In October 2019, based on clinical trial results, the FDA approved baloxavir treatment for acute uncomplicated influenza within two days of onset of symptoms in people 12 years and older who are at high risk of developing influenza-related complications. (Ison, 2020). . In this clinical trial of early initiation of antiviral treatment for uncomplicated influenza in high-risk patients, baloxavir was superior to placebo and had similar overall efficacy to oseltamivir in time to symptom relief. I did. For patients infected with influenza B virus, baloxavir significantly shortened the median time to symptom resolution by more than 24 hours compared with oseltamivir.
For patients infected with influenza B virus, baloxavir significantly shortened the median time to symptom resolution by more than 24 hours compared with oseltamivir. However, there are no data available regarding influenza treatment with baloxavir in people who are pregnant, immunocompromised, or have severe influenza who are not hospitalized.
In August 2022, the FDA expanded the approval of baloxavir for the treatment of acute uncomplicated influenza within 2 days of symptom onset in healthy children aged 5 years and older but younger than 11 years. [963 KB, 22 pages]. This is based on secondary clinical results from a randomized clinical trial of baloxavir versus oseltamivir for the treatment of uncomplicated influenza in children aged 1 to <12 years (Baker, 2021)).
In randomized clinical trials, the combination of neuraminidase inhibitors (primarily oseltamivir) and baloxavir in the treatment of hospitalized influenza patients aged 12 years and older demonstrated superior clinical efficacy (time to clinical improvement) compared with neuraminidase inhibitors and placebo (Kumar, 2022)).
In November 2020, the FDA recommended post-exposure prophylaxis for influenza for people 12 years of age and older within 48 hours of exposure to an infected person, based on the results of a clinical trial with household contacts of an index case of influenza. Expanded approval of baloxavir to include (Ikematsu, 2020). In this study, baloxavir post-exposure prophylaxis of influenza in household members (19% under 12 years of age; 73% of index household cases treated with antivirals received baloxavir within 24 hours of symptom onset) PEP) significantly reduced influenza infections.Laboratory risk confirmed in 86% of Baloxavir PEP recipients compared to placebo recipients (1.9%) [7 of 374] vs. 13.6% [51 of 375]; adjusted risk ratio, 0.14. 95% confidence interval [CI], 0.06 to 0.30. P<0.001).
In August 2022, the FDA expanded approval of baloxavir for influenza post-exposure prophylaxis in people 5 years of age and older within 48 hours of exposure to a person with the influenza label Xofluza. [963 KB, 22 pages].
