FDA Approves Genvoya for the Treatment of HIV
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.
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.For more information call (800) 445-3235 or visit Gilead.com.