7 January, 2015 — Led by Oxford University and funded by the Wellcome Trust, the trial aims to determine if the anti-viral drug brincidofovir is a safe and effective treatment for Ebola. Whilst MSF hopes that brincidofovir might help patients survive infection, it is still not sure whether this will be the case.
The trial is designed without a control group and efficacy will be determined by comparing the outcomes of the patients who participate in the trial with the outcomes of patients treated at ELWA 3 earlier in the outbreak. Randomising patients to potentially receive a placebo was not considered ethical in the context of the current Ebola outbreak.
“We know that brincidofovir has been taken safely by over 1000 people in clinical trials for other viral infections and we know that is has been shown to be effective in laboratory tests that use Ebola-infected cells. What we do not know yet is if it will be effective against Ebola in humans – this is why this trial is necessary” says Dr Jake Dunning, Trial Clinical Lead for Oxford University.
All new patients with Ebola positive blood tests will be given the opportunity to participate, with informed consent. Those who do not wish to be given the trial treatment will receive the same standard supportive care as those who do, but without the administration of the trial drug.
“With every possible treatment comes hope, and we are very excited that we may be able to help our patients beyond symptom management and routine supportive treatments like IV fluid therapy” says MSF medical coordinator Brett Adamson. “But this treatment, even if shown to be effective, will not end the epidemic. We are in a crucial phase of the outbreak in Liberia, and there are still multiple chains of transmission which means that the situation is still not under control. A coordinated and holistic response is required but together we have a very real opportunity to bring the outbreak in Liberia to an end.
”If brincidofovir is shown to be safe and effective, it will be made accessible to Ebola patients in other Ebola treatment centres through advancing the trial to the next phase.
The trial is running with the approval of the Liberian Medicines and Health Products Regulatory Authority (LMHRA), and ethics committees from the University of Liberia, MSF and Oxford University.
Since July 2014, MSF has been responding to the Ebola outbreak in Liberia. Currently the organisation is running a 50 bed Ebola treatment centre, in Paynesville, Monrovia, a 10 bed transit unit at Redemption Hospital in New Kru Town, Monrovia and health promotion activities across the city. MSF employs some 1400 national and international staff on the ground in Liberia and has treated more than 1600 Liberians confirmed to be Ebola positive. MSF is also involved in a clinical trial in Guéckédo, Guinea, and expects to begin another trial in Conakry, Guinea in the coming weeks. In Liberia MSF ran emergency operations during the fourteen years of civil conflict that raged until 2004 as well as during the post war period before handing over all projects to the Ministry of Health and other NGOS and leaving the country in 2012