Malaria journal · 2025
Therapeutic efficacy of artemether-lumefantrine and molecular markers of antimalarial resistance in Niger, 2022.
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Laminou Ibrahim Maman, Kabirou Sanoussi Maman, Arzika Ibrahima Issa, Yahaya Abdou, Ahmed Jehan, Deme Awa Bineta, Diallo Mamadou Alpha, Ngom Bassirou, Gaye Amy, Sene Aïta, Sow Djiby, Coulibaly Eric, Bahari-Tohon Zilahatou, Sanoussi Elisha, Koko Daniel, Cavros Irene
Аннотация
BACKGROUND: From August to October 2022, a therapeutic efficacy study of Niger's first-line antimalarial, artemether-lumefantrine (AL), was conducted in four sites (Aderbissinat, Boboye, Aguié, and Baban Tabki) to evaluate its therapeutic efficacy and investigate for molecular markers of antimalarial drug resistance.
METHODS: Children aged 5 to 15 years old with uncomplicated malaria were assessed in a 28 day in vivo efficacy study. Genotyping using three markers (msp1, msp2 and the PolyA microsatellite) and match counting using the WHO three-out-of-three algorithm, were used to distinguish recrudescences from new infections. A two-out-of-three algorithm was also utilized as a sensitivity analysis.
RESULTS: PCR uncorrected and corrected efficacy results at day 28 were calculated. Resistance markers were analysed by next-generation sequencing. Uncorrected treatment efficacies were 62.0% (95% CI 54-74) in Aderbissinat, 95.4% (95% CI 91-100) in Aguié, 98.7% (95% CI 96-100) in Boboye, and 50.6% (95% CI 42-62) in Baban Tabki. After PCR correction, AL efficacy was 100%, 97.5%, 100%, and 93.5%, respectively. Marker analysis revealed a high prevalence of S108N, C59R, and N51I mutations in the pfdhfr gene, and S436A and A437G mutations in the pfdhps gene. No validated or candidate pfkelch13 mutations were observed.
CONCLUSION: In all four sites evaluated, AL retains therapeutic efficacies above the 90% WHO-recommended threshold using the primary three-out-of-three match criteria. In Aguié and Baban Tabki, efficacy remained above the threshold with certain match criteria and statistical approaches but fell below the cutoff using two-out-of-three matching and per-protocol methods, suggesting emerging efficacy concerns in southern parts of the country.
METHODS: Children aged 5 to 15 years old with uncomplicated malaria were assessed in a 28 day in vivo efficacy study. Genotyping using three markers (msp1, msp2 and the PolyA microsatellite) and match counting using the WHO three-out-of-three algorithm, were used to distinguish recrudescences from new infections. A two-out-of-three algorithm was also utilized as a sensitivity analysis.
RESULTS: PCR uncorrected and corrected efficacy results at day 28 were calculated. Resistance markers were analysed by next-generation sequencing. Uncorrected treatment efficacies were 62.0% (95% CI 54-74) in Aderbissinat, 95.4% (95% CI 91-100) in Aguié, 98.7% (95% CI 96-100) in Boboye, and 50.6% (95% CI 42-62) in Baban Tabki. After PCR correction, AL efficacy was 100%, 97.5%, 100%, and 93.5%, respectively. Marker analysis revealed a high prevalence of S108N, C59R, and N51I mutations in the pfdhfr gene, and S436A and A437G mutations in the pfdhps gene. No validated or candidate pfkelch13 mutations were observed.
CONCLUSION: In all four sites evaluated, AL retains therapeutic efficacies above the 90% WHO-recommended threshold using the primary three-out-of-three match criteria. In Aguié and Baban Tabki, efficacy remained above the threshold with certain match criteria and statistical approaches but fell below the cutoff using two-out-of-three matching and per-protocol methods, suggesting emerging efficacy concerns in southern parts of the country.