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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.

http://wcms.fda.gov/FDAgov/ForConsumers/ByAudience/ForPatientAdvocates/ucm256753.htm

Download Audio Recording Podcast (22 MB)

http://wcms.fda.gov/downloads/ForConsumers/ByAudience/ForPatientAdvocates/ucm256765.mp3

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

Bocepravir

www.accessdata.fda.gov/drugsatfda_docs/label/2011/202258lbl.pdf (PDF download)

Telaprevir

www.accessdata.fda.gov/drugsatfda_docs/label/2011/201917lbl.pdf (PDF download)

Patient information for advocates

www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/ucm256712.htm

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

 




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