Wednesday, January 21, 2015

CLD- Special Issue: Quality Assessment in Liver Disease

Special Issue: Quality Assessment in Liver Disease
Read the latest issue of "Clinical Liver Diseasean official digital educational resource from the American Association for the Study of Liver Diseases. 

Table Of Contents

Series on New Treatments for Hepatitis C
The new treatments for hepatitis C virus: An advanced practice provider's perspective (pages 153–155)
Lisa Cervantes
Get step-by-step instructions on how to get antiviral treatment for patients infected with HCV based on the new IDSA/AASLD guidelines.
Article first published online: 20 JAN 2015 | DOI: 10.1002/cld.432
Watch a video presentation of this article
Watch the interview with the author

Procedures for the Liver Patient
Peter Bannas, M.D., Diego Hernando, Ph.D., Utaroh Motosugi, M.D., Alejandro Roldan, Ph.D., Scott Brian Reeder, M.D., Ph.D.
Know the current state-of-the-art techniques, and the remaining challenges, for the quantitative imaging of hepatic steatosis, iron overload, and fibrosis.
Article first published online: 20 JAN 2015 | DOI: 10.1002/cld.424
Watch a video presentation of this article
Watch the interview with the author

Sumit Singla, M.D., and Cyrus Piraka, M.D.
Endoscopic retrograde cholangiopancreatography (ERCP) revolutionized the diagnosis and management of pancreatobiliary disease, but advances in noninvasive radiographic and less invasive endoscopic imaging have transformed ERCP into an almost exclusively therapeutic procedure.
Article first published online: 20 JAN 2015 | DOI: 10.1002/cld.441
Watch a video presentation of this article

More from Procedures for the Liver Patient: Fibroscan
Keyur Patel, M.D., and Julius Wilder, M.D., Ph.D.

New Issue: Quality Assessment in Liver Disease
Michael L. Volk, M.D., MSc
Among patients with decompensated cirrhosis, hospital readmissions are common, costly, partially preventable, and independently associated with mortality.
Article first published online: 20 JAN 2015 | DOI: 10.1002/cld.420
Watch a video presentation of this article
Watch the interview with the author

Jayant A. Talwalkar, M.D., M.P.H.
Over the past 5 years there has been a tremendous amount of policy making centered around improving the performance of health care systems in the U.S., spurred by reports describing less than ideal patient-centered outcomes despite nearly 20% of the country’s gross domestic product being invested in health care.
Article first published online: 20 JAN 2015 | DOI: 10.1002/cld.425
Watch a video presentation of this article
Watch the interview with the author

Amy K. Kim, M.D., and Amit G. Singal, M.D., M.S.
HCC disproportionately affects disadvantaged populations, with the highest age-specific rates among racial/ethnic minorities. Learn about the health disparities in prevention, early detection, and treatment.
Article first published online: 20 JAN 2015 | DOI: 10.1002/cld.427
Watch a video presentation of this article
Watch the interview with the author

Jayant A. Talwalkar M.D., M.P.H.
Emerging data suggests that innovative care delivery models will also play a major role in the delivery of specialty care, including the clinical practices of general and transplant hepatology.
Article first published online: 20 JAN 2015 | DOI: 10.1002/cld.429
Watch a video presentation of this article
Watch the interview with the author

Fasiha Kanwal, M.D., M.S.H.S.
Quality assessment in chronic disease has become increasingly widespread with the need to measure and improve quality of care now even more urgent given the advent of pay-for-performance under the Affordable Care Act.
Article first published online: 20 JAN 2015 | DOI: 10.1002/cld.435
Watch a video presentation of this article
Watch the interview with the author

Tuesday, January 20, 2015

Hepatitis C Infection Treatment Will Be Discontinued

Hepatitis C Infection Treatment Will Be Discontinued

The Food and Drug Administration (FDA) is informing that Victrelis (boceprevir; Merck) 200mg capsules will be discontinued.

Victrelis is a HCV NS3/4A protease inhibitor indicated for the treatment of chronic hepatitis Cgenotype 1 infection, in combination with peginterferon alfa and ribavirin in adult patients with compensated liver disease, including cirrhosis, who are previously untreated or who have failed previous interferon and ribavirin therapy including prior null responders, partial responders, and relapsers.

Victrelis works by covalently, yet reversibly, binding to the NS3 protease active site serine (S139) through an (alpha)-ketoamide functional group to inhibit viral replication in HCV-infected host cells.

Victrelis is estimated to be available until December 2015. Discontinuation of Victrelis is not related to any product safety or efficacy matters.

For more information call (877) 888-4231 or visit Victrelis.com.

Hepatitis C drug Victrelis (boceprevir) gets pulled from manufacturer
The pharmaceutical company, Merck, has announced that they will stop the manufacture and distribution of their hepatitis C (HCV) protease inhibitor Victrelis by December 2015. As the landscape of HCV treatment has rapidly evolved, providers are no longer prescribing the medication and patients are no longer taking it in favor of newer regimens that are easier to take, and have shorter treatment durations and higher cure rates. In a similar move, Vertex discontinued their HCV drug Incivek (telaprevir) in October 2014.

Gilead, AbbVie rack up new payer deals, but hep C obstacles loom across the Atlantic

Gilead, AbbVie rack up new payer deals, but hep C obstacles loom across the Atlantic
January 20, 2015 | By Tracy Staton
The hepatitis C market is breaking new ground all over the place. As payers put the squeeze on Gilead Sciences ($GILD) and AbbVie ($ABBV) for discounts in the U.S., England's National Health Service is delaying a broad rollout of Gilead's blockbuster Sovaldi till July, citing the drug's high cost--an unprecedented move on a treatment already blessed by the country's cost-effectiveness watchdogs. 
And with AbbVie's cocktail now approved in Europe and the U.K.--under the brand names Viekirax and Exviera, rather than Viekira Pak like in the U.S.--the two drugmakers will be squaring off there in country-by-country negotiations for coverage.
Continue reading....

Hepatitis C - Benefits firms shouldn't play drug favorites: CEO

Benefits firms shouldn't play drug favorites: CEO
|
Watch Video

Regeneron Pharmaceuticals' CEO told CNBC on Tuesday that benefits companies should not try to practice medicine.

Dr. Leonard Schleifer was reacting to the recent news that Express Scripts, the country's largest pharmacy benefits manager, dropped reimbursement for Gilead Science's hepatitis C treatment because it got deep discounts from an AbbVie alternative.

Read more....

HCV Next: HCV FORECAST 2015: New Approvals, Continued Barriers to Care

Hello folks, don't miss this months edition of "HCV Next" just published online at "Healio."

Table of Contents

2014 Drug Approvals: Where We Have Been; Where We Are Going

HCV FORECAST 2015: New Approvals, Continued Barriers to Care

5 QUESTIONS
A Conversation with Henry Masur, MD

COVER STORY

Monday, January 19, 2015

UK - Viekirax plus Exviera, with or without ribavirin, is now available for hepatitis C genotype 1 and 4

Newly approved HCV treatment regimen available in the UK
Following a European Marketing Authorization last week, Viekirax plus Exviera, with or without ribavirin, is now available in the United Kingdom for the treatment of chronic hepatitis C genotype 1 and 4 infections, according to a press release.
Continue reading...

AbbVie's VIEKIRAX® (ombitasvir/paritaprevir/ritonavir) and EXVIERA® (dasabuvir) Licensed for Use in the UK for the Treatment of Chronic Hepatitis C

MAIDENHEAD, England, January 19, 2015 /PRNewswire/ --

• First treatments for chronic hepatitis C to combine three direct-acting antiviral agents to target hepatitis C virus (HCV) at multiple steps in the viral lifecycle

• VIEKIRAX® and EXVIERA®, with or without ribavirin (RBV), cleared the virus in 97 percent of chronic genotype 1 (GT1) HCV patients and was generally well tolerated

• AbbVie Care in hepatitis C also launched in the UK to help people maintain motivation, focus and stability while on treatment

AbbVie's all-oral, short course (12 weeks for the majority of patients), interferon-free treatments VIEKIRAX®(ombitasvir/paritaprevir/ritonavir) and EXVIERA® (dasabuvir) are now licensed for use in the UK with or without ribavirin (RBV) for the treatment of patients with genotype 1 (GT1) chronic hepatitis C virus (HCV) infection. VIEKIRAX® is also licensed for use in the UK with RBV in non-cirrhotic, genotype 4 (GT4) chronic hepatitis C patients.[1],[2] The availability of VIEKIRAX® and EXVIERA® in the UK follows the granting of an EU Marketing Authorisation (MA) from the European Medicines Agency (EMA).

Hepatitis C is a blood borne virus that is spread when an infected person's blood enters the bloodstream of another person.[3]Some 75-85 percent of patients infected with HCV go on to develop the chronic form of the disease.[3] Chronic hepatitis C is a silent, progressive disease that can lead to liver damage, scarring of the liver (cirrhosis), liver cancer and death.[4] More than 200,000 people in the UK are chronically infected with hepatitis C.[5] Of those chronically infected, only an estimated 3% are treated each year, despite the advent of treatments that can offer viral elimination.[5]

"New treatments, such as AbbVie's triple combination regimen containing three directly acting anti-virals, offer both naive and treatment experienced patients, including those with cirrhosis, a very high likelihood of clearing hepatitis C virus," said Professor Geoffrey Dusheiko, Emeritus Professor of Medicine, UCL Institute of Liver and Digestive Health and Royal Free Hospital. "Such highly efficacious, better tolerated and shorter treatments irrevocably change the field from interferon-based care."

VIEKIRAX® and EXVIERA® is the first treatment for chronic hepatitis C to combine three direct-acting antiviral agents with distinct mechanisms of action to target HCV at multiple steps in the viral lifecycle.[1],[2] VIEKIRAX® and EXVIERA®, with or without RBV (for 12 or 24 weeks) cleared the virus in 97 percent of GT1 patients, including 96 percent of those with compensated cirrhosis. Overall, 1.3 percent experienced a relapse and 0.5 percent experienced on-treatment virologic failure.[1],[2]Discontinuation rates due to adverse reactions was low (0.2 percent),[1],[2] and in those receiving VIEKIRAX® and EXVIERA® without RBV, the overall rates of discontinuation due to adverse reactions was zero percent.

Charles Gore, Chief Executive of The Hepatitis C Trust, welcomed the news of AbbVie's UK licences, commenting: "We are now seeing a real paradigm shift in the way HCV can be treated; for many patients, these new treatments represent curative therapies, and therapies that are significantly more tolerable than interferon-based regimens. With the licensing of AbbVie's treatments there is now more choice for treating people affected by HCV. The next important step will be for the National Institute for Health and Care Excellence (NICE) and the Scottish Medicines Consortium (SMC) to ensure access to the range of new therapies being licensed."

AbbVie UK has also launched AbbVie Care in hepatitis C, a support programme designed to help people maintain motivation, focus and stability while on treatment with VIEKIRAX® and EXVIERA®.

"AbbVie is committed to making a meaningful contribution to addressing the personal, societal and economic burden of hepatitis C. The licensing of VIEKIRAX® and EXVIERA® in the UK, and the launch of AbbVie Care in hepatitis C, brings us much closer to making this a reality and to making a positive difference in the lives of people living with and affected by hepatitis C," said Matt Regan, General Manager, AbbVie UK.

Robust Clinical Programme

The approval of VIEKIRAX® and EXVIERA® with or without RBV in chronic GT1 HCV patients is supported by a robust clinical development programme consisting of six pivotal Phase 3 studies - SAPPHIRE-I, SAPPHIRE-II, PEARL-II, PEARL-III, PEARL-IV, and TURQUOISE-II. AbbVie's treatment was evaluated in more than 2,300 GT1 patients in over 25 countries. Approval of VIEKIRAX® in chronic GT4 HCV patients was based on the Phase 2b, PEARL-I study (135 patients), in which 100 percent of GT4 patients without cirrhosis achieved SVR12 when receiving VIEKIRAX® with RBV.

Additional information about AbbVie's chronic hepatitis C clinical programme can be found on http://www.clinicaltrials.gov

About VIEKIRAX® and EXVIERA®

Each tablet of VIEKIRAX® consists of the fixed dose combination of ombitasvir 12.5mg, paritaprevir 75mg and ritonavir 50mg. The recommended oral dose of VIEKIRAX® is two tablets taken once daily with food.

Each tablet of EXVIERA® contains dasabuvir 250mg (non-nucleoside NS5B polymerase inhibitor). The recommended oral dose of EXVIERA® is 250mg (one tablet) twice daily (morning and evening). EXVIERA® must always be administered together with VIEKIRAX®.

Summary of Product Characteristics for VIEKIRAX® and EXVIERA® are available on request.

Important Safety Information for VIEKIRAX® and EXVIERA®

The safety summary is based on pooled data from phase 2 and 3 clinical trials in more than 2,600 subjects who received VIEKIRAX® and EXVIERA® with or without RBV.

Friday, January 16, 2015

Aetna backs Gilead's hepatitis C treatment and gets discount

Aetna backs Gilead's hepatitis C treatment and gets discount
BY CAROLINE HUMER

Fri Jan 16, 2015 2:34pm EST Jan 16 

(Reuters) - Aetna Inc, the third-largest U.S. health insurer, said it has negotiated a discount with Gilead Sciences Inc for its hepatitis C treatment and will offer it as the preferred choice to its nearly 20 million commercial customers.

Aetna, which posted an updated coverage policy on its website on Friday, said in a statement that it believes its price is "competitive with other recently announced agreements for this class of therapy."

Aetna and other insurers have pushed back against the high price of hepatitis C treatments and other drugs, questioning their affordability after Gilead's first drug, Sovaldi, was priced at $84,000 per treatment, or roughly $1,000 per pill, in late 2013.

The agreement followed a clinical review of other FDA-approved therapies for hepatitis C, which includes the late December approval of AbbVie Inc.'s competing treatment. Since that approval, AbbVie and Gilead have given discounts to their list prices of 30 percent or more, according to analysts.

Aetna declined to comment on the size of the discount. The company said it is not updating its 2015 financial guidance at this time.

The agreement follows similar announcements by pharmacy benefit managers Express Scripts Inc and CVS Health .

(Reporting by Caroline Humer; Editing by Alan Crosby)
Reuters

Also See:
TGIF - Review of this weeks top hepatitis C headlines

TGIF - Review of this weeks top hepatitis C headlines


TGIF - Review of this weeks top hepatitis C headlines

Finally, we're heading into the weekend, here is a review of this weeks top hepatitis C headlines, including today's updates.

For your viewing pleasure a few learning activities have been added as well. Check out Medscape for an interesting CME on the history of HCV treatment. The article is presented in an interview format with highlights on treating patients with cirrhosis (sofosbuvir/ledipasvir) and a quick look at the catchphrase "Genotype 3 is the new genotype 1."

Finish up with a video discussing SVR at 4, 12, and 24 weeks post-treatment with sofosbuvir-containing regimens or view a slideset and listen to audio presented by Ira M. Jacobson, MD., discussing all-oral HCV therapy. Additional links have been provided at the end of this post.

Today's News
Aetna backs Gilead's hepatitis C treatment and gets discount
BY CAROLINE HUMER
Fri Jan 16, 2015 2:34pm EST Jan 16
(Reuters) - Aetna Inc, the third-largest U.S. health insurer, said it has negotiated a discount with Gilead Sciences Inc for its hepatitis C treatment and will offer it as the preferred choice to its nearly 20 million commercial customers.

AbbVie Strikes Hepatitis C Discount Deal With AIDS Drug Programs
AbbVie Inc. (ABBV) has agreed to provide its breakthrough, $1,000-a-day hepatitis C treatment to state-based HIV drug programs at a substantial discount, according to a group that negotiates drug pricing for the programs.

Viekirax (ombitasvir/paritaprevir/ritonavir tablets)+EXVIERA® (dasabuvir) gets European approval for Hepatitis C 
AbbVie (NYSE: ABBV) announced that the European Commission has granted marketing authorizations for its all-oral, short-course, interferon-free treatment of VIEKIRAX®(ombitasvir/paritaprevir/ritonavir tablets)+ EXVIERA® (dasabuvir tablets).1,2 The treatment has been approved with or without ribavirin (RBV) for patients with genotype 1 (GT1) chronic hepatitis C virus (HCV) infection, including those with compensated liver cirrhosis, HIV-1 co-infection, patients on opioid substitution therapy and liver transplant recipients.1,2 Additionally, VIEKIRAX has been approved for use with RBV in genotype 4 (GT4) chronic hepatitis C patients.

Gilead blazes ahead in hep C pricing battle with two new PBM deals
Gilead Sciences ($GILD) is gaining ground in its hep C pricing battle with AbbVie ($ABBV). One week after the drugmaker joined forces with Anthem ($ANTM) to make Harvoni the primary option for the PBM's 30 million patients, Gilead inked similar deals with Humana ($HUM) and Harvard Pilgrim, edging out its competitor and raising the stakes in the companies' ongoing war.

CEO: Enanta may one day compete against its own hepatitis C drug
Don Seiffert
It's an irony that Enanta Pharmaceuticals CEO Jay Luly appreciates: The $50 million check his company will receive from partner AbbVie from the European approval of its hepatitis C drug today will largely go to fuel research into a drug which will one day compete with it.

But Sovaldi faces funding delay and Olysio not backed in all indications

The most recent issue of the American Journal of Gastroenterology evaluates the association of coffee intake with reduced incidence of liver cancer and death from chronic liver disease.

Just Published
HCV Advocate - Mid-Month Newsletter
Genotype 2: Prevalence, Cure and Viral Diaspora
AASLD 2014: Ledipasvir and Sofosbuvir in African Americans
The Five: The Flu
And more......

AGA Perspectives December 2014/January 2015
Download the full issue as a PDF.
The really incredible advances in the treatment of hepatitis C makes the issue of who should be treating these patients a very relevant question moving forward into 2015. The advent of all-oral direct-acting anti-virals, which are safe, simple and effective with good tolerability and short duration, has made this an issue that should be examined. Consider ledipasvir/sofosbuvir, a single fixed-dose combination pill with a greater than 95 percent cure rate that was approved by the FDA for genotype 1 HCV in October 2014...

Worth A Click
Updates from Hepatitis C Online, an interactive website from the University of Washington.

Hepatitis C in the Workplace: Should Health Care Professionals Disclose?
About nine months ago, a hepatitis C advocate contacted me and asked if I would be open to having a discussion on hepatitis C among healthcare professionals. Specifically, should we disclose or shouldn’t we?

A Week In Review

Drug Wars 
I assume everyone is in tune with the price war over hepatitis C drugs, on Monday Prime Therapeutics announced they will provide hepatitis C patients with both Harvoni and Viekira Pak, catch up by reading the backstory, here, update here, and today's newsAetna backs Gilead's hepatitis C treatment and gets discount

Hepatitis C Drugs Show Patients Benefit Most From Treatment Choices
Over at Forbes, Josh Bloom and Henry Miller tackle the pursuit of new hepatitis C treatments, from development to FDA approval, with a focus on the pharmaceutical industry; Hepatitis C Drugs Show Patients Benefit Most From Treatment Choices.

Harvoni versus Olysio & Sovaldi versus Viekira Pak
Don't miss this patient friendly article; Harvoni versus Olysio & Sovaldi versus Viekira Pak written by Lucinda K. Porter RN comparing Harvoni, Olysio/Sovaldi, and Viekira Pak, with a reminder that some patients and physicians may not have the opportunity to choose between the new therapies.

Big Pharma faces up to new price pressure from aggressive insurers
Many say the tide shifted with a campaign by insurers and pharmacy benefits companies against Gilead Sciences Inc's (GILD.O) $84,000 hepatitis C treatment Sovaldi. The drug represented the first effective cure for hepatitis C and quickly raked in billions of dollars in sales within its first few months on the market in 2014. Sovaldi's cost is based on a 12-week treatment regime and amounts to $1,000 a pill. By contrast, the treatment costs about $57,000 in the U.K.

The Indian Patent Controller today rejected one of Gilead’s key patent applications, which covered the drug sofosbuvir, used to treat hepatitis C (HCV). The oral drug, which first received regulatory approval in the US in November 2013, and has been priced by Gilead at US$84,000 for a treatment course, or $1,000 per pill in the US, has caused a worldwide debate on the pricing of patented medicines. A study from Liverpool University showed that sofosbuvir could be produced for as little as $101 for a three-month treatment course.

Humana opts for Gilead in hepatitis C drug battle
Humana acknowledged late Tuesday it has an exclusive deal to offer Gilead Sciences' hepatitis C drugs to its members.

Aetna CEO says no decision yet on how to cover hepatitis C drugs
The chief executive of health insurer Aetna Inc on Tuesday said that the company had not yet decided which hepatitis C drugs to cover now that there are two breakthrough treatments on the market, but said that the company was actively working on a decision

Merck Accelerates Drug-Submission Plans
Merck also plans to file an application in the first half of this year for FDA approval to market a new two-drug, single-pill combination to treat the liver disease hepatitis C. The drugs, grazoprevir and elbasvir, cured at least 90% of infected patients in a mid-stage clinical trial and Merck is testing them in late-stage studies.

Healio Headlines
Triple-drug regimen led to high HCV cure rate
January 15, 2015
The addition of a third direct-acting antiviral drug to a sofosbuvir plus ledipasvir regimen reduced the duration of treatment necessary for patients with chronic…

HCV treatment program reduced disease burden in prison
January 16, 2015
A treatment program comprising triple therapy with telaprevir, interferon and ribavirin was successful in managing hepatitis C in correctional facilities, which are known to be sites of concentrated infection, according to recent data.


HCV trial of 'one shot' drug continues
A third patient in the phase 1/2a clinical trial of TT-034, a ddRNAi-based therapeutic to treat hepatitis C virus infection, has been dosed with the highest amount of concentration of the drug in trials so far, according to a news release from Benitec Biopharma Limited.

Universal HCV screening in Canada could be cost effective, save lives
New data published in the Canadian Medical Association Journal suggest that screening all Canadians aged 25 to 64 years would be cost effective and save lives.

A novel clinicopathologic prognostic nomogram developed by researchers at the University of California, Los Angeles, accurately predicted liver transplant recipients’ chance of hepatocellular carcinoma recurrence post-transplant, according to new study data.

Alisporivir program rights returned to Debiopharm
Debiopharm Group has regained all rights to Alisporivir, a cyclophilin inhibitor being investigated for the treatment of hepatitis C virus infection, as a result of a new agreement between the pharmaceutical company and Novartis, according to a news release from the company.

Learning Activities 
Medscape
Retrospective On the Changing Landscape of HCV and Its Impact on Practice

Medscape: It has only been 25 years since the hepatitis C virus was identified. Summarize for us how far we've come since then.
Jordan J. Feld, MD: The only way I can describe the progress made in the treatment of hepatitis C is "truly remarkable." To go from discovering a virus to being able to cure the infection in almost everyone who is infected in 25 years is unprecedented in medicine, and all those involved in the process should be proud...
CME Released: 12/22/2014

AASLD Video Podcast: Concordance of Sustained Virological Response With Sofosbuvir-containing Regimens for HCV


Clinical Care Options (CCO)

Program Overview
HCV Alerts: Rapid Response to Practice-Changing Advances
On-demand downloadable slides and audio addressing important developments in the care of patients with hepatitis C.

Expert Highlight
Audio
Ira M. Jacobson, MD, presents details and perspectives on how to incorporate the latest all-oral HCV therapy into clinical practice. (30 minutes)

Slideset
Incorporating the Latest All-Oral HCV Regimen Into Clinical Practice
In this downloadable slideset, Dr. Ira Jacobson presents details and perspectives on how to incorporate the latest all-oral HCV therapy into clinical practice.
Date Posted: 1/12/2015

Have a lovely weekend folks.
Tina