New WHO guidelines for treating rhodesiense human African trypanosomiasis: expanded indications for fexinidazole and pentamidine.

Human African trypanosomiasis is a neglected tropical disease that is usually fatal without treatment. WHO has revised its rhodesiense human African trypanosomiasis treatment guidelines on the basis of an independent systematic literature review and following the GRADE methodology. This Review reports on the decision-making process and summarises the new recommendations and their potential implications for health-care professionals and policy makers. Due to data scarcity, all recommendations are conditional and based on very low certainty of evidence. Fexinidazole replaces suramin and melarsoprol as the first-line therapy in individuals aged 6 years and older with a bodyweight of 20 kg or more. As fexinidazole is effective in both stages of rhodesiense human African trypanosomiasis, a lumbar puncture for staging is no longer required. In settings in which first-choice drugs are not readily available, immediate interim treatment with pentamidine is suggested. The introduction of oral fexinidazole represents an advancement in the management of rhodesiense human African trypanosomiasis considering the life-threatening adverse reactions individuals can have to melarsoprol. However, children below the age or weight limits remain ineligible for treatment with fexinidazole.

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Copyright © 2024 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY-NC-ND 4.0 license. Published by Elsevier Ltd.. All rights reserved.

Déclaration de conflit d'intérêts

Declaration of interests JS reports that the Instituto de Higiene e Medicina Tropical–Lisbon was a partner in the European & Developing Countries Clinical Trials Partnership (EDCTP2) HAT-r-ACC project (for a clinical trial on fexinidazole in rhodesiense human African trypanosomiasis [HAT]; NCT03974178), coordinated by the Drugs for Neglected Diseases initiative (DNDi), and funded by the EDCTP. JS had a non-remunerated role in training the clinical investigators of the field teams. LB was a member of the data and safety monitoring board for the clinical trial on fexinidazole in rhodesiense HAT. PPS was employed as an advisor at the DNDi until 2021. MPB participated in the scientific advisory committee of the DNDi that dealt with the fexinidazole trials, among other projects. VL reports that the Institut de Recherche pour le Développement was a partner in the HAT-r-ACC project (for a clinical trial on fexinidazole in rhodesiense HAT [NCT03974178]), coordinated by the DNDi. VL was responsible for training project health staff in the diagnosis of HAT (two trainings, one in Malawi and one in Uganda, in 2019). AE chaired the data and safety monitoring board for the clinical trial on fexinidazole in rhodesiense HAT. AE also participated in the scientific advisory committee of the DNDi. All other authors declare no competing interests.