Each of the double-blind Phase 3 trials will randomize 840 HIV-1 infected patients containing a viral load of 1,000 copies/mL or more with a once-daily tablet containing TAF 10mg/elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg (n=420) or Stribild (n=420).
Gilead Sciences chief scientific officer research and development executive vice president Norbert Bischofberger said, "We believe that TAF’s smaller milligram size has the potential to offer safety and tolerability advantages over existing therapies, and may enable the creation of new single tablet regimens for HIV."
The patient proportion with a viral load of less than 50 copies/mL determined by the FDA-defined snapshot analysis at 24-week treatment period will be the primary endpoint of the studies.
Secondary endpoints include patient proportion with viral load of less than 20 copies/mL and 200 copies/mL as determined by FDA-defined snapshot analysis at week 48 and week 96, section of patients with viral load less than 50 copies/mL week 48 as determined by FDA Time to Loss of Virologic Response analysis, the proportion of patients with viral load less than 50 copies/mL at week 96 as measured by the FDA snapshot and TLOVR analyses and change from baseline in CD4+ cell count at weeks 48 and 96.
Study 111, the second Phase 3 study, is expected to begin shortly.