Friday, June 20, 2014

June Hepatitis C Newsletters: Two New Drugs Under FDA Review, Treatment Side Effects And So Much More....

June Hepatitis C Newsletters: Two New Drugs Under FDA Review, Treatment Side Effects And So Much More....

Each month this blog provides a link to Hepatitis Newsletters, published by advocacy groups devoted to increasing awareness and information about viral hepatitis. In addition, a rewind of hot topics, research and news is offered with a focus on HCV.

Hello folks, hope you are all enjoying your summer! We begin with this months issue of "HCV Next" recently published online over at

Designed as an in-depth specialty clinical information website, features the industry’s best news reporting, dynamic multimedia, question-and-answer columns, CME and other educational activities in a variety of formats.

HCV Next will bridge the gap between cutting edge news and the patient with HCV, by seeking to provide physicians with peer context and perspective on the latest research developments. Topics that will be discussed regularly in HCV Next are diagnostics, drug/drug interaction, combination therapies, guidelines, practice management issues, regulatory aspects, coding, general economic issues and treatment of patients in special populations and those with comorbidities.

In This Months Issue

Managing Side Effects of HCV Treatment
Leah Molloy, PharmD

Patient Profile
The Next Wave: Noninvasive Alternatives to Assess Fibrosis

Influx of Data Sets Pace for the Year Ahead

Ask the Experts
HCV Care Requires Collaborative Effort 

From A to C: 
A Brief History of the Discovery of HCV

The Take Home
The Take Home: International Liver Congress

Solid Organ Transplantation: Little Research, Big Need for Patients with HCV

Hellen Chiao, MD; Catherine T. Frenette, MD

5 Questions
A Conversation with Paul Martin, MD

Trend Watch
Action Plan to Combat Hepatitis Renewed by Federal Health Officials

A Call for Improved Prevention, Control of Coinfection in Asia

Two New Drug Combinations Under FDA Review 

Staying Safe Intervention Reduced HCV, HIV Risk in Drug Users

Vietnam Vets May Not Be at Higher HCV Risk than Nonvets

Begin Here...

For Your Viewing Pleasure

Highlights from Hepatitis C Management State of the Art

The 25th Anniversary of the Discovery of the Hepatitis C Virus

June Newsletters

Liver Lowdown is the monthly general interest e-newsletter of the American Liver Foundation.

June 2014 Edition 

In This Issue
The American Liver Foundation is making national news on topics including liver wellness, disease prevention, screening and treatment. 

There is a lot going on at the American Liver Foundation and we invite you to join us in our many events. With our Liver Life Walks, Flavors, transplant reunions and webinars, there is a lot to be a part of. Here is what we have been up to during the last few weeks.  

Most people don't associate liver disease with children. Yet thousands are diagnosed with liver disease each year. Read about three kids who not only survived but thrived.

ALF hosts a number of events throughout the year to support liver disease awareness. Check our events calendar and find one to participate in.

Looking for a delicious recipe to try tonight? We have one for you! Have a recipe to share? We would love to hear from you.

Check Us Out On Twitter and Facebook
 Twitter  Facebook

The hepc.bull, has been “Canada’s hepatitis C journal” since the late 1990′s and has been published nonstop since 2001. The monthly newsletter contains the latest research results, government policy changes, activities and campaigns you can get involved in, articles by patients and caregivers, and a list of support groups plus other useful links.

June Newsletter 

In This Issue:
HepCBC Roadshow / The Untold Story
New Drugs Now
September 17, 1950 – May 14, 2014  

Stay Connected

The New York City Hepatitis C Task Force is a city-wide network of service providers and advocates concerned with hepatitis C and related issues. The groups come together to learn, share information and resources, network, and identify hepatitis C related needs in the community. Committees form to work on projects in order to meet needs identified by the community. 

NYC Viral Hepatitis Monthly E-Newsletter

June Issue 

Harlem Hep C Task Force Meeting Highlights
Meeting highlights available here, slides for the following presentations are here. 

Get Involved! African American Hep C Action Day: July 25th 

PREP-C Psychosocial Readiness & Preparation for Hep C Treatment:
Online assessment and guidance interactive tool. Now a shorter version for less complicated cases.

Subscribe to this Newsletter

Join Us

GI & Hepatology News is the official newspaper of the AGA Institute and provides the gastroenterologist with timely and relevant news and commentary about clinical developments and about the impact of health-care policy. The newspaper is led by an internationally renowned board of editors. 

View Current Issue (Vol. 8 No. 6 June 2014): PDF | Interactive Issue 

In This Issue
PEARL-II: Oral ‘3D’ effective in HCV with prior tx failure
The investigational “3D” combination of oral antiviral drugs achieved a cure rate that was amazing in the phase III PEARL-II trial involving noncirrhotic patients with hepatitis C virus genotype 1b who had previously failed pegylated interferon– based therapy.

Larazotide soothes in celiac trial
Larazotide acetate, a first-in-class oral medication developed specifically to treat celiac disease, reduced both gastrointestinal and non-GI symptoms in patients who were symptomatic despite being on a gluten-free diet in a 74-site, randomized, double-blind phase II study.

NAFLD mortality higher in normal-weight patients
Lean patients with nonalcoholic fatty liver disease had a higher overall mortality than did overweight or obese patients with NAFLD, according to a review of 1,090 biopsy-confirmed patients in the United States, Australia, Thailand, and Europe.

Stay connected

Hep C Connections - Website
Our mission is to educate the general public about hepatitis C and to provide resources and support for those affected by the virus. Hep C Connection offers a helpline to answer your questions regarding hepatitis C (HCV). You can expect respect, patience & understanding, in clear, jargon-free language from our staff & volunteers. Call 1-800-522-HEPC (4372) today!

June Newsletter 

In This Issue
Diversity is Needed in Clinical Trials
Featured HCV Clinical Trials  

South Denver Gastroenterology, PC is currently enrolling patients for:
A phase 3 trial to investigate the efficacy and safety of a 12 week regimen of simeprevir in combination with sofosbuvir in patients that have or have never gone through treatment, with chronic HCV genotype 1 infection, and that have cirrhosis...

Eight Colorado Organizations Offered Free Hepatitis C Testing to the Public

Sign Up For Online Monthly Newsletter

Connect On Facebook

The HCV Advocate newsletter is a valuable resource designed to provide the hepatitis C community with monthly updates on events, clinical research, and education. 

HCV Advocate News & Pipeline Blog
Click Here

HCV Advocate Newsletter
June Issue

In This Issue:

HCV Drugs
Alan Franciscus, Editor-in-Chief

Lucinda K. Porter, RN

HEALTHWISE: Hepatitis C & Liver Cancer (HCC)
Lucinda K. Porter, RN 

New At HCV Advocate

Affordable Care Act (ACA) – Special Enrollment Periods
Jacques Chambers, CLU,
Benefits Consultant
Posted June 16, 2014
When health insurance companies agreed to cover everyone that applies under the Affordable Care Act (ACA), regardless of their health or medical history, they wanted some arrangement so people couldn’t wait until they felt sick to buy insurance. That was resolved by limiting enrollment to certain Open Enrollment Periods....
Continue reading here.... 

First Steps with HCV — for the Newly Diagnosed
Offers suggestions for managing the early phases of living with an HCV diagnosis.

HCV Advocate Eblast
Stay informed on the latest here to register for email alerts
Connect With HCV Advocate

The HCV Action network has launched a new website and issued an Action Update reviewing the fast track funding from NHS England for Sofosbuvir. 

The HCV Action network brings together health professionals from across the patient pathway, including GPs, specialist nurses, clinicians, drug action teams, public health practitioners, prison healthcare staff and commissioners. We provide resources for commissioners, medical and drug services professionals, promoting good practice in HCV care across the UK.

Welcome to the new HCV Action website, the home of the UK’s hepatitis C professional community. Browse our tailored resource libraries, view our case study map or find out more information here>

HCV Action Update:

HCV Action good practice case study: Addaction's Positive Support Project, Lanarkshire
This HCV Action good practice case study gives an overview of a successful 'Positive Support' service for hepatitis C patients. Run by Addaction and based in Motherwell, the service provides informed advice, active support and treatment to otherwise isolated people with hepatitis C living in Lanarkshire, Scotland. The case study gives a breakdown of the issues the project aims to address; how the project works, and its outputs and outcomes.
UK, Scotland Jun 2014 Case study PDF

View this infographic of @PHE_uk's study highlighting high costs of untreated hepatitis C:

Visit HCV Action Website here

Follow Us On Twitter

Hepatitis C news, is an online community for those living with hepatitis C. Join us for news, views and features about hep C, read the real-life experiences of our guest bloggers, and learn about living well with the condition. 

New In June @ Hepatitis C News

25 years on
This year marks the 25th anniversary of the identification of the hepatitis C virus.

 View all HEP C News Videos, here

Stay connected

TRIO is an independent, not-for-profit, international organization committed to improving the quality of life of transplant candidates, recipients, their families and the families of organ and tissue donors.
Through the TRIO Headquarters and a network of chapters, TRIO serves its members in the areas of: Awareness, Support, Education, and Advocacy. This TRIO web site is filled with information about these areas and our many programs, including local chapter contact information, so wander around these pages to learn more about TRIO or contact your local TRIO chapter. If you still don't find answers to what you are looking for, please email us at or call 1-800-TRIO-386.

June Update

ACTION: Input sought on concept document for liver distribution

TRIO E-News June 2014: "The BIG 'C's' and YOU"
Cancer in the post transplant community: A board approved challenge for a new TRIO initiative

Summer and Diabetes

Newsletter Archives

Check Us Out On Twitter and Facebook


Perth, Australia

HepatitisWA (Inc) is a non-profit community-based organisation providing free services to the community. HepatitisWA aims to assist in obtaining the best possible care and support for people affected by hepatitis, reducing discrimination and stigma directed at people living with viral hepatitis and raising community awareness in relation to hepatitis. Visit our website to learn more about viral hepatitis.

The HepatitisWA Newsletter is a quarterly publication; with each edition we endeavour to capture new developments in hepatitis B and C treatment, management and other relevant topics.

This issue we cover the following:

• Shannon's Story - Personal Perspective
• Going Viral - Viral Hepatitis News
• C the person not the disease - Feature
• Is an $84,000 hepatitis treatment drug too expensive? - Feature
• Current hepatitis C treatments - Community News
• Live Healthy with hepatitis C - Health & Lifestyle
• Hepatidings: HepatitisWA Community Activities - Community News
• WASUA's Domain: WASUA's Health Service
 • HepatitisWA Peer Support Group - Advert

Healthy You

A monthly newsletter from the National Institutes of Health, part of the U.S. Department of Health and Human Services

June Issue


ACP Internist provides news and information for internists about the practice of medicine and reports on the policies, products and activities of ACP

June Issue

Disclosing medical errors the right way
By Jessica Berthold
After a medical error, patients want an explicit statement that an error occurred, what happened, and the implications for their health. They want an outright apology, not a statement of regret. Work from global organizations is refining the right way to disclose errors.
Did the Affordable Care Act make the grade?
By Robert B. Doherty
Four years since health care reform became law, there is finally enough information to grade how well enrollment is going. It will be many more years before the program can be judged an overall success, however.

Get rid of GERD without unneeded costs, tests
By Stacey Butterfield
Gastroesophageal reflux disease can be diagnosed in the office, without the need for expensive tests such as endoscopy. Learn how to make the right diagnosis while avoiding confounding symptoms that might steer a patient toward the wrong specialist.

Follow ACP On Twitter

by Brendie Kelly on June 21, 2014
Between 2001 and 2012, Ed continued to research the new and developing treatments for Hep C. Ed regularly had his blood drawn to determine the progress of the disease, and had a liver biopsy to determine the level of fibrosis in the liver and provide his physician an assessment of histology; both important factors to consider in the management and treatment of the disease. In 2012, Ed was placed on the then current treatment cocktail of interferon injections (once per week), Ribavirin (six capsules, three each twice a day), and Victrelis (two capsules, four times a day). Due to the various risk factors, his genotype and a compromised liver, it was determined that Ed would be on this treatment regimen for a total of 48 weeks, a month shy of a year.

Merck offers nearly $4B to buy hepatitis C treatment maker Idenix Pharmaceuticals
Merck is starting a tender offer today to buy all of the outstanding shares of hepatitis C treatment maker Idenix Pharmaceuticals.

Whitehouse Station-based Merck announced earlier this month that it would pay about $3.85 billion for the Cambridge, Mass.-based company. Merck is hoping that teaming Idenix's hepatitis C medicines with its experimental drugs will produce lucrative combo therapies that quickly cure most patients with the blood-borne virus afflicting tens of millions.

Hepatitis C has become one of the hottest categories in drug research as companies race to develop a combination therapy without injections and debilitating side effects. Some have had their promising candidates fail after extensive testing, due to dangerous side effects, but Gilead Sciences is already raking in billions of dollars from its groundbreaking new drug, Sovaldi.

Merck said Friday that once the tender offer closes, Idenix stockholders will receive $24.50 in cash for each Idenix share validly tendered and not withdrawn in the offer.
Idenix shares finished at $23.99 in Thursday.

The tender offer expires on Aug. 4, unless extended.

The boards of Merck and Idenix have approved the deal, which is expected to close in the third quarter. Idenix will become a Merck subsidiary.

A 4-week hep C cure? Bristol to test drugs with Gilead's Sovaldi
In the race to find a faster cure for hepatitis C, Bristol-Myers Squibb Co said it will test its experimental antiviral drug combination with Gilead Sciences Inc's blockbuster drug Sovaldi, hoping to cut treatment time to four weeks.

Boehringer Ingelheim exits hepatitis C field, pulls regulatory filings for faldaprevir 
By: Joe Barber
Boehringer Ingelheim on Friday announced that following a strategic review the company has decided against moving forward in the field of hepatitis C. As such, the drugmaker indicated that it will withdraw all regulatory filings for faldaprevir, which had been granted accelerated assessment by the European Medicines Agency, and will discontinue further development of the protease inhibitor.

The German pharmaceutical giant Boehringer Ingelheim is stopping development of faldaprevir, its hepatitis C virus drug.

All treatment-naive and previously treated participants using a combination pill containing Gilead Science's hepatitis C virus polymerase inhibitor sofosbuvir and NS5A inhibitor ledipasvir, without ribavirin, for 12 weeks achieved sustained virological response in a Phase 3 study in Japan, where most hepatitis C patients have HCV genotype 1b.

Also See: Gilead Announces Phase 3 Data Showing That the Fixed-Dose Combination of Ledipasvir/Sofosbuvir Achieved 100 Percent Sustained Virologic Response (SVR12) Among Patients with Chronic Hepatitis C in Japan 

Benefit of HCC screening uncertain for those with chronic liver disease 
June 18, 2014
It remains uncertain whether systematic screening for hepatocellular carcinoma leads to a survival advantage in patients with chronic liver disease,... 
June 18, 2014
Baby boomers accounted for the majority of patients with hepatitis C virus who received health care in the ED and in the outpatient and inpatient...
Editor's Note: The treatment for hepatitis C is evolving rapidly, and interferon-free options are now finally possible, with impressive sustained viral response (SVR) rates. Medscape spoke with Donald M. Jensen, MD, Professor of Medicine and Director of the Department of Hepatology at the University of Chicago, about the new and forthcoming treatment options for hepatitis C, some of which were presented at the recent Digestive Disease Week (DDW) meeting; the collaboration of care among providers in the treatment of patients; and an assessment of the cost now versus the prior standard of care.... 

The aim of this study was to evaluate efficacy of the direct-acting protein inhibitor sofosbuvir in combination with RBV in treatment-naive patients with HCV genotype 1. What were the findings?
Evidence-Based Medicine, June 2014

Consensus Guidelines -- Hepatitis C Management 
This consensus guideline provides expert opinion on the current best standard of care with available agents at this point in the rapid evolution of hepatitis C therapy.
Alimentary Pharmacology & Therapeutics, June 2014

Treatment of Chronic HCV in Children and Adolescents 
How well do children respond to treatment for chronic hepatitis C?
Archives of Disease in Childhood, June 2014

Expanding Primary Care Capacity to Treat HCV Infection 
This report outlines a care model which utilizes videoconferencing and case-based learning to enhance primary care provider capacity to treat HCV infection among underserved populations.
Morbidity & Mortality Weekly Report, June 2014

DDAs for Chronic HCV Infection in Liver Transplant Patients 
Direct acting antiviral agents provide new opportunities for treatment of HCV recurrence, but are there pitfalls?
American Journal of Transplantation, June 2014  

Provided By NATAP

FDA HCV Submissions / HCV Update - Click here

U.S. FDA Grants Priority Review to AbbVie for Investigational, All-Oral, Interferon-Free Therapy for the Treatment of Genotype 1 Chronic Hepatitis C 

Hispanics & Liver Disease/Fatty Liver, Liver Cancer & Mortality Rates Increasing Particularly Among Blacks & Hispanics 

A Multicenter Compassionate Use Protocol of Daclatasvir (BMS-790052) in Combination With Sofosbuvir With or Without Ribavirin for the Treatment of Subjects With Chronic Hepatitis C - Europe 

A Multicenter Treatment Protocol of Daclatasvir (BMS-790052) in Combination With Sofosbuvir for the Treatment of Post-Liver Transplant Subjects With Chronic Hepatitis C - USA Expanded Access Open

Provided By -

Patient-reported outcomes in HCV patients with cirrhosis treated with sofosbuvir-containing regimens 
Whether the presence of cirrhosis influences patient-reported outcomes (PROs), including health-related quality of life, during treatment with newly available anti-HCV (hepatitis C virus) regimens is unclear... 

Updated June 20, 2014
An index of articles pointing the reader to the current controversy over the high price of Solvadi
Bloggers Corner

Lucinda K. Porter, RN
Hepatitis C Treatment: A Gift
Hep C Warriors Friday Forum Support Group
Just post in the comment section below and be sure to check back to see replies to your comment.   Feel free to keep the conservation going and reply back.   This is how we communicate with each other on the forum.  We care about you and your thoughts.

Stay safe and healthy, until next time.

Always Tina

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