Efficacy of pegylated interferon-α treatment for 24 months in chronic delta hepatitis and predictors of response

Background: To determine the efficacy of pegylated interferon-alpha (PEG-IFN-alpha) therapy for 24 months in chronic delta hepatitis (CDH). Methods: Patients with CDH who were treated by PEG-IFN-alpha 2a or -2b for 24 months were included in the study. Demographic, biochemical and virological parameters were recorded at baseline and during follow-up. All included patients completed a treatment period of 24 months and at least a 6 month (range 6-60) follow-up period. Biochemical and virological response rates at end of treatment and end of follow-up were calculated, and predictors of sustained virological response (SVR) were analysed. Results: In total, 32 patients (22 males; mean age +/- SD 42.7 +/- 12 years) with CDH who were treated with PEG-IFN-alpha 2a (180 mu g) or -2b (1.5 mu g/kg) once a week subcutaneously for 24 months were included in the study. All patients had compensated liver disease (25 [78%] were noncirrhotic), increased transaminase levels and HDV RNA positivity at baseline. Genotypic analyses of HDV showed genotype I in all. Mean duration of follow-up was 19.5 months. At the end of treatment, virological response was achieved in 16 (50%) patients. SVR at the end of follow-up was achieved in 15 (47%) patients. A negative HDV RNA at 6 months of treatment was the only predictor of SVR (OR=20; 95% CI 2, 195; P=0.01). Conclusions: PEG-IFN-alpha treatment achieved SVR in approximately half of the patients with CDH, and relapse rate was very low during the follow-up. Negativity of HDV RNA at 6 months may predict SVR in CDH.