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Treatment for Hepatitis C Virus Infection in Adults: Comparative Effectiveness

• CME Information
• Faculty Biographies & Disclosures
• References
• Course Presentations
• CME Posttest

CME Information

Course Overview Educational Objectives Target Audience Method of Participation

Accreditation Statement Term of Approval Peer Review Program Director

Disclaimer Disclosure Acknowledgement of Support

Course Overview

About 78 percent of patients with acute hepatitis C virus (HCV) infection develop chronic HCV infection. Chronic HCV infection has a variable course and can result in complications of the liver including cirrhosis, liver failure, and hepatocellular cancer. The goals of treating chronic HCV infection are to prevent long-term health complications and death. In the early 2000s, the combination of either pegylated interferon alfa-2a or alpha-2b with ribarvirin became the standard antiviral treatment for HCV infection. Both combinations are associated with a high rate of adverse effects. In 2011, the U.S. Food and Drug Administration (FDA) approved the first direct-acting antiviral agents, boceprevir and telaprevir, for treating chronic HCV genotype 1 infection. Each drug is administered in combination with pegylated interferon (alfa-2a or alfa-2b) plus ribavirin. Understanding the comparative benefits and harms of dual and triple therapy antiviral regimens is critical for making informed treatment decisions.

This CME activity covers the systematic review and meta analysis of the current clinical literature, conducted by the Oregon Evidence-based Practice Center, to evaluate the evidence about the comparative effectiveness, safety and tolerability of currently available therapies for chronic hepatitis C infection in adults.

Educational Objectives

At the conclusion of this activity, the participant should be able to:

• Summarize the evidence regarding the relative benefits and adverse effects of treating patients with chronic hepatitis C infection using a triple therapy regimen (telaprevir or boceprevir plus ribavirin plus pegylated interferon alfa [2a or 2b]) versus a dual therapy regimen (ribavirin plus pegylated interferon alfa [2a or 2b]).
• Identify the limitations and knowledge gaps in the current evidence regarding the relative benefits and adverse effects of dual and triple therapy regimens for patients with chronic hepatitis C infection.
• Identify the limitations and knowledge gaps in the current evidence regarding the relative benefits and adverse effects of dual and triple therapy regimens for patients with chronic hepatitis C infection.
• Identify the limitations and knowledge gaps in the current evidence regarding the relative benefits and adverse effects of dual and triple therapy regimens for patients with chronic hepatitis C infection.

Target Audience

This CME activity is designed to meet the educational needs of hepatologists, gastroenterologists, primary care physicians, and other healthcare professionals who treat patients with hepatitis C infection.

Method of Participation

This activity is in PowerPoint file format and is accompanied by talking points and references linked to PubMed abstracts.

To receive a maximum of 1.0 AMA PRA Category 1 Credit(s)™ you should:

• View the presentations in this enduring material.
• Complete the posttest (you must answer 8 out of 10 questions correctly).
• Complete and submit the CME registration and evaluation forms.

The estimated time to complete this activity, including review of the materials, is 1.0 hour(s).

Hardware/software requirements: Activities should be run with recent versions of common browsers, including Internet Explorer, Firefox, and Google Chrome.

If you have questions about the participation process, please e-mail the Office of Continuing Medical Education, cme@bcm.edu or phone 713.798.8237.

Accreditation/Credit Designation

Baylor College of Medicine is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.

Baylor College of Medicine designates this enduring material activity for a maximum of 1.0 AMA PRA Category 1 Credit(s)™.  Physicians should claim only the credit commensurate with the extent of their participation in the activity.    

Term of Approval

November 2012 through November 2015. Original release date: November 2012

Peer Review

In August 2012, this continuing medical education online enduring material was reviewed by Hashem El-Serag, MD, MPH, Professor of Medicine – Gastroenterology, Baylor College of Medicine, Michael E. DeBakey VA Medical Center, Houston, Texas. To ensure the continued scientific relevance of this enduring material, its content will be reviewed again in November 2015.

Disclosures: Nothing to disclose.

Program Director

Michael Fordis, MD
Sr. Associate Dean
Director, Center for Collaborative and Interactive Technologies
Director, John M. Eisenberg Center for Clinical Decisions and Communications Science
Baylor College of Medicine
Houston, Texas

Disclosures: Nothing to disclose.

Disclaimer

This CME activity is designed for use by healthcare professionals for educational purposes only. Information and opinion offered by the contributors represent their viewpoints. Conclusions drawn by the participant should be derived from careful consideration of all available scientific information. Prescription information and use of medical devices should be undertaken only after confirmation of information by consulting the FDA-approved uses and information.

Baylor College of Medicine makes every effort to have accurate information presented, no warranty, expressed or implied, is offered. The participant should use his/her clinical judgment, knowledge, experience, and diagnostic decision-making before applying any information, whether provided here or by others, for any professional use.

Links are provided to other Internet sites solely for the convenience of users. Once you link to another site, you are subject to the site's terms and conditions of use including copyright and licensing restrictions.

Disclosure

The Office of Continuing Medical Education (OCME) makes every effort to develop CME activities that are scientifically based, accurate, current, and objectively presented. In accordance with the Accreditation Council for Continuing Medical Education Standards for Commercial Support ^SM, Baylor College of Medicine (BCM) has implemented a mechanism requiring everyone in a position to control the content of an educational activity (e.g., directors, planning committee members, contributors, peer reviewers) to disclose any relevant financial relationships with commercial interests (drug/device companies) and manage/resolve any conflicts of interest prior to the activity. Individuals must disclose to participants the existence or non-existence of financial relationships: l) at the time of the activity or within 12 months prior; and 2) of their spouses/partners.

Baylor College of Medicine does not view the existence of interests or relationships with commercial entities as implying bias or decreasing the value of a presentation. It is up to the participants to determine whether the interests or relationships influence the presenter with regard to exposition or conclusions.

If at any time during this activity you feel that there has been commercial or promotional bias, please inform us by using the commercial bias comments box in the evaluation form. Please answer the questions about balance in the CME activity evaluation candidly.

The following individual(s) has/have reported financial or other relationship(s) with commercial entities whose products/services may relate to the educational content of this activity:

Roger Chou, MD, Reviewer: Non-public support of research – Agency for Healthcare Research and Quality
Stephen C. Pappas, MD, JD, Contributor: Consultant and member of Scientific Oversight Committee, Roche Genentech; Clinical Development and Regulatory Consultant, Abbott Pharmaceuticals

The following individual(s) has/have reported no financial or other relationships with commercial entities whose products/services may relate to the educational content of this activity:

Geetha Achanta, MSc, PhD, Medical Writer: Nothing to disclose.
Hashem El-Serag, MD, MPH, Peer Reviewer: Nothing to disclose.
Michael Fordis, MD, Activity Director: Nothing to disclose.

Some drugs/devices identified during this activity may have United States Food and Drug Administration (FDA) clearance for specific purposes only or for use in restricted research settings. The FDA has stated that it is the responsibility of the individual physician to determine the FDA status of each drug or device that he/she wishes to use in clinical practice and to use the products in compliance with the applicable law.

Baylor College of Medicine requires that all contributors disclose an unlabeled use or investigational use (not yet approved for any purpose) of pharmaceutical and medical device products, and provide adequate scientific and clinical justification for such use. Physicians are urged to fully review all the available data on products or procedures before using them to treat patients.

Acknowledgement of Support

This CME activity is supported by a contract, HHSA290200810015C, from the Agency for Healthcare Research and Quality.

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