Peginterferon alfa-2a and ribavirin for 16 or 24 weeks in HCV genotype 2 or 3
Peginterferon alfa-2a and ribavirin for 16 or 24 weeks in HCV genotype 2 or 3
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DOI：
10.1056/nejmoa066403
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发表时间：
2007-07-12
影响因子：
158.5
通讯作者：
Younossi, Z.
中科院分区：
文献类型：
--
作者：
Shiffman, Mitchell L.;Suter, Fredy;Younossi, Z.
背景：丙型肝炎病毒（HCV）基因2型或3型感染的患者接受聚乙二醇干扰素和利巴韦林治疗24周后，持续病毒学应答率约为80%。我们进行了一项大型、随机、多国家、非劣效性试验，以确定聚乙二醇干扰素α-2a和ribavirin.METHODS治疗仅16周是否可以获得相似的疗效：我们随机分配1469例HCV基因型2或3的患者，每周接受180 μ g聚乙二醇干扰素α-2a，每天加800 mg利巴韦林，持续16周或24周。持续的病毒学应答被定义为检测不到的血清HCV RNA水平（50 IU每毫升）24周后结束的treatment.RESULTS：该研究未能证明，16周的方案是非劣效于24周的方案。治疗16周的患者的持续病毒学应答率显著低于治疗24周的患者（62% vs. 70%; 16周vs. 24周的比值比，0.67; 95%置信区间，0.54 - 0.84; P < 0.001）。此外，16周组的复发率（治疗结束时检测不到HCV RNA的患者在随访期间可检测到HCV RNA水平）明显高于24周组（31% vs. 18%; P < 0.001）。治疗前血清HCV RNA水平为400，000 IU/ml或更低的患者的持续病毒学应答率在16周方案中为82%，在24周方案中为81%。在快速病毒学应答（第4周检测不到HCV RNA水平）的患者中，持续病毒学应答率在16周组为79%，在24周组为85%（P=0.02）。结论：用聚乙二醇干扰素和利巴韦林治疗HCV基因型2或3型感染患者16周，结果总体持续病毒学应答率低于标准24周方案治疗。
BACKGROUND:Patients infected with hepatitis C virus (HCV) genotype 2 or 3 have sustained virologic response rates of approximately 80% after receiving treatment with peginterferon and ribavirin for 24 weeks. We conducted a large, randomized, multinational, noninferiority trial to determine whether similar efficacy could be achieved with only 16 weeks of treatment with peginterferon alfa-2a and ribavirin.METHODS:We randomly assigned 1469 patients with HCV genotype 2 or 3 to receive 180 microg of peginterferon alfa-2a weekly, plus 800 < mg of ribavirin daily, for either 16 or 24 weeks. A sustained virologic response was defined as an undetectable serum HCV RNA level (50 IU per milliliter) 24 weeks after the end of treatment.RESULTS:The study failed to demonstrate that the 16-week regimen was noninferior to the 24-week regimen. The sustained virologic response rate was significantly lower in patients treated for 16 weeks than in patients treated for 24 weeks (62% vs. 70%; odds ratio for 16 weeks vs. 24 weeks, 0.67; 95% confidence interval, 0.54 to 0.84; P < 0.001). In addition, the rate of relapse (a detectable HCV RNA level during follow-up in patients who had undetectable HCV RNA at the end of treatment) was significantly greater in the 16-week group (31%, vs. 18% in the 24-week group; P < 0.001). The sustained virologic response rates in patients with a pretreatment serum HCV RNA level of 400,000 IU per milliliter or less was 82% with the 16-week regimen and 81% with the 24-week regimen. Among patients with a rapid virologic response (an undetectable HCV RNA level by week 4), sustained virologic response rates were 79% in the 16-week group and 85% in the 24-week group (P=0.02).CONCLUSIONS:Treatment with peginterferon and ribavirin for 16 weeks in patients infected with HCV genotype 2 or 3 results in a lower overall sustained virologic response rate than treatment with the standard 24-week regimen.