Gilead Sciences, Inc. (MM) (NASDAQ:GILD)
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5 Years : From May 2012 to May 2017
Gilead Sciences Inc.'s (GILD) four-in-one "Quad" tablet was comparable to another combination drug, Atripla, in fighting HIV infection, but with lower rates of certain neurological side effects, according to a newly released study.
Gilead has already applied for U.S. Food and Drug Administration approval to market the drug, with a decision expected by late August. Gilead is also seeking European regulatory approval for the Quad.
The Quad pill in development combines Gilead's double-drug Truvada, the drug elvitegravir and an agent that boosts blood levels of certain HIV drugs, cobicistat.
Gilead is hoping that the one-pill, once-daily Quad regimen will provide more convenience to HIV patients, many of whom now take multiple pills for treatment. Some analysts think it could become a blockbuster seller.
Gilead last year announced preliminary results of two late-stage clinical trials testing the Quad against other HIV regimens. But full results of one of those studies weren't available until they were presented Wednesday at the Conference on Retroviruses and Opportunistic Infections in Seattle.
The 700-patient study compared the Quad with Atripla, which combines three HIV medicines in a single, once-daily pill, as an initial therapy for HIV infection. Atripla is a combination of Gilead's Truvada with Bristol-Myers Squibb Co.'s (BMY) Sustiva.
The study found that 88% of Quad recipients had viral suppression 48 weeks after starting treatment, versus 84% of Atripla users, which met the study's goal of demonstrating non-inferiority.
In addition, drug discontinuation rates due to adverse events were similar, at 4% among Quad users and 5% for Atripla. The 13 patients who discontinued Quad treatment due to adverse events included one patient death, according to slides presented at the conference.
Among adverse events that occurred in at least 10% of patients, nausea was more frequent in Quad users than Atripla users. But rates of dizziness, abnormal dreams, insomnia and rash were significantly less common in Quad users than Atripla users. In addition, total cholesterol and increases in bad cholesterol levels were lower for Quad than for Atripla after 48 weeks.
"These results suggest that Quad could become an important new option for initial HIV therapy," lead researchers for the Gilead-funded study wrote in the conclusion of a summary of the study results posted online by the medical conference Wednesday.
-Peter Loftus, Dow Jones Newswires; +1-215-982-5581; firstname.lastname@example.org