慢性丙型肝炎直接抗病毒药物临床试验的有效性和安全性研究——美国FDA和欧洲EMA指南解读被引量：4

Efficacy and safety of developing direct-acting antiviral agents for treatment of chronic hepatitis C: guidance from FDA and EMA

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摘要丙型肝炎病毒（hepatitis C virus,HCV）感染是一个重要的全球健康问题,起病隐匿,慢性化程度高,是导致肝硬化和肝癌的最主要病因。直接抗病毒药物（direct-acting antiviral agents,DAAs）较聚乙二醇干扰素α（pegylated interferon,peg-IFN）联合利巴韦林（ribavirin,RBV）治疗方案可获得更高的持续病毒学应答（sustained virological response,SVR）率,并可缩短治疗时间,前景良好。DAAs新药开发将成为未来抗HCV治疗研究的趋势。

作者易盼盼戴菱菱徐平声范学工

机构地区中南大学湘雅医院感染病科病毒性肝炎湖南省重点实验室中南大学湘雅医院药物Ⅰ期临床试验研究室

出处《中国感染控制杂志》 CAS 2014年第11期698-701,共4页 Chinese Journal of Infection Control

基金国家重大新药创制专项(2012ZX09303014)

关键词直接抗病毒药物丙型肝炎干扰素病毒学应答临床试验

分类号 R512.63 [医药卫生—内科学]

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