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Peginterferon-α2a 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, PEGASYS International Study Group*
[+] Article and Author 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@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.


Ann Intern Med. 2004;140(5):346-355. doi:10.7326/0003-4819-140-5-200403020-00010
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The results of this study confirm the efficacy and safety of peginterferon-α2a and ribavirin therapy in patients with chronic hepatitis C (7). Treatment for 48 weeks with peginterferon-α2a in combination with a standard weight-based dose of ribavirin produced sustained virologic responses in 63% of patients.

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Figure 1.
Flow of participants through the study.

Patients who withdrew from treatment after 12 weeks or more and had negative hepatitis C virus RNA levels were encouraged to return for follow-up. For this reason, the number of patients who completed follow-up is higher than the number of patients who completed treatment in 2 of the 4 groups (48 weeks of treatment with peginterferon-α2a and low-dose ribavirin [48-LD] and 48 weeks of treatment with peginterferon-α2a and standard weight-based dose of ribavirin [48-SD]). *According to the protocol, patients without a virologic or biochemical response after 24 weeks of treatment were classified as nonresponders and discontinued further treatment. 24-LD = 24 weeks of treatment with peginterferon-α2a and low-dose ribavirin; 24-SD = 24 weeks of treatment with peginterferon-α2a and standard weight-based ribavirin dose; ALT = alanine aminotransferase.

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Grahic Jump Location
Figure 2.
End-of-treatment and sustained virologic response rates in patients randomly assigned to 24 or 48 weeks of treatment with peginterferon-α2a and either a low dose (800 mg/d) or standard weight-based dose of ribavirin (1000 or 1200 mg/d).

Vertical bars represent 95% CIs. The total number of patients in each group is indicated at the base of each bar. HCV = hepatitis C virus.

Grahic Jump Location
Grahic Jump Location
Figure 3.
End-of-treatment and sustained virologic response rates in patients randomly assigned to 24 or 48 weeks of treatment with peginterferon-α2a and a low-dose (800 mg/d) or standard weight-based dose of ribavirin (1000 to 1200 mg/d).

Data are grouped according to the extent of fibrosis at baseline. Vertical bars represent 95% CIs. The total number of patients in each group is indicated at the base of each bar.

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Summary for Patients

Duration and Dose of Antiviral Treatment for Chronic Hepatitis C

The summary below is from the full report titled “Peginterferon-α2a and Ribavirin Combination Therapy in Chronic Hepatitis C. A Randomized Study of Treatment Duration and Ribavirin Dose.” It is in the 2 March 2004 issue of Annals of Internal Medicine (volume 140, pages 346-355). The authors are S.J. Hadziyannis, 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, A. Lin, and A.M. Ackrill, for the PEGASYS International Study Group.

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