ArticleClinical infectious diseases : an official publication of the Infectious Diseases Society of America2020
Baloxavir Marboxil in Japanese Pediatric Patients With Influenza: Safety and Clinical and Virologic Outcomes.
Article in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 65 papers, 1 of them a synthesis that pooled it.
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Who cites it
65 citing papers in PubMed, 1 synthesis or guideline pooled it, 149 citations in OpenAlex.
- Comprehensive evaluation of therapeutic effectiveness and safety profiles of baloxavir marboxil for managing influenza virus infection in pediatric populations: a systematic review with pooled meta-analytic data.Frontiers in pediatrics · 2025Pooled it
- Single-dose suraxavir marboxil for acute uncomplicated influenza in adults and adolescents: a multicenter, randomized, double-blind, placebo-controlled phase 3 trial.Nature medicine · 2025Trial
- Baloxavir safety and clinical and virologic outcomes in influenza virus-infected pediatric patients by age group: age-based pooled analysis of two pediatric studies conducted in Japan.BMC pediatrics · 2023Trial
- Baloxavir Treatment in Adolescents With Acute Influenza: Subgroup Analysis From the CAPSTONE-1 Trial.Journal of the Pediatric Infectious Diseases Society · 2021Trial
- Baloxavir Marboxil Single-dose Treatment in Influenza-infected Children: A Randomized, Double-blind, Active Controlled Phase 3 Safety and Efficacy Trial (miniSTONE-2).The Pediatric infectious disease journal · 2020Trial
- Baloxavir Marboxil 2% Granules in Japanese Children With Influenza: An Open-label Phase 3 Study.The Pediatric infectious disease journal · 2020Trial
- Pharmacokinetics, Safety, and Exploratory Efficacy of Onradivir in Children with Acute Uncomplicated Influenza: A Multicenter, Dose-Ranging, Phase 2 Study.Infectious diseases and therapy · 2026Article
- A neuraminidase-targeting nanobody as a therapeutic candidate against influenza A and B viruses.Journal of virology · 2026Article
- Clinical impact of baloxavir-induced PA I38T/M substitutions in diverse influenza populations: a systematic review and meta-analysis.Virus research · 2026Article
- Antiviral activity of Saponin C from Liriope muscari against influenza A virus and SARS-CoV-2.Virologica Sinica · 2026Article
- Antiviral Resistance in Influenza: Clinical and Public Health Implications.Influenza and other respiratory viruses · 2026Review
- Structural and temporal dynamics of pediatric influenza prevention and treatment: a comprehensive bibliometric analysis of historical evolution and emerging trends.Translational pediatrics · 2026Article
- Population Pharmacokinetic and Exposure-Efficacy Analysis of Baloxavir Marboxil for Influenza Treatment and Post-Exposure Prophylaxis in Children.Clinical pharmacology and therapeutics · 2026Article
- Baloxavir susceptibility of seasonal influenza viruses during the first seven seasons of clinical use in Japan, 2017/18 to 2023/24.Euro surveillance : bulletin Europeen sur les maladies transmissibles = European communicable disease bulletin · 2026Article
- From neuraminidase inhibitors to novel mechanisms: expanding therapeutic strategies against influenza.Frontiers in cellular and infection microbiology · 2026Review
- Zapnometinib treatment and influenza A virus infection modulate the HLA class I ligandome in human lung adenocarcinoma cells.Frontiers in immunology · 2026Article
- Article
- Antiviral susceptibility monitoring: testing algorithm, methods, and findings for influenza season, 2023-2024.Antiviral research · 2025Article
- Baloxavir Marboxil in Chinese Pediatric Patients Aged 1 to < 5 Years with Influenza: Safety and Clinical and Virologic Outcomes.Infectious diseases and therapy · 2025Article
- Modeling Influenza Antiviral Strategies: Reducing Burden and Preventing Resistance.The Journal of infectious diseases · 2025Article
5 more citing papers are in PubMed but not listed here.
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Authors and funding
11 authors at 3 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundWe assessed the safety and effectiveness of baloxavir marboxil administration in Japanese children with influenza.
methodsThis open-label study administered 1 weight-adjusted dose of baloxavir to 107 children aged 1-11 years with laboratory-confirmed, febrile influenza virus infection of ≤48 hours duration.
resultsAdverse events (AEs) were reported in 34.6% of patients, most commonly vomiting (7.5%); no serious AEs or AEs causing discontinuation occurred. The median time to alleviation of influenza illness was 44.6 hours (95% confidence interval, 38.9-62.5 hours), to resolution of fever was 21.4 hours, and to sustained cessation of infectious viral shedding was 24.0 hours. However, viruses with amino acid substitutions in the viral polymerase acidic protein at position I38 (PA/I38T/M) emerged in 18 of 77 (23.4%) patients. Emergence was associated with longer infectious virus detectability (median time, 180.0 hours) and time to illness alleviation (median, 79.6 vs 42.8 hours in patients without PA/I38T/M-substituted viruses). Among patients with PA/I38T/M-substituted virus emergence, those with baseline hemagglutinin inhibition (HAI) antibody titer <40 experienced delay in time to illness alleviation (median, 85.4 vs 56.0 hours in patients with higher baseline HAI antibody titer).
conclusionsA single, oral dose of baloxavir marboxil was well tolerated and rapidly reduced viral titers, but the common emergence of PA/I38T/M-substituted viruses warrants consideration of alternative dosing regimens in young children. CLINICAL TRIALS REGISTRATION: Japan Pharmaceutical Information Center Clinical Trials Information (Japic CTI-163417).
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.