Baloxavir Marboxil for Uncomplicated Influenza in Adults and Adolescents
Frederick G Hayden, Norio Sugaya, Nobuo Hirotsu, Nelson Lee, Menno D de Jong, Aeron C Hurt, Tadashi Ishida, Hisakuni Sekino, Kota Yamada, Simon Portsmouth, Keiko Kawaguchi, Takao Shishido, Masatsugu Arai, Kenji Tsuchiya, Takeki Uehara, Akira Watanabe
NEW ENGLAND JOURNAL OF MEDICINE | MASSACHUSETTS MEDICAL SOC | Published : 2018
BACKGROUND: Baloxavir marboxil is a selective inhibitor of influenza cap-dependent endonuclease. It has shown therapeutic activity in preclinical models of influenza A and B virus infections, including strains resistant to current antiviral agents. METHODS: We conducted two randomized, double-blind, controlled trials involving otherwise healthy outpatients with acute uncomplicated influenza. After a dose-ranging (10 to 40 mg) placebo-controlled trial, we undertook a placebo- and oseltamivir-controlled trial of single, weight-based doses of baloxavir (40 or 80 mg) in patients 12 to 64 years of age during the 2016-2017 season. The dose of oseltamivir was 75 mg twice daily for 5 days. The prima..View full abstract
Funded by Shionogi; JapicCTI number, 153090, and CAPSTONE-1 ClinicalTrials.gov number, NCT02954354.