amantadine plus interferon-α versus interferon-α monotherapy for the treatment of chronic hepatitis-c infection in β-thalassemia major patients: a randomized double blinded pilot study in shiraz, iran

background: hepatitis-c infection is a major problem in chronically transfused patients. we compared interferon-α (inf-α) monotherapy with combination of inf-α and amantadine in the treatment of β-thalassemia major patients who were chronically infected with hcv.materials and methods: forty six thalassemia major patients who were chronically infected with hcv were randomly divided into two groups. one group (22 patients) was treated by inf-α, 3 million units every other day plus amantadine 2 mg/kg/day (case group) and the other group (24 patients) was treated by inf-α and placebo tablet (control group). the duration of treatment was 12 months in both groups. pcr for hcv and liver function tests were performed 3 months after beginning of treatment and 6 months after treatment cessation in both groups and the results were compared.results: sixteen patients were excluded from the study (12patietns in case group and 4 patients in control group) due to drug intolerance and inadequate follow up . 20 patients out of 24 patients who were treated with inf-α alone (control group) and 10 patients out of 22 patients who were treated with inf-α plus amantadine (case group) were followed for 18 months  . pcr for hcv was performed two times for all patients. initial pcr revealed that 15 patients (75.0%) became hcv negative in control group while 10 patients (100%) became hcv negative in case group.the second pcr which was performed 6 months after termination of treatment disclosed that 16 patients (80.0%) in control group were hcv negative compared to 6 patients (60.0%) in case group (p>0.05).conclusion: addition of amantadine to interferon does not improve the remission rate in hcv positive major thalassemic patients.