Gilead's 'Quad' HIV Drug Is Comparable To Atripla In Study
March 07 2012 - 4:12PM
Dow Jones News
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 3% among Quad users and 5% for Atripla.
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;
peter.loftus@dowjones.com
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