HCV Consults: Volume 1, Number 2

Democratization of Therapy

Issue: April 2015

This issue of HCV CONSULTS includes an outstanding group of articles that summarize the state of the art in HCV therapy in the first half of 2014. Approved interferon-free therapy has already become entrenched among clinicians for patients with HCV genotypes 2 and 3, while interferon regimens of unprecedented attractiveness are available for HCV G1 patients. Many clinicians are taking advantage of the approvals of simeprevir and sofosbuvir in late 2013, especially for patients with advanced fibrosis, to use a combination of the 2 agents in an off-label interferon-free regimen based on the high SVR rates and excellent tolerability reported in the COSMOS study.¹ Real-world experience and large upcoming trials will further reveal outcomes with this regimen and its destiny as an approved option.

Attendees of the annual meeting of the European Association for the Study of the Liver in April could not fail to be overwhelmed by the series of presentations that laid out the near-term future of HCV therapy. Six pivotal phase 3 trials of a fixed-dose combination pill of the NS5A inhibitor ledipasvir and the nucleotide polymerase inhibitor sofosbuvir, with or without ribavirin (3 trials), and a regimen of the protease inhibitor ABT-450 boosted by low-dose ritonavir and coformulated with the NS5A inhibitor ombitasvir (formerly ABT-267), the nonnucleoside NS5B polymerase inhibitor dasabuvir (ABT-333), and ribavirin (3 trials) demonstrated SVR rates in both treatment-naïve and treatment-experienced patients ranging from well beyond 90% to nearly universal levels in various arms. Other highlights included results of a trial evaluating the protease inhibitor asunaprevir and the NS5A inhibitor daclatasvir for patients with HCV G1b and a phase 2 trial demonstrating great promise for a combination of a second-generation protease inhibitor, MK-4172, and an NS5A inhibitor with an NS5A inhibitor, MK-8742.

The next issue of HCV CONSULTS will address these studies in detail, but the questions that will face us in the new era are taking shape. Which regimens and which patients will benefit from the addition of ribavirin? Will some patients have a higher chance of SVR if therapy duration is extended? Conversely, how short can we go? One of the phase 3 studies presented at EASL found extremely high rates of SVR with an 8-week treatment course. How focused will clinicians and patients be on extracting every last possibility of SVR based on perceived comparisons of outcomes in treatment arms across different studies or different regimens? How will we treat the seemingly rare patients who fail our new regimens — with longer duration retreatment and/or different agents? Some populations, such as HIVHCV coinfected and African American patients, are happily falling out of the category of difficult-to-cure populations, while others, such as those with decompensated cirrhosis for whom exciting initial results were presented, will likely continue to represent a more challenging group in the immediate future. Much work remains to be done.

Overall, we are witnessing a democratization of HCV therapy, with results that level the playing field across diverse patient populations. Those of us involved in the care for HCV-infected patients can only marvel at the revolution in medicine in which we are privileged to be playing a role.

Reference:

1. Sulkowski M, et al. European Association for the Study of the Liver International Liver Congress; April 9–13, 2014; London; Abstract O7.

Learning Objectives:

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

Implement new regimens for HCV by evaluating evidence-based clinical data on the safety and efficacy of new HCV treatment regimens to assist in clinical decision making.
Institute measures that provide for an integrated approach when managing HCV, including the use of laboratory testing, counseling, management of comorbidities, and compliance with established quality measures to assist in preparing HCV+ patients for treatment.
Incorporate emerging data on current combination therapies in subpopulations of HCV patients into treatment decision-making for those with cirrhosis, coinfection, or transplant.

Click here to see Education Lab Activity.

Overview

Author(s)/Faculty: Ira M. Jacobson, MD; Steven L. Flamm, MD; Robert S. Brown Jr., MD, MPH; Gregory T. Everson, MD, FACP; Nancy S. Reau, MD; Mitchell L. Shiffman, MD; Elizabeth Verna, MD, MS
Source: Healio Gastroenterology Education Lab
Type: Monograph
Articles/Items: 9
Release Date: 5/1/2014
Expiration Date: 5/1/2015
Credit Type: CME
Number of Credits: 1.5
Cost: Free
Provider: Vindico

CME Information

Provider Statement: This continuing medical education activity is sponsored by Vindico.
Support Statement: This activity is supported by educational grants from AbbVie and Genentech.
Target Audience: The intended audience for this activity is gastroenterologists, hepatologists, infectious disease specialists, nurse practitioners, physician assistants and other health care professionals involved in the treatment of patients with Hepatitis C virus (HCV).