Safety and tolerability of moxidectin and ivermectin combination treatments for lymphatic filariasis in Côte d'Ivoire: A randomized controlled superiority study.
<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...
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| Language: | English |
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Public Library of Science (PLoS)
2023-09-01
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| Series: | PLoS Neglected Tropical Diseases |
| Online Access: | https://journals.plos.org/plosntds/article/file?id=10.1371/journal.pntd.0011633&type=printable |
| _version_ | 1827351277405732864 |
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| author | Catherine M Bjerum Benjamin G Koudou Allassane F Ouattara Daphne Lew Charles W Goss Pascal T Gabo Christopher L King Peter U Fischer Gary J Weil Philip J Budge |
| author_facet | Catherine M Bjerum Benjamin G Koudou Allassane F Ouattara Daphne Lew Charles W Goss Pascal T Gabo Christopher L King Peter U Fischer Gary J Weil Philip J Budge |
| author_sort | Catherine M Bjerum |
| collection | DOAJ |
| description | <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. |
| first_indexed | 2024-03-08T01:59:48Z |
| format | Article |
| id | doaj.art-700673892a3b44b5a4de81b30bb18bb0 |
| institution | Directory Open Access Journal |
| issn | 1935-2727 1935-2735 |
| language | English |
| last_indexed | 2024-03-08T01:59:48Z |
| publishDate | 2023-09-01 |
| publisher | Public Library of Science (PLoS) |
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| series | PLoS Neglected Tropical Diseases |
| spelling | doaj.art-700673892a3b44b5a4de81b30bb18bb02024-02-14T05:33:22ZengPublic Library of Science (PLoS)PLoS Neglected Tropical Diseases1935-27271935-27352023-09-01179e001163310.1371/journal.pntd.0011633Safety and tolerability of moxidectin and ivermectin combination treatments for lymphatic filariasis in Côte d'Ivoire: A randomized controlled superiority study.Catherine M BjerumBenjamin G KoudouAllassane F OuattaraDaphne LewCharles W GossPascal T GaboChristopher L KingPeter U FischerGary J WeilPhilip J Budge<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.https://journals.plos.org/plosntds/article/file?id=10.1371/journal.pntd.0011633&type=printable |
| spellingShingle | Catherine M Bjerum Benjamin G Koudou Allassane F Ouattara Daphne Lew Charles W Goss Pascal T Gabo Christopher L King Peter U Fischer Gary J Weil Philip J Budge Safety and tolerability of moxidectin and ivermectin combination treatments for lymphatic filariasis in Côte d'Ivoire: A randomized controlled superiority study. PLoS Neglected Tropical Diseases |
| title | Safety and tolerability of moxidectin and ivermectin combination treatments for lymphatic filariasis in Côte d'Ivoire: A randomized controlled superiority study. |
| title_full | Safety and tolerability of moxidectin and ivermectin combination treatments for lymphatic filariasis in Côte d'Ivoire: A randomized controlled superiority study. |
| title_fullStr | Safety and tolerability of moxidectin and ivermectin combination treatments for lymphatic filariasis in Côte d'Ivoire: A randomized controlled superiority study. |
| title_full_unstemmed | Safety and tolerability of moxidectin and ivermectin combination treatments for lymphatic filariasis in Côte d'Ivoire: A randomized controlled superiority study. |
| title_short | Safety and tolerability of moxidectin and ivermectin combination treatments for lymphatic filariasis in Côte d'Ivoire: A randomized controlled superiority study. |
| title_sort | safety and tolerability of moxidectin and ivermectin combination treatments for lymphatic filariasis in cote d ivoire a randomized controlled superiority study |
| url | https://journals.plos.org/plosntds/article/file?id=10.1371/journal.pntd.0011633&type=printable |
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