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Viral Hepatitis

Anemia during treatment with peginterferon Alfa-2b/ribavirin and boceprevir: Analysis from the serine protease inhibitor therapy 2 (SPRINT-2) trial†‡§

  1. Mark S. Sulkowski1,¶¶,*,
  2. Fred Poordad2,‖,
  3. Michael P. Manns3,
  4. Jean-Pierre Bronowicki4,
  5. K. Rajender Reddy5,
  6. Stephen A. Harrison6,
  7. Nezam H. Afdhal7,
  8. Heather L. Sings8,
  9. Lisa D. Pedicone8,††,
  10. Kenneth J. Koury8,
  11. Vilma Sniukiene8,‡‡,
  12. Margaret H. Burroughs8,
  13. Janice K. Albrecht8,††,
  14. Clifford A. Brass8,§§,
  15. Ira M. Jacobson9,
  16. for the SPRINT-2 Trial Investigators1

Article first published online: 11 FEB 2013

DOI: 10.1002/hep.26096

Issue

Hepatology

Hepatology

Volume 57, Issue 3, pages 974–984, March 2013

Additional Information

How to Cite

Sulkowski, M. S., Poordad, F., Manns, M. P., Bronowicki, J.-P., Rajender Reddy, K., Harrison, S. A., Afdhal, N. H., Sings, H. L., Pedicone, L. D., Koury, K. J., Sniukiene, V., Burroughs, M. H., Albrecht, J. K., Brass, C. A., Jacobson, I. M. and for the SPRINT-2 Trial Investigators (2013), Anemia during treatment with peginterferon Alfa-2b/ribavirin and boceprevir: Analysis from the serine protease inhibitor therapy 2 (SPRINT-2) trial. Hepatology, 57: 974–984. doi: 10.1002/hep.26096

Author Information

  1. 1

    Johns Hopkins University School of Medicine, Baltimore, MD

  2. 2

    Cedars-Sinai Medical Center, Los Angeles, CA

  3. 3

    Medical School of Hannover, Hannover, Germany

  4. 4

    INSERM U954, Centre Hospitalier Universitaire de Nancy, Université de Lorraine, Nancy, France

  5. 5

    University of Pennsylvania, Philadelphia, PA

  6. 6

    Brooke Army Medical Center, San Antonio, TX

  7. 7

    Beth Israel Deaconess Medical Center, Boston, MA

  8. 8

    Merck Sharp & Dohme Corp., Whitehouse Station, NJ

  9. 9

    Weill Cornell Medical College, New York, NY

  1. ‖

    Texas Liver Institute/Alamo Medical Research, University of Texas, San Antonio, TX

  2. ††

    Focus Medical Communications, Parsippany, NJ

  3. ‡‡

    Warner Chilcott, Rockaway, NJ

  4. §§

    Novartis, East Hanover, NJ

  1. ¶¶

    fax: 410-583-2654

*M.D., Johns Hopkins University School of Medicine, 600 North Wolfe St, 1830, Building, Suite 445, Baltimore, MD 21287-0003

  1. †

    Potential conflict of interest: Mark S. Sulkowski has received consultancy fees and has grants/grants pending from Abbott, Bristol-Myers Squibb, Boehringer-Ingelheim, Gilead, Janssen, Merck, Novartis, Pfizer, and Vertex. Fred Poordad has received consultancy fees from Merck, Vertex, Abbott, Gilead, Achillion, Genentech, and Tibotec; has grants/grants pending from Merck; and has received payment for development of educational presentations and speaker fees from Merck, Genentech, Salix, and Gilead. Michael P. Manns has received consultancy fees from Achillion, Schering-Plough (now part of Merck), Roche, Bristol-Myers Squibb, Gilead, Boehringer-Ingelheim, Novartis, Idenix, Tibotec, Vertex, GlaxoSmithKline, and Merck; has grants/grants pending from Schering-Plough (now part of Merck), Roche, Gilead, Novartis, Boehringer-Ingelheim, and Bristol-Myers Squibb; and has received payment for development of educational presentations from Schering-Plough (now part of Merck), Roche, Bristol-Myers Squibb, GlaxoSmithKline, and Gilead. Jean-Pierre Bronowicki has received consultancy fees from Schering-Plough (now part of Merck), Roche, Gilead, Bristol-Myers Squibb, Janssen, Boehringer Ingelheim, Novartis, and Bayer; payment for lectures including service on speakers bureaus for Schering-Plough (now part of Merck), Roche, Bayer, and Bristol-Myers Squibb and travel/accommodations/meeting expenses unrelated to activities listed from Roche. K. Rajender Reddy has received consultancy fees from Roche, Merck, Salix, Vertex, Tibotec, and Human Genome Science; has grants/grants pending from Roche, Vertex, Tibotec, Bristol-Myers Squibb, and Gilead; and payment for development of educational presentations from ViralEd. Stephen A. Harrison has received grant support from Merck, is an advisory board member for Merck and Vertex; has grants/grants pending from Genentech and Bristol-Myers Squibb; and has received payment for lectures, including service on speakers bureaus for Merck. Nezam H. Afdhal has received grant support from Merck, Gilead, Vertex, GSK, Abbott, BMS, and Pharmasett. He has been a scientific advisor or consultant for Gilead, Vertex, Merck, Novartis, Tibotec, Johnson and Johnson, Medgenics, and Springbank. Heather L. Sings, Kenneth Koury, and Margaret H. Burroughs are employees of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., and hold stock and/or stock options. Vilma Sniukiene, Janice K. Albrecht, Clifford A. Brass and Lisa D Pedicone are former employees of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., and hold stock and/or stock options. Ira M. Jacobson has received consultancy fees from Bristol-Myers Squibb, Novartis, Gilead, Merck, Pfizer, Vertex, GlobeImmune, Boehringer-Ingelheim, Pharmasset, Tibotec, Abbott, Roche/Genentech, and Tibotec; Achillion, and GlaxoSmithKline; has grants/grants pending from Abbott, Merck, Tibotec, Roche/Genentech, Pharmasset, Boehringer Ingelheim, Novartis, Gilead, Vertex, GlobeImmune, Human Genome Sciences, Pfizer, and Bristol-Myers Squibb; payment for lectures including service on speakers bureaus from Merck, Vertex, Gilead, Bristol-Myers Squibb, Roche/Genentech, and Vertex; and payment for development of educational presentations from Bristol-Myers Squibb, Gilead, and Vertex.

  2. ‡

    Sponsored by Schering-Plough (now part of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ).

  3. §

    Fred Poordad is currently affiliated with Texas Liver Institute/Alamo Medical Research, University of Texas, San Antonio, TX. Lisa D. Pedicone is currently affiliated with Focus Medical Communications, Parsippany, NJ. Vilma Sniukiene is currently affiliated with Warner Chilcott, Rockaway, NJ. Janice K Albrecht is a former employee of Merck. Clifford A. Brass is currently affiliated with Novartis, East Hanover, NJ.  The views expressed herein are those of the authors and do not reflect the official policy or position of Merck Sharp & Dohme Corp, Brooke Army Medical Center, the US Army Medical Department, the US Army Office of the Surgeon General, the Department of the Army, Department of Defense, or the US Government.

  4. A complete list of SPRINT-2 Trial investigators is given in the Appendix.

  5. ¶¶

    fax: 410-583-2654

Publication History

  1. Issue published online: 28 FEB 2013
  2. Article first published online: 11 FEB 2013
  3. Accepted manuscript online: 18 OCT 2012 03:54AM EST
  4. Manuscript Accepted: 27 SEP 2012
  5. Manuscript Received: 17 MAY 2012

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Abstract

Boceprevir (BOC) added to peginterferon alfa-2b (PegIFN) and ribavirin (RBV) significantly increases sustained virologic response (SVR) rates over PegIFN/RBV alone in previously untreated adults with chronic hepatitis C genotype 1. We evaluate the relationship of incident anemia with triple therapy. A total of 1,097 patients received a 4-week lead-in of PegIFN/RBV followed by: (1) placebo plus PegIFN/RBV for 44 weeks (PR48); (2) BOC plus PegIFN/RBV using response-guided therapy (BOC/RGT); and (3) BOC plus PegIFN/RBV for 44 weeks (BOC/PR48). The management of anemia (hemoglobin [Hb] <10 g/dL) included RBV dose reduction and/or erythropoietin (EPO) use. A total of 1,080 patients had ≥1 Hb measurement during treatment. The incidence of anemia was 50% in the BOC arms combined (363/726) and 31% in the PR48 arm (108/354, P < 0.001). Among BOC recipients, lower baseline Hb and creatinine clearance were associated with incident anemia. In the BOC-containing arms, anemia was managed by the site investigators as follows: EPO without RBV dose reduction, 38%; RBV dose reduction without EPO, 8%; EPO with RBV dose reduction, 40%; and neither RBV dose reduction nor EPO, 14%. SVR rates were not significantly affected by management strategy (70%-74%), and overall patients with anemia had higher rates of SVR than those who did not develop anemia (58%). Serious and life-threatening adverse events (AEs) and discontinuations due to AEs among BOC-treated patients did not differ by EPO use. Conclusion: With BOC/PR therapy, SVR rates in patients with incident anemia were higher than nonanemic patients and did not vary significantly according to the investigator-selected approach for anemia management. Prospective studies are needed to confirm this observation. (HEPATOLOGY 2013)

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