Pegylated interferon alfa and ribavirin for 14 versus 24 weeks in patients with hepatitis C virus genotype 2 or 3 and rapid virological response
Pegylated interferon alfa and ribavirin for 14 versus 24 weeks in patients with hepatitis C virus genotype 2 or 3 and rapid virological response
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DOI：
10.1002/hep.21975
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发表时间：
2008-01-01
期刊：
影响因子：
13.5
通讯作者：
Verbaan, Hans
中科院分区：
文献类型：
--
作者：
Dalgard, Olav;Bjoro, Kristian;Verbaan, Hans
最近的一项非随机初步试验表明，基因型为2/3和快速病毒学应答（RVR）的丙型肝炎病毒（HCV）患者在治疗14周后的持续病毒学应答（SVR）率为90%。我们的目的是在一项随机对照试验中评估这一概念。在该试验中，428名基因型2或3的未经治疗的HCV RNA阳性患者入组。RVR患者随机分为14周（A组）或24周（B组）治疗。患者每周皮下注射聚乙二醇干扰素α-26（1.5 μ g/kg），每日口服利巴韦林（800-1400 mg）。两组间的非劣效性界值设定为10%，单侧显著性水平为2.5%。428例患者中有302例（71%）获得了RVR，其中298例被随机分配至A组（n = 148）或B组（n = 150）。在意向性治疗分析中，A组148例患者中有120例（81.1%）发生SVR，B组150例患者中有136例（90.7%）发生SVR（差异为9.6%; 95%置信区间为1.7-17.7）。在治疗结束后24周进行HCV RNA检测的患者中，A组139例患者中有120例（86.3%）达到了SVR，而B组146例患者中有136例（93.2%）达到了SVR（差异为6.9%; 95%置信区间为-0.1至+13.9）。结论：我们不能正式声称14周的治疗不劣于24周的治疗。然而，治疗14周后的SVR率很高，尽管更长的治疗时间可能会带来更好的SVR，但我们认为经济上的节省和更少的副作用使得仅治疗14周的基因型2或3和RVR的患者是合理的。
A recent nonrandomized pilot trial showed that hepatitis C virus (HCV) patients with genotype 2/3 and rapid virological response (RVR) had a 90% sustained virological response (SVR) rate after 14 weeks of treatment. We aimed to assess this concept in a randomized controlled trial. In the trial, 428 treatment-naive HCV RNA-positive patients with genotype 2 or 3 were enrolled. Patients with RVR were randomized to 14 (group A) or 24 (group B) weeks of treatment. Patients were treated with pegylated interferon alpha-26 (1.5 mu g/kg) subcutaneously weekly and ribavirin (800-1400 mg) orally daily. The noninferiority margin was set to be 10% between the two groups with a one-sided 2.5% significance level. RVR was obtained in 302 of 428 (71%), and 298 of these were randomized to group A (n = 148) or group B (n = 150). In the intention-to-treat analysis, SVR rates were 120 of 148 (81.1%) in group A and 136 of 150 (90.7%) in group B (difference, 9.6%; 95% confidence interval, 1.7-17.7). Among patients with an HCV RNA test 24 weeks after the end of treatment, 120 of 139 (86.3%) patients in group A achieved SVR compared with 136 of 146 (93.2%) in group B (difference, 6.9%; 95% confidence interval, -0.1 to + 13.9). Conclusion: We cannot formally claim that 14 weeks of treatment is noninferior to 24 weeks of treatment. However, the SVR rate after 14 weeks of treatment is high, and although longer treatment may give slightly better SVR, we believe economical savings and fewer side effects make it rational to treat patients with genotype 2 or 3 and RVR for only 14 weeks.