干扰素α-2b单独或联合利巴韦林作为慢性丙型肝炎的初始治疗。肝炎介入治疗组。

Interferon alfa-2b alone or in combination with ribavirin as initial treatment for chronic hepatitis C. Hepatitis Interventional Therapy Group.

作者信息

McHutchison J G, Gordon S C, Schiff E R, Shiffman M L, Lee W M, Rustgi V K, Goodman Z D, Ling M H, Cort S, Albrecht J K

机构信息

Division of Gastroenterology-Hepatology, Scripps Clinic and Research Foundation, La Jolla, CA 92037, USA.

出版信息

N Engl J Med. 1998 Nov 19;339(21):1485-92. doi: 10.1056/NEJM199811193392101.

DOI:10.1056/NEJM199811193392101

PMID:9819446

Abstract

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 alone 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<0.001 for the comparison of interferon alone with both 24 weeks and 48 weeks of combination treatment). Among patients with HCV genotype 1 infection, the best response occurred in those who were treated for 48 weeks with interferon and ribavirin. Histologic improvement was more common in patients who were treated with combination therapy for either 24 weeks (57 percent) or 48 weeks (61 percent) than in those who were treated with interferon alone for either 24 weeks (44 percent) or 48 weeks (41 percent). The drug doses had to be reduced and treatment discontinued more often in patients who were treated with combination therapy.

CONCLUSIONS

In patients with chronic hepatitis C, initial therapy with interferon and ribavirin was more effective than treatment with interferon alone.

摘要

背景

仅有15%至20%的慢性丙型肝炎患者对干扰素治疗有持续病毒学应答。我们比较了重组干扰素α-2b单药治疗与干扰素α-2b联合利巴韦林治疗对慢性丙型肝炎患者初始治疗的疗效和安全性。

方法

我们将912例慢性丙型肝炎患者随机分为两组，分别接受标准剂量的干扰素α-2b单药治疗或与利巴韦林联合治疗（根据体重，每日口服1000或1200mg），疗程为24周或48周。通过检测血清丙型肝炎病毒（HCV）RNA、血清转氨酶以及肝活检来评估疗效。

结果

接受联合治疗24周（228例患者中的70例，31%）或48周（228例患者中的87例，38%）的患者，其持续病毒学应答率（定义为治疗结束后24周血清HCV RNA水平检测不到）高于接受干扰素单药治疗24周（231例患者中的13例，6%）或48周（225例患者中的29例，13%）的患者（单药干扰素治疗与联合治疗24周及48周比较，P<0.001）。在HCV基因1型感染患者中，接受干扰素和利巴韦林治疗48周的患者应答最佳。联合治疗24周（57%）或48周（61%）的患者组织学改善比单药干扰素治疗24周（44%）或48周（41%）的患者更常见。联合治疗的患者更常需要减少药物剂量并中断治疗。