A randomized trial of amantadine and interferon versus interferon alone asinitial treatment for chronic hepatitis C

The aim of this study was to compare, in an open-label study, the efficacy and safety of a combination of interferon (IFN) and amantadine (AMA) with t hat of IFN alone in previously untreated patients with chronic hepatitis C. A total of 200 patients were randomized to 6 MU of IFN-alpha 2a 3 times pe r week, with 200 mg of AMA daily (n = 99) or to an identical dose of interf eron alpha 2a (n = 101). Patients were treated for 12 months and observed f or 6 months' posttreatment. At the completion of treatment, 28.7% of patien ts in the monotherapy group and 45.5% in the combination group had a virolo gic response (P = .014), At 6 months' posttreatment, a sustained virologic response was observed in 16.8% (95% CI: 9-23) of patients with IFN alone ve rsus 29.3% (95% CI: 19-37) of patients who were treated with combination th erapy (P = .036). In each of the 2 treatments, genotype was the only predic tive parameter for a sustained response. At the logistic regression analysi s, therapy and genotype were the only 2 parameters with an independent pred ictive value. In the combination group, at examination of month 3, hepatiti s C virus (HCV)-RNA status had a 97.6% (95% CI: 93-102) positive predictive value and a 50% (95% CI: 37-63) negative predictive value for a sustained virologic clearance. A substantial proportion of naive patients with chroni c hepatitis C have an end-pf-treatment and end-of-follow-up virologic and b iochemical response to a combination of IFN and AMA. This new treatment app ears safe and well tolerated.