Janssen Therapeutics, Division of Janssen Products, LP (Janssen), today announced the U.S. Food and Drug Administration (FDA) has approved Prezcobix (darunavir 800 mg/cobicistat 150 mg) tablets, an HIV-1 protease inhibitor combined with a CYP3A4 inhibitor, for the treatment of human immunodeficiency virus (HIV-1) in combination with other antiretroviral agents for treatment-naïve and treatment-experienced adults with no darunavir resistance-associated substitutions.

Prezcobix is a once-daily, fixed-dose antiretroviral combination tablet containing 800 mg of darunavir, marketed as Prezista in the United States, and 150 mg of cobicistat, a pharmacokinetic enhancer or “boosting” agent, developed and marketed as Tybost by Gilead Sciences, Inc., taken orally with other HIV-1 medications and with food.

“Additional options remain an important medical priority to meet the diverse needs of those living with and managing this disease,” said Karen Tashima, M.D., professor of medicine in the Division of Infectious Diseases, Brown University, director of HIV Clinical Studies, Miriam Hospital, and a lead investigator in the GS-US-216-0130 study. “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.”

For more details, go to: http://www.jnj.com/news/all/PREZCOBIX-darunavir-cobicistat-Approved-in-the-US-for-the-Treatment-of-Adults-Living-With-HIV-1