Fair Pricing Coalition Condemns Gilead Sciences on the High Price of New Hepatitis C Drug Sovaldi™, and Urges Rapid and Wide Dissemination of Support Program Details for Uninsured and Underinsured People Living with Hepatitis C Full Press Release
FDA NEWS RELEASE
The U.S. Food and Drug Administration today approved Olysio (simeprevir), a new therapy to treat chronic hepatitis C virus infection.
Full Press Release
Fair Pricing Coalition Disappointed by the High Price of New Janssen Hepatitis C Drug Olysio (simeprevir) Full Press Release
Caring Ambassadors Program
Experts Agree: We Can No Longer Ignore
the Burden of Liver Disease
The Liver Cancer Roundtable held their inaugural meeting last week in Washington, DC. The Roundtable attendees included leading academic experts in liver cancer, patient advocates, and representatives from HHS, NIH, and the CDC. Dr. Douglas LaBrecque, who co-chairs the Roundtable and has been spearheading a year-long global effort to raise awareness about liver cancer for the World Gastroenterology Organization, was encouraged by the two-day event. “This was a remarkable gathering of national and international experts,” LaBrecque stated. “The results of their passionate and enthusiastic discussions will provide the basis for a first draft of a National Action Plan for the prevention, diagnosis, care, and treatment of liver cancer.”
The full press release is available here.
Hepatitis C News
Week Ending December 8, 2013
FDA Approves 'Game Changer' Hepatitis C Drug Sofosbuvir
‘The US Food and Drug Administration (FDA) has approved the first–in–kind nuceotide analog inhibitor sofosbuvir (Sovaldi, Gilead Sciences, Inc) for the treatment of adults with chronic hepatitis C virus (HCV) infection, a widely anticipated move that is expected to dramatically improve outcomes for many patients.’
Fair Pricing Coalition Condemns Gilead Sciences on the High Price of New Hepatitis C Drug Sovaldi™, and Urges Rapid and Wide Dissemination of Support Program Details for Uninsured and Underinsured People Living with Hepatitis C
‘The Fair Pricing Coalition (FPC) today condemned Gilead Sciences for the price set for its direct acting antiviral (DAA) Sovaldi™ (sofosbuvir), a once–daily, first–in–class nucleotide polymerase inhibitor approved by the U.S. Food and Drug Administration on December 6, 2013, for the treatment of chronic hepatitis C, including those co–infected with HIV. While FPC believes that all hepatitis C virus (HCV) drugs are priced too high, the coalition of HIV and viral hepatitis treatment activists is especially dismayed by the wholesale acquisition cost (WAC) of $84,000 for a 12-week course of Sovaldi™. For comparison purposes, the FPC notes the 12-week WAC for the recently approved NS3/4A protease inhibitor Olysio&8482; (simeprevir) is $66,360.’
Fair Pricing Coalition Disappointed by the High Price of New Janssen Hepatitis C Drug Olysio (simeprevir)
‘The Fair Pricing Coalition (FPC) today expressed disappointment at the price Janssen Therapeutics set for Olysio (simeprevir), a second generation protease inhibitor (PI) approved by the U.S. Food and Drug Administration on November 22, 2013 for the treatment of chronic hepatitis C (HCV) in genotype 1 patients.’
Screening available for HCV Q80K polymorphism
‘An enhanced version of Laboratory Corp. of America’s HCV GenoSure NS3/4 test capable of determining whether patients have the hepatitis C virus Q80K polymorphism is now available, the company said in a news release’
Hepatitis C virus dried on inanimate surfaces can remain infectious for up to six weeks
‘Dried spots of blood contaminated with hepatitis C virus (HCV) can remain infectious for up to six weeks at normal room temperatures, research published in the online edition of the Journal of Infectious Diseases shows.’
EASL publishes revised clinical practice guidelines to optimise the management of hepatitis C virus
‘The European Association for the Study of the Liver (EASL) today publishes their revised Clinical Practice Guidelines (CPGs) on the management of hepatitis C virus infection (HCV) (1). The EASL guidelines, which supersede the previous version published in 2011, are designed to help physicians and other healthcare providers optimise their management of patients with acute and chronic HCV.’
Idenix Pharmaceuticals Announces Initiation of Enrollment in a Phase II All–Oral Combination Study of Samatasvir (IDX719), Simeprevir, and TMC647055 for the Treatment of Hepatitis C Virus (HCV) Infection
‘Idenix Pharmaceuticals, Inc. /quotes/zigman/90571/delayed/quotes/nls/idix IDIX +2.84% , a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases, today announced the initiation of patient enrollment in the phase II HELIX–2 clinical trial evaluating an all-oral, direct-acting antiviral (DAA) HCV combination regimen of samatasvir, Idenix's once–daily pan–genotypic NS5A inhibitor, simeprevir, a once–daily NS3/4A protease inhibitor jointly developed by Janssen R&D Ireland and Medivir AB, and TMC647055, a once–daily NS5B non–nucleoside polymerase inhibitor boosted with low–dose ritonavir developed by Janssen.’
For more Hepatitis C In The News, click here
by Benjamin Ryan
The hepatitis C pipeline: huge changes on the horizon
Hepatitis C: Prepare to meet your match. The future is almost here.
CAP-Hepatitis C Get Involved
Act Now to Impact C!
The CAP-Hepatitis C Get Involved provides tools to:
- increase public awareness of hepatitis C
- inform policy makers about current hepatitis C issues
- keep abreast of evolving issues in the hepatitis C community
Together, we can change the course of Hepatitis C.