AM Migliavacca Center for Liver Disease, First Division of Gastroenterology, Fondazione IRCCS Maggiore Hospital, Mangiagalli e Regina Elena, Università degli Studi di Milano, Milan, Italy.
Gastroenterology. 2010 Jan;138(1):108-15. doi: 10.1053/j.gastro.2009.08.071. Epub 2009 Sep 18.
BACKGROUND & AIMS: Ribavirin (RBV) combined with either pegylated interferon (PegIFN) alpha2a or PegIFNalpha2b is the standard of care for chronic hepatitis C virus (HCV) infection. Due to the lack of head-to-head studies, the 2 PegIFNs have not been directly compared. The endpoints of our study were safety and antiviral efficacy of the 2 regimens.
Treatment-naïve patients with chronic hepatitis C were randomly (1:1) assigned after stratification for HCV genotype to receive either 1.5 mcg/Kg/week PegIFNalpha2b plus RBV 800-1200 mg/day or 180 mcg/week PegIFNalpha2a plus RBV 800-1200 mg/day for 24 or 48 weeks according to HCV genotype. The study was powered to detect a difference of at least 10% in safety and efficacy of the 2 regimens.
The 212 patients on PegIFNalpha2a and the 219 patients on PegIFNalpha2b had similar baseline characteristics, including cirrhosis (20% vs 18%, respectively). By intention to treat, the 2 groups showed similar rates of treatment-related serious adverse events (1% vs 1%, respectively) and drop out rates for adverse effects (7% vs 6%, respectively). Overall, sustained virologic response (SVR) rate was higher in PegIFNalpha2a than in PegIFNalpha2b patients (66% vs 54%, respectively, P = .02), being 48% vs 32% in the 222 HCV-1 and -4 patients (P = .04), and 96% vs 82%, respectively, in the 143 HCV-2 patients (P = .01). PegIFNalpha2a independently predicted SVR in the logistic regression analysis (odds ratio, 1.88; 95% confidence interval: 1.20-2.96).
Although the 2 regimens showed a similar safety profile, the PegIFNalpha2a-based treatment yielded significantly more SVR than PegIFNalpha2b.
利巴韦林（RBV）联合聚乙二醇干扰素（PegIFN）α2a 或 PegIFNα2b 是慢性丙型肝炎病毒（HCV）感染的标准治疗方法。由于缺乏头对头研究，这两种 PegIFN 尚未进行直接比较。本研究的终点是两种方案的安全性和抗病毒疗效。
未经治疗的慢性丙型肝炎患者在 HCV 基因型分层后，按 1:1 随机分配，接受每周 1.5 mcg/Kg PegIFNα2b 联合 RBV 800-1200 mg/天或每周 180 mcg PegIFNα2a 联合 RBV 800-1200 mg/天，疗程为 24 或 48 周，取决于 HCV 基因型。本研究旨在检测两种方案在安全性和疗效方面至少 10%的差异。
212 例接受 PegIFNα2a 治疗的患者和 219 例接受 PegIFNα2b 治疗的患者具有相似的基线特征，包括肝硬化（分别为 20%和 18%）。根据意向治疗分析，两组的治疗相关严重不良事件发生率（分别为 1%和 1%）和因不良反应退出率（分别为 7%和 6%）相似。总的来说，PegIFNα2a 组的持续病毒学应答（SVR）率高于 PegIFNα2b 组（分别为 66%和 54%，P =.02），在 HCV-1 和 -4 型患者中（分别为 48%和 32%，P =.04）和在 HCV-2 型患者中（分别为 96%和 82%，P =.01）。在逻辑回归分析中，PegIFNα2a 独立预测 SVR（优势比，1.88；95%置信区间：1.20-2.96）。
虽然两种方案的安全性相似，但 PegIFNα2a 方案的 SVR 明显高于 PegIFNα2b 方案。
