Pharmaceutical
company Gilead Sciences on Tuesday announced that a second
attempt to combine its combination anti-HIV medication
Truvada with Bristol-Myers Squibb's
Sustiva--which would result in a single-pill,
once-daily HIV treatment--has failed. A first attempt
in April at combining the medications also was
unsuccessful. Gilead announced that the second
formulation of the drugs did not achieve the same
bioequivalency as individual doses of the medications. The
companies are now considering new approaches at
combining the drugs into a single pill, including
using a layering approach that would include individually
formulated layers of the medications in a single pill.
Gilead officials say they plan to study these new
formulations over the next several months, and they
hope to file for Food and Drug Administration approval
of the single-pill anti-HIV regimen in the first half of
2006 at the earliest. Gilead and BMS had originally
hoped to file for FDA approval of the combination pill
before the end of 2005.