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Efficacy of artesunate-amodiaquine for treating uncomplicated falciparum malaria in sub-Saharan Africa: a multi-centre analysis.

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dc.contributor Shoklo Malaria Research Unit, Mae Sot, Thailand. jul@shoklo-unit.com
dc.creator Zwang, Julien
dc.creator Olliaro, Piero
dc.creator Barennes, Hubert
dc.creator Bonnet, Maryline
dc.creator Brasseur, Philippe
dc.creator Bukirwa, Hasifa
dc.creator Cohuet, Sandra
dc.creator D'Alessandro, Umberto
dc.creator Djimdé, Abdulaye
dc.creator Karema, Corine
dc.creator Guthmann, Jean-Paul
dc.creator Hamour, Sally
dc.creator Ndiaye, Jean-Louis
dc.creator Mårtensson, Andreas
dc.creator Rwagacondo, Claude
dc.creator Sagara, Issaka
dc.creator Same-Ekobo, Albert
dc.creator Sirima, Sodiomon B
dc.creator van den Broek, Ingrid
dc.creator Yeka, Adoke
dc.creator Taylor, Walter R J
dc.creator Dorsey, Grant
dc.creator Randrianarivelojosia, Milijaona
dc.date 2009-11
dc.date.accessioned 2017-01-31T07:17:10Z
dc.date.available 2017-01-31T07:17:10Z
dc.identifier Efficacy of artesunate-amodiaquine for treating uncomplicated falciparum malaria in sub-Saharan Africa: a multi-centre analysis. 2009, 8:203 Malar. J.
dc.identifier 1475-2875
dc.identifier 19698172
dc.identifier 10.1186/1475-2875-8-203
dc.identifier http://hdl.handle.net/10144/98754
dc.identifier http://fieldresearch.msf.org/msf/handle/10144/98754
dc.identifier Malaria Journal
dc.identifier.uri http://dspace.mediu.edu.my:8181/xmlui/handle/10144/98754
dc.description BACKGROUND: Artesunate and amodiaquine (AS&AQ) is at present the world's second most widely used artemisinin-based combination therapy (ACT). It was necessary to evaluate the efficacy of ACT, recently adopted by the World Health Organization (WHO) and deployed over 80 countries, in order to make an evidence-based drug policy. METHODS: An individual patient data (IPD) analysis was conducted on efficacy outcomes in 26 clinical studies in sub-Saharan Africa using the WHO protocol with similar primary and secondary endpoints. RESULTS: A total of 11,700 patients (75% under 5 years old), from 33 different sites in 16 countries were followed for 28 days. Loss to follow-up was 4.9% (575/11,700). AS&AQ was given to 5,897 patients. Of these, 82% (4,826/5,897) were included in randomized comparative trials with polymerase chain reaction (PCR) genotyping results and compared to 5,413 patients (half receiving an ACT). AS&AQ and other ACT comparators resulted in rapid clearance of fever and parasitaemia, superior to non-ACT. Using survival analysis on a modified intent-to-treat population, the Day 28 PCR-adjusted efficacy of AS&AQ was greater than 90% (the WHO cut-off) in 11/16 countries. In randomized comparative trials (n = 22), the crude efficacy of AS&AQ was 75.9% (95% CI 74.6-77.1) and the PCR-adjusted efficacy was 93.9% (95% CI 93.2-94.5). The risk (weighted by site) of failure PCR-adjusted of AS&AQ was significantly inferior to non-ACT, superior to dihydroartemisinin-piperaquine (DP, in one Ugandan site), and not different from AS+SP or AL (artemether-lumefantrine). The risk of gametocyte appearance and the carriage rate of AS&AQ was only greater in one Ugandan site compared to AL and DP, and lower compared to non-ACT (p = 0.001, for all comparisons). Anaemia recovery was not different than comparator groups, except in one site in Rwanda where the patients in the DP group had a slower recovery. CONCLUSION: AS&AQ compares well to other treatments and meets the WHO efficacy criteria for use against falciparum malaria in many, but not all, the sub-Saharan African countries where it was studied. Efficacy varies between and within countries. An IPD analysis can inform general and local treatment policies. Ongoing monitoring evaluation is required.
dc.language en
dc.rights Published by BioMed Central, [url]http://www.malariajournal.com/[/url] Archived on this site by Open Access permission
dc.title Efficacy of artesunate-amodiaquine for treating uncomplicated falciparum malaria in sub-Saharan Africa: a multi-centre analysis.

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