Yu Ming-Lung, Dai Chia-Yen, Huang Jee-Fu, Chiu Chang-Fu, Yang Yi-Hsin C, Hou Nai-Jen, Lee Li-Po, Hsieh Ming-Yen, Lin Zu-Yau, Chen Shinn-Cherng, Hsieh Ming-Yuh, Wang Liang-Yen, Chang Wen-Yu, Chuang Wan-Long
Hepatobiliary Division, Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung, Taiwan.
Hepatology. 2008 Jun;47(6):1884-93. doi: 10.1002/hep.22319.
Recommended treatment for hepatitis C virus genotype 1 (HCV-1) patients is peginterferon plus ribavirin for 48 weeks. We assessed whether treatment duration of 24 weeks is as effective as standard treatment in HCV-1 patients with a rapid virological response (RVR; seronegative for hepatitis C virus [HCV] RNA at 4 weeks). Two hundred HCV-1 patients were randomized (1:1) to either 24 or 48 weeks of peginterferon-alpha-2a (180 microg/week) and ribavirin (1000-1200 mg/day) with a 24-week follow-up. The primary endpoint was a sustained virological response (SVR; seronegative for HCV RNA at 24-week follow-up). Overall, the 48-week arm had a significantly higher SVR rate (79%) than the 24-week arm (59%, P = 0.002). For 87 (43.5%) patients with an RVR, the 24-week arm had a lower SVR rate [88.9%; 95% confidence interval (CI): 80%-98%] than the 48-week arm (100%, P = 0.056). For 52 patients with low baseline viremia (<400,000 IU/mL) and an RVR, the 24-week arm had rates (CI) of relapse and SVR of 3.6% (-3%-11%) and 96.4% (89%-103%), respectively, which were comparable to those of the 48-week arm (0% and 100%) with difference (CI) of 3.6% (-7.2%-6.6%) and -3.6% (-14.3% to -0.6%), respectively. Multivariate analysis in all patients showed that RVR was the strongest independent factor associated with an SVR, followed by treatment duration, mean weight-based exposure of ribavirin, and baseline viral load.
HCV-1 patients derive a significantly better SVR from 48 weeks versus 24 weeks of peginterferon/ribavirin even if they attain an RVR. Both 24 and 48 weeks of therapy can achieve high SVR rates (>96%) in HCV-1 patients with low viral loads and an RVR.
丙型肝炎病毒1型（HCV - 1）患者的推荐治疗方案是聚乙二醇干扰素联合利巴韦林治疗48周。我们评估了对于具有快速病毒学应答（RVR；4周时丙型肝炎病毒[HCV]RNA血清学阴性）的HCV - 1患者，24周的治疗疗程是否与标准治疗同样有效。200例HCV - 1患者被随机（1:1）分为接受24周或48周的聚乙二醇干扰素α - 2a（180μg/周）和利巴韦林（1000 - 1200mg/天）治疗，并进行24周的随访。主要终点是持续病毒学应答（SVR；随访24周时HCV RNA血清学阴性）。总体而言，48周治疗组的SVR率（79%）显著高于24周治疗组（59%，P = 0.002）。对于87例（43.5%）具有RVR的患者，24周治疗组的SVR率[88.9%；95%置信区间（CI）：80% - 98%]低于48周治疗组（100%，P = 0.056）。对于52例基线病毒血症水平低（<400,000 IU/mL）且具有RVR的患者，24周治疗组的复发率和SVR率（CI）分别为3.6%（-3% - 11%）和96.4%（89% - 103%），与48周治疗组（0%和100%）相当，差异（CI）分别为3.6%（-7.2% - 6.6%）和 - 3.6%（-14.3%至 - 0.6%）。对所有患者进行多变量分析显示，RVR是与SVR相关的最强独立因素，其次是治疗疗程、基于体重的利巴韦林平均暴露量和基线病毒载量。
即使HCV - 1患者获得了RVR，接受48周聚乙二醇干扰素/利巴韦林治疗比24周治疗能显著获得更好的SVR。对于病毒载量低且具有RVR的HCV - 1患者，24周和48周的治疗均可实现高SVR率（>96%）。
