Triple Therapy With Amantadine in Treatment–Naive Patients With Chronic Hepatitis C: A Placebo–Controlled Trial

Open Access
Publisher Website
Google Scholar
Abstract
The antiviral efficacy of amantadine in patients with chronic hepatitis C is controversial. In this randomized, prospective, placebo–controlled, multicenter trial, triple therapy with interferon alfa (IFN–α)–2a plus ribavirin and amantadine (amantadine group) was compared with combination therapy IFN–α plus ribavirin (control group). Four hundred previously untreated patients with histologically proven chronic hepatitis C were randomly allocated to treatment with amantadine sulphate (100 mg twice daily orally) or a matched placebo together with IFN–α induction plus ribavirin (1,000–1,200 mg/day orally) for 48 weeks. The primary end point was sustained virologic response (SVR) defined as undetectable serum hepatitis C virus (HCV) RNA (P = .11). Among patients with HCV genotype 1 infection, the corresponding SVR rates were 39% and 31%, respectively. The virologic on–treatment response rate in week 24 was significantly higher in the amantadine group as compared with the control group (70% vs. 59%, respectively, P = .016). This beneficial effect was mainly related to HCV type 1–infected patients (63% vs. 47%, respectively, P = .012). Independent factors associated with SVR, according to multiple logistic regression analysis, were amantadine treatment, low baseline HCV RNA, platelet counts (≥250/nL), pretreatment ALT quotient ≥3, and GGT level (<28 U/L) as well as HCV genotypes other than 1. In conclusion, although we could not demonstrate a significant advantage of the triple regimen in univariate analysis, multivariate analysis offers arguments that amantadine should be considered as a potential anti–HCV drug in future studies.