RNTCP: DOTS Expansion and plans for DOTS-Plus

RNTCP: DOTS Expansion and plans for DOTS-Plus Central Tuberculosis Division Directorate General of Health Services Ministry of Health & Family Welfare Government of India

Contents Status of DOTS expansionPlans for DOTS-Plus

India: DOTS Implementation Status by District, 31st Mar 2005

Population in India covered under DOTS and total tuberculosis patients put on treatment each quarter In 2004, a globally significant cohort of 1.2 million TB patients initiated on DOTS

Case detection (New S+ve) and treatment success in DOTS areas, 1999-2004 * • Population projected from 2001 census • Estimated no. of NSP cases - 75/100,000 population per year (based on recent ARTI report)

State-wise Case-detection and treatment success rates in RNTCP areas for 2004/2003

Treatment outcome of New Smear Positive patients in 2003

India: percentage of re-treatment cases out of all smear positive cases, 2004

Treatment outcome of Retreatment patients excluding ‘Others’ in 2003

Plans for DOTS-Plus • RNTCP regimens highly effective, with low failure rates (2% in CAT I , 6% in CAT II cases) • However issue of PTB patients who remain positive following a fully supervised CAT II regimen, has previously not been well addressed by the RNTCP • Although these cases represent a small minority of overall caseload of TB patients, they constitute an on-going problem for RNTCP managers, both from an epidemiological and human rights viewpoint • Now that RNTCP is well established in 90% of the country, it is timely to develop services to address the needs of this group of patients

Plans for DOTS-Plus (…2) • MDR-TB is a laboratory diagnosis, NOT a clinical one • Hence quality assured culture and DST lab facilities must be available • For RNTCP to provide MDR-TB treatment, RNTCP will start establishing network of state-level IRLs • Aim is to have 1 such state-level IRL in each large state by 2009-10 • Requires a planned and phased programme of capacity building of such an IRL network

Plans for DOTS-Plus (…3) • RNTCP views treatment of MDR-TB patients as a “standard of care” issue • Recognizing that MDR-TB treatment is complex, treatment will follow the international DOTS Plus guidelines and will be done only in designated RNTCP DOTS Plus sites: • sites will be in a limited number of highly specialized centres, at least 1 in each large state; • sites will have ready access to an RNTCP accredited IRL; • will have adequate number of qualified staff available to manage patients; • use standardized second-line drug regimens given under daily DOT and with standardized follow-up protocols; • systems in place to deliver ambulatory DOT after an initial short period of in-patient care to stabilise patient on the second-line drug regimen; and • with a logistics system and standardized MIS in place

Plans for DOTS-Plus (…4) • Activities to be undertaken for DOTS Plus: • Formation of a national level MDR-TB / DOTS Plus Committee; • Develop national management guidelines for treatment of MDR-TB cases and DOTS Plus; • Establish procurement mechanism for second-line drugs, including systems for quality assurance of the drugs; • Identify sites for DOTS Plus; and • Enrol MDR-TB patients for treatment • DOTS Plus sites will be initiated in a phased manner similar to that for establishment of state-level IRL network, and sites will be geographically linked to the establishment of the IRLs • By 2010, plan is for 24 DOTS Plus sites, with the capacity to annually enroll 5,000 new MDR-TB cases for treatment • Planned to enroll first 100 cases in Gujarat and Maharashtra in early 2006

In 1st Year of a new DOTS Plus site, 50 new patients enrolled per site for treatment. In 2nd Year, 100 patients enrolled. From 3rd Year onwards, 200 new patients enrolled for treatment annually in each DOTS Plus site.

Summary • Rapid expansion – nearly 90% covered; 100% by end 2005 • Case detection and treatment success meeting global targets within DOTS areas • Next 5-year plan includes, DRS and DOTS-Plus • Challenges for DOTS-Plus include laboratory capacity at State level, procurement of drugs, in-hospital care and follow-up/monitoring of patients, and a system for daily DOT

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Multiyear DOTS expansion plan for India * 31st March 2005 Total Population 1111 * Projected population based on 2001 census.

Progress Towards 70% Case Detection Target* • Estimated no. of NSP cases - 75/100,000 population per year (based on recent ARTI report)

RNTCP Treatment Regimen All treatment thrice weekly. Cat I and Cat II extended one month if smear+ at end of initial intensive phase.

RNTCP: DOTS Expansion and plans for DOTS-Plus