Results of the Phase III CENTERSTONE study demonstrated that when Xofluza is taken by an individual with influenza, it lowers the risk of others in the household contracting it.
Data from the Phase III CENTERSTONE trial found that a single dose of Roche’s Xofluza significantly reduces the transmission of influenza within households. Additionally, Roche stated that this is the first time that an antiviral used in the treatment of a respiratory viral illness has demonstrated a transmission reduction benefit in a global Phase III study. Full results of the study are expected to be presented at the 2024 OPTIONS XII congress and will play a major role in discussions with regulatory bodies and public health organizations as flu season arrives.1
“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,” said Levi Garraway, MD, PhD, chief medical officer, head, global product development, Roche, in a press release. “We look forward to discussing these data with regulatory authorities and public health organizations for influenza pandemic preparedness to bring these benefits to patients.”
The global Phase III CENTERSTONE trial investigated the efficacy of single-dose Xofluza, taken within 48 hours of symptom onset, to reduce the onward transmission of influenza within households. According to Roche, the study included over 4,000 participants from the ages of five to 64 years across 272 sites globally.
All patients had been diagnosed with influenza through a polymerase chain reaction or rapid influenza diagnostic test. The primary endpoint of the study was the proportion of household contacts (HHCs) who tested positive for influenza within five days after the index patient had been treated with either Xofluza or placebo. Additionally, the secondary endpoint was the evaluation of HHCs who tested positive for influenza by day five and developed influenza symptoms.
Results found that Xofluza was well tolerated, with no new safety concerns reported.1
According to the National Institute of Health, influenza leads to approximately 36,000 deaths in the United States on a yearly basis, while 200,000 more are hospitalized. Additionally, one in every five Americans get influenza each fall season.2 The World Health Organization (WHO) states that there are around a billion cases of seasonal influenza reported annually, causing anywhere from 290,000 to 650,000 respiratory deaths per year. In children, 99% of deaths under the age of five years comes from influenza-related lower respiratory tract infections in developing countries.
While all age groups are at risk for getting influenza, pregnant women, children under the age of five years, older people, individuals with chronic medical conditions, and individuals with immunosuppressive conditions/treatments are at an increased risk. Further, healthcare workers have a high risk due to increased exposure to patients. Healthcare workers are also at risk of further spreading the virus, particularly to vulnerable individuals.3
“Seasonal influenza spreads easily, with rapid transmission in crowded areas including schools and nursing homes,” reports WHO. “When an infected person coughs or sneezes, droplets containing viruses (infectious droplets) are dispersed into the air and can infect persons in close proximity. The virus can also be spread by hands contaminated with influenza viruses. To prevent transmission, people should cover their mouth and nose with a tissue when coughing and wash their hands regularly.”
References
1. Positive phase III results show Xofluza significantly reduces the transmission of influenza viruses. Roche. September 19, 2024. Accessed September 19, 2024. https://www.roche.com/media/releases/med-cor-2024-09-19
2. Influenza. NIH. Accessed September 19, 2024. https://www.nih.gov/about-nih/what-we-do/nih-turning-discovery-into-health/influenza
3. Influenza (Seasonal). WHO. October 3, 2023. Accessed September 19, 2024. https://www.who.int/news-room/fact-sheets/detail/influenza-(seasonal)