Department of Infectious Diseases, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an 710061, Shaanxi, China.
Department of Hepatobiliary Surgery, First Affiliated Hospital, School of Medicine, Xi'an Jiaotong University, Xi an 710061, Shaanxi, China; Institute of Advanced Surgical Technology and Engineering, Xi'an Jiaotong University, Xi'an 710061, Shaanxi, China.
Int J Antimicrob Agents. 2019 Dec;54(6):780-789. doi: 10.1016/j.ijantimicag.2019.07.005. Epub 2019 Jul 6.
This systematic review and meta-analysis investigated the efficacy and safety of glecaprevir and pibrentasvir (G/P) for chronic hepatitis C virus (HCV) infection. Pubmed, Embase, Cochrane Library and Scopus were searched to identify relevant studies through August 2018. Data from eligible studies were pooled and sustained virological response rates at 12 weeks' post-treatment (SVR12) were calculated. Thirteen studies with 3082 patients were included and the overall SVR12 rate was 97.8%. The SVR12 rates of subgroups were: G/P 300 mg/120 mg and 200 mg/120 mg: 97.9% and 98.3%; HCV genotype (GT)1, GT2, GT3 and GT4-6: 99.8%, 99.2%, 96.1% and 100%; G/P and G/P plus ribavirin (RBV): 97.9% and 98.2%; G/P (300 mg/120 mg) for 8 weeks, 12 weeks and 16 weeks: 98.8%, 98.5% and 95.6%; treatment-naïve and treatment-experienced patients: 96.7% and 98.3%; patients without and with compensated cirrhosis: 99.4% and 98.8%; patients without and with human immunodeficiency virus (HIV) co-infection: 97.8% and 99.4%; and patients without and with severe renal impairment (SRI): 97.8% and 99.4%. Virological failure and relapse and serious drug-related adverse events were rare. These results indicate that 8- or 12-week G/P treatment achieved high SVR12 rates in HCV GTs 1-6 patients without or with compensated cirrhosis, with good safety profiles, irrespective of dose, RBV use, treatment-experience, HIV co-infection and renal impairment. Due to the limited number of evaluated patients with GT3 infection, further studies are needed to define optimal treatment duration for GT3 cirrhosis patients and patients with prior treatment experience of direct-acting antivirals.
本系统评价和荟萃分析研究了 glecaprevir 和 pibrentasvir(G/P)治疗慢性丙型肝炎病毒(HCV)感染的疗效和安全性。通过 2018 年 8 月在 PubMed、Embase、Cochrane 图书馆和 Scopus 上进行检索,以确定相关研究。对纳入研究的数据进行汇总,并计算治疗后 12 周的持续病毒学应答率(SVR12)。共纳入 13 项研究 3082 例患者,总体 SVR12 率为 97.8%。亚组的 SVR12 率为:G/P 300mg/120mg 和 200mg/120mg:97.9%和 98.3%;HCV 基因型(GT)1、2、3 和 4-6:99.8%、99.2%、96.1%和 100%;G/P 和 G/P 加利巴韦林(RBV):97.9%和 98.2%;G/P(300mg/120mg)治疗 8 周、12 周和 16 周:98.8%、98.5%和 95.6%;初治和经治患者:96.7%和 98.3%;无代偿性肝硬化和有代偿性肝硬化患者:99.4%和 98.8%;无人类免疫缺陷病毒(HIV)合并感染和有 HIV 合并感染患者:97.8%和 99.4%;无严重肾功能不全(SRI)和有 SRI 患者:97.8%和 99.4%。病毒学失败和复发以及严重药物相关不良事件罕见。这些结果表明,在无或有代偿性肝硬化的 HCV GT1-6 患者中,8 或 12 周的 G/P 治疗可获得较高的 SVR12 率,且具有良好的安全性,与剂量、RBV 应用、治疗经验、HIV 合并感染和肾功能不全无关。由于评估的 GT3 感染患者数量有限,需要进一步研究来确定 GT3 肝硬化患者和既往直接作用抗病毒药物治疗经验患者的最佳治疗持续时间。