丙型肝炎直接抗病毒药物安全性应用进展

Safety of direct antiviral agents for treatment of hepatitis C virus infection

近年来丙型肝炎抗病毒药物进展迅速,直接抗病毒药物(direct antiviral agent,DAA)是丙型肝炎治疗史上最大的标志性事件.自2011年第一代DAA上市以来,5年间先后又有两代DAA通过食品及药物管理局批准上市.由于具有全基因型覆盖、高有效性、服用方便等特性,DAA自应用来迅速在全球部分地区广泛使用.可以发现,DAA几乎已经解决了丙型肝炎抗病毒治疗领域的主要问题.但自其应用以来,不良事件时有报道,甚至出现了个例严重的不良事件,其安全性问题越来越引起大家的关注与重视.基于此,本文尽可能全面地叙述了自DAA临床应用以来发生的不良发应,重点关注了DAA使用中的药物间相互作用问题,希望能借此引起临床医生的注意.

Antiviral drugs for treatment of hepatitis C have grown dramatically in recent years. The emergence of direct antiviral agents （DAAs） is a major advance in hepatitis C treatment. Since the first generation DAAs appeared in 2011, two more generations of DAAs have been approved by the Food and Drug Administration in only five years. With the advantages of coverage of all genotypes, high availability and easy administration, DAAs have been widely used worldwide in recent years. DAAs have nearly solved the main problems encountered in hepatitis C antiviral therapy. However, adverse events associated with DAAs use have been reported constantly, and the safety of DAAs has attracted more and more attention. According to recent reports, the adverse reactions of DAAs have been gradually reduced from the first generation to the third generation. When combined with other drugs, the drug-drug interactions （DDIs） need special attention. In addition, the usage of DAAs in special patient groups should be cautious. In this paper, we will summarize the adverse effects and DDIs of DAAs as well as their usage in the general population and special patient groups.