Integrating Xpert MTB/RIF into PMDT & PPM activities in India

Integrating Xpert MTB/RIF into PMDT &

PPM activities in India

Dr R S GuptaDeputy Director General –TB

Central TB Division, Government of India, Ministry of Health & Family Welfare ,

New Delhi. India

GLI Meeting- 30th April -2nd May 2014

• India - world’s highest MDR-TB burden country

• 64,000 emerging annually in notified PTB cases

• Sub-national drug-resistance surveys (2005-09)

• 2.4% MDR in new, 15% MDR in previously treated cases

• 21-24% Ofx resistance, 4-7% XDR in MDR isolates

• National drug resistance survey underway

World’s largest PMDT service expansion

- Started in 2007, dramatically accelerated from 2011 to achieve

nationwide rapid scale up in March 2013

Burden of DR TB in India

Key Features of RNTCP PMDT

• Decentralized lab diagnosis and DST

• Specimen transport to LPA (45) or Xpert MTB/Rif (89)

site

• Xpert MTB/Rif or LPA – is preferred DST method and

available across India

• Treatment with standardized regimen for M/XDR TB –

largely ambulatory

• Scope of strengthening MDR-TB regimen in baseline

Ofx / Km resistance

• Base line Second Line DST started in 6 states (KA, TN,

MH, KE, GJ, DL)

Source: RNTCP Guidelines for PMDT in India – May ‘12, www.tbcindia.nic.in

Introduction of Rapid Diagnostics in India

2007 –Conventional Solid (LJ)

Culture-DST

2009 – Line Probe Assay

2011 High throughput GT Blot

2012

Xpert-MTB/Rif

- 18 site (27) RNTCP WHO FIND feasibility study

- 10 (12) sites EXPANDx TB Project

2013-14

Xpert-MTB/Rif

- 40 sites (43) RNTCP WHO UNITAID TBXpertProject

- 4 (6) sites for pediatric project-USAID

Xpert-MTB/Rif in private sector

A&N Islands

Arunachal Pradesh

Chandigarh

D&N Haveli

Daman & Diu

Goa

Karnataka

Lakshadweep

Meghalaya

Mizoram

Nagaland

Pondicherry

Sikkim

Tripura

Haryana

Delhi

Gujarat

Andhra Pradesh

Assam

Manipur

Punjab

Kerala

West Bengal

Jammu & Kashmir

Himachal Pradesh

Rajasthan

Maharashtra

Tamil Nadu

Orissa

Madhya Pradesh

Chhatisgarh

Uttar Pradesh

Uttaranchal

Jharkhand

Bihar

TRC

ANDTC

AIIMS-2

RNTCP Culture & DST Labs Network(March, 2014)

LRS

NTI

JALMA

Med Col / NGO / Private Labs (Certified)

IRL (Certified )

IRL (Under Process)

Med Col / NGO / Private Labs (Under Process)

National Reference Labs

Gurgaon

By Technology- Solid Culture: 37

- LPA: 45

- Liquid Culture:14

- Xpert-MTB/Rif : 89

C-DST Labs - 55SLDST - 7 (3

NRLs and 3IRLs, 1-NGO)

Xpert-MTB/Rif Sites

SLDST - 7 (NTI, NIRT, NITRD,IRL Ahmedabad, IRL Delhi, IRL Thiruvananthapuram, PD Hinduja)

Policy for use of Xpert-MTB/Rif in India

• Use of Xpert-MTB/Rif in programmatic settings

– For Diagnosis of Rif Resistance

• Presumptive MDR TB cases

– Prioritize Xpert-MTB/Rif to detect MTB in Presumptive

TB cases among

• People living with HIV / AIDS

• Paediatric cases

Xpert-MTB/Rif projects in India

• 18 sites under TB Unit feasibility and impact study (March 2012-December 2013)

– conducted to create in-country evidence on feasibility for rapid adoption and guide future scale-up of the technology to diagnose TB and DR TB

• 10 sites under EXPANDx TB (till December 2014)

– for further accelerating services of PMDT to diagnose DR TB

• 40 sites under UNITAID (till December 2015)

– for scale-up and deployment of Xpert-MTB/Rif as a decentralized tool and innovative PPM to diagnose TB and DR TB

• 4 sites under USAID (till June 2014)

– Accelerating access to quality TB and DR TB diagnosis for paediatric cases in 4 major cities in India

• 30 sites proposed under PEPFAR, USAID (till September 2015)

– Innovative intensified TB case finding and appropriate treatment at high burden ART centres in 4 states

1. RNTCP Xpert-MTB/Rif Feasibility Project

• Aim

o Collect evidence on the feasibility and impact of introducing Xpert-

MTB/Rif for the detection of TB and rifampicin resistance

• Objectives

o Feasibility: Establish the feasibility of decentralized deployment of

routine Xpert-MTB/Rif testing of all pulmonary TB & DR-TB

suspects in selected geographic areas

o Impact: Assess the impact of decentralized deployment of routine

Xpert-MTB/Rif testing of all pulmonary TB suspects on diagnosis of

TB & DR-TB

Xpert-MTB/Rif Feasibility Study Overall positivity of TB detection was 21.8%

Total Intervention

Total TB

Suspects tested

104276

Bac +ve TB 21130

Clinically

Diagnosed

1690

Total TB 22820

DR TB 2301

Total

bacteriologically

confirmed cases

diagnosed

Diagnosed

on Xpert

over smear

Diagnosed

on smear

over Xpert

Additional

yield on

Xpert

Yield (%)

21130 7443 542 6901 32.7%

Additional Yield of MTB on Xpert over Smear Microscopy

2. EXPANDx Project sites(Diagnosis of DR TB)

Established 12 Xpert-MTB-Rif labs to supplement the efforts and capacity of the existing reference lab network of RNTCP

Quarterly Suspect Examination on CBNAAT

across sites (Oct 2012- Mar 2014)

5115 188 165 163 153 180 190 240 299 374 352 294 252 242 253 218 186 211 160 192

42

938

1542 1525 15921756 1693

2006 2035

2542

30052840

2971

2765 2754 2826

2484 2514

2741

24822342

0

500

1000

1500

2000

2500

3000

3500

Q3

2012

Q4

2012

Q 1

2013

Q2

2013

Q3

2013

Q4

2013

Q 1

2014

Quarterly Suspect Examination on CBNAAT across sites

Rif Resistant DR TB suspect

Suspects

examined 45395

Rif +ve 4432

3. RNTCP TBXpert Project (supported by WHO, STOP TB Partnership, UNITAID & USAID)

• Under this project, 43 Xpert MTB/Rif machines and

cartridges are provided to the country to scale-up

rapid molecular diagnosis of TB and Rif resistance

• Innovate to engage private sector through public-

private mix (PPM) initiatives to improve access to

rapid testing of patients who attend both public

and private sector

A&N Islands

Arunachal Pradesh

Chandigarh

D&N Haveli

Daman & Diu

Goa

Karnataka

Lakshadweep

Meghalaya

Mizoram

Nagaland

Pondicherry

Sikkim

Tripura

Haryana

Delhi

Gujarat

Andhra Pradesh

Assam

Manipur

Punjab

Kerala

West Bengal

Jammu & Kashmir

Himachal Pradesh

Rajasthan

Maharashtra

Tamil Nadu

Orissa

Madhya Pradesh

Chhatisgarh

Uttar Pradesh

Uttaranchal

Jharkhand

Bihar

TB Xpert Project Sites- UNITAID

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

• 10 urban sites • Advocacy to have PPM• All 40 sites innovate for

PPM models

RNTCP TBXpert Project-UNITAID

– Guidance document developed for use of Xpert-MTB/Rif including innovative models for private sector engagement

– 2 National level trainings conducted (20 sites per training) to sensitize all sites.

– Onsite trainings at sites on technical aspects on handling and trouble shooting

Innovative PPM approaches

• Clear message to private providers

– Open access to tests and treatment - free of cost

– Clinical indications to test- Pedriatic, TB/HIV

– Notification and monitoring progress

– Using all medium of communications

• Standards for TB Care in India

• ICT solutions to bridge information gap

Outcome of TBXpert Project (UNITAID) from 40

sites

(Jul-Dec 2013)*

* Data source from implementing sites

2052

570

0

500

1000

1500

2000

2500

MTB detected MTB Rif Detected

4. Accelerating access to quality TB diagnosis

for pediatric cases in 4 major cities in India

• Establishment of Xpert-MTB/Rif

labs at Delhi, Chennai, Kolkata

and Hyderabad

• Identification of key hospitals

and private clinics catering to

pediatric populations and

establish referral network for

pediatric

• Engaging more number of

pediatricians for referrals

• Sensitization meeting for

identified key personnel

5. Innovative intensified TB case finding and

appropriate treatment at high burden ART

centres in India (PEPFAR)• Major Interventions

– ICF at ART centres (use of Xpert MTB/Rif)

– IPT among PLHIV

– Daily regimen for coinfected

– AIC at ART centres

• 4 high HIV burden states

– MH, KA, TN, AP

– 30 Xpert machines

PPM Initiatives to Integrate Xpert into RNTCP

• Public-Public Mix (Xpert from different source; sensitization, trainings, consumables and treatment from RNTCP)

– 4 Xpert in Government Medical Colleges

(PGI Chandigarh, AIIMS New Delhi, SMS Jaipur, BJ Medical College Gujarat)

– 4 Xpert proposed in Railways Hospital (Xpert, sensitization and trainings from RNTCP; consumables from Ministry of Railways)

• Public-Private Mix (Xpert, consumables, trainings and treatment from RNTCP)

– Xpert in 1 Private Medical Colleges (CMC Vellore)

• Private-Private Mix (Xpert diagnosis at subsidized price by private providers with technical support from NGO; treatment support from RNTCP)

– 49 Xpert under IPAQT (Initiative for Promoting Affordable, Quality TB Tests)

Vision of National Strategic Plan for Xpert-MTB/Rif

Source 2012-13 2013-14 2014-15 2015-16 2016-17

GF SSF 300 300

GoI 100 200

Other sources 129

Total 529 500

Priority areas for deployment of Xpert-MTB/Rif

• Medical Colleges with DR TB centers

• ART Centres

• Urban TB Districts

• High workload districts

Acknowledgements

• Ministry of Health & Family Welfare, GoI

• Central TB Division

• National Expert Committee

• National TB Institutes

– NIRT, Chennai

– NITRD, New Delhi

– NTI, Bangalore

– JALMA, Agra

– RMRC Bhubneswar

– BMHRC Bhopal

• State and District TB programmemanagers and staffs

• DR TB Centre committees

• Culture and DST laboratory staff

• World Health Organization

– Stop TB Partnership

– Global TB Programme

– Country Office for India

– RNTCP medical consultants

• UNITAID

• USAID

• World Bank

• The Global Fund

• FIND

• PATH

Many thanks to all