Gilead Sciences announced that it has submitted a New Drug Application (NDA) to the FDA for two doses of the fixed-dose combination of emtricitabine and tenofovir alafenamide (F/TAF) (200mg/10mg and 200mg/25mg), for the treatment of HIV-1 infections in patients ≥12 years old, in combination with other HIV antiretroviral agents.

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The F/TAF NDA is supported by data from Phase 3 clinical studies evaluating the safety and efficacy of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) for the treatment of HIV-1 infection among treatment-naive adults. Results demonstrated that the F/TAF-based regimen (administered as E/C/F/TAF) resulted in non-inferior efficacy and improved renal and bone laboratory parameters as compared to F/TDF-based therapy. The NDA is also supported by data from additional Phase 3 studies evaluating the F/TAF-based regimen (administered as E/C/F/TAF) among treatment-naive adolescents, virologically suppressed adults who switched regimens and adults with mild-to-moderate renal impairment. Lastly, bioequivalence studies demonstrated that the formulation of the fixed-dose combinations of F/TAF achieved the same drug levels in the blood as in E/C/F/TAF.

Tenofovir alafenamide is a novel nucleotide reverse transcriptase inhibitor (NRTI).

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