FDA Hepatitis Update -

["U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: FDA Hepatitis Update -

	 You are receiving this message as a subscriber to the FDA hepatitis electronic list serve. The purpose of the list serve is to relay important information about viral hepatitis-related products and issues, including product approvals, significant labeling changes, safety warnings, notices of upcoming public meetings and alerts to proposed regulatory guidances for comment.

Please do not reply to this message.

On May 23, 2011, FDA held a telephone briefing to discuss two Direct Acting Antivirals (DAAs) with health care providers and patient advocates having an interest in treatment for hepatitis C.  The call was intended to provide an overview of the safety and efficacy data and complexity of dosing regimens, and respond to questions about the use of these recently approved protease inhibitors, indicated as part of combination drug therapy, for the treatment of hepatitis C. 

The call was initiated in response to comments at the April 27 and 28, 2011 FDA Antiviral Drugs Advisory Committee meeting to consider data related to marketing applications for Victrelis (boceprevir) and Incivek (telaprevir), suggesting that additional information would be helpful in understanding the use of these drugs in clinical care.

A record of the teleconference (approximately 50 minutes) is being made available in either of two formats:

Written Transcript

Download Audio Recording Podcast (22 MB)

Labeling for these DAAs are available on the FDA web site:

Victrelis

Incivek

Richard Klein
Office of Special Health Issues
Food and Drug Administration

Kimberly Struble
Division of Antiviral Products
Food and Drug Administration

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