University of Florida, Gainesville, Florida, USA.
Gastroenterology. 2010 Oct;139(4):1267-76. doi: 10.1053/j.gastro.2010.06.062. Epub 2010 Jul 1.
BACKGROUND & AIMS: 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 μg to 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/m(2), 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.
一项 3 期主动对照研究旨在评估新型长效重组人白蛋白与干扰素 alfa-2b 融合蛋白（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。
共有 933 例患者随机接受皮下注射聚乙二醇干扰素 alfa-2a（Peg-IFNalfa-2a）180 μg/周，或 albIFN 900 或 1200 μg 每 2 周 1 次，持续 24 周，同时口服利巴韦林 800 mg/天。该研究的主要终点为持续病毒学应答（SVR）（HCV-RNA 水平，<15 IU/mL 第 48 周）。在研究期间，数据监测委员会建议所有接受 albIFN 1200 μg 治疗的患者将剂量调整为 900 μg，这影响了该治疗组的 38%。
根据意向治疗分析，Peg-IFNalfa-2a、albIFN 900 μg 和 1200 μg 的 SVR 率分别为 84.8%（95%置信区间，80.4%-88.6%）、79.8%（95%置信区间，74.9%-84.1%）和 80.0%（95%置信区间，75.1%-84.3%）。albIFN 900 μg（P =.009）和 1200 μg（P =.006）的 SVR 非劣效性主要假设成立。多变量回归分析的 SVR 独立预测因素为治疗前 HCV-RNA 水平<400,000 IU/mL、年龄<45 岁、体重指数<30 kg/m²、基因型 2、基线时γ-谷氨酰转肽酶和丙氨酸氨基转移酶升高、纤维化分期 F0-F2、无脂肪变性和亚洲地理区域（仅 Peg-IFNalfa-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停药率（3.6%-5.5%）相似。
每 2 周 900 μg albIFN 为慢性 HCV 基因型 2 或 3 患者提供了一种有效的替代治疗选择。
