Background T.b. gambiense human African trypanosomiasis (g-HAT) is a neglected tropical disease targeted by the World Health Organization (WHO) for elimination by 2030. The first all-oral treatment for g-HAT, fexinidazole (developed by DNDi), received a marketing authorization in DRC in December 2018 and was included as first-line treatment in the new WHO-HAT treatment guidelines and added to the 2019 WHO-Essential Medicines Lists. DNDi collaborated with WHO to support five HAT-endemic countries through EDCTP2.

Methods The project focused on healthcare capacity-strengthening and coordination support for the appropriate use of fexinidazole, and fexinidazole surveillance and national pharmacovigilance systems support, including for the timely and efficient reporting of adverse reactions through the HAT Platform as a communication mechanism, trainings, and reinforced pharmacovigilance channels. Regarding fexinidazole surveillance, selected health facilities’ health workers were trained on WHO-HAT treatment guidelines and safety notification, including choice of internationally compatible software with Vigibase repository. Support to national pharmacovigilance systems was provided to five target countries (DRC, Guinea, Angola, CAR, and South Sudan) through baseline assessments, set-up, and training of five national and six regional pharmacovigilance units in the DRC coordinated with the DRC national PV team.

Results During the last two years of the project, 630 healthcare workers from 243 facilities were trained on the new WHO-HAT treatment guidelines, including fexinidazole, in the five target countries. 556 HAT patients were treated with fexinidazole, and notifications of adverse events were sent to WHO and national pharmacovigilance systems. In addition, the five national pharmacovigilance systems were equipped and trained.

Conclusion This project enabled the reinforcement of five countries’ national pharmacovigilance systems and development of collaborative networking to extend safety surveillance to all drugs. Healthcare workers in all five countries were trained in the use of fexinidazole, and HAT patients are now being effectively diagnosed and treated.