Drugs

, Volume 68, Issue 6, pp 791–801

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
  • Gaetano Scotto
  • Vincenzina Fazio
  • Chiara Fornabaio
  • Alessandra Tartaglia
  • Rocco Di Tullio
  • Annalisa Saracino
  • Gioacchino Angarano
Original Research Article

DOI: 10.2165/00003495-200868060-00005

Cite this article as:
Scotto, G., Fazio, V., Fornabaio, C. et al. Drugs (2008) 68: 791. doi:10.2165/00003495-200868060-00005

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.

Copyright information

© Adis Data Information BV 2008

Authors and Affiliations

  • Gaetano Scotto
    • 1
  • Vincenzina Fazio
    • 2
  • Chiara Fornabaio
    • 1
  • Alessandra Tartaglia
    • 1
  • Rocco Di Tullio
    • 1
  • Annalisa Saracino
    • 1
  • Gioacchino Angarano
    • 1
  1. 1.Clinic of Infectious DiseasesUniversity of FoggiaFoggiaItaly
  2. 2.Clinical Chemistry LaboratoryHospital of FoggiaFoggiaItaly