Efficacy and safety of pegylated IFN alfa 2b alone or in combination with ribavirin in thalassemia major with chronic hepatitis C

Treatment of HCV infection in patients with thalassemia major (TM) is limited by the lack of large clinical trials and concerns about ribavirin-induced hemolysis.We conducted a prospective, randomized, open-label study to determine efficacy and tolerability of pegylated-interferon alfa 2b (1.5 microg/kg/week) alone (group A) or with ribavirin (12-15 mg/kg/day; group B) in patients with TM and chronic HCV infection. Patients with genotype 1 or 4 HCV were treated for 48 weeks and those with genotype 3 or 2 HCV for 24 weeks. Early viral response (EVR; after 12 weeks of treatment), end-of-treatment virological response (ETR) and sustained virological response (SVR; 6 months after stopping therapy) were assessed.Of 40 patients, 20 each were allocated to the two treatment groups. EVR rates in group A and B were 15 (75%) and 18 (90%), respectively. ETR occurred in 17/20 (85%) patients in each group. SVR occurred in 8 (40%) patients in group A and 14 (70%) in group B. Blood transfusion requirements increased in one patient in group A and four patients in group B. One patient in group A had severe sepsis and one in group B had nephrotic syndrome. Two patients in each group required reduction in drug dose.In patients with TM and chronic HCV infection, pegylated interferon alfa 2b and ribavirin combination therapy achieves a higher SVR rate than pegylated interferon alone, and is well tolerated except for an increase in blood transfusion requirement.