Combination regimen including tenofovir alafenamide for HIV/AIDS successful - Gilead Sciences

Gilead Sciences, Inc. announced that two Phase III clinical trials (Studies 104 and 111) evaluating an investigational once-daily single tablet regimen containing tenofovir alafenamide (TAF) for the treatment of HIV-1 infection in treatment-na�ve adults met their primary objectives.

The studies demonstrated that the single tablet regimen comprising elvitegravir 150 mg, cobicistat 150 mg, emtricitabine 200 mg and TAF 10 mg (E/C/F/TAF), was non-inferior to Gilead�s Stribild (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) based on the proportion of patients with HIV RNA levels (viral load) of less than 50 copies/mL at 48 weeks of therapy. In addition, E/C/F/TAF demonstrated more favorable renal and bone safety compared to Stribild. Gilead plans to submit data from Studies 104 and 111 for presentation to a scientific conference in early 2015.

Based on the results of Studies 104 and 111 and data from additional ongoing studies, Gilead plans to submit regulatory applications for E/C/F/TAF in the United States and European Union in the fourth quarter of 2014.