Fexinidazol zur oralen Therapie der Westafrikanischen Schlafkrankheit: wesentliche Änderungen für die klinische Praxis

ZUSAMMENFASSUNG

Die Schlafkrankheit (Afrikanische Trypanosomiasis) führt ohne Behandlung in der Regel zum Tod. Mit Fexinidazol steht eine rein orale Monotherapie für die westafrikanische Form zur Verfügung, welche von der Europäischen Arzneimittel-Agentur im November 2018 positiv bewertet wurde. Im August 2019 veröffentlichte die Weltgesundheitsorganisation eine neue Therapieleitlinie. Fexinidazol wird als Erstlinientherapie für die Westafrikanische Schlafkrankheit im Stadium I und im Stadium II bei < 100 Leukozyten/µl im Liquor für Patienten ≥ 6 Jahre und ≥ 20 kg empfohlen. NECT (nifurtimox-eflornithine combination therapy) ist weiterhin Erstlinientherapie für Patienten mit ≥ 100 Leukozyten/µl im Liquor – neu definiert als schweres Stadium II. Fexinidazol ist in diesem Stadium deutlich weniger effektiv. Ohne den klinischen Verdacht auf ein schweres Stadium II kann auf eine Lumbalpunktion verzichtet und eine Therapie mit Fexinidazol unter Beaufsichtigung der Einnahme durchgeführt werden.

ABSTRACT

Human African trypanosomiasis (HAT) usually progresses to death unless treated. Fexinidazole is an effective oral monotherapy against West African gambiense HAT (g-HAT). In November 2018, the European Medicines Agency adopted a positive opinion for fexinidazole. The WHO has updated its guidelines for the treatment of g-HAT in August 2019. Fexinidazole is recommended for individuals ≥ 6 years and ≥ 20 kg, in first and second stage g-HAT with < 100 leukocytes/µl in the cerebrospinal fluid. NECT (nifurtimox-eflornithine combination therapy) remains recommended for those with ≥ 100 leukocytes/µl, newly defined as severe second stage, as the failure rate in this group was significantly higher with fexinidazole. Without clinical suspicion of severe second stage, lumbar puncture can be avoided and fexinidazole given. Fexinidazole should only be administered under supervision of trained health staff.

Key words

human African trypanosomiasis - sleeping sickness - treatment - fexinidazole

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