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FDA approves Truvada for prevention of HIV/AIDS
July 16th, 2012
03:30 PM ET

FDA approves Truvada for prevention of HIV/AIDS

Adults who do not have HIV but are at risk of getting the disease will now be able to take a drug to reduce their chance of getting infected. For the first time, the U.S. Food and Drug Administration approved a drug for this use on Monday.

The drug is Truvada, an antiretroviral medication made by Gilead Sciences, Inc., which was already approved by the FDA in 2004 to help control HIV infection. 

Truvada is a combination of two HIV medications - emtricitabine (Emtriva) and tenofovir (Viread) - into one pill that is taken once a day.  As a treatment for HIV, it is always used in combination with other HIV drugs.

Recent studies showed pre-exposure prophylaxis or PrEP can reduce transmission of the virus significantly–up to 96% - when uninfected partners of people infected with HIV took Truvada.

Dr. Debra Birnkrant, M.D., director of the Division of Antiviral Products, Center for Drug Evaluation and Research at the FDA stressed Truvada alone should not be used to prevent HIV infection. It should be used in combination with other safe sex practices.

“Practicing safer sex and good health practices must be part of the treatment," Birnkrant said. “We will be putting a box warning to let those using Truvada know that it is part of the therapy with combination of safer sex practices, and that doing this, will reduce the risk of the development of AIDS/HIV.”

Dr. Anthony Fauci, director of the National Institute for Allergy and Infectious Diseases at the National Insitutes of Health, agrees.

“The approval of Truvada to prevent HIV infection in uninfected individuals who are at high risk of sexually acquired HIV infection is a signficant development, providing an important addition to our toolkit of HIV prevention interventions,” Fauci says. “However, it is critical to stress that Truvada as ‘pre-exposure prophylaxis’ should not be considered a stand-alone method, but should be used in conjunction with other proven HIV prevention stratgies such as condom use, risk-reduction counseling, and frequent HIV testing.”

Birnkrant says she hopes the right messages will get out, and that Truvada is used properly. "We have the box warning that a negative HIV test must be reported before Truvada is prescribed," she said.

According to Gilead, Truvada the most-prescribed antiretroviral in the United States. “Today’s decision is the culmination of almost 20 years of research involving investigators, academic and medical institutions, funding agencies and nearly 20,000 trial participants around the world, and Gilead is proud to have been a partner in this effort,” said Norbert Bischofberger, Executive Vice President, Research and Development and Chief Scientific Officer, Gilead Sciences.

Dr. Robert Grant, the lead investigator of the iPrEx trial at the University of California San Francisco who looked at Truvada as a prevention treatment among high-risk men who have sex with men (MSM), says the approval is a major milestone in the 30-year fight against AIDS. “The use of PrEP alongside routine HIV testing gives us a tremendous opportunity to reduce the rate of new HIV infections in this country and around the world.”

At the University of Washington another PrEP study proved very successful in reducing infection rates in couples where one partner is infected and the other is not (called serodiscordant).

“The data clearly demonstrate that Truvada as pre-exposure prophylaxis is effective at reducing the risk of HIV infection acquired through sexual exposure,” said Dr. Connie Celum, Professor of Global Health and Medicine at the University of Washington and lead investigator of the Partners PrEP trial. “It is exciting to consider the potential impact of this new HIV prevention tool, which could contribute to significantly reducing new HIV infections as part of a combination HIV prevention strategy.  Although the implementation of PrEP will bring challenges, they can be anticipated and systems developed to address these challenges."

But the AIDS Healthcare Foundation, the nation's largest HIV/AIDS group, blasted the FDA's decision. “From the beginning, we believe there was a rush to judgment by government officials and others in favor of such approval despite decidedly mixed studies offered in support."


soundoff (179 Responses)
  1. ManTex

    Perhaps they should use large doses of salt peter

    July 16, 2012 at 21:54 | Report abuse | Reply
    • Fozzyspeak

      And in your case a lobotomy?

      July 17, 2012 at 03:37 | Report abuse |
    • Dr. Bob

      I disagree. The only clear solution to a malady like this is a course of leeches.

      July 17, 2012 at 14:31 | Report abuse |
  2. Seeriously?

    We are wasting money on HIV drugs when this money could be funneled to cancer, parkinsons disease, etc.? How much of my tax money is going research how to keep gays from infecting one another? PATHETIC!!!

    July 16, 2012 at 22:07 | Report abuse | Reply
    • RetiredMD

      Not all gays have AIDS and not all AIDS patients are gay. My God, where did you get your education?

      July 16, 2012 at 22:13 | Report abuse |
    • ridiculous

      Gays, straight, it doesn't matter. Use CONDOMS.

      July 16, 2012 at 22:16 | Report abuse |
    • Observer

      Seeriously,

      You think AIDS is just spread between gays?

      Wow! Spend time doing some research so you'll know much better next time.

      July 16, 2012 at 22:18 | Report abuse |
    • ridiculous

      Actually, observer, most cases in the US are still between men who have sex with men (of course there are other means of spread, but MSM is still most common).

      July 16, 2012 at 22:24 | Report abuse |
    • Vacate

      Why would you want to spend your tax dollars on research to keep gays from getting cancer or parkinsons? Why be picky, why not just advocate to shut down all medical research? Just in case someone you don't like might benefit, gives them less of a fighting chance.

      July 16, 2012 at 22:27 | Report abuse |
    • Nitrogen

      You sound like the kind of person that would say, "Why are we spending this money on space exploration? We could be using it to help sick people!" Now it's gone back another step. Why help one group of sick people when you can help another? Why help sick people when you can fund churches??? Spread the word of god and all will be well. lol

      July 16, 2012 at 22:29 | Report abuse |
    • Sifleut

      You're a fine example of ignorance.

      July 16, 2012 at 22:35 | Report abuse |
    • Sam

      If you knew someone with HIV then I highly doubt you would've left a selfish comment like that. I was diagnosed with Leukemia last year and have 2 years of chemo left. What makes you think one disease deserves more attention than the other? You make yourself look really low with a comment like that.

      July 16, 2012 at 22:52 | Report abuse |
    • usinglogic

      Worldwide it is actually much more prevalent among heterosexual individuals...so your initial statement is just ignorant.

      July 16, 2012 at 23:25 | Report abuse |
    • Ram

      If you educate yourself, you will find out that a straight man carried it first.. Then that would be calling the whole population of Africa gay

      July 17, 2012 at 00:11 | Report abuse |
    • bittermen

      WHAT IS YOUR MAJOR MALFUNCTION?

      ARE YOU MENTALLY DEFICIENT?

      July 17, 2012 at 01:00 | Report abuse |
    • sandra perez

      I was raped in guatemala for a straight man infected, without the pills I wouldnt be alive! read the facts lady, maybe you are the reason why Cancer exists

      July 17, 2012 at 01:16 | Report abuse |
    • Adam B

      The nice thing about there being six billion people on Earth is that of these six billion people, there can be a fairly large number of scientists. Many of these scientists go into a variety of different fields. Of the ones that go into medicine, a large number of them go into medical research. Of those that do, many go into varying specialties.

      I guess the point I'm trying to make is that medical research shouldn't be viewed as a zero-sum game. Just because some researchers work with HIV treatments, others deal with neurological disorders. Still others are oncologists or immunologists.

      So fear not. In a world of six billion people, many will not be working on something that will never personally benefit you directly. It's just something you'll have to live with.

      July 17, 2012 at 01:19 | Report abuse |
    • Patriotic leftist

      I have been paying taxes to the state and fed 37 years an I have to wonder how much of MY taxes have been wasted on educating ignorant people like yourself? Or used to pay for public services to pave the roads you drive on... Or to put out fires started by your inbred families... Or to treat your illnesses in the ER that you won't end up paying for because you won't get health insurance or can't get a job because you didn't pay attention in school that my tax dollars paid for?

      If we could pick and choose what our taxes are used for... The wouldn't go to you.

      July 17, 2012 at 10:30 | Report abuse |
    • qwedie

      This money could be spent on bullets and bombs.

      July 17, 2012 at 10:42 | Report abuse |
    • MomofTeens

      Tell that to Elizabeth Glaser and her daughter.

      July 17, 2012 at 15:04 | Report abuse |
    • jw

      wow, seeriously......you seem like an angry person. why are you so hurt? to make such a mean spirited comment like that , you are resentful of someone or something in your past. I hope you are able to heal and enjoy your life more.

      July 17, 2012 at 16:40 | Report abuse |
    • nik

      How amazingly ignorant and bigotous of you. HIV doesn't only affect gay people and it's more easily acquired than cancer and parkinsons and the rest of the nonsense that came vomiting out of your keyboard. HIV is a far greater danger, to say the least. You are obviously letting your judgemental hatred (probably fueled by religion, if statistics have anything to say) cloud your judgement. Perhaps if you educated yourself on the matter, you wouldn't make such unbelievably stupid statements in the future.

      July 17, 2012 at 18:04 | Report abuse |
    • Patrick

      Who ever is not for this drug or any research completed to help the spread of HIV is clearly under educated about this disease. It's 2012 everyone, and if anyone thinks this is the last disease we will be fighting, you are truly mistaken. HIV has infected millions and NOT by being gay!

      July 18, 2012 at 05:28 | Report abuse |
    • Maggie McDuh

      Seriously how ignorant can you be? It helps the wives of men who are secretly bi-sexual, the babies of drug users, the car crash victims who got blood transfusions before science could detect HIV in it's early stages, and millions of other innocent people in low risk groups, even you and me. Why should it not help those who chose to indulge in high risk behavior too? Everyone should have a second chance.

      July 18, 2012 at 08:47 | Report abuse |
    • denny

      gays??? you are an idiot lol

      July 27, 2012 at 17:43 | Report abuse |
  3. ridiculous

    Wait.....they want insurance to spend billions on this so people can have unprotected sex? It's called CONDOMS people.

    July 16, 2012 at 22:14 | Report abuse | Reply
    • Mike

      Oh no you're using common sense...

      July 17, 2012 at 00:12 | Report abuse |
    • bigot

      sex is the only way HIV can be trasmitted? Thats news to me

      July 17, 2012 at 14:59 | Report abuse |
    • nik

      Just think... billions on HIV research is a waste yet you ignore all the free medical information on the internet (to say nothing of getting an education in the medical field) and instead choose to remain outspokenly ignorant. It's like you're holding a giant neon sign that says "The guy holding this sign is a moron."

      July 17, 2012 at 18:09 | Report abuse |
  4. Smart Potato

    Great news for science, terrible news for bigots.

    July 16, 2012 at 22:17 | Report abuse | Reply
  5. JS

    This would have been a mammoth FRONT PAGE story if it weren't for the travesty that our current Socialist Dictator has placed upon our nation.

    July 16, 2012 at 22:18 | Report abuse | Reply
    • Observer

      lol. Get serious.

      July 16, 2012 at 22:20 | Report abuse |
    • Smart Potato

      As opposed to the fascist one we had before?

      Get real, dude. Your taxes pay for plenty that you know nothing about, and that you benefit from; in fact, over 50 "socialist" programs from education to medical.

      If the Repugs can waste $58 million in advertising, it's obvious there is enough money to fix many issues in this country; they just are spoiled man-children who want their way and won't pay their fair tax share.

      July 16, 2012 at 22:23 | Report abuse |
    • Sifleut

      You're depressed, have a drink and stop watching Fox News.

      July 16, 2012 at 22:37 | Report abuse |
    • G. W. Bush

      Hey man, Obama is cool. I did all the damage. And I started A.I.D.S so this medication is needed to undo my sin...

      July 17, 2012 at 15:53 | Report abuse |
  6. SearchingForAnswers

    AND THEY STILL DID IT:
    "Most of the more than 40 health care professionals, AIDS advocates and patients who addressed the committee implored its members not to recommend the drug for the new indication"
    davidsyner "dot" blogspot "dot" com/2012/05/panel-recommends-approving-truvada-to.html

    July 16, 2012 at 22:32 | Report abuse | Reply
  7. Michael

    Does it work as good as keepitinyourpantsanol?

    July 16, 2012 at 22:35 | Report abuse | Reply
  8. Stimpy

    You don't need truvada to prevent AIDS.Just sit down and keep your mouth shut. But seriously folks, is this going to be sold over the counter or just by prescription. The latter won't work. It is the irresponsible people we need protection from, not the ones who are smart enough to get a prescription.

    July 16, 2012 at 22:39 | Report abuse | Reply
    • Fozzyspeak

      Can you take your own advice? Sit down and shut your mouth. Then no one needs to save you stupid.

      July 17, 2012 at 03:35 | Report abuse |
  9. Rick

    If someone, especially an iv user could afford the monthly cost of this drug then they would be in for a rude awakening that they will get a pittance on the black market. Also doctors can see if your taking it thru labs and if your not they can chose to stop giving the Rx. Besides, until the cure does come every tool to stop the further spreading is welcomed. As a 20+ yr. poz person I would want negatives to remain that way by using what's available. Thanx fda for getting your head out of the sand just in time for the world convention on hiv/ aids coming to our nations capital.

    July 17, 2012 at 03:32 | Report abuse | Reply
  10. Ibrahim americana

    If the drug is realy helpful as said, then we ve to give thnx to the Allmighty Allah 4 de knolledge granted 2 de scientists 2 discover dat drug..,cos we all ve been hoping n praying for a day lyk dis whn we ve a preventive mechanism 2 help reduce HIV spread in de world..may God help them...

    July 17, 2012 at 03:35 | Report abuse | Reply
    • nik

      If Allah is so powerful, why doesn't he just fix the problem? If Allah really exists, he is a malevolent god and not the god you sheep want think he is.

      July 17, 2012 at 18:15 | Report abuse |
  11. Court

    Great! Truvada for everyone. Let's just create resistant strains so that people who might actually need the drug may no longer benefit.

    July 17, 2012 at 03:46 | Report abuse | Reply
  12. Cure Crusader

    @ retiredmd what kind of doctor were you to say something so ridiculous? Did you specialize in treating dolls or did you together the Hippocratic oath that des take?
    Wow, and we wonder why after 30yrs of science we arestill seeing this pandemic continue to spread at an alarming rate especially among our young.
    Is this passing frought with poss setbacks, abuses and negative understanding about its usage? Yes
    Yet I remember when sat was the only drug avail and many died using it but many lived long enough to see more effective drugs become available also as a result of the risks and science to dealing with those risks and their effect tiveness

    July 17, 2012 at 03:56 | Report abuse | Reply
  13. katolungile

    Man "big pharma" is evil... Aren't they on Odumbo's hit list...

    July 17, 2012 at 04:00 | Report abuse | Reply
  14. katolungile

    I expect the gay population to explode now, since this disease was being used to keep their numbers under control.

    July 17, 2012 at 04:03 | Report abuse | Reply
    • tubezila

      Gay people can't reproduce with each other, you moron.

      July 17, 2012 at 12:27 | Report abuse |
    • jw

      katolungile, you just did yourself a very bad dis service by making such a statement. You will reap what you sow. Karma.

      July 17, 2012 at 16:45 | Report abuse |
  15. Me2!!!

    Sooo instead of promoting the use of condoms now we get the blue pill that cost how much??? So youll take the blue pill and all is good??? Hummm... Sounds more like a business than a cure/prevention drug... Just a thought …

    July 17, 2012 at 13:55 | Report abuse | Reply
    • nik

      sure, an ignorant incoherent one, but still a thought

      July 17, 2012 at 18:18 | Report abuse |
  16. tonyterror

    @NO Butt, No Needle, my message is definitely not angry at all. I am neither HIV positive, gay or a drug user. I am also not stupid enough to believe that gays and drug users are the only percent of the population being infected. Apparently the strategy that we have been using to stop the spread of the disease is NOT WORKING! If we continue to do the same things we will get the same results. Maybe time for a new strategy. And to your comment on being in fear of AIDS, I am niether in fear or at risk, but I am certain that the majority of the people infected were not in fear before it became a reality for them. GET TESTED RETARD.

    July 17, 2012 at 13:59 | Report abuse | Reply
    • nik

      You wouldn't be making statements like this if you knew the first thing about the disease or the drugs involved. The disease can incubate for a decade before showing up on tests, smart guy.

      July 17, 2012 at 18:19 | Report abuse |
  17. What?

    Why are uninfected people willingly sleeping with those infected with HIV and/or Aids when there is no cure? That is as dumb as playing Russian roulette.

    July 17, 2012 at 15:32 | Report abuse | Reply
    • nik

      You assume that everyone knows that they are infected. You also assume that humans only make rational decisions. After all, the game Russian Roulette actually WAS invented and played and people STILL pray to invisible gods in the sky.

      July 17, 2012 at 18:20 | Report abuse |
    • Maggie McDuh

      Where is your compassion? Those who are brave enough to stay with those they love after they find out they're HIV positive have my utmost respect. Sometimes being unselfish takes courage. Whatever your definition of "for better, for worse, in sickness and in health" is I'm sure it isn't the traditional one and I'm glad I'm not one of your 'loved' ones.

      July 18, 2012 at 09:16 | Report abuse |
  18. Wow...

    Did anyone hear the CNN newsbroadcast of this yesterday, where the female anchor mentioned the FDA approval of this drug is a great move forward for preventative health especially for gay men?!?! What year are we living in....

    July 17, 2012 at 16:34 | Report abuse | Reply
  19. Chipemba Kambwili

    Wonderful Outcome! Looking forward to how much more the committmnet can unravel.

    July 18, 2012 at 15:33 | Report abuse | Reply
  20. Chipemba Kambwili

    *Wonderful Outcome! Looking forward to how much more the commitment can unravel.

    July 18, 2012 at 15:34 | Report abuse | Reply
  21. Jack J Prof

    10 years from now, are we going to bemoan the fact that, this alternative use of an extremely effective anti-viral drug (Truvada in combination to maintain undetectable levels of the virus in HIV infected individuals) will result in Truvada resistant strains of the virus?

    The singular use of Truvada as prophylaxis against infection in a population that does not have the dedication to the daily regimen required could set up just such a scenario.

    What if the individual should become infected without realizing it? This would actually increase the likelihood of the virus developing resistance, since the second drug (necessary to keep the infection in check) would not be present in the regimen. Truvada is not sufficiently effective as a singular treatment in an infected individual.

    Good intentions often have less than desired consequences.

    July 20, 2012 at 01:52 | Report abuse | Reply
  22. willK

    Democracy Now! is doing an in-depth hour long episode on global HIV/AIDS. They are covering not only the International AIDS conference in DC, but also an alternative conference in Calcutta, India for sex workers and others who could not get into the US due to a travel ban. Watch now at democracynow.org

    July 25, 2012 at 08:25 | Report abuse | Reply
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