Summary:
Baloxavir marboxil (Xofluza) has been recently approved for the treatment of influenza and is only a SINGLE dose. This study conducted two randomized, double-blind, controlled trials involving otherwise healthy outpatients with acute uncomplicated influenza. The primary efficacy end point was the time to alleviation of influenza symptoms in the intention-to-treat infected population. The study included patients 12-64 years old of age during the 2016-2017 season.
Phase 2 trial included 4 groups:
- 10 mg of baloxavir
- 20 mg of baloxavir
- 40 mg of baloxavir
- placebo
Phase 3 trial included 3 groups:
- baloxavir & placebo
- oseltamivir & placebo
- placebo only
In conclusion, baloxavir was superior to placebo in alleviating influenza symptoms. It was also superior to both oseltamivir and placebo in reducing the viral load 1 day after initiation of the trial regiment in patients with uncomplicated influenza. The observed antiviral effects points to the potential value of using baloxavir in treating complicated or severe influenza infections because the duration of influenza virus replication is longer in high-risk groups, such as infants, the elderly, hospitalized patients and immunocompromised hosts.
Xofluza Information Pamphlet:
Xofluza – Information Pamphlet
Journal Article:
Baloxavir Marboxil for Uncomlicated Influenza in Adults and Adolescents
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