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

Objective: New treatment options for chronic hepatitis C (CHC) that offer improved efficacy, tolerability, and convenience compared with weekly interferon alfa (IFN alpha)-based regimens are needed. Longer-acting IFN alpha 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 IFN alpha-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-naive patients with genotype 1 or 2/3 CHC have shown antiviral activity and acceptable safety/tolerability of alb-IFN 900-1500 mu g every 2 weeks and 1200-1500 mu g every 4 weeks. Based on the phase 2 data, alb-IFN 900 mu g and 1200 mg every 2 weeks were selected for two ongoing phase 3 trials in IFN-naive 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.