基于高敏实时 PCR 的 HCV RNA 检测在聚乙二醇干扰素 α-2a 联合利巴韦林应答指导治疗中快速病毒学应答的定义。
Definition of rapid virologic response with a highly sensitive real-time PCR-based HCV RNA assay in peginterferon alfa-2a plus ribavirin response-guided therapy.
机构信息
Department of Internal Medicine, J.W. Goethe-University Hospital, Frankfurt, Germany.
出版信息
J Hepatol. 2010 Jun;52(6):832-8. doi: 10.1016/j.jhep.2010.01.030. Epub 2010 Mar 15.
BACKGROUND & AIMS: Assessing hepatitis C virus (HCV)-RNA levels is integral to response-guided therapy. Rules for early discontinuation and determination of treatment duration were mainly established with HCV-RNA assays with a detection limit of 50IU/ml (COBAS Amplicor HCV [CA]). The currently used real-time PCR-based COBAS Ampliprep/COBAS-TaqMan HCV (CAP-CTM) test has a detection limit of approximately 10IU/ml. It is unknown whether shortening of treatment duration to 16/24 weeks in patients with rapid virological response at week 4 (RVR) and viral loads between 10 and 50IU/ml is possible.
METHODS
We reanalysed stored serum from two large, multinational, randomized trials in which patients were treated with peginterferon alfa-2a/ribavirin (n=962). Results of CAP-CTM with truly undetectable HCV RNA and those <15IU/ml, which includes patients with residual viraemia (<15), were compared with the originally obtained results using the CA assay.
RESULTS
RVR rates were comparable for CA (<50) and CAP-CTM (<15) with 32% and 32% for genotype (gt) 1 and 50% and 49% for gt2/3 patients, respectively. A significantly smaller number of samples really had truly undetectable HCV RNA by the CAP-CTM assay (24% for gt1, 37% for gt2/3). However, sustained virological response rates after shortened treatment (16/24weeks) were not significantly different in patients with a RVR <50, a RVR <15 and RVR undetectable (82%, 83%, 83% for 24weeks gt1 and 95%, 95%, 94% for 16weeks gt2/3).
CONCLUSIONS
Shortening the treatment duration to 16/24weeks can be performed on the basis of a RVR with HCV-RNA concentrations <15IU/ml by the CAP-CTM assay.
背景与目的
评估丙型肝炎病毒 (HCV)-RNA 水平是指导治疗的关键。早期停药和确定治疗持续时间的规则主要是基于 HCV-RNA 检测下限为 50IU/ml 的检测方法（COBAS Amplicor HCV [CA]）建立的。目前使用的基于实时 PCR 的 COBAS Ampliprep/COBAS-TaqMan HCV（CAP-CTM）检测的检测下限约为 10IU/ml。尚不清楚对于在第 4 周时快速病毒学应答 (RVR)且病毒载量在 10 至 50IU/ml 之间的患者，是否可以将治疗时间缩短至 16/24 周。
方法
我们重新分析了两项大型跨国随机试验中储存的血清，这些患者接受了聚乙二醇干扰素 alfa-2a/利巴韦林（n=962）治疗。比较 CAP-CTM 检测结果为真正不可检测的 HCV RNA 和<15IU/ml（包括残留病毒血症(<15)的患者）与 CA 检测结果。
结果
CA（<50）和 CAP-CTM（<15）的 RVR 率相似，基因型 (gt) 1 分别为 32%和 32%，gt2/3 分别为 50%和 49%。用 CAP-CTM 检测确实有真正不可检测 HCV RNA 的样本数量明显较少（gt1 为 24%，gt2/3 为 37%）。然而，RVR<50、RVR<15 和 RVR 不可检测的患者缩短治疗（16/24 周）后的持续病毒学应答率没有显著差异（gt1 为 24 周时的 82%、83%、83%和 16 周时的 95%、95%、94%）。
结论
基于 CAP-CTM 检测 HCV-RNA 浓度<15IU/ml 的 RVR，可以将治疗时间缩短至 16/24 周。
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