South San Francisco, CA – The New England Journal of Medicine (NEJM) has published results from a Phase III clinical trial demonstrating that a single oral dose of Xofluza® (baloxavir marboxil) significantly reduces the transmission of influenza within households. Conducted by Genentech, a member of the Roche Group, the CENTERSTONE trial found that Xofluza lowered the odds of spreading influenza from an infected person to their household contacts by 32%.
The study is the first global Phase III trial to show that an antiviral medication can reduce the spread of a respiratory virus. While Xofluza met the primary endpoint for reducing overall influenza transmission, it also showed a clinically meaningful, though not statistically significant, reduction in the spread of symptomatic infections among household members. The antiviral was well tolerated, and no new safety concerns emerged during the trial.
“This is the first trial to demonstrate that an antiviral treatment can reduce the transmission of influenza viruses within a household, which could have significant public health implications,” said Dr. Levi Garraway, Roche’s Chief Medical Officer and Head of Global Product Development. “The findings underscore the ongoing need for strategies to ease the burden of influenza on individuals and healthcare systems.”
The CENTERSTONE trial results have been submitted to global health regulators, including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), for review.
Influenza remains a major global health challenge, infecting roughly one billion people each year, leading to millions of hospitalizations and up to 650,000 deaths annually. About one-third of influenza virus transmissions occur within households, making this setting a critical target for intervention. Additionally, the broader economic impact includes significant workplace absenteeism, as many adults miss work or continue working while symptomatic.
The trial’s findings come at a time when healthcare systems face the combined pressures of seasonal influenza and other respiratory viruses, including COVID-19. Effective treatments that can limit transmission are seen as increasingly vital for public health resilience.
The CENTERSTONE project received funding support from the U.S. Department of Health and Human Services’ Administration for Strategic Preparedness and Response and the Biomedical Advanced Research and Development Authority.
