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Albinterferon Alfa-2b was not inferior to pegylated interferon-α in a randomized trial of patients with chronic hepatitis C virus genotype 2 or 3.
- Source :
-
Gastroenterology [Gastroenterology] 2010 Oct; Vol. 139 (4), pp. 1267-76. Date of Electronic Publication: 2010 Jul 01. - Publication Year :
- 2010
-
Abstract
- Background & Aims: A phase 3 active-controlled study was conducted to assess the efficacy/safety of albinterferon alfa-2b (albIFN), a novel, long-acting, genetic fusion polypeptide of recombinant human albumin and interferon alfa-2b, in patients with chronic hepatitis C virus (HCV) genotype 2/3.<br />Methods: In all, 933 patients were randomized to open-label subcutaneous treatment with pegylated interferon-alfa-2a (Peg-IFNalfa-2a) 180 μg/wk, or albIFN 900 or 1200 μg every 2 weeks for 24 weeks, each administered with oral ribavirin 800 mg/day. The primary end point of the study was sustained virologic response (SVR) (HCV-RNA level, <15 IU/mL at week 48). During the study, the data monitoring committee recommended dose modification for all patients receiving albIFN 1200 μg to 900 μg, impacting 38% of this treatment arm.<br />Results: By intention-to-treat analysis, SVR rates were 84.8% (95% confidence interval, 80.4%-88.6%), 79.8% (95% confidence interval, 74.9%-84.1%), and 80.0% (95% confidence interval, 75.1%-84.3%) with Peg-IFNalfa-2a, and albIFN 900 and 1200 μg, respectively. The primary hypothesis of noninferiority of SVR was established for albIFN 900 μg (P = .009) and 1200 μg (P = .006). Independent positive predictors of SVR by multivariate regression analysis were pretreatment HCV-RNA level less than 400,000 IU/mL, age younger than 45 years, body mass index less than 30 kg/m(2), genotype 2, normal γ-glutamyl transpeptidase and increased alanine aminotransferase levels at baseline, fibrosis stage F0-F2, no steatosis, and Asian geographic region (Peg-IFNalfa-2a only). The 3 treatment groups showed similar rates of serious (7%-8%) and severe (13%-16%) adverse events, and discontinuations owing to adverse events (3.6%-5.5%).<br />Conclusion: Albinterferon alfa-2b 900 μg every 2 weeks provides an alternative efficacious treatment option in patients with chronic HCV genotype 2 or 3.<br /> (Copyright © 2010 AGA Institute. Published by Elsevier Inc. All rights reserved.)
- Subjects :
- Adult
Aged
Albumins adverse effects
Antiviral Agents administration & dosage
Drug Therapy, Combination
Female
Genotype
Hepacivirus genetics
Hepatitis C, Chronic virology
Humans
Interferon alpha-2
Interferon-alpha adverse effects
Male
Middle Aged
Polyethylene Glycols adverse effects
Recombinant Proteins
Ribavirin administration & dosage
Albumins therapeutic use
Antiviral Agents therapeutic use
Hepacivirus classification
Hepatitis C, Chronic drug therapy
Interferon-alpha therapeutic use
Polyethylene Glycols therapeutic use
Subjects
Details
- Language :
- English
- ISSN :
- 1528-0012
- Volume :
- 139
- Issue :
- 4
- Database :
- MEDLINE
- Journal :
- Gastroenterology
- Publication Type :
- Academic Journal
- Accession number :
- 20600017
- Full Text :
- https://doi.org/10.1053/j.gastro.2010.06.062