Department of Epidemiology and Biostatistics, School of Public Health, Nanjing Medical University, Nanjing 211166, China.
Department of Infectious Diseases, The First Affiliated Hospital of Nanjing Medical University, Nanjing 210029, China.
Can J Gastroenterol Hepatol. 2017;2017:8186275. doi: 10.1155/2017/8186275. Epub 2017 Jan 9.
It is urgent for patients with hepatitis C virus (HCV) infection to find a safe, effective, and interferon-free regimen to optimize therapy. A comprehensive analysis was performed to evaluate the efficacy and safety of the grazoprevir combined with elbasvir, with or without ribavirin (RBV), in 777 treatment-naive and treatment-experienced patients with HCV genotype 1 infection from 3 randomized controlled trials (RCTs). We collected data from the following trials: C-WORTHY (NCT01717326), C-SALVAGE (NCT02105454), and C-EDGE (NCT02105467). All patients received grazoprevir plus elbasvir with or without RBV for 12 or 18 weeks. The sustained virological response (SVR) 12 weeks after end of treatment was calculated for overall and subgroups. 568 (73%) patients were treatment-naive. Overall, 95% (95% CI: 93-96) patients achieved SVR12, 95% (95% CI: 92-96) for treatment-naive and 96% (95% CI: 92-98) for previously treated patients, respectively. Treatment duration and treatment regimen did not have great difference in SVR12 rates. The most common AEs were fatigue (18%-29%), headache (20%), nausea (8%-14%), and asthenia (4%-12%). One patient (<1%) receiving grazoprevir plus elbasvir alone and one (<1%) receiving grazoprevir plus elbasvir plus RBV had treatment-related serious AEs. The result shows that 12-week grazoprevir plus elbasvir therapy is safe and effective for treatment-naive patients with HCV genotype 1.
对于丙型肝炎病毒（HCV）感染患者来说，寻找一种安全、有效且无干扰素的治疗方案以优化治疗至关重要。我们对 3 项随机对照试验（RCT）中 777 例初治和经治 HCV 基因 1 型感染患者接受格拉瑞韦联合艾维雷韦、联合或不联合利巴韦林（RBV）的疗效和安全性进行了综合分析。我们从以下试验中收集数据：C-WORTHY（NCT01717326）、C-SALVAGE（NCT02105454）和 C-EDGE（NCT02105467）。所有患者接受格拉瑞韦联合艾维雷韦联合或不联合 RBV 治疗 12 或 18 周。治疗结束后 12 周时计算持续病毒学应答（SVR）。568 例（73%）患者为初治。总体而言，95%（95%CI：93-96）的患者获得 SVR12，初治患者为 95%（95%CI：92-96），经治患者为 96%（95%CI：92-98）。治疗持续时间和治疗方案对 SVR12 率无显著影响。最常见的 AEs 为疲劳（18%-29%）、头痛（20%）、恶心（8%-14%）和乏力（4%-12%）。接受格拉瑞韦联合艾维雷韦单药治疗的患者中，有 1 例（<1%）和接受格拉瑞韦联合艾维雷韦联合 RBV 治疗的患者中，有 1 例（<1%）发生与治疗相关的严重 AEs。结果表明，12 周格拉瑞韦联合艾维雷韦治疗方案对于初治 HCV 基因 1 型患者安全且有效。
