Janssen Therapeutics, Division of Janssen Products, LP (Janssen), 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. The FDA approval was based on bioequivalence data evaluating the use of a darunavir and cobicistat fixed-dose combination tablet versus single agents (TMC114IFD1003) and a clinical study evaluating the safety and efficacy of cobicistat-boosted darunavir for the treatment of HIV-1 in adults with no darunavir resistance-associated mutations (GS-US-216-0130).