| Release date: December 2008 Expiration date: December 31, 2009 Estimated time to complete activity: 1.5 hours |
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Activity Overview
A panel of experts was convened to provide their collective insights and interpretations of recently released data on a number of current topics relating to the treatment of patients with hepatitis C virus (HCV) infection. Points of discussion include rapid virologic response and treatment duration decisions, the role of maintenance therapy, options for nonresponding/relapsing patients, and the status and use of new antiviral drugs. This activity presents the panel’s debate-style discussion of a range of key clinical questions and features information that is relevant, new, and framed in a meaningful context.
Target Audience
This activity has been designed to meet the educational needs of physicians and other health care professionals involved in the care of patients with chronic HCV infection.
Learning Objectives
Upon completion of this activity, participants should be able to:
- List the predictors of treatment response and methods to optimize sustained virologic response
- Describe the advantages and limitations of long-term therapy with pegylated interferon + ribavirin
- Identify treatment strategies for relapsing or nonresponding patients
- Apply current and emerging clinical data to optimize treatment success
- Assess the clinical utility of HCV protease and polymerase inhibitors
John G. McHutchison, MD—Activity Chair View biography
Associate Director, Duke Clinical Research Institute
Director, GI/Hepatology Research Program
Professor of Medicine
Division of Gastroenterology
Duke University Medical Center
Durham, North Carolina
Nezam H. Afdhal, MD View biography
Associate Professor of Medicine
Harvard Medical School
Chief of Hepatology
Beth Israel Deaconess Medical Center
Boston, Massachusetts
Thomas Berg, MD View biography
Associate Director and Professor of Medicine
Charité, Campus Virchow-Clinic
Medical Department, Division of Hepatology and Gastroenterology
Charité University Medicine
Berlin, Germany
Kimberly A. Brown, MD View biography
Chief, Division of Gastroenterology and Hepatology
Henry Ford Hospital and Health System
Detroit, Michigan
Mitchell L. Shiffman, MD View biography
Chief, Hepatology Section
Medical Director, Liver Transplant Program
Virginia Commonwealth University Medical Center
Richmond, Virginia
Accreditation Statement
Curatio CME Institute is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.
Credit Designation
Curatio CME Institute designates this educational activity for a maximum of 1.5 AMA PRA Category 1 Credits™. Physicians should only claim credit commensurate with the extent of their participation in the activity.
Physicians should not claim credit for this activity if credit was previously claimed for the symposium on which this activity is based.
Method of Participation
There are no fees for participating in this CME activity. To receive credit during the period December 2008 to December 31, 2009, participants must (1) read the learning objectives and disclosure statements, (2) study the educational activity, (3) complete the posttest, and (4) complete the activity evaluation form, including the certificate information section.
To obtain a certificate, participants must receive a score of 70% or better on the posttest. The posttest can be accessed at the end of the activity. Please e-mail any questions to cmeinfo@curatiocme.com.
Medium
The Internet was selected as the instructional format to accommodate the learning preferences of a significant portion of the target audience.
Disclosure
In accordance with the ACCME’s Standards for Commercial Support, all CME providers are required to disclose to the activity audience the relevant financial relationships of everyone in a position to control content of an educational activity. A relevant financial relationship is a relationship in any amount occurring in the last 12 months with a commercial interest whose products or services are discussed in the CME activity content over which the individual has control. Relationship information appears below:
Nezam H. Afdhal, MD has disclosed the following relevant financial relationships:
| Research: | Bristol-Myers Squibb, Coley, Echosens, Gilead, GlaxoSmithKline, Idenix, Idun Pharmaceuticals, InterMune, Isis Pharmaceuticals, Novartis, Ortho Biotech, Prometheus, Quest, Salix Pharmaceuticals, Schering-Plough, United Therapeutics, Valeant Pharmaceuticals, Vertex |
| Consultant: | Arrow Pharmaceuticals, Atlas, BioCryst, Biogen, Echosens, Gilead, GlaxoSmithKline, Idenix, Idera Pharmaceuticals, InterMune, Isis Pharmaceuticals, Novartis, Ortho Biotech, Prometheus, Salix Pharmaceuticals, Schering-Plough, Sirtris, Stromedix, Valeant Pharmaceuticals, Vertex, Wyeth/ViroPharma, XTL Biopharmaceuticals Speakers Bureau Bristol-Myers Squibb, Gilead, Idenix/Novartis, Schering-Plough |
Thomas Berg, MD has disclosed the following relevant financial relationships:
| Consultant/Investigator: | Bristol-Myers Squibb, Essex Pharma, Gilead, GlaxoSmithKline, Novartis, Roche, Schering-Plough, Vertex |
| Speaker: | Bristol-Myers Squibb, Essex Pharma, Gilead, GlaxoSmithKline, Novartis, Roche, Schering-Plough, Vertex |
Kimberly A. Brown, MD has disclosed the following relevant financial relationships:
| Research: | Schering-Plough |
| Speaker: | Gilead, Roche, Schering-Plough |
John G. McHutchison, MD has disclosed the following relevant financial relationships:
| Grant/Research Support: | Abbott, Anadys Pharmaceuticals, Coley, DebloPharma, First Circle Medical, GlaxoSmithKline, GlobeImmune, Gilead, Human Genome Sciences, Idenix, Intarcia Therapeutics, Medtronics, Novartis, Pfizer, Pharmasset, Roche, Salix Pharmaceuticals, Sanofi-Aventis, Schering-Plough, Valeant Pharmaceuticals, Vertex, ViroChem, Wyeth |
| Consultant: | Abbott, Ambryx, Anadys Pharmaceuticals, Biole Therapeutics, Cerus, Coley, DebloPharma, Epiphany Biosciences, First Circle Medical, GlaxoSmithKline, Gilead, Human Genome Sciences, Idenix, Idera Pharmaceuticals, Implicit Bioscience, Intarcia Therapeutics, InterMune, National Genetics Institute, Novartis, Peregrine, Pfizer, Pharmasset, Roche, Schering-Plough, United Therapeutics, Valeant Pharmaceuticals, Vertex, ViroChem, Wyeth |
Mitchell L. Shiffman, MD has disclosed the following relevant financial relationships:
| Advisor: | Roche, Vertex |
| Grants: | Roche, Schering-Plough, Vertex |
| Speaker: | Roche, Schering-Plough |
Curatio CME Institute Staff
Barbara Bekiesz, Editor, has disclosed no relevant financial relationships.
Denise C. LaTemple, PhD, VP, Scientific Services, has disclosed no relevant financial relationships.
Jonathan S. Simmons, ELS, Managing Editor, has disclosed no relevant financial relationships.
Derek Warnick, CME Director, has disclosed no relevant financial relationships.
Disclaimer
The information presented in this activity is for continuing medical education purposes only and is not meant to substitute for the independent medical judgment of a physician regarding diagnosis and treatment of a specific patient’s medical condition.
Unapproved Product Use
This educational activity may contain discussion of published and/or investigational uses of agents that are not indicated by the US Food and Drug Administration. Curatio CME Institute and Schering-Plough do not recommend the use of any agent outside the labeled indications.
The opinions expressed in this educational activity are those of the faculty and do not necessarily represent the views of Curatio CME Institute or Schering-Plough. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications, and warnings.
| Generic Name | Trade Name | Approved Use (if any) | Unapproved/ Investigational Use |
| Boceprevir | N/A | N/A | Chronic HCV infection |
| Peginterferon alfa-2a | Pegasys® | Alone or in combination with Copegus® for treatment of adults with chronic HCV infection who have compensated liver disease and have not been previously treated with IFN-α |
|
| Peginterferon alfa-2b | PegIntron™ | Alone or in combination with Rebetol® for treatment of chronic HCV infection in adults with compensated liver disease who have not been previously treated with IFN-α |
|
| Ribavirin | Copegus®, Rebetol® | In combination with RBV for treatment of chronic HCV infection in patients with compensated liver disease who have not been previously treated with IFN-α |
|
| R1626 | N/A | N/A | In combination with PEG-IFN/RBV for treatment of chronic HCV infection |
| R7128 | N/A | N/A | In combination with PEG-IFN/RBV for treatment of chronic HCV infection |
| Telaprevir | N/A | N/A | In combination with PEG-IFN/RBV for treatment of chronic HCV infection |
Abbreviations List
| ALT | alanine aminotransferase |
| BMI | body mass index |
| Boc | boceprevir |
| BT | breakthrough |
| cEVR | complete EVR |
| CI | confidence interval |
| cIFN | consensus interferon |
| D/C | discontinuation |
| EOD | end of dosing |
| EOT | end of treatment |
| EVR | early virologic response |
| HCC | hepatocellular carcinoma |
| HCV | hepatitis C virus |
| HE | hepatic encephalopathy |
| Hgb | hemoglobin |
| HVL | high viral load |
| IC50 | 50% inhibitory concentration |
| IC90 | 90% inhibitory concentration |
| IFN | interferon |
| ITT | intent to treat |
| IU | international unit |
| LVL | low viral load |
| NNI | non-nucleoside inhibitor |
| NS | not significant |
| OR | odds ratio |
| PCR | polymerase chain reaction |
| PEG | pegylated |
| pEVR | partial EVR |
| PP | per protocol |
| RBV | ribavirin |
| RVR | rapid virologic response |
| STAT-C | specifically targeted antiviral therapy for HCV |
| SVR | sustained virologic response |
| Tmax | time to maximum concentration |
| TMA | transcription-mediated amplification |
| TVR | telaprevir |
| WT | wild type |
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