Original Research Article

BioDrugs

, Volume 16, Issue 2, pp 105-109

Peginterferon-α-2a (40kD) and Ribavirin in Patients with Chronic Hepatitis C

A Phase II Open-Label Study
  • Mark SulkowskiAffiliated withThe Johns Hopkins University School of Medicine Email author 
  • , Robert ReindollarAffiliated withCarolinas Center for Liver Disease, North Carolina
  • , David L. ThomasAffiliated withThe Johns Hopkins University School of Medicine
  • , Sherilyn Brinkley-LaughtonAffiliated withThe Johns Hopkins University School of Medicine
  • , Martha HudsonAffiliated withCarolinas Center for Liver Disease, North Carolina
  • , Jian YuAffiliated withF. Hoffmann-La Roche Inc.

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Abstract

Background and aims: Addition of a 40kD polyethylene glycol moiety to interferon-α-2a [peginterferon-α-2a (40kD)] improves pharmacokinetic properties over those of standard interferon. We conducted a phase II study to assess the safety and initial efficacy of peginterferon-α-2a (40kD) plus ribavirin combination therapy in patients with chronic hepatitis C (CHC).

Methods: Twenty patients received open-label 180μg peginterferon-α-2a (40kD) subcutaneously once weekly and oral ribavirin 1000 or 1200mg daily for patients weighing <75 or ≥75kg, respectively, for a period of 24 weeks. Patients with hepatitis C virus (HCV) genotype 1 and a virological response at week 24 received study drugs for an additional 24 weeks.

Results: A sustained virological response, defined as undetectable HCV RNA 24 (i.e. <100 copies/ml) weeks after completing the therapy, was achieved in 50% of patients in an intent-to-treat analysis (6/16 genotype 1 and 4/4 genotype non-1). Adverse events were similar to those reported with unmodified interferon plus ribavirin combination therapy. Anaemia led to ribavirin dose reduction in five patients. Neutropenia led to dose reduction in three patients treated with peginterferon-α-2a (40kD).

Conclusions: The addition of ribavirin to a once-weekly peginterferon-α-2a (40kD) regimen should be investigated in larger clinical trials.