Gilead Sciences announced that the Food and Drug Administration (FDA) has approved Descovy (emtricitabine/tenofovir alafenamide [F/TAF]) tablets for the treatment of HIV-1 infection. It is indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in patients aged ≥12 years old.
The approval of Descovy was based on Week 48 data from two Phase 3 studies (Studies 104 and 111) where the F/TAF-based regimen (given as Genvoya [elvitegravir/cobicistat/emtricitabine/TAF]) met the primary objective of non-inferiority compared to an F/TDF-based regimen (given as Stribild [elvitegravir/cobicistat/emtricitabine/TDF]) among treatment-naive adults. Some renal and bone laboratory parameter tests showed that the F/TAF-based regimen was more favorable than the F/TDF-based regimen.
Also, data from another Phase 3 study (Study 109) evaluating the F/TAF-based regimen (given as Genvoya) among virologically suppressed patients who switched from F/TDF-regimens showed that the F/TAF-based regimen was statistically non-inferior to the F/TDF-based regimens. Improvements in some bone and renal laboratory parameters were seen vs. the F/TDF-based regimens. Data from additional Phase 3 studies evaluating the F/TAF-based regimen (given as Genvoya) among virologically suppressed adults with mild-to-moderate renal impairment and among treatment-naive adolescents, and bioequivalence studies also contributed to the approval of Descovy.
Descovy combines two HIV nucleoside analog reverse transcriptase inhibitors (NRTIs). Emtricitabine inhibits HIV-1 reverse transcriptase by competing with the natural substrate deoxycytidine 5′-triphosphate and by being incorporated into nascent viral DNA, which results in chain termination. TAF, a novel targeted prodrug of tenofovir, has proven high efficacy similar to and at 1/10 of the dose of Viread (tenofovir disoproxil fumarate [TDF]). Since TAF enters cells more efficiently than TDF, it can be administered at a much lower dose with 90% less tenofovir present in the bloodstream.
Descovy carries a boxed warning regarding the risks of lactic acidosis/severe hepatomegaly with steatosis, and post-treatment acute exacerbation of hepatitis B.
Descovy is now available as 200mg/25mg fixed-dose tablets in 30-count bottles.
For more information call (800) GILEAD-5 or visit Descovy.com.