TY - JOUR
T1 - Boceprevir With Peginterferon Alfa-2a-Ribavirin Is Effective for Previously Treated Chronic Hepatitis C Genotype 1 Infection
AU - Flamm, Steven L.
AU - Lawitz, Eric
AU - Jacobson, Ira
AU - Bourlière, Marc
AU - Hezode, Christophe
AU - Vierling, John M.
AU - Bacon, Bruce R.
AU - Niederau, Claus
AU - Sherman, Morris
AU - Goteti, Venkata
AU - Sings, Heather L.
AU - Barnard, Richard O.
AU - Howe, John A.
AU - Pedicone, Lisa D.
AU - Burroughs, Margaret H.
AU - Brass, Clifford A.
AU - Albrecht, Janice K.
AU - Poordad, Fred
N1 - Funding Information:
Funding This study was sponsored by Schering-Plough (now part of Merck Sharp & Dohme Corporation, a subsidiary of Merck & Co, Inc).
PY - 2013/1
Y1 - 2013/1
N2 - Background and 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-2-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-28Bgenotype. 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).
AB - Background and 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-2-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-28Bgenotype. 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).
UR - http://www.scopus.com/inward/record.url?scp=84870947010&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84870947010&partnerID=8YFLogxK
U2 - 10.1016/j.cgh.2012.10.006
DO - 10.1016/j.cgh.2012.10.006
M3 - Article
C2 - 23064222
AN - SCOPUS:84870947010
SN - 1542-3565
VL - 11
SP - 81-87.e4
JO - Clinical Gastroenterology and Hepatology
JF - Clinical Gastroenterology and Hepatology
IS - 1
ER -