Randomized study of peginterferon-alpha2a plus ribavirin vs peginterferon-alpha2b plus ribavirin in chronic hepatitis C.
Randomized study of peginterferon-alpha2a plus ribavirin vs peginterferon-alpha2b plus ribavirin in chronic hepatitis C.
复制标题
聚乙二醇干扰素-α2a 加利巴韦林与聚乙二醇干扰素-α2b 加利巴韦林治疗慢性丙型肝炎的随机研究。
作者：
M. Rumi;A. Aghemo;G. Prati;R. D’Ambrosio;M. F. Donato;R. Soffredini;E. Del Ninno;A. Russo;M. Colombo
背景与目标
利巴韦林（RBV）联合聚乙二醇干扰素（PegIFN）α 2a或PegIFN α 2b是慢性丙型肝炎病毒（HCV）感染的标准治疗。由于缺乏头对头研究，未直接比较2种PegIFN。本研究的终点是两种方案的安全性和抗病毒疗效。
方法
根据HCV基因型分层后，将未经治疗的慢性丙型肝炎患者随机（1：1）分配接受1.5 mcg/Kg/周PegIFN α 2b + RBV 800-1200 mg/天或180 mcg/周PegIFN α 2a + RBV 800-1200 mg/天治疗24周或48周。该研究有把握度检测到两种方案的安全性和疗效差异至少为10%。
结果
212名PegIFN α 2a组患者和219名PegIFN α 2b组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，两组显示出相似的治疗相关严重不良事件发生率（分别为1%和1%）和不良反应脱落率（分别为7%和6%）。总体而言，PegIFN α 2a患者的持续病毒学应答（SVR）率高于PegIFN α 2b患者（分别为66%和54%，P = 0.02），222例HCV-1和-4患者分别为48%和32%（P = 0.04），143例HCV-2患者分别为96%和82%（P = 0.01）。在逻辑回归分析中，PegIFN α 2a独立预测SVR（比值比，1.88; 95%置信区间：1.20-2.96）。
结论
尽管两种方案显示出相似的安全性特征，但基于PegIFN α 2a的治疗产生的SVR显著高于PegIFN α 2b。
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.
METHODS
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.
RESULTS
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).
CONCLUSIONS
Although the 2 regimens showed a similar safety profile, the PegIFNalpha2a-based treatment yielded significantly more SVR than PegIFNalpha2b.