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. 6-year-old 'Rapunzel' chops off her hair for kids with cancer

      Charlie Tillotson had never wanted to cut her hair, which had grown to more than two and a half feet in length, but all th...

    2. James Franco shows Jimmy Fallon how to take a cool selfie
    3. Extreme parenting: Who are we to judge?
    4. 3 mocktails so good you won't miss the liquor
    5. LOL! OMG! Rapper DMX needs TLC after terrifying thrill ride

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 Steve Tillotson

    6-year-old 'Rapunzel' chops off her hair for kids with cancer

    7/29/2014 6:54:06 PM +00:00 2014-07-29T18:54:06
  1. Obama: EU cooperation gives Russia sanctions 'bigger bite'

    President Obama announced on Tuesday that not only would the U.S. be imposing additional sanctions on Russia’s defense, energy and financial sectors, but that the European Union would also be imposing new sanctions on the country. 

    7/29/2014 7:55:14 PM +00:00 2014-07-29T19:55:14
  1. Bravo / Steve Jennings/Bravo

    Extreme parenting: Who are we to judge?

    7/29/2014 6:52:01 PM +00:00 2014-07-29T18:52:01
  1. Minnesota man is first American to die in Ebola outbreak

    The Ebola outbreak that has killed hundreds of people in west Africa has claimed its first American; Patrick Sawyer, 40, a consultant for the Liberian government.

    7/29/2014 3:36:41 PM +00:00 2014-07-29T15:36:41
  2. American aid worker who contracted Ebola doing ‘as well as could be expected’