Interferon alfacon-1 (Advaferon): a novel synthetic interferon for the treatment of hepatitis C, its pharmacological and clinical profile.

Interferon alfacon-1 (Advaferon, also referred to as consensus interferon) is a novel synthetic recombinant type-I interferon (IFN) developed by comparing the amino acid sequences of several natural IFN-alpha subtypes and assigning the most frequently observed amino acid in each corresponding position to generate a consensus molecule. Interferon alfacon-1 binds with high affinity to type-I IFN receptors and has greater biological activity than naturally occurring IFN-alpha as assessed by its increased antiviral, anti-proliferative, and natural killer cell activities, as well as its stronger IFN-stimulated gene induction. In a multicenter, randomized, controlled study, the safety and efficacy of interferon alfacon-1 in comparison with lymphoblastoid interferon-alpha [IFN-alpha (NAMALWA)] was evaluated in patients infected with high-titer chronic hepatitis C virus (HCV). Interferon alfacon-1 (18 MIU) was superior in efficacy without additional toxicity to IFN-alpha (NAMALWA) (9 MIU) in high-titer chronic HCV patients, particularly those infected with genotype 1b. A multicenter open-label study showed that treatment with interferon alfacon-1 (12 MIU) was an effective and tolerable therapy in chronic HCV patients with low viral titers. Another multicenter open-label study showed that re-treatment with interferon alfacon-1 (18 MIU) was an effective and tolerable therapy in chronic HCV patients who relapsed after traditional IFN therapy. Collectively, these clinical studies indicate that interferon alfacon-1, as a novel synthetic interferon, may be a useful therapeutic alternative for the effective treatment of hepatitis C.