In vivo efficacy and safety of artemether–lumefantrine and amodiaquine–artesunate for uncomplicated Plasmodium falciparum malaria in Mozambique, 2018

Malaria Journal

Abel Nhama¹  Eusébio Macete¹  Pedro Aide¹  Arlindo Chidimatembue¹  Lídia Nhamússua¹  Alfredo Mayor¹  Quique Bassat¹  Arsénio Nhacolo¹  Crizolgo Salvador²  Sónia Enosse²  Samaly S. Svigel³  Naomi Lucchi³  Leah F. Moriarty³  Eric S. Halsey³  Baltazar Candrinho⁴  Rose Zulliger⁵  Abuchahama Saifodine⁶  Eva Carvalho⁷ 

[1] Centro de Investigação em Saúde de Manhiça (CISM);Instituto Nacional de Saúde (INS), Ministério da Saúde;Malaria Branch, Centers for Disease Control and Prevention;Programa Nacional de Controlo da Malária, Ministério da Saúde;United States President’s Malaria Initiative, Centers for Disease Control and Prevention;United States President’s Malaria Initiative, United States Agency for International Development;World Health Organization, WHO Country Office Maputo;

关键词: Efficacy;    Artemether–lumefantrine;    Artesunate–amodiaquine;    Uncomplicated malaria;    Children;    Mozambique;   

DOI  :  10.1186/s12936-021-03922-9

来源: DOAJ

【 摘 要 】

Abstract Background Artemisinin-based combination therapy (ACT) has been the recommended first-line treatment for uncomplicated malaria in Mozambique since 2006, with artemether–lumefantrine (AL) and amodiaquine–artesunate (AS–AQ) as the first choice. To assess efficacy of currently used ACT, an in vivo therapeutic efficacy study was conducted. Methods The study was conducted in four sentinel sites: Montepuez, Moatize, Mopeia and Massinga. Patients between 6 and 59 months old with uncomplicated Plasmodium falciparum malaria (2000–200,000 parasites/µl) were enrolled between February and September of 2018, assigned to either an AL or AS–AQ treatment arm, and monitored for 28 days. A Bayesian algorithm was applied to differentiate recrudescence from new infection using genotyping data of seven neutral microsatellites. Uncorrected and PCR-corrected efficacy results at day 28 were calculated. Results Totals of 368 and 273 patients were enrolled in the AL and AS–AQ arms, respectively. Of these, 9.5% (35/368) and 5.1% (14/273) were lost to follow-up in the AL and AS–AQ arms, respectively. There were 48 and 3 recurrent malaria infections (late clinical and late parasitological failures) in the AL and AS–AQ arms, respectively. The day 28 uncorrected efficacy was 85.6% (95% confidence interval (CI) 81.3–89.2%) for AL and 98.8% (95% CI 96.7–99.8%) for AS–AQ, whereas day 28 PCR-corrected efficacy was 97.9% (95% CI 95.6–99.2%) for AL and 99.6% (95% CI 97.9–100%) for AS–AQ. Molecular testing confirmed that 87.4% (42/48) and 33.3% (1/3) of participants with a recurrent malaria infection in the AL and AS–AQ arms were new infections; an expected finding in a high malaria transmission area. Adverse events were documented in less than 2% of participants for both drugs. Conclusion Both AL and AS–AQ have therapeutic efficacies well above the 90% WHO recommended threshold and remain well-tolerated in Mozambique. Routine monitoring of therapeutic efficacy should continue to ensure the treatments remain efficacious. Trial registration Clinicaltrials.gov: NCT04370977

【 授权许可】

Unknown