Summary

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• This summary is based on the review of two systematic review(s)/meta-analysis(es). ^[1-2]
• Fexinidazole demonstrated higher mortality (9 deaths out of 264 participants) compared to nifurtimox-eflornithine combination therapy (NECT) (2 deaths out of 130 participants), with a risk ratio (RR) of 2.22 (95% confidence interval (CI) 0.49 to 10.11; low-certainty evidence). Additionally, fexinidazole was associated with a higher relapse rate (14 out of 264 participants) compared to none in the NECT group (risk difference (RD) 0.05, 95% CI 0.02 to 0.08; moderate-certainty evidence).
• NECT was found to be non-inferior to eflornithine in terms of patients discharged alive, showing its effectiveness. Both fexinidazole and NECT were more effective than older therapies such as eflornithine and melarsoprol monotherapy for treating second-stage Trypanosoma brucei gambiense trypanosomiasis (g-HAT).
• Fexinidazole was associated with a high incidence of serious adverse events, with 31 out of 264 participants (11.7%) experiencing serious adverse events over 24 months. In comparison, NECT had fewer serious adverse events, with 13 out of 130 participants (10.0%).
• Both fexinidazole and NECT had a similarly high incidence of common adverse events, affecting 93.6% of participants in the fexinidazole group and 93.1% in the NECT group, with no significant difference between them (RR 1.01, 95% CI 0.95 to 1.06).
• The trial included participants from the Democratic Republic of the Congo and the Central African Republic, consisting of both adults and children with second-stage Trypanosoma brucei gambiense trypanosomiasis (g-HAT). No significant differences in treatment outcomes were observed among different population types or subgroups.