Antiretroviral Treatment

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ART GUIDELINES

Dr Michelle Munyoro
MBChB, MSC (UZ)
WHEN TO START ART
WHEN TO START ART

ADULTS (>19 YEARS)

• All adults regardless of WHO clinical stage and at any CD4


cell count.

• (test and treat)


WHEN TO START ART

PREGNANCY / BREASTFEEDING

• All pregnant and breastfeeding mothers regardless of


WHO clinical stage and at any CD4 cell count and
continued lifelong.
WHEN TO START ART

PREGNANCY / BREASTFEEDING

• All of them regardless of WHO clinical stage and at any


CD4 cell count and continued lifelong.

ADOLESCENTS (10-19 YEARS)

• All adolescents regardless of WHO clinical stage and at


any CD4 cell count.
WHEN TO START ART
CHILDREN < 10 YEARS

• All of them regardless of WHO clinical stage and at any


CD4 cell count.

• All children who test positive at birth testing


WHEN TO START ART

ADULTS / CHILDREN WITH TB

• All TB patients living with HIV, regardless of CD4 cell


count.
• TB treatment should be initiated first, followed by ART as
soon as possible ( 2 weeks post initiation of anti Tbs)
• ART is NOT an emergency.
• Cd4 <50 cells- defer ART upto 8 weeks
WHAT TO START
FIRST LINE DRUGS
DECEMBER 2018 UPDATE

• Dolutegravir (DTG) -based regimen is recommended as the


preferred first-line regimen for adults, adolescents, infants
and children.
• Raltegravir (RAL)-based regimen may be recommended as an
alternative first-line regimen for infants and children for
whom approved DTG dosing is not available.
• RAL-based regimen is recommended as the preferred
first-line regimen for neonates.
DTG IN PRECONCEPTION / PREGNANCY

• DTG appears to be safe when started later in pregnancy:

after the period of risk of neural tube defects, after the

first trimester.

• EFV-based regimen is recommended at conception and

up to the end of the first trimester.

• EFV based regimen can be continued throughout

pregnancy and BF
OLD GUIDELINE NEW GUIDELINE

Adults TLE TLD

Adolescents TLE TLD

Pregnancy TLE TLE -> TLD

Child 3-10 years ALE ALD

Child <3 years A/Z+L+LPV/r ALD

Neonate A/Z+L+LPV/r ZLRal


SECOND LINE DRUGS
INFANT PROPHYLAXIS

• No changes in recommendations.
• High risk infants should receive dual prophylaxis with AZT
(twice daily) and NVP (once daily) for the first 6 weeks of
life, whether they are breastfed or formula fed.
• High risk breastfed infants should continue infant
prophylaxis for an additional 6 weeks (total of 12 weeks
of infant prophylaxis) using either AZT (twice daily) and
NVP (once daily) or NVP alone.
INFANT PROPHYLAXIS
Nevirapine for 6 weeks

If PCR neg at 6 weeks – stop NVP – give CTX until 6 weeks post
cessation of Breastfeeding and retest

If PCR positive at anytime, start ART


RISK STRATIFICATION FOR NEONATES
* HIGH RISK*
• Mothers who received neither antepartum nor intrapartum
ARV drugs
• Mothers who received only intrapartum ARV
drugs
• Mothers who received antepartum and intrapartum ARV
drugs but who have detectable viral loads near delivery,
particularly when delivery was vaginal
• Mothers with acute or primary HIV infection
during pregnancy or breastfeeding
* LOW RISK *

Mothers who received ART during pregnancy with sustained


viral suppression (defined as a confirmed HIV RNA level < 50
copies/ml) near delivery and no concerns related to
adherence
PEP
DECEMBER 2018 UPDATE

• Regimen with two ARV drugs is effective, but three drugs

are preferred.

• Adults: TDF + 3TC (or FTC) + DTG

• Children: AZT + 3TC + DTG

• If DTG Not available -> ATV/r, DRV/r, LPV/r and RAL are

alternatives for both groups.


WHAT TO EXPECT IN
FIRST MONTHS OF ART
• Clinical & immunological improvement

• Viral suppression

• OIs & IRIS

• Drug hypersensitivity (ADR)


IRIS
• Paradoxical clinical deterioration after ART initiation.

• IRIS are OIs occurring within 12 weeks of ART initiation.

• M/C signs: HSV infection, HZ infection, MC.

• Unless life threatening, continue ART.

• If severe, temporarily D/C ART (+/- steroid) and re-start.


MONITORING RESPONSE &
DIAGNOSING FAILURE
FAILURES
• Clinical failure = New/recurrent clinical event (stage 4) after

6 months of treatment.

• Viral failure = Viral load > 1000 copies/mL (in 2 tests done

within 3 months) after 6 months of starting ART.

• Immunological failure = CD4 count ≤ 250 cells/mm3

following clinical failure or persistent CD4 ≤ 100


cells/mm3
TOXICITIES
DRUG TOXICITY RISK FACTOR
TDF CKD, AKI, ↓BMD, Lactic acidosis, severe Uncontrolled DM, SHTN,
hepatomegaly. ↓lying renal disease, >50
years, BMI < 18.5.

AZT Severe anemia, neutropenia, lactic acidosis, CD4 count ≤ 200 cells/mm3,
hepatomegaly, lipoatrophy, lipodystrophy, BMI > 25.
myopathy.
EFV CNS toxicity, mental symptoms, convulsions, Depression, MR, SD, ↓lying
hepatotoxicity, severe skin and hepatic disease, HBV, HCV
hypersensitivity reactions. co-infection.
NVP Hepatotoxicity, severe skin rash, ↓lying hepatic disease,
hypersensitivity reaction (SJS). HBV, HCV co-infection, high
baseline count.
ABC Hypersensitivity reactions HLA-B*5701 allele
DTG Hepatotoxicity, severe skin and HBV, HCV co-infection, liver
hypersensitivity reactions, nausea, diarrhoea. disease
RAL Rhabdomyolysis, myopathy Statins
LPV/r ECG changes, hepatomegaly, pancreatitis, ↓lying hepatic disease,
dyslipidemia, diarrhoea. HBV, HCV, CVS disorders.
DRUG INTERACTIONS
1. Anti TBs
• PIs are C/I with Rifampicin; Rifabutin used instead.
• Rifampicin significantly lowers conc. of DTG; BD dosing can
be used instead of OD.

2. Hep C Virus
• PIs and NRTIs are C/I with Simeprevir.
• PIs and NRTIs have many interactions with Daclatasvir & to
be used with caution.
• AZT with Ledipasvir and Sofosbuvir have an increased risk of
anemia and hepatic decompensation.
3. ANTI-FUNGAL
• NVP decreases conc. of Itraconazole and Ketoconazole.

4. ANTIMALARIAL
• EFV increases conc. of Artesunate and Amodiaquine and
causes elevated transaminases.
• PIs are C/I with Halofantrine and Lumefantrine.

5. OPIOIDS
• EFV decreases Methadone concentration.

6. STATINS
• PIs increase conc. of lovastatin and simvastatin.
6. ANTI-HISTAMINES
• PI+NNRTI with astemizole and terfenadine cause severe life-
threatening reactions like cardiac arrythmias.

7. OTHER INTERACTIONS
• DTG is C/I with simultaneous use of cation-containing
antacids, laxatives, multivitamins and mineral supplements
due to risk of chelation.
• If DTG is used, it should be given 2 hours before or 6 hours
after the medications containing polyvalent cations.
REFERENCES
1. WHO, Consolidated guidelines on the use of antiretroviral
drugs for treating and preventing HIV infection, 2016.
2. WHO, Updated recommendations on first-line and second-
line antiretroviral regimens and post-exposure prophylaxis
and recommendations on early infant diagnosis of HIV,
December 2018.
3. Bhushan Kumar, Sexually Transmitted Infections.

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