Although the
antiviral effects of
amantadine sulphate (1-aminoadamantan sulphate) have not been characterized for the hepatitis C virus (HCV), previous pilot studies have suggested promising results in patients with
chronic hepatitis C. The aim of the present study was to compare the efficacy, safety, and health-related quality of life (HRQOL) of
interferon alfa (IFN-alpha) alone or in combination with oral
amantadine for treatment of
chronic hepatitis C. One hundred nineteen previously untreated patients with
chronic hepatitis C were randomly allocated to treatment with IFN-alpha2a at a dose of 6 megaunits 3 times a week subcutaneously for 24 weeks, followed by 3 megaunits thrice weekly for an additional 24 weeks plus
amantadine sulphate administered orally 100 mg twice a day for 48 weeks or the same IFN regimen plus a matched placebo. The primary endpoint was undectable serum HCV
RNA (<1,000 copies/mL) at week 24
after treatment. At the end of treatment and the 24-week follow-up period serum HCV
RNA was undetectable in 20 (34%) and 6 (10%) of the 59 patients treated with the combination IFN-alpha plus
amantadine and in 20 (33%) and 13 (22%) of the 60 patients treated with IFN-alpha alone, respectively (P = n.s.). Discontinuation of
therapy for adverse events was similar in both treatment groups. Although treatment with IFN-alpha worsened HRQOL, combination with
amantadine showed a substantial trend to improve
fatigue and vigor. In conclusion, combination
therapy IFN-alpha plus
amantadine is as effective as IFN-alpha monotherapy in previously untreated patients with
chronic hepatitis C.