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Peginterferon-2a and Ribavirin Combination Therapy in Chronic Hepatitis C

A Randomized Study of Treatment Duration and Ribavirin Dose

Stephanos J. Hadziyannis, MD; Hoel Sette, Jr., MD; Timothy R. Morgan, MD; Vijayan Balan, MD; Moises Diago, MD; Patrick Marcellin, MD; Giuliano Ramadori, MD; Henry Bodenheimer, Jr., MD; David Bernstein, MD; Mario Rizzetto, MD; Stefan Zeuzem, MD; Paul J. Pockros, MD; Amy Lin, MS; Andrew M. Ackrill, PhD, for the PEGASYS International Study Group*

2 March 2004 | Volume 140 Issue 5 | Pages 346-355

Background: Treatment with pegylated interferon (peginterferon) and ribavirin for 48 weeks is more effective than conventional interferon and ribavirin in patients with chronic hepatitis C.

Objective: To assess the efficacy and safety of 24 or 48 weeks of treatment with peginterferon-2a plus a low or standard dose of ribavirin.

Design: Randomized, double-blind trial.

Setting: 99 international centers.

Patients: 1311 patients with chronic hepatitis C.

Intervention: Peginterferon-2a, 180 µg/wk, for 24 or 48 weeks plus a low-dose (800 mg/d) or standard weight-based dose (1000 or 1200 mg/d) of ribavirin.

Measurement: Sustained virologic response: undetectable HCV RNA concentration at the end of treatment and during 12 to 24 weeks of follow-up.

Results: Overall and in patients infected with HCV genotype 1, 48 weeks of treatment was statistically superior to 24 weeks and standard-dose ribavirin was statistically superior to low-dose ribavirin. In patients with HCV genotype 1, absolute differences in sustained virologic response rates between 48 and 24 weeks of treatment were 11.2% (95% CI, 3.6% to 18.9%) and 11.9% (CI, 4.7% to 18.9%), respectively, between standard- and low-dose ribavirin. Sustained virologic response rates for peginterferon-2a and standard-dose ribavirin for 48 weeks were 63% (CI, 59% to 68%) overall and 52% (CI, 46% to 58%) in patients with HCV genotype 1. In patients with HCV genotypes 2 or 3, the sustained virologic response rates in the 4 treatment groups were not statistically significantly different.

Conclusion: Treatment with peginterferon-2a and ribavirin may be individualized by genotype. Patients with HCV genotype 1 require treatment for 48 weeks and a standard dose of ribavirin; those with HCV genotypes 2 or 3 seem to be adequately treated with a low dose of ribavirin for 24 weeks.

*Members of the PEGASYS International Study Group are listed in the Appendix.

Editors' Notes Context Optimal treatment regimens of pegylated interferon (peginterferon) and ribavirin for chronic hepatitis C are undecided. Contribution This multicenter randomized trial found that, in patients with hepatitis C virus genotype 1, treatment for 48 weeks with peginterferon-2a plus standard doses of ribavirin (1000 or 1200 mg/d) led to sustained virologic responses more often than did 24-week treatment and combination therapy with low-dose ribavirin. Longer treatment duration and higher ribavirin dose was not necessary in patients with genotype 2 or 3. Implications Patients with hepatitis C virus genotype 1 require higher ribavirin doses and longer treatment than do those with genotype 2 or 3. –The Editors

 

Author and Article Information

From Henry Dunant Hospital, Athens, Greece; Instituto de Infectologia Emílio Ribas, São Paulo, Brazil; Veterans Affairs Medical Center, Long Beach, California; Mayo Clinic Scottsdale, Scottsdale, Arizona; Hospital General Universitario, Valencia, Spain; Hôpital Beaujon, Clichy, France; Georg-August-Universität Göttingen, Göttingen, Germany; Mount Sinai School of Medicine, New York, New York; North Shore University Hospital, Manhasset, New York; Ospedale San G. Battista, Universita di Torino, Torino, Italy; University Hospital, Homburg/Saar, Germany; The Scripps Clinic, La Jolla, California; Roche, Nutley, New Jersey; and Welwyn Garden City, United Kingdom.

Acknowledgments: The authors and members of the PEGASYS International Study Group thank Drs. Chris Pappas, Michael Brunda, Matei Popescu, and Joseph Hoffman of Roche for assisting with the conduct of this study and the preparation of this manuscript.

Grant Support: By Roche, Basel, Switzerland.

Potential Financial Conflicts of Interest:Employment: A. Lin (Hoffmann-La Roche), A.M. Ackrill (Roche); Consultancies: S.J. Hadziyannis (Roche), P. Marcellin, H. Bodenheimer Jr. (Roche), D. Bernstein (Roche), S. Zeuzem (Roche, Schering-Plough, Yamanouchi), P.J. Pockros (Roche); Honoraria: S.J. Hadziyannis (Bristol-Myers Squibb, Gilead, Roche, Schering-Plough), T.R. Morgan (Roche, Schering-Plough), P. Marcellin, H. Bodenheimer Jr. (Roche, Schering), D. Bernstein (Roche), S. Zeuzem (Roche, Schering-Plough, Yamanouchi), P.J. Pockros (Roche); Grants received: T.R. Morgan (Roche, Schering-Plough), V. Balan (Roche), H. Bodenheimer Jr. (Roche, Schering), D. Bernstein (Roche), S. Zeuzem (Roche, Schering-Plough, Yamanouchi), P.J. Pockros (Roche); Grants pending: T.R. Morgan (Roche, Schering-Plough), V. Balan (Roche), P.J. Pockros (Roche).

Requests for Single Reprints: Stephanos J. Hadziyannis, MD, Department of Medicine and Hepatology, Henry Dunant Hospital, 107 Mesoghion Avenue, Athens, Greece 11526; e-mail, hadziyannis{at}ath.forthnet.gr.

Current Author Addresses: Dr. Hadziyannis: Department of Medicine and Hepatology, Henry Dunant Hospital, 107 Mesoghion Avenue, Athens, Greece 11526.

Dr. Sette: Instituto de Infectologia "Emilio Ribas," Ambulatorio de Hepatologi, Av. Dr. Arnaldo 165, São Paulo, SP, Brazil 01239-040.

Dr. Morgan: Veterans Affairs Medical Center, 111G, 5901 East Seventh Street, Long Beach, CA 90822.

Dr. Balan: Mayo Clinic Hospital, 5777 East Mayo Boulevard, Phoenix, AZ 85054.

Dr. Diago: Hospital General de Valencia, Av. Tres Cruces s/n, Valencia, Spain 46014.

Dr. Marcellin: Hôpital Beaujon, 100 Boulevard du General Leclerc, Clichy, France 82110.

Dr. Ramadori: Universitätsklinik Göttingen, Zentrum Innere Medizin, Robert-Koch Strasse 40, Göttingen, Germany 37075.

Dr. Bodenheimer: Mount Sinai Medical Center, 1 Gustave L. Levy Place Atran 708, Box 1633, New York, NY 10029-6574.

Dr. Bernstein: North Shore University Hospital, 300 Community Drive, Manhasset, NY 11030.

Dr. Rizzetto: University of Torino, Corso Bramante 88, Torino, Italy 10126.

Dr. Zeuzem: University Hospital, Department of Internal Medicine II, D-66421 Homburg/Saar, Germany.

Dr. Pockros: The Scripps Clinic, 10666 North Torrey Pines Road, La Jolla, CA 92037.

Dr. Lin: Hoffmann-La Roche, 340 Kingsland Street, Nutley, NJ 07110.

Dr. Ackrill: Roche Products Limited, 40 Broadwater Road, Welwyn Garden City, Hertfordshire, United Kingdom AL7 3AY.

Author Contributions: Conception and design: S.J. Hadziyannis, A. Lin, A.M. Ackrill.

Analysis and interpretation of the data: S.J. Hadziyannis, T.R. Morgan, P. Marcellin, S. Zeuzem, A. Lin, A.M. Ackrill.

Drafting of the article: S.J. Hadziyannis, D. Bernstein, S. Zeuzem, A. Lin, A.M. Ackrill.

Critical revision of the article for important intellectual content: S.J. Hadziyannis, T.R. Morgan, V. Balan, M. Diago, P. Marcellin, G. Ramadori, H. Bodenheimer Jr., D. Bernstein, S. Zeuzem, P.J. Pockros, A. Lin, A.M. Ackrill.

Final approval of the article: S.J. Hadziyannis, T.R. Morgan, V. Balan, M. Diago, P. Marcellin, G. Ramadori, H. Bodenheimer Jr., D. Bernstein, S. Zeuzem, P.J. Pockros, A. Lin, A.M. Ackrill.

Provision of study materials or patients: H. Sette Jr., T.R. Morgan, V. Balan, M. Diago, P. Marcellin, G. Ramadori, H. Bodenheimer Jr., D. Bernstein, M. Rizzetto, S. Zeuzem, P.J. Pockros.

Statistical expertise: A. Lin.

Collection and assembly of data: S.J. Hadziyannis, H. Sette Jr., T.R. Morgan, H. Bodenheimer Jr., S. Zeuzem, A. Lin.

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