U.S. FDA Panel Recommends Gilead’s Quad for HIV

From U.S. Centers for Disease Control and Prevention

May 14, 2012

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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.