WHO issues new recommendations for Ebola treatment, calls for improved approach

The World Health Organization (WHO) has published its first guidelines for the treatment of Ebola virus disease, with strong new recommendations for the use of two monoclonal antibodies. WHO is calling on the global community to increase access to these life-saving medicines.

Ebola is a severe and often fatal disease caused by the Ebola virus. Previous Ebola outbreaks and responses have shown that early diagnosis and treatment with optimized supportive care—with fluid and electrolyte replacement and symptomatic treatment—significantly improves survival. Now, after a systematic review and meta-analysis of randomized clinical trials of therapeutic drugs for this disease, the WHO has made strong recommendations for two monoclonal antibody treatments: mAb114 (Ansuvimab; Ebanga) and REGN-EB3 (Inmazeb).

Developed in accordance with WHO guidelines standards and methods, and published simultaneously in English and French, the guidelines will support healthcare providers caring for Ebola patients and policy makers involved in preparedness and response to the outbreak. Clinical trials were conducted during the Ebola outbreak, with the largest trial conducted in the Democratic Republic of the Congo, demonstrating that the highest level of scientific rigor can be applied even during an Ebola outbreak under difficult circumstances.

The new guidelines complement clinical care guidelines that outline the optimized supportive care that Ebola patients should receive, from relevant tests to be performed, to pain management, nutrition and co-infections, and other approaches that put the patient on the best path to recovery.

“This therapeutic guide is a key tool in the fight against Ebola,” said Dr. Richard Kojan, co-chair of the WHO-selected Expert Guideline Development Group and president of ALIMA, the Alliance for International Medical Action. “It will help to convince communities, healthcare professionals and patients that this life-threatening disease can be treated with effective medicines. From now on, people infected with the Ebola virus will have a better chance of recovery if they seek care as soon as possible. As with other infectious diseases, timeliness is key and people should not hesitate to consult health professionals as soon as possible to ensure the best possible care.”

The two recommended therapies have shown clear benefits and can therefore be used for all patients confirmed to be positive for the Ebola virus, including the elderly, pregnant and lactating women, children and newborns of mothers with confirmed Ebola in the first seven days after delivery. Patients should receive the recommended neutralizing monoclonal antibodies as soon as possible after laboratory confirmation of the diagnosis.

There she is recommendations on therapy that should not be used to treat patients: this includes ZMapp and remdesivir.

All these recommendations apply only to the disease caused by the Ebola virus (EBOV; Zaire ebolavirus).

“Advances in supportive care and therapy over the past decade have revolutionized the treatment of Ebola. Ebola virus disease was previously considered an almost certain killer. However, this is no longer the case,” said Dr. Robert Fowler of the University of Toronto, Canada and co-chair of the guideline development group. “Providing patients with the best supportive care, combined with treatment with monoclonal antibodies—MAb114 or REGN-EB3—now leads to recovery in the vast majority of people.”

Access to both of these treatments remains challenging, especially in resource-poor areas. These drugs should be where patients need them most: where there is an active Ebola outbreak or where the risk of an outbreak is high or very likely. WHO is ready to support countries, manufacturers and partners in improving access to these treatments, and to support national and global efforts to increase the accessibility of biotherapeutics and their corresponding biotherapeutic products, WHO has published the first call for manufacturers of therapeutics against Ebola virus disease to share their medicines for evaluation from by the WHO Prequalification Unit, a key step to improve access to medicines for communities and countries affected by Ebola.

“We have seen incredible improvements in the quality and safety of clinical care during the Ebola outbreak,” said Dr Janet Diaz, head of the clinical management unit in WHO’s Health Emergencies Programme. “Doing the basics well, including early diagnosis, providing optimized supportive care while evaluating new therapies in clinical trials, changed what was possible during the Ebola outbreak. This is what led to the development of a new standard of patient care. However, timely access to these life-saving interventions must be a priority.”

Although the WHO was able to make strong recommendations for the use of the two therapeutic agents, there is a need for further research and evaluation of clinical interventions, as there are still many uncertainties. Further improvements could be made in supportive care, and in our understanding and characterization of Ebola virus disease and its long-term consequences, and to ensure continued inclusion of vulnerable populations (pregnant women, newborns, children and the elderly) in future research.