Drugs

FDA Drug Safety Podcast for Healthcare Professionals: Important drug interactions between Victrelis (boceprevir) and ritonavir-boosted human immunodeficiency virus (HIV) protease inhibitor drugs

Narrator: Welcome to the FDA Drug Safety Podcast for Healthcare Professionals from the Division of Drug Information. Today’s topic: Important drug interactions between Victrelis (boceprevir) and ritonavir-boosted human immunodeficiency virus (HIV) protease inhibitor drugs

Steve Jackson, a pharmacist in the Division, will provide you with additional information about this Communication.

Guest Speaker: On February 8, 2012, the Food and Drug Administration issued a Drug Safety Communication notifying healthcare professionals and patients that drug interactions between the hepatitis C virus, or HCV protease inhibitor Victrelis and the ritonavir-boosted HIV protease inhibitors atazanavir, lopinavir, and darunavir, can potentially reduce the effectiveness of these medicines when they are used together.

Patients should not stop taking any of their medications 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 Victrelis with Norvir in combination with Reyataz or Prezista, or with Kaletra reduced the blood levels of the HIV medicines and Victrelis in the body. 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 (PDF - 67KB) with information about this drug interaction study.

At this time FDA recommends that Healthcare Professionals be aware that:

Drug interactions between Victrelis and ritonavir-boosted atazanavir, lopinavir, and darunavir can potentially reduce the effectiveness of these medicines when co-administered.
Healthcare professionals who have initiated Victrelis in combination with peginterferon alfa and ribavirin in HIV-HCV co-infected patients on fully suppressive antiretroviral therapy containing a ritonavir-boosted protease inhibitor should discuss these findings with those patients, and closely monitor those patients for HCV treatment response and for potential HCV and HIV virologic rebound.
Victrelis and Incivek were approved in May, 2011, each in combination with peginterferon alfa and ribavirin for treatment of genotype 1 chronic hepatitis C in adult patients with compensated liver disease. Neither NS3/4A protease inhibitor is approved for treatment of patients co-infected with HIV. Drug interaction data with Incivek and ritonavir-boosted HIV protease inhibitors can be found in the Incivek drug label. Information about clinical trials in HIV-HCV co-infected patients can be found at ClinicalTrials.gov.
Adverse events involving Victrelis or HIV protease inhibitors should be reported to the FDA MedWatch program at www.fda.gov/medwatch.

Narrator: Thank you for listening. The FDA is committed to keeping healthcare professionals informed of the latest safety information. A link to this communication, including the complete Data Summary, can be found at www.fda.gov/DrugSafetyCommunications. If you have drug questions, you can reach us at druginfo@fda.hhs.gov.