Studies 104 and 111 of Genvoya (elvitegravir 150 mg, cobicistat 150 mg, emtricitabine 200 mg and tenofovir alafenamide 10 mg) for treatment of HIV-1 show higher rates of virologic suppression compared to Gilead�s Stribild.- Gilead Sciences

Gilead Sciences, Inc. announced 144-week data from two Phase III studies (Studies 104 and 111) evaluating the safety and efficacy of Genvoya (elvitegravir 150 mg, cobicistat 150 mg, emtricitabine 200 mg and tenofovir alafenamide 10 mg) for the treatment of HIV-1 infection in treatment-naïve adults. Through Week 144, Genvoya demonstrated significantly higher rates of virologic suppression compared to Gilead’s Stribild (elvitegravir 150 mg, cobicistat 150 mg, emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg), based on the percentage of patients with HIV-1 RNA levels less than 50 copies/mL. Patients receiving Genvoya also demonstrated favorable renal and bone laboratory parameters compared to those treated with Stribild. The data were presented in a poster session (Poster 0393) at the 2017 Conference on Retroviruses and Opportunistic Infections (CROI) in Seattle.

Genvoya is indicated as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients 12 years of age and older who have no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA levels less than 50 copies/mL) on a stable antiretroviral regimen for at least six months with no history of treatment failure and no known resistance to the components of Genvoya. Genvoya has a boxed warning in its product label regarding the risks of lactic acidosis/severe hepatomegaly with steatosis, and post treatment acute exacerbation of hepatitis B.

Comment: Genvoya was approved by the European Commission on 19 November 2015 and by the FDA on 5 November 2015.