在 HCV 基因型 2 或 3 感染和 RVR 的患者中，14 周的治疗与 24 周的治疗非劣效。两项斯堪的纳维亚试验的汇总分析。

In patients with HCV genotype 2 or 3 infection and RVR 14 weeks treatment is noninferior to 24 weeks. Pooled analysis of two Scandinavian trials.

机构信息

Medical Department, Rikshospitalet, Oslo.

出版信息

Eur J Gastroenterol Hepatol. 2010 May;22(5):552-6. doi: 10.1097/MEG.0b013e328335b29e.

DOI:10.1097/MEG.0b013e328335b29e

PMID:20154627

Abstract

AIM

To compare 14 and 24 weeks treatment to patients with HCV genotype 2 or 3 infection and rapid virological response (RVR).

MATERIALS AND METHODS

Patients included in two Scandinavian trials, one nonrandomized pilot trial (n=122) and one randomized controlled trial (RCT) (n=428) were entered into a pooled database. In both trials treatment naïve patients with genotype 2 or 3 were treated with pegylated interferon alpha 2b (1.5 microg/kg, subcutaneous) weekly and ribavirin (800-1400 mg, orally) daily. Primary endpoint was sustained virological response (SVR). RVR was defined as HCV RNA less than 50 IU/ml after 4 weeks of treatment. In the pilot trial all patients with RVR were treated for 14 weeks and in the RCT patients with RVR were randomised to either 14 or 24 weeks treatment. Patients treated per protocol were included in the primary analysis. The noninferiority margin was set to be 10% between the two groups with a one-sided 5% significance level.

RESULTS

In patients with RVR and genotype 2 or 3 SVR was obtained in 181 of 199 (91.0%) and 93 of 98 (94.9%) after 14 and 24 weeks treatment, respectively. The observed difference in SVR rates was 3.9% (90% confidence interval: +1 to -8.8). The relapse rate was highest among those older than 40 years and those with genotype 3 and high viral load, but prolongation of treatment from 14 to 24 weeks did not reduce the relapse rate substantially in any of these groups.

CONCLUSION

In patients with HCV genotype 2 or 3 infection and RVR 14 weeks treatment is noninferior to 24 weeks.

摘要

目的

比较治疗 HCV 基因型 2 或 3 感染和快速病毒学应答（RVR）患者的 14 周和 24 周治疗。

材料和方法

纳入两项斯堪的纳维亚试验的患者，一项非随机试验（n=122）和一项随机对照试验（RCT）（n=428）进入一个汇总数据库。在这两项试验中，基因型 2 或 3 的治疗初治患者接受聚乙二醇干扰素α 2b（1.5μg/kg，皮下）每周一次和利巴韦林（800-1400mg，口服）每日一次治疗。主要终点是持续病毒学应答（SVR）。RVR 定义为治疗后 4 周时 HCV RNA 小于 50IU/ml。在试验中，所有 RVR 患者均接受 14 周治疗，而在 RCT 中，RVR 患者随机接受 14 或 24 周治疗。按方案治疗的患者纳入主要分析。两组之间的非劣效性边界设定为 10%，单侧 5%显著性水平。

结果

在 RVR 且基因型 2 或 3 的患者中，分别有 199 例中的 181 例（91.0%）和 98 例中的 93 例（94.9%）在 14 周和 24 周治疗后获得 SVR。观察到的 SVR 率差异为 3.9%（90%置信区间：+1 至-8.8）。年龄大于 40 岁、基因型 3 和高病毒载量的患者复发率最高，但延长治疗时间从 14 周延长至 24 周并未显著降低这些患者群体中的复发率。