Pilot study of interferon-alpha with and without amantadine for the treatment of hepatitis C in HIV coinfected 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.


METHODS
A prospective open randomized pilot trial was conducted to test interferon-alpha (6 million units/day for the 1st month followed by 6 million thrice weekly) and amantadine versus interferon-alpha 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.


CONCLUSIONS
Among patients on highly active antiretroviral therapy, the addition of interferon-alpha with or without amantadine was inefficient and poorly tolerated, but had no negative influence on HIV infection. Eligibility for the study was unexpectedly low.
Sax
H
H
Division of Infectious Diseases, University of Geneva Hospitals, Switzerland. hugo.sax@hcuge.ch
Friedl
A
A
Renner
E
E
Steuerwald
M H
MH
Weber
R
R
D000328:Adult; D000547:Amantadine / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D000998:Antiviral Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D018791:CD4 Lymphocyte Count; D004347:Drug Interactions; D005260:Female; D015658:HIV Infections / Q000150:complications*; D006526:Hepatitis C / Q000188:drug therapy* / Q000209:etiology; D006801:Humans; D016898:Interferon-alpha / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D008297:Male; D008875:Middle Aged; D010349:Patient Compliance; D018579:Patient Selection; D011446:Prospective Studies
D000998:Antiviral Agents; D016898:Interferon-alpha; D000547:Amantadine