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dc.contributor.authorMarie A. Onyambokoen_US
dc.contributor.authorRichard M. Hoglunden_US
dc.contributor.authorSue J. Leeen_US
dc.contributor.authorCharlie Kabedien_US
dc.contributor.authorDaddy Kayembeen_US
dc.contributor.authorBenjamin B. Badjangaen_US
dc.contributor.authorGareth D.H. Turneren_US
dc.contributor.authorNikky V. Jacksonen_US
dc.contributor.authorJoel Tarningen_US
dc.contributor.authorRose McGreadyen_US
dc.contributor.authorFrancois Nostenen_US
dc.contributor.authorNicholas J. Whiteen_US
dc.contributor.authorNicholas P.J. Dayen_US
dc.contributor.authorCaterina Fanelloen_US
dc.contributor.otherUniversite de Kinshasaen_US
dc.contributor.otherNHS Foundation Trusten_US
dc.contributor.otherUniversity of Oxforden_US
dc.contributor.otherMahidol Universityen_US
dc.contributor.otherNuffield Department of Clinical Medicineen_US
dc.identifier.citationAntimicrobial Agents and Chemotherapy. Vol.64, No.3 (2020)en_US
dc.description.abstractCopyright © 2020 Onyamboko et al. Artemether-lumefantrine antimalarial efficacy in pregnancy could be compromised by reduced drug exposure. Population-based simulations suggested that therapeutic efficacy would be improved if the treatment duration was increased. We assessed the efficacy, tolerability, and pharmacokinetics of an extended 5-day regimen of artemether-lumefantrine compared to the standard 3-day treatment in 48 pregnant women and 48 nonpregnant women with uncomplicated falciparum malaria in an open-label, randomized clinical trial. Babies were assessed at birth and 1, 3, 6, and 12 months. Nonlinear mixed-effects modeling was used to characterize the plasma concentration-time profiles of artemether and lumefantrine and their metabolites. Both regimens were highly efficacious (100% PCR-corrected cure rates) and well tolerated. Babies followed up to 1 year had normal development. Parasite clearance half-lives were longer in pregnant women (median [range], 3.30 h [1.39 to 7.83 h]) than in nonpregnant women (2.43 h [1.05 to 6.00 h]) (P=0.005). Pregnant women had lower exposures to artemether and dihydroartemisinin than nonpregnant women, resulting in 1.2% decreased exposure for each additional week of gestational age. By term, these exposures were reduced by 48% compared to nonpregnant patients. The overall exposure to lumefantrine was improved with the extended regimen, with no significant differences in exposures to lumefantrine or desbutyl-lumefantrine between pregnant and nonpregnant women. The extended artemether-lumefantrine regimen was well tolerated and safe and increased the overall antimalarial drug exposure and so could be a promising treatment option in pregnancy in areas with lower rates of malaria transmission and/or emerging drug resistance.en_US
dc.rightsMahidol Universityen_US
dc.subjectPharmacology, Toxicology and Pharmaceuticsen_US
dc.titleA randomized controlled trial of three-versus five-day artemether-lumefantrine regimens for treatment of uncomplicated Plasmodium falciparum Malaria in Pregnancy in Africaen_US
Appears in Collections:Scopus 2020

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