Skip to main content

Advertisement

Log in

From Trials to a Real Hospital Setting: Effectiveness of Pegylated Interferon-α-2b/Ribavirin Combination Therapy for Naïve Chronic Hepatitis C Patients

  • Original Paper
  • Published:
Digestive Diseases and Sciences Aims and scope Submit manuscript

Abstract

Registration trials regarding pegylated interferon treatment of hepatitis C have created great expectations for improved results, but there is little information on actual outcomes in everyday hospital practice. We aimed to define the effectiveness of this treatment in a hospital setting. Seventy-four naïve patients with hepatitis C treated with 12 kD-pegylated-interferon-α-2-b/ribavirin (PEG-IFN) were retrospectively analyzed in comparison with 54 patients treated with IFN-α-2-b/ribavirin (STANDARD IFN) and with results of three main registration trials. Overall sustained viral response rates were 46% in the STANDARD IFN group and 54% in PEG-IFN group, ranging from 48–61% in similar arms of the registration trials considered, although more of our patients presented comorbidity and high-grade fibrosis, and our dosages at outset of PEG-IFN were lower than optimal (mean 1.18 μg/kg BW). In our hospital setting, the effectiveness of PEG-IFN/ribavirin therapy appeared similar to that reported in large registration trials.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Similar content being viewed by others

References

  1. McHutchison JG, Davis GL, Esteban R, Poynard T, Ling M-H, Garaud J-J, Albrecht J (2001) Durability of sustained virological response in patients with chronic hepatitis C after treatment with interferon alfa 2b alone or in combination with ribavirin. Hepatology 34:244A

    Google Scholar 

  2. Imazeki F, Yokosuka O, Fukai K, Saisho H (2003) Favorable prognosis of chronic hepatitis C after interferon therapy by long-term cohort study. Hepatology 38:493–502

    Article  PubMed  CAS  Google Scholar 

  3. Khokhar N (2004) Late relapse in chronic hepatitis C after sustained viral response to interferon and ribavirin. Journal of Gastroenterology and Hepatology 19:471–472

    Article  PubMed  CAS  Google Scholar 

  4. EASL International Consensus Conference on Hepatitis C (1999) Consensus statement. J Hepatol 30:956–961

    Article  Google Scholar 

  5. Poynard T, Leroy V, Cohard M, Thevenot T, Mathurin P, Opolon P, Zarski JP (1996) Meta-analysis of interferon randomized trials in the treatment of viral hepatitis C: effects of dose and duration. Hepatology 24:778–789

    Article  PubMed  CAS  Google Scholar 

  6. McHutchison JG, Poynard T (1999) Combination therapy with interferon plus ribavirin for the initial treatment of chronic hepatitis C. Semin Liver Dis 19 Suppl 1:57–65

    Google Scholar 

  7. Davis GL, Esteban-Mur R, Rustgi V, Hoefs J, Gordon SC, Trepo C, Shiffman ML, Zeuzem S, Craxi A, Ling MH, Albrecht J (1998) Interferon alfa-2b alone or in combination with ribavirin for the treatment of relapse of chronic hepatitis C. International Hepatitis Interventional Therapy Group. N Engl J Med 339:1493–1499

    Article  PubMed  CAS  Google Scholar 

  8. Piai G, Rocco P, Tartaglione MT, Ciarleglio A, Focareta R, Grimaldi E, Ievoli F, Iuliano D, Pacelli M, Forte G (2003) Triple (interferon, ribavirin, amantadine) versus double (interferon, ribavirin) re-therapy for interferon relapser genotype 1b HCV chronic active hepatitis patients. Hepatol Res 25:355–363

    Article  PubMed  CAS  Google Scholar 

  9. Saracco G, Olivero A, Ciancio A, Carenzi S, Smedile A, Cariti G, Andreoni M, Orsi PG, Biglino A, Tabone M, Roffi L, Croce G, Manca A, Tappero G, Ciccone G, Rizzetto M (2001) A randomized 4-arm multicenter study of interferon alfa-2b plus ribavirin in the treatment of patients with chronic hepatitis C not responding to interferon alone. Hepatology 34:133–138

    Article  PubMed  CAS  Google Scholar 

  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 (2000) Peginterferon alfa-2a in patients with chronic hepatitis C. N Engl J Med 343:1666–1672

    Article  PubMed  CAS  Google Scholar 

  11. Fried MW, Shiffman ML, Reddy KR, Smith C, Marinos G, Goncales FLJr, Haussinger D, Diago M, Carosi G, Dhumeaux D, Craxi A, Lin A, Hoffman J, Yu J (2002) Peginterferon alfa-2a plus ribavirin for chronic hepatitis C virus infection. N Engl J Med 347:975–982

    Article  PubMed  CAS  Google Scholar 

  12. Lindsay KL, Trepo C, Heintges T, Shiffman ML, Gordon SC, Hoefs JC, Schiff ER, Goodman ZD, Laughlin M, Yao R, Albrecht JK (2001) Hepatitis Interventional Therapy Group. A randomized, double blind trial comparing pegylated interferon alfa-2b to interferon alfa-2b as initial treatment for chronic hepatitis C. Hepatology 34:395–403

    Article  PubMed  CAS  Google Scholar 

  13. Manns MP, McHutchison JG, Gordon SC, Rustgi VK, Shiffman M, Reindollar R, Goodman ZD, Koury K, Ling M, Albrecht JK (2001) Peginterferon alfa-2b plus ribavirin compared with interferon alfa-2b plus ribavirin for initial treatment of chronic hepatitis C: a randomized trial. Lancet 358:958–965

    Article  PubMed  CAS  Google Scholar 

  14. Knodell RG, Ishak KG, Black WC, Chen TS, Craig R, Kaplowitz N, Kiernan TW, Wollman J (1981) Formulation and application of a numerical scoring system for assessing histological activity in asymptomatic chronic active hepatitis. Hepatology 1:431–435

    Article  PubMed  CAS  Google Scholar 

  15. McHutchison JG, Manns M, Patel K, Poynard T, Lindsay KL, Trepo C, Dienstag J, Lee WM, Mak C, Garaud JJ, Albrecht JK (2002) International Hepatitis Interventional Therapy Group. Adherence to combination therapy enhances sustained response in genotype-1-infected patients with chronic hepatitis C. Gastroenterology 123:1061–1069

    Article  PubMed  CAS  Google Scholar 

  16. Hadziyannis SJ, Sette HJr, Morgan TR, Balan V, Diago M, Marcellin P, Ramadori G, Bodenheimer HJr, Bernstein D, Rizzetto M, Zeuzem S, Pockros PJ, Lin A, Ackrill AM (2004) PEGASYS International Study Group. Peginterferon-alpha2a and ribavirin combination therapy in chronic hepatitis C: a randomized study of treatment duration and ribavirin dose. Ann Intern Med 140:346–355

    PubMed  CAS  Google Scholar 

  17. Shehab TM, Fontana RJ, Oberhelman K, Marrero JA, Su GL, Lok AS (2004) Effectiveness of interferon alpha-2b and ribavirin combination therapy in the treatment of naive chronic hepatitis C patients in clinical practice. Clin Gastroenterol Hepatol 2:425–431

    Article  PubMed  CAS  Google Scholar 

  18. Jensen DM, Cotler SJ, Lam H, Harb G, Shillington A (2004) A comparison of hepatitis C treatment and outcomes at academic, private and Veterans’ Affairs treatment centers. Aliment Pharmacol Ther 19:69–77

    Article  PubMed  CAS  Google Scholar 

  19. Kumar D, Wallington-Beddoe C, George J, Lin R, Samarasinghe D, Liddle C, Farrell GC (2003) Effectiveness of interferon alfa-2b/ribavirin combination therapy for chronic hepatitis C in a clinic setting. Med J Aust 178:267–271

    PubMed  Google Scholar 

  20. Clouston AD, Jonsson JR, Purdie DM, Macdonald GA, Pandeya N, Shorthouse C, Powell EE (2001) Steatosis and chronic hepatitis C: analysis of fibrosis and stellate cell activation. J Hepatol 34:314–320

    Article  PubMed  CAS  Google Scholar 

  21. Falck-Ytter Y, Kale H, Mullen KD, Sarbah SA, Sorescu L, McCullough AJ (2002) Surprisingly small effect of antiviral treatment in patients with hepatitis C. Ann Intern Med 136:288–292

    PubMed  CAS  Google Scholar 

Download references

Acknowledgments

We wish to thank Mrs. P. Feola, Mrs. M. Iodice, and the whole nursing staff for their daily work in liver clinic; Dr A. Lonardo for revising manuscript with appreciated suggestions; and Mrs. Mary Spears for her final English language revision.

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to Guido Piai.

Rights and permissions

Reprints and permissions

About this article

Cite this article

Piai, G., Scalice, E., Focareta, R. et al. From Trials to a Real Hospital Setting: Effectiveness of Pegylated Interferon-α-2b/Ribavirin Combination Therapy for Naïve Chronic Hepatitis C Patients. Dig Dis Sci 51, 1619–1626 (2006). https://doi.org/10.1007/s10620-006-9110-8

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s10620-006-9110-8

Keywords

Navigation