Pilot Study of Interferon-α with and without Amantadine for the Treatment of Hepatitis C in HIV Co-infected Individuals on Antiretroviral Therapy.

Background: Concurrent potent therapy of hepatitis C (HCV) and HIV includes at least five antiviral drugs. Drug interactions, toxicity, tolerance and acceptance by patients of such treatment regimens are unknown. Study design: A prospective open randomized pilot trial was conducted to test interferon-α (6 million units/day for the 1st month followed by 6 million thrice weekly) and amantadine versus interferon-α monotherapy for tolerability and feasibility among HIV and HCV co-infected patients on stable antiretroviral combination therapy. Results: 1,013 HIV-infected patients were consecutively evaluated. 314 were anti-HCV antibody positive; only eight (2.4%) were eligible. Major reasons for exclusion were: normal. transaminase levels (34%), ongoing intravenous drug use (33%), or recent change in antiretroviral. therapy (31%). Study drugs were stopped in all of the seven patients enrolled because of side effects and/or failure of anti-HCV therapy. CD4 lymphocyte counts and HIV-1 RNA remained stable. Conclusion: Among patients on highly active antiretroviral. therapy, the addition of interferon-α with or without amantadine was inefficient and poorly tolerated, but had no negative influence on HIV infection. Eligibility for the study was unexpectedly low. [ABSTRACT FROM AUTHOR]