Arase Yasuji, Suzuki Fumitaka, Sezaki Hitomi, Suzuki Yoshiyuki, Kawamura Yusuke, Kobayashi Masahiro, Akuta Norio, Hosaka Tetsuya, Yatsuji Hiromi, Ikeda Kenji, Kobayashi Mariko, Kumada Hiromitsu
Department of Hepatology, Toranomon Hospital, Tokyo.
Intern Med. 2008;47(14):1301-7. doi: 10.2169/internalmedicine.47.0797. Epub 2008 Jul 15.
The aim of this study was to determine the suitable treatment period in patients who achieve virological response during combination therapy of peginterferon and ribavirin for chronic hepatitis C virus infection.
Inclusion criteria were HCV-genotype 1b, serum HCV RNA level of > or =100 KIU/ml before treatment, and negativity of serum HCV RNA during treatment. The 366 patients were enrolled in this retrospective cohort study. Patients were classified into four groups according to difference of response: rapid-virological response (RVR) at week 4 after the initiation of treatment (n=37), early-virological response (EVR) at week 5-12 (n=161), late-virological response (LVR) at week 13-24 (n=131), and superlate-virological response (SLVR) at week 25-48 (n=37). A non-relapse in patients with undetectable HCV RNA during therapy was defined as clearance of HCV RNA 6 month after the cessation of therapy.
Of the 366 patients, 241 had non-relapse and the non-relapse rate in each group was 89% (33/37) in RVR, 79% (127/161) in EVR, 54% (71/131) in LVR, and 27% (10/37) in SLVR. In RVR, 26 of 27 patients with continuance of negative HCV RNA of > or =30 weeks during treatment had non-relapse. In EVR, patients with period of negative HCV RNA of > or =40 weeks had non-relapse rate of 90% (71/79). In LVR and SLVR, all nine patients with continuance of negative HCV RNA of > or =60 weeks had non-relapse.
A suitable treatment period of combination therapy for chronic hepatitis C should be determined based on the time of attainment of negative HCV RNA.
本研究旨在确定在聚乙二醇干扰素和利巴韦林联合治疗慢性丙型肝炎病毒感染过程中实现病毒学应答的患者的合适治疗疗程。
纳入标准为丙型肝炎病毒基因1b型、治疗前血清丙型肝炎病毒RNA水平≥100 KIU/ml以及治疗期间血清丙型肝炎病毒RNA阴性。366例患者纳入本回顾性队列研究。根据应答差异将患者分为四组：治疗开始后第4周的快速病毒学应答（RVR，n = 37）、第5 - 12周的早期病毒学应答（EVR，n = 161）、第13 - 24周的晚期病毒学应答（LVR，n = 131）以及第25 - 48周的超晚期病毒学应答（SLVR，n = 37）。治疗期间丙型肝炎病毒RNA检测不到的患者无复发被定义为治疗停止后6个月丙型肝炎病毒RNA清除。
366例患者中，241例无复发，每组的无复发率分别为RVR组89%（33/37）、EVR组79%（127/161）、LVR组54%（71/131）、SLVR组27%（10/37）。在RVR组中，治疗期间丙型肝炎病毒RNA持续阴性≥30周的27例患者中有26例无复发。在EVR组中，丙型肝炎病毒RNA阴性持续时间≥40周的患者无复发率为90%（71/79）。在LVR组和SLVR组中，丙型肝炎病毒RNA持续阴性≥60周的所有9例患者均无复发。
慢性丙型肝炎联合治疗的合适疗程应根据丙型肝炎病毒RNA转阴时间来确定。
