Safety Alerts for Human Medical Products > Victrelis (boceprevir) and Ritonavir-Boosted Human Immunodeficiency Virus (HIV) Protease Inhibitor Drugs: Drug Safety Communication - Drug Interactions

Safety Alerts for Human Medical Products > Victrelis (boceprevir) and Ritonavir-Boosted Human Immunodeficiency Virus (HIV) Protease Inhibitor Drugs: Drug Safety Communication - Drug Interactions

Victrelis (boceprevir) and Ritonavir-Boosted Human  Immunodeficiency Virus (HIV) Protease Inhibitor Drugs: Drug Safety Communication  - Drug Interactions
[UPDATED 04/26/2012]

FDA notified healthcare professionals that the Victrelis drug label has been  revised to state that co-administration of Victrelis (boceprevir), a hepatitis C  virus (HCV) protease inhibitor, along with certain ritonavir-boosted human  immunodeficiency virus (HIV) protease inhibitors, is not recommended. The  findings of a drug-drug interaction study and clinical trial showed that  co-administration increased of the possibility of reducing the effectiveness of  the medicines, permitting the amount of HCV or HIV virus in the blood to  increase. Ritonavir-boosted HIV protease inhibitors include ritonavir-boosted  Reyataz (atazanavir), ritonavir-boosted Prezista (darunavir), and Kaletra  (lopinavir/ritonavir).

[Posted 02/09/2012]

AUDIENCE: Infectious Disease, Pharmacy

ISSUE: FDA notified healthcare 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.

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.


BACKGROUND: Victrelis is a hepatitis C virus (HCV) protease  inhibitor used with the medicines peginterferon alfa and ribavirin to treat  chronic (long-lasting) hepatitis C infection in adults. HIV protease inhibitors  are a class of anti-viral drugs used to treat HIV infection. Ritonavir is an HIV  protease inhibitor used to “boost” other HIV protease inhibitors, increasing  their levels in the blood and making them more effective.


RECOMMENDATION: 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.
Healthcare 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:
Complete and submit the report Online: www.fda.gov/MedWatch/report.htm 
Download  form  or call 1-800-332-1088  to request a reporting form, then complete and return to the address on the  pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including a link to the Drug Safety Communication at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm291144.htm