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Oral fexinidazole for stage 1 or early stage 2 African Trypanosoma brucei gambiense trypanosomiasis: A prospective, multicentre, open-label, cohort study

The Lancet Global Health Jun 19, 2021

Mesu VKBK, Kalonji WM, Bardonneau C, et al. - Fexinidazole was established as the first oral monotherapy to be effective against non-severe stage 2 human African trypanosomiasis caused by Trypanosoma brucei gambiense (g-HAT) in a pivotal study. Researchers herein investigated its safety and efficacy in early g-HAT. They conducted a multicentre, open-label, single-arm cohort study recruiting 238 patients with stage 1 or early stage 2 g-HAT from eight treatment centres in the Democratic Republic of the Congo. For inclusion, following criteria were to be fulfilled: being older than 15 years, being able to ingest at least one complete meal per day (or at least one sachet of Plumpy'Nut), a Karnofsky score greater than 50, evidence of trypanosomes in the blood or lymph but no evidence of trypanosomes in the CSF, willingness to be admitted to hospital to take treatment, having a permanent address, and being able to comply with the follow-up visit schedule. Among these patients, 195 (82%) patients had stage 1 g-HAT and 43 (18%) had early stage 2 g-HAT. Patients were provided 1,800 mg fexinidazole once per day on days 1–4 then 1,200 mg fexinidazole on days 5–10. At 12 months treatment was identified as effective for 99% of the patients. Headache and vomiting were the most frequent adverse events. Overall outcomes support the value of fexinidazole as a first-line treatment option in the early stages of g-HAT.

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