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

ABSTRACT

Background 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. Methods We conducted a prospective, randomized, openlabel study to determine efficacy and tolerability of pegylatedinterferon alfa 2b (1.5 μg/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. Results 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. Conclusions 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.