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FDA approves first drug shown to reduce HIV risk in the uninfected

Updated: July 16, 2012 10:53PM



The Food and Drug Administration has approved the first drug shown to reduce the risk of HIV infection to uninfected people, a milestone in the 30-year battle to fight the virus that causes AIDS.

Gilead Sciences Inc.’s pill Truvada was approved Monday as a preventive measure for individuals who are at high risk of acquiring HIV, such as those who have sex with HIV-infected partners.

Gilead already markets Truvada as a treatment to HIV-positive people. Now, company studies have been shown to prevent people from becoming infected with the virus.

A three-year study found that daily doses cut the risk of infection in healthy gay and bisexual men by 42 percent, when accompanied by condoms and counseling.

Another study found that Truvada reduced infection by 75 percent in heterosexual couples in which one partner was infected with HIV and the other was not.

A so-called pre-exposure prophylaxis (PrEP) drug has long been a goal to help prevent the spread of HIV/AIDS.

“Today’s approval marks an important milestone in our fight against HIV,” FDA Commissioner Dr. Margaret Hamburg said. “Every year, about 50,000 U.S. adults and adolescents are diagnosed with HIV infection, despite the availability of prevention methods and strategies to educate, test, and care for people living with the disease.”

But Truvada’s groundbreaking preventive ability has exposed disagreements about managing the disease among those in the HIV community. Groups including the AIDS Healthcare Foundation asked the FDA to reject the new indication, saying it could give patients a false sense of security and reduce the use of condoms, the most reliable preventive measure against HIV.

AIDS Foundation of Chicago, meanwhile, called the FDA’s decision to approve Truvada “exciting.”

“Our challenge now is to implement PrEP as strategically as possible, and to ensure the people who need it most, those who are most at risk for HIV, have access,” said David Ernesto Munar, president and CEO of AIDS Foundation of Chicago.

The FDA is recommending that patients be tested to prove that they are HIV-negative before receiving the drug and then at three-month intervals.

The cost of Truvada is approximately $13,900 per year, a Gilead spokeswoman said.

AP, Contributing: Monifa Thomas



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