Showing posts with label AASLD 2015 Meeting. Show all posts
Showing posts with label AASLD 2015 Meeting. Show all posts

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 HepatitisC.net.
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

Newsletter

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 OASISclinic.org 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 Sjögren 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

Newsletter
December 2015 Hep Free NYC Newsletter

In This Newsletter
Upcoming Events
Advocacy
New Tools
News
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! 
November 
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

HepCBC’s MONTHLY NEWSLETTER
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

Topics

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
Eradication
Conferences
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

Highlights
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

LATEST NEWS FROM THE HEPATITIS C TRUST
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

View newsletter archive


Connect With Us On Twitter
 

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 www.hepb.org

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

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

View all entries, here

Blogs At HepMag.com
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 HepMag.com 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.

Tina

Friday, November 20, 2015

ASTRAL-2: Sovaldi/velpatasvir bests standard therapy in HCV genotype 2

Healio: Additional headlines from Highlights from The Liver Meeting 2015

ASTRAL-2: Sovaldi/velpatasvir bests standard therapy in HCV genotype 2
SAN FRANCISCO — A fixed-dose combination of Sovaldi and velpatasvir yielded better sustained virologic response rates in patients with genotype 2 hepatitis C virus than Sovaldi and ribavirin, the current standard of care, according to findings presented at The Liver Meeting 2015.
Mark S. Sulkowski, MD, of Johns Hopkins University, noted that there is currently no ribavirin-free regimen approved for the treatment of this patient population. The open-label study had broad inclusion criteria, allowing for patients with treatment experience and cirrhosis, and was conducted at 51 centers in the U.S.

November 17, 2015
SAN FRANCISCO — A fixed-dose combination of Sovaldi and velpatasvir yielded 99% SVR12 across a number of genotypes, according to a presentation…

Sovaldi, velpatasvir, GS-9857 show efficacy in challenging populations
November 17, 2015
SAN FRANCISCO — A cohort including patients with genotype 3 disease demonstrated high SVR12 rates after treatment with Sovaldi, velpatasvir (or…

New England Journal Of Medicine 

Sofosbuvir and Velpatasvir for HCV Genotype 2 and 3 Infection
Here, we present the results of two randomized, controlled, phase 3 trials (ASTRAL-2 and ASTRAL-3) in which treatment with a fixed-dose combination tablet of sofosbuvir and velpatasvir for 12 weeks was compared with standard treatment with sofosbuvir plus ribavirin for 12 or 24 weeks in patients who had received prior treatment for HCV genotype 2 or 3 infection and in those who had not received such treatment, including those with compensated cirrhosis.

Sofosbuvir and Velpatasvir for HCV in Patients with Decompensated Cirrhosis
The NS5B nucleotide inhibitor sofosbuvir is approved for the treatment of HCV infection in combination with other agents.13,14 Velpatasvir (formerly known as GS-5816, Gilead Sciences) is an investigational inhibitor of the HCV NS5A protein with antiviral activity against all HCV genotypes.15-17 The combination of velpatasvir and sofosbuvir with or without ribavirin provided high rates of sustained virologic response in patients with all HCV genotypes in phase 2 clinical trials.18,19 In the phase 3 ASTRAL-1, ASTRAL-2, and ASTRAL-3 trials (now published in theJournal),20,21 treatment with sofosbuvir–velpatasvir in a fixed-dose combination tablet for 12 weeks resulted in high rates of sustained virologic response among patients with HCV genotypes 1 through 6 without cirrhosis or with compensated cirrhosis.

Sofosbuvir and Velpatasvir for HCV Genotype 1, 2, 4, 5, and 6 Infection
We conducted a phase 3 trial (ASTRAL-1) to assess the efficacy and safety of 12 weeks of treatment with a fixed-dose combination of velpatasvir and sofosbuvir among both previously treated and untreated patients who were chronically infected with HCV genotype 1, 2, 4, 5, or 6, including those with compensated cirrhosis.

Slide presentation with full text @ NATAP

Thursday, November 19, 2015

Watch Patients Treated For Hepatitis C: Studying possible regression in cirrhosis/ fibrosis


Q&A With Ana Maria Crissien From Scripps Green Hospital: Studying Regression In Liver Disease
Conference Coverage > AASLD 2015
Nov 19, 2015 | Adam Hochron
A considerable amount of research has been done looking at how liver disease can progress in patients, but a recent study looked at possible regression in conditions like cirrhosis and fibrosis. Ana Maria Crissien, MD, from the Scripps Green Hospital in California discussed the results of this research during the annual Liver Meeting in San Francisco.



2015 Liver Meeting | AASLD 2015

Q&A with Barry Schlansky, MD, from Oregon Health & Science University: Taking a New Look at Liver Transplants for Obese Patients VIDEO
Nov 18, 2015 | AASLD 2015 | Adam Hochron
In the past, patients deemed obese (especially those who were morbidly obese) may have been passed over for a life-saving liver transplant. A recent study showed they may be just as viable candidates for the procedure as others in the patient population.

Should Obese Patients Get Liver Transplants?
Nov 18, 2015 | AASLD 2015 | Gale Scott
Obese people are generally less healthy than those of normal weight, but that should not be a barrier to liver transplantation, researchers said at the 2015 Liver Meeting (AASLD) in San Francisco, CA.

Nations Awaiting Price Break in HCV Drugs
Nov 18, 2015 | AASLD 2015 | Gale Scott
Price is still the main obstacle in getting hepatitis C direct-acting antivirals to nations that need them, panelists agreed at a "global challenges" forum at the 2015 Liver Meeting in San Francisco, CA.

Who Gets a Liver? Transplant Centers Differ on Substance Abuse Abstinence Rules
Nov 17, 2015 | AASLD 2015 | Gale Scott
Donor livers are scarce, donated organs are precious, and transplant surgeons make the final call on whether to transplant. When the question of whether to give a liver to a patient who uses marijuana, drinks too much alcohol, or even smokes tobacco comes up, the issue gets tricky.

HCV: Making it Rare in the US Will Cost $106 Billion, Study Finds
Nov 17, 2015 | AASLD 2015 | Gale Scott
The annual US cost of HCV treatment before direct-acting antivirals was $7 billion and since then it has grown to $21 billion, but that cost should drop when generics arrive, to $14 million annually by 2030. Making it a rare disease over the next 25 years will take $106 billion, researchers project.

Vitamin E Looks Promising, Safe, for Liver Disease
Nov 17, 2015 | AASLD 2015 | Gale Scott
Researchers see promise in vitamin E treatment for NASH.

Coverage starts here.....



Watch Independent Expert Review on AASLD 2015: Discussion on HCV therapeutic options and developments



Replay from 11/16 Available! - CME Satellite Symposium
11/16/15 - San Francisco, CA

CLICK HERE TO VIEW THE PROGRAM

HCV in 2015 - The CME Internet Symposium: AASLD 2015 Expert Review will feature four HCV experts reviewing and discussing key presentations on chronic hepatitis C presented at AASLD 2015. 

The review and discussion will focus on HCV therapeutic options and developments, including: current treatment and management strategies, algorithms and recommendations; therapies in development; epidemiology; and diagnosis and clinical management of specific patient populations, including HCV/HIV co-infected and cirrhotic patients.

This activity will enable participating health care providers caring for HCV-infected patients to become aware of and understand the data presented at this important conference and appropriately utilize those data to improve patient care. All online components of the program can be accessed at www.viraled.com

This program is produced by the Postgraduate Institute for Medicine and ViralEd, Inc. It is not a session created by or presented at AASLD 2015 and it is not sanctioned by the organizers of AASLD 2015.

US calls for a ban on advertising prescription drugs

US calls for a ban on advertising prescription drugs
BY SUSAN KELLY

The American Medical Association on Tuesday called for a ban on advertising prescription drugs and medical devices directly to consumers, saying the ads drive patients to demand expensive treatments over less costly ones that are also effective.

The influential doctors' group said the new policy reflects physicians' concerns that marketing spending on a proliferation of advertising is helping to drive up drug prices. The group voted at its annual meeting in Atlanta to support a ban.

"Direct-to-consumer advertising also inflates demand for new and more expensive drugs, even when those drugs may not be appropriate," AMA Board Chair-elect Patrice Harris said in a statement.

The United States and New Zealand are the only two countries that allow direct-to-consumer advertising of prescription drugs.

AMA said drugmakers' spending on advertising has shot up 30 percent in the last two years to $4.5 billion. TV commercials for drugs such as Bristol-Myers Squibb's lung cancer medicine Opdivo and Gilead Sciences' Hepatitis C treatment Harvoni were among this year's ad campaigns.

US Democratic presidential candidate Hillary Clinton has proposed cracking down on direct-to-consumer advertising and other measures to stop what she called "price gouging" by pharmaceutical companies. Clinton's plan would prevent companies from deducting what they spend on direct-to-consumer ads from their tax bills.

A series of court decisions has determined the ads cannot be banned outright because they are a form of commercial speech protected by the US Constitution. The AMA did not address how the ban could be accomplished without being overturned in court.

PhRMA, the largest US trade group for the pharmaceutical industry, said the ads increase consumer awareness of available treatments for diseases, including undiagnosed conditions.

"Providing scientifically accurate information to patients so that they are better informed about their health care and treatment options is the goal of direct-to-consumer pharmow said in an email.

According to a US Food and Drug Administration analysis this year, 52 percent of Americans believe direct-to-consumer ads do not have enough information about risks and 46 percent say the ads aceutical advertising about prescription medicines," PhRMA spokesman Tina Stlack information about benefits.

http://www.reuters.com/article/2015/11/17/us-pharmaceuticals-advertising-idUSKCN0T62WT20151117#6SFFdTwWfHwemQBq.97

Wednesday, November 18, 2015

AASLD 2015 - The Risk of Developing Liver Cancer Even After Being Cured from Hepatitis C

The Risk of Developing Liver Cancer Even After Being Cured from Hepatitis C

SAN FRANCISCO, Nov. 15, 2015 /PRNewswire/ -- Hepatocellular carcinoma (HCC) remains one of the cancers growing in frequency and mortality in the United States. Patients with hepatitis C virus (HCV) left untreated will often progress to cirrhosis and HCC. Direct acting antivirals (DAAs) now used to treat patients with HCV have achieved almost universal cure rates. However, the risk of HCC following cure is not clear. Researchers from Houston VA Medical Center and Baylor College of Medicine (Houston, TX) presented data at the annual meeting of the American Association for the Study of Liver Diseases on the risk of developing HCC in patients with HCV who have achieved sustained virologic response (SVR).

This retrospective national cohort study examined the records of patients who achieved SVR using interferon-based therapy and who had at least one year of follow up in the national VA system. There were 10,738 patients who achieved SVR and had no HCC prior to SVR. Of those patients who achieved SVR, 100 developed HCC after SVR.

Dr. El-Serag, the study's principal investigator, concluded that the risk of developing HCC after being cured of HCC remains elevated with an overall incidence of 0.33 percent per year. Being older, or having cirrhosis at the time of SVR were associated with annual HCC risk of 0.9% and 1.55%, respectively. Diabetes and previous genotype 3 were also associated with an additional increased risk of developing HCC after HCV cure. Dr. El-Serag addresses those at an increased risk of developing HCC, "Subgroups such as age 65 years and older, those with diabetes and especially those with cirrhosis have even higher rates -- closer to or higher than 1 percent per year -- of developing HCC."

"The results pertain to mostly male veterans treated with interferon-based treatments and therefore may not be generalizable to women, nonveterans and those cured using DAA," cautioned Dr. El-Serag. He added, "We still need to examine large cohorts of DAA-cured patients, and examine several demographic, clinical, and genetic factors that may serve as predictor or prognostic markers.

When asked to address the overall significance of this study, Dr. El-Serag replied, "We will be facing large numbers of cured HCV patients and this study gives us a glimpse what the clinical course might be. It is clear that while cure considerably reduces HCC risk in general, it does not eliminate it especially when cirrhosis is present and in those who get cured at an old age. Therefore, the sooner we cure patients the better off we are. Furthermore continued vigilance and HCC surveillance is warranted after cure in these subgroups."

Abstract title: Incidence and predictors of hepatocellular carcinoma following sustained virological response: A national cohort study

AASLD is the leading medical organization for advancing the science and practice of hepatology. Founded by physicians in 1950, AASLD's vision is to prevent and cure liver diseases. This year's Liver Meeting®, held in San Francisco, CA, November 14-17, will bring together more than 9,000 researchers from 55 countries.

A pressroom will be available from November 13 at the annual meeting. For copies of abstracts and press releases, or to arrange researcher interviews, contact Gregory Bologna at 703-299-9766.

Press releases and all abstracts are available online at www.aasld.org.

Tuesday, November 17, 2015

NEJM EDITORIAL: Simple, Effective, but Out of Reach? Public Health Implications of HCV Drugs

EDITORIAL 
John W. Ward, M.D., and Jonathan H. Mermin, M.D., M.P.H.
November 17, 2015
DOI: 10.1056/NEJMe1513245

The results of four clinical trials showing the excellent safety and efficacy of a 12-week course of sofosbuvir (an NS5B inhibitor licensed in the United States in 2013) and velpatasvir (a new NS5A inhibitor) in treating patients with hepatitis C infection (HCV) are reported now in the Journal.1-3 In two of these studies, ASTRAL-1 and ASTRAL-2, 97 to 100% of patients with HCV genotype 1a, 1b, 2, 4, 5, or 6 had a sustained virologic response at 12 weeks after the end of therapy, a marker that is indicative of virologic cure. Similar efficacy was observed among patients in whom previous treatment had failed and those with compensated cirrhosis, factors that have been associated with a reduced response to the treatment of HCV infection.4
We conducted a phase 3 trial (ASTRAL-1) to assess the efficacy and safety of 12 weeks of treatment with a fixed-dose combination of velpatasvir and sofosbuvir among both previously treated and untreated patients who were chronically infected with HCV genotype 1, 2, 4, 5, or 6, including those with compensated cirrhosis.

Sofosbuvir and Velpatasvir for HCV Genotype 2 and 3 Infection
Here, we present the results of two randomized, controlled, phase 3 trials (ASTRAL-2 and ASTRAL-3) in which treatment with a fixed-dose combination tablet of sofosbuvir and velpatasvir for 12 weeks was compared with standard treatment with sofosbuvir plus ribavirin for 12 or 24 weeks in patients who had received prior treatment for HCV genotype 2 or 3 infection and in those who had not received such treatment, including those with compensated cirrhosis.

Sofosbuvir and Velpatasvir for HCV in Patients with Decompensated Cirrhosis
The number of patients with decompensated cirrhosis caused by chronic infection with the hepatitis C virus (HCV) is projected to rise in the coming decade.1 For many years, the only treatment option for such patients was liver transplantation. Recently, however, clinical trials of newly approved direct-acting antiviral agents have shown that it is possible to treat HCV infection safely and effectively in patients with decompensated cirrhosis and that successful treatment is associated with early improvement in liver function.2-11 The possible long-term benefits of treatment on existing liver disease remain unknown. The only regimen that is currently approved for the treatment of HCV infection in patients with decompensated cirrhosis is 24 weeks of ledipasvir–sofosbuvir plus ribavirin, which is approved in Europe for patients with HCV genotypes 1 and 4.12 A highly effective regimen to treat HCV infection of all genotypes in patients with decompensated liver disease that has acceptable side effects would address a significant unmet medical need.

The NS5B nucleotide inhibitor sofosbuvir is approved for the treatment of HCV infection in combination with other agents.13,14 Velpatasvir (formerly known as GS-5816, Gilead Sciences) is an investigational inhibitor of the HCV NS5A protein with antiviral activity against all HCV genotypes.15-17 The combination of velpatasvir and sofosbuvir with or without ribavirin provided high rates of sustained virologic response in patients with all HCV genotypes in phase 2 clinical trials.18,19 In the phase 3 ASTRAL-1, ASTRAL-2, and ASTRAL-3 trials (now published in theJournal),20,21 treatment with sofosbuvir–velpatasvir in a fixed-dose combination tablet for 12 weeks resulted in high rates of sustained virologic response among patients with HCV genotypes 1 through 6 without cirrhosis or with compensated cirrhosis.

We conducted a phase 3, open-label trial to assess the efficacy and safety of a fixed dose of sofosbuvir–velpatasvir with or without ribavirin for 12 weeks or sofosbuvir–velpatasvir for 24 weeks in patients infected with HCV genotypes 1 through 6 and with decompensated cirrhosis...

AASLD Coverage @ Healio 
ASTRAL-1: Sofosbuvir/velpatasvir shows pangenotypic activity
SAN FRANCISCO — A fixed-dose combination of Sovaldi and velpatasvir yielded 99% SVR12 across a number of genotypes, according to a presentation at the Late Breakers session of The Liver Meeting 2015.

“Although there has been phenomenal progress in HCV therapy over the last few years, interferon-free regimens are not pangenotypic and, therefore, most regimens need to be selected for specific patient groups,” Jordan J. Feld, MD, of the Toronto Western Hospital Liver Centre, said in his presentation.

November 16, 2015
Source:University Health Network (UHN)

Summary:Researchers have found that a simple drug regimen delivered over 12 weeks achieved sustained eradication of several genotypes of the hepatitis C virus (HCV) in 99 per cent of the trial's patients.

Chronic HCV is known as a "silent" killer because symptoms often don't appear until the liver is severely damaged. Left undiagnosed, HCV can lead to cirrhosis which can progress to liver failure or liver cancer. HCV is primarily spread by blood-to-blood contact and is associated with intravenous drug use, contact with poorly sterilized medical equipment and blood transfusions before 1992.

Researchers at the Toronto Western Hospital (TWH) Liver Clinic have found that a simple drug regimen delivered over 1​2 weeks achieved sustained eradication of several genotypes of the hepatitis C virus (HCV) in 99 per cent of the trial's patients.

The study, released in the New England Journal of Medicine, showed that receiving a once daily drug combination of sofosbuvir-velpatasvir for a 12 week period was effective in both treatment-naïve and previously treated patients with HCV genotype 1, 2, 4, 5, or 6, including those with compensated cirrhosis (where scarring of the liver has occurred but patients have yet to experience symptoms as a result of it).

"This drug regimen changes the standard of care in treating patients with HCV -- we can now cure almost everyone with a very simple treatment," said Dr. Jordan Feld, Hepatologist, Francis Family Liver Clinic, TWH and the first author of the study. "It's incredibly gratifying to be part of research where we not only cure a disease but can also think about eliminating HCV in Canada."

Current approved treatments for chronic HCV are not equally effective in combating the virus' different genotypes. Testing to determine the genotype and subtype of the virus is required before treatment could be initiated. But the combination of sofosbuvir-velpatasvir has been shown to be applicable to all strains of HCV, effectively eliminating the need to test for the viral genotype -- an obstacle that often delayed treatment.

The regimen was tested in an international, randomized, double-blind placebo-controlled phase three trial conducted at 81 sites in eight different countries. After 12 weeks, 99 per cent of the 624 patients who had been treated with a daily tablet of sofosbuvir-velpatasvir experienced a sustained virologic response -- the medical term for eradication or cure of HCV -- meaning that patients remained free of the virus three months after completing treatment. None of the 116 patients receiving a placebo experienced the same result.

"This is truly a one size fits all treatment that is very easy to administer and extremely well tolerated," said Dr. Feld. "Our challenge now is getting treatment to those who need it. Over half of people living with hepatitis C remain undiagnosed. Fortunately this regimen, along with other advances in therapy, will allow us to move treatment out of specialty clinics so that we can deliver care and ideally cure all infected Canadians."

Chronic HCV is known as a "silent" killer because symptoms often don't appear until the liver is severely damaged. Left undiagnosed, HCV can lead to cirrhosis which can progress to liver failure or liver cancer. HCV is primarily spread by blood-to-blood contact and is associated with intravenous drug use, contact with poorly sterilized medical equipment and blood transfusions before 1992.

Approximately 170 million people are infected with chronic HCV worldwide with an estimated 252,000 in Canada. HCV causes the greatest burden of disease, measured in years of life lost, than any infectious disease in Canada.​

Story Source:
The above post is reprinted from materials provided by University Health Network (UHN). Note: Materials may be edited for content and length.

Journal Reference:
Jordan J. Feld, Ira M. Jacobson, Christophe Hézode, Tarik Asselah, Peter J. Ruane, Norbert Gruener, Armand Abergel, Alessandra Mangia, Ching-Lung Lai, Henry L.Y. Chan, Francesco Mazzotta, Christophe Moreno, Eric Yoshida, Stephen D. Shafran, William J. Towner, Tram T. Tran, John McNally, Anu Osinusi, Evguenia Svarovskaia, Yanni Zhu, Diana M. Brainard, John G. McHutchison, Kosh Agarwal, Stefan Zeuzem.Sofosbuvir and Velpatasvir for HCV Genotype 1, 2, 4, 5, and 6 Infection. New England Journal of Medicine, 2015; 151116141724000 

Monday, November 16, 2015

Liver Disease A Serious Concern in Veteran Population

Q&A With Lauren Beste From VA Puget Sound Health Care System: Liver Disease A Serious Concern in Veteran Population

Conference Coverage > AASLD 2015
Nov 16, 2015 | Adam Hochron



With an aging veteran population there are a number of conditions that need to be treated in these patients as well as others of their generation, particularly in when it comes to liver disease. Lauren Beste, MD, MSc, from the VA Puget Sound Health Care System in Seattle discussed a recent study looking at how conditions like cirrhosis and hepatocellular carcinoma are treated and the prevalence of these conditions in the veteran population during the recent Liver Meeting in San Francisco.

Source 

AASLD Coverage 

Q&A With Melissa Harris From Bristol-Myers Squibb: Expanding Hepatitis C Treatment To New Genotypes And Populations VIDEO
Nov 16, 2015 | AASLD 2015 | Adam Hochron
Hepatitis C is becoming a more commonly treated condition in many of its genotypes while others continue to present problems for the pharmaceutical and medical communities. Work is being done to overcome those challenges around the world.

Alcoholic Hepatitis: Filtering Device Helped Younger, Less Ill Patients
Nov 14, 2015 | AASLD 2015 | Gale Scott
A human-cell-based liver support system meant to keep patients alive despite acute liver failure did not help overall survival in a trial, but showed promise for a subset of patients. Those patients were younger and not as sick—though all subjects enrolled had alcoholic hepatitis.

Hepatitis C: Looking for an Effective Regimen for Genotype 3
Nov 14, 2015 | AASLD 2015 | Gale Scott
Hepatitis C genotype 3 can be hard to cure, but researchers presenting a study at the Liver Meeting (AASLD) in San Francisco, CA, said they have found a regimen that works.

HCV in Egypt: Success in Treating Genotype 4
Nov 14, 2015 | AASLD 2015 | Gale Scott
Egypt has the highest prevalence of hepatitis C in the word and most of it (90%) is genotype 4. Researchers presenting a study at the Liver Meeting (AASLD) in San Francisco, CA, reported success in a trial of ravidasvir

Insurance Lagging on Paying for HCV Antivirals
Nov 14, 2015 | AASLD 2015 | Gale Scott
The high costs of direct-acting antivirals to treat hepatitis C infection is no secret, but neither is the fact that the drugs are cost-effective. Pennsylvania researchers found insurers were lagging in approving payment for the drugs in their four-state region, with Medicaid programs the worst offenders.

HCV Antiviral Resistance a Challenge
Nov 14, 2015 | AASLD 2015 | Gale Scott
Despite the success of direct antivirals in curing hepatitis C, there are concerns about resistance to the drugs.

ABBVIE Announces High SVR In Phase 2 studies With Pan-Genotypic Investigational Regimen ABT-493 AND ABT-530

ABBVIE ANNOUNCES HIGH SUSTAINED VIROLOGIC RESPONSE RATES IN PHASE 2 STUDIES WITH PAN-GENOTYPIC, INVESTIGATIONAL REGIMEN IN PATIENTS WITH CHRONIC HEPATITIS C

- INVESTIGATIONAL HCV REGIMEN WITH ABT-493 AND ABT-530 EVALUATING A PAN-GENOTYPIC, ONCE-DAILY TREATMENT OPTION WITH SHORTER DURATION OF THERAPY

- LATE-BREAKING DATA DEMONSTRATE 97 PERCENT SVR(12) IN GENOTYPE 1 NON-CIRRHOTIC CHRONIC HEPATITIS C PATIENTS AFTER 8 WEEKS OF TREATMENT WITH ABT-493 AND ABT-530

- FIRST PATIENT ENROLLED IN PHASE 3 TRIALS

Nov 16, 2015
NORTH CHICAGO, Ill.Nov. 16, 2015 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced data from the SURVEYOR studies of its investigational HCV regimen, ABT-493, an NS3/4A protease inhibitor, and ABT-530, an NS5A inhibitor, that show high rates of sustained virologic response at 12 weeks post-treatment (SVR12) in non-cirrhotic patients with chronic hepatitis C virus (HCV) infection. After 12 weeks of treatment, SVR12 rates achieved were 97-100 percent in genotype 1 (GT1), 96-100 percent in genotype 2 (GT2) and 83-94 percent in genotype 3 (GT3) patients.1,2,3 These data are being presented at The Liver Meeting® 2015, the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in San Francisco.
Separately, in a late-breaking presentation of the SURVEYOR-I study, data show non-cirrhotic GT1 chronic HCV patients who received a shorter duration of treatment for 8 weeks with ABT-493 and ABT-530 achieved a SVR12 rate of 97 percent.4
"These results are encouraging and contribute to scientific knowledge about the potential for pan-genotypic options for treating chronic hepatitis C," said Fred Poordad, M.D., vice president of Academic and Clinical Affairs at The Texas Liver Institute in San Antonio. "These data mark another important step in the continued research to help address the unmet needs of patients and the medical community."
SURVEYOR-I and SURVEYOR-II are ongoing Phase 2 clinical studies that evaluate the safety and efficacy of ABT-493 and ABT-530, with or without ribavirin (RBV), for 8 to 12 weeks. These data presented at AASLD include non-cirrhotic patients with GT1, GT2 and GT3 chronic HCV infection. Data in additional patient populations (genotypes 4-6) will be presented at future meetings.
"The SURVEYOR trials offer important new information about the potential to treat patients with chronic hepatitis C across multiple genotypes with our two direct-acting antiviral investigational regimen," said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. "AbbVie's ongoing hepatitis C research program demonstrates our commitment to make a remarkable impact on the lives of HCV patients."
About SURVEYOR-I  SURVEYOR-I is an ongoing Phase 2 two-part study designed to evaluate the safety and efficacy of ABT-493 and ABT-530, with and without ribavirin (RBV), for 8 to 12 weeks, in cirrhotic and non-cirrhotic adult genotype 1 (GT1) patients, and non-cirrhotic adult patients with genotypes 4, 5 or 6 chronic HCV infection who were new to therapy or did not respond to previous treatment with pegylated interferon (pegIFN)/RBV (null responder).1,4
In Part 1 of SURVEYOR-I, with 12 weeks of treatment, no patients discontinued treatment due to severe adverse events. The most commonly-reported direct-acting antiviral related adverse reactions (>10 percent of patients) were fatigue, headache and nausea. One patient experienced a serious adverse event of metastatic prostate cancer, unrelated to the study drugs and had onset after completion of study treatment.1 In Part 2, with 8 weeks of treatment, there were no study-related serious or severe adverse events reported. One subject discontinued the study at treatment week 4 due to adenocarcinoma, unrelated to study drugs. The most frequent adverse event (>10 percent of patients) was fatigue.4
About SURVEYOR-II  SURVEYOR-II is an ongoing Phase 2 three-part study designed to evaluate the safety and efficacy of ABT-493 and ABT-530, with or without ribavirin (RBV), in cirrhotic and non-cirrhotic adult patients with genotype 2 (GT2) or genotype 3 (GT3) chronic HCV infection who were new to therapy or had failed previous treatment with pegIFN/RBV.2,3 In GT2 study patients, the most commonly-reported direct-acting antiviral (DAA)-related adverse reactions (>10 percent of patients) were fatigue, nausea, diarrhea and headache. No GT2 study patients discontinued treatment due to an adverse event; one patient experienced a serious adverse event of atrial fibrillation unrelated to the study drugs.2 In GT3 study patients, the most commonly-reported DAA-related adverse reactions (>10 percent of patients) were fatigue, nausea and headache. One patient discontinued treatment due to DAA- and RBV-related adverse events of abdominal pain and heat sensation. Two patients experienced a serious adverse event, one with pneumonia and one with B-cell lymphoma, both unrelated to the study drugs.3  Part 1 results of the SURVEYOR-II are presented at AASLD.

Overview of SURVEYOR-I and SURVEYOR-II Clinical Data Presented at AASLD:
SURVEYOR-I (Genotype 1, Non-cirrhotic)
Number of Patients (n)/
Patient Population
Duration of Treatment
 Treatment Arm
Treatment Regimen
SVR12Rates

 n=40

Treatment-naïve=63%

pegIFN/RBV null responders=37%

12 weeks



Arm A



ABT-493 (200mg) + ABT-530 (120mg) once daily

100%
(n=40/40)

n=39

Treatment-naïve=64%

pegIFN/RBV null responders=36%


Arm B



ABT-493 (200mg) + ABT-530 (40mg) once daily

97%
(n=38/39)

 n=34

Treatment-naïve=85%

pegIFN/RBV treatment experienced=15%
8 weeks
Arm K
ABT-493 (300mg) + ABT-530 (120mg) once daily

97%
(n=33/34)
SURVEYOR-II (Genotype 2, Non-cirrhotic)
Number of Patients (n)/
Patient Population
Duration of Treatment
Treatment Arm
Treatment Regimen
SVR12Rates
n=74

Treatment-naïve=88%

pegIFN/RBV treatment
experienced=12%

12 weeks


Arm A



ABT-493 (300mg) + ABT-530 (120mg) once daily

96%
(n=24/25)
Arm B
ABT-493 (200mg) + ABT-530 (120mg) once daily
100%
(n=24/24)


Arm C


ABT-493 (200mg) + ABT-530 (120mg) once daily + RBV (weight-based, 1000 or 1200mg) twice daily
100%
(n=25/25)
SURVEYOR-II (Genotype 3, Non-cirrhotic)
Number of Patients (n)/
Patient Population
Duration of Treatment
Treatment Arm
Treatment Regimen
SVR12Rates



n=30

Treatment-naïve=90%

pegIFN/RBV treatment
experienced=10%






12 weeks



Arm D

ABT-493 (300mg) + ABT-530 (120mg) once daily
93%
(n=28/30)

n=30

Treatment-naïve=93%

pegIFN/RBV treatment
experienced=7%

Arm E
ABT-493 (200mg) + ABT-530 (120mg) once daily
93%
(n=28/30)

n=31

Treatment-naïve=90%

pegIFN/RBV treatment
experienced=10%

Arm F

ABT-493 (200mg) + ABT-530 (120mg) once daily + RBV (weight-based, 1000 or 1200mg) twice daily
94%
(n=29/31)

n=30

Treatment-naïve=93%

pegIFN/RBV treatment
experienced=7%

Arm G

ABT-493 (200mg) + ABT-530 (40mg) once daily

83%
(n=25/30)


About AbbVie's HCV Clinical Development Program
AbbVie's HCV clinical development program is intended to advance scientific knowledge and the clinical care of people with chronic HCV infection by investigating pan-genotypic (genotypes 1-6), all-oral, ribavirin-free, once-daily treatment options including shorter (8-12 weeks) duration therapy. AbbVie's investigational regimen includes ABT-493, an NS3/4A protease inhibitor, and ABT-530, an NS5A inhibitor. ABT-493 and ABT-530 are currently being evaluated in Phase 2 studies with a multinational Phase 3 program in genotypes 1 through 6 initiated in November 2015.
ABT-493 was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals (NASDAQ: ENTA) for HCV protease inhibitors and regimens that include protease inhibitors. ABT-493 is being developed by AbbVie for use in combination with AbbVie's other investigational medicines for the treatment of hepatitis C.
About AbbVie AbbVie is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott Laboratories. The company's mission is to use its expertise, dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the world's most complex and serious diseases. Together with its wholly-owned subsidiary, Pharmacyclics, AbbVie employs more than 28,000 people worldwide and markets medicines in more than 170 countries. For further information on the company and its people, portfolio and commitments, please visit www.abbvie.com. Follow @abbvie on Twitter or view careers on our Facebook or LinkedIn page.
Forward-Looking Statements  Some statements in this news release may be forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," in AbbVie's 2014 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission.  AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.
1 Poordad, F., et al. SURVEYOR-I: 98% – 100% SVR4 in HCV Genotype 1 Non-Cirrhotic Treatment-Naïve or Pegylated Interferon/Ribavirin Null-Responders with the Combination of the Next Generation NS3/4A Protease Inhibitor ABT-493 and NS5A Inhibitor ABT-530; Oral presentation #41; presented at The Liver Meeting®, the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in San FranciscoNovember 13-17, 2015.
2 Wyles, D., et al. SURVEYOR-II: High SVR4 Rates Achieved With the Next Generation NS3/4A Protease Inhibitor ABT-493 and NS5A Inhibitor ABT-530 in Non-Cirrhotic Treatment-Naïve and Treatment-Experienced Patients With HCV Genotype 2 Infection; Oral presentation #250; presented at The Liver Meeting®, the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in San FranciscoNovember 13-17, 2015.
3 Kwo, P, et al. SURVEYOR-II: High SVR4 Rates Achieved With the Next Generation NS3/4A Protease Inhibitor ABT-493 and NS5A Inhibitor ABT-530 In Non-Cirrhotic Treatment-Naïve and Treatment-Experienced Patients With HCV Genotype 3 Infection; Oral presentation #248; presented at The Liver Meeting®, the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in San FranciscoNovember 13-17, 2015.
4 Poordad, F., et al. 100% SVR4 in HCV Genotype 1 Non-Cirrhotic Treatment-Naïve or -Experienced Patients With the Combination of ABT-493 and ABT-530 for 8 Weeks (SURVEYOR-I); Poster presentation #LB-14; presented at The Liver Meeting®, the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in San Francisco,November 13-17, 2015.
SOURCE AbbVie
For further information: Media, Jackie Finley, +1 (847) 937-3998, jaquelin.finley@abbvie.com, or Jillian Griffin, +1 (847) 935-9331, jillian.griffin@abbvie.com; or Investor Relations, Liz Shea, +1 (847) 935-2211, liz.shea@abbvie.com