Drugs

FDA Drug Safety Podcast for Healthcare Professionals: Updated information on drug interactions between Victrelis (boceprevir) and certain boosted HIV protease inhibitor drugs

Narrator: Welcome to the FDA Drug Safety Podcast for Healthcare Professionals from the Division of Drug Information. Today’s topic: This update is a follow-up to the FDA Drug Safety Communication (or DSC) from February 4, 2012 titled: Important drug interactions between Victrelis (boceprevir) and ritonavir-boosted HIV protease inhibitor drugs.

LT Beth Carr, a U.S. Public Health Service pharmacist in the Division, will provide you with additional information about this Communication.

Guest Speaker: On April 26, 2012, the FDA issued a DSC notifying the public that co-administration of Victrelis, a hepatitis C virus, HCV, protease inhibitor, along with certain ritonavir-boosted HIV protease inhibitors, is not recommended at this time because of the possibility of reducing the effectiveness of the medicines, permitting the amount of HCV or HIV viral load to increase. Ritonavir-boosted HIV protease inhibitors include ritonavir-boosted Reyataz (atazanavir), ritonavir-boosted Prezista (darunavir), and Kaletra (lopinavir/ritonavir).

Healthcare professionals who started patients infected with both chronic HCV and HIV on Victrelis while the patient was taking antiretroviral therapy containing one of these ritonavir-boosted protease inhibitors should closely monitor patients for treatment response and for potential HCV or HIV virologic rebound.

Ritonavir is an HIV protease inhibitor that is taken as a small dose along with other HIV protease inhibitors in order to increase their levels in the blood and make them more effective. This is known as ritonavir boosting.

In February 2012, FDA issued a DSC regarding a drug-drug interaction study, which showed that taking Victrelis while taking any one of the three ritonavir-boosted HIV protease inhibitors could reduce the desired blood levels of both medicines. Because lower blood levels could lead to less effective treatment of HCV and HIV infections, FDA recommended that healthcare professionals closely monitor the treatment response of the patients who might be taking these drug combinations.

There is limited information on the effectiveness of Victrelis and ritonavir-boosted HIV protease inhibitors when they are used together in patients co-infected with HIV and HCV. A small clinical trial measured treatment outcomes of HIV-HCV co-infected patients whose HCV infection was treated with either peginterferon/ribavirin or boceprivir plus peginterferon/ribavirin and whose HIV infection was treated with ritonavir-boosted atazanavir, ritonavir-boosted darunavir, lopinavir/ritonavir, or raltegravir (Isentress).

In light of both the findings of the drug-drug interaction study and the clinical trial, FDA has revised the Victrelis drug label to state that co-administration of Victrelis with ritonavir-boosted Reyataz, ritonavir-boosted Prezista, or Kaletra to patients infected with both chronic HCV and HIV is not recommended at this time.

FDA is aware that a larger clinical trial is planned that will evaluate HCV treatment with boceprevir and peginterferon/ribavirin in patients infected with both HCV and HIV who are also receiving HIV antiretroviral therapy containing ritonavir-boosted HIV protease inhibitors. FDA will communicate any important new information about co-administration of these drugs in co-infected patients when it becomes available.

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.