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Boceprevir for chronic HCV genotype 1 infection in patients with prior treatment failure to peginterferon/ribavirin, including prior null response.
- Source :
-
Journal of hepatology [J Hepatol] 2014 Apr; Vol. 60 (4), pp. 748-56. Date of Electronic Publication: 2013 Dec 19. - Publication Year :
- 2014
-
Abstract
- 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.<br />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.<br />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.<br />Conclusions: Re-treatment with BOC/PR improved SVR rates in all patient subgroups, including those with prior null response.<br /> (Copyright © 2014 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved.)
- Subjects :
- Adult
Aged
Antiviral Agents adverse effects
Drug Resistance, Viral genetics
Drug Therapy, Combination
Female
Genotype
Hepacivirus classification
Hepacivirus drug effects
Humans
Interferon alpha-2
Interferon-alpha adverse effects
Male
Middle Aged
Polyethylene Glycols adverse effects
Proline administration & dosage
Proline adverse effects
Recombinant Proteins administration & dosage
Recombinant Proteins adverse effects
Ribavirin adverse effects
Treatment Failure
Treatment Outcome
Viral Load drug effects
Antiviral Agents administration & dosage
Hepacivirus genetics
Hepatitis C, Chronic drug therapy
Hepatitis C, Chronic virology
Interferon-alpha administration & dosage
Polyethylene Glycols administration & dosage
Proline analogs & derivatives
Ribavirin administration & dosage
Subjects
Details
- Language :
- English
- ISSN :
- 1600-0641
- Volume :
- 60
- Issue :
- 4
- Database :
- MEDLINE
- Journal :
- Journal of hepatology
- Publication Type :
- Academic Journal
- Accession number :
- 24362076
- Full Text :
- https://doi.org/10.1016/j.jhep.2013.12.013