Janssen announced that the Food and Drug Administration (FDA) has approved Prezcobix (darunavir and cobicistat) tablets for the treatment of HIV-1 infection in combination with other antiretroviral agents for treatment-naive and treatment-experienced adults with no darunavir resistance-associated substitutions (V11I, V32I, L33F, I47V, I50V, I54L, I54M, T74P, L76V, I84V, L89V).

Prezcobix combines darunavir (Prezista), an HIV-1 protease inhibitor, and cobicistat (Tybost; Gilead), a CYP3A4 inhibitor. Darunavir selectively inhibits the cleavage of HIV-1 encoded Gag-Pol polyproteins in infected cells, thus preventing the formation of mature virus particles. Cobicistat enhances the systemic exposure of CYP3A4 substrates through its selective mechanism-based inhibition.

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The FDA approval was based on bioequivalence data that evaluated the use of a darunavir/cobicistat fixed-dose combination tablet vs. single agents (TMC114IFD1003), as well as a clinical study that evaluated 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). The efficacy of Prezcobix is also supported by efficacy shown in clinical trials of darunavir plus ritonavir, and pharmacokinetic trials showing similar exposures of darunavir boosted with cobicistat vs. darunavir boosted with ritonavir. In addition, two Phase 3 studies, ARTEMIS and ODIN, studied the the use of darunavir plus ritonavir once daily.

Prezcobix will be available as 800mg/150mg fixed-dose tablets in 30-count bottles.

For more information call (800) 526-7736 or visit Prezcobix.com.