The U.S. Federal Drug Administration (FDA) recently approved Descovy, a new, two-drug fixed dose combination tablet that is designed to treat patients who have HIV-1 infections.
This new treatment includes two HIV nucleoside analog reverse transriptase inhibitors (NRTIs), emtricitabine (FTC) and tenofovir alafenamide (TAF). Each of the tablets has 200 milligrams of FTC as well as 25 milligrams of TAF; this amount is equal to the 28 milligrams of tenogovir alafenamide fumarate.
Descovy needs to be combined in a treatment regimen that involves other antiretroviral agents. Once the two are combined, they make a complete treatment plan for the patients.
The officials with the FDA used a relative bioavailability trial as the evidence for their approval. The trial showed that FTC and TAF exposures with Descovy were similar to the exposures found in Genvoya.
Because of earlier trials confirming the safety and effectiveness of Genvoya, the researchers did not need to conduct a clinical trial that assessed the safety and effectiveness of Descovy, as well.
With the TAF exposures in Descovy, patients experienced adequate antiviral effect, similar to the patients in Genvoya. TAF exposures involving FTC/TAF 200 milligrams/25 milligrams included boosted protease inhibitors to enhance the results over the ones found in Genvoya.