If you have any
questions about this process, please email
the Center for Continuing and Outreach
Education at firstname.lastname@example.org or call CCOE Enrollment Services at (800) 227-4852.
SPONSOR Sponsored by François-Xavier Bagnoud Center, School of Nursing, Rutgers, The State University of New Jersey and the Center for Continuing and Outreach Education at Rutgers Biomedical and Health Sciences.
This activity is supported by an educational grant from the New Jersey Department of Health (NJDOH)—Division of HIV, STD and TB Services, through an MOA titled “Education and Training for Physicians and other Healthcare Professionals in the Diagnosis and Treatment of HIV/AIDS.”
Statement of Need
Given the relatively high prevalence of chronic hepatitis C (HCV) in the US (about 1% or 2.7 million infections) and the high risk of developing chronic infection (75–85%), chronic liver disease (60–70%), cirrhosis (5–20%), or dying due to chronic infection (1–5%), treatment of chronic HCV is important. Until 2011, the only treatment for chronic HCV was pegylated interferon with ribavirin, a regimen with low success rates (often ranging as low as 11-37%) and a significant degree of anemia that complicated therapy.
In 2011 the US Food and Drug Administration (FDA) approved the first two direct-acting antivirals (DAAs): boceprevir and telaprevir. In late 2013 the FDA approved two additional DAAs to treat adults with chronic HCV: simeprevir in November and sofosbuvir in December. Given the effectiveness, once daily dosing, shorter treatment course, and tolerability of simeprevir and sofobuvir, these two drugs have made boceprevir and telaprevir as well as all pre-2013 treatment guidelines obsolete. By late 2013, HCV treatment guidelines (including the CDC regimens outlined in the STD Treatment Guidelines, 2010) were considered out of date. Instead, healthcare professionals should turn to the Infectious Diseases Society of America (IDSA) and American Association for the Study of Liver Diseases (AASLD) web-based process for current evidence-based, expert-developed recommendations for HCV management.
This pace of change in the HCV field is likely to continue as there are a number of drugs in Phase 3 testing that are likely to be FDA-approved in 2014 or 2015. These drugs are expected to be at least as effective as simeprevir and sofobuvir, and in some cases more effective or preferable for specific patient populations such as those with documented early fibrosis.
This activity is designed for physicians, nurses, health educators, and other health care professionals in New Jersey who are involved in the care of people co-infected with HIV and Hepatitis C.
Method of Participation
Participants should read the learning objectives, review the activity in its entirety, and then complete the self-assessment test, which consists of a series of multiple-choice questions. Upon completing this activity as designed and achieving a passing score of 70% or more on the self-assessment test and submitting a course evaluation, participants will receive a printable credit statement.
Estimated time to complete this activity as designed is 1.0 hour for nurses, and .75 hour for physicians.
Upon completion of this activity, participants should be able to:
- Incorporate current HCV treatment recommendations by the American Association for the Study of Liver Diseases (AASLD) in daily practice.
- Evaluate the efficacy and safety of current and emerging therapeutic strategies for the treatment of HCV.
Activity Directors/CME Academic Advisors
Shobha Swaminathan, MD, Assistant Professor, Division of Infectious Diseases, Department of Medicine, Rutgers New Jersey Medical School
Margaret Evans, MSN, RN, CCOE Primary Nurse Planner; Nurse Manager for Education and Performance Improvement at Robert Wood Johnson Medical Group.
Virginia Allread, MPH
Linda Berezny, RN, BA Supervising Program Development
Specialist, Prevention and Education, NJDOH,
Division of HIV, STD and TB Services
Carolyn Burr, RN, EdD, Deputy Director, FXB Center, Rutgers
Ellen Dufficy, RN, Nurse Consultant, Ryan White Part D, NJDOH, Division of HIV, STD and TB Services
Alicia Gambino, MA, CHES, Director of Public Education, New Jersey Poison Information & Education System
Sindy Paul, MD, MPH, FACPM, Medical Director, New Jersey Board of Medical Examiners
Joanne Phillips, RN, MS, Education Specialist, FXB Center, Rutgers
Sarah Quinless, BA, Program Coordinator, FXB Center, Rutgers
Jihad Slim, MD, Chief of Infectious Disease, Saint Michael’s Medical Center, Newark, NJ
Michelle Thompson, Program Manager, FXB Center, Rutgers
Elizabeth Ward, MSJ, Executive Director, Rutgers CCOE
Virginia Allread, MPH
Credit is no longer available for this activity.
In order to help ensure content objectivity, independence, and fair balance, and to ensure that the content is aligned with the interest of the public, CCOE has resolved all potential and real conflicts of interest through content review by non-conflicted, qualified reviewers. This activity was peer-reviewed for relevance, accuracy of content and balance of presentation by Shobha Swaminathan, MD and Joanne Phillips, RN, MS.
This activity was field tested for time required for participation by Bonnie R. Abedini, MSN, RN; David John Cennimo, MD; Debra Chew, MD; Jojy Cheriyan, MD, MPH, MPhil; Anna M. Haywood, RN, MSN; Mary C. Krug, RN, MSN, APN; Kinshasa Morton, MD; and Kara Winslow, BSN, RN.
In accordance with the disclosure policies of Rutgers University and to conform with ACCME and FDA guidelines, individuals in a position to control the content of this educational activity are required to disclose to the activity participants: 1) the existence of any relevant financial relationship with any entity producing, marketing, re-selling, or distributing health care goods or services consumed by, or used on, patients, with the exemption of non-profit or government organizations and non-health care related companies, within the past 12 months; and 2) the identification of a commercial product/ device that is unlabeled for use or an investigational use of a product/ device not yet approved.
Jihad Slim, MD receives grant/research support from AbbVie, Bristol-Myers Squibb, Gilead, and MSD; and is a member of the speakers bureau of AbbVie, Bristol-Myers Squibb, Genentech, Gilead, Janssen, and MSD. The author, activity directors, all other planning committee members, peer reviewers and field testers have no relevant financial relationships to report.
Off-Label Usage Disclosure
This activity provides an overview of the following HCV drugs/drug combinations, which are not yet FDA approved: daclatasvir (DCV) + asunaprevir (ASV); DCV, ASV + BMS- 791325; ledipasvir; fixed-dose combination of ledipasvir/ sofosbuvir; faldaprevir; miravirsen; DCV + sofosbuvir; ABT- 450/r, ABT-267, ABT-333 + RBV.
The views expressed in this activity are those of the faculty. It should not be inferred or assumed that they are expressing the views of NJDOH – Division of HIV, STD and TB Services, any manufacturer of pharmaceuticals or devices, or Rutgers University. It should be noted that the recommendations made herein with regard to the use of therapeutic agents, varying disease states, and assessments of risk, are based upon a combination of clinical trials, current guidelines, and the clinical practice experience of the participating presenters. The drug selection and dosage information presented in this activity are believed to be accurate. However, participants are urged to consult all available data on products and procedures before using them in clinical practice.
Copyright © 2014 Rutgers University
All rights reserved including translation into other languages. No part of this activity may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopying, recording, or any information storage and retrieval systems, without permission in writing from Rutgers University.
Please direct CE related or technical questions to Rutgers at 973-972-4267 or email email@example.com.