PMID- 33340316
OWN - NLM
STAT- MEDLINE
DCOM- 20210818
LR  - 20220531
IS  - 2048-7207 (Electronic)
IS  - 2048-7193 (Print)
IS  - 2048-7193 (Linking)
VI  - 10
IP  - 4
DP  - 2021 Apr 30
TI  - Baloxavir Treatment in Adolescents With Acute Influenza: Subgroup Analysis From 
      the CAPSTONE-1 Trial.
PG  - 477-484
LID - 10.1093/jpids/piaa145 [doi]
AB  - BACKGROUND: Baloxavir marboxil has demonstrated safety and efficacy in treating 
      adult and adolescent outpatients with acute influenza (CAPSTONE-1 trial). Here, 
      we report a subgroup analysis of outcomes in adolescents from the trial. METHODS: 
      CAPSTONE-1 was a randomized, double-blind, placebo-controlled study. Eligible 
      adolescent outpatients (aged 12-17 years of age) were randomized in a ratio of 
      2:1 to a single dose of baloxavir 40/80 mg if less than/greater than or equal to 
      80 kg or placebo. The main outcomes were the time to alleviation of symptoms 
      (TTAS), duration of infectious virus detection, and incidence of adverse events 
      (AEs). RESULTS: Among 117 adolescent patients, 90 (77%) comprised the 
      intent-to-treat infected population (63 baloxavir and 27 placebo; 88.9% A(H3N2)). 
      The median TTAS was 38.6 hours shorter (95% confidence interval: -2.6, 68.4) in 
      the baloxavir group compared with placebo (median TTAS, 54.1 hours vs 92.7 hours, 
      P = .0055). The median time to sustained cessation of infectious virus detection 
      was 72.0 hours for baloxavir compared with 120.0 hours for placebo recipients (P 
      < .0001). Treatment-emergent PA/I38X-substituted viruses were detected in 5 of 
      the 51 (9.8%) baloxavir recipients. In the safety population (76 baloxavir and 41 
      placebo), AEs were less common in baloxavir than placebo recipients (17.1% vs 
      34.1%; P = .0421). In the baloxavir group, no AEs except for diarrhea were 
      reported in 2 or more patients. CONCLUSIONS: Baloxavir demonstrated clinical and 
      virologic efficacy in the otherwise healthy adolescents with acute influenza 
      compared with placebo. There were no safety concerns identified. These results 
      were similar to the adult population in CAPSTONE-1 and support baloxavir as a 
      treatment option in adolescents.
CI  - (c) The Author(s) 2020. Published by Oxford University Press on behalf of The 
      Journal of the Pediatric Infectious Diseases Society.
FAU - Portsmouth, Simon
AU  - Portsmouth S
AD  - Clinical Development, Shionogi Inc., Florham Park, New Jersey, USA.
FAU - Hayden, Frederick G
AU  - Hayden FG
AD  - Division of Infectious Diseases and International Health, University of Virginia 
      School of Medicine, Charlottesville, Virginia, USA.
FAU - Kawaguchi, Keiko
AU  - Kawaguchi K
AD  - Project Management Department, Shionogi & Co., Ltd., Osaka, Japan.
FAU - Ishibashi, Toru
AU  - Ishibashi T
AD  - Project Management Department, Shionogi & Co., Ltd., Osaka, Japan.
FAU - Kinoshita, Masahiro
AU  - Kinoshita M
AD  - Project Management Department, Shionogi & Co., Ltd., Osaka, Japan.
FAU - Shishido, Takao
AU  - Shishido T
AD  - Drug Discovery & Disease Research Laboratory, Shionogi & Co. Ltd., Osaka, Japan.
FAU - Tsuchiya, Kenji
AU  - Tsuchiya K
AD  - Project Management Department, Shionogi & Co., Ltd., Osaka, Japan.
FAU - Uehara, Takeki
AU  - Uehara T
AD  - Project Management Department, Shionogi & Co., Ltd., Osaka, Japan.
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
PL  - England
TA  - J Pediatric Infect Dis Soc
JT  - Journal of the Pediatric Infectious Diseases Society
JID - 101586049
RN  - 0 (Antiviral Agents)
RN  - 0 (Dibenzothiepins)
RN  - 0 (Morpholines)
RN  - 0 (Pyridones)
RN  - 0 (Triazines)
RN  - 4G86Y4JT3F (baloxavir)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Antiviral Agents/adverse effects
MH  - *Dibenzothiepins/therapeutic use
MH  - Double-Blind Method
MH  - Humans
MH  - Influenza A Virus, H3N2 Subtype
MH  - *Influenza, Human/drug therapy
MH  - Morpholines/therapeutic use
MH  - Pyridones/therapeutic use
MH  - Triazines
PMC - PMC8087144
OTO - NOTNLM
OT  - adolescent
OT  - baloxavir
OT  - cap-dependent endonuclease
OT  - influenza
EDAT- 2020/12/20 06:00
MHDA- 2021/08/19 06:00
PMCR- 2020/12/19
CRDT- 2020/12/19 12:04
PHST- 2020/07/10 00:00 [received]
PHST- 2020/11/18 00:00 [accepted]
PHST- 2020/12/20 06:00 [pubmed]
PHST- 2021/08/19 06:00 [medline]
PHST- 2020/12/19 12:04 [entrez]
PHST- 2020/12/19 00:00 [pmc-release]
AID - 6042166 [pii]
AID - piaa145 [pii]
AID - 10.1093/jpids/piaa145 [doi]
PST - ppublish
SO  - J Pediatric Infect Dis Soc. 2021 Apr 30;10(4):477-484. doi: 
      10.1093/jpids/piaa145.