A single dose of baloxavir marboxil successfully reduced influenza symptoms in children and adults by a day, according to research published in the New England Journal of Medicine.
Researchers performed two randomized, double-blind, controlled trials: in the phase two trial, participants received baloxavir or a placebo, and in the phase three trial, they were given baloxavir, oseltamivir, or a placebo. Patients were between 12 and 64 years old and had acute, uncomplicated influenza but were otherwise healthy.
In phase 2 & 3 RCTs, baloxavir showed evidence of clinical symptom relief and antiviral activity against #influenza. However, influenza-resistant variants appeared to develop with treatment. Full trial results: https://t.co/kwGSE3aqWK pic.twitter.com/U1qmfNk2UK
— NEJM (@NEJM) September 5, 2018
In phase two, the median time to alleviation of symptoms in patients who were given baloxavir was 23.4 to 28.2 hours shorter than the placebo group. In phase three, the median time was 53.7 hours in baloxavir recipients (similar to that of the oseltamivir recipients) and 80.2 hours for those who received a placebo. The baloxavir group also had greater reductions viral load after one day of treatment than the other two groups.
Adverse effects were also less likely in the baloxavir group, occurring in 20.7% of patients, compared to 24.6% of placebo and 24.8% of oseltamivir recipients. No deaths occurred, and one oseltamivir patient was hospitalized.
Faster relief from the flu could be just around the corner. Studies are showing an experimental drug called Baloxavir can help ease flu symptoms within just a few days, much like Tamiflu. https://t.co/B6D4ZjcwQc
— WDTN (@WDTN) September 6, 2018
“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,” the authors wrote.
“Baloxavir shows remarkable antiviral potency in uncomplicated influenza, and if approved by the Food and Drug Administration, it would be an important addition to our treatment options for influenza,” said lead researcher Dr. Frederick G. Hayden. “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.”