Langlet P, D'Heygere F, Henrion J, Adler M, Delwaide J, VAN Vlierberghe H, Mulkay JP, Lasser L, Brenard R, Horsmans Y, Michielsen P, Laureys A, Nevens F
A randomised trial of pegylated-interferon-alpha-2a plus ribavirin with or without amantadine in treatment-naïve or relapsing chronic hepatitis C patients. [JOURNAL ARTICLE]
Aliment Pharmacol Ther 2009 May 26.
Summary Background The combination therapy of pegylated-interferon-alpha2a plus ribavirin is considered as the standard of care for patients with chronic hepatitis C. A sustained viral response is obtained in 40-50% of naïve patients with genotype 1 and in around 80% of naïve patients with genotype 2 or 3. Aim To assess whether amantadine, added to the conventional bi-therapy, could improve the treatment efficacy. Methods 630 patients (intent-to-treat population) with chronic hepatitis C were randomized into two groups: 316 patients (treatment group) received pegylated-interferon-alpha2a (180mug once weekly) plus ribavirin (1000-1200mg/daily) with amantadine (200mg/daily); 314 patients (control group) received pegylated-interferon-alpha2a (180mug once weekly) plus ribavirin (1000-1200mg/daily) without amantadine. The duration of the treatment was 48 weeks for genotypes 1, 4, 5 and 6, and 24 weeks for genotypes 2 and 3. Results There was no statistically significant difference between treatments groups for any of the variables tested for. Subgroups of patients likely to take advantage of the addition of amantadine were not identified. Conclusions This large study definitely excludes the role of amantadine in addition of conventional bitherapy in the treatment of chronic hepatitis C patients.
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