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

Autor: Nhama A; Centro de Investigação em Saúde de Manhiça (CISM), Maputo, Mozambique.; Instituto Nacional de Saúde (INS), Ministério da Saúde, Maputo, Mozambique., Nhamússua L; Centro de Investigação em Saúde de Manhiça (CISM), Maputo, Mozambique., Macete E; Centro de Investigação em Saúde de Manhiça (CISM), Maputo, Mozambique.; Direção Nacional de Saúde Pública, Ministério da Saúde, Maputo, Mozambique., Bassat Q; Centro de Investigação em Saúde de Manhiça (CISM), Maputo, Mozambique.; Barcelona Institute for Global Health (ISGlobal), Hospital Clínic - Universitat de Barcelona, Barcelona, Spain.; ICREA, Pg. Lluís Companys 23, 08010, Barcelona, Spain.; Pediatric Infectious Diseases Unit, Pediatrics Department, Hospital Sant Joan de Déu (University of Barcelona), Barcelona, Spain.; Consorcio de Investigación Biomédica en Red de Epidemiología y Salud Pública (CIBERESP), Madrid, Spain., Salvador C; Instituto Nacional de Saúde (INS), Ministério da Saúde, Maputo, Mozambique., Enosse S; Instituto Nacional de Saúde (INS), Ministério da Saúde, Maputo, Mozambique., Candrinho B; Programa Nacional de Controlo da Malária, Ministério da Saúde, Maputo, Mozambique., Carvalho E; World Health Organization, WHO Country Office Maputo, Maputo, Mozambique., Nhacolo A; Centro de Investigação em Saúde de Manhiça (CISM), Maputo, Mozambique., Chidimatembue A; Centro de Investigação em Saúde de Manhiça (CISM), Maputo, Mozambique., Saifodine A; United States President's Malaria Initiative, United States Agency for International Development, Maputo, Mozambique., Zulliger R; United States President's Malaria Initiative, Centers for Disease Control and Prevention, Maputo, Mozambique., Lucchi N; Malaria Branch, Centers for Disease Control and Prevention, Atlanta, GA, USA., Svigel SS; Malaria Branch, Centers for Disease Control and Prevention, Atlanta, GA, USA., Moriarty LF; Malaria Branch, Centers for Disease Control and Prevention, Atlanta, GA, USA.; United States President's Malaria Initiative, Atlanta, GA, USA., Halsey ES; Malaria Branch, Centers for Disease Control and Prevention, Atlanta, GA, USA.; United States President's Malaria Initiative, Atlanta, GA, USA., Mayor A; Centro de Investigação em Saúde de Manhiça (CISM), Maputo, Mozambique.; Barcelona Institute for Global Health (ISGlobal), Hospital Clínic - Universitat de Barcelona, Barcelona, Spain.; Consorcio de Investigación Biomédica en Red de Epidemiología y Salud Pública (CIBERESP), Madrid, Spain., Aide P; Centro de Investigação em Saúde de Manhiça (CISM), Maputo, Mozambique. pedro.aide@manhica.net.; Instituto Nacional de Saúde (INS), Ministério da Saúde, Maputo, Mozambique. pedro.aide@manhica.net.
Jazyk: angličtina
Zdroj: Malaria journal [Malar J] 2021 Oct 02; Vol. 20 (1), pp. 390. Date of Electronic Publication: 2021 Oct 02.
DOI: 10.1186/s12936-021-03922-9
Abstrakt: 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.
(© 2021. The Author(s).)
Databáze: MEDLINE
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