Efficacy and safety of two-dose regimens of peginterferon alpha-2a compared with interferon alpha-2a in chronic hepatitis C: A multicenter, randomized controlled trial

被引：55

作者：

Pockros, PJ

Carithers, R

Desmond, P

Dhumeaux, D

Fried, MW

Marcellin, P

Shiffman, ML

Minuk, G

Reddy, KR

Reindollar, RW

Lin, A

Brunda, MJ

机构：

[1] Scripps Clin, Div Gastroenterol Hepatol, La Jolla, CA 92037 USA

[2] Univ Washington, Seattle, WA 98195 USA

[3] St Vincents Hosp, Melbourne, Vic, Australia

[4] Hop Henri Mondor, F-94010 Creteil, France

[5] Emory Univ, Sch Med, Atlanta, GA USA

[6] INSERM, Clichy, France

[7] Virginia Commonwealth Univ, Med Coll Virginia, Richmond, VA 23298 USA

[8] Hlth Sci Ctr, Winnipeg, MB, Canada

[9] Univ Miami, Miami, FL 33152 USA

[10] Carolinas Ctr Liver Dis, Charlotte, NC USA

[11] Roche, Nutley, NJ USA

来源：

AMERICAN JOURNAL OF GASTROENTEROLOGY | 2004年 / 99卷 / 07期

关键词：

D O I：

10.1111/j.1572-0241.2004.30306.x

中图分类号：

R57 [消化系及腹部疾病];

学科分类号：

摘要：

OBJECTIVES: This study compared the efficacy and safety of peginterferon alpha-2a 135 mug/wk, peginterferon alpha-2a 180 mug/wk and interferon alpha-2a in patients with chronic hepatitis C. METHODS: A total of 639 patients received peginterferon alpha-2a 135 mug or 180 mug once weekly, or interferon alpha-2a 3 MIU thrice weekly for 48 wk. RESULTS: Sustained virological responses were significantly higher with peginterferon alpha-2a than with interferon alpha-2a 3 MIU (28% in the 135 mug and 180 mug peginterferon alpha-2a groups vs 11% with interferon alpha-2a, p = 0.001). The proportion of patients with clinically significant histological improvement was lower in the peginterferon alpha-2a 135 mug (48%) than the 180 mug group (58%, p = 0.035 vs peginterferon alpha-2a 135 mug), but similar to that in the interferon alpha-2a group (45%, p = 0.820 vs peginterferon alpha-2a 135 mug and p = 0.017 vs peginterferon alpha-2a 180 mug, respectively). The overall safety profiles were similar for the three treatments. CONCLUSIONS: In patients with chronic hepatitis C, peginterferon alpha-2a 135 mug/wk and 180 mug/wk produced similar sustained virological response rates, both of which were significantly higher than that achieved with interferon alpha-2a thrice weekly. A significantly higher proportion of patients treated with the 180 mug dose of peginterferon alpha-2a had clinically significant histological improvement.

引用

页码：1298 / 1305

页数：8

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