Authors: Scotto, Gaetano¹; Fazio, Vincenzina²; Fornabaio, Chiara¹; Tartaglia, Alessandra¹; Di Tullio, Rocco¹; Saracino, Annalisa¹; Angarano, Gioacchino¹

Source: Drugs, Volume 68, Number 6, 2008 , pp. 791-801(11)

Publisher: Adis International

Abstract:

Objectives: The purpose of this randomized open-label study was to assess the efficacy of treatment with pegylated interferon-α-2a versus pegylated interferon-α-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-α plus ribavirin for ≥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-α-2a 180 μg once weekly, while the other was treated with subcutaneous pegylated interferon-α-2b 1.5 μg/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 ≥2 log₁₀ 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-α-2a and seven patients receiving pegylated interferon-α2b discontinued treatment as a result of severe adverse effects. After 12 weeks of treatment, viral load reduction was >2 log₁₀ with both pegylated interferon-α-2a (−2.53) and pegylated interferon-α-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-α-2a and in 15 of 54 patients (27.7%) receiving pegylated interferon-α-2b. When terminating follow-up, an SVR was observed in 11 of 54 patients (20.4%) who received pegylated interferon-α-2a and 10 of 54 patients (18.4%) receiving pegylated interferon-α-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.

Keywords: Hepatitis C; Peginterferon alfa 2a; Peginterferon alfa 2b; Ribavirin

Document Type: Research article

Affiliations: 1: 1 Clinic of Infectious Diseases, University of Foggia, Foggia, Italy 2: 2 Clinical Chemistry Laboratory, Hospital of Foggia, Foggia, Italy

Publication date: 2008-01-01

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