Use of fexinidazole in gambiense human African trypanosomiasis: a retrospective analysis of cases treated in Lui Hospital, South Sudan (2018-2024)

Purpose: Fexinidazole, an oral molecule, replaced pentamidine and combined treatment with nifurtimox and eflornithine (NECT) therapy for stage 1 and non-severe stage 2 gambiense human African Trypanosomiasis (g-HAT), respectively. The study aims to evidence differences of outcome at discharge and adverse drug reactions (ADRs) between fexinidazole and pentamidine/NECT regimens in patients with stage 1 and non-severe stage 2 g-HAT admitted to Lui Hospital (Western Equatoria, South Sudan), a historical g-HAT focus. Methods: Data of patients (n = 86) admitted to Lui Hospital from July 2018 to June 2024 with g-HAT diagnosis were included. Among them, we considered for the analysis patients eligible for both fexinidazole and pentamidine/NECT regimens (i.e. patients without symptoms/signs compatible with severe stage 2 g-HAT). Results: In the study population 17% of patients were registered with an unfavourable outcome (signs or symptoms of g-HAT at discharge or death attributable to g-HAT or g-HAT treatment occurred during hospitalization). No significant differences between fexinidazole and pentamidine/NECT in terms of outcome at discharge (23% vs. 6%, p = 0.230) and ADRs frequency (70% vs. 50%, p = 0.181) were reported. Although fexinidazole cohort experienced more gastro-intestinal ADRs than pentamidine/NECT cohort (63% vs. 19%, p = 0.005), discontinuation of oral treatment has not been recorded. Conclusion: Patients treated with fexinidazole and pentamidine/NECT showed similar results in terms of outcome at discharge and ADRs, in line with current data available in literature. However, few real-life studies on efficacy of fexinidazole treatment were published: to our knowledge, this is the first one conducted in South Sudan.