FDA Hepatitis Update - Victrelis (boceprevi​r) label change reflects drug-drug interactio​n informatio​n 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