A randomised study of peginterferon and ribavirin for 16 versus 24 weeks in patients with genotype 2 chronic hepatitis C
A randomised study of peginterferon and ribavirin for 16 versus 24 weeks in patients with genotype 2 chronic hepatitis C
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DOI：
10.1136/gut.2006.102558
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发表时间：
2007-04-01
期刊：
影响因子：
24.5
通讯作者：
Chuang, Wan-Long
中科院分区：
文献类型：
--
作者：
Yu, Ming-Lung;Dai, Chia-Yen;Chuang, Wan-Long
背景资料：对于感染丙型肝炎病毒基因型2（HCV 2）的患者，推荐的治疗方法是聚乙二醇干扰素目的：评估较短的16周治疗是否与标准的24周治疗一样有效。方法：将HCV 2感染患者随机分为1：2与聚乙二醇干扰素α-2a治疗16周（n = 50）或24周（n = 100）的比值（180 μ g/周）和基于体重的利巴韦林1000 - 1200 mg/天，随访期为24周。快速病毒学应答（RVR）定义为治疗4周时HCV RNA血清阴性，主要终点持续病毒学应答（SVR）定义为随访24周时HCV RNA血清阴性。RVR和SVR的发生率为86%（43/50，95%置信区间（CI）76%至96%）和94%（47/50，CI 87%至100%），与24周组的87%（87/100，CI 80%至94%）和95%（95/100，CI 91%至99%）相当。在16周组（100% vs 57%，p = 0.015）和24周组（98% vs 77%，p = 0.002）中，RVR患者的SVR率显著高于无RVR患者。多因素分析显示RVR和年龄是影响SVR的独立因素。两个治疗组的耐受性同样良好。脱发的发生率在24周组（49%）明显高于16周组（20%，p = 0.001）。结论：16周和24周的聚乙二醇干扰素治疗与体重为基础的利巴韦林在1000-1200 mg/天的剂量提供了相同的疗效，在4周达到RVR的HCV 2患者。
Background: The recommended treatment for patients infected with hepatitis C virus genotype 2 (HCV2) is pegylated interferon (peginterferon) and ribavirin for 24 weeks.Aim: To assess whether a shorter 16-week treatment is as effective as a standard 24- week treatment.Methods: Patients with HCV2 infection were randomised in a 1:2 ratio to either 16 weeks (n = 50) or 24 weeks (n = 100) of treatment with peginterferon alpha-2a (180 mu g/week) and weight-based ribavirin 1000 1200 mg/day, with a 24-week follow-up period. A rapid virological response (RVR) was defined as seronegative for HCV RNA at 4 weeks of treatment, and the primary end point, sustained virological response (SVR), as seronegative for HCV RNA at the 24-week follow-up.Results: The rate of RVR and SVR was 86% (43/50, 95% confidence interval (CI) 76% to 96%) and 94% (47/50, CI 87% to 100%), respectively, in the 16-week group, which was comparable to 87% (87/100, CI 80% to 94%) and 95% (95/100, CI 91% to 99%) in the 24-week group. Patients with RVR had a significantly higher SVR rate than patients without RVR in both 16-week (100% vs 57%, p = 0.015) and 24-week groups (98% vs 77%, p = 0.002). Multivariate analysis showed that RVR and age were independent factors associated with SVR. Both treatment arms were equally well tolerated. The incidence of alopecia was significantly higher in the 24-week group (49%) than in the 16-week group (20%, p = 0.001).Conclusion: 16 weeks and 24 weeks of peginterferon treatment with weight-based ribavirin at a dose of 1000-1200 mg/day provided equal efficacy in patients with HCV2 who achieved RVR at 4 weeks.