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

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A randomized trial of amantadine and interferon versus interferon alone as

initial 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 that of IFN alone in

previously untreated

patients with chronic hepatitis C. A total of 200 patients were randomized to 6

MU of IFN-2a 3 times

per week, with 200 mg of AMA daily (n = 99) or to an identical dose of

interferon 2a (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. (HEPATOLOGY

2001;33:989-993.)

This is a promising alternative to IFN and Riba.