A multicenter, randomized, controlled clinical trial of interferon alfacon-1 in comparison with lymphoblastoid interferon-alpha in patients with high-titer chronic hepatitis C virus infection

Abstract

This multicenter, randomized, controlled study evaluated the efficacy and safety of interferon alfacon-1 (r-IFN-αcon1) compared with lymphoblastoid interferon-alpha (IFN-αn1) in patients with high-titer chronic hepatitis C virus (HCV) infection. Two hundred and seven patients were randomized to receive either 18 MIU (μg) r-IFN-αcon1 or 9 MIU IFN-αn1 daily for 2 weeks, followed by the administration of the study drugs three times weekly for 22 weeks. The primary endpoint was sustained virological response defined as the inability to detect serum HCV RNA at the end of the 24 week post-treatment observation period. In the intention-to-treat analysis, r-IFN-αcon1 produced a slightly but not significantly higher proportion of sustained virological response than IFN-αn1 (26.3 vs. 20.7% P=0.392). In patients with high baseline titer and genotype 1b, the proportion of sustained virological response was significantly higher in the r-IFN-αcon1 cohort, than the IFN-αn1 cohort (16.7 vs. 3.3%, P=0.017). The adverse events commonly reported were flu-like symptoms, anorexia, insomnia, and alopecia. Types and frequencies of the adverse events were similar in the two cohorts. The results of this study show that r-IFN-αcon1 is an effective and tolerable therapy in patients with chronic HCV with high viral titer. The results also indicate that 18 MIU r-IFN-αcon1 is superior in efficacy without additional toxicity to 9 MIU IFN-αn1 in high-titer chronic HCV patients, particularly with genotype 1b.