Baloxavir marboxil approved for postexposure prophylaxis of influenza
The approved indication for baloxavir marboxil has been expanded in the US and in Europe to include postexposure prophylaxis of influenza for patients 12 years of age and older.
The safety and efficacy of baloxavir marboxil in postexposure prophylaxis is supported by one multicenter, double-blind, randomized, placebo-controlled trial conducted in Japan during the 2018-2019 season.
Participants were assigned in a 1:1 ratio to receive either a single dose of baloxavir marboxil or placebo. The primary end point of the trial was clinical influenza, confirmed by reverse transcriptase-polymerase chain reaction testing over a period of 10 days.
The study found that the percentage of participants in whom clinical influenza developed was significantly lower in the baloxavir marboxil group than in the placebo group (1.9% vs. 13.6%) (adjusted risk ratio 0.14; 95% confidence interval [CI] 0.06 to 0.30; P<0.001). The incidence of adverse events reported during the trial was similar in the two groups (22.2% in the baloxavir marboxil group and 20.5% in the placebo group).
Baloxavir marboxil was previously approved for the treatment of uncomplicated influenza in patients 12 years of age and older who have been symptomatic for no more than 48 hours.
See Management: treatment algorithm
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Summary
Definition
History and exam
Key diagnostic factors
- winter season
- current influenza outbreak
- unvaccinated
- fever with cough
Risk factors
- age ≥65 years
- age 6-59 months
- chronic cardiovascular or respiratory conditions
- diabetes
- hemoglobinopathy
- immunocompromise
- chronic kidney disease (CKD)
- pregnancy
- caregivers and household contacts of high-risk groups
- healthcare workers
Diagnostic investigations
Investigations to consider
- viral culture
- direct immunofluorescent antibody staining
- reverse transcriptase-polymerase chain reaction
- serology
- enzyme immunoassay (EIA)
- rapid diagnostic tests
- chest x-ray
Treatment algorithm
Contributors
Authors
Staff Physician
Department of Pulmonary, Allergy and Critical Care
Cleveland Clinic
Cleveland
OH
Disclosures
CR declares that she is on Advisory boards for CSL Behring and Speakers Bureau Biocryst.
Peer reviewers
Associate Professor
Medical Director of Infection Control
Infectious Disease
Department of Medicine
SUNY Upstate Medical University
Syracuse
NY
Disclosures
WJ declares that he has no competing interests.
Associate Professor of Clinical Medicine and Environmental Health Sciences
Columbia University College of Physicians and Surgeons
New York
NY
Disclosures
RLM declares that she has no competing interests.
Chief
SUNY Buffalo School of Medicine
Division Allergy and Immunology
Buffalo
NY
Disclosures
MS declares that he has no competing interests.
Associate Professor
Department of General Practice and Primary Health Care
Ghent University
Ghent
Belgium
Disclosures
ADS declares that she has no competing interests.
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