Children must be centered in Ebola treatment and prevention research

Specifically, children must have timely access to pediatric formulations for ongoing trials of oral post-exposure prophylaxis (PEP), including the oral antiviral pill obeldesivir that is manufactured by US-based Gilead Sciences.

The current Ebola disease outbreak in Democratic Republic of Congo (DRC), which is caused by the Bundibugyo virus, has disproportionately affected children. The proportion of children under 5 years old who were diagnosed and subsequently died from the virus is significantly higher than that of adults, as of August 4, among patients with confirmed cases whose age is recorded. Delayed inclusion in trials, lack of pediatric dosing guidance, and safety concerns often prevent children from accessing medical countermeasures like oral antivirals and monoclonal antibodies.

Currently, the EBO-PEP study, which began on July 14, is evaluating the oral antiviral obeldesivir for preventing infection after high-risk exposure to Ebola disease caused by the Bundibugyo virus. If this medicine proves to be effective, it could offer a practical and scalable method to protect people who have had recent contact with someone with Ebola. While children weighing less than 66 pounds (approximately 12 years old or younger) have been excluded from the trial in its original design, we expect a planned protocol amendment to include children over 44 pounds will soon be accepted.

However, due to the lack of an available pediatric formulation of obeldesivir and the absence of published data supporting tablet crushing or dissolution, children under 44 pounds who are age 6 or younger are still excluded from this study. While the trial is conducting a sub-protocol for those excluded — an alternative treatment regimen would be operationally very difficult in outbreak settings, especially for young children.

Gilead has recently expressed willingness to make pediatric formulations of obeldesivir available soon, but it is unclear when a related clinical trial with oral formulations would start. 

Dr. Neal Russell, MSF pediatric advisor, said today:

“Too often, the inclusion of children in the development of medical countermeasures to address public health emergencies is left to the ‘small print.’ But today — with children at a disproportionately high risk of dying if infected with Ebola in the current outbreak in DRC — their inclusion is paramount.

"Researchers, donors, and other stakeholders must urgently support a pediatric obeldesivir sub-study, build on existing dosing guidance, and accelerate the evaluation of other oral antivirals and monoclonal antibodies as post-exposure prophylaxis. We need to generate the evidence now so that children can access effective preventive treatments alongside everyone else — not after the outbreak is over.

"Gilead — the pharmaceutical corporation manufacturing obeldesivir — has committed to reproducing the antiviral in its pediatric formulation. We hope that Gilead will provide a clear and accelerated timeline for doing so, and that stakeholders can organize pediatric studies with this formulation — or with modified adult tablets as soon as possible — so that all children at risk can be included in studies evaluating which post-exposure prophylaxis options are most practical, timely, and effective.”