聚乙二醇干扰素α-2a联合利巴韦林治疗48周与72周用于治疗第4周时丙型肝炎病毒RNA可检测的患者。

Peginterferon-alfa2a plus ribavirin for 48 versus 72 weeks in patients with detectable hepatitis C virus RNA at week 4 of treatment.

作者信息

Sánchez-Tapias José M, Diago Moisés, Escartín Pedro, Enríquez Jaime, Romero-Gómez Manuel, Bárcena Rafael, Crespo Javier, Andrade Raúl, Martínez-Bauer Eva, Pérez Ramón, Testillano Milagros, Planas Ramón, Solá Ricard, García-Bengoechea Manuel, Garcia-Samaniego Javier, Muñoz-Sánchez Miguel, Moreno-Otero Ricardo

机构信息

Hospital Clínic, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Barcelona, Spain.

出版信息

Gastroenterology. 2006 Aug;131(2):451-60. doi: 10.1053/j.gastro.2006.05.016.

DOI:10.1053/j.gastro.2006.05.016

PMID:16890599

Abstract

BACKGROUND & AIMS: Patients with chronic hepatitis C who do not respond rapidly to therapy have a low chance of developing a sustained virologic response (SVR) when treated for 48 weeks. This study investigated whether treatment for 72 weeks increases the rate of SVR in patients with detectable hepatitis C virus (HCV)-RNA levels at week 4 of treatment.

METHODS

A total of 510 treatment-naive patients were treated with peginterferon-alfa2a (180 microg/wk) plus ribavirin (800 mg/day). Patients with detectable HCV-RNA levels at week 4 (n = 326) were randomized to complete 48 (group A, n = 165) or 72 weeks (group B, n = 161) of treatment. Patients with undetectable HCV-RNA levels at week 4 (n = 184) were allocated into group C (n = 148) or group D (n = 36), according to HCV genotype and baseline viremia, and treated for 24 or 48 weeks, respectively. All patients were followed-up for 24 weeks after the end of treatment.

RESULTS

The end-of-treatment response rate (61%) was similar in groups A and B, but the SVR rate was higher in group B (45% vs 32% in A; P = .01). In genotype 1-infected patients randomized to group A (n = 149) or B (n = 142), SVR rates were 28% and 44%, respectively (P = .003). The incidence of adverse events was similar in all groups. Treatment discontinuation was more frequent in group B (36%) than in group A (18%) (P = .0004). SVR rates in groups C and D were 79% and 64%, respectively.

CONCLUSIONS

Extension of treatment with peginterferon-alfa2a plus ribavirin from 48 to 72 weeks significantly increases the rate of SVR in patients with detectable viremia at week 4 of treatment.

摘要

背景与目的

对治疗反应不迅速的慢性丙型肝炎患者，接受48周治疗时获得持续病毒学应答（SVR）的几率较低。本研究调查了治疗72周是否会提高治疗第4周时丙型肝炎病毒（HCV）-RNA水平可检测的患者的SVR率。

方法

总共510例初治患者接受聚乙二醇化干扰素-α2a（180μg/周）加利巴韦林（800mg/天）治疗。治疗第4周时HCV-RNA水平可检测的患者（n = 326）被随机分为完成48周（A组，n = 165）或72周（B组，n = 161）治疗。治疗第4周时HCV-RNA水平不可检测的患者（n = 184）根据HCV基因型和基线病毒血症被分配到C组（n = 148）或D组（n = 36），分别接受24周或48周治疗。所有患者在治疗结束后随访24周。

结果

A组和B组的治疗结束时应答率（61%）相似，但B组的SVR率更高（45%对A组的32%；P = 0.01）。在随机分为A组（n = 149）或B组（n = 142）的基因1型感染患者中，SVR率分别为28%和44%（P = 0.003）。所有组的不良事件发生率相似。B组（36%）的治疗中断比A组（18%）更频繁（P = 0.0004）。C组和D组的SVR率分别为79%和64%。