Single-Dose Flu Drug Could Be Promising

After only one dose, the investigational drug baloxavir marboxil successfully and safely reduced influenza symptoms and viral load, according to the results of a recent study.

Baloxavir marboxil, a selective inhibitor of influenza cap-dependent endonuclease, has shown therapeutic activity in preclinical models of influenza A and B.

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To further examine this drug, researchers conducted 2 randomized, double-blind, controlled trials involving patients with acute uncomplicated influenza. Following a placebo-controlled trial in which participants were given doses ranging from 10 to 40 mg, the researchers conducted a placebo- and oseltamivir-controlled trial of single, weight-based doses of baloxavir (40 or 80 mg) in patients aged 12 to 64 years. Oseltamivir was given as a dose of 75 mg twice daily for 5 days.

The median time to symptom alleviation was 23.4 to 28.2 hours shorter in the baloxavir group than in the placebo group in the phase 2 trial. In the phase 3 trial, which included 1064 patients, the time to alleviation was 53.7 hours with baloxavir, compared with 80.2 hours with placebo, and was similar with baloxavir and oseltamivir.

Reductions in viral load after 1 day were greater with baloxavir than placebo or oseltamivir, and adverse events were reported 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 1 day after initiation of the trial regimen in patients with uncomplicated influenza. Evidence for the development of decreased susceptibility to baloxavir after treatment was also observed,” the researchers concluded.

—Michael Potts

Reference:

Hayden FG, Sugaya N, Hirotsu N, et al. Baloxavir marboxil for uncomplicated influenza in adults and adolescents [published online September 6, 2018]. N Engl J Med.

DOI: 10.1056/NEJMoa1716197