Understanding HCV Nonresponse and Identifying Candidates for Retreatment
Source: New Management Strategies for HCV Nonresponders and Relapsers

Module

Mitchell L. Shiffman, MD, reviews the various types of virologic response in hepatitis C virus–infected patients treated with interferon and ribavirin-based regimens and explains how to identify patients who would be good candidates for retreatment if they fail to achieve sustained virologic response.

Learning Objectives

Upon completion of this activity, participants should be able to:

  • Specify standard definitions of response and nonresponse to hepatitis C virus therapy
  • Discuss factors associated with nonresponse to hepatitis C virus therapy
  • Report criteria that may help to identify nonresponders who are good candidates for retreatment
  • Summarize data from studies of different retreatment strategies
  • Describe appropriate virologic goals of therapy for nonresponders undergoing retreatment

Topics covered include:

  • Introduction
  • Defining the Patterns of Virologic Response and Nonresponse
  • Rapid Virologic Response
  • Achieving Undetectable HCV RNA After Week 4 and Slow Virologic Response
  • Early Virologic Response and Nonresponse Virologic Patterns
  • Breakthrough and Relapse
  • Identifying Candidates for Retreatment: Null Response
  • Identifying Candidates for Retreatment: Partial Virologic Response
  • Identifying Candidates for Retreatment: Noncompliance, Medication Errors and Dose Reduction
  • Identifying Candidates for Retreatment: Failure to Recognize That Virologic Response Has Occurred
  • Identifying Candidates for Retreatment: Insufficient Treatment Duration
  • Conclusions
  • Summary of Clinical Implications
 

Faculty

  • Mitchell L. Shiffman
    MD

Credit Information

  • Release Date:
    October 04, 2007
  • Expiration Date:
    October 03, 2008
  • Physicians:
    maximum of 1.0 AMA PRA Category 1 Credit
  • Registered Nurses:
    1.0 Nursing contact hour

Information on this Educational Activity

Disclosure of Conflicts of Interest

Postgraduate Institute for Medicine (PIM) assesses conflict of interest with its instructors, planners, managers, and other individuals who are in a position to control the content of CME activities. All relevant conflicts of interest that are identified are thoroughly vetted by PIM for fair balance, scientific objectivity of studies utilized in this activity, and patient care recommendations. PIM is committed to providing its learners with high-quality CME activities and related materials that promote improvements or quality in healthcare and not a specific proprietary business interest of a commercial interest.

The faculty and CCO staff reported the following financial relationships or relationships to products or devices they or their spouse/life partner have with commercial interests related to the content of this CME activity.

 

Faculty

Mitchell L. Shiffman, MD


Director, Liver Institute of Virginia
Bon Secours Virginia Health System
Richmond and Newport News, Virginia

Mitchell L. Shiffman, MD, has disclosed that he has received consulting fees and fees for non-CME services from Roche and Valeant Pharmaceuticals. He has also received support for contracted research from Roche, Schering-Plough, Valeant Pharmaceuticals, Vertex, and Wyeth Pharmaceuticals.
 

Staff

Michael A. Craig, MSc


Managing Editor
Clinical Care Options, LLC

Michael Craig, MSc, has no significant financial interests to disclose.
 

Edward King, MA


Vice President, Editorial
Clinical Care Options, LLC

Edward King, MA, has no significant financial relationships to disclose.
 

Eurona E. Tilley, MS


Clinical Editor
Clinical Care Options, LLC

Eurona Tilley, MS, has no significant financial interests to disclose.
 

The following PIM clinical content reviewers, Linda Graham, RN; Jan Hixon, RN; and Trace Hutchison, PharmD, hereby state that they or their spouse/life partner do not have any financial relationships or relationships to products or devices with any commercial interests related to the content of this CME activity of any amount during the past 12 months.

Disclosure of Unlabeled Use
This educational activity may contain discussion of published and/or investigational uses of agents that are not indicated by the FDA. Postgraduate Institute of Medicine (PIM) and Clinical Care Options, LLC do not recommend the use of any agent outside of the labeled indications.

Mitchell L. Shiffman, MD, discusses the unlabelled use of interferon alfacon-1, high-dose peginterferon alfa-2a, and ribavirin and extended treatment duration for the retreatment of patients with previous hepatitis C virus therapy nonresponse.

The opinions expressed in the educational activity are those of the faculty and do not necessarily represent the views of PIM and Clinical Care Options, LLC. Please refer to the official prescribing information for each product for discussion of approved indication, contraindications, and warnings.

Disclaimer
Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. The information presented in this activity is not meant to serve as a guideline for patient management. Any procedures, medications, or other courses of diagnosis or treatment discussed or suggested in this activity should not be used by clinicians without evaluation of their patient’s conditions and possible contraindications on dangers in use, review of any applicable manufacturer’s product information, and comparison with recommendations of other authorities.

 

Target Audience

This activity is intended for physicians, registered nurses, and other healthcare community members providing frontline clinical care for persons with chronic hepatitis C.


Purpose

The purpose of this activity is for participants to enhance their knowledge regarding the optimal management of patients who fail to achieve response to initial therapy for chronic hepatitis C, including retreatment strategies.


Learning Objectives

Upon completion of this activity, participants should be able to:

  • Specify standard definitions of response and nonresponse to hepatitis C virus therapy
  • Discuss factors associated with nonresponse to hepatitis C virus therapy
  • Report criteria that may help to identify nonresponders who are good candidates for retreatment
  • Summarize data from studies of different retreatment strategies
  • Describe appropriate virologic goals of therapy for nonresponders undergoing retreatment
 

Physician Continuing Medical Education

Accreditation Statement

This activity has been planned and implemented in accordance with the Essential Areas and Policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint sponsorship of Postgraduate Institute for Medicine and Clinical Care Options, LLC. Postgraduate Institute for Medicine is accredited by the ACCME to provide continuing medical education for physicians.

Credit Designation

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

 

Nursing Continuing Education

Accreditation Statement

CNA/ANCC

This educational activity for 1.0 contact hour(s) is provided by Postgraduate Institute for Medicine (PIM).

PIM is an approved provider of continuing education by the Colorado Nurses Association, an accredited approver by the American Nurses Credentialing Center’s Commission on Accreditation.

California Board of Registered Nursing

Postgraduate Institute for Medicine is approved by the California Board of Registered Nursing, Provider Number 13485 for 1.2 contact hours.

 

 

Commercial Support


This program is supported by an educational grant from Valeant Pharmaceuticals.

 

Program Medium


This program has been made available online, and in print.

 

Site Requirements


  • Internet Explorer 7+, Firefox 3+, Safari 3+, or Chrome
  • JavaScript enabled
  • 1024x768+ screen resolution
  • Adobe Flash Player
 

Instructions for Credit

Participation in this self-study activity should be completed in approximately 1 hour. To successfully complete this activity and receive credit, participants must follow these steps during the period from October 04, 2007, through October 03, 2008:

1. Register online at http://www.clinicaloptions.com.
2. Read the target audience, learning objectives, and faculty disclosures.
3. Study the educational activity online or printed out.
4. Submit answers to the posttest questions and evaluation questions online.

You must receive a test score of at least 70% and respond to all evaluation questions to receive a certificate. After submitting the evaluation, you may access your online certificate by selecting the certificate link on the posttest confirmation page. Records of all CME activities completed can be found on the "CME Manager" page. There are no costs/fees for this activity.

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