CLDF Title
Home | Contact Us | Bookmark
About CLDF Centers of Educational Expertise  
Live CME Meetings Telewebs Webcasts Slide Library Abstract Library Conference Highlights
Reuters Health Information (2013-10-23): Gilead's hepatitis C drug sofosbuvir safe, effective: FDA reviewers


Gilead's hepatitis C drug sofosbuvir safe, effective: FDA reviewers

Last Updated: 2013-10-23 12:32:09 -0400 (Reuters Health)

(Reuters) - Sofosbuvir from Gilead Sciences is safe and effective when used in combination with other therapies to treat hepatitis C, according to reviewers with the U.S. Food and Drug Administration.

Their review was posted on the FDA website on Wednesday ahead of an October 25 meeting of an outside panel of medical experts who will recommend whether or not the agency should approve the drug.

"The currently available data support a favorable benefit-risk assessment for the use of sofosbuvir as part of a combination regimen for the treatment of chronic hepatitis C," the reviewers said.

"No major safety issues associated with sofosbuvir use have been identified to date."

Gilead is seeking approval to market the drug in combination with ribavirin for patients with HCV genotype 2 and genotype 3, and for patients awaiting a liver transplant.

If approved, this would be the first all-oral treatment for genotypes 2 and 3. Current therapies typically include oral ribavirin and the once-weekly injectable drug interferon. Both can cause debilitating side effects.

Gilead is also seeking to market sofosbuvir in combination with ribavirin and interferon for patients with genotype 1, regardless of prior treatments, and for patients with genotypes 4, 5 and 6 who have not previously been treated.

Chronic hepatitis C affects at least 3 million people in the United States, according to the U.S. Centers for Disease Control. HCV genotype 1 is the most common form, accounting for about 70% of cases.

Current standard treatments for genotype 1 often include an oral protease inhibitor, such as boceprevir (Victrelis, Merck) and telaprevir (Incivek, Vertex).

Slide Library
Abstract Library
Slide Library
Abstract Library
Slide Library
Abstract Library
Live CME Meetings
Slide Library
Abstract Library
Slide Library
Abstract Library
CLDF Follow Us
About CLDF
Mission Statement
Board of Trustees
Board of Advisors
CLDF Supporters
Other Resources
Liver News Library
Journal Abstracts
Hep C Link to Care
Centers of
Educational Expertise
Substance Use Disorder
  The Chronic Liver Disease Foundation is a non-profit organization with content developed specifically for healthcare professionals.
© Copyright 2012-2015 Chronic Liver Disease Foundation. All rights reserved. This site is maintained as an educational resource for US healthcare providers only.
Use of this Web site is governed by the Chronic Liver Disease Foundation terms of use and privacy statement.