Human African trypanosomiasis (HAT, also colloquially referred to as sleeping sickness), caused by T. brucei gambiense and T. brucei rhodesiense, remains a moderate risk (>1/10,000 inhabitants per year in endemic areas) despite focussed control efforts. Transmitted by the bite of an infected tsetse fly, HAT is biphasic with a first (hemolymphatic) stage that progresses to a second (meningoencephalitic) stage in which patients experience progressively worsening neurological symptoms and eventually die if left untreated. Historical treatment options for meningoencephalitic HAT include melarsoprol, eflornithine, and nifurtimox/eflornithine combination therapy (NECT), though melarsoprol is highly toxic and each treatment requires lengthy infusions that are difficult to administer in resource-limited settings. Fexinidazole, which was originally developed in the 1970s/80s by Hoechst AG and subsequently rediscovered through the Drugs for Neglected Diseases Initiative (DNDi) in 2005, is the first all-oral treatment for first and second stage HAT caused by T. brucei gambiense.
Fexinidazole received a positive opinion from the European Medicines Agency (EMA) in November 2018 and was approved by the FDA on July 16, 2021. It is currently marketed by Sanofi-Aventis.
Fexinidazole is a nitroimidazole indicated for the treatment of both first-stage (hemolymphatic) and second-stage (meningoencephalitic) Trypanosoma brucei gambiense human African trypanosomiasis (HAT) in patients 6 years of age and older weighing at least 20 kg.
Due to the decreased efficacy observed in patients with severe second stage HAT (cerebrospinal fluid white blood cell count (CSF-WBC) >100 cells/μL), fexinidazole should only be used in these patients if there are no other available treatment options.
Lwala Hospital, Lwala, Kadeberamaido, Uganda
Rumphi District Hospital, Rumphi, Malawi
Hospital Clinic, Barcelona, Catalunia, Spain
Dipumba Hospital, Mbuji-Mayi, Kasaï Oriental Province, Congo, The Democratic Republic of the
Bandundu Hospital, Bandundu, Kwilu Province, Congo, The Democratic Republic of the
Bagata Hospital, Bagata, Kwilu Province, Congo, The Democratic Republic of the
Biotrial, Rennes, France
Plataforma de Atención Integral de Pacientes con Enfermedad de Chagas, Tarija, Bolivia
Plataforma Atención Integral de Pacientes con Enfermedad de Chagas, Cochabamba, Bolivia
Doka Hospital, Doka, Gedaref, Sudan
CRT (Centre de Réference et de Traitement) Dipumba, Dipumba general hospital, Mbuji Mayi, East Kasai, Congo
HGR ISANGI hospital, Isangi, Province Orientale, Congo
Masi Manimba Hospital, Masi Manimba, Bandundu - DRC, Congo
SGS Aster s.a.s., Paris, France
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