Categories of TB

Case definition

• A bacteriologically confirmed TB case is one from whom a biological

specimen is positive by smear microscopy, culture or WRD. All such cases
should be notified, regardless of whether TB treatment has started.
• A clinically diagnosed TB case is one who does not fulfil the criteria for
bacteriological confirmation but has been diagnosed with active TB by a
clinician or other medical practitioner who has decided to give the patient a
full course of TB treatment.

Bacteriologically confirmed or clinically diagnosed cases of TB are also classified

according to
• Aanatomical site of disease
2. History of previous treatment
3. Drug resistance
• HIV status
 Anatomical site of disease
• Pulmonary tuberculosis (PTB) refers to any bacteriologically confirmed or clinically
diagnosed case of TB involving the lung parenchyma or the tracheobronchial tree. A
patient with both pulmonary and extrapulmonary TB should be classified as a case of PTB
bacteriologically confirmed or clinically diagnosed case of EPTB.

• Extrapulmonary tuberculosis (EPTB) refers to any TB involving organs other than the
lungs, e.g. pleura, lymph nodes, abdomen, genitourinary tract, skin, joints and bones,
meninges.

History of previous TB

• New patients: Patients who have never been treated for TB or have taken anti-TB drugs for less
than 1 month.Previously treated patients: Patients who received 1 month or more of anti-TB
drugs in the past. They are further classified by the outcome of their most recent course of
treatment as follows
• Relapse patients have previously been treated for TB. were declared cured or treatment
completed at the end of their most recent course of treatment, and are now diagnosed with a
recurrent episode of TB (either a true relapse or a new episode of TB caused by reinfection).
• . Treatment after failure patients are those who have previously been treated for TB and
whose treatment failed at the end of their most recent course of treatmelist
• Treatment after loss to follow-up patients have previously been treated for TB and were
declared lost to follow-up at the end of their most recent course of treatment. (These were
previously known as treatment after default patients.)
• Other previously treated patients are those who have previously been treated for TB but whose
outcome after their most recent course of treatment is unknown or unundocumented
• Patient with unknown previous TB treatment history do not fit into any of the categories
listed above. New and Patients with unknown previous TB treatment history relapse cases of TB
Drug resistance

• Monoresistance: resistance to one first-line anti-TB drug only.

• . Polydrug resistance: resistance to more than one first- line anti-TB drug
(other than both isoniazid and rifampicin).

• Multidrug resistance: - resistance to at least both isoniazid and rifampicin

• Extensive drug resistance: resistance to any fluoroquinolone and at least

one of three second-line injectable drugs (capreomycin, kanamycin and
amikacin), in addition to multidrug resistance.foo e. Rifampicin resistance:
resistance to rifampicin detected using phenotypic or genotypic methods,
with or without resistance to other anti-TB drugs. It includes any resistance to
rifampicin, whether monoresistance, multidrug resistance, polydrug
resistance or extensive drug resistance.

Based on HIV status

• HIV-positive TB patient refers to any bacteriologically confirmed or clinically diagnosed case of

TB who has a positive result from HIV testing conducted at the time of TB diagnosis or other
documented evidence of enrolment in HIV care, such as enrolment in the pre-ART register or in
the ART register once ART has been started.

• HIV-negative TB patient refers to any bacteriologically confirmed or clinically diagnosed case of

TB who has a negative result from HIV testing conducted at the time of TB diagnosis. Any HIV-
negative TB patient subsequently found to be HIV-positive should be reclassified accordingly,

• HIV status unknown TB patient refers to any bacteriologically confirmed or clinically diagnosed
case of TB who has no result of HIV testing and no other documented evidence of enrolment in
HIV care. If the patient's HIV status is subsequently determined, he or she should be reclassified
accordingly.
TB Diagnostics

NTEP ENDORSED TB DIAGNOSTICS

Sputum collection :Done in microscropy centres DMC Labs
2 sputum samples ; Spot sample and early morning sample
Checked within 24 hours of collection
Squamous epithelial cells <10%, Minimum 5ml sputum

MICROSCOPY:
ZIEL NEILSEEN STAINING for acid fast bacilli.
FLOURESENCE STAINING with AURAMINE O RHADAMINE
stain (best test)

CULTURE;
Solid ; Lowenstein Jansen medium
Automated: Bactec,MGIT
• GENOTYPIC TESTS (RAPID MOLECULAR TESTS)
• CBNAAT (Catridge based nucleic acid amplification test )
• Highly specific , Diagnostic and confirmatory
• Turnaround time :90 minutes within 2 hours
• Rifampicin status
• Gene Xpert . Machine name
• Other tests ; line prone asaay (all first line and second line drug resistance ) within 2 days report , Tru naat

• RADIOLOGY
• CHEST XRAY ; Cavitations seen
• Non specific , non diagnostic

• TUBERCULIN SKIN TEST / MONTOUX TEST

• May be diagnostic in children . NOT IN ADULTS
• Test read after 72 hours
• > 15 mm induration without risk factors, > 5mm induration with risk factors (HIV, Immunocompetent)

NEWER INITIATIVES
• NIKSHAY: TB surveillance using case based web based IT system
COMPONENTS ARE : master management , user details, TB patient
Details(dot provider, hiv status , contact tracing), referral, mobile
Application for tb notification, SMS alerts to patients and officers.

TB NOTIFICATION : Its now mandatory for all health care providers to report each TB case to DISTRICT HEALTH
OFFICER /CHIEF MEDICAL OFFICER every month

BAN ON SEROLOGY : because they are based on antibody which are highy variable in different individual

DIRECT BENEFIT TRANSFER SCHEME : To patients registered in NIKSHAY . It is AADHAR LINKED .

 DIAGNOSTIC ALGORITHM
FOR PTB IN ADULTS

Case definitions

1. Microbiologically confirmed TB.

A presumptive TB case from whom a biological specimen is positive for AFB/
Mycobacterium tuberculosis on culture/ positive for tuberculosis through Rapid
Diagnostic Molecular Tests
• Clinically diagnosed TB.
A presumptive TB case who is not microbiologically confirmed,BUT has been
diagnosed with active TB by a clinician on the basis of X ray abnormalities,
histopathology or clinical signs with a decision to treat the patient with a full
course of ATT.
 Diagnostic algorithm for
paediatric pulmonary tb
➢ Cases of tuberculosis in children usually represent between 6-8 per cent of all tuberculosis
in age group of under 15 years.
➢ The source of infection to a child is usually an adult, often a family member with sputum
smear positive tuberculosis.
➢ An infant whose mother has sputum smear-positive ptb has high chance of becoming
infected.
DAILY DOSE
REGIMEN
IN NTEP
• The principle of treatment for tuberculosis is to
administer daily fixed dose combinations of 1st line
ANTI TB drugs in appropriate weight band
• FIXED DOSE COMBINATIONS (FDCs)
Refers to products containing 2 or more active
ingredients in fixed doses,
o Simplicity of treatment
o Increased patient compliance
o Easy to adjust dosage by weight

• Patients started on TB treatment becomes 50-80 per

cent non infectious within 48 hours of starting ANTI
TB DRUGS.

H = 75 mg
R= 150 mg
Z= 400 mg
E= 275 mg
INTENSIVE = 56 DOSES
CONTINUATION= 112 DOSES
• FDC FOR CHILDREN
• H = 50 mg
• R= 75 mg
• Z= 150 mg
• E is given separately= 100 mg
• Same regimen as for adults, 2 months of
intensive and 4 months of continuation phase
 ADVERSE EFFECTS-
• HEPATOTOXICITY, a major side effect
occurs in patients taking rifampicin with
pre existing liver disease
• LOSS OF VISUAL ACUITY, due to
Ethambutol
• Nephrotoxicity and ototoxicity with
Streptomycin
 NEWER DRUGS IN TB
INTRODUCTION
There is an unmet need to develop drugs
acting via novel targets with better efficacy
with least chance for drug interactions and a
desirable toxicity profile. To combat these
problems, newer targets and drugs against TB
are being explored and many newer drugs are
in the pipeline of development.

BEDAQUILINE

• It is the first drug with a novel mechanism of action against

M. tuberculosis to be approved since 1971.
• Mechanism of action - Bedaquiline inhibits adenosine 5′-
triphosphate (ATP) synthase in mycobacteria, has in vitro
activity against both replicating and nonreplicating bacilli,
and has bactericidal and sterilizing activity.
• CYP3A4 is the major isoenzyme involved in the metabolism of
bedaquiline, and potent inhibitors or inducers of this enzyme
cause clinically significant drug interactions.
DELAMANID

• Mechanism of action - It acts by inhibiting the synthesis of

mycobacterial cell wall components, methoxy mycolic acid
and ketomycolic acid.

INCLUSION CRITERIA FOR NEWER DRUGS

• Patient aged >6 yrs having MDR/RR TB

• Non preganant female
• Patients with controlled stable arrythmia.
EXCLUSION CRITERIA FOR NEWER DRUGS

• Pregnancy and lactating mother

• Cardiac arrhythmia, conduction abnormality, prolonged
QTcF>500
• History of additional risk factors for Torsade de Pointes, e.g.
Heart failure, hypokalaemia, family history of long QT
syndrome

CONCLUSION

Recent approval of anti-TB drugs such as bedaquiline and

delamanid has boosted our confidence in managing drug-
resistant TB.
The desirable properties of good efficacy, least toxicity, and
absence of interaction with antiretroviral drugs might make
delamanid an important option in treating MDR-TB, XDR-TB, and
TB in HIV-positive individuals.
 TUBERCULOSIS AND HIV
● HIV infection increases the likelihood that new infections
with M.tuberculosis will progresses rapidly to TB disease due
to immune suppression.
● People who are infected with both tuberculosis and HIV are
25 to 30 times more likely to develop tuberculosis.
● People with HIV who have been cured of tuberculosis
infection may be more at risk of developing tuberculosis
again.
● Community education is needed to increase awareness that
tuberculosis is curable and ,most important,that people are
no longer infectious after the first few weeks of treatment.

Diagnosis of tuberculosis in people with HIV

● Early detection of TB in HIV patients: screening based on presence of
4 clinical symptoms (current cough,weight loss,fever,night sweats).Strengthen
intensified case finding at ART.Offering upfront CBNAAT among presumptive TB
cases among PLHIV

● Early detection of DR-TB in HIV patients:using culture and drug

susceptibility test,prompt initiation of ART in HIV infected DR-TB cases,prompt
linkage of hiv infected DR-TB cases to ART centres
Treatment for HIV infected TB
patients
● ART medical officer will categorize clinically diagnosed TB
cases and initiate daily anti TB treatment in fixed dosage
combination as per RNTCP guidelines at ART centre itself
● Treatment of HIV positive individuals with MDR-TB is same as
for HIV negative patients.
● ART must be offered to all patients with HIV and TB and HIV
and MDR-TB irrespective of CD4 cell count.
● Start anti-TB treatment first and then start ART as TB
treatment alone doesn’t significantly increase CD4 cell count
nor decreases the HIV viral load.
● To prevent opportunistic infections co-trimoxazole preventive
therapy must be provided.

● Isoniazid preventive therapy for PLHIVs:IPT

is globally recommended for prevention of
incident TB among HIV infected individuals.It is
the most effective bactiricidal drug available
currently.It protects against the progression of
latent-TB to active diseases i.e reactivation.
 TUBERCULOSIS AND
DIABETES

• People with weak immune system as in diabetes are

at higher risk of progresssing from latent to active TB.

• The risk is 2-3 times higher than the non diabetic

people.

• It suggested that all people living with TB should be

screened for diabetes and screening for TB in diabetes
should be considered.
NATIONAL FRAMEWORK FOR JOINT TB-
DIABETES COLABORATIVE ACTIVITIES
• THEY ARE,
1) Activities to improve diagnosis and management of diabetes.
• Screening of all registered TB patients for diabetes.
• Ensuring diabetes management among TB patients.

2) Activities to improve diagnosis and management of TB among diabetic patients

,
-Intensified detection of TB disease among diabetic patients.
-ensuring TB infection control measures in health care system.

3) Joint monitoring and evaluation.

4) TB patients diagnosed with DIABETES should receive the same
duration of TB treatment with daily regimen as non-
diabetic patients.
Thank you

Summary ….
● RNTCP———NTEP (January 2020)
● NTEP:
a) Organisation structure of NTEP b) objectives c)strategies
d)Goals
● NTEP diagnostic tools and categories of TB: sputum smear
microscopy,culture,drug sensitivity testing, rapid molecular
diagnostic tests(LPA,NAAT,CBNAAT)
● Diagnostic algorithm of PTB:
sputum smear examinations – ZN staining
chest X-ray.
Smear: positive/negative(
respective criteria to be followed)
● Diagnostic algorithm of paediatric TB:
Sputum examination- CBNAAT is preferred
MTB:detected/not detected (respective criteria to
be followed)

Drug regimen for TB

● Treatment regimen
intensive phase(2HRZE).
Continuation phase (4HRE)
● Daily dose schedule for adults-as per weight bands
● Drug dosage for paediatric TB
● Grouping of medicines recommended for use in MDR-TB
 • Newer drugs
• Rifabutin,Roxithromycin,Clarithromycin,Cytokine
`q immunotherapy,Bedaquiline,these are the newer anti-tb drugs
• Needed due to the complexity and toxicity of the current TB drug regimes.
•
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These drugs need to provide few drug to drug interactions.
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•

•
Impact of HIV on TB
HIV infected persons are more susceptible to infectious diseases because of
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weakening of immune system,TB is the commonest opportunistic infection
among people living with HIV/AIDS.
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• Impact of TB on HIV
2`1
• ``````````
When TB occurs in HIV positives,TB accelerates the progress of HIV by
increasing the replication of virus
• Worsens the immune system and increases susceptibility to opportunistic
infection and death.

• TB and Diabetes Milietus

• People with diabetes are at higher risk of progressing from latent to active
TB.
• The risk is 2-3 times higher than people without diabetes

• END TB Strategy
• The WHO’s End TB Strategy was adopted by world health Assembly in 2014 as
part of sustainable development goals(SDGs)
• Vision-A world free of TB,-Zero deaths,disease and suffering due to TB
• Goal-To end the global TB epidemic with targets to reduce TB death by 95%
and to cut new cases by 90% between 2015 and 2035.
1) According to NTEP, how will you classify a TB patient who
had taken antitubercular drugs for only 3 weeks in the past?

A. New case
B. Previously treated case
C. Treatment after loss to follow up
D. Recurrent TB case

2) WHO recommended a control strategy for TB known as:

A. DOTS
B. Gene therapy
C. Morphine
D. MCT

3 ) Which day was declared World Tuberculosis day by WHO?

A. 24 March
B. 24 April
C. 7 April
D. 14 November

4) What was the theme of World Tuberculosis Day 2022?

A. Invest to End TB. Save Lives

B. The Clock is Ticking
C. It’s TIME
D. It’s time to end the stigma

5) Where is the National Tuberculosis Institute located?

A. Mumbai
B. Bangalore
C. Delhi
D. Hyderabad

6) IPT is recommended for prevention of TB in which

condition?

A. HIV
B. Leprosy
C. Measles
D. COVID
7) RNTCP renamed to NTEP in:

A. January 2019
B. March 2020
C. January 2020
C. March 2019

8) To prevent opportunistic infections which drug is given?

A. Ciprofloxacin
B. Amoxicillin
C. Azithromysin
D. Co- trimoxazole

9) Which of the following is not a first line drug for TB?

A. Rifampin
B.Isoniazid
C.Kanamycin
D. Ethambutol

10) Which of the following test are used to determine the

prevalence of TB infection?

A. Sputum examination
B.Mantoux test
C.CB-NAAT
D.Chest X-Ray