Peginterferon alfa-2b and weight-based or flat-dose ribavirin in chronic hepatitis C patients: a randomized trial. Academic Article uri icon

Overview

abstract

  • UNLABELLED: This prospective, multicenter, community-based and academic-based, open-label, investigator-initiated, U.S. study evaluated efficacy and safety of pegylated interferon (PEG-IFN) alfa-2b plus a flat or weight-based dose of ribavirin (RBV) in adults with chronic hepatitis C. Patients (n = 5027) were randomly assigned to receive PEG-IFN alfa-2b 1.5 microg/kg/week plus flat-dose (800 mg/day) or weight-based (800-1400 mg/day) RBV for 48 weeks (patients with genotype 1, 4, 5, or 6) and for 24 or 48 weeks (genotype 2/3 patients). Primary end point was sustained virologic response (undetectable [<125 IU/mL] serum hepatitis C virus RNA at 24-week follow-up). Sustained virologic response, but not end-of-treatment, rates were significantly higher with weight-based than with flat-dose RBV (44.2% versus 40.5%; P = 0.008). Sustained virologic response rates by intention-to-treat analysis were 34.0% and 28.9%, respectively, in genotype 1 patients (P = 0.005) and 31.2% and 26.7%, respectively, in genotype 1 patients with high baseline viral load (P = 0.056). In genotype 2/3 patients, rates were not significantly different (61.8% and 59.5%, respectively) regardless of treatment duration. Besides greater hemoglobin reductions with weight-based RBV, safety profiles were similar across RBV dosing groups, including the 1400-mg/day group. CONCLUSION: PEG-IFN alfa-2b plus weight-based RBV is more effective than flat-dose RBV, particularly in genotype 1 patients, providing equivalent efficacy across all weight groups. RBV 1400 mg/day is appropriate for patients 105 to 125 kg. For genotype 2/3 patients, 24 weeks of treatment with flat-dose RBV is adequate; no evidence of additional benefit of extending treatment to 48 weeks was demonstrated.

authors

  • Jacobson, Ira M
  • Brown, Robert S.
  • Freilich, Bradley
  • Afdhal, Nezam
  • Kwo, Paul Y
  • Santoro, John
  • Becker, Scott
  • Wakil, Adil E
  • Pound, David
  • Godofsky, Eliot
  • Strauss, Robert
  • Bernstein, David
  • Flamm, Steven
  • Pauly, Mary Pat
  • Mukhopadhyay, Pabak
  • Griffel, Louis H
  • Brass, Clifford A

publication date

  • October 1, 2007

Research

keywords

  • Antiviral Agents
  • Hepatitis C
  • Interferon-alpha
  • Ribavirin

Identity

Scopus Document Identifier

  • 36348981708

PubMed ID

  • 17894303

Additional Document Info

volume

  • 46

issue

  • 4