1. Efficacy, safety, and tolerability of albendazole and ivermectin based regimens for the treatment of microfilaraemic loiasis in adult patients in Gabon: A randomized controlled assessor blinded clinical trial.
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Zoleko-Manego, Rella, Kreuzmair, Ruth, Veletzky, Luzia, Ndzebe-Ndoumba, Wilfrid, Ekoka Mbassi, Dorothea, Okwu, Dearie G., Dimessa-Mbadinga-Weyat, Lia B., Houtsa-Temgoua, Roselyne D., Mischlinger, Johannes, McCall, Matthew B. B., Kresmner, Peter G., Agnandji, Selidji T., Lell, Betrand, Adegnika, Ayôla A., Mombo-Ngoma, Ghyslain, and Ramharter, Michael
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ALBENDAZOLE ,IVERMECTIN ,CLINICAL trials ,APPRAISERS ,ORAL drug administration - Abstract
Background: There is a lack of systematic evidence for strategies to control loiasis transmission in highly endemic regions. Here we assessed albendazole and ivermectin based treatment regimens to reduce Loa loa microfilaraemia in Gabon. Methods: Eligible adult patients with L. loa microfilaraemia between 5,000 and 50,000 microfilariae/ml were randomized to either a control or one of three intervention groups (1:2:2:2 allocation ratio) consisting of three-week twice daily 400mg oral albendazole followed by 1) no treatment, 2) two further weeks of twice daily 400mg albendazole, or 3) a single dose of ivermectin in this open label randomized assessor blinded controlled clinical trial. The primary outcome was the proportion of participants with L. loa microfilaraemia ≤ 100 mf/ml at Day 168. Results: In the efficacy-population of 42 patients 0 (0%; control group), 1 (9%; 3-week albendazole), 5 (39%; 5-weeks albendazole) and 2 (22%; 3-week albendazole plus single dose ivermectin) participants met the primary outcome of microfilaraemia below 100/ml at day 168. A 80–90% reduction of microfilaraemia was observed in the active treatment groups. Conclusion: The 5-week regimen of albendazole or a 3-week regimen of albendazole followed by ivermectin were most efficacious to reduce microfilaraemia. All therapeutic regimens were well tolerated and safe. Trial registration: Trial registered at the Pan-African Clinical Trials Registry: PACTR201807197019027. Author summary: To date there is a lack of safe treatment options to be used for the control of Loa loa transmission in highly endemic regions. This study assessed the parasitological efficacy of albendazole alone (three or five weeks regimen) or albendazole (three weeks regimen) with a single dose of ivermectin for the reduction of microfilaraemia in adult patients in Gabon. This proof of concept study showed highest efficacy of about 90% reduction of microfilaraemia when albendazole was given twice daily for five weeks or albendazole was administered twice daily for three weeks followed by single dose ivermectin. As there were no safety concerns these findings indicate that albendazole based treatment regimens may in principle be useful for implementation in population-based control programs. To overcome the problem associated with prolonged oral treatment regimens new injectable drug formulations with extended release of active substances may be considered to facilitate implementation of such control programs. [ABSTRACT FROM AUTHOR]
- Published
- 2023
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