Most people don’t understand that we have limited options to treat folks with the flu.
They still think that Tamiflu is some kind of wonder drug.
It isn’t. At best, if you take it within 48 hours of the start of your flu symptoms, you might “shorten the duration of fever and illness symptoms, and may reduce the risk of complications from influenza.”
Other flu drugs aren’t that much better, which is why they are typically reserved for those who are considered at high risk for flu complications.
What to Know About Xofluza for the Flu
That’s why many of us welcomed news of a new flu drug – Xofluza (baloxavir marboxil).
“This is the first new antiviral flu treatment with a novel mechanism of action approved by the FDA in nearly 20 years. With thousands of people getting the flu every year, and many people becoming seriously ill, having safe and effective treatment alternatives is critical. This novel drug provides an important, additional treatment option.”
Scott Gottlieb, M.D., FDA Commissioner
Unfortunately, while it has a new mechanism to treat the flu, there are plenty of reasons to not get too excited about Xofluza, despite what the headlines might be telling you:
- the clinical benefit seems similar to Tamiflu
- the two studies that were used to get Xofluza approved only looked at folks with mild to moderate flu symptoms (those with severe flu symptoms were excluded) and only looked at folks without complex medical problems, so we don’t know if it reduces hospitalizations, flu complications, or deaths from flu
- flu virus strains might be able to mutate and develop resistance to Xofluza, although it is not clear if these strains could then be passed to others
- the single dose treatment is only approved for adults and kids who are at least 12 years old
- at $120 to $150, it is more expensive than generic Tamiflu
Still, if it works just as well as Tamiflu, but really does have fewer side effects, then that is a good thing, especially if it isn’t overused.
“The significant reduction in influenza viral replication with baloxavir treatment suggests the potential for reducing influenza virus spread to close contacts and should be studied through randomized, controlled trials in households and during institutional influenza outbreaks such as in longterm care facilities.”
Timothy M. Uyeki, M.D., M.P.H., M.P.P. on A Step Forward in the Treatment of Influenza
Could Xofluza make you less contagious to others?
That would be a good way to control outbreaks.
Why isn’t it approved for younger kids? The pediatric studies haven’t been completed yet, but among the postmarketing studies that the FDA are requiring are in infants, children between the ages of 12 months to less than 12 years, and the final report of a pediatric study from Japan.
Other postmarketing studies of Xofluza will include hospitalized patients, the use of Xofluza as post-exposure prophylaxis to prevent influenza in household contacts of an index case, and to monitor resistance.
Should folks be excited about Xofluza? While it is certainly nice to have an alternative to Tamiflu, an alternative that worked a lot better would have really gotten most of us excited.
Right now we’ll settle for folks only using anti-viral flu medications, whether it is Tamiflu, Relenza, or Xofluza, when they are truly necessary – for high risk children and adults.
Remember, not everyone with the flu needs these medications.
And they are certainly not a substitute for a flu vaccine, unless you have a true medical contraindication to getting vaccinated.
More on Xofluza
- FDA – FDA approves new drug to treat influenza
- FDA – Xofluza NDA Approval Letter
- Xofluza package insert
- A new drug for influenza
- FDA Approves Xofluza: What Makes This New Flu Treatment Different
- A Step Forward in the Treatment of Influenza
- CDC – Influenza Antiviral Medications: Summary for Clinicians
- New evidence, same conclusion: Tamiflu only modestly useful for influenza
- FDA – Tamiflu (oseltamivir phosphate) Information
- FDA – Tamiflu: Consumer Questions and Answers
- FDA – Tamiflu Pediatric Adverse Events: Questions and Answers
- CDC – Children and Flu Antiviral Drugs
- CDC – Mixing Tamiflu with Sweet Liquids
- CDC– Opening and Mixing Oseltamivir Capsules with Liquids if Child Cannot Swallow Capsules
Last Updated on October 26, 2018 by Vincent Iannelli, MD