Boceprevir With Peginterferon Alfa-2a-Ribavirin Is Effective for Previously Treated Chronic Hepatitis C Genotype 1 Infection

被引：55

作者：

Flamm, Steven L. ^{[1
]}

Lawitz, Eric ^{[2
]}

Jacobson, Ira ^{[3
]}

Bourliere, Marc ^{[4
]}

Hezode, Christophe ^{[5
]}

Vierling, John M. ^{[6
,7
]}

Bacon, Bruce R. ^{[8
]}

Niederau, Claus ^{[9
]}

Sherman, Morris ^{[10
]}

Goteti, Venkata ^{[11
]}

Sings, Heather L. ^{[11
]}

Barnard, Richard O. ^{[11
]}

Howe, John A. ^{[11
]}

Pedicone, Lisa D. ^{[11
]}

Burroughs, Margaret H. ^{[11
]}

Brass, Clifford A. ^{[11
]}

Albrecht, Janice K. ^{[11
]}

Poordad, Fred ^{[12
]}

机构：

[1] NW Feinberg Sch Med, Div Gastroenterol & Hepatol, Chicago, IL USA

[2] Alamo Med Res, Dept Hepatol, San Antonio, TX USA

[3] Weill Cornell Med Coll, Ctr Study Hepatitis C, Div Gastroenterol & Hepatol, New York, NY USA

[4] Fdn Hop St Joseph, Dept Hepatogastroenterol, Marseille, France

[5] Univ Paris Est, Hop Henri Mondor, AP HP, INSERM,Dept Hepatol,U955, Creteil, France

[6] Baylor Coll Med, Dept Med, Houston, TX 77030 USA

[7] Baylor Coll Med, Dept Surg, Houston, TX 77030 USA

[8] St Louis Univ, Sch Med, Dept Internal Med, Div Gastroenterol & Hepatol, St Louis, MO USA

[9] Katholische Kliniken, Dept Med, Oberhausen, Germany

[10] Toronto Gen Hosp, Dept Med, Toronto, ON M5G 1L7, Canada

[11] Merck Sharp & Dohme Corp, Whitehouse Stn, NJ USA

[12] Cedars Sinai Med Ctr, Dept Hepatol & Liver Transplantat, Los Angeles, CA 90048 USA

来源：

CLINICAL GASTROENTEROLOGY AND HEPATOLOGY | 2013年 / 11卷 / 01期

基金：

美国国家卫生研究院;

关键词：

Protease Inhibitor; Antiviral Therapy; Clinical Trial; Liver Disease; RIBAVIRIN; ALPHA-2A;

D O I：

10.1016/j.cgh.2012.10.006

中图分类号：

R57 [消化系及腹部疾病];

学科分类号：

摘要：

BACKGROUND & AIMS: The addition of boceprevir to therapy with peginterferon alfa-2b and ribavirin results in significantly higher rates of sustained virologic response (SVR) in previously treated patients with chronic hepatitis C virus (HCV) genotype-1 infection, compared with peginterferon alfa-2b and ribavirin alone. We assessed SVR with boceprevir plus peginterferon alfa-2a-ribavirin (PEG2a/R) in patients with identical study entry criteria. METHODS: In a double-blind, placebo-controlled trial, 201 patients with HCV genotype-1 who had relapsed or not responded to previous therapy were assigned to groups (1: 2) and given a 4-week lead-in phase of PEG2a/R, followed by placebo plus PEG2a/R for 44 weeks (PEG2a/R) or boceprevir plus PEG2a/R for 44 weeks (BOC/PEG2a/R). The primary end point was SVR 24 weeks after therapy ended. RESULTS: The addition of boceprevir after 4 weeks of lead-in therapy with PEG2a/R significantly increased the rate of SVR from 21% in the PEG2a/R group to 64% in the BOC/PEG2a/R group (P < .0001). Among patients with poor response to interferon therapy (<1-log(10) decline in HCV RNA at week 4), 39% in the BOC/PEG2a/R group had SVRs, compared with none of the patients in the PEG2a/R group. Among patients with good response to interferon (>= 1-log(10) decline), 71% in the BOC/PEG2a/R group had SVRs, compared with 25% in the PEG2a/R group. A >= 1-log(10) decline in HCV RNA at treatment week 4 was the strongest independent predictor of SVR, exceeding that of IL-28B genotype. Among 8 patients who began the study with HCV amino acid variants associated with boceprevir resistance, 3 (38%) achieved SVRs. Fifty percent of patients in the BOC/PEG2a/R group developed anemia (hemoglobin <10.0 g/dL), compared with 27% in the PEG2a/R group; 43% vs 21%, respectively, developed neutropenia (neutrophil count <750/mm(3)). CONCLUSIONS: The addition of boceprevir after 4 weeks of lead-in therapy with PEG2a/R caused significantly higher rates of SVR in previously treated patients with chronic HCV genotype-1 infection, compared with patients given only PEG2a/R. ClinicalTrials.gov Identifier: NCT00845065.

引用

页码：81 / U216

页数：11

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