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U.S. Department of Health and Human Services

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Victrelis (boceprevir) label change reflects drug-drug interaction information with HIV protease inhibitors

On April 20, 2012, FDA updated the Victrelis (boceprevir) label to include drug-drug interactions between Victrelis and Norvir (ritonavir) in combination with the HIV protease inhibitors Reyataz (atazanavir), Prezista (darunavir), and Kaletra (lopinavir/ritonavir) The main changes to the label are highlighted below. Other changes were made to the Medication Guide to reflect the new interaction data.

Section 7: Drug Interactions was updated to include information regarding the following drug-drug interactions

Atazanavir/ritonavir: Concomitant administration of boceprevir and atazanavir/ritonavir resulted in reduced steady-state exposures to atazanavir and ritonavir. Coadministration of atazanavir/ritonavir and boceprevir is not recommended.

Darunavir/ritonavir: Concomitant administration of boceprevir and darunavir/ritonavir resulted in reduced steady-state exposures to boceprevir, darunavir and ritonavir. Coadministration of darunavir/ritonavir and boceprevir is not recommended.

Lopinavir/ritonavir Concomitant administration of boceprevir and lopinavir/ritonavir resulted in reduced steady-state exposures to boceprevir, lopinavir and ritonavir. Coadministration of lopinavir/ritonavir and boceprevir is not recommended.

Ritonavir: When boceprevir is administered with ritonavir alone, boceprevir concentrations are decreased.

Section 12: Clinical Pharmacology was updated to include the magnitude of interaction between boceprevir and HIV protease inhibitors.

Victrelis is a protease inhibitor for the treatment of HCV infection and manufactured by Schering Corporation, a subsidiary of Merck & Co

The complete, revised label will be posted soon at Drugs@FDA.

Richard Klein
Office of Special Health Issues
Food and Drug Administration

Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration