A phase-2, randomized, multicenter, placebo-controlled, proof-of-concept trial of oral fexinidazole in adults with chronic indeterminate Chagas disease

by Torrico F, Gascón J, Ortiz L, Pinto J, Rojas G, Palacios A, Barreira F, Blum B, Gabriel Schijman AG, Vaillant M, Strub-Wourgaft N, Pinazo MJ, Bilbe G, Ribeiro I, on behalf of the FEXI-CHAGAS study group. Clinical Infectious Diseases 2022; ciac579. doi: 10.1093/cid/ciac579

Summary: Pre-clinical data for the sleeping sickness treatment fexinidazole has shown efficacy against the causative agent of Chagas disease, T. cruzi, and a lack of genotoxicity. The authors describe a double-blind, randomised, placebo-controlled study of this potential treatment for Chagas disease, conducted in Bolivia. Six regimens were tested: 1200 or 1800 mg fexinidazole per day for 2, 4, or 8 weeks. Enrolment was interrupted after 4/47 patients presented with transient asymptomatic grade-3 and 4 neutropenia, while rapid, sustained clearance of parasitemia was observed in all treated patients with available data, varying between 66.7% (1200 mg, 2 weeks) and 100.0% (1800 mg, 2 weeks). Further exploratory exposure-response analysis suggested that low dosages of fexinidazole may be safe and effective.

This article is an ‘accepted manuscript’ and is not yet in its final published form.

The post A phase-2, randomized, multicenter, placebo-controlled, proof-of-concept trial of oral fexinidazole in adults with chronic indeterminate Chagas disease first appeared on DNDi.

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