From the Guidelines
Xofluza (Baloxavir) is not more effective than Tamiflu (Oseltamivir) according to the most recent guidelines from the American Academy of Pediatrics (AAP) in 2024 1. The AAP recommends oseltamivir as the preferred postexposure chemoprophylaxis for patients with influenza A and/or B, with specific dosing guidelines for different age groups and weights.
- For adults, the recommended dose of oseltamivir is 75 mg, twice daily, for 5 days for treatment, and 75 mg, once daily, for 7 days for chemoprophylaxis.
- For children, the dosing varies by weight, with 30 mg, twice daily, for those weighing 12-15 kg, and up to 75 mg, twice daily, for those weighing over 40 kg. In contrast, baloxavir is approved by the FDA for treatment of acute uncomplicated influenza within 2 days of illness onset, with a single oral dose based on body weight: 2 mg/kg for those under 20 kg, 40 mg for those weighing 20-80 kg, or 80 mg for those over 80 kg 1. While baloxavir may have some advantages, such as a more convenient single-dose regimen, the AAP guidelines prioritize oseltamivir due to its established efficacy and safety profile.
- Oseltamivir has a well-documented history of use and a broader range of indications, including treatment and chemoprophylaxis for influenza A and B.
- Baloxavir, on the other hand, is not recommended as monotherapy for treatment of influenza in individuals who are severely immunocompromised, and its use is not recommended for persons who are pregnant or breastfeeding 1. Ultimately, the choice between Xofluza and Tamiflu should be based on individual patient factors, potential side effects, and local resistance patterns, in consultation with a healthcare provider.
From the FDA Drug Label
In Trial T0832, ... There was no statistically significant difference in the median time to improvement of influenza symptoms in the subjects who received XOFLUZA (73 hours) and those who received oseltamivir (81 hours)
- The primary efficacy endpoint was time to improvement of influenza symptoms
- No statistically significant difference was observed between Xofluza and Tamiflu in terms of median time to improvement of influenza symptoms
- The median time to improvement of influenza symptoms was 73 hours for Xofluza and 81 hours for oseltamivir 2 Xofluza (Baloxavir) is not more effective than Tamiflu (Oseltamivir) based on the available data.
From the Research
Efficacy of Xofluza (Baloxavir) Compared to Tamiflu (Oseltamivir)
- Xofluza (Baloxavir) has been shown to be efficacious in improving influenza symptoms, with similar efficacy to oseltamivir in some studies 3, 4.
- Baloxavir can reduce influenza viral load more rapidly than oseltamivir 3, 5.
- A clinical trial found that single-dose baloxavir had superior efficacy to placebo and similar efficacy to oseltamivir for ameliorating influenza symptoms in high-risk outpatients 4.
- Another study found that baloxavir had a similar time to alleviation of symptoms compared to oseltamivir, but with greater reductions in viral loads 5.
Comparison of Time to Improvement of Influenza Symptoms
- The median time to improvement of influenza symptoms was shorter in the baloxavir group (73.2 hours) compared to the oseltamivir group (81.0 hours) in one study 4.
- However, the difference in time to improvement of influenza symptoms between baloxavir and oseltamivir was not significant in this study 4.
Safety and Tolerability
- Baloxavir has been shown to be well tolerated, with a safety profile comparable to placebo 4, 6.
- Adverse events were reported in a similar percentage of patients in the baloxavir and oseltamivir groups in one study 4.
- The incidence of adverse events was similar in the baloxavir and placebo groups in another study 6.