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The Democratic Republic of the Congo (DRC) has approved the use of five investigational therapeutics to treat Ebola virus disease (EVD), marking the first time such treatments have been available in the midst of an Ebola outbreak in the country, the World Health Organization (WHO) said Wednesday.
Four of the five approved drugs are currently in the country, which are Zmapp, GS-5734, REGN monoclonal antibody combination, and mAb114, under the framework of compassionate use and expanded access, the WHO said.
Clinicians working in the treatment centers will make decisions on which drug to use as deemed helpful for their patients, and appropriate for the setting. The treatments can be used as long as informed consent is obtained from patients and protocols are followed, with close monitoring and reporting of any adverse events.
Earlier in May, WHO convened a group of independent scientific experts to evaluate investigational therapeutics for EVD during the current outbreak in the DRC. They found that there are many pathogens for which no proven effective intervention exists.
For some pathogens there may be interventions that have shown promising safety and efficacy in the laboratory and in relevant animal models, but that have not yet been evaluated for safety and efficacy in humans.
Under normal circumstances, such interventions undergo testing in clinical trials that are capable of generating reliable evidence about safety and efficacy. However, in the context of an outbreak characterized by high mortality, it can be ethically appropriate to offer individual patients investigational interventions on an emergency basis outside clinical trials, WHO said.
According to WHO statistics, as of Wednesday, a total of 58 EVD cases have been reported, including 27 deaths, 37 lab-confirmed, 14 probable and seven suspected cases. Information about the extent of the outbreak remains limited and investigations are ongoing.
Currently, WHO considers the public health risk to be very high at the national level, and also sets the risk at the regional level at high level. Globally, the risk is currently considered low, but WHO said as further information becomes available, the risk assessment will be reviewed.
Meanwhile, the DRC, the WHO and partners have also developed a comprehensive strategic response plan for points of entry to avoid the spread of the disease to other provinces or at the international level.
The plan includes mapping strategic points of entry and the locations of areas where travelers congregate and interact with the local population, and therefore are at risk of Ebola virus disease transmission based on population movement.
The plan involves implementing health measures at the identified points of entry or traveler congregation points, such as risk communication and community engagement, temperature checks, provision of hand hygiene and sanitation materials, and the development of alert, investigation and referral procedures.
The WHO, however, has noted that the Ebola outbreak does not currently meet the conditions for a public health emergency of international concern, and that there should be no international travel or trade restrictions.
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