Friday, January 16, 2015

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

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.

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