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Introduction <p>Baloxavir 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&#xa0;≥&#xa0;5&#xa0;years in China. There were limited data on baloxavir in Chinese pediatric patients aged 1 to&#xa0;&lt;&#xa0;5&#xa0;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.</p> Methods <p>In this single-arm, multicenter trial, patients received a single oral dose of baloxavir (2&#xa0;mg/kg for participants weighing&#xa0;&lt;&#xa0;20&#xa0;kg, or 40&#xa0;mg for participants weighing&#xa0;≥&#xa0;20&#xa0;kg to&#xa0;&lt;&#xa0;80&#xa0;kg). The primary endpoint was safety. Efficacy, virology, and palatability endpoints were also assessed.</p> Results <p>All 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.</p> Conclusion <p>A single, oral dose of baloxavir was well-tolerated in Chinese children aged 1 to&#xa0;&lt;&#xa0;5&#xa0;years, with rapid influenza virus clearance and associated symptom alleviation, suggesting baloxavir was an important treatment option for Chinese pediatric patients with influenza.</p> Trial Registration <p>The study was registered at the Chinese Clinical Trial Registry (ChiCTR) on March 14, 2025 (registration no. ChiCTR2500098911); Retrospectively registered.</p>

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Baloxavir Marboxil in Chinese Pediatric Patients Aged 1 to < 5 Years with Influenza: Safety and Clinical and Virologic Outcomes

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年10月23日

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  • Yuchuan Li,
  • Peng Guo,
  • Chenguang Jia,
  • Ju Yin,
  • Yuncui Yu,
  • Qiang Qin,
  • Xiaoyan Zhang,
  • Shunying Zhao,
  • Haiming Yang,
  • Weihua Zhang,
  • Yuguang Liang,
  • Qian Ding,
  • Man Tian,
  • Yiping Chen,
  • Chunmei Zhu,
  • Fang Wang,
  • Jing Ma,
  • Lisu Huang,
  • Yongping Xie,
  • Jing Bi,
  • Sainan Shu,
  • Chengsong Zhao

摘要

Introduction

Baloxavir 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.

Methods

In 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.

Results

All 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.

Conclusion

A 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 Registration

The study was registered at the Chinese Clinical Trial Registry (ChiCTR) on March 14, 2025 (registration no. ChiCTR2500098911); Retrospectively registered.