Gilead announced that the Food and Drug Administration (FDA) has approved Genvoya (elvitegravir, cobicistat, emtricitabine, tenofovir alafenamide) tablets for the treatment of HIV-1 infection in patients aged ≥12 years weighing ≥35kg.

Genvoya is indicated for patients who have no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA <50 copies/mL) on a stable regimen for ≥6 months with no history of treatment failure and no known substitutions associated with resistance to the individual components of Genvoya. This marks the first tenofovir alafenamide (TAF)-based regimen to be FDA-approved.

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Genvoya was evaluated in a Phase 3 HIV clinical program that included over 3,500 treatment-naive, virologically suppressed, renally impaired, and adolescent patients. Week 48 data from two Phase 3 double-blind studies (Studies 104 and 111) among 1,733 treatment-naive patients met its primary objective of non-inferiority compared to Stribild (elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate [TDF]). The combined analysis showed 92.4% of patients treated with Genvoya and 90.4% of patients treated with Stribild had HIV-1 RNA levels <50 copies/mL at Week 48. Results of some renal and bone laboratory parameters also favored Genvoya vs. Stribild. 

Study 109 evaluated Genvoya among virologically suppressed patients who switched from TDF-based regimens (n=1,436). By Week 48, 1,196 patients had completed therapy and Genvoya proved to be statistically non-inferior to TDF-based regimens as shown by percentages of patients with HIV-1 RNA levels <50 copies/mL. In addition, data from Phase 3 studies of Genvoya among adolescents and patients with mild-to-moderate renal impairment supported the FDA approval. 

Genvoya will be available as 150mg/150mg/200mg/10mg fixed-dose tablets in 30-count bottles. 

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