Tuesday, February 14, 2012

Hepatitis C News Ticker

Happy Valentines Day !

Today CNBC interviewed Idenix CEO Ronald Renaud, the discussion was focused around the experimental hepatitis C drug IDX184. View the video here on the blog, or at CNBC. You may recall in September the FDA halted a trial of IDX184 and IDX320 because of elevated liver function tests in three participants during the study.

This month  Idenix received notification from the U.S. Food and Drug Administration (FDA) that the partial clinical hold on IDX184 has been removed and that the Company's 12-week phase IIb study evaluating IDX184 in combination with pegylated interferon and ribavirin (PegIFN/RBV) may continue.

More information on IDX184 is available at NATAP with a collection of interim data under the heading: IDX184 a weak nuke?

If you're interested on Feb 16th Vertex will be live in a webcast from the Leerink Swann 2012 Global Healthcare Conference. For the HCV community the webcast may offer an insight into existing and  future experimental hepatitis C drugs.

The presentations will be webcast live and may be accessed from ‘Events & Presentations’ on the home page of Vertex’s website at www.vrtx.com. A replay of the webcasts will also be available on the Company’s website for two weeks following the presentations. To ensure a timely connection, it is recommended that users register at least 15 minutes prior to the scheduled webcast.
Register here.
Click here for more information.

Until then Seeking Alpha published this Vertex transcript from Feb 2:

A personal apology goes out to Seeking Alpha for not properly listing the source to their article- 
This is Google's cache of  The Hepatitis C Gold Rush - Looking For The Right Fit For Idenix’s Drug IDX184, the original link to the article is no longer active. View more from the author here.

Hepatitis C Research/Studies/Abstracts

Updates @ NATAP

HCV Abstract from gastrohep.com
Intravenous drug use is not a barrier to achieving a sustained virological response in HCV infection, reports the latest issue of the Journal of the Viral Hepatitis.

Hepatitis C virus (HCV) is commonly transmitted by intravenous drug use but drug users are under represented in many treatment cohorts, this is because of the assumption of lowered treatment success.

Dr Jafferbhoy and colleagues from the United Kingdom assessed HCV treatment outcomes in active intravenous drug users, and patients on opiate substitution therapy.

The Tayside HCV treatment database was retrospectively analysed for consecutively treated patients based on risk factor for acquisition of HCV.

Primary end point was sustained virological response.
Controls undergoing laparoscopy had normal sensitivity
Journal of Viral Hepatitis

The team evaluated 291 consecutively treated patients.

The overall sustained virological response rate was 55%.

The researchers found that sustained virological response rates by risk factor were 61% for non- intravenous drug use patients, 55% for ex- intravenous drug use, and 47% for active intravenous drug use patients.

In the groups G1 patients sustained virological response included 53% for non- intravenous drug use patients, 31% for ex–intravenous drug use patients, and 35% for active intravenous drug use.

In the non-G1 patients, sustained virological response rates were 65% for non- intravenous drug use, 77% for ex- intravenous drug use patients, and 54% for active intravenous drug use.

Ex- intravenous drug use had a significantly better sustained virological response than active intravenous drug use, other differences were not significant.

Dr Jafferbhoy's team concludes, "We demonstrate that sustained virological response rates in the active drug users, and those on opiate substitution therapy can be achieved which are comparable with non- intravenous drug use infected individuals."

"Intravenous drug use in those engaged with treatment services should not be seen as a barrier to treatment of HCV."

14 February 2012

 In The News

Dynavax Technologies Corporation Release: Phase 3 Data on HEPLISAV in Adults Aged 18-55 Published in VACCINE BERKELEY, CA-- - Dynavax Technologies Corporation announced today that results of a pivotal Phase 3 trial of HEPLISAV were published online in the journal VACCINE.

PARIS, February 14, 2012 /PRNewswire/ --

CAP™ is a parameter for steatosis assessment and quantification.

At the 2012 Conference of the Asian Pacific Association for the Study of the Liver (APASL) taking place this year in Taipei from February 16th to February 19th, Echosens, a pioneer and major player in non-invasive hepatic diagnosis, will present for the first time in Asia its latest product, the new FibroScan® 502 Touch, widening the range of FibroScan® devices now available.

Equipped with a new and more ergonomic tactile interface, and based on patented Vibration-Controlled Transient Elastography (VCTE™), the latest FibroScan®provides a reliable, accurate and reproducible assessment of liver tissue stiffness. This technology, developed by Echosens, is unique in measuring liver stiffness at a pre-determined and controlled 50 Hz frequency.
Echosens' FibroScan® 502 Touch represents a quicker and more complete device built around our latest generation of patented liver dedicated elastography engine.

FibroScan® 502 Touch also offers enhanced patient data management with more complete and personalized exam reports.

Continuing Echosens' history of innovation, the FibroScan®502 Touch is further enhanced by the integration of the latest technological invention: CAP™ (Controlled Attenuation Parameter), a new parameter for steatosis assessment and quantification. Indeed, one of the latest publications[1] underlines the strength of CAP™ performance in detecting steatosis and differentiating steatosis grades. Moreover, this study on patients with chronic hepatitis C, shows that compared to liver biopsy, CAP™ is less prone to sampling error and can explore a liver volume 100 times larger. Both steatosis and fibrosis can be evaluated non-invasively during the same procedure using FibroScan®. (more about this publication)

To learn more about the FibroScan® range, you can meet us at the Echosens Booth (D04-05-06) in the Exhibition Hall during APASL.

You may also visit our website http://www.echosens.com to let us know how we can support you.


Source -  

The U.S. Food and Drug Administration granted Gilead Sciences Inc.'s (GILD) antiretroviral drug Truvada a priority-review schedule, advancing what could become the first treatment labeled for HIV prevention.

By approving Gilead's supplemental new-drug application, the agency gave Truvada a six-month priority-review schedule, a designation given to drug candidates that provide major advances or offer treatment where no adequate therapy exists.

Gilead has dominated the HIV-treatment market. The FDA in August approved Complera, another Gilead HIV treatment for patients new to therapy.

The FDA approved Truvada in 2004 as a treatment for HIV-1 infection, making it the most-prescribed antiretroviral treatment in the U.S. It is not indicated for treatment of uninfected adults.

Gilead submitted its supplemental application in December. The agency later set a June 15 target review date for Truvada, and an advisory panel will discuss the treatment during its regularly scheduled meeting in May.

The company based its application on results from two large placebo-controlled trials of Truvada sponsored by the U.S. National Institutes of Health and the University of Washington.

Shares were recently up 12 cents at $55.02 after hours. The stock has climbed 43% over the past year.

-By Drew FitzGerald, Dow Jones Newswires; 212-416-2909; Andrew.FitzGerald@ dowjones.com
Read More At: Morning Star Advisor

For Your Reading Pleasure: A Valentines Day Special At Grand Rounds
Grand Rounds is the weekly summary of the best healthcare writing online, featuring stories, opinion and analysis from doctors, nurses, patients, researchers and administrators, as well as journalists. Each Tuesday, a different blogger takes the helm, publishing a new edition of Grand Rounds on their site. Each edition features the host’s picks for the ten best healthcare links of the week.

This Weeks Host For Feb 14, 2012

Grand Rounds: February 14th, 2012–Valentine’s Day version
To those who submitted posts, I say thanks. I appreciate that you did. Medical Grand Rounds keeps going because of you, the medical blogger. Your voice, your impressions, your passions and your human stories make our field such a great canvas.
Let’s get it started:

I was delighted that one of the medical blogosphere’s best writers, Dr. Rob Lamberts (@doc_rob) sent me this beautiful post, which recaps three heart-warming patient vignettes. Each brief story celebrates what lies at the heart of medicine—using our skill and compassion to see people through illness.
But there’s more. Way more. Dr Rob makes it clear that medicine isn’t a one-way street: that in serving our patients, our hearts are also soothed. Thanks Doc. Glad you are back. Y’all should follow his new blog, More Musings (of a Distractible Kind). 

To Read additional submissions click here

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