Interferon-alpha Lozenges for Prevention of Relapse in Hepatitis C

A Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Low-Dose Human Interferon-alpha During the 6-Month Follow-up Period of Standard Combination Therapy for Hepatitis C Virus Infection

The purpose of this study is to determine whether lozenges of interferon-alpha that are dissolved in the mouth can prevent relapse in patients with hepatitis C virus infection who had a complete virologic response after receiving a combination of injected interferon-alpha and oral ribavirin.

Inclusion Criteria:

• HCV genotype 1b
• Will be completing pegylated IFN-alpha and ribavirin therapy within 4 weeks
• Serum HCV RNA negative within 4 weeks of study entry

Exclusion Criteria:

• Child-Pugh score of B or C
• Decompensated liver function
• History of malignancy within past 5 years
• Other causes of liver disease besides HCV infection
• Uncontrolled diabetes or hypertension
• Unwilling to use two forms of birth control during study treatment