Retrospective analysis finds similar outcomes for fexinidazole and pentamidine/NECT in patients with g-HAT, highlighting gastrointestinal ADR differences.
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.
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Mariotti et al. (2025) studied this question.
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