HCV New Drug Research: Summary Of The 47th European Association for the Study of the Liver 2012 EASL - The promise of all oral hepatitis C drug regimens

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DDW 2013 - May 18-21, 2013 - Orlando, FL

Digestive Disease Week - The conference will showcase the latest advances in GI research, medicine and technology in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery

View Media and DDW Updates

Hot Topics - May 2013

Interferon-free, treat-all approach cost effective, beneficial for chronic HCV

European Medicines Agency Validates Gilead's Marketing Application for Sofosbuvir for the Treatment of Hepatitis C

(On April 08) Gilead Submitted New Drug Application to U.S. FDA for Sofosbuvir (GS-7977) for the Treatment of Hepatitis C

Current and Future Therapies for Hepatitis C Virus Infection

If the past is a harbinger of the future, therapy for HCV infection will probably continue to advance at a brisk pace. Many additional potent agents are in the clinical pipeline, and interferon-free regimens are likely to dominate the HCV therapeutic landscape within the next 5 years.....

Summary EASL 2013 - New HCV DAAs on their way soon: what do the phase III studies tell us?

At this year's EASL in Amsterdam with over 9600 delegates the phase III study results for the two "second wave HCV protease inhibitors" faldaprevir and simeprevir each in combination with pegylated interferon (PEG-IFN) and ribavirin (RBV) for HCV genotype 1 patients were presented as well as the phase III findings for the polymerase inhibitor sofosbuvir again in combination with PEG-IFN/RBV for treatment of genotypes 1,4,5 and 6. In addition phase III results of the first interferon free combination of sofosbuvir with ribavirin for treatment of genotype 2 and 3 were presented....

EASL Webcast

HCV: Highlights from EASL 2013/Fred Poordad, MD

Best of the EASL 2013 on hepatitis C - webcast with Dr Andrew Muir

Hepatitis C in the United States Perspective

Care for hepatitis C is evolving rapidly, with increasingly effective and better-tolerated antiviral therapies being evaluated and approved for use. It's clear, however, that not everyone who would qualify for therapy has been tested and identified, referred for appropriate care, and offered or given the best therapy available. Furthermore, currently used antiviral drugs - pegylated interferon and ribavirin "base" plus either telaprevir or boceprevir - can cost more than $70,000 for a full course of therapy. It is expected that the new oral antiviral agents will be just as expensive, at least in the short term.

Hepatitis C Therapy Update 2013-What About Interferon-free Regimens?

U.S. FDA grants priority review to Simeprevir (TMC435) for combination treatment of genotype 1 chronic hepatitis C

AbbVie's ABT-450- Breakthrough Therapy Designation from the U.S. Food and Drug Administration Granted to Investigational HCV Regimen

Gilead Sofosbuvir and ledipasvir: Plans to initiate a third Phase 3 clinical trial with and without ribavirin

April
Cost will limit uptake of off-label Gilead/Bristol-Myers Squibb Hep C combo, despite best-in-class data

ViewPoints: New Hep C data validates Gilead's solo approach

Gilead Submits New Drug Application to U.S. FDA for Sofosbuvir (GS-7977) for the Treatment of Hepatitis C-- Sofosbuvir Would Form Basis of First All-Oral Regimen for HCV Genotype 2 and 3 Patients, and Interferon-Sparing Regimen for Genotype 1 Patients --

Anemia Top Side Effect of HCV Antivirals

Hepatitis C Virus Infection: Looking for Interferon Free Regimens

Review: NS5A Inhibitors in the Treatment of Hepatitis

VX-135/daclatasvir: Vertex signs agreement with Bristol-Myers for all-oral midstage studies for hepatitis C treatments

March
Simeprevir (TMC435) - Janssen Submits New Drug Application to U.S. FDA

Miravirsen- Hepatitis C drug goes after patients’ RNA

Update on Phase 3 Study of Oral Fixed-Dose Combination of Sofosbuvir and Ledipasvir for Genotype 1 Hepatitis C Patients‏

Hepatitis C - Presidio Collaboration with Boehringer Ingelheim for interferon-free Phase IIa clinical trial

February
Gilead hepatitis C drug sofosbuvir (GS-7977) meets goal of fourth late-stage study

EASL-Burden of Liver Disease in Europe: Looks at leading causes of cirrhosis and primary liver cancer in Europe

Gilead Announces SVR Rates from Two Phase 3 Studies of Sofosbuvir (GS-7977) for Hepatitis C

Potential IFN-Free Regimens For HCV

IDX184 and IDX19368 - Idenix drops development of hepatitis C drugs

January
Interferon free regimens for the “difficult to treat”: are we there?

Current Prospects for Interferon-free Treatment of Hepatitis C in 2012
Numerous other DAAs are in clinical development, and phases 2 and 3 trials are evaluating interferon-free combination DAA therapy. Interferon-free sustained virologic responses have now been achieved with combinations of asunaprevir and daclatasvir; sofosbuvir and ribavirin; sofosbuvir and daclatasvir; faldaprevir and BI207127; ABT-450, ritonovir and ABT-333; ABT-450, ritonovir and ABT-072; miracitabine, danoprevir and ritonavir; and alisporivir and ribavirin. Some drugs are genotype-specific in their activity, whereas others are pan-genotypic, and differential responses for the genotype 1 subtypes 1a and 1b have emerged with many DAA combinations. Viral breakthrough and resistance are important considerations for future trial design. The prospect of interferon-free combination DAA therapy for hepatitis C virus is now finally becoming a reality.

2013-Guide to Clinical Trials for People with Hepatitis C

Bristol-Myers to Hold Talks On Settling Claims of Hepatitis C Patients

Treat Now or Wait?
The debate rather to treat HCV now or wait is ongoing, in the journal "Liver International" factors which affect the decision to treat now or delay therapy are discussed. You can view the article here: Patients with HCV and F1 and F2 fibrosis: treat now or wait?

Of Interest
Lucinda K. Porter, RN Shares A Personal Experience: Starting 12 weeks of sofosbuvir, GS-5885, and ribavirin

Coming in September 2013
A second book authored by Lucinda K. Porter, RN: Hepatitis C Treatment One Step at a Time: Inspirational Readings and Practical Tips for Successful Hepatitis C Treatment

First Book
FREE FROM HEPATITIS C

Clinical Trial Updates
ClinicalTrials.gov: updated in the last 30 days

HCV PipelineHCV Advocate - News & Pipeline Blog

Chronic Hepatitis C Infection: Treat Now or Wait?

2012
INCIVEK® (telaprevir)-Updates label after reports of a ‘small number of fatal skin reactions’

Vertex discloses Hep C drug deaths

HCV Transplant Studies GS-7977 Also Telaprevir & Boceprevir

Perspectives and challenges of interferon-free therapy for chronic hepatitis C

Hepatitis C–What Are Your Treatment Choices: New Webinar

Setbacks in HCV Drug Development Highlight Uncertainties in Treat or Wait Decisions

So You Think You’re a Hepatitis C Expert
Back in July Clinical Care Options released part one of a three part online quiz containing 35 questions on hepatitis C, answered by nine world-renowned hepatology experts. In October CCO released part two of the series which included case scenarios from 11 leading international experts on hepatitis C, and today part three was released!

Idenix: FDA Places IDX19368 Hepatitis C Treatment on Clinical Hold

IDX184-Idenix hepatitis C drug put on partial hold

BMS halts the development of BMS-986094 due to patient death

BMS-986094-Bristol-Myers Sued Over Heart Damage In Hepatitis C Drug Trial

Guidelines

2011
An update on treatment of genotype 1 chronic hepatitis C virus infection: 2011 practice guideline by the American Association for the Study of Liver Diseases

2012
Long-term management of the successful adult liver transplant: 2012 practice guideline by the -AASLD

VA guidelines for management and treatment of HCV, published in the American Journal of Gastroenterology

UK consensus guidelines for the use of the protease inhibitors boceprevir and telaprevir in genotype 1 chronic hepatitis C infected patients

Nonalcoholic Fatty Liver Disease (NAFLD)
New Clinical Practice Guideline Developed for Nonalcoholic Fatty Liver Disease

EASL-Liver Cancer
2012-New guidelines on the management of hepatocellular carcinoma (HCC).
These guidelines result from a joint collaboration between the European Association for the Study of the Liver (EASL) and the European Organization for Research and Treatment of Cancer (EORTC).

EASL-Hepatitis B
EASL-April 2012 Revised Clinical Practice Guidelines on the Management of Chronic Hepatitis B

HCV Information and Educational Resources

Clinical Liver Disease -Digital Liver Disease Journal
This journal is an official digital educational resource from the American Association for the Study of Liver Diseases.
Visitors are able to view videos, full data, and download files in either HTML or PDF formats
View all issues here.

Projects In Knowledge
Offered at the site is a program series of HCV Video Case Vignettes. In the videos individual patient case studies are discussed, topics include side effects, drug-drug interactions, treatment duration, and outcome.

AASLD - Liver Learning
If you haven't yet explored the "Liver Learning" section available @ the AASLD web site you're missing out on the November meeting webcasts, video podcasts, abstracts and more.

Other HCV Sites:
These links will take you to the premier Hepatitis C sites and keep you informed with breaking news, clinical studies, new drugs, podcasts, newsletters, support, personal experiences, chat rooms, forums and more.

2012 Articles Of Interest

2012-New Antiviral Agents for Hepatitis C
This article describes the direct acting antivirals and host-targeted agents that have recently been approved or have been tested in HCV-infected patients and discusses their two current paths of clinical development: with or without interferon-α.

Standardization of Terminology of Virological Response in the Treatment of Chronic Hepatitis C

Protease inhibitors: Silver bullets for chronic hepatitis C infection?
Recent trials evaluated the safety and efficacy of two protease inhibitors, boceprevir (Victrelis) and telaprevir (Incivek), added to standard care with pegylated interferon and ribavirin, in patients with chronic hepatitis C virus (HCV) infection. These drugs open the door for triple therapy and other new therapies involving combinations of other direct-acting antiviral agents to become the new standard of care for this population.

Treatment of chronic hepatitis C genotype 1 with triple therapy comprising telaprevir or boceprevir
A significant increase in the number of patients with CHC to be treated is expected for 2012, with triple therapy regimens that are more complex. These expected developments represent a significant challenge and will stretch current resources.
The present Swiss Association for the Study of the Liver (SASL) expert opinion statement is not intended as guideline but shall provide some guidance on the management of CHC genotype 1 and the use of TPV and BOC

Updated Feb-2012
If you have just been diagnosed with hepatitis C or considering HCV therapy click here for easy to understand information.

Drug Interaction Charts
Telaprevir/Boceprevir/Peg-IFN alfa

Patient Assistance Program
INCIVEK/Telaprevir and VICTRELIS (Boceprevir) Patient Assistance Programs

Medication Guides;
Prescribing Information for INCIVEK including the Medication Guide.
VICTRELIS™- Boceprevir: Prescribing Information and Medication Guide
Peginterferon alfa
Ribavirin

Hepatitis C-New Protease Inhibitor (NS3/4A) Drug Resistance Test
LabCorp has begun offering nationwide its hepatitis C GenoSure NS3/4A assay, which is designed to identify NS3 and NS4A mutations and NS3-associated resistance to a pair of recently approved HCV protease inhibitors.

GET TESTED

Click here to order a FREE Home Access Hepatitis C Test Kit

How Soon Should I Get Tested After Exposure ?

After the exposure (especially if the blood exposure involved another person known to have the hepatitis C virus), it is recommended that testing for the hepatitis C antibody be performed at 4 to 6 months after the exposure OR that testing for the hepatitis C virus itself (a test often called an HCV PCR or hepatitis C viral load test) be performed 4 to 6 weeks after the potential exposure. These tests are done to determine whether or not hepatitis C infection has occurred as a result of the exposure.;

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HCV New Drug Research

Summary Of The 47th European Association for the Study of the Liver 2012 EASL - The promise of all oral hepatitis C drug regimens

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