Weekend Reading - Natural History And Conditions Related To HCV

Greetings to all, welcome to this edition of Weekend Reading. Thanks to Henry E. Chang, a quick overview of HCV and related conditions is the focus on the blog today. The good doctor often tweets PDF full text HCV articles on twitter, follow him here.

The Stats
Today, approximately 2.7 million Americans are infected with hepatitis C, with an estimated 130–200 million people worldwide. Of persons infected with hepatitis C, 15-25 percent will recover (spontaneous clearance) and 75-85 percent will become chronically infected.

A Review of the Natural History of Chronic Hepatitis C Infection
The natural history of hepatitis C remains controversial. Among HCV-infected individuals progression to advanced liver disease generally requires decades but is influenced by several host factors. For instance studies have shown factors such as; (age, sex, race, genetics), viral characteristics (genotype), behavioral (smoking, alcohol), metabolic factors (insulin resistance, obesity), and co-infection (Hepatitis B and HIV) may impact the degree of fibrosis and progression to cirrhosis as well as the potential for development of liver cancer. These factors are discussed in a review of the natural history of hepatitis C, published in the 2014 issue of  North American Journal Of  Medicine And Science.

Alcohol
Does Alcohol  Influence Spontaneous Clearance?
The effects of alcohol on spontaneous clearance of acute hepatitis C virus infection in females versus males; Results indicate that abstaining from drinking alcohol may increase the likelihood of spontaneous clearance among women.

Although, chronic infection can be cured about 90% of the time with FDA approved treatments, host factors still determine disease progression in people without viral eradication. As an example, persons with HCV-related cirrhosis, who consume light-to-moderate alcohol, compared to people who do not drink - increase the risk for liver cancer.

But can host factors influence mortality risk in people who successfully clear the virus with HCV therapy?
In an article reviewing a study published in the Journal of Hepatology (2016), Michael Carter writes about the mortality rates among people with HCV who achieve SVR. Again, host factors/health risk behaviors were an important factor for mortality. He writes; Most of the excess mortality was due to drug use or liver cancer. Several modifiable characteristics were associated with subsequent mortality risk, including drug use and heavy alcohol consumption. People without these risk factors – approximately a third of the study population – had survival that matched that of the general population. Here is the article; People with HCV attaining SVR continue to have increased mortality risk but this is due to alcohol and drug use.

Disease Progression

Researchers often reference a unique cohort of HCV patients when describing the natural history of hepatitis C. Never has there been a more perfect natural history study, in that - the known dates of infection were clear and precise. This for the most part is difficult to achieve since the time of acute HCV infection is often impossible to establish.

The somewhat famous and tragic cohort include 704 Irish women (1977-1978) and 917 German women (1978-1979) who were exposed to hepatitis C from contaminated Anti-D immunoglobulin, all from a single source. Researchers have studied the aging population of women at 17, 20, 25 and 35 years after infection.

In the German cohort previous studies suggest low rates of liver disease progression at 20 and 25 years after infection, showing only 0.5% end-stage liver cirrhosis at 25 years after infection, according to an article published in Hepatology 2014;58:49–57.

In the article investigators extended the study to 35 years after infection comprising of 718 patients of the original anti-D cohort.

Mortality at 35 Years After Infection
Figure 4 summarizes the overall mortality of the German HCV cohort at 35 years after infection in relation to the HCV infection status.

In total, 30 patients (4.2%) of the actual study cohort died since 1979. In the group of HCV RNA-negative patients, 10 (3.0%) died, among them 2 who were classified as inoculated patients without hepatitis, 7 with spontaneous recovery from HCV infection, and 1 with SVR after treatment who died of a malignant disease other than HCC.

In the group of HCV RNA-positive patients, 20 (5.3%) died, among them 9 (1.3%) who succumbed to definite HCV-related end-stage liver complications, such as esophageal variceal bleeding or hepatic coma. The remaining 11 HCV RNA-positive patients (1.5%) died from additional non-liver-related causes, such as cardiac failure, nonliver malignancy, apoplectic insult, or accident.

Click on image to enlarge

Conclusion: The present study provides further evidence for a mild, but significant, disease progression at 35 years after infection in the German HCV (1b)-contaminated anti-D cohort. Patients with self-limited HCV infection or SVR after antiviral treatment were protected from progressive liver disease and showed the best clinical long-term outcome.
Review the article; Evaluation of liver disease progression in the German HCV (1b)-contaminated anti-D cohort at 35 years after infection.

Of Interest
New study launched to discover how “super” immune system can prevent hepatitis C
Scientists from Trinity College Dublin are seeking volunteers who were exposed to anti-D contaminated with hepatitis C virus (HCV) between 1977 and 1979 as they attempt to discover why some people are naturally protected from HCV infection, while others are not.

Extrahepatic Manifestations
Review this series of great articles on the extrahepatic manifestations of HCV.

Published in Journal of Advanced Research

Volume 8, Issue 2, March 2017, Pages 85–87

Index Of Articles

Extrahepatic manifestations in hepatitis C virus infection

Current level of evidence on causal association between hepatitis C virus and type 2 diabetes: A review

Hepatitis C virus and cardiovascular: A review

New insights into HCV-related rheumatologic disorders: A review
Vasculitic syndromes in hepatitis C virus: A review
Hepatitis C and kidney disease: A narrative review
Hepatitis C virus and non-Hodgkin’s lymphomas: A minireview

Hepatitis C virus infection, and neurological and psychiatric disorders – A review

Begin here...

HCV Advocate
An Overview of Extrahepatic Manifestations of Hepatitis C

Of Interest

HCV - Fatty liver disease and genotype 3
In this post a collection of journal articles and videos reviewing HCV and fatty liver disease is offered; with a focus on individuals afflicted with both conditions. In addition given the development of steatosis (abnormal levels of fat in your liver) is higher in people with HCV and genotype 3, links are provided to current therapies in this difficult to cure genotype. Finishing off with several tips to help keep your liver healthy.

An Overview Of Hepatitis C Medications
Treatment Options in Hepatitis C — The Current State of the Art
By Stefan Zeuzem published in the January 2017 issue of Deutsches Ärzteblatt International
This review is based on relevant publications retrieved by a selective literature search, and particularly on studies and reviews concerning the course and treatment of hepatitis C.
Begin here...

Clinical Care Options
How Data From the 2016 Boston Hepatology Meeting Will Influence Future HCV Patient Management

Mark S. Sulkowski MD - 1/31/2017
I am really enjoying treating patients with HCV infection in this era of highly effective direct-acting antivirals (DAAs). Think about it: Our patients present with life-threatening, chronic infections, and we cure more than 95% of them with few adverse events. Other than insurance challenges, what’s not to love?
Despite the relatively easy road to cure with modern therapy in most of my HCV-infected patients, I can think of 2 recent patients who presented challenges: a patient with relapse and resistance associated substitutions (RASs) after treatment with a DAA and a patient with genotype 3 HCV infection and severely reduced renal function...
*Free registration required to view article

Achieving A Cure

Liver- and Non-Liver Related Critical Events Down in HCV and Cirrhosis

For patients with hepatitis C virus (HCV) infection and biopsy-proven cirrhosis, sustained viral response (SVR) is associated with a reduction in critical events, both liver and non-liver related, according to research recently published in Gastroenterology.

Helpful Links

HCV Advocate

Clinical Trials Reference Guide
Users can search for a hepatitis C clinical trial by category (genotype), or learn how to evaluate a clinical trial and become familiar with commonly used terms. HCV Advocate offers an easy to navigate HCV Medications Blog as well, organized by HCV genotype.

2017-HCV Genotypes/Treatment
Offered on this page of the blog is research updates with a focus on treating HCV according to genotype using FDA approved and investigational medicines. Information is extracted from news articles, peer-reviewed journals, as well as liver meetings/conferences, research manuscripts and interactive learning activities. 

Hopefully, this small summary will leave you with a better understanding of the natural history of  hepatitis C, conditions outside the liver (Extrahepatic Manifestations) and medications used to treat the virus.   

May you all enjoy the rest of your weekend.

Tina

Update - New Liver Test Guidelines

Anyone living with chronic liver disease is all too familiar with a simple blood test called a "liver function test." When my own test results are good - it's a huge relief.

An Update
If you haven't heard, the American College of Gastroenterology (ACG) has issued new guidelines on the evaluation of abnormal "liver chemistries."

A Big Change
According to Medscape; The new guidelines state that the normal ALT range is 19 to 25 IU/L for women and 29 to 33 IU/L for men. The article is patient friendly, an easy read, start here.

Don't Call It A Liver Function Test
As for "liver function tests" the ACG now suggests that "liver function tests" be referred to as "liver chemistries" or "liver tests.

The reasoning behind the name change is simple "Liver Function Tests" are not true measures of hepatic function. If you skipped the Medscape article, listen to this short podcast hosted by Arefa Cassoobhoy, MD, MPH to learn more about the liver test guidelines.

Here is a quick summary from Consultant 360;

ACG: Guidelines for Evaluating Abnormal Liver Chemistries
Among the recommendations:

• Men who consume more than 210 grams of alcohol per week and women who consume more than 140 grams of alcohol per week and have higher levels of serum aspartate aminotransferase (AST) than ALT  should be considered at risk for alcoholic liver disease and receive counseling for alcohol cessation.
• Screening for alpha-1 anti trypsin deficient with alpha-1 anti-trypsin phenotype is highly recommended for patients with persistently elevated AST or ALT.
• Patients with abnormal liver chemistries should be asked about prescribed and over-the-counter medications, non-prescribed complementary or alternative medicines, and dietary or herbal supplements that may be associated with drug induced liver injury.
• Liver biopsy is recommendation if serologic testing and imaging fails to explain a diagnosis, to stage a condition, or if multiple diagnosis are possible.

Continue reading here....

For more information read the complete - ACG Clinical Guideline: Evaluation of Abnormal Liver Chemistries (CME) available @ nature.com.

Enjoy the weekend!
Tina

The Treatment of Hepatitis C- An Introduction to the Use of New Medicines.

If case you missed it ..... two articles worth reading.

Editorial - The Treatment of Hepatitis C— An Introduction to the Use of New Medicines

09 January 2017
Dtsch Arztebl Int 2017; 114(1-2): 9-10; DOI: 10.3238/arztebl.2017.0009

Wörmann, B

An editorial accompanying the article “Treatment Options in Hepatitis C — The Current State of the Art,” by Stefan Zeuzem in this issue of Deutsches Ärzteblatt International

When Deutsches Ärzteblatt International invited me to write an editorial on the treatment of hepatitis C, I hesitated. The topic is evidently relevant not only to gastroenterology, but also to my own specialty, hematology/oncology; it is, however, currently surrounded by emotionally charged debate, sparked by the many new drugs against hepatitis C and their high prices. For both specialties, the availability of new treatment options coincides with major progress in our understanding of the disease. Yet discussions of how patients with hepatitis C should be treated are often narrowly centered on the question of drug costs, and the views expressed on the matter are often rigid and partisan. We can learn much from the way the new drugs for hepatitis C have been dealt with up to now.

Continue to full text article HTML, or Download PDF-Version

U.S. FDA Grants Priority Review to AbbVie’s Investigational HCV Regimen of Glecaprevir/Pibrentasvir (G/P)

Priority review shortens FDA review timelines from ten months to six months. Review studies presented at the Liver Meeting, news articles, and data on glecaprevir/pibrentasvir (G/P) published in peer-reviewed journals, here.

Enanta Announces U.S. FDA Grants Priority Review to AbbVie’s Investigational HCV Regimen of Glecaprevir/Pibrentasvir (G/P) for the Treatment of Chronic Hepatitis C in All Major Genotypes (GT1-6)
                        

• If approved, G/P may provide an eight-week, once-daily, ribavirin-free cure* for HCV patients new to treatment who have any of the major HCV genotypes, without cirrhosis
• G/P includes Enanta’s second protease inhibitor, glecaprevir (ABT-493)

February 02, 2017 08:16 AM Eastern Standard Time

     

WATERTOWN, Mass.--(BUSINESS WIRE)--Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a research and development-focused biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today announced that the U.S. Food and Drug Administration (FDA) has accepted AbbVie’s New Drug Application (NDA) for its investigational, pan-genotypic regimen of glecaprevir/pibrentasvir (G/P) being evaluated for the treatment of all major genotypes (GT1-6) of chronic hepatitis C virus (HCV), and has granted the NDA priority review. Glecaprevir is Enanta’s second protease inhibitor being developed through its collaboration with AbbVie and is one of the two new direct-acting antivirals in G/P.
The FDA grants priority review designation to medicines that it determines have the potential to provide significant improvements in the safety and effectiveness of the treatment of a serious disease. The NDA is supported by data from eight registrational studies in AbbVie's G/P clinical development program, which evaluated more than 2,300 patients in 27 countries across major HCV genotypes and special populations.
  
About AbbVie’s G/P HCV Clinical Development Program
AbbVie’s glecaprevir/pibrentasvir (G/P) clinical development program was designed to investigate a faster path to virologic cure* for all major HCV genotypes (GT1-6) and with the goal of addressing treatment areas of continued unmet need.
  
G/P is an investigational, pan-genotypic regimen that is being evaluated as a potential cure in 8 weeks for HCV patients without cirrhosis and who are new to treatment, who make up the majority of HCV patients. AbbVie is also studying G/P in patients with specific treatment challenges, such as genotype 3 HCV patients, patients who were not cured with previous DAA treatment, and patients with chronic kidney disease (CKD), including patients on dialysis.
  
G/P is a once-daily regimen that combines two distinct antiviral agents in a fixed-dose combination of glecaprevir (100mg), an NS3/4A protease inhibitor, and pibrentasvir (40mg), an NS5A inhibitor. G/P (300/120mg) is dosed once-daily as three oral tablets.
  
Additional information on AbbVie’s clinical trials for G/P is available at www.clinicaltrials.gov.
*Patients who achieve a sustained virologic response at 12 weeks post treatment (SVR₁₂) are considered cured of hepatitis C.

http://www.businesswire.com/news/home/20170202005659/en/Enanta-Announces-U.S.-FDA-Grants-Priority-Review

2017 February Hepatitis Newsletters - AbbVie's Glecaprevir/Pibrentasvir

2017 February Hepatitis Newsletters
Hello everyone, welcome to this months index of newsletters, with links pointing you to the latest headlines, journal articles, and recent posts by your favorite HCV bloggers.

Quick Links

Check out an article all about Probiotics, over at MD Whistleblower, written by Michael Kirsch, M.D. Or sit back and watch Karen Hoyt from I Help C discuss Hepatic Encephalopathy. Jump over to HCV Advocate and read; Is It Really ‘FDA Approved? updated recently by the FDA. Finally, don't forget to mark your calendar for an upcoming Treatment Access Webinar; Strategies to address reimbursement restrictions for Hep C treatment: Lessons from Australia, presented by CATIE, CanHep C and The Kirby Institute.

In The News - AbbVie's Glecaprevir/Pibrentasvir (G/P)
In December AbbVie submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration for Glecaprevir/Pibrentasvir (G/P), last month AbbVie's G/P regimen was granted accelerated assessment by the EMA, on Feb 1, AbbVie submitted a New Drug Submission (NDS), and received priority review from Health Canada. Today, Feb 2, Glecaprevir/Pibrentasvir G/P received accelerated review; U.S. FDA Grants Priority Review to AbbVie’s Investigational HCV Regimen of Glecaprevir/Pibrentasvir (G/P) for the Treatment of Chronic Hepatitis C in All Major Genotypes (GT1-6).

AbbVie's Glecaprevir/Pibrentasvir (G/P) is an investigational regimen for the treatment of all hepatitis C genotypes (GT1-6).  According to AbbVie's press release Glecaprevir/Pibrentasvir may provide a shorter, eight week treatment option for hepatitis C patients without cirrhosis and who are new to treatment. AbbVie is also studying G/P in patients with specific treatment challenges, such as genotype 3, patients who were not cured with previous DAA treatment and those with Chronic kidney disease (CKD), including patients on dialysis. The following journal updates discuss the above mentioned patient population; Glecaprevir/Pibrentasvir (G/P) in HCV genotype 1-infected patients who failed previous DAA containing therapy (Hepatology), patients with chronic genotype 3 HCV infection (Medscape) and patients with chronic kidney disease (MD Magazine). AbbVie press release: SVR12 Rates in Genotype 1 Japanese Patients.

HIV and Hepatitis - Glecaprevir/Pibrentasvir  
The Liver Meeting (AASLD 2016)
Studies presented at the Liver Meeting showed that glecaprevir/pibrentasvir taken for 8 or 12 weeks cured 98%-99% of non-cirrhotic treatment-naive and treatment-experienced people with HCV genotypes 1, 2, 4, 5, and 6 in the Phase 3 ENDURANCE trials. In the Phase 2 SURVEYOR-2 study the combo taken for 12 or 16 weeks cured at least 96% of treatment-naive and treatment-experienced people with HCV genotype 3 and cirrhosis. Glecaprevir/pibrentasvir also cured almost all hepatitis C patients with advanced kidney disease in the EXPEDITION-4 trial.

In The News

BLACK HISTORY MONTH: Pioneer turns sights to hepatitis C
Researched by SANDRA SEALEY
02 February 2017
WAYNE LAMAR GREAVES, originally from Church Hill, St Lucy, was always interested in science and why things worked the way they did. As a student at Harrison College he was fond of catching frogs and dissecting them in biology class.

Trump immigration ban upends international work on disease     

February 1, 2017

Amy Maxmen

Diseases don’t respect borders, laws or walls. And efforts to combat them rely on networks of scientists to detect outbreaks early, understand how the diseases operate and then intervene. Researchers say that President Donald Trump’s travel ban challenges that process, putting the United States at risk.

How Dual Hepatitis B, C Infection Differs from Single Infection

February 1, 2017
The bodies of patients infected with both hepatitis B virus (HBV) and hepatitis C virus (HCV) respond to the diseases differently than those infected with only one of the two. A recent study conducted by Fei Chen, PhD, of the University of South China, and colleagues compared the virological and immunological features of patients with dual and single infections and found significant differences.

Risk of liver cancer low in patients with cirrhosis, study finds
February 1, 2017
The results of a study by researchers at The University of Nottingham suggest that the risk of liver cancer in patients with cirrhosis may be much lower than previously thought.
The study found that only 1.2 per cent of patients with alcoholic cirrhosis and 1.1 per cent of patients with cirrhosis of unknown cause will develop HCC within a decade. The highest 10-year incidence of HCC was among those with cirrhosis due to chronic viral hepatitis (four per cent).

Of Interest
January 31, 2017
Regulus Announces Continuation of RG-101 Clinical Hold - FDA requests longer-term follow-up data from ongoing studies

Report Cites Liver Failure Risk With New Hepatitis C Drugs
January 26, 2017
Researchers find 524 cases of liver failure in people taking some of the drugs. Experts say the findings are inconclusive, the fatality rate is low, and the report should not influence prescribing.

Medscape Medical News, January 26, 2017

Douglas Dieterich, MD, director of the Institute for Liver Medicine at the Mount Sinai Health System in New York City, downplayed the significance of the report and said the findings should not change physician practice.

"The data in this report do not conclusively prove the hepatitis C medications Sovaldi and Harvoni cause liver failure. Without clear evidence of cause and effect, we cannot risk this information deterring patients from seeking the care they need," he said in a prepared statement.

"This is data from all over the world and we know the standards of medical care are not equivalent," Dr Dieterich told Medscape Medical News.

He pointed out that the 165 deaths among 250,000 patients comes to a rate of .00066. Even if the drugs caused the liver failure — and this report doesn't prove that — the rate "is likely much lower than that of the liver disease itself," he said. "We don't know how many of these patients were cirrhotics but even healthy cirrhotics have a 10% per year mortality rate. For decompensated, it's more like 30%."

"We have a new Hepatitis C epidemic of under-30-year-olds," Dr Dieterich said. "We shouldn't be scaring them away with a report like this that has no relevance for 99.9% of the population."

Continue reading article...

Newsletters
We begin with HCV Advocate, a patient advocacy organization dedicated to providing patient information and support.

HCV Advocate

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

February Newsletter

Topics
HealthWise – Connecting the Heart and the Liver – Lucinda K. Porter, RN. Lucinda talks about the health of these important organs. The number of people who die from heart disease annually is staggering.

Under The Umbrella – Harm Reduction and Hepatitis C – Matthew Zielske. Matthew discusses aspects of harm reduction geared towards hepatitis C transmission. He is also working on many new Harm Reduction fact sheets for the HCV Advocate Website. Three new fact sheets are listed below.

SnapShots – Alan Franciscus. In this month’s column I cover three studies—deaths caused by hepatitis C among Mexican Americans, non-Hispanics Whites and non-Hispanic Blacks, the changes in the most common indications for liver transplants and transplant waitlists and finally, a study that looked at the best practice to screen people at risk (including Baby Boomers) for hepatitis C in an effort to increase screening. All three studies are very illuminating.

Drug Pipeline — no changes in this month’s Drug Pipeline

What’s Up! – New this month are three Harm Reduction Fact Sheets:
Harm Reduction and Alcohol
Harm Reduction and Indirect Sharing
Harm Reduction Definitions

Coming Mid-February: Hepatitis C Drug Pipeline and Conference Coverage – The new feature will be populated by our conference coverage from 2016, from EASL and AASLD, and future conferences as well as current and future articles about drugs in development.

The Hepatitis C Mentor and Support Group (HCMSG)
The Hepatitis C Mentor and Support Group (HCMSG) was founded to address the lack of awareness, support, and services for people living with Hepatitis C (including patients co-infected with other conditions such as HIV/AIDS and Hepatitis B), and patients in need of or living with liver transplants. To address these needs, we provide resources and services to foster the development and operation of successful support groups for Hepatitis C and co-infected patients. These services are provided to prospective and current support group facilitators FREE OF CHARGE. In the future, we will also provide one-on-one mentoring services to Hepatitis C and liver transplant patients.

New 2017 Patient Newsletter
All Newsletters
Visit - HCMSG Blog

The New York City Hepatitis 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.

January 2017 Hep Free NYC Newsletter

All Newsletters - Archives

HCV Action

HCV Action brings together hepatitis C health professionals from across the patient pathway with the pharmaceutical industry and patient representatives to share expertise and good practice.

HCV Action e-update: January 2017
31 Jan 2017

Pacific Hepatitis C Network (PHCN)
Welcome to the Pacific Hepatitis C Network (PHCN) newsletter. This is where we review all of the major current issues and events around hepatitis C and hep C treatments. It is an email that includes links to our recent blog posts—including links to blog posts about Public Health Agency of Canada funding.

Subscribe

Subscribers to our mailing list will receive a bi-weekly newsletter, via email, highlighting all of the blog posts written by PHCN and published for PHCN's Newsletter and Hep C TIP News. Current subscribers of either blog will begin receiving this one bi-weekly newsletter. Open them for information and links to blog posts that interest you.

Sign up here.

What’s Been Recently Published About Hep C

The following highlights a variety of December/January published studies, articles, and press releases about hepatitis C and hepatitis C treatments.

Begin here...

Save The Date - February 6th at 12-1:30pm

Treatment Access Webinar
Click here for more information and to register for the webinar on February 6th at 12-1:30pm PST.

In collaboration with CanHepC, CTAC, and the Kirby Institute in Australia, CATIE is organizing a webinar looking at strategies to address Canada’s current restrictive and inconsistent approach to direct-acting antiviral (DAA) access and lessons we can learn from the Australian model.

Register now and learn from experts such as Alison Marshall and Greg Dore of Australia’s The Kirby Institute; and Helen Tyrell of Hepatitis Australia. Engage in discussion with Adam Cook of CTAC and Action Hepatitis Canada; Community Organizer Zoe Dodd.

GI & Hepatology News
Over 17,000 gastroenterologists and hepatologists rely on GI & Hepatology News every month to cover the world of medicine with breaking news, on-site medical meeting coverage, and expert perspectives both in print and online. The official newspaper of the AGA Institute was launched in partnership with IMNG in January 2007.

Newsletter - February 2017
Review all newsletters - Past Issues

Weekly Bull

For over a decade HepCBC a Canadian non-profit organization has published an incredible monthly newsletter offering awareness, personal stories and basic information about HCV.

Recently the highly successful newsletter has been retired, however without fail a new publication "The Weekly.Bull" will continue to serve us well, here is the latest issue.

Latest Issue: Weekly Bull

British Liver Trust

The British Liver Trust is the leading UK liver disease charity for adults – we provide information and support; increase awareness of how liver disease can be prevented and promote early diagnosis; fund and champion research and campaign for better services.

January 2017 Newsletter, all Newsletters here.

Blog Updates From Around The Web
Read inspiring HCV articles recently published by a small list of wonderful bloggers. These bloggers update us with personal stories filled with easy to understand information about treating or living with viral hepatitis.

Hepatitis B Foundation
The Hepatitis B Foundation is a national nonprofit organization dedicated to finding a cure for hepatitis B and helping to improve the lives of those affected worldwide through research, education and patient advocacy. Our monthly electronic newsletter, provides research updates, healthy liver tips, information on public health initiatives, and other HBF news.
Click here to subscribe

If Hepatitis B Is Sexually Transmitted, How Come My Partner Isn’t Infected?
February 1, 2017
By Christine Kukka
I thought hepatitis B was sexually transmitted? I just tested positive, but my partner tested negative, we’ve been together for years, what gives?
This question is a common one. Hepatitis B is indeed easily transmitted sexually, so why do some people — who were not vaccinated — never get hepatitis B from their sexual partners?

January 11, 2017
It’s Flu Season: When You Have Hepatitis B, Too Much Tylenol Can Damage Your Liver
Cold season is here and sometimes getting a flu shot and consistently washing our hands aren’t enough to keep colds at bay. If you do get sick, make sure the over-the-counter medication you take doesn’t damage your liver while it’s relieving your aches and pains.

I Help C
Your Best Friends Guide To Hepatitis C and Cirrhosis
Karen Hoyt
This site is dedicated to helping those who have Hepatitis C or Cirrhosis. I'm not a doctor, but I'll be your Best Friend.

Hepatic Encephalopathy
Video - Help for Hepatic Encephalopathy
Help for Hepatic Encephalopathy is usually medications like Xifaxan or Lactulose. I made some Youtube Video blogs for you about how diet and exercise can help.
View latest video, view all videos here

HEPATITISC.NET
At HepatitisC.net we empower patients and caregivers to take control of Hepatitis C by providing a platform to learn, educate, and connect with peers and healthcare professionals.

Victim or Victor
By Daryl Luster - January 31, 2017
Over the years I have spoken to some people in the community who feel victimized because of their diagnosis of hepatitis C. It doesn’t sound the same with everyone and this is...

Practicing Self-Care on a Budget
By Editorial Team - January 30, 2017
We’ve previously defined and described the importance of self-care, and have given examples of how you can practice it in your daily life. While some tasks are easier than others, it isn’t...

Hepatitis C Researchers Eye Pre-Exposure Prophylaxis
By Jenelle Marie Davis - January 29, 2017
What Is It? Pre-exposure prophylaxis (often written out in the abbreviated word “PrEP”) is a medical treatment decision in which antiviral hepatitis C drugs are given to an individual who has definitely...

Read other recent HepatitisC.net headlines
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MD Whistleblower
Michael Kirsch, M.D.
I am a full time practicing physician and writer. I write about the joys and challenges of medical practice including controversies in the doctor-patient relationship, medical ethics and measuring medical quality. When I'm not writing, I'm performing colonoscopies.

Probiotics Promote Digestive Health - Is There a Germ of Truth
January 29, 2017
Several times each week, I am asked about the value of probiotics. Many of my patients are already on them, based on a personal recommendation or an advertisement. As a gastroenterologist, I routinely treat patients with all varieties of diarrhea conditions, such as irritable bowel disease, ulcerative colitis, Crohn’s disease, lactose intolerance, celiac disease and the highly feared gluten sensitivity. Many of them arrive in the office with a probiotic in hand waiting for me to pass judgment. These patients look to me as a Digestive Supreme Court Justice as they sit on the edge of their chairs waiting for my ruling in the case of Probiotics vs Disease.

Hep BOOMers
Hep BOOMers is dedicated to the millions of Baby Boomers who contracted hepatitis C and to the boom in medical research that could cure them.

Phony Harvoni spurs new packaging in Japan
Posted on January 20, 2017 by Elizabeth
Gilead Sciences in Japan has decided to change the packaging of Sovaldi and Harvoni in that country. The direct-acting antivirals will now be sold in blister packs rather than bottles, which would make it harder for counterfeiters to scam patients who have hepatitis C.

Creating a World Free of Hepatitis C

By Lucinda K. Porter
Welcome to my website and blog. My name is Lucinda Porter and I am a nurse committed to raising awareness about hepatitis C. I believe that we can create a world free of hepatitis C. We do this together, one step at a time.

Important Information That Everyone Needs
by Lucinda Porter on February 2, 2017

Lately we hear a lot about fake news and alternative facts. Leading news organizations bypass reporting the news and publish opinion pieces about what is truth and what is a lie. It can all get quite fuzzy.

Take with a Grain of Salt
on January 26, 2017
Last year, I had a lot of medical problems. Nothing life-threatening, all of them treatable. I don’t want to write a litany of woes, but I will discuss one of my issues in this post – Meniere’s Disease. If you’ve never heard of it, and want to know more, look it up. Vertigo, loss of balance, and hearing loss are the common symptoms. Tinnitus is a constant companion.
Continue reading....

HEP - Blog Updates
Hep is an award-winning print and online brand for people living with and affected by viral hepatitis. Offering unparalleled editorial excellence since 2010, Hep and Hep Magazine are the go-to source for educational and social support for people living with hepatitis.

Hepatitis C Treatment in the USA
By Greg Jefferys
Greg Jefferys shares his opinion and concerns about the problems some people in the US have accessing treatment.

Hepatitis C in the News: Reading Between the Lines
By Lucinda K. Porter, RN
Is the news you are reading about hepatitis accurate? Sometimes you need to read between the lines.

What a New Year Can Mean to You
By Karen Hoyt
The new year can be a time of new beginnings , especially for people with health issues such as liver disease.

Misleading Hep-C Article
By Carleen McGuffey
I wonder how many people considering treatment for hepatitis c will read this and decide its too risky?

Conquering Hep C Patients; Where Are They Now?
By Connie M. Welch
A look at one person with cirrhosis who was cured of hepatitis C, and how she is doing years later.

Healthy You
‘Geriatric tsunami’ carries elderly obesity
From the February ACP Internist, copyright © 2017 by the American College of Physicians
By Mollie Durkin
By 2030, more than 20% of the U.S. population is expected to be over the age of 65, according to the U.S. Census Bureau. As John A. Batsis, MD, FACP, sees it, “We're in the midst of a geriatric tsunami.” And the wave may carry with it patients with obesity and poor eating habits.

Happy Valentines Day!
Tina

How Dual Hepatitis B, C Infection Differs from Single Infection

How Dual Hepatitis B, C Infection Differs from Single Infection
Feb 01, 2017 | Dava Stewart
The bodies of patients infected with both hepatitis B virus (HBV) and hepatitis C virus (HCV) respond to the diseases differently than those infected with only one of the two. A recent study conducted by Fei Chen, PhD, of the University of South China, and colleagues compared the virological and immunological features of patients with dual and single infections and found significant differences.

In some areas, among particularly high-risk populations, HBV/HCV dual infection is relatively common. The researchers noted that there is increasing evidence that such dual infections are more difficult to treat, and that there is a higher likelihood of disease advancement—from chronic hepatitis to cirrhosis and hepatocellular carcinoma. Previous studies seemed to indicate that dual infection has different virologic and immunologic profiles than single infections, but those studies have yielded inconsistent results.

Continue reading....

Risk of liver cancer low in patients with cirrhosis, study finds

Risk of liver cancer low in patients with cirrhosis, study finds
01 Feb 2017 00:15:00.000

PA 18/17

The results of a study by researchers at The University of Nottingham suggest that the risk of liver cancer in patients with cirrhosis may be much lower than previously thought.

Liver cancer – or hepatocellular carcinoma (HCC) – is one of the most serious complications of cirrhosis, or scarring of the liver, caused by long-term liver damage.

However, an analysis of health records, published in the academic journal Alimentary Pharmacology and Therapeutics, found that the 10-year incidence of HCC in UK patients with cirrhosis is actually only four per cent, or lower.

Joe West, Professor of Epidemiology in the University’s School of Medicine, led the study and believes that the results could better inform doctors on how best to focus resources for the benefit of patients with liver damage.

He said: “This very low incidence of HCC occurrence in people with cirrhosis caused by alcohol or of unknown origin suggests that surveillance for HCC among these groups is likely to benefit patients little.

“As surveillance incurs substantial cost, it is therefore unlikely to represent value for money for the NHS. There may well be other ways of spending this money that would benefit patients far more.”
Cirrhosis is caused by long-term damage to the liver, which leads to a build-up of scar tissue which replaces healthy tissue and eventually can result in liver failure.

The researchers identified more than 3,000 patients with cirrhosis of the liver using the UK’s General Practice Research Database between 1987 and 2006 and then cross-referenced this information with diagnoses of HCC on linked national cancer registries.

The study found that only 1.2 per cent of patients with alcoholic cirrhosis and 1.1 per cent of patients with cirrhosis of unknown cause will develop HCC within a decade. The highest 10-year incidence of HCC was among those with cirrhosis due to chronic viral hepatitis (four per cent).

http://www.nottingham.ac.uk/news/pressreleases/2017/january/risk-of-liver-cancer-low-in-patients-with-cirrhosis-study-finds.aspx

Health Canada Grants Priority Review to AbbVie's Glecaprevir/Pibrentasvir (G/P) for Chronic Hepatitis C Genotypes (GT1-6)

Health Canada Grants Priority Review to AbbVie's Investigational Regimen of Glecaprevir/Pibrentasvir (G/P) for the Treatment of Chronic Hepatitis C in All Major Genotypes (GT1-6)
February 1, 2017

If approved, G/P may provide a shorter, eight week, once-daily, ribavirin-free treatment option for the majority of HCV patients without cirrhosis

AbbVie's New Drug Submission is supported by data from its global registrational clinical development program across all major HCV genotypes and in patients with specific treatment challenges

MONTREAL , Feb. 1, 2017 /CNW/ - AbbVie, a global biopharmaceutical company, today announced it has submitted a New Drug Submission (NDS), and received priority review from Health Canada, for its investigational, pan-genotypic regimen of glecaprevir (ABT-493)/pibrentasvir (ABT-530) (G/P) for the treatment of all major chronic hepatitis C virus (HCV) genotypes.

If approved, G/P may provide a shorter treatment duration for genotypes 1-6 (GT1-6) in patients without cirrhosis, who make up a large portion of HCV patients in Canada , and an additional treatment option to patients with compensated cirrhosis (Child-Pugh A). G/P is also intended to address the unmet medical needs of patients with specific treatment challenges, including those with severe chronic kidney disease (CKD) and those not cured with previous direct acting antiviral (DAA) treatment.

"HCV patients with severe chronic kidney disease present a complex challenge for physicians to treat. This is particularly true in those with genotype 2 and 3 infection, and those with cirrhosis," said Dr. Curtis Cooper , Director of the Regional Hepatitis Program at the Ottawa Hospital. "Recent clinical trial results are a positive development in AbbVie's investigation of the G/P regimen for patients with chronic kidney disease, who currently have limited HCV treatment options."

"At no other time in history has the goal of eliminating hepatitis C in Canada been within reach like it is now, said Stéphane Lassignardie, General Manager, AbbVie Canada. "We are firmly committed to seeing this goal accomplished. As such, we have invested significantly in recent years in clinical trials in Canada for our investigational, pan-genotypic G/P regimen and will continue collaborating with Health Canada to help provide a cure for as many Canadians as possible living with HCV."

AbbVie's NDS is supported by data from eight registrational studies in AbbVie's G/P clinical development program, which evaluated more than 2,300 patients in 27 countries, including 174 patients in Canada , across all major HCV genotypes and special populations. Patient populations studied included GT1-6, those new and experienced to antiviral treatment, those with compensated cirrhosis and without cirrhosis, and patients with specific treatment challenges, including those with severe CKD, and those not cured with a prior DAA-containing regimen. The registrational program for G/P was designed to investigate a faster path to virologic cure* for all major HCV genotypes (GT1-6) and with the goal of addressing areas of continued unmet need.

On January 24 , AbbVie announced its marketing authorization application (MAA) for G/P has been validated and is now under accelerated assessment by the European Medicines Agency (EMA). On December 19, 2016 , AbbVie submitted its New Drug Application (NDA) for G/P to the U.S. Food and Drug Administration (FDA) for the treatment of GT1-6 chronic HCV. And on September 30, 2016 , AbbVie announced that G/P was granted Breakthrough Therapy Designation by the FDA for genotype 1 patients not cured with prior direct-acting antivirals.

G/P is an investigational product and its safety and efficacy have not been established. Additional information on the clinical trials for G/P is available at www.clinicaltrials.gov.

http://finance.yahoo.com/news/health-canada-grants-priority-review-130000011.html