HCV VOICE II: Optimizing Virological Outcomes with Integrated HCV Education

Issue: October 2015

Treatment decisions for patients with hepatitis C virus (HCV) should ideally be guided by evidence from phase 3 clinical trials, systematic literature reviews, and comparative effectiveness trials. However, with the rapid pace of developments in this field, such information is not available for the direct-acting antiviral (DAA) therapies. In fact, only a limited number of phase 3, randomized controlled trials have been conducted with such agents, and no comparisons have been performed across regimens. Certain populations seen frequently in clinical practice — such as women, blacks, older patients, those with comorbidities, and those who have failed previous treatment — have been underrepresented in the investigations to date. Clinicians are seeking a better understanding of the responses that might be anticipated when these treatment regimens are used in the broader spectrum of patients managed in real-world practice.

To provide perspectives on these issues, Purdue University and Vindico Medical Education organized a panel of experts who addressed recent clinical trial data in the context of new insights from a large-scale, real-world initiative: the Hepatitis C Therapeutic Registry and Research Network (HCV-TARGET). This ongoing, longitudinal, observational study, conducted at 53 academic and community medical centers in North America and Europe, represents an important opportunity to examine the efficacy of DAAs in specific subgroups of interest. These recognized experts offer insights into the efficacy of various DAA regimens in clinical trials, outcomes that may be expected in actual practice, and special considerations in unique populations according to factors such as genotype and presence of cirrhosis.

I wish to thank the participants for their contributions to this program and the preparation of this monograph. The information presented here can help physicians better understand the current climate of HCV management from the standpoint of interpreting the clinical trials database and its relationship to the real-world setting.

Chronic hepatitis C virus infection is a leading cause of cirrhosis, end-stage liver disease, hepatocellular carcinoma, and death from liver disease in the United States. The discovery, development, and availability of direct-acting antiviral agents (DAAs) offers new treatment options and the possibility of improved outcomes for newly diagnosed patients, as well as those who have experienced a relapse or failed to respond to previous treatment. However, their use introduces new challenges and adds to the complexity of HCV treatment and care. The Hepatitis C Therapeutic Registry and Research Network (HCV-TARGET) is an international consortium of academic and community investigators prospectively enrolling patients treated with HCV regimens that include a DAA to assess the effects of HCV therapy in the broader population. The HCV-TARGET initiative aims to continue to evaluate the safety and efficacy of HCV regimens, including a robust data set of traditionally underrepresented patient populations, such as those with cirrhosis, null responders, older adults, African Americans, Hispanics, and patients infected with mutated strains of HCV. This CME monograph, HCV VOICE II: Optimizing Virological Outcomes with Integrated HCV Education, will consider real-world data of patients treated with new regimens to provide an understanding of how and when specific regimens are most beneficial, particularly in challenging patients with HCV genotype 1, and will discuss the current HCV practice guidelines, how to decipher and apply them to clinical practice.

Click here to see this Education Lab Activity.

Learning Objectives

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

Apply the 2014 AASLD practice guidelines to real-world case scenarios representative of difficult-to-treat patient populations with hepatitis C.
Examine real-world data, in addition to clinical trial data, when determining the most appropriate treatment course for challenging patients with genotype 1 HCV.
Assess the safety and efficacy of newly approved second generation DAA regimens in challenging patients with genotype 1 HCV.

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Overview

Author(s)/Faculty: Michael W. Fried, MD; Mark S. Sulkowski, MD; Nancy Reau, MD; Ira M. Jacobson, MD; David R. Nelson, MD
Source: Healio Gastroenterology Education Lab
Type: Monograph
Articles/Items: 8
Release Date: 3/10/2015
Expiration Date: 3/10/2016
Credit Type: CME
Number of Credits: 1.5
Cost: Free
Provider: Purdue University

CME Information

Provider Statement: This continuing medical education activity is provided by Perdue University with Educational Partner Vindico Medical Education.
Support Statement: This activity is supported by educational grants from Janssen Therapeutics, division of Janssen Products LP.
Target Audience: The intended audience for this activity is gastroenterologists, nurse practitioners, physician assistants, and other health care professionals involved in the treatment of patients with the hepatitis C virus (HCV).