Saturday, December 5, 2015

December Hepatitis Newsletters: Highlights From AASLD 2015 - Treating Genotype 3, Cirrhosis and Liver Cancer

December Hepatitis Newsletters: Spotlight On Daryl Luster, With Highlights From AASLD 2015

Greetings everyone, welcome to this months index of Newsletters filled with highlights from the 66th American Association for the Study of Liver Diseases Annual Meeting. 

Your favorite bloggers have written some wonderful articles as well, plus a new interview with Daryl Luster, our very own advocate, author and President of the Board of Directors at Pacific Hepatitis C Network

Daryl was featured in an interview recently on; The American Journal Of Medicine Hepatitis C Resource Center Blog, which tackled some of the following powerful topics; HCV treatment restrictions, stigma, discrimination, drug cost, harm reduction and access to care, to name a few.

It begins, here...

Daryl’s Articles
Read all of Daryl’s articles on
On a personal level connect with Daryl on Facebook, and follow him on Twitter.

AASLD 2015 - Review
In case you missed it, review key data presented at the meeting over at ViralEd and CCO. 

If that seems too clinical, scroll through this months newsletters for additional AASLD highlights, written by devoted HCV advocates, with you, the patient in mind. 

December 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.

Read The HCV Advocate Daily
Current edition


This month’s HCV Advocate newsletter is all about The Liver Meeting held in San Francisco, CA. There was much information about hepatitis C (HCV) presented, and there were demonstrations held—what more could anyone want? In Part 1 of our Liver Conference coverage Lucinda and I report on the following: 

Snapshots – I cover some of the most exciting late-breaking posters about HCV treatment including treating genotype 3, cirrhosis and post-transplant HCV and those pesky RAVs with multiple drug combinations in clinical development. 
HealthWise – Lucinda covers advocacy issues including the protests at AASLD and she discusses her favorite posters and presentations.

What’s New!
We have overhauled our medical glossary and herbal glossary to make it easier to navigate. Check them out!

We have begun a new feature highlighting some of the best websites for our readers. In this edition we are recommending that has tons of information, brochures and informational videos that you can download free of charge.

Lastly, we would like to take this time to ask you to think about donating to our organization—the Hepatitis C Support Project, a Project of the Tides Center. Any contribution you can afford will help us to provide the much-needed education and support that we provide to the hepatitis C community. Click here to learn more. 

In Case You Missed It

November Mid-Month Newsletter
Feds to Medicaid: Stop HCV Treatment Restrictions
by Alan Franciscus
This is good news for patients who have been denied HCV treatment by Medicaid. It will also mean that the government will investigate HCV pricing policies and insurance denial practices.

by Alan Franciscus
The combination of sofosbuvir plus velapasvir (with and without ribavirin) to treat genotypes 1 through 6 has completed Phase 3 clinical studies, and Gilead has submitted the data to the Food and Drug Administration for marketing approval. Read about the results.

Social Security and Medicare Changes for 2016
by Jacques Chambers
It is that time of year that some people need to start making changes to their Social Security or Medicare. Read this informative article by Jacques to find out the latest information and changes to these two important programs.

HCV Drugs
by Alan Franciscus
There was a lot of news in the world of HCV drugs — such as a teaser to a study that will be released at AASLD — curing people with 3 weeks of treatment, a safety warning about Viekira Pak and Technivie, and going bananas to treat HIV, HCV and the flu.

HCV SnapShots
by Alan Franciscus
This month’s column features two abstracts including HCV and the risk of preterm birth, and how statins reduce the progression to cirrhosis.

The Five: Pan-Genotypic Drugs
by Alan Franciscus
This month’s The Five discusses the various aspects of pan-genotypic drugs and why they are the future of HCV treatment.

View past newsletters here....

Connect With HCV Advocate


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.

December 2015 – Newsletter
Editor-in-Chief, Prof Massimo Colombo MD

In This Issue

What’s new at AASLD 2015
Several novelties concerning the advances in the field of hepatitis C were reported at the AASLD 2015 meeting. I will focus my report on the real-world data on treatment with direct acting antivirals (DAA), those obtained in some selected populations (genotype 3, acute hepatitis C, persons who inject drugs [PWID], decompensated cirrhosis), the problem of NS5A-associated resistance associated variants (RAVs), and some of the results of soon-to-be-approved medications.

A report from The 2015 Liver Meeting: The AASLD Global Forum
The 2015 Liver Meeting in San Francisco offered an occasion for experts from around the world to meet and discuss the latest findings in hepatology. The Global Forum was an event dedicated to the advances in treatment of chronic hepatitis C and the challenges that remain to fight the battle against HCV worldwide.

Next-generation sequencing as an emerging weapon of molecular epidemiology to track patients at risk of hepatocellular carcinoma
Q. Professor Zucman-Rossi, is our understanding of the risk factors of hepatocellular carcinoma exhaustive?
The vast majority of hepatocellular carcinomas (HCC) occur on a cirrhotic background developed after a chronic liver disease usually related to infections by hepatitis B or C viruses, high alcohol consumption, metabolic genetic diseases or obesity. Apart from these major risk factors, the contribution of others such as tobacco remains to be ascertained. Whereas HCC risk increases with the severity and duration of cirrhosis development, an increased number of HCC are discovered in non-cirrhotic patients. Particularly in these cases, we can hypothesize that exposure to additional risk factors and/or genetic predisposition could contribute significantly to the development of HCC.

Metabolic steatohepatitis and liver cancer
Q. Professor Dufour, when was the link between liver cancer and metabolic syndrome established?
In the last decades, research in the field of hepatocellular carcinoma has been focused on the link with hepatitis B virus and hepatitis C virus and, on the therapeutic front, on the development of systemic target therapy which lead to the approval of sorafenib in 2007. The landscape is changing with the realization that effective treatment of chronic viral hepatitis will reduce the number of patients at risk of developing hepatocellular carcinoma.

An update on treatment for hepatocellular cancer (HCC)
Q. Professor Galle, is liver cancer a hard to treat disease?
Hepatocellular cancer (HCC) is a disease with dismal prognosis and worldwide the third leading cause of cancer-related mortality, behind lung and stomach cancers. In the majority of patients, HCC is a deadly complication of liver cirrhosis resulting from underlying liver disease such as viral hepatitis. The remaining hepatic reserve of the cirrhotic patient contributes significantly to the availability of therapeutic options and often dictates outcome.

Extra-hepatic manifestations of hepatitis C
Q. What organs besides the liver are affected by HCV
A higher prevalence of immune-related disorders has been found in patients with HCV infection compared to uninfected controls, one above all mixed cryoglobulinemia and its sequelae, ranging from cutaneous and visceral vasculitis to glomerulonephritis and B cell non-Hodgkin’s lymphoma. The ability of HCV to target lymphocytes-the most important step in the pathogenesis of virus-related immunological disorders- can explain also the important role of HCV in the genesis of systemic autoimmune diseases like Sj√∂gren syndrome, rheumatoid arthritis, hemolytic anemia and severe thrombocytopenia. The virus has been implicated also in organ-specific autoimmune diseases like thyroid disorders and autoimmune hepatitis.

Emerging and re-emerging infections in the era of globalization
Q & A session on emerging and re-emerging infections in the era of globalization with Prof Alessandro Zanetti, Department of Public Health-Microbiology-Virology, Faculty of Medicine, University of Milan, Italy.

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

December 2015 Hep Free NYC Newsletter

In This Newsletter
Upcoming Events
New Tools
Training & Technical Assistance
Journal Articles & Reports
Job Board
Funding Board
Join our network!

Upcoming Activist Webinars
The Cost of Production for HCV Treatment
Treatment Action Group. Dec 8 (10 AM)

DAAs Drastically Simplify Hep C Diagnosis and Monitoring.
Treatment Action Group. Dec 10 (9 AM).

Meeting Highlights
The Brooklyn Hep C Task Force meeting included informative and exciting presentations on various hepatitis topics. Check out our meeting notes to view these presentations! 
11-4-2015 Brooklyn Hep C Task Force Meeting Notes

View our past meeting reports here

View all newsletters, here.

Subscribe to this Newsletter

Join Us



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.

December Newsletter
hepc.bull -- 12 2015


Generic Drug Company
Before my visit to Lupin Limited in Pune, India, on November 20, 2015: OK, this is to prepare you for what I learned about generic drugs on November 20th. Close your eyes. What do you envision when I say: “Generic Drug Company in India”? If you’re like me, you probably have viewed these companies as inferior to companies which research and develop new drugs, rightfully hold the patents, and make the big bucks. After all, generic companies simply copy what someone else has spent years—in many cases, decades—working on, discovering the uses and analyzing the structure of unique new Active Pharmaceutical Ingredient (API) molecules. They perfect the dosage and discover side-effects through clinical trials, while at the same time they’ve had to explore many research ‘dead ends’ which result in zero ‘payback’ before finally hitting on the ‘pay dirt’ of a commercially viable product.

SVR-HCC risk
Hepatocellular carcinoma (HCC) is the most common liver cancer suffered by those with hepatitis C; it is often found in those who have not been treated whose disease has progressed. The new treatments, direct-acting antivirals (DAAs) are curing almost everyone, but researchers in Houston, TX wanted to know if the risk of HCC goes away.

Other viruses that affect the Liver
Those of us who have or have had hepatitis C must take extra care so as to not get other infections, since many if not most of us still have scarring, even if the virus is gone. This means taking care, as before, not to expose our bodies to toxins or anything that can cause liver inflammation (such as tobacco, alcohol and fast foods).

Treatment Map
The Canadian Treatment Action Council (CTAC) in Toronto has developed a great new free online tool for getting the most current HCV treatment news in Canada

Holiday Letter from HepCBC
Gilead GT 4-6
Would YOU?/
Honour Roll

Begin here...

View All Newsletters, Here

Stay Connected


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

December 2015 PDF ( 13.7MB) | December 2015 Interactive Version

FDA warns of serious liver injury from HCV drugs
Sofosbuvir/velpatasvir works in HCV
IDWeek: Despite better drugs, HCV deaths keep rising
GI and liver diseases remain public health burden

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

Stay connected


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.

In November, HCV Action published three new case studies, each highlighting hepatitis C services or projects that are both innovative and highly successful in terms of improving outcomes for patients.

NICE publishes final guidance for three new hepatitis C treatmentsThe National Institute for Health and Care Excellence (NICE) have this month published final guidance recommending the use of Harvoni, Daklinza and Viekirax (with or without Exviera) for the treatment of people with hepatitis C. The guidance will result in significantly wider access to the new, non-interferon, direct acting anti-viral treatments, which have shorter treatment durations and much less severe side-effects for patients when compared to interferon-based

A new report on sustainable healthcare
3 Dec 15

Call in Parliament for a national hepatitis C improvement framework
1 Dec 15

NICE releases final guidance for access to Harvoni, Viekirax and Daklinza hepatitis C treatments
25 Nov 15

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Blogs Around The Web

AJM Hepatitis C Resource Center - Hepatitis C Blog 
The AJM Hepatitis C Resource Center provides both primary care providers and specialists with continually updated treatment guidelines, and an up-to-date repository of informative, freely-available, full-text articles to encourage effective HCV screening and diagnosis, and to highlight the promise of novel treatment regimens.

Exclusive Hepatitis C Interview: Daryl Luster
In your experience as a patient and also as someone who now works in this area, what are the biggest challenges associated with the hepatitis C epidemic in the U.S.?

DARYL LUSTER: In the U.S. and the world, the issue is access to screening, quality care, and treatment. I mean, really, that’s a major issue. It’s quite complicated in the U.S. because of the fact that there is no real universal health care in America. In fact, some people have no insurance, no coverage whatsoever.

In Case You Missed It - Exclusive HCV Interview: Lucinda K Porter, RN

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. Visit

Top Stories

India Launches Drive to Eradicate Hepatitis B Virus
Nov 30 – The health ministry in collaboration with UNICEF launched a media campaign, including megastar Amitabh Bachchan, with the resolve to make India Hepatitis B Virus-free by the next decade.
Read more.

Functional Liver Cells Grown in the Lab
Nov 30 – Researchers have developed a new technique for growing human liver cells in the laboratory, described as the “holy grail of liver research”, and would allow for a more efficient, lower cost means of studying viral hepatitis, liver cancer, fatty liver, and drug toxicity.
Read more.

Coffee Linked to Reduced Liver Fibrosis in People with HBV, HCV, and NAFLD
Nov 30 – Drinking coffee was associated with lower liver stiffness, a non-invasive measure used to estimate liver fibrosis, in people with hepatitis B, hepatitis C, and non-alcoholic fatty liver disease (NAFLD). 

Tuesday, December 1, 2015
World AIDS Day - Coinfection with HIV and Viral Hepatitis
An estimated 1.2 million persons are living with HIV in the United States. Of people living with HIV in the United States, about 25 percent are coinfected with hepatitis C virus (HCV), and about 10 percent are coinfected with hepatitis B virus (HBV). People living with HIV infection are disproportionately affected by viral hepatitis, and those who are coinfected are at increased risk for serious, life-threatening complications. HIV coinfection more than triples the risk for liver disease, liver failure, and liver-related death from HCV. Because viral hepatitis infection is often serious in people living with HIV and may lead to liver damage more quickly, CDC recommends all persons at risk for HIV be vaccinated against hepatitis B and be tested for HBV and HCV infection. December 1st has been designated World AIDS Day, creating an opportunity not only for raising awareness about HIV infection, but educating health professionals and the general public worldwide about the overwhelming burden of HIV and viral hepatitis coinfection, and the importance of testing, care, and treatment.

View more @ HBV Advocate Blog

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

Gilead’s Pricing of Hepatitis C Drugs Investigated by Senate
on DECEMBER 3, 2015

View all entries, here

Blogs At
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.

Kim Bossley
Hepatitis C Advocate and Co-Founder, The Bonnie Morgan Foundation
Getting your TEAM formed - part 1 
The important part is that your get your life on track and have someone there to help you hold yourself accountable. Everyone deserves to be cured....regardless.
Click here

HIV/Hep C Co-infection activist; on treatment
1 December 2015: World AIDS Day
On World AIDS Day I am grateful for all the activists who fought hard for access to the life saving medication which keeps me, and many hundreds of thousands of others, alive today. I also remember the thousands of men and woman who didn't live long enough to benefit from the medication.

Greg Jefferys
My Hep C Travel Diary, Hepatitis C Advocate
Dare we Dream of a Hep C-free Australia? 
The Liver Clinic at St Vincent's Hospital in Sydney will now monitor patients who are having their Hepatitis C treated with Indian generics.
Click here

Grace Campbell
A nom de guerre for a person living with hepatitis C on Viekira Pak + Ribavirin
Last Entry: Hepatitis C: It's 4 in the morning ...
It's 4am, I'm wide awake and for the first time in many years I am not frightened about the future.
Click here

Connie M. Welch
Passionate Encourager for Christ, Writer, Speaker, and Hep C Warrior
Overcoming Obstacles with Hep C
Hep C has many stages. Overcoming obstacles with Hep C is possible. No matter where you're at in fighting Hep C
click here 

Matt Starr
Hepatitis, Liver Disease Support Coach
The Grouse and Waiting with Hep C
I have hepatitis C. I waited a long time for changes in my health, as a decade of battles with ongoing disease that changed my life. Ups and downs occurred, with lowlights that included a liver transplant, different treatments with low chances of success, and complications that continued beyond my sister's loving gift of her live liver donation. I won't go into details here, as it would end up reading like the long story that it is.
Connect With Us On Twitter and Facebook

Enjoy the weekend, be safe.


Friday, December 4, 2015

EMA Validates Gilead’s Marketing Application for Sofosbuvir/Velpatasvir for the Treatment of Hepatitis C

European Medicines Agency Validates Gilead’s Marketing Application for Fixed-Dose Combination of Sofosbuvir/Velpatasvir for the Treatment of Hepatitis C

If Approved, SOF/VEL Would be the First All-Oral, Pan-Genotypic Single Tablet Regimen for Chronic HCV in Europe --

-- SOF/VEL Granted an Accelerated Assessment by the European Medicines Agency --
December 04, 2015 05:28 AM Eastern Standard Time

FOSTER CITY, Calif.--(BUSINESS WIRE)--Gilead Sciences, Inc. (Nasdaq:GILD) today announced that its Marketing Authorization Application (MAA) for an investigational, once-daily fixed-dose combination of the nucleotide analog polymerase inhibitor sofosbuvir (SOF) 400 mg and velpatasvir (VEL) 100 mg, an investigational pan-genotypic NS5A inhibitor, for the treatment of chronic hepatitis C virus (HCV) infection, has been fully validated and is now under assessment by the European Medicines Agency (EMA). The data included in the application, which was submitted on November 17, 2015, support the use of SOF/VEL among patients with genotype 1-6 HCV infection, including patients with compensated and decompensated cirrhosis.

“If approved, SOF/VEL will represent a significant step forward in the potential to control and eliminate hepatitis C, as the first and only fixed-dose regimen offering high SVR rates with just 12 weeks of treatment for patients with all HCV genotypes.”Tweet this

“Despite advances in the treatment of HCV, there is a need for simple, highly effective pan-genotypic therapies, particularly for patients with genotype 3 HCV infection, who traditionally have been more difficult to cure,” said Norbert Bischofberger, PhD, Executive Vice President of Research and Development and Chief Scientific Officer at Gilead. “If approved, SOF/VEL will represent a significant step forward in the potential to control and eliminate hepatitis C, as the first and only fixed-dose regimen offering high SVR rates with just 12 weeks of treatment for patients with all HCV genotypes.”

The MAA for SOF/VEL is supported by four Phase 3 ASTRAL trials, which evaluated the fixed-dose combination in hepatitis C genotypes 1-6. Of the 1,035 patients treated with SOF/VEL for 12 weeks in the ASTRAL-1, ASTRAL-2 and ASTRAL-3 studies, 1,015 (98 percent) achieved the primary efficacy endpoint of SVR12. The ASTRAL-4 study randomized 267 patients with decompensated cirrhosis (Child-Pugh class B) to receive 12 weeks of SOF/VEL with or without ribavirin (RBV), or 24 weeks of SOF/VEL. Ninety-four percent of patients who received SOF/VEL plus RBV for 12 weeks achieved an SVR12, while 83 percent and 86 percent of patients who received SOF/VEL for 12 weeks and 24 weeks, respectively, achieved SVR12. These data were presented at the American Association for the Study of Liver Diseases (AASLD) annual meeting in November 2015, and were also published in The New England Journal of Medicine.

Patients treated with SOF/VEL for 12 weeks in ASTRAL-1, ASTRAL-2 and ASTRAL-3 had similar adverse events compared with placebo-treated patients in ASTRAL-1. The most common adverse events in the four ASTRAL studies were headache, fatigue and nausea.

SOF/VEL is the third investigational medicinal product from Gilead for HCV infection to receive Accelerated Assessment by the EMA. This, however, does not assure a positive opinion from the EMA’s Committee for Medicinal Products for Human Use (CHMP) or final approval by the European Commission. Review of the MAA will be conducted under the centralized licensing procedure, which, if authorized, provides marketing authorization in all 28 member states of the European Union, Norway and Iceland. If approved, SOF/VEL could be available for marketing in the European Union in 2016. Gilead has also submitted a regulatory application for SOF/VEL in the United States.

SOF/VEL is an investigational product and its safety and efficacy has not yet been established.

For more information on Gilead Sciences, please visit the company’s website at or call Gilead Public Affairs at +44 (208) 587-2477.

Thursday, December 3, 2015

HCV Most Common Infectious Cause of Death, Yet Still Underestimated

HCV Most Common Infectious Cause of Death, Yet Still Underestimated
Carly Szabo
Publish Date: Wednesday, December 02, 2015

Hepatitis C infection causes more deaths than HIV, hepatitis B, and tuberculosis combined.

Despite the advent of direct acting antivirals (DAAs) in the fight against hepatitis C virus (HCV) in recent years, deaths related to HCV infection continue to rise in the United States, according to data presented at IDWeek 2015 in San Diego, California.

Even though death certificate data indicates that hepatitis C is the most common infectious cause of death, even more so than HIV, hepatitis B and tuberculosis combined, HCV-related mortality is still likely underestimated.

According to the US Centers for Disease Control and Prevention, there are between 3 and 4 million people living with HCV in the United States. Many of those infected were born between the years of 1945 and 1965; however, new data shows a spike in infections among younger intravenous drug users.

HCV has the potential to advance to severe liver disease including cirrhosis, liver cancer and end-stage liver failure. The virus is also the leading cause of liver transplantation, according to

A new study that evaluated a national multiple-cause-of-death (MCOD) database from 2003 to 2013 and data from the Chronic Hepatitis Cohort Study (CHeCS), which showed deaths with hepatitis C recorded on death certificates increased from 11,051 in 2003 to nearly 20,000 in 2013.

Deaths associated with all 59 other notifiable infectious conditions decreased from nearly 25,000 in 2003 to just 18,002 in 2013. The study also analyzed “hidden” mortality rates among people believed to have access to evolving HCV care and curative treatments.

Among more than 12,000 people receiving care in the CHeCS, the mortality rate doubled from about 2.3 per 100 person-years to 5.5 per 100 person-years from 2007 to 2013, respectively.

Of 1600 CHeCS patients who died, only 19% had HCV listed as the cause of death on their certificates, even though more than 75% showed evidence of liver disease prior to death, according to

When taking this percentage and applying it to the general population, it can be estimated that 75,000 deaths in 2013 were attributable to HCV.

“Deaths in chronic HCV-infected persons, even when grossly under-enumerated on death certificates, far outstrip deaths from 60 other infectious conditions reportable to CDC,” the investigators concluded. “Control of the ‘chronic’ and the ‘acute’ outbreaks will require a multipronged approach, with interventions along a testing-to-cure continuum of care.”

According to the analysis, the hepatitis C cascade of care shows that of the 3.2 million people living with HCV in the United States, 50% have had HCV antibody tests, 38% have received hepatitis C care, 23% have had HCV RNA tests, 11% have received treatment and only 6% have achieved sustained virological response, or what is considered to be cured.

Data from Gilead Sciences, producers of two of the curative treatments for HCV, Sovaldi (sofosbuvir) and Harvoni, shows that prescriptions for sofosbuvir-based regimens reached 470,000 in the second quarter of 2015.

Yet, while the number of people receiving HCV treatment rises, barriers still exist to achieving universal treatment. Some of these barriers include the expense of treatment, clinicians thinking hepatitis C is a benign chronic condition that doesn’t require treatment, and reluctance to help people who inject drugs.

As more competition enters the marketplace and people become more educated about the risk factors that accompany an HCV infection, the frequency of HCV-related deaths should go down over time.

See more at:

Wednesday, December 2, 2015

AbbVie Announces FDA Acceptance of NDA for VIEKIRA PAK® to Treat Genotype 1 Chronic Hepatitis C Virus Infection

AbbVie Announces FDA Acceptance of New Drug Application for a Once-Daily Formulation of VIEKIRA PAK® (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets) to Treat Genotype 1 Chronic Hepatitis C Virus Infection

- If approved, this regimen will be the first all-oral, co-formulated three direct-acting antiviral treatment for adult patients with genotype 1 (GT1) chronic hepatitis C virus (HCV) infection

- New formulation reflects AbbVie's ongoing commitment to scientific innovation for people living with HCV

- Decision from FDA on New Drug Application anticipated in second half of 2016

The proposed dosing for the fixed-dose formulation (dasabuvir, ombitasvir, paritaprevir, ritonavir tablets) is three oral tablets once daily with a meal, with or without twice-daily RBV, potentially offering another important treatment option for people living with GT1 HCV. The NDA filing is supported by data from two bioavailability studies. Currently, VIEKIRA PAK is taken twice daily as three tablets in the morning and one tablet in the evening, taken with a meal.

NORTH CHICAGO, Ill., Dec. 2, 2015 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced its New Drug Application (NDA) has been accepted by the U.S. Food and Drug Administration (FDA) for a once-daily, fixed-dose formulation of the components of VIEKIRA PAK® (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets). VIEKIRA PAK is an all-oral, interferon-free treatment approved with or without ribavirin (RBV) in the United States for patients with genotype 1 (GT1) chronic hepatitis C virus (HCV) infection, including those with compensated cirrhosis. VIEKIRA PAK is not for people with decompensated cirrhosis.

The proposed dosing for the fixed-dose formulation (dasabuvir, ombitasvir, paritaprevir, ritonavir tablets) is three oral tablets once daily with a meal, with or without twice-daily RBV, potentially offering another important treatment option for people living with GT1 HCV. The NDA filing is supported by data from two bioavailability studies. Currently, VIEKIRA PAK is taken twice daily as three tablets in the morning and one tablet in the evening, taken with a meal.

"Nearly one year after the launch of VIEKIRA PAK, AbbVie is pleased to announce the acceptance of a New Drug Application for a once-daily formulation for the treatment of patients with chronic genotype 1 hepatitis C," said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. "This milestone further underscores AbbVie's commitment to offer people living with hepatitis C optimized treatment options."

The Centers for Disease Control and Prevention (CDC) estimates that in the United States, approximately 2.7 million people are chronically infected with HCV.i Genotype 1 is the most prevalent form of HCV in the U.S., accounting for approximately 74 percent of all cases.ii Hepatitis C is inflammation of the liver caused by an infection with HCV. It is transmitted when an infected person's blood enters the bloodstream of an uninfected person. There are six major HCV genotypes (GT1-6). Presently, there is no vaccine for HCV infection.

VIEKIRA PAK® (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets) is a prescription medicine used with or without ribavirin to treat adults with genotype 1 chronic (lasting a long time) hepatitis C (hep C) virus infection, including people who have a certain type of cirrhosis (compensated).

VIEKIRA PAK is not for people with advanced cirrhosis (decompensated). If people have cirrhosis, they should talk to a doctor before taking VIEKIRA PAK.

When taking VIEKIRA PAK in combination with ribavirin, people should read the Medication Guide that comes with ribavirin, especially the important pregnancy information.

What is the most important information to know about VIEKIRA PAK?
VIEKIRA PAK may cause severe liver problems, especially in people with certain types of cirrhosis. These severe liver problems can lead to the need for a liver transplant, or can lead to death.
VIEKIRA PAK can cause increases in liver function blood test results, especially if people use ethinyl estradiol-containing medicines (such as some birth control products).
Ethinyl estradiol-containing medicines (combination birth control pills or patches, such as Lo Loestrin® FE, Norinyl®, Ortho Tri-Cyclen Lo®, Ortho Evra®; hormonal vaginal rings such as NuvaRing®; and the hormone replacement therapy medicine, Fem HRT®) must be stopped before starting treatment with VIEKIRA PAK. If these medicines are used as a method of birth control, another method must be used during treatment with VIEKIRA PAK, and for about 2 weeks after treatment with VIEKIRA PAK ends. A doctor can provide instruction on when to begin taking ethinyl estradiol-containing medicines.
A doctor should do blood tests to check liver function during the first 4 weeks of treatment and then as needed.

A doctor may tell people to stop taking VIEKIRA PAK if signs or symptoms of liver problems develop. A doctor must be notified right away if any of the following symptoms develop or if they worsen during treatment with VIEKIRA PAK: tiredness, weakness, loss of appetite, nausea, vomiting, yellowing of the skin or eyes, color changes in stools, confusion, or swelling of the stomach area.

VIEKIRA PAK must not be taken if people:
have certain liver problems take any of the following medicines: alfuzosin hydrochloride (Uroxatral®) • carbamazepine (Carbatrol®, Epitol®, Equetro®, Tegretol®) • colchicine (Colcrys®) • efavirenz (Sustiva®, Atripla®) • ergot containing medicines, including ergotamine tartrate (Cafergot®, Migergot®, Ergomar®, Ergostat®, Medihaler®, Wigraine®, Wigrettes®), dihydroergotamine mesylate (D.H.E. 45®, Migranal®), methylergonovine (Ergotrate®, Methergine®) • ethinyl estradiol-containing medicines • gemfibrozil (Lopid®) • lovastatin (Advicor®, Altoprev®, Mevacor®) • midazolam (when taken by mouth) • phenytoin (Dilantin®, Phenytek®) • phenobarbital (Luminal®) • pimozide (Orap®) • rifampin (Rifadin®, Rifamate®, Rifater®, Rimactane®) • sildenafil citrate (Revatio®), when taken for pulmonary artery hypertension (PAH) • simvastatin (Zocor®, Vytorin®, Simcor®) • St. John's wort (Hypericum perforatum) or a product that contains St. John's wort • triazolam (Halcion®) have had a severe skin rash after taking ritonavir (Norvir®)

What should people tell a doctor before taking VIEKIRA PAK?
If they have: liver problems other than hep C infection, HIV infection, or any other medical conditions.

If they have had a liver transplant. If they take the medicines tacrolimus (Prograf®) or cyclosporine (Gengraf®, Neoral®, Sandimmune®), a doctor should check blood levels and, if needed, may change the dose of these medicines or how often they are taken, both during and after treatment with 

If they are pregnant or plan to become pregnant or if they are breastfeeding or plan to breastfeed. It is not known if VIEKIRA PAK will harm a person's unborn baby or pass into breast milk. A doctor should be consulted about the best way to feed a baby if taking VIEKIRA PAK. Pregnant females who have both hep C and HIV infection should talk with a doctor about enrolling in the antiretroviral pregnancy registry.

About all the medicines they take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Some medicines interact with VIEKIRA PAK.
A new medicine must not be started without telling a doctor. A doctor will provide instruction on whether it is safe to take VIEKIRA PAK with other medicines.
When VIEKIRA PAK is finished, a doctor should be consulted on what to do if one of the usual medicines taken was stopped or if the dose changed during VIEKIRA PAK treatment.

What are the common side effects of VIEKIRA PAK?
For VIEKIRA PAK used with ribavirin, side effects include tiredness, nausea, itching, skin reactions such as redness or rash, sleep problems, and feeling weak.
For VIEKIRA PAK used without ribavirin, side effects include nausea, itching, and sleep problems.

These are not all of the possible side effects of VIEKIRA PAK. A doctor should be notified if there is any side effect that is bothersome or that does not go away.

This is the most important information to know about VIEKIRA PAK. For more information, talk with a doctor.

People are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088.

Click here for full Prescribing Information, including the Medication Guide.

If people cannot afford their medication, they should contact for assistance.

VA can't afford drug for veterans suffering from hepatitis C

VA Doctor Invented Hepatitis C Cure, Sold It For $400 Million Profit
December 3, 2015 by Benjamin Krause
Apparently, Dr. Raymond Schinazi, a VA doctor since 1983, founded a company named Pharmasset and led the scientific team that discovered sofosbuvir while working at VA. That is the substances used in current hep C pill treatments.

So who really owns the hepatitis C cure? Taxpayers or the VA employee who invented it while a full-time VA employee? Dr. Schinazi claimed it was all his.

VA can't afford drug for veterans suffering from hepatitis C
On Tuesday, a Senate report found Gilead Sciences, which makes a cure for a fatal form of hepatitis, is more interested in profits than patients. The cure was invented under the leadership of a celebrated doctor in the Department of Veterans Affairs, but at $1,000 a pill, even the VA can't afford to save the lives of veterans who need it.

Dr. Raymond Schinazi founded the company, Pharmasset, and led the scientific team that discovered sofosbuvir. He also works for the Department of Veterans Affairs and has since 1983.

He said he is only a 7/8th's government employee. So what he does with his remaining time is up to him.

He said he is spending less than 1/8th of his time on private companies.

"Well, even less than that. I'm very efficient," he said

Dr. Schinazi made more than $400 million when he sold his company for $11 billion to pharmaceutical giant Gilead in 2012.


Australians must be given access to this life-saving Hepatitis C treatment

Australians must be given access to this life-saving Hepatitis C treatment

By Amanda Bresnan

There's been a major campaign undertaken by people living with Hepatitis C, the medical community, and the organisations who represent and advocate on behalf of people living with hepatitis C, to have these new drugs listed on the Pharmaceutical Benefits Scheme (PBS).

These Hepatitis C treatments have already been approved by the PBAC and the reason for the delay in providing them to patients is the ongoing negotiations with the product sponsors over price.

The federal Health Minister, Sussan Ley, previously made some positive statements which suggested the possibility of treatments being listed by December 2015; however, this listing is looking less and less likely to occur....

Tuesday, December 1, 2015

Sovaldi Investigation Finds Revenue-Driven Pricing Strategy Behind $84,000 Hepatitis Drug

December 3, 2015 by Benjamin Krause
Apparently, Dr. Raymond Schinazi, a VA doctor since 1983, founded a company named Pharmasset and led the scientific team that discovered sofosbuvir while working at VA. That is the substances used in current hep C pill treatments.

Gilead pricing for Sovaldi hepatitis C drug slammed by senators
The drug maker was aware more patients could have been treated if Sovaldi were priced for less than $1,000 a pill, or $84,000 for a full course of treatment. Instead, it refused to lower the price or offer meaningful discounts in order to maximize and outmaneuver competition, the investigation found. And Gilead did the same thing with its Harvoni follow-up treatment...

US lawmakers allege Gilead used "revenue-driven" pricing model for hepatitis C drugs
(Ref: The United States Senate Committee on Finance, Bloomberg)
December 1st, 2015
By: Joe Barber
A report released Tuesday by US Senators Ron Wyden and Charles Grassley claims that Gilead Sciences priced the hepatitis C treatments Sovaldi (sofosbuvir) and Harvoni (ledipasvir/sofosbuvir) with the sole goal of maximising revenue. The report was based on an investigation of 20 000 pages of internal company documents, dozens of interviews with health care experts and data from Medicaid programmes in all 50 states and the District of Columbia.......

For Immediate Release
December 01, 2015

Wyden-Grassley Sovaldi Investigation Finds Revenue-Driven Pricing Strategy Behind $84,000 Hepatitis Drug

18-Month Investigation Reveals a Pricing and Marketing Strategy Designed to Maximize Revenue with Little Concern for Access or Affordability
Report Includes Landmark Release of Medicaid Data: In 2014, More than $1 Billion Spent by Medicaid Programs on Sovaldi Treated Less than 2.4 Percent of Enrolled Patients with Hepatitis C
Medicare Spent More on Gilead Hepatitis C Drugs in the First Half of 2015 than in All of 2014 
WASHINGTON – Senate Finance Committee Ranking Member Ron Wyden, D-Ore., and senior committee member Chuck Grassley, R-Iowa, today released the results of an 18-month investigation into the pricing and marketing of Gilead Sciences’ Hepatitis C drug Sovaldi and its second-wave successor, Harvoni. Drawing from 20,000 pages of internal company documents, dozens of interviews with health care experts, and a trove of data from Medicaid programs in 50 states and the District of Columbia, the investigation found that the company pursued a marketing strategy and final wholesale price of Sovaldi – $1,000 per pill, or $84,000 for a single course of treatment – that it believed would maximize revenue. Building on that price, Harvoni was later introduced at $94,500. Fostering broad, affordable access was not a key consideration in the process of setting the wholesale prices.
In the 18 months following Sovaldi’s approval, Medicare spent nearly $8.2 billion before rebates on Sovaldi and Harvoni. Over that same span, Medicare’s monthly spending on Hepatitis C treatments increased more than six-fold. In 2014 alone, Medicare and Medicaid combined to spend more than $5 billion on Sovaldi and Harvoni before rebates. That total is projected to climb in 2015. Gilead’s recent financial statements show U.S. sales of Sovaldi and Harvoni, including through public programs and private payers, totaled $20.6 billion after rebates in the 21 months following Sovaldi’s introduction.
Senators Wyden and Grassley will hold a press conference today at 11:15 a.m. in the Senate Radio/TV GalleryS-325, to discuss the investigation. Details are below, including a streaming feed for media unable to attend in person. Further resources are also online and additional findings from the investigation are below.
“Gilead pursued a calculated scheme for pricing and marketing its Hepatitis C drug based on one primary goal, maximizing revenue, regardless of the human consequences. There was no concrete evidence in emails, meeting minutes or presentations that basic financial matters such as R&D costs or the multi-billion dollar acquisition of Pharmasset, the drug’s first developer, factored into how Gilead set the price. Gilead knew these prices would put treatment out of the reach of millions and cause extraordinary problems for Medicare and Medicaid, but still the company went ahead. If Gilead’s approach to pricing is the future of how blockbuster drugs are launched, it will cost billions and billions of dollars to treat just a fraction of patients,” Senator Wyden said. “America needs cures for cancer, Alzheimer’s, diabetes and HIV. If those cures are unaffordable and out of reach to millions who need them, Congress will not have met its responsibilities to the American people. I reject the idea that America has to choose between soaring, out-of-reach drug prices and one-size-fits-all government policies. Solving this challenge will take fresh, bipartisan thinking and political independence to bring people together.”
“The Finance Committee has tremendous responsibility in overseeing the federal programs paying for prescription drug coverage,” Senator Grassley said.  “With that responsibility, the committee should know how the costs to the public programs and private insurance companies of a single innovative drug entering the market without competition can have major effects on which patients get the new drug and when.  This report sheds light on one example of the pricing decisions made by one company with a new prescription medicine that entered the market without competition in high demand.  This might be an example that received the most attention in some time, but it won’t be the last.  I look forward to discussions with my colleagues and the public on the policy questions in the report.  I encourage everyone to read the report for the level of detail into pricing strategy that we don’t often see.” 
Additional major findings from the investigation include:
  • Gilead justified Sovaldi’s high price point based on price-per-cure: Documents acquired during the course of investigation illustrate that Gilead was aware it was in a position to create clear savings for payers, but chose to pursue a “regimen neutral” price justified by “cost-per-cure” calculations that resulted in greater revenue per treatment than previous direct acting anti-virals [see page 42]. Given the increased clinical efficacy of Sovaldi, Gilead believed that it was more than justified in using the cost-per-cure pricing model [37, 46].
  • Gilead set a high price for Sovaldi with an eye toward ensuring a future high price for Harvoni: The documentation reviewed shows that Gilead considered a number of factors in determining a price point for Sovaldi, including costs for the existing standard of care for Hepatitis C treatment and setting a high baseline for the next wave of drugs, such as Harvoni [32-58]. In documents obtained during the course of investigation, Gilead officials noted the “value capture opportunity is in Wave 1,” and “Wave 2 access will be enhanced with a high Wave 1 price.” It went on to say that “[a]t any price, access for Wave 2 improves as the price for Wave 1 is increased, suggesting that Wave 1 will set a price benchmark against which Wave 2 will ultimately be evaluated.” By elevating the price for the new standard of care set by Sovaldi, Gilead intended to raise the price floor for all future Hepatitis C treatments, including its follow-on drugs and those of its competitors [44].
  • Gilead underestimated the degree of access restrictions that it expected would result from its pricing decision: Gilead set a price as high as it thought the market would bear before significant access restrictions would be imposed [30]. Gilead’s analyses were ultimately incorrect on this point as many payers adopted substantial access restrictions at the final price of $84,000 [81-88, 96-98].
  • Despite significant access restrictions, Gilead refused to significantly lower the net price: When confronted with the widespread initiation of access restrictions [99-106], Gilead refused to offer substantial discounts and did not significantly modify its contracting strategy to improve patient access. For example, Gilead offered Medicaid programs supplemental rebates of up to 10 percent; however, its offer came with the precondition that states had to drop some or all of their access restrictions [106]. For states already facing a steep financial burden, accepting that precondition in most cases would have increased the budgetary impact rather than easing it [107]. Only five state Medicaid programs reached agreements with Gilead to receive supplemental rebates in 2014 [138].
  • The burdens on Medicare, Medicaid, and the Bureau of Prisons were significant: The price of Sovaldi constituted a large burden—notably among state Medicaid programs, Medicare, and the BOP—and triggered access restrictions across public and private payers, thus limiting the number of Hepatitis C-infected patients who could access the new treatment options [81-88, 96-98]. For example, state Medicaid programs nationwide spent $1.3 billion before rebates on the drug in 2014. Even with that expenditure, less than 2.4 percent of the roughly 700,000 Medicaid enrollees with Hepatitis C were treated with Sovaldi [82-87]
  • Competition entered the market, prices responded, but there are still significant concerns: Three days following Viekira Pak’s approval on December 19, 2014, Express Scripts Holding Co., the nation’s largest pharmacy benefit manager, announced that it would make Viekira Pak its preferred treatment for Hepatitis C genotype 1 and would no longer cover Sovaldi and Harvoni for these patients [112]. Gilead responded in January and February 2015 by entering into discounting agreements for Harvoni and Sovaldi with CVS, Anthem, Humana, Aetna, and UnitedHealth Group. Cigna struck agreements with Gilead for Harvoni only [113]. Even as competition lowered prices for therapies, this report documents that concerns remain, particularly in the public payer community, about high costs for treating millions of people in the U.S. infected with Hepatitis C, as well as the budgetary effects of a future single source innovator that might not face competition as quickly [114-122].
The report in full is available here.
An executive summary is available here.
A timeline of events pertaining to Gilead, Sovaldi and Harvoni is available here.
A glossary of terms pertaining to the investigation is available here.
Letters from state Medicaid programs are available here
Information on today’s press conference and a link to streaming video is below:
Who: Senator Ron Wyden, D-Ore.Senator Chuck Grassley, R-Iowa 
What: Press conference on the findings of an 18-month, bipartisan investigation into the pricing of Gilead Sciences’ Hepatitis C drugs Sovaldi and Harvoni 
Where: Senate Radio/TV Gallery (S-325)U.S. Capitol Building Washington, DC 20510
When: December 1, 2015 11:15 a.m.
Streaming Feed:

Enhanced treatment for hepatitis C could cut prevalence by 80%

Enhanced treatment for hepatitis C could cut prevalence by 80%
By Ziba Kashef

Novel antiviral therapies for hepatitis C could reduce the prevalence of the blood-borne infection by more than 80%, according to an analysis by Yale researchers. The finding raises the possibility of greatly reducing, and even eliminating, hepatitis C in the United States if enhanced screening and treatment efforts target high-risk populations.

The study published online Dec. 1 in Clinical Infectious Diseases.

Recently approved direct-acting antiviral medications have transformed treatment for individuals with hepatitis C virus (HCV), and are effective in over 90% of cases. The antivirals have the potential to significantly reduce or eliminate HCV in two ways: through treatment to prevent HCV-related complications and deaths, and by preventing further transmission among injection-drug users.

To study the effects of the new treatments on the U.S. population, the Yale team developed a transmission model to predict the effect of treatment with direct-acting antivirals over time. They also quantified the impact of use of the antivirals at current and at enhanced screening and treatment rates. Their analysis included outcomes such as cirrhosis, liver transplants, and mortality.

“The key finding is that a four-fold increase to the number of patients treated each year could virtually eliminate HCV from the non-injecting population within a decade,” said Jeffrey Townsend, associate professor of public health and senior author of the study. More modest increases in screening and treatment would also markedly reduce new infections and mortality, Townsend and co-authors determined.

The researchers also noted that expanded screening and treatment alone would not be sufficient to reduce HCV among individuals most at risk — injection-drug users. “In order to completely eliminate HCV, efforts to access that community are extremely important,” said David Durham, lead author of the study. Such efforts might include enhanced screening and treatment with the new therapies in combination with targeted behavioral interventions such as needle-exchange programs or opioid substitution therapy.

“We should be very optimistic about the prospect of eliminating HCV as a disease within the U.S. using these direct acting antivirals, especially if they are combined with targeted behavioral interventions to reduce transmission,” said Townsend. However, he added, “due to the currently high cost of these treatments, as a society we need to think carefully about how to make that happen.”

Other Yale authors include David P. Durham, Laura A. Skrip, Dr. R. Douglas Bruce, Dr. Silvia Vilarinho, and Alison P. Galvani. Elamin H. Elbasha is a co-author.

The research was funded by the Notsew Orm Sands Foundation and Merck.