BACKGROUND & AIMS Glecaprevir plus pibrentasvir (G/P) is a pangenotypic, once-daily, ribavirin-free direct-acting antiviral (DAA) treatment for hepatitis C virus (HCV) infection. In nine phase II or III clinical trials, G/P therapy achieved rates of sustained virologic response 12 weeks after treatment (SVR12) of 93-100% across all six major HCV genotypes (GTs). An integrated efficacy analysis of 8- and 12-week G/P therapy in patients without cirrhosis with HCV GT 1-6 infection was performed. METHODS Data were pooled from nine phase II and III trials including patients with chronic HCV GT 1-6 infection without cirrhosis who received G/P (300 mg/120 mg) for either 8 or 12 weeks. Patients were treatment naïve or treatment experienced with peginterferon, ribavirin, and/or sofosbuvir; all patients infected with HCV GT 3 were treatment naïve. Efficacy was evaluated as the SVR12 rate. RESULTS The analysis included 2,041 patients without cirrhosis. In the intent-to-treat population, 943/965 patients (98%) achieved SVR12 when treated for eight weeks, and 1,060/1,076 patients (99%) achieved SVR12 when treated for 12 weeks; the difference in rates was not significant (p = 0.2). A subgroup analysis demonstrated SVR12 rates > 95% across baseline factors traditionally associated with lower efficacy. G/P was well tolerated, with one DAA-related serious adverse event (<0.1%); grade 3 laboratory abnormalities were rare. CONCLUSIONS G/P therapy for eight weeks in patients with chronic HCV GT 1-6 infection without cirrhosis achieved an overall SVR12 rate of 98% irrespective of baseline patient or viral characteristics; four additional weeks of treatment did not significantly increase the SVR12 rate, demonstrating that the optimal treatment duration in this population is eight weeks. LAY SUMMARY In this integrated analysis of nine clinical trials, patients with chronic HCV genotype 1-6 infection without cirrhosis were treated for either 8 or 12 weeks with the direct-acting antiviral regimen glecaprevir/pibrentasvir (G/P). The cure rate was 98% and 99% following 8 and 12 weeks of treatment, respectively; the difference in rates was not significant (p = 0.2), nor was there a significant difference in the cure rates across the two treatment durations on the basis of baseline patient or viral characteristics. These results, along with a favourable safety profile, indicate that G/P is a highly efficacious and well-tolerated pangenotypic eight-week therapy for most patients with chronic HCV infection.

中文翻译：

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8 周和 12 周 Glecaprevir/Pibrentasvir 的高 SVR12：对无肝硬化的 HCV 基因型 1-6 患者的综合分析

背景与目的 Glecaprevir 加 pibrentasvir (G/P) 是一种泛基因型、每日一次、不含利巴韦林的直接作用抗病毒 (DAA) 治疗丙型肝炎病毒 (HCV) 感染。在九项 II 期或 III 期临床试验中，G/P 疗法在所有六种主要 HCV 基因型 (GT) 中实现了 93-100% 的治疗后 12 周持续病毒学应答率 (SVR12)。对 HCV GT 1-6 感染的无肝硬化患者进行了 8 周和 12 周 G/P 治疗的综合疗效分析。方法 数据来自九项 II 期和 III 期试验，包括接受 G/P（300 毫克/120 毫克）治疗 8 周或 12 周的无肝硬化的慢性 HCV GT 1-6 感染患者。患者未接受过聚乙二醇干扰素、利巴韦林和/或索非布韦治疗；所有感染 HCV GT 3 的患者均未接受治疗。疗效评价为 SVR12 率。结果 该分析包括 2,041 名无肝硬化的患者。在意向治疗人群中，943/965 名患者（98%）在治疗 8 周时达到 SVR12，1,060/1,076 名患者（99%）在治疗 12 周时达到 SVR12；率的差异不显着（p = 0.2）。一项亚组分析表明，在传统上与较低疗效相关的基线因素中，SVR12 率 > 95%。G/P 耐受性良好，发生 1 起 DAA 相关的严重不良事件（<0.1%）；3 级实验室异常很少见。结论 无肝硬化的慢性 HCV GT 1-6 感染患者的 G/P 治疗 8 周实现了 98% 的总体 SVR12 率，无论基线患者或病毒特征如何；额外 4 周的治疗并未显着提高 SVR12 率，表明该人群的最佳治疗持续时间为 8 周。概述 在这项对九项临床试验的综合分析中，慢性 HCV 基因 1-6 型感染但无肝硬化的患者接受了直接作用抗病毒方案 glecaprevir/pibrentasvir (G/P) 8 或 12 周的治疗。治疗8周和12周治愈率分别为98%和99%；比率差异不显着（p = 0.2），基于基线患者或病毒特征的两个治疗持续时间的治愈率也没有显着差异。这些结果，连同良好的安全性，