Nakaya Mika, Enomoto Masaru, Fujii Hideki, Kobayashi Sawako, Iwai Shuji, Morikawa Hiroyasu, Tamori Akihiro, Sakaguchi Hiroki, Kawada Norifumi
Department of Hepatology, Osaka City University, Graduate School of Medicine, Japan.
Osaka City Med J. 2013 Dec;59(2):79-89.
The real-time PCR, such as Abbott RealTime assay, have replaced end-point PCR, such as Amplicor assays, for the measurement of HCV RNA. However, 'response-guided therapy' to use on-treatment response for tailoring the duration of treatment with peginterferon-alpha and ribavirin has not been fully evaluated for real-time PCR.
43 patients with HCV genotype 1 (24 who had complete early virological responses (cEVR) on Amplicor assay and received 48-week therapy, and 19 who had late virological responses (LVR) and received 72-week therapy) were recruited. Using a RealTime assay, we retrospectively measured HCV RNA in stored sera.
In 10 samples obtained during therapy, HCV RNA was undetectable on the Amplicor assay, but detectable on the RealTime assay. Among patients with cEVR on the Amplicor assay, those with detectable HCV RNA on the RealTime assay at week 12 were less likely to have a sustained virological response (SVR) than those without (2/4 vs 17/20, p = 0.116). Among patients with LVR on the Amplicor assay, those with HCV RNA detectable on the RealTime assay at week 24 were significantly less likely to have SVR than those without (1/4 vs 12/15, p = 0.041).
The RealTime assay may be useful for tailoring duration of treatment for the patient with HCV genotype 1.
实时荧光定量PCR,如雅培实时检测法,已取代终点PCR,如Amplicor检测法,用于检测丙型肝炎病毒(HCV)RNA。然而,对于实时荧光定量PCR,尚未充分评估使用治疗期间反应来调整聚乙二醇化干扰素-α和利巴韦林治疗疗程的“反应导向治疗”。
招募了43例HCV基因1型患者(24例在Amplicor检测中具有完全早期病毒学应答(cEVR)并接受48周治疗,19例具有晚期病毒学应答(LVR)并接受72周治疗)。使用实时检测法,我们回顾性地检测了储存血清中的HCV RNA。
在治疗期间获得的10份样本中,Amplicor检测法检测不到HCV RNA,但实时检测法可检测到。在Amplicor检测中具有cEVR的患者中,在第12周实时检测法可检测到HCV RNA的患者比未检测到的患者获得持续病毒学应答(SVR)的可能性更小(2/4 vs 17/20,p = 0.116)。在Amplicor检测中具有LVR的患者中,在第24周实时检测法可检测到HCV RNA的患者比未检测到的患者获得SVR的可能性显著更小(1/4 vs 12/15,p = 0.041)。
实时检测法可能有助于调整HCV基因1型患者的治疗疗程。