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.
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Influenza infection is characterized by upper and lower respiratory tract symptoms of rhinorrhea, cough, fever, chills, headache, and myalgia.
Typically presents in winter season.
Can occur in local community outbreaks, epidemics, and, rarely, pandemics.
Vaccination for prevention is available.
Acute respiratory tract infection typically caused by influenza A or B virus. The virus is transmitted by inhalation of infected respiratory secretions that have been aerosolized through coughing, sneezing, or talking.
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Department of Pulmonary, Allergy and Critical Care
CR declares that she is on Advisory boards for CSL Behring and Speakers Bureau Biocryst.
Medical Director of Infection Control
Department of Medicine
SUNY Upstate Medical University
WJ declares that he has no competing interests.
Associate Professor of Clinical Medicine and Environmental Health Sciences
Columbia University College of Physicians and Surgeons
RLM declares that she has no competing interests.
SUNY Buffalo School of Medicine
Division Allergy and Immunology
MS declares that he has no competing interests.
Department of General Practice and Primary Health Care
ADS declares that she has no competing interests.
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