September 17, 2020

Background: Baloxavir (trade name Xofluza) was approved for the treatment of acute, uncomplicated influenza in patients > 12 years of age in October 2018. However, high-quality data has been underwhelming at best for its efficacy in treatment. Back in November of 2018, REBEL EM concluded:

Clinical Take Home Point: Consistent with every other study on anti-viral medications for influenza, baloxavir appears to decrease duration of symptoms, especially in patients treated within 24 hours of symptoms, BUT a massive exclusion list, cost of the medication, increased resistance after initiation, results only applicable to H3N2 (88% of patients with flu), no comparison to standard care (i.e. symptom based therapy), pharma sponsored study, and no patient oriented outcomes, it is hard to make an argument for the use of baloxivir in patients with confirmed influenza. This trial should be a reminder as to why an industry funded trial, without full release of data, and cherry picked endpoints should not be used to change practice.

Continued research on effective anti-influenza drugs is critically important particularly with the potential for a “double pandemic” in the coming months. While treatment results are modest at best, baloxavir has potential as a prophylactic medication as well.

November 19, 2018

Background: On October 24th, 2018, Roche, the maker of oseltamivir, announced that the US Food and Drug Administration (FDA) approved Xofluza (baloxavir marboxil) for the treatment of acute, uncomplicated influenza in people 12 years of age and older. Historically, there have been two classes of influenza treatment, the M2 ion-channel inhibitors, and the neuraminidase inhibitors, however circulating influenza viruses have become largely resistant to M2 ion-channel inhibitors and the emergence of newer strains of influenza (H1N1) could threaten the utility of neuraminidase inhibitors as well. I have written previously about the Tamiflu Debacle and why this is a medication we should not prescribe to immunocompetent patients. In this post, we attempt to answer a different question: Is baloxavir approval another debacle or does it actually improve patient oriented outcomes?