RNTCP TOG guidline 2016

1. Treatment of Tuberculosis
RNTCP UPDATE

3. Introduction
• Pulmonary tuberculosis is caused predominantly by
Mycobacterium tuberculosis when droplet nuclei with bacilli
are inhaled. In accordance with the virulence of the organism
and the host defense, tuberculosis can occur in the lungs or in
extrapulmonary organs.
• All those who get infected do not necessarily develop TB
disease.
• The life time risk of breaking down to disease among those
infected with TB is 10-15%.
• Determinants such as diabetes mellitus ,tobacco smoking ,
alchohol abuse and malnutrition also increases the risk of
progression from infection to TB disease.

4. Burden Of Tuberculosis
• As per the Global TB report 2017 the estimated incidence of TB in
India was approximately 28,00,000 accounting for about a quarter
of the world’s TB cases.
• It is estimated that about 40% of the Indian population is infected
with TB bacteria, the vast majority of whom have latent rather than
active TB.
• It is estimated that about 2.2 lakhs people die due to TB annully.
TB India 2017 Revised National TB Control Programme Annual Status Report, New Delhi

5. RNTCP
• The national tuberculosis programme of India (NTP) was initiated in
1962 and was originally designed for domiciliary treatment, using
self-administered standard drug regimen.
• In 1992, the Government of India with World Health Organization
(WHO) and Swedish International Development Corporation Agency
(SIDA) reviewed the tuberculosis (TB) situation and the
performance of NTP which revealed that the NTP, though
technically sound, suffered from managenal weakness, inadequate
funding, over-reliance on X-ray for diagnosis, frequent interrupted
supplies of drugs and low rate of treatment completion.
• In 1997, Revised TB Control Programme (RNTCP) was launched
which formulated and adopted the internationally recommended
Directly Observed Short Course (DOTS) strategy as the most
systemic and cost-effective approach to revitalize the TB control
programme in India.

6. • The objectives of RNTPCP were to achieve at least 85% cure
rate among the new smear-positive cases initiated on
treatment and thereafter a case detection rate of at least 70%
of such cases.
• The first technical and operational guidelines for RNTCP were
developed during the initial years of implementation of the
programme and were updated in 2005.
• As per the RNTCP National Strategic Plan , the program has a
vision of achieving a "TB free India", and aims to achieve
Universal Access to TB control services.
• The program provides, various free of cost, quality
tuberculosis diagnosis and treatment services across the
country through the government health system. It seeks to
employ the WHO recommended tuberculosis control strategy,
DOTS(Directly Observed Treatment, Short Course), to the
Indian scenario.

7. • 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 of the
national strategic plan are:
To achieve 90% notification rate for all cases
• To achieve 90% success rate for all new and 85% for re-
treatment cases
• To significantly improve the successful outcome of
treatment for DRTB cases
• To achieve decreased morbidity and mortality for HIV-
associated TB cases
• To improve the outcome of TB care in the private sectors

8. Case finding and Diagnosis strategy
• To achieve universal access to early accurate diagnosis of
TB and enhancing case finding efficiency,
– identification of presumptive TB cases at the first point of care
– and linking them to the best available diagnostic tests is of
paramount importance.
• Early case detection is vital to interrupt the transmission
of TB disease.
• Note: In addition, contacts of microbiologically confirmed TB Patients,
PLHIV, diabetics, malnourished, cancer patients, patients on immune-
suppressants or steroid should be regularly screened for sign and
symptoms of TB

9. Definitions of presumptive TB
• Presumptive Pulmonary TB refers to a person with
any of the symptoms and signs suggestive of TB
including
• cough >2 weeks,
• fever > 2 weeks,
• significant weight loss,
• haemoptysis,
• any abnormality in chest radiograph.

10. • Presumptive Extra Pulmonary TB refers to the
presence of organ specific symptoms and signs like
– swelling of lymph node,
– pain and swelling in joints,
– neck stiffness, disorientation, etc
– and/or constitutional symptoms like significant weight loss,
persistent fever for 2 weeks, night sweats.

11. • Presumptive paediatric TB refers to children with
• persistent fever
• and/ or cough for more than 2 weeks,
• loss of weight*/no weight gain
• and/or history of contact with infectious TB cases**.
• "History of unexplained weight loss or no weight gain in past 3
months;
• *loss of weight is defined as loss of more than 5% body weight
as compared to highest weight recorded in last 3 months.
• **In a symptomatic child, contact with a person with any form
of active TB with in last 2 years may be significant.

12. • Presumptive DRTB refers to those TB patients who
have
– failed treatment with first line drugs,
– paediatric TB non responders,
– TB patients who are contacts of DR-TB (or Rif resistance),
– TB patients who are found positive on any follow-up
sputum smear examination during treatment with first line
drugs,
– previously treated TB cases,
– TB patients with HIV co-infection.

13. DIAGNOSTIC TOOLS
Tools for microbiological confirmation of TB
Under RNTCP, the acceptable methods for microbiological
diagnosis of TB are:
• Sputum Smear Microscopy (for AFB):
– Zeihl-Neelson Staining
– Fluorescence staining
• Culture:
– Solid (Lowenstein Jensen) media
– Automated Liquid culture systems e.g. BACTEC MGIT 960,
BactiAlert.
– Drug Sensitivity Testing:

14. DIAGNOSTIC TOOLS CONT..
• Rapid molecular diagnostic testing:
– Line Probe Assay for MTB complex and detection of RIF&
INH resistance
– NucleicAcid Amplification Test (NAAT) Xpert MTB/Rif
testing using the GeneXpert system

15. Other diagnostic tools
• Radiography
• Where available, CXR to be used as a screening tool to
increase sensitivity of the diagnostic algorithm.
• Any abnormality in chest radiograph should further be
evaluated for TB including microbiological confirmation.
• In the absence of microbiological confirmation, careful
clinical assessment for TB diagnosis should be done.
• Diagnosis of TB based on X-ray will be termed as clinically
diagnosed TB.

16. Other diagnostic tools cont..
• Tuberculin Skin Test(TST) & Interferon Gamma Release
Assay (IGRA)
– The exact advantage of IGRA in high burden countries like India
is still not clear, hence these are not recommended for use for
adults in diagnostic algorithm for tuberculosis in India.
• Serological tests
– The Government of India issued Gazette notification (vide 433E 7th
June 2012) has banned the manufacture, importation, distribution and
use of currently available commercial serological tests for diagnosing
TB. These tests are not recommended for diagnosis of TB.

18. PMDT guideline INDIA 2017

20. Treatment of tuberculosis
• The goals of Tuberculosis treatment are:
– To decrease case fatality and morbidity by ensuring relapse
free cure
– To minimize and prevent development of drug resistance
– To render patient non-infectious, break the chain of
transmission and to decrease the pool of infection

21. Case definitions
Microbiologically confirmed TB case refers to a presumptive TB
patient with
– biological specimen positive for acid fast bacilli,
– or positive for Mycobacterium tuberculosis on culture,
– or positive for tuberculosis through Quality Assured Rapid
Diagnostic molecular test.
Clinically diagnosed TB case refers to 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.

22. • Microbiologically confirmed or clinically diagnosed
cases of TB are also classified according to
– Anatomical site of disease
– History of previous treatment
– Drug Resistance

23. Classification based on anatomical site of disease
• a) Pulmonary tuberculosis (PTB) refers to any
microbiologically confirmed or clinically diagnosed case
of TB involving the lung parenchyma or the tracheo-
bronchial tree.
• b) Extra Pulmonary tuberculosis (EPTB) refers to any
microbiologically confirmed or clinically diagnosed case
of TB involving organs other than the lungs such as
pleura, lymph nodes, intestine, genitourinary tract, joint
and bones, meningesof the brain etc.
• Miliary TB is classified as PTB because there are lesions in
the lungs.
• A patient with both pulmonary and extrapulmonary TB
should be classified as a case of PTB.

24. Classification based on history of TB treatment
• a) New case – A TB patient who has never had
treatment for TB or has taken anti-TB drugs for less
than one month is considered as a new case. (No
change in new guidelines.)

25. • b) Previously treated patients have received 1 month or
more of anti-TB drugs in the past. This may be
• I. Recurrent TB case- A TB Patient previously declared
as successfully treated (cured/treatment completed) and
is subsequently found to be microbiologically confirmed
TB case is a recurrent TB case. (Previously called relapse.)
• II. 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)

26. Previously treated patients cont..
• III. Treatment after loss to follow-up A TB patient
previously treated for TB for 1 month or more and was
declared lost to follow-up in their most recent course of
treatment and subsequently found microbiologically
confirmed TB case
• IV. 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 undocumented.
• c) Transferred In: ATB patient who is received for
treatment in a Tuberculosis Unit, after registered
fortreatment in another TB unit is considered as a case of
transferred in.

27. Classification based on drug resistance
• a. Mono-resistance (MR): A TB patient, whose biological
specimen is resistant to one first-line anti-TB drug only.
• b. Poly-Drug 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.
• c. Multi Drug Resistance (MDR): A TB patient, whose
biological specimen is resistant to both isoniazid and
rifampicin with or without resistance to other first line drugs,
based on the results from a quality assured laboratory.

28. • Classification based on drug resistance cont…
• d. Extensive Drug Resistance (XDR): A MDR TB case
whose biological specimen is additionally resistant to
– a fluoroquinolone (ofloxacin, levofloxacin, or moxifloxacin)
– and a second-line injectable anti TB drug (kanamycin,
amikacin, or capreomycin) from a quality assured
laboratory.

29. Treatment
• Drug Regimen
According to the previous guidelines, drug regimen for
drug-sensitive TB was as follows:
• Standard intermittent regimen with 2 categories of treatment
• Treatment under direct observation of Drug Provider
• Category decided by MO (category I/II)
• Drugs to be taken three times a week under direct
observation
• Intensive phase (IP) for 2–3 months – all doses given under
supervision
• Continuation phase (CP) for 4–5 months – first dose of the
week given under supervision.

30. • But there are significant changes in the drug regimen in the
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.

31. • 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
• while the other three drugs will be continued for another 16
weeks as daily dosages.

32. • For previously treated cases:
• IP will be of 12 weeks, where injection Streptomycin will
be stopped after 8 weeks
• and 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
• while rest of the drugs will be continued for another 20
weeks as daily dosages.

34. • Management of extra-pulmonary TB (new guidelines) –
• 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).

35. • According to the new guidelines, ATD are
to be given in fixed dose combination as
daily doses; drug doses for adult TB is as
follows:

38. Other Treatment Factors

41. Follow-up of treatment: There are some changes in
the new guidelines
• Clinical follow-up – (new addition)
• Should be at least monthly – the patient may visit the
• clinical facility, or the medical officer may conduct
• the review when she/he visits the house of the patient
• to observe improvement of chest symptoms, weight
• gain, control the co-morbid conditions such as HIV and
• diabetes and to monitor any adverse reaction to ATD.

42. • 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.

44. • 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)
• However, there was no provision of long-term
follow-up
• in the previous guidelines.