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FDA approves Prezcobix for treatment of HIV-1
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The FDA has approved an antiretroviral combination drug for the treatment of HIV-1 infection in adults, according to a press release.
Darunavir/cobicistat (Prezcobix, Janssen Therapeutics), an HIV-1 protease inhibitor combined with a CYP3A4 inhibitor, is intended for treatment-naive and treatment-experienced adults without darunavir resistance-associated substitutions. It is a once-daily, fixed-dose tablet, containing 800 mg darunavir and 150 mg cobicistat, and is intended to be taken orally with other antiretrovirals and food.
“Additional options remain an important medical priority to meet the diverse needs of those living with and managing this disease,” Karen Tashima, MD, of Brown University and director of HIV clinical studies at The Miriam Hospital, said in the press 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.”
Clinical studies of the treatment demonstrated darunavir exposure that was comparable to darunavir boosted with 100 mg ritonavir. FDA approval was based on bioequivalence data comparing darunavir/cobicistat with single-agent treatment, as well as a clinical study in which safety and efficacy were evaluated among 313 eligible HIV patients. Adverse reactions evaluated through 24 weeks were similar to those reported in trials of darunavir co-administered with 100 mg ritonavir. The most common events were diarrhea, nausea, rash, headache, abdominal pain and vomiting.
“Treating HIV remains an urgent health care need, and it’s important for adults living with HIV to have regular discussions with a health care provider about treatment options that are right for them,” Richard Nettles, MD, vice president of medical affairs at Janssen Therapeutics, said in the release. “The approval of Prezcobix exemplifies Janssen’s ongoing commitment to developing new treatment options for those living with HIV and builds upon the legacy of darunavir.”