Abstract
Background
A significant proportion of hepatitis C patients treated with unmodified interferon plus ribavirin fail to respond. The optimal therapy for these patients has not been established yet. The objective of this study was to assess the efficacy and safety of peginterferon plus ribavirin with or without amantidine in such patients.
Methods
In this open-label, prospective controlled trial, a total of 63 patients were randomly divided into groups A and B with a ratio of 1:2. Group A (21 patients) received weekly peginterferon alpha-2b, 1.5 μg/kg concomitantly with ribavirin 1000–1200 mg per day. Group B (42 patients) received peginterferon and ribavirin as in group A, plus amantidine 200 mg per day.
Results
At the completion of treatment, serum levels of hepatitis C virus RNA were undetectable in 14% and 12% of patients in groups A and B, respectively (P=NS). Hepatitis C virus RNA remained undetectable 24 weeks after the end of treatment in one patient (5%) in group A and three patients (7%) in group B (P=NS). Sustained viral clearance was associated with sustained normalization of serum alanine aminotransferase level. Both drug regimens had similar side effect profiles.
Conclusion
Peginterferon plus ribavirin therapy with or without amantidine is associated with a low sustained virological response in patients who failed interferon and ribavirin combination therapy.