Department of General Internal Medicine, Kyushu University Hospital, Higashi-ku, Fukuoka, 812-8582, Japan.
J Infect Chemother. 2012 Oct;18(5):689-97. doi: 10.1007/s10156-012-0396-5. Epub 2012 Mar 27.
The aim of this large-scale analysis was to assess the effect of 48-week pegylated interferon (PEG-IFN) α-2b and ribavirin (RBV) therapy on virological relapse by patients infected with hepatitis C virus (HCV) genotype 1. The relationship between virological relapse and the dose of PEG-IFNα-2b and RBV was investigated in 619 patients who had once cleared HCV RNA during PEG-IFNα-2b and RBV treatment for 48 weeks. The overall virological relapse rate was 34.1% (211 of 619). The relapse rate was 59.5% (22 of 37) for patients who received <6 mg/kg/day of RBV, even if a sufficient dose of PEG-IFNα-2b (≥1.5 μg/kg/day) was received. In contrast, the relapse rate was 28.1% (16 of 57) for patients who received ≥12 mg/kg/day of RBV, irrespective of the PEG-IFNα-2b dose. The relapse rates were significantly increased with the reduction of the RBV dose for both PEG-IFNα-2b doses of ≥1.2 and <1.2 μg/kg/week (P < 0.0001 and P = 0.0006, respectively). Moreover, the relapse rate was 41.2% (35 of 85) for patients with an early virological response (EVR) who received <6 mg/kg/day of RBV. The relapse rates were significantly increased with the reduction of the RBV dose in both those patients with an EVR and those with a late virological response (P = 0.0006 and P = 0.0088, respectively). To summarize, for HCV genotype 1 patients treated with PEG-IFNα-2b and RBV, the virological relapse of HCV was RBV dose-dependent, irrespective of the dose of PEG-IFNα or the effect of early viral kinetics.
本大规模分析旨在评估聚乙二醇干扰素（PEG-IFN）α-2b 和利巴韦林（RBV）治疗 48 周对 HCV 基因型 1 感染患者病毒学复发的影响。在曾接受过 PEG-IFNα-2b 和 RBV 治疗 48 周清除 HCV RNA 的 619 例患者中，研究了病毒学复发与 PEG-IFNα-2b 和 RBV 剂量之间的关系。总的病毒学复发率为 34.1%（619 例中有 211 例）。对于接受 <6mg/kg/天 RBV 的患者，即使接受了足够剂量的 PEG-IFNα-2b（≥1.5μg/kg/天），复发率也高达 59.5%（37 例中有 22 例）。相比之下，对于接受 ≥12mg/kg/天 RBV 的患者，无论 PEG-IFNα-2b 剂量如何，复发率均为 28.1%（57 例中有 16 例）。对于两种剂量的 PEG-IFNα-2b（≥1.2μg/kg/周和 <1.2μg/kg/周），随着 RBV 剂量的减少，复发率均显著增加（P<0.0001 和 P=0.0006）。此外，对于接受 <6mg/kg/天 RBV 的早期病毒学应答（EVR）患者，复发率为 41.2%（85 例中有 35 例）。在 EVR 患者和晚期病毒学应答（LVR）患者中，随着 RBV 剂量的减少，复发率均显著增加（P=0.0006 和 P=0.0088）。总之，对于接受 PEG-IFNα-2b 和 RBV 治疗的 HCV 基因型 1 患者，HCV 的病毒学复发与 RBV 剂量相关，而与 PEG-IFNα 的剂量或早期病毒动力学的效果无关。
