Single-dose baloxavir superior to Tamiflu in uncomplicated influenza

According to a new study, single-dose baloxavir is superior to Tamiflu in uncomplicated influenza.

The researchers found that single-dose baloxavir was superior to placebo in alleviating influenza symptoms, and was superior to both oseltamivir and placebo in reducing the viral load 1 day after initiation of the trial regimen in healthy outpatients with acute uncomplicated influenza. It was also without evident safety concerns. The study has been published in the New England Journal of Medicine.

The researchers investigated the efficacy of baloxavir marboxil for uncomplicated influenza in adults and adolescents. Outcomes suggest that single-dose baloxavir was safe and had superior outcomes to placebo in alleviating influenza symptoms. Baloxavir marboxil is a selective inhibitor of influenza cap-dependent endonuclease in preclinical models of influenza A and B virus infections, including strains resistant to current antiviral agents

The researchers conducted two randomized, double-blind, controlled trials recruiting otherwise healthy outpatients with acute uncomplicated influenza. During the 2016–2017 season, after a dose-ranging (10 to 40 mg) placebo-controlled trial, a placebo- and oseltamivir-controlled trial of single, weight-based doses of baloxavir (40 or 80 mg) in patients 12 to 64 years of age were conducted. In all the subjects 75 mg oseltamivir was administered twice daily for 5 days. The time to alleviation of influenza symptoms in the intention-to-treat infected population was assessed as the primary efficacy endpoint.

It was found that with baloxavir and oseltamivir, time to alleviation of symptoms was similar. In addition relative to placebo or oseltamivir, baloxavir was correlated with greater reductions in viral load 1 day after initiation of the regimen. The researchers noted adverse events in 20.7% of baloxavir recipients, 24.6% of placebo recipients, and 24.8% of oseltamivir recipients.

"Single-dose baloxavir was without evident safety concerns, was superior to placebo in alleviating influenza symptoms, and was superior to both oseltamivir and placebo in reducing the viral load one day after initiation of the trial regimen in patients with uncomplicated influenza," the authors concluded.