@article{98825,
  keywords = {Infectious Diseases, Public Health, Environmental and Occupational Health},
  author = {Bjerum CM and Koudou BG and Ouattara AF and Lew D and Goss CW and Gabo PT and King CL and Fischer PU and Weil GJ and Budge PJ},
  editor = {Deye G},
  title = {Safety and tolerability of moxidectin and ivermectin combination treatments for lymphatic filariasis in Côte d’Ivoire: A randomized controlled superiority study},
  abstract = {<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>
},
  year = {2023},
  journal = {PLOS Neglected Tropical Diseases},
  volume = {17},
  pages = {1-12},
  publisher = {Public Library of Science (PLoS)},
  issn = {1935-2735},
  url = {https://journals.plos.org/plosntds/article/file?id=10.1371/journal.pntd.0011633&type=printable},
  doi = {10.1371/journal.pntd.0011633},
  language = {Eng},
}