ArticleInfectious diseases and therapy2025
Baloxavir Marboxil in Chinese Pediatric Patients Aged 1 to < 5 Years with Influenza: Safety and Clinical and Virologic Outcomes.
Article in Infectious diseases and therapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
introductionBaloxavir marboxil (baloxavir), a cap-dependent endonuclease inhibitor, has been proven safe and efficacious against influenza and approved for the treatment of influenza in children aged ≥ 5 years in China. There were limited data on baloxavir in Chinese pediatric patients aged 1 to < 5 years with influenza. This study aimed to evaluate the safety, clinical efficacy, and virologic outcomes of baloxavir for treating influenza in this younger age group.
methodsIn this single-arm, multicenter trial, patients received a single oral dose of baloxavir (2 mg/kg for participants weighing < 20 kg, or 40 mg for participants weighing ≥ 20 kg to < 80 kg). The primary endpoint was safety. Efficacy, virology, and palatability endpoints were also assessed.
resultsAll 100 enrolled children completed the study and received baloxavir. Adverse events were reported in 29 (29.0%) children, most commonly bronchitis and diarrhea. No death or adverse events leading to discontinuation occurred. Eighty children were included in the clinical efficacy and virologic assessment. The median [95% confidence interval (CI)] time to resolution of influenza signs and symptoms was 150.17 (90.23, NE) h. The median duration of fever was 38.65 (95% CI 25.32, 42.35) h. Infectious virus titers rapidly declined by day 2 post-dose. The proportion of subjects with a positive viral titer was reduced to 8.7% at this timepoint. Of the 100 children enrolled, more than 70% of children rated baloxavir as favorable in the palatability test.
conclusionA single, oral dose of baloxavir was well-tolerated in Chinese children aged 1 to < 5 years, with rapid influenza virus clearance and associated symptom alleviation, suggesting baloxavir was an important treatment option for Chinese pediatric patients with influenza.
trial registrationThe study was registered at the Chinese Clinical Trial Registry (ChiCTR) on March 14, 2025 (registration no. ChiCTR2500098911); Retrospectively registered.
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