Roche announced today that an in-depth review of the phase III CENTERSTONE study of Xofluza® (baloxavir marboxil) was published in the New England Journal of Medicine (NEJM). One By demonstrating that a single oral dose of Xofluza taken by influenza patients decreased the likelihood of untreated household members catching the virus by 32%, the trial achieved its main goal. One Xofluza demonstrated a clinically significant decrease in the primary secondary endpoint of influenza virus transmission that results in symptoms, even if statistical significance was not attained. No new warning signs were found, and Xofluza was well tolerated.
This trial is the first to demonstrate an antiviral effect that reduces transmission of influenza viruses within a household. This result may potentially have broad-reaching implications for public health,
This publication reminds us of the ongoing societal need for solutions that can help ease the burden of influenza on society.
Levi Garraway
Health authorities, such as the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA), have received the results of the CENTERSTONE experiment.
CENTERSTONE
A worldwide phase III experiment called CENTERSTONE [NCT03969212] examined the effectiveness of taking a single dosage of Xofluza within 48 hours of the onset of symptoms in order to lessen the spread of influenza within homes. Over 4,000 participants participated in the trial, which was spread across 272 locations worldwide. Index patients (IPs) were otherwise healthy individuals aged 5 to 64 who had received a diagnosis of influenza through a polymerase chain reaction (PCR) or rapid influenza diagnostic test, as well as household contacts (HHCs). The US FDA and top influenza specialists contributed to the design of this randomized, placebo-controlled study.
The percentage of HHCs that tested positive for influenza within five days of the IP receiving either Xofluza or a placebo (1:1 randomization within 48 hours of symptom start) was the main outcome. The probabilities of transmission were 32% lower with Xofluza than with a placebo (adjusted odds ratio [aOR] = 0.68 [95.38% CI: 0.50–0.93]; adjusted incidence of transmission: 13.4% with placebo vs. 9.5% with baloxavir; p=0.013).
Xofluza demonstrated a clinically significant decrease in the important secondary endpoint of influenza virus symptomatic transmission by day five, however, statistical significance was not attained. The probabilities of transmission leading to symptoms were reduced by 25% (aOR = 0.75 [95.38% CI: 0.50–1.12]; p=0.155). For other endpoints, such as transmission up to day nine and transmission at the household level, numerical decreases were noted.
Xofluza® (baloxavir marboxil)
By blocking the cap-dependent endonuclease protein, Xofluza, a first-in-class oral medication administered once, inhibits viral multiplication and shortens the duration of infectiousness and illness. In non-clinical investigations, Xofluza has shown efficacy against a variety of influenza viruses, including avian strains (H7N9, H5N1) and oseltamivir-resistant strains both in vitro and in vivo.
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Graduated from the University of Kerala with B.Sc. Botany and Biotechnology. Attained Post-Graduation in Biotechnology from the Kerala University of Fisheries and Ocean Science (KUFOS) with the third rank. Conducted various seminars and attended major Science conferences. Done 6 months of internship in ICMR – National Institute of Nutrition, Hyderabad. 5 years of tutoring experience.
