02865nas a2200289   4500000000100000008004100001260003700042653002400079653005700103100001400160700001400174700001600188700001000204700001200214700001200226700001200238700001500250700001200265700001300277700001100290245016800301856009900469300000900568490000700577520197700584022001402561       2023                            d  bPublic Library of Science (PLoS)10aInfectious Diseases10aPublic Health, Environmental and Occupational Health1 aBjerum CM1 aKoudou BG1 aOuattara AF1 aLew D1 aGoss CW1 aGabo PT1 aKing CL1 aFischer PU1 aWeil GJ1 aBudge PJ1 aDeye G00aSafety and tolerability of moxidectin and ivermectin combination treatments for lymphatic filariasis in Côte d’Ivoire: A randomized controlled superiority study  uhttps://journals.plos.org/plosntds/article/file?id=10.1371/journal.pntd.0011633&type=printable  a1-120 v173 a<p><strong>Background:</strong> 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.</p>

<p><strong>Methods:</strong> 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.</p>

<p><strong>Results:</strong> 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).</p>

<p><strong>Conclusion:</strong> 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.</p>
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