Texas Liver Institute, University of Texas Health Science Center, San Antonio, TX.
Merck & Co., Inc, Kenilworth, NJ.
Hepatology. 2017 Feb;65(2):439-450. doi: 10.1002/hep.28877. Epub 2016 Dec 19.
Direct-acting antiviral agents (DAAs) represent the standard of care for patients with hepatitis C virus (HCV) infection. Combining DAAs with different mechanisms may allow for shorter treatment durations that are effective across multiple genotypes. The aim of the C-SWIFT study was to identify the minimum effective treatment duration across multiple genotypes. C-SWIFT was an open-label, single-center trial in treatment-naïve patients with chronic HCV genotype (GT)1 or 3 infection. All patients received elbasvir (EBR) 50 mg/grazoprevir (GZR) 100 mg with sofosbuvir (SOF) 400 mg for 4-12 weeks. Patients with GT1 infection who failed therapy were eligible for retreatment with EBR/GZR+SOF and ribavirin for 12 weeks. The primary efficacy endpoint was sustained virological response [SVR]12 (SVR of HCV RNA <15 IU/mL 12 weeks after the end of therapy). Rates of SVR12 were 32% (10 of 31) and 87% (26 of 30) in patients without cirrhosis with GT1 infection treated for 4 and 6 weeks and 80% (16 of 20) and 81% (17 of 21) in GT1-infected patients with cirrhosis treated for 6 and 8 weeks. Among GT3-infected patients without cirrhosis, SVR12 was 93% (14 of 15) and 100% (14 of 14) after 8 and 12 weeks. SVR12 in GT3-infected patients with cirrhosis was 83% (10 of 12) after 12 weeks of treatment. Twenty-three GT1-infected patients who relapsed following initial treatment completed retreatment; all achieved SVR12. In the initial treatment phase, there was one serious adverse event of pneumonia, which led to treatment discontinuation, and during retreatment, 1 patient discontinued ribavirin because of pruritus.
Data from this study support the use of 8-week treatment regimens that maintain high efficacy, even for patients with HCV GT3 infection. Retreatment of patients who failed short-duration therapy was achieved through extended treatment duration and addition of ribavirin. (Hepatology 2017;65:439-450).
直接作用抗病毒药物（DAAs）是丙型肝炎病毒（HCV）感染患者的标准治疗方法。将具有不同机制的 DAA 联合使用可能会缩短治疗时间，并且对多种基因型均有效。C-SWIFT 研究的目的是确定多种基因型的最短有效治疗时间。C-SWIFT 是一项在初治的慢性 HCV 基因型（GT）1 或 3 感染患者中进行的开放性、单中心试验。所有患者均接受 Elbasvir（EBR）50mg/grazoprevir（GZR）100mg 联合索非布韦（SOF）400mg 治疗 4-12 周。治疗失败的 GT1 感染患者有资格接受 EBR/GZR+SOF 和利巴韦林治疗 12 周。主要疗效终点是持续病毒学应答（SVR）12（治疗结束后 12 周 HCV RNA <15IU/mL）。无肝硬化的 GT1 感染患者接受 4 周和 6 周治疗的 SVR12 率分别为 32%（31 例中的 10 例）和 87%（30 例中的 26 例），肝硬化的 GT1 感染患者接受 6 周和 8 周治疗的 SVR12 率分别为 80%（20 例中的 16 例）和 81%（21 例中的 17 例）。无肝硬化的 GT3 感染患者的 SVR12 率分别为 93%（15 例中的 14 例）和 100%（14 例中的 14 例），而肝硬化的 GT3 感染患者的 SVR12 率为 83%（12 例中的 10 例）。23 例初始治疗后复发的 GT1 感染患者完成了补救治疗，均获得 SVR12。在初始治疗阶段，有 1 例严重肺炎不良事件导致治疗中断，在补救治疗期间，1 例患者因瘙痒而停止使用利巴韦林。
本研究数据支持使用 8 周治疗方案，该方案可保持较高的疗效，甚至对 HCV GT3 感染患者也如此。通过延长治疗时间和添加利巴韦林，可实现对短期治疗失败患者的补救治疗。（《肝脏病学》2017；65：439-450）
