Safety and tolerability of moxidectin and ivermectin combination treatments for lymphatic filariasis in Côte d'Ivoire: A randomized controlled superiority study.

Autor: Bjerum CM; Center for Global Health and Diseases, Case Western Reserve University School of Medicine, Cleveland, Ohio, United States of America., Koudou BG; Université Nangui Abrogoua, Abidjan, Côte d'Ivoire.; Centre Suisse de Recherche Scientifique en Côte d'Ivoire, Abidjan, Côte d'Ivoire., Ouattara AF; Université Nangui Abrogoua, Abidjan, Côte d'Ivoire.; Centre Suisse de Recherche Scientifique en Côte d'Ivoire, Abidjan, Côte d'Ivoire., Lew D; Division of Biostatistics, Washington University School of Medicine, St. Louis, Missouri, United States of America., Goss CW; Division of Biostatistics, Washington University School of Medicine, St. Louis, Missouri, United States of America., Gabo PT; Centre Hospitalier Régional d'Agboville, Agboville, Côte d'Ivoire., King CL; Center for Global Health and Diseases, Case Western Reserve University School of Medicine, Cleveland, Ohio, United States of America.; Veterans Affairs Research Service, Cleveland Veterans Affairs Medical Center, Cleveland, Ohio, United States of America., Fischer PU; Infectious Diseases Division, Department of Medicine, Washington University School of Medicine, St. Louis, Missouri, United States of America., Weil GJ; Infectious Diseases Division, Department of Medicine, Washington University School of Medicine, St. Louis, Missouri, United States of America., Budge PJ; Infectious Diseases Division, Department of Medicine, Washington University School of Medicine, St. Louis, Missouri, United States of America.
Jazyk: angličtina
Zdroj: PLoS neglected tropical diseases [PLoS Negl Trop Dis] 2023 Sep 18; Vol. 17 (9), pp. e0011633. Date of Electronic Publication: 2023 Sep 18 (Print Publication: 2023).
DOI: 10.1371/journal.pntd.0011633
Abstrakt: Background: Moxidectin is a macrocyclic lactone registered for the treatment of human onchocerciasis. The drug has a good safety profile, large volume of distribution and a long elimination half-life. This paper reports tolerability data from the first use of moxidectin in persons with Wuchereria bancrofti infection.
Methods: In this randomized, open-label, masked-observer superiority trial, adults with Wuchereria bancrofti microfilaremia in Côte d'Ivoire were randomized to 1 of 4 treatment arms: ivermectin + albendazole (IA), moxidectin + albendazole (MoxA), ivermectin + diethylcarbamazine (DEC) + albendazole (IDA), or moxidectin + DEC + albendazole (MoxDA). As part of a larger efficacy trial, all participants were closely monitored for 7 days after treatment.
Results: One hundred sixty-four individuals were treated, and monitored for treatment emergent adverse events (TEAE). Eighty-seven participants (53%) experienced one or more mild (grade 1) or moderate (grade 2) TEAE. Four participants had transient Grade 3 hematuria after treatment (3 after IDA and 1 after IA). There were no serious adverse events. There were no significant differences in frequency or types of TEAE between treatment groups (IA = 22/41 (53%), MoxA = 24/40 (60%), IDA = 18/41 (44%), MoxDA = 15/42 (36%), p = 0.530). Fifty-nine participants (36%) had multiple TEAE, and 8.5% had a one or more grade 2 (moderate) TEAE. Grade 2 TEAE were more frequent after triple drug treatments (IDA, 14.6%; MoxDA, 9.5%) than after two-drug treatments (IA, 7.3%; MoxA, 2.5%). There was no difference in TEAEs based on baseline Mf counts (OR 0.69 (0.33, 1.43), p-value 0.319).
Conclusion: All treatment regimens were well tolerated. We observed no difference in safety parameters between regimens that contained ivermectin or moxidectin.
Trial Registration: Clinicaltrials.gov, NCT04410406.
Competing Interests: The authors have declared that no competing interests exist.
(Copyright: © 2023 Bjerum et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)
Databáze: MEDLINE
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