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索磷布韦/维帕他韦固定剂量组合用于治疗慢性丙型肝炎病毒感染。

Sofosbuvir/velpatasvir fixed-dose combination for the treatment of chronic hepatitis C virus infection.

作者信息

Nehra V, Rizza S A, Temesgen Z

机构信息

Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota, USA.

Division of Infectious Diseases, Mayo Clinic, Rochester, Minnesota, USA.

出版信息

Drugs Today (Barc). 2017 Mar;53(3):177-189. doi: 10.1358/dot.2017.53.3.2604176.

DOI:10.1358/dot.2017.53.3.2604176
PMID:28447075
Abstract

The fixed-dose combination of sofosbuvir, a nucleotide analogue NS5B polymerase inhibitor, and velpatasvir, a second-generation NS5A inhibitor, has been approved by the United States Food and Drug Administration and the European Medicines Agency for the treatment of adult patients with chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5 or 6 infection. This combination, administered over 12 weeks as a single-tablet regimen, has resulted in high cure rates in all 6 HCV genotypes and in a variety of patient populations, including patients without cirrhosis, patients with compensated cirrhosis and patients with HIV coinfection. In patients with decompensated cirrhosis, high cure rates were also achieved over 12 weeks with sofosbuvir/velpatasvir plus ribavirin. Patients who had failed prior treatment with an NS5A-containing regimen were able to achieve high cure rates following 24 weeks of treatment with sofosbuvir/velpatasvir plus ribavirin. Sofosbuvir/velpatasvir was well tolerated, the most common adverse events being headache, fatigue and nausea.

摘要

核苷酸类似物NS5B聚合酶抑制剂索磷布韦与第二代NS5A抑制剂维帕他韦的固定剂量组合已获美国食品药品监督管理局和欧洲药品管理局批准,用于治疗成人慢性丙型肝炎病毒(HCV)1、2、3、4、5或6型感染患者。这种组合作为单片方案给药12周,在所有6种HCV基因型以及包括无肝硬化患者、代偿期肝硬化患者和合并HIV感染患者在内的各种患者群体中均产生了高治愈率。在失代偿期肝硬化患者中,索磷布韦/维帕他韦联合利巴韦林治疗12周也取得了高治愈率。先前含NS5A方案治疗失败的患者,在接受索磷布韦/维帕他韦联合利巴韦林治疗24周后能够获得高治愈率。索磷布韦/维帕他韦耐受性良好,最常见的不良事件为头痛、疲劳和恶心。

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Sofosbuvir/velpatasvir fixed-dose combination for the treatment of chronic hepatitis C virus infection.索磷布韦/维帕他韦固定剂量组合用于治疗慢性丙型肝炎病毒感染。
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