First trial of Ebola antiviral begins in DRC outbreak

Researchers in the Democratic Republic of Congo began enrolling participants on July 14 in the EBO-PEP trial, the first clinical study testing Gilead Sciences' ↗ 1.87% experimental antiviral obeldesivir as post-exposure prophylaxis against the Bundibugyo Ebola virus, according to ALIMA, one of the trial's implementing partners.alima+1

The trial, sponsored by France's ANRS MIE (National Agency for Research on AIDS and Emerging Infectious Diseases) and conducted in collaboration with the DRC's National Institute for Biomedical Research (INRB) and ALIMA, launched in Ituri Province — the epicenter of the outbreak that has killed more than 450 people since being declared in May.anrs+1

How the Trial Works

Obeldesivir, an oral antiviral developed by Gilead Sciences, will be given to adults and children over 12 who have had direct contact with a confirmed Bundibugyo case within the preceding five days and are not yet showing symptoms. The double-blind, placebo-controlled trial will monitor participants daily for 21 days, with a final visit at 42 days. A second sub-protocol will provide remdesivir on a compassionate-use basis to children under 12 and pregnant or breastfeeding women with high-risk exposure.ebo-pep+2

A Parallel Treatment Trial

The EBO-PEP launch follows the start of the PARTNERS trial, which enrolled its first patient on July 1 and is testing remdesivir and Mapp Biopharmaceutical's monoclonal antibody MBP134 as treatments for confirmed Bundibugyo cases. The WHO has said the treatment trial could take months and require more than 1,000 participants to determine whether the therapies are effective.reuters+2

An Outbreak Without Approved Tools

There are no licensed vaccines or treatments for the Bundibugyo strain of Ebola, which has caused only three documented outbreaks since its discovery in 2007. As of July 1, WHO reported 1,460 confirmed cases and 452 deaths in the DRC, with 20 cases confirmed in neighboring Uganda. The WHO declared the outbreak a Public Health Emergency of International Concern on May 17.who+4

"In the absence of a specific treatment, care relies primarily on symptom management and intensive supportive therapy," Doctors Without Borders noted in a briefing on the outbreak.doctorswithoutborders