Background/aims: The intravenous administration of interferon-beta may be effective for the treatment of chronic hepatitis C, as is intramuscular interferon-beta. We compared the efficacy and safety of twice-a-day versus once-a-day of natural interferon-beta for the initial treatment of patients with chronic hepatitis C.
Methodology: Forty-nine patients with chronic hepatitis C, with less than 5 Meq/mL serum hepatitis C virus-RNA, were randomly assigned into one of the two treatment groups A and B and treated with natural interferon-beta following two different protocols. Twenty-two patients were treated with twice-a-day interferon-beta (3 MU) for 3 weeks followed by once-a-day interferon-beta (6 MU) for 5 weeks (group A), and 20 patients were treated with once-a-day interferon-beta (6 MU) for 8 weeks (group B). Seven patients did not complete the treatment protocol. Efficacy was assessed by measuring the serum levels of hepatitis C virus-RNA and aminotransferase.
Results: The rate of sustained virological response was significantly higher in group A (14 of 22 patients, 63.6%) than in group B (6 of 20 patients, 30.0%) (P < 0.05). Among patients with hepatitis C virus-RNA level less than 1 Meq/mL, the sustained virological response rate was significantly higher in group A (13 of 15 patients, 86.7%) than in group B (5 of 12 patients, 41.7%) (P < 0.05). However, the sustained virological response rate in patients with hepatitis C virus levels more than 1 Meq/mL was not significantly different between group A (1 of 7 patients, 14.3%) and group B (1 of 8 patients, 12.5%).
Conclusions: Twice-a-day interferon-beta therapy is more effective than once-a-day interferon-beta for the treatment of chronic hepatitis C patients with hepatitis C virus-RNA levels less than 1 Meq/mL.