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FDA Supplemental Information About Using Boceprevir and Telaprevir

July/August 2011

On 23 May 2011, the 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 FDA Antiviral Drugs Advisory Committee meeting in April, suggesting that additional information would be helpful in understanding the use of boceprevir and telaprevir drugs in clinical care.

A record of the teleconference (approximately 50 minutes) is available as a transcript and podcast.


Download Audio Recording Podcast (22 MB)

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

Bocepravir (PDF download)

Telaprevir (PDF download)

Patient information for advocates

Links to external websites are current at time of posting but not maintained.


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This article was provided by HIV i-Base. It is a part of the publication HIV Treatment Bulletin. Visit HIV i-Base's website to find out more about their activities, publications and services.
See Also
Talk to a Physician About HIV/Hepatitis Coinfection in Our "Ask the Experts" Forums
More Hepatitis C Overviews and Guides
Find out how a Walgreens specially trained pharmacist can help you

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