BACKGROUND AND AIMS Glecaprevir/pibrentasvir is approved for treating adults infected with hepatitis C virus (HCV) genotypes 1-6. In clinical trials, glecaprevir/pibrentasvir was associated with high rates of sustained virologic response at post-treatment Week 12 (SVR12) and was well tolerated. A systematic review and meta-analysis of the real-world effectiveness and safety of glecaprevir/pibrentasvir were undertaken. METHODS Real-world studies reporting SVR12 in adults with HCV infection (N≥20) treated with glecaprevir/pibrentasvir were identified in journal publications from January 1, 2017, to February 25, 2019, and congress presentations through April 14, 2019. Random-effects meta-analysis was used to determine SVR12 rates using data from ≥2 cohorts; intention-to-treat (ITT) analyses included patients treated with glecaprevir/pibrentasvir who had SVR12 data available, discontinued early, or were lost to follow-up; modified ITT (mITT) analyses excluded those with non-virologic failure. Naïve pooling was used to calculate adverse event (AE) rates. RESULTS Overall, 12,531 adults were treated with glecaprevir/pibrentasvir (18 cohorts). Of patients with post-treatment Week 12 data, SVR12 rates were 96.7% (95% CI, 95.4-98.1) in the ITT population (n=8,583, 15 cohorts) and 98.1 % (95% CI, 97.1-99.2) in the mITT population (n=7,001, 14 cohorts). SVR12 rates were ≥95% across subgroups (HCV genotype, cirrhosis status, treatment history, treatment duration, on-label treatment, and subgroups of interest). AEs were reported in 17.7% (1,271/7,199) of patients (8 cohorts). Serious AEs were reported in 1.0% (55/5,522) of patients (6 cohorts). The most frequent AEs were pruritus, fatigue, and headache. AE-related treatment discontinuations were reported in 0.6% (33/5,595) of patients (6 cohorts). CONCLUSIONS Consistent with clinical trials, real-world evidence indicates that glecaprevir/pibrentasvir is a well-tolerated and highly effective pangenotypic treatment for a broad range of HCV-infected patients.

中文翻译：

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glecaprevir/pibrentasvir 治疗慢性 HCV 感染患者的真实有效性和安全性：荟萃分析

背景和目的 Glecaprevir/pibrentasvir 被批准用于治疗感染丙型肝炎病毒 (HCV) 基因型 1-6 的成人。在临床试验中，glecaprevir/pibrentasvir 与治疗后第 12 周（SVR12）的高持续病毒学应答率相关，并且耐受性良好。对 glecaprevir/pibrentasvir 的真实有效性和安全性进行了系统回顾和荟萃分析。方法 在 2017 年 1 月 1 日至 2019 年 2 月 25 日期间的期刊出版物和截至 2019 年 4 月 14 日的大会报告中，确定了真实世界研究报告了接受 glecaprevir/pibrentasvir 治疗的成人 HCV 感染（N≥20）的 SVR12。使用 ≥ 2 个队列的数据，使用效果荟萃分析来确定 SVR12 率；意向治疗 (ITT) 分析包括接受 glecaprevir/pibrentasvir 治疗的患者，这些患者有 SVR12 数据可用、提前停药或失访；改良的 ITT (mITT) 分析排除了非病毒学失败的患者。Naïve pooling 用于计算不良事件 (AE) 发生率。结果 总体而言，12,531 名成人接受了 glecaprevir/pibrentasvir（18 个队列）治疗。在治疗后第 12 周数据的患者中，ITT 人群（n=8,583，15 个队列）中的 SVR12 率为 96.7%（95% CI，95.4-98.1），而在 ITT 人群中为 98.1%（95% CI，97.1-99.2） mITT 人群（n=7,001，14 个队列）。跨亚组（HCV 基因型、肝硬化状态、治疗史、治疗持续时间、标签上治疗和感兴趣的亚组）的 SVR12 率≥95%。17.7% (1,271/7,199) 的患者（8 个队列）报告了 AE。严重 AE 在 1 中报告。0% (55/5,522) 的患者（6 个队列）。最常见的 AE 是瘙痒、疲劳和头痛。0.6% (33/5,595) 的患者（6 个队列）报告了与 AE 相关的治疗中断。结论与临床试验一致，现实世界的证据表明，glecaprevir/pibrentasvir 是一种耐受性良好且高效的泛基因型治疗方法，适用于广泛的 HCV 感染患者。