Abstract
BackgroundAnti-malarial resistance is a threat to recent gains in malaria control. This study aimed to assess the efficacy and safety of artesunate–amodiaquine (ASAQ) and artemether–lumefantrine (AL) in the management of uncomplicated malaria and to measure the prevalence of molecular markers of resistance of Plasmodium falciparum in sentinel sites in Maferinyah and Labé Health Districts in Guinea in 2016.MethodsThis was a two-arm randomised controlled trial of the efficacy of AL and ASAQ among children aged 6–59 months with uncomplicated Plasmodium falciparum malaria in two sites. Children were followed for 28 days to assess clinical and parasitological response. The primary outcome was the Kaplan–Meier estimate of Day 28 (D28) efficacy after correction by microsatellite-genotyping. Pre-treatment (D0) and day of failure samples were assayed for molecular markers of resistance in the pfk13 and pfmdr1 genes.ResultsA total of 421 participants were included with 211 participants in the Maferinyah site and 210 in Labé. No early treatment failure was observed in any study arms. However, 22 (5.3%) participants developed a late treatment failure (8 in the ASAQ arm and 14 in the AL arm), which were further classified as 2 recrudescences and 20 reinfections. The Kaplan–Meier estimate of the corrected efficacy at D28 was 100% for both AL and ASAQ in Maferinyah site and 99% (95% Confidence Interval: 97.2–100%) for ASAQ and 99% (97.1–100%) for AL in Labé. The majority of successfully analysed D0 (98%, 380/389) and all day of failure (100%, 22/22) samples were wild type for pfk13. All 9 observed pfk13 mutations were polymorphisms not associated with artemisinin resistance. The NFD haplotype was the predominant haplotype in both D0 (197/362, 54%) and day of failure samples (11/18, 61%) successfully analysed for pfmdr1.ConclusionThis study observed high efficacy and safety of both ASAQ and AL in Guinea, providing evidence for their continued use to treat uncomplicated malaria. Continued monitoring of ACT efficacy and safety and molecular makers of resistance in Guinea is important to detect emergence of parasite resistance and to inform evidence-based malaria treatment policies.
Highlights
Anti-malarial resistance is a threat to recent gains in malaria control
Molecular markers of resistance Deoxyribonucleic acid (DNA) was isolated from 443 samples, including 421 pretreatment and 22 day-of-late treatment failure samples
All 9 observed pfk13 mutations were polymorphisms that have not been associated with artemisinin resistance
Summary
Anti-malarial resistance is a threat to recent gains in malaria control. This study aimed to assess the efficacy and safety of artesunate–amodiaquine (ASAQ) and artemether–lumefantrine (AL) in the management of uncomplicated malaria and to measure the prevalence of molecular markers of resistance of Plasmodium falciparum in sentinel sites in Maferinyah and Labé Health Districts in Guinea in 2016. Progress in providing effective treatment of malaria is facing challenges including parasite resistance to anti-malarial drugs, in South East Asia [5]. In response to these major threats, the World Health Organization (WHO) recommends periodic surveillance of anti-malarial first- and second-line treatment efficacy to provide data to national programmes for evidencebased malarial treatment policies [6]. This strategy is based on assessing both clinical and biological parameters along with analysis of molecular makers of resistance [4]
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