This study assessed the efficacy and safety of ribavirin‐free coformulated glecaprevir/pibrentasvir (G/P) in patients with hepatitis C virus genotype 3 infection with prior treatment experience and/or compensated cirrhosis, a patient population with limited treatment options. SURVEYOR‐II, Part 3 was a partially randomized, open‐label, multicenter, phase 3 study. Treatment‐experienced (prior interferon or pegylated interferon ± ribavirin or sofosbuvir plus ribavirin ± pegylated interferon therapy) patients without cirrhosis were randomized 1:1 to receive 12 or 16 weeks of G/P (300 mg/120 mg) once daily. Treatment‐naive or treatment‐experienced patients with compensated cirrhosis were treated with G/P for 12 or 16 weeks, respectively. The primary efficacy endpoint was the percentage of patients with sustained virologic response at posttreatment week 12 (SVR12). Safety was evaluated throughout the study. There were 131 patients enrolled and treated. Among treatment‐experienced patients without cirrhosis, SVR12 was achieved by 91% (20/22; 95% confidence interval [CI], 72‐97) and 95% (21/22; 95% CI, 78‐99) of patients treated with G/P for 12 or 16 weeks, respectively. Among those with cirrhosis, SVR12 was achieved by 98% (39/40; 95% CI, 87‐99) of treatment‐naive patients treated for 12 weeks and 96% (45/47; 95% CI, 86‐99) of patients with prior treatment experience treated for 16 weeks. No adverse events led to discontinuation of study drug, and no serious adverse events were related to study drug. Conclusion: Patients with hepatitis C virus genotype 3 infection with prior treatment experience and/or compensated cirrhosis achieved high SVR12 rates following 12 or 16 weeks of treatment with G/P. The regimen was well tolerated. (Hepatology 2018;67:514‐523).

中文翻译：

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Glecaprevir/Pibrentasvir 用于治疗有肝硬化和/或既往治疗经验的 HCV 基因型 3 患者：部分随机 III 期临床试验


本研究评估了不含利巴韦林的复方 glecaprevir/pibrentasvir (G/P) 对于具有既往治疗经验和/或代偿性肝硬化（治疗选择有限的患者群体）的基因型 3 丙型肝炎病毒感染患者的疗效和安全性。 SURVEYOR-II，第 3 部分是一项部分随机、开放标签、多中心、3 期研究。接受过治疗（既往干扰素或聚乙二醇干扰素±利巴韦林或索磷布韦加利巴韦林±聚乙二醇干扰素治疗）的无肝硬化患者按 1:1 随机分配接受 12 或 16 周的 G/P（300 mg/120 mg），每天一次。初治或接受过治疗的代偿性肝硬化患者分别接受 G/P 治疗 12 周或 16 周。主要疗效终点是治疗后第 12 周出现持续病毒学应答的患者百分比 (SVR12)。在整个研究过程中评估了安全性。共有 131 名患者入组并接受治疗。在接受过治疗的无肝硬化患者中，91%（20/22；95%置信区间[CI]，72-97）和95%（21/22；95% CI，78-99）的患者达到了SVR12与 G/P 分别为期 12 或 16 周。在肝硬化患者中，接受治疗 12 周的初治患者中有 98%（39/40；95% CI，87-99）实现了 SVR12，接受治疗 12 周的患者中有 96%（45/47；95% CI，86-99）达到了 SVR12。有治疗经验的患者治疗16周。没有不良事件导致停止研究药物，也没有与研究药物相关的严重不良事件。结论：具有既往治疗经历和/或代偿性肝硬化的丙型肝炎病毒基因型 3 感染患者在接受 G/P 治疗 12 或 16 周后获得了较高的 SVR12 率。该方案耐受性良好。 （肝病学 2018；67：514-523）。