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Background/Aims: Amantadine may augment virological response rates to interferon-based therapy in chronic hepatitis C patients. Using a novel design, amantadine was studied in na ve genotype 1 patients treated in combination with peginterferon alfa-2a (40KD)/ribavirin. Methods: Patients enrolled in this randomized, placeo-controlled multicenter trial were stratified by single-dose interferon sensitivity (stratum I, 24 h HCV-RNA decline >1.4log 10; II, 0.8-1.39log10; III, < 0.8log10; a reliable means of identifying nonresponders to interferon/ribavirin) and fibrosis grade (F0/1/2 vs. F3/4) at baseline. All patients received peginterferon alfa-2a (40KD) 180 μ g/week plus ribavirin 1000-1200 mg/day and were randomized to receive amantadine 100 mg twice daily (N=114) or placebo (N=95) for 48 weeks. Results: Week 24 virological response rates in strata II and III, the primary outcome, were similar in patients treated with amantadine (63.7% ) or placebo (65.7% ), as were sustained virological response rates at week 72 (46.5 and 51.6% , respectively). Adverse event profiles were similar and amantadine did not improve health-related quality of life compared with placebo. Interferon sensitivity was the only significant predictor of treatment outcome. Conclusions: Adding amantadine to peginterferon alfa-2a (40KD)/ribavirin combination therapy does not augment virological response rates in genotype 1 patients. Virological response was almost exclusively determined by interferon sensitivity at baseline.
Using a novel design, amantadine was studied in na ve genotype 1 patients treated in combination with peginterferon alfa-2a (40KD) / ribavirin. Methods: Patients enrolled in this randomized, placeo-controlled multicenter trial were stratified by single-dose interferon sensitivity (stratum I, 24 h HCV-RNA decline> 1.4 log 10; II, 0.8-1.39 log 10; All tissues received peginterferon alfa-2a (40 kD) 180 μg / week plus ribavirin 1000-1200 mg / day and were randomized to receive amantadine 100 mg twice daily (N = 114) or placebo (n = 95) for 48 weeks. Results: Week 24 virological response rates in strata II and III, the primary outcome, were similar in patients treated with amantadine (63.7%) or placebo (65.7%), as were sustained virolo gp in response to at week 72 (46.5 and 51.6%, respectively). Adverse event profiles were similar and amantadine did not improve health-related quality of life compared with placebo. Interferon sensitivity was the only significant predictor of treatment outcome. Conclusions: Adding amantadine to peginterferon alfa-2a (40KD) / ribavirin combination therapy does not augment virological response rates in genotype 1 patients. Virological response was not determined determined by interferon sensitivity at baseline.