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FDA approves first drug for reducing the risk of sexually acquired HIV

Monday, July 16, 2012

WASHINGTON — The U.S. Food and Drug Administration on Monday approved Truvada, the first drug approved to reduce the risk of HIV infection in uninfected individuals who are at high risk of HIV infection, or who may engage in sexual activity with HIV-infected partners.

Truvada was previously approved by the FDA to be used in combination with other anti-retroviral agents for the treatment of HIV-infected adults and children 12 years or older.

“Today’s approval marks an important milestone in our fight against HIV,” said FDA Commissioner Margaret A. Hamburg, M.D.

“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,” Hamburg said.

In a clinical trial involving 2,499 HIV-negative men or transgender women who have sex with men and with evidence of high risk behavior for HIV infection, Truvada was effective in reducing the risk of HIV infection by 42 percent compared with placebo.

In a second clinical trial of 4,758 heterosexual couples where one partner was HIV-infected and the other was not, Truvada reduced the risk of becoming infected by 75 percent compared with placebo.

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

Full details on Truvada and the clinical trials are available via the FDA.

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15 more reader comments:

  1. Profit again than natural marijuana

    Posted on Monday, July 16, 2012 at 6:10pm
  2. Bout damn time!

    Posted on Monday, July 16, 2012 at 6:13pm
  3. It has to be taken every single day and costs over $1,000 a month. (without insurance)

    Posted on Monday, July 16, 2012 at 6:13pm
  4. I’m worried about prophylactic antiretroviral drug use and the potential for ART resistant HIV strains…

    Posted on Monday, July 16, 2012 at 6:16pm
  5. And what about people with HIV who are on Truvada? Don’t they care about the shortages this will create?

    Posted on Monday, July 16, 2012 at 6:17pm
  6. Hopefully Canada can get this too?

    Posted on Monday, July 16, 2012 at 6:23pm
  7. I don’t trust the FDA

    Posted on Monday, July 16, 2012 at 6:26pm
  8. About time since they’ve been sitting on this for years!

    Posted on Monday, July 16, 2012 at 6:38pm
  9. um… yay? I can see how this would be a miracle for couples with 1 HIV+ person, or if it has a “morning after” effect for rape victims, but it just seems like a dangerous thing for stupid people. I hope it’s only by prescription.

    Posted on Monday, July 16, 2012 at 6:47pm
  10. I just hope that people do not take this as an invitation to have unsafe sex. Still stay safe people!

    Posted on Monday, July 16, 2012 at 6:50pm
  11. wow, another drug company profits as the expense of a healthy person taking chemotherapy.. hmmm

    Posted on Monday, July 16, 2012 at 7:11pm
  12. i take medicine today that was approved by the fda medicine does me quite well

    Posted on Monday, July 16, 2012 at 7:17pm
  13. @Jim, no it can’t be taken as a morning after thing. That’s what POST exposure prophylaxis is for. That’s been approved for years!

    Posted on Monday, July 16, 2012 at 7:56pm
  14. Just don’t forget safe sex practices. We still need to keep our guards up!

    Posted on Monday, July 16, 2012 at 10:40pm
  15. nooooo! dont do it! you are just being a guinne pig for these sick bastards that have legal immmunity from being prosecuted

    Posted on Monday, July 16, 2012 at 11:31pm