Early and sustained virological response in non-responders with chronic hepatitis C: a randomized open-label study of pegylated interferon-alpha-2a versus pegylated interferon-alpha-2b.

OBJECTIVES: The purpose of this randomized open-label study was to assess the efficacy of treatment with pegylated interferon-alpha-2a versus pegylated interferon-alpha-2b, both plus ribavirin, in inducing early and sustained virological response (EVR and SVR) in chronic hepatitis C non-responders. PATIENTS AND METHODS: A total of 108 patients with chronic hepatitis C who were non-responders to previous combined therapy (standard interferon-alpha plus ribavirin for > or = 3 months) were enrolled and equally randomized into two groups in this intention-to-treat analysis. The patients exhibited similar baseline features. One group received subcutaneous pegylated interferon-alpha-2a 180 microg once weekly, while the other was treated with subcutaneous pegylated interferon-alpha-2b 1.5 microg/kg once weekly. Ribavirin 15 mg/kg/day was included in both protocols. Treatment duration for EVR was 12 weeks. Patients who demonstrated non-detectable hepatitis C virus (HCV) RNA or a > or = 2 log(10) reduction in viral load at week 12 continued therapy up to 48 weeks, with assessments every 3 months during a follow-up of 24 weeks. RESULTS: All patients in both groups completed the EVR study, then seven patients receiving pegylated interferon-alpha-2a and seven patients receiving pegylated interferon-alpha2b discontinued treatment as a result of severe adverse effects. After 12 weeks of treatment, viral load reduction was >2 log(10) with both pegylated interferon-alpha-2a (-2.53) and pegylated interferon-alpha-2b (-2.48) with no significant difference. At the end of week 48, HCV RNA was undetectable in 14 of 54 patients (25.9%) receiving pegylated interferon-alpha-2a and in 15 of 54 patients (27.7%) receiving pegylated interferon-alpha-2b. When terminating follow-up, an SVR was observed in 11 of 54 patients (20.4%) who received pegylated interferon-alpha-2a and 10 of 54 patients (18.4%) receiving pegylated interferon-alpha-2b. The incidence and severity of adverse events was similar in both groups. CONCLUSIONS: Our results seem to show that in chronic hepatitis C patients who are non-responsive to previous therapy, EVR to the two pegylated interferons did not significantly differ with a similar therapeutic efficacy defined as SVR.