Boceprevir for Previously Treated Chronic HCV Genotype 1 Infection

被引：1316

作者：

Bacon, Bruce R. ^{[1
]}

Gordon, Stuart C. ^{[2
]}

Lawitz, Eric ^{[3
]}

Marcellin, Patrick ^{[4
]}

Vierling, John M. ^{[5
]}

Zeuzem, Stefan ^{[6
]}

Poordad, Fred ^{[7
]}

Goodman, Zachary D. ^{[8
,9
]}

Sings, Heather L. ^{[10
]}

Poordad, Fred ^{[7
]}

Goodman, Zachary D. ^{[8
,9
]}

Sings, Heather L. ^{[10
]}

Boparai, Navdeep ^{[10
]}

Burroughs, Margaret ^{[10
]}

Brass, Clifford A. ^{[10
]}

Albrecht, Janice K. ^{[10
]}

Esteban, Rafael ^{[11
,12
]}

机构：

[1] St Louis Univ, Sch Med, St Louis, MO 63110 USA

[2] Henry Ford Hosp, Detroit, MI 48202 USA

[3] Alamo Med Res, San Antonio, TX USA

[4] Univ Paris Diderot, Hop Beaujon, Clichy, France

[5] Baylor Coll Med, Houston, TX 77030 USA

[6] JW Goethe Univ Hosp, Dept Med, Frankfurt, Germany

[7] Cedars Sinai Med Ctr, Los Angeles, CA 90048 USA

[8] Inova Fairfax Hosp, Falls Church, VA USA

[9] Betty & Guy Beatty Ctr Integrat Res, Falls Church, VA USA

[10] Merck, Sharp & Dohme, Whitehouse Stn, NJ USA

[11] Hosp Gen Univ Vall Hebron, Barcelona, Spain

[12] Inst Carlos III, Ctr Invest Biomed Red Enfermedades Hepat & Digest, Barcelona, Spain

来源：

NEW ENGLAND JOURNAL OF MEDICINE | 2011年 / 364卷 / 13期

关键词：

CHRONIC HEPATITIS-C; PEGINTERFERON ALPHA-2B; PROTEASE INHIBITOR; RIBAVIRIN; INTERFERON; THERAPY;

D O I：

10.1056/NEJMoa1009482

中图分类号：

R5 [内科学];

学科分类号：

100201 [内科学];

摘要：

BACKGROUND In patients with chronic infection with hepatitis C virus (HCV) genotype 1 who do not have a sustained response to therapy with peginterferon-ribavirin, outcomes after retreatment are suboptimal. Boceprevir, a protease inhibitor that binds to the HCV nonstructural 3 (NS3) active site, has been suggested as an additional treatment. METHODS To assess the effect of the combination of boceprevir and peginterferon-ribavirin for retreatment of patients with chronic HCV genotype 1 infection, we randomly assigned patients (in a 1: 2: 2 ratio) to one of three groups. In all three groups, peginterferon alfa-2b and ribavirin were administered for 4 weeks (the lead-in period). Subsequently, group 1 (control group) received placebo plus peginterferon-ribavirin for 44 weeks; group 2 received boceprevir plus peginterferon-ribavirin for 32 weeks, and patients with a detectable HCV RNA level at week 8 received placebo plus peginterferon-ribavirin for an additional 12 weeks; and group 3 received boceprevir plus peginterferon-ribavirin for 44 weeks. RESULTS A total of 403 patients were treated. The rate of sustained virologic response was significantly higher in the two boceprevir groups (group 2, 59%; group 3, 66%) than in the control group (21%, P<0.001). Among patients with an undetectable HCV RNA level at week 8, the rate of sustained virologic response was 86% after 32 weeks of triple therapy and 88% after 44 weeks of triple therapy. Among the 102 patients with a decrease in the HCV RNA level of less than 1 log(10) IU per milliliter at treatment week 4, the rates of sustained virologic response were 0%, 33%, and 34% in groups 1, 2, and 3, respectively. Anemia was significantly more common in the boceprevir groups than in the control group, and erythropoietin was administered in 41 to 46% of boceprevir-treated patients and 21% of controls. CONCLUSIONS The addition of boceprevir to peginterferon-ribavirin resulted in significantly higher rates of sustained virologic response in previously treated patients with chronic HCV genotype 1 infection, as compared with peginterferon-ribavirin alone.

引用

页码：1207 / 1217

页数：11

共 20 条

[1]

Boceprevir, an NS3 Protease Inhibitor of HCV [J].