RNTCPCurrent Trends

Dr. Ganesh PatelResident (3rd)

MD (Pulmonary Medicine)Dept. of Pulmonary Medicine, GMC Kota

Guided by

Dr Suman Khangarot (Professor )GMC Kota

In our country…

Evolution of TB Control In India

• 1962 National TB Programme (NTP)• 1992 Programme Review (GOI, WHO and SIDA)

» only 30% of patients diagnosed; » of these, only 30% treated successfully

• 1993 RNTCP pilot began• 1998 RNTCP scale-up ( 2% of the total population coverage

by RNTCP)• 2001 450 million population covered• 2004 >80% of country covered

• 2006 Entire country covered by RNTCP

OVER EMPHASIS ON X-RAYS FOR DIAGNOSIS-INADEQUATE FUNDING,POOR QUALITY MICROSCOPY-NON-STANDARD TREATMENT REGIMENS-LOW RATES OF TREATMENT COMPLETION-LACK OF SYSTEMATIC INFORMATION ON TREATMENT OUTCOME-ONLY 30% OF ESTIMATED TB PATIENTS WERE DIAGONOSED-ONLY 30% OF THE DIAGONOSED CASES WERE TREATED

SUCCESSFULLY

Revised National Tuberculosis Control Programm (RNTCP) was needed.

GOAL §TO REDUCE MORTALITY AND MORBIDITY FROM TB§TO INTERRUPT CHAIN OF TRANSMISSSION

OBJECTIVES

§ACHIEVEMENT OF AT LEAST 85%CURE RATE OF INFECTIOUS CASES §DETECTION OF ATLEAST 70%OF ESTIMATED CASES§INFORMATION, EDUCATION, COMMUNICATION AND IMPROVED

OPERATIONAL RESEARCH ACTIVITIES.

COMPONENTS

§POLITICAL COMMITMENT§GOOD QUALITY SPUTUM MICROSCOPY§UNINTERRUPTED SUPPLY OF GOOD QUALITY DRUGS§DIRECTLY OBSERVED TREATMENT§ACCOUNTABILITY

Introduction• TB was declared as a global health

emergency in 1993• RNTCP as a Pilot project: 1993• RNTCP Phase-1: 1999–2006• RNTCP Phase-II: 2006-2011• Five year plan of “TB Free India”

Difference in NTP and RNTCP

8

NTP RNTP

Case detection and treatment 70% case detection and 85% cure rate

Case finding was active by the health worker

Case finding is passive by quality microscopy

Only one sputum smear examination used to be done

2 sputum examination ( spot, morning)

Patients not categorised for treatment

Patient categorised into two types for treatment purpose

Chemotherapy was not supervised Chemotherapy is supervised by DOTs-agent

Case detection rate and success rate less than 50%

Case detection rate is more than 85% and success rate is more than 85%

• Goal 6: “Combat HIV/AIDS, malaria and other diseases”– Target 8: “By 2015, to have halted and begun

to reverse the incidence of malaria and other major diseases…”• Indicator 23: between 1990 and 2015 to halve

prevalence of TB disease and deaths due to TB • Indicator 24: to detect 70% of new infectious

cases and to successfully treat 85% of detected sputum positive patients

NTF Presentations for RNTCP Sensitization First edition 10th Nov

06

Millennium Development Goals

By 2005:◦ At least 70% people with sputum smear positive TB will be

diagnosed.◦ At least 85% cured.

By 2015:◦ Global burden of TB (prevalence and death rates) will be reduced

by 50% relative to 1990 levels. Reduce prevalence to <150 per lakh population Reduce deaths to <15 per lakh population

◦ Number of people dying from TB in 2015 should be less than 1 million, including those co-infected with HIV

By 2050:◦ Global incidence of TB disease will be less than or equal to 1 case

per million population per year

NTF Presentations for RNTCP Sensitization First edition 10th Nov

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Stop TB Partnership Targets

• Vision: A world free of TB

• Goal: To dramatically reduce the global burden of TB by 2015 in line with Millennium Development Goals and the Stop TB Partnership targets

NTF Presentations for RNTCP Sensitization First edition 10th Nov

06

Stop TB Strategy, 2006

Global TB report

• Globally, TB incidence has fallen by an average of 1.5% per year since 2000 and is now 18% lower than the level of 2000.

• In 2014, TB killed 1.5 million people (1.1 million HIV-negative and 0.4 million HIV-positive).

• Of the 9.6 million new TB cases in 2014, 58% were in the South-East Asia (SEAR) and Western Pacific regions.

• From 2016, the Goal is to end the global TB epidemic by implementing the End TB Strategy.

Global TB report

• The Target of Halving the TB Mortality rate by 2015 (compared with 1990) met in 4 WHO regions

- The Region of the Americas, - The Eastern Mediterranean Region, - The South-East Asia Region, - The Western Pacific Region &

Global TB report

• All three of the 2015 targets (for incidence, prevalence and mortality) were met in:

Brazil, Cambodia, China, Ethiopia, India, Myanmar, the Philippines, Uganda and Viet Nam.

Global TB report

Population Coverage and Patients Registered

A brief history of tuberculosis control in India. Geneva, Switzerland: World Health Organisation; 2010.

India• India: 2nd most populous country• Accounts for a Quarter of the world's annual

incidence of TB. • Every year in India: 2 million- Develop TB in India & 300,000- Die of TB.• Treated: Over 15 million patients and • Lives saved: 3 million, by the Revised National TB Control Programme (RNTCP) over the last decade.

India Accounts for Nearly One-third of the Global TB Burden

INDIACHINA

INDONESIA

BANGLADESH

NIG

ERIA

PAK

ISTA

N

PH

ILIP

PIN

ES

TB is a Leading Killer of Women

48,000101,000

493,000538,000

605,000

TropicalDiseases

STD MaternalMortality

Malaria TB

Deaths among women

Source: World Health Report, 1999.

0

5000

10000

15000

20000

25000

30000

0-14 15-24 25-34 35-44 45-54 55-64 >65

MaleFemale

Age (years)

Num

ber o

f pat

ient

sNew Smear-positive Case Detection by Age and Sex—2001More than 80% of the patients are in the economically productive (15-54 years) age group

Data Source:1.8 lakh new smear-positive patients detected during 2001

Statistics-2014• In 2014, RNTCP covered a population of 12,656

lakh. • TB suspects examined by sputum smear

microscopy: 87.83 lakh• Cases Registered for treatment: 14.44 lakh• Registered TB cases Knowing their HIV status:

72%• HIV infected TB patients were initiated on CPT:

94% • Initiated on ART: 91%

TB and AIDS

10%

60%

0%10%20%30%40%50%60%70%

PPD+/HIV-negative PPD+/HIV-positive

Lifetime risk of TB

Making TB a notifiable disease in India

With the aim of improving the collection of patient care information, in 7 May 2012 India declared TB to be a notifiable disease.

Indicators

Burden of Tuberculosis

Case finding activities & Notification rates

12th Five year Plan (2012-17)• Budget: 4500 Crore• Theme: Universal Access for Quality Diagnosis &

Treatment for all TB patients in the community• Target “Reaching the Unreached”.• Goal: “Universal access to TB care and treatment

for all”• Vision 2020: To significantly reduce TB burden in

India by ensuring universal access to quality assured TB care as per Standards for TB Care in India (STCI).

31

Early detection & Rx of 90% cases (DR-TB & HIV-TB) Rx 90% of new TB patients, 85% of previously-treated Reduce default rate : new TB cases to < 5%

re-treatment TB cases to < 10% Extend RNTCP services to patients in private sector To ensure Notification of all TB cases in Nikshay

(incremental step to close the gap of missing TB cases in India)

13,000 microscopy centers for sputum smear microscopy and Culture and DST laboratories.

Objectives

Contd…

• 62 RNTCP certified Culture and DST laboratories in the country which includes laboratories from Public sector (IRL, Medical College), Private and NGO laboratories.

• Currently 89 Cartridge Based Nucleic Acid Amplification Test (CBNAAT)

• First National anti TB Drug Resistance Survey (NDRS) is being conducted across 120 TB Units in the country and will test drug resistance to drugs other than Rifampicin and Isoniazid.

• More than 330 Medical Colleges are involved with RNTCP through the task force mechanism and are contributing in diagnosis, management and formulating policies for the program.

Successful Partnerships• Indian Medial Association (IMA), • Catholic Bishops’ Conference of India (CBCI), • Foundation for Innovative New Diagnostics

(FIND), • World Vision, The International Union against

Tuberculosis and Lung Diseases (The UNION) &

• The Clinton Health Access Initiative (CHAI)

o The objectives of RNTCP are to achieve and maintain a cure rate of at least 85% among new sputum smear-positive cases and to achieve and maintain detection of atleast 70% of such cases in the population.

NTCP

RNTCP

1. Political and

administrative

commitment

2. Good quality

diagnosis, primarily

by sputum smear

microscopy

3. Uninterrupted

supply of good

quality drugs

4. Directly observed treatment

(DOT)

5. Systematic

monitoring and

accountability

Components of DOTS

40

Structure of RNTCP

Microscopy vs X-ray

0102030405060708090

100 Sputum AFB

X-ray

X-ray

40%

False Positive True Positive

60%

SpecificityNTI, Bangalore, 1974

98%

50%

Directly observed treatment (DOT) is one element of the

DOTS strategy

An observer watches and helps

the patient swallow the tablets

Direct observation ensures treatment for the entire course• with the right

drugs• in the right

doses• at the right

intervals

Directly Observed Treatment

DOT is Necessary Even WhenDrug Supply Ensured

0%10%20%30%40%50%60%70%80%90%

100%88%

61%

Treatment Success

DOT No DOTSource: Chaulk CP, Kazandjian VA. Directly observed therapy for treatment completion of pulmonary tuberculosis: Consensus Statement of the Public Health Tuberculosis Guidelines Panel. JAMA 1998;279:943-8.

Risk of Failure or Relapse was 15 Times Higher among Patients Taking Treatment Without Observation Compared to Patients

Receiving Treatment Under Observation

Observed treatment Unobserved treatment0%

10%

20%

30%

40%

50%

Data Source: Pathanamthitta District, Kerala, IJTLD, 2000

3%

44%

NTF Presentations for RNTCP Sensitization First edition 10th Nov

06

Unique features of RNTCP

• District TB Control Society

• Modular training

• Patient wise boxes

• Sub-district level supervisory staff (STS, STLS)

for treatment & microscopy

• Robust reporting and recording system

o A pulmonary TB suspect is defined as:An individual having cough of 2 weeks or moreContacts of smear-positive TB patients having cough of any durationSuspected/confirmed extra-pulmonary TB having cough of any durationHIV positive patient having cough of any duration

Diagnostic Algorithm for PTB

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

49

Definitions: Revised definitions as per WHO• Presumptive case: Patient who present with symptoms or signs suggestive of TB ( earlier

known as TB suspect)

• Case Definitions

• A bacteriologically confirmed TB case (BCTB): Biological specimen positive by microscopy, culture or Xpert MTB/RIF.

• A clinically diagnosed TB case (CDTB): Clinically diagnosed by the practitioner but not bacteriologically confirmed.

• Both the above case can be classified according to

• Anatomical site of disease

• History of Previous treatment

• Drug resistance

• HIV resistance

• PTB:Any BCTB or CDTB case involving the lung parenchyma or tracheobronchial tree. A person with both PTB and EPTB should be classified as PTB

• EPTB:Any BCTB or CDTB involving organs other than lungs.

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Classification based on anatomical site of disease

Classification based on history of previous TB treatment. ( Patient registration group)• New patients:Never been treated or taken ATT for less than one month.

• Previously treated patients: Patients who received 01 month or more of ATT in the past;

• Relapse

• Treatment after failure

• Treatment after loss to follow up

• Other previously treated patients

• Patients with unknown previous TB treatment history

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Previously treated patients

Declared cured or treatment completed

diagnosed with recurrent episodes of TB

treatment failed at the end of treatment

earlier called as Treatment after default

declared lost to follow up at the end of treatment

outcome not known or undocumented

Previously treated patients but does not fit in any above category

Relapse

Previously treated patients

Previously treated patients

Previously treated patients

Treatment after Failure

Treatment after loss to follow up

Other previously treated patients

Patients with unknown previous TB treatment history

Classification based on Drug Resistance

52

resistance to one 1st line Anti-TB drug only

Monoresistance

resistance to more than one 1st line Anti-TB drug only

Polydrug resistance

resistance to at least both H and R

Multi drug resistance

resistance to any fluoroquinolone and at least 3 second line injectables ( Capreomycin, Kanamycin and amikacin) in addition to MDR

Extensively drug resistance

resistance to Rifampicin with or without resistance to other drugs

RR-TB

Classification based on HIV status

53

BCTB or CDTB

HIV positive result

HIV - Positive TB patients

HIV negative result

HIV - Negative TB patients

No result of HIV testing

HIV - status unknown TB patients

Scientific Basis of DOTS

• Domiciliary Treatment

• Diagnosis by Microscopy

• Short course chemotherapy

• Intermittent chemotherapy

• Directly observed treatment

Basis for Domiciliary TreatmentSmear-positive TB patients can be treated effectively

at home with no added risk to contacts

Series Total Patients

Favorable Response

(%)

Relapse(%)

Total contacts

Attack rate(%)

Home 82 86 14 245 10.5

Sanat-orium

81 92 12 264 11.5

TRC, 1959

Which bacilli are acted upon by the ATT drugs?

Treatment Regimens

Category ofTreatment Type of Patient Regimen*

Category I All new pulmonary (smear-positive and negative), extra pulmonary and ‘others’ TB patients.

2H3R3Z3E3+ 4H3R3

Category II TB patients who have had more than one month anti-tuberculosis treatment previously

Relapse , Failure, Treatment After Default, Others

2H3R3Z3E3S3 + 1H3R3Z3E3 + 5H3R3E3

Basis for RegimensCAT I: New sputum smear Positive patients,

high bacillary population, chances for naturally occurring resistant mutants higher,therefore 4 drugs in intensive phase

CAT II: Because of previous treatment, chances of harboring resistant bacilli are higher; hence 5 drugs in IP and total duration of treatment is 8 months.In continuation phase lower bacterial population;hence less chance of resistant organisms, therefore 3 drugs are enough.

Best way to Prevent MDR/XDR TB is cure TB patientswith DOTSFamous saying is "FIRST HIT IS BEST HIT"

Regimen for Non-DOTS treatment in RNTCP Areas

o Self administered non rifampicin containing regimen

o Needed in few cases of adverse reaction to rifampicin and pyrazinamide

o Upto a maximum of 1% of patients may get Non-DOTS treatment in an RNTCP area.

o Tuberculosis treatment card to be filled for these patients as well

Regimen for Non-DOTS treatment in RNTCP Areas

Treatment RegimenNon-DOTS Regimen 2HSE+10 HE

Remember the correct doses of anti TB Drugs!

Basis for Intermittent Therapy

Growth of M. tuberculosis during and after exposure to INH

Log Viable Units of M TB

Days

INH added

INH washed

All anti-tuberculosis drugs except Thioacetazone, have a lag phase

Comparing the Daily Versus the Intermittent Regimens of the Anti-Tubercular Chemotherapy in the Initial Intensive Phase in Non-HIV,

Sputum Positive, Pulmonary Tuberculosis PatientsPranab Kumar Mandal,1 Abhijit Mandal,2 and Sujit Kumar Bhattacharyya3

J Clin Diagn Res. 2013 Feb; 7(2): 292–295.

• Conclusion: Both the intermittent and the daily regimens showed equal sputum conversion rates and the drug default cases were found more in the intermittent group. However, the adverse reactions were found more in the daily regimen category.

Drug doses in RNTCP

THE CODE AND DOSAGE

Patients who weigh 60kg or more receive additional Rifampicin 150mg.

Patients who are more than 50 years old ,receive streptomycin 500mg

Patients who weigh less than 30 kg, receive drug as per body weight.

Pediatric weight bands

Monitoring of Treatmento Follow up sputum

microscopy determineso Conversion rateo Cure rate

o Sputum smear microscopy scheduleo Initial sputum

examinationo End of Intensive phase

of treatmento 2 months into

Continuation phase of treatment

o End of treatment

Cat. of Rx

Pre–RxSputu

m

Test at month

If: result

Then

Cat–1+ 2

- C.P. – Sputum at 4 & 6 m

+ I.P. for 1month, Sp. At 3, 5 & 7

- 2- C.P. Sputum at 6 months

+ I.P. for 1 month, SP. at 3, 5 & 7

Cat–II + 3- C.P. Sputum at 5 & months

+ I.P. for 1 month, Sp. at 4, 6 & 9

Schedule of follow-up sputum smear examination

Treatment outcome definition

69

Advanced RNTCP RegimesDrug Resistant TB (PMDT)

o MDR TB – Resistant to INH & Rifampicin

CAT V- XDR TB

o XDR TB- MDR TB+ Resistant to Second line injectable Anti TB drug & Fluroquinolone

Public Health Concern

• The decline in TB incidence: Slow• Mortality- Unacceptably High and • Emergence of Drug-Resistant TB: Major public health

concern.

Challenges:• Prompt, accurate diagnosis and effective treatment of

TB.• Uninterrupted supply of Drugs• Engaging the private sector effectively.

Private sector health care

A source of mismanagement of TB and hence of drug resistance.

- Use of incorrect Diagnostics- Incorrect regimes- Lack of supervision- Lack of regulation for over the counter

drugs for TB

• why people in India seek care from the private sector

- poor knowledge about TB- poor knowledge about services available through the national programme- the convenience of services- a desire for confidentiality- a desire for personalized care.

Private sector health care

“Many people are unaware that all the medicines needed to treat TB patients are available free of cost at Indian government hospitals. Most people tend to spend huge amounts in private hospitals.”-Bhalchandra Chorghade (Sr Correspondent DNA)

Why are correct doses important?

Ref: Mishra G, Mulani J. Tuberculosis Prescription Practices In Private And Public Sector In India. NJIRM. 2013; 4(2): 71-78.

Why are correct doses important?

Ref: Mishra G, Mulani J. Tuberculosis Prescription Practices In Private And Public Sector In India. NJIRM. 2013; 4(2): 71-78.

http://www.visualbee.com/upgrade.html

World TB Day 2015: Gear up to end TB

Some practical pointso 1. TB is a notifiable disease.o 2. If you are not sure of individualized treatment regime, please do not

start it. Instead you may register the patient under RNTCP.o 3. Do not start a fluroquinolone to a TB suspect.o 4.Please do simple sputum microscopy for afb smear for all TB

suspects, rather than directly starting from higher investigations like CT scan.

o 5. Serological TB tests are banned in India eg. TB IgG and TB IgM.o 5. Do not even attempt to treat drug resistant TB, in absence of

requisite training. Refer to specialist/ RNTCP /PMDT.

References• National Strategic Plan for Tuberculosis

Control 2012–2017; RNTCP• TBFACTS.ORG; Information about

Tuberculosis• TB India 2015; Annual Status Report• Global Tuberculosis Report 2015 by WHO• Standards for TB Care in India Manual by

WHO.

Thanks a lot for your cooperation