Prezcobix, from Janssen Therapeutics, is intended for use with other antiretroviral agents for treatment-naive and treatment-experienced adults with HIV-1 infection with no darunavir resistance–associated mutations.
The recommended dosage of Prezcobix is one tablet taken once daily with food.
The FDA approval was based on bioequivalence data evaluating the use of the darunavir and cobicistat fixed-dose combination tablet vs 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 company said in a news release.
"Additional options remain an important medical priority to meet the diverse needs of those living with and managing this disease," Karen Tashima, MD, director of HIV Clinical Studies, Miriam Hospital, Providence, Rhode Island, who led the GS-US-216-0130 study, said in the release.
"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," Dr Tashima said.
The GS-US-216-0130 study evaluated 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 coadministered with ritonavir 100 mg, the company says. The most common adverse reactions of at least moderate intensity (grade 2 or higher) were diarrhea, nausea, rash, headache, abdominal pain, and vomiting.
Full prescribing information is available on the manufacturer's website.
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Cite this: Darunavir/Cobicistat (Prezcobix) Combo Pill Clears FDA - Medscape - Jan 30, 2015.