Who Moved My PEG? The Changing Future of Anti-HCV Therapy

FACULTY
Nezam H. Afdhal, MD
Chief of Hepatology
Director, Liver Center
Beth Israel Deaconess
   Medical Center
Boston, Massachusetts

Hashem B. El-Serag, MD, MPH
Associate Professor of Medicine
Department of Medicine
Michael E. DeBakey VA
   Medical Center and
   Baylor College of Medicine
Houston, Texas

Mark S. Sulkowski, MD
Associate Professor of Medicine
Medical Director, Viral Hepatitis
   Center
Johns Hopkins University
   School of Medicine
Division of Infectious Disease
Baltimore, Maryland

PROGRAM OVERVIEW

The story of anti-hepatitis C virus (HCV) therapy began in 1997 when interferon alfa-2a and -2b were approved for the treatment of HCV. The next year, Spencer Johnson, MD, published his parable about change, Who Moved My Cheese? The book's timing was fortuitous because change, as both a directive and a descriptor, would apply to the next 10 or more years of anti-HCV therapy. In 1998, the combination of ribavirin and interferon was approved. In 2001 and 2002, standard interferon gave way to newly approved peginterferon alfa-2b and -2a, respectively, as the approved standard of care in combination with ribavirin.

Since that time, researchers, not willing to lay aside the quest for greater efficacy, have continued to study adjustments of constituent doses, alternative interferons, alternative ribavirins, predictors of success, and strategies to manage toxicity. Abstract books from national and international liver meetings pour forth evidence of changing hypotheses, new data, and more finely nuanced conclusions. Novel therapies now emerging under the banner of change include specifically targeted antiviral therapy for HCV (STAT-C). STAT-C agents in phase II testing—boceprevir (SCH 503034), telaprevir, and valopicitabine—represent a bold contrast to the immunomodulatory action of current interferon-based therapies.

This webcast is a replay of the live satellite symposium, held on May 20, and will examine the future direction of anti-HCV therapy and help clinicians embrace the changes ahead. _______________________________________

ACTIVITY AGENDA

Introduction
Eugene R. Schiff, MD (Chair)

The Handwriting on the Wall: The Increasing Challenge of HCV Disease Burden
Hashem B. El-Serag, MD, MPH

Reality Check: Assessing the Present to Anticipate the Future
Nezam H. Afdhal, MD

Finding Our Way in the Maze: Changing Direction Toward More Effective Treatment
Mark S. Sulkowski, MD

Q & A
Faculty Panel

Conclusion
Eugene R. Schiff, MD

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TARGET AUDIENCE

This CME activity is designed for gastroenterologists and other clinicians who treat patients with HCV infection.

ACTIVITY GOAL

The goal of Who Moved My PEG? The Changing Future of Anti-HCV Therapy is to provide state-of-the-art, clinically relevant information that will provide clinicians with new insights into HCV epidemiology and disease burden imposed by chronic HCV; role of HCV in the development of HCC; goals for treatment success; methods for minimizing resistance in HCV as compared with HIV and HBV; current and emerging approaches to anti-HCV therapy, including STAT-C (protease and polymerase inhibitors), and the potential role that these agents may play in the future.

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LEARNING OBJECTIVES

• Integrate knowledge of disease burden imposed
by chronic HCV to determine the importance of intervention that minimizes the sequelae, including HCC, of chronic HCV.

• Utilizing an understanding of the parameters for anti-HCV treatment success, assess viral load, liver function tests, and liver fibrosis/inflammation in considering treatment strategies that may improve outcomes.

• Differentiate potential efficacy and safety considerations of protease and polymerase inhibitors, based on preliminary data, as therapeutic options in the treatment of patients with HCV infection in the future.

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CME INFORMATION—PHYSICIANS

Statement of Accreditation
Projects In Knowledge is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.

Credit Designation
Projects In Knowledge designates this educational activity for a maximum of 1.5 AMA PRA Category 1 Credits^TM. Physicians should only claim credit commensurate with the extent of their participation in the activity.

Contract for Mutual Responsibility in CME
Projects In Knowledge has developed the contract to demonstrate our commitment to providing the highest quality professional education to clinicians, and to help clinicians set educational goals to challenge and enhance their learning experience.
For more information on the contract, click here.

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DISCLOSURE INFORMATION
The Disclosure Policy of Projects In Knowledge requires that presenters comply with the Standards for Commercial Support. All faculty are required to disclose any personal interest or relationship they or their spouse/partner have with the supporters of this activity or any commercial interest that is discussed in their presentation. Any discussions of unlabeled/unapproved uses of drugs or devices will also be disclosed in the course materials.
For complete prescribing information on the products discussed during this CME activity, please see your current Physicians' Desk Reference (PDR).

Nezam H. Afdhal, MD, has received research support from Bristol-Myers Squibb, Coley Pharmaceutical Group, EchoSens, Gilead Sciences, Inc, GlaxoSmithKline, Idenix Pharmaceuticals, Idun Pharmaceuticals, Inc, InterMune Inc, Isis Pharmaceuticals, Inc, Novartis Pharmaceuticals Corporation, Ortho Biotech Products, LP, Prometheus Laboratories, Inc, Quest Pharmaceutical Services, Salix Pharmaceuticals, Inc, Schering-Plough Corporation, United Therapeutics, Valeant Pharmaceuticals International, and Vertex Pharmaceuticals Incorporated; is a consultant for Arrow Pharmaceuticals, Atlas Pharmaceuticals, BioCryst Pharmaceuticals, Inc, Biogen Idec, EchoSens, Gilead Sciences, Inc, GlaxoSmithKline, Idenix Pharmaceuticals, Idera Pharmaceuticals, Inc, InterMune Inc, Isis Pharmaceuticals, Inc, Novartis Pharmaceuticals Corporation, Ortho Biotech Products, LP, Prometheus Laboratories, Inc, Salix Pharmaceuticals, Inc, Schering-Plough Corporation, Sirtris Pharmaceuticals, Stromedix, Inc, Valeant Pharmaceuticals International, Vertex Pharmaceuticals Incorporated, ViroPharma Incorporated, Wyeth Pharmaceuticals, and XTL Biopharmaceuticals Ltd; and is on the speakers bureaus of Bristol-Myers Squibb, Gilead Sciences, Inc, Idenix Pharmaceuticals, Novartis Pharmaceuticals Corporation, and Schering-Plough Corporation. Dr. Afdhal has disclosed that he will reference unlabeled/unapproved uses of consensus interferon in non-responders, PEG-IFN as maintenance therapy, and ribavirin in higher than approved doses.

Hashem B. El-Serag, MD, MPH, has received research support from Schering-Plough Corporation and is a consultant for Vertex Pharmaceuticals Incorporated. Dr. El-Serag will not reference unlabeled/unapproved use of drugs or devices.

Eugene R. Schiff, MD, has received grant/research support from Abbott Laboratories, Bayer Pharmaceuticals Corporation, Bristol-Myers Squibb, Coley Pharmaceutical Group, Gilead Sciences, Inc, GlaxoSmithKline, Idenix Pharmaceuticals Inc, Ortho Biotech Products, LP, Prometheus Laboratories Inc, Roche Diagnostics, Roche Molecular Systems, Roche Pharmaceuticals, Schering-Plough Corporation, SciClone Pharmaceuticals, and Vertex Pharmaceuticals Incorporated; is a consultant for Abbott Laboratories, Achillion Pharmaceuticals, Bayer Pharmaceuticals Corporation, Bristol-Myers Squibb, Cadence Pharmaceuticals, Gilead Sciences, Inc, GlaxoSmithKline, GlobeImmune, Inc, Idenix Pharmaceuticals Inc, Novartis Pharmaceuticals Corporation, Ortho Biotech Products, LP, Pfizer Inc, Pharmasset, Inc, Prometheus Laboratories Inc, Roche Molecular Systems, Salix Pharmaceuticals, Inc, Schering-Plough Corporation, and SciClone Pharmaceuticals; and is on the speakers bureau of Gilead Sciences, Inc, Ortho Biotech Products, LP, and Schering-Plough Corporation.

Mark S. Sulkowski, MD, has received grant/research support from Bristol-Myers Squibb, Human Genome Sciences, Idenix Pharmaceuticals, Roche Laboratories, Schering-Plough Corporation, Valeant Pharmaceuticals International, and Vertex Pharmaceuticals Incorporated; and is on the scientific advisory boards of Bristol-Myers Squibb, Human Genome Sciences, Idenix Pharmaceuticals, Merck & Co, Inc, Roche Laboratories, Schering-Plough Corporation and Vertex Pharmaceuticals Incorporated. Dr Sulkowski has disclosed that he will reference uses of currently marketed agents: ritonavir, and investigational agents: boceprevir, HCV-796, R1626, telaprevir, and valopicitabine.

Peer Reviewer has disclosed no significant relationships.

Projects In Knowledge's staff members have no significant relationships to disclose.

Conflicts of interest are thoroughly vetted by the Executive Committee of Projects In Knowledge. All conflicts are resolved prior to the beginning of the activity by the Trust In Knowledge peer review process.

The opinions expressed in this activity are those of the faculty and do not necessarily reflect those of Projects In Knowledge.

This CME activity is provided by Projects In Knowledge solely as an educational service. Specific patient care decisions are the responsibility of the clinician caring for the patient.

This independent CME activity is supported by an educational grant from Vertex Pharmaceuticals Incorporated.

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