Baloxavir marboxil for uncomplicated influenza in children:a multicenter, randomized, non-inferiority trial

Abstract

Baloxavir marboxil (BM), a newly approved drug for influenza treatment, is prescribed for pediatric patients less frequently than for adults. The purpose of this study was to evaluate the non-inferiority of the clinical effects of BM to oseltamivir for children aged ＜6 years and that of BM to laninamivir for children aged ≥ 6 years. We enrolled 201 influenza patients aged 1 to 15 years from December 2018 through October 2019. The participants were divided according to age (age ＜ 6 years or age ≥ 6 years), and then randomly assigned to the BM or neuraminidase inhibitors (NAIs) group. The primary outcome was the time to fever resolution after treatment. In the age group ＜ 6 years, the median time for the BM and oseltamivir groups was 24.0 h vs. 32.0 h. In the age group ≥ 6 years, the median time of the BM and laninamivir groups was 29.8 h vs. 32.5 h. These results met criteria for non-inferiority. The type and frequency of side effects were almost the same between the BM and NAIs groups. In conclusion, BM would be an effective therapeutic option for children as well as adults.