THE Food and Drug Administration (FDA) on Thursday, Nov. 5, approved a new drug to treat HIV in patients 12 years of age and older.
The drug, Genvoya, is a fixed-dose combination tablet that treats HIV-1 in adults and pediatric patients weighing at least 77 pounds, who have never previously taken HIV therapy and HIV-infected adults whose HIV-1 virus is currently suppressed. Genvoya contains elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide.
“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, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, said in a statement.
The new form of tenofovir in Genvoya has not been previously approved. It provides lower levels of tenofovir on the bloodstream, but higher levels within cells where HIV-1 replicates, according to an FDA release.
The safety of the drug was evaluated through four clinical trials involving 3,171 participants. Individuals were randomly assigned to take either Genvoya or another FDA-approved HIV treatment. Results indicated that the new drug effectively decreased viral loads and was comparable to other treatment options.
An estimated 1.2 million people aged 13 and older have HIV, according to the Centers for Disease Control, while an additional 150,000 people in the same age range are infected with the virus but are unaware of it.
Genvoya is not recommended for patients with severe kidney impairment.
