丙型肝炎无干扰素全口服治疗临床Ⅲ期试验进展

Progress of interferon-free oral drugs in phase Ⅲ clinical trials for hepatitis C treatment

丙型肝炎病毒（hepatitis C virus,HCV）为黄病毒属的单股正链RNA病毒,主要通过血液传播,慢性化程度高。目前的标准治疗是聚乙二醇干扰素（pegylated IFN-α）联合利巴韦林（ribavirin,RBV）。自1989年首次鉴定出HCV以来[1],HCV的干扰素治疗虽然有缓慢的进展,如长效干扰素的使用,但仍无法摆脱其不良反应多、持续病 毒学应答率（sustained virologic response，SVR）不够高及使用不便等缺点。近几年，丙型肝炎的抗病毒治疗研究突飞猛进。

Hepatitis C virus is a single stranded RNA virus categorized to the genus Flavirus.HCV infection is transmitted via blood and characterized by high chronic rate.Hepatitis C poses a major health threat worldwide with approximately 160 million chronically infected individuals.The standard therapy for HCV infection in the past decade is using pegylated IFN-αplus ribavirin.However,IFN-αtreatment showed low response rate,high averse effect,and would be eventually replaced by emerging new drugs.The combination of ribavirin therapy may prevent relapse,as well as increase sustained response rate,while its usage remains to be further investigated.In 2011,FDA approved the NS3 protease and NS5 Binhibitor telaprevir and boceprevir as the first generation of direct-acting antiviral agents.In 2013,the approval of sofosbuvir in hepatitis C treatment opened a new chapter for all-oral but non-interferon therapy.During the 2014 International Liver Congress,the annual meeting held by the European Association for the Study of the Liver（EASL）,several promising therapies against hepatitis C infection concluded from phase Ⅲ trials were reported.The patients included treatment nave and treatment-experienced,with or without cirrhosis,as well as patients infected with type 1HCV.The sustained virologic response rates reached over 90%.This review summarizes the recent progresses from phaseⅢ trials on all-oral,interferon-free anti-HCV virus treatments.