Abstract
BackgroundThe World Health Organization recommends regularly assessing the efficacy of artemisinin-based combination therapy (ACT), which is a critical tool in the fight against malaria. This study evaluated the efficacy of two artemisinin-based combinations recommended to treat uncomplicated Plasmodium falciparum malaria in Burkina Faso in three sites: Niangoloko, Nanoro, and Gourcy.MethodsThis was a two-arm randomized control trial of the efficacy of artemether-lumefantrine (AL) and dihydroartemisinin-piperaquine (DP). Children aged 6–59 months old were monitored for 42 days. The primary outcomes of the study were uncorrected and PCR-corrected efficacies to day 28 for AL and 42 for DP. Molecular markers of resistance to artemisinin derivatives and partner drugs were also analysed.ResultsOf 720 children enrolled, 672 reached study endpoints at day 28, 333 in the AL arm and 339 in the DP arm. PCR-corrected 28-day per protocol efficacy in the AL arm was 74% (64–83%) in Nanoro, 76% (66–83%) in Gourcy, and 92% (84–96%) in Niangoloko. The PCR-corrected 42-day per protocol efficacy in the DP arm was 84% (75–89%) in Gourcy, 89% (81–94%) in Nanoro, and 97% (92–99%) in Niangoloko.No Pfk13 mutation previously associated with artemisinin-resistance was observed. No statistically significant association was found between treatment outcome and presence of the 86Y mutation in the Pfmdr1 gene. There was also no association observed between treatment outcome and Pfpm2 or Pfmdr1 copy number variation.ConclusionThe results of this study indicate evidence of inadequate efficacy of AL at day 28 and DP at day 42 in the same two sites. A change of first-line ACT may be warranted in Burkina Faso.Trial Registry Pan African Clinical Trial Registry Identifier: PACTR201708002499311.Date of registration: 8/3/2017https://pactr.samrc.ac.za/Search.aspx
Highlights
The World Health Organization recommends regularly assessing the efficacy of artemisinin-based combination therapy (ACT), which is a critical tool in the fight against malaria
A change of first-line ACT may be warranted in Burkina Faso
In the AL arm the 28-day PCRcorrected ACPR rates were below 80% in two of the three sites (Nanoro and Gourcy), indicating inadequate efficacy of this ACT
Summary
The World Health Organization recommends regularly assessing the efficacy of artemisinin-based combination therapy (ACT), which is a critical tool in the fight against malaria. This study evaluated the efficacy of two artemisinin-based combinations recommended to treat uncomplicated Plasmodium falciparum malaria in Burkina Faso in three sites: Niangoloko, Nanoro, and Gourcy. In 2005, after the decline in efficacy of chloroquine [4,5,6], artemisinin-based combination therapy (ACT) (artemether-lumefantrine [AL] and artesunate-amodiaquine [ASAQ]) was adopted as the first-line treatment for uncomplicated malaria, but only became available 2 years later [7]. Starting in 2014, the use of ASAQ at public facilities was gradually discontinued as recommended by WHO for areas where seasonal malaria chemoprevention with amodiaquine plus sulfadoxine-pyrimethamine is implemented [8]. Dihydroartemisinin-piperaquine (DP) was added as an additional first-line option in 2017 [9]
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