Center for Hepatitis C, Atlanta Medical Center, Atlanta, Georgia; Department of Internal Medicine, Medical College of Georgia, Augusta, Georgia; Department of Internal Medicine, Emory School of Medicine, Atlanta, Georgia.
Department of Graduate Medical Education, Atlanta Medical Center, Atlanta, Georgia.
Gastroenterology. 2015 Apr;148(4):762-70.e2; quiz e11-2. doi: 10.1053/j.gastro.2014.12.027. Epub 2014 Dec 31.
BACKGROUND & AIMS: The efficacy and safety of interferon-free regimens for the treatment of chronic hepatitis C virus (HCV) infections require further evaluation and comparison with those of interferon-containing regimens. We compared a regimen of peginterferon, ribavirin, and sofosbuvir with a regimen of simeprevir and sofosbuvir in patients with HCV infection and unfavorable treatment features.
We performed a prospective open-label study of 82 patients with chronic HCV genotype 1a infection and Child's grade A cirrhosis enrolled from 2 clinics at a single center in Atlanta, Georgia, from December 2013 through January 2014. Fifty patients (61%) had not responded to treatment with peginterferon and ribavirin (null responders), and 32 (39%) were therapy naive; 39 (48%) were African American. Subjects were assigned randomly to groups given simeprevir (150 mg/day) and sofosbuvir (400 mg/day) (n = 58 in the final analysis) or peginterferon alfa 2b (1.5 mcg/kg/wk), ribavirin (1000-1200 mg/day), and sofosbuvir (400 mg/day) (n = 24 in the final analysis). Both regimens were given for 12 weeks. The primary trial end point was the proportion of patients with undetectable HCV-RNA levels 12 weeks after therapy completion (SVR12).
A significantly greater percentage of patients (93%) given simeprevir and sofosbuvir achieved an SVR12 than those given the interferon-containing regimen (75%) (P = .02). Patients given the interferon-containing regimen had a significantly higher rate of virologic relapse than patients given simeprevir and sofosbuvir (P = .009), as well as worse self-reported outcomes and more side effects. Quality-of-life scores were higher in patients with SVR12 than those without, regardless of treatment regimen.
In a prospective study of patients with chronic HCV genotype 1a infection and cirrhosis (48% African American and 61% prior null responders), a 12-week regimen of simeprevir and sofosbuvir produced a significantly higher rate of SVR12 and was better tolerated, with a lower viral relapse rate, than a 12-week regimen of peginterferon, ribavirin, and sofosbuvir. Clinicaltrials.gov no: NCT021683615.
对于慢性丙型肝炎病毒（HCV）感染的治疗，无干扰素方案的疗效和安全性需要进一步评估，并与含干扰素方案进行比较。我们比较了聚乙二醇干扰素、利巴韦林和索非布韦方案与西米普韦和索非布韦方案在具有不利治疗特征的 HCV 感染患者中的疗效。
我们在佐治亚州亚特兰大的 2 家诊所进行了一项前瞻性、开放性标签研究，共纳入了 82 例慢性 HCV 基因型 1a 感染且伴有 Child A 级肝硬化的患者，入组时间为 2013 年 12 月至 2014 年 1 月。50 例患者（61%）对聚乙二醇干扰素和利巴韦林治疗无应答（无应答者），32 例（39%）为初治患者；39 例（48%）为非裔美国人。患者被随机分配至接受西米普韦（150 mg/天）和索非布韦（400 mg/天）（最终分析 58 例）或聚乙二醇干扰素 alfa 2b（1.5 mcg/kg/周）、利巴韦林（1000-1200 mg/天）和索非布韦（400 mg/天）（最终分析 24 例）治疗。两组治疗均持续 12 周。主要试验终点是治疗结束后 12 周时 HCV-RNA 水平不可检测的患者比例（SVR12）。
接受西米普韦和索非布韦治疗的患者中，有 93%（93%）达到 SVR12，显著高于接受含干扰素方案治疗的患者（75%）（P=0.02）。接受含干扰素方案治疗的患者病毒学复发率显著高于接受西米普韦和索非布韦治疗的患者（P=0.009），且自我报告结局更差，副作用更多。无论治疗方案如何，SVR12 患者的生活质量评分均高于未达到 SVR12 的患者。
在一项针对慢性 HCV 基因型 1a 感染和肝硬化患者（48%为非裔美国人，61%为既往无应答者）的前瞻性研究中，12 周的西米普韦和索非布韦方案治疗的 SVR12 率显著更高，且耐受性更好，病毒复发率更低，优于 12 周的聚乙二醇干扰素、利巴韦林和索非布韦方案。临床试验.gov 注册号：NCT021683615。
