Janssen Therapeutics, Division of Janssen Products, LP (Janssen), has 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.i
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.”
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).
The efficacy of PREZCOBIX is based on efficacy demonstrated in clinical trials of darunavir co-administered with ritonavir and pharmacokinetic trials showing similar exposures of darunavir when boosted with cobicistat compared to darunavir boosted with ritonavir. Two Phase 3 studies in the darunavir clinical development program, ARTEMIS (TMC114-C211) and ODIN (TMC114-C229), studied the once-daily use of darunavir co-administered with ritonavir.
In the GS-US-216-0130 study, which was conducted with darunavir 800 mg and cobicistat 150 mg administered as single entities in 313 HIV-infected patients, adverse reactions evaluated through Week 24 did not differ substantially from those reported in clinical trials with darunavir co-administered with ritonavir 100 mg. During the darunavir clinical development program, where darunavir was co-administered with ritonavir 100 mg once or twice daily, the most common adverse reactions (incidence greater than or equal to 5 percent) of at least moderate intensity (greater than or equal to Grade 2) were diarrhea, nausea, rash, headache, abdominal pain and vomiting.i
[i] PREZCOBIX (darunavir and cobicistat). Prescribing Information. United States. Janssen Therapeutics. January 2015.
[ii] Centers for Disease Control and Prevention. MMWR. 2001;50(21);429-456.
[iii] Centers for Disease Control and Prevention. “Today’s HIV/AIDS Epidemic.” 2013. http://www.cdc.gov/nchhstp/newsroom/docs/hivfactsheets/todaysepidemic-508.pdf. Accessed January 2015.
[iv] Centers for Disease Control and Prevention. HIV/AIDS Surveillance Report. 2012; vol 24. http://www.cdc.gov/hiv/pdf/statistics_2012_HIV_Surveillance_Report_vol_24.pdf. Accessed January 2015.
Source: Janssen Therapeutics