By Siddhi Mahatole
July 14 (Reuters) – Researchers in the Democratic Republic of Congo said on Tuesday they have started enrolling participants in a trial testing Gilead Sciences’ experimental antiviral obeldesivir as a post-exposure treatment for the ongoing Bundibugyo Ebola outbreak in Congo and Uganda.
Congo’s National Institute for Biomedical Research and France’s ANRS Emerging Infectious Diseases — with support from humanitarian aid groups, Alliance for International Medical Action (ALIMA) and Medecins Sans Frontieres — are leading the trial in Ituri province, the epicentre of the outbreak, the agencies said in a joint statement.
The trial is designed to assess whether post-exposure treatment can reduce the risk of developing Ebola infection after contact with the virus.
The study aims to enroll about 1,000 people aged 12 years and older, who had high-risk exposure to a confirmed Ebola case within the previous five days but have not developed symptoms.
Participants will be monitored daily for 21 days, with a final follow-up at 42 days.
Obeldesivir has shown activity against filoviruses, including the Bundibugyo Ebola virus, in pre-clinical studies.
Gilead said it has donated 2,400 bottles of obeldesivir and 2,000 vials of remdesivir to support the trial.
The project has received initial funding of 3.4 million euros ($3.87 million) from the Global Health EDCTP3 partnership supported by the European Commission, and $1 million from the Africa Centres for Disease Control and Prevention.
Africa CDC also helped secure an additional $5 million in funding commitments from South Africa and the Democratic Republic of Congo.
The study also includes a separate compassionate-use protocol under which Gilead’s injectable antiviral remdesivir would be given to children under 12 years and pregnant or breastfeeding women exposed to the virus.
The outbreak has led to 1,963 confirmed cases in Congo, including 719 deaths, according to government data.
($1 = 0.8777 euros)
(Reporting by Siddhi Mahatole in Bengaluru; Editing by Shilpi Majumdar)
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