Campillo J. T., Bikita P., Hemilembolo M., Louya F., Missamou F., Pion Sébastien, Boussinesq Michel, Chesnais C. (2022). Safety and efficacy of levamisole in loiasis : a randomized, placebo-controlled, double-blind clinical trial. Clinical Infectious Diseases, [Early access], [9 p.]. ISSN 1058-4838.
Titre du document
Safety and efficacy of levamisole in loiasis : a randomized, placebo-controlled, double-blind clinical trial
Année de publication
2022
Auteurs
Campillo J. T., Bikita P., Hemilembolo M., Louya F., Missamou F., Pion Sébastien, Boussinesq Michel, Chesnais C.
Source
Clinical Infectious Diseases, 2022,
[Early access], [9 p.] ISSN 1058-4838
Background Individuals with high microfilarial densities (MFDs) of Loa loa are at risk of developing serious adverse events (SAEs) after ivermectin treatment. Pretreatment with drugs progressively reducing Loa MFDs below the risk threshold might help prevent these SAEs. We assessed the safety and efficacy of levamisole for this purpose. Methods A double-blind, randomized, placebo-controlled, MFD-ascending trial was conducted in the Republic of the Congo. Participants were treated in 3 cohorts defined by pretreatment MFD and levamisole dose (cohort 1: 1.0kg and 1.5mg/kg; cohorts 2 and 3: 2.5mg/kg). Safety outcomes were occurrence of SAE and adverse event frequency during the first week. The efficacy outcomes were MFD reduction from baseline and proportions of individuals with at least 40% and 80% MFD reduction at day 2 (D2), D7, and D30. Results The 2 lowest doses (1.0mg/kg and 1.5mg/kg) caused no SAEs but were ineffective. Compared with placebo, 2.5mg/kg levamisole caused more mild adverse events (10/85 vs. 3/85, P=.018), a higher median reduction from baseline to D2 (-12.9% vs. +15.5%, P<.001), D7 (-4.9% vs. +18.7%, P<.001), and D30 (-0.5% vs. +13.5%, P=.036) and a higher percentage of participants with >40% MFD reduction at D2 (17.5% vs. 1.2%, P<.001), D7 (11.8% vs. 6.3%, P=.269), and D30 (18.5% vs. 9.6%, P=.107). Conclusions A single 2.5mg/kg levamisole dose induces a promising transient reduction in Loa loa MFDs and should encourage testing different regimens. Single dose of levamisole (2.5mg/kg) is safe in Loa loa-infected subjects and reduces microfilaremia temporarily. Higher doses or longer regimens should be tested to evaluate whether levamisole can be used as a pretreatment to prevent post-ivermectin Loa-related encephalopathy.
Plan de classement
Santé : généralités [050]
;
Entomologie médicale / Parasitologie / Virologie [052]
Description Géographique
CONGO
Localisation
Fonds IRD [F B010084754]
Identifiant IRD
fdi:010084754
