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according to Jeffrey Baker, MD, of Clinical Research Prime, Idaho Falls, and associates.
In the double-blind, randomized, controlled MiniSTONE-2 phase 3 trial, the investigators randomized 112 children aged 1-12 years to baloxavir and 57 to oseltamivir. The predominant influenza A subtype was H3N2 for both groups, followed by H1N1pdm09. Demographics and baseline characteristics were similar between treatment groups, the investigators wrote in the Pediatric Infectious Disease Journal.
The time to alleviation of signs and symptoms was a median 138 hours for those receiving baloxavir and 150 hours for those receiving oseltamivir, a nonsignificant difference. Duration of fever and of all symptoms also were similar between groups, as was the time to return to normal health and activity.
A total of 122 adverse events were reported in 84 children, with 95% of adverse events being resolved or resolving by the end of the study. The incidence of adverse events was 46% in those receiving baloxavir and 53% in those receiving oseltamivir, a nonsignificant difference, with the most common adverse event in both groups being gastrointestinal disorders. No deaths, serious adverse events, or hospitalizations were reported, but two patients receiving oseltamivir discontinued because of adverse events.
The study was funded by F. Hoffmann-La Roche. Dr. Baker and a coauthor received funding through their institutions for the conduct of the study; several coauthors reported being employed by and owning stocks in F. Hoffmann–La Roche. One coauthor reported receiving consultancy fees from F. Hoffmann–La Roche and grants from Shionogi.
SOURCE: Baker J et al. Pediatr Infect Dis J. 2020 Jun 5. doi: 10.1097/INF.0000000000002747.
according to Jeffrey Baker, MD, of Clinical Research Prime, Idaho Falls, and associates.
In the double-blind, randomized, controlled MiniSTONE-2 phase 3 trial, the investigators randomized 112 children aged 1-12 years to baloxavir and 57 to oseltamivir. The predominant influenza A subtype was H3N2 for both groups, followed by H1N1pdm09. Demographics and baseline characteristics were similar between treatment groups, the investigators wrote in the Pediatric Infectious Disease Journal.
The time to alleviation of signs and symptoms was a median 138 hours for those receiving baloxavir and 150 hours for those receiving oseltamivir, a nonsignificant difference. Duration of fever and of all symptoms also were similar between groups, as was the time to return to normal health and activity.
A total of 122 adverse events were reported in 84 children, with 95% of adverse events being resolved or resolving by the end of the study. The incidence of adverse events was 46% in those receiving baloxavir and 53% in those receiving oseltamivir, a nonsignificant difference, with the most common adverse event in both groups being gastrointestinal disorders. No deaths, serious adverse events, or hospitalizations were reported, but two patients receiving oseltamivir discontinued because of adverse events.
The study was funded by F. Hoffmann-La Roche. Dr. Baker and a coauthor received funding through their institutions for the conduct of the study; several coauthors reported being employed by and owning stocks in F. Hoffmann–La Roche. One coauthor reported receiving consultancy fees from F. Hoffmann–La Roche and grants from Shionogi.
SOURCE: Baker J et al. Pediatr Infect Dis J. 2020 Jun 5. doi: 10.1097/INF.0000000000002747.
according to Jeffrey Baker, MD, of Clinical Research Prime, Idaho Falls, and associates.
In the double-blind, randomized, controlled MiniSTONE-2 phase 3 trial, the investigators randomized 112 children aged 1-12 years to baloxavir and 57 to oseltamivir. The predominant influenza A subtype was H3N2 for both groups, followed by H1N1pdm09. Demographics and baseline characteristics were similar between treatment groups, the investigators wrote in the Pediatric Infectious Disease Journal.
The time to alleviation of signs and symptoms was a median 138 hours for those receiving baloxavir and 150 hours for those receiving oseltamivir, a nonsignificant difference. Duration of fever and of all symptoms also were similar between groups, as was the time to return to normal health and activity.
A total of 122 adverse events were reported in 84 children, with 95% of adverse events being resolved or resolving by the end of the study. The incidence of adverse events was 46% in those receiving baloxavir and 53% in those receiving oseltamivir, a nonsignificant difference, with the most common adverse event in both groups being gastrointestinal disorders. No deaths, serious adverse events, or hospitalizations were reported, but two patients receiving oseltamivir discontinued because of adverse events.
The study was funded by F. Hoffmann-La Roche. Dr. Baker and a coauthor received funding through their institutions for the conduct of the study; several coauthors reported being employed by and owning stocks in F. Hoffmann–La Roche. One coauthor reported receiving consultancy fees from F. Hoffmann–La Roche and grants from Shionogi.
SOURCE: Baker J et al. Pediatr Infect Dis J. 2020 Jun 5. doi: 10.1097/INF.0000000000002747.
FROM THE PEDIATRIC INFECTIOUS DISEASE JOURNAL