Drug Resistant TB PMDT Status and Challenges

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1 Drug Resistant TB PMDT Status and Challenges DR ROHIT SARIN MD, DTCD, FNCCP DIRECTOR NATIONAL INSTITUTE OF TB & RESPIRATORY DISEASES SRI AUROBINDO MARG : NEW DELHI

2 Estimated number of MDR-TB Cases, 2012* ~ 2/3 third of all cases are in 4 countries Russian Federation 46,000 (15% of global MDR burden) China 59,000 (20% of global MDR burden) 3.6% new cases 20.2% previously treated cases * among notified TB cases South Africa 8,100 (3% of global MDR burden) India 64,000 (22% of global MDR burden)

3 India v/s top 12 high MDR burden countries 26% 5% 30% 87% 190% 102%

4 Countries that had reported at least one DR-TB case countries 9.6% MDR TB cases have DR TB 16.5%MDR-TB cases with additional resistance to fluoroquinolones

5 Burden of DR TB- Indian Scenario India has world s highest MDR-TB burden 64,000 emerging annually among notified PTB cases Sub-national drug resistance surveys ( ) 2.4% MDR in new, 15% MDR in previously treated cases 21-24% Ofx resistance, 4-7% DR in MDR isolates National drug resistance survey underway

6 Is MDR-TB a real threat in India? State representative DRS survey- (patients at entry from Public sector microscopy centres) State Proportion of MDR amongst new TB cases Proportion of MDR amongst re-treatment TB cases Gujarat 2.4% 17.4% Maharashtra 2.7% 14% Andhra Pradesh 1.8% 11.8%

7 Is DR TB a real threat in India? High DR / pre-dr levels out of DR suspects undergoing Second-line Drug Susceptibility Testing at NRLs Source: National TB Institute, Bangalore

8 The case of Mumbai and the TDR-TB outbreak Jan 2012 March 2012 WHO and CTD took a stand: Such cases pose a formidable challenge to clinicians and public health authorities No reliable definition beyond DR-TB Improvements in the accuracy of drug susceptibility testing to certain drugs Release of innovative new drugs will, however, change this position in future. India turned this crisis into opportunities for improvements in Mumbai and country wide Udwadia ZF, Amale RA, Ajbani KK, Rodrigues C. Totally drug-resistant tuberculosis in India. Clin Infect Dis Feb 15;54(4):

9 RNTCP PMDT Vision Plan of PMDT service expansion By : o Complete geographical coverage for PMDT services (achieved) o DST for all smear-positive re-treatment TB cases at diagnosis (597 districts achieved) By 2015: o + DST for all smear negative TB (re-treatment) cases & any HIV TB case registered under RNTCP (expected by March 2014) By 2017: o 120 C-DST labs being established and strengthened o pert-mtb-rif in 950 sites at districts and medical colleges across the country o Treat at least 40,000 MDR cases annually by 2017 (120 DR TB Centers) o Treat ~ 160,000 MDR-TB & ~4,100 DR-TB cases over next 5 yrs ( )

10 District wise coverage of RNTCP PMDT services under various MDR-TB suspect criteria by districts Feb 2014 CRITERIA A 107 CRITERIA B 151 CRITERIA C 446

11 PMDT Diagnostic Services Status & Update

12 Technology used to diagnose MDR-TB by districts Feb 2014 LPA 428 CBNAAT 208

13 C-DST Labs - 54 SLDST - 6 (3 NRLs and 2 IRL, 1-NGO) RNTCP Culture & DST Labs Network (January, 2014) Jammu & Kashmir HARYANA Himachal Pradesh Punjab AIIMS-2 Chandigarh LRS Uttaranchal Haryana Gurgaon Delhi Sikkim Arunachal Pradesh Uttar Pradesh Rajasthan JALMA Assam Bihar Nagaland NDTC Gujarat Madhya Pradesh Chhatisgarh Jharkhand Meghalaya West Bengal Tripura Mizoram Manipur Daman & Diu D&N Haveli Orissa IRL (Certified ) By Technology - Solid Culture: 37 - LPA: 43 - Liquid Culture:14 - CB-NAAT : 80 Maharashtra Goa Karnataka NTI Andhra Pradesh TRC IRL (Under Process) Med Col / NGO / Private Labs (Certified) Med Col / NGO / Private Labs (Under Process) National Reference Labs CB-NAAT Sites Pondicherry Lakshadweep Kerala Tamil Nadu A&N Islands

14 RNTCP Policy on CB-NAAT Use of CB-NAAT endorsed as a rapid molecular diagnostic tool in following programmatic situations: o For Diagnosis of Rif Resistance MDR TB Suspects (A,B,C) o For MTB positive results Treat as per RNTCP guidelines o For Rif Resistance results Re-treatment cases Treat with MDR TB Regimen New cases Re-confirm with LPA (LC/Solid in S-ve cases) and Treat with MDR TB Regimen after confirming Rif Resistance o For CB NAAT results from private sector For TB (acceptable if QA Re-calibration of machine done annually) For R resistant results in new cases - re-confirm with o LPA in S+ve cases or o Liquid/Solid C-DST in S-ve Cases

15 RNTCP TB pert Project supported by WHO, STOP TB Partnership, UNITAID & USAID Under this project, 40 CB-NAAT machines and cartridges are provided to the country to scale-up rapid molecular diagnosis of TB and Rif resistance (MDR-TB) 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

16 Jammu & Kashmir TB pert Project Sites Gujarat Daman & Diu Rajasthan P P D&N Haveli Goa Lakshadweep Punjab Karnataka Chandigarh Haryana Maharashtra P Kerala Himachal Pradesh Delhi Uttaranchal Madhya Pradesh P P P P Uttar Pradesh Andhra Pradesh P Tamil Nadu Chhatisgarh Pondicherry Jharkhand Orissa Bihar Sikkim P P Meghalaya West Bengal Tripura Arunachal Pradesh Assam Mizoram Nagaland Manipur Decentralized DST P PPM Advocacy to have PPM GoI - place 10 urban site machines in Govt. institutes All 40 sites innovate for PPM A&N Islands models

17 TBpert Project Facility Reporting Sheet All 40 sites to report on A. Number of patients referred from Private providers B. Of A, Number of new and relapse cases detected with MTB positive and Rif sensitive / indeterminate C. Of A, Number of Rif resistant cases detected D. Number of new cases with Rif Resistance sent to RNTCP certified lab for re-confirmation E. Of D, number re-confirmed

18 Second Line DST Scale up Plan Existing SLDST 7 Labs SL DST Proficiency Testing to be completed o In the 37 planned labs By 2Q Labs JALMA Agra, IRLs -Hyderabad, Nagpur, Jaipur, Delhi, Ajmer and JJ Mumbai ) By , IRLs-Pune, Bangalore, Cuttack, Puducherry, Karnal, Chennai, Guwahati, Kolkata, Indore, Lucknow, PGI Chandigarh, GMC Jamnagar, AIIMS New Delhi By IRL- Patiala, Agra, Raipur, Ranchi, Indore, Patna, GMC Silliguri, RMRC Bhubaneswar, BMHRC-Bhopal, GMC-Vishakhapatnam, BHU-Varanasi, KIMS- Hubli, Bhagalpur, Madurai, Raichur, Jodhpur o Extended to private labs already certified by RNTCP for FLD

19 Priorities for lab strengthening Optimally utilize all existing technology for diagnosis (LPA and CB-NAAT )and follow-up culture (Solid and Liquid) Expedite the development and proficiency testing for liquid culture Rapid Implementation of NIKSHAY PMDT module at all laboratories

20 Innovative PPM initiatives to increase access Initiative for Promoting Affordable, Quality TB Tests (IPAQT) is a consortium of 50 private diagnostic laboratories Established agreements with Cepheid Inc, Hain LifeScience and Becton Dickenson to allow access to concessional prices for pert MTB/RIF, first-line line probe assays, and liquid culture in the private sector Participating laboratories need to be accredited to assure quality; they must report confirmed cases to RNTCP; they must adhere to a ceiling price when charging patients Laboratories participating in IPAQT have approximately 3000 franchisee laboratories and over specimen collection centres across India, thus increasing access to rapid, accurate and affordable diagnostics for patients seeking care in the country s extensive private sector

21 Diagnostic Challenges & Solutions Deployed Challenges Solutions Access to rapid molecular DST limited due to weak case finding systems and sample transport 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 Limited access to Second Line DST due to lack of systems Lack of clarity on RNTCP policy for CB-NAAT and R&R systems Streamlining systems and training to improve suspect identification, prompt sample collection & transport systems from PHIs/DMCs 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 State to expedite SLD PT Clear policy on CB-NAAT, Lab SOP & QA updated with CB-NAAT indicators

22 PMDT Treatment Services Status & Challenges

23 DRTB Case finding effort Sum of MDRTB cases initiated on Rx Sum of MDRTB Suspects Cumulative data up to December 2013 MDRTB Suspects tested MDRTB Put on Rx DR TB Put on Treatment Y2007 Y2008 Y2009 Y2010 Y2011 Y2012 Y2013 Sum of MDRTB cases initiated on Rx Sum of MDRTB Suspects

24

25 Analysis of reasons of not initiating lab confirmed MDR TB cases on treatment Consolidated data for 1Q12 131, 5% 163, 6% 98, 4% N = , 68% 173, 7% 234, 9% 37, 1% Died Referred Not willing for Rx Not traced Being traced PreRx eval On MDR Rx

26 Treatment outcomes Latest 4 Cohorts (2010) Patients registered Success Rate Failure Death Default (48%) 263 (7%) 773 (21%) 708 (20%) Interim 12 month outcomes Patients registered (latest 4 quarters 2Q11-1Q12) Culture Culture Culture not negative Positive known Death Default (51%) 432 (9%) 517 (11%) 695 (15%) 597 (13%) High level of second line drug resistance (Ofx ~ 24%) Heavily treatment experienced cohorts Gaps in case holding capacity

27 1Q07 2Q07 3Q07 4Q07 1Q08 2Q08 3Q08 4Q08 1Q09 2Q09 3Q09 4Q09 1Q10 2Q10 3Q10 4Q10 1Q11 2Q11 3Q11 4Q11 1Q12 Attrition = Loss due to death, default, treatment stopped due to any reason, failure and switched to DR regimen % loss at 6 month % loss at 12 month % loss at 24 month 69% Actions Required: Review districts to address quality gaps with 55% 54% 54% 54% 55% indicators like 53% 47% % put on Rx, 44% 47% 41% % 39% culture not known and % defaults Underperforming districts to be closely 31% 27% 27% 24% 25% 27% 26% 26% 27% 27% 18% 19% 20% 21% 23% supervised 24% and monitored 20% 19% 16% 17% 17% 19% 16% 15% 16% 15% 17% monitoring 10% 12% 11% 11% 12% 9% Intensify supervision (use job-aides) and

28 Treatment Challenges & Solutions Deployed Challenges ~ 10% loss from Dx to Rx : Delay in treatment initiation in spite of rapid DST Tracing patients due to poor case holding Solutions Shift to Criteria C with LPA/CB-NAAT CB-NAAT to offer decentralized DST and same day diagnosis Improve DOTS, timely results and coordination Limited DR TB Centers and bed capacity to cope with enhanced case load due to Criteria C with LPA/CB-NAAT Low treatment outcomes due to high interim attrition of patients Culture Not Known, Default, Died Fast-track DR-TB Centre Strengthen districts capacity for ambulatory PTE, ADR management DR TB Centre Scheme in 2014 Reinforce counseling, FU & ADR Mx Intensify SME for improve case holding Integrated Rx Algorithm for DR TB Bedaquiline controlled introduction Manual information management SLD logistic & supply chain management NIKSHAY for PMDT in 2014 Good packing & storage of PWBs More Store Assist, Outsource SCM

29 Priorities in 2014 Focus to enhance quality of services through intensified supervision and monitoring Scaling up Second Line DST capacity across India Streamlining TB Notification, Lab surveillance and NIKSHAY Further strengthening PPM and developing Urban TB Control models Finalization and Dissemination of STCI & Partnership Guidelines Involvement of Large Corporate Hospitals under new RNTCP NGO PP Schemes to facilitate o TB Notification o Sample collection centres under Private Private partnership o DR TB Centre o C-DST Lab.etc.

30 Thank You!

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