Randomized, double-blind, placebo-controlled trial of interferon alfa2a with and without amantadine as initial treatment for chronic hepatitis C.

Abstract

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.

• Authors: S Zeuzem, G Teuber, U Naumann, T Berg, J Raedle, S Hartmann, U Hopf
• Journal: Hepatology (Baltimore, Md.) (Hepatology) Vol. 32 Issue 4 Pt 1 Pg. 835-41 (Oct 2000) ISSN: 0270-9139 [Print] United States
• PMID: 11003631 (Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Antiviral Agents
• Interferon alpha-2
• Interferon-alpha
• RNA, Viral
• Recombinant Proteins
• Amantadine

Topics

• Adolescent
• Adult
• Aged
• Amantadine (administration & dosage)
• Antiviral Agents (therapeutic use)
• Double-Blind Method
• Drug Therapy, Combination
• Female
• Hepatitis C, Chronic (drug therapy, pathology, virology)
• Humans
• Interferon alpha-2
• Interferon-alpha (administration & dosage, adverse effects, therapeutic use)
• Liver (pathology)
• Male
• Middle Aged
• Quality of Life
• RNA, Viral (analysis)
• Recombinant Proteins