Glecaprevir plus pibrentasvir for chronic hepatitis C virus genotype 1, 2, 4, 5, or 6 infection in adults with compensated cirrhosis (EXPEDITION-1): a single-arm, open-label, multicentre phase 3 trial
Glecaprevir plus pibrentasvir for chronic hepatitis C virus genotype 1, 2, 4, 5, or 6 infection in adults with compensated cirrhosis (EXPEDITION-1): a single-arm, open-label, multicentre phase 3 trial
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DOI：
10.1016/s1473-3099(17)30496-6
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发表时间：
2017-10-01
影响因子：
56.3
通讯作者：
Mensa, Federico J.
中科院分区：
文献类型：
--
作者：
Forns, Xavier;Lee, Samuel S.;Mensa, Federico J.
背景每日一次、不含病毒唑、泛基因型、直接作用的抗病毒方案，即格拉匹韦与匹布他韦联合配制，在2期和3期研究中显示出高的持续病毒学应答率。我们的目的是评估12周的疗效和安全性的glecaprevir和pibentasvir在丙型肝炎病毒（HCV）感染和代偿cirrhosis.Methods的患者，我们做了这个单臂，开放标签，多中心的3期研究在40个网站在比利时，加拿大，德国，南非，西班牙和美国。我们招募了年龄在18岁或18岁以上的HCV基因型1、2、4、5或6型感染和代偿性肝硬化患者。患者要么是HCV治疗初治，要么对干扰素或聚乙二醇干扰素联合或不联合利巴韦林治疗，或索非布韦加利巴韦林联合或不联合聚乙二醇干扰素治疗无反应。口服格列匹韦（300 mg）与匹布他韦（120 mg）联合给药，每日一次，持续12周。主要疗效终点为治疗后12周的持续病毒学应答（HCV RNA
Background The once-daily, ribavirin-free, pangenotypic, direct-acting antiviral regimen, glecaprevir coformulated with pibrentasvir, has shown high rates of sustained virological response in phase 2 and 3 studies. We aimed to assess the efficacy and safety of 12 weeks of coformulated glecaprevir and pibrentasvir in patients with hepatitis C virus (HCV) infection and compensated cirrhosis.Methods We did this single-arm, open-label, multicentre phase 3 study at 40 sites in Belgium, Canada, Germany, South Africa, Spain, and the USA. We enrolled patients aged 18 years or older with HCV genotype 1, 2, 4, 5, or 6 infection and compensated cirrhosis. Patients were either HCV treatment-naive or had not responded to treatment with interferon or pegylated interferon with or without ribavirin, or sofosbuvir plus ribavirin with or without pegylated interferon. Oral glecaprevir (300 mg) coformulated with pibrentasvir (120 mg) was administered once daily for 12 weeks. The primary efficacy endpoint was sustained virological response at post-treatment week 12 (HCV RNA