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.[163]
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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Summary
Definition
History and exam
Key diagnostic factors
- exposure to Ebola virus in previous 21 days
- fever
- myalgia
- conjunctival injection
Other diagnostic factors
- fatigue
- anorexia
- diarrhea
- vomiting
- severe headache
- abdominal pain or heartburn
- cough, dyspnea, chest pain
- sore throat
- prostration
- tachypnea
- maculopapular rash
- bleeding
- hepatomegaly
- lymphadenopathy
- hiccups
- tachycardia
- hypotension
- neurological signs
Risk factors
- living or working in, or arrival from, endemic area in previous 21 days
- contact with infected body fluids
- occupational exposure
- butchering or consumption of meat from infected (or potentially infected) animals
- bioterrorism
Diagnostic investigations
1st investigations to order
- reverse transcriptase-polymerase chain reaction (RT-PCR)
- malaria investigations
Investigations to consider
- serum electrolyte levels
- BUN/serum creatinine
- blood lactate
- ABG
- CBC
- coagulation studies
- urinalysis
- LFTs
- serum amylase level
- blood cultures
- serum blood glucose
- antigen-capture enzyme-linked immunosorbent assay (ELISA)
- IgM and IgG antibodies
- chest x-ray
Treatment algorithm
Contributors
Authors
Senior Lecturer (Honorary Consultant)
Liverpool School of Tropical Medicine and Royal Liverpool University Hospital
Liverpool
UK
Disclosures
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
Liverpool
UK
Disclosures
MF declares that he has no competing interests.
Wellcome Trust/MoD Research Fellow
Liverpool School of Tropical Medicine
Liverpool
UK
Disclosures
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).
Clinical Lecturer
University College London
Honorary Clinical Lecturer
London School of Hygiene and Tropical Medicine
London
UK
Disclosures
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.
Peer reviewers
Wade Hampton Frost Professor of Epidemiology
Professor of Medicine, Microbiology, and Pathology
Chief
Division of Infectious Diseases and International Health
University of Virginia
Charlottesville
VA
Disclosures
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
Houston
TX
Disclosures
LO-Z declares that he has no competing interests.
Consultant in Microbiology and Infectious Diseases
Royal Free London NHS Foundation Trust
London
UK
Disclosures
SM declares that he has no competing interests.
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