FDA approves first treatment for Ebola virus infection
The Food and Drug Administration (FDA) has approved atoltivimab/maftivimab/odesivimab, formerly known as REGN-EB3, for the treatment of Zaire ebolavirus infection in adults and children.
The three monoclonal antibodies in the mixture target the glycoprotein that is on the surface of the Ebola virus. The antibodies bind to the glycoprotein simultaneously and block the attachment and entry of the virus into cells.
The approval is based on results of the PALM trial, a multi-center, open-label, randomized controlled trial, as well as part of an expanded access program conducted in the Democratic Republic of the Congo during the 2018 outbreak. About 33% of patients who received atoltivimab/maftivimab/odesivimab died at 28 days, compared to 51% of patients in the control group.
The most common adverse effects were fever/chills, tachycardia, tachypnea, and vomiting.
The FDA also approved the first vaccine for Ebola virus infection in late 2019.
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Initial stages of Ebola virus infection are nonspecific, which makes the differential diagnosis broad; therefore, clinical suspicion of the infection with prompt isolation is very important in the context of a history of exposure.
Management is centered around early recognition of infection, coupled with effective isolation and optimized supportive care in a hospital setting.
Case fatality rates range from 25% to 90%, but the average rate was approximately 50% in the 2014 outbreak in West Africa (the largest outbreak to date), and 66% in the 2018-2020 outbreak in the Democratic Republic of the Congo (the second largest outbreak to date). Survivors often have prolonged ill health with significant disability.
As there is the possibility of infected people traveling, all countries should have tested and practiced protocols ready for screening and managing patients.
A severe, often fatal, zoonotic infection caused by infection by a virus of the Filoviridae family (genus Ebolavirus). There are currently six known species: Zaire ebolavirus, Sudan ebolavirus, Tai Forest ebolavirus, Bundibugyo ebolavirus, Reston ebolavirus, and Bombali ebolavirus. Of these, only four are known to cause disease in humans - Zaire, Sudan, Tai Forest, and Bundibugyo ebolavirus. Ebola virus infection is part of the group of conditions known as viral hemorrhagic fevers, and was formerly known as Ebola hemorrhagic fever.
History and exam
Senior Lecturer (Honorary Consultant)
Liverpool School of Tropical Medicine and Royal Liverpool University Hospital
NJB is an author of several references cited in this monograph. NJB is partially supported by the National Institute of Health Research Health Protection Unit in Emerging and Zoonotic Infections at the University of Liverpool and Public Health England. He is affiliated with the Liverpool School of Tropical Medicine. Views expressed in this monograph are those of the contributor and do not necessarily represent the official position of the National Health Service, the National Institute for Health Research, the Department of Health, or Public Health England.
Specialist Trainee in Infectious Diseases
Royal Liverpool University Hospital
MF declares that he has no competing interests.
Wellcome Trust/MoD Research Fellow
Liverpool School of Tropical Medicine
TEF is an author of a number of references cited in this monograph. TEF is a consultant/expert panel member to the World Health Organization, and is funded by the UK Surgeon General and the Wellcome Trust. TEF has received research grants from the Medical Research Council and the UK Public Health Rapid Support Team (UK-PHRST).
University College London
Honorary Clinical Lecturer
London School of Hygiene and Tropical Medicine
CFH declares that she has no competing interests.
Dr Nicholas J. Beeching, Dr Manuel Fenech, Dr Tom E. Fletcher, and Dr Catherine F. Houlihan would like to thank Dr Colin Brown (Infectious Disease Lead, Kings Sierra Leone Partnership) for his helpful comments and insights. CB declares that he has no competing interests.
Wade Hampton Frost Professor of Epidemiology
Professor of Medicine, Microbiology, and Pathology
Division of Infectious Diseases and International Health
University of Virginia
WAP declares that he has no competing interests.
Professor of Medicine and Epidemiology
UT Health Medical School
Medical Director of Epidemiology
Memorial Hermann Texas Medical Center
LO-Z declares that he has no competing interests.
Consultant in Microbiology and Infectious Diseases
Royal Free London NHS Foundation Trust
SM declares that he has no competing interests.
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