FDA Approves Gilead’s HIV Drug Genvoya

The FDA Nov. 5 approved Genvoya as a complete regimen for treating HIV-1 infection in adults and pediatric patients who are at least 12 years old.

Genvoya is a fixed-dose combination tablet containing elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide.

The product, which is marketed by Gilead Sciences Inc., is approved for HIV-infected adults and children who are at least 12 years old and weigh at least 77 pounds (35 kilograms) and who have never taken HIV therapy, and HIV-infected adults whose HIV-1 virus is currently suppressed, the Food and Drug Administration said. While Genvoya isn’t recommended for patients with severe ...