The World Health Organisation (WHO) on Monday announced that the co-sponsors of the Ebola therapeutics trial in the DR Congo had announced advances that will bring patients a better chance of survival. According to the UN health agency, two out of the four drugs being tested are more effective in treating Ebola. “Moving forward, these are the only drugs that future patients will be treated with,” reads part of a WHO update on the Ebola drug trials. This is a post-infection treatment and not a vaccine as the whole world is accustomed to. Scientists say the results are very good news for the fight against Ebola as the news marks a first for people who already have been infected. Four drugs were trialled by an international research group co-ordinated by the WHO on patients in the DR Congo, where there is a major outbreak of the virus. The study dubbed Pamoja Tulinde Maisha (PALM [together save lives]) is a randomized, controlled trial of four investigational agents (ZMapp, remdesivir, mAb114 and REGN-EB3) for the treatment of patients with Ebola. It was found that more than 90% of those infected can survive if treated early with the two most effective drugs, named REGN-EB3 and mAb114. The drugs attack the Ebola virus with antibodies and neutralise its impact on human cells. Their trial began on November 20, 2018 in the DR Congo as part of the emergency response to an ongoing Ebola outbreak in the North Kivu and Ituri Provinces. It was the first-ever multi-drug trial for an Ebola treatment. The study is co-sponsored by the DR Congo’s Institut National de Recherche Biomédicale (INRB) and the U.S’s National Institute of Allergy and Infectious Diseases (NIAID); carried out by an international research consortium coordinated by the WHO; and supported by four pharmaceutical companies (MappBio, Gilead, Regeneron, and Ridgeback Biotherapeutics). “From now on, we will no longer say that Ebola is incurable,” Jean-Jacques Muyembe, director general of the INRB which has overseen the trial’s operations on the ground is quoted saying. A joint WHO-NIAID-INRB release states that as of last Friday, the trial had enrolled 681 patients toward an enrollment total of 725. Patients were enrolled at four Ebola Treatment Centers (ETCs) in Beni, Katwa, Butembo and Mangina. These treatment centers were overseen by staff from the INRB, and three medical humanitarian organizations: the Alliance for International Medical Action (ALIMA), the International Medical Corps (IMC), and Médecins Sans Frontières (MSF). “The trial is monitored by an independent Data and Safety Monitoring Board (DSMB) that meets periodically to review interim safety and efficacy data and to make recommendations to the study team and the sponsors,” reads part of the release. As a result of their August 9 review, the DSMB recommended that the study be stopped and that all future patients be randomized to receive either REGN-EB3 or mAb114 in what is being considered an extension phase of the study. “This recommendation was based on the fact that an early stopping criterion in the protocol had been met by one of the products, REGN-EB3. The preliminary results in 499 study participants indicated that those individuals receiving REGN-EB3 or mAb114 had a greater chance of survival compared to those participants in the other two arms.” Consequently, the chief investigators of the study, its statistician and co-sponsors accepted this recommendation, and the Ebola treatment center staff at the sites were promptly informed. According to the August 12 release, patients who were randomized to ZMapp or remdesivir in the previous 10 days now have the option, “at the discretion of their treating physician,” to receive either REGN-EB3 or mAb114. It is noted that while the final analysis of the data can occur only after all the data are generated and collected – likely late September or early October 2019 – the DSMB and the study leadership “felt the preliminary analysis of the existing data was compelling enough to recommend and implement these changes in the trial immediately.” According to latest statistics from WHO, Ebola has so far claimed 1,888 lives in DR Congo. Remain vigilant Despite the good news, Mallick Kayumba, the Spokesperson of the Ministry of Health, said their advice on prevention measures stands. The Government has sustained robust community awareness and mobilisation, vaccination of frontline workers, creating EVD treatment centres, and stepping up surveillance. Rwandans, Kayumba reiterated, must remain ever vigilant so as to prevent the outbreak coming to Rwanda. Kayumba said: “The most important element in prevention is that we must all continue to be careful and up our prevention measures; avoid shaking hands, wash hands as much as possible, and stay away from the affected red zones.” “For example, going to affected regions has to be avoided and people must avoid, for example, going to a burial when they do not know the actual cause of death. People also need to quickly share information and alert pertinent institutions as we advised, if they saw a suspected case.” Rwanda remains without any Ebola case registered to date.
