FDA staff: Gilead's Truvada may help reduce HIV risk

WASHINGTON (Reuters) - Gilead Sciences Inc's Truvada tablets appear safe and effective for reducing the risk of HIV infection, U.S. regulators said on Tuesday. But they recommended a cautious approach for using the drug in efforts to prevent the virus that causes AIDS.

Food and Drug Administration staff said Truvada, which is already being used by patients with the human immunodeficiency virus, is well tolerated overall by uninfected people and may prevent infection in high-risk individuals when used in combination with other strategies.

FDA staff also acknowledged a strong correlation between the drug's efficacy at reducing HIV infection and the willingness of those taking it to adhere to the treatment.

Their 47-page review document said preventive use of the drug -- a combination of Gilead's HIV drugs Emtriva, also known as emtricitabine, and Viread, or tenofovir -- should be weighed carefully against an individual's risk for infection, readiness to adhere to the treatment and potential for kidney problems.

"The individual at risk may be spared infection with a serious and life-threatening illness that requires lifelong treatment," the report said.

Truvada represents a potential milestone in the evolution of the worldwide AIDS epidemic by offering a tablet capable of preventing infection. An estimated 1.2 million Americans have HIV, according to the Centers for Disease Control and Prevention.

An outside panel of experts is scheduled to examine the FDA review documents on Thursday and make recommendations that U.S. health regulators will consider in deciding whether the drug should be used as a preventive treatment.

Some experts warn that the drug is only partly effective against HIV and that using it to prevent infection could cause protection from the virus to falter if patients fail to adhere to treatment.

Shares in Gilead Sciences were off 1.5 percent at $49.17 after the FDA released the review document.

CONCERNS OVER DRUG RESISTANCE

UBS analyst Matthew Rodin told investors that the review should have only limited impact on the company because Truvada, which has FDA approval to treat people infected with HIV, is already being used off-label as a prophylactic.

He said a Friday advisory committee meeting on Gilead Sciences' Quad HIV pill for controlling the HIV virus could have bigger implications for the company. Quad is seen as key to Gilead's continued dominance of the market for HIV drugs.

Meanwhile, FDA staff acknowledged that resistance is likely to occur among people who become infected while taking the drug. "The frequency of resistance might be minimized by limiting the duration of drug exposure after infection occurs," the review document said.

The Boston-based Fenway Health Institute, which advocates for the lesbian, gay, bisexual and transgender communities, issued a statement calling on the FDA to approve the drug as a means of reducing the risk of HIV infection.

"If the FDA approves the additional indication of the use of tenofovir-emtricitabine ... health programs and individuals will have improved choices," the group said.

In a 2010 landmark study in the New England Journal of Medicine, researchers found that giving a daily dose of Truvada to men who have sex with men can reduce HIV infection rates 44 percent.

But other research shows that Truvada's high price makes it too costly to provide it to all homosexual and bisexual men, who account for more than half of the estimated 56,000 new infections annually in the United States.

A team of researchers at Stanford University had estimated that giving a daily preventive dose of the drug to all U.S. men who have sex with men would cost $495 billion over 20 years in terms of the cost of drugs and healthcare visits.

The strategy would be far more effective if it targeted men who are at high risk of developing HIV because they have five or more sexual partners a year, they said.

If just 20 percent of these high-risk individuals took the drug, the research team found, it could prevent 41,000 new infections over a period of 20 years at a cost of about $16.6 billion.

(Reporting By David Morgan, editing by Dave Zimmerman, Maureen Bavdek and Gunna Dickson)

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FDA panel recommends Gilead's Quad for HIV

WASHINGTON (Reuters) - A U.S. Food and Drug Administration panel of outside experts on Friday recommended the use of Gilead Sciences Inc's Quad pill for untreated HIV patients.

The FDA advisory committee voted 13-1 to endorse the four-drugs-in-one treatment, but members said there should be effective monitoring for potential kidney problems among patients and urged further research to determine the drug's safety profile for women, who have been under-represented in clinical research.

The panel's recommendation will now be taken into account by agency regulators, who are expected to decide on final approval for Quad by August 27.

An overwhelming number of the experts said they were satisfied with Gilead's demonstration of safety and efficacy.

But Dr. Michelle Estrella of Johns Hopkins University School of Medicine, the panel's lone 'no' vote, said data on potential renal problems and women's health was too limited to justify her approval.

"There are plenty of alternatives to Quad," she said. "There's no huge hurry in approving this drug before the outstanding studies are completed."

Gilead shares closed 1.2 percent higher at $51.84 after the committee voted.

Wall Street analysts said the panel's action was expected and predicted more good news for Gilead on the FDA front.

"Approval of the Quad is likely with renal monitoring. Renal monitoring is not a particular concern," J.P. Morgan analysts said in a note to investment clients. "We believe the Quad will further strengthen Gilead's market leading HIV business."

In fact, the new drug 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.

On Thursday, the panel also recommended Gilead's Truvada pill as the first-ever drug for use in preventing HIV infections.

Nearly 1.2 Americans are infected with the human immunodeficiency virus that causes AIDS and the HIV epidemic grows by 50,000 new cases each year, according to the U.S. Centers for Disease Control and Prevention.

Company research shows Quad to be 88 percent effective at suppressing HIV infection, surpassing 84 percent efficacy for Atripla. But data also indicated a disproportionate number of kidney problems among the hundreds of patients who participated in clinical trials.

It combines the experimental integrase inhibitor elvitegravir with the boosting agent cobicistat and two older nucleotide reverse transcriptase inhibitors - emtricitabine and tenofovir.

If approved by the FDA, Gilead executives said Quad would provide HIV suffers with the first ever once-daily integrase inhibitor, a class of drug designed to block the spread of HIV by preventing the virus from binding with the DNA of host cells.

Advocates said the one-a-day regimen would encourage patients to adhere to the treatment with Quad, boosting the likelihood of high efficacy outside the clinical atmosphere.

But HIV activists who provided public testimony warned policymakers to be wary of new HIV drugs that provide only marginal improvements over current treatments but allow drug makers to charge significantly higher prices at a time when public assistance can be restricted by government budget constraints.

"Reduced access here in America is compelling AIDS activists to rethink the rules on drug pricing," said James Driscoll of the AIDS Healthcare Foundation, a Los Angeles-based nonprofit group that provides care for nearly 170,000 HIV and AIDS patients.

Gilead said it has yet to establish a price for Quad. Atripla currently costs about $20,000 a year.

(Reporting By David Morgan; Editing by Gerald E. McCormick, M.D. Golan, Gary Hill)

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