December HCV Newsletters And Updates: Epclusa most effective for HCV genotype 3 vs. other DAAs

December HCV Newsletters And Updates

Greetings everyone, here is your digest of December Newsletters, along with today's news and updates. 

News In Review

Top Story
Epclusa most effective for HCV genotype 3 vs. other DAAs
December 5, 2016
Researchers in the Netherlands found that Sovaldi plus velpatasvir, known as Epclusa in the United States, was the most effective regimen for the treatment of hepatitis C genotype 3 infection compared with other direct-acting antiviral regimens, according to published findings.

“The findings of our network meta-analysis can be used to prioritize DAA regimens for HCV genotype 3 patients in guidelines and clinical practice,” Joost P.H. Drenth, MD, PhD, professor of gastroenterology and hepatology, Radboud University Medical Center, the Netherlands, and colleagues wrote.
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Family Practice News
Frontline Medical News
Hepatitis Outlook
Publish date: November 29, 2016
By: Richard Pizzi
A single-center trial of direct-acting antivirals in treatment-naive patients with chronic hepatitis C virus genotype (GT)1 or 3 infection supported the use of 8-week DAA treatment regimens that maintain high efficacy, even for patients infected with HCV GT3 infection.

Results from the OSIRIS study revealed that simeprevir plus sofosbuvir for 12 weeks achieved a 100% sustained virologic response rate in hepatitis C virus genotype 4-infected patients with or without compensated cirrhosis.
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BASL - British Association for the Study of the Liver
Hepatocellular carcinoma increase rate slows in USA
The overall rate of increase in hepatocellular carcinoma (HCC) slowed between 2010 and 2012, found a nationwide US study. However, it did increase in some sub-groups such as men aged 55 to 64, and whites/Caucasians.

Researchers at Baylor College of Medicine in Texas analysed data from the US Cancer Statistics registry, which covers 97% of the population of all 50 states.

They found that the HCC incidence increased from 4.4/100,000 in 2000 to 6.7/100,000 in 2012, increasing by 4.5% annually between 2000 and 2009, but only by 0.7% annually between 2010 and 2012.

The average annual percentage change (AAPC) between 2000 and 2012 was higher in men (increase of 3.7%) than women (increase of 2.7%), and highest in 55 to 59-year-olds (AAPC 8.9%) and 60 to 64-year-olds (AAPC 6.4%).

By 2012, rates in Hispanics surpassed those in Asians, and rates in Texas surpassed those in Hawaii (9.71/100,000 vs 9.68/100,000). Geographic variation within individual race and ethnic groups was observed, but rates were highest in all major race and ethnic groups in Texas.

Reference - Incidence of hepatocellular carcinoma in all 50 United States, from 2000 through 2012. White DL, Thrift AP, Kanwal F et al. Gastroenterology. 2016 Nov 23 [Epub ahead of print]

Read all research and news updates, here...

Dr. Joseph S. Galati
Discussions about the liver and everything else related to health and wellness.
Visit The Blog of Dr. Joseph S. Galati

Fatty Liver: What Treatment is Available?
Published on Dec 4, 2016
Joe Galati, M.D.
Dr. Joe Galati and Liver Specialists of Texas has research protocols for those diagnosed with NASH, fatty liver disease, or non-alcoholic fatty liver disease.

Fatty liver can be complicated by cirrhosis and liver cancer, and the need for liver transplant. Fatty liver disease should not be ignored. New research drugs and medicines are being developed.

In The News

DHHR Secretary gives update on practices used to fight West Virginia’s drug epidemic
CHARLESTON, W.Va. — Karen Bowling, cabinet secretary for the State Department of Health and Human Resources Bureau for Public Health, told members of a legislative interim committee what’s working and what’s not when it comes to fighting West Virginia’s drug epidemic.

Hundreds of VA dental patients possibly exposed to HIV, hepatitis
(CNN) — Nearly 600 patients who received dental care at a Wisconsin Veterans Affairs medical center may have been exposed to HIV, hepatitis B and C and now face an anxious wait to find out if they were infected.

WHO Prequalifies First Hepatitis C Diagnostic
Regulatory Focus-12 minutes ago
The World Health Organization (WHO) on Monday announced it has prequalified its first hepatitis C virus (HCV) rapid diagnostic test, which will help diagnose ...

(CNN)National Steak and Poultry issued a recall of more 1.9 million pounds of its ready-to-eat chicken products, the Unites States Department of Agriculture said Monday. The products are sold as fully cooked for consumers to heat and serve, but they may be undercooked. Undercooked poultry can harbor bacteria. . A complete list of recalled products can be found on the USDA website

VA dentist resigns after possibly infecting 600 veterans with HIV and hepatitis
TOMAH, Wis., Dec. 3 (UPI) -- An unidentified Department of Veterans Affairs dentist in Wisconsin resigned after possibly exposing hundreds of patients to HIV and hepatitis B and C.

Officials at Tomah Veterans Affairs Medical Center announced Friday the dentist, who placed veterans at risk by reusing his tools, resigned after initially moving to an administrative role, The Milwaukee Journal Sentinel reported.

The latest figures have outlined 10 most prescribed and most expensive drugs on the Pharmaceutical Benefits Scheme (PBS) in the past year.
The figures are particularly notable due to the introduction of two new hepatitis C drugs, which were introduced to the PBS in March.

People who consistently smoked an average of less than one cigarette per day over their lifetime had a 64 percent higher risk of earlier death than never smokers, and those who smoked between one and 10 cigarettes a day had an 87 percent higher risk of earlier death than never smokers, according to a new study from researchers at the National Cancer Institute (NCI). Risks were lower among former low-intensity smokers compared to those who were still smokers, and risk fell with earlier age at quitting. The results of the study were reported Dec. 5, 2016, in JAMA Internal Medicine. NCI is part of the National Institutes of Health.


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

Check out what we have in store for you in the December Newsletter

Dear Advocaters,
It’s hard to believe that it’s December and 2017 is right around the corner.  It’s been a busy year at the HCV Advocate and this month’s issue is no exception.  Lucinda K. Porter RN and I have each picked some of our favorite abstracts from this year’s AASLD’s Liver Meeting.  Matthew Zielske’s article continues on the theme of research to discuss turning research and education into practice.

The Five by Alan Franciscus – I have picked five abstracts that I think are some of the most interesting including alcohol and treatment, HBV reactivation during and after HCV treatment, patient descriptions of fatigue (my favorite), curing HCV and diabetes, and the cost of generic direct-acting antiviral medications.

HealthWise by Lucinda K. Porter—AASLD – Lucinda has picked various abstracts such as payer treatment restrictions, pre-existing liver disease treatment and outcomes of breast cancer, hepatitis C reactivation in patients with cancer, alcohol and treatment outcome, fatigue, HAV and HBV vaccination in people with liver disease, and surveillance and screening of liver cancer.

Under the Umbrella by Matthew Zielske –The challenges of proving what we know – Matthew writes about the importance of communication and some of the discrimination that people face when seeking information and medical care.

HCV Advocate Pipeline has been updated with phase 2 information about AbbVie’s combination of glecaprevir plus pibrentasvir to treat genotype 1, 3,4, 5, and 6.  Hint – very high cure rates.

What’s Up!
Check out our new Easy C fact sheets:
What are RAVs
Taking HCV Meds – Adherence
We have updated our HCSP fact sheet:
Adherence to HCV Therapy

Coming Next Month
The Top News Stories of 2016
A New Fact Sheet Series: Harm Reduction

Many thanks for your continued support,
Alan and the HCV Advocate team

Latest treatment news and information for patient advocates and people working in hepatitis in Europe.

November 2016 Newsletter
News from the 2016 AASLD Liver Meeting
New pangenotypic combinations
Hepatitis C genotype 3
Real world treatment performance matches the best clinical trial results
Treatment scale-up and the continuum of care
Liver cancer in people treated with direct-acting antivirals
Hepatitis B treatment
Generic hepatitis C drugs
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Hepatitis B and C Public Policy Association
 The Hepatitis Public Policy Association aims to urge and facilitate the formulation of public policies at national and international level for the communication, prevention and management of the spread of viral Hepatitis B and C. The Association’s unique approach in furtherance of this aim is to gather together, and work in partnership with, the major stakeholders in the field of these diseases including regulators, patients, clinicians, public health and civil society communities and the private sector.

Treatment of HCV with Direct Acting Antivirals in Italy
1) The real cost of DAAs
2) The potential savings to be made for the INHS by treating all HCV patients
3) The number of patients to treat
4) The real capacity of the hospitals authorized to prescribe DAAs;
Side effects of prohibition
The biggest and unexpected side effect of denying treatment to more than 100,000 patients, is the use of generic drugs imported from other countries. We have seen an exponential increase in the import of generic drugs against HCV from India and Egypt. Given that Italian regulations are extremely restrictive concerning this issue, this has caused controversies and problems also for the Italian physicians who were unprepared to deal with this situation. It is almost impossible to know exactly how many patients have imported these drugs, but certainly we could speculate at least 500.
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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.

HEP Winter 2016 - Special Issue
Through the Uprights
Alive and Kicking
Beware Herbal and Dietary Supplements
Read this issue online, here...
View interactive publication, here...
Past issues, here...

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.

Check out the new Hep C resources addressing needs of people who use drugs
Share this road map of resources for New York City immigrants with clients.
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Newsletter 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: November 2016
New HCV Action case studies highlight effective testing services

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.
December 2016 issue of GI & Hepatology
Past Issues

NIH News in Health
Check out the December issue of NIH News in Health, the monthly newsletter bringing you practical health news and tips based on the latest NIH research.

Making a Healthier Home
Cast Toxins From Your Living Space

Tai Chi and Your Health
A Modern Take on an Ancient Practice
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In Case You Missed It

Acetaminophen, supplements and other medications may trigger drug-induced liver injury
More than 1,000 medications, with acetaminophen being the most common, have been associated with drug-induced liver injury (DILI).

AASLD Review
Sift through highlights from The Liver Meeting arranged by the following topics;
1) AASLD Summary - Watch Expert Review
​2) Multimedia
​​3) Safety Profile
​4) Ethnicity on HCV Patient Outcomes
​5) Reinfection
6) Sofosbuvir or Daclatasvir-Based Regimens
7) Key data indexed by pharmaceutical company
8) Treatment with direct-acting antiviral (DAA) agents; Veterans and Elderly
9) HCV and Liver Disease; Fibrosis, Cirrhosis, Liver Cancer, Liver Transplant, Liver Failure,​ and Fatty Liver/non-alcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH)
10) Latest News
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Sofosbuvir, daclatasvir combo best treatment for HCV cryoglobulinemia vasculitis

Conference Coverage
Sofosbuvir, daclatasvir combo best treatment for HCV cryoglobulinemia vasculitis
By: Deepak Chitnis
Frontline Medical News

– A combined regimen of sofosbuvir and daclatasvir is the best option to treat patients with hepatitis C virus infections experiencing cryoglobulinemia vasculitis, according to the findings of a new study presented at the annual meeting of the American College of Rheumatology.

“The HCV cryoglobulinemia vasculitis is a very important vasculitis because it represents 5% of chronically infected HCV patients in the world,” explained David Saadoun, MD, of Sorbonne Universities, Paris. “It’s sometimes a life-threatening vasculitis because patients may develop inflammation [so] there’s a need for very active and well-tolerated treatment.”​

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HCV Experts Discuss Impact of Trump Administration​ AND Got Hep B and Worried About the Trump Effect on Your Obamacare?

Article Published Online @ Healio
HCV experts discuss impact of Trump administration​
Results of a Reuters/Ipsos poll taken during Nov. 9-14, 2016 indicated that more than 20% of Americans wanted President-elect Donald J. Trump to focus on health care in his first 100 days in office. However, when HCV Next reached out to a cross-section of experts for commentary on exactly what Trump could realistically expect to accomplish in health care, and how he would accomplish it, there were more questions than answers. Of note, some experts declined to comment.
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Article Published Online @ Hepatitis C Foundation
Got Hep B and Worried About the Trump Effect on Your Obamacare? Experts Say No Changes Expected Before 2018
By Christine Kukka
It is time to sign up, re-enroll or change your health insurance plan in the Affordable Care Act’s Health Insurance Marketplace, also known as Obamacare. Millions of Americans – many of them with pre-existing medical conditions such as hepatitis B — get their much-needed health insurance through this plan.

But President-elect Donald Trump has promised to repeal the Affordable Care Act (ACA), which funds the program, and now Republicans will have control of the House and Senate. What should we, who require health insurance to cover our doctor visits, lab tests and costly antiviral treatment to keep our livers healthy, do? Should we sign up for 2017?
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Wales approves new hepatitis C drug while England deliberates

BMJ 2016; 355 doi:
(Published 01 December 2016)
Cite this as: BMJ 2016;355:i6499

Wales approves new hepatitis C drug while England deliberates

Piotr Ozieranski1, Lawrence King2

A new drug for hepatitis C has been approved for use in Wales ahead of its appraisal by the National Institute for Health and Care Excellence (NICE) for use in England and is being made available to patients in line with the Welsh strategy to prevent the transmission of the virus.

The All Wales Medicines Strategy Group recommended Epclusa (sofosbuvir with velpatasvir) for use in the NHS in Wales after concluding that the treatment would be cost effective for most patients.1 The treatment will be funded under the Welsh patient access scheme. The price proposed by its manufacturer, Gilead, is confidential but likely to involve a discount from the UK list price of about £40 000 (€47 000; $50 000) …

Download Article, here....

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.

NIH Statement on World AIDS Day 2016

  • Thursday, December 1, 2016
  • Posted by HCV New Drugs
  • File Under ,

NIH Statement on World AIDS Day 2016

Anthony S. Fauci, M.D., Director, National Institute of Allergy and Infectious Diseases
Carl W. Dieffenbach, Ph.D., Director, Division of AIDS, NIAID

This year, the world marked the 35th anniversary of the first published reports of what would come to be known as HIV/AIDS. This disease has wrought enormous suffering and devastation and caused more than 35 million deaths. Yet today, thanks to remarkable achievements in biomedical science and public health, we have the tools to build a better future for individuals living with HIV and for those at risk of infection. We are hopeful that new approaches currently under exploration could expedite the end of the HIV/AIDS pandemic.

The greatest scientific accomplishment in HIV research has been the development of effective treatments that suppress the virus and prolong the lives of those living with HIV. Over time, scientists have refined and optimized antiretroviral therapy, delivering safer, more effective drugs that are easier to take. Today, a person living with HIV on antiretroviral therapy can expect to live a nearly normal lifespan.

Antiretroviral therapy has been transformational for both individuals and communities. Large studies conducted in diverse settings, from U.S. cities to African villages, have demonstrated the power of treatment to preserve the health of those living with HIV. Additionally, studies have proven that when an individual living with HIV is on antiretroviral therapy and the virus is durably suppressed, the risk that he or she will sexually transmit the virus is negligible. Research also has repeatedly demonstrated that HIV incidence diminishes when HIV testing is aggressively implemented, individuals with HIV infection are linked to treatment, and support is provided to keep them in care. The power of treatment as prevention cannot be underestimated in helping to achieve global targets to dramatically reduce new infections and improve the health of those already living with HIV.

The National Institutes of Health (NIH) is supporting the development of new, innovative methods to prevent the spread of HIV, building on proven HIV prevention tools such as antiretroviral treatment; condoms; voluntary medical male circumcision; and pre-exposure prophylaxis (PrEP), a daily pill that uninfected people can take to prevent infection. Earlier this week, NIH announced the start of HVTN 702, a large HIV vaccine efficacy trial in South Africa that builds on the modest success of the RV144 vaccine trial conducted in Thailand. The HVTN 702 vaccine candidate is designed to prevent infection by the HIV strain most commonly found in southern Africa. About 3,700 people become infected with HIV every day in sub-Saharan Africa.

In April, NIH launched the Antibody-Mediated Prevention Trial (AMP) to test whether a broadly neutralizing antibody delivered intravenously to uninfected individuals is safe, tolerable and effective at preventing HIV infection. Many scientists believe that if an HIV vaccine could elicit broadly neutralizing antibodies in people, it would protect them from infection. By giving participants this antibody directly, researchers expect to gain critical insights to inform HIV prevention and vaccine science.

NIH is testing HIV prevention options that address the unique needs of women, such as a vaginal ring infused with the antiretroviral drug dapivirine, which reduced the risk of HIV infection by only a modest 27 percent in a large clinical trial reported this year. Additional analyses suggest that this product may be much more effective when used regularly. A study launched in July aims to clarify further the relationship between adherence to the ring and efficacy, as well as to understand better the complexities women face when adhering to a vaginal ring.

Science has made remarkable strides in preventing the transmission of HIV from mother to infant during pregnancy, birth and breastfeeding. This summer, researchers reported the results of the PROMISE study, which demonstrated that for mothers living with HIV whose immune systems are in good health, taking a three-drug antiretroviral regimen during breastfeeding essentially eliminates HIV transmission to their infants.

While preventing new infections is essential, it remains critical that the 36.7 million people living with HIV globally benefit from cutting-edge science. Today’s treatments are lifesaving, yet people living with HIV still suffer from higher rates of chronic disease than their uninfected counterparts. Clinical trials are exploring interventions to help prevent these diseases. One example is the REPRIEVE study, a large, international trial exploring the use of a statin drug to prevent heart disease in women and men living with HIV.

Researchers also are working toward the goal of inducing sustained viral remission or absence of viral rebound following discontinuation of antiretroviral therapy. They are testing a number of approaches to successfully withdraw antiretroviral therapy in individuals whose virus is well controlled. In October, a provocative and potentially important advance was achieved in an animal study: An antibody directed against a cell surface marker involved in the homing of lymphocytes to the gut given together with antiretroviral therapy for 5 weeks in monkeys infected with a monkey version of HIV led to a sustained suppression of viral rebound for up to 2 years following discontinuation of all therapy. A study is now underway to explore this strategy in people living with HIV.

These global efforts bring hope on this World AIDS Day that an end to the HIV/AIDS pandemic is achievable. We applaud the trial participants, researchers, health care professionals, advocates and others who are working to make this future a reality.

NIAID conducts and supports research — at NIH, throughout the United States, and worldwide — to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available on the NIAID website.

About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit