Journal of Hepatology
Volume 51, Issue 1 , Pages 21-28 , July 2009

Positive and negative prediction of sustained virologic response at weeks 2 and 4 of treatment with albinterferon alfa-2b or peginterferon alfa-2a in treatment-naïve patients with genotype 1, chronic hepatitis C

  • Avidan U. Neumann

      Affiliations

    • Bar-Ilan University, Goodman Faculty of Life Sciences, Bldg. 212, Rm. 210, 52900 Ramat-Gan, Israel
    • Corresponding Author InformationCorresponding author. Tel.: +972 3 5317970; fax: +972 3 6356353.
    • ,
  • Stephen Pianko

      Affiliations

    • Monash University Medical School, Victoria, Australia
    • ,
  • Stefan Zeuzem

      Affiliations

    • J.W. Goethe-University Hospital, Frankfurt, Germany
    • ,
  • Eric M. Yoshida

      Affiliations

    • University of British Columbia, Vancouver, Canada
    • ,
  • Yves Benhamou

      Affiliations

    • Hôpital Pitié-Salpêtrière, Paris, France
    • ,
  • Moshe Mishan

      Affiliations

    • Bar-Ilan University, Goodman Faculty of Life Sciences, Bldg. 212, Rm. 210, 52900 Ramat-Gan, Israel
    • ,
  • John G. McHutchison

      Affiliations

    • Division of Gastroenterology, Duke Clinical Research Institute, Durham, NC, USA
    • ,
  • Erik Pulkstenis

      Affiliations

    • Human Genome Sciences, Inc., Rockville, MD, USA
    • ,
  • G. Mani Subramanian

      Affiliations

    • Human Genome Sciences, Inc., Rockville, MD, USA

Received 14 November 2008 ,Revised 22 December 2008 ,Accepted 12 January 2009.

References 

  1. Shepard CW, Finelli L, Alter MJ. Global epidemiology of hepatitis C virus infection. Lancet Infect Dis. 2005;5:558–567
  2. Fried MW, Shiffman ML, Reddy KR, Smith C, Marinos G, Gonçales FL, et al. Peginterferon alfa-2a plus ribavirin for chronic hepatitis C virus infection. N Engl J Med. 2002;347:975–982
  3. Manns MP, McHutchison JG, Gordon SC, Rustgi VK, Shiffman M, Reindollar R, et al. 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
  4. Patel K, Muir AJ, McHutchison JG. Diagnosis and treatment of chronic hepatitis C infection. BMJ. 2006;332:1013–1017
  5. 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
  6. Zeuzem S. Heterogeneous virologic response rates to interferon-based therapy in patients with chronic hepatitis C: who responds less well?. Ann Intern Med. 2004;140:370–381
  7. Ferenci P, Fried MW, Shiffman ML, Smith CI, Marinos G, Gonçales FL, et al. Predicting sustained virological responses in chronic hepatitis C patients treated with peginterferon alfa-2a (40 KD)/ribavirin. J Hepatol. 2005;43:425–433
  8. Carlsson T, Reichard O, Norkrans G, Bläckberg J, Sangfelt P, Wallmark E, et al. Hepatitis C virus RNA kinetics during the initial 12 weeks treatment with pegylated interferon-alpha 2a and ribavirin according to virological response. J Viral Hepat. 2005;12:473–480
  9. Jensen DM, Morgan TR, Marcellin P, Pockros PJ, Reddy KR, Hadziyannis SJ, et al. Early identification of HCV genotype 1 patients responding to 24 weeks peginterferon alpha-2a (40 kd)/ribavirin therapy. Hepatology. 2006;43:954–960
  10. Martı´nez-Bauer E, Crespo J, Romero-Gómez M, Moreno-Otero R, Solá R, Tesei N, et al. Development and validation of two models for early prediction of response to therapy in genotype 1 chronic hepatitis C. Hepatology. 2006;43:72–80
  11. Yu JW, Wang GQ, Sun LJ, Li XG, Li SC. Predictive value of rapid virological response and early virological response on sustained virological response in HCV patients treated with pegylated interferon alpha-2a and ribavirin. J Gastroenterol Hepatol. 2007;22:832–836
  12. Subramanian GM, Fiscella M, Lamousé-Smith A, Zeuzem S, McHutchison JG. Albinterferon alpha-2b: a genetic fusion protein for the treatment of chronic hepatitis C. Nat Biotechnol. 2007;25:1411–1419
  13. Zeuzem S, Yoshida EM, Benhamou Y, Pianko S, Bain VG, Shouval D, et al. Albinterferon alfa-2b dosed every two or four weeks in interferon-naïve patients with genotype 1 chronic hepatitis C. Hepatology. 2008;48:407–417
  14. Colombatto P, Ciccorossi P, Maina AM, Civitano L, Oliveri F, Coco B, et al. Early and accurate prediction of Peg-IFNs/ribavirin therapy outcome in the individual patient with chronic hepatitis C by modeling the dynamics of the infected cells. Clin Pharmacol Ther. 2008;84:212–215
  15. Conjeevaram HS, Fried MW, Jeffers LJ, Terrault NA, Wiley-Lucas TE, Afdhal N, et al. Peginterferon and ribavirin treatment in African American and Caucasian American patients with hepatitis C genotype 1. Gastroenterology. 2006;131:470–477
  16. Zeuzem S, Pawlotsky JM, Lukasiewicz E, von Wagner M, Goulis I, Lurie Y, et al. International, multicenter, randomized, controlled study comparing dynamically individualized versus standard treatment in patients with chronic hepatitis C. J Hepatol. 2005;43:250–257

☆ The authors (except M. Misham) who have taken part in this study have declared a relationship with the manufacturers of the drugs involved. G. Mani Subramanian and E. Pulkstenis are employees of Human Genome Sciences Inc., Rockville, Maryland, USA. J.G. McHutchison has received research grants from HGS, for conduct of this and other clinical trials related to this drug. All funding received from HGS Inc. went towards the cost of the clinical trial. A. Neumann is a consultant for and has received research grants from Human Genome Sciences Inc., Rockville, Maryland, USA. SP, SZ, EMY and YB are all investigators on trails related to this drug. M. Misham has nothing to disclose. ClinicalTrials.gov identifier NCT00115908.

PII: S0168-8278(09)00089-0

doi: 10.1016/j.jhep.2009.01.017

Journal of Hepatology
Volume 51, Issue 1 , Pages 21-28 , July 2009

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