LATEST TB TREATMENT UPDATES

1. REVISED NATIONAL TUBERCULOSIS
CONTROL PROGRAMME UPDATES
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Presenter: Dr. JITHIN GEORGE

2. India is the highest tuberculosis burden country accounting for
more than one-fifth of the global incidence
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Indonesia
6%
Nigeria
5%
Other countries
20%
Other 13 HBCs
16% China
14%
South Africa
5%
Bangladesh
4%
Ethiopia
3%
Pakistan
3%
Phillipines
3%
India
21%
Source: WHO Geneva; WHO Report 2014: G Tuberculosis Control; Surveillance, Planning and Financing
Global annual incidence = 9.6 million
India annual incidence = 2.2 million
India is 17th
among 22
High Burden
Countries (in terms of
TB incidence rate)

3. What is the RNTCP?
3

4. RNTCP
4

5. RNTCP
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6. Objectives of RNTCP
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7. END TB STRATEGY
VISION - A world free of TB – Zero Deaths , Disease and Suffering due to
TB
GOAL - END THE GLOBAL TB EPIDEMIC
INDICATORS
Reduction of TB Death
Compared with
2015(%)
Reduction in TB
Incidence Rate
Compared to 2015(%)
TB Affected Family
facing Catastrophic
cost due to TB(%)
MILESTONES TARGETS
2020 2035 SDG 2020 END TB
2035
35% 75% 90% 95%
20%
(<85/100,000
)
50%
(<55/100,000
)
80%
(<20/100,000
)
90%
(<10/100,000
)
0 0 0 0

8. The Components Of The New
End TB Strategy
 Pursue High quality DOTS expansion and enhancement
 Address Tuberculosis/HIV, MDR-TB and other challenges
 Contribute to health system strengthening
 Engage all health care providers
 Empower people with Tuberculosis, and communities
 Enable and promote research
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9. Unique Features of RNTCP
 District Tuberculosis Control Society
• Modular training
• Patient wise boxes
• Sub-district level supervisory staff (STS, STLS) for
treatment & microscopy
• Robust reporting and recording system
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10. Case Findings
Most common symptom of TB
 Cough for 2 weeks or more

11. 11
Definitions of presumptive TB

13. •Presumptive DR TB-
Refers to those patient who have failed treatment
with first line drugs, patients who are contacts of DR-
TB ,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.

14. •Microbiologically confirmed TB Case-
Refers to a presumptive TB Patient with
biological specimen positive for acid fast
bacilli, or positive for Mycobacteriuom
tuberculosis on culture, or positive for
tuberculosis through quality assured rapid
diagnostic molecular test.
Case definitions

15. •Clinically diagnosed TB Case-
Refers to a presumptive TB Patient who is
not microbiologically confirmed, but has
been diagnosed by the 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.

16. • Pulmonary tuberculosis (PTB)-
Refers to any microbiologically confirmed or
clinically diagnosed case of TB involving the lung
parenchyma or the tracheo-bronchial tree.
• 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 node,
intestine, genitourinary tract, joints and bones,
meninges of the brain etc.
Miliary TB is classified as pulmonary TB because
there are lesions in the lungs.
A patient with both PTB and EPTB should be
classified as a case of PTB.

17. New case – A TB patient who has never had treatment for TB
or has taken ATD for <1 month.
Previously treated patients have received one month or
more ATD in the past. This may be:
•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 is a recurrent TB case. (Previously called relapse.)
•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.

18. •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.
•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.

19. Transferred in:
A TB Patient who is received for treatment in a Tuberculosis
Unit, after registered for treatment in another TB Unit .
Mono resistance (MR) – A TB patient whose biological
specimen is resistant to one first-line anti-TB drug only.
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.
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.)

20. 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.
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.)

21. Treatment outcomes
Cured
A microbiologically confirmed TB at the beginning of the
treatment who was smear- or culture-negative at the end of
complete treatment
Treatment completed
Treatment completed as recommended by the national
policy without evidence of failure BUT no record that three or
more consecutive cultures taken at least 30 days apart are
negative after the intensive phase
Treatment success
TB patients either cured or treatment completed are
accounted in the treatment success. (New addition).

22. Lost to follow-up
A TB patient whose treatment was interrupted for one
consecutive month or more. (New addition).
Not evaluated
A TB patient for whom no treatment outcome is assigned.
(Former transfer out).
Treatment regimen changed
Previously, it was called as switched over to MDR treatment.
A patient who has been diagnosed as having MDR-TB by an
RNTCP accredited laboratory, prior to being declared as
Failure, and is placed on the RNTCP MBR-TB treatment
regimen.

23. Died
Patient who died during the corse of treatment regardless of
any cause.
Failure
A TB patient whose biological specimen is positive by smear
or culture at the end of the treatment. (Changed).

24. Tools for microbiological
confirmation of TB
 Sputum Smear Microscopy (for AFB): Zeihl-
Neelson Staining and Fluorescence staining.
 Culture: Solid (Lowenstein Jensen) media or
Agar-based 7H11/10 medium
 Automated Liquid culture systems.
 Drug Sensitivity Testing:
 Modified DST for MGIT (Mycobacteria growth
indicator tube system) 960 system (for both first
and second line drugs).

25. Rapid molecular diagnostic testing:
 Line Probe Assay for MTB complex and detection of RIF& INH
resistance
 Nucleic Acid Amplification Test (NAAT) Xpert MTB/Rif testing using
the GeneXpert system. Used in sputum and as well as extra-
pulmonary specimen. Dx of DR-TB.
Radiology, TST(tuberculin skin test) ,IGRA (interferon gamma release
assay) are other tools for diagnosis of tuberculosis.

26. Two samples are collected within a day or two consecutive days.
One sample is collected on the spot under supervision and other is
collected early in the morning.
 Sputum should be at least 2 ml in quantity.
 Results of sputum tests should be reported within a day.

27. Diagnostic Algorithms for
Pulmonary Tuberculosis
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29. Sputum Specimen
specimen
“a” (first
specimen)
The spot sputum specimen, irrespective of
whether it is collected prior or after the
morning specimen
specimen “b”
second
specimen
The morning specimen
“c” specimen The space for the “c” specimen should be left
blank.
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30. Sputum Smear Interpretation
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If The Slide Has
(NO. Of AFB)
Result Grading No. Of Fields
To Be
Examined
No AFB In 100 Oil Immersion Fields Neg 0 100
1-9/100 Oil Immersion Fields Pos Scanty* 100
10-99/100 Oil Immersion Fields Pos 1+ 100
1-10/Oil Immersion Field Pos 2+ 50
>10/Oil Immersion Field Pos 3+ 20
*Record Actual Number Of Bacilli Seen In 100 Fields – eg. “Scanty 4”
Smear-positive results including those of scanty positives are always recorded
in Red ink in the tuberculosis laboratory register

31.  The most common symptom of pulmonary Tuberculosis is a
persistent cough for two weeks or more
 Patients suspected to have pulmonary Tuberculosis should have two
sputum smears examined
 Sputum samples should be examined as soon as possible and not
later than 2 DAYS after it is collected
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32. The strategies adopted in the treatment of TB are based
on both scientific and operational research.
1. Domiciliary treatment
2. Short course chemotherapy
3. Intermittent regimen
4. Direct observation of treatment
Domiciliary Treatment
Domiciliary chemotherapy has been proved to be as effective
as sanatoria treatment. Smear-positive TB patients treated
on a domiciliary basis have achieved high cure rates as good
as those when treated at sanatorium, besides having
other social benefits of being at home.

33. Short Course Chemotherapy
Short course chemotherapy regimens have made it possible to
treat and cure TB patients in as short a period as six to eight
months. Reduction in the duration of treatment regimens was
possible because of the introduction of Rifampicin and
Pyrazinamide. Thus contributed to improvement in the treatment
adherence.

34. Isoniazid (H): Isoniazid is a potent drug, exerting early
bactericidal activity, prevents emergence of drug resistant
mutants to any companion drug and has low rates of adverse
drug reactions.
Rifampicin (R): Rifampicin is a potent bactericidal and
sterilizing drug acting on semidormant bacilli which multiply
intermittently, thereby causing relapse.
Pyrazinamide (Z): Pyrazinamide is a bactericidal and
sterilizing drug effective in eliminating the semi-dormant
bacilli multiplying slowly in an acidic environment.
Ethambutol (E): Ethambutol is an effective bacteriostatic
drug helpful in preventing emergence of resistance to other
companion drugs.
Streptomycin (S): Streptomycin is a bactericidal drug known
to reduce septicaemia and toxicity

35. Intermittent Treatment
Intermittent regimens should only be used in a programme
of directly observed treatment (DOT). The formulation of
intermittent regimens in the treatment of TB is based on the
principle of existence of lag period. “In vitro experiments
demonstrated that, after a culture of M. tuberculosis is
exposed to certain drugs for some time, it takes several
days before new growth occurs”. Thus, there is no need to
maintain blood levels of drugs for 24 hours in the treatment
of tuberculosis
Advantages of intermittent regimen are:
1. As effective as daily treatment
2. Facilitates DOT
3. Reduction in total quantity of drugs consumed
4. Fewer adverse reactions

36. Directly Observed Treatment Short-course Chemotherapy
(DOTS)
DOT is a supportive mechanism that ensures the best
possible results in treatment of TB. Here, a DOT Provider
helps the patient in taking the treatment, thereby ensuring
adherence.
Studies shown that there will be poor treatment outcome and
high death rates in the absence of DOT, even when regular
supply of drugs is ensured. Hence, by providing DOT, RNTCP
ensures that patients receive the right drugs, in the right
doses, at the right intervals and for the right duration.

37. The five key components of DOTS
1. Political commitment to control Tuberculosis
2. Case detection by sputum smear microscopy
examination among symptomatic patients
3. Patients are given anti-Tuberculosis drugs
under the direct observation of the health care
provider/community DOT provider.
4. Regular, uninterrupted supply of anti-
Tubeculosis drugs
5. Systematic recording and reporting system that
allows assessment of treatment results of each
and every patient and of whole Tuberculosis
control programme
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39. Treatment
Groups
Type of
patient
Regimen
Intensive Phase
(IP)
Continuation
Phase (CP)
New
•New includes
former categories I
and III
•Red coloured Box
•TOTAL -78 dose
•Sputum smear-
positive
•Sputum smear-
negative
•Extra-pulmonary
•Others
2H3R3Z3E3 4H3R3
Previously
Treated
•Smear-positive
relapse
•Smear-positive
failure
•Smear-positive
treatment after
default
•Others
2H3R3Z3E3S3
/ 1H3R3Z3E3
5H3R3E3
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“NEW”
•Red coloured
Box
•78 dose
•Includes former
categories I & III
•TOTAL -78 dose

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41. Dosages For Anti-tuberculosis
Drugs In mg/Kg Body Wt
Drug Daily Dosage, mg/kg
(range)
Daily
Treatment
Treatment
three times a
week
Isoniazid H 5 (4-6) 10 (8-12)
Rifampicin R 10 (8-12) 10 (8-12)
Streptomycin S 15 (12-18) 15 (12-18)
Ethambutol E 15 (13-17) 30 (25-35)
Pyrazinamide Z 25 (20-30) 35 (30-40)

42. New daily regimen

43. Weight band :-

44. Adverse Effects of ATD

48. Follow-up of treatment:
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.
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.)

49. •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.
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.

55. TB Rx IN LIVER DISORDERS- 3
REGIMENS

56. EXTRAPULMONARY TB