No benefit to ribavirin maintenance therapy in HCV patients after liver transplant
Calmus Y. J Hepatol. 2012;57:564-571.
Patients with HCV who underwent liver transplant did not benefit from maintenance therapy with ribavirin alone following treatment with ribavirin and peginterferon, according to recent results.
The study included 101 patients who had undergone liver transplant for end-stage, HCV-positive, HBsAg-negative liver disease. All participants had biopsy-proven chronic HCV and stage 1 fibrosis or higher, and had completed 12 months of combination therapy with peginterferon alpha-2a and ribavirin. Researchers randomized 78 participants to receive either ribavirin (n=41) or placebo (n=37) for an additional 12 months of maintenance therapy, with 6 months of follow-up.
During maintenance therapy and follow-up, the per-protocol rate of treatment response was 54.4% after 15 months from initiation of combination therapy, 47.9% after 18 months, 51.4% at 24 months and 47.3% after 30 months. At no point during maintenance therapy or follow-up did investigators observe a significant difference in response between the treated and placebo groups. Relapse rates were also similar between the groups at all evaluated time points.
No statistically significant difference was found between the groups regarding mean viral load, GGT levels, METAVIR activity or fibrosis scores. Transaminases levels decreased significantly among treated patients compared with placebo at this point (P=.034), but were similar between groups upon completion of follow-up.
Investigators found independent associations between SVR and basal creatinine levels (OR=5.53, 95% CI, 1.07-28.49 for levels over 130 µmol/L compared with below 130 µmol/L), patient weight (OR=0.23, 95% CI, 0.07-0.77 for patients weighing more than 70 kg compared with less than 70 kg) and a viral load reduction after 3 months of treatment (OR=8.67, 95% CI, 0.92-81.32).
“Our results clearly show that ribavirin alone has no effect on the virological response, assessed in terms of viral response or in terms of viral load,” the researchers wrote. “… These data are more than ever relevant today, since adding a protease inhibitor to [peginterferon alpha 2a] and ribavirin therapy may increase the side effects, such as anemia. In contrast, the use of ribavirin as maintenance therapy provides no additional benefit.”
No benefit to ribavirin maintenance therapy in HCV patients after liver transplant
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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
Gilead Announces U.S. FDA Priority Review Designation for Sofosbuvir for the Treatment of Hepatitis C
Hepatitis C: The Pace of Progress/Interferon-Free Treatment Still Searching
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....
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
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
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
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
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?
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
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?
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
The International Liver Congress 2013 of the European Association for the Study of the Liver (EASL), will take place April 24 to 28 in Amsterdam, The Netherlands.
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EASL: Direct-acting antivirals now ready for prime time with promising alternatives on the way
AbbVie is a new, independent biopharmaceutical company composed of Abbott’s former proprietary pharmaceutical business
ABT-267, ABT-333-non- nucleoside, ABT-450/r
r = ritonavir
Faldaprevir/ (BI 201335)
MK-5172 and Daclatasvir
MK-5172 and Daclatasvir-Merck Enters Agreement with Bristol-Myers Squibb to Conduct a Phase II Clinical Trial
CCO's independent conference coverage
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
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
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-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
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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.
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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.
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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
If you have just been diagnosed with hepatitis C or considering HCV therapy click here for easy to understand information.
Patient Assistance Program
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Prescribing Information for INCIVEK including the Medication Guide.
VICTRELIS™- Boceprevir: Prescribing Information and Medication Guide
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.
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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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- New HCV Drugs
- Keeping current on the potential arrival of new improved hepatitis C drugs. As once a hepatitis C patient myself (I successfully treated the virus with standard HCV therapy in 2000) I understand the difficult decisions and overwhelming fear that ensues after being diagnosed with this serious and life-changing disease. This blog serves as a starting point for information on the rapidly evolving number of new agents in development to treat hepatitis C. Tina