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Malaria Diagnostics and
Medicines
Malaria Diagnostics and
Medicines
Silvia Schwarte Diagnosis, Treatment and VaccinesGlobal Malaria Programme
WHO/UNICEF Technical Briefing SeminarEssential Medicines Policies1 November 2011 - Geneva
3 Global Malaria Programme
WHO/UNICEF TBS | 1 November 2011
Suspected malaria cases tested by microscopy or RDT
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010
Africa
Americas
Eastern Mediterranean
Europe
South-East Asia
Western Pacific
Preliminary analysis: WHO WMR 2011
Proportion of malaria cases in Africa confirmed by RDTs
4 Global Malaria Programme
WHO/UNICEF TBS | 1 November 2011
Scaling-up RDTs: The example of Senegal (2007-2009)
Suspected cases
Tested cases
Treated cases
Positive cases
5 Global Malaria Programme
WHO/UNICEF TBS | 1 November 2011
WHO product testing for malaria RDTs: Round 1 to 3 results for P. falciparum
6 Global Malaria Programme
WHO/UNICEF TBS | 1 November 2011
WHO product testing for malaria RDTs: round 1 to 3 results for P. vivax
7 Global Malaria Programme
WHO/UNICEF TBS | 1 November 2011
RDT improvement from Round 1 to Round 3 for the 23 re-submitted products
• P. falciparum– Mean PDS: 61.3 to 74.7– Median PDS: 63.1 to 83.8
• P. vivax– Mean PDS: 31.1 to 60.7– Median PDS: 30.0 to 62.9
PDS increase at 200 parasites/ml
‘Test 1’ = 2009, ‘Test 2’ = 2011
8 Global Malaria Programme
WHO/UNICEF TBS | 1 November 2011
Malaria RDT product testing: market impact and funding requirements
Response to WHO malaria RDT Product Testing Expression of Interest (EOI) in Rounds 1-4
Funding status for product testing, lot testing and recombinant antigen development
Funding securedPledge (soft)No funding secured
10 Global Malaria Programme
WHO/UNICEF TBS | 1 November 2011 (last updated February 2011)
Artesunate sulfadoxine-pyrimethamine (AS-SP)Dihydroartemisinin-piperaquine (DHA-PPQ)
Artesunate-amodiaquine (AS-AQ)Artesunate-mefloquine (AS-MQ)
Artemether-lumefantrine (AL)
Source: http://www.who.int/malaria/publications/treatment-policies/en/index.html
1st-line antimalaria treatment policies in 80 countries with CQ-resistant falciparum
malaria
DHA-PQP 1st-line treatment:
- China (or AS-AQ or other) - Cambodia (specific areas) - Ghana (or AL or AS-AQ) - Nigeria (or AL or AS-AQ) - Indonesia - Myanmar (or AL or AS-MQ) - Viet Nam
11 Global Malaria Programme
WHO/UNICEF TBS | 1 November 2011
0.5 0.6 2.1 5
31.3
82.7
97
130
165
182
0
50
100
150
200
2001 2002 2003 2004 2005 2006 2007 2008 2009 2010
0
10
20
30
40
50
60
70
80
ACT procured No countries: ACT 1st line No countries deploying
6-24 months from adoption to implementation6-24 months from adoption to implementation
Mil
lio
ns
of
AC
T t
reat
men
t c
ou
rses
Cu
mu
lati
ve n
um
ber
of
cou
ntr
ies
WHO policy on ACTsWHO policy on ACTs
GF appeal GF appeal on ACTson ACTs
GF appeal GF appeal on ACTson ACTs
701.2 million ACT treatment courses supplied
for public sector use up to 2010 9.1 million treatment courses of DHA-PQP in 2007-10
Supply shortageSupply
shortage
12 Global Malaria Programme
WHO/UNICEF TBS | 1 November 2011
Tightening relation between global ACT supply and demand
Warning signsWarning signs since July 2011: • Longer lead times for ACT orders, i.e. >> 2-4 months• Limited capacity of major ACT manufacturers to accept
additional large orders for delivery in 2011• Increased price of artemisinin on the “spot” marketContributing factorsContributing factors::• Increased volume and number of ACT orders from First-Line-
Buyers to AMFm in May - June 2011 ("levers" recently introduced) Total orders confirmed:
135.7 million (as of 29.6.11)
14 Global Malaria Programme
WHO/UNICEF TBS | 1 November 2011
Malaria Vaccine (I)RTS,S/AS01 Phase 3 Trial ongoing enrolling over 15,000 African
infants
RTS,S/AS01
– RT: Malaria protein (Segment of P. falciparum sporozoite surface protein)
– S,S: Hepatitis B protein – AS01: Adjuvant system 01 (most potent of many adjuvants
tested)
• Developed by GSK with funding from BMGF through PATH Malaria Vaccine Initiative (MVI)
• Phase 2 data shows 40-60% efficacy over up to 18 months against clinical malaria in 2 recent field trials
• Currently in Phase 3 trials, at least 5 years ahead of other candidates
• WHO Malaria Vaccine Technical Expert Group constituted in 2009, joint between Vaccine and Malaria Departments (JTEG)
15 Global Malaria Programme
WHO/UNICEF TBS | 1 November 2011
Malaria Vaccine (II) Timing for WHO policy recommendations
• First interim data became publicly available on 18 Oct 2011 (NEJM), in a non-target population (5-17 months olds without co-administration of other EPI vaccines): these data will not lead to WHO policy recommendation.
• JTEG has advised WHO to base policy recommendation on the review of:
– full Phase 3 data in the target population (infants 6 weeks old at first vaccination in co-administration with EPI vaccines) with 30 months follow-up,
– site-specific clinical malaria efficacy, – severe malaria efficacy, and – impact of booster dose at 18 months.
• WHO policy recommendation may occur in 2015, if Phase 3 data supports it. Policy-makers should be aware that WHO has defined its policy process and does not expect a policy recommendation before 2015 for RTS,S/AS01.
• For specific queries contact Dr Vasee Moorthy (e-mail: [email protected])