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Ryan Jaslow /

CBS News/ July 16, 2012, 1:34 PM

Truvada approved by FDA as first HIV-prevention pill

CBS News
(CBS News) Truvada has been approved by the Food and Drug Administration as the first pill to prevent HIV.

Gilead Sciences' Truvada has been taken by people over 12 with human immunodeficiency virus in conjunction with other antiretroviral drugs since it was first approved by the FDA in 2004. The new approval applies in combination with safer sex practices for preventative use in healthy individuals who are at a high risk for HIV or who may have sex with HIV-positive partners.

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"Today's approval marks an important milestone in our fight against HIV,"  FDA Commissioner Dr. Margaret A. Hamburg said in a press release. "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. New treatments as well as prevention methods are needed to fight the HIV epidemic in this country."

In the announcement, the FDA strongly recommended against Truvada's use to prevent disease transmission in individuals who may already have HIV.

The most common side effects reported with Truvada were diarrhea, nausea, abdominal pain, headache and weight loss. Serious side effects were uncommon.

In May, a panel of expert advisers who make recommendations to the FDA voted to back Truvada's use for HIV prevention in healthy, high-risk individuals but the FDA was not bound to accept the panel's recommendation. The experts at the time questioned the drug's effectiveness for females, who have shown much lower rates of protection in the research.

Research showing Truvada may prevent HIV transmission first arose in 2010, when a government study found it cut infection risk in healthy gay and bisexual men by 42 percent, when accompanied by condoms and STD counseling. Another study found the pill may reduce HIV risk by 75 percent among heterosexual couples in which one partner is infected with the virus. Some doctors had already been prescribing Truvada off-label for HIV prevention.

Following the FDA advisory panel's initial recommendation in May, some HIV advocates hailed the announcement as "nearing a watershed moment in our fight against HIV."

© 2012 CBS Interactive Inc. All Rights Reserved.
17 Comments Add a Comment
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tallgirl1014 says:
This is huge!!! You know the corporations that some really hate, well this corporation worked hard to come up with something to save life's and if you don't know this yet, Donald Rumsfeld has been the chairman of this company since 1997. Maybe we should think again before wanting to tax corporations that help others and put people to work.
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knewsteerrrrr says:
"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. New treatments as well as prevention methods are needed to fight the HIV epidemic in this country."

Too bad what that says is those 50,000 a year are too STUPID to take the education to heart and use protection ANYWAY, so they deserve to get HIV then. Personally I think the funds used for this should be CUT totally and put into aa medical research that benefits EVERYONE- cancer research, as almost everyone will be affected by it one way or another while 99.99% of HIV is in those involved in sex without protection- by THEIR choice!
Either get educated- HIV material is EVERYWHERE! get over the macho garbage, use a rubber or get a good dog- but if you are going to "do" women or other humans and not use protection, then don't come whining about the problem YOU made for yourself willingly, or expect the rest of US to pay for your pills!
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hypnotoad72 replies:
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A cure for HIV would be better, as that would help everyone. A 'prevention' alternative is okay, but it's a waste of money given how many other forms of prevention exist. And, yes, that includes being conscientious of others...

Oh, there are people who lie about their status and willfully affect it. "Choice" is only relevant or legitimate when everybody is being truthful upfront.
raulgreekmexican replies:
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KNEWSTEERRRRR,
I was raped and found out I was positive 6 months later, so do you say I am stupid too? Don't talk, unless you know. There are also many people in the world who will not disclose their status due to HIV stigma, and not because of "macho garbage" as you say. I work for an HIV prevention agency in Chicago, and I've heard many different stories. Another fact for you, the U.S does not care to give enough money for HIV care, the money comes from- Private sectors, Donations, or Donor Governments. I'm only 22yo, and for me to hear your moronic load of bull it is not right. As a for cure for HIV, I tested HIV negative last month, I've been getting constantly tested and I come out negative every time, so I am officially negative not undetectable. There are cures which will be distributed out to the public hopefully soon. But, please if you people want to open your mouth and bark out garbage, make sure you know your facts. Morons.

Sincerely,
Raul.
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baileycccc says:
You really have to hand it to Big Pharma, they are the Greatest Salesmen of All Time. People stand in line to take their synthetic poisons that are laced with terrible side effects and they pay top dollar for the privileged.

If the public knew the real story of bribes, false testing results and untold pain and death they might not be so eager to be a Ginny pig for their profit.
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knewsteerrrrr replies:
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The alternative is death...
hypnotoad72 replies:
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knewsteerrrrr -

True, but unlike those magazine ads, people who take the medications are not so happy and chirpy. The side-effects are pretty bad...
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baileycccc says:
You really have to hand it to Big Pharma, they are the Greatest Salesmen of All Time. People stand in line to take their synthetic poisons that are laced with terrible side effects and they pay top dollar for the privileged.

If the public knew the real story of bribes, false testing results and untold pain and death they might not be so eager to be a Ginny pig for their profit.
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hypnotoad72 says:
Another reason for people to lie about their HIV status or to gloss over the issue. Everybody, pop the pill and regardless of side-effects it might have... you can't trust others so trust the medicine companies...

Ironic, isn't it?
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vsmit replies:
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The drug won't work on straight people, another thing the "medicine companies" won't tell you. LOL
hypnotoad72 replies:
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vsmit -

If all you can do is make asinine comments followed by a lame "LOL" and try to pass that off as serious commentary... I pity you.
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fredisalive says:
sure, a drug to give folks a false sense of security! Keep bagging it!
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Mays2011 replies:
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my thoughts exactly!
hypnotoad72 replies:
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*bingo*

We'd rather sell medications than teach ethics, morals, responsibility, and consciousness toward society.

True, the drug has its place, but we treat drugs as a synthetic panacea.
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singlepayer4all says:
Still, I wouldnt be going into any asian go-go bars anytime soon without out a glove on, even with this pill.
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