Pharmacy Services

Boceprevir (Victrelis) - Drug Interactions With Ritonavir-Boosted HIV Protease Inhibitors (Atazanavir, Darunavir, Lopinavir)

April 27, 2012

FDA issued a Drug Safety Communication in February, 2012 to notify healthcare professionals and patients about a drug interaction between boceprevir and certain HIV medications (atazanavir, darunavir, lopinavir when used in combination with ritonavir) resulting in decreased effectiveness of both medications. A drug interaction study evaluating boceprevir in combination with ritonavir, and atazanavir (Reyataz), darunavir (Prezista), or lopinavir and ritonavir (Kaletra) in healthy volunteers showed decreased blood concentrations of both boceprevir and the HIV medication.

The boceprevir product labeling was updated with this new information in April, 2012.

A small clinical trial evaluated HIV viral loads and Hepatitis C Virus (HCV) viral loads in patients taking either raltegravir (Isentress), lopinavir/ritonavir (Kaletra), ritonavir-boosted darunavir (Prezista), or ritonavir-boosted atazanavir (Reyataz) to treat their HIV and either boceprevir plus ribavirin/peginterferon or ribavirin/peginterferon to treat their HCV. After 12 weeks of HCV-treatment, patients taking boceprevir were more likely to have undetectable levels of HCV virus in their blood. Virologic rebound of HIV blood levels occurred in 3/64 patients taking boceprevir compared to 4/34 patients who did not receive boceprevir. A larger trial is planned to further evaluate boceprevir for the treatment of HCV in patients infected with both HIV and HCV.

Patients should continue HCV and HIV medications unless otherwise directed by their healthcare provider. If boceprevir and rotinavir-boosted HIV medications are co-administered, closely monitor HCV and HIV blood levels.

Additional information is available at the following links:

MedWatch Alert (updated 4/26/12):
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm291144.htm
Drug Safety Communication (4/26/12):
http://www.fda.gov/Drugs/DrugSafety/ucm301616.htm
Drug Safety Communication (2/9/12):
http://www.fda.gov/Drugs/DrugSafety/ucm291119.htm
Boceprevir Prescribing Information (4/20/12):
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202258s002lbl.pdf
Dear Healthcare Profession Letter (2/6/12):
http://www.merck.com/newsroom/pdf/FINAL_DHCP_2_6_2012.pdf

Updated
April 27, 2012; February 13, 2012. University of Utah Drug Information Service. Copyright 2012, Drug Information Service, University of Utah, Salt Lake City, UT.