Antiviral Shows Significant Reduction in Transmission of Influenza
Roche announced positive topline results from the phase 3 CENTERSTONE study that evaluated the efficacy of baloxavir marboxil for the reduction of direct flu transmission.
Positive topline results have been announced from a phase 3 trial evaluating the efficacy of baloxavir marboxil (Xofluza) for the reduction of direct influenza transmission, pharmaceutical company Roche announced in a release.1 The study is the first to demonstrate a transmission reduction benefit from an antiviral for a respiratory viral illness.
Antiviral Shows Significant Reduction in Transmission of Influenza / blessing 123 - stock.adobe.com
Data from the phase 3 CENTERSTONE (NCT03969212) study showed that baloxavir marboxil met its primary endpoint of the proportion of household contacts who tested positive for influenza within 5 days after the index patient had been treated. Roche said the results will be presented at the 2024 OPTIONS XII for the Control of Influenza Congress being held in Australia September 29 to October 2.
READ MORE: GSK Announces Positive Topline Data for Co-Administration of RSV, Shingles Vaccines
CENTERSTONE was a multicenter, randomized, double-blind, placebo-controlled, phase 3 clinical efficacy study assessing the efficacy of baloxavir marboxil to reduce the onward transmission of influenza within households. The study cohort included 4176 participants between the ages of 5 to 64 years who tested positive for influenza but were otherwise healthy. The study took place at 272 sites across the world.
Patients randomly received either a single oral dose of baloxavir marboxil or placebo. Patients under 12 received either 2 mg/kg or 40 mg baloxavir marboxil, and those 12 or older received either 40 mg or 80 mg baloxavir marboxil. Patients were included if they had a positive PCR or rapid influenza diagnostic test.
The primary study endpoint was the proportion of household contacts who tested positive for influenza within 5 days after the index patient had been treated. Key secondary study endpoints included the proportion of household contacts who tested positive for influenza by day 5 and developed symptoms, virological transmission at the household level by day 5, and virological transmission by day 9.
The study found that a single oral dose of baloxavir marboxil taken by a participant infected with influenza significantly reduced the likelihood that others in their household would contract the virus. The therapy was also seen to be well tolerated throughout the study period, with no new safety signals being identified.
“Building on Xofluza’s established efficacy in treating and preventing influenza after exposure, this new evidence of transmission reduction represents an important advance that could help improve health outcomes at an individual and community level,” Levi Garraway, MD, PhD, chief medical officer and head of Global Product Development at Roche, said in a release.1 “We look forward to discussing these data with regulatory authorities and public health organizations for influenza pandemic preparedness to bring these benefits to patients.”
Baloxavir marboxil is a first-in-class single-dose oral medicine with an innovative mechanism of action designed to block viral replication by inhibiting the cap-dependent endonuclease protein. It has demonstrated efficacy in various flu viruses, including in vitro activity against oseltamivir-resistant strains and the avian strains H7N9 and H5N1.
The therapy is approved in the US for the treatment of influenza in individuals 5 years of age and older who have been symptomatic for no more than 48 hours who are otherwise healthy or at high risk of developing influenza-related complications, and for the prevention of influenza in individuals 5 years of age and older following contact with a person who has the flu.
READ MORE: Influenza Resource Center
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