NEWER UPDATES ABOUT TB GUIDELINES AS NTBCP

1. Dr. Siddharth
Medical Consultant – TB
World Health organization
Recent Updates in
National TB Elimination Program

2. Learning Objectives
• Basics of TB management
• TB preventive treatment guidelines.
• DR-TB management guidelines.
• Index TB guidelines – EP sample collection
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3. TB Burden- Global v/s India
Estimates of TB
Burden (2021)
Global
(Million)
India % of
Global
Incidence TB cases 10.6 3 Million 28.3%
Mortality of TB 1.4 494,000 35.3%
Incidence HIV TB 0.7 54,000 7.7%
Mortality of HIV-TB 0.18 11,000 5.9%
MDR-TB 0.45 119,000 26.4%
Children with TB 1.1 356,000 32.4%
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4. ENDTB SUMMIT
13TH MARCH 2018
• Landmark event towards complete
elimination of TB from the country
• Hon’ble Prime Minister Shri Narendra
Modi announced targets for Ending TB
by 2025, much ahead of the global
SDG targets of 2030
• Emphasized importance of working
together for the cause as the disease is
linked to the betterment of the lives of
the poor
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5. Vision:
A world free of TB
Zero TB deaths,
Zero TB disease, and
Zero TB suffering
Goal:
End the Global TB
epidemic
Vision, goal, targets, milestones
(2,8 million)
(4.8 lakh)
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6. Co-morbidities with increased risk of TB:
• HIV infection:
- 16-27 times higher life time risk of developing TB among PLHIV
• Diabetes Mellitus:
- 2-3 times of higher risk of developing TB among uncontrolled diabetic patients
• Smoking/ use of tobacco:
- 2.5 times of higher risk of TB among smokers
• Malnutrition:
- Leads to increased risk of TB especially among children with household contacts
of TB patients
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7. Definitions of presumptive TB
•Cough > 2 weeks
•Fever > 2 weeks
•Significant weight loss
•Haemoptysis
•Abnormal chest radiograph
Presumptive pulmonary TB
•Swelling of lymph nodes
•Pain and swelling in joints
•Neck stiffness
•Disorientation
•Constitutional symptoms
Presumptive extra pulmonary TB
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8. Definitions of presumptive TB
• Persistent fever or cough > 2
weeks
• Loss of weight or no weight gain
• H/o contact with infectious TB
cases
Presumptive paediatric TB
•Failed treatment with first line drugs
•Paediatric TB non responders
•Contacts with DR –TB
•Positive cases during follow up
•Previous TB cases
Presumptive DR TB
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9. TB Care
Smear Microscopy
CBNAAT
X-Ray
USG/CT/MRI
Clinical Judgement
Medicine Pediatrics Surgery Obs/Gynae Ortho
Pulm
Skin ENT Ophthal
DMC cum DOT Centre/Drug Resistant TB Ward
Treatment for
Drug Sensitive TB
Treatment for
Drug Resistant TB
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10. Treatment of DS-TB
• Frequency of dosage : DAILY (7 day/week)
• Single daily dosage
• New case & Previously treated DSTB regimen :-2 HRZE + 4HRE
• No extension of Intensive Phase
• Continuation phase may be extended for 3 to 6months in special situations
like bone and joint TB, spinal TB with neurological involvement and Neuro –
Tuberculosis
• Weight Band wise drug dosage (5 weight bands in adults & 6 weight bands in
children's)
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11. 4FDC 3FDC
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12. Revised Daily Dose Schedule for Adults - >18Yrs
(as per weight bands)- 14th May 2019
Weight band Number of tablets
Intensive phase Continuation phase
HRZE (4FDC) HRE (3FDC)
75/150/400/275 mg 75/150/275 mg
25-34 kg 2 2
35-49 kg 3 3
50-64 kg 4 4
65-75 kg 5 5
≥75kg* 6 6
* Patients >75kg may receive 5 tablets /day if they do not tolerate this dose.
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13. Drug Dosage for Paediatric TB- upto 18Yrs
*A=Adult FDC (HRZE = 75/150/400/275; HRE = 75/150/275)
Weight category Number of tablets
(dispersible FDCs)
Intensive phase Continuation phase
HRZ (3FDC) E HR (2FDC) E
50/75/150 100 50/75 100
4-7 kg 1 1 1 1
8-11 kg 2 2 2 2
12-15 kg 3 3 3 3
16-24 kg 4 4 4 4
25-29 kg 3 + 1A* 3 3 + 1A* 3
30-39 kg 2 + 2A* 2 2 + 2A* 2
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14. • Rs. 500/- per month given to every TB patient through DBT for duration of treatment
• Scheme rolled out from April 2018
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NIKSHAY Poshan Yojana
Incentives
Incentive for Treatment supporter
Incentive for
Private providers
Incentive for
Informant
• Drug sensitive TB : Rs. 1000/- at
completion of treatment
• Drug Resistant Case: Rs.5000/-
at completion of treatment
• Notification incentive : Rs. 500/-
for a diagnosed TB case
• Outcome incentive : Rs. 500/-
• An Informant is eligible for
incentive of Rs. 500/- for a
confirmed TB case

15. PMTPT Guidelines - 2021
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16. Algorithm for TB screening and TPT
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NO
Defer preventive
treatment
YES
Give preventive treatment5
NO
NO
<5 years
TST or IGRA
Symptomatic?2
Investigate for active TB
Follow-up for active TB as necessary, even for patients who have completed preventive treatment
YES
Abnormal
YES
Positive or unavailable Negative
Preventive treatment
contraindicated?4
No active TB
Normal or
unavailable
5 years +
CXR6
Any symptom1 of
current cough or fever or weight loss or
night sweats
Household contact
HIV positive Other risk group 3

17. TB Preventive Treatment – DSTB contacts
Target population Treatment
• People living with HIV (+ ART)
o Adults and children >12 months
o Infants <12 months with HIV in contact with active TB
• HHC below 5 years of pulmonary* TB patients
• 6-months daily isoniazid (6H)
OR
• 3-month weekly Isoniazid and
Rifapentine (3HP) in persons older than
2 years
• HHC 5 years and above of pulmonary* TB patients#
• Children/adult on immunosuppressive therapy, silicosis,
anti-TNF treatment, dialysis, transplantation
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18. 18
Regimen Dose by age and weight band
Six months of daily levofloxacin
(6Lfx) for contacts of R resistant
FQ sensitive patients#
Age > 14 years, by body weight: < 45 kg, 750 mg/day; ≥ 45 kg, 1g/day
Age < 15 years (range approx. 15–20 mg/kg/day), by body weight:
5–9 kg: 150 mg/day
10–15 kg: 200–300mg/day
16–23 kg: 300–400mg/day
24–34 kg: 500–750mg/day
Four months of rifampicin daily
(4R) for contacts of H resistant R
sensitive patients*
Age 10 years & older: 10 mg/kg/day@
Age <10 years: 15 mg/kg/day (range, 10–20 mg)
# Lfx 100 mg dispersible tablets available for children. Children receiving 6Lfx should be watched for joint abnormalities.
* In children from 0-14 years, 4R should only be used after ruling out active TB in limited geographies/populations for
evidence generation to guide future scale up for country wide implementation.
@ Maximum dose of R would be 600 mg/day.
Note: 6H can be considered as the TPT regimen option for contacts of index patients with RR-TB with FQ and H sensitive,
after ruling out active TB in them.
TB Preventive Treatment – DR TB contacts

19. PMDT Guidelines - 2021
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20. Classification and Definitions of DR-TB.…1
• Multidrug-resistant TB (MDR-TB). A TB patient, whose biological specimen is
resistant to both H and R with or without resistance to other first-line anti-TB drugs.
MDR-TB patients may have additional resistance to any/all FQ or any other anti-TB
drug.
• Pre-extensively drug resistant TB (Pre-XDR-TB). TB caused by Mycobacterium
tuberculosis strains that fulfil the definition of MDR/RR-TB and are also resistant to
any fluoroquinolone.
• Extensively drug resistant TB (XDR-TB). TB caused by Mycobacterium tuberculosis
strains that fulfil the definition of MDR/RR-TB and are also resistant to any
fluoroquinolone (levofloxacin or moxifloxacin) and at least one additional Group A
drug (presently to either bedaquiline or linezolid [or both]).
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21. DR-TB Diagnostic Algorithm
All notified TB patients
Presumptive TB
R resistance detected R resistance not detected
H resistance not detected
H resistance detected
• PLHIV
• EPTB
• Smear -ve/NA with X-ray
suggestive of TB including
paediatric
• Vulnerable populations
• Contact of DR TB patient
Non responder to treatment
FL – LPA$,
SL – LPA$ and
DST for Mfx(1.0), Lzd*,
Cfz*, Z*, Bdq*, Dlm*
NAAT#
FL LPA$
SL LPA$
DST for Z*
DST for Mfx (1.0) & Lzd only if FQ or Z
resistance detected
# NAAT include CBNAAT & TruNAAT
*whenever available
$ Culture isolates to be subjected to LPA for smear negative specimens
For discordance resolution – see text
• DS TB
• H mono/poly
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22. Regimen class Intensive phase Continuation phase
H mono/poly DR TB (R resistance not detected and H resistance)
All oral H mono-poly DR TB
regimen@
(6/9) Lfx R E Z
MDR/RR TB
Shorter Bdq MDR TB regimen@ Bdq(6) (4-6)Lfx Eto Cfz Z Hh E (5) Lfx Cfz Z E
All oral longer MDR TB
regimen@
(18-20) Bdq(6) Lfx Lzd# Cfz Cs
DRTB Regimen and duration
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23. INDEX- TB
GUIDELINES
(INDian EXtra-pulmonary Tuberculosis
Guidelines)
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24. • 5.8 million people developed tuberculosis globally in 2021
• 1.5 million perished in 2020
• EPTB accounts for:
• 15-20% of all TB cases in HIV negative patients
• 40-50% of all TB cases in HIV positive patients
EPTB: Extra-pulmonary Tuberculosis * Global Tuberculosis Report, 2021
Burden of the Disease
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25. Why to collect- Rationale
Evidence required to establish etiological relationship between microorganism and
disease
Diagnosis of TB Detection of Drug Resistance Monitoring treatment
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26. What to collect- Types of Samples
Fluids
• Spinal
• Pleural
• Pericardial
• CSF
• Synovial
• Ascitic
• Bone Marrow
• Bronchial washings
• Nasal Secretions
• Gastric washings
• Urine
• Vitreous fluid
• Blood
• Swabs
Tissues
• Tissues
• Lymph Node
• Tissue Biopsy
• Stool
• Bone
• Endometrial
scrapping
Aspirate
• Fine Needle
Aspirate
• Pus
Pulmonary
• Sputum
• Induced sputum
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27. In which to collect- Containers used for Sample collection
Sterile screw capped
conical tube
Sputum container
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Specimen collection container: Sterile 50 ml screw capped and graduated conical bottom
polypropylene tube

28. Quality of Sputum specimen
1. Thick (semi solid), coughed out deeply from
the lungs
2. Mucopurulent (yellowish mucus)
3. Adequate in quantity
4. Properly labelled container
1. Contains only saliva, (watery),nasal
secretions, food / tobaco particles
2. Inadequate quantity (less than 2 ml)
3. Not properly labelled container
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Good Quality Sample Poor Quality Sample

29. Collection of Extra Pulmonary sample- 1
Blood:
• Blood for isolating M. tuberculosis should be
generally discouraged for the low diagnostic yield
and high possibility of contamination with respect
to the technique required for its culture.
• Specific indications- liquid/Solid culture
• Body fluids should be aseptically collected in a sterile container by the physician using
aspiration techniques or surgical procedures.
• Specimens should be transported to the laboratory as quickly as possible.
Pleural fluid :
• Considered a suboptimal specimen as tubercle
bacilli
• The minimum volume for pleural fluid required
for processing for culture is 20–50ml.
• The fluid is collected using pleural tap or
thoracocentesis.
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30. Tissues:
• Aseptically collected tissues are collected in
sterile containers preferably without fixatives or
preservatives.
• If the specimen is to be shipped, it should be
protected from drying by adding sterile saline
and maintaining a temperature of 4-15 degree
C.
• Specimens should be transported to the
laboratory as quickly as possible.
Collection of Extra Pulmonary sample-2
Bronchial secretions:
Other respiratory specimens that can be submitted
to the laboratory for mycobacteria culture are
• bronchial secretions (minimum volume: 2-
5ml) and
• bronchial alveolar lavage (BAL) (minimum
volume of 20 – 50 ml).
Pericardial fluid :Should be collected using ultra
sonogram
CSF: Lumbar Puncture
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31. Swabs:
• A sterile absorbent cotton swab should be used
for collection.
• The best time for the collection is early morning
before food and drinks are taken.
• The swab should be placed in a screw capped
container containing normal (0.9%) saline to
prevent drying..
• Swabs except for laryngeal swabs or from
discharging sinus should be avoided.
Collection of Extra Pulmonary sample-3
Urine:
Among specimens expected to be contaminated,
urine is the most common.
• Early morning sample should be collected in
screw capped sterile containers.
• Once received in the laboratory, urine must be
immediately processed or centrifuged and the
pellet refrigerated for further processing.
• As excretion of tubercle bacilli in urine is
intermittent, three early morning specimens
must be collected on different days.
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32. Gastric Lavage :
• In children, who rarely produce sputum, the aspiration of the early morning (gastric content) may be
used for TB diagnosis.
• This is done as an inpatient procedure.
• This should be transported immediately to the lab and processed (not more than 4 hours) to prevent
the killing action of the acid content in the gastric lavage on the tubercle bacilli.
• In the event of delay, the sample can be neutralised using 1-2 ml of sterile 10 % sodium bicarbonate
solution depending on the volume of gastric aspirate.
Collection of Extra Pulmonary sample - 4
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33. Precautions
 Samples for culture should never be collected in
formalin.
 If histo pathological examination is required, two
samples should be collected
 No preservative (unless indicated) should be used for
any extra-pulmonary specimen for culture.
 Necessary instructions are to be given to the concerned
staff for sending the biopsy specimen in normal saline
for culture and NOT IN FORMALIN as it will kill the bacilli.
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34. When to transport – Turn Around Time
IMMEDIATE
AT DIAGNOSTIC CENTRE
NO BATCHING OF SPECIMEN AT COLLECTION SITES
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35. 1. Should Xpert MTB/Rif be recommended for use in diagnosis of:
• Lymph node TB
• TB meningitis
• Pleural TB?
Key question - 1
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36. First line test for diagnosis of pulmonary TB and endorsed by NTEP for the
same
Widely available and an attractive option as it provides faster results
Not reliable in certain EPTB cases, hence, indiscriminate and unregulated use
may lead to higher false negative results
Need for Guidelines on Xpert?
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37. 1. Should Xpert MTB/Rif be recommended for use in diagnosis of:
Key question - 1
Site of disease Recommendations
Lymph node TB • Should be used as an additional test to culture and cytology
TB meningitis • Additional test.
• Negative test will not rule out TB.
• Clinical features and CSF profile to be considered to start ATT.
Pleural TB • High false negatives.
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38. 2. How long should ATT be given in the treatment of
• Lymph node TB
• TB meningitis
• Abdominal TB ?
Key questions - 2
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39. 2. How long should ATT be given in the treatment of
Key question - 2
Site of disease Recommendations
Lymph node TB Standard 6months regimen (2HRZE+4HRE)
TB meningitis First line ATT for 9months
Abdominal TB Standard 6months regimen (2HRZE+4HRE)
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40. Thank you 40