RNTCP

1. D R . V . D I N E S A P R A B H U ,
P R O F A N D H O D O F P U L M O N A R Y M E D I C I N E ,
G O V T . M E D I C A L C O L L E G E , T H R I S S U R
RNTCP, Current Guidelines

2. India accounts for 1/5th of all TB incidence
cases in the world
Non-HBCs
20%
Pakistan
3%
Ethiopia
3%
Philippines
3%
South Africa
5%
Bangladesh
4%
Nigeria
5%
Indonesia
6%
China
14%
India
20%
Other 13 HBCs
16%
Source: WHO Global Report 2009
Global annual incidence = 9.4 million
India annual incidence = 1.98 million

3. Evolution of TB Control in India
 1950s-60s Important TB research at TRC and NTI
 1962 National TB Programme (NTP)
 1992 Programme Review
 only 30% of patients diagnosed;
 of these, only 30% treated successfully
 1993 RNTCP pilot began
 1998 RNTCP scale-up
 2001 450 million population covered
 2004 >80% of country covered
 2006 Entire country covered by RNTCP

4. Objectives of the RNTCP
 To achieve and maintain a Cure Rate of at
least 85% among new sputum smear-
positive patients detected
 To achieve and maintain a Case Detection
Rate of at least 70% of all such patients

5. Revised NTCP
 Pilot tested in 1993
 Uses the DOTS strategy
 RNTCP now covers the entire country (all 632
districts; over 1.17 Billion people) – as of 24th
March 2006
 Over12.3Million patients put on DOTS in India,
& 2.2million Lives saved

6. The 5 components of DOTS
 Political & administrative
commitment
 Diagnosis by good quality
sputum microscopy
 Adequate supply of good
quality drugs
 Directly observed treatment
 Systematic monitoring &
Accountability

7. What is the Scientific
Basis for DOTS?

8. Scientific Basis of DOTS
 Sputum microscopy
 Domiciliary treatment
 Short course chemotherapy
 Intermittent chemotherapy
 Directly observed treatment

9. Sputum microscopy
• Provides definitive diagnosis
• Easy to perform
• Replicable
• Cost effective
• 50% of the new pTB pts. expected to be SS+

10. Microscopy is More Objective and Reliable than
X-ray
 Inter-observer variability is much
less with microscopy than with x-
ray
 AFB microscopy provides
information on infectiousness of
the patient, which x-ray does not
 AFB microscopy allows
prioritization of cases, which x-
ray does not
 AFB microscopy is also an
objective method to follow the
progress of patients on treatment

11. X-ray is an Important Complementary Tool
• Highly sensitive; with low specificity
• Plays a useful supportive role:
• May lead to over-diagnosis
–May miss the diagnosis of other
diseases (e.g. malignancies)
• NOT a good tool for follow-up of
patients on ATT

12. Other Diagnostic Tests
Mantoux gives evidence of infection, not
disease
ESR is not specific
 Culture is specific, sensitive
 But time consuming, costly, requires specialized labs
 Other tests like PCR, Ig Assays etc.
 No value over conventional techniques
 Highly sensitive, but poor specificity

13. Scientific Basis of DOTS
 Sputum microscopy
 Domiciliary treatment
 Short course chemotherapy
 Intermittent chemotherapy
 Directly observed treatment

14. The Madras Study
TRC, 1959
 Domiciliary treatment as effective as
sanatorium treatment
 No additional benefit by bed rest or
special diet
 Risk of infection among contacts similar
 Most patients do not need hospitalization
 Lowered economic burden on society

15. Scientific Basis of DOTS
 Sputum microscopy
 Domiciliary treatment
 Short course chemotherapy
 Intermittent chemotherapy
 Directly observed treatment

16. Short course chemotherapy
TRC studies, 1968 - 87
 Favourable results with short courses of ATT
 6 months adequate for NSP patients
 8 months adequate for retreatment cases
 Durations adequate to prevent MDR TB
 More convenient and economical
 Direct observation more feasible
 Improved patient compliance to treatment

17. Scientific Basis of DOTS
 Sputum microscopy
 Domiciliary treatment
 Short course chemotherapy
 Intermittent chemotherapy
 Directly observed treatment

18. Lag period
 When tubercle bacilli are exposed to a drug
for a short time (6–24 hours) and, after
careful removal of the drug, are transferred to
a drug free medium, the surviving bacilli start
to grow again after an interval of several days.
 All tuberculosis drugs have been tested for
their ability to produce a lag period, in order
to determine whether they are suitable for
intermittent regimens

19. Scientific Basis of DOTS
 Sputum microscopy
 Domiciliary treatment
 Short course chemotherapy
 Intermittent chemotherapy
 Directly observed treatment

20. What is the need for DOT?
 At least 1/3 of patients on self-administered Rx
fail to adhere to Rx
 Impossible to predict which patients will take
medicines
 DOT necessary at least in the IP of Rx to
ensure adherence and smear conversion
 TB patient missing 1 attendance can be traced
immediately and counseled.

21. The famous pathanamthitta study

22. Directly observed treatment
 Ensures the best possible results in TB treatment
 Observer watches & assists patient swallow the tablets
 Ensuring that the patient receives the medication
 Many patients who do not receive DOT stop ATT
 Poor results and high death rates in the absence of DOT
 Observing the patients during the entire course
 Ensures that the patient receives the right drugs
 Ensures the right doses
 Ensures the right intervals

23. Diagnosis of TB
 Cough for ≥2 weeks (TB suspects) screened from
OPD/clinics and referred for sputum microscopy
 Sputum microscopy performed at quality assured
Designated Microscopy Centres (DMCs)
 If sputum is initially negative and remains so after a
course of antibiotic, despite persisting symptoms,
then X-ray chest is done
 Standard diagnostic algorithm for pulmonary TB
 Patients diagnosed as Sputum +ve and Sputum –ve PTB
 Extra-Pulmonary TB is diagnosed based on clinical
evaluation and histopathological evidence

25. Intensive Phase
 Aims for a rapid killing of bacilli
 A state of non-infectiousness achieved within a
short period 2/52
 Quick relief of symptoms
 Smear negativity by 2/12
 Prevent development of drug resistance

26. Continuation Phase
 Aims to eliminate remaining bacilli
 Killing of “persisters” prevents relapses
 Multi-drug regimens and DOT necessary (unless
R not used) even though risk of emergence of drug
resistance is less as fewer bacilli remain

28. Categorization of Patients
 Classified into two groups based on H/o
previous treatment
 New cases: All new pulmonary (sputum positive
and negative) and extra pulmonary TB patients
 Previously treated cases: Patients who have
more than one month Anti TB Rx previously
(default, failure and relapse)

29. Regimen for new cases
 Regimen: 2H3R3E3Z3 / 4 R3H3
 IP: 8 weeks (24 doses)
 CP:18weeks (54 doses)
 If sputum is + ive at the end of two months, IP is
continued for another one month (12 doses)
 CP is for 4 months

30. New cases cont….
 For TBM in new cases, Inj SM is used in place of
EMB in IP (H3R3Z3S3 instead of H3R3Z3E3)
 CP for patients with TBM and spinal TB is 7 months
 Hence total duration of Rx is 9 months
 Steroids recommended for TBM and TB Pericarditis

31. Regimen for Previously treated cases
 Regimen: 2S3H3R3Z3E3/1H3R3Z3E3/5H3R3E3
 If sputum is + ive at the end of three months, IP is
extended for another one month (12 doses, four
weeks)
 If sputum remains +ive at the end of extended IP,
sputum is send to an accredited RNTCP C&DST lab
for C&S testing

32.  CP is for 5 months (22weeks, 66 doses) H3R3E3
 At least first dose of every week being directly
observed
 Relapse case have better outcome than Failure and
Treatment after default cases

33. Follow-up Sputum Tests
 At the end of Intensive Phase
 Two months into Continuation Phase
 At the end of Continuation Phase

34.  Drug Resistant case: A patient whose TB is due to
tubercle bacilli that are resistant in vitro to at least to
one Anti TB drug according to accredited laboratory
methods in an RNTCP accredited laboratory

35.  MONO RESISTANCE: A patient whose TB is due to
tubercle bacilli that are resistant in vitro to exactly to
one anti TB drug in an RNTCP accredited laboratory

36.  POLY RESISTANCE: A patient whose TB is due to
tubercle bacilli that are resistant in vitro to more
than one anti TB drug, except not due to INH and
Rifampicin in an RNTCP accredited laboratory

37. Multi Drug Resistant Tuberculosis
 DEFINITION: An isolate of M. Tuberculosis
resistant to at least INH and Rifampicin with or
without other antitubercular drugs based on DST
result from an RNTCP accredited culture and DST
laboratory.

38. How does drug resistance happen?
 When these drugs are misused or mismanaged.
 When patients do not complete their full course of
treatment;
 When health-care providers prescribe the wrong treatment,
the wrong dose, or length of time for taking the drugs;
 When the supply of drugs is not always available;
 When the drugs are of poor quality.

39. Who is at risk for getting MDR TB?
People who
 Are irregular in taking medicines
 Do not take all of their TB medicine as told by their doctor or
nurse
 Relapse
 Come from areas of the world where drug-resistant TB is
common
 Have been exposed to DR TB

40. Extensively drug resistant TB-XDRTB
 DEFINITION: TB showing resistance to INH,
Rifampicin, and any fluroquinoline, and at least one
of the three injectable drugs used in Anti TB
treatment: Capriomycin, Kanamycin and Amikacin

41. Link between TB and HIV
 HIV co-infection strongest known risk factor for
the progression of latent TB infection
 Conversely, TB is amongst the most common
causes of morbidity and mortality in people living
with HIV/AIDS
 Immune response to TB bacilli increases HIV
replication leading to a rapid progression of HIV
disease
 Optimal access to DOTS will significantly reduce
morbidity and mortality in PLWHA

42. Treatment of TB in HIV
 TB can be successfully treated even in HIV-infected patients
 But, cannot alone prevent people from dying of AIDS
 In addition to TB treatment, ART and CPT needed for those eligible
 DOTS is the treatment of choice
 Intermittent SCC is effective
 National policy is to provide RNTCP Cat-I to new cases and Cat-II to
re-treatment cases
 Higher relapse rates have been observed especially in those
treated with non-Rifampicin containing regimen
 Whether true relapse or re-infection?
 Drug interactions between Rifampicin and ARVs
 National policy is to start ART after completing anti-TB treatment, or
modify ART by replacing Nevirapine with Efavirenz for the duration of
TB treatment

43. What is New in RNTCP, effective April 2009
EARLIER NOW
3 weeks cough 2 weeks cough
3 sputum specimens
required
2 sputum specimens
At least 2specimens
should be positive
1 positive is enough

44.  Category 3 is phased out
 Ethambutol is reintroduced and dose is @ 20mg/KG
 PPM – Public Private Mix

45. Public-Private share in national
health programs

46. Scheme for treatment adherence
 All private practitioners involved as DOTS
Centres
 Private practitioner provides DOT services to TB
Patients
 PP has to undergo 4 hours of intensive training
in Training Module for Medical Practitioners

47. DMC in Thrissur District
 Doctors’ Laboratory, Chelakara
 St. James Hospital, Chalakudy
 Modern Laboratory, Kodungallur
 Co Operative Hospital, Irinjalakuda

48. New in RNTCP Cont…
 Reference Laboratory is set up for high quality
culture and sensitivity tests
 Vigilance for MDRTB
 For TBM, Inj SM is substituted for Ethambutol in
IP
 NTP should record and report two age groups for
children (0-4 yrs and 5-14yrs)