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
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)
India 61,000
(22% of global MDR burden) 2.4% in New Cases
15% among previously treated
China 54,000
(20% of global MDR burden)
* among notified TB cases
South Africa 6,900
(3% of global MDR burden) Source: Global TB Control Report 2014
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, www.tbcindia.nic.in *Cartridge based – nucleic acid amplification tests
Introduction of WHO Endorsed Rapid Diagnostics in India
2007 – Conventional
Solid (LJ) Culture-DST
2009 – Line Probe Assay
2011 High throughput
GT Blot
2012
CB-NAAT
- 18 site (27) RNTCP WHO FIND feasibility study
- 10 (12) sites EXPANDx TB Project
2013-14
CB-NAAT
- 40 sites (43) RNTCP WHO UNITAID TBXpert Project
- 4 (6) sites for pediatric project-USAID
2015 - CB-NAAT
-30 ART sites RNTCP WHO USAID
TB-HIV Project
- 300 sites RNTCP /TGF Grant
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
8000
32000
80000
144000
160000
160000
1,5
00
8,0
00
15,0
00
25,0
00
30,0
00
32,0
00
0
20000
40000
60000
80000
100000
120000
140000
160000
180000
2010 2011 2012 2013 2014 2015
% S
+ r
etr
eatm
ent
patients
for
DST Patients tested for MDR-TB MDR-TB treated
*Based on RNTCP 2012 goal of MDR diagnosis for all S+ retreatment patients,
India’s response to “Call for Action” at Ministerial Meeting - Beijing 2009
43 labs - LPA and LJ
(33 with MGIT 960)
National PMDT Scale up Plan (2011–12)
Second Line Drug
supply
Lab Capacity &
sample transport
Staffing & Training at all levels
Central Appraisals of Districts
MDR ward and
outpatient care
readiness
Participatory approach to planning PMDT Scale up w.e.f. Nov 2010
(state plans aligned to national resources)
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
35 States planned scale up of PMDT
services with
support of GoI-WHO-Partners
Source: RNTCP National PMDT Scale-up Plan 2011-12, www.tbcindia.nic.in
District wise diagnostic technology available and MDR-TB diagnostic criteria
2010
District wise diagnostic technology available and MDR-TB diagnostic criteria
2011
District wise diagnostic technology available and MDR-TB diagnostic criteria
2012
District wise diagnostic technology available and MDR-TB diagnostic criteria
2013
District wise diagnostic technology available and MDR-TB diagnostic criteria
2014
PMDT Services established in India by years
Service Delivery Components 2007 2008 2009 2010 2011 2012 2013 2014
States with 100% coverage of PMDT 1 2 2 11 35 35 36
PMDT implementing districts 8 74 124 141 260 625 704 712
C-DST Labs with any technology 4 9 17 22 36 45 51 58
Labs with LPA 3 18 33 41 49
Xpert-MTB-Rif Sites 18 30 80 89
Districts linked to WRD (LPA/Xpert) 20 167 597 704 712
DR TB Centers functional 2 7 18 20 50 86 99 127
Linked DR-TB Centers functional 50
30
9
15
11
81
44
11
00
1
17
69
6
10
60
14
18
21
45
25
54
08
109 308
2341 3288
4297
17284
23162
25652
62 190
1174 2182 3378
14117
21093
24073
3 127 392 1262
0
5000
10000
15000
20000
25000
30000
0
50000
100000
150000
200000
250000
3000002
00
7
20
08
20
09
20
10
20
11
20
12
20
13
20
14
Nu
mb
er
of
DR
TB
cas
es
Nu
mb
er
of
Pre
sum
pti
ve M
DR
TB
te
ste
d
DR TB case finding and treatment initiation efforts, India-2007-2014
Sum of MDRTB Suspects Sum of MDRTB cases detected
Sum of MDRTB cases initiated on Rx Sum of XDR TB cases initiated on Rx
LPA GT Blot
CB-NAAT Participatory Planning
57%
94%
66%
Presumptive MDR tested 582228
MDR-TB cases diagnosed 76441
MDR-TB cases put on treatment 66269
XDR-TB cases put on treatment 1784
MDR-TB cases and additional rifampicin-resistant TB cases (red) detected compared with TB cases enrolled on MDR-TB treatment
(blue) 2009–2013, in 4 high MDR-TB burden countries
Source: Global TB Control Report 2014
0
5000
10000
15000
20000
25000
30000
2007 2008 2009 2010 2011 2012 2013 2014
India
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
Constraints Accelerators
Financing Ambitious GoI funding + resource mobilization TGF, UNITAID, WHO, USAID
Technical assistance High end TA - WHO India, FIND, PATH, partners National institutes and private players
Execution gaps - slow pace in few states
Thrust on monitoring to address gaps Fast-tracking districts & indication for DST
Lag in laboratory capacity development
Fast-tracking labs with WRD (LPA/NAAT) Sample transport to address lab deficits
Human resources, trainings & appraisals
Scaled up National PMDT Training Centers Team building, mentoring for appraisals
Balanced acceleration of PMDT Scale up Lessons Learnt
RNTCP PMDT Vision Plan of PMDT service expansion (2015-19)
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 1000+ 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
First National Anti Tuberculosis Drug Resistance Survey of India (2014-15)
formally Launched on 6th September 2014 by the Hon’ble Health Minister
Alignment of Lab and PMDT Scale up plans (2014-19)
40000 45000
50000 55000
60000
27
50
32
50
35
00
37
50
40
00
0
20000
40000
60000
80000
2014-15 2015-16 2016-17 2017-18 2018-19
MDR-TB XDR-TB
Technology 2014-15 2015-16 2016-17 2017-18 Total
CB-NAAT 119(300) 200 200 200 1019
LPA 46 0 0 0 46
Liquid C-DST 40 20 20 20 100
Solid C-DST 55 25 20 20 120
SL-DST 16 6 10 8 40
Note: Figures relate to procurement year, enrollment of the patients will be in the subsequent year
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)
India committed to the five priority actions to address the global MDR-TB crisis
Many thanks to all
