1. Baloxavir Marboxil 2% Granules in Japanese Children With Influenza: An Open-label Phase 3 Study
- Author
-
Takeki Uehara, Toru Ishibashi, Kenji Tsuchiya, Hiroki Sakaguchi, Pedro A. Piedra, Takato Yokoyama, Chisako Sato, and Takao Shishido
- Subjects
Microbiology (medical) ,Dibenzothiepins ,Male ,medicine.medical_specialty ,Pyridones ,Drug Compounding ,Morpholines ,Phases of clinical research ,Administration, Oral ,Antimicrobial Reports ,baloxavir marboxil ,Antiviral Agents ,Virus ,03 medical and health sciences ,0302 clinical medicine ,Pharmacokinetics ,Japan ,children ,030225 pediatrics ,Internal medicine ,Drug Resistance, Viral ,Influenza, Human ,Clinical endpoint ,Medicine ,Humans ,030212 general & internal medicine ,Child ,business.industry ,Triazines ,Granule (cell biology) ,Infant, Newborn ,Infant ,Viral Load ,Regimen ,Titer ,Infectious Diseases ,Child, Preschool ,Pediatrics, Perinatology and Child Health ,ComputingMethodologies_DOCUMENTANDTEXTPROCESSING ,Female ,Open label ,business ,influenza ,granules ,Tablets - Abstract
Supplemental Digital Content is available in the text., Background: A granule formulation of baloxavir marboxil, a selective inhibitor of influenza cap-dependent endonuclease, was newly developed for children with difficulty swallowing tablets. Methods: A multicenter open-label study was conducted during the 2017–2018 influenza season to assess the safety, pharmacokinetics and clinical/virologic outcomes of single, oral, weight-based doses of baloxavir granules in Japanese children infected with influenza virus. The primary clinical endpoint was the time to illness alleviation of influenza. Results: All 33 enrolled children completed the study and received baloxavir (1 mg/kg for 12 children weighing 4-log decrease in infectious viral titer occurred on day 2 and a temporary 2-log increase on day 4. Polymerase acidic protein/I38T/M-substituted viruses were detected in 5 children infected with influenza A, but none with influenza B. Conclusions: Baloxavir granules and the weight-based dose regimen were considered to be well tolerated in children, with rapid influenza virus reduction and associated symptom alleviation. Evidence of baloxavir activity against influenza B was observed, but further data are required for confirmation.
- Published
- 2020