Interferon alfa-2b alone or in combination with ribavirin as initial treatment for chronic hepatitis C

Interferon alfa-2b alone or in combination with ribavirin as initial treatment for chronic hepatitis C
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DOI:
10.1056/nejm199811193392101
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发表时间:
1998-11-19
影响因子:
158.5
通讯作者:
Albrecht, JK
Albrecht, JK
中科院分区:
医学1区
文献类型:
--
作者:
McHutchison, JG;Gordon, SC;Albrecht, JK

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只有15%-20%的慢性丙型肝炎患者对干扰素治疗有持续的病毒学应答。我们比较了重组干扰素α-2b单独与干扰素α-2b联合利巴韦林治疗慢性丙型肝炎患者的疗效和安全性。方法我们将912例慢性丙型肝炎患者随机分为标准剂量干扰素α-2b单独治疗组和干扰素α-2b联合利巴韦林治疗组(每天口服1000或1200 mg,取决于体重)24或48周。通过检测血清丙型肝炎病毒(HCV)RNA和血清转氨酶以及肝活检来评估疗效。(定义为治疗完成后24周检测不到血清HCV RNA水平)在接受联合治疗24周或24周的患者中较高干扰素单药治疗24周(231例患者中的13例,6%)或48周(225例患者中的29例,13%)(P
Background Only 15 to 20 percent of patients with chronic hepatitis C have a sustained virologic response to interferon therapy. We compared the efficacy and safety of recombinant interferon alfa-2b atone with those of a combination of interferon alfa-2b and ribavirin for the initial treatment of patients with chronic hepatitis C.Methods We randomly assigned 912 patients with chronic hepatitis C to receive standard-dose interferon alfa-2b alone or in combination with ribavirin (1000 or 1200 mg orally per day, depending on body weight) for 24 or 48 weeks. Efficacy was assessed by measurements of serum hepatitis C virus (HCV) RNA and serum aminotransferases and by liver biopsy.Results The rate of sustained virologic response (defined as an undetectable serum HCV RNA level 24 weeks after treatment was completed) was higher among patients who received combination therapy for either 24 weeks (70 of 228 patients, 31 percent) or 48 weeks (87 of 228 patients, 38 percent) than among patients who received interferon alone for either 24 weeks (13 of 231 patients, 6 percent) or 48 weeks (29 of 225 patients, 13 percent) (P