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达卡他韦治疗慢性丙型肝炎患者的安全性与疗效

Safety and efficacy of daclatasvir in the management of patients with chronic hepatitis C.

作者信息

Manolakopoulos Spilios, Zacharakis George, Zissis Miltiadis, Giannakopoulos Vassilis

机构信息

2 Department of Internal Medicine, Hippocration General Hospital, Athens Greece (Spilios Manolakopoulos).

Endoscopy Unit, Limassol General Hospital and St George's University of London Medical School at the University of Nicosia, Republic of Cyprus (George Zacharakis); Department of Internal Medicine, University Hospital, Prince Sattam Bin Abdulaziz University, Al Kharj, KSA (George Zacharakis).

出版信息

Ann Gastroenterol. 2016 Jul-Sep;29(3):282-96. doi: 10.20524/aog.2016.0041. Epub 2016 May 11.

Abstract

Daclatasvir (Daklinza™), a new oral direct-acting antiviral, is an inhibitor of hepatitis C virus NS5A protein and has recently been approved in the United States, Europe and Japan in chronic hepatitis C. It shows potent pangenotypic activity and moderately high genetic barrier to resistance improving the sustained virological response (SVR) rates. In COMMAND phase 2 trials, daclatasvir demonstrated high SVR rates in HCV genotype 1-4 chronically infected patients treated with peginterferon-a (pegIFNα) plus ribavirin (RBV). Furthermore, it produced even higher response rates in all-oral combination with sofosbuvir, an interferon-free regimen, with or without ribavirin, in patients with advanced liver disease, HCV/HIV coinfection, liver transplantation in ALLY studies and other real-world studies. This narrative review provides information on the pharmacological properties, role, efficacy and safety of daclatasvir-containing regimens in chronic hepatitis C patients. Daclatasvir administered once-daily in combination with sofosbuvir is an effective 12-week treatment in adult patients with chronic hepatitis C and is generally safe and well tolerated.

摘要

达卡他韦(Daklinza™)是一种新型口服直接抗病毒药物,是丙型肝炎病毒NS5A蛋白的抑制剂,最近已在美国、欧洲和日本获批用于治疗慢性丙型肝炎。它显示出强大的泛基因型活性和对耐药性的中等高度遗传屏障,提高了持续病毒学应答(SVR)率。在COMMAND 2期试验中,达卡他韦在接受聚乙二醇干扰素α(pegIFNα)加利巴韦林(RBV)治疗的HCV 1-4型慢性感染患者中显示出高SVR率。此外,在ALLY研究和其他真实世界研究中,在晚期肝病、HCV/HIV合并感染、肝移植患者中,与索磷布韦进行全口服联合使用(无论是否使用利巴韦林)的无干扰素方案中,它产生了更高的应答率。这篇叙述性综述提供了含达卡他韦方案在慢性丙型肝炎患者中的药理特性、作用、疗效和安全性的信息。达卡他韦与索磷布韦联合每日一次给药,对成年慢性丙型肝炎患者是一种有效的12周治疗方案,总体上安全且耐受性良好。

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