Efficacy and safety of acoziborole in patients with human African trypanosomiasis caused by Trypanosoma brucei gambiense: a multicentre, open-label, single-arm, phase 2/3 trial

by Kande Betu Kumeso V, Mutombo Kalonji W, Rembry S, Valverde Mordt O, Ngolo Tete D, Prêtre A, Delhomme S, Ilunga Wa Kyhi M,Camara M,Catusse J, Schneitter S, Nusbaumer M, Mwamba Miaka E, Mahenzi Mbembo H, Makaya Mayawula J, Layba Camara M, Akwaso Massa F, Kaninda Badibabi L, Kasongo Bonama A, Kavunga Lukula P, Mutanda Kalonji S, Mariero Philemon P, Mokilifi Nganyonyi R, Embana Mankiara H, Akongo Nguba AA, Kobo Muanza V, Mulenge Nasandhel E, Nzeza Bambuwu AF, Scherrer B, Strub-Wourgaft N, Tarral A. Lancet Infectious Diseases 2022. doi: 10.1016/S1473-3099(22)00660-0.

Summary: Although fexinidazole has improved treatment of gambiense human African trypanosomiasis (g-HAT), disease severity needs to be assessed, possibly involving lumbar puncture, and treatment taken for 10 days. The authors describe a phase 2/3 study in hospitals in DRC and Guinea to assess the safety and efficacy of acoziborole, a potential single dose disease-stage-independent oral treatment. The 18-month treatment success rate was 95% in 167 patients with late-stage and 100% in 41 patients with early stage g-HAT. The benefit-risk profile was positive, regardless of disease stage and no substantial drug-related safety signals were identified. Given the high efficacy and favourable safety profile, acoziborole holds promise in the efforts to reach the WHO goal of interrupting HAT transmission by 2030.

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