Open forum infectious diseases · 2024
Safety and Short-term Efficacy of a Single Dose of 2 mg Moxidectin in Loa loa-Infected Individuals: A Double-Blind, Randomized Ivermectin-Controlled Trial With Ascending Microfilarial Densities.
Клиническое исследованиеСтатьяНазвание и аннотация: Перевод в очереди
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Wafeu Guy S, Lepage Tristan M, Campillo Jeremy T, Efon-Ekangouo Arnauld, Nana-Djeunga Hugues-Clotaire, Nzune-Toche Narcisse, Domche André, Sumo Laurentine, Njitchouang Guy-Roger, Tsasse Martine Augusta Flore, Bopda Jean, Balog Yves Aubin, Niamsi-Emalio Yannick, Mbickmen-Tchana Stève, Talla Gervais Kamga, Kana Yannick Sédrick Nguedia, Messina Félicité Diane Maga, Pion Sébastien D, Kuesel Annette C, Kamgno Joseph, Boussinesq Michel, Chesnais Cedric B
Аннотация
BACKGROUND: In 2018, the US Food and Drug Administration approved the macrocylic lactone moxidectin (MOX) at 8 mg dosage for onchocerciasis treatment in individuals aged ≥12 years. Severe adverse reactions have occurred after ivermectin (IVM), also a macrocyclic lactone, in individuals with high Loa microfilarial density (MFD). This study compared the safety and efficacy of a 2 mg MOX dose and the standard 150 µg/kg IVM dose in individuals with low L loa MFD.
METHODS: A double-blind, randomized, ivermectin-controlled trial of a 2 mg moxidectin dose was conducted in Cameroon between May and July 2022. It enrolled 72 adult men with L loa MFD between 5 and 1000 microfilariae/mL. Outcomes were occurrence of adverse events (AEs) and L loa MFD reduction rate during the first month off treatment.
RESULTS: No serious or severe AEs occurred among the 36 MOX- or the 36 IVM-treated individuals. Forty-nine AEs occurred in the MOX arm versus 59 AEs in the IVM arm. Grade 2 AE incidence was higher among IVM- than MOX-treated participants (38.5% and 14.3%, respectively, P = .043). Median MFD reduction rates were significantly higher after IVM than MOX at day 3 (70.2% vs 48.5%), day 7 (76.4% vs 50.0%), and day 30 (79.8% vs 48.1%).
CONCLUSIONS: A single 2 mg MOX dose is as safe as 150 µg/kg IVM in patients with low L loa MFD. Further studies with higher MOX doses and in patients with higher MFD are warranted.
CLINICAL TRIALS REGISTRATION: NCT04049851.
METHODS: A double-blind, randomized, ivermectin-controlled trial of a 2 mg moxidectin dose was conducted in Cameroon between May and July 2022. It enrolled 72 adult men with L loa MFD between 5 and 1000 microfilariae/mL. Outcomes were occurrence of adverse events (AEs) and L loa MFD reduction rate during the first month off treatment.
RESULTS: No serious or severe AEs occurred among the 36 MOX- or the 36 IVM-treated individuals. Forty-nine AEs occurred in the MOX arm versus 59 AEs in the IVM arm. Grade 2 AE incidence was higher among IVM- than MOX-treated participants (38.5% and 14.3%, respectively, P = .043). Median MFD reduction rates were significantly higher after IVM than MOX at day 3 (70.2% vs 48.5%), day 7 (76.4% vs 50.0%), and day 30 (79.8% vs 48.1%).
CONCLUSIONS: A single 2 mg MOX dose is as safe as 150 µg/kg IVM in patients with low L loa MFD. Further studies with higher MOX doses and in patients with higher MFD are warranted.
CLINICAL TRIALS REGISTRATION: NCT04049851.