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.

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.

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.

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%).

CONCLUSION:

Albinterferon alfa-2b 900 μg every 2 weeks provides an alternative efficacious treatment option in patients with chronic HCV genotype 2 or 3.

• Authors: David R Nelson, Yves Benhamou, Wan-Long Chuang, Eric J Lawitz, Maribel Rodriguez-Torres, Robert Flisiak, Jens W F Rasenack, Wiesław Kryczka, Chuan-Mo Lee, Vincent G Bain, Stephen Pianko, Keyur Patel, Patrick W Cronin, Erik Pulkstenis, G Mani Subramanian, John G McHutchison, ACHIEVE-2/3 Study Team
• Journal: Gastroenterology (Gastroenterology) Vol. 139 Issue 4 Pg. 1267-76 (Oct 2010) ISSN: 1528-0012 [Electronic] United States
• PMID: 20600017 (Publication Type: Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2010 AGA Institute. Published by Elsevier Inc. All rights reserved.

Chemical References

• Albumins
• Antiviral Agents
• Interferon alpha-2
• Interferon-alpha
• Recombinant Proteins
• Polyethylene Glycols
• Ribavirin
• albinterferon alfa-2b
• peginterferon alfa-2a

Topics

• Adult
• Aged
• Albumins (adverse effects, therapeutic use)
• Antiviral Agents (administration & dosage, therapeutic use)
• Drug Therapy, Combination
• Female
• Genotype
• Hepacivirus (classification, genetics)
• Hepatitis C, Chronic (drug therapy, virology)
• Humans
• Interferon alpha-2
• Interferon-alpha (adverse effects, therapeutic use)
• Male
• Middle Aged
• Polyethylene Glycols (adverse effects, therapeutic use)
• Recombinant Proteins
• Ribavirin (administration & dosage)