Genvoya, New Single-Tablet HIV Regimen Containing Tenofovir Alafenamide, Approved By FDA

On Nov. 5, the U.S. Food and Drug Administration (FDA) approved elvitegravir/cobicistat/ emtricitabine/tenofovir alafenamide (E/C/F/TAF), which will be marketed as Genvoya, for the treatment of HIV in adults and children over 12.

E/C/F/TAF is a single-tablet combination regimen, the first FDA-approved regimen to contain tenofovir alafenamide (TAF), a prodrug of tenofovir that has been shown to be more potent at lower doses and gentler on the bones and kidneys than tenofovir disoproxil fumarate (TDF, Viread).

Previous clinical trials showed that E/C/F/TAF was noninferior to elvitegravir/cobicistat/ emtricitabine/tenofovir disoproxil fumarate (Stribild), while offering better bone and kidney safety.

Another clinical trial showed that switching to E/C/F/TAF from efavirenz/tenofovir/emtricitabine (Atripla) maintained viral suppression in addition to bone and kidney safety benefits.

E/C/F/TAF is approved for treatment-naive patients, as well as adults with undetectable viral loads on other regimens, according to the FDA press release. Additionally, E/C/F/TAF is not recommended for patients with severe kidney disease, but can be taken by those with moderate kidney disease.

"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 Edward Cox, M.D., director of the Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research, in the press release.

The FDA will decide on two other coformulations containing TAF in early 2016: an updated version of tenofovir/emtricitabine (Truvada) at two different doses for combination with other antiretrovirals, and an updated version of rilpivirine/tenofovir/emtricitabine (Complera).