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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.

 

Any diagnostic or therapeutic recommendations and all opinions presented are those of the individual contributor. They do not necessarily represent the views of IDSA. The reader assumes all risks in using this information. The IDSA Hepatitis C Discussion Forum is in full compliance with HIPPA. IDSA bears no responsibility for the accuracy of participant comments and will bear no legal liability for discussion results.

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FDA Internal Review of Sofosbuvir
tkim@idsociety.org
Posted: Wednesday, October 23, 2013 1:21 PM
Joined: 2/20/2013
Posts: 38


"Friday's FDA panel review of Gilead's hep C drug sofosbuvir is shaping up as a marketing event. In an internal staff review released this morning, regulators said that the hep C drug combined with ribavirin would offer the first all-oral treatment for two key genotypes of hepatitis C patients, offering faster cures and an improved safety profile over anything currently on the market. And it presents a promising alternative for the large number of patients who can't tolerate the harsh impact of interferon injections."

To read more, please visit: http://www.fiercebiotech.com/story/fda-review-heralds-first-class-status-gileads-hep-c-drug-sofosbuvir/2013-10-23?utm_medium=nl&utm_source=internal
 

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