Grazoprevir and Elbasvir in Patients with Genotype 1 Hepatitis C Virus Infection: A Comprehensive Efficacy and Safety Analysis.
Grazoprevir and Elbasvir in Patients with Genotype 1 Hepatitis C Virus Infection: A Comprehensive Efficacy and Safety Analysis.
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格拉佐瑞韦和艾尔巴韦治疗基因 1 型丙型肝炎病毒感染患者：综合疗效和安全性分析
DOI：
10.1155/2017/8186275
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发表时间：
2017
影响因子：
2.7
通讯作者：
Yu R
中科院分区：
文献类型：
--
作者：
Yao Y;Yue M;Wang J;Chen H;Liu M;Zang F;Li J;Zhang Y;Huang P;Yu R
背景资料。丙型肝炎病毒感染患者迫切需要找到一种安全、有效、无干扰素的治疗方案来优化治疗。对来自3个随机对照试验(RCT)的777例未接受治疗和有治疗经验的丙型肝炎病毒1型感染患者进行了综合分析，以评估联合应用利巴韦林(RBV)或不联合利巴韦林(RBV)治疗的疗效和安全性。方法。我们收集了以下试验的数据：C-Wastance(NCT01717326)、C-SAVAVage(NCT02105454)和C-EDGE(NCT02105467)。所有患者接受加或不加RBV的格拉佐韦加艾尔巴韦治疗12周或18周。在治疗结束12周后计算总体和亚组的持续病毒学应答(SVR)。结果。568例(73%)患者未接受治疗。总体而言，95%(95%CI：93-96)的患者达到了SVR12，95%(95%CI：92-96)的患者接受了治疗，96%(95%CI：92-98)的患者接受了治疗。治疗时间和治疗方案对SVR12的发生率无明显影响。最常见的不良反应是乏力(18%~29%)、头痛(20%)、恶心(8%~14%)和乏力(4%~12%)。1名患者(1%)单独接受格拉佐韦加艾尔巴韦治疗，1名患者(1%)接受格拉佐韦加艾尔巴韦加RBV治疗，出现与治疗相关的严重不良反应。结论。结果表明，12周的格拉佐韦联合艾尔巴韦治疗未治疗的丙型肝炎病毒1型患者是安全有效的。
Background. 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). Method. 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. Results. 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. Conclusions. The result shows that 12-week grazoprevir plus elbasvir therapy is safe and effective for treatment-naive patients with HCV genotype 1.