Influenza treatment and prevention
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New England Journal of Medicine publishes phase III data showing single-dose Xofluza significantly reduces influenza virus transmission
GlobeNewswire News Room· 2025-04-25 05:00
Core Insights - Roche announced the publication of the phase III CENTERSTONE trial results for Xofluza, demonstrating a 32% reduction in the odds of influenza transmission among untreated household members [1][5][4] - The trial's findings may have significant public health implications, highlighting the need for effective influenza treatments [1][2] - Xofluza was well tolerated with no new safety signals identified, and results have been submitted to health authorities including the FDA and EMA [1][4] Group 1: CENTERSTONE Trial Overview - The CENTERSTONE trial was a global phase III study involving over 4,000 participants across 272 sites, focusing on the efficacy of a single-dose Xofluza taken within 48 hours of symptom onset [3][5] - The primary endpoint was the proportion of household contacts testing positive for influenza within five days after treatment, showing a statistically significant reduction in transmission [4][5] - The trial design was developed with input from the FDA and influenza experts, emphasizing its scientific rigor [3] Group 2: Influenza Burden and Treatment Need - Seasonal influenza affects approximately one billion people annually, leading to millions of hospitalizations and up to 650,000 deaths worldwide [2][7] - A significant portion of influenza transmission occurs within households, with 75% of working adults experiencing absenteeism due to influenza-related illness [2][5] - The co-circulation of multiple respiratory viruses underscores the urgent need for effective influenza treatment options [2][6] Group 3: Xofluza Details - Xofluza is a first-in-class, single-dose oral antiviral that inhibits viral replication, approved in over 75 countries for treating uncomplicated influenza [6][8] - It has shown effectiveness against various influenza strains, including those resistant to other treatments [6][8] - The drug represents a significant innovation in influenza treatment, being the first new antiviral approved in nearly 20 years [6][8]