SummaryThalassaemia patients with genotype 1 or 4 chronic hepatitis C virus (HCV) infection were randomised to receive peginterferon alpha-2a 180 mg/week ribavirin for 48 weeks. Primary efficacy variable was sustained viral response (SVR) at 72 weeks. Thirty-two patients were evaluated; 20 enrolled. Baseline characteristics were comparable. SVR occurred in four of 12 and five of eight patients in the monotherapy and combination groups (30% and 62AE5%; P ¼ 0AE19), respectively. Undetectable RNA at 12 weeks and age <18 years were associated with improved SVR (P < 0AE05). Transfusion requirements rose by 34% in the combination arm (P ¼ 0AE08). Peginterferon/ribavirin was effective in thalassaemics with HCV and moderate iron overload.

BACKGROUND: Treatment of thalassemia patients with HCV using combination interferon and ribavirin is limited to few case series. DESIGN: Multicenter randomized single-blinded trial comparing PEG-IFN a-2a +/− ribavirin in thalassemia major patients with chronic HCV. METHODS: 20 patients with HCV genotypes 1 and 4 were randomized into Group A (PEG-IFN 180 mg SC once weekly) and B [PEG-IFN and ribavirin (≥10.6 mg/kg/d)] for 48 weeks. Baseline studies included liver biopsy (histology and iron concentration), quantitative PCR, and HCV genotyping. The primary end point was a SVR 24 weeks post-treatment. Secondary end points were transfusion requirements, EVR, ETR, and biochemical response. RESULTS: Baseline characteristics of both groups were comparable. The mean age was 21.6 ± 11 years in group A and 16.5 ± 3.9 in group B. Fibrosis grade >1 was present in 42% in group A and 50 % in group B. Mean viral load was 137,570 IU/ml and 178,087 IU/ml respectively. Genotype 1 was found in 66% in group A and 87% in group B. EVR occurred in 8/12 in group A and 6/8 in group B (67 and 75% respectively). ETR was observed in 7/12 in group A and 6/8 in group B (59.3% and 75% respectively). Transfusion requirements increased by 55% in group B versus 21% in group A (p=0.08). Adverse events were not significantly different between treatment groups. CONCLUSIONS: This interim report suggests that combination PEG-IFN and ribavirin is effective at achieving ETR in thalassemics, is associated with an increase in transfusion requirements but no other significant side effects. Additional follow up and patient recruitment is needed to evaluate long term safety and sustained viral response.