Albinterferon alfa-2b, a novel fusion protein of human albumin and human interferon alfa-2b, for chronic hepatitis C

ABSTRACT

Objective: New treatment options for chronic hepatitis C (CHC) that offer improved efficacy, tolerability, and convenience compared with weekly interferon alfa (IFNα)-based regimens are needed. Longer-acting IFNα formulations with reduced dosing requirements and improved tolerability have been a focus of drug development efforts. The objective of this report is to review the characteristics, pharmacokinetics, pharmacodynamics, and clinical and virologic outcomes reported in studies of albinterferon alfa-2b (alb-IFN), a novel fusion protein of human albumin and human IFNα-2b.

Methods: This review was based on all published data regarding alb-IFN to date. An unlimited PubMed database search was conducted using the keywords ‘albuferon,’ ‘albinterferon,’ and ‘albumin AND interferon.’

Results: Albinterferon alfa-2b has been developed for the treatment of CHC. This agent exhibits a prolonged half-life and duration of antiviral activity that indicate potential suitability for dosing intervals of 2–4 weeks. Phase 2 trials in prior IFN nonresponders and IFN-naïve patients with genotype 1 or 2/3 CHC have shown antiviral activity and acceptable safety/tolerability of alb-IFN 900–1500 µg every 2 weeks and 1200–1500 µg every 4 weeks. Based on the phase 2 data, alb-IFN 900 µg and 1200 µg every 2 weeks were selected for two ongoing phase 3 trials in IFN-naïve patients with genotype 1 and 2/3 CHC.

Conclusions: Albinterferon alfa-2b exhibits high antiviral activity, and appears to offer safety/tolerability comparable to the current standard of care, and health-related quality-of-life benefits in patients with CHC. Its ability to maintain drug concentrations above the 90% effective concentration over prolonged dosing intervals suggests that it may be an ideal partner for combination therapy with direct antiviral agents in CHC. The results of the phase 3 trials are eagerly anticipated as they should greatly clarify the future role of alb-IFN in the treatment of CHC.

Key words: :

• Alb-IFN
• Albinterferon alfa-2b
• Chronic hepatitis C
• Hepatitis C virus
• Interferon

Acknowledgments

Declaration of interest: This review was sponsored by Human Genome Sciences, Inc., Rockville, MD, USA and Novartis Pharma AG, Basel, Switzerland. V. K. R. thanks Matt Stenger and Geoff Marx, BioScience Communications, New York, NY, USA for editorial assistance.