FDA Approves Prezcobix HIV Treatment

The FDA has approved Janssen Therapeutics’ darunavir and cobicistat (Prezcobix) for the treatment of human immunodeficiency virus (HIV-1) in combination with other antiretroviral agents for adults with no darunavir resistance-associated substitutions.

Prezcobix, an HIV-1 protease inhibitor combined with a CYP3A4 inhibitor, will be launched as a once-daily, fixed-dose combination tablet containing 800 mg of darunavir and 150 mg of cobicistat. The drug is the second HIV treatment containing cobicistat to be approved this week.

The FDA’s nod was based on data from a number of studies evaluating the efficacy and safety of Prezcobix. The research team found that the adverse events associated with the use of Prezcobix through week 24 were comparable to those observed in clinical trials evaluating darunavir co-administered with 100 mg of ritonavir. The most common side effects of at least moderate intensity included diarrhea, nausea, rash, headache, abdominal pain, and vomiting.

“Treating HIV remains an urgent healthc are need, and it's important for adults living with HIV to have regular discussions with a healthcare provider about treatment options that are right for them,” said Richard Nettles, MD, Vice President of Medical Affairs at Janssen Therapeutics, in a press 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.”

“Additional options remain an important medical priority to meet the diverse needs of those living with and managing this disease,” added Karen Tashima, MD, professor of medicine in the Division of Infectious Diseases at Brown University and director of HIV Clinical Studies at Miriam Hospital, 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.”