Presented by Dr. Radhika Ghongane KMC Manipal

1. RECENT CHANGES IN RNTCP
GUIDELINES
BY- Dr.Radhika
MODERATOR- Dr.Amithash

2. INTRODUCTION
• Revised TB Control Programme (RNTCP) was launched in 1993
• It formulated and adopted the internationally recommended Directly
Observed Short Course (DOTS) strategy
• Objectives of RNTPCP were,
1. to achieve atleast 85% cure rate among new smear-positive cases
2. a case detection rate of atleast 70% of cases

3. • The first technical and operational guidelines for RNTCP were
developed during the initial years of implementation of the
programme.
• They were updated in 2005
• Current guidelines on TB care are in line with RNTCP national strategic
plan for TB control 2012–2017

4. GOALS AND OBJECTIVES
• The goal of the national strategic plan is to achieve universal access of quality of
TB diagnosis and treatment of all TB patients in the community.
• The objectives are:
1. 90% notification rate for all cases
2. 90% success rate for all new and 85% for re-treatment cases
3. To significantly improve the successful outcome of treatment for DRTB cases
4. To achieve decreased morbidity and mortality for HIV-associated TB cases
5. To improve the outcome of TB care in the private sectors

5. • A key focus area was strengthening the recording and reporting systems
• In May 2012, a Govt. of India was issued which mandates all health care
providers to notify every TB case and/or treated to the local authorities
• Web-based TB notification system NIKSHAY was established to provide
platform for notification
• The major change in the organization structure of RNTCP is the formation
of one TB Unit per block/1.5–2.5 lakh population in urban areas in contrast
to previous RNTCP guidelines
• previous RNTCP guidelines, where there was one TB Unit per 5 lakh
population/1 per 2.5 lakh in tribal, hilly and difficult areas.

6. Changes in RNTCP guidelines includes,
• DEFINITIONS OF CASES
• DIAGNOSTIC ALGORITHMS
• DRUG REGIMENS
• FOLLOW-UP OF TREATMENT
• DEFINITIONS OF TREATMENT OUTCOMES
• DRUG-RESISTANT TUBERCULOSIS

7. PRESUMPTIVE TB-CASES DEFINITION
Refers to a person with any of the symptoms or signs suggestive of TB:
• cough >2 weeks
• fever >2 weeks
• significant weight loss
• hemoptysis
• any abnormalities in chest radiography
As per the previous guidelines, a pulmonary TB suspect was defined as:
• An individual having cough for 2 weeks or more
• Contacts of smear-positive TB patients having cough for any duration
• Suspected/confirmed extra-pulmonary TB having cough for any duration
• HIV-positive patient having cough for any duration.

8. PRESUMPTIVE DRTB CASES DEFINITION
• TB patients who have 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

9. CLASSIFICATION OF TB
• On basis of history of previous treatment-
1. New case
2. Previously treated patient-
a) Recurrent TB case
b) Treatment after failure
3. Treatment after loss to follow-up

10. 1. New case – A TB patient who has never had treatment for TB or has taken ATD for
<1 month (No change in new guidelines)
2. Previously treated patients have received one month or more ATD in the past. This
may be:
(a) Recurrent TB case – A TB patient previously declared as successfully treated
(cured/treatment completed) and who is subsequently found to be
microbiologically confirmed TB case.
-Previously called relapse
(a) 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 treatment.
-Previously, it was called failure where a TB patient is sputum-positive at 5
months or more after initiation of treatment.

11. 3. Treatment after loss to follow-up – A TB patient previously treated
for TB for one month or more and who was declared lost to follow-up
in their most recent course of treatment and subsequently found
microbiologically confirmed TB cases.
Previously called treatment after default – A patient who has received
treatment for TB for a month or more from any source and return for
treatment after having defaulted, that is, not taking ATD consecutively
for 2 months or more and found to have smear-positive.

12. CLASSIFICATION OF TB
• on the basis of drug resistance-
1. Mono resistance (MR)
2. Poly resistance (PDR)
3. Multi-drug resistance (MDR)
4. Rifampicin resistance (RR)
5. Extensive drug resistance (XDR)

13. 1. Mono resistance (MR) – A TB patient whose biological specimen is
resistant to one first-line anti-TB drug only.
2. Poly resistance (PDR) – A TB patient whose biological specimen is
resistant to more than one first-line anti-TB drug, other than both INH and
Rifampicin.
3. Multi-drug resistance (MDR) – A TB patient whose biological specimen is
resistant to both INH and Rifampicin with or without resistance other
first-line ATD, based on results from a Quality Assured Laboratory.
(No changes)

14. 4. Rifampicin resistance (RR) – Resistance to Rifampicin detected by
phenotypic or genotypic methods with or without resistant to other
ATD excluding INH.
Patient with RR should be managed as if they are in MDR TB case.
5. Extensive drug resistance (XDR) – MDR TB case whose biological
specimen was resistant to a Fluroquinolone (FQ) and a second-line
injectable ATD from a Quality Assured Laboratory.
(No changes)

15. CLASSIFICATION OF TB
• On basis of bacteriological status-
1. Microbiologically confirmed TB case
2. Clinically diagnosed TB case
• Classification is done according to,
1. Anatomical site of disease
2. History of previous TB
3. Drug resistance

16. 1. Microbiologically confirmed TB case- a presumptive TB patient with
biological specimen positive for AFB or positive for MTB on culture,
or positive for TB through Quality Assured Rapid Diagnostic
molecular test.
2. Clinically diagnosed TB case- a presumptive TB patient 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
anti-TB treatment.

18. DIAGNOSTIC ALGORITHM OF PULMONARY TB
Sputum positive
& no risk for DRTB
Sputum positive
& risk for DRTB
Microbiologically
confirmed TB
Cartridge-Based Nucleic Acid
Amplification Test (CBNAAT)
Microbiologically
confirmed
drug-sensitive TB
Rifampicin
resistant TB

19. DIAGNOSTIC ALGORITHM OF PULMONARY TB
Smear negative and
CXR suggestive of TB
2nd smear and CBNAAT
simultaneously
Microbiologically
confirmed
drug-sensitive TB
Rifampicin
resistant TB
Smear negative and CXR
not suggestive of TB but
high clinical suspicion
CB-NAAT testing

20. DIAGNOSTIC ALGORITHM OF PULMONARY TB
RIF indeterminate result
Additional CB-NAAT to
get a valid result
Indeterminate on 2nd
occasion
Send to Intermediate Reference Laboratory (IRL) or Line
Probe Assay (LPA) or Liquid Culture and DST

21. DIAGNOSTIC ALGORITHM OF PULMONARY TB
• Whenever facilities are available, effort should be made to obtain DST
results of all drugs
• If both the sputum smear and CXR are negative, the patient should be
referred to a pulmonologist
• All key population (PL-HIV, children, Extra-Pulmonary TB, etc.) will
preferentially get a CBNAAT

23. DRUG-SENSITIVE TB REGIMEN
Previous guidelines:
• Standard intermittent regimen
• Treatment under direct observation of Dots provider (DP)
• Category decided by MO (category I/II)
• Drugs to be taken 3 times a week under direct observation of DP,
1. Intensive phase (IP) for 2–3 months – all doses given under
supervision
2. Continuation phase (CP) for 4–5 months – first dose of the week
given under supervision.

24. DRUG-SENSITIVE TB REGIMEN
New guidelines:
Principle of treatment of TB has been shifted towards daily regimen
with administration of daily fixed dose combination of first-line ATD as
per appropriate weight bands.

25. Daily regimen for new TB cases
• Treatment in IP will consist of 8 weeks of INH, Rifampicin, Pyrazinamide and
Ethambutol in daily dosages as per four weight bands categories
• There will be no need for extension of IP
• Only Pyrazinamide will be stopped in CP
• Other three drugs will be continued for another 16 weeks as daily dosages

26. Daily regimen for previously treated TB cases
• IP will be of 12 weeks, where injection Streptomycin will be stopped after 8 weeks
• The remaining four drugs in daily dosages as per weight band for another 4 weeks
• No need of extension of IP
• At the start of CP, Pyrazinamide will be stopped
• Rest of the drugs will be continued for another 20 weeks as daily dosages.

27. • According to the new guidelines, ATD are to be given in fixed dose
combination as daily doses according to weight bands

28. MANAGEMENT OF EXTRA-PULMONARY TB
There is only one change as follows:
• The CP in both new and previously treated cases may be extended 3–
6 months in certain TB such as CNS, skeletal, disseminated TB, and so
on based on clinical decision of the treating physicians
• Extension beyond 3 months will only be on recommendation of
experts of concerned field.
(In the previous guidelines, extension of ATD in case of CNS and skeletal
TB was maximum 3 months)

29. FOLLOW-UP OF TREATMENT
• Clinical follow-up (new addition)
• Follow-up laboratory investigation
• Long-term follow-up

30. CLINICAL FOLLOW-UP
• Should be at least monthly
• Can be in clinical facility/patient’s house
• To observe improvement of chest symptoms, weight-gain
• Control the co-morbid conditions such as HIV and diabetes
• To monitor any adverse reaction to ATD

31. FOLLOW-UP LABORATORY INVESTIGATION
For PTB cases –
• Sputum smear examination at the end of IP and at the end of treatment
(In the previous guidelines, follow-up sputum smear to be done at 2, 4 and 6
months for new cases and 3, 5 and 8 months in previously treated cases)
• In case of clinical deterioration, the Medical Office may consider repeat sputum
smear even during CP (New addition)
• At the completion of treatment, sputum smear and culture should be done for
every patient
• CXR – to be offered whenever required and available.

32. LONG-TERM FOLLOW-UP
• After completion of treatment, the patient should be followed up at
the end of 6, 12, 18 and 24 months
• Any clinical symptoms and/or cough, sputum microscopy and/or
culture should be considered (New addition)
(no provision of long-term follow-up in the previous guidelines)

33. Difference of RNTCP regimen between new and
previous guidelines

34. TREATMENT OUTCOMES
1. Cured- A microbiologically confirmed TB at the beginning of the
treatment who was smear or culture-negative at the end of complete
treatment. (Changed)
2. Treatment success- TB patients either cured or treatment completed
are accounted in the treatment success. (New addition)
3. Failure- A TB patient whose biological specimen is positive by smear
or culture at the end of the treatment. (Changed)

35. TREATMENT OUTCOMES
4. Lost to follow-up- A TB patient whose treatment was interrupted for
one consecutive month or more. (New addition)
5. Not evaluated- A TB patient for whom no treatment outcome is
assigned. (known as transfer out previously)
6. Treatment regimen changed- Previously, it was called as switched
over to MDR treatment.

36. MDR/RR TB CASES (without additional
resistance)
• 6–9 months of IP
• IP includes Kanamycin, Levofoxacin, Ethambutol, Pyrazinamide,
Ethionamide and Cycloserine
• 18 months of CP
• CP includes Levofoxacin, Ethambutol, Ethionamide and Cycloserine
(no change)

37. MDR/RR TB CASES
• If INH resistance is not known or DST result shows sensitivity to INH,
then addition of INH in the above-mentioned regimen of ATD is to be
done
(New addition)
• All MDR TB cases would be subjected to Liquid Culture and DST at
baseline for Kanamycin and Levofloxacin.

38. NEW ADDITIONS TO DRTB GUIDELINES
• If RR by CBNAAT, then add INH in the standard dose till result of LPA/LC and DST.
• For new patients diagnosed as TB and RR by CBNAAT – repeat CBNAAT and send
the sample for liquid culture
TB and RR by
CBNAAT

39. MTB+ and RR by
CBNAAT
Repeat CBNAAT +
sample for LC
2nd CBNAAT
shows RR
2nd CBNAAT shows
R sensitiveness

40. DRUG RESISTANT TB
• Introduction of new ATD under RNTCP - Bedaquiline (BDQ)
• New class of drug, diaryl-quinoline
• MOA = targets MTB-ATP synthase, which is essential for supply of
energy to the bacterium
• Has strong bactericidal and sterilizing activities against MTB

41. • Advantages-
1. No cross-resistance with first and second-line ATD
2. Significant benefit in improving the time to culture conversion in
MDR-TB patients
• Basic criterion –
1. Adult aged ≥18 years having pulmonary MDR TB
2. Non-pregnant females

42. Management of TB patients with liver disorder
• If the serum alanine amino transferase level is more than 3 times
normal before initiation of treatment, the regime should be:
(a) Containing two hepatotoxic drugs- HRE for 9 months/ HRE+S for 2
months f/b HR for 7 months/ HEZ for 6–9 months
(b) Containing one hepatotoxic drug: HE+S for 2 months f/b HE for 10
months
(c) Containing no hepatotoxic drugs: HE+ FQ for 18–24 months

43. Initiation of first-line ART in relation to ATD
• Start ATT first
• Start ART as soon as TB treatment is tolerated (between 2 weeks and
2 months)
• TLE (tenofovir+lamivudine+efavirenz) to be given for patients not on
ART