Dalgard Olav, Bjøro Kristian, Hellum Kjell Block, Myrvang Bjørn, Ritland Ståle, Skaug Kjell, Raknerud Nils, Bell Helge
Department of Medicine, Aker University Hospital, Oslo, Norway.
Hepatology. 2004 Dec;40(6):1260-5. doi: 10.1002/hep.20467.
The aim of this study was to determine the efficacy of 14 weeks of treatment in patients infected with hepatitis C virus (HCV) genotype 2 or 3 who achieve early virological response (EVR). In a noncontrolled multicenter trial, 122 treatment-naive patients received 1.5 mug/kg pegylated interferon alfa-2b subcutaneously once weekly and 800 to 1,400 mg/d ribavirin based on body weight. Treatment was stopped at week 14 in patients with EVR, defined as undetectable HCV RNA at weeks 4 and 8. Patients without EVR were assigned to 24 weeks of treatment. The primary end point was sustained virological response (SVR), defined as undetectable HCV RNA 24 weeks after end of treatment. Among the 122 patients, 95 (78%) had EVR and received 14 weeks of treatment. The remaining 27 (22%) were treated for 24 weeks. SVR was obtained in 85 (90%) of 95 patients in the 14-week treatment group and 15 of (56%) 27 in the 24-week treatment group. Altogether, SVR was obtained in 100 of 122 patients (82%; 95% CI, 75%-89%). SVR after 14 weeks of treatment was achieved more frequently among genotype 3a patients with low viral load compared with high viral load (98% vs. 79%; P = .019). Logistic regression analysis showed that absence of bridging fibrosis/cirrhosis was the only independent predictor of SVR. In conclusion, patients with genotype 2 or 3 and EVR obtained a high SVR after 14 weeks of treatment. The results need to be confirmed in a randomized, controlled study before this treatment approach can be recommended, particularly for patients with genotype 3 and high viral load or severe fibrosis.
本研究的目的是确定对丙型肝炎病毒(HCV)基因2型或3型感染且获得早期病毒学应答(EVR)的患者进行14周治疗的疗效。在一项非对照多中心试验中,122例初治患者接受皮下注射1.5μg/kg聚乙二醇化干扰素α-2b,每周1次,以及根据体重给予800至1400mg/d的利巴韦林。对于EVR患者(定义为第4周和第8周时HCV RNA检测不到),治疗在第14周停止。无EVR的患者接受24周治疗。主要终点是持续病毒学应答(SVR),定义为治疗结束后24周HCV RNA检测不到。在122例患者中,95例(78%)有EVR并接受了14周治疗。其余27例(22%)接受了24周治疗。14周治疗组的95例患者中有85例(90%)获得SVR,24周治疗组的27例中有15例(56%)获得SVR。总共,122例患者中有100例(82%;95%CI,75%-89%)获得SVR。与高病毒载量的基因3a型患者相比,低病毒载量的基因3a型患者在14周治疗后更频繁地获得SVR(98%对79%;P = 0.019)。逻辑回归分析显示,无桥接纤维化/肝硬化是SVR的唯一独立预测因素。总之,基因2型或3型且有EVR的患者在14周治疗后获得了较高的SVR。在推荐这种治疗方法之前,尤其是对于基因3型、高病毒载量或严重纤维化的患者,这些结果需要在随机对照研究中得到证实。