February 8, 2012
Facts About Victrelis (Boceprevir) and HIV Protease Inhibitors
Patients should not stop taking any of their medicines without talking to their healthcare professional. Patients should contact their healthcare professional if they have any questions or concerns.
Healthcare 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 Healthcare Professional letter with information about this drug interaction study.
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.
Report a serious problem:
Regular Mail: Use postage-paid FDA Form 3500
Mail to: MedWatch 5600 Fishers Lane
Rockville, MD 20857
No comments have been made.
The content on this page is free of advertiser influence and was produced by our editorial team. See our content and advertising policies.
|Sex and the HIV Reservoir: New Research Points to the Powerful Effect of Estrogen|
|First U.S. Failure of Truvada as PrEP Is Reported at IDWeek|
|Post-AIDS 2018 Updates on HIV Cure Research|
|On-Demand PrEP Is Great. Now, What About Women?|
|High Rates of Anal HPV Infection in Gay Men Using PrEP in IPERGAY: The Role of Vaccination|