Tuesday, April 4, 2017

Medicaid Reimbursement for Oral Direct Antiviral Agents for the Treatment of Chronic Hepatitis C

Medicaid Reimbursement for Oral Direct Antiviral Agents for the Treatment of Chronic Hepatitis C
Kohtaro Ooka , MD 1 , James J. Connolly , MD 1 and Joseph K. Lim , MD 2

SUPPLEMENTARY MATERIAL is linked to the online version of the paper at http://www.nature.com/ajg

Am J Gastroenterol advance online publication, 4 April 2017; doi: 10.1038/ajg.2017.87

All-oral direct-acting antiviral (DAA) regimens are an excellent modality to treat chronic hepatitis C virus (HCV) infection. Federal Medicaid law requires states to cover all drugs from manufacturers with rebate agreements with the Department of Health and Human Services within their FDA label. However, because of their high cost, many state Medicaid agencies do not cover DAAs for those who have mild liver disease or who abuse substances (1 ,2) . These restrictions persist despite many analyses that confirm that DAA regimens are cost-effective (reduce the cost per quality adjusted life year) ( 3,4 ) and result in savings in healthcare spending ( 5 ). We sought to assess whether and how these restrictions have changed since oral DAAs fi rst came on the market. On the basis of our experience and anecdotal evidence, we expected that despite loosening of restrictions, the majority of states have restrictions in excess of those recommended by professional societies.

View Article
Download PDF

Full Text Articles
I highly suggest you follow Henry E. Chang on Twitter if you are interested in reading full text articles about the treatment and management of hepatitis C. The above link was tweeted on 4/4/17

Sofosbuvir - WHO prequalifies first generic active ingredient for hepatitis C medicines

WHO prequalifies first generic active ingredient for hepatitis C medicines

On 31 March 2017, WHO for the first time prequalified a generic active pharmaceutical ingredient (API) for hepatitis C – sofosbuvir. Sofosbuvir is an essential ingredient for new, highly effective medicines to treat hepatitis C called direct active antivirals (DAAs). The prequalified product’s manufacturer is Mylan Laboratories Ltd - INDIA.

The emergence of DAAs in 2014 gave new hope to the 80-110 million people suffering from chronic hepatitis C, a disease that attacks the liver and kills approximately 700 000 people each year. The new medicines have an average 90% cure rate, have fewer side effects than previously available therapies and treatment regimens generally last just twelve weeks against the many months required with the older medicines. But these products are priced prohibitively, even for health systems in high-income countries.

Through a series of pricing strategies, including sub-licensing agreements, generic competition and price negotiations, some countries are making progress in tackling the disease. However, high-income and upper-middle-income countries are excluded from some of these arrangements and are often forced to ration treatment by making it available only for the sickest patients. To date, many of the people who need treatment before the virus causes permanent and often lethal liver damage are not accessing it.

By prequalifying the API, WHO has identified a quality source for generic manufacturers who wish to produce sofosbuvir. This should increase the availability of affordable generic medicines, thereby contributing to increased patient access. For example, generic competition has so far reduced prices in a number of countries: a three-month course of treatment in Egypt dropped from US$ 900 in 2015 to less than US$ 200 in 2016, and in Pakistan the same course today costs as little as
US$ 100.

Hepatitis C Blog, Journal and Newsletter Update For April 2017

April Updates
I love April, Easter is just around the corner, a favorite holiday for all the little people in our family. Living here in Michigan I sure do look forward to spring, although it seems to be starting off slow this year.

In any event thanks for stopping by, welcome to this month's collection of blog, journal and newsletter updates.

In The News
The hepatitis market is experiencing a revolution due to new types of treatments, and patients are benefitting. Where are we with this global disease?

Pharmacists can help optimize care in patients with hepatitis C virus
Drug-drug interactions (DDIs) are common in patients taking hepatitis C virus (HCV) medications, and the involvement of a clinical pharmacist could benefit the interdisciplinary hepatology team, researchers reported in the World Journal of Gastroenterology

Revived GOP health care talks could hurt those with pre-existing conditions
They could also opt not to cover the treatments needed by patients with costly illnesses, such as cancer, diabetes and hepatitis C. That would work out well for ...
SAN FRANCISCO (CN) — A Chicagoland pharmaceutical company claims in court that Swiss drug giant Novartis “has sought to patent the hepatitis C virus, itself,” so that anyone who tries to study or cure the disease must license the Novartis patents.

Statin use significantly decreased decompensation in patients with HBV- and HCV-related cirrhosis, with a borderline effect observed in patients with alcoholic…
On 31 March 2017, WHO for the first time prequalified a generic active pharmaceutical ingredient (API) for hepatitis C – sofosbuvir. Sofosbuvir is an essential ingredient for new, highly effective medicines to treat hepatitis C called direct active antivirals (DAAs). The prequalified product’s manufacturer is Mylan Laboratories Ltd - INDIA

Blog Updates

hepCoalition
hepCoalition.org is conceived as a tool to support the development of a global advocacy movement on access to hepatitis C diagnostics, treatment and support for people living with a high risk for HCV in low- and middle-income countries, and particularly for people who use drugs and people living with HIV/HCV.
hepCoalition.org is developed by Médecins du Monde and Treatment Action Group.

The HepC Pill Bill An insight into the availability, pricing and accessibility of HCV treatment

By Mrinalini Anand
4 April 2017
Introduction to Direct Acting Antivirals

Hepatitis C treatment has remarkably evolved over the years. The previously known standard HCV regimen consisted of a course of pegylated interferon injections and ribavirin tablets, which all in all were expensive, toxic, and needed 24 to 28 weeks to act. With the advent of new Direct Acting Antivirals (DAAs) in 2011, HCV regimens changed significantly. Sofosbuvir became the first drug to be approved for the new generation HCV treatment. DAAs have an edge over the previous medications, in the aspects of, being better tolerated and being more efficient in a shorter duration (90% cure rates after the first 12 weeks of treatment).
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(TAG) Treatment Action Group
Treatment Action Group (TAG) is an independent, activist and community-based research and policy think tank fighting for better treatment, prevention, a vaccine, and a cure for HIV, tuberculosis, and hepatitis C virus.

With every major election, particularly one that secures or fortifies Republican control of the White House, Senate, or House of Representatives, a certain amount of worry and strategy realignment is to be expected from public health activists and civil society. Following one of the biggest upsets in political history, in which Donald Trump rode a wave of populist and nationalist sentiments to become the 45th president of the United States and all but guaranteed a right-wing trifecta, the concern among health justice leaders has been unprecedented....
Continue reading TAGline April 2017 FINAL.pdf
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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.

Seven Years Hep C Free
By Daryl Luster - March 30, 2017
I am now seven years hep C free, and I thought I might take this opportunity to look back. It has been a short seven years, or at least it feels that...

Vietnam Vet Killed by Hepatitis C Added to D.C. Memorial
By Jenelle Marie Davis - March 29, 2017
The History In the United States, the Vietnam War was considered very controversial while it was occurring. However, since the creation of the Vietnam Veterans Memorial to soldiers who died in that...

Injection Drug Users Do Very Well on Sovaldi-Based Hep C Treatment
By Jenelle Marie Davis - March 28, 2017
Hepatitis C and Injection Drug Users Although hepatitis C can be contracted in numerous ways, the most common method of transmission is through the use of an infected needle. This sometimes occurs...

The Fine Line 7: Friends, Pain, and Tissues
By Rick Nash - March 27, 2017
The Fine Line is a series of stories from Rick. Check out part 1, part 2, part 3, part 4, part 5, & part 6! Fighting Through the Pain Pain medications, like...

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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.

Greg Jefferys
The Rapid Healing of Hep C with Direct Acting Antivirals
One of the amazing things about treating Hep C with the new DAAs is just how fast they work on getting rid of the Hepatitis C virus.

Hepatitis C Genotype 3

I have written a couple of times about the length of time for a Hepatitis C treatment, mostly about doing 12 weeks instead of 8 weeks when treating Genotype 1 with Harvoni, just to err on the side of caution. However, whilst the length of treatment for for genotype 3 with Sofosbuvir + Daclatasvir should ideally be 24 weeks, many doctors still tell patients that they should only consider 12 weeks.

Lucinda K. Porter, RN
Living Donation Liver Transplantation
Cirrhosis is the most common reason for liver transplantation in the United States. For decades, chronic hepatitis C virus (HCV) infection was the main cause of cirrhosis in the U.S., but non-alcoholic fatty liver disease (NAFLD) is quickly catching up.

Hepatitis C Treatment and Racial Differences
Until recently, medical literature has reported fairly evenly distributed SVR rates. However, a recent article in Hepatology (February 2017) found that there is a difference in response rates between Blacks and non-Blacks, even when DAAs are used.

Stay Updated
The latest from Hep bloggers.
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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.

Like Hepatitis B, Addiction Is a Chronic Disease That Needs Treatment Without Judgement
By Christine KukkaAddiction is a chronic disease, like hepatitis B, type II diabetes, cancer and heart disease. These diseases all run in families, are influenced by environment and behavior, and are notoriously difficult to treat.

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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.

Is My Doctor Up to Date?
Professional training and development are critical. Police officers, educators, orthodontists, painters, chief executives, musicians and chefs all need ongoing training to remain current. Job requirements evolve, and we must adapt. An accountant who hasn’t kept up with new or anticipated tax law changes might not account for much when computing your tax obligation or refund.
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HealthNewsReview.org
The mission of HealthNewsReview.org is to improve the public dialogue about health care by helping consumers critically analyze claims about health care interventions and by promoting the principles of shared decision-making reinforced by accurate, balanced and complete information about the tradeoffs involved in health care decisions. HealthNewsReview.org evaluates health care journalism, advertising, marketing, public relations and other messages that may influence consumers and provides criteria that consumers can use to evaluate these messages themselves. Improving the quality and flow of health care news and information to consumers can be a significant step towards meaningful health care reform.

No evidence given for claim that statins are beneficial for patients with chronic liver disease.
This release from the American Physiological Society summarizes a review of 50 studies on the
effects of statins on liver function.

I’ll admit this is predictable, but I can’t resist: It’s a tale of two news releases. Released on the same day, about the same study, but with very different headlines. 

Links
Blog
Website
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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.

Resisting the Coming Austerity: Medicaid in the Crosshairs
The 2016 election is in large part a story of the failure of existing health policy to adequately address a health crisis among the working class. The largest voter margins in favor of Trump comprise many people in poor health. This includes the opioid overdose epidemic currently occurring among predominantly white, suburban, and rural communities battered by deindustrialization and dimmed economic prospects. Affordable Care Act (ACA) repeal and replace legislation, presently defeated with the fall of the American Health Care Act (AHCA) but still an ambition of the White House administration and Republican Congress, threatened to make a bad situation worse.

New drug breakthrough can cure hep C in kids
A new cure for hepatitis C in children and adolescents is on the way, promising to help some of the silent victims of a nationwide heroin epidemic. A Cincinnati Children's Hospital Medical Center doctor who helped lead the research for the drug combination says the new medication regiment brings hope for all children with the disease.

Visit - HCMSG Blog
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AGA Journals - Blog
Dr. Kristine Novak is the science editor for Gastroenterology and Clinical Gastroenterology and Hepatology. She has worked as an editor at biomedical research journals and as a science writer for 15 years, covering advances in gastroenterology, hepatology, cancer, immunology, biotechnology, molecular genetics, and clinical trials. She has a PhD in cell biology and an interest in all areas of medical research.

A review article in the March issue of Gastroenterology discusses different hypotheses about the cells responsible for liver tumorigenesis. The article also reviews the different classes of liver tumors, based on the molecular features, and how these affect patient prognosis. Daniela Sia et al describe the distinct molecular and clinical features of hepatocellular
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Just For Fun Or Not

Brian C. Joondeph, MD | Physician | April 4, 2017
I’m only human. We have our good days and bad days just like anyone else. We try to always have a smile on our faces, be upbeat and cheerful. But we, too, are affected by life’s challenges — work, family, finances, health, and so on. Don’t be too quick to judge and criticize!
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Hot Topics

American Gastroenterological Association
AGA Reading Room - Medpage Today

Latest Articles
New HCV Tx Works Well for Severe Liver Disease
High Cure Rates for HCV Patients Undergoing Liver Transplant with New DAAs
Begin, here
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Infohep - Europe
The aim of infohep.org is to develop a high-quality online resource to increase awareness of viral hepatitis, its treatment, and the needs of people living with viral hepatitis in Europe.

In The News
Harm reduction should address the specific needs of couples who inject drugs
Roger Pebody / 03 April 2017
The sharing of drug injecting equipment most often occurs between sexual partners, but the ways in which couples manage risks and care for each other have been largely ignored by harm reduction ...

Contents
Early treatment for hepatitis C
Access to hepatitis C treatment in South East Asia
Cancers
Liver cancer and treatment for viral hepatitis
Direct-acting antiviral treatment achieves high cure rates in the most advanced liver disease patients with HIV co-infection
Glecaprevir/pibrentasvir combination does not interact with HIV medications
Hepatitis A outbreak in Europe
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    World Hepatitis Alliance
    World Hepatitis Alliance (WHA) presents hepVoice, a monthly magazine with updates on the latest projects, news from WHA members and key developments in the field of hepatitis
    Begin, here.....
    Download PDF
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    HepCBC - Canada
    HepCBC is a non-profit organization run by and for people infected and affected by hepatitis C. Our mission is to provide education, prevention and support to those living with HCV.

    Weekly Newsletter
    Latest Issue: Weekly Bull
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    Journal Updates

    American Academy of Neurology
    Hepatitis B and C may be linked to increased risk of Parkinson's disease
    We report strong evidence in favor of an elevation of rates of subsequent PD in patients with hepatitis B and hepatitis C. These findings may be explained by factors peculiar to viral hepatitis, but whether it reflects consequences of infection, shared disease mechanisms, or the result of antiviral treatment remains to be elucidated. Further work is needed to confirm this association and to investigate pathophysiologic pathways, potentially advancing etiologic understanding of PD more broadly
    Article - Download PDF
    Download Editorial, here....
    Media Coverage Of This Article, here

    Gastroenterology
    Elbasvir, grazoprevir in patients with HCV infection and compensated cirrhosis
    Patients with compensated, Child-Pugh A cirrhosis were allowed entry into the EBR/GZR phase 2/3 clinical trial program, and we have therefore conducted an integrated analysis of 402 patients with HCV GT1, 4, or 6 infection and compensated cirrhosis who received EBR/GZR alone or with RBV in these studies.
    Full Text, here
    Media Coverage Of This Article, here

    Healio
    Grazoprevir/Elbasvir Effectively Induces SVR in HCV with Prior Failure
    Zepatier treatment for 12 weeks, with or without ribavirin, was highly effective for induction of sustained virologic response in patients infected with hepatitis C genotypes 1, 4 or 6, who failed prior peg-interferon and ribavirin treatments, according to the results of the C-EDGE Treatment
    Experienced trial.

    Spleen size, platelet transit time useful in assessment of liver fibrosis
    Concomitant morbidities included hepatocellular carcinoma (either secondary to hepatitis C or other causes), non-alcoholic steatohepatitis and other ...

    Reactivation of hepatitis B is an infrequent but not rare complication of DAA therapy in HBV/HCV coinfected patients.  The availability of curative treatments for hepatitis C has placed increased emphasis on diagnosing and treating this condition.   This is an apt time, however, to also remind ourselves of the importance of screening all HCV infected patients for HBV.   As with immunosuppressive drug therapy, HBV screening and early treatment  are the key elements in preventing HBVr during DAA therapy.

    Medicaid Reimbursement for Oral Direct Antiviral Agents for the Treatment of Chronic Hepatitis C
    Kohtaro Ooka , MD 1 , James J. Connolly , MD 1 and Joseph K. Lim , MD 2
    SUPPLEMENTARY MATERIAL is linked to the online version of the paper at http://www.nature.com/ajg
    Am J Gastroenterol advance online publication, 4 April 2017; doi: 10.1038/ajg.2017.87
    All-oral direct-acting antiviral (DAA) regimens are an excellent modality to treat chronic hepatitis C virus (HCV) infection. Federal Medicaid law requires states to cover all drugs from manufacturers with rebate agreements with the Department of Health and Human Services within their FDA label. However, because of their high cost, many state Medicaid agencies do not cover DAAs for those who have mild liver disease or who abuse substances (1 ,2) . These restrictions persist despite many analyses that confirm that DAA regimens are cost-effective (reduce the cost per quality adjusted life year) ( 3,4 ) and result in savings in healthcare spending ( 5 ). We sought to assess whether and how these restrictions have changed since oral DAAs first came on the market. On the basis of our experience and anecdotal evidence, we expected that despite loosening of restrictions, the majority of states have restrictions in excess of those recommended by professional societies.
    View Article
    Download PDF
    ____________________________________________
    Many green tea supplements on the market claim to help with weight loss or a healthier metabolism, but health experts at Consumer Reports warn the products could actually be dangerous and recommend you avoid them altogether.

    Health Fraud Scams
    Health fraud scams refer to products that claim to prevent, treat, or cure diseases or other health conditions, but are not proven safe and effective for those uses. Health fraud scams waste money and can lead to delays in getting proper diagnosis and treatment. They can also cause serious or even fatal injuries.  
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    In Case You Missed It
    US could be rid of hepatitis B and C as public health problems, preventing nearly 90,000 deaths by 2030, with better attention to prevention, screening, treatment, and creative financing for medicines
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    April Newsletters

    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

    April Newsletter

    HealthWise – Sleep: The Key to a Healthy Liver by Lucinda K. Porter, RN. In this month’s column Lucinda explores the connection between sleep, the liver, a person’s health and the dreaded daylight saving time.

    SnapShots—by Alan Franciscus. I discuss three studies: Zepatier to treat people with bleeding disorders, the transformation of HCV treatment from the interferon era to direct-acting antiviral era with the VA system and finally the incidence of fatty liver in people with HIV, HCV, HIV/HCV coinfection and those with neither—and the very surprising outcome from the study.

    Under the Umbrella—Five Ways Hepatitis C is Unique to Women by Matthew Zielske. Matthew lays out five important facts about women and hepatitis C that you may or may not know about women infected with hepatitis C.

    What’s Up!
    HCSP Fact Sheets *Updated*:

    Bleeding Disorders
    HCSP Guide *Updated*

    A Guide to Understanding HCV
    Harm Reduction *New*:
    Begin, here
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    NVHR NEWSLETTER
    The National Viral Hepatitis Roundtable is a broad coalition working to fight, and ultimately end, the hepatitis B and hepatitis C epidemics. We seek an aggressive response from policymakers, public health officials, medical and health care providers, the media, and the general public through our advocacy, education, and technical assistance.

    View all newsletters, here

    Recent Additions
    NVHR Hails National Academies Hepatitis B & C Elimination Strategy
    The National Viral Hepatitis Roundtable hails the release of the National Academies of Sciences, Engineering, and Medicine's report A National Strategy for the Elimination of Hepatitis B & C.
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    Hepatitis C Coalition Quarterly Newsletter - UK
    The Hepatitis C Coalition is a group of leading clinicians, patient organisations, professional groups, industry and other interested parties committed to the reduction of morbidity and mortality associated with hepatitis C and its eventual elimination.  The Hepatitis C Coalition has funding from AbbVie, Gilead Sciences and Merck Sharp & Dohme.

    This quarterly newsletter provides a concise summary of developments in hepatitis C for policymakers, clinicians, commissioners, local government, charities and others with an interest in hepatitis C or public health.

    Quarterly Newsletter
    Public Health England (PHE) has published a report on Hepatitis C in England, subtitled, ‘Working towards its elimination as a major public health threat.’

    Hepatitis C Trust launches Patient Perspectives and Nurses' Perspectives reports

    Begin, here
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    Pacific Hepatitis C Network (PHCN) - Canada
    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.

    New Online
    Relapse, Recurrence, Null & Partial Response/rs: The Basics
    In hepatitis C and hep C treatment there are three ‘R’s that are big, sad, and scary. They are the bringers of sadness that if doctors, friends, and communities could protect someone from, they would.

    April Newsletter
    Daryl Luster, Pacific Hepatitis C Network's president, uses his vast experience with hep C to write about his thoughts about the virus in blog posts published online by HepatitisC.net.

    Hepatitis C Tip News
    Drug Pipeline 
    Advocacy
    Help4Hep: Canada’s Hep C Helpline
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    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.

    Liver Disease

    Review all newsletters, here
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    British Liver Trust  - UK
    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.

    View all Newsletters here.

    A firm foundation for working towards eliminating hepatitis C as a major public health threat in England
    Since new direct acting antiviral drugs have become available, the initial focus has understandably been on their role in averting severe hepatitis C-related liver disease and preventing the early death that can result from this.

    In fact, our recently published hepatitis C report suggests that we may be making headway here, with better access to improved treatment leading to the first fall in deaths from this indication observed in a decade.
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    HCV Action - UK
    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.

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

    View all issues, here.
    ____________________________________________

    Check back for updates.

    Stay safe, healthy and informed.
    Tina

    Elbasvir, grazoprevir in patients with HCV infection and compensated cirrhosis

    Safety and Efficacy of Elbasvir/Grazoprevir in Patients With Hepatitis C Virus Infection and Compensated Cirrhosis: An Integrated Analysis

    Full Text Article
    Persons with hepatitis C virus (HCV) infection are at risk of progressive liver disease, cirrhosis, and decompensation. We analyzed the effects of the direct-acting antiviral agents elbasvir and grazoprevir in patients with HCV infection and compensated cirrhosis, combining data from 6 clinical trials.

    Patients with compensated, Child-Pugh A cirrhosis were allowed entry into the EBR/GZR phase 2/3 clinical trial program, and we have therefore conducted an integrated analysis of 402 patients with HCV GT1, 4, or 6 infection and compensated cirrhosis who received EBR/GZR alone or with RBV in these studies.
    Continue to full text article published in the May issue of  @ Gastroenterology

    Media Coverage Of This Study
    From the Journals
    Elbasvir, grazoprevir beat HCV despite compensated cirrhosis
    Publish date: April 3, 2017
    By: Amy Karon Internal Medicine News

    Twelve weeks of combination therapy with elbasvir and grazoprevir (EBR/GZR) achieved sustained virologic response in 98% of treatment-naive patients with compensated cirrhosis and chronic hepatitis C (HCV) genotype 1, 4, or 6 infections, and in 89% of treatment-experienced patients, according to a pooled analysis of six industry-sponsored trials.

    Concomitant ribavirin offered “no incremental benefit” for treatment-naive patients, while 16 or 18 weeks of EBR and GZR with ribavirin achieved SVR12 in 100% of treatment-experienced patients, wrote Ira M. Jacobson, MD, of Mount Sinai Beth Israel and Icahn School of Medicine at Mount Sinai, New York, and his associates.

    Noninvasive tests for fibrosis - Editorial: combining elastography with blood test for fibrosis assessment in chronic hepatitis C

    Invited Editorial

    Editorial: combining elastography with blood test for fibrosis assessment in chronic hepatitis C Authors H. D. Trivedi, M. Lai

    First published: 3 April 2017
    DOI: 10.1111/apt.14011

    Editorial: combining elastography with blood test for brosis assessment in chronic hepatitis C 
    View Both Editorial and Authors Reply
    Download PDF

    The imprecision and invasive nature of the liver biopsy has led to the development of several validated non-invasive fibrosis markers, which have decreased the need for liver biopsy in chronic hepatitis C patients. In the realm of highly effective oral therapies, management is affected by the presence or absence of severe fibrosis, which would warrant surveillance screening for hepatocellular carcinoma and oesophageal varices. Vibration controlled transient elastography (VCTE) is a validated non-invasive modality that is widely used with an AUROC of 0.90 for detecting advanced fibrosis.[1] The limitation of VCTE is its potential overestimation of fibrosis, particularly in those with obesity or increased necroinflammatory activity.[2, 3] In contrast, serologic markers have historically led to underestimation of fibrosis levels.[4, 5] Combination of VCTE with other markers have shown favorable results[1] and have been proposed by national guidelines.[6, 7]

    Calés et al. evaluated the performance of a serologic test (FibroMeterV2G) with VCTE (Fibroscan) as two separate constitutive tests, as well as a single combined test (FibroMeterVCTE2G), for the detection of severe fibrosis in hepatitis C patients.[8] They found increased accuracy with the combination test, compared to individual tests alone, especially when there was concordance between the tests, validating the recommendation of using combined tests. The authors conclude that if the constitutive tests are concordant, then the diagnosis can be accepted, and if discordant, FibroMeterVCTE2G should be pursued. However, in cases (3.2%) of strict discordance, the FibroMeterVCTE2G is unreliable for detecting severe fibrosis (accuracy of 44%) and requires alternative measures for fibrosis (i.e. liver biopsy). The authors projected a reduction in the liver biopsy rates from 28% to 1% with the use of this diagnostic algorithm.

    This study validates EASL-ALEH and AASLD-IDSA recommendations to combine biomarkers with VCTE and shows the combined test to have improved accuracy, especially when there is concordance, eliminating the need for an invasive liver biopsy in the majority of patients. However, the claim that the liver biopsy rate is reduced from 28% to 1% should be taken with some caution as the authors did not provide the invalid and failure rate of VCTE, one of major components in their combination test. Although VCTE has revolutionised the non-invasive measurement of fibrosis, unreliable results and failure to obtain results have been reported in 3% and 16% of cases, respectively, mostly due to obesity and operator experience.[3] It would be important to see how the combined test performs in the United States population, which has a higher mean body mass index than this study cohort from France. While the accuracy of the FibroMeterVCTE2G is excellent, it still leaves 8% of patients misclassified, making it important that the clinician still thoroughly evaluates the patient's clinical, radiologic and laboratory data. The role of this combination test in monitoring the progression or regression of fibrosis, as well as its applicability to other chronic liver disease is an important avenue for research.

    Monday, April 3, 2017

    EPCLUSA™ - Alberta Also Broadens Access for Patients with Less Advanced Disease Who Have Other Health Conditions

    -- Alberta Also Broadens Access for Patients with Less Advanced Disease Who Have Other Health Conditions --

    MISSISSAUGA, ON , April 3, 2017 /CNW/ - Gilead Sciences Canada, Inc. ( Gilead Canada ) today announced, effective immediately, Alberta will provide public access to EPCLUSA™ (sofosbuvir/velpatasvir) tablets, the first once-daily, pan-genotypic single tablet regimen for the treatment of adults with genotype 1-6 chronic hepatitis C virus (HCV) infection. This listing will support patients to access curative therapy, and will advance Canada's efforts to achieving its World Health Organization commitment to eliminate hepatitis C by 2030.

    EPCLUSA, one tablet taken daily for 12 weeks, is for use in adult patients without cirrhosis or with compensated cirrhosis, and in combination with ribavirin (RBV) for those with decompensated cirrhosis. It is also the first single tablet regimen approved for the treatment of patients with genotypes 2 and 3, without the need for RBV.

    The approval of EPCLUSA was supported by data from four international Phase 3 studies, ASTRAL-1, ASTRAL-2, ASTRAL-3 and ASTRAL-4. Of the 1,035 patients without cirrhosis or with compensated cirrhosis treated with EPCLUSA for 12 weeks in the ASTRAL-1, ASTRAL-2 and ASTRAL-3 studies, 1,015 (98 per cent) achieved SVR12 (sustained virologic response 12 weeks after the end of treatment). In ASTRAL-4, patients with decompensated cirrhosis who received EPCLUSA with RBV for 12 weeks achieved a high SVR12 rate (94 per cent) compared to those who received EPCLUSA for 12 weeks or 24 weeks without RBV (83 per cent and 86 per cent, respectively). The most common adverse events in the four ASTRAL studies were headache and fatigue, and were comparable in incidence to the placebo group included in ASTRAL-1.

    The listing in Alberta follows the completion of a recent agreement between the pan-Canadian Pharmaceutical Alliance (pCPA) with member provincial, territorial and federal drug plans to fund this innovative therapy for patients. In addition, aligned with the pCPA agreement, Alberta will expand access to include patients with less advanced disease (fibrosis scores of F0 or F1) if they have been diagnosed with certain co-existing factors. All HCV patients with fibrosis scores of F2 or higher also remain eligible for reimbursement.

    For more information on the expanded access criteria:
    https://www.ab.bluecross.ca/dbl/pdfs/dbl_full_list.pdf


    "We now have the ability to cure almost all patients with chronic HCV with a simple and safe 12-week treatment, regardless of viral genotype or patient history," said Dr. Stephen Shafran , Professor of Medicine, Division of Infectious Disease, University of Alberta. "Broader access to EPCLUSA, particularly at the earlier stage of the disease, means that we can move more quickly to help patients achieve a cure, improve their quality of life, and prevent cases of advanced liver disease that is a significant financial burden for the healthcare system."

    In Alberta , the Public Health Agency of Canada estimates that more than 24,000 people are living with chronic HCV. In Canada, it is estimated that 250,000 Canadians are living with chronic HCV, with thousands of new cases diagnosed each year. There are six genotypes of hepatitis C. Genotype 1 infection is the most prevalent genotype in Canada representing 64.1 per cent of infected individuals. Genotypes 2 and 3 account for approximately 14.1 per cent and 20.2 per cent of infections in Canada , whereas genotypes 4, 5, and 6 are less prevalent in Canada (0.3 per cent).

    "Canada, and other countries, have committed to eliminating hepatitis C by 2030, and to accomplish this goal we need to significantly increase treatment rates," said Dr. Morris Sherman , Chairperson, Canadian Liver Foundation and hepatologist at Toronto General Hospital. "Treatment regimens are getting shorter, simpler and more widely effective across genotypes meaning that treatment is now easier for both patients and physicians to manage.

    "Currently, an estimated 44 per cent still remain undiagnosed, so increasing treatment rates also means improving screening and diagnosis, which is why the Canadian Liver Foundation recommends that all Canadians born between 1945-1975 receive a one-time test for hepatitis C," added Dr. Sherman. "Treatment should be an option for everyone, but the cost of treatment has been an obstacle. We're glad to see that the pCPA and the provinces are taking steps to make these treatments accessible regardless of where someone lives or their ability to pay."

    " Gilead Canada is pleased that the pCPA and Alberta Health are recognizing the innovation and clinical value of EPCLUSA for the treatment of all genotypes of hepatitis C in a single tablet regimen," said Kennet Brysting, General Manager, Gilead Canada . "Broader treatment access for patients will potentially have a profound impact on disease elimination efforts in Canada , and supporting such efforts is a key priority for our company. We will continue to work closely with all jurisdictions to bring this simple and cost-effective curative treatment to all eligible patients, regardless of their genotype or stage of fibrosis."

    Painful Joints?


    Painful Joints?
    Early Treatment for Rheumatoid Arthritis Is Key

    Painful, swollen, and stiff joints can be a sign of arthritis. Rheumatoid arthritis is one of the most common forms. The pain and stiffness can interfere with your life at home and at work. For some people, the disease is mild, but for others it can be disabling. Scientists continue to search for the cause of this disease and for ways to improve treatment.

    Arthritis is an inflammation of the joints. There are over 100 types of arthritis. While their symptoms can be similar, their underlying causes vary. Osteoarthritis is the most common type of arthritis. It’s far more common than rheumatoid arthritis. Osteoarthritis is caused by wear and tear on your joints. In rheumatoid arthritis, your immune system—which normally helps protect your body from infection and disease—starts attacking your joint tissues.

    Anyone can get rheumatoid arthritis. The disease most often begins in middle age or later. But it can occur at any age. Even children sometimes get a similar form of arthritis. Some types of arthritis affect one joint at a time, but rheumatoid arthritis can affect your whole body.

    It’s important to get the correct diagnosis because each form of arthritis needs to be treated differently. To diagnose rheumatoid arthritis, doctors use medical history, physical exams, X-rays, and lab tests. There’s no single test for the disease. It’s not easy to diagnose.

    “The joint swelling in rheumatoid arthritis is squishy, and very different from the hard bony enlargement of the finger joints that is sometime present in osteoarthritis,” explains Dr. Michael M. Ward, who oversees rheumatoid arthritis research at NIH.

    Your joints may appear red and feel warm. Pain and stiffness may be worse after you wake up or have been resting for a long time. Over time, your immune system damages the tough, flexible tissue (cartilage) that lines joints. This damage can be severe and deform your joints.

    Scientists don’t know exactly what causes rheumatoid arthritis. It’s likely a combination of genetics and environmental triggers, such as tobacco smoke or viruses. Hormones may also play a role. More women are diagnosed with rheumatoid arthritis than men. The disease sometimes improves during pregnancy or flares up after pregnancy.

    What scientists do know is that the damage is caused by the immune system gone awry. The body’s defense system mistakenly attacks the membrane that lines joints, such as in the wrists, fingers, and toes. Joints in the neck, knees, hips, ankles, and elsewhere can also be affected.

    “The immune system is supposed to be something that does good things for you,” says Dr. M. Kristen Demoruelle, an NIH-funded arthritis expert at the University of Colorado Anschutz Medical Campus. “It’s supposed to help you fight infections. But in rheumatoid arthritis—for reasons that we don’t yet understand—the immune system gets confused and then starts to attack your joints instead.”

    There’s no cure for rheumatoid arthritis. But there are effective treatments. Treatment can relieve pain, reduce joint stiffness and swelling, and prevent further joint damage.

    Research advances have improved patient outcomes in the past 10 to 20 years. Doctors no longer wait to start treating a person with rheumatoid arthritis. Now, they know to begin treatment right away—before joint damage worsens. Early detection is very important to increase the chance that treatment is successful.

    “If we can get you into low disease activity by 6 months and remission [no signs of the disease] by 1 year, we’ve got an incredibly good chance of the disease having a very minimal impact on your life,” says Dr. Vivian P. Bykerk, an NIH-funded arthritis researcher at the Hospital for Special Surgery in New York.

    There are many different classes of drugs available. Many of the drugs, like NSAIDs (nonsteroidal anti-inflammatory drugs) and steroids, work by reducing inflammation. Such drugs may be used in combination with others that have been shown to slow joint destruction.

    NIH scientists helped develop a new class of drug for rheumatoid arthritis called Janus kinase (JAK) inhibitors. These drugs work by suppressing the body’s immune response. Several years ago, the first drug in this new class was approved by FDA for moderate to severe rheumatoid arthritis. Researchers continue to investigate new types of drugs and drug combinations.

    “We really have to rely on our experience. We consider the combination of signs, symptoms, and blood tests to choose the right treatment,” Bykerk explains. Once treatment for rheumatoid arthritis is underway, patients need frequent checkups. Doctors may need to try and adjust different drugs or drug combinations to find the best fit for each person. Treatments are usually required for the long term to maintain control of the disease. For some people, symptoms go on for years, even a lifetime. Sometimes after months of mild disease, symptoms can flare up again.

    Bykerk also works on an NIH-supported team of scientists who are searching for more effective treatment approaches. The team analyzes joint tissue and blood samples from people with rheumatoid arthritis to better understand the genes and proteins that trigger and drive the disease. The researchers aim to learn why some people respond differently to different treatments. They also hope to one day be able to tailor treatments to each person. Other studies are exploring how long people need to be treated once the disease is under control to prevent it from returning.

    Rheumatoid arthritis can affect virtually every area of your life, from work to relationships. If you have rheumatoid arthritis, there are many things you can do to help maintain your lifestyle and keep a positive outlook. Exercise helps keep your muscles healthy and strong, preserve joint mobility, and maintain flexibility. Rest helps to reduce joint inflammation, pain, and fatigue. Ask your doctor how best to balance exercise and rest for your situation.

    New research advances continue to help improve quality of life for people with rheumatoid arthritis. Talk with your doctor about how to treat your joint pain and stiffness so that you can lead a full, active, and independent life.

    References
    Rheumatoid arthritis. Smolen JS, Aletaha D, McInnes IB. Lancet. 2016 Oct 22;388(10055):2023-2038. doi: 10.1016/S0140-6736(16)30173-8. Review. PMID: 27156434

    Estimates of the prevalence of arthritis and other rheumatic conditions in the United States. Part I. Helmick CG, Felson DT, Lawrence RC, Gabriel S, Hirsch R, Kwoh CK, Liang MH, Kremers HM, Mayes MD, Merkel PA, Pillemer SR, Reveille JD, Stone JH; National Arthritis Data Workgroup. Arthritis Rheum. 2008 Jan;58(1):15-25. doi: 10.1002/art.23177. PMID: 18163481

    NIH News in Health, April 2017

    Sunday, April 2, 2017

    Can a non-specialist competently care for patients with hepatitis C infection?

    Hepatitis C Care: It's Cookbook Medicine, Expert Tells Physicians
    Conference Coverage > ACP 2017Mar 31, 2017 | Gale Scott

    Internal medicine physicians may encounter patients in their practice who could benefit from the expertise of a gastroenterologist.

    Speaking today at the American College of Physicians Internal Medicine Meeting (ACP 2017) in San Diego, California, Hashem El-Serag, MD, MPH, of Baylor College of Medicine in Houston, a professor of gastroenterology and hepatology gave a standing-room only audience a quick course in his specialties so they could treat many of these patients. El-Serag is a well-known expert on hepatocellular carcinoma, and has published over 350 papers on the topic.

    Among his subjects today was whether a non-specialist can competently care for patients with hepatitis C infection.