Transcript Status of RNTCP - Madhya Pradesh

Update on MDR TB services
under RNTCP
Dr D Behera
Director
LRS Institute of Tuberculosis and Respiratory Diseases
New Delhi
contents
• Burden of MDR-TB in India
• RNTCP response to the challenge of MDR-TB
• Status, vision and challenges
• Recent Key policy changes
India
21%
•
India is highest TB burden country with an
Other countries
20%
annual 1.98 million incident cases
•
Estimated prevalence of 2.29 million cases
•
Annual deaths due to TB 2,76,000
•
TB/HIV Prevalence
– 2.31 million population living with HIV;
Other 13 HBCs
16%
China
14%
Phillipines
3%
Pakistan
3%
Ethiopia
3%
Indonesia
6%
Bangladesh
4%
Nigeria
South Africa 5%
5%
100%
– ~ 0.9 million co-infected
– ~5% of TB patients estimated to be HIV +
80%
7.3
million
4.2
million
60%
40%
20%
0%
21%
1.9
million
24%
Estimated Incidence of TB
Source: WHO Geneva; WHO Global Report 2009 & Short update to 2009 report
1.3
million
India
Cases Notified
Rest of world
Challenges to TB Control
• Wide variations in capacity of Health
Systems across the country
• Burden due to TB-HIV Co-infection
• Ensuring adherence of treatment for
migratory population
• Large and unregulated Private Sector
• Limited availability of new rapid diagnostic
tools, drugs and vaccine
• Drug Resistance
Global Burden of MDR-TB*
0.44 million
“incident” cases
27 HBC which
account for 85% of
all cases
79%
1.
2.
3.
4.
5.
6.
China – 100,000
India- 99,000
Russian Fed. – 38,000
Pakistan- 15,000
Phillipines-13,000
South Africa- 13,000
* WHO 2010 M/XDR-TB Global Report on Surveillance and Response
Drug resistant TB in India
• MDR-TB
– India has 2nd highest MDR-TB burden in the world after China
– As per DRS surveys done in 2005-06 in the states of Gujarat and
Maharashtra prevalence of MDR-TB is:
• <3% in new cases and 14-17% in previously treated cases
• As per WHO estimates 99,000 MDR cases emerged in India in 2008
• Mono and Poly resistance (Non MDR) TB
– Relatively high levels of non MDR resistance to H & S seen both in new
and previously treated cases, either as mono-resistance or PDR
Drug resistance in cases detected in
prevalence surveys 1968-2003
25
Percentage
20
15
H
10
S
SH
5
HR
0
1968-70 1971-73 1973-75 1976-78 1979-81 1981-83 1984-86 1991-92 1994-96 1999-01 2001-03
Year
Source: TRC Chennai
Drug resistant TB in India
• Extensively Drug Resistant TB (XDR-TB)
– Reported in India though the data is limited and nonrepresentative
– Gujarat DRS survey shows
• No XDR-TB amongst new cases
• 4% amongst those previously treated cases found to be
MDR
• High levels of non-XDR resistance seen to Ofx and Eto in
both new and previously treated cases
57 countries
XDR –TB in the world as of March 2010
XDR-TB in India
Study
Setting
No. of MDR
cases
No. Of HIV
+ve
Prevalence of
XDR-TB (%)
Reference
Mondal and
Jain, 2007
Tertiary care
centre,
Lucknow
68
Not Reported
5(7.4)
Emerg Infect
Dis, 2007
Jain et al, 2007
Teritiary care
centre, Mumbai
326
Not reported
36 (11)
ATS, abstract,
2007
Singh et al,
2007
Tertiary care
center, New
Delhi
12
All HIV –
infected
4 (33,3)
AIDS, 2007
Thomas et al,
2007
Field trial,
Chennai
66
Not reported
1(1.5)
IJT, 2007
Sharma et al,
2009
AIIMS, New
Delhi, tertiary
care hospital
211
All HIVnegative
5(2.4)
IJMR, 2009
Ramchandran
et al, 2009
Gujrat, Field
study
216
Not reported
7(3.1)
All previously
treated cases
IJTLD,2009
Causes of drug resistance
• Essentially a man made phenomenon
• Inadequate Regimens
– Irrational use
– Inappropriate combinations
– Sub-optimal doses and duration
• Inadequate supply or poor quality of drugs
• Inadequate drug intake
DOTS Strategy adopted by
RNTCP addresses all these
issues
RNTCP Response to Drug
resistance TB
Multi-faceted approach …..

Key focus is on prevention

Sustained high-quality DOTS implementation

Promote rational use of anti-TB drugs

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 the threat of second-line anti-TB drug
resistance and management of XDR-TB
Strategies…..
• Prevention of drug resistance through sustained
high-quality DOTS implementation
• Improve laboratory capacity
• Effective treatment of MDR-TB patients
– RNTCP DOTS Plus (Category IV services)

Promote rational use of anti-TB drugs in the
country
• Implement infection control measures
MDR-TB services under rntcp
DOTS PLUS – model of care
DOTS PLUS SITE
(IN-PATIENT FACILITY)
CULTURE AND DST LAB
SPUTUM SAMPLE
Initial hospitalization
followed by
ambulatory care
RESULT
MDR CASE
Follow up protocol
•Physical exam
•Culture
•Kidney function
DISTRICT
MDR CASE
MDR SUSPECT
•Cat I/III failure
•Cat II sm+ at 4 months of Rx
•Contacts of MDR cases
HEALTH FACILITY
(PHI)
Treatment Delivery
• Standardized regimen- Cat IV
– Intensive phase (6-9 months)
• Kanamycin, levofloxacin (ofloxacin), Cycloseine, Ethionamide, Z, E
– Continuation phase (18 months)
• Levofloxacin (Ofloxacin), Cycloseine, Ethionamide , E
– PAS is used as a substitute drug
– Three weight bands –
• 16-25 Kg ; 26-45 Kg and >45 Kg
– Daily DOT (Kanamycin is given 6/7 days)
– Follow up
• Smear and Culture monthly during IP and quarterly during CP
• S Creatinine monthly till Kanamycin is administered
– Patients who remain culture + after 6 months of Rx are
subjected to SLDST (Km and Ofx)
• If found to be XDR will be started on Cat V regimen
DOTS Plus Site – Gujarat
DOTS-Plus In-patient site
•Tertiary level centre @1 per 10 million population
•Dedicated in-patient facility with infection control measures in place
•Trained staff available
•Facilities for pre-Rx assessment & management of adverse reactions
Drug logistics
• Quality assured drugs procured nationally
– GLC
– GoI procurement
• Supply line
– Loose drugs supplied to State drug stores
– Repackaged into 3 monthly IP and CP boxes
– Supplied to the districts and downwards
– Loose drugs provided at DOTS Plus sites
• Logistics and reporting on consumption
integrated with first line drugs
3 monthly drug box
Recording and reporting
•
Standardized records and reports
– Treatment card
– DOTS Plus TB register
– C & DST lab register
– DTC Referrral register
•
Quarterly reporting
– Case finding report
– Interim culture conversion reports
– Final outcome report
•
Plan to establish a dedicated web based
DOTS Plus information management
system shortly
Status of rntcp dots plus
services
• 2005
History…….
– Plan to initiate DOTS Plus services under RNTCP II project (2006-2011)
• 24 IRLs to be established and enroll 5000 patients on treatment annually
– Constitution of National DOTS Plus committee
• 2006
– National DOTS Plus guidelines developed
• 2007
– Gujarat and Maharashtra initiate MDR services
• 62 patients enrolled on Rx
• 2008
– Services available in 8 States- AP, WB, Haryana, Kerala and Delhi
• 252 patients enroled on Rx
• 2009
– Services available in 10 States-Rajasthan and Orissa
• 1415 patients enroled on Rx
Present status
• 10 States
implementing
DOTS Plus
services
– 127/632
districts covered
• Another 5 States
to initiate
services shortly
• More than 2300
patients on
treatment
10 States
implementing
MDR services
JAMMU & KAS HMIR
HIMACHAL P RADE SH
PUNJAB
CHD
UTTARAKHAND
ARUNACHAL PRADE SH
HARYANA
DELHI
RAJASTHAN
SIKKIM
UTTAR PRADE SH
BIH AR
ASS AM
NAGALAND
MEGHALAYA
MANIPUR
JHARKHAND
GUJARAT
TRIPURA
WEST BENGAL
MADHYA P RADE SH
MIZORAM
CHHATISGARH
ORIS SA
MAHARASHTRA
Implementing DOTS Plus
Implement shortly
Under preparation
ANDHRA PRADE SH
GOA
KARNATAKA
PO NDIC HERR Y
TAMIL NADU
KERALA
~2300 patients
on Rx
Status of c & dst labs 2Q10
• 14 C & DST labs accredited
– 10 IRLs
• Gujarat, Maharashtra, AP, Kerala, Delhi, West Bengal, Tamil Nadu, Rajasthan, Orissa
and Jharkhand
– 4 other sector labs
• Medical Colleges- CMC, Vellore; SMS Jaipur
• NGO Lab- BPRC, Hyderabad
• Private sector – Hinduja Hospital, Mumbai
• Labs to be accredited shortly
– IRL- Haryana;
– KGMU, Lucknow
• Labs under accreditation process
– IRL-Chattisgarh, Uttarakhand
– PGI, Chandigarh; AIIMS, New Delhi,
– Quest diagnostics; Ranbaxy Mumbai, Metropolis , Mumbai
RNTCP Culture & DST Labs
JAMMU & KAS HMIR
(15 August 2010)
Sr inagar
10 Govt and
4 other
sector labs
accredited
HARYANA
Jamm u
HIMACHAL P RADE SH
Tanda MC
NDTC
Dharampur
CHD
Dehradun
Karnal UTTARAKHAND
AIIMS
LRS
PUNJAB
Patiala
ARUNACHAL PRADE SH
HARYANA
Gurgaon
DELHI
SIKKIM
Agra
Jaipur
RAJASTHAN
UTTAR PRADE SH
JALMA
BIH AR
Lucknow
Ajm er
Jodhpur
JHARKHAND
Jabalpur
MADHYA P RADE SH
Ahmedabad
Guwahati
Ranchi
ASS AM
MEGHALAYA
Patna
GUJARAT
Itanagar
Gangtok
TRIPURA
WEST BENGAL
NAGALAND
Im phal
MANIPUR
MIZORAM
Kolkata
Indor e
Jamnagar
CHHATIS GARH
Nagpur
Cuttack
Wardha
Raipur
MAHARASHTRA
Mumbai JJMC
PDHH
Pune
ORIS SA
Hyderabad
Vizag
BPRC, Hyd
ANDHRA PRADE SH
GOA
IRL (Accredited)
KARNATAKA
IRL (Under Accreditation)
Manipal
Bangalore
NTI
TRC
Chennai
CMC Vellore
PO NDIC HERR Y
TAMIL NADU
KERALA
Thiruvananthapuram
IRL (Equipments being supplied)
Med Col / NGO / Private Labs (Accredited)
Med Col / NGO / Private Labs (Under Accreditation)
Med Col / NGO / Private Labs (Preparatory)
National Reference Labs
Final Treatment outcomes
• First cohort of patients (2007)
Patients
registered
Cured
Rx
completed
Failure
Death
Default
62
32(52%)
1 (1%)
5 (7%)
12 (20%)
12 (20%)
– Most of them were chronic cases with h/o
multiple Cat II treatments
– High level of second line drug resistance
Dots plus vision
….road ahead
DOTS Plus Vision……
• By 2010, RNTCP Category IV services will be introduced in all states with
complete geographical coverage by 2012
• By 2012, 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
Multi-year plan…..
% S+ retreatment patients for DST
100%
160000
90%
160000
144000
160,000
140,000
80%
120,000
70%
100,000
60%
50%
80,000
80000
40%
60,000
30%
35000
20%
32000
30000
25000
15000
10%
0%
8000
20,000
8000
1500
2009
40,000
0
2010
2011
Patients tested for MDR-TB
2012
2013
2014
MDR-TB detected
*Based on RNTCP 2012 goal of MDR diagnosis for all S+ retreatment patients,
Strategies for achieving the vision
• Enhancing the laboratory capacity
– National Laboratory scale up plan
– Additional support from private and NGO laboratories
• Scaling up treatment services
• Mobilization of Resources
Lab scale up plan
• ~43 laboratory units to be established
– Enhanced sputum processing capacity
– Solid culture and DST in all lab units
– Line Probe Assay (LPA) in all lab units
– Liquid culture in 33 lab units
Lab unit
2010-11
2011-12
2012-13
Total
Enhanced capacity for solid
culture and sputum processing
12
13
18
43
Establish Molecular unit-LPA
12
13
18
43
Establish liquid culture systems
13
9
11
33
Expected annual DST capacity
35000
80000
144000
220000
Scaling up treatment services
• DOTS Plus sites
– 120 DOTS Plus sites across the country (1/10 m population)
– Tertiary care centres with in patient facilities
– Upgraded to incorporate infection control measures
– Function
• Pre-treatment evaluation and treatment initiation
• Follow up of progress of patient
• Management of adverse reactions
• Recording and Reporting
• Uninterrupted supply of adequate quality assured second line
drugs
• Provision for daily DOT
– Includes 6-9 months of injectables
Resource mobilization
• 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
World
Bank
2350
3450
4550
9000
13250
UNITAID
4850
5000
-
-
-
Global
Fund Rd 9
-
5350
18000
17500
14500
Total
8000
15000
25000
30000
32000
Recent Key policy
changes
Recent Key policy changes….
• Revision of MDR-TB suspect definition
– Cat I and III failures
– Cat II patients who remain smear positive after 4 months of treatment
or later
– Contacts of MDR-TB cases found to have smear positive TB
• Replacement of Ofloxacin by Levofloxacin in Cat IV regimen
– Regimen will now be
• IP: Km, Lvx, Cs, Eto, Z, E (6-9 months)
• CP: , Lvx, Cs, Eto, E (18 months)
• Earlier exclusion criteria (pregnancy, paediatric age group,
intake of SLD >1 mth) removed
Key policy changes ….2
• Guidelines on the management of XDR-TB patients under RNTCP
finalized
– XDR-TB to be suspected in Category IV patients who remain culture
positive after 6 months of treatment, SLDST to be done
– Such patients are to be treated with the Category IV regimen
• Guidelines on management of patients who default from
Category IV treatment for more than 2 months and subsequently
report back to RNTCP developed
• Management of DR-TB patients other than MDR-TB
– Patients with any rifampicin resistance will be treated with the MDR
TB regimen, in addition to those with MDR-TB.
– Need to generate more evidence on treatment of other forms of
mono and poly (non MDR) drug resistant TB
Challenges in achieving the
vision
Challenges in diagnosis of MDR TB…
• Delay in establishment of accredited state level
laboratories due to a host of reasons
• Sub-optimal functioning of the accredited labs
– Non-availability of trained manpower
• Dedicated regular staff in addition to the contractual posts
– Uninterrupted power supply
• Diagnostic delay with conventional method (3-4 months
turn around time)
• Special requirements for introduction of newer rapid
diagnostics- laboratory infrastructure and training
Treatment Challenges…….
• Long duration, toxic, expensive treatment
– ~2,100 $ per patient course
• Daily ambulatory DOT
– 6-9 months of injectables
• Availability of DOTS-Plus in-patient sites (1 per 10 million
population)
• Extensive training, supervision and monitoring needed at all levels
• Ensuring treatment adherence and timely follow up
• Uninterrupted supply of second line drugs
•
Rational use of anti-TB drugs
•
Problem
– In 2006, substantial quantity of FLDs and almost 100% of SLDs were sold and used
outside of RNTCP
– Well documented that management of TB patients outside of RNTCP is often poor
leading to risk of failure of treatment and development of drug resistance
– Large unregulated private sector
– Conflict of Interest
– Easy availability of anti TB drugs
•
Steps to promote rational use of anti TB drugs
– “Chennai Consensus Statement” developed and disseminated
– IMA on behalf of RNTCP interacting with MCI for guidelines to all healthcare
providers on rational use of anti TB drugs
– Interactions with office of DCGI to draft guidelines for the regulation of anti-TB
drugs, especially SLDs,
– Encouragement of additional pre-qualified drug manufacturers
Infection Control…….
•
Problem
– Infection control considered synonymous with waste management
– Lack of National guidelines on Airborne Infection control in context of TB
– Overcrowding/lack of space at health facilities
– Lack of awareness and commitment of hospital administrators
•
Steps taken
– National Airborne Infection Control Committee constituted
– “National guidelines for airborne infection control” for all healthcare facilities
developed and pilot tested
– Provision of support to upgrade IC measures at
• DOTS-Plus site indoor facilities
• Intermediate Reference laboratories
– Collaboration with AIDS control programme to ensure IC measures at ICTCs and
ART centres
– Encouraging Medical Colleges (through NTF, ZTF and STF mechanism) to develop
and implement infection control measures
Role of medical
colleges in supporting
scale up of dots plus
services under rntcp
strengthening lab capacity
•
Medical colleges (public and private) with functional Mycobacteriology
laboratories encouraged to apply for accreditation
•
Steps for accreditation– Download the application format for accreditation from www.tbcindia.org
– Submit the format to the State TB Officer with a copy to CTD
– Pre-accreditation visit
– Proficiency testing
– Accreditation
•
Once accredited the lab can provide diagnostic and follow up services
under RNTCP
•
RNTCP will provide financial/commodity assistance for services provided
Treatment services
•
•
RNTCP can benefit from the rich experience of the Medical Colleges in
treating MDR TB
Medical Colleges (Public and Private) can serve as DOTS Plus sites
– Dedicated in patient facility (ward)
•
•
Separate space/ward for Male and Female patients
Adequate number of beds
– Facilities for pre-treatment evaluation
– Constitution of DOTS Plus site Committee
– Upgradation to incorporte infection control measures
•
Responsibilities
– Treatment initiation and follow up of MDR patients
– Management of adverse reactions
– Recording and Reporting
•
RNTCP support
– Funds upto 10 lakhs for upgradation
– Human Resource- 1 Medical Officer; 1 Statistical Assistant
– Computer with Internet facility
Thought for the day