TY - JOUR
T1 - Boceprevir for chronic HCV genotype 1 infection in patients with prior treatment failure to peginterferon/ribavirin, including prior null response
AU - Vierling, John M.
AU - Davis, Mitchell
AU - Flamm, Steven
AU - Gordon, Stuart C.
AU - Lawitz, Eric
AU - Yoshida, Eric M.
AU - Galati, Joseph
AU - Luketic, Velimir
AU - McCone, Jonathan
AU - Jacobson, Ira
AU - Marcellin, Patrick
AU - Muir, Andrew J.
AU - Poordad, Fred
AU - Pedicone, Lisa D.
AU - Albrecht, Janice
AU - Brass, Clifford
AU - Howe, Anita Y.M.
AU - Colvard, Lynn Y.
AU - Helmond, Frans A.
AU - Deng, Weiping
AU - Treitel, Michelle
AU - Wahl, Janice
AU - Bronowicki, Jean Pierre
N1 - Funding Information:
P. Marcellin: Grant/Research support from Roche, Gilead, BMS, Vertex, Novartis, Janssen-Tibotec, MSD, Boehringer, Abbott, Pfizer, and Alios BioPharma; Speaker/Expert for Roche, Gilead, BMS, Vertex, Novartis, Janssen-Tibotec, MSD, and Abbott.
Funding Information:
This study was sponsored and funded by Merck, Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., which markets boceprevir under the brand name VICTRELIS.
Funding Information:
J.M. Vierling: Grants/ research support from Abbott, Bristol-Meyers-Squibb, Conatus, Gilead, Globeimmune, Idenix-Novartis, Merck (formerly Schering), Novartis, Pfizer, Pharmasset (now Gilead), Roche, Vertex, and Zymogenetics (now BMS); Advisory Committees/Review Panels for Abbott, Bristol-Meyers-Squibb, Gilead, Globeimmune, Janssen, Novartis, Roche, Schering (now Merck), and Vertex.
Funding Information:
J. Galati: Research grants from Merck and Gilead; Speaker fees from Merck and Gilead.
PY - 2014/4
Y1 - 2014/4
N2 - Background & Aims Boceprevir with peginterferon/ribavirin (BOC/PR) leads to significantly higher sustained virological response (SVR) rates in patients with chronic hepatitis C and partial response or relapse after prior treatment with peginterferon/ribavirin. We studied the efficacy of BOC/PR in patients with prior treatment failure, including those with a null response (<2-log10 decline in HCV RNA), to peginterferon/ribavirin. Methods Patients in the control arms of boceprevir Phase 2/3 studies who did not achieve SVR were re-treated with BOC/PR for up to 44 weeks. Patients enrolling >2 weeks after end-of-treatment in the prior study received PR for 4 weeks before adding boceprevir. Results Of 168 patients enrolled, four discontinued from the PR lead-in and 164 received BOC/PR. Baseline viral load was >800,000 IU/ml in 77% of patients; 62% had HCV genotype 1a, and 10% were cirrhotic. In the ITT analysis (all 168 patients), SVR was achieved in 20 (38%) of 52 patients with prior null response, 57 (67%) of 85 with prior partial response, and 27 (93%) of 29 with prior relapse. In the mITT analysis (164 BOC/PR-treated patients), SVR rates were 41% (20/49), 67% (57/85), and 96% (27/28), respectively. SVR was achieved by 48% of patients with <1-log10 decline in HCV-RNA after lead-in and 76% of those with ≥1-log10 decline or undetectable HCV-RNA after lead-in. The most common adverse events were anemia (49%), fatigue (48%), and dysgeusia (35%); 8% of patients discontinued due to adverse events. Conclusions Re-treatment with BOC/PR improved SVR rates in all patient subgroups, including those with prior null response.
AB - Background & Aims Boceprevir with peginterferon/ribavirin (BOC/PR) leads to significantly higher sustained virological response (SVR) rates in patients with chronic hepatitis C and partial response or relapse after prior treatment with peginterferon/ribavirin. We studied the efficacy of BOC/PR in patients with prior treatment failure, including those with a null response (<2-log10 decline in HCV RNA), to peginterferon/ribavirin. Methods Patients in the control arms of boceprevir Phase 2/3 studies who did not achieve SVR were re-treated with BOC/PR for up to 44 weeks. Patients enrolling >2 weeks after end-of-treatment in the prior study received PR for 4 weeks before adding boceprevir. Results Of 168 patients enrolled, four discontinued from the PR lead-in and 164 received BOC/PR. Baseline viral load was >800,000 IU/ml in 77% of patients; 62% had HCV genotype 1a, and 10% were cirrhotic. In the ITT analysis (all 168 patients), SVR was achieved in 20 (38%) of 52 patients with prior null response, 57 (67%) of 85 with prior partial response, and 27 (93%) of 29 with prior relapse. In the mITT analysis (164 BOC/PR-treated patients), SVR rates were 41% (20/49), 67% (57/85), and 96% (27/28), respectively. SVR was achieved by 48% of patients with <1-log10 decline in HCV-RNA after lead-in and 76% of those with ≥1-log10 decline or undetectable HCV-RNA after lead-in. The most common adverse events were anemia (49%), fatigue (48%), and dysgeusia (35%); 8% of patients discontinued due to adverse events. Conclusions Re-treatment with BOC/PR improved SVR rates in all patient subgroups, including those with prior null response.
KW - Boceprevir
KW - Null response
KW - Partial response
KW - Relapse
KW - Sustained virological response
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U2 - 10.1016/j.jhep.2013.12.013
DO - 10.1016/j.jhep.2013.12.013
M3 - Article
C2 - 24362076
AN - SCOPUS:84896400773
SN - 0168-8278
VL - 60
SP - 748
EP - 756
JO - Journal of Hepatology
JF - Journal of Hepatology
IS - 4
ER -
