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Hepatitis C

Welcome to Hepatitis C Management Discussion Board! The Hepatitis C Management Discussion Board provides Infectious Disease Clinicians a platform to connect with colleagues to exchange information, case studies, complications, and new developments on matters concerning hepatitis C treatment and management. Certain case studies will be developed into clinical vignettes and will be available to Infectious Disease Clinicians for future reference. Please be respectful of all participants and their respective comments. Please read our Terms of Use and Discussion Forum Guidelines.


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AbbVie Submits FDA Application for All Oral HCV Therapy
Posted: Tuesday, April 22, 2014 1:52 PM
Joined: 2/20/2013
Posts: 40

"AbbVie has submitted an FDA application for its promising all-oral hepatitis C treatment, expecting approval this year as it prepares for a three-way race with perceived leaders Gilead Sciences and Merck.

The drug, a combination of three antiviral agents, is part of a new class of highly effective hep C treatments that eschew shots and work without interferon, a painful adjunct to standard therapy that keeps some patients at bay. Across 6 Phase III studies in more than 2,300 patients with the tough-to-treat genotype 1 hep C, AbbVie's therapy charted impressive 12-week cure rates, notching a 99% sustained virologic response mark in some populations. The company's FDA filing falls right in line with its previously disclosed schedule, and AbbVie has said it plans to launch the cocktail therapy later this year.

That should put it right behind Gilead, which in February filed an application for a combo of its own that pairs the blockbuster antiviral Sovaldi with an NS5A inhibitor called ledipasvir."

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