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Gilead to Start Advanced Trial of First Four-in-One AIDS Drug
  By Marilyn Chase
Jan. 12 (Bloomberg) -- Gilead Sciences Inc. expects to begin the first trial to test the effectiveness of its experimental four-in-one AIDS-drug pill early in the second half of this year, President John Milligan said in an interview.
Gilead, based in Foster City, California, is in discussions with the Food and Drug Administration about the size and scope of the trial, Milligan said today in an interview during the JP Morgan Healthcare Conference in San Francisco. The trial also will evaluate the safety of the Quad pill.
Gilead, the global leader in treatments for human immunodeficiency virus that causes AIDS, derives 80 percent of its $5 billion in annual sales from AIDS treatments. The company markets Atripla, a three-in-one daily pill containing its dual drug pill Truvada plus Bristol-Myers Squibb Co.'s Sustiva.
"The fixed dose Quad pill is the most exciting thing we're working on," Milligan said.
The Quad pill would be Gilead's first to combine only its own AIDS drugs, Milligan said. It would contain the two-in-one HIV pill Truvada, plus Gilead's new compound elvitegravir that blocks an enzyme called integrase that the virus needs to insert itself into its victim's genes. The Quad also would include a booster medicine Gilead developed.
A main advantage of the new pill is that it would offer an alternative for those who can't tolerate Sustiva's central nervous system side effects, including bad dreams and hallucinations, Milligan said. In addition, birth defects seen in animal studies of Sustiva could also make some doctors reluctant to prescribe the drug for women who may have children.
The Quad pill would be especially important for persons of African descent who are hardest hit by the virus, because they metabolize Sustiva more slowly, making its side effects more pronounced, according to Milligan.
"If Sustiva isn't useful, the Quad may be of more benefit," Milligan said.
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