FDA Green Lights Combination Medication for Treating HIV-1

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Officials with Gilead Sciences announced that the Food and Drug Administration (FDA) has approved emtricitabine/tenofovir alafenamide [F/TAF]) (Descovy) tablets for the treatment of HIV-1 infection. The medication is indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in patients aged ≥12 years old. 

The FDA approval 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 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, according to a statement from Gilead.

Officials note that this treatment 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.

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