Rntcp current guidelines

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

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

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

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

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

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

What is the Scientific

Basis for DOTS?

Scientific Basis of DOTS

Sputum microscopy

Domiciliary treatment

Short course chemotherapy

Intermittent chemotherapy


Sputum microscopy

• Provides definitive diagnosis

• Easy to perform

• Replicable

• Cost effective

• 50% of the new pTB pts. expected to be SS+

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

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

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


Sputum microscopy





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


Sputum microscopy






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


Sputum microscopy





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


Sputum microscopy





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.

The famous pathanamthitta study


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

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

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

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

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)

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

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

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

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

Follow-up Sputum Tests

At the end of Intensive Phase

Two months into Continuation Phase

At the end of Continuation Phase

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

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

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

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.

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.

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

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

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

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

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

Category 3 is phased out

Ethambutol is reintroduced and dose is @ 20mg/KG

PPM – Public Private Mix

Public-Private share in national health programs

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

DMC in Thrissur District

Doctors’ Laboratory, Chelakara

St. James Hospital, Chalakudy

Modern Laboratory, Kodungallur

Co Operative Hospital, Irinjalakuda

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)

Rntcp current guidelines

Health & Medicine

treatment xray

followup of patients

progress of patients

notafb microscopy

tb incidence cases

contacts similarmost

xrayafb microscopy

components of dots