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FDA Approves Two New Drugs for Treatment of Chronic Hepatitis C

May 2011

FDA Approves IncivekTM (telaprevir) and VictrelisTM (boceprevir) for Hepatitis C

The U.S. Food and Drug Administration approved Incivek (telaprevir) to treat certain adults with chronic hepatitis C infection. Incivek is used for patients who have either not received interferon-based drug therapy for their infection or who have not responded adequately to prior therapies. Incivek is approved for use with interferon therapy made up of peginterferon alfa and ribavirin.

The current standard of care for patients with chronic hepatitis C infection is peginterferon alfa and ribavirin taken for 48 weeks. Less than 50 percent of patients respond to this therapy.

Incivek is a tablet taken three times a day with food. Incivek should be taken for the first 12 weeks in combination with peginterferon alfa and ribavirin. Most people with a good early response to the Incivek combination regimen can be treated for 24 weeks rather than the recommended 48 weeks of treatment with the standard of care. Incivek is part of a class of drugs referred to as protease inhibitors, which work by binding to the virus and preventing it from multiplying.

INCIVEK (750 mg) is given as two 375-mg tablets three times daily for 12 weeks. It is packaged in weekly boxes that include daily blister strips to help patients keep track of their doses.

More information about Incivek is available at the FDA website:
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm256299.htm

Prescribing information for Incivek (telaprevir) is available at:
http://pi.vrtx.com/files/uspi_telaprevir.pdf

Earlier this month, the FDA approved Victrelis (boceprevir), another new treatment for chronic hepatitis C. Victrelis is used for patients who still have some liver function, and who either have not been previously treated with drug therapy for their hepatitis C or who have failed such treatment. Victrelis is approved for use in combination with peginterferon alfa and ribavirin.

More information about Victrelis is available at the FDA website:
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm255390.htm

Prescribing information for Victrelis (boceprevir) is available at:
http://www.merck.com/product/usa/pi_circulars/v/victrelis/victrelis_pi.pdf