JaramilloE_DOTSPLUS []

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Management of drug resistant TB
and the need of TB laboratory strengthening
4th Meeting of Subgroup on laboratory capacity strengthening
Paris, France, October 23-24
Ernesto Jaramillo
Oct 2005
World Health Organization
WHO/STB/THD
1
MDR TB Burden Among All Cases by Regions
MDR TB cases
260,000
% MDR TB
240,000
No.MDR cases
26%
% MDR TB
24%
220,000
22%
200,000
20%
180,000
18%
160,000
16%
140,000
14%
120,000
12%
100,000
10%
80,000
8%
WHO/STB/THD
Western Pacific
Region
Oct 2005
South-east Asia
0%
Africa high HIV
incidence
0
Africa low HIV
incidence
2%
Eastern
Mediterranean
Region
20,000
Latin America
4%
Eastern Europe
40,000
Central Europe
6%
Established
Market Economies
60,000
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All MDR TB Cases by Regions
Africa low HIV
incidence, 9,629
Established Market
Economies, 1,607
Central Europe, 858
Latin America,
11,129
Eastern
Mediterranean
Region, 19,582
Western Pacific
Region, 172,465
Africa high HIV
incidence, 40,938
Global burden:
458,359 cases
Eastern Europe,
60,214
South-east Asia,
141,936
Oct 2005
WHO/STB/THD
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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).
Oct 2005
WHO/STB/THD
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Response to MDR-TB by linking concepts
ACCESS
Price & quality
GLC
RATIONAL
USE OF
DRUGS
mechanism
POLICY
FOR TB
CONTROL
Oct 2005
WHO/STB/THD
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Advantages of applying to the WHO GLC mechanism
Oct 2005

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
WHO/STB/THD
6
WHO-GLC approved DOTS-Plus projects
by October 2005 (in 29 countries)
GLC-approved DOTS-Plus projects
Oct 2005
WHO/STB/THD
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
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Scaling up of DOTS-Plus through the GLC
40
Projects approved
October 2005 – 35 projects
12,500 patients
35
30
25
20
15
10
5
0
2000
Oct 2005
2001
2002
2003
WHO/STB/THD
2004
2005
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Preliminary results of DOTS-Plus projects




Oct 2005
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 linedrugs 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
WHO/STB/THD
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Preliminary results of DOTS-Plus projects
 DOTS:
quality standards, consolidation and expansion
 Training
of human resources for management of drug resistant TB
 Laboratory
 Size
capacity strengthened
and quality of market of second-line TB drugs
 Commitment
Oct 2005
of GFATM to fund management of drug resistant TB
WHO/STB/THD
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New Guidelines on management of drug resistant TB
As in most programs failures of a category 1 regimen are at increased risk of having MDRTB 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
Oct 2005
WHO/STB/THD
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WHO 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
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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
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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

Oct 2005
CAN THIS SUBGROUP HELP?
WHO/STB/THD
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