FDA Approves New Combination Treatment for HIV-1


A new drug has been approved by the US Food and Drug Administration (FDA) for patients diagnosed with HIV-1.

A new drug has been approved by the US Food and Drug Administration (FDA) for patients diagnosed with HIV-1.

According to a press release from Janssen Therapeutics, the FDA approved Prezcobix (darunavir 800 mg/cobicistat 150mg), which is a protease inhibitor combined with a CYP3A4 inhibitor, “in combination with other antiretroviral agents for treatment-naïve and treatment-experienced adults with no darunavir resistance-associated substitutions.”

The new drug is taken once daily by patients as a tablet that includes 800mg of darunavir (marketed as Prezista) in the US, and 150 mg of cobicistat (marketed as Tybost), which is a “pharmacokinetic enhancer.”

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

The study Tashima led included 313 HIV patients over 24 weeks who were compared with patients who took darunavir and 100 mg of ritonavir. The press release noted that, “adverse reactions evaluated through Week 24 did not differ substantially from those reported in clinical trials,” with the other option. Some adverse reactions included diarrhea, nausea, rash, headache, abdominal pain, and vomiting.

“Treating HIV remains an urgent healthcare 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, for Janssen.

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