FDA approves Gilead’s new HIV drug Genvoya

SILVER SPRING, Md. — The Food and Drug Administration announced that it had approved Gilead Sciences’ Genvoya (elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide, or E/C/F/TAF) to treat HIV. The drug, according to Gilead, is the first HIV treatment using a TAF-based regimen to get approval. 

 

“Today’s approval of a fixed dose combination containing a new form of tenofovir provides another effective, once daily complete regimen for patients with HIV-1 infection,” said Dr. Edward Cox, M.D., director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research.

 

The drug can be used in adults and children 12 years of age and older who haven’t taken an HIV therapy before, and HIV-positive adults whose virus is suppressed. The drug uses a new form of tenofovir that keeps the drug’s levels in the bloodstream low, but high in the cells where the disease replicates, in an effort to reduce side effects.