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慢性丙型肝炎标准治疗早期监测中 HCV-RNA 和 HCV 核心抗原的模式。

Patterns of HCV-RNA and HCV core antigen in the early monitoring of standard treatment for chronic hepatitis C.

机构信息

Department of Clinical Medicine, University of Bologna, Bologna, Italy.

出版信息

J Clin Virol. 2013 Mar;56(3):207-11. doi: 10.1016/j.jcv.2012.11.012. Epub 2012 Dec 13.

Abstract

BACKGROUND

An early drop of HCV-RNA levels is useful in assessing response to antiviral treatment in chronic hepatitis C; the first recommended time point is 4 weeks after the start of therapy.

OBJECTIVES

We evaluated retrospectively HCV-RNA and HCVAg levels at different time points to assess the clinical value of an early monitoring.

STUDY DESIGN

Thirty-five patients with chronic hepatitis C infected by genotype 1b and consecutively enrolled in an open-label study on PegIFN plus Ribavirin and/or ketoprofene were tested for HCV-RNA (real-time PCR) and HCVAg (ARCHITECT) at baseline and after 1 and 2 days and 1, 2, 4 and 12 weeks after the start of treatment. Treatment response was assessed according to the EASL consensus criteria.

RESULTS

In the 17 sustained responders (SR) the median log decrease of HCV-RNA and HCVAg at the different time points was 0.40 and 0.37; 1.36 and 0.84; 1.47 and 0.97; 2.34 and 1.86; 2.51 and 2.32; 3.28 and 2.61, respectively. The best time point to predict SR was 2 weeks after the start of therapy, with a sensitivity, specificity and overall accuracy of 76.9%, 86.7% and 82.1% for HCV-RNA and 81.8%, 75.0% and 76.8% for HCVAg, respectively.

DISCUSSION

An early monitoring is at least equally effective than standard monitoring in predicting response to hepatitis C therapy. The similarity of HCV-RNA and HCVAg kinetics suggests that HCVAg may be useful in the early phases as a trigger to evaluate HCV-RNA levels at earlier time points for a personalized approach to therapy monitoring.

摘要

背景

HCV-RNA 水平的早期下降可用于评估慢性丙型肝炎抗病毒治疗的应答;推荐的第一个时间点是治疗开始后 4 周。

目的

我们回顾性评估了不同时间点 HCV-RNA 和 HCVAg 水平,以评估早期监测的临床价值。

研究设计

35 例感染基因型 1b 的慢性丙型肝炎患者连续入组一项聚乙二醇干扰素联合利巴韦林和/或酮咯酸的开放性研究,在基线和治疗开始后 1、2 天以及 1、2、4 和 12 周时检测 HCV-RNA(实时 PCR)和 HCVAg(ARCHITECT)。根据 EASL 共识标准评估治疗应答。

结果

在 17 例持续应答者(SR)中,不同时间点 HCV-RNA 和 HCVAg 的中位对数下降分别为 0.40 和 0.37;1.36 和 0.84;1.47 和 0.97;2.34 和 1.86;2.51 和 2.32;3.28 和 2.61。预测 SR 的最佳时间点是治疗开始后 2 周,此时 HCV-RNA 的敏感性、特异性和总准确性分别为 76.9%、86.7%和 82.1%,HCVAg 分别为 81.8%、75.0%和 76.8%。

讨论

早期监测与标准监测在预测丙型肝炎治疗应答方面同样有效。HCV-RNA 和 HCVAg 动力学的相似性表明,HCVAg 可能在早期作为触发因素有用,以在更早的时间点评估 HCV-RNA 水平,从而实现治疗监测的个体化方法。

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