1 Oct 2005 WHO/STB/THD World Health Organization 4 th Meeting of Subgroup on laboratory capacity strengthening Paris, France, October Ernesto Jaramillo Management of drug resistant TB and the need of TB laboratory strengthening

2 Oct 2005 WHO/STB/THD 26% 24% 22% 20% 18% 16% 14% 12% 10% 8% 6% 4% 2% 0% MDR TB Burden Among All Cases by Regions % MDR TBMDR TB cases

3 Oct 2005 WHO/STB/THD All MDR TB Cases by Regions Global burden: 458,359 cases

4 Oct 2005 WHO/STB/THD The WHO ‘Green Light Committee’ mechanism The mechanism of WHO and its partners of the Stop TB Partnership to enabling access to second-line anti-TB drugs in low- and middle-income countries to treat multidrug resistant tuberculosis under programmatic conditions and following specific guidelines ( Guidelines for management of drug resistant tuberculosis ).

5 Oct 2005 WHO/STB/THD Response to MDR-TB by linking concepts GLCmechanism ACCESS Price & quality RATIONAL USE OF DRUGS POLICY FOR TB CONTROL

6 Oct 2005 WHO/STB/THD Advantages of applying to the WHO GLC mechanism l Access to quality-assured drugs l Access to low-cost drugs l Access to a continuous drug supply l Access to technical assistance l Access to an external monitoring mechanism l Increased rational use of drugs l Creation of wide evidence base for policy development l Ensures consolidation of DOTS as the strategy to control TB

7 Oct 2005 WHO/STB/THD WHO-GLC approved DOTS-Plus projects by October 2005 (in 29 countries) GLC-approved DOTS-Plus projects Abkhazia Azerbaijan Bolivia Costa Rica Dominican Rep Egypt El Salvador Estonia Georgia Haiti Honduras India Jordan Kenya Kyrgyzstan Latvia Lebanon Malawi Mexico Moldova Nepal Nicaragua Peru Philippines Romania Russia Syria Tunisia Uzbekistan

8 Oct 2005 WHO/STB/THD Scaling up of DOTS-Plus through the GLC October 2005 – 35 projects 12,500 patients

9 Oct 2005 WHO/STB/THD Preliminary results of DOTS-Plus projects l 12,500 have been approved for enrolment; around 6,000 patients have been enrolled and 1,300 have completed treatment l 57% of the MDR-TB cases treated are resistant to all first line- drugs and also to second-line anti-TB drugs l Treatment success rates range from 61-82% l Only 2% of patients have stopped treatment due to adverse events

10 Oct 2005 WHO/STB/THD Preliminary results of DOTS-Plus projects l DOTS: quality standards, consolidation and expansion l Training of human resources for management of drug resistant TB l Laboratory capacity strengthened l Size and quality of market of second-line TB drugs l Commitment of GFATM to fund management of drug resistant TB

11 Oct 2005 WHO/STB/THD New Guidelines on management of drug resistant TB As in most programs failures of a category 1 regimen are at increased risk of having MDR- TB and because the category 2 regimen has poor results in MDR-TB (and may result in amplification of drug-resistance):  Countries should get representative DRS results for the different retreatment categories, with focus on failure cases  Patients at high risk of/with MDR-TB should receive a category 4 regimen  The introduction of category IV regimens should be limited to well performing DOTS programs which meet all DOTS-Plus framework requirements (quality assured lab, rational treatment design, human and financial resources, etc)  Countries should use category 2 regimens until they have built appropriate capacity for management of drug resistance TB

12 Oct 2005 WHO/STB/THD WHO position and its partners on MDR-TB l DOTS implementation is a priority to stop MDR-TB creation l Management of MDR-TB being mainstreamed into DOTS expansion strategic plans: sound TB control encompasses adequate management of retreatment and chronic cases, and not only new cases l MDR-TB properly addressed in all countries, with drugs accessible and well managed l WHO assistance for countries to benefit from GFATM financial support for MDR-TB

13 Oct 2005 WHO/STB/THD Main barriers to manage drug resistant TB l Poor integration of the MDR-TB control activities in the structure of the NTP l Lack of registration of quality-assured second-line TB drugs l Poor understanding of drug side effects, its prevention, detection and management l Poor TB laboratory capacity and/or performance (quality control/assurance for smear/culture/DST) l Absence of, or limited data on basic epidemiology of drug resistance l Lack of experience in managing second-line drugs to treat MDR-TB under programmatic conditions l Inadequate facilities to hospitalize and/or treat MDR-TB patients l Poor capacity to deliver social support to facilitate adherence to treatment

14 Oct 2005 WHO/STB/THD Main barriers to manage drug resistant TB l Poor TB laboratory capacity and/or performance at country level: – quality control and quality assurance for Smear Culture DST – All them essential to establish situation of drug resistance in a country; and to diagnose and monitor treatment response in drug resistant TB l Limited capacity of SNRLs to assist NRL to meet needs for managing drug resistant TB l CAN THIS SUBGROUP HELP?