多中心评估 Abbott RealTime HCV 检测用于监测慢性丙型肝炎抗病毒治疗患者。

Multi-center evaluation of the Abbott RealTime HCV assay for monitoring patients undergoing antiviral therapy for chronic hepatitis C.

机构信息

Medizinische Klinik 1, Klinikum der J.W. Goethe-Universität, Frankfurt am Main, Germany.

出版信息

J Clin Virol. 2011 Oct;52(2):133-7. doi: 10.1016/j.jcv.2011.07.007. Epub 2011 Jul 30.

DOI:10.1016/j.jcv.2011.07.007

PMID:21803650

Abstract

BACKGROUND

Hepatitis C virus (HCV) RNA monitoring during antiviral therapy is essential for early prediction of treatment success and failure to peginterferon alfa/ribavirin (PEG-IFN/RBV) therapy.

OBJECTIVES

In this multi-center study we assessed the clinical utility of the Abbott RealTime HCV assay for monitoring patients undergoing antiviral therapy for chronic infection with HCV genotypes (GT) 1-3.

STUDY DESIGN

We analyzed serum from 361 patients with chronic hepatitis C who had been treated with PEG-IFN/RBV. The predictive value of rapid virologic response (RVR), partial (≥2log(10) decline) and complete (HCV-RNA undetectable) early virologic response (pEVR/cEVR) based on RealTime HCV for achieving sustained virologic response was evaluated. In addition, the utility of RealTime HCV to tailor treatment duration according to individual virologic responses was studied in a subset of 136 GT 1 patients and compared to the reference tests, Versant HCV Quantitative 3.0 (bDNA) and Qualitative (TMA) assay.

RESULTS

At week 4 of therapy, patients with RVR had a 100% and 93.5% probability to achieve an SVR in GT 1 and GT 2/3 patients, respectively. At week 12, patients who did not achieve a pEVR had a 97.2% and 100% probability of not achieving an SVR. In addition, assignment of GT 1 patients to abbreviated or extended treatment durations based on low baseline HCV-RNA (<800,000IU/mL) and RVR or pEVR was highly concordant between RealTime HCV and bDNA/TMA assays (97.8% and 91.9%, respectively).

CONCLUSIONS

The RealTime HCV assay is suitable for monitoring virologic response to PEG-INF/RBV therapy and tailoring treatment duration accordingly.

摘要

背景

丙型肝炎病毒 (HCV) RNA 监测在抗病毒治疗期间对于早期预测聚乙二醇干扰素α/利巴韦林 (PEG-IFN/RBV) 治疗的成功和失败至关重要。

目的

在这项多中心研究中，我们评估了 Abbott RealTime HCV 检测在监测接受 HCV 基因型 (GT) 1-3 慢性感染抗病毒治疗的患者中的临床效用。

研究设计

我们分析了 361 例接受 PEG-IFN/RBV 治疗的慢性丙型肝炎患者的血清。评估了基于 RealTime HCV 的快速病毒学应答 (RVR)、部分 (≥2log(10) 下降) 和完全 (HCV-RNA 不可检测) 早期病毒学应答 (pEVR/cEVR) 对实现持续病毒学应答的预测价值。此外，我们还研究了 136 例 GT 1 患者亚组中根据个体病毒学应答调整治疗时间的 RealTime HCV 的效用，并与参考检测 Versant HCV Quantitative 3.0 (bDNA) 和定性 (TMA) 检测进行了比较。

结果

治疗第 4 周，RVR 患者在 GT 1 和 GT 2/3 患者中实现 SVR 的概率分别为 100%和 93.5%。治疗第 12 周，未达到 pEVR 的患者实现 SVR 的概率为 97.2%。此外，根据基线 HCV-RNA(<800,000IU/mL) 和 RVR 或 pEVR 对 GT 1 患者进行缩短或延长治疗时间的分配，RealTime HCV 与 bDNA/TMA 检测高度一致 (分别为 97.8%和 91.9%)。