| Issue Date: January 23, 2001
Designed as teaching materials for presentations to clinicians who have an interest in the assessment, diagnosis, treatment, and ongoing management of patients with hepatitis C.
This slide kit was produced with an unrestricted educational grant from  as part of the Projects In Knowledge Education Initiative in Gastroenterology. |
A Letter From the Co-Chairs
Dear Colleague:
Treating hepatitis C virus (HCV) infection is more important than ever. The incidences of decompensated cirrhosis and hepatocellular carcinoma are increasing, as are the demand for liver transplants and liver-related mortality. Treatment, however, can alter the natural history of HCV infection, slowing, halting, and possibly even reversing progression to these serious complications. The latest addition to our treatment armamentarium, pegylated formulations of interferon, represents the latest advance in the treatment of HCV infection. Peginterferon offers expanded efficacy and convenience compared with standard interferon, and in combination with ribavirin is expected to be the next standard of care. By applying and building on what we already know to promote adherence to new treatment regimens with pegylated interferons, we can expect even better treatment outcomes.
Projects In Knowledge has developed this slide kit for you to use in any lectures or presentations you may give, or for other professional activities for which it may be useful. Its purpose is to help you educate clinicians about the clinical issues and recommended approaches to care for HCV-infected patients. This kit, with accompanying lecture notes, will provide you with practical strategies for optimizing outcomes by individualizing patient care.
We hope that you find this slide kit a valuable aid in your work to educate the medical community about vital issues on treatment of HCV infection and to show clinicians the practical steps they may take to help their HCV-infected patients.
Sincerely,
 |
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| Eugene R. Schiff, MD |
Willis C. Maddrey, MD |
| Co-Chair |
Co-Chair |
Co-Chairs
Willis C. Maddrey, MD
Executive Vice President for Clinical Affairs
Professor of Internal Medicine
University of Texas
Southwestern Medical Center at Dallas
Dallas, Texas |
Eugene R. Schiff, MD
Professor of Medicine
Chief, Division of Hepatology
Director, Center for Liver Diseases
University of Miami School of Medicine
Miami, Florida |
| Faculty |
|
Nezam H. Afdhal, MD
Associate Professor of Medicine
Harvard Medical School
Chief of Hepatology
Beth Israel Deaconess Medical Center
Boston, Massachusetts |
Karen L. Lindsay, MD
Associate Professor of Clinical Medicine
Gastrointestinal and Liver Diseases
Keck School of Medicine
University of Southern California
Los Angeles, California |
Ira M. Jacobson, MD
Vincent Astor Professor
of Clinical Medicine
Chief, Division of Gastroenterology
and Hepatology
Weill Medical College
of Cornell University
New York Weill-Cornell Medical Center
New York, New York |
Bruce A. Luxon, MD, PhD
Associate Professor of Medicine
St Louis University School of Medicine
St Louis, Missouri
John G. McHutchison, MD
Medical Director, Liver Transplantation
Division of Gastroenterology/Hepatology
Scripps Clinic and Research Foundation
La Jolla, California |
Disclosure Information
This material was produced in accordance with the ACCME Essentials and Standards for Commercial Support. This kit may be used in the context of a CME activity only if it is sponsored by Projects In Knowledge, an ACCME-accredited provider of CME.
The Disclosure Policy of Projects In Knowledge requires that faculty participating in a CME activity disclose to the activity audience any significant relationship they may have with a pharmaceutical or medical equipment company, product, or service that may be mentioned as part of their presentation, as well as any relationship with the commercial supporter of this activity.
This slide kit was produced with the support of an unrestricted educational grant from Schering Hepatitis Innovations.
This material may include a discussion of therapies that are unapproved for use or investigational, ongoing research, or preliminary data.
The opinions expressed within this slide kit are those of the faculty and do not necessarily reflect those of the sponsor or the commercial supporter.
Nezam H. Afdhal, MD, has received grant/research support from Diacrin, Gilead Sciences, Roche Pharmaceuticals, and Schering Corporation; has been a member of the speakers bureaus for Astra Pharmaceuticals LP, Roche Pharmaceuticals, and Schering Corporation; and has been a consultant for Diacrin.
Ira M. Jacobson, MD, has received grant/research support from Gilead Sciences, Glaxo Wellcome Inc, and Schering Corporation; and has been a member of the speakers bureaus for Glaxo Wellcome Inc and Schering Corporation.
Karen L. Lindsay, MD, has received grant/research support from Glaxo Wellcome Inc, Hoffmann-LaRoche, and Schering-Plough Corporation; and has been a consultant for Amgen Inc and Glaxo Wellcome Inc.
Bruce A. Luxon, MD, PhD, has indicated no significant relationships.
Willis C. Maddrey, MD, has been a consultant for Amgen Inc, Glaxo Wellcome Inc, Eli Lilly and Company, Ribozyme Pharmaceuticals Inc, and Schering Laboratories.
John G. McHutchison, MD, has received grant/research support from and/or has been a consultant for Amgen Inc, Bristol-Myers Squibb, ISIS Pharmaceuticals, National Genetics Institute, Ribozyme Pharmaceuticals Inc, and Schering Laboratories; and has been a member of the speakers bureaus for Amgen Inc, Chiron Corporation, and Schering Laboratories.
Eugene R. Schiff, MD, has received grant/research support from Glaxo Wellcome Inc, Schering Laboratories, and SmithKline Beecham Pharmaceuticals; has been a consultant for Amgen Inc, Gilead Sciences, Glaxo Wellcome Inc, Medeva Pharmaceuticals Inc, National Genetics Institute, Ortho-McNeil Pharmaceutical Inc, Roche Diagnostics, Schering Laboratories, and SciClone Pharmaceuticals; and has been a member of the speakers bureaus for Amgen Inc, Astra Merck Inc, Glaxo Wellcome Inc, and Schering Laboratories.
Technical Requirements
| PC: |
Requires Microsoft® Powerpoint® 97 or later. |
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| MacOS: |
Requires Microsoft® Powerpoint® 98 or later. |
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Suggested Readings
| 1. |
Davis GL, Albright JE, Cook S, Rosenberg D. Projecting the future healthcare burden from hepatitis C in the United States. Hepatology. 1998;28:390A. |
| 2. |
Sobesky R, Mathurin P, Charlotte F, et al. Modeling the impact of interferon alfa treatment on liver fibrosis progression in chronic hepatitis C: a dynamic view. The MULTIVIRC Group. Gastroenterology. 1999;116:378-386. |
| 3. |
Wong JB, Koff RS. Watchful waiting with periodic liver biopsy versus immediate empirical therapy for histologically mild chronic hepatitis C. Ann Intern Med. 2000;133:665-675. |
| 4. |
Manns MP, McHutchison JG, Gordon S, et al. Peginterferon alfa-2b plus ribavirin compared to interferon alfa-2b plus ribavirin for the treatment of chronic hepatitis C: 24-week treatment analysis of a multicenter, multinational phase III randomized controlled trial [abstract 552]. Presented at: 51st annual meeting of AASLD; October 27-31, 2000; Dallas, Tex. |
| 5. |
McHutchison JG, Gordon SC, Schiff ER, et al. Interferon alfa-2b alone or in combination with ribavirin as initial treatment for chronic hepatitis C. International Hepatitis Interventional Therapy Group. N Engl J Med. 1998;339:1485-1492. |
| 6. |
Poynard T, Marcellin P, Lee SS, et al. Randomised trial of interferon a 2b plus ribavirin for 48 weeks or for 24 weeks versus interferon a 2b plus placebo for 48 weeks for treatment of chronic infection with hepatitis C virus. International Hepatitis Interventional Therapy Group. Lancet. 1998;352:1426-1432. |
| 7. |
Davis GL, Esteban-Mur R, Rustgi V, et al. 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. 1998;339:1493-1499. |
| 8. |
Bacon BR, Rauscher JA, Smith-Wilkaitis NL, Koehler KM. Interferon-ribavirin combination: sustained response in previous interferon monotherapy nonresponders. Hepatology. 1999;30:372A. |
| 9. |
Bacon BR, Rauscher JA, Smith-Wilkaitis NL, Koehler KM, Antal MJ, Di Bisceglie AM. Interferon-ribavirin combination: 24 vs. 48 weeks of treatment in previous monotherapy nonresponders. Presented at: Schering Rebetron Investigators Meeting; February 10-13, 2000; Fort Lauderdale, Fla. |
| 10. |
McHutchison JG, Poynard T. Combination therapy with interferon plus ribavirin for the initial treatment of chronic hepatitis C. Semin Liver Dis. 1999;19(suppl 1):57-65. |
| 11. |
Poynard T, McHutchison J, Goodman Z, Ling M-H, Albrecht J, for the ALGOVIRC Projects Group. Is an "à la carte" combination interferon alfa-2b plus ribavirin regimen possible for the first-line treatment in patients with chronic hepatitis C? Hepatology. 2000;31:211-218. |
| 12. |
McHutchison JG. The effect of dose reduction on sustained response in patients with chronic hepatitis C receiving interferon alfa-2b in combination with ribavirin [abstract 247]. Presented at: 51st annual meeting of AASLD; October 27-31, 2000; Dallas, Tex. |
| 13. |
Physician’s Desk Reference, 55th ed. Montvale, NJ: Medical Economics Company; 2001. |
| 14. |
Glue P, Fang J, Sabo R, et al. Peg-interferon-a -2b: pharmacokinetics, pharmacodynamics, safety and preliminary efficacy data [abstract 116]. Hepatology. 1999;30(suppl 4):189A. |
| 15. |
Glue P, Rouzier-Panis R, Raffanel C, et al. A dose-ranging study of pegylated interferon alfa-2b and ribavirin in chronic hepatitis C. Hepatitis C Interventional Therapy Group. Hepatology. 2000;32:647-653. |
| 16. |
Modi MW, Fried M, Reindollar RW, et al. The pharmacokinetic behavior of pegylated (40KDA) interferon alfa-2a (PEGASYSTM) in chronic hepatitis C patients after multiple dosing [abstract 939]. Presented at: 51st annual meeting of AASLD; October 27-31, 2000; Dallas, Tex. |
| 17. |
Algranati NE, Sy S, Modi M. A branched methoxy 40 kDa polyethylene glycol (PEG) moiety optimizes the pharmacokinetics (PK) of peginterferon a -2a (PEG-IFN) and may explain its enhanced efficacy in chronic hepatitis C (CHC) [abstract 120]. Hepatology. 1999;30:190A. |
| 18. |
Xu Z-X, Hoffman J, Patel I, Joubert P. Single-dose safety/tolerability and pharmacokinetic/pharmacodynamics (PK/PD) following administration of ascending doses of pegylated interferon (PEG-IFN) and interferon a -2a to healthy subjects [abstract 2157]. Hepatology. 1998;28;702A. |
| 19. |
Modi MW, Fulton JS, Buckmann DK, Wright TL, Moore DJ. Clearance of pegylated (40 kDa) interferon alfa-2a (PEGASYS®) is primarily hepatic [poster presentation]. Presented at: 51st annual meeting of AASLD; October 27-31, 2000; Dallas, Tex. |
| 20. |
Heathcote EJ, Shiffman ML, Cooksley GE, et al. Peginterferon alfa-2a in patients with chronic hepatitis C and cirrhosis. N Engl J Med. 2000;343:1673-1680. |
| 21. |
Martin P, Mitra S, Farrington K, Martin NE, Modi MW. The pharmacokinetics of pegylated (40 kDa) interferon alfa-2a (PEGASYS®) are unaffected by renal impairment [poster presentation]. Presented at: 51st annual meeting of AASLD; October 27-31, 2000; Dallas, Tex. |
| 22. |
Trepo C, Lindsay K, Niederau C, et al. Pegylated interferon alfa-2b (PEG-INTRON) monotherapy is superior to interferon alfa-2b (INTRON A) for the treatment of chronic hepatitis C [abstract GS2/07]. J Hepatol. 2000;32(suppl 2):29. |
| 23. |
Zeuzem S, Feinman SV, Rasenack J, et al. Peginterferon alfa-2a in patients with chronic hepatitis C. N Engl J Med. 2000;343:1666-1672. |
| 24. |
Lee SS, Heathcote EJ, Reddy R, et al. Prognostic factors and early predictability of sustained viral response (SVR) in patients treated with pegylated (40 kDa) interferon alfa-2a (PEGASYSTM): a new profile [abstract 843]. Presented at: 51st annual meeting of AASLD; October 27-31, 2000; Dallas, Tex. |
| 25. |
Neumann AU, Zeuzem S, Brunda MJ. Rapid viral response to treatment with pegylated (40kDa) interferon alfa-2a (PEGASYSTM) is strongly predictive of a sustained virologic response in patients with chronic hepatitis C (CHC) [abstract 633]. Presented at: 51st annual meeting of AASLD; October 27-31, 2000; Dallas, Tex. |
| 26. |
Sulkowski MS, Reindollar R, Yu J. Pegylated interferon alfa-2a (PEGASYSTM) and ribavirin combination therapy for chronic hepatitis C: a phase II open-label study. Presented at: Digestive Disease Week; May 20-23, 2000; San Diego, Calif. |
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