TY - JOUR
T1 - A randomized trial of amantadine and interferon versus interferon alone as initial treatment for chronic hepatitis C
AU - Mangia, A.
AU - Minerva, N.
AU - Annese, M.
AU - Leandro, G.
AU - Villani, M. R.
AU - Santoro, R.
AU - Carretta, V.
AU - Bacca, D.
AU - Giangaspero, A.
AU - Bisceglia, M.
AU - Ventrella, F.
AU - Dell'Erba, G.
AU - Andriulli, A.
PY - 2001
Y1 - 2001
N2 - 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 that of IFN alone in previously untreated patients with chronic hepatitis C. A total of 200 patients were randomized to 6 MU of IFN-α2a 3 times per week, with 200 mg of AMA daily (n = 99) or to an identical dose of interferon α2a (n = 101). Patients were treated for 12 months and observed for 6 months' posttreatment. At the completion of treatment, 28.7% of patients in the monotherapy group and 45.5% in the combination group had a virologic 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 versus 29.3% (95% CI: 19-37) of patients who were treated with combination therapy (P = .036). In each of the 2 treatments, genotype was the only predictive parameter for a sustained response: At the logistic regression analysis, therapy and genotype were the only 2 parameters with an independent predictive value. In the combination group, at examination of month 3, hepatitis 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 naïve patients with chronic hepatitis C have an end-of-treatment and end-of-follow-up virologic and biochemical response to a combination of IFN and AMA. This new treatment appears safe and well tolerated.
AB - 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 that of IFN alone in previously untreated patients with chronic hepatitis C. A total of 200 patients were randomized to 6 MU of IFN-α2a 3 times per week, with 200 mg of AMA daily (n = 99) or to an identical dose of interferon α2a (n = 101). Patients were treated for 12 months and observed for 6 months' posttreatment. At the completion of treatment, 28.7% of patients in the monotherapy group and 45.5% in the combination group had a virologic 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 versus 29.3% (95% CI: 19-37) of patients who were treated with combination therapy (P = .036). In each of the 2 treatments, genotype was the only predictive parameter for a sustained response: At the logistic regression analysis, therapy and genotype were the only 2 parameters with an independent predictive value. In the combination group, at examination of month 3, hepatitis 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 naïve patients with chronic hepatitis C have an end-of-treatment and end-of-follow-up virologic and biochemical response to a combination of IFN and AMA. This new treatment appears safe and well tolerated.
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U2 - 10.1053/jhep.2001.23537
DO - 10.1053/jhep.2001.23537
M3 - Article
C2 - 11283865
AN - SCOPUS:17744398404
VL - 33
SP - 989
EP - 993
JO - Hepatology
JF - Hepatology
SN - 0270-9139
IS - 4
ER -