Overview of Drug Resistant TB in India and National Scale up of MDR TB Diagnosis and Treatment

Similar documents
India s Contribution in Rolling out Newer and Rapid Diagnostics towards PMDT Scale-up

Experience with implementation of Xpert MTB/RIF in India. Dr K S Sachdeva Addl. DDG (TB), Government of India

Revised National Tuberculosis Control Programme

Briefing on Intensified Malaria Control Project-3 (IMCP-3)

Haryana-06 Delhi-07 Total disabled population Persons 455, , , ,886 13, ,454 Males 273, ,908 68, ,872 8, ,44

PREVENTION AND EARLY DETECTION OF CANCER. Will the Minister of HEALTH AND FAMILY WELFARE be pleased to state:

India's voice against AIDS. December 2012

Tuberculosis-HIV epidemic situation and emerging challenges in North India

HEALTHCARE OF ELDERLY PEOPLE. Will the Minister of HEALTH AND FAMILY WELFARE be pleased to state:

GOVERNMENT OF INDIA MINISTRY OF HEALTH AND FAMILY WELFARE DEPARTMENT OF HEALTH AND FAMILY WELFARE

Overview of the Presentation

Performance of RNTCP NTI Bulletin 2005,41/3&4,

Revised National Tuberculosis Control Programme (RNTCP) Dr.Kishore Yadav J Assistant Professor

Role of RNTCP in the management MDR-TB

DFID India VAW strategy

6.10. NUTRITIONAL STATUS OF TRIBAL POPULATION

7.10. NUTRITIONAL STATUS OF TRIBAL POPULATION

Swiss Re Institute Symposium Insurance at the crossroad of technology development and growth opportunities. 31 October 2017

Update on Management of

TB-HIV in the South-East Asia Region

Delivering Integrated HIV/TB Services in India: Challenges and Opportunities in National AIDS Control Program (NACP) IV.

A I D S E p I D E m I c u p D A t E a S I a ASIA china India

J of Evolution of Med and Dent Sci/ eissn , pissn / Vol. 4/ Issue 80/ Oct. 05, 2015 Page 14013

Revitalization of PPFP/PPIUCD Services in India Dr Bulbul Sood Country Director Jhpiego/India

WR s Speech on inaugural ceremony of Community based Programmatic Management of Drug resistance TB (CPMDT).

Outcome Results of Programmatic Management of Drug Resistant Tuberculosis in 84 Patients From North Coastal Andhra Pradesh

7.2 VITAMIN A DEFICIENCY

Supplementary webappendix

India HIV Estimates-2006

Achieving Polio Eradication in India. Emergency Preparedness and Response Plan 2011

Procurement update: StopTB Partnership - Global Drug Facility (GDF)

IODINE DEFICIENCY DISORDERS

Challenges in Scaling-up TB/HIV collaborative activities in a diverse HIV epidemic -India

PROJECT ŚVETANA (Dawn) Elimination of new HIV infections among children by Scaling up PPTCT services in private health sector

GOVERNMENT OF INDIA MINISTRY OF HEALTH AND FAMILY WELFARE DEPARTMENT OF HEALTH AND FAMILY WELFARE

DECENTRALISED PLANNING, IMPLEMENATION &MONITORING OF HEALTH CARE IN INDIA

Implementation and scale-up of the Xpert MTB/RIF system for rapid diagnosis of TB and MDR-TB. Global Consultation

Elizabeth A. Talbot MD Assoc Professor, ID and Int l Health Deputy State Epidemiologist, NH GEISELMED.DARTMOUTH.EDU GEISELMED.DARTMOUTH.

Need and strategy for sentinel surveillance for drug resistance in leprosy in India

TUBERCULOSIS IN THE SAARC REGION AN UPDATE 2006

Reach the 3 Million Find, Treat, Cure TB BASIC CONTENTS OF RNTCP WEBSITE OF THE DIRECTORATE OF HEALTH SERVICES, ODISHA

DRUG RESISTANCE IN TUBERCULOSIS CONTROL. A GLOBAL AND INDIAN SITUATION

How best to structure a laboratory network with new technologies

MDR, XDR and Untreatable Tuberculosis and Laboratory Perspectives. Martie van der Walt TUBERCULOSIS EPIDEMIOLOGY & INTERVENTION RESEARCH UNIT

Revised National Tuberculosis Control Programme

CHARACTERISTICS OF SURVEY RESPONDENTS 3

BMJ Open ESTIMATE OF HIV PREVALENCE AND NUMBER OF PEOPLE LIVING WITH HIV IN INDIA

Rural Healthcare Infrastructural Disparities in India: a Critical Analysis of Availability and Accessibility

2. Treatment coverage: 3. Quality of care: 1. Access to diagnostic services:

Bihar State AIDS Control Society, Patna 17 th August 2016

RAPID DIAGNOSIS AND TREATMENT OF MDR-TB

A Call to Action Children The missing face of AIDS

TUBERCULOSIS CONTROL SAARC REGION

Let s Talk TB A Series on Tuberculosis, A Disease That Affects Over 2 Million Indians Every Year

WOMEN ENTERPRENEURSHIP STAUS, CHALLENGES AND PROBLEMS

NEW STRATEGIES OF TB CONTROL IN INDIA : ARE WE ON THE RIGHT TRACK?

Treatment Outcome of Pulmonary and Extra Pulmonary Tuberculosis Patients in TB and Chest Disease Hospital DOT Centre, Goa, India

HIV Prevention, Care and Treatment Services in Prisons of North-Eastern States of India

Let s Talk TB. A Series on Tuberculosis, A Disease That Affects Over 2 Million Indians Every Year

Multidrug-Resistant TB

3. THE NATIONAL SURVEY-

Postpartum IUD Expansion and Scale-up: Challenges, Opportunities and Essential Program Practices

MAPPING LIFE SCIENCES RESEARCH OF INDIA

Production of High Quality Disease Free Frozen Semen from HGM bulls. S Gorani

2010 global TB trends, goals How DOTS happens at country level - an exercise New strategies to address impediments Local challenges

CHAPTER 5 FAMILY PLANNING

The burden of cancers and their variations across the states of India: the Global Burden of Disease Study

FOREWORD. Sayan Chatterjee. Sayan Chatterjee. 30 November, 2012

Guidelines on Programmatic Management of Drug Resistant TB (PMDT) in India

About National Tobacco Control Cell (NTCC)

SUMMARY OF THE DIABETIC RETINOPATHY AND RETINOPATHY OF PREMATURITY INITIATIVES IN INDIA MID-TERM REVIEW

Role of National Rural Employment Guarantee Scheme in achieving Gender Equality in Rural India

The WHO Global Project on anti-tb drug resistance surveillance: background, objectives, achievements, challenges, next steps

South Asia: Action Plans, future directions and needs

International Journal of Health Sciences and Research ISSN:

Revitalising community engagement for TB and TB/HIV prevention, diagnosis and treatment

Flour Fortification: Millers and Governments Working Together to Reduce Vitamin and Mineral Deficiencies. Annoek van den Wijngaart 10 October 2012

Scale up of MDR TB Management in the Philippines: Lessons Learned

A roadmap for TB laboratory strengthening within WHO policy frameworks and national laboratory strategies

Department Of AIDS Control (DAC) Ministry of Health and Family Welfare, GOI Chandralok Building, 36 - Janpath, New Delhi

Chapter 2 Changing Calorie Consumption and Dietary Patterns

GOVERNMENT OF INDIA MINISTRY OF HEALTH AND FAMILY WELFARE DEPARTMENT OF HEALTH AND FAMILY WELFARE

: uptake and impact of Xpert MTB/RIF

The changing patterns of cardiovascular diseases and their risk factors in the states of India: the Global Burden of Disease Study

Tuberculosis Screening and IPT: Experience from India

May, 2013 and Updated December, 2013

Scaling up of collaborative TB/HIV activities in concentrated HIV epidemic settings. A case study from India

Ageing in India: The Health Issues

The Three I s for HIV/TB and Rolling out IPT beyond Pilot -India

Supplementary appendix

XXVI IUSSP International Population Conference in Marrakech, Morocco, 2009

MDR-TB: Medicine quality and rational use

Meta Gene 2 (2014) Contents lists available at ScienceDirect. Meta Gene

Global summary of the AIDS epidemic, December 2007

7.11. MICRONUTRIENT DEFICIENCIES

Narcotics Control Bureau

Progress Report March 2016

Definitions and reporting framework for tuberculosis 2013 revision. Dennis Falzon Global Forum of Xpert MTB/RIF Implementers Annecy 17 April 2013

7.5 South-East Asian Region: summary of planned activities, impact and costs

Immunization. A Process Evaluation of Pulse Polio Immunization. Jotna Sokhey, Stephen Atwood*, Jon Andrus +, K. Suresh* and K.

Transcription:

Overview of Drug Resistant TB in India and National Scale up of MDR TB Diagnosis and Treatment Dr. K S Sachdeva Chief Medical Officer TB (SAG) Central TB Division DGHS, MoHFW, GoI New Delhi Facing the Reality of Multidrug Resistant Tuberculosis: Challenges and Potential Solutions in India April 18 th 19 th 2011, New Delhi, India

TB Burden in India India is highest TB burden country Annual 2 million incident cases Estimated prevalence of 3 million cases Annual deaths due to TB 280,000 ~5% of TB patients also HIVpositive Phillipines 3% Pakistan 3% Other countries 20% Other 13 HBCs 16% China 14% Ethiopia 3% Bangladesh 4% Nigeria South Africa 5% 5% India 21% Indonesia 6% Source: WHO Geneva; WHO Global TB Report 2010

MDR TB in India India has 2nd highest MDR-TB burden in the world after China Est. MDR TB emerging annually 99,000 (73,000 in S+ve) Population-based drug resistance surveillance in 3 states shows low MDR prevalence in new cases State (survey year) Population MDR among new cases MDR among previously-rx cases Gujarat (2007 08) 56 million 2.4% 17.4% Maharashtra (2008) 108 million 2.7% 14.0% Andhra Pradesh ( 09) 86 million 1.8% 11.8%

Second-line drug resistance among MDR TB patients Population-based data very limited Gujarat state drug resistance surveillance N=219 MDR cases detected FQ resistance=24%, KM=3% XDR=3% among MDR all 7 XDR TB cases previously-treated, none among new MDR cases

Over the counter drugs in any pharmacy

DOTS Plus in India (Programmatic Management of MDR TB) Guidelines and Strategies

DOTS Plus (PMDT) under RNTCP DOTS-Plus activities approved under RNTCP Phase II PIP (2006-11) DRS in Gujarat and Maharashtra (2005-06) National DOTS-Plus Committee formed (2005) DOTS Plus Guidelines developed (2006) National Lab Scale-up Plan for establishment of a network of accredited labs for diagnosis Uninterrupted supply of quality assured second line anti-tb drugs Information systems and data management DOTS-Plus is an integral component of RNTCP to manage MDR-TB to be implemented through India s public health and programmeinfrastructure

RNTCP response to MDR TB Prevention Sustained high-quality DOTS implementation Promote rational use of anti-tb drugs Implement infection control measures Stopping transmission Improve laboratory capacity: Diagnosing MDR-TB Effective treatment of MDR-TB patients Initiation and rapid scale up of MDR-TB services Evaluate the extent of second-line anti-tb drug resistance and management strategies

RNTCP: Vision and Objectives Vision To provide universal access to quality diagnosis and treatment for all TB patients in the community By 2015 Early detection of at least 90% of all TB patients in the community, including HIV-associated TB Initial screening of all smear-positive TB patients for drug resistant TB Offer of HIV Counseling and testing for all TB patients Successful treatment of at least 90% of all new TB patients and at least 85% of all previously-treated Promote rational use of anti TB drugs

Strategy to Scale-up Lab services Scale up number of culture and DST laboratories nationwide to at least 43 by 2013 Increase throughput per laboratoryby Investment in sputum processing capacity Introduction of high-throughput molecular DST Establish automated liquid culture systems Strengthen specimen transport systems & electronic results reporting Strengthen reference labs Establish and scale-up training capacity Engage private sector and medical college contractual laboratory services

Strategy to scale up treatment services Strengthened human resource capacity DOTS plus coordinator in every district Additional staff at labs and DOTS plus sites DOTS Plus site growth 120 DOTS Plus sites across the country (10 million pop) Upgraded to national airborne infection control standards Advocate with Indian Drug Manufacturers with GDF support Adhere to WHO Prequalification and GDF QA systems Develop SLD production plans with National drug demand in view Integrated national on-line electronic recording and reporting system (E-TB Manager Brazil Model being adapted by MSH) Advocate rational use of anti-tb drugs (FQ in respiratory cases)

MDR TB diagnosis current approach MDR suspect criteria All TB patients failing first-line regimen All previously-treated patients smear-positive at the end of extended intensive phase or later (CAT II) Smear-positive contacts of known MDR cases DST at accredited laboratory LPA if available is preferred DST method Treatment started on basis of RIF resistance only (RIF mono-resistance rare)

DOTS Plus Model of care CULTURE -DST LAB DOTS PLUS SITE (IN-PATIENT FACILITY) SPUTUM SAMPLE Initial hospitalization followed by ambulatory care MDR SUSPECT Cat I failure Cat II sm+ at 4 months of Rx Contacts of MDR cases RESULT DISTRICT HEALTH FACILITY (PHI) MDR CASE MDR CASE Follow up protocol Physical exam Culture Kidney function

RNTCP DOTS-plus decentralized and DOTS Plus Site 1 per 10 million pop. Medical college, inpatient MDR ward District level ~1.5 4 million pop. Coordinates MDR case-finding, follow-up exams, reporting. integrated care model Initial ~1 week hospitalization. Remaining care ambulatory unless inpatient care or specialist consultation needed. Health facility Manage minor side effect Supervise DOTS provider Most patient care done at local level by routine health staffs and programmestaff. DOTS provider Local health facility, paramedical village doctor, private provider, community volunteer

MDR TB Treatment regimen Standardized treatment algorithm: Category 4 Intensive phase (6-9 months): Kanamycin, Levofloxacin, Cycloserine, Ethionamide, PZA, Ethambutol If 4 th month culture-positive, treatment continued till culture-negative Continuation phase (18 months): Levofloxacin, Cycloserine, Ethionamide, Ethambutol PAS is used as a substitute drug in case of intolerance Daily DOT (Kanamycinis given 6/7 days throughout IP) Three weight bands to simplify drug logistics 16-25 Kg ; 26-45 Kg and >45 Kg RNTCP CATEGORY IV regimen: 6 (9) Km Ofx (Lvx) Eto Cs Z E / 18 Ofx (Lvx)Eto Cs E

Drug logistics Quality-assured drugs from international procurement GLC procurement GoIprocurement -ICB Supply line Loose drugs supplied to State drug stores Repackaged at State Drug Stores into monthly IP or CP packs, 3 per box Supplied to the districts and downwards Loose drugs provided at DOTS Plus sites Logistics and reporting on consumption integrated with first line drugs monthly IP packs (3) in quarterly IP drug box

Status of DOTS Plus in India

GUJARAT Jamnagar Accredited: N=25 4 NRLs 12 IRLs 9 other sector LPA: 4 labs Pending accredit: 8 RAJASTHAN Jodhpur Ahmedabad Mumbai PDHH GOA Jammu PUNJAB JJMC Pune JAMMU & KASHMIR HARYANA Gurgaon Ajmer Jaipur KARNATAKA Manipal Patiala Srinagar HIMACHAL PRADESH Dharampur Dehradun Karnal CHD UTTARAKHAND DELHI Agra ANDHRA PRADESH TAMIL NADU KERALA UTTAR PRADESH Lucknow MADHYA PRADESH Indore MAHARASHTRA NTI JALMA Bangalore Thiruvananthapuram Tanda MC Nagpur Wardha Hyderabad BPRC, Hyd Jabalpur CHHATISGARH Raipur TRC Chennai CMC Vellore PONDICHERRY RNTCP Culture & DST Labs (Mar, 2011) A JHARKHAND TRIPURA Ranchi WEST BENGAL ORISSA Vizag BIHAR Patna NDTC Cuttack AIIMS LRS SIKKIM Gangtok Kolkata Guwahati MEGHALAYA IRL (Accredited) ARUNACHAL PRADESH Itanagar ASSAM IRL (Under Accreditation) Imphal MANIPUR MIZORAM IRL (Equipments being procured) NAGALAND Med Col / NGO / Private Labs (Accredited) Med Col / NGO / Private Labs (Under Accreditation) Med Col / NGO / Private Labs (Preparatory) National Reference Labs

DOTS Plus Status (Dec 10)-1 Initiated in 2007 in Gujarat and Maharashtra Expanded in a phased manner 12 States are implementing basic DOTS Plus services in some districts Cumulative, till Dec 2010 19,178 MDR suspects examined 3605 patients initiated on treatment 6 States to initiate services shortly Remaining States to initiate basic services by end 2011 JAMMU & KASHMIR HIMACHAL PRADESH PUNJAB CHD UTTARAKHAND HARYANA ARUNACHAL PRADESH DELHI SIKKIM RAJASTHAN UTTAR PRADESH BIHAR ASSAM NAGALAND MEGHALAYA MANIPUR GUJARAT MADHYA PRADESH JHARKHAND TRIPURA WEST BENGAL MIZORAM CHHATISGARH MAHARASHTRA ORISSA ANDHRA PRADESH GOA KARNATAKA PONDICHERRY TAMIL NADU KERALA Implementing DOTS Plus Launching early 2011 Under preparation

DOTS Plus Status (Dec 10) -2 288 million (24%) population of India have access to DOTS Plus Services 141/658 (21%) of districts with MDR diagnostic and treatment services available Hyderabad initiated the pilot of suspect criteria B (all S+ RT cases) in Jan 11 A (139 Districts) B (1 District)

Diagnosis & Treatment Initiation Status of MDR TB Year 2007 to 2010 Sum of MDRTB Suspects Sum of MDRTB cases detected Sum of MDRTB cases initiated on Rx 12000 10000 8000 7333 10025 6000 4000 2000 0 309 109 62 1511 308 190 1981 1175 2967 2178 2007 2008 2009 2010 Cumulative Status MDR TB Suspects 19178 MDR TB Cases Detected 5365 (28%) MDR TB Cases Initiated on Treatment 3605 (67%)

Involvement of other sectors Successful partnership established with Private sector, NGOs, MCs and civil society partners under DOTS Plus in implementing states Laboratory Services: 9other sector C-DST labs accredited (BPRC-Hyderabad, PD Hinduja-Mumbai, CMC-Vellore, SMS-Jaipur, RMRCT (ICMR)-Jabalpur, JJ Hospital-Mumbai, Choitram Indore, BMHRC Bhopal and DFIT Nellore) 8other sector C-DST labs near accreditation (PGI Chandigarh, AIIMS-New Delhi, QUEST-Gurgaon, SRL-Mumbai, Gurgaon & Kolkata, RMRC Port Blair & Dibrugarh) FIND support for LPA/Liquid Culture for 43 labs under EXPAND TB Project Treatment Services: 14/20 (70%) functional DOTS Plus Sites are located in Medical Colleges Enhance social support & vocational rehabilitation provided through NGOs (supported by Elli Lily &Co. and GLRA) Under GF R9, Civil Society Partners The Union and World Vision to support RNTCP prevent emergence of DRTB through improved access to quality DOTS services Scale up Planning: FIND extended support by aligning their work-plans to national scale-up plan Independent external validation of National Plan by Clinton Foundation (with WHO)

PMDT expansion plans RNTCP DOTS Plus Vision.way forward

RNTCP DOTS Plus Vision: By 2011, RNTCP Category IV services will be introduced in all states with complete geographical coverage by 2012 By 2013, access to laboratory based quality assured MDR-TB diagnosis and treatment for all smear positive re-treatment TB cases and new cases who have failed an initial first-line drug treatment By 2015, access to MDR-TB diagnosis and treatment for all smear positive TB (new and re-treatment) cases registered under RNTCP RNTCP plans to initiate at least 30,000 MDR cases on treatment annually by 2013

Laboratory Scale-up Plan 43 laboratories to be established & strengthened Enhanced sputum processing capacity (staff, centrifuges, BSC) Solid culture and DST capacity in all lab units Line Probe Assay (LPA) in all laboratories Liquid culture in 33 laboratories Element 2010-11 2011-12 2012-13 Total Enhance sputum processing capacity 12 +13 +18 43 Establish LPA 12 +13 +18 43 Establish liquid culture systems 13 +9 +11 33 Expected annual DST capacity 35,000 80,000 144,000 220,000 Cepheid GeneXpert Field Demonstration Study proposed in 2011 -might accelerate the drug demand once Cepheid is programme policy Source: RNTCP National Laboratory Scale-up Plan 2010, www.tbcindia.org

Plan for patients to be tested and treated for MDR-TB % S+ retreatment patients for DST 180000 160000 140000 120000 100000 80000 60000 40000 20000 0 Patients tested for MDR-TB 2010 achievements 10,025 tested 2,178 initiated treatment 32000 8000 1,500 8,000 80000 15,000 144000 MDR-TB detected 25,000 160000 160000 30,000 32,000 2010 2011 2012 2013 2014 2015 *Based on RNTCP 2013 goal of MDR diagnosis for all S+ retreatment patients,

Resources for SLD procurement Lab scale up to be undertaken with support from UNITAID Expand TB Global Fund RCC and Rd 9 World Bank USAID through WHO Second line drugs Source 2010-11 2011-12 2012-13 2013-14 2014-15 Global Fund RCC 800 1200 2450 3500 4250 WorldBank 2350 3450 4550 9000 13250 UNITAID 4850 5000 - - - Global Fund Rd 9-5350 18000 17500 14500 Total 8000 15000 25000 30000 32000 Procurement through GLC 5650 (70%) 11550 (77%) 20450 (82%) 21000 (70%) 18750 (60%)

National DOTS Plus Scale-up Plan, 2011-12 (Operational Plan Developed from State Micro-plans) Source: Consolidation of State wise DOTS Plus micro-plans developed during the series of meetings with 35 states organized by CTD at New Delhi in November 2010

Expansion by MDR TB Suspect Criteria. move towards Universal Access Criteria A (Currently used) Criteria B (next level) Criteria C (universal access) Failures of New Pulm. TB Cases Failures and Non-Converters of Smear Positive Re- Treatment Pulm. TB Cases Contacts of confirmed MDR TB cases All Smear Positive Re-Treatment Pulm. TB cases registered for treatment (Relapse, TAD, Failure and Others) All Smear Positive Pulm. TB Cases (New and RT) registered for treatment Estimations of MDR Suspects and Cases were done using 2009 National Data by districts

CumulativePlan for 2011-2012 MDR TB Suspects enrollment plan 1,33,830 suspects MDR TB Cases enrollment plan 25,137 cases

DOTS Plus Coverage by Geography & Suspects Criteria - As on December 2010 A (140 Districts) B (1 District)

Planned DOTS Plus Coverage by Geography & Suspects Criteria - As on December 2012 A (319 Districts) B (251 Districts) C (35 Districts)

Summary of Scale up by Geography and Suspects Criteria Active 2010 2011 2012 States* 12 35 (100%) 35 Total Districts 141 (21%) 390 (37%) 605 (92%) Criteria A 140 246 319 Criteria B 1 141 251 Criteria C 0 3 35 * States with at least 1 district implementing Geographical coverage by Mar 13 for 44 districts from states like MP, PB and NE states Some states/districts start directly with suspect Criteria B

National Scale up by lab technology Consolidated plan of 66 labs includes 43 planned labs and other private, NGO, ICMR and Medical College labs

States Lab Capacity v/s Demand Summary Variation by States Self sufficient for Diagnosis Need Backup for Diagnosis Self sufficient for Follow Up AP*, HR, JH, KE, MP,MH, PD, RJ*, UR, CD Need Backup for Follow Up OR, TN*, WB BI, CG, DL,GA, GU, HP, JK, KA, PB, UP, 8NE, 4UTs * Will face intermittent deficits in lab capacity Lab Capacity Back up to be arranged from NRLs, IRLs of adjoining states, Purchase services from Private labs (under RNTCP NGO PP Schemes)

Drug deficit in plan: (-2104 courses) CumulativePlan for 2011-2012 Drug Envelop (15 monthsworking stock) 22,222 courses MDR TB Cases enrollment plan 24,326cases

Challenges -1 Delay in establishment and accreditation of laboratories Diagnostic delay with conventional method (3-4 months turn around time) Special requirements for introduction of newer rapid diagnostics laboratory infrastructure and training Improving efficiency of MDR suspect identification and referral

Efficiently starting treatment on diagnosed MDR TB patients Deaths, refusals with long delay; LPA may reduce this Challenges -2 Uninterrupted supply of second-line drugs Cost escalation (~2,100 $) reduces number of patients Extensive training, supervision and monitoring needed at all levels, nationwide Dramatic demand on local programmestaff for supervision, ensuring treatment adherence and timely follow up

Summary Expansion of PMDT / DOTS Plus well-underway in India Plans established, resources in place Key threats SLD cost, availability, quality and procurement Success of laboratory scale-up Second-line drug resistance Electronic Information System being deployed After a long time, some successes are visible on the horizon

Thanks for your attention

Acknowledgements National DOTS Plus Committee Central TB Division Chief Medical Officers K Sachdeva P Saxena State and District RNTCP programme Staffs DOTS plus site committees Culture and DST laboratory Staff WHO P Dewan M Parmar RNTCP medical consultants The Union FIND-India

XDR-TB in India Study Setting No.of MDR cases Mondaland Jain, 2007 Jain et al, 2007 Singh et al, 2007 Thomas et al, 2007 Sharma et al, 2009 Ramchandran et al, 2009 Tertiary care centre, Lucknow Teritiarycare centre, Mumbai Tertiary care center, New Delhi Field trial, Chennai AIIMS,New Delhi, tertiary care hospital Gujarat, Field study No. Of HIV +ve Prevalence of XDR-TB (%) Reference 68 Not Reported 5(7.4) EmergInfect Dis, 2007 326 Not reported 36 (11) ATS, abstract, 2007 12 All HIV infected 4 (33,3) AIDS, 2007 66 Not reported 1(1.5) IJT,2007 211 All HIVnegative 216 Not reported 7(3.1) Allpreviously treated cases 5(2.4) IJMR, 2009 IJTLD,2009

Dosage and Weight Bands S.No Drugs 16-25 Kgs 26-45 Kgs >45 Kgs 1 2 3 4 5 6 7 8 Kanamycin Levofloxacin Ethionamide Ethambutol Pyrazinamide Cycloserine PAS (80% w/v)* Pyridoxine 500 mg 250 mg 375 mg 400 mg 500 mg 250 mg 5 gm 50 mg *In case of PAS with 60% w/v the dose will be increased to 7 gm (16-25 Kg); 14 gm (26-45 Kg) and 16 gm (> 45 Kg) 500 mg 500 mg 500 mg 800 mg 1250 mg 500 mg 10 gm 100mg All drugs to be given as single daily dose. If intolerance to Eto/Cs/PAS can be divided into 2 doses 750 mg 750 mg 750 mg 1000 mg 1500 mg 750 mg 12 gm 100mg

Drug logistics State Drug Store 3 months drug boxes Loose drugs DTC and TU DOTS Plus site Domiciliary Treatment by DOT Provider Preparation of 3 monthly drug boxes Ensuring uninterrupted supply Strict monitoring because of short shelf life expiry

Total MDR patients Alive, On Treatment and Culture Negative at 12 months after treatment initiation 400 350 300 250 200 150 100 50 0 CumulativeStatus 0 0 0 0 Sum of 12m reg MDR TB Cases Regup to 3Q09 984 MDR TB Cases who are alive, on Rx and Culture Negative at 12 months 29 18 33 15 49 18 26 13 Sum of 12m alive, on Rx & CN 549 (56%) 45 24 1 2 3 4 1 2 3 4 1 2 3 4 70 35 153 87 238 151 341 188 0 2007 2008 2009

Analysis of Poor initial microbiological outcomes in initial PMDT pilot cohort Summary Very high prevalence of FQ resistance in initial MDR treatment cohorts Number small, patients highly treatment experienced, all had failed re-treatment regimen Poor 12-month interim outcomes Low initial culture conversion, high re-version Ofxresistance, low BMI, and missing 1-week during IP independently associated with initial non-conversion Source: Solanki RN et al., Association of poor culture-conversion with fluoroquinolone resistance in Gujarat, Western India Nov 10

Initial cohort treatment outcomes CumulativeStatus Registered up to 2Q08 Success Rate Death Rate Failure Rate Default Rate 137 59 (43%) 28 (20%) 21 (15%) 29 (21%) High level of second line drug resistance Heavily treatment experienced cohort

Activity In place Expand TB Solid Culture Labs (43) Equipment 17 Labs* Consumables 2010-15 (8 Labs) LPA Labs (43) Equipment 5 labs ** 40 Labs 3 Labs Consumables - 2010-14 2014-15 Liquid Culture Labs (33) GF Rd 9 GF RCC GoI/WB WHO/ USAID 21* Labs 5 Labs* 2010-15 (35 Labs) BSL 3 7 # labs 20 labs 6 labs Equipment 4 Labs 29 Labs *Includes Consumables 27 IRLs, 4 NRLs, Govt. Medical College Labs and 2010-14 ICMR labs 2014-15 **Basic LPA equipment provided through FIND demo project; Other high through put Sputum processing 33 $ LPA equipment to be provided under Expand TBx labs 6 $ labs # 4 NRLs and 3 FIND demo project sites; Human Resource 1 MB, 2 LT $ 33 +6= 39; Not to be provided to NRLs as they are reference site and not service delivery sites 1 MB,1 LT 1 MB, 1 LT

Partners and areas of support Partners WHO / USAID WorldBank Global Fund UNITAID FIND PATH / USAID Area of Support TA(Consultants GDF/CTD/States) Procurement (Lab equipments & SLD) Evidence building through OR National PPM Lab Consultation & National Experience Sharing for Labs Overall programmemanagement (Infrastructure -IRLs, DP Sites, Stores; HR, Lab consumables, honorarium, PPM, SME etc.) Procurement (Lab equipments, consumables & SLD) Overall programme management (8 states) Procurement (Lab equipments, consumables & SLD) Enhanced lab capacity in 43 labs (with LPA & Liquid Cul[33]) through FIND Engaging Civil Society Partners (ACSM) through The Union and World Vision Enhance lab capacity in 43 labs (with LPA & Liquid Cul[33]) Procurement (Lab equipments, consumables & SLD) Introduce New Rapid Diagnositics(LPA, Liquid Culture) Enhance lab capacity in 43 labs (with LPA & Liquid Culture[33]) through Expand TB project (with funding from GF) Support RNTCP in AIC Pilot ( incltraining of Architects/Engineers) Support in up-gradation of Labs to BSL III and installation of equipments Organize DOTS Plus Experience sharing workshops for implementing states

Objectives: Planning meetings with States To articulate the operational strategy to achieve the RNTCP vision for PMDT scale up To align state plans with the available resources (CAT IV drugs, and lab capacity) as per the National lab scale up and SLD procurement plan. Outcome: To have a national comprehensive DOTS Plus scale up micro-plan, matched to drug supply and lab capacity, with implications for appraisal and training responsibilities understood by all.

Methods Conduct "backfill" drug quantity calculation for the state Determine how many new patients can be initiated on Rx by states Using assumptions based on current national experience With timelines for all prep activities (Civil works, staffing, training, appraisals) Set out clear timelines (by pending processes) for service initiation by each lab in the states and at what capacity of Culture & DST District planning worksheets to match MDR suspects / cases with available lab capacity and drug envelop match each district over time with the right lab and the right suspect criteria Determine national training and appraisal needs to meet the scaleup plan for the state

Assumptions validated by current experience Assumptions of MDR Rates based on Suspect Criteria All States Kerala MDR suspects, from whom diagnostic specimen cannot be Collected 20% 7% RT end-ip positive who are positive at 4 month, beyond RT Failures 15% 25% NSP failures with RIF resistance 15% 10% RT non converters with RIF resistance 50% 25% RT failures with RIF resistance 50% 25% NSN failures with RIF resistance 10% 10% Number of s+ Contacts per MDR case 33% 33% S+ve Contacts of MDR cases with RIF resistance 50% 50% RT type Relapse registered with RIF resistance 10% 10% RT type Failure registered with RIF resistance 50% 30% RT type TAD registered with RIF resistance 12% 12% RT type Others S+ve registered with RIF resistance 10% 10% NSP registered with RIF resistance 2.5% 2.5% Assumptions of Rx drop out rates of diagnosed MDR cases based on Lab test LJ/MGIT Culture Diagnosed MDR cases, not initiated on CAT IV 30% 30% LPA Diagnosed MDR cases, not initiated on CAT IV 10% 10%

Scale up in Districts/States determined by timelines for C-DST Lab accreditation or service linkage Procurement of Packing material and arranging transport for samples and 3m PWB DOTS Plus Site identification, Up-gradation for AIC, Committee formation, Staff training Up-gradation of State and District Drug Stores for Storage of SLD National and State level Trainings and Appraisals

5 National training batches conducted since Dec 10 ~ 320 key staff trained since Dec Strategy to meet the National Training Demands: 1. Develop 4 th National DOTS Plus Training Centre at Trivandrum, Kerala 2. Arrange training batches @ 2 per month with batch size ~ 40 (240 trainees / quarter) 3. Identify trainers from experienced states National Institutes, DP Site Committee, STDC, WHO Consultants apart from CTD facilitators. 4. Training budget from Gujarat, Andhra Pradesh, Kerala and Delhi for National Training in Annual Action Plan 2011-12 to be approved at CTD. 5. Develop annual training calendar and monitor progress 10 State teams and Phase 1 districts of all 35 states trained at national level

Appraisals conducted since 2010 Maharashtra 7 districts Andhra Pradesh 3 districts Himachal Pradesh -2 districts Jharkhand 2 districts UP 1 district Strategy to meet the unrealistic CTD Appraisal Demands: 1. Simplify CTD Appraisal format and develop normative guidelines (like CIE) 2. Develop Core Group to conduct Appraisals STOs, STDC Directors, DP Site Committee, WHO Consultants, External Resources from Partners. 3. Fast-track lab accreditations, civil works for DP Sites (AIC), SDS, DDS and HRD. 4. Ensure State appraisals of all districts and monitor compliance to recommendations before CTD appraisals 5. Develop CTD appraisal matrix and calendar 6. Arrange Multiple team of Core Group members to conduct simultaneous appraisals