and some more...in some ways the comparison with isentress and...

and some more...

in some ways the comparison with isentress and prezista is useful in that they are recent accelerated approvals

but it is also comparing apples with oranges, as they are also very different drug classes to ATC

in summary, integrasess/protease inhibitors might expect bigger short term (e.g. 24 wk) viral/cd4 improvements than the longer term/less resistance nrti activity

so, lets compare the atc phiii results to the current gold standard nrti, tenofovir

Through week 24, the time-weighted average change from baseline HIV RNA in the Viread arm was -0.61 log versus -0.03 log in the placebo arm; similarly, the mean change in the absolute CD4 T cell count in the Viread arm was +11 versus -5 cells/mm3 in the placebo arm. At week 24 a total of 149 patients (40%) in the Viread arm had <400 copies/mL versus 20 patients (11%) in the placebo arm. In addition, 71 patients (19%) in the Viread arm versus 2 patients (1%) in the placebo arm had <50 copies/mL at week 24.

so VL reduction = -0.61
cd4 = +11
<400 = 40%
<50 = 19% both not sig diff from placebo (not active control)

ATCs numbers stack up very well against these!

see more here for tenofovir www.fda.gov/ohrms/DOCKETS/ac/01/.../3792s1_02_FDA-tenofovir.ppt