Abstract

Despite advances in treating chronic hepatitis C, newer treatments are required. Albumin fusion technology allows the enhanced pharmacokinetic properties of albumin to be combined with the pharmacodynamic properties of other agents. Albumin-interferon-α has an extended half-life that supports bimonthly or monthly dosing and may provide superior steady-state exposure to interferon. Preclinical studies show that albumin-interferon has better antiviral activity and pharmacokinetics than either standard or pegylated interferons. Phase I–II and Phase IIa studies that have explored a wide dose range (from 10 to 1200 μg) in interferon-experienced and -naïve patients have shown the drug to be safe and well tolerated, with no dose-limiting adverse events. Its half-life is 6–7 days and it is detectable 4 weeks after a single dose. The longer term safety and efficacy of albumin-interferon and ribavirin is being evaluated in both interferon-naïve patients and nonresponders to previous standard and pegylated interferon therapy.

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