聚乙二醇干扰素α-2b联合利巴韦林治疗基因1b型感染的慢性丙型肝炎患者24周与48周疗程的随机试验：台湾的一项初步研究

A randomized trial of 24- vs. 48-week courses of PEG interferon alpha-2b plus ribavirin for genotype-1b-infected chronic hepatitis C patients: a pilot study in Taiwan.

作者信息

Yu Ming-Lung, Dai Chia-Yen, Lin Zu-Yau, Lee Li-Po, Hou Nei-Jen, Hsieh Ming-Yen, Chen Shinn-Cherng, Hsieh Ming-Yuh, Wang Liang-Yen, Chang Wen-Yu, Chuang Wan-Long

机构信息

Hepatobiliary Division, Faculty of Internal Medicine, College of Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan.

出版信息

Liver Int. 2006 Feb;26(1):73-81. doi: 10.1111/j.1478-3231.2005.01196.x.

DOI:10.1111/j.1478-3231.2005.01196.x

PMID:16420512

Abstract

BACKGROUND

To assess the efficacy of 24- or 48-week peginterferon/ribavirin treatment of Taiwanese patients with chronic hepatitis C virus genotype-1b (HCV-1b) infection, and to identify subgroups of patients in whom the 48-week treatment has benefits.

METHODS

We assigned 60 patients receiving peginterferon-alpha-2b (80-100 mcg/week) plus ribavirin (1000-1200 mg/day), depending on body weight, for 24 or 48 weeks, with a 3:1 randomization ratio.

RESULTS

The sustained virological response (SVR) rate was significantly higher in the 48-week (80.0%, 12/15) than in the 24-week group (48.9%, 22/45, P < 0.05). The 60 patients were classified into two subgroups according to the presence of unfavorable baseline predictors: viral loads > or = 400,000 IU/ml or a hepatic fibrosis score of 3-4. In 19 patients without an unfavorable predictor, the SVR rate was comparable in the 24-week (78.6%) and 48-week (75.0%) groups; in patients with either unfavorable predictors, the SVR rate was significantly higher in the 48-week (81.1%, 9/11) than in the 24-week group (36.7%, 11/30, P = 0.015). The discontinuation rate was significantly higher in the 48-week (20.0%, 3/15) than in the 24-week group (2.2%, 1/45, P < 0.05).

CONCLUSION

A 48-week course of peginterferon-alpha-2b/ribavirin was more effective than a 24-week course in Taiwanese HCV-1b patients, mainly in those with high viral loads and/or advanced hepatic fibrosis.

摘要

背景

评估聚乙二醇干扰素/利巴韦林治疗台湾慢性丙型肝炎病毒1b型（HCV-1b）感染患者24周或48周的疗效，并确定48周治疗有益的患者亚组。

方法

我们根据体重为60例患者分配聚乙二醇干扰素α-2b（80-100微克/周）加利巴韦林（1000-1200毫克/天），治疗24周或48周，随机分组比例为3:1。

结果

48周组的持续病毒学应答（SVR）率（80.0%，12/15）显著高于24周组（48.9%，22/45，P<0.05）。根据基线不利预测因素的存在情况，将60例患者分为两个亚组：病毒载量≥400,000 IU/ml或肝纤维化评分为3-4。在19例无不利预测因素的患者中，24周组（78.6%）和48周组（75.0%）的SVR率相当；在有任何一种不利预测因素的患者中，48周组的SVR率（81.1%，9/11）显著高于24周组（36.7%，11/30，P=0.015）。48周组的停药率（20.0%，3/15）显著高于24周组（2.2%，1/45，P<0.05）。