Albinterferon Alfa-2b was not inferior to pegylated interferon-α in a randomized trial of patients with chronic hepatitis C virus genotype 2 or 3.
Albinterferon Alfa-2b was not inferior to pegylated interferon-α in a randomized trial of patients with chronic hepatitis C virus genotype 2 or 3.
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DOI：
10.1053/j.gastro.2010.06.062
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发表时间：
2010-10
期刊：
影响因子：
29.4
通讯作者：
ACHIEVE-2/3 Study Team
中科院分区：
文献类型：
--
作者：
Nelson DR;Benhamou Y;Chuang WL;Lawitz EJ;Rodriguez-Torres M;Flisiak R;Rasenack JW;Kryczka W;Lee CM;Bain VG;Pianko S;Patel K;Cronin PW;Pulkstenis E;Subramanian GM;McHutchison JG;ACHIEVE-2/3 Study Team
进行了一项III期活性对照研究，以评估重组人白蛋白和干扰素α-2b的新型长效基因融合多肽albIFN α-2b（albIFN）在慢性丙型肝炎病毒（HCV）基因型2/3患者中的疗效/安全性。总共有933名患者随机接受开放标签皮下注射聚乙二醇干扰素-α-2a（Peg-IFNalfa-2a）180 μg/wk或albIFN 900或1200 μg，每2周一次，持续24周，每次口服利巴韦林800 mg/天。研究的主要终点是持续病毒学应答（SVR）（第48周HCV-RNA水平<15 IU/mL）。在研究期间，数据监测委员会建议所有接受albIFN 1200 μ g至900 μg的患者调整剂量，影响该治疗组的38%。通过意向治疗分析，SVR率为84.8%。Peg-IFN α-2a和albIFN 900和1200 μg分别为79.8%（95%置信区间，74.9%-84.1%）、79.8%（95%置信区间，75.1%-84.3%）和80.0%（95%置信区间，75.1%-84.3%）。确立了albIFN 900 μg（P = .009）和1200 μg（P = .006）的SVR非劣效性的主要假设。通过多变量回归分析，SVR的独立阳性预测因子为治疗前HCV-RNA水平低于400，000 IU/mL，年龄小于45岁，体重指数小于30 kg/m2，基因型2，基线时γ-谷氨酰转肽酶正常和丙氨酸转氨酶水平升高，纤维化分期F0-F2，无脂肪变性和亚洲地理区域（仅Peg-IFN α-2a）。3个治疗组的严重（7%-8%）和重度（13%-16%）不良事件发生率以及因不良事件而停药的发生率相似（3.6%-5.5%）。干扰素α-2b 900 μg每2周一次为慢性HCV基因型2或3型患者提供了一种替代有效的治疗选择。
A phase 3 active-controlled study was conducted to assess the efficacy/safety of albinterferon alfa-2b (albIFN), a novel, long-acting, genetic fusion polypeptide of recombinant human albumin and interferon alfa-2b, in patients with chronic hepatitis C virus (HCV) genotype 2/3. In all, 933 patients were randomized to open-label subcutaneous treatment with pegylated interferon-alfa-2a (Peg-IFNalfa-2a) 180 μg/wk, or albIFN 900 or 1200 μg every 2 weeks for 24 weeks, each administered with oral ribavirin 800 mg/day. The primary end point of the study was sustained virologic response (SVR) (HCV-RNA level, <15 IU/mL at week 48). During the study, the data monitoring committee recommended dose modification for all patients receiving albIFN 1200 μgto 900 μg, impacting 38% of this treatment arm. By intention-to-treat analysis, SVR rates were 84.8% (95% confidence interval, 80.4%–88.6%), 79.8% (95% confidence interval, 74.9%–84.1%), and 80.0% (95% confidence interval, 75.1%–84.3%) with Peg-IFNalfa-2a, and albIFN 900 and 1200 μg, respectively. The primary hypothesis of noninferiority of SVR was established for albIFN 900 μg(P = .009) and 1200 μg(P = .006). Independent positive predictors of SVR by multivariate regression analysis were pretreatment HCV-RNA level less than 400,000 IU/mL, age younger than 45 years, body mass index less than 30 kg/m2, genotype 2, normal γ-glutamyl transpeptidase and increased alanine aminotransferase levels at baseline, fibrosis stage F0–F2, no steatosis, and Asian geographic region (Peg-IFNalfa-2a only). The 3 treatment groups showed similar rates of serious (7%–8%) and severe (13%–16%) adverse events, and discontinuations owing to adverse events (3.6%–5.5%). Albinterferon alfa-2b 900 μg every 2 weeks provides an alternative efficacious treatment option in patients with chronic HCV genotype 2 or 3.
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