Pilot study of interferon-alpha 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 [east 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 te st interferon-alpha (6 million units/day for the ist month followed by 6 mi llion thrice weekly) and amantadine versus interferon-a monotherapy for tol erability 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 dru gs were stopped in all of the seven patients enrolled because of side effec ts 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 add ition of interferon-a with or without amantadine was inefficient and poorly tolerated, but had no negative influence on HIV infection. Eligibility for the study was unexpectedly low.