Sunday, August 2, 2015

August Newsletters: The Cure for Gilead, New drugs, Genotypes, Plus Hepatitis C and Nonalcoholic Fatty Liver Disease

August Newsletters: The Cure for Gilead, New drugs, Genotypes, Plus Hepatitis C and Nonalcoholic Fatty Liver Disease
Welcome to this months index of August "Newsletters" with a few updates from around the Web and today's news. 

**All newsletters published page updated Aug 7
Remember that some websites publish their newsletters in the second or third week of the month, in this case updates will be added to this post as they become available with a reminder on both Twitter and Facebook.

Doylestown researchers close in on hepatitis B treatment

Hepatitis C - Janssen starts a study to evaluate simeprevir and odalasvir on AL-335 pharmacokinetics

We begin with an in-depth article on the steep price of Gilead's Sofosbuvir, and the insurers who are denying coverage to patients in dire need of treatment, published online at "The Blog" over at HuffPost Business.

The Cure for Gilead
Jeffrey Sachs
The bottom line must be access. Gilead's patent rights must not be construed as the right to leave millions to suffer or die from a disease for which a low-cost cure exists. By abusing patents in that way, Gilead and the US political system in recent years have turned the proper use of patents -- as an important tool to incentivize R&D -- into a veritable license to kill, which must never become acceptable in a sane society.
Continue reading....

Of Interest
Aging will affect Medicare’s Hepatitis C mortality and cost
By Bruce S. Pyenson, Gabriela Dieguez, Ryan Cannon | 16 July 2015
Baby Boomers make up the majority of HCV-infected people in the U.S. The nature of HCV infection means that if patients are not treated prior to Medicare eligibility, the disease will progress in some patients and future Medicare expenditures may rise. The future cost of treating medical complications due to HCV infection poses a burden not yet fully understood.
This report was commissioned by AbbVie.
 Download the PDF

Two New Drugs FDA Approved For HCV Genotype 3 and 4
At the end of July the FDA approved two new drugs for hepatitis C, one for genotype 3 and the other for genotype 4. Provided in this post is the lowdown on both drugs with a few informational links and a video by Dr. Joseph Galati offering us a quick review of Daklinza "daclatasvir."

Genotype 4 - Technivie
Summary from "Medscape" article:

The first drug combination is AbbVie's Technivie/ombitasvir, paritaprevir, and ritonavir for use with ribavirin in adults with HCV genotype 4.

The safety and efficacy of Technivie with ribavirin were evaluated in 135 adults with chronic HCV genotype 4 infections without cirrhosis in the PEARL-I clinical trial

SVR rates for Technivie with and without ribavirin 
Out of 135 participants - 91 received Technivie with ribavirin once daily for 12 weeks and 44 received Technivie once daily without ribavirin for 12 weeks.

SVR rates for Technivie with ribavirin 
All patients who received Technivie with ribavirin achieved sustained virologic response at 12 weeks (SVR12)

SVR rates for Technivie with out ribavirin
91% of those who received Technivie without ribavirin achieved sustained virologic response at 12 weeks (SVR12)

Common side effects with Technivie plus ribavirin include fatigue, asthenia, nausea, insomnia, pruritus, and other skin reactions.

More from "Medscape"
Elevations of liver enzymes to greater than five times the upper limit of normal occurred in approximately 1% of study patients, according to the FDA. This occurred more often in women taking contraceptives containing ethinyl estradiol. Contraceptives containing ethinyl estradiol must be discontinued prior to starting Technivie, the FDA says. They recommend that liver enzyme testing be performed during the first 4 weeks of starting treatment, and as clinically indicated thereafter.

The three drugs included in Technivie are also included in Viekira Pak (AbbVie), previously approved for the treatment of HCV genotype 1 infection.

PEARL-I: In the phase 2b PEARL-I study, investigators examined the efficacy of a 12-week course of ombitasvir plus paritaprevir plus ritonavir with or without ribavirin in patients with chronic HCV genotype 4 infection; the study enrolled treatment-naive and treatmentexperienced patients, but excluded patients with cirrhosis. Note the regimen used in this trial did not include dasabuvir, because dasabuvir does not have activity against genotype 4 HCV. For the 86 treatment-naive patients, SVR12 was achieved in 40 (91%) of 44 patients who received ombitasvir plus paritaprevir-ritonavir without ribavirin and in 42 (100%) of 42 that received ombitasvir plus paritaprevir plus ritonavir with ribavirin. This study, showed an excellent treatment response with a 24-week regimen of ombitasvir plus paritaprevir plus ritonavir for genotype 4 infection, particularly if ribavirin is added to the regimen.
Source - Hepatitis C Online

Genotype 3 -  Daklinza "Daclatasvir"
The other drug is Daklinza "daclatasvir" from Bristol-Myers Squibb, used with Gilead's sofosbuvir "Sovaldi" without ribavirin for HCV Genotype 3 infection.

According to Medscape's article;
In the clinical trial deemed ALLY-3 the safety and efficacy of daclatasvir 60 mg plus with sofosbuvir 400 mg once daily for 12 weeks were evaluated in 152 treatment-naive and treatment-experienced adults with chronic HCV genotype 3 infection. They were monitored for 24 weeks post treatment.

SVR rates for Daklinza in treatment-naive patients and treatment-experienced with and without cirrhosis

Treatment-naive - no cirrhosis
SVR12 was achieved in 98% of the treatment-naive patients with no cirrhosis of the liver

Treatment-naive - with cirrhosis
SVR12 was achieved in 58% of the treatment-naive patients with cirrhosis.

Treatment-experienced - no cirrhosis
In the treatment-experienced group, SVR12 was achieved in 92% of patients with no cirrhosis

Treatment-experienced - with cirrhosis
In the treatment-experienced group, SVR12 was achieved in 69% of patients with cirrhosis

Daclatasvir carries a warning that symptomatic bradycardia and cases requiring pacemaker intervention have been reported when amiodarone is given with sofosbuvir in combination with another HCV direct-acting antiviral, including daclatasvir. "Co-administration of amiodarone with Daklinza in combination with sofosbuvir is not recommended," the FDA advises.

In this parallel-arm phase 3 trial, investigators assigned 101 treatment-naive genotype 3 patients and 51 treatment-experienced genotype 3 patients to a 12-week all-oral regimen of daclatasvir 60 mg once daily and sofosbuvir 400 mg once daily. Cirrhotic patients comprised 19% and 25% of these groups respectively. An SVR12 was achieved in 90% of treatment-naive and 86% of treatment-experienced GT 3 patients, with viral relapse responsible for nearly all the treatment failures. The presence of cirrhosis was associated with a lower SVR12 rate at 63% overall, regardless of treatment experience. This combination was generally safe and well tolerated with the most frequent adverse events being headache, fatigue and nausea.
Source - Hepatitis C Online


Daklinza and TECHNIVIE
Package insert, dosage, warnings, drug interactions, side effects, news and research

Great summary of the two new approved drugs by Lucinda Porter
FDA Approves New Hepatitis C Medications to Treat Genotypes 3 and 4

To check out more information on all genotypes, click here.

Daclatasvir Approved for Genotype 3 Hepatitis C
Short patient video covering Daclatasvir, published a few days ago by Joe Galati, M.D.

Worth A Click
Genotype in Hepatitis C Determines Treatment Course/Genotype 1 is Common with Increasingly Effective Treatment

Other News
Kenneth E. Sherman, MD, PhD, of the University of Cincinnati College of Medicine, and colleagues investigated Sovaldi (sofosbuvir, Gilead Sciences) 400 mg and Daklinza (daclatasvir, Bristol Myers Squibb) 60 mg (which was dose adjusted for concomitant combination antiretroviral therapy [cART]: 30 mg with ritonavir-boosted protease inhibitors, 90 mg with non-nucleoside reverse transcriptase inhibitors except rilpivirine [Edurant, Janssen Therapeutics]) in patients coinfected with HIV/HCV coinfection.

Heather McCormack addressing the cycle that leads to high rates of viral hepatitis infection in Indigenous Australians and sharing materials to support them

Whats new around the Web?

Cases 1-10 Now Ready For Viewing
"ViralEd" has recently completed their launch of "HCV Virtual Patient."

The program is an easy to follow video CME with a look at different case scenarios. This activity is a helpful starting point for people who failed treatment, have cirrhosis or want to learn more about current treatment options for various HCV genotypes. This program is amazing folks, enjoy the follow-up questions. 

After each detailed case is discussed a list of multiple choice questions will appear, in order to move forward the question must be answered correctly, if you don't know the answer click on the "curbside consult" button located in the bottom corner of the presentation.  Instructions will be explained after launching the program. 

Although this learning activity is clinical in nature and directed at physicians, patients will most certainly find the program beneficial, here is a screen shot of each case.

Begin here....

New at Healio: HCV Next 

"HCV Next" offers information on a range of topics, which include diagnosis, new combination therapies, side effects, drug/drug interaction, guidelines, fatty liver disease and more.

Click here to read the following articles which appeared in the July 2015 print edition of "HCV Next" published online at "Healio."

Clinical Liver Disease (CLD)
Clinical Liver Disease (CLD) is the latest online learning resource of AASLD. Clinical in focus, CLD blends text, audio, video, webinars, and other interactive content into educational interventions launched every other month. These interventions are designed for any physician or health care provider caring for a patient with liver disease.

Special Issue: The Future in Liver Medicine & Palliative Care

Clinical Liver Disease
July 2015 Volume 6 , Issue 1 Pages 1–26

A Few Topics
Liver fibrosis: Therapeutic armory 40 years on (pages 1–4)
Histologic and noninvasive estimates of liver fibrosis (pages 5–8)

August 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.

August Issue
A Brief Overview: Outbreaks of Acute HCV Infections in the U. S.
Alan Franciscus, Editor-in-Chief
In this review, I will discuss the outbreaks of acute infections of hepatitis C across the United States in urban and rural centers and why the numbers are (again) under reported.

HealthWise: Hepatitis C and Nonalcoholic Fatty Liver Disease
Lucinda K. Porter, RN
Hepatitis C increases the risk of nonalcoholic fatty liver disease (NAFLD), a metabolic disease that generally occurs in overweight patients. You can do something about NAFLD, and this article suggests how. 

Alan Franciscus, Editor-in-Chief
Read about how treatment with Harvoni improves patient-reported outcomes, how HCV works to escape the immune system and become a chronic infection, and a new test to tell the difference between acute and chronic infection.

FDA Safety Alert
The Food and Drug Administration (FDA) has issued a communication strengthening an existing warning label that non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs) increase the chance of a heart attack or stroke.

HCV and Depression
Alan Franciscus, Editor-in-Chief
There does seem to be a pretty strong link between HCV and Depression. Add on to that just having a chronic disease, such as hepatitis C, the difficulty of being approved for the new medications, being a baby boomer—and it is not surprising that many people with hepatitis C are depressed. 

In Case You Missed It

Hepatitis C: The Problem with Numbers
Alan Franciscus, Editor-in-Chief
In this article, I will discuss the published numbers of acute and chronic HCV and what some experts believe is a better estimate of the number of acute, chronic and annual deaths caused by hepatitis C

The Next HCV Drugs
Alan Franciscus, Editor-in-Chief
This month’s “The Five” will discuss the most promising drugs in development, including a couple of combinations of drugs submitted to, and likely to be approved by, the Food and Drug Administration (FDA) by the end of this year or early next year. 

Medicare at Age 65
Jacques Chambers, CLU
Unlike those on SSD who are enrolled automatically in Parts A & B of Medicare, people turning age 65 must actively choose whether or not to enroll in Medicare in addition to deciding which parts are appropriate for them. As well you must enroll in Medicare at the appropriate times or penalty surcharges can be added to the premiums, and they will last as long as you are on Medicare. 

Alan Franciscus, Editor-in-Chief
This month’s column discusses hepatitis C interferon-free regimes in the elderly, and hepatitis B virus reactivation during successful treatment of hepatitis C virus with sofosbuvir and simeprevir. Read more...

HCSP Events
Alan Franciscus, Editor-in-Chief
Check out what's coming to your neighborhood soon!

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

Connect With HCV Advocate



HepCBC Hepatitis C Education and Prevention Society

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

August HepC Bull Newsletter
hepc.bull -- 08 2015

WHD Events - Lighting up the BC Leg! 
Presenting to HIV/AIDS - Legal experts Transit Ads
HepCBC Staff Changes 
Letters to/from Fed. Health Minister Public Tests 
Honour Roll Conferences 
Manifesto Care Programs

View All Newsletters, Here

Stay Connected


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

In accordance with the Foundation’s mission, the e-newsletter is disseminated to provide information about the prevention, treatment and cure of liver disease, as well as the organization’s research and advocacy endeavors.

Liver Lowdown content includes updates about the Foundation’s educational and signature programs; an in-depth focus on specific types of liver disease, and profiles of liver patients’ and caregivers’ personal experiences.

The American Liver Foundation is pleased to announce its 2015 research award winners. These awards provide critical support to outstanding scientists early in their careers, promoting a new generation of liver disease researchers.

This year’s 11 award winners will join over 800 scientists and physicians who have pursued careers in liver disease research and treatment as a result of receiving these early-career grants. The program has provided over $25 million in research funding since 1979.

“ALF is delighted by the range and depth of applications that we received,” said Tom Nealon III, Esq, Chief Executive Officer and National Board Chair of ALF. The 2015 awardees are studying diverse liver diseases, including biliary and liver fibrosis, cholangiocarcinoma, hepatocellular carcinoma, hepatitis, and nonalcoholic steatohepatitis.”

Irwin M. Arias, MD, a Triple Emeritus: Professor of Medicine (Albert Einstein College of Medicine) Physiology (Tufts) and National Institutes, called ALF’s support for new researchers critical. “We continue to need bright young people who will further advance liver research, broaden our understanding of liver biology and make new discoveries that will lead to better diagnostics and treatments,” he said. Dr. Arias, through his work with the American Association for the Study of Liver Disease (AASLD), helped found the American Liver Foundation in 1976. He served for many years on the ALF National Board as well its New England Chapter Board.

The American Liver Foundaton’s research program is funded through the generous donations of individuals who want to eradicate liver disease. Awards recipients were selected by a committee of experts in the field of hepatology, co-chaired by Rohit Loomba, MD, MHSc and Jasmohan Bajaj, MD. You can find a list of our 2015 award winners and their projects here. See how we they changing the future.

Welcome to the July/August 2015 edition of the Liver Lowdown. Click on the links below and check out our featured stories for the month!

This issue of Liver Lowdown is all about Research! Learn more about ALF's 2015 research award recipients, and make sure you scroll down for highlights from the 2015 International Liver Congress, and an update on one of our 2014 Post-Doctoral Fellowship recipients.

The emerging public health challenge of non-alcoholic fatty liver disease (NAFLD) was a hot topic at the meeting.

News about hepatitis C is changing at a rapid pace. There are many treatments being investigated and more calls to action about testing.

In 2014, the American Liver Foundation provided funding to 11 early-career scientists from some of the nation’s leading academic institutions who are making the study of liver disease their life’s work. Read about grantee Zenobia Cofer, PhD.

In 2014, the American Liver Foundation provided funding to 11 early-career scientists from some of the nation’s leading academic institutions who are making the study of liver disease their life’s work. Read about grantee Zenobia Cofer, PhD.

ALF continues to make news around the country. Liver Life Walks and Flavors events, as well as education about topics such as fatty liver disease and the impact of alcohol on the liver are just a few.

ALF hosts a number of events throughout the year to support liver disease awareness. Check our events calendar and find one to participate in, including Liver Life Walks, Challenges and Flavors events in August and September.

View all newsletters

To receive the newsletter when it's "hot off the press" please join our email list.

Check Us Out On Twitter and Facebook
 Twitter  Facebook

The primary goal of the Caring Ambassadors Program is to help individuals with challenging health conditions to become ambassadors for their own health. We are here to help you—that is now and always will be our singular focus.

Monthly Pubmed Review of the most relevant research on HCV
Download: Literature Review Updates

Check back for July review. 


Weekly News
Weekly news updates are currently posted on the Internet site and sent out via e-blast to provide up-to-date information on what has been covered in the news regarding hepatitis C in the previous week. Topics include all stories related to hepatitis C as well as personal stories and events.

Connect with us on Facebook

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

GI & Hepatology Newsletter

Download - August 2015 issue.

Read breaking news stories now: visit the GI & Hepatology News website.

Stay connected



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

August 2015 Hep Free NYC Newsletter

Provider Guidance | Alcohol Screening and Counseling for Patients with Hepatitis. NYC Health Dept.

Tips for Patients | Alcohol and Hepatitis: Create an Action Plan (English & Spanish). NYC Health Dept.

View all newsletters, here.

Subscribe to this Newsletter

Today's Heroin Epidemic. CDC Vital Signs. Between 2002 and 2013, the rate of heroin-related overdose deaths nearly quadrupled, and more than 8,200 people died in 2013.

Addressing the Opioid Epidemic in the United States. NASTAD Blog. NASTAD has released a Statement of Urgency: Addressing the Opioid Epidemic in the United States. The Statement calls on the Nation for an immediate, comprehensive, effective and science-based approach to address the prevention, care and treatment needs of individuals at risk for or living with substance use disorders.

Obituaries Shed Euphemisms to Chronicle Toll of Heroin. NY Times. A group calledUNITE to Face Addiction, a coalition of advocacy groups, is planning a rally in Washington on Oct. 4, called “the day the silence ends.” The goal is to raise awareness about addiction being “treatable and preventable” for the estimated 22 million Americans in its grip.

Pregnancy Is the Best Time for Some Vaccines. NY Times. Article mentions Hep B vaccination during pregnancy.

FDA approves DAKLINZA in combination with Sofosbuvir for HCV genotype 3 infection.

NYC Council allocated funding to Hepatitis B & C Services in FY2016. Designations have yet to be named. In FY2015 NYC Council funded hepatitis B & C patient navigation services and clinical provider capacity building through the Check Hep B, Check Hep C, IDUHA Hep C Peer Navgation, and Empire Liver Foundation initiatives.

Hep C: The Facts Booklet with New Treatment Information (NYC Health Dept)The Hep C: The Facts booklet has been updated to reflect the advancements in Hep C treatment made in the last few years. Find treatment comparisons and information on the stages of Hep , types of liver tests, and resources. Download the booklet in English or Spanish or order free of cost by calling 311. Download the Hep C … 

Project INSPIRE: NYC Hep C Care Coordination Program
Project INSPIRE is a comprehensive Hepatitis C Care Coordination Program. The program is open to people diagnosed with hepatitis C who have Medicaid or Medicare. Patients enrolled in Project INSPIRE will receive expert patient navigation and clinical care coordination services to help go through the hepatitis C medical evaluation and treatment for hepatitis C with ease. … 

New Release | Hep B & C Mobile App
New Release! The NYC Health Dept’s free Liver Health app now offers both Hep C and Hep B information. The NYC Liver Health App includes: Hep B and C risk assessment Hep B and C self management checklist Alcohol screening Site locator providing testing and medical care sites Connection to online support and resources News alerts Download … 
Continue reading New Release | Hep B & C Mobile App→

All News...

Join Us
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 are the go-to source for educational and social support for people living with hepatitis.

Hepatitis News
Our top stories and the best of everything else out there

Your Online Hepatitis Community
Check out what everyone's talking about in the Hep Forums.


Karen Hoyt
Hepatitis C Advocate
Time to get Listed for a Liver Transplant
Karen Hoyt
(2015-07-29 05:55:50)
The liver transplant team looked at 3 different areas of my life. Physical, Psycho-social, and Financial. It's like a 3 legged stool. If one leg is weak, the other two can't hold up.

Karen Hoyt
This is an email to a Best Friend who is waiting on their liver transplant. I thought you might like to read about what to expect after a liver transplant. As always, pardon any errors. I’m 3 months post and still a lil goofy.

My Hep C Travel Diary, Hepatitis C Advocate
Greg Jefferys
Hepatitis C Treatment: Two Weeks to Go 
(2015-08-02 14:06:48)
Well only two weeks to go until the end of my treatment. I guess it is time for a review of the last ten weeks.

A pseudonym for a person living with hepatitis C on Viekira Pak + Ribavirin
Grace Campbell
Hepatitis C, social media and me 
(2015-08-01 19:25:18)
If you are looking for wise and knowledgeable tweets about hep C, I'm sure someone else will deliver far more intelligent tweets than I ever could.

Dr. Andrew Pugliese
(2015-07-24 08:42:56)
My mother's story is one of maybe millions that were typical of their time. None of it was done maliciously, but out of pure naivety, because they just didn't know about the risks.

What's New in Hepatitis C Treatment
By Lucinda K. Porter, RN on July 20, 2015
I have worked in the hepatitis C field for about eighteen years. In 1997, there was one hepatitis C treatment - interferon. Eventually, ribavirin was approved, and until 2011, I only had to remember the brand names of these two medications. In short, hepatitis C treatment didn't change much.

Everyday Health - Hepatitis C

President of the Hepatitis C Association
Infected with the virus for more than 40 years, Susan Simon spent years looking for a hepatitis C cure.

How I Beat Hepatitis C After a Liver Transplant
By Beth W. Orenstein
Reviewed by Farrokh Sohrabi, MD
Unexpected Hepatitis C Diagnosis Tests required for the insurance change revealed Roncari had a hepatitis C...

Health worker Paul Bolter was already counseling adults with hepatitis C when he found out that he was infected.

Today, thanks to the medical and... hard to help both women and men with hepatitis C, and...

By Karen Appold
Reviewed by Pat F. Bass, III, MD, MPH
positive for the hepatitis C virus. "Because only a small percent of children gets hepatitis C from their...

Healthy You

Full Text
Increased risk of hepatocellular carcinoma in chronic HCV patients with new onset diabetes
31 July 2015
A study published ahead of print the Alimentary Pharmacology & Therapeutics reports an increased risk of hepatocellular carcinoma in chronic HCV patients with new onset diabetes.

Statins Improve SVR Rates, Lower Cirrhosis, HCC risk in HCV Therapy
Researchers from the University of Pittsburgh, including Adeel A. Butt, MD, MS, FIDSA, and colleagues from the VA Pittsburgh, Hamad Healthcare Quality Institute of Hamad Medical Corporation in Doha, Qatar, and Harvard Medical School, investigated the effect of statins on antiviral therapy for HCV by analyzing data of 7,248 eligible patients who received HCV therapy and had a follow-up of at least 24 months. Forty-six percent of all the patients reviewed received statin therapy. 

Online symptom-checkers are often wrong
(Reuters Health) - Online symptom checkers often misdiagnose patients’ problems, often encouraging people to seek care for minor issues that don’t need immediate attention and other times incorrectly telling people with true emergencies that treatment can wait, a U.K. study suggests

Is there really a middle-class drinking 'epidemic' in over-50s?
"Middle-class over-50s have become a generation of problem drinkers," the Mail Online reports – a headline that actually has little basis in fact.

Q&A With Robert S. Brown Jr. From Weill Cornell Medical College: Alternative and Complementary Medicine In Treating Hepatitis C 
MD Magazine TV

Stay well

No comments:

Post a Comment