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.
http://www.chicagotribune.com/health...,1977575.story
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