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Early and Sustained Virological Response in Non-Responders with Chronic Hepatitis C

A Randomized Open-Label Study of Pegylated Interferon-α-2a versus Pegylated Interferon-α-2b

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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.

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Acknowledgements

No sources of funding were used to assist in the preparation of this manuscript. The authors have no conflicts of interest that are directly relevant to the content of this article. The authors would like to thank all the participants in the study reported in this article.

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Authors and Affiliations

  1. Clinic of Infectious Diseases, University of Foggia, Luigi Pinto Street, 1α, 71100, Foggia, Italy

    Gaetano Scotto MD, Chiara Fornabaio, Alessandra Tartaglia, Rocco Di Tullio, Annalisa Saracino & Gioacchino Angarano

  2. Clinical Chemistry Laboratory, Hospital of Foggia, Foggia, Italy

    Vincenzina Fazio

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  1. Gaetano Scotto MD
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  2. Vincenzina Fazio
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Correspondence to Gaetano Scotto MD.

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Scotto, G., Fazio, V., Fornabaio, C. et al. Early and Sustained Virological Response in Non-Responders with Chronic Hepatitis C. Drugs 68, 791–801 (2008). https://doi.org/10.2165/00003495-200868060-00005

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