FDA report on Gilead's Quad focuses on kidney safety

WASHINGTON Wed May 9, 2012 11:21am EDT

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WASHINGTON (Reuters) - Gilead Sciences Inc's Quad pill appears to be effective at controlling HIV infection but could lead to kidney problems, a U.S. Food and Drug Administration staff report said on Wednesday.

The regulators said the four-drugs-in-one treatment has a generally acceptable safety profile. But they found evidence of disproportionate numbers of adverse renal events among test subjects that may need to be monitored.

They also cautioned that safety measures for women could be limited because only a small number of women were tested.

The staff document will be scrutinized on Friday by an FDA panel of outside experts whose recommendations will be considered when the agency decides whether to approve Quad. A final decision is expected by August 27.

Quad is seen as key to Gilead's continued dominance of the market for HIV drugs. Most of the company's current drug sales, which totaled $8.1 billion last year, come from Atripla, a once-daily pill that combines Truvada with Bristol-Myers Squibb's Sustiva. Truvada consists of Gilead's older HIV drugs Emtriva and Viread.

Gilead shares were up 1.8 percent to $50.34 in morning trading after the FDA released the staff review.

J.P. Morgan analysts called the review "fairly benign," saying potential kidney issues were already well known. "Given what we view as minor issues, we believe the panel will likely support approval," the analysts said in a note to clients.

Foster City, California-based Gilead is asking the FDA to approve Quad for use in HIV-infected patients who have not received any other treatment.

Quad combines the experimental integrase inhibitor elvitegravir and boosting agent cobicistat with Truvada.

Company research showed that after 48 weeks of treatment, 88 percent of patients receiving Quad achieved target levels of the HIV virus, compared with 84 percent of patients who took Atripla.

No more than 12 percent of test subjects were women, prompting staff to note that knowledge about the drug's safety for female HIV patients may be limited.

FDA staff said the Quad patients were more likely to experience adverse kidney events, including alcohol poisoning and renal failure. They noted that one of Quad's components, tenofovir, was previously shown to be associated with new or worsening kidney problems in some patients.

Gilead has proposed steps to address kidney-related issues. The company recommended that kidney function be tested before treatment and that the Quad be withheld from patients suffering renal impairment or discontinued for those who develop problems after beginning treatment.

FDA staff asked Friday's advisory committee to comment on Quad's safety profile, given the potential for kidney problems, including the need for further monitoring and post-marketing studies to further define risks and optimal use.

(Reporting By David Morgan; Editing by Maureen Bavdek and John Wallace)

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