Viral Hepatitis

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Individualized treatment strategy according to early viral kinetics in hepatitis C virus type 1–infected patients†‡

  1. Thomas Berg1,§,*,
  2. Viola Weich1,
  3. Gerlinde Teuber2,
  4. Hartwig Klinker3,
  5. Bernd Möller4,
  6. Jens Rasenack5,
  7. Holger Hinrichsen6,
  8. Tilman Gerlach7,
  9. Ulrich Spengler8,
  10. Peter Buggisch9,
  11. Heike Balk10,
  12. Myrga Zankel10,
  13. Konrad Neumann11,
  14. Christoph Sarrazin2,
  15. Stefan Zeuzem2

Article first published online: 6 APR 2009

DOI: 10.1002/hep.22991

Issue

Hepatology

Hepatology

Volume 50, Issue 2, pages 369–377, August 2009

Additional Information

How to Cite

Berg, T., Weich, V., Teuber, G., Klinker, H., Möller, B., Rasenack, J., Hinrichsen, H., Gerlach, T., Spengler, U., Buggisch, P., Balk, H., Zankel, M., Neumann, K., Sarrazin, C. and Zeuzem, S. (2009), Individualized treatment strategy according to early viral kinetics in hepatitis C virus type 1–infected patients. Hepatology, 50: 369–377. doi: 10.1002/hep.22991

Author Information

  1. 1

    Universitätsklinikum Charité, Campus Virchow-Klinikum, Universitätsmedizin Berlin, Berlin, Germany

  2. 2

    Medizinische Klinik 1, Klinikum der Johann Wolfgang Goethe Universität Frankfurt a.M., Frankfurt, Germany

  3. 3

    Medizinische Klinik und Poliklinik II der Universität Würzburg, Würzburg, Germany

  4. 4

    Hepatologische Schwerpunktpraxis Charlottenburger Str., Berlin, Germany

  5. 5

    Medizinische Universitätsklinik Freiburg, Freiburg, Germany

  6. 6

    Klinikum der Christian-Albrechts-Universität, Kiel, Germany

  7. 7

    Klinikum Großhadern, Ludwig-Maximilians-Universität, München, Germany

  8. 8

    Medizinische Universitätsklinik II, Bonn, Germany

  9. 9

    Medizinische Universitätsklinik Eppendorf, Hamburg, Germany

  10. 10

    Essex Pharma GmbH, München, Germany

  11. 11

    Charité, Institut für Biometrie und Klinische Epidemiologie, Berlin, Germany

  1. §

    fax: (49)-30-450-553903.

*Medizinische Klinik m. S. Hepatologie und Gastroenterologie, Charité, Campus Virchow-Klinikum, Universitätsmedizin Berlin, Augustenburger Platz 1, 13353 Berlin, Germany

  1. †

    Presented in part at the Annual Meetings of the European Association for the Study of the Liver and the American Association for the Study of Liver Diseases in 2006.

  2. ‡

    Potential conflicts of interest: Dr. Berg advises, is on the speakers' bureau of, and received grants from Roche and Schering-Plough. Dr. Klinker is a consultant for and lectures for Bristol-Myers Squibb, and GlaxoSmithKline. He also lectures for Boehringer Ingelheim, Roche, Gilead, and Tibotec. He lectures for and received grants from Essex. He is a consultant for Merck Sharp & Dohme and received grants from Abbott. Dr. Buggisch is on the speakers' bureau of Roche. Dr. Sarrazin is on the speakers' bureau of and received grants from Essex. Dr. Zeuzem is a consultant for, advises, is on the speakers' bureau of, and received grants from Roche and Schering-Plough.

Publication History

  1. Issue published online: 29 JUL 2009
  2. Article first published online: 6 APR 2009
  3. Accepted manuscript online: 6 APR 2009 12:00AM EST
  4. Manuscript Accepted: 15 MAR 2009
  5. Manuscript Received: 25 OCT 2008

Funded by

  • Essex Pharma (Munich, Germany), a subsidiary of Schering-Plough (Kenilworth, NJ)
  • Bayer Diagnostics
  • German Competence Network for Viral Hepatitis (Kompetenznetz Hepatitis, Hep-Net), funded by the German Ministry of Education and Research. Grant Number: 01 KI 0102
  • VIRGIL European Network of Excellence Combating Viral Resistance to Treatments

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Abstract

Individualized treatment on the basis of early viral kinetics has been discussed to optimize antiviral therapy in chronic hepatitis C virus (HCV) infection. Individually tailored reduction in treatment duration in HCV type 1–infected patients represents one possible strategy. Four hundred thirty-three patients were randomly assigned to receive either 1.5 μg/kg peginterferon alfa-2b weekly plus 800-1,400 mg ribavirin daily for 48 weeks (n = 225, group A) or an individually tailored treatment duration (18-48 weeks; n = 208, group B). In the latter group, treatment duration was calculated using the time required to induce HCV RNA negativity (branched DNA [bDNA] assay; sensitivity limit, 615 IU/mL) multiplied by the factor 6. All bDNA negative samples were retested with the more sensitive transcription-mediated amplification (TMA) assay (sensitivity limit, 5.3 IU/mL). Sustained virologic response (SVR) rates were significantly lower in group B (34.6% versus 48.0% [P = 0.005]) due to higher relapse rates (32.7% versus 14.2% [P< 0.0005]). Important predictors of response were the levels of baseline viremia as well as the time to TMA negativity on treatment. Taking the simultaneous presence of low baseline viral load (<800,000 IU/mL) and a negative TMA test within the first 4 weeks as predictors for treatment response, SVR rates were comparable between both treatment schedules with an SVR probability of >80% obtained in patients treated for only 18 or 24 weeks. Conclusion: The individualized treatment strategy according to time to bDNA negativity failed to provide comparable efficacy compared with the standard of care. The inferiority of the individualized protocol may be explained by the use of a less sensitive HCV RNA assay, and also by underestimation of the importance of baseline viremia. (HEPATOLOGY 2009.)

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