The U.S. Food and Drug Administration (FDA) approved PREZCOBIX™ (darunavir /cobicistat) tablets for the treatment of human immunodeficiency virus (HIV-1), Janssen Therapeutics, Division of Janssen Products, LP (Janssen) announced on Jan. 29.
PREZCOBIX is an HIV-1 protease inhibitor combined with a CYP3A4 inhibitor for HIV-1 treatment in grouping with additional antiretroviral reasons for treatment-naïve and treatment-experienced adults without darunavir resistance-associated substitutions. The medication is administered once a day as a fixed-dose.
The FDA authorization was an outcome of data assessing the usage of a darunavir and cobicistat combined tablet against single agents and a study considering the safety of cobicistat-boosted darunavir for the treatment of HIV-1 in adults without darunavir resistance-associated mutations.
“This approval gives physicians the option of a darunavir-based fixed-dose combination tablet to treat adults living with the HIV-1 infection, which can help reduce the number of pills in their overall treatment regimen,” said Karen Tashima, professor of medicine in the Division of Infectious Diseases, Brown University and director of HIV Clinical Studies, Miriam Hospital.
Around 1.2 million people in the in the United States live with HIV, and there are 50,000 additional diagnoses each year.
“The approval of PREZCOBIX™ exemplifies Janssen’s ongoing commitment to developing new treatment options for those living with HIV and builds upon the legacy of darunavir,” said Richard Nettles, vice president of Medical Affairs, Janssen Therapeutics.