Influenza infection

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: approach

See Management: treatment algorithm

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