Second attempt at
combination anti-HIV pill fails

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.