Gilead's TAF-based HIV regimen meets 48-week primary objective

US HIV/AIDS giant Gilead Sciences (Nasdaq: GILD) says 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-naive adults met their primary objectives.

The studies demonstrated that the single tablet regimen comprising elvitegravir 150mg, cobicistat 150mg, emtricitabine 200mg and TAF 10mg (E/C/F/TAF), was non-inferior to Gilead's Stribild (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate) 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.

"As individuals with HIV are living longer, there is a need for treatments that are not only highly effective, but also offer an improved safety profile," said Norbert Bischofberger, executive vice president, R&D, and chief scientific officer of Gilead Sciences. "Based on these Phase III results, we believe that the E/C/F/TAF single tablet regimen has the potential to optimize HIV therapy for a wide range of treatment-naive patients," he added.