New England Journal of Medicine Publishes Phase III Data Showing Single-dose Xofluza Significantly Reduces Influenza Virus Transmission
– Detailed results from the CENTERSTONE trial show treatment with Xofluza reduced the odds of transmission, or spread of influenza virus, from an infected person to household members by 32% –
– CENTERSTONE is the first global phase III trial that demonstrates the benefit of an antiviral in reducing the spread of a respiratory virus –
– Reducing the spread of infection within households could help limit transmission within institutions and communities, potentially easing the burden of both seasonal and pandemic influenza on healthcare systems –
“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,” said
Results from the CENTERSTONE trial have been submitted to health authorities, including the
Influenza poses a significant health and economic burden, particularly for those at high risk of influenza-related complications. Every year, seasonal influenza infects an estimated one billion people worldwide and causes millions of hospitalizations, with up to 650,000 deaths globally. Approximately one-third of all influenza virus transmission occurs within households. As many as 75% of working adults experience approximately two days of absenteeism due to influenza, whether they or someone within their household is sick, with most reporting that they go to work despite exhibiting symptoms. In the event of a pandemic, influenza would likely have a significant impact on the overall functioning of healthcare systems. With the co-circulation and burden of multiple respiratory viruses (including COVID-19) infecting individuals within and outside of the winter season, it is more important than ever to have effective options to treat and prevent the spread of influenza.
This project has been supported in whole or in part with federal funds from the
About CENTERSTONE
The CENTERSTONE study [NCT03969212] was a global Phase III trial investigating the efficacy of single-dose Xofluza, taken within 48 hours of symptoms onset, to reduce the onward transmission of influenza within households. The study ran across 272 sites across the globe, with over 4,000 participants, and involved otherwise healthy patients from five to 64 years who had been diagnosed with influenza via a Polymerase Chain Reaction (PCR) or rapid influenza diagnostic test, known as index patients (IPs) and those within their household (known as household contacts, HHCs). The primary endpoint was the proportion of HHCs who tested positive for influenza within five days after the IP had been treated with either Xofluza or placebo. The secondary endpoint looked at the proportion of HHCs who tested positive for influenza by Day five and developed influenza symptoms. The design of this randomized, placebo-controlled trial was developed with inputs from the
About Xofluza® (baloxavir marboxil)
Xofluza 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, potentially reducing the duration of infectiousness and disease. Xofluza’s mechanism of action has demonstrated efficacy in a wide range of influenza viruses, including in vitro activity against oseltamivir-resistant strains and avian strains (H7N9, H5N1) in non-clinical studies.
Xofluza is approved in more than 80 countries for the treatment of uncomplicated influenza types A and B. In the
Xofluza was discovered by Shionogi & Co., Ltd. and is being further developed and commercialized globally in collaboration with the
Xofluza
XOFLUZA is a prescription medicine used to:
-
treat the flu (influenza) in people 5 years of age and older who have flu symptoms for no more than 48 hours and who are:
- otherwise healthy or
- at high risk of developing problems from the flu
- prevent the flu in people 5 years of age and older following contact with a person who has the flu (post-exposure prophylaxis).
XOFLUZA does not treat or prevent illness that is caused by infections other than the influenza virus.
XOFLUZA does not prevent bacterial infections that may happen with the flu.
It is not known if XOFLUZA is safe and effective for the treatment and prevention of the flu in children less than 5 years of age. XOFLUZA is not for use in children less than 5 years of age.
Important Safety Information
Who should not take XOFLUZA?
- Do not take XOFLUZA if you are allergic to baloxavir marboxil or any of the ingredients in XOFLUZA
What should I tell my healthcare provider before using XOFLUZA?
-
Tell your healthcare provider about all of your medical conditions, including if you are:
- Pregnant or plan to become pregnant. It is not known if XOFLUZA can harm your unborn baby.
- Breastfeeding or plan to breastfeed. It is not known if XOFLUZA passes into your breast milk.
- Talk to your healthcare provider before you receive a live flu vaccine after taking XOFLUZA.
- Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, antacids, laxatives, vitamins, and herbal supplements.
What are the possible side effects of XOFLUZA?
Serious side effects may include
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Allergic reaction. Get emergency medical help right away if you develop any of the following signs or symptoms of an allergic reaction:
- trouble breathing
- skin rash, hives or blisters
- swelling of your face, throat or mouth
- dizziness or lightheadedness
The most common side effects of XOFLUZA for treatment of the flu in adults and adolescents (12 years of age and older) were diarrhea, bronchitis, nausea, sinusitis, and headache.
The most common side effects of XOFLUZA for treatment of the flu in children (5 years of age to less than 12 years of age) were diarrhea and vomiting.
These are not all the possible side effects of XOFLUZA. Call your healthcare provider for medical advice about side effects.
XOFLUZA is not effective in treating or preventing infections other than influenza. Other kinds of infections can have symptoms like those of the flu or occur along with flu and may need different kinds of treatment. Tell your healthcare provider if you feel worse or develop new symptoms during or after treatment with XOFLUZA or if your flu symptoms do not start to get better.
You are encouraged to report side effects to
Please see full Prescribing Information, including Patient Product Information.
About
Influenza is a serious infectious disease and represents a significant burden to public health. In the
About
Founded more than 40 years ago,
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