Genvoya, a fixed-dose combination tablet containing elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide, recently was approved by the U.S. Food and Drug Administration (FDA) for use as a complete regimen for the treatment of HIV-1 infection in patients 12 and older.
“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,” Dr. Edward Cox, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research.
Genvoya is indicated for HIV-infected patients who weigh at least 77 pounds, who have never received HIV therapy or whose HIV-1 virus is suppressed.
Four clinical trials using 3,171 test subjects were run to test Genvoya's safety and efficacy. The drug was proven to be effective in decreasing viral loads.
Genvoya is marketed by Gilead Sciences Inc. of Foster City, California.
FDA approves Genvoya for HIV treatment
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