This document summarizes updates to India's Revised National Tuberculosis Control Program (RNTCP) guidelines. Some key changes include: - Expanding the criteria for presumptive TB cases to include high-risk groups like contacts of confirmed cases and those with comorbidities. - Introducing a new diagnostic algorithm and case definitions. Daily fixed-dose combination therapy is now recommended over intermittent regimens. - Updated treatment guidelines for drug-sensitive TB, drug-resistant TB, and special groups like pregnant women, those with liver or kidney disease. - New classifications, treatment durations and regimens defined for various resistance patterns from mono- to extensive drug resistance. - Revised follow-

1. RNTCP
UPDATES

2. Evolution of TB Control in India
1950s-60s Important TB research at TRC and NTI
1962 National TB Program (NTP)
1992 Program Review (GOI, WHO & SIDA)
only 30% of patients diagnosed
of these only 30% treated successfully
1993 RNTC pilot began
1998 RNTCP Scale up (2 % of the total population by RNTCP)
2001 450 million population covered
2004 > 08% of country covered
2006. Entire country covered by RNTCP
2016 Technical and operational guidelines
2017. RNTCP has updated guidelines for programmatic
management of drug resistant TB

3. • To achieve 90% notification for all cases
• To achieve 90% success rate for all new cases and 85% for previously
treated cases
• To significantly improve the successful outcome of treatment of DRTB
cases.
• To achieve decreased morbidity and mortality of HIV associated TB cases.
• To improve outcome of TB care in private sectors.
RNTCP: NATIONAL STRATEGIC PLAN
2012-2017

4. CASE DEFNITIONS
MICROBIOLOGICALLY CONFIRMED TB CASE CLINICALLY DIAGNOSED TB CASE
A presumptive TB patient with
● Biological specimen Positive for AFB in
● AFB smear
● Culture
● Molecular methods
A presumptive TB patient with
● Radiological abnormalities
● Histopathology
● Clinical signs
Consistent with active TB
Case definition like smear positive TB, smear negative TB are removed in new guidelines

5. Case finding & Diagnostic strategy
Presumptive pulmonary TB
refer to patients with any of the symptoms
and signs suggestive of TB
• Cough> 2 weeks
• Fever >2 weeks
• Significant weight loss
• Hemoptysis
• Any abnormalities in chest radiograph
NEW GUIDELINES PREVIOUS GUIDELINES
In new guidelines in addition contacts of micro biologically confirmed TB
patients, PLHIV ,DM ,malnourished, cancer pts, pts on immune suppressants
are screened regularly
Pulmonary TB suspect
• Cough of >=2 weeks
• Cough of any duration of
1. Contacts of smear positive TB
2. Contacts of EPTB
3. HIV positive patients.

6. Case finding & Diagnostic strategy
Presumptive extra pulmonary TB
Organ specific symptoms and signs
• Like swelling of lymph nodes
• Pain and swelling in joints.
• Neck stiffness, disorientation
And or constitutional symptoms
• Significant weight loss
• Persistent fever >2 weeks
• Night sweats
This is similar to previous guidelinesguidelines

7. Case finding & Diagnostic strategy
Presumptive drug resistant TB
• TB patients who failed treatment with first line anti tubercular
drugs(ATD)
• Pediatric TB non responder
• TB patients who are contacts of DRTB
• TB patients who are found positive on any follow up sputum
smear examination during treatment with first line ATD
• Previously treated TB cases
• TB patients with HIV co infection.

8. Diagnostic Algorithm for Pulmonary TB

9. Diagnostic Algorithm for Extra Pulmonary TB

10. DIAGNOSTIC ALGORITHM FOR DRUG RESISTANT TB

11. Contd…..
Classification based on drug resistance :
• Monoresistant – resistance to one 1st lineATT
• Poly drug resistant – resistance to more than one first line ATT other
than INH & RIFA
• Multiresistance drug– resistance to both INH & RIFA with or without
resistant to other drugs
• Extensive Drug resistance – MDR + resistance to 2nd line ATT
( fluroquinolones and injectable 2nd line
ATT)

12. . .
CASE DEFNITIONS

13. TREATMENT
• Intermittent regimen
• extension of IP by 1 month if sputum positive
• Ethambutol in CP of cat II regimen only
• No fixed dose, limited weight band
• Follow up laboratory only.
• No long term follow up
• Daily drug – Fixed drug combination
(FDC) according to weight bands.
• No extension of IP
• Ethambutol in CP of both catI & cat
II regimen
• Fixed dose combinatioc(FDC) as per
weight band
• Follow up– up clinical ,and /
laboratory investigation
• .Long term follow up up to 2 yrs
PREVIOUS GUIDELINES NEW GUIDELINES

14. From Intermittent Regimen To Daily Fixed Dose combination
as per weight
14

15. .
FIXED DOSE COMBINATION : WEIGHT BANDS-ADULTS

16. Treatment : DRUG SENSITIVE TB
PREVIOUS GUIDELINES
Tb case IP CP
NEW 2 (HRZE)3 4( HR)3
PREVIOUSLY
TREATED
2 (HRZES)3
+(HRZE)3
5 (HRE)3
Tb case IP CP
NEW 2 HRZE 4 HRE
PREVIOUSLY
TREATED
2 HRZES
+HRZE
5 HRE
• Daily regimen….FDC
• Ethambutol introduced in cp of new cases.
• No extension of IP
NEW GUIDELINES

17. Tb case Intensive phase Continuation phase
MDR (6-9)Km, Lfx ,Eto ,Cs, Z, E (18) Lfx ,Eto ,Cs, Z, E
R-RESISTANT + H sensitive/
unknown
(6-9)Km, Lfx ,Eto ,Cs, Z, E, H (18) Lfx ,Eto ,Cs, Z, E, H
All MDR isolates
• Liquid culture drug sensitivity done for Km and Lfx
• Appropriate modification doneaccording to
culture’
TREATMENT : DRUG RESISTANT TB

18. Diagnosis of EPTB using the Xpert
MTB/RIF test
● Lymph node TB:
❖Xpert MTB/RIF should be used as an additional test to
conventional smear microscopy,culture and cytology in
FNAC SPECIMENS.

19. • TB Meningitis:
❖Xpert may be used as an adjunctive test for TBM . A
negative Xpert result on a CSF specimen does not rule
out TBM . Treatment decision can be taken based on
clinical features and CSF profile.

20. ● Pleural TB
❖Xpert MTB/RIF should not be used to diagnose pleural
TB.

21. . .
PRE TREATMENT EVALUATION DRUG RESISTANT TB

22. Treatment : MONODRUG RESISTANT TB
5 EFFECTIVE DRUGS
• Total treatment duration : 9 to 12
months
• Intensive phase – 3 to 6 months
• Continuation phase – 6 months
(to discontinue injectable SLD)
A TB patient ,whose biological specimen is resistant to one first line anti TB drug ( FLD )only.
INJECTABLE
SECOND LINE DRUGS
FLUROQUINOLONE RIFAMPICIN
SENSITIVE
FIRST LINE DRUG (HZE)
SENSITIVE
FIRST LINE DRUG (HZE)

23. Treatment : INH MONO RESISTANT TB
Tb case Intensive phase Continuation phase
INH RESISTANT TB +
RIFAMPICIN SENSITIVE
(DST of SEZ not known)
(3-6)Km, Lfx ,R Z, E (6) Lfx ,R, Z, E
Decision to use INH in the regimen
LIQUID
CULTURE
HIGH
RESISTANC
E
OMIT INH
LOW
RESISTANC
E
HIGH DOSE
INH
LPA
KAT G
MUTATION
OMIT INH
INH A
MUTATION
HIGH DOSE
INH

24. TREATMENT : POLYDRUG RESISTANT TB
Biological specimen resistant to > one FLD other than H & R
• Total treatment duration : 9 to 12
months
• Intensive phase – 3 to 6 months
• Continuation phase – 6 months
(to discontinue injectable SLD)
INJECTABLE
SECOND LINE DRUGS
FLUROQUINOLONE RIFAMPICIN
SENSITIVE
FIRST LINE DRUG (HZE)
ANY ONE GROUP IV DRUG
(Eto,Cs,PAS)

25. Treatment : MDR / RR-TB with additional resistance
Resistance
to EMB
• omit EMB
Resistance
to PYZ
• Omit PYZ
Resistance
to EMB +
PYZ
• omit EMB + PYZ / add
PAS in IP + CP
Resistanc
e to
LFX
• omit LFX/ add MFX + PAS +
CFZ
Resistance
to MFX
• Omit MFX/ Add LFX + PAS +
CFZ
Resistance
to LFX +
MFX
• omit LFX + MFX / add CFZ + PAS + LZD
• Duration of IP 6-12 Months
ADDITIONAL RESISTANCE TO FLD’S ADDITIONAL RESISTANCE TO FQ’S

26. Treatment : MDR / RR-TB with additional resistance
Resistance
to Km
• omit Km/ add Cm
Resistance
to Cm
• Omit Cm/ Add Km
Resistance
to
Km + Cm
• omit Km + Cm
• add CFZ + PAS + LZD
• Duration of IP 6-12 Months
ADDITIONAL RESISTANCE TO INJECTABLE SLD’S

27. Duration of treatement for EPTB
● Lymph node TB
❖ Six-month ATT standard first-line regimen is recommended
for peripheral lymph node TB .
● Abdominal TB
❖ Six-month ATT standard first-line regimen is recommended
for abdominal TB.
● TB meningitis
● TB meningitis should be treated with standard first-line ATT
for at leat nine months.

28. Tb case Intensive phase Continuation phase
XDR (6-12)Cm, PAS, Mfx , High dose H
CFZ,lzd, Amx/clv
(18), PAS, Mfx , High dose H CFZ,
lzd,
Amx/clv
• All DR –TB treatment are to be given on daily basis
under supervision.
TREATMENT : EXTENSIVE DRUG RESISTANT TB

29. FOLLOW UP : DRUG SENSITIVE TB
positive DRUG SENSITIVITY TEST
• MICROBIOLOGICAL
- END OF IP
- END OF TREATMENT
• Weight- monthly
• Chest xray – if required
• Physical evaluation – whenever
required
LABORATORY
CLINICAL
• In the presence of clinical deterioration, the MO consider sputum examination
• even during CP.
• At completion of treatment sputum and/or culture done for every patient.

30. . .
TREATMENT OUTCOMES

31. Drug Main effects Rare effects
Isoniazid Peripheral neuropathy
Skin rash
Hepatitis
Sleepiness and lethargy
Convulsions
Psychosis
Arthralgia
Anaemia
Rifampicin Gastrointestinal: abdominal
pain, nausea, vomiting
Hepatitis
Generalised cutaneous
reactions
Thrombocytopenic purpura
Osteomalacia
Pseudomemberanous colitis
Pseudoadrenal crisis
Acute renal failure
Haemolytic anaemia
Pyrazinamide Arthralgia
Hepatitis
Gastrointestinal
Cutaneous reactions
Sideroblastic anaemia
Ethambutol Retrobulbar neuritis Generalised cutaneous
reactions
Arthralgia
Peripheral neuropathy
Hepatitis (very rare)
Adverse drug reaction FLDs

32. ADVERSE DRUG EFFECTS :SLD
• Ototoxicity
• Nephrotoxicity
• Vertigo
• Electrolyte
imbalance
Kanamycin,
capreomycin
• GI symptoms,
• convulsions
• QTprolongation,
• arthralgia
Quinolones-
oflox,mfx,Lf
• GI upsets,
excessive
salivation,
hepatitis
• Hypothyroidism,
• Gynaecomastia,
• neuropathy
ethionamide
• CNS : convulsions, dizziness,
• tremor, insomnia,
• suicidal tendency, depression
• hypersensitivity reaction
CYCLOSERINE
• GI upsets, skin rash
hepatitis GI symptoms,QT
• prolongation, arthralgia
• Hypokalemia,hepatiti
• Hypothyroidism
PAS

33. TB IN PREGNANCY AND LACTATION
•A successful TB treatment is important for successful outcome of pregnancy
•With exception to STREPTOMYCIN all first line drugs are safe in pregnancy
•Lactating women should receive ATT full course
•Breastfeeding must be continued
•Lactating mother to follow COUGH HYGINE MEASURES
•Baby should receive BCG followed by INH prohylaxsis with
pyridoxine 5mg/kg for 6 months

34. .
DR-TB in pregnancy
Pregnancy screening is mandatory in pretreatment
evaluation
Women of
child bearing
age group
presumptive
MDR-TB
To use
appropriate
contraceptive
till culture and
DST results
To take specialist opinion when found to be pregnant prior or during treatment

35. .
Usual TB
regimen with
anticipation
of
hepatotoxicity
Current
excessive
alcohol use
h/o acute
hepatitis
Hepatitis
virus
carriage
TB and Liver disorders

36. .
• Pyrazinamide
• Ethionamide
• PAS
HEPATOTOXIC
DRUGS
• SLDs can be used safely
• Less hepatotoxic than FLDs
• However PYZ + Etm should be avoided
Mild hepatic
impairment
• Consider other etiologies
• Alcohol,viral,Non TB drug induced etc..
Hepatitis when
on SLDs
TO MONITOR LFT DURING TREATMENT IF PRE TREATMENT LFT DERANGED
DR-TB in Liver diseases
Risk increases with pre existing liver disease

37. TB in Renal failure
CKD Patients are at increased risk in developing Pulmonary & Extra pulmonary TB
NEPHROTOXIC
DRUGS
Ethambuamol
Metabolites of
Pyrazinamide
Streptomycin
Requires dose and interval modifications

38. Dose modifications
Pyrazinamide
25mg/kg
(thrice weekly)
Ethambutol
15mg/kg
(thrice weekly)
Streptomycin
15mg/kg
(twice/thrice weekly)
Dosing intervals must be increased in STAGE 4 & 5 CKD
When on INH in severe renal insufficiency pyridoxine to be added
to prevent
peripheral neuropathy
Contd…