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Table of Contents
Vol. 53, No. 3, 2010
Issue release date: April 2010
Section title: Original Paper
Intervirology 2010;53:146–153
(DOI:10.1159/000274975)

Efficacy and Tolerability of Pegylated Interferon-α2a plus Ribavirin versus Pegylated Interferon-α2b plus Ribavirin in Treatment-Naive Chronic Hepatitis C Patients

Lee S.a · Kim I.H.a · Kim S.H.a · Kim S.W.a · Lee S.O.a · Lee S.T.a · Kim D.G.a · Lee C.S.a · Choi C.S.b · Cho E.Y.b · Kim H.C.b
aDepartment of Internal Medicine, Research Institute for Medical Science, Chonbuk National University Medical School and Hospital, Jeonju, and bDepartment of Internal Medicine, Wonkwang University College of Medicine and Hospital, Iksan, South Korea
email Corresponding Author

Abstract

Objectives: The authors compared the efficacies and tolerabilities of pegylated interferon-α2a (PEG-IFN-α2a) + ribavirin and pegylated interferon-α2b (PEG-IFN-α2b) + ribavirin for the initial treatment of chronic hepatitis C. Methods: A total of 126 treatment-naive patients (29.4% genotype 1, 70.6% genotype non-1) were treated with PEG-IFN-α2a 180 µg/week (group A, n = 79) or PEG-IFN-α2b 1.5 µg/kg/week (group B, n = 47) with ribavirin (800 mg/day for genotype non-1 or 1,000–1,200 mg/day for genotype 1) for 24 (genotype non-1) or 48 weeks (genotype 1). Results: End-of-treatment virologic response, sustained virologic response, and biochemical response were not significantly different in groups A and B (84.8 vs. 89.4%, 70.9 vs. 72.3%, and 70.9 vs. 74.5%, respectively; p > 0.05). In patients with the HCV genotype 1 or non-1, treatment responses were not significantly different. Multivariate analysis showed that HCV genotype only was an independent factor that affected sustained virologic response (p = 0.048). The proportions of treatment discontinuations in groups A and B were similar (10.1 vs. 10.6%; p = 1.000). Conclusions: PEG-IFN-α2a or PEG-IFN-α2b + ribavirin combination therapies showed similar efficacies and tolerabilities as initial treatments for chronic hepatitis C.

© 2010 S. Karger AG, Basel


  

Key Words

  • Chronic hepatitis C
  • Pegylated interferon-α2a
  • Pegylated interferon-α2b
  • Ribavirin

References

  1. Lauer GM, Walker BD: Hepatitis C virus infection. N Engl J Med 2001;345:41–52.
  2. Poynard T, Yuen MF, Ratziu V, Lai CL. Viral hepatitis C: review. Lancet 2003;362:2095–2100.
  3. Liang TJ, Rehermann B, Seeff LB, Hoofnagle JH: Pathogenesis, natural history, treatment, and prevention of hepatitis C. Ann Intern Med 2000;132:296–305.
  4. Ghany MG, Strader DB, Thomas DL, Seeff LB; American Association for the Study of Liver Diseases: Diagnosis, management, and treatment of hepatitis C: an update. Hepatology 2009;49:1335–1374.
  5. Farrell GC: New hepatitis C guidelines for the Asia-Pacific region: APASL consensus statements on the diagnosis, management and treatment of hepatitis C virus infection. J Gastroenterol Hepatol 2007;22:607–610.
  6. Fried MW, Shiffman ML, Reddy KR, Smith C, Marinos G, Gonçales FL Jr, Häussinger D, Diago M, Carosi G, Dhumeaux D, Craxi A, Lin A, Hoffman J, Yu J: Peginterferon alfa-2a plus ribavirin for chronic hepatitis C virus infection. N Engl J Med 2002;347:975–982.
  7. Manns MP, McHutchison JG, Gordon SC, Rustgi VK, Shiffman M, Reindollar R, Goodman ZD, Koury K, Ling M, Albrecht JK: Peginterferon alfa-2b plus ribavirin compared with interferon alfa-2b plus ribavirin for initial treatment of chronic hepatitis C: a randomised trial. Lancet 2001;358:958–965.
  8. Hadziyannis SJ, Sette H Jr, Morgan TR, Balan V, Diago M, Marcellin P, Ramadori G, Bodenheimer H Jr, Bernstein D, Rizzetto M, Zeuzem S, Pockros PJ, Lin A, Ackrill AM; PEGASYS International Study Group: Peginterferon-α2a and ribavirin combination therapy in chronic hepatitis C: a randomized study of treatment duration and ribavirin dose. Ann Intern Med 2004;140:346–355.
  9. Harris JM, Martin NE, Modi M: Pegylation – a novel process for modifying pharmacokinetics. Clin Pharmacokinet 2001;40:539–551.
  10. Zeuzem S, Feinman SV, Rasenack J, Heathcote EJ, Lai MY, Gane E, O’Grady J, Reichen J, Diago M, Lin A, Hoffman J, Brunda MJ: Peginterferon alfa-2a in patients with chronic hepatitis C. N Engl J Med 2000;343:1666–1672.
  11. Foster GR: Pegylated interferons: chemical and clinical differences. Aliment Pharmacol Ther 2004;20:825–830.
  12. Glue P, Fang J, Rouzier-Panis R, Raffanel C, Sabo R, Gupta SK, Saif M, Jacobs S: Pegylated interferon-α2b: pharmacokinetics, pharmacodynamics, safety, and preliminary efficacy data. Clin Pharmacol Ther 2000;68:556–567.
  13. Peginterferon-α2a Prescribing Information. Roche Laboratories, Inc., Nutley, NJ, USA.
  14. Peginterferon-α2b Prescribing Information. Schering-Plough Corp., Kenilworth, NJ, USA.
  15. Ascione A, De Luca M, Tartaglione MT, Lampasi F, Galeota Lanza A, Picciotto FP, Di Costanzo GG, Leandro G: Peginterferon-α2a plus ribavirin versus peginterferon-α2b plus ribavirin in naive patients with chronic hepatitis C virus infection: results of a prospective randomised trial. J Hepatol 2008;48(suppl 2):S370.

    External Resources

  16. Rumi M, Aghemo A, Prati GM, D’Ambrosio R, Donato MF, Russo A, Cerami N, Soffredini R, Colombo M: Randomized study comparing peginterferon alfa-2a plus ribavirin and peginterferon alfa-2b plus ribavirin in naive patients with chronic hepatitis C: final results of the Milan Safety Tolerability (MIST) study. Hepatology 2008;48(suppl 1):404A.
  17. McHutchison JG, Lawitz EJ, Shiffman ML, Muir AJ, Galler GW, McCone J, Nyberg LM, Lee WM, Ghalib RH, Schiff ER, Galati JS, Bacon BR, Davis MN, Mukhopadhyay P, Koury K, Noviello S, Pedicone LD, Brass CA, Albrecht JK, Sulkowaski MS; for the IDEAL Study Team: Peginterferon alfa-2b or alfa-2a with ribavirin for treatment of hepatitis C infection. N Engl J Med 2009;361:580–593.
  18. Davis GL, Wong JB, McHutchison JG, Manns MP, Harvey J, Albrecht J: Early virologic response to treatment with peginterferon alfa-2b plus ribavirin in patients with chronic hepatitis C. Hepatology 2003;38:645–652.
  19. Bruno R, Sacchi P, Ciappina V, Zochetti C, Patruno S, Maiocchi L, Filice G: Viral dynamics and pharmacokinetics of peginterferon-α2a and peginterferon-α2b in naive patients with chronic hepatitis C: a randomized, controlled study. Antiviral Ther 2004;9:491–497.
  20. Silva M, Poo J, Wagner F, Jackson M, Cutler D, Grace M, Bordens R, Cullen C, Harvey J, Laughlin M: A randomised trial to compare the pharmacokinetic, pharmacodynamic, and antiviral effects of peginterferon alfa-2b and peginterferon alfa-2a in patients with chronic hepatitis C (COMPARE). J Hepatol 2006;45:204–213.

  

Author Contacts

In Hee Kim, MD
Department of Internal Medicine, Research Institute of Clinical Medicine
Chonbuk National University Medical School and Hospital
634-18 Keumam-dong, Dukjin-ku, Jeonju, Jeonbuk 561-712 (South Korea)
Tel. +82 63 250 1677, Fax +82 63 254 1609, E-Mail ihkimmd@chonbuk.ac.kr

  

Article Information

Received: August 5, 2009
Accepted after revision: October 20, 2009
Published online: January 13, 2010
Number of Print Pages : 8
Number of Figures : 1, Number of Tables : 4, Number of References : 20

  

Publication Details

Intervirology (International Journal of Basic and Medical Virology)

Vol. 53, No. 3, Year 2010 (Cover Date: April 2010)

Journal Editor: Liebert U.G. (Leipzig)
ISSN: 0300-5526 (Print), eISSN: 1423-0100 (Online)

For additional information: http://www.karger.com/INT


Copyright / Drug Dosage / Disclaimer

Copyright: All rights reserved. No part of this publication may be translated into other languages, reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying, recording, microcopying, or by any information storage and retrieval system, without permission in writing from the publisher or, in the case of photocopying, direct payment of a specified fee to the Copyright Clearance Center.
Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in goverment regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug.
Disclaimer: The statements, opinions and data contained in this publication are solely those of the individual authors and contributors and not of the publishers and the editor(s). The appearance of advertisements or/and product references in the publication is not a warranty, endorsement, or approval of the products or services advertised or of their effectiveness, quality or safety. The publisher and the editor(s) disclaim responsibility for any injury to persons or property resulting from any ideas, methods, instructions or products referred to in the content or advertisements.

Abstract

Objectives: The authors compared the efficacies and tolerabilities of pegylated interferon-α2a (PEG-IFN-α2a) + ribavirin and pegylated interferon-α2b (PEG-IFN-α2b) + ribavirin for the initial treatment of chronic hepatitis C. Methods: A total of 126 treatment-naive patients (29.4% genotype 1, 70.6% genotype non-1) were treated with PEG-IFN-α2a 180 µg/week (group A, n = 79) or PEG-IFN-α2b 1.5 µg/kg/week (group B, n = 47) with ribavirin (800 mg/day for genotype non-1 or 1,000–1,200 mg/day for genotype 1) for 24 (genotype non-1) or 48 weeks (genotype 1). Results: End-of-treatment virologic response, sustained virologic response, and biochemical response were not significantly different in groups A and B (84.8 vs. 89.4%, 70.9 vs. 72.3%, and 70.9 vs. 74.5%, respectively; p > 0.05). In patients with the HCV genotype 1 or non-1, treatment responses were not significantly different. Multivariate analysis showed that HCV genotype only was an independent factor that affected sustained virologic response (p = 0.048). The proportions of treatment discontinuations in groups A and B were similar (10.1 vs. 10.6%; p = 1.000). Conclusions: PEG-IFN-α2a or PEG-IFN-α2b + ribavirin combination therapies showed similar efficacies and tolerabilities as initial treatments for chronic hepatitis C.

© 2010 S. Karger AG, Basel


  

Author Contacts

In Hee Kim, MD
Department of Internal Medicine, Research Institute of Clinical Medicine
Chonbuk National University Medical School and Hospital
634-18 Keumam-dong, Dukjin-ku, Jeonju, Jeonbuk 561-712 (South Korea)
Tel. +82 63 250 1677, Fax +82 63 254 1609, E-Mail ihkimmd@chonbuk.ac.kr

  

Article Information

Received: August 5, 2009
Accepted after revision: October 20, 2009
Published online: January 13, 2010
Number of Print Pages : 8
Number of Figures : 1, Number of Tables : 4, Number of References : 20

  

Publication Details

Intervirology (International Journal of Basic and Medical Virology)

Vol. 53, No. 3, Year 2010 (Cover Date: April 2010)

Journal Editor: Liebert U.G. (Leipzig)
ISSN: 0300-5526 (Print), eISSN: 1423-0100 (Online)

For additional information: http://www.karger.com/INT


Article / Publication Details

First-Page Preview
Abstract of Original Paper

Received: 8/5/2009
Accepted: 10/20/2009
Published online: 1/13/2010
Issue release date: April 2010

Number of Print Pages: 8
Number of Figures: 1
Number of Tables: 4

ISSN: 0300-5526 (Print)
eISSN: 1423-0100 (Online)

For additional information: http://www.karger.com/INT


Copyright / Drug Dosage

Copyright: All rights reserved. No part of this publication may be translated into other languages, reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying, recording, microcopying, or by any information storage and retrieval system, without permission in writing from the publisher or, in the case of photocopying, direct payment of a specified fee to the Copyright Clearance Center.
Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in goverment regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug.
Disclaimer: The statements, opinions and data contained in this publication are solely those of the individual authors and contributors and not of the publishers and the editor(s). The appearance of advertisements or/and product references in the publication is not a warranty, endorsement, or approval of the products or services advertised or of their effectiveness, quality or safety. The publisher and the editor(s) disclaim responsibility for any injury to persons or property resulting from any ideas, methods, instructions or products referred to in the content or advertisements.

References

  1. Lauer GM, Walker BD: Hepatitis C virus infection. N Engl J Med 2001;345:41–52.
  2. Poynard T, Yuen MF, Ratziu V, Lai CL. Viral hepatitis C: review. Lancet 2003;362:2095–2100.
  3. Liang TJ, Rehermann B, Seeff LB, Hoofnagle JH: Pathogenesis, natural history, treatment, and prevention of hepatitis C. Ann Intern Med 2000;132:296–305.
  4. Ghany MG, Strader DB, Thomas DL, Seeff LB; American Association for the Study of Liver Diseases: Diagnosis, management, and treatment of hepatitis C: an update. Hepatology 2009;49:1335–1374.
  5. Farrell GC: New hepatitis C guidelines for the Asia-Pacific region: APASL consensus statements on the diagnosis, management and treatment of hepatitis C virus infection. J Gastroenterol Hepatol 2007;22:607–610.
  6. Fried MW, Shiffman ML, Reddy KR, Smith C, Marinos G, Gonçales FL Jr, Häussinger D, Diago M, Carosi G, Dhumeaux D, Craxi A, Lin A, Hoffman J, Yu J: Peginterferon alfa-2a plus ribavirin for chronic hepatitis C virus infection. N Engl J Med 2002;347:975–982.
  7. Manns MP, McHutchison JG, Gordon SC, Rustgi VK, Shiffman M, Reindollar R, Goodman ZD, Koury K, Ling M, Albrecht JK: Peginterferon alfa-2b plus ribavirin compared with interferon alfa-2b plus ribavirin for initial treatment of chronic hepatitis C: a randomised trial. Lancet 2001;358:958–965.
  8. Hadziyannis SJ, Sette H Jr, Morgan TR, Balan V, Diago M, Marcellin P, Ramadori G, Bodenheimer H Jr, Bernstein D, Rizzetto M, Zeuzem S, Pockros PJ, Lin A, Ackrill AM; PEGASYS International Study Group: Peginterferon-α2a and ribavirin combination therapy in chronic hepatitis C: a randomized study of treatment duration and ribavirin dose. Ann Intern Med 2004;140:346–355.
  9. Harris JM, Martin NE, Modi M: Pegylation – a novel process for modifying pharmacokinetics. Clin Pharmacokinet 2001;40:539–551.
  10. Zeuzem S, Feinman SV, Rasenack J, Heathcote EJ, Lai MY, Gane E, O’Grady J, Reichen J, Diago M, Lin A, Hoffman J, Brunda MJ: Peginterferon alfa-2a in patients with chronic hepatitis C. N Engl J Med 2000;343:1666–1672.
  11. Foster GR: Pegylated interferons: chemical and clinical differences. Aliment Pharmacol Ther 2004;20:825–830.
  12. Glue P, Fang J, Rouzier-Panis R, Raffanel C, Sabo R, Gupta SK, Saif M, Jacobs S: Pegylated interferon-α2b: pharmacokinetics, pharmacodynamics, safety, and preliminary efficacy data. Clin Pharmacol Ther 2000;68:556–567.
  13. Peginterferon-α2a Prescribing Information. Roche Laboratories, Inc., Nutley, NJ, USA.
  14. Peginterferon-α2b Prescribing Information. Schering-Plough Corp., Kenilworth, NJ, USA.
  15. Ascione A, De Luca M, Tartaglione MT, Lampasi F, Galeota Lanza A, Picciotto FP, Di Costanzo GG, Leandro G: Peginterferon-α2a plus ribavirin versus peginterferon-α2b plus ribavirin in naive patients with chronic hepatitis C virus infection: results of a prospective randomised trial. J Hepatol 2008;48(suppl 2):S370.

    External Resources

  16. Rumi M, Aghemo A, Prati GM, D’Ambrosio R, Donato MF, Russo A, Cerami N, Soffredini R, Colombo M: Randomized study comparing peginterferon alfa-2a plus ribavirin and peginterferon alfa-2b plus ribavirin in naive patients with chronic hepatitis C: final results of the Milan Safety Tolerability (MIST) study. Hepatology 2008;48(suppl 1):404A.
  17. McHutchison JG, Lawitz EJ, Shiffman ML, Muir AJ, Galler GW, McCone J, Nyberg LM, Lee WM, Ghalib RH, Schiff ER, Galati JS, Bacon BR, Davis MN, Mukhopadhyay P, Koury K, Noviello S, Pedicone LD, Brass CA, Albrecht JK, Sulkowaski MS; for the IDEAL Study Team: Peginterferon alfa-2b or alfa-2a with ribavirin for treatment of hepatitis C infection. N Engl J Med 2009;361:580–593.
  18. Davis GL, Wong JB, McHutchison JG, Manns MP, Harvey J, Albrecht J: Early virologic response to treatment with peginterferon alfa-2b plus ribavirin in patients with chronic hepatitis C. Hepatology 2003;38:645–652.
  19. Bruno R, Sacchi P, Ciappina V, Zochetti C, Patruno S, Maiocchi L, Filice G: Viral dynamics and pharmacokinetics of peginterferon-α2a and peginterferon-α2b in naive patients with chronic hepatitis C: a randomized, controlled study. Antiviral Ther 2004;9:491–497.
  20. Silva M, Poo J, Wagner F, Jackson M, Cutler D, Grace M, Bordens R, Cullen C, Harvey J, Laughlin M: A randomised trial to compare the pharmacokinetic, pharmacodynamic, and antiviral effects of peginterferon alfa-2b and peginterferon alfa-2a in patients with chronic hepatitis C (COMPARE). J Hepatol 2006;45:204–213.