Capacity development to facilitate access to fexinidazole
Objective: Support fexinidazole access for gambiense sleeping sickness patients through capacity strengthening activities at national and local levels of the health system in line with the WHO treatment guidelines.
Project start: 2020
National HAT Control Programme of the Democratic Republic of Congo
National HAT Control Programme of the Republic of Guinea
The project, known as FEX-g-HAT, is facilitating the delivery and uptake of fexinidazole, the first all-oral treatment for sleeping sickness, into selected African endemic countries through strengthened health care capacity and coordination via: the HAT Platform, a clinical research, training and access-supporting network of over 120 institutions; through trainings in the use of new tools; and reinforced pharmacovigilance channels for introduction of the new treatment.
The FEX-g-HAT project brings together a consortium of experts: DNDi, the National Control Programmes for Human African Trypanosomiasis of the Democratic Republic of Congo and Guinea, the Research Institute for Development (IRD), and the Institute of Tropical Medicine Antwerp.
Access activities for fexinidazole continued throughout 2022, including in additional countries where the drug has been adopted as the first-line treatment for sleeping sickness caused by T.b. gambiense. Training on the new treatment guidelines was completed. Using fexinidazole as an example, the team is now concentrating on improving routine pharmacovigilance reporting in five countries (Democratic Republic of the Congo [DRC], Central African Republic, Guinea, Angola, and South Sudan). In the DRC, these efforts provided an opportunity for DRC’s National Centre for Pharmacovigilance (CNPV) to raise awareness on pharmacovigilance reporting more broadly, stimulating reporting on adverse events for drugs other than fexinidazole.
In addition, the results of an ethnographic study conducted in the DRC to understand how various factors shape communities’ knowledge, perceptions, and behavior related to sleeping sickness were published in the journal Diseases.
In 2021, FEX-g-HAT focused on strengthening health system capacity to use fexinidazole as a first-line treatment for sleeping sickness caused by T.b. gambiense (g-HAT) and to monitor patients treated with the new drug. In Angola, Central African Republic (CAR), Democratic Republic of the Congo (DRC), Guinea, and South Sudan, DNDi and consortium partners delivered trainings on fexinidazole treatment guidelines, supervised pharmacovigilance activities, and worked to reinforce national pharmacovigilance systems with support from the HAT Platform. These activities aim to facilitate sustainable reporting to accompany full introduction of the new treatment and adoption of revised treatment guidelines in all countries. Despite the challenges presented by the COVID-19 pandemic, g-HAT-endemic countries succeeded in increasing access to fexinidazole as a first-line treatment.
In 2020, training activities of health care providers were carried out focussing on serological screening, updating new HAT treatment guidelines and pharmacovigilance, to support improved detection and early treatment of gambiense sleeping sickness. Activities to ensure effective tracking and to facilitate access to fexinidazole were also undertaken.
Furthermore, in the DRC, 26 focal points from three regional pharmacovigilance centres have been trained.
News & resources
- 22 February 2023 - HAT Platform Newsletter No. 22
- 26 September 2022 - Communities’ perception, knowledge, and practices related to human African trypanosomiasis in the Democratic Republic of Congo, Diseases
- 22 February 2021 - HAT Platform Newsletter No. 21
- 1 April 2020 - Latest advances in control of sleeping sickness: Towards elimination, Bulletin of the Netherlands Society for Tropical Medicine and International Health
- 29 March 2020 - How clinical research can contribute to strengthening health systems in low resource countries, Tropical Medicine and Infectious Diseases
This project (grant CSA2018HS-2526) is part of the European and Developing Countries Clinical Trials Partnership Association (EDCTP2) programme supported by the European Union.
Democratic Republic of the Congo – Ministère de la Santé de la République Démocratique du Congo (Projet de Développement du Système de Santé financé par la Banque Mondiale)
France – Ministry For Europe and Foreign Affairs
France – French Development Agency (AFD)
Germany – German Corporation for International Cooperation (GIZ) on behalf of the Government of the Federal Republic of Germany
Germany – Federal Ministry of Education and Research (BMBF) through KfW
Norway – Norwegian Agency for Development Cooperation (Norad), Norwegian Ministry of Foreign Affairs, as part of Norway’s in-kind contribution to EDCTP2
Spain – Spanish Agency for International Development Cooperation (AECID)
Switzerland – Republic and Canton of Geneva, International Solidarity Service
Switzerland – Swiss Agency for Development and Cooperation (SDC)
The Netherlands – Dutch Ministry of Foreign Affairs (DGIS)
UK – UK aid
Bill and Melinda Gates Foundation
Brian Mercer Trust
Else Kröner Fresenius Award for Development Cooperation in Medicine 2020
Médecins Sans Frontières International
Stavros Niarchos Foundation (SNF)
Takeda Pharmaceutical Company Limited
The ELMA Foundation
UBS Optimus Foundation
Other private foundations and individuals
Get our latest news, personal stories, research articles, and job opportunities.