RNTCP

Presenter - Dr Supriya Jamatia
Moderator - Prof Ksh Birendra
RNTCP
REVISED NATIONAL TUBERCULOSIS CONTROL PROGRAMME

TUBERCULOSIS
 Caused by M tuberculosis
 Mostly affecting Lungs
 Life time risk
 Primarily airborne transmission
10 – 15%  Among infected
> 30%  if Diabetic
10% /year  if co- infected with HIV

DISEASE BURDEN
TB burden 2015 : Global vs India

Estimates of TB burden
2016
Rate
(per 100 000 population)
Incidence
(includes HIV+TB)
211 (109–345)
Incidence (MDR/RR-TB) 11 (7.2–15)
Incidence (HIV+TB only) 6.6 (4.3–9.4)
Mortality (excludes HIV+TB) 32 (24–40)
Mortality (HIV+TB only) 0.92 (0.5–1.5)
INCIDENCE IN INDIA(2016)

 1962
 1961-1986
 1986-1993
 1997
 2007
 May 2012
Evolution of TB control program in India
National TB programme
Era of conventional chemotherapy
Directly Observed Treatment Short course(DOTS)
RNTCP roll-out
DOTS plus services for management of MDR- TB patients
Notification of TB is made mandatory by GOI

RNTCP
GOAL
To decrease mortality and morbidity due to TB
and cut down the chain of transmission of
infection.
OBJECTIVE
To achieve and maintain:
1. Cure rate of at least 90% among newly
detected smear positive (infectious) PTB cases
2. Case detection of at least 85% of the
expected new smear positive PTB cases in the
community

UNIQUE FEATURES OF RNTCP
I. District TB Control Society
II. Modular training
III. Patient wise boxes
IV. Sub-district level supervisory staff (STS, STLS)
for treatment & microscopy
V. Robust reporting and recording system

NATIONAL REFERENCE
LABORATORIES
INTERMEDIATE REFERENCE
LABORATORY
 Monitor and supervise IRL
 DST, LPA and CBNAAT
activities.
 Consist of :
 3 microbiologist
 4 laboratory technicians
 Quality improvement
workshop
 Monitoring of EQA activities,
mycobacterial culture and DST
and also drug resistance
surveillance in selected states.
 Technical training to lab
technicians.

2012 – 2017
 Aimed at achieving universal
access to quality diagnosis
and treatment.
 Treatment of drug resistant
TB.-MDR, XDR
National StrategicPlan(NSP)
2017 – 2025
 This NSP proposes strategies to
rapidly decline TB in the country
by 2030 in line with the global
End TB targets.
 Four pillars of NSP

Vision, Goals and Targets of NSP
VISION
TB-Free India with zero deaths, disease and poverty
due to tuberculosis.
TARGETS 1. Private sector engagement
2. Plugging the leak from TB care cascade
3. Active TB case-finding among key populations
4. Specific protection for prevention from
development of active TB in high risk groups.
GOAL
To achieve a rapid decline in burden of TB, morbidity
and mortality while working towards elimination of
TB in India by 2025.

Diagnosis of TB
1. Smear microscopy for Acid Fast Bacilli.
 Sputum smear stained with ZN staining
 Fluorescence stains and examined under direct
or indirect microscopy with or without LED.
2. Radiography
3. Tuberculin skin test

4. Culture
 solid media
 liquid media
5. Rapid diagnostic molecular test
 Line probe assay for MTB complex
 Real-time PCR based nucleic acid amplification test
CBNAAT for MTB complex.
Diagnosis of TB- cont

 Diagnostic algorithm for extra pulmonary TB
Presumptive EPTB pt
Appropriate specimen from site
Not
available
High clinical
suspicion
Available
CBNAAT Liquid culture
MTB
detected
MTB not
detected
Rif
sensiti
ve
Micro
biolog
ically
confir
med
EPTB
Rif
indeter
mined
Repeat
CBNAAT
on fresh
specimen
Rif
resistan
ce
Intermediate on 2nd specimen ,
collect fresh sample for liquid
culture
Culture
positive
Microbiol
ogically
confirmed
EPTB
Culture
negative
No TB
Use
other
diagnost
ic tools
Clinical
ly
diagnos
ed TB
Alternate
diagnosis
Refer to mang
of Rif
resistance

TB CLASSIFICATION
Microbiologically confirmed TB Case
 Presumptive TB Patient with biological specimen Positive for
AFB on culture
 Positive for TB through quality assured rapid diagnostic
Molecular Tests
•
Clinically Diagnosed TB Case
 Presumptive TB Patient not microbiologically confirmed
 Diagnosed as active TB by clinician based on CXR
abnormality/HPE /Clinical signs with a decision to treat the
patient with full course of ATT

Pulmonary Tuberculosis:
• Any case microbiologically or clinically diagnosed case of TB
involving lung parenchyma or tracheo- bronchial tree
Extra- Pulmonary Tuberculosis:
• Any microbiologically or clinically diagnosed cases of TB
involving organs other than lungs e.g. pleura, lymph
nodes,meninges etc.
Miliary TB Classified as PTB as there are lesions in lung.
Patient with both Pulmonary and Extra-Pulmonary TB should
be classified as a case of PULMONARY TUBERCULOSIS
DEFINITIONS

TREATMENT GROUPS TYPE OF PATIENT
NEW
1. Microbiologically confirmed TB
case (Definitive TB case)
2. Clinically diagnosed TB case
(Probable TB)
PREVIOUSLY TREATED
1. Recurrent TB
2. Treatment after failure
3. Treatment after loss to follow-up
4. Other previously treated patient

Previously Treated
A TB patient who has received one month or more of
anti‐TB drugs in the past
1. Recurrent
A TB Patient declared as successfully treated
(cured/treatment completed) as is subsequently
found to be microbiologically confirmed TB case
2 Treatment after Failure
A TB patient who has previously been treated for TB
and his treatment failed at the end of their most
recent course of treatment
3 Treatment after LFU
(Lost to Follow-Up)
A TB patient previously treated for TB for 1 month or
more and was declared LFU in the end of their most
recent course of treatment and subsequently found
microbiologically Positive
4 Other previously
Treated patients
TBpatientswhohavebeenpreviouslytreatedforTB but
whoseoutcomeaftertheirmostrecentcourseof treatment
isunknownordocumented
TYPES OF TB PATIENTS

TREATMENT OUTCOME
CURED
Microbiologically confirmed TB patients at the
beginning of treatment who was smear or culture
negative at the end of the complete treatment
TREATMENT
COMPLETED
A TB patient who completed treatment without
evidence of failure or clinical deterioration BUT
with no record to show that the smear or culture
results of biological specimen in the last month of
treatment was negative, either because test was not
done or because result is unavailable
FAILURE
TB patient whose biological specimen is positive by
smear or culture at end of treatment

TREATMENT OUTCOME- Cont
Lost to follow up
TB patient whose treatment was interrupted
for 1 consecutive month or more
Not Evaluated
TB Patient for whom no treatment outcome is
assigned. This includes former “transfer-out
Died
TB patient who has died during the course of anti-
TB treatment

DRUG RESISTANCE
Mono-
Resistant(MR)
Resistant to one 1st line ATD
Poly-Drug
Resistant(PDR)
More than one 1st line ATD other than INH & R
Multi Drug
Resistant(MDR)
both INH & R with or without resistance to other
first line drugs.
Rifampicin
Resistant(RR)
R resistance with or without other ATD excluding
INH.
Managed as MDR TB
Extensively Drug
Resistant(XDR)
MDR + resistant to FQ and Second Line
Injectables ATD

1. Daily regimen for pediatric TB
2. Daily regimen for all forms of TB.
3. Daily regimen for all TB/ HIV co-infected pts.
4. Pilots for universal access to TB cases.
5. Bedaquilline conditional access program.
6. Universal Drug Susceptibility test(UDST) under RNTCP
Newer initiatives

Anti- Tuberculous Treatment (Daily)
TYPE OF TB CASE TREATMENTREGIMEN
NEW
(A TB patient who has never had
Treatment with anti‐TB drugs or has
taken it for less
than one month)
2H7R7Z7E7
+
4H7R7E7
PREVIOUSLY TREATED
(A TB patient who has received one
month or more of anti‐TB
drugs in the past)
2H7R7Z7E7S7
+
1H7R7Z7E7
+
5H7R7E7
4 FDC will be used in IP 3FDCwillbeusedinCP

FEATURES OF DAILY REGIMEN
Drug will taken DAILY
 Dose will calculated for Body weight.
 Reduce the pill burden
 Improve treatment compliance.
 Child friendly formulations
 Single daily dosage
 4 weeks per month (28 Doses)

Fixed Drug Combination(FDC)
4 FDC  R150 H75 Z400 E275mg 3FDC  R150 H75 E275mg

Continuation Phase can be extended 3 MONTHS
1. TB SPINE WITH NEUROLOGICAL INVOLVEMENT
2. OSTEO ARTICULAR TB
3. DISSEMINATED TB/MILIARY TB
4. NEUROLOGICAL TB

ISONIAZID CHEMOPROPHYLAXIS
 < 6 yrs child
 Contacts of smear positive TB
 After ruling out active TB disease
 Irrespective of BCG status
 Isoniazid 10 mg/kg/day daily for 6 months

Integrated drug resistant TB algorithm

Typeof TBCase
INTENSIVE PHASE
CONTINUATION PHASE
DURATION DRUGS DURATION DRUGS
1. Kanamycin
1. Levofloxacin
2. Ethionamide
3. Cycloserine
4. Ethambutol
5. isoniazid
2. Levofloxacin
RR-TB 6to9
months
3. Ethionamide
4. Cycloserine
5. Pyrazinamide
18months
6. Ethambutol
7. isoniazid
1. Kanamycin
MDR –TB
6to9
months
2. Levofloxacin
3. Ethionamide
4. Cycloserine
5. Pyrazinamide
6. Ethambutol
18months
1. Levofloxacin
2. Ethionamide
3. Cycloserine
4. Ethambutol
MDR/RR-TB Treatment

Typeof
TBCase
INTENSIVEPHASE CONTINUATIONPHASE
DURATION DRUGS DURATION DRUGS
XDR-
TB
6to12
months
1. Capreomycin
2. Para-
aminosalicylicacid
3. Moxifloxacin
4. Highdose-H
5. clofazimine
6. linezolid
7. Amoxi-clav
18months
1. Para-aminosalicylic
acid
2. Moxifloxacin
3. Highdose-H
4. clofazimine
5. linezolid
6. Amoxi-clav
XDR-TB Treatment

Drug Resistant TB findings and treatment
initiation effort 2007- 2017

TB-HIV coordination
 Intensified TB case finding in all ART centers.
 HIV testing of TB patients is now mandatory
 RNTCP has prioritized diagnosis of presumptive TB
among HIV patients with rapid high sensitivity tests.

BEDAQUILINE REGIMEN
ELIGIBLITY :-
 MDR/RR-TB With resistance to FQ or SLI.
 Treatment failure of MDR/RR-TB With resistance to FQ or SLI.
 Treatment failure of XDR-TB
 XDR-TB With resistance to FQ or SLI or both
 Pregnancy & Cardiac arrhythmia are contraindicated
 Age should be >18 yr.
•After obtaining second line drug sensitivity test, patient started on BDQ
•DR-TB Centre will decide the regimen
•All patients are maintained indoor during the 1st - 2 week of treatment

WEEK DOSE +OBR**
0to2 400mg Daily+OBR
3to24 200mg 3timesperwk+OBR
25toendoftreatment STOP OBR
BEDAQUILINE REGIMEN
** OBR- Optimised Background Regimen

Non-Tuberculous Mycobacterium(NTM)
 Empiric therapy not recommended
 Suggestive treatment
- Rifampicin 400-600 mg OD;
- Ethambutol 800-1200mg OD;
- Clarithromycin 1mg OD:
- Inj Amikacin 750mg-1gm thrice weekly for first 2-3 month
 IP for 3 month maximum 6month
 CP 12month after sputum culture conversion
 Not included in RNTCP

Management of DR-TB pt with pregnancy

1. NIKSHAY
TB surveillance using case based web IT system.
Launched in May 2012
TB patient registration and details of diagnosis, DOT provider,
HIV status, follow up, contact tracing, outcomes.
Details of solid and liquid culture and DST, LPA, CBNAAT
details.
DR-TB patient registration
Referral and transfer of patients.
Private health facility registration and TB notification
NEW INITIATIVES

2. TB notification
GOI made it mandatory from 7th May 2012 for all
healthcare providers to notify every TB cases to
local authorities.
3. Ban on TB serology
Serology tests are based on antibody response,
which is highly variable in TB and may reflect remote
infection rather than active disease.

Linking Pradhan Mantri Jan-Dhan Yojana, AADHAR
and NIKSHAY for direct cash benefits to patients.
Direct Benefit Transfer(DBT)

Reducing the out of pocket expenditure
for TB patients

Mobile based “Pill-in-Hand”
adherence monitoring tool
 Hidden number printed on the strip behind the drug
 Patient need to give a missed call to the number
 This will documented in a centralized ICT unit
 Electronic treatment record
 Helps to monitor treatment adherence

RNTCP

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