Study on Hepatitis C Treatment Using Ribavirin and Pegylated Interferon in Thalassemia Patients (SCRIPT): One Year Report.

Abstract

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.

Treatment of chronic hepatitis C in polytransfused thalassaemic patients: a meta-analysis

“…One study was excluded because it did not provide enough information on methodology and outcome [13], one further study was excluded because it just reported early viral response [14] and two other studies were excluded because they did not report SVR [15,16]. Four duplicate publications of the same patients’ data as seminar proceedings were also excluded from analysis [17–20]. Two further studies were excluded because they defined complete, partial and non‐response according to ALT level at the end of treatment [21,22], one conference proceedings in Italian language were also excluded [23].…”

Low Dose Ribavirin for Treatment of Hepatitis C Virus Infected Thalassemia Major Patients; New Indications for Combination Therapy

“…Previously in a meta-analysis of literature, we showed that peginterferon monotherapy can induce a SVR rate of 28 percent in thalassemia major patients, while combination therapy of peginterferon and ribavirin (low dose therapy, accompanying by tight monitoring of patients) elicits a SVR rate of 44 percent [ 20 ]. The small sample size and lack of control group in included studies were two major downsides of our meta-analysis [ 21 ][ 22 ][ 23 ][ 24 ][ 25 ][ 26 ]. Indeed, this study has been designed to address this issue and to reach a more precise estimation of ribavirin tolerability and the effect of its low dose administration on improving SVR in HCV infected thalassemia major patients.…”