Date: February 9, 2012
The U.S. Food and Drug Administration (FDA) is notifying health care professionals and patients that drug interactions between the hepatitis C virus (HCV) protease inhibitor Victrelis (boceprevir) and certain ritonavir-boosted human immunodeficiency virus (HIV) protease inhibitors (atazanavir, lopinavir, darunavir) can potentially reduce the effectiveness of these medicines when they are used together.
Patients should not stop taking any of their medicines without talking to their health care professional. Patients should contact their health care professional if they have any questions or concerns.
Health care professionals who have started patients infected with both chronic HCV and HIV on Victrelis and antiretroviral therapy containing a ritonavir-boosted protease inhibitor should closely monitor patients for HCV treatment response and for potential HCV and HIV virologic rebound.
A drug interaction study showed that taking boceprevir (Victrelis) with ritonavir (Norvir) in combination with atazanavir (Reyataz) or darunavir (Prezista), or with Kaletra (lopinavir/ritonavir) reduced the blood levels of the HIV medicines and boceprevir in the body (see Data Summary below). FDA will be updating the Victrelis drug label to include information about these drug interactions.
Merck and Company has issued a Dear Health Care Professional letter (PDF - 67KB) with information about this drug interaction study.
Additional Information for Patients
Additional Information for Health Care Professionals
A pharmacokinetic study evaluated drug interactions between boceprevir (Victrelis) and ritonavir-boosted human immunodeficiency virus (HIV) protease inhibitors in healthy volunteers (n=39). In the study, concomitant administration of Victrelis (boceprevir) with ritonavir (Norvir) in combination with atazanavir (Reyataz), darunavir (Prezista), or with lopinavir/ritonavir (Kaletra) resulted in reduced exposures of the HIV medicines and boceprevir. Victrelis reduced mean trough concentrations of ritonavir-boosted atazanavir, lopinavir, and darunavir by 49, 43 and 59 percent, respectively. Mean reductions of 34 to 44 percent and 25 to 36 percent were observed in area under the curve (AUC) and peak concentration (Cmax) of atazanavir, lopinavir, and darunavir. Co-administration of ritonavir-boosted atazanavir with Victrelis did not alter the exposure (AUC) of boceprevir, but co-administration of Victrelis with lopinavir/ritonavir or ritonavir-boosted darunavir decreased the AUC of boceprevir by 45 and 32 percent, respectively.
Health care professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
Facts about Victrelis (boceprevir) and HIV protease inhibitors
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