Ethiopian Informer
ADDIS ABABA (EI) – The Africa Centers for Disease Control and Prevention (Africa CDC) disclosed that the first clinical trial to assess the efficacy of post-exposure prophylaxis against the current Bundibugyo Ebola virus outbreak begins Tuesday in the Democratic Republic of the Congo (DRC) and Uganda. The trial evaluates the antiviral obeldesivir to successfully protect high-risk contacts, hoping to quickly halt the spread of the deadly disease across the regions.
The Africa CDC, in a statement issued Tuesday, said recruitment of participants for this first clinical trial begins on Tuesday in the Ituri province in eastern DRC, the epicenter of the outbreak. The first patients are being recruited at centers set up adjacent to Ebola treatment facilities in Bunia and Rwampara, with vital field support from humanitarian organizations ALIMA and Medecins Sans Frontieres.
The recruitment phase, which aims to enrol a total of nearly 1,000 participants, will conclude depending on the dynamics of the outbreak. The National Institute for Biomedical Research in Kinshasa, the ANRS Emerging infectious diseases, and the NGO ALIMA are jointly launching this critical trial project alongside all their partners to successfully evaluate this post-exposure prophylaxis strategy.
The Africa CDC declared the Bundibugyo Ebola outbreak in the DRC and Uganda a public health emergency of continental security on May 18, just one day after the World Health Organization (WHO) declared the situation a public health emergency of international concern, highlighting the threat posed by the virus to regional and global health security.
Currently, no effective treatment or vaccine against the Bundibugyo virus is available. To address this health crisis, WHO experts have recommended evaluating the effectiveness of several therapeutic and preventive measures. In order to prevent the onset of the disease among high-risk contacts, priority has been firmly given to the oral antiviral obeldesivir, which was developed by Gilead Sciences.
The EBO-PEP platform trial, which has been in preparation since 2024, aims to assess the efficacy of various drugs used as a post-exposure prophylaxis strategy among high-risk contacts of filovirus disease in several countries across Sub-Saharan Africa. Its first implementation specifically focuses on evaluating the experimental drug obeldesivir as a targeted preventive measure in the DRC and Uganda.
Participants, including adults and children over the age of twelve, must have been in direct contact with a confirmed Ebola case within the preceding five days and must not be showing any signs of the disease. Each enrolled participant will be carefully monitored on a daily basis for twenty-one days, with a final medical visit scheduled at forty-two days.
A second sub-protocol is also fully planned to administer another antiviral drug, remdesivir, to children under twelve and pregnant or breastfeeding women who have experienced high-risk contact. This alternative approach on a compassionate use basis is entirely necessary because the currently available data regarding obeldesivir in these highly specific populations remain insufficient to permit its safe widespread use.
“Prevention is essential to stopping this outbreak and protecting those at highest risk of infection. If successful, the EBO-PEP trial could establish post-exposure prophylaxis as a game-changing approach for preventing Ebola disease among people who have been exposed to the virus,” the Africa CDC statement quoted Tedros Adhanom Ghebreyesus, WHO Director General, as saying.
