Friday, April 4, 2014

April HCV Newsletters: The HCV Debate - To Treat Or Defer

The HCV Debate: To Treat Or Defer

An article in the April issue of HepCBC's newsletter highlights a debate rather to treat HCV now or wait for future therapies. This highly entertaining and informative forty minute discussion took place in Toronto at the Canadian Association Liver conference.  

Topics include; Adverse consequences of deferring HCV therapy, new agents, SVR rates for genotypes 1-3, and cost. This presentation is easy to understand, a must see for anyone considering HCV therapy. View video presentation, here

HCV Newsletters

Welcome to the April edition of HCV newsletters, brought to you by a few generous individuals dedicated to bringing awareness and hope to people living with hepatitis C.

Spring Fever Is Here!

Is anyone having a particularly strong bout of spring fever? Maybe a little energy boost, or a certain enthusiasm for life, love, even cleaning?

Spring fever is our salvation from a long hard winter, a real biological phenomenon, according to Google.

Apparently during winter the body releases high levels of melatonin, a hormone that helps regulate sleep and is sensitive to light.  (Over the course of human evolution early humans often spent winter in a state of near-hibernation).

Once spring arrives with longer days and more daylight the body releases less of the hormone. However, soon the mood-altering chemical serotonin kicks in, levels apparently rise in spring. Enter a frenzy of house-cleaning, divorce, marriage proposals, children acting out, driving too fast, and that love struck spring fever! Although, the latter never arrived here in Michigan.

Living with hepatitis C, like spring, can be a journey of mood-altering moments; up and hopeful one minute and depressed and doubtful the next. The ebb and flow of hepatitis C is difficult to manage alone, especially when the virus leads to serious liver problems such as cirrhosis or cancer. Help is on the way, basic information about liver health, cirrhosis, even manopause, as well as new agents to treat HCV is offered in this months update and newsletters. 

Living With Cirrhosis

We begin with HCV advocate and author Karen Hoyt the creator of; Your Best Friends Guide To Hepatitis C. This month Karen is featured in four new videos which discuss tips, information and encouraging strategies for living with cirrhosis and HCV.
Begin Here....

Liver Health

A collection of latest research, news articles and health tips about viral hepatitis and liver health.
Begin Here...

Women and HCV

New From Hepatitis C New Drug Research and Liver Health

The effect of hepatitis C on the female gender  remains a controversial topic, literature into various aspects of infection, such as spontaneous clearance, progression of fibrosis, response to interferon-based therapy favor women but vary in different study cohorts, and have been found to be highly influenced by two female host factors; age and menopausal status.

In this slide-set we explore all of the above, HCV transmission and gender specific host factors that can influence disease progression using recent literature published in the Journal of Viral Hepatitis, and Hepatology, as well as the article; “Women With Chronic Hepatitis C Virus Infection Recommendations for Clinical Practice,” found in the July 2013 issue of Southern Medical Journal.
Begin Here........ 

Liver Cancer

Hepatitis C, Liver Cancer, and Bad New for Patients: It’s Never Easy
Primary liver cancer, or hepatocellular carcinoma, is a growing problem we face in the care of patients with chronic liver disease, especially hepatitis C. The number of new cases of liver cancer I see each week has grown steadily over the past 15 years. A lot of this has to do with the aging population of patients with hepatitis C. It is well known that the development of liver cancer is a function of time. The longer you liver with hepatitis C, the annual chance of developing cancer increases. The incidence of developing liver cancer is approximately 3-8% per year. Liver cancer is highest in those with cirrhosis; the risk of cancer in hepatitis C patients without cirrhosis is significantly reduced.
Continue reading.... 

News - Fibrosis / Cirrhosis / Liver Cancer / Transplants 

Clinical Trials

 Expanded access is currently available for this treatment. 
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
Tuesday, March 25, 2014 12:00 PM Identifier: NCT02097966

This study is STILL currently recruiting participants in the U.S. 
Phase III Daclatasvir and Sofosbuvir for Genotype 3 Chronic HCV (ALLY 3)

This study is STILL currently recruiting participants in the U.S. 
Phase III Daclatasvir, Sofosbuvir, and Ribavirin in Cirrhotic Subjects and Subjects Post-liver Transplant

To learn more about Hepatitis C virus clinical trials or to find out if a study is enrolling patients in your area, please click here. updated in the last 30 days

Gilead Announces Results From Phase 3 Study of Sofosbuvir Among Hepatitis C Patients in Japan
This week Gilead announced data from a Phase 3 study conducted in Japan using sofosbuvir in combination with ribavirin which included 153 patients with genotype 2.  SVR12 rates among treatment-naïve and treatment-experienced patients were at 98 percent (n=88/90) and 95 percent (n=60/63), respectively. Of the 153 patients who received treatment, 11 percent (n=17) had documented cirrhosis.

Gilead is also conducting a Phase 3 study in Japan evaluating the efficacy and safety of a once-daily fixed-dose combination of the NS5A inhibitor ledipasvir 90 mg and sofosbuvir 400 mg with and without ribavirin for the treatment of patients with genotype 1 chronic HCV infection, the most common strain of HCV in Japan. SVR12 results are expected in the second half of 2014.

Simeprevir and Sofosbuvir

Phase 3 Trials evaluating Simeprevir and Sofosbuvir have been initiated
Study design
The first trial, called OPTIMIST-1 or TMC435HPC3017, is a phase III, open-label, randomized study investigating the efficacy and safety of simeprevir 150 mg in combination with sofosbuvir 400 mg.
The combination will be administered once daily for 8 or 12 weeks in chronic HCV genotype 1 infected patients without cirrhosis who are HCV treatment naïve or treatment experienced. This study will enroll approximately 300 patients in the U.S. and Canada.

The second trial, called OPTIMIST-2 or TMC435HPC3018, is a phase III, open-label, single-arm study investigating the efficacy and safety of simeprevir 150 mg in combination with sofosbuvir 400 mg.

The combination will be administered once daily for 12 weeks in HCV genotype 1 infected patients with cirrhosis who are HCV treatment naïve or treatment experienced. This study will enroll approximately 100 patients in the U.S. and Canada.

Ribavirin will not be administered in the OPTIMIST trials. The primary efficacy endpoint in each study is the proportion of patients achieving sustained virologic response 12 weeks after the end of treatment (SVR12)......
Read more here.......

Preparing for the uncertain yet inevitable: Off-label combinations of antiviral agents in hepatitis C virus
This article will address anticipated issues regarding off-label use of HCV medications, including the role of the U.S. Food and Drug Administration (FDA), consumer pressure, medical society guidelines, and third-party payers. Off-label issues specific to the United States will be described; however, many concepts, such as uncertainties of cost, label regulation, and reimbursement, can be applied to health care systems globally.
Read more here @ NATAP....

Watch-Recent FDA approval of sofosbuvir and simeprevir - Implications for current HCV treatment
Will Sofosbuvir and/or Simeprevir Replace the Previous Generation of Antiviral Agents?

 The High Cost Of New Hepatitis C Drugs

Ohio Medicaid admits ‘strong merit’ to treating hepatitis C with Sovaldi, but $1K pills give pause
For private plans that run Medicaid managed care, the problem was that the drug was approved late last year after they’d set 2014 monthly per-member payments from states. Plans are responsible for excess medical costs above that fixed amount unless a state makes an exception to directly pay for certain treatments and drugs.

“While an official decision is likely to be made some time soon, there does appear to be strong merit to making this drug available through prior authorization and under the close guidance of specialists in hepatitis C treatment,” said a statement from the Ohio Department of Medicaid.
More here...... 

Hepatitis C advocate seeks PharmaCare coverage for Sovaldi
For Cheryl Reitz and about 150 million people across the world, hope carries the name Sovaldi. It’s a new prescription drug for hepatitis C, a contagious liver disease that can lead to death.

“There’s a good chance that we’ll be able to wipe out hepatitis C from the face of the Earth,” Reitz told the Straight in a phone interview today (April 4).

However, salvation comes with a hefty price tag...

Costs to Public of USD 84,000 Hep C Drug 'Outrageous'
Kaiser Permanente said it is using Gilead Sciences' new hepatitis C drug, Sovaldi (sofosbuvir), even though its $84,000 treatment price is 'outrageous.' 

Cost analysis of sofosbuvir/ribavirin versus sofosbuvir/simeprevir for genotype 1 HCV in interferon ineligible/intolerant individuals, or Daclatasvir+Sofosbuvir 
The study results suggest that a 12-week course of sofosbuvir/simeprevir is a more cost-effective treatment for genotype 1 chronic hepatitis C virus than 24 weeks of sofosbuvir/RBV among interferon-ineligible/intolerant individuals, supporting the AASLD/IDSA guidance and offering implications for both clinical and regulatory decision-making as well as pharmaceutical pricing. Download the PDF here  provided by NATAP

Skin Adverse Events During Dual and Triple Therapy for HCV-Related Cirrhosis
We report a case of a patient who discontinued telaprevir because of severe skin eruptions and who, during ribavirin and interferon treatment, after a period free of skin lesions, developed new dermatological lesions different than those experienced during telaprevir treatment.
Begin here.... 

Investigational Drugs

Treatment of chronic hepatitis C virus infection in the near future
A collection of news, and relevant links specific to new HCV drugs making their way to market. In addition an early preview of what to expect at EASL 2014, as well as an article discussing new direct-acting antiviral agents published online in the February 2014 issue of Gastroenterology & Endoscopy News , finally a review published in Annals Of Hepatology December issue; Treatment of chronic hepatitis C virus infection in the near future.

Of Interest

Increased risk of cirrhosis and HCC in patients infected with HCV genotype 3
Kanwal et al. HCV Genotype 3 is Associated with an Increased Risk of Cirrhosis and Hepatocellular Cancer in a National Sample of U.S. Veterans with HCV. Hepatology 2014; doi: 10.1002/hep.27095. [Impact Factor = 12.00]

The authors identified patients infected with HCV confirmed by a positive PCR and had genotyping results from the VA HCV Clinical Case Registry between 2000 and 2009. 110,484 patients with an active HCV viraemia were identified, of which 79.9% had genotype 1, 11.8% genotype 2, 7.5% genotype 3 and 0.9% genotype 4 disease. Patients with genotype 3 disease tended to be younger, but despite this had a higher risk of developing cirrhosis (unadjusted hazard ratio [HR] 1.40, 95%CI 1.32–1.50) and HCC (HR 1.66, 95%CI 1.48–1.85) compared to genotype 1 patients. After adjusting for demographics, clinical and antiviral treatment factors the risk of cirrhosis and HCC was 31% and 80% higher in patients with genotype 3 versus genotype 1 disease.

**Therefore genotype 3 is associated with a significantly greater risk of developing cirrhosis and HCC compared to HCV genotype 1.

Updated Daily: News and research with a focus on treating HCV according to genotype

Video - Reinfection: Does It Limit HCV Treatment as Prevention?
We have seen tremendous advances in the options for the treatment of HCV. They offer many possibilities, including what we know about HIV treatment, as a way of preventing new infections and limiting the extent of the HCV epidemic.

Let's talk about some of your recent work on reinfection with HCV and what this means. How big a problem is it in your communities, and what do you know about how this affects the prospects of treatment as prevention? 

Learning About HCV 

Recommendations for Testing, Managing, and Treating Hepatitis C
New recommendations for HCV management.

Hepatitis C Online Course
The University of Washington was funded by the Division of Viral hepatitis to develop a self-study, interactive course for medical providers on Hepatitis C infection. At this time, Module 1: Screening and Diagnosis of Hepatitis C Infection and Module 2: Evaluation, Staging, and Monitoring of Chronic Hepatitis C are active. Additional modules will be posted soon. 

Prevention, Care and Treatment of Viral Hepatitis

Updated Action Plan to Combat Viral Hepatitis Released
Today, federal partners launched an updated Action Plan for the Prevention, Care and Treatment of Viral Hepatitis (2014-2016)-PDF, building upon the nation’s first comprehensive cross-agency action plan to combat viral hepatitis. To access the full Action Plan for the Prevention Care and Treatment of Viral Hepatitis (2014-2016) visit 

Coming Soon....

European Association for the Study of the Liver (EASL) International Liver Congress 2014
This months meeting will take place April 9 - 13, 2014 in London, England.

Abstracts showing abstract title, author names and abstract data are available ahead of the congress. Click here for early media updates

April Index Of Hepatitis C Newsletters

This early index does not include all publications, updates will be shared on Twitter as additional newsletters are released.  

ALF Newsletter Added April 10

Welcome to the April 2014 edition of the Liver Lowdown.

In This Issue

Approximately 6,000 liver transplants are performed in the U.S. each year. How do you prepare for a transplant and what is life like after? ALF sits down with a renowned transplant surgeon to help you find the answers.

Many people may not realize that livers can come from a live donor. It’s an exciting area and with the shortage of cadaver organs, it can help patients desperately waiting for new livers. Read about one young man’s story of survival and friendship.

ALF patient advocates and staff participates in events across the country to raise much-needed funds for our public education and research programs. Here is what we have been up to during the last month.

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

Should you get tested for hepatitis C? Do you want to know about our upcoming webinars or participate in our Faces of Liver Disease campaign? Here is some information you should know.

ALF hosts a number of events throughout the year to support liver disease awareness.

Check Us Out On Twitter and Facebook
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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
April 2014

In This Issue:
CROI: 2014
Alan Franciscus, Editor-in-Chief

HEALTHWISE: Hepatitis C; Harm Reduction; and Health
Lucinda K. Porter, RN

Lucinda K. Porter, RN

HBV Journal Review
April 1, 2014, Vol 11, no 4
by Christine M. Kukka
Connect With HCV Advocate

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

In This Issue
April Features

Stamp Out Smoking
Tobacco-Free Living

Researchers have found effective ways to help people quit smoking—or prevent them from starting in the first place. The tricky part is putting these tools to use.  

The Sting of Shingles
Vaccine, Treatments Reduce Risks 

If you’ve ever had chickenpox, you may be at risk for a painful disease called shingles as you grow older. Fortunately, you can take steps to prevent shingles or ease its serious effects.

Health Capsules 
Nurse Staffing Affects Patient Safety
Updated Report on Heroin
Featured Website: Understanding Health News

Find Us On Facebook

HepCBC Hepatitis C Education and Prevention Society

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.
Liver Cancer Meeting – Link to Slideshows
Liver Cancer rates and deaths are rising all over the world; much of this increase is due to hepatitis C. Three of us from HepCBC attended a Liver Cancer (hepatocellular carcinoma or HCC) conference on Feb. 11th in Toronto, sponsored by the Canadian Assn. for the Study of the Liver (CASL). There will be an article summarizing the most interesting findings in the hepc.bull newsletter soon. Meanwhile, here is a link to the Powerpoint slides: video presentation here.

April Newsletter

In This Issue
Treat Now vs. Treat Later: Why Defer Treatment?
View video presentation, here

HCV Treatment Delivery by GPs?
Editor: This is the story of “C”, narrated in a series of sporadic emails that we have knit into a sort of diary

In Case You Missed It 
2014 Update: Treat Hepatitis C Now Or Wait? 
Released In March by - Hepatitis C New Drug Research and Liver Health
A collection of slides which offer SVR rates on both FDA approved and investigational HCV agents, including interferon-free regimens in late stage clinical trials. A few other  topics touch on off-label use by combining two newly approved drugs, terminology used to determine treatment response and links to relevant information.
Begin here.......

Stay Connected


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 April @ Hepatitis C News

ABC syringe: making invisible risk visible
April 2nd, 2014 An innovative two-year academic study has led to an effective means of combating the re-use of disposable syringes.

What are clinical trials?
March 27th, 2014 Clinical trials are research studies in which people volunteer to test new drugs, medical devices or combinations of currently used drugs.

Published on Apr 1, 2014
Another monthly round-up of all the latest news on hepatitis C from around the world.

This month we take a look at Gilead Science's new treatment, Sovaldi, and the growing issues around fair pricing. Also, we give tips on talking to family and friends about your hep C. Finally we put the spotlight on Anthony Keidis and his journey with the virus.

 View all News Videos

Stay connected

NYC Hep C Task Force
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

***April Newsletter - please check back

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Join Us

GI & Hepatology News
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.

***April Newsletter - please check back

Stay connected

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

Current Issue - April Issue

For hypertension, how low to go?
By Charlotte Huff
Updated blood pressure guidelines may have created more questions than closure, internists have found, as they try to determine how aggressively to treat hypertension and what goals to set for subpopulations of patients, such as those with diabetes. Experts react to the “paradigm shift” in lowering hypertension.

Men’s Health
Maintaining men’s health in middle age
By Leah Lawrence
Adrenopause, somatopause, andropause … manopause? They all give internists pause when considering men’s health as they reach middle age. As men try to maintain optimum health, doctors need to define what exactly that is.
Follow ACP On Twitter

Herbs and Spices

Can certain herbs and spices really boost immunity, control blood sugar, lower blood pressure and ease joint pain?

Improving your health using herbs and spices
As registered dietician Alison Ryan discusses in this Stanford Hospital & Clinics video, a growing body of scientific evidence suggests the answer is yes. During the 90-minute presentation, she explains in detail how ginger, turmeric, cinnamon and other ingredients can add a healthful punch to any meal, snack, or beverage by working to curb inflammation and prevent or delay certain types of cell damage. The talk is part of the Healthy Strides Ernest Rosenbaum Cancer Survivorship Lecture Series presented by the Cancer Supportive Care Program at Stanford.

Previously: How food may influence our cells and overall health and Nature/nurture study of type 2 diabetes risk unearths carrots as potential risk reducers

Source - Stanford News

Enjoy this lovely month!

Always Tina

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