Interferon and amantadine in combination as initial treatment for chronic hepatitis C patients

Background/Aims: To evaluate the efficacy and tolerance of amantadine in co mbination with interferon in the treatment of chronic hepatitis C. Methods: Multi-centre trial including 180 chronic hepatitis C patients with out cirrhosis, randomly enrolled to receive interferon 6 MU every other day for 6 months followed by 3 MU for further 6 months (group A, 90 patients), or the same schedule plus amantadine 200 mg/day (group B, 90 patients). Pr imary end-point was a sustained virological and biochemical response, secon dary end-points were on-treatment (third month) and end-of-treatment respon se rates. Results: The two groups had similar demographic, biochemical and virologica l characteristics. A sustained response after 6 months follow-up was observ ed in 17% of group A and 24% of group B patients (P not significant), an en d-of-treatment response was observed in 37% in group A and 47% in group B ( P not significant), an on-treatment response was observed in 46% in group A and 61% in group B patients (P < 0.05). No major side effects due to amant adine administration were observed. Conclusions: Adding amantadine to interferon did not improve the sustained treatment efficacy. However, the rate of early response at the third month of therapy was significantly higher in the combination therapy group. (C) 2 001 European Association for the Study of the Liver. Published by Elsevier Science B.V. All rights reserved.