聚乙二醇干扰素α-2a与利巴韦林用于丙型肝炎病毒2型或3型感染患者，疗程为16或24周。
Peginterferon alfa-2a and ribavirin for 16 or 24 weeks in HCV genotype 2 or 3.
作者信息
Shiffman Mitchell L, Suter Fredy, Bacon Bruce R, Nelson David, Harley Hugh, Solá Ricard, Shafran Stephen D, Barange Karl, Lin Amy, Soman Ash, Zeuzem Stefan
机构信息
Virginia Commonwealth University Medical Center, Richmond, VA 23298, USA.
出版信息
N Engl J Med. 2007 Jul 12;357(2):124-34. doi: 10.1056/NEJMoa066403.
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 mug 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. (ClinicalTrials.gov number, NCT00077636 [ClinicalTrials.gov].).
背景
丙型肝炎病毒（HCV）2型或3型感染患者在接受聚乙二醇干扰素和利巴韦林治疗24周后，病毒学持续应答率约为80%。我们进行了一项大型、随机、多国、非劣效性试验，以确定聚乙二醇干扰素α-2a和利巴韦林仅治疗16周是否能取得相似疗效。
方法
我们将1469例HCV 2型或3型感染患者随机分为两组，分别接受每周180μg聚乙二醇干扰素α-2a加每日800mg利巴韦林治疗16周或24周。病毒学持续应答定义为治疗结束后24周血清HCV RNA水平检测不到（<50 IU/ml）。
结果
该研究未能证明16周治疗方案不劣于24周治疗方案。接受16周治疗的患者病毒学持续应答率显著低于接受24周治疗的患者（62%对70%；16周与24周的比值比为0.67；95%置信区间为0.54至0.84；P<0.001）。此外，16周治疗组的复发率（治疗结束时HCV RNA检测不到但随访期间可检测到HCV RNA水平）显著高于24周治疗组（31%对18%；P<0.001）。治疗前血清HCV RNA水平为每毫升400,000 IU或更低的患者，16周治疗方案的病毒学持续应答率为82%，24周治疗方案为81%。在快速病毒学应答（第4周时HCV RNA检测不到）的患者中，16周治疗组的病毒学持续应答率为79%，24周治疗组为85%（P=0.02）。
结论
HCV 2型或3型感染患者接受聚乙二醇干扰素和利巴韦林治疗16周，其总体病毒学持续应答率低于标准的24周治疗方案。（临床试验注册号，NCT00077636 [ClinicalTrials.gov]。）
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