Needs Assessment
Chronic hepatitis B (CHB) remains a global health problem, with 400 million chronically infected worldwide. Determining what constitutes best practice for patient management in chronic hepatitis B (CHB) is challenging and requires a clear understanding of current treatment strategies and the most appropriate therapeutic endpoints with which to measure clinical success. Furthermore, physicians treating patients with CHB must have a complete appreciation of the risk:benefit relationship for each therapeutic option. In recent years, the number of available treatment options for chronic hepatitis B has increased considerably. The advent of newer immune-based and/or antiviral therapies is paving the way towards improved clinical outcomes in patients with HBeAg-positive and HBeAg-negative chronic hepatitis B. However, identifying patients who will respond to therapy, rationalizing therapy choices and monitoring therapeutic endpoints for particular treatment strategies are therefore crucial for effective CHB disease management.

With new data being reported especially relating to the long-term outcomes of therapy It is important that physicians are armed with the information they need to make the best treatment choices to improve disease management and outcomes for patients with CHB.

Target Audience
These slide presentations are primarily aimed to assist physicians and physicians-in-training specializing in internal medicine, infectious disease, gastroenterology and hepatology.

Learning objectives
An expert faculty was assembled to present both clinical research and practical information on the latest advances in the treatment of patients with chronic hepatitis B. The purpose of this course is to take you through the evaluation of recent clinical evidence on approved and investigational therapies in the context of treatment decisions you are faced with in everyday clinical practice. This will strengthen your understanding of treatment options and help ultimately to improve patients’ outcomes. On completion of the slide presentations you will be able to understand the following:

• The clinical differences between HBeAg-positive and HBeAg-negative chronic hepatitis B and the most appropriate treatment endpoints for each; including those endpoints most important for long-term clinical success
• The rationale for the use of interferon-based or nucleos(t)ide analog therapies in chronic hepatitis B, their mechanism of action and the outcomes of anti-HBV therapy
• The relationship between the immune response and viral clearance (acute vs chronic infection), the role of the immune system in response to therapy and the effect of anti-HBV treatments on the immune response
• The impact of new data, including longer-term follow-up data and how this evidence may improve treatment outcomes and disease management
• Which patients might respond best in HBeAgpositive and HBeAg-negative disease
• How to optimize patient management through finite vs maintenance therapy.

Course contents and user instructions
This course includes five PowerPoint slide presentations from the CME-certified symposium held on the 13th November 2005 at the San Francisco Marriott

• Presentation 1: Michael W Fried, MD - Introduction
• Presentation 2: Marion Peters, MD - Assessing treatment success – which endpoints are most clinically relevant in the long term?
• Presentation 3: Graham Cooksley, MD - Outcomes of anti-HBV therapy – immune-based therapies vs direct Antivirals by
• Presentation 4: Patrick Marcellin - Is the natural history of CHB altered with anti-HBV therapy?
• Presentation 5: Robert Perrillo, MD and Jenny Heathcote, MD - Finite vs maintenance therapy – where do you start?
• Hepatitis B Question Sheet, posttest and Evaluation - Once you have reviewed all the slides you can print off and complete the evaluation and the posttest to obtain CME credits.

To undertake this self-study course you will need to review all five of the PowerPoint presentations. You can do this by simply clicking on the PowerPoint file and you will be given the choice to open the file from its current location or save it to your desktop. It is advisable to review these presentations in the correct order. Once you have reviewed all the slides you can print off and complete the evaluation and the posttest to obtain CME credits, further instructions on the completion of these forms are below.

Accreditation
The Center for Bio-Medical Communication, Inc. (CBC) is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. This CME activity was planned and produced in accordance with ACCME essentials.

CME Credit
CBC designates this educational activity for a maximum of 1.5 Category 1 credits towards the AMA Physician’s Recognition Award. Each physician should claim only those hours of credit that he/she actually spent in the educational activity. The American Medical Association has determined that physicians not licensed in the US who participate in this CME activity are eligible for AMA PRA category 1 credit.

Instructions for CME Credit
The pdf posttest available on this site provides the opportunity to assess your knowledge and understanding of the material presented in the course.

To obtain 1.5 Category 1 CME credits, you must:

• Provide the requested personal information
• Complete CME Posttest by circling the correct responses on the answer sheet
• Answer the program evaluation questions
• Sign the posttest and evaluation form
• Keep a copy and mail or fax the answer sheet/evaluation form to the Center for Bio-Medical Communication (see contact below).
• Please ensure that all personal details on the PDF form are completed correctly and legibly.

Center for Bio-Medical Communication, Inc.
Attn: Hepatitis B Posttest
433 Hackensack Avenue, 9th Floor
Hackensack, NJ 07601
Phone: (+1) 201-342-5300
Fax: (+1) 201-342-7555

Tests will be graded and, in approximately 6 weeks, a CME certificate will be mailed to each participant who achieved a score of 70% or greater.

Disclosure
Disclosure is requested when faculty members are confirmed. This educational activity may include discussion of an unlabeled use or an investigative use not yet approved for a commercial product. Therefore, it is incumbent on individuals participating in this activity to be aware of these factors in interpreting its contents and evaluating its recommendations. Every effort has been made to encourage faculty to disclose any commercial relationships or personal benefits that may be associated with their participation in this activity. The following indicates the faculty and the nature of their commercial relationships and offlabel or investigative use discussion.

As part of CBC’s mechanism for resolving potential conflicts of interest, the contents of this activity have undergone peer review by an independent CME reviewer.

Michael W Fried, MD
Grant/Research Support – GlaxoSmithKline, Roche, Idenix, Valeant Pharmaceuticals
Consultant – Roche, Idenix
Scientific Advisor – Idenix
Speakers Bureau – Roche, Idenix, Valeant Pharmaceuticals

Marion Peters, MD
Grant/Research Support – Gilead Sciences, Roche
Consultant – Roche, Bristol-Myers Squibb, Idenix
Scientific Advisor – Imedoptions
Speakers Bureau – Roche, Bristol-Myers Squibb, Gilead Sciences, Schering-Plough

Graham Cooksley, MD
Grant/Research Support – Roche, GlaxoSmithKline, Gilead Sciences, Schering-Plough, Bristol-Myers Squibb
Scientific Advisor – Roche
Speakers Bureau – Roche

Patrick Marcellin, MD
Grant/Research Support – Bayer, Bristol-Myers Squibb, Gilead Sciences, GlaxoSmithKline, Human Genome Sciences, Idenix Novartis, Maxim Pharmaceuticals, Roche, Schering-Plough, Valeant Pharmaceuticals, Vertex Pharmaceuticals
Scientific Advisor – Bristol-Myers Squibb, Chiesi Pharmaceuticals, Gilead Sciences, GlaxoSmithKline, Human Genome Sciences, Idenix-Novartis, Roche, Schering-Plough, Valeant Pharmaceuticals, Vertex Pharmaceuticals
Speakers Bureau – Bayer, Bristol-Myers Squibb, Gilead Sciences, GlaxoSmithKline, Roche, Schering-Plough

Jenny Heathcote, MD
Grant/Research Support – Gilead Sciences, GlaxoSmithKline, Roche
Scientific Advisor – Roche, Gilead Sciences
Speakers Bureau – Roche

Robert Perrillo, MD
Grant/Research Support – Roche, Schering-Plough
Scientific Advisor – GlaxoSmithKline, Roche, Valeant Pharmaceuticals

Off-Label Product Discussion
The following faculty members have disclosed that they may/will discuss unlabeled or investigative use of a commercial product: Graham Cooksley, MD; Robert Perrillo, MD.

Disclaimer
This CD-ROM is designed to be a permanent record of the CME-certified satellite symposium ‘Treating Chronic Hepatitis B in Practice Increasing Options: Improving Outcomes’, presented on the 13th November 2005 at the San Francisco Marriott. The symposium content draws on currently available treatment guidelines and new data to discuss current treatment options for chronic hepatitis B. The symposium content is for guidance only.

The views expressed in this CD-ROM reflect the knowledge and experience of the faculty and are not necessarily those of the grant provider (Roche) or the CME provider (CBC).

Validity
Release date: 01 December 2005
Expiration date: 31 December 2006

Acknowledgement
This CD-ROM is supported by an unrestricted educational grant from Roche

Faculty

Presenters:

Michael W Fried, MD
Professor of Medicine
Director of Hepatology
Division of Gastroenterology and Hepatology
University of North Carolina, Chapel Hill, USA

Marion Peters, MD
Professor of Medicine
Chief of Hepatology Research
Division of Gastroenterology
University of California,
San Francisco, USA

Graham Cooksley, MD
Professorial Research Fellow
Department of Medicine
University of Queensland
Royal Brisbane Hospital,
Brisbane, Australia

Patrick Marcellin, MD
Professor of Medicine
Head of the Viral Hepatitis Research Center
University of Paris
Service d’Hépatologie and INSERM CRB3
Hôpital Beaujon, Clichy, France

Jenny Heathcote, MD
Professor of Medicine
Head of the Clinical Studies Resource Center
Toronto Western Hospital
University Health Network, Toronto, Canada

Robert Perrillo, MD
Professor of Medicine
Director of Academic Affairs
Section of Gastroenterology
Ochsner Clinic Foundation
New Orleans, USA

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