Hirotsu N, et al. Baloxavir marboxil in Japanese pediatric patients with influenza: safety and clinical and virologic outcomes. Clin Infect Dis. 2019 Sep 20.
We assessed the safety and effectiveness of baloxavir marboxil administration in Japanese children with influenza.
This open-label study administered one weigth-adjusted dose of baloxavir to 107 children aged 1-11 years with laboratory-confirmed, febrile influenza virus infection of <48 hours duration.
Adverse 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 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 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).
A 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.
- MicroRNA-206 Inhibits Influenza A Virus Replication by Targeting Tankyrase 2 17 hours ago
- Influenza A Virus Nucleoprotein Activates the JNK Stress-Signaling Pathway for Viral Replication by Sequestering Host Filamin A Protein 17 hours ago
- Energy Landscape for the Membrane Fusion Pathway in Influenza A Hemagglutinin From Discrete Path Samplin 17 hours ago
- Influenza A Viruses in Ruddy Turnstones ( Arenaria interpres); Connecting Wintering and Migratory Sites with an Ecological Hotspot at Delaware Bay 17 hours ago
- Development and Assessment of Two Highly Pathogenic Avian Influenza (HPAI) H5N6 Candidate Vaccine Viruses for Pandemic Preparedness 17 hours ago