Randomized comparison of 12 or 24 weeks of peginterferon α-2a and ribavirin in chronic hepatitis C virus genotype 2/3 infection
Randomized comparison of 12 or 24 weeks of peginterferon α-2a and ribavirin in chronic hepatitis C virus genotype 2/3 infection
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DOI：
10.1002/hep.22253
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发表时间：
2008-06-01
期刊：
影响因子：
13.5
通讯作者：
Norkrans, Gunnar
中科院分区：
文献类型：
--
作者：
Lagging, Martin;Langeland, Nina;Norkrans, Gunnar
以前的试验研究了治疗持续时间短于24周的慢性丙型肝炎病毒（HCV）基因型2/3感染的疗效，结果不一致。本研究的目的是比较12周或24周治疗的疗效，并确定适合短期治疗的患者。来自丹麦、芬兰、挪威和瑞典的31个中心的382名基因型2/3感染患者[意向治疗（ITT）人群]被随机分配至聚乙二醇干扰素α-2a（180 μ g/周）联合利巴韦林（800 mg/天）治疗12周或24周。在ITT人群中，12周的治疗效果劣于24周（持续病毒应答[SVR]率：59% vs 78%，P < 0.0001），在基因型2（56% vs 82%，P = 0.006）或基因型3（58% vs 78%，P = 0.0015）感染的患者亚组中，12周的治疗效果劣于24周。无论纤维化分期如何，均观察到这些差异。年龄和第7天和第29天的HCV-RNA水平是SVR的独立预测因素。短期治疗对于< 40岁的患者是有用的，特别是如果HCV-RNA在第29天检测不到，以及对于≥ 40岁的患者，只要HCV-RNA在第7天低于1000 IU/mL，并且在第29天检测不到。对于≥ 40岁的患者，如果这两个标准都不符合，则治疗24周上级（P < 0.0001）。结论：聚乙二醇干扰素/利巴韦林治疗12周的HCV基因型2/3感染总体上不如24周的治疗，但可能是有用的，在一些患者的快速初步清除病毒。
Previous trials investigating the efficacy of treatment durations shorter than the standard of 24 weeks for chronic hepatitis C virus (HCV) genotype 2/3 infections have yielded discordant results. The aims of this investigator-initiated phase 1111 study were to compare the efficacy of 12 or 24 weeks of treatment and to identify patients suitable for short-term therapy. Three hundred eighty-two genotype 2/3-infected patients [intention-to-treat (ITT) population] at 31 centers in Denmark, Finland, Norway, and Sweden were randomized to 12 or 24 weeks of peginterferon alpha-2a (180 mu g/week) plus ribavirin (800 mg/day). Twelve weeks of therapy was inferior to 24 weeks in the ITT population (sustained viral response [SVR] rates: 59% versus 78%, P < 0.0001) and in the subgroups of patients infected with genotype 2 (56% versus 82%, P = 0.006) or 3 (58% versus 78%, P = 0.0015). These differences were observed regardless of the fibrosis stage. Age and HCV-RNA levels on days 7 and 29 were independent predictors of SVR. Short-term treatment was useful in patients < 40 years old, especially if HCV-RNA was undetectable on day 29, and also in patients >= 40 years old, provided that HCV-RNA was below 1000 IU/mL on day 7 in addition to being undetectable on day 29. If neither of these two criteria were met for patients >= 40 years old, 24 weeks of therapy was superior (P < 0.0001). Conclusion: Peginterferon/ribavirin treatment for 12 weeks in HCV genotype 2/3 infection is overall inferior to 24 weeks of treatment but may be useful in some patients with a rapid initial clearance of virus.