Bonn University Hospital, Bonn, Germany.
Chelsea and Westminster Hospital, London, UK.
Lancet HIV. 2015 Aug;2(8):e319-27. doi: 10.1016/S2352-3018(15)00114-9. Epub 2015 Jul 9.
Hepatitis C virus (HCV) infection is a leading cause of morbidity and mortality in patients with HIV-1. The C-EDGE CO-INFECTION study assessed the efficacy, safety, and tolerability of grazoprevir (MK-5172) plus elbasvir (MK-8742) in patients with HCV and HIV co-infection.
In this uncontrolled, non-randomised, phase 3, open-label, single-arm study, treatment-naive patients with chronic HCV genotype 1, 4, or 6 infection and HIV co-infection, with or without cirrhosis, were enrolled from 37 centres in nine countries across Europe, the USA, and Australia. Patients were either naive to treatment with any antiretroviral therapy (ART) or stable on ART for at least 8 weeks. All patients received grazoprevir 100 mg plus elbasvir 50 mg in a fixed-dose combination tablet once daily for 12 weeks. The primary endpoint was sustained virological response (HCV RNA <15 IU/mL) 12 weeks after the end of therapy (SVR12). The primary population for efficacy analyses was all patients who received at least one dose of study treatment. This study is registered with ClinicalTrials.gov, number NCT02105662.
Between June 11, 2014, and Aug 29, 2014, 218 patients were enrolled and received grazoprevir plus elbasvir for 12 weeks, all of whom completed follow-up at week 12. SVR12 was achieved by 210 (96%) of 218 patients (95% CI 92·9-98·4). One patient did not achieve SVR12 because of a non-virological reason, and seven patients without cirrhosis relapsed (two subsequently confirmed as reinfections). All 35 patients with cirrhosis achieved SVR12. The most common adverse events were fatigue (29; 13%), headache (27; 12%), and nausea (20; 9%). No patient discontinued treatment because of an adverse event. Two patients receiving ART had transient HIV viraemia.
This HCV treatment regimen seems to be effective and well tolerated for patients co-infected with HIV with or without cirrhosis. These data are consistent with previous trials of this regimen in the monoinfected population. This regimen continues to be studied in phase 3 trials.
Merck Sharp & Dohme Corp.
丙型肝炎病毒（HCV）感染是 HIV-1 患者发病率和死亡率的主要原因。C-EDGE 合并感染研究评估了格拉瑞韦（MK-5172）联合艾尔巴韦（MK-8742）在 HCV 和 HIV 合并感染患者中的疗效、安全性和耐受性。
在这项非对照、非随机、开放标签、单臂的 3 期研究中，来自欧洲、美国和澳大利亚的 37 个中心共招募了 218 例初治慢性 HCV 基因型 1、4 或 6 感染且合并 HIV 感染、伴或不伴肝硬化的患者。患者要么对任何抗逆转录病毒治疗（ART）均无治疗史，要么至少接受了 8 周的稳定 ART 治疗。所有患者均接受格拉瑞韦 100mg 加艾尔巴韦 50mg 固定剂量复方片剂，每日一次，共 12 周。主要终点是治疗结束后 12 周时持续病毒学应答（HCV RNA<15IU/mL）（SVR12）。疗效分析的主要人群是所有至少接受一剂研究治疗的患者。这项研究在 ClinicalTrials.gov 上注册，编号为 NCT02105662。
2014 年 6 月 11 日至 2014 年 8 月 29 日，共有 218 例患者接受了格拉瑞韦加艾尔巴韦治疗 12 周，所有患者均在第 12 周完成了随访。218 例患者中有 210 例（96%）达到 SVR12（95%CI92.9-98.4）。1 例患者因非病毒学原因未达到 SVR12，7 例无肝硬化的患者复发（其中 2 例随后确认为再感染）。所有 35 例肝硬化患者均达到 SVR12。最常见的不良反应是疲劳（29 例，13%）、头痛（27 例，12%）和恶心（20 例，9%）。没有患者因不良反应而停止治疗。两名接受 ART 治疗的患者出现短暂的 HIV 病毒血症。
对于合并 HIV 感染的患者，无论是否伴有肝硬化，这种 HCV 治疗方案似乎是有效且耐受良好的。这些数据与该方案在单感染人群中的先前试验一致。该方案仍在 3 期临床试验中进行研究。
默克 Sharp & Dohme 公司。
