Strengthening and Aligning Diagnosis and Treatment of Drug Resistant TB in India

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1 Strengthening and Aligning Diagnosis and Treatment of Drug Resistant TB in India Dr K S Sachdeva Additional Deputy Director General Central TB Division Ministry of Health & Family Welfare Government of India

2 Estimated number of MDR-TB Cases, 2014 ~ 2/3 third of all cases are in 4 countries Russian Federation 41,000 (15% of global MDR burden) China 54,000 (20% of global MDR burden) * among notified TB cases Source: Global TB Control Report 2014 South Africa 6,900 (3% of global MDR burden) India 61,000 (22% of global MDR burden) 2.4% in New Cases 15% among previously treated

3 Key Features of PMDT in India Decentralized lab diagnosis and DST Specimen transport to CB-NAAT* sites or LPA labs CB-NAAT 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 Ofloxacin / Kanamycin resistance Base line Second Line DST started in six states of India (DL, GU, KA, KE, MH, TN) Source: RNTCP Guidelines for PMDT in India May 12, *Cartridge based nucleic acid amplification tests

4 Introduction of WHO Endorsed Rapid Diagnostics in India 2009 Line Probe Assay 2011 High throughput CB-NAAT GT Blot ART sites RNTCP 2012 WHO CB-NAAT USAID CB-NAAT 2007 Conventional Solid (LJ) Culture-DST TB-HIV Project - 18 site (27) RNTCP WHO FIND feasibility study sites RNTCP /TGF Grant - 10 (12) sites EXPANDx TB Project - 40 sites (43) RNTCP WHO UNITAID TBXpert Project - 4 (6) sites for pediatric project-usaid

5 Indication to presume M/XDR-TB & offer DST Criteria A : All failures of first line regimen Non-converters in previously treated cases Contacts of known MDR TB case Criteria B : All smear +ve previously treated PTB cases at diagnosis Any smear +ve follow up case Criteria C : All smear -ve previously treated cases at diagnosis HIV associated new TB cases For XDR TB: if culture +ve at 6 months and culture reverted cases baseline where local lab capacity is available

6 % S+ retreatment patients for DST ,500 8, ,000 25,000 30,000 32, India s response to Call for Action at Ministerial Meeting - Beijing 2009 Patients tested for MDR-TB MDR-TB treated labs - LPA and LJ (33 with MGIT 960) *Based on RNTCP 2012 goal of MDR diagnosis for all S+ retreatment patients,

7 National PMDT Scale up Plan ( ) Participatory approach to planning PMDT Scale up w.e.f. Nov 2010 (state plans aligned to national resources) MDR ward and outpatient care readiness Central Appraisals of Districts Second Line Drug supply 35 States planned scale up of PMDT services with support of GoI- WHO-Partners Staffing & Training at all levels Lab Capacity & sample transport Collective wisdom in planning Mobilize resources balance lab and treatment capacity HRD, pre-services appraisals Monitoring and review of states to accelerate quality scale up PMDT by all players Coordinated troubleshooting Goal: Nation-wide PMDT service roll-out by Dec 12 Source: RNTCP National PMDT Scale-up Plan ,

8 District wise diagnostic technology available and MDR-TB diagnostic criteria 2010

9 District wise diagnostic technology available and MDR-TB diagnostic criteria 2011

10 District wise diagnostic technology available and MDR-TB diagnostic criteria 2012

11 District wise diagnostic technology available and MDR-TB diagnostic criteria 2013

12 District wise diagnostic technology available and MDR-TB diagnostic criteria 2014

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14 PMDT Services established in India by years Service Delivery Components States with 100% coverage of PMDT PMDT implementing districts C-DST Labs with any technology Labs with LPA Xpert-MTB-Rif Sites Districts linked to WRD (LPA/Xpert) DR TB Centers functional Linked DR-TB Centers functional 50

15 Number of Presumptive MDR TB tested Number of DR TB cases DR TB case finding and treatment initiation efforts, India % Participatory CB-NAAT Presumptive Planning MDR tested MDR-TB cases diagnosed GT Blot LPA 66% MDR-TB cases put on treatment % 3378 XDR-TB cases put on treatment Sum of MDRTB Suspects Sum of MDRTB cases initiated on Rx Sum of MDRTB cases detected Sum of XDR TB cases initiated on Rx

16 MDR-TB cases and additional rifampicin-resistant TB cases (red) detected compared with TB cases enrolled on MDR-TB treatment (blue) , in 4 high MDR-TB burden countries India Source: Global TB Control Report 2014

17 Challenges and solutions deployed Challenges Access to rapid molecular DST limited due to weak case finding systems Setting up of Liquid Culture Labs Infrastructure upgrades to BSL III & HR Foreseeable follow up capacity crisis in most of the states on shift to Criteria C with rapid molecular tests Loss from Dx to Rx : Delay in treatment initiation in spite of rapid DST Tracing patients due to poor case holding Limited DR TB Centers and bed capacity to cope with enhanced case load due to Criteria C with LPA/CB-NAAT Solutions Linking states to labs in adjoining states prompt sample collection & transport systems streamlining systems and training to improve suspect identification State to take the ownership Enhance coordination to fast-track BSL III & HRD for LC labs FU capacity enhancement through 1 sample per follow up culture policy Fast track application of potential labs to reach proficiency stage with NRLs Budget for C-DST Schemes - private labs Shift to Criteria C with LPA/CB-NAAT CB-NAAT to offer decentralized DST and same day diagnosis Improve DOTS, timely results and coordination Fast-track DR-TB Centre Strengthen districts capacity for ambulatory PTE, ADR management DR TB Centre Scheme in 2014

18 Balanced acceleration of PMDT Scale up Lessons Learnt Constraints Financing Technical assistance Execution gaps - slow pace in few states Lag in laboratory capacity development Human resources, trainings & appraisals Accelerators Ambitious GoI funding + resource mobilization TGF, UNITAID, WHO, USAID High end TA - WHO India, FIND, PATH, partners National institutes and private players Thrust on monitoring to address gaps Fast-tracking districts & indication for DST Fast-tracking labs with WRD (LPA/NAAT) Sample transport to address lab deficits Scaled up National PMDT Training Centers Team building, mentoring for appraisals

19 RNTCP PMDT Vision Plan of PMDT service expansion ( ) Vision: Significantly reduce DR-TB burden in India by ensuring universal access to quality assured TB care Goals: To offer universal DST and DST guided treatment to at least 90% of all forms of TB cases To enhance treatment outcomes of DR TB patients (MDR, XDR and Mono- Poly DR-TB ) managed both in public and private sectors Objectives: Offer universal DST and DST guided treatment for all forms of TB cases Establish and strengthen at least 120 C-DST labs Scale up access to Xpert-MTB-Rif in at least sites Treat at least 60,000 MDR cases annually - District DR-TB Centers in every district with existing centers to serve as nodal centers for M/XDR TB cases Treat ~ 2,55,000 MDR-TB & ~17,250 XDR-TB cases

20 First National Anti Tuberculosis Drug Resistance Survey of India ( ) formally Launched on 6 th September 2014 by the Hon ble Health Minister

21 Alignment of Lab and PMDT Scale up plans ( ) Technology Total CB-NAAT 119(300) LPA Liquid C-DST Solid C-DST SL-DST MDR-TB XDR-TB Note: Figures relate to procurement year, enrollment of the patients will be in the subsequent year

22 Apply Learnt Lesson Participatory Planning with States and supporting review PMDT Planning and Forecasting tool updated Implement scale up linked to local capacity and move towards universal DST & DST guided Rx, from a baseline across country of Criteria C & priority groups, with strengthened supervision & monitoring. Staged scale up steps: Baseline plus initial SL DST (MDR/RR-TB) Universal DST for H & R in all registered TB patients (using rapid molecular tests) Any H/RR/HR case - DST guided Rx (using rapid molecular tests + LC)

23 India committed to the five priority actions to address the global MDR-TB crisis

24 Many thanks to all