Department of Gastroenterology and Hepatology, NTT West Kyushu Hospital, 1-17-27 Shinyashiki, Kumamoto 862-8655, Japan.
J Gastroenterol. 2012 Sep;47(9):1014-21. doi: 10.1007/s00535-012-0560-9. Epub 2012 Mar 2.
Pegylated interferon (PegIFN) plus ribavirin is the standard therapy for patients with chronic hepatitis C genotype 1. Although several randomized clinical trials have compared PegIFNα-2a with PegIFNα-2b, these 2 regimens have not been directly compared in Asian patients. We, therefore, compared the safety and antiviral efficacy of these agents in Japanese patients.
A total of 201 PegIFN-naïve, chronic hepatitis C patients were randomly assigned to once-weekly PegIFNα-2a (180 μg) or PegIFNα-2b (60-150 μg) plus ribavirin. We compared the sustained virological response (SVR) rates between the 2 regimens and analyzed their effects in relation to baseline characteristics, including single nucleotide polymorphisms (SNPs) near the interleukin-28B (IL28B) gene (rs8099917).
PegIFNα-2a was associated with a higher SVR rate than PegIFNα-2b (65.3 vs. 51.0%, P = 0.039). PegIFNα-2a and SNPs near IL28B independently predicted SVR (odds ratio 2.36; 95% confidence interval [CI] 1.19-15.50, and odds ratio 7.31; 95% CI 3.45-4.68, respectively) in logistic regression analysis. PegIFNα-2a was more effective than PegIFNα-2b (81.8 vs. 62.7%, P = 0.014) in IL28B TT genotype patients, despite similarly low SVR rates in patients with TG or GG genotypes (36.4 vs. 35.9%). Patients weighing <60 kg, women, and patients aged >60 years had significantly higher SVR rates with PegIFNα-2a than with PegIFNα-2b (63.9, 61.3, and 67.3% vs. 43.8, 43.3,and 39.2%, respectively).
PegIFNα-2a plus ribavirin resulted in higher SVR rates than PegIFNα-2b plus ribavirin in Japanese patients. PegIFNα-2a-based treatment should therefore be the preferred choice for women, older or low-weight patients, and those with the IL28B TT genotype.
聚乙二醇干扰素（PegIFN）联合利巴韦林是慢性丙型肝炎基因型 1 患者的标准治疗方法。虽然几项随机临床试验比较了 PegIFNα-2a 与 PegIFNα-2b，但这两种方案并未在亚洲患者中进行直接比较。因此，我们比较了这两种药物在日本患者中的安全性和抗病毒疗效。
共纳入 201 例 PegIFN 初治的慢性丙型肝炎患者，随机分为每周一次 PegIFNα-2a（180μg）或 PegIFNα-2b（60-150μg）联合利巴韦林组。我们比较了两种方案的持续病毒学应答（SVR）率，并分析了它们与基线特征（包括白细胞介素 28B（IL28B）基因附近的单核苷酸多态性（SNP））之间的关系。
PegIFNα-2a 方案的 SVR 率高于 PegIFNα-2b 方案（65.3% vs. 51.0%，P=0.039）。PegIFNα-2a 和 IL28B 附近的 SNP 独立预测 SVR（优势比 2.36；95%置信区间[CI] 1.19-15.50 和优势比 7.31；95%CI 3.45-4.68）。在 logistic 回归分析中。IL28B TT 基因型患者中，PegIFNα-2a 比 PegIFNα-2b 更有效（81.8% vs. 62.7%，P=0.014），而 TG 或 GG 基因型患者的 SVR 率相似（36.4% vs. 35.9%）。体重<60kg、女性和年龄>60 岁的患者接受 PegIFNα-2a 治疗的 SVR 率明显高于接受 PegIFNα-2b 治疗的患者（63.9%、61.3%和 67.3% vs. 43.8%、43.3%和 39.2%）。
与 PegIFNα-2b 联合利巴韦林相比，PegIFNα-2a 联合利巴韦林在日本患者中可获得更高的 SVR 率。因此，对于女性、年龄较大或体重较轻的患者，以及 IL28B TT 基因型患者，应首选 PegIFNα-2a 治疗。
