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. 2023 Nov 1;42(11):983-989.
doi: 10.1097/INF.0000000000004062. Epub 2023 Aug 17.

Safety and Efficacy of Baloxavir Marboxil in Influenza-infected Children 5-11 Years of Age: A Post Hoc Analysis of a Phase 3 Study

Jeffery B Baker  1 , Stanley L Block  2 , Steven E Cagas  3 , Laura Burleigh Macutkiewicz  4 , Colleen Collins  3 , Mitra Sadeghi  3 , Sriparna Sarkar  4 , Sarah Williams  4
Affiliations

Safety and Efficacy of Baloxavir Marboxil in Influenza-infected Children 5-11 Years of Age: A Post Hoc Analysis of a Phase 3 Study

Jeffery B Baker et al. Pediatr Infect Dis J. .

Abstract

Background: miniSTONE-2 (NCT03629184) was a global, phase 3, randomized, controlled study that investigated the safety and efficacy of single-dose baloxavir marboxil in otherwise healthy children 1-<12 years of age and showed a positive risk-benefit profile. This post hoc analysis evaluated the safety and efficacy of baloxavir versus oseltamivir in children 5-11 years old with influenza.

Methods: Children received single-dose baloxavir or twice-daily oseltamivir for 5 days. Safety was the primary objective. Efficacy and virological outcomes included time to alleviation of symptoms, duration of fever and time to cessation of viral shedding by titer. Data were summarized descriptively.

Results: Ninety-four children 5-11 years old were included (61 baloxavir and 33 oseltamivir). Baseline characteristics were similar between the groups. The incidence of adverse events was balanced and low in both treatment groups, with the most common being vomiting (baloxavir 5% vs. oseltamivir 18%), diarrhea (5% vs. 0%) and otitis media (0% vs. 5%). No serious adverse events or deaths occurred. Median (95% CI) time to alleviation of symptoms with baloxavir was 138.4 hours (116.7-163.4) versus 126.1 hours (95.9-165.7) for oseltamivir; duration of fever was comparable between groups [41.2 hours (23.5-51.4) vs. 51.3 hours (30.7-56.8), respectively]. Median time to cessation of viral shedding was shorter in the baloxavir group versus oseltamivir (1 vs. ≈3 days).

Conclusions: Safety, efficacy and virological results in children 5-11 years were similar to those from the overall study population 1-<12 years of age. Single-dose baloxavir provides an additional treatment option for pediatric patients 5-11 years old with influenza.

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Conflict of interest statement

This post hoc analysis was funded by F. Hoffmann LaRoche Ltd and Genentech, Inc., and this funding contributed to the trial design, data interpretation and writing of this report. The authors thank Denise Kenski, PhD, of Health Interactions, Inc, for providing editorial assistance, which was funded by F. Hoffmann LaRoche Ltd and Genentech, Inc., in accordance with Good Publication Practice (GPP2022) guidelines ( https://www.ismpp.org/gpp-2022 ). S.E.C., C.C., M.S., S.S. and S.W. are the employees of Genentech, Inc, and hold shares of Roche. L.B.M. is the employee of Roche Products Ltd and holds shares of Roche. The other authors have no conflicts of interest to disclose.

Figures

FIGURE 1.
FIGURE 1.
Patient disposition. ITTi indicates intent-to-treat influenza-infected; RT-PCR, reverse transcriptase–polymerase chain reaction.
FIGURE 2.
FIGURE 2.
Kaplan-Meier plots of (A) time to cessation of viral shedding by virus titer, (B) time to alleviation of symptoms (4 patients in the baloxavir group and 6 in the oseltamivir group were censored) and (C) sensitivity analysis of time to alleviation of symptoms per treatment group in the intent-to-treat influenza-infected population. NE indicates not evaluable.
See this image and copyright information in PMC

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