On Thursday, the FDA signed off on Genvoya, a new complete treatment regimen for HIV-1 infection in adults and pediatric patients 12 years or older.
Genyova is a fixed-dose combination tablet containing cobicistat, elvitegravir, emtricitabine and tenofovir alafenamide, according to an FDA statement.
"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," Edward Cox, MD, director of the Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research, said in a statement.
The FDA evaluated the treatment's safety and efficacy in 3,171 patients and results showed it was effective in reducing viral loads compared to other FDA-approved treatments. The drug carries a boxed warning alerting patients and providers it can cause both a buildup of lactic acid in the blood and severe liver problems. These problems can be fatal, but the most significant side effect associated with Genvoya was nausea.