HIV pill Truvada approved by FDA panel for preventative use

GlobalPost

Truvada, a popular HIV treatment pill, was approved for preventative use by an FDA panel on Thursday, a milestone in the fight against AIDS. 

The Food and Drug Administration's advisory committee voted 19-3 in support of the drug's use for controlling HIV infection among the most at-risk group - men who have sex with men, Reuters reported

"I think this is a huge milestone," Dr. Robert Grant, associate director of the Center for AIDS Research at the University of California, who led the panel's research, told CBS News. "I think we are in an era for the first time when we can see the end of the AIDS epidemic."

More from GlobalPost: Truvada, an HIV treatment pill, one step closer to being approved for prevention by FDA

The pill, which is manufactured by California-based Gilead Sciences, combines two medicines (Emtriva and Viread) that inhibit the reproduction of HIV, NPR reported

While Truvada is already approved as an HIV treatment, and doctors are allowed to prescribe it "off-label" for prevention, the FDA panel's approval formally allows the drug to be marketed for preventative use, according to the Associated Press. An official decision from the agency is expected by June 15, though the FDA usually follows advisers' recommendations, the AP reported. 

Despite the approval, the panel raised several concerns during their 12-hour meeting on Thursday, including the probability of Truvada reducing the use of condoms, the most reliable defense against HIV, CBS News reported. The experts also debated the pill's effectiveness amongst women, who showed much lower rates of protection in studies, according to CBS. 

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The daily pill also needs to be taken diligently: patients who didn't take Truvada regularly were not protected, CBS reported. 

"The trouble is adherence, but I don't think it's our charge to judge whether people will take the medicine," Dr. Tom Giordano of Baylor College of Medicine, who voted in favor of the drug, told CBS News. "I think our charge is to judge whether it works when it's taken and whether the risks outweigh the benefits."

Nick Literski, a federal worker in Seattle who has been taking Truvada for over a year because his partner has AIDS, called the FDA decision "a huge step forward," according to the AP. 

Using the drug for prevention "is really allowing people to make educated choices about their health," said Literski, whose insurance covers his preventive treatment. 

The decision will likely lead many more insurance companies to pay for the costly drug, which ranges from just under $11,000 up to $14,000, the AP reported. 

Almost 1.2 million Americans are infected with HIV, and 50,000 people a year have contracted the sexually transmitted disease for the past two decades, Reuters reported. Studies showed Truvada to be over 90 percent effective at preventing HIV infection among test subjects who took the drug as prescribed, according to Reuters. 

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