Peginterferon alfa-2a plus ribavirin versus interferon alfa-2a plus ribavirin for chronic hepatitis C in HIV-coinfected persons
Peginterferon alfa-2a plus ribavirin versus interferon alfa-2a plus ribavirin for chronic hepatitis C in HIV-coinfected persons
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DOI：
10.1056/nejmoa032653
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发表时间：
2004-07-29
影响因子：
158.5
通讯作者：
van der Horst, C
中科院分区：
文献类型：
--
作者：
Chung, RT;Andersen, J;van der Horst, C
背景：慢性丙型肝炎病毒（HCV）感染是同时感染人类免疫缺陷病毒（HIV）的人的主要并发症的原因。然而，在这些人中治疗HCV感染与高不耐受率和低应答率相关。我们进行了一项多中心，随机试验比较聚乙二醇干扰素加利巴韦林与干扰素加利巴韦林治疗慢性丙型肝炎合并HIV感染者。方法：共66例受试者被随机分配到接受180微克的聚乙二醇干扰素α-2a每周48周，和67例受试者被分配到接受600万IU的干扰素α-2a每周三次，12周，然后300万IU每周三次，36周。两组均按照剂量递增方案接受利巴韦林治疗。在第24周，没有病毒学应答的受试者（HCV RNA水平大于或等于60 IU/ml者）进行肝活检，病毒学应答或组织学改善者继续用药。结果：聚乙二醇干扰素和利巴韦林治疗与持续病毒学应答率显著升高相关（治疗结束后24周HCV RNA水平低于60 IU/ml）（27%对12%，P=0.03）。在聚乙二醇干扰素和利巴韦林治疗组中，只有14%的HCV基因1型感染者有持续的病毒学应答（51例中有7例），而HCV基因1型以外的受试者有73%有持续的病毒学应答（15例中有11例，P
BACKGROUND:Chronic hepatitis C virus (HCV) infection is a cause of major complications in persons who are also infected with the human immunodeficiency virus (HIV). However, the treatment of HCV infection in such persons has been associated with a high rate of intolerance and a low rate of response. We conducted a multicenter, randomized trial comparing peginterferon plus ribavirin with interferon plus ribavirin for the treatment of chronic hepatitis C in persons coinfected with HIV.METHODS:A total of 66 subjects were randomly assigned to receive 180 microg of peginterferon alfa-2a weekly for 48 weeks, and 67 subjects were assigned to receive 6 million IU of interferon alfa-2a three times weekly for 12 weeks followed by 3 million IU three times weekly for 36 weeks. Both groups received ribavirin according to a dose-escalation schedule. At week 24, subjects who did not have a virologic response (those who had an HCV RNA level greater than or equal to 60 IU per milliliter) underwent liver biopsy, and medications were continued in subjects with either a virologic response or histologic improvement.RESULTS:Treatment with peginterferon and ribavirin was associated with a significantly higher rate of sustained virologic response (an HCV RNA level of less than 60 IU per milliliter 24 weeks after completion of therapy) than was treatment with interferon and ribavirin (27 percent vs. 12 percent, P=0.03). In the group given peginterferon and ribavirin, only 14 percent of subjects with HCV genotype 1 infection had a sustained virologic response (7 of 51), as compared with 73 percent of subjects with an HCV genotype other than 1 (11 of 15, P