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

• Main Authors: Catherine M Bjerum (Author), Benjamin G Koudou (Author), Allassane F Ouattara (Author), Daphne Lew (Author), Charles W Goss (Author), Pascal T Gabo (Author), Christopher L King (Author), Peter U Fischer (Author), Gary J Weil (Author), Philip J Budge (Author)
• Format: Book
• Published: Public Library of Science (PLoS), 2023-09-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.

Summary

<h4>Background</h4>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.<h4>Methods</h4>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.<h4>Results</h4>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).<h4>Conclusion</h4>All treatment regimens were well tolerated. We observed no difference in safety parameters between regimens that contained ivermectin or moxidectin.<h4>Trial registration</h4>Clinicaltrials.gov, NCT04410406.

Item Description

1935-2727
1935-2735
10.1371/journal.pntd.0011633