丙型肝炎病毒蛋白酶抑制剂（PI）是构成丙型肝炎直接抗病毒药物（DAA）方案的主要药物类别之一。该类药物主要经肝脏细胞色素P450代谢，有潜在的肝毒性。群体药物代谢动力学研究数据显示，PI类药物在亚洲/亚裔人群的代谢较西方白种人慢，在亚洲/亚裔人群中开展的临床试验和真实世界研究结果均显示该类药物有引起肝酶和胆红素水平升高的风险。我国医务工作者对PI类药物潜在的肝脏安全风险应给予充分重视，不能过分依赖欧美地区的安全性数据。选择含PI的DAA方案前应准确评估患者基线肝脏疾病程度，考量其疾病进展风险。对于失代偿期肝病患者，禁用PI类药物；对于无肝硬化或代偿期肝硬化患者，在给予PI类药物治疗期间应密切监测其肝功能，注意管理肝脏相关不良事件。“,”Hepatitis C virus protease inhibitors (PIs) are one of the major categories that constitute directly acting antivirals (DAA) regimen in the treatment for hepatitis C. These drugs are mainly metabolized by liver cytochrome P450 and have potential hepatotoxicity. Population pharmacokinetic study data showed that the metabolism of PIs was slower in Asians than that in White/Caucasian subjects, and the results of clinical trials and real-world studies in Asians showed that these drugs had the risk of causing liver enzyme abnormalities and bilirubin elevations. Medical workers in our country should pay full attention to the potential risks of PIs in liver safety, and should not rely too much on safety data in Europe and America. The baseline liver disease severity should be accurately assessed before selecting the DAA regimen containing PIs and the risk of disease progression should be considered. PIs are contraindicated in patients with decompensated liver disease. For patients without cirrhosis or with compensated cirrhosis, the liver function should be closely monitored during the administration of PIs and the management of liver-related adverse events should be paid attention to.