Oct 2005 WHO/STB/THD 1World Health Organization

44thth Meeting of Subgroup on laboratory capacity strengthening Meeting of Subgroup on laboratory capacity strengthening Paris, France, October 23-24Paris, France, October 23-24

Ernesto JaramilloErnesto Jaramillo

Management of drug resistant TBManagement of drug resistant TBand the need of TB laboratory strengtheningand the need of TB laboratory strengthening

Oct 2005 WHO/STB/THD 2

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No.MDR cases

% MDR TB26%

24%

22%

20%

18%

16%

14%

12%

10%

8%

6%

4%

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MDR TB Burden Among All Cases by RegionsMDR TB Burden Among All Cases by Regions

% MDR TBMDR TB cases

Oct 2005 WHO/STB/THD 3

All MDR TB Cases by RegionsAll MDR TB Cases by Regions

Eastern Europe, 60,214

Africa high HIV incidence, 40,938

Latin America, 11,129

Eastern Mediterranean

Region, 19,582

Central Europe, 858

Established Market Economies, 1,607

South-east Asia, 141,936

Western Pacific Region, 172,465

Africa low HIV incidence, 9,629

Global burden:Global burden:458,359 cases458,359 cases

Oct 2005 WHO/STB/THD 4

The WHO ‘Green Light Committee’ mechanismThe 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).

Oct 2005 WHO/STB/THD 5

Response to MDR-TB by linking conceptsResponse to MDR-TB by linking concepts

GLCGLCmechanismmechanism

ACCESSACCESSPrice & qualityPrice & quality

RATIONAL RATIONAL USE OF USE OF DRUGSDRUGS

POLICY POLICY FOR TB FOR TB

CONTROLCONTROL

Oct 2005 WHO/STB/THD 6

Advantages of applying to the WHO GLC mechanismAdvantages of applying to the WHO GLC mechanism

Access to quality-assured drugs

Access to low-cost drugs

Access to a continuous drug supply

Access to technical assistance

Access to an external monitoring mechanism

Increased rational use of drugs

Creation of wide evidence base for policy development

Ensures consolidation of DOTS as the strategy to control TB

Oct 2005 WHO/STB/THD 7

WHO-GLC approved DOTS-Plus projects WHO-GLC approved DOTS-Plus projects by October 2005 (in 29 countries)by October 2005 (in 29 countries)

GLC-approved DOTS-Plus projectsGLC-approved DOTS-Plus projects

Abkhazia AzerbaijanBoliviaCosta RicaDominican RepEgyptEl Salvador Estonia GeorgiaHaitiHondurasIndiaJordan Kenya KyrgyzstanLatvia LebanonMalawiMexicoMoldova NepalNicaraguaPeruPhilippinesRomaniaRussia SyriaTunisiaUzbekistan

Oct 2005 WHO/STB/THD 8

Scaling up of DOTS-Plus through the GLC Scaling up of DOTS-Plus through the GLC

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2000 2001 2002 2003 2004 2005

Projects approved October 2005 – 35 projects12,500 patients

Oct 2005 WHO/STB/THD 9

Preliminary results of DOTS-Plus projectsPreliminary results of DOTS-Plus projects

12,500 have been approved for enrolment; around 6,000 patients have been enrolled and 1,300 have completed treatment

57% of the MDR-TB cases treated are resistant to all first line-drugs and also to second-line anti-TB drugs

Treatment success rates range from 61-82% Only 2% of patients have stopped treatment due to

adverse events

Oct 2005 WHO/STB/THD 10

Preliminary results of DOTS-Plus projectsPreliminary results of DOTS-Plus projects

DOTS: quality standards, consolidation and expansion

Training of human resources for management of drug resistant TB

Laboratory capacity strengthened

Size and quality of market of second-line TB drugs

Commitment of GFATM to fund management of drug resistant TB

Oct 2005 WHO/STB/THD 11

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 regimenThe 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

Oct 2005 WHO/STB/THD 12

WHO position and its partners on MDR-TBWHO position and its partners on MDR-TB

DOTS implementation is a priority to stop MDR-TB creation

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

MDR-TB properly addressed in all countries, with drugs accessible and well managed

WHO assistance for countries to benefit from GFATM financial support for MDR-TB

Oct 2005 WHO/STB/THD 13

Main barriers to manage drug resistant TB Main barriers to manage drug resistant TB

Poor integration of the MDR-TB control activities in the structure of the NTP Lack of registration of quality-assured second-line TB drugs Poor understanding of drug side effects, its prevention, detection and management Poor TB laboratory capacity and/or performance (quality control/assurance for

smear/culture/DST)

Absence of, or limited data on basic epidemiology of drug resistance

Lack of experience in managing second-line drugs to treat MDR-TB under programmatic conditions

Inadequate facilities to hospitalize and/or treat MDR-TB patients Poor capacity to deliver social support to facilitate adherence to treatment

Oct 2005 WHO/STB/THD 14

Main barriers to manage drug resistant TB Main barriers to manage drug resistant TB

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

Limited capacity of SNRLs to assist NRL to meet needs for managing drug

resistant TB

CAN THIS SUBGROUP HELP?