Tenofovir alafenamide fumarate: Phase III data

The 96-week, double-blind, international Phase III Study 111 trial in 866 treatment-naive patients with HIV-1 infection and viral load >=1,000 copies/mL showed that once-daily oral TAF/elvitegravir/cobicistat/emtricitabine met the primary endpoint of non-inferiority to Gilead's Stribild elvitegravir/cobicistat/emtricitabine/tenofovir in the proportion of patients with HIV RNA levels of <50 copies/mL at week 48 (91.6% vs. 88.5%, 95% CI: -1, 7.1). Patients receiving TAF/elvitegravir/cobicistat/emtricitabine also had significantly smaller median reductions from baseline in lumbar spine (1.11% vs. 2.81%, p<0.001) and hip BMD (0.74% vs. 2.78%, p<0.001) vs. Stribild. Both regimens were generally well tolerated. Gilead also reported data from the Phase III Study 104 trial of the TAF-based regimen. Both trials include an open-label rollover extension. The company plans to submit additional data from the trials for presentation at a scientific conference in early 2015. Next quarter, Gilead plans to submit regulatory applications in the U.S. and EU for TAF/elvitegravir/cobicistat/emtricitabine.

TAF is also in Phase III testing as monotherapy to treat HBV infection. Gilead markets Stribild -- a once-daily tablet comprising Vitekta elvitegravir, Tybost cobicistat and Truvada emtricitabine/tenofovir -- in the U.S. and EU for HIV-1 infection. The company also markets Emtriva emtricitabine, a nucleoside analog reverse transcriptase inhibitor (NRTI), and Truvada. In the EU, Vitekta, an HIV integrase inhibitor, is approved for HIV-1 infection, and Tybost, an inhibitor of cytochrome P450 family 3 subfamily A ( CYP3A; CYP3), is approved as a pharmacokinetic enhancer of protease inhibitors atazanavir and darunavir as part of antiretroviral combination therapy for HIV-1 infection. ...