of ART in infants below four weeks .................................................................. 16
Table 7. Simplified regimen for ART in infants, children, adolescents and adults ................... 16
Table 8. Drug--drug interactions--INSTIs .................................................................................... 18
Table 9. Optimized regimen for ART in a stable adult or adolescent patient ........................... 20
Table 10. Common ADRs due to ARVs ......................................................................................... 20
Table 11. Proposed second-line regimens for adults and adolescents, children and infants.. 22
Table 12. Starting ART in infants, children, adolescents and adults ......................................... 23
Table 13. Steps to manage the common side-effects of ART ..................................................... 24
Table 14. Measures to optimize adherence to ART ..................................................................... 25
Table 15. Guidance for preparing the patient for better compliance and adherence .............. 26
Table 16. Assessment of adherence and its remedial measures ............................................... 26
Table 17. Factors that may influence adherence........................................................................ 27
Table 18. Overview of tasks to be completed before ART initiation .......................................... 30
Table 19. Initial laboratory investigations for PLHIVs ................................................................ 31
Table 20. Care of PLHIVs based on stage of disease ................................................................... 32
Table 21. Follow-up schedule for ART patients .......................................................................... 34
Table 22. Differentiated follow-up mechanism for PLHIVs ........................................................ 35
Table 23. Standard package of care for adult and adolescent PLHIVs in Timor-Leste ............. 38
Table 24. Standard package of care for HIV-exposed and HIV-infected infants ....................... 39
Table 29. Standard co-trimoxazole desensitization protocol (8 days) ...................................... 44
Table 31. Basket of contraception based on WHO 2018 guidelines .......................................... 46
Table 42. Commonly used NSAIDS in management of intractable pain in PLHIVs ................... 76
Table 43. Commonly used opioids in pain management in PLHIVs .......................................... 76
Table 45. Classification of IRIS ..................................................................................................... 77
Table 50. TB treatment regimens ................................................................................................ 83
Table 62. Management of chronic kidney disease in adult PLHIVs .......................................... 101
Table 68. Total calorie needs of HIV-infected children ............................................................ 107
$$$
.." !-*( *)ҍ' $)$./ -*! '/#
dr. Odete Maria Freitas Belo, MPH

Minister of Health
Dili
July 2022
Timor-Leste is considered as “HIV Low Endemic Country”. The estimated adult

prevalence of HIV was 0.2 % in 2021 with estimated 1400 People Living with HIV
(PLHIVs) at the end of December 2021. HIV/AIDS continues to be driven primarily by
transmission of infections among Key Population.
I am very pleased to note that National AIDS Programme has revised the national
guidelines on HIV treatment, and Elimination to Mother to Child Transmission (EMTCT)
based on updated WHO recommendations.
The updated guidelines for antiretroviral therapy and management of opportunistic

infections (OI) for children, adolescents, and adults Living with HIV, aims to provide
guidance and support to health care workers involved in the HIV/AIDS clinical
management, including ART and OI, in Timor-Leste.
HIV treatment and services, including ARV and OI treatment, are provided free of
charge for all Timorese citizens through the government-run health facilities and select
private centres namely, Bairo Pite Clinic and Maluk Timor Clinic at CHC Vera Cruz.
The key audiences for these guidelines are policy makers in the MoH and the managers
of the NAP who formulate country specific HIV treatment guidelines. In addition, health
professionals- including doctors, nurses, and educators working both in Govt. and
Non- Govt. Organizations (NGOs) involved in management and care of HIV patients and
organizing treatment services – are expected to use this updated and consolidated
guideline.
I look forward to the successful implementation of and adherence to the revised ART
guidelines (2021 Edition) by all PLHIV care providers.
Dr. Odete Maria Freitas Belo, MPH

Minister of Health
$1
Message from WHO Representative
Dr. Arvind Mathur

WHO Representative to Timor-Leste
World Health Organization
Dili
July 2022
I am proud to present the national guidelines on HIV treatment. The guideline

development was completed by the Ministry of Health (MoH) with technical assistance
from WHO. I congratulate and thank everyone who contributed to this revision.
This guideline aims to provide guidance and support to health care workers involved in
the HIV/AIDS clinical management, including ART and OI, in Timor-Leste. Recently,
WHO has come out with many new updates based on the evidence from other clinical
trials. The latest guideline brought out in July 2019 provides an evidence-based
recommendation for use of dolutegravir-based triple ART.
The national guideline development has been developed in close consultation with the
Technical Working Group for ART in Timor-Leste and supported by WHO. The guideline
aims at:
1. Revising and consolidating existing ART and OI guidelines and incorporate

WHO recommendations for all age groups, gender and populations
2. Providing a standard approach for the use of ART with uniform recording and
reporting formats
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WHO is committed to continue its support to the national program to End Inequities
and End AIDS and to ensure that the country can meet the target of elimination of AIDS
as a public health problem by 2030.
Dr. Arvind Mathur

WHO Representative
1
Acknowledgements
Timor-Leste brought out its first ART and OI guidelines in 2011 and were revised in
2014 and 2017. This is the 2021 revision necessitated by the updates provided by WHO
in the past two years.
The Ministry of Health, Democratic Republic of Timor-Leste gratefully acknowledges

the contributions from the National AIDS Programme, WHO, The Global Fund, and
National HIV, Hepatitis and STI Technical Advisory Group (TAG) for their valuable
support and contributions in revising the national guidelines on HIV treatment and
EMTCT.
The final guidelines were reviewed by the TAG, WHO SEARO HIV Unit, WHO Country
Office and NAP Team lead by Mr Bernardino da Cruz.
The Ministry of Health gratefully acknowledges the financial support provided from
The Global Fund for TB, AIDS and Malaria (GFATM) and the continued technical
support from the World Health Organization (WHO).
1$
Acronyms and abbreviations
ABC Abacavir
ACT artemisinin based combination therapy
AFB acid fast bacilli
ART/ARV antiretroviral therapy/antiretrovirals
AZT azidothymidine or zidovudine
AZV Atazanavir
BID or b.i.d or bid ‘Bis in die’ in Latin means twice in a day
BMI body mass index
CDC department of communicable disease control
CHC community health centre
CLHIV children living with HIV/AIDS
CM cryptococcal meningitis
CMV cytomegalovirus
CTX co-trimoxazole
3TC Lamivudine
DDI Didanosine
DST drug sensitivity test
DTG Dolutegravir
EMTCT elimination of mother to child transmission of HIV/AIDS,
syphilis,and hepatitis B
EFV Efavirenz
EPTB extra pulmonary tuberculosis
FDC fixed dose combination
Hb Haemoglobin
HBV hepatitis B virus
HCV hepatitis C virus
HNGV Hospital National GuidoValadarès
IM intra-muscular
INH Isoniazid
INSTI integrase strand transfer inhibitors
IPT isoniazid preventive therapy
IRIS immune reconstitution inflammatory syndrome
IV Intravenous
LFT liver function tests
LPV/r lopinavir boosted with ritonavir
MCH mother and child health
MoH ministry of health
MUAC mid-upper arm circumference
NGO non-governmental organization
NNRTI non-nucleoside reverse transcriptase inhibitor
NNT number need to treat
NRTI nucleoside reverse transcriptase inhibitor
NVP Nevirapine
OD once daily
OI opportunistic infections
1$$
PCP Pneumocyctiscarinii (jirovici) pneumonia
PI protease inhibitor
PLHIV people living with HIV and AIDS
PMTCT prevention mother to child transmission
RAL Raltegravir
SPC standard package of care
STI sexually transmitted infections
TB Tuberculosis
TDF Tenofovir
VL viral load
ZDV zidovudine
1$$$
Chapter 1
Introduction
International HIV/AIDS situation

By the end of 2019, there were an estimated 38.0 million (31.6–44.5 million) people living with HIV
(PLHIV) worldwide. With 1.7 million new infections (1.2–2.2 million) and 690 000(500 000–970 000)
deaths, the disease is far from gone. The number of people with access to antiretro viral therapy
(ART) was 25.4 million (20.5–24.3
million). While new HIV infections
fell by 39% and HIV-related deaths
fell by 39% amid 2010 and 2019,an
estimated 12.1 million lives were
saved due to ART. It is heartening to
note that 68% of adults and 53% of
children living with HIV/AIDS
(CLHIV) are on lifelong ART and 85%
of all pregnant and breastfeeding
women are also accessing ART.1
Sexual transmission accounts for
more than 80% of HIV transmission.
New research has found that using
treatment as prevention can reduce
the number of new HIV infections
significantly. Starting ART early with Fig. 1. The 30 years of HIV/AIDS control effort, 1988--
proper adherence has shown to 2018
decrease transmission in sero
discordant couples by 96%.2 However, this must be used in combination with other HIV prevention
options such as consistent condom use, voluntary male circumcision and a few partners.
1 Global HIV and AIDS statistics- 2020 fact sheet. Geneva: UNAIDS
(https://www.unaids.org/en/resources/fact-sheet, accessed 28 November 2020).
2https://www.hptn.org/research/studies/hptn052.
1

Years Hours 72 hours Years
Fig. 2. Four opportunities for HIV prevention

Source: Cohen, Myron S et al. Antiretroviral treatment of HIV-1 prevents transmission of HIV-1: where do we go from here? Lancet. 2013;
382: 1515--24 doi:10.1016/S0140-6736(13)61998-4.
Improvement in the quality of life for those who are HIV positive includes universal access to ART
and opportunistic infections (OI) treatment. This is possible with availability of free antiretrovirals
(ARVs), a sustainable resource flow, planning and coordination in procurement among health
workers, a strong and effective participation of civil society and PLHIVs, strengthening prevention
and treatment services and advocacy of human rights. Increased access to treatment can make a
significant impact on HIV-related mortality and enable people to lead healthy lives.
HIV/AIDS in Timor-Leste

"$
The first case of HIV infection in
Timor-Leste was reported in 2001. " "
The country has diagnosed !$
cumulatively 716 cases since 2003.3
!
The mode of transmission is
overwhelmingly sexual. There are $ $
#
only three cases, though doubtful, of !
"
transmission through infected blood
$
and sevencases of mother to child $
% #
transmission recorded in the

programme database. #!!% #!"!"" #!"& #!"'
The estimated adult prevalence of HIV Fig. 3. HIV prevalence (%) in Timor-Leste, 2004---2019
was 0.1% (2019). Thus, there were
3Program report. National HIV/AIDS program, updated October 2019. Ministry of Health, Democratic
Republic of Timor-Leste.
2
approximately, 909 PLHIVs at the end of December 2019. The prevalence among the female sex
workers (FSW) has reduced from a high of 2.76 (3%) in 2004 to no new cases detected in integrated
biological and behavioural surveillance (IBBS), 2016. Similarly, the prevalence among men having
sex with men (MSM) has reduced from a high of 1.0% (2004) to 0.4% (IBBS, 2016). The estimated adult
prevalence has come down from 0.5% (2004) to 0.1% (2019).
The National HIV/AIDS Programme (NAP) is in its second decade of implementation. Things have
gone well for this country because the HIV prevalence has not increased. The prevalence in the
neighbouring country is many times higher than that of Timor-Leste, and it shares a large part of
its borders with Nusa Tengara Timur (NTT) region of Indonesia.
ART was initiated in Timor-Leste through the private sector (Bairo Pite Clinic) in 2002, using
donated ARV drugs. The public sector followed through with the Hospital Nacional Guido Valadares
(HNGV) starting its first ART clinic in 2005 by a generous support from the Government of Brazil for
first-line ARV drugs, technical assistance, and training of health workers. Since 2007, the country
received its ARV through the Global Fund programme (Round 9).
In 2017, the Government of Timor-Leste resolved to provide all the PLHIVs with ART irrespective of
their immune status or CD4 count, and also introduced HIV viral load (VL)monitoring for follow up
of PLHIVs on ART (The ‘Test and Treat’ policy is provided in Annex 1. ‘Test and Treat’ protocol for
Timor-Leste).
Timor-Leste is a signatory to the Sustainable Development Goals (SDGs). Goal 3, Target 3.3 is about
bringing an end to epidemics of AIDS, TB, malaria and neglected tropical diseases and combat
hepatitis, water-borne diseases, and other communicable diseases. Moreover, the UN 90-90-90
strategy of ending AIDS by 2030 has some interim milestones of:
• 90% of estimated PLHIVs know their status, of which
• 90% are accessing sustained lifesaving ART, of which
• 90% have sustained viral suppression.
The current achievements are presented in Fig. 4.
3
Fig. 4. HIV treatment cascade, 2020 (Cumulative data until December 2020)
HIV treatment and services, including ARV and OI treatment, are provided free of charge for all
Timorese citizens through the government-run health facilities and select private centres namely,
Bairo Pite Clinic and Maluk Timor Clinic at CHC Vera Cruz. The Constitution of the Democratic
Republic of Timor-Leste, approved on the 22 March 2002, states that the citizens of Timor-Leste
have the following as a fundamental right, duty, freedom and guarantee regarding health:
• Everyone has the right to health and medical care, and the duty to protect and promote
them
• The State shall promote the establishment of a national health service that is universal and
general. The national health service shall be free of charge in accordance with the
possibilities of the State and in conformity with the law
• The national health service shall have, as much as possible, a decentralised participatory
management.
Objectives of the guideline
This guideline aims to provide guidance and support to health care workers involved in the
HIV/AIDS clinical management, including ART and OI, in Timor-Leste. Recently, WHO has come out
with many new updates based on the evidence from other clinical trials. The latest guideline
brought out in July 2019 provides an evidence-based recommendation for use of dolutegravir-
based triple ART.
The guideline has been developed in close consultation with the Technical Working Group for ART
in Timor-Leste and supported by WHO. It considered in detail the present epidemiological situation
of HIV infection in Timor-Leste, demand and sustainability for ART in the country.
The guideline aims at:
• Revising and consolidating existing ART and OI guidelines and incorporate WHO
recommendations for all age groups, gender and populations
• Providing a standard approach for the use of ART with uniform recording and reporting
formats
• Providing a transition plan for shifting to dolutegravir-based regimen.
4
Chapter 2
HIV testing
HIV testing service for OPD and IPD

The model followed in Timor-Leste includes a pre-test information followed by testing and a post-
test counselling. Essentially build on the model of ‘opt out’ approach, i.e., the HIV test is offered
unless the patient actively opts out of the procedure. It is also known as provider-initiated testing
and counselling (PITC).
Pre-test information
Pre-test information may be provided in group, where resources do not permit individual sessions,
but preferably on a one-to-one basis.
Pre-test information should include at the minimum:
• The reasons why HIV testing and counselling are recommended
• The benefits of testing, as well as the potential adverse outcomes (violence, stigma,
abandonment, etc.)
• The fact that the result will remain confidential
• The fact that the patient has the right to decline the test and that testing will be performed
unless the patient exercises that right (opt out approach)
• The fact that declining the test will not affect the patient’s access to services that do not depend
upon knowledge of HIV status
• The follow-up services that are available in the case of either an HIV-negative or an HIV-positive
test result
• The HIV testing process (drawing of blood or finger-prick, testing procedure, timing of results)
• An opportunity to ask the healthcare provider questions.
Additional pre-test information for women who are or may become pregnant should include the
risks of HIV transmission to infants, measures that can be taken to reduce mother-to-child
transmission, including ARV prophylaxis, infant feeding counselling and the benefits to infants of
early diagnosis of HIV.
Verbal communication is adequate for the purpose of obtaining informed consent to diagnostic
HIV testing.
Pre-test information does not include individual risk assessment.
The patient has the option to accept or refuse the test to be performed.
HIV testing services

Three tests algorithms are currently used for diagnosis of HIV in any adult, adolescent or children
(above 18 months of age). The diagnostic algorithm for HIV testing for adults, adolescents and
children >18 months is given in Fig.5.
5

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Fig. 5. Diagnostic algorithm for HIV testing
Post-test counselling
Post-test counselling should be provided for all people, whether they test HIV positive or negative.
The test result should be provided in a written format to all patients -- negative and positive.
The aims of post-test counselling are:
• To give the test result to the client, whether positive or negative
• To provide emotional support to help the person to cope with the result if
positive
• To discuss the physical, emotional and social implications of a positive result
• To discuss prevention for HIV-positive and -negative individuals
• To refer the client for any care or treatment indicated
• To advocate for prevention of HIV so that the person remains HIV negative.
6
Table 1. Protocols to be followed for outcomes of an HIV test
Criteria What to do?

Negative HIV test • Give the result simply and clearly
• Explain the meaning of the result and the window period if
there has been at-risk behaviour in the preceding three months
• Discuss any other immediate concerns the person might raise
• Discuss the importance of staying negative; provision of
condoms and demonstration using a penis model
• Assess whether the patient needs referral to more extensive
post-test counselling session or additional prevention support,
for example, through community-based services
Positive HIV test • Give the result simply and clearly, and give the client time to
consider the result
• Check with open-ended questions that the person understands
the meaning of the result
• Allow the patient to ask questions
• Let the person talk about his/her feelings about the results
• Acknowledge the shock of the diagnosis; offer support
• Determine how the client will get through the next few hours or
days
• Discuss any immediate concerns, including personal safety
(suicide, depression, anger, violence)
• Check to see who might be available to offer immediate support
• Provide information about the Peer Group (PLHIV) network and
its roles
• Discuss disclosure of the result and when it happens and with
whom. Suggest telling only closest contacts (spouse, significant
other) in the short term
• Discuss how to protect partner(s) from infection and explain the
use of condoms
• If the client is healthy, explain how to maintain good health
• Describe follow-up support available in the health facility, i.e.,
treatment of OI, TB, OI prophylaxis and ART
• Arrange a specific date and time for follow-up counselling visits
(including family planning) and medical care; ideally the same
day as the HIV diagnosis and ensure referrals for other services
as appropriate.
It is very important to adapt the postcounselling to the needs of each client and avoid "one
conversation fits all" approach. The discussion should be based on the concerns of the client.
Some clients receiving a positive HIV result may be unable to understand and absorb a lot of
information due to their emotional state. Therefore, the counsellor should first assist them
psychologically and offer further session(s) to explain general facts.
7
Chapter 3
Technical guidance on ART
ART has been a game changer for HIV/AIDS globally. It has not only allowed PLHIVs to live a
dignified life, but also improved their quality of life and life expectancy. Timor-Leste has been
offering its citizens free ARTs since 2010. It also introduced ‘Test and Treat’ for all in 2017.
ART consists use of a combination of at least three ARV drugs from different classes to inhibit the
replication of HIV and reduce viremia to undetectable levels. Continued suppression of viral
replication leads to the restoration of immune response, reflected by an increase in the CD4
count.
There are two lines of ART available in the country, namely, first-line and second line. The first-
line consists of two nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) backbone
(e.g., tenofovir, zidovudine and abacavir) and one NNRTI (e.g., nevirapine and efavirenz) or
integrase strand transfer inhibitors (INSTI) (e.g., dolutegravir and raltegravir) and second-line
NRTIs/NtRTIs + Protease Inhibitors (e.g., lopinavir, ritonavir and atazanavir). ART was earlier
known as highly active ART (HAART) and as combination ART (cART).
With the new guidance from WHO, a new drug dolutegravir (Class: Integrase Inhibitors) is now
recommended as the first choice among the first-line. Dolutegravir has been introduced in Timor-
Leste since April 2020, and it has been planned to scale up.
WHO also recommends a ‘test and treat’ or ‘treat-all’, which states:
• PLHIVs belonging to all populations and age groups, including pregnant women and
children, irrespective of their CD4 count levels, are now eligible for treatment
• The once-per-day combination pill is now recommended for all adults living with HIV,
including pregnant women, and those with TB, hepatitis and other coinfections.
The guidelines are ambitious in their expected impact, yet simplified in their approach, and firmly
rooted in evidence. Starting ART early keeps PLHIV alive, healthier and reduces the risk of
transmitting the virus to their sexual and drug-sharing partners. It also has the further advantage
of simplifying the operational demands on programmes.
In Timor-Leste, the national programme follows the ‘Test and Treat’ policy.
All individuals with confirmed HIV infection are eligible for ART irrespective of
CD4 cell levels, WHO clinical stage, age, pregnancy or breastfeeding status,
coinfection status, risk group, or any other criteria.
8
Table 2. Special consideration for initiation of ART
Population Timing of ART initiation Comments
Pregnant and breastfeeding Support ART initiation as early as Intensive adherence counselling
women possible after testing positive for and close follow-up required
HIV because of limited time for patient
preparation
Infants (< 12 months old) Support ART initiation on the same Intensive adherence counselling
day as mother after testing positive and close follow-up required
for HIV because of limited time for
caregiver preparation
Patients with strong motivation to Support ART initiation as soon as Intensive adherence counselling
start ART immediately they meet ART Readiness and close follow-up required
Assessment criteria after testing because of limited time for patient
positive for HIV preparation
Patients with newly diagnosed TB Start anti-TB treatment Monitor closely for IRIS
immediately and initiate ART as
soon as anti-TB medications are
well tolerated, preferably within 2–
4 weeks. For TB meningitis and
disseminated TB, consider delaying
ART for up to 8weeks or more
Patients with cryptococcal Defer ART until after completing Monitor closely for IRIS
meningitis (CM) 5weeks of CM treatment and
symptoms have resolved
Patients for whom adherence will Start ART as soon as adequate A treatment supporter (preferably
be particularly challenging support systems are in place for from PLHIV group) should be
adherence (e.g., psychiatric assigned to all patients with
treatment for a patient with mental complex adherence challenges
illness; caregiver identified for an
orphan, etc.)
All other patients Start ART as soon as possible once Adequate ART preparation, and
they meet ART Readiness continued adherence monitoring
Assessment criteria and support is recommended after
ART initiation for all patients
Objectives of ART
HIV is not curable, but definitely treatable. Early in the course of the disease, a pool of latently
infected CD4 cells was noted. This is the means by which HIV infection escapes the ART drugs. It
persists within the organs/cells and fluids (e.g., brain, liver and lymphoid tissue), despite
prolonged suppression of plasma viremia by ART to <50 copies/mL. The primary aim of ART is to
prolong the viral suppression for the immune cells to carry out their normal functions. ART is
provided with the following objectives in mind:
• Increase survival and improved quality of life of PLHIVs – clinical
• Enforce maximum VL suppression---virological
• Immune reconstitution that is beneficial to the patient–immunological
• Use of cART to achieve maximum benefit with minimal adverse effects–therapeutic
• Achieve secondary prevention of HIV transmission–preventive.
Due to the continued viral suppression, the destruction of CD4 lymphocyte cells is reduced and
over time there is an increase in the CD4 count, which is accompanied by partial restoration of
pathogen-specific immune function. This leads to a reduction in OIs, reduced morbidity and
mortality.
9
Principles of ART
HIV life cycle and classification of ART drugs

HIV targets and terminates the CD4 cells of the immune system. CD4 cells are a type of white blood
cells that play a major role in protecting the body from infection. In fact CD4 cells are like leaders
who direct the other soldiers to fight the infection. HIV uses the machinery of the CD4 cells to
multiply and spread throughout the body. This process, which is carried out in seven steps or
stages, is called the HIV life cycle.
Fig. 6. HIV life cycle and classes of ART drugs

Source: AIDSinfo. US Department of Health and Human Services (https://aidsinfo.nih.gov/understanding-hiv-aids/fact-
sheets/19/73/the-hiv-life-cycle,accessed 29 October 2019).
Based on the HIV replication or life cycle, the ARVs are classified into seven classes namely, the
nucleotide reverse transcriptase inhibitors (NRTIs), non-nucleoside reverse transcriptase
inhibitors (NNRTIs), protease inhibitors (PIs), fusion inhibitors (FIs), CCR5 antagonists, post
attachment inhibitors and Integrase strand transfer inhibitors (INSTIs):
10
• NRTIs block reverse transcriptase (an HIV enzyme Site 3 in Fig. 6). HIV uses reverse
transcriptase to convert its RNA (single stranded) into DNA (double stranded) (reverse
transcription), e.g., Zidovudine (ZDV), Lamivudine, Abacavir, Didanosine and Tenofovir
(Nucleotide reverse transcriptase inhibitor)
• NNRTIs bind to and block HIV reverse transcriptase (an HIV enzyme). HIV uses reverse
transcriptase to convert its RNA into DNA (reverse transcription), e.g., Nevirapine and
Efavirenz
• PIs block protease (an HIV enzyme). By blocking protease, PIs prevent new (immature) HIV
from becoming a mature virus that can infect other CD4 cells, e.g., Lopinavir, Ritonavir,
Atazanavir, etc.
• INSTIs block integrase (an HIV enzyme). HIV uses integrase to insert (integrate) its viral
DNA into the DNA of the host CD4 cell. Blocking integrase prevents HIV from replicating,
e.g., Dolutegravir, Raltegravir, etc.
• A FI blocks the HIV envelope from merging with the host CD4 cell membrane (fusion). This
prevents HIV from entering the CD4 cell, e.g., Enfuvirtide, etc.
• CCR5 antagonists block the CCR5 coreceptor on the surface of certain immune cells, such
as CD4 T lymphocytes (CD4 cells). This prevents HIV from entering the cell, e.g., Maraviroc,
Aplaviroc, etc.
• Post-attachment inhibitors are a class of drugs that bind to the CD4 receptor on a host CD4
cell. This blocks HIV from attaching to the CCR5 and CXCR4 coreceptors and entering the
cell. Post-attachment inhibitors are part of a larger group of HIV drugs called entry
inhibitors, e.g., Ibalizumab.
The classes of ARTs available in Timor-Leste are given in Table 3.
Table 3. Characteristics of ART drugs available (and proposed) in Timor-Leste

Class Drug name Dose Food Adverse effects
interactions
Nucleotide Tenofovir (TDF) 300 mg once None Renal toxicity, bone
reverse daily demineralization
transcriptase
inhibitors
(NtRTIs)
Zidovudine (AZT) 300 mg twice No food related Anaemia, neutropenia,
daily issues noted bone marrow
Infants and suppression,
children: gastrointestinal
Weight band- intolerance, headache,
based dosing insomnia, myopathy,
lactic acidosis, skin and
nail hyperpigmentation
Nucleoside
Lamivudine (3TC) 150 mg twice No food-related Minimal toxicity, rash
reverse
daily or 300 mg issues noted (though very rare)
transcriptase
once daily
inhibitors
Infants and
(NRTIs)
children:
Weight band-
based dosing
Abacavir (ABC) 300 mg twice No food related Hypersensitivity
daily or 600 mg issues noted reaction in 3–5% (can be
once daily fatal), fever, rash,
Infants and fatigue, nausea,
children: Weight vomiting, anorexia,
11
band-based respiratory symptoms
dosing (sore throat, cough,
shortness of breath);
Rechallenging after
reaction can be fatal.
Efavirenz 600 mg once Avoid taking CNS symptoms
(EFV) daily (bedtime after high fat (dizziness, somnolence,
administration is meals insomnia, confusion,
suggested to hallucinations,
decrease CNS agitation) and
side-effects) personality change.
Rash occurs, but less
common than NVP.
Nevirapine (NVP) 200 mg once None Hepatitis (usually within
Non-nucleoside daily for 14 days, 12 weeks);sometime
reverse followed by 200 life-threatening hepatic
transcriptase mg twice daily toxicity. Skin rash
inhibitors Infants and occasionally progressing
(NNRTIs) children: weight to severe conditions,
band-based including Stevens
dosing Johnson syndrome
(SJS) and toxic
epidermal necrolysis
(TEN). Patients who
develop severe hepatic
toxicity or grade 4 skin
rashes should not be
rechallenged
Lopinavir/ritonavir(LPV/r) 200 mg None Diarrhoea, nausea,
heat stable tablets Lopinavir/50 mg vomiting, abnormal lipid
ritonavir fixed profiles, glucose
dose tablet intolerance
2 tablets twice
daily
Infants and
children: weight
Protease band-based
inhibitors (PIs) dosing
Darunavir (DRV)* 600 mg twice a None Hepatotoxicity, skin
day(when used rash, diarrhoea, nausea,
with Ritonavir headache,
100 mg twice hyperlipidaemia, serum
daily) transaminase elevation,
Infants and hyperglycaemia
children: weight
band-based
dosing
Dolutegravir (DTG) 50mg once daily None Insomnia and headache.
Infants and Dolutegravir can cause
children: weight serious, life-threatening
band-based side-effects. These
Integrase strand
dosing include hypersensitivity
transfer
(allergic) reactions and
inhibitors
liver problems. People
(INSTI)
with a history of HBV or
HCV infection or who
have elevated results on
liver function tests may
12
have an increased risk of
developing new or
worsening liver
problems while taking
dolutegravir
Raltegravir 400mg twice None Rhabdomyolysis,
(RAL)* daily myopathy, myalgia,
Infants and diarrhoea, fever, rash,
children: weight Stevens-Johnson
band-based syndrome, toxic
dosing epidermal necrolysis,
hepatitis and hepatic
failure
*Darunavir and Raltegravir are currently not available in Timor-Leste
ART regimens in Timor-Leste

The first-line regimens are presented in Table 4.
Table 4. Proposed first-line regimens for adults, adolescents, children and infants
A. Adults and adolescents
First-line Alternative first-line Special considerations

TDF+3TC+DTG • TDF+3TC+EFV400 • TDF + 3TC+ EFV600
• AZT + 3TC + EFV600
• TDF+3TC+LPV/r
B. Children and neonates
First-line Alternative first-line Special considerations
Children
ABC+3TC +DTG • ABC+3TC+LPV/r • ABC + 3TC + EFV (or NVP)
• ABC+3TC+RAL • AZT +3TC + EFV (or NVP)
• AZT + 3TC + LPV/r (or RAL)
Neonates
AZT +3TC + RAL* • AZT+3TC+NVP • AZT+3TC+LPV/r
• ABC + 3TC + LPV/r (ATV/r or
DRV/r)
*Raltegravir (RAL) is currently not available in Timor-Leste and not used. The alternative first line
AZT+3TC+NVP will be the first line choice in neonates till RAL is available.
13
Table 5. Dosing of solid and liquid formulations for infants and children of four weeks of age and older
14
Notes:
1. The dosage of infants less than 4 weeks is presented in Table 6.
2. NVP dose escalation with half dose for 2 weeks as in adults. The infants who are on NVP prophylaxis can initiate the full dose when detected HIV positive.
3. LPV/r requires cold chain for storage and transportation. Heat stable tablet formulations are available and should be used instead. They should not be chewed, crushed or dissolved. Adult 200/50
mg tablets could be used for children with weight band 14.0–24.9 kg.
4. LPV/r pellets are also available, but should not be used in infants below 3 months of age.
5. DRV if administered must be done along with 0.5 mL of RTV 80 mg/mL oral suspension if less than 15 kg and with RTV 50 mg solid formulation in children weighing 15 – 30 kg.
6. WHO recommends use of RAL granules for children as young as 4 weeks, but availability remains a challenge. Also, this formulation has not been investigated for wider use and adverse effects.
Currently RAL is not available in Timor-Leste.
15
The dosage of ART in infants less than four weeks is presented in Table 6.
Table 6. Dosage of ART in infants below four weeks
Weight band
ART drug Formulation
2–3 kg 3--4 kg 4–5 kg
AZT 10 mg/mL 1 mL 1.5 mL 1.0 mL
NVP 10 mg/mL 1.5 mL 2.0 mL 1.0 mL
3TC 10 mg/mL 0.5 mL 0.8 mL 1.0 mL
LPV/r 80/20 mg/mL 0.6 mL 0.8 mL 1.0 mL
RAL 100 mg/sachet sachet sachet sachet
Notes:
1. NVP for treatment can be initiated with twice daily dosing for infants < 2 weeks of age (they do not
require once-daily lead-in dosing).
2. Do not use LPV/r solution in infants aged <2 weeks of age. LPV/r pellets should not be used in infants
younger than 3 months.
It may be confusing to provide the proper ART schedule in children as there are many challenges including
the measurement of proper weight. Table 7provides a simplified version for use by the clinician.
Table 7. Simplified regimen for ART in infants, children, adolescents and adults
Age Preferred regimen Dosing (based on weight band)
Neonates AZT+3TC+NVP (RAL**) Refer to Table 6. Dosage of ART in infants below four
weeks
3–5.9 kg: ABC/3TC (120/60 mg): 0.5 tab b.i.d plus LPV/r
(80/20 mg/mL): 1.5 mL b.i.d
6–9.9 kg: ABC/3TC (120/60 mg): tab am and 1 tab pm
plus LPV/r (80/20 mg/mL): 1.5 mL b.i.d
4 weeks to less 10–13.9 kg: ABC/3TC (120/60 mg): 1 tab b.i.d, plus LPV/r
ABC + 3TC + LPV/r
than 3 years (80/20 mg/mL): 2 mLb.i.d, or LPV/r (100/25 mg): 2 tabs
am and 1 tab pm
14–9.9 kg: ABC/3TC (120/60 mg): 1 tab am and 1.5 tabs
pm, plus LPV/r (80/20 mg/mL): 2.5 mL b.i.d, or LPV/r
(100/25mg): 2 tab b.i.d
3–10 years 20–24.9 kg: ABC/3TC (120/60 mg): 3 tabs once daily, plus
(and < 35 kg LPV/r (200/50 mg): 1 tab b.i.d
ABC + 3TC + LPV/r
body weight) 25–34.9 kg: ABC/3TC (600/300 mg): 1 tab once daily, plus
LPV/r (200/50 mg): 2 tab am and 1 tab pm
> 10 years or TDF + 3TC + EFV600 to be TDF/3TC/EFV (300/300/600 mg): 1 tab once daily or
body weight > transitioned to
35 kg TDF + 3TC + DTG* or TDF/3TC/DTG (300/300/50 mg): 1 tab once daily or
TDF +3TC + EFV*400 TDF/3TC/EFV (300/300/400 mg): 1 tab once daily
Note: * Currently introduced and available across Timor-Leste.
** RAL is not available in Timor-Leste and thus alternate first line is the preferred regimen till RAL is
available in Timor-Leste.
Introducing Dolutegravir
Class of drug: Anti-retroviral-integrase inhibitor
Used in treatment of HIV infection in any adults, adolescents and children weighing more than
30 kg (USFDA guidance).
16
Efficacy
The efficacy of DTG has been demonstrated in several randomized control trials conducted
among ART naïve (SINGLE, SPRING, FLAMINGO) and experienced patients (STRIIVING).4,5,6,7
Among the treatment naïve patients, DTG is superior to both efavirenz (EFV) and ritonavir-
boosted darunavir, and noninferior to raltegravir– a twice-daily dosed integrase inhibitor.
Recent systematic reviews and meta-analysis conducted by WHO have showed that DTG-based
regimens are better tolerated and tend to be protective against treatment discontinuation due
to adverse events (AEs), when compared with EFV 600.8
Dosage forms and strengths

Tablets: 10 mg, 25 mg and 50 mg as single or combined fixed dose combinations (FDCs).
Known AEs
• Side-effects: Common side-effects include insomnia, headache, tiredness,
redistribution of body fat, depression, etc.
• Hypersensitivity reactions: They have been reported and were characterized by rash,
constitutional findings, and sometimes organ dysfunction, including liver injury (less
than 1%)
• Hepatotoxicity: Hepatic AEs have been reported in patients receiving a dolutegravir-
containing regimen. Patients with underlying hepatitis B or C may be at increased risk for
worsening or development of transaminase elevations
• Embryo-fetal toxicity: Initial results from Tspeamo study showed risk of neural tube
defect among women who became pregnant while on DTG. As more evidences have
become available, the risk of neural tube defects with DTG is only marginally higher than
other ARVs. DTG has major benefits of health of mother and prevention of MTCT of HIV,
and hence women of child-bearing age need to be counselled on benefits and risks of
DTG to make an informed choice
• Risk of AEs or loss of virologic response due to drug interactions: This can happen
with calcium-containing agents such as antacids, calcium supplements, carbamazepine,
iron supplementation, etc.
Drug interactions
1. Rifampicin
4Walmsley S, Antela A, Clumeck N, Duiculescu D, Eberhard A, Gutiérrez F et al. Dolutegravir plus

abacavir-lamivudine for the treatment of HIV-1 infection. N Engl J Med. 2013; 369: 1807–18.
5Stellbrink H, Reynes J, Lazzarin A, Voronin E, Pulido F, Felizarta F et al. Dolutegravir in antiretroviral-
naïve adults with HIV-1: 96-week results from a randomized dose-ranging study. AIDS. 2013; 27: 1771–
78.
6Clotet B, Feinberg J, van Lunzen J, Khuong-Josses MA, Antinori A, Dumitru I et al. Once daily
dolutegravir versus darunavir plus ritonavir in antiretroviral-naive adults with HIV-1 infection
(FLAMINGO):48-week results from the randomised open-label phase 3b study. Lancet. 2014;
383(9936):2222—31.
7Trottier B, Lake JE, Logue K, Brinson C, Santiago L, Brennan C et al. Dolutegravir/abacavir/lamivudine
versus current ART in virally suppressed patients (STRIIVING): a 48-week, randomized, non-inferiority,
open-label, Phase IIIb study. AntivirTher. 2017; 22(4):295–305.
8Kanters S, Vitoria M, Doherty M, Socias ME, Ford N, Forrest J et al. Comparative efficacy and safety of
first-line antiretroviral therapy for the treatment of HIV infection: asystematic review and network meta-
analysis. Lancet HIV. 2016;3:e510–20.
17
• Rifampicin lowers DTG levels: increase DTG to 50 mg twice daily for patients on
rifampicin
• There are no significant drug interactions between DTG and other currently used anti-
TB medications (including for MDR-TB).
2. Mineral supplements, including antacids containing calcium, zinc, magnesium or aluminium;
iron supplements; prenatal vitamins (which contain iron and calcium)
• These supplements decrease the absorption of DTG: administer DTG at least 2 hours
before or 6 hours after taking any of these supplements
• Dose separation is not required for calcium and iron supplements (including prenatal
vitamins), if DTG is taken with a meal
• It is critical to educate patients about this important drug interaction because many of
them get these supplements and antacids over the counter without informing their
health care provider.
3. Carbamazepine, phenobarbital and phenytoin
• These anticonvulsants decrease DTG levels: use a different anticonvulsant if available.
• If DTG must be co-administered with these drugs, then increase to DTG 50 mg twice
daily, although there is little data to guide this.
4. Metformin
• DTG increases levels of metformin; the levels of DTG are not affected: use a lower dose
of metformin (often 50% of usual dose) and monitor glycemic control. Use a maximum
daily dose of metformin 1 g
5. Other drug–drug interactions with DTG and RAL (Table 8).
Table 8. Drug--drug interactions--INSTIs

Drugs Dolutegravir Raltegravir
Efavirenz Co-administration not recommended Efavirenz decreases RAL plasma
because EFV decreases levels of DTG levels, but it is unlikely to be clinically
significant
Rifampicin Increase DTG to 50 mg b.i.d when co- Increase RAL to 800 mg b.i.d when co-
administered with rifampicin (for administered with rifampicin (for
children, use double the standard children, use double the standard
weight based DTG dose) weight-based RAL dose; there is no
There is no known drug interaction data to guide dose adjustment for
between DTG and rifabutin children below 2 years of age)
Rifabutin may alter RAL plasma levels,
but it is unlikely to be clinically
significant
Bedaquiline (BDQ) No interactions expected No interactions expected
Delamanid (DLM) No interactions expected No interactions expected
Metformin DTG may increase metformin plasma No interactions expected
levels. Hence, metformin dose may need
to be decreased. Limit daily metformin
dose to 1000 mg
DTG does NOT require a dose
adjustment when used with metformin
Anticonvulsants Avoid use of DTG with carbamazepine, No interactions expected
-Carbamazepine phenobarbital, or phenytoin because
-Phenobarbital they decrease DTG plasma levels
-Phenytoin If the DTG must be used in combination
with any of these anticonvulsants then
increase DTG dose to 50mg BD and
monitor VL
18
Mineral supplements and Administer DTG at least 2 hours before Do not use calcium, magnesium and
antacids containing or 6 hours after taking any of these aluminium containing antacids with
cations (e.g., calcium, supplements (note: if taking DTG with a RAL
iron, zinc, magnesium, meal, then it is safe to take at the same
aluminium), including time as prenatal vitamins, calcium, or
prenatal vitamins iron)
There are no drug–drug interactions
between DTG and proton pump
inhibitors or H2 blockers used for
gastritis
Known contraindications
• Effective contraception needs to be offered to adult women, adolescent girls of the child
bearing age or potential. DTG can be prescribed for adult women and adolescent girls of
childbearing age or potential who wish to become pregnant or who are not otherwise
using or accessing consistent and effective contraception, if they have been fully
informed of the potential increase in the risk of neural tube defects (at conception and
until the end of the first trimester). If women identify pregnancy after the first trimester,
DTG should be initiated or continued for the duration of the pregnancy
• DTG is contraindicated for any patient with a history of hypersensitivity reaction to DTG
• DTG is not currently recommended for patients with end-stage renal disease or end-
stage liver disease, because it has not been evaluated in these populations.
Monitoring and changing the regimen of ART

Clinical and laboratory monitoring during ART is done to identify and treat CIs, assess and
manage adverse drug reactions (ADRs),evaluate response to treatment and change the ART
drugs, if an active intervention is required. The purpose of monitoring is to ensure that the
patient gets the optimized regimen and has minimal side-effect while the objectives of ART are
met.
Indications for changing ART regimens include optimizing therapy for patients who have
undetectable VL, managing ADRs or toxicity, drug–drug interactions, comorbidity and treatment
failure (virological, immunological and clinical) and responding to pregnancy intention.
Patients who are virally suppressed on first-line ART may benefit from regimen modification,
even if they are currently tolerating their regimen well and have no drug–drug interactions
requiring a change. Regimen modifications may be done for age/weight transitions among
children and adolescents and to simplify a regimen, prevent long-term toxicity and improve
cost-effectiveness.
WHO’s current recommendations suggest transition of patients on first-line treatment from
TDF+3TC+EFV to TDF+3TC+DTG. There is enough evidence to suggest that this change in regimen
is not only beneficial to the patient, but also has improved tolerability and lesser side-effects.
Studies too suggest that this optimized regimen with INSTI inhibitor and the tail and two NRTIs
as the backbone may have a better VL suppression and a longer duration, as compared to NNRTI
tail with two NRTI backbones.
The possibility of new side-effects when changing to a new ARV, particularly side-effects
common to all ARVs (headache, nausea and diarrhoea) and any side-effect specific to the new
ARV should always be kept in mind. It is commonly noted that most side-effects resolve with
continued use after 1–2 weeks.
19
Table 9 recommends the substitution for various ART drugs for a stable adolescent or adults on
ART.
Table 9. Optimized regimen for ART in a stable adult or adolescent patient

Existing ART Switch to Alternatives
EFV DTG(if currently on rifampicin-containing TB Continue EFV
treatment, then continue EFV until TB
treatment is completed before switching to
DTG) or else shift to DTG with double dose of
DTG (50 mgBD)
NVP DTG EFV, if tolerated, or LPV/r combination
LPV/r DTG Continue the same regimen or
switch to ATV/r, which is currently not
available in Timor-Leste
AZT TDF ABC if indications of renal complications are

noted
Usual reason for changing ART is the ADRs to one or more ART drugs that are used in the cART.
Patients starting ART should be educated on its potential side-effects and all other prescribed
medication. ADRs can have a significant impact on patient adherence and must be identified
early and managed aggressively.
DTG has been introduced in a phased manner in Timor-Leste from September 2020. This country
has limited experience with this ARV drug, and thus an intense pharmacovigilance needs to be
in place to detect the initial signs of DTG AEs.
Details on changing the ARV drugs for any serious ADRs are provided in Table 10.
Table 10. Common ADRs due to ARVs
ARV drug ADR Comments
NRTIs (and NtRTIs)
TDF Renal dysfunction Risk factors: Underlying renal disease; age >
40 years; BMI < 18.5 (or body weight < 50 kg);
diabetes; hypertension; concomitant PI use
or nephrotoxic drug
Anaemia, neutropenia Risk factors: CD4 count < 200 cells/mm3; BMI
< 18.5 (or body weight < 50 kg); anaemia at
baseline; concurrent use of other drugs with
AZT similar ADR (cotrimoxazole, ganciclovir,
ribavirin)
Lactic acidosis Risk factors: obesity and pregnancy
Lipoatrophy Risk factors: low CD4 count
ABC ABC hypersensitivity reaction Do not re-challenge
NNRTIs
CNS side-effects Risk factors: Pre-existing psychiatric
disorder
EFV
Gynaecomastia Switch from EFV to an alternative, and
consult if gynecomastia does not improve
All NNRTIs Rash/hypersensitivity Risk factors: for NVP hypersensitivity, women
(NVP>>EFV>ETR) with CD4 count > 250 cells/mm3, men with
CD4 count > 400 cells/mm3
PIs
GI intolerance (LPV/r>DRV/r>ATV/r) Refer to physician/internist or
LPV/r
gastroenterologist
20
Dyslipidaemia (LPV/r>DRV/r>ATV/r) Risk factors: Obesity; sedentary lifestyle;
diet high in saturated fats and cholesterol
INSTI
Insomnia Give in the morning, if no improvement then
try giving with low fat meal or on empty
DTG
stomach
Rash/hypersensitivity Refer to dermatologist/physician or internist

1 1'1&11 1 1)1&11
1 1 1&1,1 1 11 1&1

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1-'1#"""1 ,1 1-)#"""1
1&11
/.1 /.1
1 11 1
1 11 1 1-(1#"""11/.1
+11

• 1 1 1 1$1 1 1 • 1 1 11
1 11 1 *10*1 1 11
!111 • 1 11
• 1 1%11 11 1 1
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Fig. 7. Algorithm for managing single drug substitution
Changing of ARVs due to treatment failure

VL is the test of choice for monitoring response to ART and identifying treatment failure.
Frequency of routine VL monitoring for specific populations is given below:
• Age 0–24 years old: every 6 months
• Age 25 years old: at 6 months after ART initiation, then at 12 months and then annually
• Pregnant or breastfeeding: at confirmation of pregnancy (if already on ART) or 3 months
after ART initiation (if ART initiated during pregnancy/ breastfeeding), and then every 6
months until cessation of breastfeeding before making any drug substitution (if no VL
results from the prior 6 months)
21
• 3 months after any regimen modification (including single-drug substitutions), and then
as per population group
• For any patient with a detectable VL, follow the VL monitoring algorithm.
Treatment failure is suspected when a patient has a high VL 1000 copies/mL after at least 6 months
of using ART. It is only confirmed when VL is 1000 copies/mL after assessing for and addressing poor
adherence or other reasons for high VL, and then repeating VL after at least three months of excellent
adherence to allow for viral resuppression.
Note: Diagnosing treatment failure based on clinical and immunological criteria has poor
sensitivity and specificity. Every attempt should be done to diagnose treatment failure based on
VL. Nonadherence is the most frequent cause of treatment failure. As per the VL monitoring
algorithm, adherence issues must be addressed before confirming treatment failure.
Second-line regimens
The proposed second-line regimens for ART for adults and adolescents, children and infants are
given in Table 11.
Table 11. Proposed second-line regimens for adults and adolescents, children and infants
A. Adults and adolescents
Failing first-line Current options Alternative options

TDF + 3TC + EFVor NVP • AZT + 3TC + DTG • AZT + 3TC + LPV/r
• TDF + 3TC + LPV/r
AZT + 3TC + EFV or NVP • TDF + 3TC + DTG • TDF + 3TC + LPV/r
TDF + 3TC + DTG • AZT + 3TC + LPV/r (or ATV/r) • AZT + 3TC + DRV/r
B. Children and neonates

Failing first-line Current options Alternative options
ABC + 3TC + LPV/r • AZT+ 3TC + DTG • AZT + 3TC + RAL*
AZT + 3TC + LPV/r • ABC+ 3TC + DTG • ABC + 3TC + RAL*
ABC + 3TC + NVP or EFV • AZT+ 3TC + DTG • AZT + 3TC + LPV/r (orATV/r
orDRV/r)*
AZT + 3TC + NVP or EFV • ABC+ 3TC + DTG • ABC + 3TC + LPV/r (or ATV/r or
DRV/r)
Note:*Raltegravir, Atazanavir (ATV) and Darunavir (DRV) is not available in Timor-Leste as of now.
Important considerations for first-line treatment failure in children
Second-line ART in infants and children is more challenging to manage. It is important that these
children and their caregivers undergo thorough clinical and psychosocial assessment to rule out
other coinfections or nonadherence as the reason for a sustained high VL.
All children failing first-line should be discussed in the technical working group(TWG) and
preferably with an experienced paediatric ART provider prior to change of ART to second line.
However, this should not cause undue delay in switching a failing regimen.
The choices for infants and children failing an alternative first-line regimen are limited and need
to be discussed with the TWG. Some of these children will require HIV drug resistant testing (HIV
DR) to determine the most suitable second-line regimen. As of now, HIV DR is not available in
Timor-Leste.
22
Starting of ART regimen
An ART regimen for the patient needs to be started as early as possible preferably within 2 weeks
of detection. Table 12 provides a quick reference to starting ART in all, namely, infants, children,
adolescents and adults.
Table 12. Starting ART in infants, children, adolescents and adults
Condition Recommended steps
Any undiagnosed active infection with fever Diagnose and treat first; start ART when stable
TB • Start TB treatment first; start ART as soon as possible after 2
weeks and before 2 months
• For those with CD4 less than 50/cmm, start ART within 2 weeks
• Caution is needed for PLHIV with TB meningitis, since
immediate ART is associated with more severe adverse events
than initiating ART 2 months after the start of TB treatment
PCP • Treat PCP first; start ART when PCP treatment is completed
Invasive fungal diseases: Oesophageal • Start treatment for oesophageal candidiasis first; start ART as
candidiasis, penicilliosis, histoplasmosis, soon as the patient can swallow comfortably
etc. • Treat penicilliosis and histoplasmosis first; start ART when
patient is stabilized or OI treatment is completed
CM Treat Cryptococcal Meningitis. ART initiation should be deferred
until there is evidence of sustained clinical response to antifungal
therapy and after 4weeks of induction and consolidation treatment
with Amphotericin B containing regimen
Bacterial pneumonia Treat pneumonia first; start ART when treatment is completed
Malaria Treat malaria first; start ART when treatment is completed
Acute diarrhoea which may reduce Diagnose the cause and treat diarrhoea first; start ART when
absorption of ART diarrhoea is stabilized or controlled
Nonsevere anaemia (Hb< 9 g/dL) Start ART if no other causes for anaemia are found (HIV is often the
cause of anaemia)
Skin conditions such as PPE and Start ART (ART is therapeutic)
seborrhoeic dermatitis, psoriasis,
HIV-related exfoliative dermatitis
Suspected MAC, cryptosporidiosis and Start ART (ART is therapeutic)
microsporidiosis
Cytomegalovirus retinitis Start treatment for cytomegalovirus (CMV) urgently and start ART
after 2weeks of CMV treatment
Toxoplasmosis Treat toxoplasmosis; start ART after 6 weeks of treatment and when
patient is stabilized
Management of common side-effects to ART

In a vast majority of cases, there is minimal side-effect to starting ART. It can be managed easily
either through counselling and/or symptom-based treatment. Table 13provides the steps to be
taken for common side-effects.
23
Table 13. Steps to manage the common side-effects of ART
Signs or symptoms Response
Headache Give paracetamol. Assess for meningitis, especially in severely immune-
depressed patient (stage III or IV and/or CD4<200). If on AZT or EFV, reassure
that it is common and self-limited. If persists more than 2weeks, check
intensively for untreated CNS infection, IRIS, then consider switching ARV drug
if still persistent. Refer to HNGV
Fever Look for possible causes of fever. Control fever

Fatigue This commonly lasts 4–6 weeks, especially when starting AZT. If severe or
longer than this, refer to HNGV
Pallor If possible, measure Hb. If severe pallor or symptoms or Hb <8.5g/dL, take
appropriate decision (blood transfusion (see national guideline for blood
transfusion), prescribe supportive ferrous sulphate, switch AZT to TDF or ABC)
Anxiety, nightmares, These may be due to EFV. Give it at night. Counsel and support (usually lasts < 3
depression and insomnia weeks). EFV should be interrupted if symptoms are persistent or severe
depression or suicidal or psychosis. EFV may need to be interrupted and
switched to NVP or LPV/r, if NVP can’t be prescribed. Refer to HNGV
Rash If on NVP, assess carefully. If wet, generalized or peeling associated with fever
or mucosal involvement, stop drugs and refer to HNGV
Nausea Take the drugs with food. If on AZT, reassure that itis common, usually self-
limited. Treat symptomatically. If vomiting, hospitalization may be needed for
appropriate support. Refer to HNGV
Diarrhoea Hydrate. Follow diarrhoea guidelines. Reassure the patient that if due to ART, it
will improve in a few weeks. Follow-up in 2weeks. Meanwhile, look for other
causes of diarrhoea
Jaundice or abdominal pain Stop drugs. See appropriate hepatotoxicity flowchart. Refer to HNGV
Tingling, numbness, pain in If new or worse on treatment, sign of mitochondrial toxicity. Refer to HNGV
the feet/legs
Cough or difficulty Look for respiratory infections: TB, PCP, bacterial pneumonia, cryptococcosis,
inbreathing cytomegalovirus infection and manage accordingly. Refer to HNGV
ART education and adherence

Strict adherence to treatment with ARV drugs is very important. Poor adherence leads rapidly to
the development of viral resistance, and hence to treatment failure. This means a patient should
not miss taking pills more than three times a month in case of a twice-daily regimen.
ART should be adapted to patient's lifestyle. Adherence problems should be anticipated, and
solutions explored with the patients. It is necessary to not underestimate the importance of
emotional support given to the patient and his/her family (Table 14).
“Extent to which a person’s behaviour--- the taking of medication and the following of a healthy
lifestyle including a healthy diet and other activities – corresponds with the agreed
recommendations of the health care providers” (sic.) (WHO, 2003).
24
Table 14. Measures to optimize adherence to ART
Measures Details
Ensure free and simplified • Provide free ARV drugs: see section on access to HIV/AIDS care
treatment with uninterrupted • Ensure no stockout of ARV drugs
supply of ARV • Simplify treatment minimizing pill burden with FDC
Prepare health facilities and set up • Make health facility user-friendly and trustworthy: respect
PLHIV groups for adherence confidentiality, overcome stigma and discrimination. All the staff of
support the health centre should be trained on confidentiality
• Train all health workers for adherence support and ensure that the
same adherence messages are given by all health workers to patients
• Promote and facilitate peer support groups of PLHIV introduced
trough the health facility (if large number of patients, organize groups
according to ART duration, gender, adults/children, etc.)
• Mobilize community volunteers for treatment education and
adherence support (information about HIV and its treatment) in the
community
Prepare patients before initiating • Establish a trusting relationship with health workers and provide
ART necessary information
• Encourage participation of PLHIV to support groups
• Assess factors that help determine capability for follow-up, i.e.,
regular attendance to the clinic, transportation difficulties, adherence
to CTX prophylaxis
• Encourage patients to identify a treatment assistant, ideally a
household member or a friend, who can accompany them to clinic
appointments and help to support them with adhering to treatment
on a day-to-day basis
Monitor adherence and provide • Develop an appointment schedule with possibility of access to
ongoing support and education services between planned visits for advices and care, if needed
• An organized appointments record will also help the health providers
to identify patients missing appointments and hence not picking up
the drugs
• Give buffer stock for a few days (e.g., give one box of 30 days and ask
the patient to come back after 28 days)
• Assess adherence to treatment in a supportive manner
Prepare patients before initiating ART

The most important issues regarding adherence are:
• A good understanding by the patient of ART requirement and a strong motivation to take
the ART
• An inclusion process that maintains a strong focus on treatment education
• Two to three education sessions may be enough, though some patients will need more
time.
Table 15provides guidance to preparing the patient for better compliance and adherence.
25
Table 15. Guidance for preparing the patient for better compliance and adherence
Criteria Steps
ART • Lifesaving, but requires a lifelong commitment from the patient
• The ARV drugs do not cure HIV/AIDS infection
• The ARV drugs do not prevent HIV transmission to others; patients
need to practice prevention, i.e., condom use
Need for complete adherence • Must be taken evening at the right time (every 24 hours) in case of once-
daily regimen such as TDF/3TC/EFV, without interruption
• Must be taken morning and evening at the right time (every 12 hours)
in case of twice-daily regimen such as AZT/3TC/NVP, without
interruption
• If the patient forgets more than three times a month, treatment may
fail in the long run
• If a patient forgets a dose, do not take a double dose; instead take the
forgotten dose if within 4hours of usual time; beyond 4hours wait until
the next usual dose; in both cases report event to counsellor at next
visit
• Drugs must not be shared with the family members or friends, patients
must take full doses
Side-effects and interaction • Warn patients about common expected side-effects, i.e., headache,
nausea, fatigue, skin rash, and what to do if side-effects occur (but do
not overload patients with information, or frighten them)
• Explain food interaction with ARV drugs, if any
Importance of HIV status • Support from family or friends
disclosure for support from others • Support from other PLHIV, or peer support by joining PLHIV support
group
Assessment of adherence to treatment
Adherence assessments should be done on a monthly basis at least for the first 6 months of ART.
The goal is to identify patients who are having difficulty with adhering to treatment so that extra
assistance can be offered to them (Table 16).
Table 16. Assessment of adherence and its remedial measures
Review the medications with the patient, If poor adherence, determine

with/without the treatment assistant Problem
Ask in a respectful and non-judgemental way: • Side-effects?
• Many patients have trouble taking their • Simply forgot?
medications. What trouble are you having? • Falling asleep in the evening?
• Can you tell me when/how you take the pills? • Ran out of pills?
• When is it the most difficult for you to take the • Which dose missed: morning or evening?
pills? • Remind you of HIV?
• It is sometimes difficult to take the pills on time. • Misunderstood?
How many have you missed in the last 4 days • Changed work situation?
and in the last month? • Not comfortable taking the pills around others?
• Stigma?
• Different timing when away from home or holiday,
travel, weekend?
• Seldom at home and disorganized?
• Problem with diet (food availability)?
• Another medical problem?
• Screen for alcohol use, depression
• Others
26
Ask about the common important factors that may • Address all the common challenging factors, myths
and misconceptions and stigma
interfere with adherence
Ask about stigma related to taking the pills
Count pills: The health worker counts the number of • Reiterate the need for adherence, if less than 95%
• Explain and discuss the measures that could be
pills remaining in the bottle or box and compares it
adopted to improve adherence
to the number of pills that should be remaining if
adherence had been 100% since the last visit. The
monthly adherence (%) may be calculated: (tablets
dispensed to be taken– tablets returned that were
supposed to be taken)/(tablets prescribed) x 100
For example, (28 5)/28 x100= 89% adherence
Also note the self-reporting by patients (they are asked to report their own adherence using
open-ended questions as mentioned above) and pill counts are routinely used to monitor
adherence. The methods based on self-reporting or auto-evaluation tend to overestimate
adherence.
Specific tools may be used and may be particularly useful during the first months of treatment,
such as pill boxes, agenda, calendars, booklets, flipchart, flyers, alarm clock, etc.
Good clinical evolution (especially weight gain and improvement of general status) also
indicates adherence to treatment, as a patient taking his/her treatment properly will respond
better to ARV drugs.
The main reasons for missed doses are:
• Forgetting
• Being too busy
• Being away from home
• Change in daily routine
• Being depressed
• Having adverse side-effects
• Being too ill.
The factors that influence adherence are given in Table 17.
Table 17. Factors that may influence adherence

Factors Promote adherence Reduce adherence
Patient • Motivated patient • Alcoholism or other substance abuse
• Good understanding of HIV/AIDS • Depression
disease and therapy • Poor understanding of the disease or
• Education given in patient’s own therapy
language prior to and during • Fear of stigmatization
therapy • Non-disclosure of HIV status to family
• Participation in support group member or friend
• Treatment supporter identified • Poor social support, living alone
Disease Late or symptomatic HIV/AIDS • Early, asymptomatic disease
disease • No change in health status
Therapy • Small number of tablets to • Large and frequent (more than twice a
swallow day) number of tablets
• Few adverse events • Severe or ongoing minor side-effects
• Empathic health staff • Food requirement
• Treatment at cost
27
• Friendly environment in the • Follow-up visits too frequent and
health facility transportation problems
• Too long time to spend in the clinic
Practical orientation
Treatment education and adherence sessions are usually conducted by counsellors or nurses
trained in counselling. PLHIVs should also be involved in facilitating such sessions, as they will
share their own experience in taking the drugs and better motivate their peers.
Sessions may be organized individually or in a group. This will depend on the workload linked to
HIV/AIDS activities. Group sessions have advantages over individual ones such as timesaving
(particularly in setting with high work load) and exchanges of questions, experiences, difficulties
encountered, etc. among patients.
Written information should also be provided with posters and pamphlets, preferably in patients’
own language. The therapeutic educating material will have to be developed for Timor-Leste
and translated in adequate dialect according the districts.
It is advised to report adherence issues in the medical file for the medical staff to be aware of the
problems, if any.
Calculating adherence
There are number of ways of measuring adherence like self-reporting by patient, pill count,
home visit, patient diary, etc. Pill count is the most used method to assess adherence. In each
follow-up visit, patient should be asked to bring the pill box with the unconsumed remaining
pills. For more than one type of pill, adherence needs to be calculated for all drug combinations
separately, and reasons for different adherence patterns to different drugs should be explored.
Following formula is used to calculate the adherence:
Examples:
1. Tab TLD (Single pill daily) = No. of pill balance- 9, patient returns on 28th day.
Adherence calculation:
(30 – 9)/28 100 = 75%.
28
2. Tab ZLN (One pill twice daily dose) = No. of pill balance- 23, patient returns on 25th day.
Adherence calculation:
(60 – 23)/(25 2) 100 = 37/50 100 = 74%
3. Tab TL +LPV/r (TL and ATV/r two pills once daily dose) = No. of pill balance- 9 TL and11 ATV/r,
patient returns on 25th day.
Adherence calculation: Individual drug combination adherence needs to be calculated and
whichever is lower, can be considered for reporting purpose.
TL adherence = (30 – 9)/25 100 = 21/25 100 = 84%
LPV/r adherence = (30 – 11)/25 100 = 19/25 100 = 76%
Hence overall adherence = 76%.
4. Tab ZL +LPV/r (ZL--one pill twice daily and LPV/r two pills twice daily dose) = No. of pill
balance- 11 ZL and 25 LPV/r, patient returns on 25th day. Adherence calculation: Individual
drug combination adherence needs to be calculated, and whichever is lower can be
considered for reporting purpose.
ZL Adherence = (60 – 11)/(25 2) x 100 = 49 / 50 100 = 98%
LPV/r adherence = (120– 25)/(254) 100 = 95/100 100 = 95%
Adherence calculation: Individual drug combination adherence needs to be calculated, and
whichever is lower can be considered for reporting purpose.
Hence, overall adherence = 95%.
29
Chapter 4
ART operational guidance: assessment of adolescents and adults
with HIV infection
Timor-Leste has a ‘Test and Treat’ policy in HIV. ART is available free of cost for all PLHIVs
among Timorese citizens. The programme should be linking all HIV positives to lifelong ART
at any ART clinic. The sections below follow the patient and provide the required guidance
for each step.
Initial HIV consultation
When the patient comes to the ART centre, s/he could be still in a state of shock and denial.
Therefore, the counsellor/nurse/doctor or public health professional should be aware of this
situation. The initial or first visit is important from this point of view. The major steps that should
be taken are:
• Create a relationship of trust with the patient
• Evaluate the patient--take proper history, conduct detailed clinical examination and
then request for specific laboratory investigation as part of ART work up
• Fill the ART card and register
• If the patient is having a coinfection or any OI, treat it first and then go for the other work
up
• Assess if the patient has ever been exposed to any ARVs
• Conduct a detailed nutritional assessment
• Conduct a detailed mental health assessment and need for psycho-social support.
It is a good practice to use WHO clinical staging (Annex 7)for the patient to correlate the findings
with the laboratory investigations. The tasks required for initiation of ART are given in Table 18.
Table 18. Overview of tasks to be completed before ART initiation
Tasks Details
• Social and demographic history, household history, i.e., date of first HIV test,
partner informed, partner tested, partner on treatment, number of children,
EMTCT intervention, children HIV tested, children on treatment
History • Medical history, e.g., TB history
• Sexual and reproductive health background if appropriate, e.g., signs and
symptoms of STI, refer for Papsmear on annual basis
• Allergies, e.g., to sulphonamides
• Other medications, including ARVs, in the past/herbal remedies/drug or toxic
addiction (alcohol and drugs use)/food habits
• History of recent acute illness (es)
• Symptoms of active TB, i.e., four symptoms screening namely, 1) cough; 2)
fever; 3) weight loss; and 4) night sweats
• Symptoms suggestive of latent TB infection (LTBI): No symptoms of active TB
infection, but history of exposure to TB patients may be present
Clinical • Complete physical examination, even in the absence of symptoms, including
examination temperature
• Weight, height, oedema and BMI or W/H% or mid-upper arm circumference
(MUAC)
• Signs of active TB, e.g., lymph node, chest signs
WHO clinical staging • Stage patients according to WHO clinical classification (see Annex 5)
• Start co-trimoxazole prophylaxis
30
Diagnosis and • Treat any OI diagnosed in line with national protocols 6
treatment of • Refer for AFB smear, GeneXpert® testing and/or X-ray if suspicion of TB disease
intercurrent • Start nutrition supplement, if needed
infections
Laboratory • Take blood samples for CD4 count and HIV VL (preferably if no inter-current OI,
investigations as OI can decrease the level of CD4 even more than what it is in reality)
• Other blood tests according to protocol (RPR, HBsAg, HCV AB, Hb, KFT and urine
routine examination)
For more details on each task please refer to Annex 8. Assessment of patient during the first
visit to ART centre.
Initial laboratory investigation of PLHIVs

The laboratory investigations of PLHIVs should be based on the status during the present
assessment. It should be directed towards confirming the clinical suspicion and uniform for
all PLHIVs who are to be put on ART (Table 19).
Table 19. Initial laboratory investigations for PLHIVs
Test Comment
HIV specific test
Confirm and document positive Follow HIV testing algorithm
HIV test result
CD4 cell count • Recommended at baseline for all patients (CD4% for children 5
years old) for differentiated care and prophylaxis
• If CD4 200 cells/mm3 (for adults and adolescents), then laboratory
may perform a serum cryptococcal antigen (sCrAg) on the same
sample to screen for cryptococcal infection (If available)
HIV VL (HIV-1 RNA) • Currently recommended for all patients who are starting ART
• Subject to availability of adequate cartridges of HIV load, the
guidelines for HIV VL testing may be revised to move from targeted
testing to routine testing later (However, current WHO guidelines
do not recommend HIV VL as a baseline)
Serum cryptococcal antigen • No cryptococcal antigen testing is recommended at the baseline
(sCrAg)
HIV DR • Not currently recommended as a baseline investigation
Other laboratory tests
Hb (preferably fullblood count, if • Recommended for all
available) • If Hb is < 9.0 g/dL, AZT should be avoided
Pregnancy status • Pregnancy status should be determined for all women of
reproductive age (based on history of last menstrual period, and if
uncertain, irregular, or delayed, then a urine pregnancy test should
be performed)
Urine routine examination • Recommended for all patients
Creatinine Recommended for all patients
Serum Creatinine as baseline, if above the normal limits, then
proceed for creating clearance test.
Calculate Creatinine Clearance (CrCl), Annex 15
If HBV negative and CrCl 50 mL/min then TDF should be avoided
If HBV positive and CrCl 50 mL/min then TDF should still be used
CrCl is also used for dose adjustment of NRTIs, CTX and fluconazole
Syphilis serology (VDRL, TPHA, or Recommended for all PLHIVs who are sexually active
RPR)
Glucose, lipid profile Recommended for all PLHIVs
HBsAg • Recommended for all adolescent and adult PLHIV (plus children
who did not complete routine childhood immunizations)
31
If negative, patients should be immunized for HBV as soon as they
achieve confirmed viral suppression
If positive, refer to Section 9 for management of HIV/HBV
coinfection
HCV antibody • Recommended for any PLHIVs with history of drug use
ALT (SGOT) • Not recommended as baseline investigation unless there is a
specific clinical reason (e.g., patient with history of hepatitis, signs
or symptoms of liver disease, or risk of liver disease -- alcoholics,
HBV or HCV infection, hepatotoxic drugs such as fluconazole, etc.)
Note: It is likely that all ART centres may not be having facilities to do all the tests mentioned
above. It is recommended that they do the tests that are available, but collect the samples for
referring to nearest referral centres where these are possible and start the ART.
ART should not be delayed for want of baseline investigations and physician on
site should take a decision on this based on history and clinical examination (WHO
staging)
Tailored approach to care

It is likely that many PLHIVs who present to the programme may have advanced disease. In
that case, the level of care may have to be enhanced to address the challenges.
Table 20 provides a concise direction on tailored approach based on stage of the disease.
Table 20. Care of PLHIVs based on stage of disease

Patients who present with advanced HIV disease: WHO stage 3 or 4, or CD4 count 200 cell/mm3 (or CD4%
25% for children 5 years old)
Package of care Standard package of care (

Chapter 5
ART operational guidance: standard package of care (SPC) for PLHIVs)
• Intensive management of presenting illnesses and malnutrition
• Priority for identification, management and prevention of OIs, including
GeneXpertTM (Xpert® MTB/RIF) for TB diagnosis for all PLHIVs with
presumptive TB
• Cryptococcal antigen screening for adolescents and adults with CD4 200
cells/mm3 or clinical suspicion of meningitis (any age)
• Cotrimoxazole preventive therapy (CPT)
• Isoniazid preventive therapy (IPT)
• Priority for ART initiation (caution, if suspected or confirmed TB, TB
meningitis, or cryptococcal meningitis
• Close monitoring for development of immune reconstitution inflammatory
syndrome (IRIS)
Location of services • Management at any ART service delivery point; all facility levels; home visits
may be required if unable to come to facility
• Initial management and ART initiation by trained and experienced health
care worker
• Consultation with TWG, mentors, and senior clinicians as needed (connect
with NAP)
32
•Referral to a higher-level facility when feasible, if consultation is not
adequate to stabilize the patient
Treatment preparation • ART is required to prevent further damage to the immune system
and adherence • Starting ART soon will decrease risk of disease progression, including
counselling wasting and other infections
• ART is the most important treatment to restore health
• ART will reduce the risk of transmitting HIV to others
Frequency of follow-up • Weekly follow-up until ART initiation, and then at week 2 and 4 after ART
initiation, and then monthly until confirmed viral suppression
• More frequent visits or hospitalization may be required to stabilize acute
medical conditions and address psychosocial and other concerns
Patients who present well: WHO stage 1 or 2, and CD4 count > 200 cell/mm3 (or CD4% > 25% for children
5 years old)
Package of care Standard package of care (

Chapter 5
ART operational guidance: standard package of care (SPC) for PLHIVs)
• Same-day or rapid ART initiation (as soon as patient is ready, preferably
within 2weeks)
Location of services • Management at any ART service delivery point; all facility levels
• Initial management and ART initiation by trained and experienced
healthcare worker and physician
Treatment preparation • ART is the most important treatment to maintain good health and an active
and adherence life
counselling • Starting ART soon will decrease risk of developing wasting and other
infections
• ART will reduce the risk of transmitting HIV to others
Frequency of follow-up • Weekly follow-up until ART initiation, and then at week 2 and 4 after ART
initiation, and then monthly until confirmed viral suppression
• Additional visits as required to address any medical or psychosocial
concerns
Monitoring ART during the first year

ART is a lifelong effort. Preparing the patient during the initial visits is beneficial for reducing
the dropouts in the programme. A sustained treatment literacy effort is beneficial. However,
it needs to be understood that majority of side-effects of ART occur within the first couple of
months after initiation.
Monitoring of patients on ART is also determined by the duration the patient has been on
treatment as well as how well they understand the treatment and response to ART. Follow-
up includes scheduled clinical appointments, unscheduled clinical assessments for patients
with concerns/complaints, routine and as-needed laboratory monitoring. The details of such
follow-up schedule are presented in Table 21.
After ART initiation, patients need to be followed up closely for development of adverse drug
events (ADEs), identify and address barriers to adherence, and development of IRIS
(particularly for those who initiate ART with advanced HIV disease). A reasonable follow-up
schedule for most patients is 2 weeks and 4 weeks after ART initiation, then monthly until
viral suppression is confirmed. If HIV VL is detectable at 6 months, they will need additional
assessments for and management of the reason/s for detectable VL, with close follow-up until
33
viral suppression is achieved. Patients with confirmed viral suppression should be followed-
up every 1–3 months based on patient preference and clinician judgment, with additional
unscheduled visits any time the patient has a concern. Clinical follow-up can be spaced
further once the patient has been on ART for a year or more and meets the criteria as “stable”.
Children and adolescents should be followed-up at least every 1–3 months.
Table 21. Follow-up schedule for ART patients

ART Weeks Months after ART 1 year
Initia Prep. after
l visit ART
Appointment Every 2 4 2 3 4 5 6 Stable – 3 Every 3--6
week Unstable- 1 months
depending on
stability
History and At each visit At each
physical clinical visit
examination
Treatment At each visit At each visit
adherence and
literacy
TB screening At every visit using ICF screening tool (4 symptoms screening) and document the result
CD4 count Baseline, and then only if develops treatment failure (to assess for risk of OIs), or if
defaults from care (off ART) for at least 6 months (confirmed LFU cases)
For patients on secondary prophylaxis for CM, repeat CD4 every 6 months until CD4

>100 cells/mm3 for two consecutive measures 6 months apart and VL undetectable,
after which CM prophylaxis and CD4 monitoring can be discontinued
HIV VL For PCR positive HEIs: baseline at the time of ART initiation
Age 0–24 years: every 6 months
Age 25 years: at month 6 after ART initiation and month 12 then annually thereafter
All age groups: before any drug substitution for patients on ART for at least 6 months
with no VL results from the last 6 months

All age groups: after any regimen change (including single drug substitutions), perform
VL at month 3 after regimen modification, and then as per population group
All age groups: any patient with a detectable VL during routine monitoring, follow VL
monitoring algorithm
Hb Baseline then symptom directed; if on AZT, baseline then weeks 2, 4 and 12

Pregnancy status At every visit for reproductive age (by history +/- urine pregnancy test)
(for reproductive
age group)
Urine analysis Baseline and then annually
(Routine) and
creatine
Plasma glucose Baseline and then annually

and lipid profile
HBsAg Baseline, followed by immunization for all patients who screen negative (after viral

suppression is confirmed)
Syphilis serology Baseline, then annually in those at-risk and as part of routine ANC profile
34
Drug resistance
Not recommended in Timor-Leste as facilities are not available
testing
ALT (SGPT) Not recommended as routine baseline or follow-up unless specific clinical indication
Cervical cancer Should be done as per national guidelines. The recommended guidance is once every year
HCV Not recommended as routine or follow up unless specifically indicated
Source: Ministry of Health, National AIDS & STI Control Program. Guidelines on use of antiretroviral drugs for treating and
preventing HIV infection in Kenya. Nairobi: NASCOP. 2018 (Adapted for use in Timor-Leste with permission).
Follow-up of PLHIV beyond the first year of ART

The first year of ART is crucial. Experience from the National HIV/AIDS Programme, Timor-
Leste, suggests that intensive monitoring during the first year allows for better adherence,
but the dropouts increase after the first year. Hence, year two and three are equally crucial
and challenging. After the first year of ART, most patients should have developed good
adherence habits, have satisfactory coping mechanisms and support systems in place, and
should have achieved full virological suppression. With their improved self-care, these
“stable patients” are expected to require less follow-up and monitoring than other patients.
This may allow resources to be concentrated on difficult and challenging patients.
The differentiated follow-up mechanism, suggested by WHO, allows for improved impact
with limited resources (Table22).
Table 22. Differentiated follow-up mechanism for PLHIVs

Criteria Details
Unstable patients
Unstable patients (any of the following)
• On their current ART regimen for < 12 months
• Any active OIs (including TB) in the previous 6 months
• Poor or questionable adherence to scheduled clinic visits in the previous 6 months
• Most recent VL: detectable (including low-level viremia and VL 1,000 copies/mL)
• Has not completed 6 months of IPT
• Pregnant or breastfeeding
• BMI < 18.5
• Age < 20 years
• Healthcare team has concerns about providing longer follow-up intervals for the patient*
Package of care • Standard package of care (Section 5)
• Case management to address reason/s for not meeting stable eligibility
criteria
Location of services • Management at any ART service delivery point; all facility levels
• Consultation with MDT, CSC, mentors, and senior clinicians as needed
• Referral to a higher-level facility, if consultation is not adequate to stabilize
the patient
Counselling focus • ART is the most important treatment to improve health and return to an
active life
• Targeted counselling to address reason/s they have not met stable eligibility
criteria
Follow-up frequency • Every 1--3 months, based on clinical judgment and the specific reason/s they
have not met stable eligibility criteria
• Additional visits as required to address any medical or psychosocial concerns
Stable patients
Stable patients (all the following criteria)
• On their current ART regimen for 12 months
• No active OIs (including TB) in the previous 6 months
• Adherent to scheduled clinic visits in the previous 6 months
• Most recent VL: undetectable (VL < 1000 copies/mL)
35
• Has completed 6 months of IPT
• Nonpregnant or nonbreastfeeding
• BMI 18.5
• Age 20 years
• Healthcare team has no concerns about providing longer follow-up intervals for the patient
• Standard package of care (Section 5)
Package of care • Monitoring of VL and other routine investigations timed to coincide with other
patients’ appointments and clinical follow-up visits
• Re-assess the criteria for stable patient at every visit
Location of services • Clinical review at any ART centre

• If unstable or other criteria for referral, send to higher centre in Dili
Counselling focus • Encourage patients to continue to do what they are doing. They are doing well
• Remind them that any significant life event could change the current status
Follow-up frequency • Clinical review should be done every 3 months
• ART may be distributed for 3 months at a time
• Patients on injectable contraceptives should also be closely monitored and
must be provided condoms and other contraceptives as needed
• Additional visits to address any social or psychosocial concerns
Source: Ministry of Health, National AIDS & STI Control Program. Guidelines on use of antiretroviral drugs for treating and
preventing HIV infection in Kenya. Nairobi: NASCOP 2018 (Adapted for use in Timor-Leste with permission).
The tailored care approach for PLHIVs also include children, pregnant and breastfeeding
women and adolescents. For caregivers/parents who are enrolled in ART as stable patients,
their children or adolescents who also meet “stable” patient criteria (other than the age
criteria) can be considered eligible for longer follow-up. This should follow a family-centred
approach in which the family is given aligned appointments with longer prescription
periods.
Children would require close monitoring of growth and developmental milestones, and
weight-based dose adjustments of their ART and CPT till the age of two years.
Adolescents have unique challenges with adherence related to their psychological
development and social support systems. For those enrolled as stable patients with less
frequent appointments, psychosocial support and ongoing adherence assessments and
counselling should be aligned with ART centre visits and outreach follow-up.
Pregnant/breastfeeding women may be clinically stable but should be followed-up with
their HIV clinic appointments with focused ANC visits and with follow-up of the HIV-exposed
infant (enhanced postnatal prophylaxis, ePNP).
Advanced disease management
Globally the burden of morbidity and mortality associated with HIV infection has decreased
largely due to expansion of ART coverage, timely detection, and a trend of treating people
earlier in the course of disease progression. However, the decline in AIDS-related deaths
appears to have plateaued during the past three years due to a trend towards later detection
of HIV.
Timor-Leste has a low prevalence of HIV and that poses additional challenges in timely
detection of people with HIV and larger linkage losses. This in turn leads to higher mortality
as patients tend to present late or often missed in HIV diagnosis. In 2019, there was almost
15% mortality of patients initiated on ART in the same year. The programme is committed to
reduce mortality as well as morbidity among PLHIVs and improve quality of their life. In this
36
regard Timor-Leste will focus on the earlier detection of people with HIV and reducing
mortality by adopting WHO guidelines on advanced disease management (ADM). WHO has
defined ADM as CD4 cell count <200cells/mm3 or WHO clinical stage 3 or 4 event for adults and
adolescents. All children younger than five years old with HIV are considered as having
advanced HIV disease. WHO recommends a package of interventions for those with advanced
disease, which includes screening, treatment and/or prophylaxis for major OIs, rapid ART
initiation, and intensified adherence support interventions to everyone presenting with
advanced HIV disease.
In line with WHO package on ADM, Timor-Leste will roll out four key interventions for
patients presenting with advanced disease:
A. Diagnostic
1. Urine for LAM for TB for those with CD less than 100 or at any CD 4 count for those
with any other serious illness
2. Cryptococcal antigen (CrAg) test using later flow assay for those with CD less than
200
These are in addition to testing for TB by Xpert MTB/RIF for those with symptomatic illness.
B. Therapeutic
1. Fluconazole pre-emptive therapy for CrAg-positive patients without evidence of
meningitis with CD less than 100 (or 200).
This will be in addition to routine TPT and CPT as eligible.
C. Rapid ART initiation
This means initiation of ART on same day or as soon as patient has understood need for
adherence to lifelong ART. By definition, rapid initiation means within seven days.
D. Intensified adherence support
Tailored adherence support during initial 3-6 months including home visits, for those
presenting with advanced disease.
As per global data, it is presumed that TLS will also have around 30–35% of new patients
presenting with advanced disease and some of existing patients while failing on ART may be
defined as those with advanced disease. This translates to nearly 100–125 patients presenting
with advanced disease who will need urine LAM test and CrAg test. In addition, around 75–80
patients are likely to present with CD less than 100 and will require daily fluconazole therapy
3–6 months. Around 5–7% of those with advanced disease will have cryptococcal meningitis
who will need Amphotericin B and flucytosine therapy. These components will be met
through the within allocation part for the funding grant as preventing mortality is key to
success of ART programme.
37
Chapter 5
ART operational guidance: standard package of care (SPC) for PLHIVs
The SPC consists of the following elements:

• ART
• Positive health and prevention
• Identifying and supporting cases of gender-based violence (GBV) or intimate-partner
violence (IPV)
• Screening and management for TB
• Screening and management of other coinfections and OIs
• Reproductive health services (in collaboration with RMNCHA programme)
• Screening for noncommunicable diseases (NCDs)
Chapter
• Assessing and management of mental health5
• Nutritional services
ART
• operational guidance:
Prevention of other standard package of care (SPC) for PLHIVs
infections.
The SPC should always be applied using a patient- and family-centred approach. Patient-
centred
The SPC care includes:
consists of the1) considering
following the individual patient’s health needs; 2) eliciting and
elements:
addressing the patient’s concerns and expectations; 3) involving the patient’s family (and/or
• ART
friends as appropriate) in decision-making; and 4) respecting the patient’s values and
• Positive
preferences. health and prevention
Family-centred care identifies, engages and provides care to all HIV-positive
• Identifying and supporting
family members, prevents new infections cases of gender-based
among familyviolence
members (GBV) or intimate-partner
at-risk, and promotes
violenceand
family support (IPV)
awareness. This is part of counselling and follow-up routine for PLHIVs on
ART.• Screening and management for TB
• Screening and management of other coinfections and OIs
The SPC and its subcomponents are presented in Table 23.
• Reproductive health services (in collaboration with RMNCHA programme)
• Screening for noncommunicable diseases (NCDs)
• Assessing and management of mental health
• Nutritional services
Table 23. Standard package of care for adult and adolescent PLHIVs in Timor-Leste
• Prevention of other infections.
Components of standard package of Sub-components
The
careSPC should always be applied using a patient- and family-centred approach. Patient-
centred care includes: 1) considering the individual patient’s health needs; 2) eliciting and
ART • Patient preparation
addressing the patient’s concerns and•expectations;
ART 3) involving the patient’s family (and/or
friends as appropriate) in decision-making; and (clinical
• Monitoring 4) respecting the patient’s values and
and laboratory)
preferences. Family-centred care identifies, engages and provides care to all HIV-positive
family members, prevents new infections among family members at-risk, and promotes
38
family support and awareness. This is part of counselling and follow-up routine for PLHIVs on
ART.
The SPC and its subcomponents are presented in Table 23.
Table 23. Standard package of care for adult and adolescent PLHIVs in Timor-Leste
Components of standard package of Sub-components
care
ART • Patient preparation

• ART
• Monitoring (clinical and laboratory)
38
Positive health, dignity and • Positive health, dignity and prevention components
prevention; GBV and IPV screening; o Disclosure
and HIV education/counselling o Partner/family testing
o Condom use
o Family planning
o STI screening, prevention and treatment
o Adherence counselling and support
• GBV/IPV screening and support
• HIV education/counselling
Specific OI screening and prevention • Cotrimoxazole preventive therapy
• TB
o Intensified case finding
o Isoniazid preventive therapy
• ART for TB/HIV coinfected patients
• Cryptococcal meningitis
Reproductive health services • Sexually transmitted infections screening and management
• Family planning and preconception services
• Maternal healthcare
• Cervical cancer screening
NCDs screening and management • Hypertension
• Diabetes mellitus
• Dyslipidaemia
• Chronic kidney disease
• Other NCDs
Mental health screening and • Depression
management • Alcohol and drug use/addiction
Nutritional services • Assessment
• Counselling and education
• Management and support
Prevention of other infections • Immunizations
• Malaria
• Safe water, sanitation and hygiene
The HIV-exposed and HIV-infected infants would need a closer follow-up and intensive care
for an improved survival. Table 24 provides a brief guidance on the different sub-
components.
Table 24. Standard package of care for HIV-exposed and HIV-infected infants
Sub-components of SPC
Determine HIV status at first contact through HTS/EID and link to HIV care
Provide ARV prophylaxis (ePNP) for all HEIs and ART for all HIV-infected children; perform baseline clinical
and laboratory assessment
Provide nutritional assessment, counselling and support and monitor growth and development of the child
Ensure that all immunizations are provided as per the national schedule
Assess clinically at every visit, treat infections early, identify and manage ADRs aggressively and refer
appropriately where specialized care is required
Screen for OIs and provide prophylaxis (cotrimoxazole, isoniazid), deworm every 6 months (starting at 1
year of age) and provide supplemental Vitamin A every 6 months (starting at age 6 months)
39
Educate the caregiver on all aspects of care for the child including infant feeding, immunizations, personal
hygiene, adherence, child disclosure and follow-up requirements
Provide age-appropriate psychosocial support for the family and child and refer to community-based
support programmes as appropriate
Ensure that the caregiver and family members are receiving appropriate care, support and treatment
Provide intensive case management for mother/infant pair until 2 years postpartum; identify defaulters
and prioritize this population for tracking
ART
The ‘Test and Treat’ policy for PLHIVs in Timor-Leste allows to put on ART all PLHIVs
irrespective of their CD4 count and condition. It is also recommended that once detected
patient should be put on ART at the earliest opportunity, preferably within 2 weeks.
The choice of first-line ARVs have been revised by WHO in their interim guidelines in 2018. This
was ratified in their subsequent version in December 2018.
The same was placed before the TWG meeting in June 2019. TWG came up with the following
recommendations (June 2019 and September 2019):
• The preferred regimen for first-line ART to use DTG instead of EFV for all adults,
adolescents, pregnant women and children above 10 years of age, i.e., the preferred
first-line will be: 1) TDF+3TC+DTG instead of TDF+3TC+EFV
• Continue the same regimen for children below 10 years as before, i.e., ABC+3TC+LPV/r
(ABC + 3TC + DTG and AZT + 3TC + NVP (RAL9) for neonates)
The deliberations and discussions around DTG are presented later in this guideline.
The proposed regimen is presented in Table 4.
The details of the ARV drugs, interactions and toxicities are presented in the chapter on ART.
Positive health and GBV prevention
Positive health and living with dignity are the rights of every PLHIV. The rights also include reducing
risk of onward transmission of HIV and prevention of gender-based and intimate partner violence. They
are covered under six core areas or domains (Table 25).
Table 25. Services to be provided for positive health and prevention for PLHIVs
Domain Components
Disclosure of HIV status • Assessment of disclosure status, particularly to sexual partners
• Assisted disclosure
Note: for children and adolescents, it is also necessary to evaluate for and
support age-appropriate HIV disclosure to the child/adolescent
Partner testing • HIV testing of sexual partners
• HIV testing of other family members at risk
• Enrolment of positive partners/family members into HIV care
• Engagement of negative partners and family members in care and
support for index patient
Condom use • Risk minimization
• 3Cs of condoms use – correct and consistent condom use
• Provision of condoms
9Currently not available in Timor-Leste.

40
Family planning • Intention to have a child (assessment)
• Preconception counselling
• Contraception until ready for pregnancy
STIs • Screening of STIs as per protocol (please refer to enhanced syndromic
management of STIs in Timor-Leste, 2017)
Treatment adherence • Benefits and importance of adhering to ART
GBV is high in Timor-Leste. UN Women reports a lifetime physical and/or sexual IPV of 59%.10
The same is true for women or key population (sex worker, MSM and transgender) accessing
ART services. Given the magnitude of GBV or IPV, the success of ART would depend upon
addressing this issue as best as possible.
Screening of ART patients who have experienced GBV or IPV would be the first step towards
providing support services for GBV/IPV. Some basic questions that could be asked during the
first/initial visit should be:
“It is common to note that intimate partner violence or gender-based violence in Timor-Leste
is high. Many of us have experienced these kinds of issues in the past and continue to
experience it even today. Violence is common in a women’s life, but there is help available.
Please share your experience with us so that we could support you/direct you to appropriate
places”. Now I would like to ask you some questions. Please be assured that a complete
confidentiality will be maintained.
• Within the past year, has someone ever hit, kicked, slapped, or otherwise physically hurt
you?
• Has someone ever threatened to hurt you?
• Has someone ever forced you to do something sexually that made you feel
uncomfortable?
If the answer to any of the questions is yes, the patient must be counselled for GBV/IPV and
referred to a specialized IPV centre that is available at HNGV.
Screening and management for TB

All PLHIVs must be screened at every visit for TB (intensive case finding, ICF). In Timor-Leste,
PLHIVs are screened at every visit using a 4S screening tool (four symptom screening tool). If
any of the symptoms are positive, the patient must be referred to a designated microscopy
centre and tested for TB. GeneXpertTM11 is the preferred method for screening the sputum for
TB bacilli in an HIV infected. For any extra pulmonary TB (EPTB) such as TB lymphadenitis, TB
meningitis, etc., specific symptoms may have to be explored.
All PLHIVs older than 12 months of age who screen negative for TB should be provided with
6months of IPT, unless they have a specific contraindication.
For more details, please refer to Chapter on HIV-TB coinfection.
10http://evaw-global-database.unwomen.org/en/countries/asia/timor-leste.
11GeneXpertTM is a platform for cartridge based nucleic acid amplification test (CBNAAT) for TB with
a sensitivity of 97% and specificity of 99% for detecting Mycobacterium tuberculosis.
41
Screening and management of other coinfections and OIs
There are many coinfections that can lead to challenging circumstances for the HIV infected.
Hepatitis B and C coinfections can lead to higher side-effects with ART. It is important to
screen for hepatitis B in Timor-Leste as the prevalence is high (~4–7% in blood bank
screening).
HIV-hepatitis B and C
Prevalence of hepatitis B in Timor-Leste is estimated to be around 7% in blood donors.12 It is
higher among MSMs and sex workers (10.0% and 8.3%, respectively).13Hepatitis B is a very
strong DNA virus. It uses a double replication mechanism to replicate and thus is highly
infective. More importantly, the hepatitis B virus (HBV) can cause liver cirrhosis and cancer.
Hence, a dual infection is highly damaging to the individual.
Chronic infection with hepatitis B is likely to have occurred during the infancy. It could be due
to mother to child transmission or acquiring the infection in childhood. HBV is also
transmitted through sexual route and blood transfusions, and use of infected syringes and
needles.
Hepatitis C is less common in Timor-Leste. The prevalence estimated from blood bank is
approximately, 3.5% (2015). The routes of transmission are the same as HIV or hepatitis B.
Details of this coinfection are presented in the chapter on HIV and hepatitis coinfection.
Co-trimoxazole prophylaxis
Co-trimoxazole is a FDC of two antimicrobial drugs (sulfamethoxazole and trimethoprim) that
covers a variety of bacterial, fungal and protozoan infections. Co-trimoxazole preventive
therapy is a feasible, well tolerated and inexpensive intervention for PLHIVs to reduce HIV-
related morbidity and mortality.
Daily co-trimoxazole(CTX)prophylaxis reduces mortality and morbidity in HIV/AIDS patients
by reducing the risk of development and recurrence of pneumocystis pneumonia as well as
by decreasing the incidence of toxoplasmosis, malaria and of some bacterial infections (the
drug is active against streptococcus pneumonia, haemophilus influenza, salmonella,
legionella, nocardia, methicillin-sensitive staphylococcus aureus and many Gram-negative
bacilli). Also, CTX prophylaxis reduces mortality by 25–50% in TB/HIV coinfection.
In 2013, WHO issued a guideline of continuing lifelong CPT for all PLHIVs irrespective of their
immune status or clinical condition. This was different from the guidelines issued earlier
where immunological status was the mainstay of starting and stopping the treatment. In
Timor-Leste, the current considerations are as follows:
• Malaria infection is rare and just five cases detected in 201914
• Bacterial infection rates are moderate15
• Presence of pneumocystis pneumonia among PLHIVs is also low16
• Other bacterial infection rates are moderate.17
12http://www.searo.who.int/entity/hepatitis/tls-2018_ar.pdf?ua=1, accessed 14 October 2019.

13ibid
14Program data from National Malaria Program, updated 30 September 2019.
15Data from HNGV June 2019.
16Programme data from ART centres, September 2019.
17ibid
42
However, the presence of diarrhoeal diseases, bacterial pneumonia and other bacterial
infections is high in Timor-Leste. Thus, the updated recommendations from WHO are
applicable to the country (Table 26).
Table 26. Starting and stopping CPT prophylaxis

Population Recommendations
When to start CPT When to stop CPT
Adults and Primary prophylaxis • If CD4 not available: do not
adolescent PLHIVs • Irrespective of WHO clinical stage: discontinue CTX prophylaxis
including pregnant CD4 <350 cells/mm3 or • If CD4 available: due to high
women • WHO clinical stage II, III and IV: prevalence of bacterial infection
Irrespective of CD4 count and malaria in Timor-Leste, itis
Secondary prophylaxis recommended to discontinue
• For all patients who have completed CTX prophylaxis only after CD4
successful treatment for PCP until increased to 350 cells/mm3 or
CD4 is >350 cells/mm3 maintained above and after at least 6 months
over a period of 6 months of ART
Children (above 5 Follow same recommendations as adults Follow same recommendations as
years) adults
HIV exposed, but Start at 6 weeks Stop when confirmed to be HIV
uninfected infants uninfected
HIV-TB coinfection Initiate for everyone with active TB Follow adults or children’s criteria for
regardless of CD4 cell count stopping
HIV-hepatitis B or C Follow adults or children’s Follow adults or children’s criteria for
coinfection recommendations for starting CPT stopping
Newly detected HIV Follow adults or children’s Follow adults or children’s criteria for
infection not started recommendations for starting CPT, but stopping
on ART start CPT first and wait for 1–2 weeks to
start ART
Note: In most cases, the PLHIV presents to the ART centre with low to moderate CD4 counts (<350 cells/mL). Thus, CPT is likely
to be provided together with ART.
In such cases, it is better to start CPT prophylaxis in the first or initial visit and then start ART. This will allow for the side-effects
of ART to be differentiated from those of ART.
Dosing of co-trimoxazole preventive therapy

Co-trimoxazole can cause anaemia and neutropenia. In some cases, rashes may also be
present. But overall, the incidence of side-effects is low if weight band is followed (Table 27).
WHO’s 2006 guidelines on CTX provides a detailed guidance on grading and management of
side-effects. A simplified version for drug associated is presented in Table 288.
Table 27. Dose of co-trimoxazole prophylaxis treatment as per weight band

Weight band/ Oral suspension (240 Single strength tablet Double strength tablet
population mg/5 mL) (480 mg) (960 mg)
1--4 kg/infant 2.5 mL tablet NA
5--8 kg/infant 5 mL tablet tablet
9--16 kg/child 10 mL 1 tablet tablet
17--30 kg/child- 15 mL 2 tablets 1 tablet
adolescent
> 30 kg/adults or 20 mL 2 tablets 1 tablet
adolescents
Adults (any weight) 2 tablets 1 tablet
43
Table 28. Grading and management of drug rashes due to co-trimoxazole18
Severity level Characteristics Management
Grade 1 (mild) Localized rashes. Dry with Continue CTX; close monitoring; symptomatic
erythema and fine papular treatment with antihistamines +/- topical steroids (NOT
lesions; itching and affects < oral steroids)
50% of the body surface
Grade 2 Diffused rashes or target Stop CTX and follow desensitization protocol;
(moderate) lesions. Dry with erythema and symptomatic treatment with antihistamines +/- topical
fine papular lesions; itching and steroids (NOT oral steroids); trial of desensitization after
affects > 50% of the body symptoms completely resolved.
surface Can continue CTX if with careful and repeated
observation and follow-up. Provide symptomatic
treatment, such as antihistamines if required
Grade 3 Diffused rashes and vesicles. Stop CTX and should not be re-challenged with CTX;
(severe) Mucosal involvement; admission to hospital for supportive management (IV
blistering; usually limited to fluids, wound care, pain control, infection control,
one site or location monitoring for super-infection); patient should NEVER
be re-challenged with CTX or other sulpha-containing
drugs; document and report adverse event and issue
patient alert card
Grade 4 Extensive or generalized Stop CTX and should not be re-challenged with CTX;
(potentially life bullous lesions OR ulceration of admission in hospital for supportive management (IV
threatening) mucous membrane involving fluids, steroids, wound care, pain control, infection
two or more distinct mucosal control, monitoring for super-infection); patient should
sites OR Stevens-Johnson NEVER be re-challenged with CTX or other sulpha-
syndrome OR Toxic epidermal containing drugs; document and report adverse event
necrolysis and issue patient alert card
Source: Adapted from DAIDS AE Grading Table Corrected Version 2.1July 2017.
Management of PLHIVs with co-trimoxazole allergy

A rash may occasionally develop, usually about 7--14 days following initiation of CPT. It is
often a relatively mild maculopapular rash with or without itching. Rarely, rash may develop
with severe exfoliation of the skin and Stevens-Johnson syndrome. Assess the severity of
rashes and then manage accordingly (Table 13).
Desensitization is effective in most patients with mild to moderate rash. It is seen from
majority of studies and programme experiences around the globe that approximately 70–
75% (Number needed to treat (NNT), 4.55 (95 CI 3.03-9.09) of patients who are allergic to
sulpha drugs have been successfully desensitized.19
There are two types of desensitization protocols dependent upon the need to start CTX (Table
29).
Table 25. Standard co-trimoxazole desensitization protocol (8 days)
Day Dose of TMP-SMX suspension (40/200 mg per 5 mL)
Day 1 0.5 mL (4/20 mg TMP-SMX)
Day 2 1 mL (8/40 mg of TMP-SMX)
18U.S. Department of Health and Human Services, National Institutes of Health, National Institute
of Allergy and Infectious Diseases, Division of AIDS. Division of AIDS (DAIDS) Table for grading the
severity of adult and pediatric adverse events, Corrected Version 2.1. July 2017
(https://rsc.niaid.nih.gov/sites/default/files/daidsgradingcorrectedv21.pdf, accessed 18 October 2019).
19Lin D, Li W-K, Rieder MJ. Cochrane database (https://www.cochrane.org/CD005646/HIV_this-
review-examines-strategies-to-enable-the-continued-use-of-the-antibiotic-cotrimoxazole-in-patients-
with-hivaids-to-treat-or-prevent-opportunistic-infections-in-patients-who-previously-experienced-
hypersensitivity-to-this-drug, accessed 17 October 2019).
44
Day 7 1 single strength tablet (80/400 mg of TMP-SMX)
Day 8 2 single strength or 1 double strength tablet (16/800 mg of TMP-SMX
Other prophylaxis in PLHIV
Table 30. Type of prophylaxis of OIs in PLHIVs
Type of What
When to
Name of OI Prophylaxi to Adult dose When to stop
start
s start
CD4 < 350 CD4 > 350cells/
One double
cells/cmm cmm (at least on two
strength tablet
Pneumocystis Co- or WHO occasions, done 6
(Sulfamethoxaz
pneumonia Primary trimox clinical months apart) and
ole800 mg +
(PCP) azole stage 3 or devoid of any WHO
Trimethoprim
4 clinical stage 3 and 4
160 mg)
conditions conditions
One double
CD4 > 350cells/ cmm (at
strength tablet After
least on two occasions,
Co- (Sulfamethoxaz successful
done 6 months apart)
Secondary trimox ole treatment
and devoid of any WHO
azole 800 mg + for PCP
clinical stage 3 and 4
Trimethoprim (21 days)
conditions
160 mg)
Recommended as part of advance disease management for PLHIVs who
Primary
have CD4 <100 cells/mm3
After
successful
treatment
of
cryptococ
Cryptococcal cal
meningitis Tab meningitis CD4 > 200 cells/ cmm (at
Flucon
Secondary Fluconazole (induction least on two occasions,
azole
200 mg phase of done 6 months apart)
2-3 weeks
and
consolidat
ion phase
of 8
weeks)
Reproductive health services

Sexually transmitted infections (STIs)
Screening for syphilis using rapid plasma reagin (RPR) should be performed as a routine
investigation for all pregnant women. It is part of the ANC package.
PLHIV should be assessed for symptoms of STIs using the enhanced syndromic management
of STIs. Sexual partners should be treated as well. Risk reduction counselling and provision
of condoms are an integral part of STI treatment.
Patients who have persistent signs and symptoms of STIs after syndromic treatment should
be referred to a specialist at HNGV.
45
Family planning and pre-conception counselling
Pregnancy should be determined for all women of reproductive age at every visit (based on
history of last menstrual period and, if uncertain, irregular, or delayed, then refer to mother
and child health (MCH) section in the CHC or hospital for a urine test).
Many PLHIVs would be interested to conceive and may seek appropriate advice regarding the
outcomes. It is necessary to provide proper counselling and services to address this issue. For
patients who do not have an immediate desire to become pregnant, dual contraception
should be provided immediately with follow-up appointments scheduled to ensure no
interruption in contraception provision.
Table 31outlines contraception options for PLHIVs based on the ARVs they are using.
Table 3126. Basket of contraception based on WHO 2018 guidelines

TB
Contraceptive methods ARVs
medications
NNRTI PI INSTI
NRTI EFV or LPV/r DTG RAL Rifampicin
NVP
Depot medroxy progesterone

acetate (DMPA)
Norethisterone enantate (Net-EN) ± ± ±
Implants (Norplant II) ± ± ±
Combined oral contraceptive pills ± ±
Intra uterine ± (May be recommended for PLHIVs who are stable on ART). Not
Initiation
devices (CuT- recommended for all PLHIVs with advanced disease
380Ag) Continuation ± ± ± ± ± ±
Condoms
Emergency contraceptive pills
Fertility awareness-based Can use if menstrual cycle is regular, though reliability is not as good
methods (FAB) as hormonal contraceptive methods or IUD. Encourage to use in
combination with condoms to prevent STI/HIV transmission
Lactational amenorrhoea method Effective for women who are less than 6months postpartum, are
(LAM) exclusively breastfeeding, and have not resumed menses. Encourage
to use in combination with condoms to prevent STI/HIV transmission
Spermicides and diaphragm
Note: Condoms are usually combined with other methods of contraception for triple prevention namely, HIV/AIDS, STIs and
hepatitis B and C.
Dolutegravir was not part of WHO 2018 recommendations for family planning for PLHIVs. The reference for DTG interactions
has been taken from DAIDS (https://aidsinfo.nih.gov/drugs/509/dolutegravir/0/professional, accessed 30 September 2019).
PLHIVs, who intend to become pregnant and wish to have a healthy baby, should be
counselled accordingly. Table 32 provides guidance for the preconception services that
would be required.
Table 32. Preconception messages and services for PLHIVs

Scenario Messages Pre-conception services
Women or couples with All PLHIVs qualify for ART, ART for all PLHIVs, including those
intention to conceive with initiation preferably intending to become pregnant
Baseline investigations
46
within two weeks of HIV Hb (with management of
diagnosis anaemia)
Deferring pregnancy until Syphilis screening
confirmed viral suppression Cervical cancer screening
reduces risk of vertical
transmission to the baby, STI symptom screening
improves infant outcomes,
and reduces risk of cross- Nutritional assessment,
transmission to the sexual counselling and support
partner
Unprotected sex should be Folic acid supplementation
limited to days when Standard VL after 6months on ART
ovulation is expected (based to confirm viral suppression
on basal temperature
monitoring, fertility calendar
based on menstrual cycles,
and/or fertility calendar app)
Routine ANC and delivery by
a skilled birth attendant
improves outcomes for
mother and baby
Additional messages for Defer unprotected sex until confirmed viral suppression in the HIV
discordant couples: male positive partner
partner HIV positive In situations where viral suppression is challenging, consider
specialist referral for additional options such as sperm washing and
artificial insemination
Additional messages for Defer unprotected sex until confirmed viral suppression in the HIV-
discordant couples: female positive partner
partner HIV positive Discuss self-insemination during the peri-ovulatory period, where
appropriate/as preferred
In situations where viral suppression is challenging, consider
specialist referral for additional options such as artificial
insemination
47
Chapter 6
Management of opportunistic infections
Pneumocystis pneumonia
Pneumocystis pneumonia (PCP) is caused by Pneumocystis jirovecii, a fungus and OI. The
nomenclature of the organism has changed; Pneumocystis carinii now refers only to the
Pneumocystis that infects rats, and P. jirovecii refers to species that infects humans.
However, the abbreviation PCP is still used. It is commonly noted that initial infection with P.
jirovecii usually occurs in early childhood. Almost two-thirds of healthy children have
antibodies to P. jirovecii by age 2–4 years.20
The transmission routes follow normal pattern of airborne infections. However, the disease
could also be acquired through re-activation (like TB) from a latent infection. PCP used to be
the most common infection before the era of ARVs. Literature suggests that almost 70–80%
of PLHIVs would be affected by PCP during the course of the HIV disease.21,22,23,24
Clinical manifestations
Table 33. Clinical features of PCP in HIV infected
Feature Mild Moderate Severe
• Normal while • Some discomfort while at • Breathless, increased
resting rest, but essentially heart rate even when at
• With exertion, normal rest
there may • Widespread rales are • All clinical features are
Clinical breathlessness usually present exaggerated and may have
and increased • Fever is present evidence of lung collapse
heart rate • Other features as of mild (spontaneous
• Diffused dry disease pneumothorax)
cellophane
rales on
auscultation
may be present
• Fever is
sometimes
present
20Pifer LL, Hughes WT, Stagno S, Woods D. Pneumocystis carinii infection: evidence for high
prevalence in normal and immunosuppressed children. Pediatrics. 1978;61(1):35–41

(http://www.ncbi.nlm.nih.gov/pubmed/400818, accessed 16 October 2019).
21Keely SP, Stringer JR, Baughman RP, Linke MJ, Walzer PD, Smulian AG. Genetic variation among
Pneumocystis carinii hominis isolates in recurrent pneumocystosis. J Infect Dis. 1995;172(2):595–8

(http://www.ncbi.nlm.nih.gov/pubmed/7542688).
22Helweg-Larsen J, Tsolaki AG, Miller RF, Lundgren B, Wakefield AE. Clusters of Pneumocystis
carinii pneumonia: analysis of person-to-person transmission by genotyping. QJM. 1998;91(12):813–

20 (http://www.ncbi.nlm.nih.gov/pubmed/10024946).
23Huang L, Beard CB, Creasman J et al. Sulfa or sulfone prophylaxis and geographic region predict
mutations in the Pneumocystis carinii dihydropteroate synthase gene. J Infect Dis. 2000;182(4):1192–
8 (http://www.ncbi.nlm.nih.gov/pubmed/10979917).
24Sassi M, Ripamonti C, Mueller NJ et al. Outbreaks of Pneumocystis pneumonia in 2 renal transplant
centers linked to a single strain of Pneumocystis: implications for transmission and virulence. Clin
Infect Dis. 2012;54(10):1437–44 (http://www.ncbi.nlm.nih.gov/pubmed/22431811).
48
• Oral thrush may
be an
accompanimen
t
Investigation
s < 35 35–45 > 45
• DaO2
(mm of
Hg) >70 > 70 50 – 70
• PaO2
(mm of
Hg)
Usually non-specific May show some abnormalities • Typically, diffuse,
and normal like ‘ground glass’ appearance bilateral, symmetrical
X-ray “ground-glass” interstitial
infiltrates emanating from
the hila in a butterfly
pattern.
• Spontaneous
pneumothorax
Image 1.Bilateral interstitial

infiltrates in an HIV-infected
patient with PCP
Image 2. PCP associated

right-sided pneumothorax
Treatment of PCP25
I. For mild to moderate: Total duration of treatment is 21 days
Preferred therapy:
• TMP-SMX: (TMP 15–20 mg/kg/day and SMX 75–100 mg/kg/day) PO (3 divided
doses), or
• TMP-SMX 2 DS tablets PO three times daily.
Alternative therapy:
Dapsone 100 mg PO daily plus TMP 15 mg/kg/day PO (3 divided doses), or
Primaquine 30 mg (base) PO daily plus Clindamycin PO (450 mg every 6 hours or 600
mg every 8 hours), or
Atovaquone 750 mg PO twice daily with food.
25https://aidsinfo.nih.gov/guidelines/brief-html/4/adult-and-adolescent-opportunistic-
infection/321/pneumocystis-pneumonia, accessed 18 October 2019.
49
II. For moderate to severe: Total duration of treatment is 21 days
Preferred therapy:
• TMP-SMX: (TMP 15–20 mg and SMX 75–100 mg)/kg/day IV given every 6 or 8 hours,
may switch to PO formulations after clinical improvement.
Alternative therapy:
• Pentamidine 4 mg/kg IV once daily infused over 60 minutes; may reduce the dose
to pentamidine 3 mg/kg IV once daily in the event of toxicities, or
• Primaquine 30 mg (base) PO once daily plus (Clindamycin [IV 600 mg every 6 hours
or 900 mg every 8 hours] or [PO 450 mg every 6 hours or 600 mg every 8 hours]).
Note: Adjunctive corticosteroids are indicated in moderate to severe cases of PCP (see
indications and dosage recommendations below).
Adjunctive Corticosteroids
For moderate to severe PCP based on the following criteria:
• PaO2<70 mmHg at room air, or
• Alveolar-arterial DO2 gradient 35 mmHg.
Dosing schedule:
• Prednisone doses (beginning as soon as possible and within 72 hours of PCP therapy)
(AI)
o Days 1–5: 40 mg PO twice daily
o Days 6–10: 40 mg PO daily
o Days 11–21: 20 mg PO daily
• IV methylprednisolone can be given as 75% of prednisone dose.
Cryptococcal meningitis (CM)

Most HIV-associated cryptococcal infections are caused by Cryptococcus neoformans, but
occasionally Cryptococcus gattii is the etiology. C. neoformans is found worldwide, whereas
C. gattii is found most often in Australia and similar subtropical regions and Timor-Leste.
Before the advent of ART, approximately 5– 8% of HIV-infected patients in many countries
were diagnosed with disseminated cryptococcosis.26
26Aberg J, WG. P. Cryptococcosis. In: Dolin R MH, Saag MS, editor. AIDS therapy. New York, NY:
Churcill Livingstone; 2002:498–10.

50
Clinical manifestations
The clinical manifestations range from a variety of features. Many of them are non-specific
such as fever, malaise and headache. There may be
features of meningeal irritation like neck rigidity and
photophobia. Some patients experience
encephalopathic symptoms, such as lethargy, altered
mentation, personality changes, and memory loss that
are usually a result of increased intracranial pressure.
Unfortunately, cryptococcosis is usually disseminated
when diagnosed in an HIV patient and can affect any
organ. Skin lesions may show many different
manifestations, including umbilicated skin lesions
mimicking molluscum contagiosum. Isolated
pulmonary infection may be possible. Symptoms and
signs include cough and dyspnoea in association with
an abnormal chest radiograph, which typically
demonstrates lobar consolidation (circle), though Image 3. Pulmonary cryptosporidiosis
in HIV infected
nodular infiltrates have been reported (arrow).
Source: Radeopedia.org
Pulmonary cryptococcosis may present as acute
respiratory distress syndrome and mimic Pneumocystis pneumonia.
PLHIVs including adults and adolescents should receive cryptococcal screening if clinically
suspected. The management algorithm for PLHIVs with cryptococcosis is given in Fig. 8.
51
HIV-infected adults or adolescents
CD4 200 cells/mm3
Screen for S.CrAg
Positive for S.CrAg Negative for S.Cr.Ag
Symptom screen: No cryptoccocal treatment

Progressive headache, required
fever, malaise, neck pain,
confusion Initiate ART within 2
weeks
Symtomatic:
Asymptomatic:
Admit the patient and do a Lumber
Follow treatment algorithm for
puncture and test for CrAg and
presumtive treatment
Xpert(R) MTB/RIF
CSF Cr Ag positive CSF Cr Ag negative
1. Treat for CM with Amphotericin,

Flucanazole and Therapeutic LPs
1. Pre-emptive therapy for non-meningeal disease with
2. Defer ART until completed 5 weeks of fluconazole 800 mg per day for 2 weeks, followed by
ART and complete resolution of symptoms fluconazole 400 mg per day for 8 weeks, followed by
fluconazole 200 mg for at least 1 year and until CD4
count >100 cells/mm3 for two measures 6 months apart
AND VL is undetectable (LDL)
2. Initiate ART within 2 weeks
Fig.8. Management algorithm for PLHIVs with suspected cryptococcosis
52
Source: Adapted from AIDSInfo - Guidelines for the prevention and treatment of opportunistic infections in adults and
adolescents with HIV (https://aidsinfo.nih.gov/guidelines/brief-html/4/adult-and-adolescent-opportunistic-
infection/333/cryptococcosis).
Note:
1. LP is recommended for all S.CrAg positive patients irrespective of symptoms with management based on LP
results. If LP is not available to rule out meningeal disease, then patients should be treated for possible CM, even
if asymptomatic.
2. Patients with CM are at high risk of developing life-threatening IRIS; deferring ART has shown to improve survival
for these specifics.
3. Fluconazole use during pregnancy increases the risk of birth defects. All pregnant women who screen positive with
serum CrAg should be offered a lumbar puncture (irrespective of symptoms) to determine if they have
cryptococcal meningitis.
4. Fluconazole requires a dose adjustment for impaired renal function, when CrCl mL/min then use 50% of the
standard recommended dose.
5. When using high-dose fluconazole, check ALT after 1week of treatment and based on symptoms thereafter.
Management of CM27
Treatment for cryptococcosis consists of three phases: initiation, consolidation and
maintenance therapy (Table 34).
Table 34. Treatment options for CM in PLHIVs
Population Regimen Initiation Consolidation Maintenance Remarks
Preferred Amphotericin B Fluconazole 200
0.7- 1mg/kg/day+ mg/day for at
Flucytocin 100 least 1 year and
mg/kg/day + until CD4
Fluconazole 800
Fluconazole 800 count> 100
Adults mg per day (2
mg per day (1 cells/mm3for Defer ART
weeks)
week)2 two measures6 until after
Alternate Fluconazole1,200 months apart completing
mg daily (2 weeks) AND VL 5 weeks of
isundetectable2 CM
Preferred Amphotericin B Fluconazole6m treatment
0.7–1.0 mg/kg/day g/kg/day up to and
+Flucytocin 100 200 mg/day symptoms
mg/kg/day+ have
Fluconazole 6-12
Children and Fluconazole 12 resolved
mg/kg/day up to
adolescents mg/kg/day (up to
800 mg/day
max 800 mg/day)
Alternate Fluconazole12 Fluconazole12
mg/kg/day (up to mg/kg/day up
max 1200 mg/day) to 800 mg/day
Source: 1. Guidelines on the diagnosis, prevention and management of cryptococcal disease in HIV-infected adults,
adolescents and children: supplement to the 2016 consolidated guidelines on the use of antiretroviral drugs for treating and
preventing HIV infection. Geneva: World Health Organization; 2018. Licence: CC BY-NC-SA 3.0 IGO.
2.https://aidsinfo.nih.gov/guidelines/brief-html/4/adult-and-adolescent-opportunistic-infection/333/cryptococcosis.
Further, if Amphotericin B is used, then the following protocol should be used for monitoring
the treatment.
Adults
• Use at least 1 L of normal saline (NS) with 20 mmol of KCl over 2--4 hours before each
controlled infusion of Amphotericin B (Deoxycholate) given with 1 L of 5% dextrose
• Add two tablets of 8 mEqKCl orally twice daily
27https://aidsinfo.nih.gov/guidelines/html/4/adult-and-adolescent-opportunistic-
infection/333/cryptococcosis, accessed 19 October 2019.
53
• An additional one 8 mEqKCl tablet twice daily may be added in the second week
• Include magnesium supplementation at 250 mg tablet of magnesium trisilicate twice
daily (or 4 mEq tablets of magnesium chloride twice daily).
Adolescents and children
• Use 1 L of normal saline with 20 mmol of KCl over 2--4 hours before each controlled
infusion of Amphotericin B. Darrows or Ringer’s solutions can also be used
• Avoid KCl replacement in patients with pre-existing renal impairment or
hyperkalaemia.
Managing hypokalaemia and raised creatinine levels
Obtain a routine baseline and twice weekly potassium and creatinine:
• If K < 3.3 mmol/L, administer 1 L of normal saline with KCl 40 mmol in normal saline
or 1--2 tablets of 8mEq KCl every 8 hours. Add magnesium. Monitor potassium daily
• If creatinine level increases > 2-fold from baseline, omit dose of Amphotericin B,
increase hydration to 1 L every 8 hours. If there’s improvement, re-start Amphotericin
B at 0.7 mg/kg/day on alternate days. If no improvement, discontinue Amphotericin
B, give fluconazole 1600 mg/day to complete induction. Monitor creatinine daily.
Therapeutic lumbar punctures are a critical component of the management of CM and should
be standard of care. For all patients with symptomatic CM, perform daily therapeutic lumbar
punctures:
• If opening pressure is 40 cm: draw off enough CSF to reduce pressure to 20 cm
• If opening pressure is > 40 cm: draw off enough CSF to reduce pressure by 50%
• Continue daily LPs until pressure is normal for three consecutive days
• Restart LPs, if symptoms return
• If measuring intracranial pressure is not possible (even using a giving set and tape
measure), then perform daily therapeutic LPs until severe headache subsides,
removing 10--20 mL of CSF each time.
Prevention of other infections

This section deals with the other OIs.
Common conditions frequently causing fever in PLHIVs

There are many conditions that cause fever among the PLHIVs, and the common ones are
presented in Table 35.
Table 35. Management of recurrent or persistent fever
Persistent or recurrent fever with no or limited findings
Common • Non-HIV related conditions: malaria, urinary tract infection,

causes etc.
• Mycobacterium: TB, mycobacterium avium complex
• Bacteraemia, i.e., salmonella, streptococcus pneumonia
• Systemic fungal infection: cryptococcosis
• Other: CMV, HIV (with no other pathogen), drug reaction
54
Diagnosis Look for the cause through:
• History taking
• Physical examination
• Complementary investigations, i.e., malaria smear, urinalysis, AFB smear, chest X-ray, total
and differential leukocyte count, CSF examination
Prophylaxis CTX also reduces the incidence of some bacterial infections, malaria and toxoplasmosis
Treatment According to findings
Lymphadenopathy (Progressive generalized)

Lymphadenopathy is common in HIV infected. It should be treated and handled
appropriately and with care. The common causes of lymphadenopathy are presented in
Table 36.
Table 36. Differential diagnosis of lymphadenopathy in PLHIVs

Broad disease category Specifics
Malignancies Kaposi’s sarcoma, Lymphomas (non-Hodgkin’s mostly), metastasis,
skin neoplasms
Infections
Viral Adenovirus, cytomegalovirus, hepatitis, herpes zoster, HIV, infectious

mononucleosis (Epstein-Barr virus), rubella
Bacterial Brucellosis, cat-scratch disease (Bartonella), chancroid, cutaneous

infections (staphylococcal or streptococcal), lymphogranuloma
venereum, primary and secondary syphilis, TB, tularaemia, typhoid
fever
Granulomatous
Berylliosis, coccidioidomycosis, cryptococcosis, histoplasmosis,
silicosis
Other
Fungal, helminthic, lyme disease, rickettsial, scrub typhus,
toxoplasmosis
Autoimmune disorders Dermatomyositis, rheumatoid arthritis, Sjogren’s syndrome, still’s
disease, systemic lupus erythematosus
Miscellaneous/unusual conditions Angio-follicular lymph node hyperplasia (Castleman disease),
histiocytosis, kawasaki disease, kikuchilymphadenitis, kimura
disease, sarcoidosis
Iatrogenic causes Medications, serum sickness
Source: Adapted from Gaddey HL, Riegel AM. Unexplained lymphadenopathy: evaluation and differential diagnosis. Am Fam
Physician. 2016 Dec 1;94(11):896--903.
Diagnosis:
Rule out local or contiguous infection, which might explain lymphadenopathy
Chest X-ray and lymph node aspiration for AFB in case any of the following are
present: fever, weight loss, asymmetrical nodes, tenderness, extra nodal foci such as
skin lesions
PGL: painless enlarged nodes, >1 cm diameter, in two or more noncontiguous sites
(excluding inguinal sites) for three or more months)
RPR for syphilis.
55
Treatment
According to findings.
Respiratory infections
The common organisms causing respiratory infections range from common to many
uncommon ones as well.
Opportunistic causes of respiratory infections in PLHIVs:
Tuberculosis
Bacterial pneumonia
Pneumonia due to Pneumocystis jiroveci (PCP)
Penicilliosis
Cryptococcosis
Histoplasmosis
Coccidioidomycosis
Aspergillosis
Helminthic diseases
Toxoplasma pneumonitis
Mycobacterium Avium Complex (MAC)
Pulmonary Kaposi Sarcoma.
Diagnosis of respiratory symptoms:
• Based on clinical symptoms and findings
• Sputum examination
• Chest X-rays.
HIV and TB
Please refer to
56
Chapter.
Bacterial pneumonia
Table 37. Bacterial pneumonia in PLHIVs
Bacterial pneumonia
Patients can develop serious pneumococcal infection despite a relatively preserved CD4 count. Recurrent
pneumococcal pneumonia is common (up to 25% within 6 months).
Symptoms Typical bacterial pneumonia due to S. Pneumoniae, Moraxella and H. Influenzae

• Acute respiratory infection, which is often abrupt, with high fever, chills, productive
cough of yellow/green sputum, unilateral pleuritic chest pain. Orthopnoea, fatigue
and malaise are also common. Physical examination shows: fever, tachypnoea,
tachycardia, localised rales or Ronchi.
Atypical pneumonia due to mycoplasma, Chlamydia pneumoniae
• Symptoms of lower respiratory tract infection with subacute onset, mild fever,
productive or nonproductive cough. Chest often clear.
Unusual bacterial organisms: S. aureus, other Gram –bacteria, Legionella. Acute severe
pneumonia. Often in severely immune depressed patients.
Diagnosis Chest X-ray shows lobar consolidation. A typical presentation includes multi-lobar, nodular,
reticulonodular patterns
Sputum examination (Gramstain and AFB)
Prophylaxis Daily CTX may reduce the incidence of bacterial pneumonia
Treatment Typical bacterial pneumonia:

First-line: amoxicillin (50 mg/kg/day po divided over 3 doses x7 days)
Second-line: amoxicillin/clavulanate (625 mg po tid to qid x 7days)
Atypical pneumonia, and/or patient severely immune-depressed: Amoxicillin (50
mg/kg/day po divided over 3 doses x 7 days)with doxycycline (100 mg po bid x 7 days) or
erythromycin (1000 mg po bid x 7 days)
If severe and requires hospitalisation:
Amoxicillin(+/-clavulanate)(1g IV tid to qid) orceftriaxone (1 to 2 g IV od) with erythromycin
(50 mg/kg/day IV divided in 4 doses) or doxycycline (100 mg po bid), for one 1week.
57
Pneumonia due to Pneumocystis jiroveci (PCP)
This part was dealt in detail earlier. For any other type of pneumonia, it is recommended that
the PLHIV be referred to a specialist centre (Referral Hospital, HNGV for expert opinion)
Oral lesions, odynophagia and dysphagia

The most common mouth problems in HIV/AIDS patients are thrush, ulcerations,
angular cheilitis and oral hairy leucoplakia.
Dysphagia (difficulties in swallowing) and odynophagia (pain in swallowing) are frequent
symptoms in severely immune-depressed patients and are mostly due to candidiasis
infection, though other causes may be responsible.
The diagnosis of oro-oesophageal conditions is usually clinical.
58
Table 38. Management options for mouth pain in PLHIVs
Infection or Likely cause Symptoms and signs Diagnosis Treatment and Comments
condition prophylaxis
Oral thrush or Candida albicans Two presentations are Clinical features and Topical: Miconazole Maintain oral hygiene.
candidiasis WHO possible: laboratory: Wet mount microscopy nitrate (10 mg gum patch Use of soft toothbrush,
stage 2 Creamy white using KOH preparation od x 7 days) gently scrubbing the
pseudomembranous plaques: tongue and gums at
this is the most common CD4 count is usually < 500/mm3 Systemic treatment: least 3-4 times a day,
presentation, covering areas Fluconazole (200 mg po and then rinsing the
of superficial ulceration on the od x 7 days). mouth with salt water
gums, palate, buccal mucosa If no improvement is seen or lemon water mix;
and tongue; are easily after 7 days of topical Rinsing the mouth with
detached by a tongue treatment or warm salty water or
depressor and cause taste if the oropharynx is mouthwash after eating
disturbances. involved or and between meals;
Erythematous patches: which if the infection is Increase fluid intake;
present as multiple, flat, red, Image 1. Oral candidiasis recurrent (i.e., >2 Modify food intake—eat
non-removable plaques, relapses, or 1 relapse if more frequently,
mostly on the palate and the deeply smaller meals.
59
tongue, causing burning immunosuppressed,

sensation within 3 months)
Oral ulcerations: Herpes simplex There are two common Clinical features and Painkiller: paracetamol Same as above
WHO stage 2 disease, CMV causes of oral ulcerations: CD4 count is usually <350/ mm3 for (500mg to 1g qid x 1
if recurrent Malignancies • Herpes Simplex H. simplex week) for mild pain,
Multiple aetiology stomatitis/ulcers due to tramadol (50mg qid x 1
HSV: vesicles with rupture week) for severe pain
that transform in pain and
ulceration. Usually Topical antiseptics:
located on gums, hard Gentian violet mouth
plate, lips, and adjacent wash or diluted solution
facial skin of povidone-iodine 0.5%,
• Aphthous ulcers at least twice a day.
(unknown aetiology): Image 2.Vesicles due to Herpes Acyclovir (400mg tid or
well-circumscribed simplex 200 mg 5 times daily x 10
lesions with a whitish days) is given
covering surrounded by a systematically as clinical
reddish halo; small or differential diagnosis
large, single or multiple; between herpetic and
anywhere in the mouth; aphthous ulcers is
usually deeper than difficult.
herpetic ulcers, but In case of deep ulcers or
differential diagnosis is no-response to acyclovir:
difficult try prednisone
• Ulcers can also be caused 20 mg po od x 7 days.
by CMV, deep mycosis, If secondarily infected:
some bacterial infections amoxicillin (50mg/kg/day
and malignancies po divided over 3 doses x
7 days) + metronidazole
(400 mg po tid x 7 days)
Angular cheilitis Multiple aetiology, but Cracking, pain, and Clinical features are usually
mostly fungal in origin sometimes bleeding from the pathognomonic
corners of the mouth.
It is fungal in origin
60
complicated by inflammation
Image 3.Angular cheilitis

Oral hairy cell Epstein-Barr virus Unilateral or bilateral Clinical andCD4 count is Rarely symptomatic and Maintain good oral
leucoplakia adherent white or grey <500/mm3 do not need treatment, hygiene
patches on lingual lateral but is indicative of
margins. Patches are irregular immune suppression
folds and cannot be scraped
off
Image 4.Oral hairy cell

leucoplakia due to EBV
Oesophagitis Candida albicans Severe candidiasis infection Suspected presence of oro- Adult: Maintain oral hygiene
(oesophageal may extend into the lower pharyngeal thrush, odynophagia Fluconazole – oral 200mg
candidiasis) – WHO pharynx and oesophagus. day 1, Then, 100 mg daily;
stage 4 Symptoms may include Oesophagoscopy doses up to 400 mg/day
dysphagia, odynophagia, may be used based on
substernal patient’s response. Treat
61
chest pain, vomiting after for a minimum of 3

feeding, and feelings of weeks and for at least 2
obstruction and epigastric weeks following
pain or heartburn. Patients resolution of symptoms
may also be asymptomatic. Paediatric:
Usually it presents along with Fluconazole – oral,
oropharyngeal candidiasis, 6mg/kg stat day 1 then
but it can also occur 3mg/kg/day for 14--21
independently days or
Image 5.Oesophageal
Ketoconazole 3.3--
candidiasis
6.6mg/kg/day x 14--21
days
Image courtesy: Image 1 - St Mary's Hospital Medical School/Science Photo Library. Image 2 - Photograph from David H. Spach, MD, University of Washington, Seattle. Image 3 - frank60/ Shutterstock.com.
Image 4- Mark Rogers Darling/ JCan Dent Assoc 2018;84:i8. Image 5 –Saleem N/ http://www.journalmc.org.
Management of mouth pain
Mouth lesions
History and physical examination, i.e., is there

any ulcer, painful swallowing, problem in
feeding
Yes. Also signs of No signs of

oesophageal oesophageal
involvement are seen involvement noted
Treat for oesophageal No sign of oesophageal

candidiasis involvement
Oral thrush – Oral thrush – Oral thrush –

No mouth only mouth + mouth
improvement pharynx ulcerations
Treat with pain

Miconazole gum killers, topical
patch antiseptics and
Treat with Acyclovir Acyclovir
for H. simplex
No No
improvement improvement
Fluconazole
for 1 week
No
improvement
Treat with
Prednisolone for
aphthous ulcer
Fig. 9. Management of mouth pain in PLHIVs

Source: Adapted from fact sheet 653: HIV and the Mouth – AIDS infonet(http://www.aidsinfonet.org/fact_sheets/view/653, accessed 18
November 2019).
62
Diarrhoea in HIV infection
Diarrhoea is a common challenge among PLHIVs. In earlier days, chronic diarrhoea was one of the
markers of AIDS defining illness. In practice, diarrhoea is perhaps the commonest problems noted
among PLHIVs.
In any case of diarrhoea,
• Assess hydration status
• Provide nutritional advice such as continued diet with cooked food and frequent rehydration
with boiled water
• Provide hygiene advice such as hand washing with soap to prevent recurrent diarrhoeal
diseases
• If possible, take stool sample for laboratory examination (although this is rarely possible in
practice).
Table 39 provides a snapshot view of the management for acute and chronic diarrhoea.
Table 39. Management of diarrhoea in PLHIVs
Condition Causative Symptoms and Treatment
organisms signs
Two syndromes • Assess hydration status. If moderate, treat
may be possible: with ORS and boiled water. If severe, refer for
Dysentery: • Dysentery: hospitalization
Shigella, Diarrhoea • Assess the diarrhoea duration. If less than
Acute diarrhoea
Enterohaem with blood 3days, do not give antibiotics
orrhagic E. and/or • In presence of blood and/or mucous: treat
Definition:
coli, mucous in the with ciprofloxacin (500 mg po bid) and
3 loose stools daily
Salmonella stools, with or metronidazole (400 or 500 mg po tid), for
for 3 to 10 days;
non-typhi without fever 7days. Caution: antidiarrhoeals are contra-
Most common in the
species, indicated in this case
early stages of HIV
Campylobac • Watery or • In watery or nonspecific diarrhoea: treat with
infection;
ter or non-specific CTX (960mg po bid x 7 days) if the patient is
No weight loss or
Entamoeba diarrhoea, not under CTX prophylaxis or with amoxicillin
very slight weight
histolytica with or (500 mg po qid x 7 days)
loss, and disappears
Viruses, E. without fever • As antidiarrhoeals, use loperamide (4 mg as
spontaneously or
coli, loading dose then 2 mg after each stools with
with appropriate
Clostridium a maximum of 16 mg/day)
treatment
difficile,
Staphylococ
cus aureus or
Yersinia
Isosporabelli Usually watery, • Not all causes may be treatable in resource
, with or without limited settings(i.e., CMV, mycobacterium
Cryptosporid fever, leading to avium complex)
iosis, malabsorption • For some causes, the best results are obtained
Chronic diarrhoea
Cyclospora, and wasting with immune reconstitution by ART (i.e.,
Microsporidi syndrome. Cryptosporidia, CMV)
Definition:
umspecies, • Assess hydration status. If moderate, treat
> 3 loose or watery
Mycobacteri Blood and/or with ORS and boiled water. If severe, refer for
stools/day for > 30
um avium mucous might be hospitalization
days, continuously
complex, HIV present if chronic • If presence of blood and/or mucous, treat
or episodically;
itself amoebiasis; with ciprofloxacin and metronidazole as acute
More common
infection by diarrhoea
during the later
giardia presents as In presence of watery or nonspecific diarrhoea,
stages of the HIV
Entamoebah nonspecific treat with:
infection
istolyticaor diarrhoea with • CTX 960mg bid + Metronidazole 400 or 500 mg
CMV; Giardia bloating and tid for 1 week. If no response: increase CTX to
intestinalis flatulence 960mg - 2 tabs bid for 1 week+ albendazole
400mg bid for 2--4 weeks
63
• Give antidiarrhoeal and start ARV
Skin lesions in HIV infection

Skin lesions are common in PLHIVs. There are many reasons for the plethora of skin lesions such as
lack of hygiene, immunosuppression, etc. The lesions include Kaposi sarcoma, thrush, several
bacterial infections and herpes. Others, like photodermatitis, may be linked to immune reconstitution
inflammatory syndrome due to revival of immune response to ARV drug therapy or the drugs
themselves.
The common HIV-associated skin diseases are:
• Viral infections: herpes simplex, herpes zoster, molluscumcontagiosum (poxvirus)
• Fungal infections: candidiasis, cutaneous ringworm
• Bacterial infections: folliculitis, furunculosis, pyoderma
• Parasite infections: scabies
• Neoplasm: Kaposi sarcoma
• Other dermatitis: papular pruritic infection (PPE), seborrheic dermatitis, xerosis,
photodermatitis
• Drug reactions: ARV (i.e., Nevirapine), antibiotics (i.e., CTX, streptomycin).
The diagnosis is clinical.
Skin manifestations are usually seen below CD4 count of < 500/mm.3
Some common skin infections and their treatment are presented in Table 40.
Table 40. Common skin infections and their treatment
Herpes simplex
Symptoms HSV-1 or orolabialis on the mouth, face and skin

HSV-2 or genitalis on the genitals, rectum, skin and meninges
Sensory prodrome in the affected area rapidly followed by evolution of painful lesions from papules to
vesicles, ulcer and crusting stages
In severely immune-depressed patients, extensive, deep, non-healing ulcers are seen in the mouth and
on perineum/buttocks
Treatment Limited oral lesions: gentian violet topically, paracetamol (1g qid x 10 days) for mild pain,
carbamazepine (200mg po od x 10 days) for moderate to severe pain
Genital lesions and extensive painful oral ulcers: Acyclovir (400 mg po tid or 200 mg po 5 times daily x 7
days) and paracetamol 500 mg three times a day for 3--4 days
Recurrent Recurrence occurs frequently (more than 6/year): preventive therapy with acyclovir may be required
infections (200 mg tid or 300 bid)
In HIV+ For pregnant women who report a history of genital herpes, acyclovir treatment is given from 36 weeks
pregnant of gestation through to minimize risk of transmission to the baby
women
Herpes Zoster (WHO stage 2 disease)
64
Symptoms • Prodrome of headache, photophobia, and malaise, but usually no fever; followed by tingling or
pruritis or pain that resembles a burn or muscle
injury in the affected dermatome. A painful
maculopapular rash appears that evolves to
vesicles, pustules, and scabs over 3–5 days
(dermatomal presentation) with healing over 2–4
weeks
• Complication: Post herpetic neuralgia after
healing of scars
Image 1. Herpes zoster in

HIV infection
Treatment Topical treatment: gentian violet (no calamine lotion!)

Systemic treatment
If patient presents within 72 hours of rash beginning: Acyclovir(800 mg 5 x/day x 7 days)
Paracetamol (1g qid) and carbamazepine (200mg po bid x 10 days)to prevent post-herpetic neuralgia
Cutaneous or mucosal candidiasis
Symptoms Cutaneous candidiasis: wet and itchy lesions with scaling and satellite papules. Also causes vaginitis:
vaginal irritation, itching, burning and thick white discharge
Treatment Cutaneous:
Topical treatment
1st line: gentian violet or Whitefield's ointment topically (x 2–4 weeks)
2nd line: Clotrimazole 1% cream topically (x 2–4 weeks)
Systemic treatment in severe cases fluconazole 100mg weekly for 4 weeks or give 100mg daily for 7 days
Vaginitis:
Clotrimazole pessary (200 mg od every night x 3 days or 100 mg od every night x 6 days) or fluconazole
if persistent or recurrent
Tinea pedis & Tineacorporis (cutaneousring worm)
Symptoms Tines pedis is characterized by peeling, cracking and scaling skin in the interdigital web areas, mainly
between toes, along with occasional redness and blisters on the soles and sides of feet
Tines corporis is characterised by a pruriginous annular, and erythematous lesion with a raised,
erythematous active edge. It may be single or disseminated lesions of varying size
Treatment Topical treatment

1st line: Whitefield's ointment or gentian violet topically (x 2–4 weeks)
2nd line: Clotrimazole 1% cream topically (x 2–4 weeks)
Systemic treatment in severe cases fluconazole 100mg weekly for 4 weeks
Folliculitis
Symptoms Presents as an eruption with papules and pustules on face, trunk and extremities; usually very pruritic
causing excoriations; multiple exacerbations and remissions
65
Treatment Topical treatment
No supra-infection: C/C solution or ointment, topically (bid x 2 wks); Mild supra-infection: C/C ointment
+ Neomycin, topically (bid x 2 weeks)
Systemic treatment, if severe supra-infection with cloxacillin (500 mg po qid x 7 days)
Scabies (common in Timor-Leste)

Epidemiology and context Scabies is a ectoparasitic infection of the skin that is caused by the mite
sarcoptesscabiei var. hominis. Pandemic throughout the
world, it is estimated there may be around 150 million
cases,28 but is particularly problematic in population
with low hygiene, overcrowding. social disruption and
shortage of water. In HIV-infected populations,
prevalence has been reported as between 0.5% and6% in
adults and 2% and 10% in children.29
Transmission is mainly by skin to skin contact with
infected individuals. Normally transmission is rare
through innate objects and fomites, but is common in Image 2. Sarcoptes
immunocompromised individuals scabiei
Symptoms Two main forms of presentation may be seen:1) Classical; and 2) Atypical or crusted
form
Classical scabies: Small red papules that are intensely
pruritic, especially at night. Sometimes presentation
is the "burrow," a 3--15 mm line that represents the
superficial tunnel the female mite digs to lay eggs.
Interdigital web spaces of the fingers, the wrists,
axillary areas, female breasts (particularly the skin of
the nipples), peri-umbilical area, penis, scrotum and
buttocks Image 3. Classical scabies
Crusted scabies (Norwegian scabies):
Presentation could be also hyperkeratosis of the knees, elbows and trunk. Scabies is
usually atypical in advanced disease; it may be far more extensive than usual including
areas above the neck
Treatment Mild to moderate scabies
Topical treatment: Permethrin 5% (two applications) or Benzyl benzoate 25%
topically to whole body except face nightly for 3 nights.
If there is poor response to treatment, or permethrin treatment is not feasible, then
two doses of oral ivermectin at 200 µg/kg/dose (10 mg in a 50 kg person) is
recommended (each 1week apart)
Remember to also treat clothes, bed linen and all family members.
Severe or crusted scabies
Both topical and systemic treatment is recommended
Topical: 5% permethrin crème (several applications) every 2--3 days for 1–2 weeks
Systemic: ivermectin (200 µg/kg/dose) for three doses (days 1, 2 and8); five doses (1,
2, 8, 9 and15) or seven doses (1, 2, 8, 9, 15, 22 and29). Physician discretion is advised
based on severity of infection
Pruritic papular eruption (PPE)
Epidemiology Papular pruritic eruption is one of the most common skin conditions associated with
HIV disease in tropical and subtropical regions, with reported prevalence of 11–46%
Pathophysiology of papular pruritic eruption is not well understood. Some suggests,
hypersensitivity to arthropod bites and a form delayed hypersensitivity to arthropod
antigens in the reconstitution syndrome
28Hay RJ. Scabies – learning from animals. J EurAcad Dermatol Venereol. 2004; 18:129–30.
29Patton LL, Phelan JA, Ramos-Gomez FJ, Nittayananta W, Shiboski CH, Mbuguye TL. Prevalence and
classification of HIV-associated oral lesions. Oral Dis. 2002; 8(S 2):98–10.
66
Symptoms Chronic symmetric papular eruption, mostly on extremities,
lower back, buttocks; very pruritic, and frequently secondarily
infected
Lesions are at different stage of evolution: early blisters,

inflamed papules, old inactive lesions. Might remain with post-
inflammatory pigmentation
Scabies, eosinophilic folliculitis and drug eruptions should

always be considered in the differential diagnosis Image 4. PPE in
HIV infected
Treatment Primary treatment is ART

Vaseline moisturizers mixed with Hydrocortisone 1% ointment (x 2weeks)
Povidone-iodine solution 0.5% (x 2 weeks) if evidence of superadded infection is
present. Add tab doxycycline for any infected dermatitis
Other therapeutic measures include:

• Phototherapy – with UVB and PUVA
• Pentoxyphyllin
Epidemiology Seborrhoeic dermatitis is a chronic condition that can affect people at any age. It
tends to wax and wane and is prone to recurrence after treatment
Seborrhoeic dermatitis has been reported to be associated with several conditions,
including HIV. In HIV-infected patients, prevalence is much higher and occurs early in
the course of HIV disease, with a mean CD4 count at presentation of higher than
500/mm3
Symptoms Adults:
Seborrhoeic dermatitis on the scalp manifests as
dry, flaking desquamation (dandruff)or yellow,
greasy scaling with erythema. In adolescence and
adulthood, it usually begins as mild greasy scaling
of the scalp with erythema and scaling of the
nasolabial folds or the postauricular skin
Children: Image 5. Seborrhoeic
In infants, seborrhoeic dermatitis may present as dermatitis in HIV infection
thick, greasy scales on the vertex of the scalp -
cradle cap seborrhoeic dermatitis
In older children, it manifests as dry, flaking desquamation(dandruff) or yellow,
greasy scaling with erythema
Differential diagnoses are psoriasis, eczema and Tinea capitis
In HIV infected, the occurrence is much more common and severe. It may be extensive
and cover the whole body. It may be more resistant to treatment and prone to
frequent relapses and recurrence
Treatment Mild seborrhoeic dermatitis
HIV-infected children and adults should be treated with topical ketoconazole 2% or
clotrimazole 1% two to three times per week for4weeks, with a maintenance
treatment once per week or as needed
Severe seborrhoeic dermatitis
HIV-infected children and adults unresponsive to first-line therapy should be treated
with a combination therapy of topical antifungals (e.g., clotrimazole 1% or
ketoconazole 2%) and topical corticosteroids
ART should be the support required to reduce the frequency of recurrence and
relapses
Psoriasis
Epidemiology Extensive psoriasis is observed in HIV patients; however, the incidence may not be
increased
67
Symptoms Common ones are:
• Rashes or patches of red, inflamed skin often
covered with loose, silver-coloured scales. In
severe cases, the plaques will grow and merge
into one another, covering large areas
• Itchy, painful skin that can crack or bleed
• Small areas of bleeding where the involved Image 6. Psoriasis in HIV
skin is scratched infection
• Problems with fingernails and toenails,
including discoloration and pitting. The nails may also begin to crumble or
detach from the nail bed
• Scaly plaques on the scalp
Treatment Mild seborrhoeic dermatitis
HIV-infected children and adults should be treated with topical ketoconazole 2% or
clotrimazole 1% 2–3 times per week for4weeks, with a maintenance treatment once
per week or as needed
Severe seborrhoeic dermatitis
HIV-infected children and adults unresponsive to first-line therapy should be treated
with a combination therapy of topical antifungals (e.g., clotrimazole 1% or
ketoconazole 2%) and topical corticosteroids
ART should be the support required to reduce the frequency of recurrence and
relapses
Kaposisarcoma (KS)
Epidemiology KS, a tumour of endothelial cell origin, is an AIDS-defining illness caused by the
humanherpesvirus-8 (HHV-8). It remains the most common
malignancy in PLHIVs, especially in sub-Saharan Africa
The advent of ART has had a profound influence on the epidemiology of HIV-
associated KS, particularly in developed countries, and has been associated with a
substantial reduction in KS incidence
Sexual route seems to be the main route of transmission for KS
Symptoms Adults
Characteristic appearance of skin lesions, which
can present as macules, papules, nodules or
plaques, ranging in colour from faint pink to
purple to brown. These lesions may also be
present on the oral and genital mucosa, with or
without accompanying internal organ
involvement. Associated dissemination to
lymphatics may occur, with or without painful
lymphoedema and/or lymphadenopathy Image 7. KS in HIV
Children
The presentation and outcome of KS in children may differ from that in adults. For
example, children often present without characteristic skin lesions and at higher CD4
count levels. This has implications regarding staging and treatment of paediatric KS
and use of adult staging criteria as the basis for selecting treatment may not be
applicable in all cases (WHO, 2014)30
Visceral: digestive (usually asymptomatic) or pulmonary, lymph nodes
Classification/ case definitions Two basic types:

Mild/moderate and severe
Mild/moderate KS Severe KS
• Confined to skin and/or lymph • Symptomatic visceral disease
nodes (pulmonarya or gastrointestinalb)
• No symptomatic visceral disease
30Guidelines on the treatment of skin and oral HIV-associated conditions in children and adults. Geneva:World
Health Organization; 2014.16--25.
68
• No significant oral disease (i.e., • Extensive oral KS lesions, which
does notinterfere with chewing or interfere with chewing or
swallowing) swallowing
• No significant oedema affecting • Painful or disabling tumour-
function associated facial/genital/
• Not functionally disabling or peripheral oedema or ulcerated
immediately life-threatening tumours
• Life-threatening or functionally
disabling disease
• Progressivec or persistent KS
despite ART
Note: aSymptomatic pulmonary KS, suggested by shortness of breath, hemoptysis or
moderate/severe cough, which cannot be attributed to other pulmonary conditions.
b Symptomatic gastrointestinal KS, suggested by bleeding from mouth or rectum, which cannot
be attributed to other gastrointestinal conditions.

c Progressive disease is defined as: an increase of 25% or more in the size of previously existing
lesions and/or the appearance of new lesions or new sites of disease and/or a change in the
character of 25% of more of the skin or oral lesions from macular to plaque-like or nodular. The
development of new or increasing symptomatic tumour associated oedema or effusion is also
considered to represent disease progression.
Source: Adapted from ACTG (1997) and WHO Classifications (2014).
Staging criteria The AIDS Clinical Trials Group (ACTG) staging classification was developed in the pre-
ART era to establish a common language to use in describing AIDS-associated KS and
the probability of survival
The adult classification is based on three criteria: tumour extent (T), the status of the
patient’s immune system as measured by CD4 cell count (I) and presence of systemic
symptoms (S). Each factor is further grouped into good risk (0) or poor risk (1)
Criteria Good prognosis Poor prognosis

Tumour (T) (T0) Tumour confined (T1) Tumour-associated
to skin and/or oedema or ulceration;
lymphnodes and/or extensive oral KS;
minimal oral diseasea gastrointestinal KS; KS in
othernon-nodal viscera
Immune system (I) (I0) CD4 cells 150/µL (I1) CD4 cells <150/µL
Systemic illness (S) (S0) No history of OIs (S1) History of OIs and/or
and/or thrush thrush
Absence of ‘B’ Presence of ‘B’

symptomsb symptomsb
Performance status: Performance status:
Karnofsky score 70 Karnofsky score <70
Other HIV-related illness
(e.g., neurologicaldisease,
lymphoma)
Note: a ‘Minimal oral disease’ defined as non-nodular KS confined to the palate
b ‘B’ symptoms: unexplained fever, drenching night sweats, >10% involuntary weight loss, or
diarrhoea persisting more than 2weeks.
Source: Adapted from Krown et.al (1997).
In children, there is no uniform criteria for staging. However, the following is

commonly used:
• Stage I: <10 KS lesions isolated to the skin without significant associated
oedema
• Stage II: 10 KS lesions isolated to the skin, or lesions involving the
palate/oral mucosa, subcutaneous nodules, lymph nodes and/or bone
marrow (i.e., two cytopoenias not otherwise explained)
• Stage III: Disseminated KS involving the lymphatics resulting in
lymphoedema (i.e., “woody” oedema) in the extremities and/or groin
69
• Stage IV: Systemic KS, defined as pulmonary KS with noted
infiltrates/effusions on chest radiography, abdominal involvement with
intra-abdominal nodes, hepatomegaly and/or ascites and/or cardiac
involvement with cardiomegaly and associated pericardial effusion
Source: Adapted from Mitsuasu (1987) and Stephan et. al (2011).
Treatment In HIV-infected adults, adolescents and children diagnosed with mild/moderate KS,
immediate ART initiation is recommended
Severe/symptomatic disease
In HIV-infected adults, adolescents and children diagnosed with severe symptomatic
KS, immediate ART initiation in combination with systemic chemotherapy is
recommended
“Recommended chemotherapy regimens in adults, adolescents and children may

include vincristine with bleomycin and doxorubicin (ABV), bleomycin with vincristine
(BV), and when available or feasible, liposomal anthracyclines (doxorubicin or
daunorubicin), paclitaxel or oral etoposide, at sites with the infrastructure, staff and
resources to administer chemotherapy drugs and provide appropriate monitoring
and supportive care” (sic.) (WHO 2014)
However, in Timor-Leste, the chemotherapeutic regimens are very few. The above-
mentioned drugs are not available in the country. Thus, as of current, the
recommended treatment for KS is ART.
Molluscum contagiosum
Epidemiology Molluscum contagiosum is a skin infection of viral origin. It usually affects young children, but
also sexually active young adults and the immunosuppressed, such as people infected with HIV
Incidence of molluscum contagiosum is estimated to be between 2% and 8%, while in
the HIV infected, it is estimated to be 5–18%31
Superficial viral infection of the epidermis caused by a pox virus and spread by skin-
to-skin contact
Symptoms Lesions are pearly white or skin-coloured papules with
a central umbilication. It can occur anywhere on the
body including the external genitalia, but is most
commonly seen on the face and trunk in children
In PLHIVs, the lesions are usually persistent, frequently
recur, have a fulminant clinical presentation and a
longer duration of clinical manifestation. They may be
disseminated, but with a predilection for the head, neck
Image 8. Molluscum
and genital area contagiosum in HIV infection
Treatment ART should be the primary treatment of extensive and/or unusually distributed molluscum
contagiosum in HIV-infected patients. The disease is self-limiting and, in many cases, could
resolve on its own
Eosinophilic folliculitis
Epidemiology Prevalence of HIV-associated eosinophilic folliculitis varies greatly across different
populations. Before the widespread use of ART in the developing countries, this was commonly
seen in moderate to severe immune suppression
The development of HIV-associated eosinophilic folliculitis is strongly associated with advanced

immunosuppression, especially CD4 counts < 250 cells/mm,3 and low CD4 nadir (< 50 cells/mm3)
31Husak R, Garbe C, Orfanos CE. Mollusca contagiosa in HIV-patients. clinical manifestations, relation to the
immunological status and prognostic significance. [German] Mollusca contagiosabei HIV-Infektion.
Klinische Manifestation, BeziehungzumImmunstatus und prognostischeWertigkeitbei 39 Patienten.
Hautarzt. 1997; 48(2):103–9.
70
Symptoms HIV-associated eosinophilic folliculitis manifests as 2–3 mm erythematous, highly pruritic
wheallikepapules, most frequently affecting the shoulders, trunk, upper arms, neck and
forehead.Lesions are follicular and are often markedly excoriated
Severe pruritus may cause sleep impairment, distress and even depression. However, the
diagnostic challenge is differentiating between other dermatoses. The table below provides a
differentiating feature for the types of dermatoses:
Criteria Eosinophilic Papular pruritic Scabies
folliculitis eruptions
Itching Severe and Severe and Night-time itching
throughout day and throughout day and and partner itching
night night
Skin lesions • Oedematous, • Hyperpigmented • Small papules,
wheal like and skin- papulovesicles
papules coloured • “Burrows”
• Excoriations papules
• Severe
excoriations and
scarring, and
sometimes
prurigo-like
lesions
Distributions • Neck, forehead, • Predominantly • Finger web
cheeks and trunk extensor surface spaces, palms,
of extremities forearms, axilla,
and trunk areola and
nipple,
umbilicus,
external
genitalia
• No facial lesions
Histopathology • Characteristic • Suggestive, but • Suggestive
variable unless mite is
visualized
Treatment ART should be the primary treatment of eosinophilic folliculitis in HIV-infected patients
All HIV-infected adults (including pregnant women), adolescents and children who
have been initiated on ART and who subsequently develop HIV-associated eosinophilic
folliculitis should not discontinue the ART
Additional symptomatic therapy is recommended for the duration of the persistent
symptoms with, depending on severity:
• Oral antihistamine such as promethazine HCl, chlorpheniramine maleate or cetirizine, add
• Topical corticosteroids if no response to antihistamine; add
• Oral fluconazole if response is poor; add
• Permethrin 5% crème applied above the waist
71
Management of neurological disorders in HIV infection
The assessment of the patient with headache should include the

Neurological complications in
presence orabsence of neurological symptoms, including: HIV patients may be due to:
• Evidence of meningeal irritation or raised intracranial • HIV(HIV encephalopathy)
pressure (neck stiffness, photophobia, vomiting and • OIs(Toxoplasmosis,
bradycardia in the presence of fever) due to bacterial cryptococcal meningitis
and fungal meningitis • Neurosyphilis
• Seizures and focal neurological deficits (paresis, cranial
• Malignancies (primary CNS
nerve palsies, movement disorders, ataxia and aphasia) lymphoma)
due to toxoplasmosis, tuberculoma, cryptococcoma,
• Drugs (e.g., EFV, etc.)
lymphoma and PML) Box 1. Common neurological
• Changes in mental status (loss of concentration, complications in HIV infection
personality change, confusion and cognitive
impairment) and dementia due to TB meningitis, CM and HIV dementia
• Visual disturbances due to CMV(floaters, scotoma and flashing lights).
HIV infection itself may cause encephalopathy and the neurological complications could be due to
other infections as well.
Some of these conditions require advanced investigations for diagnosis, but the most common seen
in resource-limited settings may be clinically strongly suspected (toxoplasmosis) or diagnosed only
with CSF examination (meningitis).
Malaria used to be an endemic disease in Timor-Leste. With substantial effort, the country has been
able to reach the doorstep for elimination and less than 10 cases of malaria are being detected per
year. Thus, in the differential diagnosis of meningeal conditions malaria should be the last option.
CD4 is very useful in narrowing the differential diagnosis. Patientson ARVs and cotrimoxazole
prophylaxis may be at lower risk of some infections such as malaria and toxoplasmosis, but they
should still be considered.
Toxoplasmosis is the most common cause of focal brain disease in HIV patients. It is, therefore, worth
treating any HIV positive patient presenting with focal neurological signs, with or without fever (Table
41).
72
Table 41. Management of neurological disorders
Toxoplasmosis (WHO Stage 4 disease)

Epidemiology and Toxoplasmosis is a zoonosis caused by the obligate intracellular parasite, Toxoplasma gondii,
life cycle and has a worldwide distribution. Majority of the infection is caused in cats and humans, but
can infect any mammal and birds
Most of the horizontal transmission to humans
is caused by ingestion of tissue cysts in infected
meat, or by ingestion of water or food
contaminated with sporulated oocysts from
the environment, and less frequently directly
from feline faeces
In patients with HIV infection, most cases of
toxoplasmosis are reactivation disease
occurring when the CD4 T-lymphocyte (CD4)
cell count is <50 cells/mm3
Although not known, it is presumed that in
Timor-Leste, the prevalence should be high
owing to presence of numerous feline species
and poor hygiene levels
Symptoms and Central nervous system (CNS) manifestations are the most common presentation of
diagnosis toxoplasmosis and include toxoplasma cerebral abscess and encephalitis
Common symptoms include:
• Constellation of severe headache, fever and focal neurological signs (such as hemiparesis)
is typical
• Altered mental status such as confusion, change in behaviour, seizures, coma, eye pain and
reduced vision
• Involvement of other organs such as lungs, eyes, heart, liver and pancreas lead to
retinochoroiditis, pneumonitis, myocarditis and other manifestations of disseminated
infection
Physical examination would demonstrate neurological abnormalities
Usual presentation is below CD4 count of < 100 cells/mm3
Diagnosis of toxoplasma encephalitis is most often presumptive, rather than definitive
Treatment Toxoplasma encephalitis
Sulfadiazine 1000 mg four times a day (or 1500 mg four times a day, if weight is more than
60 kg)plus
Pyrimethamine 200 mg loading dose followed by 50 mg daily (or 75 mg daily, if weight is
more than 60 kg) plus
Folinic acid 10 mg daily
Duration: 6–8 weeks or more
If condition deteriorates, alternative diagnosis may be considered and dexamethasone 4 mg
four times a day tapered over a few days should be used.
Prophylaxis Please refer to section on CTX prophylaxis
Bacterial meningitis
Epidemiology Bacterial meningitis may be common in many HIV infections, especially if the CD4 counts are
below 100 cell/mm3
Although cryptococcal and TB meningitis would be common in HIV infected in Timor-Leste

(Programme data), bacterial meningitis would rank third in the series. Unfortunately, mortality
from any of these diseases is high. Most common causative organism is N. meningitis
(Meningococcus), followed by Streptococcus pneumoniae, Haemophilus influenza, etc.
Symptoms High pyrexia, violent headache, photophobia, vomiting, and
sometimes decreased level of consciousness
On clinical examination, neck stiffness (can be absent in some aetiologies), positive Kernig and
Brudzinski signs, and petechial lesions (if meningococcus)
Diagnosis CSF examination:
Turbid appearance
73
Poly morpho nuclear cells > 500/mm3
Low glucose
Increased protein usually > 1g/L
Treatment Ceftriaxone 2g IV od x 7 days
Peripheral neuropathy (PNP)
Epidemiology Nearly 33% of people infected with HIV/AIDS experience some peripheral nerve damage.
Peripheral neuropathy can by caused by HIV virus itself by certain drugs used in the treatment
of HIV/AIDS (Didanosine, Zalcitabin, Stavudine, etc.) or other complications (dapsone, INH,
metronidazole, vincristine, ethambutol, etc.) or as a result of OIs (e.g., CMV, candidiasis [thrush],
herpes, TB). Neuropathy could also result from other associated causes, such as alcohol
consumption and vitamin B deficiency
Symptoms HIV-related neuropathy presents as sensory loss, pain and numbness in the extremities
(toes and feet). Ankles, calves and fingers are involved in more advanced cases
Sharp, stabbing pain, "shooting electrical feeling", in post-herpetic neuralgia
Burning, tingling, pins and needles in drugs associated peripheral neuropathy
Diagnosis Usually clinical in resource-constraint settings
Nerve conduction studies are a good compliment and confirmation
Treatment Combination ART using safer drugs is the way to go. Current regimens of
Tenofovir+Lamivudine+Efavirenz is not known to cause PNP, dolutegravir based regimens are
also not known to cause acute PNP
In coinfection with TB, pyridoxine (vit B6) is a regular complement and reduces the incidence of
PNP in coinfected patients
Alcohol intake is very high in Timor-Leste and is one of the major causative factors for PNP.
Adequate counselling is a must on reducing the risk of PNP due to alcohol
For intractable pain, amitriptyline (25 to 75 mg po) at bedtime (can increase up to200 mg, if
necessary)
For post-herpetic neuralgia: carbamazepine (200 mg po bid) for 2–4 weeks could be added
Educate patients to identify early signs of PNP
Recommend good foot care, comfortable shoes, and walking aids
Recommend balanced diet to avoid vitamin deficiencies
Recommend exercise or massage to improve circulation of feet
Palliative care
Palliative care is the provision of appropriate relief from physical and psychological discomfort in the
absence of cure. However, in HIV infection, the need for palliative care arises more often not only due
to absence of cure, but also mainly to support during the treatment of many types of OIs that develops
during the course of infection. Palliative care extends, if necessary, to support in bereavement.
In the current era of ART, there should be very few circumstances when medical care is no longer
effective, or the side-effects outweigh the benefits of treatment. These would include end-stage liver
or renal diseases.
Palliative care includes:
Pain relief
Appropriate nursing care to keep the person comfortable
Psychological support
No aggressive treatments.
An initial assessment of the patient’s pain includes believing the patient's complaint, establishing the
severity of the pain preferably by using a visual scale (pain quoted from 0 to 10, 0 being no pain at all)
74
and assessing the restriction it causes. A physical examination that includes a psychological
assessment is important to rule out any treatable causes of the pain.
Fig. 10. Visual analogue scale with Wong-Baker faces for assessment of pain
The analgesic ladder (WHO) defines three levels of pain with adapted painkillers for each level(Fig. 11):
Nonopioids such as aspirin,
paracetamol and ibuprofen
Weak opioids such as codeine
and dextropropoxyphene
Strong opioids such as
morphine and tramadol.
The adjuvants that can be used to

enhance the efficacy of these drugs are
carbamazepine, diazepam,
amitriptyline and prednisolone.
Follow the protocol given below for pain
control in PLHIVs:
If possible, give oral painkillers Fig. 11. WHO analgesic ladder for pain
and not injectables
Give painkillers at fixed-time intervals
Start with low dose and increase until the patient is comfortable
Give next dose before previous dose wears off (specifically in chronic pain)
Treatment must be individualized for the patient.
Table 42 provides the guide to pain management using oral non-steroidal anti-inflammatory drugs
(NSAIDs).
75
Table 27. Commonly used NSAIDS in management of intractable pain in PLHIVs
Drug Dose
1. Paracetamol/Acetaminophen 650 mg every 4 hourly oral
2. Aspirin 650 mg every 4 hourly oral
3. Ibuprofen 200–800 mg every 6 hourly oral
4. Diclofenac sodium 50–75 mg every 8–12 hourly oral
5. Aceclofenac 100–200 mg every 12 hourly oral
Table 28.Commonly used opioids in pain management in PLHIVs

Drug Dose
1. Codeine phosphate 60 mg every 3–4 hourly oral
2. Tramadol HCl 50 mg every 6 hourly oral
3. Oxycodone hydrochloride 10 mg every 3–4 hourly oral
4. Morphine sulphate (plain) 30 mg every 3–4 hourly oral
5. Morphine sulphate (sustained release tabs) 30 mg every 12 hourly oral
6. Morphine sulphate (injectable) 10 mg every 3–4 hours i.v
Apart from this, there may be situations where there are special needs to individual patients. Table 44 provides
guidance to managing some special situations.
Table 44. Management of pain in special situations in HIV infection

Situations Management
Burning pains; abnormal sensation pains; severe shooting Pregabalin 75 mg twice a day or start low-dose
pains with relatively little pain in between, pins and needles amitriptyline at 12.5 mg at night and then increase
to 25 mg after 2 weeks and then increase to 50 mg
after another 2 weeks
Muscle spasms in end-of-life care or paralyzed patient Diazepam 5 mg orally
Herpes zoster (or shooting pain following it) Low-dose amitriptyline 12.5–25 mg daily
Refer patients with ophthalmic zoster Early eruption: acyclovir if available; apply gentian
violet/povidone iodine if ruptured vesicles
Gastrointestinal pain from colic only after intestinal Use dicyclomine HCl 10–20 mg every eight hourly
obstruction has been excluded (i.e., vomiting, no stool and gas oral along with paracetamol 500--650 mg every
passing, visible bowel movements) eight hours (or Mefenamic acid 250–500 mg)
Bone pain or renal colic or dysmenorrhoea Ibuprofen (200–400 mg and paracetamol (325 mg)
combination 3–4 times a day or
Mefenamic acid (250–500 mg) 3–4 times a day
If pain is from: When giving end-of-life care and referral is not
Swelling around tumour desired, one can consider use of steroids under
Severe oesophageal ulceration and cannot swallow careful clinical supervision
Nerve or spinal cord compression
Persistent severe headache (likely from increased
intracranial pressure)
Additional methods for pain control

Combine these with pain medications if the patient agrees and it helps:
Emotional support
Physical methods:
o Touch (stroking, massage, rocking and vibration)
o Ice or heat
o Deep breathing.
Cognitive methods: distraction such as radio, music, and imagining a pleasant scene
Prayer (with respect to patient’s practice)
76
o Traditional practices which are helpful and not harmful—get to know what can help
in the local setting.
Some special conditions in HIV management
Immune reconstitution inflammatory syndrome (IRIS)

IRIS describes some inflammatory disorders associated with paradoxical worsening of pre-existing
infectious processes following the initiation of ART. Pre-existing infections may have been previously
diagnosed and treated, or they may be subclinical, undiagnosed and later unmasked by the host’s
regained capacity to mount inflammatory response (Table 45).
IRIS does not indicate a failure of ART, as it shows an immunological and virological response to
ART(Fig.12).
Under programmatic conditions and
field level, the following working
definition could be adopted for use:
“IRIS is a paradoxical inflammatory
reaction against a foreign antigen (alive
or dead) in patients who have started
ART with reconstitution (improved
functioning) of their immune system.
The immune system, once it regains
some function, is now able to respond
against the foreign antigen”
Fig. 12. Immune reconstitution inflammatory syndrome
Table 4529. Classification of IRIS

Categories Target antigen
Infection–unmasking Viable replicating infective antigen
Infection-paradoxical Dead or dying organisms
Autoimmune Host
Malignancies Possible tumour or associated pathogen
Source: Devesh J. Dhasmana, Keertan Dheda, Pernille Ravn, Robert J. Wilkinson and Graeme Meintjes. IRIS in HIV infected patients receiving
antiretroviral therapy pathogenesis, clinical manifestations &management. Drugs,2008; 68 (2):191–208.
Diagnosis criteria
MostorallofthefollowingfeaturesshouldbepresentinordertomakethediagnosisofIRIS:
• The presence of stage 2, 3 and 4 symptoms that have developed after the commencement of
ART, or had improved with ART, and have since worsened
• Symptoms consistent with an inflammatory condition that c a n n o t be explained by an acute
drug-resistant infection, a bacterial superinfection, ADRs, treatment failure due to obvious
lack of adherence or drug malabsorption
77
• Evidence of good response to ART with immune reconstitution (e.g., increase from baseline of
CD4 and undetectable VLs)
• The timing of onset is variable. Most of IRIS developed within the first two months after ART
initiation (in 2/3 of patients). IRIS can also occur within a few days after initiating ART, or as
late as three years after its commencement.
Pathogens involved
The most frequently reported associated infections are mycobacterium tuberculosis (MTB),
cryptococcus, KS, localised herpeszoster, mycobacterium avium complex (MAC), and CMV. The clinical
features of IRIS are strongly related to the type of pre-existing OI.
IRIS prevention
Aim to treat and stabilise known OIs prior to initiation of ART, unless severely immunocompromised
or unwell, where delay in ART may result in increased mortality from the current OI, or the
development of other OIs in the interim.
Clinician awareness of IRIS is especially important so that it can be identified quickly and managed
correctly.
IRIS management
• Treat the underlying OI
• Continue ART despite IRIS.
If severe, treat with NSAIDs or corticosteroids to decrease the inflammatory syndrome. Treatment
with corticosteroids must be an individualized decision as such treatment could be harmful. Initiate
with prednisolone 1 mg/kg/day (maximum 60 to 80 mg/day), and then decrease the dose over 4–6
weeks.
ART may be interrupted if the patient is experiencing life-threatening IRIS despite the initiation of
corticosteroids. Patients should then be treated for a period of time for the underlying infection before
resuming ART (Table 46).
Table 46. Management protocol in case of IRIS
Severity Definition Management
of IRIS
Mild Resolves over time • Treat the OI and manage the associated symptoms
in most patients • Treat IRIS-associated inflammation:
Symptomatic o NSAIDS for discomfort associated with mild inflammation/fever
treatment is often o Inhaled steroids for bronchospasm or cough associated with mild
enough pulmonary inflammation
• Surgical intervention:
o Drainage of abscesses
o Excision of inflamed and painful lymph nodes
Severe • Threatens a • Treat the OI and manage the associated symptoms
patient’s • Manage the IRIS-associated inflammation:
functional o If NOT cryptococcal meningitis or KS: give 1--2 mg/kg prednisone for 1–2
state weeks. Follow with a period of individualized tapering of the dose
• Cause o Do not use corticosteroids for the management of CM or KS-related IRIS
permanent • Closely monitor patients on corticosteroid therapy for:
disability o Hyperglycaemia
o Hypertension
78
• Potentially o Mental status changes
lead to death o Avascular necrosis
Examples: o Worsening of an existing infection
• Decline in o Predisposition to a new infection (e.g., TB and CMV)
pulmonary
capacity from
TB or MAC
infection
• Neurologic
complications
from
cryptococcal
infection
• Loss of vision
from CMV
retinitis
infection
79
Chapter 7
TB and HIV
TB diagnosis and treatment

HIV is the most powerful known risk factor for reactivation of LTBI to active disease. In PLHIVs, there
is also a higher risk of rapid TB progression to active disease soon after infection with
Mycobacteriumtuberculosis. A person infected with HIV has 10 times higher risk of developing TB,
than those who are uninfected. TB can occur at any point during progression of HIV infection, but the
risk of developing TB rises sharply with worsening immune status. Available evidence show that
PLHIVs are nearly 29 times (26–31 times) more likely to develop TB as compared to people without
HIV in the same country.32
HIV status Life time risk of developing TB

Negative 5–10%
Positive 50% (or 10–30% per year33)
HIV positive patients with TB, who are not receiving ART, have a higher case-fatality both during and
after anti-TB treatment. Also, HIV+smear-negative pulmonary TB cases and EPTB have a worse
prognosis than HIV+smearpositive PTB cases. The high case fatality rates are due in a large part to TB,
but also attributable to other HIV-related infections that might be present at the same time. In
addition, failure, recurrence and relapse rates after TB treatment are higher in HIV-coinfected
patients.
In an individual infected with HIV, the presence of other infections, including TB, may allow HIV to
multiply more quickly due to additional weakening of the immune system. This results in more rapid
progression of HIV disease. TB is also one of the leading causes of mortality among the HIV+
individuals.
General principles of management of HIV-TB coinfected patients
• Intensified case finding using 4-symptom complex for TB screening; fast-tracking and referral
of symptomatic patients for Xpert® MTB/RIF test and other appropriate investigations, as
required, for TB diagnosis
• If a patient with active TB is diagnosed with HIV, the priority is to start TB treatment in
accordance with the national TB treatment guidelines
• Co-trimoxazole prophylaxis should be given to all HIV–TB patients.
Diagnosis of TB in HIV positive patient

PTB is the commonest form of TB in HIV+ patients. The presentation depends on the degree of immune
suppression.
32Tuberculosis
prevalence surveys: a handbook. Geneva: World Health Organization; 2011.
33Maartens G, Wilkinson RJ. Tuberculosis. Lancet online. August 2007 (www.thelancet.com, accessed 14
September 2019).
80
In the early stages of HIV infection, when immunity is only partially compromised, the features are
typical of PTB.
As immune deficiency advances, HIV-infected patients present with atypical pulmonary disease
resembling primary TB or EPTB or disseminated disease. Bacterial co-pathogens are frequent in HIV-
coinfected patients (Table47).
Table 47. Features of PTB in different stages of HIV infection

Stage of HIV infection
Features of PTB Early Late
Clinical picture Chronic cough (any duration) sputum Weight loss and fever>TB must be
production excluded in any patient presenting
Weight loss+/- fever, night sweats, loss of with wasting syndrome
appetite, breathlessness, chest pain,
haemoptysis
Cough and haemoptysis are less common in HIV+ PTB patients as immuno
deficiency increases (less cavitation, inflammation and endobronchialirritation).
However, chronic cough lasting more than
2–3 weeks is also highly predictive of TB disease in PLHIVs
Sputum smear result Often positive Often negative
CXR findings • Upper lobe infiltrates • Interstitial infiltrates especially

• Bilateral infiltrates in lower zones
• Cavitation • Hilar adenopathy and/or pleural
effusion
• Sometimes miliary
• No cavitation
• No abnormality
Table 48. Differential diagnosis of PTB in HIV-infected adult patients

Differential diagnosis Details
Acute bacterial pneumonia • Shorter history
• All clients with cough >2 weeks should be referred to exclude TB (i.e., sputum
smear microscopy for AFB, chest X-ray)
• Chest X-ray: lobar infiltrate or may be negative
Pneumocystis pneumonia • Sub-acute and insidious onset
• Later stage of HIV infection (CD4 count <200/mm3)
• Dry cough, mucoid sputum (if any), progressive dyspnoea
• Chest X -ray: bilateral d i f f u s e infiltrates (ground glass appearance) or may
be normal or may have findings of spontaneous pneumothorax
Kaposi’ssarcoma • Typical lesions found on the skin and mucous membranes (oral cavity)
• Cough, haemoptysis and dyspnoea
• Pleural fluid is blood-stained
Diagnosis of PTB in HIV+ patient

Intensified case finding (ICF) involves systematic screening for active TB among high-risk populations
at each visit to a health facility. PLHIV should be regularly screened for TB during every visit to the ART
centres using the 4-symptom (4S) complex---current cough, fever, weight loss and night sweats---
81
among adults. In children, the 4S complex includes current cough, fever, poor weight gain and history
of contact with a TB case(Fig. 13). The 4S screening has a sensitivity of 85%.34
4 symptom screening for PLHIV: 4 symptom screening for child PLHIV

• Fever • Fever
• Current cough • Current cough
• Night sweats • Poor weight gain
• Weight loss • H/O contact with TB patient Start anti-TB
treatment and DO
NOT stop ART
4S screening: Refer for TB

Positive for any diagnosis to TB TB positive
one centre
HIV positive on
ART
Negative Consider for TPT TB negative
Fig. 11. HIV-TB coinfection: algorithm for screening HIV positive individuals
Diagnosis of EPTB
Tuberculosis may infect any tissue or organ system of the body.
The commonest forms of EPTB in HIV+ patients are lymphadenopathy, pleural, peritoneal and
pericardial effusion, miliary and meningeal TB.
Presentation of EPTB in HIV+ patients is generally not different from that in HIV negative ones. Suspect
disseminated TB in all HIV-infected people who experience rapid or marked weight loss, fever and
night sweats.
When to suspect EPTB?
TB lymph nodes are difficult to distinguish clinically from other causes of enlarged nodes. Therefore,
needle aspiration should be carried out at the first visit(Table 49).
Table 49. Differential diagnosis of EPTB in HIV-infected adult patients
High suspicion of TB, if Probably not TB, if
Lymph node • 2cm or more in size, • KS in skin or mouth: KS nodes
TB symmetrical/localized • Symmetrical: Lymphoma or
painless swelling, HIV lymphadenopathy
firm/fluctuant/fistulated • Tender, inflamed, purulent: bacterial or fungal
cervical location, weight • Site other than cervical (although EPTB
loss, night sweats and fever lymphadenopathy may be anywhere)
Pleural • Unilateral Bilateral: heart failure, pneumonia
effusion Clinical KS/other malignancy
Aspirate or fluid is:
• cloudy/pus
34Getahun H et al. Development of a standardised screening rule for tuberculosis in people living with HIV in
resource constrained settings: individual participant data meta-analysis of observational studies. PLoS
Medicine, 2011; 8(1):e1000391.doi:10.1371/journal.pmed.1000391Meta-analysis of 12 studies and 8,148.
82
• Aspirate of fluids is clear • fails to clot
and straw coloured and
clots on standing in a tube
• Weight loss, night sweats
and fever
• Rivalta test+35
Disseminated TB Weight loss, fever and cough Differential diagnosis with salmonella, malaria,
Abnormal CXR (including cryptococcus, kala-azar, lymphoma
military pattern) Rigors, very breathless (RR>30/min), severe diarrhoea, blood
Large spleen/liver in stool, positive cryptococcal antigen, malaria smear or
Night sweats, anaemia likely pathogen isolated from blood culture
Pericardial Lung fields clear (but may have Noninfectious, cardiac problems
effusion bilateral pleural effusion) Rigors: bacterial pericarditis murmur: probable valvular
Weight loss, night sweats, fever disease
Evidence of TB elsewhere High blood pressure
TB meningitis • Weight loss, night sweats, Other causes of meningitis, especially cryptococcal
fever CSF clear with high meningitis, bacterial meningitis, etc.
protein, low glucose and
lymphocytes and negative
for Ag crypto or Indian ink
• Evidence of TB elsewhere
TB treatment regimens
There are several possible regimens depending on the patient’s diagnostic category (Table 50).
Table 30. TB treatment regimens
Diagnostic Patient category Treatment regimens
category Intensive phase Continuation phase
All new patients:
New case • PTB smear positive
• PTB smear negative 2 RHEZ 4 RH
• EPTB
Failure to improve
Some TB–HIV patients fail to improve, or even deteriorate, during anti-TB treatment. They continue
to have, or develop new, respiratory problems. In any case, TB treatment must not be interrupted.
First check adherence to TB treatment, and then consider the possibilities given in Table 51.
Table 51. Possibilities for treatment failure

Original diagnosis Possibilities
Sputum smear negative PTB Incorrect diagnosis. For example:
• Other pathogens (pneumocystis pneumonia, bacterial pneumonia,
mycoses, e.g., cryptococcus, Kaposi‘ssarcoma,CMV), heart failure
• Chronic obstructive airways disease
• DR-TB
• IRIS
Sputum smear positive PTB • Superimposed infection with other pathogens
• DR-TB
• Lung abscess (empyema)
• IRIS
35The Rivalta Test is a simple and inexpensive method that can be used in resource-limited settings to
differentiate a transudate from exudates.
83
For a patient with suspected EPTB, who has started on anti-TB treatment without bacteriological or
histological confirmation, the clinical response to treatment should be assessed after two months. If
there is no improvement, a clinical reassessment should be performed, and an alternative diagnosis
is sought. TB treatment should be continued and completed unless TB is excluded (culture). If it is
confirmed that TB is not present, the TB treatment should be ceased.
IRIS may occur in 33% of patients diagnosed with TB and who have been started on ART. It typically
presents within three months of the initiation of ART but can occur as early as five days. Patients with
TB-associated IRIS most commonly present with fever and with worsening of pre-existing
lymphadenopathy or respiratory disease. The symptoms are like the paradoxical reactions seen in
immuno-competent patients on ATT but occur more frequently.
Most cases resolve without any intervention and ART can be safely continued. Serious reactions, such
as tracheal compression caused by massive adenopathy or respiratory difficulty, may occur.
Therapy may require the use of anti-inflammatory drugs, including corticosteroids.
TPT guideline on adults and adolescent living with HIV
The algorithm for TB screening (Fig. 14) in adults and adolescents living with HIV is based on
recommendations published in the recently updated WHO guidelines on LTBI.
Fig. 14. Algorithm for screening adults and adolescents living with HIV for TB

" #&! Treat

% for TB

" " " "

84
Note:
a
Every adult and adolescent should be evaluated for eligibility to receive ART. Infection control measures should be prioritized to reduce M.
tuberculosis transmission in all settings in which care is provided. b Chest radiography can be done if available, particularly for people living
with HIV on ART, but is not required to classify patients into TB and non-TB groups.
Contraindications include: active hepatitis (acute or chronic), regular and heavy alcohol consumption and symptoms of peripheral
neuropathy. History of TB and current pregnancy should not be contraindications for starting preventive treatment.
d
Xpert MTB/RIF should be used as the initial diagnostic test for TB.
Children living with HIV
Infants and children living with HIV who have poor weight gain, fever or current cough or who have a
history of contact with a case of TB should be evaluated for TB and other diseases that cause such
symptoms. If the evaluation shows no TB, these children should be offered preventive treatment,
regardless of their age.
Poor weight gain is defined as reported weight loss, very low weight-for-age (< –3 z-score),
underweight (weight forage < –2 z-score), confirmed weight loss (> 5% since the last visit or growth
curve flattening)
Children and infants < 1 year of age should be given preventive treatment only if they have a history
of household contact with a TB case and active TB has been excluded in investigations.
HIV-negative household contacts of a person with PTB

On reviewing the evidence and considering the field conditions in Timor-Leste, and high TB incidence
rate (498/100000), the country consultation process during the guidelines revision workshop in May
2019 concluded that the implementation of a simple algorithm for ruling out active TB in household
contacts before preventive treatment initiation would be feasible in the country. The algorithm can
be used by health workers at peripheral level. Research on symptom-based screening of children’s TB
contacts indicates that this contact management strategy is safe and more feasible in resource-
limited settings than contact screening based on diagnoses. The algorithm should, therefore, be used
for HIV-negative household contacts of persons with pulmonary TB of all ages (Fig. 15).
85
Fig. 15. Algorithm for screening HIV-negative household contacts of a person with pulmonary TB
Patients must be free of any TB and non-TB related symptoms to be considered well. b The most common TB-related
Note: a
symptoms are persistence of cough, fever, weight loss and night sweats.
Treatment for LTBI

Based on recommendations published in the recently updated WHO guidelines on LTBI, the NTP will
use the following drug regimens for at-risk populations that should receive LTBI treatment:
PLHIVs
• Weekly rifapentine plus isoniazid for 3 months (3HP)
A new systematic review was conducted to compare the effectiveness of a 3-month weekly regimen
of rifapentine plus isoniazid with that of isoniazid monotherapy. The review covered 4 RCTs, of which
2 RCTs involved adults with HIV from South Africa, Peru and in several countries with a low incidence
of TB. No significant difference was found in the incidence of active TB between participants (adults
with HIV infection, adults without HIV infection and children) given a 3-month weekly regimen of
rifapentine plus isoniazid and 6 or 9 months of isoniazid monotherapy. Furthermore, the risk for
hepatotoxicity was significantly lower with the 3-month weekly regimen of rifapentine plus isoniazid
in adults with HIV.
HIV-negative household contacts of a person with PTB

• Weekly rifapentine plus isoniazid for 3 months (3HP) for children above 2 years
This is based on recommendations published in the recently updated WHO guidelines. The advantage
of 3HP is minimum number of doses (12) among other regimens, and hence higher acceptability, well-
tolerated, high treatment completion rate, and higher efficacy than other INH and INH-Rifampicin
combined regimens. 3HP would likely be most suitable in Timor-Leste settings where the need of
preventive treatment coverage and its completion is relatively higher than other regions.
86
It is crucial to strengthen household contact investigations in contacts above 2 years by using the
following regimen:
• Weekly rifapentine plus isoniazid for 3 months (3HP) for children above 2 years. In case,
rifapentine is not available, daily rifampicin plus isoniazid for 3 months (3RH) should be
provided.
For children contacts below 2 years, daily rifampicin plus isoniazid for 3 months (3RH) should be
provided. This regimen is based on recommendations published in the recently updated WHO
guidelines indicating that the efficacy and the safety profile of 3–4 months’ daily rifampicin plus
isoniazid were similar to those of 6 months’ isoniazid.
For adult contacts 3HP is recommended considering the ease of administration (once weekly, 12 doses
instead of daily 90 doses of 3RH). In the long term 3HP (1 HP when it is formally recommended by WHO)
may be the regimen to aim for considering treatment duration.
The shorter treatment duration is expected to facilitate the implementation of LTBI treatment in the
country-specific conditions in Timor-Leste.
ART initiation in HIV-TB coinfection

In the absence of ART, TB therapy alone neither significantly increase the CD4 cell count, nor
significantly decrease the HIV VL. Thus, CD4 counts measured during active TB are likely to reflect the
actual level of immunosuppression. As with all PLHIVs, those who are diagnosed with TB/HIV
coinfection should be on ART and CPT as part of the standard package of care for PLHIVs (Table 52).
Table 52. Timing of ART initiation in HIV--TB coinfection

Criteria Action
Patients who are not yet on ART • Start TB treatment immediately
• Initiate ART as soon as anti-TB medications are tolerated,
preferably within 2 weeks; for TB meningitis consider delaying ART
for up to 8weeks
• Monitor closely for IRIS
Patients who are already on ART • Start TB treatment immediately
• Continue ART, making any required adjustments to the ART
regimen based on drug–drug interactions
• Monitor closely for IRIS
Patient being treated concurrently for TB and • MDR-TB and HIV coinfection should be managed in settings where
HIV requires close monitoring for toxicity close toxicity monitoring and follow-up by experienced clinicians
are possible
• Patients on TDF and aminoglycosides are at high risk for renal
toxicity and require close monitoring
The ART regimens would need to be modified in case of HIV--TB coinfection. With the Dolutegravir-
based regimens now in place , concomitant use of rifampicin needs dose adjustment.. The preferred
ART regimens are summarized in Table 53.
87
Table 53. Preferred ART regimens in HIV--TB coinfection
Age First-line ART regimen in HIV--TB coinfection
< 4 weeks Start anti-TB treatment immediately; start ART after 4weeks of age, once tolerating
anti-TB drugs
4 weeks < 3 years • ABC + 3TC + LPV/r + RTV (additional ritonavir)
• After completion of TB treatment, revert to the recommended first-line regimen
(ABC + 3TC + LPV/r)
3–10 years ABC + 3TC + EFV
> 10 years • Give TDF/3TC/DTG FDC am + DTG 50mg pm for duration of rifampicin-containing
TB treatment and for an additional 2 weeks after TB treatment is completed,
then revert to TDF/3TC/DTG FDC OD
• Alternate TDF + 3TC + EFV
Pregnant women • TDF+3TC+DTG
• Put on TB treatment as early as possible after detection. Follow adult guidelines
for all other issues
88
Chapter 8
Post-exposure prophylaxis (PEP)
PEP is short-term use of ART to reduce the likelihood of HIV infection after potential exposure. Health
care workers(HCWs) are prone to accidental exposure to blood and other body fluids or tissues in their
day to day working. There are many factors that contribute to the increased risk of occupational HIV
exposure. First, with the scale-up of HIV testing services (HTS) and ART services more and more people
with HIV are coming in contact with health care personnel (HCP). Second, as PLHIVs receiving ART
benefit from living longer, they are more likely to survive and their chances of coming in contact with
the HCP are increasing, and thus the increased chances of accidental exposure to HIV-infected blood
and other body fluids.
In order to avoid exposure to HIV, precautions should be taken when handling possibly contaminated
body fluids including the use of appropriate barriers such as gloves, gowns and goggles; care with
sharps including minimizing blind surgical procedures and proper handling and disposal of sharps;
safe disposal of contaminated waste; safe handling of soiled linen; adequate disinfection procedures
and universal hepatitis B vaccination of nonimmune at risk groups including HCWs, police, prison staff
and rescue workers. These are collectively referred as ‘Standard Precautions’.
Some definitions
‘Exposure’, which may place an HCP at risk of blood-borne infection, is defined as:
• A percutaneous injury (e.g., needle-stick or cut with a sharp instrument)
• Contact with the mucous membranes of the eye or mouth
• Contact with nonintact skin (when the exposed skin is chapped skin or afflicted with
dermatitis)
• Contact with intact skin when the duration of contact is prolonged with blood or other
potentially infectious body fluids.
‘Occupational exposure’ refers to exposure to potential blood-borne infections (HIV, HBV and HCV)
that occurs during performance of job duties.
‘Non-occupational exposure’ refers to exposure to potential blood-borne infections (HIV, HBV and
HCV) outside of the workplace setting like unsafe sex and sexual assault.
‘Post-exposure prophylaxis (PEP)’ refers to the comprehensive management instituted to minimize
the risk of infection following potential exposure to blood-borne pathogens (HIV, HBV and HCV).This
includes first aid, counselling, risk assessment, relevant laboratory investigations based on informed
consent of the source and exposed person, depending on the risk assessment, the provision of short
term (4 weeks) of ARV drugs, with follow-up and support, including maintaining confidentially.
Table 54. Risk of exposure from different body fluids

Exposure to body fluids considered ‘at risk' Exposure to body fluids considered 'not at risk,' unless
these fluids contain visible blood
• Blood • Tears
• Semen • Sweat
• Vaginal secretions • Urine and faeces
• Cerebrospinal fluid • Saliva
• Synovial, pleural, peritoneal, and pericardial • Sputum
fluid • Vomitus
• Amniotic fluid
• Other body fluids contaminated with visible
blood
89
For human bites, clinical evaluation must include the possibility that both the person bitten and the
person who inflicted the bite were exposed to bloodborne pathogens. Transmission of HIV infection
after human bites has been rarely reported.
The average risk of acquiring HIV infection following different types of occupational exposure is low
compared to the risk of acquiring infection with HBV or HCV. In terms of occupational exposure, the
important routes are needle stick exposure (0.3% risk for HIV, 9–30 % for HBV and 1–1.8% for HCV) and
mucous membrane exposure (0.09% for HIV). The estimated per act probability of acquiring HIV from
an infected source by exposure route is presented in Table 55.
Table 55. Risk of transmission of HIV virus through different routes from an infected source
Exposure route Risk per10000 exposures 95% CI
Parenteral exposure
Blood transfusion (infected blood) 9250 (92.5%) 8900-–9610
Needle-sharing injection drug use 63 (0.63%) 41–92
Percutaneous needle stick 23 (0.23%) 0–46
Sexual exposure
Receptive anal intercourse 138 (1.38%) 102–186
Insertive anal intercourse 11 (0.11%) 4–28
Receptive penile vaginal intercourse 8 (0.08%) 6–11
Insertive penile vaginal intercourse 4 (0.04%) 1–14
Receptive oral sex Low 0–4
Insertive oral sex Low 0–4
Vertical transmission
Mother-to-child transmission 2260 (22.6%) 1700–2900
Source: Patel P, Borkowf CB, Brooks JT, Lasry A, Lansky A, Mermin J. Estimating per-act HIV transmission risk: a systematic review. AIDS.
2014;28(10):1509--19. doi: 10.1097/QAD.0000000000000298. PMID: 24809629; PMCID: PMC6195215.
Practices that influence risk of occupational exposure

Certain work practices increase the risk of needle stick injury such as:
• Recapping needles (most dangerous)

• Transferring a body fluid between containers
• Handling and passing needles or sharps after use
• Failing to dispose of used needles properly in puncture-resistant sharps containers
• Poor healthcare waste management practices.
Steps to protect oneself from occupational exposure
• Strict compliance with Standard Precautions (earlier referred as Universal precautions)Annex

11: Standard Precautions in Health Care
• Avoid the use of injections where safe and effective alternatives are available, e.g., oral, drugs
• Avoid recapping needles
• Plan for safe handling and disposal of needles after use
• Promptly dispose of used needles in appropriate sharps disposal containers
• Report all needle stick and sharps-related injuries promptly to ensure that you
o Receive appropriate follow-up care
o Participate in training related to infection prevention
o Use devices with safety features provided by the institute (wherever possible)
90
o Record and monitor injuries with an injury register in each location of healthcare
setting.
Photograph 1. Recapping of needles - the right and wrong way
Management of exposure person
Step 1: Management of exposure site--First Aid

For skin—if the skin is pierced by a needle-stick or sharp instrument:
• Immediately wash the wound and surrounding skin with water and soap and rinse
• Do not scrub
• Do not use antiseptics or skin washes
• Don’t use bleach, chlorine, alcohol and betadine.
After a splash of blood or body fluids:

Unbroken skin:
• Wash the area immediately
• Do not use antiseptics.
For eye:
91
• Irrigate exposed eye immediately with water or normal saline
• Sit in a chair, tilt the head back and ask a colleague to gently pour water or normal saline over
the eye
• If wearing contact lens, leave them in place while irrigating, as they form a barrier over the eye
and will help protect it. Once the eye is cleaned, remove the contact lens and clean them in
the normal manner. This will make them safe to wear again
• Do not use soap or disinfectant on the eye.
For mouth:
• Spit fluid out immediately
• Rinse the mouth thoroughly, using water or saline and spit again. Repeat this process several
times
• Do not use soap or disinfectant in the mouth
• Consult the designated physician of the institution for management of the exposure
immediately.
Step 2: Establish eligibility for PEP

Assess the chances of HIV or HBV/HCV transmission risk. If reasonable risk is
found, the person should be eligible for PEP.
PEP should be ideally started within 2 hours after exposure. It is effective till
72 hours and not effective at all after 72 hours.
A designated person/trained doctor must assess the risk of HIV and HBV
transmission following an accidental exposure. This evaluation must be
made rapidly, so as to start any treatment as soon as possible after the
accident. The assessment must be made thoroughly (because not every accidental exposure requires
prophylactic treatment).
The exposed individual should have confidential counselling and assessment by an experienced
physician. S/he should be assessed for pre-existing HIV infection.
Step 3: Counselling for PEP

For an informed consent, exposed persons (clients) should receive appropriate information about
what PEP is and its risk and benefits. It should be clear that PEP is not mandatory. The client should
understand details of window period, baseline test, drugs that are used, their safety and efficacy, and
issues related to these drugs during pregnancy and breastfeeding.
S/he should be counselled on safe sexual practices till both baseline and 3months’ HIV test are found
to be negative.
Step 4: Assessing need for PEP and prescribing PEP

The decision on the need for PEP for HIV (following an occupational exposure in health care worker)
will depend on the exposure as well as source person’s HIV status and the extent of disease, if the
source has been confirmed positive.
Step 5: Recommended regimens

A three-drug HIV PEP Kit is available. It contains two separate combinations:
92
• Tab tenofovir disoproxil fumarate(TDF) 300mg + lamivudine (3TC) 300mg and tab dolutegravir
50 mg to be taken once daily. The duration is for 28 days
• It also contains: Pregnancy detection kit and emergency contraception pill (Levonorgestrel –
75 mg).
93
Chapter 9
HIV-Hepatitis coinfection
HIV and HBV have similar transmission routes. Acute HBV infection in HIV positive people is associated
with increased risk of chronicity, reduced chances of spontaneous clearance, higher rates of
replication and reactivation, and therefore increased incidence of chronic liver disease, cirrhosis and
hepatocellular carcinoma (HCC). Additionally, HIV/HBV coinfection has been associated with rapid
HIV disease progression and poorer HIV treatment outcomes. Other complications of HIV/HBV
coinfection include increased incidence of drug-related hepatotoxicity, drug--toxin interactions and
ART-related immune reconstitution hepatitis.
The term Acute HBV infection refers to new-onset hepatitis B infection that may or may not be icteric
or symptomatic. Diagnosis is based on detection of hepatitis B surface antigen (HBsAg) and IgM
antibodies to hepatitis B core antigen (anti-HBc). Recovery is accompanied by clearance of HBsAg
with seroconversion to anti-HBs (antibodies to hepatitis B surface antigen), usually within 3 months.
The term Chronic HBV infection is defined as persistence of hepatitis B surface antigen (HBsAg) for 6
months or more after acute infection with HBV. Around 20–40% of PLHIVs will fail to clear HBV beyond
6months and will become chronically infected.
Evaluation of HIV and hepatitis B coinfected persons

The risk of HBV infection may be higher in HIV-infected adults, and therefore all persons newly
diagnosed with HIV should be screened for HBsAg. Those found positive for hepatitis B surface antigen
should be evaluated further following the guidelines for evaluation of those with hepatitis B infection.
Look for signs of cirrhosis and hepatic decompensation like jaundice, conjunctival haemorrhages,
anaemia, spider angioma, palmar erythema, petechiae, clubbing, gynaecomastia, testicular atrophy,
parotid enlargement, asterixis (liver flaps, flapping tremors), caput medusa, ascites, oedema,
longitudinal veins alongside of abdomen, hepatomegaly, hepatic bruit, venous hum and
splenomegaly.
The lab investigations, besides routine haemogram and chemistry, should specifically include liver
function tests (LFT), prothrombin time, alpha-fetoprotein (AFP), ultrasound and upper GI endoscopy.
The virological examination should include HBeAg--marker of HBV replication and infectivity, anti-
HBe antibody and HBV DNA quantitative (Real-time PCR).
A non-invasive technique to assess liver cirrhosis like transient elastography (FibroScan®) is available
in HNGV in Timor-Leste. FibroScan® is a specialised ultrasound machine that measures fibrosis
(scarring) and steatosis (fatty change) in liver. Fatty change is when fat builds up in your liver cells. It
is a very good tool to measure the stiffness of liver and thus give a fair assessment of the stage of liver
cirrhosis. Table 56provides guidance to the level of fibrosis based on FibroScan® results.
Table 56. Interpreting FibroScan(R) results in different liver diseases
Disease F0--F1 F2 F3 F4
Hepatitis B 2–7 kPa 8–9 kPa 8–11 kPa 18 kPa or higher
Hepatitis C 2–7 kPa 8–9 kPa 9–14 kPa 14 kPa or higher
HIV/HCV coinfection 2–7 kPa 7–11 kPa 11–14 kPa 14 kPa or higher
Cholestatic disease 2–7 kPa 7–9 kPa 9–17 kPa 17 kPa or higher
Nonalcoholic fatty liver 2–7 kPa 7.5–10 kPa 10–14 kPa 14 kPa or higher
disease (NAFLD or NASH)
Alcohol-related disease 2–7 kPa 7–11 kPa 11–19 kPa 19 kPa or higher
94
Source: Understanding your FibroScan® Results. Memorial Sloan Kettering Cancer Centre. Patients and Caregivers
(https://www.mskcc.org/cancer-care/patient-education/understanding-your-fibroscan-results,accessed 29 September 2019).
In case of non-availability of FibroScan® machine, APRI score, i.e., Aspartate aminotransferase (AST)-
to-platelet ratio index (APRI) can be calculated to estimate the hepatic fibrosis based on a formula
derived from AST and platelet concentrations. The formula is as follows:
Another method is to use FIB-4 score, index for estimating hepatic fibrosis based on a calculation
derived from AST, ALT and platelet concentrations and age. The formula for calculating the score is
given above.
Treatment of HIV and hepatitis B coinfected patients

A detailed algorithm of WHO recommendations on the management of persons with chronic hepatitis
B infection is given in Annex 10. Management of chronic hepatitis B infection – WHO .
The indications for antiviral treatment in chronic hepatitis B (CHB) are as below:
• All adults, adolescent, children with CHB and clinical evidence of

compensated/decompensated cirrhosis (or APRI score >2 in adults) should be treated,
regardless of ALT, HBeAg status, HBV DNA levels
• Treatment is recommended for adults with CHB, who do not have clinical evidence of cirrhosis
(or based on APRI score 2 in adults), but are aged > 30 years and have persistently elevated
ALT levels and evidence of high-level HBV replication (HBV DNA > 20000 IU/ mL) regardless of
HBeAg status
• If HBV DNA testing is unavailable, but patients have persistently elevated ALT, treat for hepatitis
B regardless of HBeAg status.
The management guidelines for HIV and hepatitis B coinfection are summarized in Table 57.
Table 57. Management guidelines for HIV and hepatitis B coinfection

Criteria Details
When to start ART? All persons diagnosed with HIV infection should be initiated on ART regardless of
CD4 count or WHO clinical staging or age group or population sub-groups
Choice of regimen Nucleoside analogues with activity against both HIV and HBV such as 3TC and TDF
should be included in the first-line ART regimen for HIV-infected patients who are
HBsAg-positive (and HBeAg-positive, if known)
In view of higher incidence of hepatotoxicity with NVP in coinfected patients, it is
preferable to use EFV unless contraindicated
DTG can be used when introduced and scaled up. However, it is planned to be
introduced in a phased manner and thus not being put as the preferred drug in
the regimen
95
Preferred regimen TDF +3TC +EFV (TDF may be replaced by AZT in case of TDF toxicity or
contraindications)
Second-line regimen TDF and 3TC should be continued as part of the second-line ART following initial
ART failure, even if it was used in the first-line regimen
HBV resistance Ideally, 3TC should be used either with TDF or not at all, because HBV resistance
to 3TC develops quickly. HBV resistance to 3TC develops in 50% of patients after
two years and in 70% after four years of treatment, if 3TC is the only active anti-
HBV drug in the ART regimen
Therapy outcomes HBV seroconversion (loss of HBeAg and development of HBeAg) occurs in 11–22%
of HBeAg-positive HIV-infected patients who are treated with 3TC containing
regimen for one year
Hepatic flares HBV flares on ART start soon after the initiation of ART as a manifestation of IRIS.
Discontinuation of 3TC may also result in hepatic flares
Prevention of HBV infection

The risk of HBV infection could be higher in HIV-infected adults, and therefore all persons newly
diagnosed with HIV should be screened for HBsAg and immunized, if not infected. Those already
infected with HBV (HBsAg positive) do not require HBV vaccine. Those who are surface antigen
negative need to be vaccinated against hepatitis B, besides following other precautions(Table 58).
Table 58. Treatment regimen for hepatitis B infection
Vaccine type Dose (intramuscular) Schedule
Adjuvanted HBV vaccine Standard dose (0.5–1mLas
‘0’ dose followed by dose on 1, 2 and
appropriate
6 months
Nonadjuvanted HBV vaccine Double the dose
HIV and HCV coinfection

Viral hepatitis C infection is associated with significant morbidity and mortality. Chronic HCV infection
can cause a wide spectrum of liver disease, potentially leading to severe liver damage, including
cirrhosis, organ failure and hepatocellular carcinoma. It accounts for nearly 12–32% of all cases of
liver cancer and 10–20% cases of liver cirrhosis, both of which have high treatment costs and poor
outcomes.
HIV-positive persons at risk of HCV coinfection should be identified and offered HCV treatment. The
recent introduction of direct acting antiviral therapies (DAAs) for treatment of HCV has simplified the
management of HIV/HCV coinfection, making it possible to manage uncomplicated HIV/HCV infection
safely even in primary care settings.
Screening
HCV serology should be offered to individuals at risk of HCV infection. These include:
• People who inject or use drugs (limited in Timor-Leste)
• Persons who have had tattoos, body piercing or scarification procedures from settings of
doubtful infection prevention precautions
• Children born to HCV positive mothers.
Up to 45% of individuals who are infected with HCV spontaneously clear the infection. HCV positive
individuals should be offered nucleic acid HCV RNA testing to establish presence of chronic HCV
infection.
Prevention
General measures for prevention of bloodborne infections are effective in preventing HCV
transmission as given below:
96
1. Recommendations for healthcare settings
• Hand hygiene: including surgical hand preparation, handwashing and use of gloves
• Safe handling and disposal of sharps and waste
• Effective disinfection and sterilization
• Provision of safe blood and blood products
• Training of healthcare providers.
2. Recommendations for prevention of sexual transmission

• Correct and consistent condom use
• Access to prevention services for sex workers and other people at risk (including screening and
treatment STIs, frequent testing for HIV and HCV)
• Treatment of HIV/HCV coinfection.
97
Chapter 10
Other comorbidities in HIV and their management
Screening and management for NCDs in PLHIVs

There is high incidence of mortality and morbidity associated with NCDs such cardiovascular diseases
(CVDs), diabetes, liver diseases, kidney diseases, etc. because of high inflammatory state due to HIV
infection, and side-effects of some ARVs also.
Traditional risk factors for cardiovascular diseases include: 1) tobacco use; 2) alcoholism; 3) poor food
habits; 4) obesity; 5) physical inactivity; 6) familial history; 7) age, etc. Many of the factors can be
modified, but many are hereditary.
This section provides a brief overview of the management of NCDs. For more details, the reader is
referred to more comprehensive management guidelines for each of these diseases.
CVDs
CVDs such as hypertension, cerebrovascular accidents, myocardial infarction are common in HIV
infected, if risk factors are present. Smoking is the single-most common cause of increase in
cardiovascular diseases and as such measures to address this issue will be of importance to prevent
untimely deaths and morbidity.
Lifestyle modification including tips to quit cigarette smoking is beneficial. Table 59provides ‘leads’
to address this issue.
Table 59. Suggested steps in lifestyle modification in adult PLHIVs with CVD risk
Smoking cessation
Smoking cessation has multiple short-and long-term benefits, including
• Reduced premature aging/wrinkling of skin
• Improved fitness and quicker recovery from common infections
• Reduced risk of respiratory infections and chronic lung disease
• Reduced risk of high blood pressure, diabetes, kidney disease, heart disease, and stroke
• Improved infant outcomes (for pregnant women who smoke)
• Reduced risk of cancers: lung, bladder, breast, mouth, throat, oesophagus
• Better response to ART (better viral suppression)
• Reduced risk of developing TB or dying from TB
Tobacco dependence treatment and cessation programmes should combine behavioural/counselling
support with pharmacotherapy treatment where necessary and available. For further details on cessation
interventions, refer to the Tobacco control guidelines for Timor-Leste
Dietary changes and weight loss
Weight loss to maintain a healthy BMI (nutritionists to be engaged in patient care)
Drink at least 8 glasses of water per day
Reduce/abstain from alcohol
Decrease sugar intake
Reduce red meat intake
Cut down consumption of fatty foods, fat for flavouring and fried foods
Increase intake of whole grains, vegetables, fruit and beans
Increase intake of fish
Consume less than 5 g (just under a teaspoon) of salt per day
Physical activity
Active lifestyle with moderate-intensity physical activity
30 minutes of aerobic activity such as brisk walking, at least 5 days per week
98
Hypertension is common in Timor-Leste. It is diagnosed when the average systolic blood pressure is
140 mmHg or higher, or when the average diastolic blood pressure is 90 mmHg or higher, taken on
two or more separate days.36 The suggested screening steps and management measures are
presented in Table 60.
Table 60. Management of hypertension for adult PLHIVs
Screening
BP should be measured and recorded for every adult at every visit
Diagnosis
Hypertension requiring intervention is defined as BP 140/90 mmHg on two or more separate days
Investigations of patients with hypertension
Urine analysis to access kidney disease and diabetes
Creatinine, Na, K: to assess for kidney disease (Referral Hospitals (RHs) and HNGV)
Blood glucose: to assess for diabetes (All CHCs, RHs and HNGV)
Complete blood count: anaemia may indicate chronic kidney disease
Lipid profile: dyslipidaemia is a cardiovascular risk factor (Available in RHs and HNGV)
ECG: to assess for cardiac pathology including cardiomegaly, ventricular dysfunction, ischemic heart disease, etc.
(Available in RHs and HNGV)
Management of hypertension
If baseline BP is 120--139/80-89 (prehypertension)
• Lifestyle modification, along with monthly BP monitoring
If baseline BP is 140--159/90--99
• Lifestyle modification (Table 20) for up to 6 months, along with monthly BP monitoring
If does not meet treatment target with lifestyle modifications, then add drugs to lifestyle modification
• In PLHIVs without kidney disease or diabetes, first-line antihypertensive therapy is a thiazide diuretic such as
hydrochlorothiazide starting at 12.5 mg OD (maximum dose 25 mg OD) OR a calcium channel antagonist such
as amlodipine starting at 2.5 mg OD (maximum 10 mg OD)
• In PLHIVs with kidney disease or diabetes, the first antihypertensive should be an ACE-I such as Captopril or
Enalapril 2.5--10 mg OD (maximum dose is 20 mg BD); with referral to a physician, if available
• Introduce one drug at a time. If the target blood pressure is not reached within one month after initiating
therapy, the dosage of the initial medication should be increased. Titrate to maximum recommended dosage
(if tolerated) before adding an additional drug
• If inadequate response once dose has been titrated, an additional agent may be required, e.g.,
hydrochlorothiazide starting at 12.5 mg OD (maximum dose 25 mg OD)
• If inadequate response to two agents, consider consultation with or referral to a physician
Note: Calcium-channel blockers have known drug interactions with PIs and NNRTIs and should be used with
caution. ACE-I and thiazide diuretics do not have significant interactions with ARVs.
If baseline BP 160/100 mmHg
• Initiate lifestyle modifications and introduce antihypertensive medications concurrently
36WHO Western Pacific Region, Korean Ministry of Health and Welfare and Community Care Project, Korea.
Diagnosis and management of patients with hypertension. a non-communicable disease education manual for
primary care professionals and patients.
https://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=2&cad=rja&uact=8&ved=2ahUKEwi_zJ
D426vlAhWUTX0KHRZ1C0kQFjABegQICxAG&url=https%3A%2F%2Fapps.who.int%2Firis%2Frest%2Fbitst
reams%2F1147546%2Fretrieve&usg=AOvVaw39eYMws6ehuvtTfKRAZfDK.
99
Grading of hypertension
Fig.12. Stages of hypertension - WHO

Source: WHO Western Pacific Region, Korean Ministry of Health and Welfare and Community Care Project, Korea. Diagnosis and
management of patients with hypertension. a non-communicable disease education manual for primary care professionals and patients.
2017
Diabetes
Diabetes is common in Timor-Leste. Part of WHO Package of Essential Noncommunicable Disease
Interventions (PEN), diabetes is a chronic, metabolic disease characterized by elevated levels of blood
glucose (or blood sugar), which leads to major damage to the heart, blood vessels, eyes, kidneys, and
nerves over a period. The most common is type 2 diabetes (NIDDM37), occurring in adults. The body
becomes resistant to insulin or doesn't make enough insulin. In the past three decades, the
prevalence of type 2 diabetes has risen dramatically in countries of all income levels. Type 1 diabetes,
once known as juvenile diabetes or insulin-dependent diabetes, is a chronic condition in which the
pancreas produces little or no insulin by itself. Management of diabetes in adult PLHIVs is given in
Table 61.
STEPS survey done in Timor-Leste in 2014 shows that 1.5% of all respondents had raised fasting blood
sugar levels.38
Table 61. Management of diabetes in adult PLHIVs
Screening
Blood glucose (fasting or random) should be evaluated at baseline for all PLHIVs, then annually if baseline screening
is normal; urine dipstick for protein and glucose can be used if blood glucose testing is not available
Diagnosis
Diabetes Mellitus is defined as fasting blood sugar 7.0 mmol/L (126 mg/dL), or random blood sugar 11.1 mmol/L
(199.9 mg/dL), or HbA1C> 6.5%, or oral glucose tolerance test 11.1 mmol/L (199.8 mg/dL)
Abnormal results should be repeated to confirm the diagnosis, particularly for patients without symptoms of diabetes
(such as 3 Ps -- polyuria, polydipsia, polyphagia, weight loss)
Management of diabetic patients
Treatment targets: HbA1C 7.0% or fasting blood sugar levels of 4 – 7 mmol/L (70-126 mg/dL)
37NIDDM – Noninsulin dependent diabetes mellitus.

38Noncommunicable diseases risk factors: STEPS survey Timor-Leste.WHO SEARO, MoH TL and UNTL.
2014 (https://apps.who.int/iris/bitstream/handle/10665/204496/Timor-
Leste_2014_STEPS_FactSheet.pdf?sequence=1&isAllowed=y, accessed 18 September 2019).
100
For patients with pre-diabetes (abnormal results but does not meet criteria above for diabetes) monitor FBS or HbA1C
every three months and encourage lifestyle modifications
For patients with diabetes, monitor HbA1C (or FBS if HbA1C not available) every three months
Lifestyle modification (weight loss, nutritional support to manage portion sizes and calculate glycaemic index of
various foods to help with control of blood sugar) for 3--6 months
If does not meet treatment target with lifestyle modifications, then add drugs
•Metformin
Obtain baseline creatinine; do NOT use metformin if creatinine clearance <45 mL/min
Start with low dose (500 mg OD or BD) and titrate up every 1--2 weeks until reaches 1 g BD (or maximum
tolerated dose if less than 1 g BD)
• If does not meet treatment targets with metformin for 3--6 months at maximum tolerated dose, then consider
adding drug from another class (such as glibenclamide) and/or specialist consultation. Some patients may
require insulin
Note: DTG may increase metformin plasma levels: monitor blood glucose levels; dose reduction of metformin
may be required, and maximum daily dose of metformin should be 1g
• At every visit: A thorough history (to elicit features of hypoglycaemia, other CVD risk factors, neuropathy,
diabetic foot ulcers) and a physical exam (for BP, neuropathy, foot ulcers)
Additional routine screening for patients with diabetes
• Annual ophthalmology examination for diabetic retinopathy (HNGV or RHs)
• Annual urinalysis: start on an ACE-I/ARB if proteinuria develops (even if BP normal)
Note: Patients with DM are at increased risk of developing TB.
Chronic kidney disease (CKD)

Kidney diseases are common in Timor-Leste. Anecdotal evidence suggests that it may be
multifactorial causality. Low water intake, chronic urinary tract infection (UTI), and high total
dissolved solids in water may be the primary cause. Familial kidney diseases have not been
investigated, and so glomerulopathies cannot be commented upon.
In screening for CKDs, patients who are at a higher risk of developing renal disease include: 1) pre-
existing renal disease; 2) hypertension; 3) diabetes mellitus; 4) severe wasting (weight below 60 kg in
adults);5) age > 45 years; 6) WHO stage 3 or 4; 7) low CD4 count or high HIV VL; and 8) concomitant
nephrotoxic agents. Additionally, glomerular disease directly related to HIV infection, commonly
known as HIV-associated nephropathy (HIVAN), is an important cause of CKD among PLHIVs.
Prevention, early identification and management of kidney disease are important to reduce the
burden of dialysis and other complications (Table 62).
Table 31. Management of chronic kidney disease in adult PLHIVs
Screening
Urinalysis (for protein) and serum creatinine should be evaluated at baseline for all PLHIVs and monitored annually
Diagnosis
Impaired renal function is defined as creatinine clearance < 90 mL/min, or dipstick proteinuria 1
Abnormal results should be repeated to confirm diagnosis
CKD is defined as evidence of kidney damage that persists for at least 3months
Management of diabetic patients
Management depends on the cause of the renal impairment; additional investigations and/or specialist consultation
may be required
Consultations with a physician is recommended
Treat dehydration promptly and aggressively
If on TDF-containing regimen, substitute with another ARV, if CrCl<50 mL/min with the exception of patients with
HBV/HIV coinfection for renal dose adjustments of TDF and 3TC for patients with HIV/HBV coinfection) Avoid
nephrotoxic drugs (e.g., aminoglycosides and NSAIDS)
Evaluate for and treat hypertension
All NRTIs, except ABC, require dose adjustments for renal impairment depending on the severity. NNRTIs, PIs and
INSTIs do not require dose adjustments for impaired renal function

Note: DTG may cause a small rise in serum creatinine levels, but this does NOT represent a decline in renal function.
101
Mental health screening and management
PLHIVs are susceptible to psychological disturbances due to HIV itself and perceptions regarding HIV
in their environment. Common ones include psychological disturbances like depression and suicide,
anxiety, internalized stigma, posttraumatic stress disorder (PTSD), cognitive difficulties such as
dementia (HIV-associated dementia), and perceived lack of social support. Any of these can
significantly interfere with a patient’s sense of well-being and their adherence. However, depression
and alcohol/drug addiction are most significantly seen in PLHIVs across the globe.
In Timor-Leste, the incidence of dementia is not known, but assumed to be widespread due to country
context. It is a postconflict country with severe history of trauma in the past during their
independence wars. Depression is the commonest mental disorder (unipolar disorder).
Depression
PLHIVs are more susceptible to episodic depression. It is estimated that the relative risk is 3--6 times
higher for PLHIVs compared to general population. This has a profound effect not only with quality of
life of PLHIVs, but also the treatment outcomes with ARVs and immune response (increase in CD4
levels).
All PLHIVs should receive basic screening for depression before initiating ART, and thereafter
annually using the following two questions:
• During the past 2weeks have you often been bothered by feeling down, depressed, or hopeless?
• During the past 2weeks have you often been bothered by little interest or pleasure in doing things?
If the answer to any of the questions is ‘yes’, or the PLHIV has HIV VL > 1000 copies per mL, it is prudent
to screen with an expanded questionnaire.
A simple depression questionnaire that could be used is presented in Table 63.
Table 63. Depression screening questionnaire

PHQ – 9 Depression screening questionnaire Name ____________ Date: __________
Ask the patient the questions below for each of the nine symptoms and circle the response for each question. After asking
all questions, add the points for each column at the bottom. The total score is the sum of the column totals. Interpretation
and management recommendations are provided at the bottom of the table.
Question: “Over the last 2weeks, how often have you Not at all Several days More than Nearly every
been bothered by any of the following problems?” half of the day
days
1. Little interest in doing things 0 1 2 3
2. Feeling down, depressed or hopeless 0 1 2 3
3. Trouble falling or staying asleep or sleeping too 0 1 2 3
much
4. Feeling tired or having little energy 0 1 2 3
5. Poor appetite or overeating 0 1 2 3
6. Feeling bad about yourself – or that you are a 0 1 2 3
failure and have let your family down
7. Trouble concentrating on things, such as 0 1 2 3
reading the newspaper or watching TV
8. Moving or speaking so slowly that other people 0 1 2 3
could have noticed
9. Thought that you would be better off dead or 0 1 2 3
hurting yourself
Total = _____________ = = = =
102
If you have checked off any of these problems, how difficult these Not difficult at all
problems made it for you to do your work, take care of things at home Somewhat difficult
or get along with other people () Very difficult
Extremely difficult
Interpretation of PHQ-9 score and recommended management
Total score Provisional diagnosis Recommended management
0–4 Depression unlikely Repeat screening in future if new concerns that depression has
developed
5–9 Mild depression • Provide counselling support and continue to monitor; refer to
mental health team, if available
• If patient is on EFV, substitute with a different ARV after ruling
out treatment failure
10–14 Moderate depression* • Provide supportive counselling. Refer to psychologist, if
Moderate – severe available
15–19
depression • If patient is on EFV, substitute with a different ARV after ruling
out treatment failure
• Begin antidepressant medication (or, if unfamiliar with use of
20–27 Severe depression antidepressants, then refer to an experienced clinician)
• Refer to a medical officer, psychiatrist, or mental health team,
if available
Note: *Symptoms should ideally be present for at least 2weeks for a diagnosis of depression and before considering
treatment with antidepressant medication. Severe depression may require patients to start on antidepressants
immediately.
Source: PHQ-9 Copyright © Pfizer Inc. All rights reserved. Reproduced with permission. PRIME-MD ® is a trademark of Pfizer Inc.
(https://www.uspreventiveservicestaskforce.org/Home/GetFileByID/218,accessed 20 September 2019).
Depression is a known ADR with EFV, though it is often mild and temporary. Patients on EFV who
develop any persistent symptoms of depression should be switched to another ARV after ruling out
treatment failure.
Management of depression
Patients with mild depression should receive supportive counselling, which may include:
• Psychoeducation on the following key messages
o Depression is common and can happen to anyone
o Depressed people often have exaggerated negative opinions about themselves, their
life and their future
o Effective treatment is possible
• Counselling on self-management
o Continuing ART as prescribed
o Continuing activities that they used to find interesting/pleasurable
o Maintaining a regular sleep cycle
o Keeping physically active
o Participating in community/social events
o Returning to clinic if any thoughts of self-harm
• Addressing psychosocial stressors
o Explore potential stressors in the patient’s life
o Assist in problem-solving to reduce stressors
o Assess for and manage intimate partner violence
• Reactivation of or referral to social networks, including peer support groups
• Regular follow-up until symptoms improved and stable.
103
Use of antidepressant drugs
• Fluoxetine, a specific serotonin receptor inhibitor (SSRI), could be used and has shown to be
effective in the overall management of depression among PLHIVs. It has low drug interactions
with efavirenz and thus could be used as the first-line antidepressants
• Initial dose should be 10--20 mg per day in the mornings and then increase to 80 mg as a
maximum dose for any patient. Usually, the following schedule is well tolerated with patients
on TDF+3TC+EFV. With protease inhibitor, LPV/r, the interaction with fluoxetine is minimal.
No dose adjustment is necessary39
o Start with fluoxetine 10 mg in the morning for 2 weeks. Increase the dose to 20 mg
from 3rd week till the 6th week. Response usually takes 6--8 weeks
o If no appreciable improvement noted, i.e., no increase in scores PHQ-9 after 8 weeks,
increase dosage to 40 mg and then wait for another 6 weeks for response
o If low or no improvement noted, please refer the patient to a psychiatrist
• If there is good response with fluoxetine, then continue the same for at least 6 months before
tapering off the dose. A weekly schedule is recommended. So, if the maintenance dose is 60
mg, then taper to 50 mg in week one, 40 mg in week two, 30 mg in week three and so on till
reaching 10 mg in week five and the stop.
Nutritional assessment and counselling

In Timor-Leste, the prevalence of malnutrition is high. The assessment of nutritional status of children
and adults is poor. The trends of malnutrition among under 5 over three nutrition surveys (DHS 2009-
-10, TLFNS 2013 and DHS 2016) are presented in the Fig. 17.
.'
,/!(
-'
,'!)
,' ++!. +,!-
+'
*.!.
+'

*' )+
(/!-
)'
((
('
'

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Fig. 13. Trends of malnutrition status of U5 children in Timor-Leste, 2009--2016
Proper and adequate nutrition is the mainstay of treating chronic diseases. Nutritionally adequate
PLHIVs will always show improved outcomes. Good nutrition contributes to reducing risk and
frequency of other infections, delaying progression of HIV infection to AIDS, a healthy appearance and
weight, and reducing the side-effects of ART.
All PLHIVs must receive nutritional assessment, counselling and support, which needs to be
customized to the individual, and should include:
39http://arv.ucsf.edu/insite?page=ar-00-02&post=10&param=4, accessed 19 September 2019.
104
1. Nutrition assessment and diagnosis (should be timed with routine clinic visits, preferably
monthly for the first year of life, and then quarterly up to age of 5 years, and then every 3--6 months
as appropriate)
a. Anthropometric (Tables 68--70 provide interpretation and required actions for
anthropometric results for children and adults)
b. Biochemical (investigations as listed in Table 19 for baseline and Table 21 for follow-up
investigations)
c. Clinical (physical examination as described in
Table 18 for initial evaluation) • !#4 !4$#!#4
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attain/maintain good nutritional status
d. Look well and live a healthy life
e. Identifying locally available foods they can access given their own context, food safety and
food preparation
f. Helping the PLHIV to plan meals and snacks with a variety of foods in order to meet their
energy and nutrient needs and treatment plans
g. Identifying any constraints, the PLHIV may face and find ways to minimize them
h. Helping the PLHIVs to understand the
potential side-effects and food
• 4$ !4!4!$!4014# 44
interactions of the medicines they are
• #!4&4"4!4#"44!4
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i. Exploring with the PLHIVs the cause(s) • #4"$!#4!4!/4&44
of poor appetite and appropriate 44
responses (type of food, disease, pain,
depression, anxiety, or side-effects of
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prescription, therapeutic feeds,
• !244
fortified blended flour- Box 3). Tables • 4##"4
66and 67 provide malnutrition
management recommendations for
Box 3. List of nutrition equipment and supplies
adults and children available in Timor-Leste
105
b. Complementary foods for children aged 6--24 months to prevent malnutrition
c. Micronutrient supplements to prevent vitamin and mineral deficiencies
d. Point-of-use water purification to prevent waterborne disease
e. Food security and linkage to community services, such as household food support, home-
based care, agricultural extension services, and economic strengthening and livelihood
support.
MUAC is the commonest measure done for children and pregnant/lactating women (Table64).
Table 64.Interpretation and management of malnutrition using MUAC
MUAC level by age ( in cm in children below 18
years) Interpretation Recommended measures
6–59 months 5–9 years 10–17 years
• Irrespective of clinical signs,
admission (referral) for
stabilization/therapeutic
Severe acute
< 11.5 < 13.5 < 14.5 rehabilitation
malnutrition (SAM)
• Treat diseases that may be there
• Rule out TB by doing a 4S screening
and investigate for paediatric TB
• May be treated as in-patient and
provided supplementary nutrition
Moderate acute
11.5–12.5 13.5–14.5 14.5–18.5 • Treat diseases that may be there
malnutrition
• Rule out TB by doing a 4S screening
and investigate for paediatric TB
Mild acute • Provide nutritional education and
12.6–13.5 NA NA
malnutrition counselling
• Education and counselling for care
> 13.5 NA NA Normal
givers
Pregnant and breastfeeding women
23 Malnourished • Provide nutritional support
> 23 • Provide nutritional education and
Normal
counselling
Source: Adapted from publications with permission from WHO, Kenya Institute of Medical Sciences, Nairobi and CDC.
Body mass index (BMI) is used as primary measure to assess

malnutrition in adults. HIV illness itself causes muscle wasting and
loss of body weight (thus was referred as ‘slims disease’). The
interpretation of BMI is provided in Table 65.
Table 65. Interpretation of BMI and recommended management
BMI level Interpretation Recommended measures
< 16 Severe malnutrition • Refer for facility-based therapeutic intervention;
rehabilitation with therapeutic foods; counselling on intake
issues and possible metabolic issues
• 4S screening for TB
16.0–18.4 Underweight (mild • Nutrition counselling and supplementary feeding
malnutrition) • 4S screening for TB
18.5–24.9 Normal • Nutritional counselling, consistent exercise to build muscles
25.1–29.9 Pre-obesity (overweight) • Nutritional counselling to reduce energy intake; aerobic
physical activity to reduce weight
• Screen for NCDs such as hypertension, coronary heart
disease, diabetes, etc.
> 30.0–34.9 Obesity class I • Counselling to change lifestyle and reduce energy intake;
> 35.0–39.9 Obesity class II aerobic physical activity to reduce weight
> 40 Obesity class III • Screen for NCDs such as hypertension, coronary heart
disease, diabetes, etc.
106
Source:https://www.who.int/nutrition/publications/bmi_asia_strategies.pdf,accessed 27 September 2019.
Weight for age growth charts are the recommended measurement tool for children under 5 years (5–
60 months). However, WHO table could be used for detection and prompt treatment of SAM in Timor-
Leste (Table 67).
Table 66. Assessment criteria and interpretation in infants and children aged 5--60 months
Source: Adapted from Ministry of Health, National AIDS & STI Control Program. Guidelines on use of antiretroviral drugs for treating and
preventing HIV infection in Kenya. 2018 edition. Nairobi, Kenya: NASCOP, August 2018. Print. Permission sought.
Table 67. WHO diagnostic criteria for SAM in children 5--60 months of age
Indicator Measure Z score - Cut-off
Severe wasting Weight for height < -3 SD
Severe wasting MUAC < 115 mm
Bilateral oedema Clinical sign
Source: WHO child growth standards and the identification of severe acute malnutrition in infants and children. a joint statement by the
World Health Organization and the United Nations Children’s Fund. WHO Geneva and UNICEF, New York
(https://www.who.int/nutrition/publications/severemalnutrition/9789241598163_eng.pdf,accessed 22 October 2019).
Moreover, the HIV-infected infants and children have requirement of some additional calories while
the intake is calculated. Table 68provides the requirement for infants and children with HIV and
malnutrition.
Table 32. Total calorie needs of HIV-infected children
Source: Guidelines for an integrated approach to the nutritional care of HIV-infected children (6 months-14 years). Geneva: World Health
Organization.2009. Print. (https://www.who.int/nutrition/publications/hivaids/9789241597524/en/,accessed 22 October 2019).
107
Fig. 18. Management of severe acute malnutrition in children
Source: Reproduced from WHO child growth standards and the identification of severe acute malnutrition in infants and children. ajoint
statement by the World Health Organization and the United Nations Children’s Fund. WHO Geneva and UNICEF, New
York(https://www.who.int/nutrition/publications/severemalnutrition/9789241598163_eng.pdf.,accessed 22 October 2019).
108
Annex 1. ‘Test and Treat’ protocol for Timor-Leste
Goals and objectives

The overall goal of Timor-Leste’s National Test and Treat policy for HIV/AIDS is ‘to reduce the incidence
of HIV infection by providing expanded prevention, diagnosis and treatment options’.
The objectives of this policy are:
• Increase HIV testing for vulnerable population
• Increase access to treatment for people living with HIV/AIDS
• Ensure quality of universal HIV test and treat services
• Implement appropriate evidence-based communication and community strategies to increase
public and health care provider awareness on Test and Treat services.
In order to meet the objectives, time-bound broad activities are planned (Table A1.1).
Table A1.1. Planned broad activities to reduce the incidence of HIV infection
Objectives/Activities Timelines Details
1. Increase HIV testing for vulnerable population
Act 1: Map out the municipalities and areas reporting Phase I: July--Dec Phase I: Expand HIV testing for
low HIV testing 2017 ANC/STI/KP
Act 2: Expand ANC HIV testing across all Current – Five/four municipalities and
municipalities in a phased manner Phase II: Jan-- SAR of Oecusse across Timor-Leste
Act 3: Expand HIV testing for all registered TB June 2018 Expand to:
patients 1. Ermera
Act 4: Expand HIV testing for all STI and chronically ill 2. Aileu
patients across all municipalities in a phased manner
3. Ainaro
Act 5: Expand HIV testing for key population to all
4. Manatutu
municipalities in a phased manner
Phase II: Expand to remaining
Act 6: Reorganize the logistical management system
municipalities:
for HIV test kits to ensure zero stockouts of HIV test
kits 5. Viqueque
Act 7: Conduct training for lab technicians, nurses, 6. Lautem
midwives and public health workers on HIV testing 7. Manufahi
service and its reporting system
Act 8: Conduct training for key population groups on
HIV testing service and community-based HIV testing
2. Increase access to treatment for PLHIVs
Act 1: Introduce case-based surveillance system for July--Dec 2017 Revise formats and reporting to be
HIV testing services and ART implemented across all ART centres
Act 2: Conduct training on treatment care and support and HIV testing centres by the end of
for doctors, nurses, lab technicians, midwives and Dec 2017
public health workers in each municipality
Act 3:Conduct specialized training for HIV VL testing New format will be introduced from
and monitoring, second-line ART and adherence July to Sept 2017 and will be
Act 4: Create awareness on HIV testing and treatment monitored with old formats till Dec
through media and other campaigns 2017. Dual reporting for Sept–Dec.
period to evaluate the quality of HIV
case-based surveillance reports
3. Ensure quality of universal HIV test and treat services
Act 1: Scale up internal and external quality assurance Phase I: July17-- Quality assurance protocols for HIV
for HIV testing, CD4 and HIV VL Dec 2018 testing is already developed and in
108
Act 2: Set up CD4 and HIV VL interface for all current use. However, quality assurance
patients Phase II: Jan-- Dec protocols for CD4 and HIV VL will be
Act 3: Shift to HIV VL as standards of monitoring and 2019 developed during Phase I (July to Dec
care in a phased manner 2017) and will be piloted and scaled
up across Timor-Leste in a
consolidated manner from Jan–Dec
2018
4. Implement appropriate evidence-based communication and community strategies to increase public and health
care provider awareness on Test and Treat services
Act 1: Develop culturally appropriate and gender- July 17--Dec 18 IEC materials for ‘Test and Treat’
sensitive IEC materials and communication strategies would be developed and used for
for creating awareness on ‘Test and Treat’ for awareness generation and behaviour
HIV/AIDS change communication
Act 2: Pilot the IEC materials and communication
strategies in select municipalities It is important that appropriate
Act 3: Revise the IEC materials and communication indicators be used to measure the
strategies based on inputs from pilot and implement impact of such communication
across Timor-Leste strategies and materials
Act 4: Measure the impact of communication materials
and strategies
Quality of care
‘Test and Treat’ services for HIV/AIDS just do not mean expanded services and implementation alone.
Expansion and scale up will be quality assured as per global standards of HIV care. Thus, starting from
diagnosis of HIV to getting the appropriate regimen and monitoring the level of disease through either
CD4 counts or HIV VL need to be of assured quality. A case in point will be of a person who was tested
HIV positive, but not through a quality assured testing may truly not be HIV positive and may be put on
ART. Such issues are not infrequent in large set ups in many countries, and controls must be put in place
to ensure such things do not happen.
One of the ways of addressing the quality issue will be to have in-service training on clinical guidelines,
counselling and attitude building to address stigma and discrimination for service delivery providers.
This has the potential to promote uptake of testing and further improve adherence and retention in
care.
A nonexhaustive list of priority training areas for service providers is given below:
• Clinical guidelines on managing HIV as a chronic illness
• Counselling and testing
• Key populations and their special needs (sensitization)
• Retention in care with special emphasis on adherence to ART and other medications
• Integration with other basic service package for HIV and STI prevention.
Quality is not a onetime affair and needs to be rigorously monitored regularly to maintain the standards.
Target audience
This policy document and its associated clinical guideline are intended for staff of Ministry of Health,
Timor-Leste, specifically the National HIV/AIDS and STI programme, Maternal, Child and Adolescent
health programme, National TB programme and other associated programmes of communicable
109
disease control and NCD control programme as well as civil societies implementing HIV/AIDS, TB and
MCH programmes.
Ethical and legal considerations

This policy is based on human rights approach and in accordance with the Constitution of Timor-Leste.
It is based on equality, right to privacy and confidentiality, and right to medical services for all Timorese
population.
Monitoring and evaluation of this policy

The existing system of HIV reporting will be utilized to monitor the implementation of this policy. The
indicators that will be used for monitoring the policy implementation are:
• Percentage of estimated HIV positive who know their status
• Percentage of HIV positives who are on ART
• Percentage of adults and children known to be on treatment 12 months after initiation of ART.
Revised eligibility for ART under Test and Treat policy

“Any person irrespective of age or sex who has a confirmed HIV positive diagnosis from any designated
laboratory in Timor-Leste”.
110
Annex 2. HTS protocol
A. For general clients

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B. For ANC, TB and STI patients
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111
Annex 3. Patient registration form
Patient Card (KartaunPasientes)
PID code: Date of registration Date of discharge Outcome

LFU
Transferred
Dead
First name: Middle name: Family name:
Address: Electoral card:

Home:
Landline:
Phone No.
Mobile:
Name: Patient’s link: Phone No:
Contact for tracing:
(use only in case of patient failing to call; confidentiality should not be breached)
Date of birth: Male

Female
Marital status: Single Widow
Married Divorced
Profession:
Spouse: …………….Years HIV test: yes/no ID code: ………………

Children: 1: …………. Years HIV test: yes/no ID code: ………………
2: …………. Years HIV test: yes/no ID code: ………………
Mode of entry: HTS VCCT HTS- HTS- EMTCT Transferred Other:
PITC: PITC: from another
TB STI ART centre
Date of first HIV+ test: Weight on BMI Past TB dates

enrolment
Past exposure to ARV Date of ARV previous Names of ARV drugs taken
drugs: exposition: previously:
yes/no
Drug allergy: Name of ARV drugs allergy: Non-ARV drugs allergy:

yes/no
112
Annex 4.Patient monitoring form (Adult and paediatric)
DEPARTAMENTODOENÇASCONTAGIOZAS-PROGRAMAHIV/AIDS
ID code:……………………Naran:…………………………Visita: ontime late unplanned

Date of consultation/hospitalization: ………../…………/………..
Next appointment: ………../…………/………..
If hospitalized, date of discharge: …………./…………/……… Pulse:…………./min
Temp:……………...
Main complaints:…………………………………………………………………………………………………… BP:………………...
Weight:…………kg
Height:………....m
Anamnesis:……………………………………………………………………………………………………………...
………………………………………………………………………………………………………………………………….. BMI or W/H%…….
………………………………………………………………………………………………………………………………….. Lab tests:
………………………………………………………………………………………………………………………………… Date:…../……./…...
Physical examination: HIV VL: ………..
Pallor:
CD4:………../mL
Lymphnodes:
Cardiovascular system: S1 S2 Murmurs Hb :…...…….g/dL
Respiratory system: S. Creat:……………..
Neurological symptoms:
ALAT:…………….
Abdomen
Urinary-genital symptoms: WHO clinical stage:
Skin: X-ray:………………
Sputum:…………….
Diagnosis………………………………………………………………………………………………………………….
…………………………………………………………………………………………………………………………………………
…………………………………………………………………………………………………………………………………………
Comments and prescription (other than ARV):………………………………………………………………………………………………
……………………………………………………………………………………………………………………………………………………………………………………………
……………………………………………………………………………………………………………………………………………………………………………………………
……………………………………………………………………………………………………………………………………………………………………………………………
……………………………………………………………………………………………………………………………………………………………………………………………
Main drugs (ARV) Dose Code Intolerance

1. TDF+3TC+EFV
2. TDF+3TC & NVP
3. AZT+3TC&EFV
4. AZT+3TC+NVP
5. TDF+3TC+DTG
6. AZT+3TC & DTG
7. TDF+3TC & LPV/r
8. AZT+3TC & LPV/r
9. ABC+3TC & LPV/r
Other drugs
10. CTX Prophy.
11. Fluconazole Prophy.
113
(Codes B: Begin. C: Continue, CI Continue with Intolerance, R: Restart, SF: Stop for Failure. SI: Stop for Intolerance. SC: Stop
non-compliance. SP: Stop for Patient request, S: Stop other)
Centre ID
HIV tes
No. of
No. of
Cumul
HIV co
No. of
No. of n
No. of
No. of
Total N
Total N
No. of
No. of
Total N
ART pr
No. of A
No. of
No. of
No. of
Total N
Total N
No. of A
No. of A
Total N
Cumul
No. of A
No. of A
Total N
114
Annex 5. Monthlydata reporting form
Annex 5. Monthlydata reporting form
Month/Year: Person responsible:
Centre ID: Month/Year: Person responsible:
Criteria Data
Criteria Data
g services
HIV testing services
ents tested during the period
HIV positive during No. of patients tested during the period
the period
No. of new HIV positive during the period
e No. of HIV positive patients
t report (on ART and Cumulative
diagnosed,No.
butofnot
HIV started
positiveART)
patients
HIV cohort report (on ART and diagnosed, but not started ART)
positive patients in the active cohort at the end of the previous period
No. of HIV positive patients in the active cohort at the end of the previous period
HIV positive patients < 15 years enrolled during the period
No. of new HIV positive patients < 15 years enrolled during the period
Male
Male
Female
Female
HIV positive patients >or = 15 years enrolled during the period
No. of new HIV positive patients >or = 15 years enrolled during the period
Male
Male
Female
ents transferred in during the period Female
No. of patients transferred in during the period
f new HIV positive patients enrolled during the period
Total No. of new HIV positive patients enrolled during the period
f death during the period
Total No. of death during the period
positive patients transferred out during the period
positive patients LFU No. of HIVthe
during positive
periodpatients transferred out during the period
No. of HIV positive patients LFU during the period
f HIV positive patients in the active cohort at the end of the period
amme Total No. of HIV positive patients in the active cohort at the end of the period
ART programme
patients at the end of the previous period
No. of ARV patients at the end of the previous period
ents < 15 years initiated on ART during the period
No. of patients < 15 years initiated on ART during the period
Male
Male
Female
ents 15 years initiated on ART during the period Female
No. of patients 15 years initiated on ART during the period
Male
Male
Female
Female
ents on ART transferred in during the period
No. of patients on ART transferred in during the period
f patients initiated on ART during the period
f ART patients dead Total
duringNo. ofperiod
the patients initiated on ART during the period
Total No. of ART patients dead during the period
patients transferred out during the period
No. of ART patients transferred out during the period
patients LFU during the period
No. of ART patients LFU during the period
f ART patients in the active cohort at the end of the period
e No. of ARV patientsTotal No. of
initiated ARTthe
since patients in theofactive
beginning cohort at the end of the period
the programme
Cumulative No. of ARV patients initiated since the beginning of the programme
patients < 15 years switched to second-line treatment during the period
No. of ART
patients 15 years switched to patients < 15treatment
second-line years switched
duringtothe
second-line
period treatment during the period
No. of ART patients 15 years switched to second-line treatment during the period
f ART patients switched to second-line treatment during the period
Total No. of ART patients switched to second-line treatment during the period
115
115
Cumulative No. of ART patients on second-line treatment since the beginning of the
programme
EMTCT
See EMTCT data reporting form
116
Annex 6. Appointment and tracing registers
This register is used for improving the programmatic performance for improved impact.
Example of ‘appointment agenda’
Week 9/05 to ID code Counsellor Doctor Lab
13/05/11
Monday ID0011JF X X -
2–5pm ID0687ML XX X HIV VL
ID0541HT Hb,CD4
Tuesday Off Off Off Off
Wednesday ID0225JK Hb, LFT

8–10 am
Thursday Off Off Off Off
Friday ID0225JK X X
8 am–12pm
Example of ‘tracing register’

ID code Date of Tracing activities Outcome
defaulting
ID0154DE 5 Jan 2019 Phone call: 5 Jan 2019 (no reply) Died on 24 August
Home visit: 22 Jan 2019 2019
ID0314TR 10 Jan 2019 Phone call:10 Jan 2011(will come on 15 Came back to
Jan 2011) consultation on 24
Phone call:15 Jan2011(no reply) Jan 2011
Home visit: 22 Jan 2011(family stigma:
provide information to family to
encourage medical follow-up)
ID0114AZ 2 Feb 2019 Phone call: 02 Feb 2019 (no reply) Declared missed
Home visit:10 Feb2 019 (wrong case on 10 Feb 2019
address)
Declared LFUon2
Contacted PLHIV group – Estrella Plus and
May 2019
Esperança
Peer group mobilization: no success
117
Annex 7. WHO clinical staging
WHO has developed tools to support the medical staff involved in HIV clinical care to assess the medical
conditions and to orientate the decision in terms of immune suppression. They should be used as
additional tools and do not replace the need of HIV VL or CD4 count.
There are two clinical staging tables; one is developed for OIs in adults and adolescents, the second one
is developed for OIs in children.
The purposes of the clinical tables are:
• For assessment at baseline or entry into HIV/AIDS care to guide decisions on when to start CTX
prophylaxis, start ART and other HIV-related interventions
• To assess current clinical status of individuals in HIV/AIDS care, either on or off ART
• To encourage clinical care providers to offer diagnostic testing for HIV inpatients exhibiting the
clinical events suggestive of HIV disease
• To guide clinicians in assessing the response to ART, particularly where CD4 count is not easily
available, e.g., new or recurrent stage III/IV events may suggest failure of response to treatment.
Table A 7.1. WHO clinical staging of HIV infection in adults, adolescents and children
Stage Adults and adolescents Children

Primary HIV • Asymptomatic • Asymptomatic
infection • Acute retroviral syndrome • Acute retroviral syndrome
Clinical stage 1 • Asymptomatic • Asymptomatic
• Persistent generalized • Persistent generalized
lymphadenopathy lymphadenopathy
Clinical stage 2 • Moderate unexplained weight • Unexplained persistent
loss(<10% of presumed or hepatosplenomegaly
measured bodyweight) • Recurrent or chronic upper RTIs
• Recurrent RTIs (Sinusitis, (Otitis media, otorrhoea,
tonsillitis, otitis media, sinusitis, tonsillitis)
pharyngitis) • Herpes zoster
• Herpes zoster • Lineal gingival erythema
• Angular cheilitis • Recurrent oral ulceration
• Recurrent oral ulceration • Papularpruritic eruption
• Papularpruritic eruption • Fungal nail infections
• Fungal nail infections • Extensive wart virus infection
• Seborrheicdermatitis • Extensive molluscum
contagiosum
• Unexplained persistent parotid
enlargement
Clinical stage 3 • Unexplained severe weight loss • Unexplained moderate
(>10% of the presumed or malnutrition not adequately
measured bodyweight) responding to standard therapy
• Unexplained chronic diarrhoea • Unexplained persistent
for more than 1 month diarrhoea (14 days or more)
• Unexplained persistent fever • Unexplained persistent fever
(intermittent or constant for (above 37.5°C, intermittent or
longer than1month) constant, for longer than
• Persistent oral candidiasis 1month)
• Oral hairy leucoplakia (OHL)
118
• PTB • Persistent oral candidiasis (after
• Severe bacterial infections (such the first 6weeksof life)
as • OHL
pneumonia, empyema, • Lymph node TB
pyomyositis, bone or joint • PTB
infection, meningitis, and • Severe recurrent bacterial
bacteraemia) pneumonia
• Acute necrotizing ulcerative • Acute necrotizing ulcerative
stomatitis, gingivitis or gingivitis or periodontitis
periodontitis • Unexplained anaemia (<8 g/dL),
• Unexplained anaemia (<8 g/dL, neutropenia(<0.5 x 109/L) or
neutropenia (<0.5 x 109/L) chronic thrombocytopaenia
and/orchronic (<50x 109/L)
thrombocytopaenia (<50 x109/L) • Symptomatic lymphoid
interstitial pneumonitis
• Chronic HIV-associated lung
disease, including
bronchiectasis
Clinical stage 4 • HIV wasting syndrome • Unexplained severe wasting,
• Pneumocystis (jiroveci) stunting or severe malnutrition
pneumonia not responding to standard
• Recurrent severe bacterial therapy
pneumonia • Pneumocystis (jiroveci)
• Chronic herpes simplex infection Pneumonia
(orolabial, genital or anorectal of • Recurrent severe bacterial
more than 1month duration or infections (such as empyema,
visceral at any site) pyomyositis, bone or joint
• Oesophageal candidiasis infection, meningitis, but
(orcandidiasis of trachea, excluding pneumonia)
bronchi or lungs) • Chronic Herpes simplex
• EPTB infection (orolabial or cutaneous
• Kaposi sarcoma of more than 1 month duration
• Cytomegalovirus infection orvisceral at any site)
(retinitis or infection of other • Oesophageal candidiasis (or
organs) candidiasis of trachea, bronchi
• Central nervous system or lungs)
toxoplasmosis • EPTB
• HIV encephalopathy • Kaposi sarcoma
• Extra pulmonary cryptococcosis, • Cytomegalovirus infection
including meningitis (retinitis or infection of other
• Disseminated nontuberculous organs with onset at age more
mycobacterial infection (NTM) than 1month)
• Progressive multifocal • Central nervous system
leukoencephalopathy (PML) toxoplasmosis (after the
• Chronic cryptosporidiosis neonatal period)
• Chronic isosporiasis • HIV encephalopathy
• Disseminated mycosis (extra • Extra pulmonary cryptococcosis,
pulmonaryhistoplasmosis, including meningitis
coccidioidomycosis) • NTM
• Lymphoma (cerebral or B-cell • PML
non-Hodgkin) • Chronic cryptosporidiosis (with
• Symptomatic HIV-associated diarrhoea)
nephropathy or cardiomyopathy • Chronic isosporiasis
119
• Recurrent septicaemia • Disseminated endemic mycosis
(including (extra pulmonary
nontyphoidalsalmonella) histoplasmosis,
• Invasive cervical carcinoma coccidioidomycosis,
• Atypical disseminated penicilliosis)
leishmaniasis • Cerebral or B-cell
nonHodgkinlymphoma
• HIV-associated nephropathy or
cardiomyopathy
120
Annex 8. Assessment of patient during the first visit to ART centre
The initial visit provides the opportunity to establish a meaningful patient-provider relationship. The clinician
should elicit concerns and expectations with open, non-judgmental, and clear communication. The details are
presented as tabular format for ease of use (Table A8.1).
Table A 8.1. Assessment of patient during the first visit to ART centre
History Comments
• Main complaints and current Ask about:
symptoms • Coinfections such as hepatitis B and C,
• Include symptoms of TB and TB visceral leishmaniasis, etc.
contacts • Other comorbid conditions such as
diabetes, hypertension, kidney
diseases, liver diseases, etc.
• 4 symptoms screening for TB and fill
up the intensified case finding tool
• Date of first positive HIV test • Document history of TB
• Past and current comorbidities (e.g., • Document previous or current ARV
TB, cryptococcal meningitis, use (including for EMTCT, PEP, PrEP
Current history
hypertension, diabetes, kidney and and ART)
and complaints
liver diseases) • Establish current medications
• Current medications, including (prescription, nonprescription, and
herbal medicine/traditional herbal) likely to adversely interact
medicine with ARVs
• Drug allergies, especially sulpha • Establish reasons for hospitalization
allergy (for using co-trimoxazole at
later date
• ARV exposure history
• History of hospitalization
• Family history of chronic disease or
cancer
Psychosocial • Ask about education, employment • Establish and document social
history and family marital status support structures
• Any history of mental illness • Establish possible presence of mental
• Disclosure and self-stigma health concerns
• Substance use including alcohol, • Encourage disclosure to trusted close
tobacco, marijuana, narcotics, relations/friends and sexual partners
injection drug use, etc. • Elicit and begin to address possible
• Nutritional history and adequacy of barriers to adherence
nutritional intake and household • Link to additional facility and
food security community support resources,
including psychosocial support
groups, peer mentors, etc.
• History of STIs • Speak about secondary prevention
• Any current symptoms (ART) and avoiding reinfection with
• Current sexual practices STIs
Sexual and • Partner HIV status and disclosure to • HIV and ART status of sexual partner/s
reproductive sexual partner(s) • Discuss intention of pregnancy and
history • Pregnancy history and age of all contraception needs
living children • Encourage contact tracing and HIV
• Menstrual history, family planning testing for sexual partners and all
and plans for pregnancy children of HIV-infected women and
121
• History of cervical cancer screening all children whose mothers’ HIV status
is unknown
Notes:
Assign and document the initial WHO clinical stage and manage presenting illnesses
Growth and developmental milestone must be assessed and used for WHO staging in children
Differentiate between patients with advanced disease versus those who are clinically well to guide acuity of follow-up.
Physical Comments
examination
General Assess general mood, measure and • Calculate BMI as: weight (kg)/
impression, vital record weight, height, MUAC (in children heightm2)
signs and and pregnant women), temperature, • Use Z-scores for children
anthropometric pulse rate, BP, respiratory rate, pulse • Monitor growth trends for children
measurements oximetry (if patient has respiratory
complaints or has difficulty in breathing)
General Central nervous system (focal defects,
examination retina); mental state examination (for
mental status); abdomen (for liver or
splenic enlargement); respiratory (for
dullness to percussion; crackles or
wheezes); cardiovascular (for peripheral
pulses, oedema, heart sounds); if
• Prompt treatment of inter-current
specific symptoms:
illness contributes towards success of
genitourinary/anorectal system (for
ART and reduction in early morbidity
ulcers, discharge, condylomata/warts,
and mortality
prostate examination for men 45 years
• Asymmetric or rapidly enlarging
of age). Speculum examination with
lymph nodes will require fine needle
cervical cancer screening for females
aspiration cytology or biopsy
Central nervous system (focal defects,
• Cervical cancer screening (if not done
retina); mental state examination (for
in the past year) and appropriate
mental status); abdomen (for liver or
management
splenic enlargement); respiratory (for
• Monitoring developmental
dullness to percussion; crackles or
milestones for children
Systemic wheezes); cardiovascular (for peripheral
examination pulses, oedema, heart sounds); if specific
symptoms: genitourinary/anorectal
system (for ulcers, discharge,
condylomata/warts, prostate
examination for men 45 years of age).
Speculum examination with cervical
cancer screening for females
Problem list with differential diagnosis • Assign and document the initial WHO
and management plan for each problem clinical stage and manage presenting
(including investigations, treatment, illnesses
referrals and follow-up) • Growth and developmental milestone
must be assessed and used for WHO
Summary
staging in children
• Differentiate between patients with
advanced disease versus those who
are clinically well to guide acuity of
follow-up
Note: Laboratory assessment is not a prerequisite to ART initiation. It should not cause delay in starting
ART.
122
Annex 9. National referral system
Transfer of medical information
When the patient is referred from an ART centre to another one, the patient will receive a copy or
summary of his/her update status and a referral letter to provide to his/her doctor at the other end of
the referral. All the relevant information should be shared to provide the best quality medical care (Fig.
A9.1. A9.1).

Fig. A9.1.Referral flow and confidentiality
National coding system
Documents provided will NOT mention names, but only “PID and ART No.” The code is used only once
and will NEVER be attributed to another patient. The record of the ID codes will be kept at the ART
centres in a locked cabinet and it is the only place, together with the patient individual medical record,
where the ID code and the name will be associated. The names and codes will NOT be shared in any
case with anyone outside the scope of medical services or peer support (shared confidentiality). The
code is attributed where the patient is attending the HIV services for the first time. The ID code will
remain the same till the end. Specifically, it is recommended to have one unified ID code that will
remain same even when patient is transferred from one site to other within Timor-Leste. It will be part
of the counselling to educate the patient in remembering his/her ID code. An ART card will be provided
to the patient with his/her ID code in writing and all the necessary details.
The definition of the national ID code follows the described rule below:
1. HNGV: HN-001, HN-002,HN-003…

2. Bairo Pite Clinic: BP-001, BP-002, BP-003…
123
3. CHC VERA Cruz: VC-001, VC-002, VC-003....
4. Regional Hospital (RH) Baucau:BC-001, BC-002, BC-003…
5. RH Oecusse: OC-001, OC-002, OC-003…
6. RH Maliana: ML-001, ML-002,ML-003…
7. RH Maubisse: MB-001, MB-002,MB-003…
8. RH Suai: SU-001, SU-002, SU-003…
Example 1
A patient has been diagnosed HIV positive at the HIV testing centre (HTC) of Maliana. After post-test
counselling, the patient accepts to see the doctor and to enter in the HIV medical cohort of Maliana ART
centre. Only when the patient comes for his first medical consultation, the ID code will be attributed to
this particular patient. Hence, if the patient presents himself at Maliana ART centre, and he is the first to
come in the centre, he will receive the code ML-001. Next time when he comes for a medical visit, the
patient will present his ID code and the counsellor will easily find his medical record as per his ID code
ML-001.
Example 2
If the patient is the 50th of the HIV medical cohort of Maliana, his/her ID code will be ML-050.
Example 3
If the patient is tested HIV positive in Dili and after post-test counselling, the patient decides to go to
Maliana for his/her first medical HIV check-up. The patient will be registered in the HIV cohort of Maliana
ART centre. In Maliana ART centre, there may be already 55 patients registered in the HIV positive
medical cohort. Therefore, the ID code of this new patient will be ML-056.
Logistics
The patients referred to Dili may be supported for their transport, accommodation, and food expenses.
The peer network (Estrela Plus and Esperança) will work closely with MoH to support this endeavour.
The peer group will support the referred patients and make sure they receive proper accommodation
and transport to the medical services. They will refer/recommend the patients to the appropriate
NGO/service in charge of such support.
Infrastructure and services
Hospital Nationalin Dili (Hospital Nacional Guido Valadares, HNGV)
The ART centre at HNGV will also function as national referral centre for HIV/AIDS medical
management. The overall in charge would be one of the designated physicians from the department of
internal medicine (internist).
The ART centre is currently being managed by a medical doctor from the programme, and if required a
specialist consultation is available for the patient.
124
HNGV is considered as the centre of excellence for HIV/AIDS medical management. It has the technical
and laboratory facilities to provide accurate diagnosis for most OIs that may occur in an HIV infected.
The HNGV is responsible to provide the following
services: 1. HIV testing services (VCCT/PITC)
2. EMTCT
• Pre-ART assessment 3. STI management
• OI management 4. ART (First- and second-line)
• First-line ART initiation as per ‘Test and 5. Specialist consultation (Internal
Treat’ policy medicine, paediatrics, surgery,
• Routine monthly medical monitoring of obstetrics&gynaecology, STI, eye, ENT,
patient chest, gastroenterologyand neurology)
6. Coinfections - TB, hepatitis and VL
• Early detection of failure -- clinical, 7. PLHIV support network (Estrela Plus
immunological and virological failure and Caritas)
monitoring 8. Laboratory support at National Labs
• Switch to second-line ART as appropriate (CD4, HIV VL and other routine
• Monitoring of patients on second-line ART. investigations)
9. Radiology – X-ray, Ultrasound and CT
HNGV will also be responsible for transitioning the scan.
patients from current first-line of tenofovir + Box A9.1. Services available at HNGV
lamivudine + efavirenz (TLE) to tenofovir +
lamivudine + dolutegravir (TLD) based regimens as per protocol detailed in the section on first-line ART.
The services currently available at HNGV are given in Box A9.1.
Bairo Pite Clinic (BPC)
BPC is a private NGO clinic that started the first ART services for PLHIVs in Timor-Leste (2002). It is in Dili
and serves almost half of all PLHIVs on treatment.
BPC provides the same outpatient services as HNGV. However, the clinic does not have intensive care
unit and full diagnostic facilities (i.e., CT scan, lab-specific tests, CSF, etc.) for which the patient is
referred to HNGV.
Other ART centres (6):
• Referral Hospital Baucau (HOREX)
• Referral Hospital Maubisse
• Referral Hospital Maliana
• Referral Hospital Suai
• Referral Hospital Oecusse (HRO)
• CHC Vera Cruz, Dili.
The referral hospitals are responsible to provide the following services:

• Referral to HNGV of all newly HIV positive diagnosed patients
• Pre-ART assessment
• OI management
• First-line ART initiation as per ‘Test and Treat’ policy
• Routine monthly medical monitoring of patient
• Early detection of failure -- clinical, immunological and virological failure monitoring
125
• Referral to HNGV/CHC Vera Cruz for expert opinion for challenging cases
• Transition to dolutegravir-based regimens (TLD and ZLD)
• Referral to national labs for HIV VL.
Reference to HNGV/CHC Vera Cruz for any reason will benefit financial or logistic support for transport,
accommodation and basic food expenses in Dili as per available ART support mechanism.
Some referral hospitals (RH Maliana, Oecusse and Baucau) have functioning CD4 machines (PARTEC®).
Thus, immunological monitoring is possible in these centres.
However, the referral hospitals are currently not responsible for:
• Treating complicated OIs and coinfections (HIV with hepatitis B)
• Assessing treatment failure
• Switching to second-line ART.
Organization of HIV/AIDS services

HIV/AIDS activities should be integrated in the running services of the hospitals and use the existing
human and infrastructure resources.
HIV and ART consultations:

• Open twice*a week on fixed days
• On appointment for patient follow-up during these two fixed days
• Anytime in case of unexpected medical event
• No specific ward; patients should be dispatched according to their condition:**
o TB department
o Internal medicine
o Surgery
o Gynaecology/Obstetrics.
Note: *The frequency of weekly consultation will be revised according to the patients load in each ART centre.
**Infection control should be prioritized and the patient living with HIV should be protected against contamination of other
infectious diseases from the ward where he/she is hospitalized.
The following medical staff should be officially appointed as HIV focal persons by the clinical directors
to the HIV/AIDS medical services:
Medical doctors Nurses
HNGV 1—2 2
Bairo Pite Clinic 1—2 2
Referral Hospitals/CHC Vera Cruz 1 1
Nurses could be counsellors as well, but where counsellors are not nurses, a certified nurse should also
be appointed for HIV medical services.
The medical doctors of HNGV and BP should be able to provide quality HIV medical services to HIV
positive patients including first- and second-line ART, and also support transition to Dolutegravir-
based ART in complicated cases.
126
It must be further noted that some patients are achieving adequate HIV VL suppression with the current
regimens namely, TLE and ZLE. The clinical decision to shift the patients should be taken in close
consultation with experts (TRG members as per Transition Plan)
The nurses of HNGV, BPC and CHC Vera Cruz should be able to follow the instructions and directions of
the medical doctors and additionally able to provide adequate treatment literacy to the HIV positive
patients as per protocol.
The medical doctors and nurses of the RH should be able to recognize:
• ARV drug side-effects
• First sign of OIs
• First sign of treatment failure.
All the staff within the health facility should be at least able to recognize signs and symptoms of HIV
infection and refer to the specific medical doctor or nurse for further investigation and appropriate
counselling.
Patient circuits:
1. Outpatient department (OPD)
Patient should go directly to counsellor room

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Fig. 14.2. Flow chart for patient circuit in ART centre (OPD)
• Registration(As per format Annex 3. Patient registration )

• Prepare patient file and medical follow-up form (Annex 4.Patient monitoring form
(Adult and paediatric))
• Adherence counselling: problems to be recorded in the patient file
• Nutritional assessment: to be recorded in the file
• Vital signs to be registered on the new follow-up form
• Present complaints: in case of emergency, alert the doctor and prioritize the patient.
Patient should go to see the doctor in the doctor room(One patient at a time)
127
• Medical history to be recorded on the follow-up form
• Clinical examination to be recorded on the follow-up form
• Prescription to be recorded on the follow-up form and filled
• Appointment to be recorded on the follow-up form.
Patient should go back to the counsellor room

• Counsellor to take the prescription
• Counsellor to ask the OPD pharmacy for non-ARV items
• Counsellor to prepare ARVs prescribed
• Counsellor to supply drugs with therapeutic education to the patient
• Counsellor to write the next appointment in the appointment agenda and on the patient
appointment card.
2. Inpatient department (IPD) and counselling

a. Cases with HIV status not known
The cases who are admitted to the wards
under any of the departments such as
surgery, obstetrics and gynaecology,
paediatrics, etc. may be screened for HIV
based on the discretion of the attending
physician. The following protocol must be

adhered to while ordering an HIV test:
• Informed consent to be recorded
in the patient file (verbal consent is
enough, but a mention of the same

in the case sheet is required)
• Follow the 5 Cs of counselling
namely, a) Consent; b) Fig. A9.3.5Cs of HTS counselling
The status of HIV positive patients should always
Confidentiality; c) Correct results;
be treated as highly confidential.
d) Counselling; and e) Connection
The medical records of an HIV positive individual
(Linkage to ART, if detected to be HIV
should be ‘sealed’ and kept in locked closet.
positive)
• Evaluate the patient for starting ART in Sharing information within the health care team
about a patient’s HIV status is only permissible if
consultation with ART physician the patient has given consent or if it is clinically
• Initiate the ART as per protocol indicated.
• Follow-up as per protocol. Disclosure in public interest: This can be one of the
conditions of shared confidentiality even if explicit
The attending physician should call the HIV consent has not been taken. For disclosure to be
counsellor for counselling and testing. Follow justified, the risk of harm to others must be serious
provider-initiated testing and counselling enough to outweigh the patient’s right to
confidentiality.
(PITC) protocols (please refer to Annex 1. ‘Test
and Treat’ protocol for Timor-Leste). Box A9.2. Shared confidentiality
Note: Once patient is confirmed HIV positive, the doctor trained for HIV care and treatment should
oversee HIV-related problems, but other issues (surgery, gynaecology, etc.) remain under the specialist
responsibility.
128
At discharge, the patient should be referred to the counsellor room for administrative records, drugs
supply and next appointment record.
b. IPD for known HIV+ cases

• Either patient is hospitalized through emergency and if the patient has disclosed positive results
must be linked to ART
• Depending on his/her status, family should be encouraged to inform the counsellor or HIV
doctor as soon as possible for better quality of care
• Either patient is hospitalized after OPD consultation as deemed necessary by the attending
physician
• Patient should be hospitalized in the ward corresponding to his condition and the HIV doctor
should follow the patient at the ward where he/she is hospitalized for HIV related condition and
should coordinate with specialist doctors for non-HIV related conditions. It is important that
confidentiality about the HIV status of the patient is respected among the strictly needed
medical staff in charge of the medical management of the patient (Box A2: Shared
confidentiality)
• At discharge, the patient should be referred to the counsellor room for administrative records,
drugs supply and next appointment record.
3. Medical file and confidentiality

An individual code is given at each new HIV positive registration; this same code should be used in place
of names whenever names should not be disclosed (i.e., blood tests, drugs prescription, etc.)
The normal codes of medical confidentiality need to be maintained, but this should not be extended to
a ‘secrecy’ that leads to practices that are potentially dangerous for other patients at large. Further it
must be noted that practice for ‘Standard Precautions’40 is a must for handling infectious patients.
The medical files need to be kept securely. Patients should be encouraged to disclose their status if
they are seen outside their regular HIV/AIDS consultations (e.g., in emergency in OPD). Attempts should
be made to ensure confidentiality and only clinicians involved in their HIV/AIDS care should know the
HIV status of the patients.
The ART pharmacy need to be integrated with the general one. A locked cabinet/cupboard is needed to
securely store ARV drugs and OI medicines, if any. The keys of the cabinet need to be available any time
(day and night and weekend).
Free care: HIV/AIDS care is provided free of charge by the Ministry of Health (MoH).
40The set of principles advocated for prevention of infection control in health care set up are: a) Hand hygiene; b)
Use of personal protective equipment such as gloves, gown, facial protection, etc.; c) Prevention of needle stick
injuries from sharp instruments; d) Respiratory hygiene and cough etiquette; e) Environmental cleaning; f)
Handling of linens; g) Waste disposal; and h) patient care equipment.
129
Annex 10. Management of chronic hepatitis B infection – WHO algorithm
Source: Guidelines for the prevention, care and treatment of persons with chronic hepatitis B infection. Geneva: World Health Organization.
2015. p.xxvi.
130
Annex 11. Standard precautions – WHO recommendations
Source: Standard precautions in health care. Geneva: World Health Organization.2007 (https://www.who.int/docs/default-
source/documents/health-topics/standard-precautions-in-health-care.pdf?sfvrsn=7c453df0_2).
131
National HIV/AIDS Programme
Department of Communicable Diseases
Ministry of Health

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Guidelines for Antiretroviral Therapy

& Management of Opportunistic Infections

National HIV/AIDS Programme

Message from Hon’ble Minister of

dr. Odete Maria Freitas Belo, MPH

Timor-Leste is considered as “HIV Low Endemic Country”. The estimated adult

The updated guidelines for antiretroviral therapy and management of opportunistic

Dr. Odete Maria Freitas Belo, MPH

Dr. Arvind Mathur

I am proud to present the national guidelines on HIV treatment. The guideline

1. Revising and consolidating existing ART and OI guidelines and incorporate

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Dr. Arvind Mathur

The Ministry of Health, Democratic Republic of Timor-Leste gratefully acknowledges

International HIV/AIDS situation

Years Hours 72 hours Years

Fig. 2. Four opportunities for HIV prevention

The current achievements are presented in Fig. 4.

HIV testing service for OPD and IPD

HIV testing services

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Fig. 5. Diagnostic algorithm for HIV testing

Criteria What to do?

HIV life cycle and classification of ART drugs

Fig. 6. HIV life cycle and classes of ART drugs

Table 3. Characteristics of ART drugs available (and proposed) in Timor-Leste

ART regimens in Timor-Leste

A. Adults and adolescents

First-line Alternative first-line Special considerations

Dosage forms and strengths

4Walmsley S, Antela A, Clumeck N, Duiculescu D, Eberhard A, Gutiérrez F et al. Dolutegravir plus

Table 8. Drug--drug interactions--INSTIs

Monitoring and changing the regimen of ART

Table 9. Optimized regimen for ART in a stable adult or adolescent patient

AZT TDF ABC if indications of renal complications are

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Fig. 7. Algorithm for managing single drug substitution

Changing of ARVs due to treatment failure

A. Adults and adolescents

Failing first-line Current options Alternative options

B. Children and neonates

Important considerations for first-line treatment failure in children

Management of common side-effects to ART

Fever Look for possible causes of fever. Control fever

ART education and adherence

Prepare patients before initiating ART

Assessment of adherence to treatment

Table 16. Assessment of adherence and its remedial measures

Review the medications with the patient, If poor adherence, determine

Table 17. Factors that may influence adherence

Initial laboratory investigation of PLHIVs

Tailored approach to care

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