Single-Dose Drug Can Shorten Flu Symptoms by About 1 Day
A single dose of a new influenza drug can significantly shorten the duration of the illness in teens and adults, according to a study published in the New England Journal of Medicine.
Two multicentre, double-blind randomised trials found that baloxavir marboxil shortened the duration of flu symptoms by about 1 day and more quickly cleared the virus compared with placebo in otherwise healthy teens and adults.
The larger of the 2 studies also found that baloxavir’s effect on symptoms was similar to that of a 5-day course of oseltamivir but that baloxavir had significantly greater antiviral potency. The studies identified no notable side effects.
“Baloxavir shows remarkable antiviral potency in uncomplicated influenza, and if approved by the US Food and Drug Administration, it would be an important addition to our treatment options for influenza,” said Frederick G. Hayden, MD, University of Virginia School of Medicine, Charlottesville, Virginia. “Of note, because baloxavir has a novel antiviral action in inhibiting the endonuclease of the virus, the drug is inhibitory for influenza A and B viruses including those that may be resistant to currently available drugs.”
The first trial was conducted in Japan in 2016 and evaluated the drug’s safety and effectiveness in 389 adults aged 20 to 64 years. Study participants received either the drug or a placebo. Median flu symptom duration among those who received the drug was 23.4 hours to 28.2 hours shorter than those who received the placebo. The drug was approved for use in Japan in children and adults in February 2018.
The second study was conducted in the United States and Japan during the 2016-17 influenza season. It compared baloxavir with both a placebo and oseltamivir in 1,064 otherwise healthy study participants aged 12 to 64 years with proven influenza. The median time to resolution of flu symptoms was 26.5 hours shorter among those who received baloxavir than the 80.2 hours reported among those who were given placebo. Baloxavir and oseltamivir produced similar reductions in symptom duration, but baloxavir required only a single dose compared with the standard 5-day oseltamivir regimen.
“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,” the authors wrote.
In both trials, the rate of adverse events reported by study participants was similar, regardless of whether participants had been given a placebo or baloxavir.
The drug was accepted for priority review by the US Food and Drug Administration in June; a decision is expected by late December.
SOURCE: University of Virginia Health System