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GEN News Highlights : May 24, 2011

FDA Clears Vertex’ Incivek as Combination Therapy for Chronic HCV Type 1

Phase III studies demonstrated that adding telaprevir to PEGinterferon and ribavirin significantly improves SVR rates.

FDA approved Vertex Pharmaceuticals’ Incivek™ (telaprevir) tablets for the treatment of chronic hepatitis C genotype 1 in patients with compensated liver disease. Approval covers the use of Incivek in combination with pegylated interferon and ribavirin, in both treatment-naive patients and previously treated individuals who relapsed or did not respond to their initial therapy.  

Approval of Incivek in the U.S. was based on data from three Phase III studies demonstrating that adding the drug to PEGinterferon and ribavirin significantly improved sustained viral response (SVR) rates, irrespective of previous treatment regimens.

Treatment-naive patients receiving the triple combination therapy demonstrated an SVR rate of 79%, compared with 46% for those treated using PEGinterferon and ribavirin alone. Among participants who had previously been treated for chronic HCV infection but failed to achieve viralogic cure, adding Incivek to PEGinterferon and ribavirin similarly boosted SVR rates when compared with treatment using PEGinterferon and ribavirin.

For previous relapsers, SVR increased from 22% to 86% with the addition of Incivek therapy, while for partial responders the SVR rate increased from 15% to 59%. Among patients who didn’t respond to previous therapy, the Incivek combination led to an SVR of 32%, compared with 5% for nonresponders subsequently treated using PEGinterferon and ribavirin alone.