Angelico, Mario and Cepparulo, Mario and Angelico, Francesco and Francioso, Simona and Barlattani, Angelo and Di Candilo, Francesco and Della Vecchia, R. and Demelia, Luigi and De Sanctis, G. and Gentile, S. and Grieco, Antonio and Parruti, Giustino and Sabusco, Giuseppe and Tarquini, L. and Tosti, A. and Zaru, Salvatore (2004) A Randomized controlled trial of amantadine plus interferon-alpha2a vs. interferon-alpha alone in naive patients with chronic hepatitis C randomized according to the early virological response to interferon-alpha2a monotherapy. Alimentary Pharmacology and Therapeutics, Vol. 19 (3), p. 339-347. eISSN 1365-2036. Article.
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Background: An early virological response to interferon-α treatment is a strong predictor of sustained response, but it has never been exploited to stratify patients in clinical trials.
Aim: To evaluate the efficacy of amantadine plus interferon-α compared with interferon alone in naive patients with chronic hepatitis C who were randomized on the basis of the early virological response to interferon-α.
Methods: One hundred and eighty-one patients received recombinant interferon-α (3 MU three times weekly) for 2 months and 164 were evaluated for early (i.e. month 2) virological response. Hepatitis C virus (HCV) RNA-negative patients (n = 66) were randomized to receive 3 MU of interferon-α three times weekly, with or without amantadine (200 mg/day); HCV RNA-positive patients (n = 98) were randomized to receive 6 MU of interferon-α three times weekly, with or without amantadine (200 mg/day). HCV RNA-positive patients at 6 months discontinued treatment, and all others completed 12 months.
Results: At month 6, HCV RNA-negative patients made up 54.2% of the interferon + amantadine group and 42.0% of the monotherapy group (P = 0.07). At month 12, HCV RNA-negative patients made up 38.5% of the interferon + amantadine group and 28.4% of the monotherapy group (N.S.). The sustained virological response rates were 21.6% and 20.9%, respectively (N.S.).
Conclusion: The addition of amantadine does not enhance the sustained virological response to interferon-Î± in naive patients with chronic hepatitis C; however, an additive effect of amantadine occurs in the first 6 months, mainly in patients without an early response to monotherapy. Early response to interferon-α is a strong predictor of sustained virological response.
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