Viral Hepatitis

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Peginterferon alfa-2b and weight-based or flat-dose ribavirin in chronic hepatitis C patients: A randomized trial†‡§

  1. Ira M. Jacobson1,¶,*,
  2. Robert S. Brown Jr2,
  3. Bradley Freilich3,
  4. Nezam Afdhal4,
  5. Paul Y. Kwo5,
  6. John Santoro6,
  7. Scott Becker7,
  8. Adil E. Wakil8,
  9. David Pound9,
  10. Eliot Godofsky10,
  11. Robert Strauss11,
  12. David Bernstein12,
  13. Steven Flamm13,
  14. Mary Pat Pauly14,
  15. Pabak Mukhopadhyay15,
  16. Louis H. Griffel15,
  17. Clifford A. Brass15

Article first published online: 25 SEP 2007

DOI: 10.1002/hep.21932

Issue

Hepatology

Hepatology

Volume 46, Issue 4, pages 971–981, October 2007

Additional Information

How to Cite

Jacobson, I. M., Brown, R. S., Freilich, B., Afdhal, N., Kwo, P. Y., Santoro, J., Becker, S., Wakil, A. E., Pound, D., Godofsky, E., Strauss, R., Bernstein, D., Flamm, S., Pauly, M. P., Mukhopadhyay, P., Griffel, L. H. and Brass, C. A. (2007), Peginterferon alfa-2b and weight-based or flat-dose ribavirin in chronic hepatitis C patients: A randomized trial. Hepatology, 46: 971–981. doi: 10.1002/hep.21932

Author Information

  1. 1

    Weill Medical College of Cornell University, Center for the Study of Hepatitis C, New York Presbyterian Hospital, New York, NY

  2. 2

    Columbia University College of Physicians & Surgeons, New York Presbyterian Hospital, New York, NY

  3. 3

    Baptist Medical Center, Kansas City, MO

  4. 4

    Beth Israel Deaconess Medical Center, Boston, MA

  5. 5

    Indiana University School of Medicine, Indianapolis, IN

  6. 6

    Atlantic Gastroenterology Associates, Egg Harbor Township, NJ

  7. 7

    Austin Gastroenterology, PA, Austin, TX

  8. 8

    California Pacific Medical Center, San Francisco, CA

  9. 9

    Indianapolis Gastroenterology RSCH, Indianapolis, IN

  10. 10

    Bach and Godofsky, MD PA, Bradenton, FL

  11. 11

    Northwest Georgia Gastroenterology Associates, PC, Marietta, GA

  12. 12

    North Shore University Hospital, Manhasset, NY

  13. 13

    Northwestern University, Feinberg School of Medicine, Chicago, IL

  14. 14

    Kaiser Permanente, Sacramento, CA

  15. 15

    Schering-Plough Research Institute, Kenilworth, NJ

  1. fax: 646-962-0355

*Division of Gastroenterology and Hepatology, Center for the Study of Hepatitis C, Weill Medical College of Cornell University, 1305 York Avenue, 4th Floor, New York, NY 10021

  1. †

    Potential conflicts of interest: Ira M. Jacobson, Schering-Plough consultant, speaker bureau, research support; Merck consultant, GlobeImmune consultant, research support, Human Genome Sciences consultant, research support; Coley consultant, research support; Gilead consultant, speaker bureau, research support; Vertex consultant, research support; Intermune consultant, research support; Intarcia consultant; Valeant consultant, research support; GlaxoSmithKline consultant; Idenix consultant, speaker bureau, research support; Novartis, consultant speaker bureau, research support; Bristol-Myers Squibb consultant, speaker bureau; Boehringer Ingelheim consultant; XTL consultant. Robert S. Brown, Jr., Schering-Plough consultant, research support, honoraria; Bradley Freilich, Schering-Plough speaker bureau, research support; Nezam Afdahl, Schering-Plough consultant, speaker bureau, research support; Paul Kwo, Schering-Plough research support; Adil E. Wakil, Schering-Plough speaker bureau, Roche speaker bureau; Steven Flamm, Schering-Plough research support; Pabak Mukhopadhyay, Louis H. Griffel, Schering-Plough employee; Clifford A. Brass, Schering-Plough employee.

  2. ‡

    Trial registration number NCT00299936, available at http://clinicaltrials.gov

  3. §

    See Editorial on Page 953

Publication History

  1. Issue published online: 25 SEP 2007
  2. Article first published online: 25 SEP 2007
  3. Manuscript Accepted: 23 JUL 2007
  4. Manuscript Received: 24 APR 2007

Funded by

  • Schering-Plough Corp., Kenilworth, NJ

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Abstract

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 μg/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. (HEPATOLOGY 2007;46:971–981.)

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