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

Abstract

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.