聚乙二醇干扰素联合利巴韦林治疗老年慢性丙型肝炎的疗效和安全性。

Efficacy and safety of pegylated interferon combined with ribavirin for the treatment of older patients with chronic hepatitis C.

机构信息

Hepatobiliary Division, Department of Internal Medicine, Kaohsiung Medical University Hospital, Graduate Institute of Medicine, Kaohsiung Medical University, Kaohsiung 807, Taiwan.

出版信息

J Infect Dis. 2010 Mar;201(5):751-9. doi: 10.1086/650470.

DOI:10.1086/650470

PMID:20102281

Abstract

BACKGROUND

The present study evaluated the efficacy and safety of pegylated interferon (PegIFN)/ribavirin treatment in elderly patients with hepatitis C virus (HCV) infection.

METHODS

Seventy elderly patients with hepatitis C virus (HCV) infection (group A; age, > or = 65 years) and 140 sex- and HCV genotype-matched controls (group B; age, 50-64 years) were allocated to receive a PegIFN-alpha-2a/ribavirin standard-of-care regimen.

RESULTS

Group A had a significantly higher rate of treatment discontinuation (21.4% vs 6.4%; P = .001) and grade 3 or 4 adverse events (34.3% vs 20%; P = .002) than group B. In intention-to-treat analysis, the sustained virologic response (SVR) rate was substantially lower in group A than in group B (67.1% vs 78.6%; P = .07). The inferiority of the SVR rate in group A was observed among patients with HCV genotype 1 (HCV-1) (51.9% vs 75.9%; P = .03) but not among patients with HCV genotype 2 or 3 (HCV-2/3) (76.7% vs 80.2%; P = .65). Among patients in group A who had a rapid virologic response, those infected with HCV-1 and those infected with HCV-2/3 had similar SVR rates (80% and 87.9%, respectively). For patients receiving treatment for >80% of its expected duration, SVR rates were similar between the 2 groups (80.4% vs 82.6%, respectively), regardless of viral genotype.

CONCLUSIONS

Older patients with HCV infection, especially those in the subgroup infected with HCV-1, had a greater frequency of adverse events and poorer adherence to the standard-of-care regimen, which may be the major reason for treatment inferiority.

TRIAL REGISTRATION

Clinicaltrials.gov identifier NCT00629824 .

摘要

背景

本研究评估了聚乙二醇干扰素（PegIFN）/利巴韦林治疗老年丙型肝炎病毒（HCV）感染患者的疗效和安全性。

方法

70 例老年丙型肝炎病毒（HCV）感染患者（A 组；年龄≥65 岁）和 140 例性别和 HCV 基因型匹配的对照者（B 组；年龄 50-64 岁）接受 PegIFN-α-2a/利巴韦林标准治疗方案。

结果

A 组治疗中断率（21.4% vs. 6.4%；P=0.001）和 3 级或 4 级不良事件发生率（34.3% vs. 20%；P=0.002）显著高于 B 组。意向治疗分析显示，A 组持续病毒学应答（SVR）率显著低于 B 组（67.1% vs. 78.6%；P=0.07）。在 HCV-1 感染患者中观察到 A 组的 SVR 率较差（51.9% vs. 75.9%；P=0.03），但在 HCV-2/3 感染患者中则无差异（76.7% vs. 80.2%；P=0.65）。在 A 组快速病毒学应答患者中，HCV-1 感染和 HCV-2/3 感染患者的 SVR 率相似（分别为 80%和 87.9%）。对于接受治疗超过预计治疗时间 80%的患者，两组的 SVR 率相似（分别为 80.4%和 82.6%），与病毒基因型无关。