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聚乙二醇干扰素联合利巴韦林治疗失败后的慢性丙型肝炎患者应用普通干扰素联合利巴韦林挽救治疗:一项全国性退伍军人事务部临床实践研究。

Retreatment of hepatitis C with consensus interferon and ribavirin after nonresponse or relapse to pegylated interferon and ribavirin: a national VA clinical practice study.

机构信息

Gastroenterology Section, Department of Veterans Affairs Medical Center (VAMC), 4150 Clement Street (111B), San Francisco, CA 94121, USA.

出版信息

Dig Dis Sci. 2011 Aug;56(8):2439-48. doi: 10.1007/s10620-011-1746-3. Epub 2011 Jun 2.

DOI:10.1007/s10620-011-1746-3
PMID:21633833
Abstract

BACKGROUND

Studies of the retreatment with consensus interferon (CIFN) and ribavirin (RBV) of hepatitis C virus (HCV)-infected patients who failed prior pegylated interferon alfa/ribavirin (PEG-IFN/RBV) have found quite variable efficacy and tolerability of this therapy. As such, CIFN/RBV use and efficacy in clinical practice were evaluated within the Department of Veterans Affairs (VA), the largest national, integrated system for HCV care.

AIMS

The purpose of this study was to determine rates of sustained virologic response (SVR) and patterns of CIFN/RBV use in the VA. Methods included retrospective review of national VA data in HCV-infected patients who had previously failed≥12 weeks of PEG-IFN/RBV and were prescribed CIFN/RBV between October 1, 2003 and September 30, 2006.

RESULTS

A total of 597 patients met the study criteria. CIFN was primarily dosed as 15 mcg subcutaneously daily combined with standard doses of RBV. Mean treatment duration was 21 weeks; CIFN was discontinued within 4 weeks in 24%. Hematological growth factors were used in 49%. Post-treatment viral loads were available in 385 patients. SVR to CIFN/RBV was achieved in 11%, and was significantly higher in prior PEG-IFN/RBV relapsers compared with nonresponders (31% vs. 6%, respectively; P<0.0001). A 2-log10 or greater drop in HCV RNA after 24 weeks of PEG-IFN/RBV was a predictor of subsequent SVR to CIFN/RBV.

CONCLUSIONS

CIFN/RBV was used frequently in clinical practice for retreatment of PEG-IFN/RBV. In this setting, early treatment discontinuation was common. Overall SVR was low, although response was significantly better in prior PEG-IFN/RBV relapsers and those who had a 2-log(10) or greater decline than in nonresponders.

摘要

背景

曾接受聚乙二醇干扰素α(PEG-IFN)联合利巴韦林(RBV)治疗失败的丙型肝炎病毒(HCV)感染患者,应用共识干扰素(CIFN)联合 RBV 再治疗的研究结果显示,该治疗方案的疗效和耐受性差异较大。因此,在美国退伍军人事务部(VA)——HCV 治疗最大的全国性综合系统内,评估了 CIFN/RBV 的应用和疗效。

目的

本研究旨在确定 VA 中 CIFN/RBV 治疗的持续病毒学应答(SVR)率和应用模式。方法:回顾性分析 2003 年 10 月 1 日至 2006 年 9 月 30 日期间,曾接受≥12 周 PEG-IFN/RBV 治疗失败的 HCV 感染患者的国家 VA 数据,这些患者接受了 CIFN/RBV 治疗。

结果

共有 597 例患者符合研究标准。CIFN 主要剂量为皮下注射 15 mcg,每日 1 次,联合标准剂量 RBV。平均治疗时间为 21 周;4 周内停药者占 24%。49%的患者应用了血液学生长因子。385 例患者提供了治疗后病毒载量。CIFN/RBV 治疗的 SVR 率为 11%,既往 PEG-IFN/RBV 复发者显著高于无应答者(分别为 31%和 6%;P<0.0001)。PEG-IFN/RBV 治疗 24 周后 HCV RNA 下降 2 个对数级以上是 CIFN/RBV 后续 SVR 的预测因素。

结论

CIFN/RBV 在临床实践中常用于 PEG-IFN/RBV 治疗失败的再治疗。在此背景下,早期治疗中断较为常见。总体 SVR 率较低,但在既往 PEG-IFN/RBV 复发者和 HCV RNA 下降 2 个对数级以上者中,SVR 显著优于无应答者。

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