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A Food and Drug Administration
advisory panel on Friday voted 13-1 to recommend Gilead Sciences Inc.’s Quad
pill for people with HIV who have never been treated. However, the independent
experts said patients taking the drug should be monitored for possible kidney
problems, and they urged more research to assess the safety of Quad for women,
who were under-represented in clinical trials.
The panel’s sole “no” voter said
data on potential kidney problems and on women’s health were too limited to
justify approval. “There are plenty of alternatives to Quad,” said Dr. Michelle
Estrella of Johns Hopkins University School of Medicine. “There’s no huge hurry
in approving this drug before the outstanding studies are completed.”
The pill is a combination of four
agents: an experimental integrase inhibitor (elvitegravir), a booster
(cobicistat), and two nucleotide reverse transcriptase inhibitors
(emtricitabine and tenofovir).
In clinical trials, Quad was 88
percent effective in suppressing HIV, besting Gilead HIV treatment Atripla’s
efficacy of 84 percent. Nonetheless, trial data suggest there were a
disproportionate number of kidney problems.
The once-daily pill schedule would
help patients adhere to Quad, boosting treatment efficacy, said Gilead. The
firm said it has not set a possible price for Quad. In an era of restricted
public assistance for treatment, AIDS advocates worry about the cost of new
AIDS drugs that offer only modest improvements in treatment.
The panel’s recommendation will be
taken up by FDA regulators, and a decision on final approval is expected August
27.
The Friends of AIDS Foundation is
dedicated to enhancing the quality of life for HIV positive individuals and
empowering people to make healthy choices to prevent the spread of the HIV
virus. To learn more about The Friends of AIDS Foundation, please visit: http://www.friendsofaids.org.
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