在中国,本地和进口的直接作用的型肝炎抗病毒药物之间是否存在有效性和安全性的差异?
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Zhitao Wang1, Youbing Ran1, Yihan Fu1
1School of Health Policy and Management, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Infectious diseases of poverty
|July 24, 2025
概括
针对型肝炎的局部直接作用抗病毒药物 (DAA) 的疗效和安全性与进口选择相比较. 这表明,当地的DAA可以提高中国的C型肝炎治疗率,等待进一步的研究.
科学领域:
- 肝病学和传染病的研究
- 药物经济学和药物开发
背景情况:
- 针对型肝炎 (C型肝炎) 的本地直接作用抗病毒药物 (DAA) 在中国未得到充分利用,尽管其成本优于进口替代品.
- 关于本地与进口DAA的比较疗效和安全性的证据有限,这可能解释了市场差异.
研究的目的:
- 系统地评估和比较本地和进口DAA在中国C型肝炎治疗中的有效性和安全性.
- 确定有效性或安全性的差异是否解释了当地的DAA的较低市场份额.
主要方法:
- 对19项随机对照试验和82项单臂试验 (SATs) 的系统审查和元分析,涉及在中国注册的5种本地和6种进口DAA.
- 随机效应实证贝叶斯模型用于元分析,子组分析和元回归来比较结果.
- 评估的结果包括持续的病毒学反应,复发,病毒学突破,严重不良事件 (SAE) 和不良事件 (AE).
主要成果:
- 在本地和进口DAA之间,在持续的病毒学反应,复发,病毒学突破或严重不良事件方面没有发现统计学上显著的差异.
- 超回归显示当地的DAA在控制患者种族时,不良事件 (AE) 的发生率高出33.7% (P < 0.001).
- 在本地和进口泛基因型DAA之间没有观察到AEs的显著差异.
结论:
- 当地和进口的DAA在严重不良事件方面表现出可比的疗效和安全性.
- 当地的泛基因型DAA有可能增加中国的C型肝炎治疗率,与标准护理保持一致.
- 建议对多种不同患者群体进行进一步的头对头研究,以产生用于临床和政策决策的强有力的证据.
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