FDA Approves Genvoya, A New Once-Daily HIV Regimen

By Eric Brus

This fall, the U.S. Food and Drug Administration (FDA) announced the approval of a new one-pill-a-day HIV treatment regimen called Genvoya, made by Gilead Sciences. Genvoya is a tablet containing four drugs: elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide. The recommended dosage of Genvoya is one tablet taken once daily with food.

Genvoya is the first approved anti-HIV pill to contain a new form of the drug tenofovir called tenofovir alafenamide, or TAF for short. The older form of tenofovir -- called tenofovir disoproxil fumarate or TDF -- was approved by the FDA in 2001. TDF is a component in most current HIV treatment regimens, as well as in the only FDA-approved pill to prevent HIV transmission (Truvada).

The new form of tenofovir (TAF) provides lower levels of drug in the bloodstream, but higher levels within the cells, where the HIV virus replicates. It was developed to help reduce drug side effects, including decreased bone density and kidney toxicity, sometimes seen in persons taking the older form of tenofovir (TDF). The hope is that the substitution of TAF for TDF will significantly reduce the risk of side effects and long-term toxicities.

Genvoya is very similar to another Gilead once-daily tablet called Stribild, which was approved in 2012. Both tablets contain the drugs elvitegravir, cobicistat, and emtricitabine, but in Genvoya the TAF form of tenofovir is substituted for the TDF form contained in Stribild. The wholesale acquisition cost of Genvoya is expected to be the same as for Stribild, about $31,400 per year. "Our request to Gilead that Genvoya be priced neutrally with Stribild was heard," noted Lynda Dee, co-chair of the Fair Pricing Coalition, a group that negotiates pricing with drug-makers. "We now need to ensure that this welcome addition is priced affordably for all cash-strapped public insurance programs and that future TAF-inclusive co-formulations are priced to ensure access for all people living with HIV."

It is worth noting that Gilead has also filed for FDA approval of a new version of the two-drug combination pill Truvada, in which TAF will be substituted for TDF. If approved, as expected, the tablet will receive a new name and may be used in place of Truvada for HIV treatment and prevention.

Eric Brus is the Director of Health Information at AIDS Action Committee. This report is produced by the Health Library of the AIDS Action Committee in collaboration with the New England AIDS Education and Training Center Minority AIDS Initiative Project. The full version is available online.