Interferon alfa2a induction therapy in combination with ribavirin and amantadine for the treatment of naive patients with chronic HCV infection

Summary.  Pilot studies have suggested that the addition of amantadine to interferon (IFN) is effective against hepatitis C virus (HCV). Furthermore, IFN induction therapy seems to improve virological response rates. In this open, randomized, multicentre trial we compared safety and efficacy of a triple therapy comprising IFN α 2a, ribavirin and amantadine using high induction doses (6 MU IFN α daily for the first 6 weeks) against a therapy with standard IFN α dosages over the entire treatment period plus amantadine and ribavirin. A total of 158 naive patients with chronic HCV infection were randomized 1:1. Group A ( n  = 81): induction therapy with 6 MU IFN α daily for 6 weeks, followed by 6 MU three times a week (tiw) for 18 weeks and then 3 MU tiw until week 48. Group B ( n  = 77): standard therapy with 6 MU IFN α tiw for 24 weeks, followed by 3 MU until week 48. All patients received oral ribavirin (10 mg/kg/day) and amantadine (200 mg/day). The triple therapy was safe and well tolerated. There were no significant differences between the groups with respect to biochemical response rates. Groups A and B did not differ in virological response rates at the end of treatment (33% vs 35%) or at the end of the 6 month follow up period (37% vs 39%). We could not detect favourable effects on sustained virological response rates using induction therapy, in either genotype 1 or non-1 infected patients. In summary, induction therapy with 6 MU IFN α daily did not result in increased overall response rates compared with standard IFN α dosages of 6 MU tiw.