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日本 HCV 基因 1 型患者中聚乙二醇干扰素联合利巴韦林延长治疗的疗效与缓慢病毒学应答。

The efficacy of extended treatment with pegylated interferon plus ribavirin in patients with HCV genotype 1 and slow virologic response in Japan.

机构信息

Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine, 2-2 Yamadaoka, Suita, Osaka, 565-0871, Japan.

出版信息

J Gastroenterol. 2011 Jul;46(7):944-52. doi: 10.1007/s00535-011-0403-0. Epub 2011 May 7.

Abstract

BACKGROUND

Which patients with hepatitis C virus (HCV) genotype 1 can benefit from extended treatment with pegylated interferon (Peg-IFN) plus ribavirin is unknown, although the overall sustained virologic response (SVR) rate has been shown to improve in patients with a late virologic response (LVR), defined as detectable serum HCV RNA at week 12 and undetectable at week 24.

METHODS

Among 1163 chronic hepatitis C patients with genotype 1 treated with Peg-IFN plus ribavirin combination therapy, 213 patients with an LVR were examined in this study. In addition, we selected 81 patients of matched sex and age from each of the 48- and 72-week treatment groups, using the propensity score, to compare the efficacy of the two treatment durations.

RESULTS

With 72-week treatment, the timing of HCV RNA disappearance and the hemoglobin level at baseline showed a strong correlation with the SVR on multivariate analysis. Earlier HCV RNA disappearance was associated with a better SVR rate, regardless of the ribavirin dose (HCV RNA disappearance at week 16, 74%; at week 20, 52%; and at week 24, 31%, p = 0.01). The SVR rate with 72-week treatment was higher than that with 48-week treatment, irrespective of age, sex, or the platelet value, and, especially in aged patients (≥65 years old), the SVR rate increased markedly with 72-week treatment (48 weeks, 25% vs. 72 weeks, 56%; p < 0.05).

CONCLUSIONS

An earlier response predicts a higher SVR rate in patients with an LVR given 72-week treatment. Extended treatment with Peg-IFN plus ribavirin for patients with an LVR improved the treatment efficacy, even for aged patients.

摘要

背景

虽然已经证明,对于那些出现晚期病毒学应答(定义为第 12 周时血清 HCV RNA 可检测而第 24 周时不可检测)的患者,总体持续病毒学应答(SVR)率会提高,但仍不清楚哪些丙型肝炎病毒(HCV)基因型 1 患者可以从聚乙二醇干扰素(Peg-IFN)加利巴韦林的延长治疗中获益。

方法

在接受 Peg-IFN 加利巴韦林联合治疗的 1163 例慢性丙型肝炎基因型 1 患者中,对 213 例出现 LVR 的患者进行了本研究。此外,我们还通过倾向评分,从每个 48 周和 72 周治疗组中各选择 81 例性别和年龄匹配的患者,以比较两种治疗持续时间的疗效。

结果

在 72 周治疗中,HCV RNA 消失的时间和基线时的血红蛋白水平在多变量分析中与 SVR 具有很强的相关性。无论利巴韦林剂量如何,较早的 HCV RNA 消失与更高的 SVR 率相关(第 16 周时 HCV RNA 消失,74%;第 20 周时,52%;第 24 周时,31%,p=0.01)。无论年龄、性别或血小板值如何,72 周治疗的 SVR 率均高于 48 周治疗,尤其是在老年患者(≥65 岁)中,72 周治疗的 SVR 率显著增加(48 周,25%比 72 周,56%;p<0.05)。

结论

对于接受 72 周治疗的 LVR 患者,早期应答可预测更高的 SVR 率。对于 LVR 患者,延长 Peg-IFN 加利巴韦林治疗可提高治疗效果,甚至对老年患者也是如此。

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