Efficacy of interferon alfacon-1 daily induction therapy followed by three-times weekly therapy in patients with chronic hepatitis C virus infection with high and low viral titers

Abstract

This open-label, multicenter, dose-escalation study evaluated the effectiveness and tolerability of 9 to 21 μg interferon alfacon-1 in Japanese patients with chronic HCV infections. Patients were given either 9, 12, 15, 18, or 21 μg of interferon alfacon-1 subcutaneously once daily for the first 2 weeks, followed by administration three times a week for 24 weeks. Serum HCV RNA and ALT levels were assessed at baseline, at the end of the 2-week daily treatment, at the end of 26 weeks of treatment, and at the end of the 6-month post-treatment observation period. Sustained virological response in the overall dose group at the end of the 6-month observation period was 70.0% (7/10) in low viral-titer patients and 32.3% (10/31) in high viral-titer patients. Only 12.8% (5/39) of patients who received 9–18 μg interferon alfacon-1 required dose reductions or treatment withdrawals due to adverse events, compared with 45.5% (5/11) administered 21 μg. Adverse events most commonly observed were flu-like symptoms, insomnia, and nausea, consistent with those expected from administration of existing interferons. The present results indicate that interferon alfacon-1 may be an effective therapy for patients with high HCV titers, and warrant further evaluation in a larger study population.