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Purpose <p>Fexinidazole, an oral molecule, replaced pentamidine and combined treatment with nifurtimox and eflornithine (NECT) therapy for stage 1 and non-severe stage 2 <i>gambiense</i> human African Trypanosomiasis (<i>g</i>-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 <i>g</i>-HAT admitted to Lui Hospital (Western Equatoria, South Sudan), a historical <i>g</i>-HAT focus.</p> Methods <p>Data of patients (<i>n</i> = 86) admitted to Lui Hospital from July 2018 to June 2024 with <i>g-</i>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 <i>g</i>-HAT).</p> Results <p>In the study population 17% of patients were registered with an unfavourable outcome (signs or symptoms of <i>g</i>-HAT at discharge or death attributable to <i>g</i>-HAT or <i>g</i>-HAT treatment occurred during hospitalization). No significant differences between fexinidazole and pentamidine/NECT in terms of outcome at discharge (23% vs. 6%, <i>p</i> = 0.230) and ADRs frequency (70% vs. 50%, <i>p</i> = 0.181) were reported. Although fexinidazole cohort experienced more gastro-intestinal ADRs than pentamidine/NECT cohort (63% vs. 19%, <i>p</i> = 0.005), discontinuation of oral treatment has not been recorded.</p> Conclusion <p>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.</p>

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

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  • 发表日期：

    2025年9月4日

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  • Francesca Mariotti,
  • Riccardo Paggi,
  • Matteo Basilico,
  • Sofia Pettenuzzo,
  • Grant Sebit Benson,
  • Abiodun Amodu,
  • Lorenzo Zammarchi,
  • Stefano Rusconi,
  • Chiara Scanagatta,
  • Giovanni Putoto,
  • Stefano Dacquino,
  • Elena Gelormino

摘要

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.