1. Headline
  1. Headline
By
updated 7/16/2012 1:16:36 PM ET 2012-07-16T17:16:36

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

  1. More from TODAY.com
    1. See this family take photos with Santa for 60 straight years

      Many kids will take their pictures with Santa Claus for a few winters, but four siblings in Seattle, Washington, have kept...

    2. Doctor, 103, shares secrets to longevity: 'Pick the right spouse'
    3. Steal this easy holiday party trick for a stunning veggie platter
    4. Check that crazy cat person off your list with these purrfect gifts
    5. Quiz: Which Christmas movie family is most like yours?

The agency approved Gilead Sciences' pill Truvada as a preventive measure for people who are at high risk of acquiring HIV through sexual activity, such as those who have HIV-infected partners.

Public health advocates say the approval could help slow the spread of HIV, which has held steady at about 50,000 new infections per year for the last 15 years. An estimated 1.2 million Americans have HIV, which develops into AIDS unless treated with antiviral drugs. With an estimated 240,000 HIV carriers unaware of their status, doctors and patients say new methods are needed to fight the spread of the virus.

Gilead Sciences Inc. has marketed Truvada since 2004 as a treatment for people who are already infected with the virus.

But starting in 2010, studies showed that the drug could actually prevent people from contracting HIV when used as a precautionary measure. 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.

Last year 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.

Because Truvada is on the market to manage HIV, some doctors already prescribe it as a preventive measure. FDA approval will allow Gilead Sciences to formally market the drug for that use, which could dramatically increase prescribing.

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.

But FDA scientists said Monday said there was no indication from clinical trials that Truvada users were more likely to engage in risky sexual behavior.

"What we found was that condom use increased over time and sexually transmitted infections either remained at baseline levels or decreased," said Dr. Debra Birnkrant, FDA's director of antiviral products. "So in essence, we don't have any strong evidence that condoms were not used or there was a decrease in condom use."

Copyright 2012 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

Discuss:

Discussion comments

,

Most active discussions

  1. votes comments
  2. votes comments
  3. votes comments
  4. votes comments

More on TODAY.com

  1. Courtesy of the Wilson family co

    See this family take photos with Santa for 60 straight years

    12/17/2014 11:10:30 PM +00:00 2014-12-17T23:10:30
  1. North Korea is behind Sony hack, US officials say

    U.S. officials now say they believe North Korea was behind the computer hacking attack on Sony Entertainment.

    12/17/2014 11:20:01 PM +00:00 2014-12-17T23:20:01
  1. AFP-Getty Images file

    Prince William dares to call Kate's dream hair a 'nightmare'

    12/17/2014 5:34:33 PM +00:00 2014-12-17T17:34:33
  1. Handout / Reuters

    'Glorious day': Freed American Alan Gross says it's good to be home

    12/17/2014 7:35:11 PM +00:00 2014-12-17T19:35:11