A randomized trial of pegylated‐interferon‐α2a plus ribavirin with or without amantadine in the re‐treatment of patients with chronic hepatitis C not responding to standard interferon and ribavirin

Summary Background There is yet no established treatment for chronic hepatitis C patients non‐responder to standard interferon and ribavirin. Aim To evaluate efficacy and safety of pegylated‐interferon‐α2a plus ribavirin with or without amantadine in such patients. Methods 161 non‐responders to standard interferon and ribavirin were randomized into two groups: 81 patients (Group 1) were given weekly Peg‐IFN‐α2a 180 μg plus ribavirin 1000–1200 mg/daily for 12 months, 80 patients (Group 2) received weekly Peg‐IFN‐α2a 180 μg plus ribavirin 1000–1200 mg/daily and amantadine 200 mg/daily for 12 months. Results At the end of follow‐up, HCV‐RNA was negative in 29.6% of Group 1 and in 21.2% of Group 2 patients (P = 0.22). Patients with genotypes 1 and 4 responded better to bi‐therapy (21.7%) than to triple therapy (17.3%, P = 0.5) while among patients with genotypes 2 and 3 there was a trend towards a higher sustained virological response rate when retreated with triple treatment (80% vs. 75%, P = 0.82). On multivariate analysis, genotype 1 or 4, high body mass index and >20% reduction of Peg‐interferon were associated with the treatment failure. Conclusions The addition of amantadine does not improve the overall SVR rate in non‐responder patients retreated with Peg‐IFN and ribavirin; however, about 30% of non‐responders may achieve a sustained response, in particular patients with genotypes 2 and 3 show a high SVR (75%).