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FDA Approves Truvada Which Claims to Reduce Risk of HIV Infection: VIDEO

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The FDA today approved  Gilead Sciences' pill Truvada as a preventive measure for people who are at high risk of acquiring HIV through sexual activity, the AP reports:

TruvadaPublic 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 past 15 years.

An estimated 1.2 million Americans have HIV, which develops into AIDS unless treated with antiviral drugs. An estimated 240,000 HIV carriers remain unaware of their status.

Gilead Sciences has marketed Truvada, which can cost up to $14,000 a year, since 2004 as a treatment for people who are already infected with the virus.

Writes the FDA in a press release:

As part of PrEP, HIV-uninfected individuals who are at high risk will need to take Truvada daily to lower their chances of becoming infected with HIV should they be exposed to the virus. Again, PrEP indication means Truvada is approved for use as part of a comprehensive HIV prevention strategy that includes other prevention methods, such as safe sex practices, risk reduction counseling, and regular HIV testing.

As a part of this action, FDA is strengthening Truvada's Boxed Warning to alert health care professionals and uninfected individuals that Truvada for PrEP must only be used by individuals who are confirmed to be HIV-negative prior to prescribing the drug and at least every three months during use to reduce the risk of development of resistant HIV-1 variants. The drug is contraindicated for PrEP in individuals with unknown or positive HIV status.

Watch Dr. Anthony Fauci of the National Institute of Allergies and Infectious Diseases discuss the drug with PBS Newshour's Ray Suarez, AFTER THE JUMP...

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Comments

  1. Funny, they used to find cures for diseases. I guess that wasn't profitable. Now they find expensive drugs you can take forever, and they have lots of side effects, and you will make the drug companies rich because if you don't take them, you are likely to die.

    Posted by: quality | Jul 16, 2012 8:09:20 PM


  2. @Quality A little overly cynical there, I think. The pharma company that comes up with a cure for AIDS will make a mother-lode off of it, so they have every incentive to keep trying to find a cure (or a vaccine).

    As for this drug, I cannot imagine shelling out $15,000 a year and putting a chemical substance into my body every single day when there are other ways to avoid HIV-infection. But I guess some will think it is worth it.

    Posted by: Rick | Jul 16, 2012 8:20:05 PM


  3. I'm with Rick on this one

    Posted by: GeorgeM | Jul 16, 2012 8:40:13 PM


  4. Nah, Quality is right on this one.

    You make a "mother-lode" precisely one time when you find the cure. A perpetuity is much more sustainable from the corporate POV.

    And don't forget, where there's symptoms from bad medicine, there's always bad medicine to treat them.

    Posted by: neptune | Jul 16, 2012 8:51:29 PM


  5. I don't think you'd have to pay $15k/annually for this drug. That's the cost of it, but insurance will likely cover a portion of this just like they do for other medications that cost a lot more than your co-pay.

    Posted by: gabriel | Jul 16, 2012 9:00:57 PM


  6. @Rick and Georgem,
    I'm with Quality on this. Pharmaceutical patents last 20 years giving Gilead Sciences little incentive to work on something better until they are reaching the end of patent protection and a cheaper generic form is available. The academic community or a public health research facility is a more likely place where a cure or vaccine will be developed.

    When it comes to big pharmaceutical companies, it's no longer surprising when new treatments come out "coincidentally" as patents expire, but real solutions never seem materialize from these companies.

    Posted by: Garst | Jul 16, 2012 9:07:33 PM


  7. @ Quality is spot on, however, it's not just the profitability of the treatments, but the billions of dollars in funding for research. This isn't just AIDS. It's cancer, diabetes, and any number of such illnesses. Rick, calls Quality cynical, I call Rick naive if he believes for one instant that Pharma has any interest other than profit. If they did, they would release patents on these meds, to allow for affordable generic versions to be made available. They haven't, other than for Africa, and then only under intense international pressure.

    Posted by: Kenneth | Jul 16, 2012 9:09:12 PM


  8. 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"

    http://davidsyner.blogspot.com/2012/05/panel-recommends-approving-truvada-to.html

    Posted by: SearchingForAnswers | Jul 16, 2012 9:14:35 PM


  9. I agree with Rick. From a risk reduction standpoint, we still don't know what the long term effects an HIV negative person will have taking the drug. The approval's value may be in the drug's use in other types of trials that could lead to some other breakthrough.

    Posted by: AngelaChanning | Jul 16, 2012 9:29:22 PM


  10. @Quality: They didn't find a new drug, they just proved that a drug used for treatment can also work for prevention in high-risk MSM. It's a great thing.

    Posted by: AT | Jul 16, 2012 9:36:37 PM


  11. Has Fauci disclosed his financial interest in this recommendation? This jerk has never acted selflessly about HIV or anything as far as I know.

    Posted by: me2 | Jul 16, 2012 9:38:45 PM


  12. Question: how are men who are inconsistent about putting a condom on going to be consistent about taking a medication like this daily?

    Posted by: mike128 | Jul 16, 2012 9:40:31 PM


  13. @SEARCHINGFORANSWERS: the people who were advocating against it were almost all nurses from Florida who were sent to the FDA hearings by the AIDS Healthcare Foundation, an organization that has been strongly against PrEP from the beginning. I watched their testimony online (I'm a public health professional, I nerd out about these things) and they were not scientific, they only gave anecdotes about this patient or that patient. This is not a solution for everyone, but it could have a major impact on high-risk indiviudals taking it, their partners, serodiscordant couples (one HIV+, one HIV-), and the epidemic in general by reducing transmission in the most at risk, and thus reducing the risk to everyone.

    Posted by: AT | Jul 16, 2012 9:43:23 PM


  14. TRUVADA is another drug pushed through FDA for widespread release. It can be used as a way to give a false negative on a test for HIV, leading some ppl to be unaware they are HIV +. There are numerous side effects and the long term effects of use have yet to be fully recognized. I also question the release of it at this time, I need to look into it farther but TRUVADA is 8 years into its patent life that expires after 12 years. i suspect that an extension for the patent will be requested by Gilead based on the new market they now have. Baring that it will aggressively marketed to the queer community as a way for them to embrace Barebacking again, take more risks with their sexual health and as a way to not be scared of HIV anymore. It is a treatment not a cure.

    Posted by: Thrutch | Jul 16, 2012 9:44:17 PM


  15. So you use it and then feel more comfortable having unsafe sex? Kind of stupid. Keep working scientists.

    Posted by: cjt | Jul 16, 2012 9:47:10 PM


  16. "Funny, they used to find cures for diseases."


    Do you have any idea on how difficult it is to develop an anti-viral? Do you have any idea on how difficult it is to develop an effective anti-viral treatment once the virus enters the host's cells? Do you have any idea how pernicious, how resilient viruses are, and what scientists grapple with?


    Posted by: Nat | Jul 16, 2012 9:51:59 PM


  17. "When it comes to big pharmaceutical companies, it's no longer surprising when new treatments come out "coincidentally" as patents expire, but real solutions never seem materialize from these companies."

    Why would it be surprising?

    It normally decades of research and development to produce a pharmaceutical product. It takes all of five minutes of searching to find out what treatments are emerging from each company.

    Posted by: Nat | Jul 16, 2012 9:54:51 PM


  18. "Funny, they used to find cures for diseases."

    Very few diseases are actually cured. Influenza, which has resulted in far worse pandemics than HIV, is not cured. Medical science has managed to vaccinate one disease out of existence.

    Most diseases are still in the same stage that HIV is - ways of treating it, reducing its symptoms and delaying or halting progression, but the disease itself remains a real and viable risk.

    Posted by: We are Here | Jul 16, 2012 10:00:46 PM


  19. I wish Quality was right, but the money will stop eventually if a cure is found… most people one on one have good intentions; however large sterile corporations tend to create an environment where fear and greed rule out over the public welfare.

    Posted by: Mike | Jul 16, 2012 10:31:14 PM


  20. As a health care provider, I'm very excited about Truvada being approved for PrEP - this medication is intended to be used in high risk individuals who regularly do not use condoms. It's not a perfect solution, but if it prevents just one infection in 100 - it's worth it.
    And someone could change behavior over time, and then stop using the medication. Other medications are being tested now for this same purpose, so there will be other options besides Truvada.
    And I know of no one working in HIV who thinks this is a bad idea. Not when I'm getting 2 - 3 newly diagnosed HIV+ patients per week.

    Posted by: Borborygmy | Jul 16, 2012 10:33:28 PM


  21. This "treatment" as a form of prevention seems utterly bizarre when a condom and a little common sense can be had at a fraction of the cost, sans any reactions/side effects from a drug with plenty of them.

    Doubly so since this would be no vaccination against the disease or panacea to the problem; people who take this drug but still engage in risky (ie condom-less) behavior can and will still be able to get HIV.

    Moreover, while I agree with others here that the likelihood of someone who doesn't 'religiously' practice the use of condoms with new partners suddenly taking a pill everyday is astronomically slim, it should be noted that there are going to be some people out there who will absolutely do that.

    I wonder about the risk that, once they take this medication, medication that could very well (and probably will) make them sick, that they're going to wonder to themselves, "gee? do I really need to use this condom? I'm on this medication and it even makes me sick, so it must be working, can't I just forget it this one time?" and thus be more likely to engage in risky behavior, totally off-setting the use of the medication as a preventative tool to begin with. The likelihood of that happening in the slim population in which this medication could be useful seems relatively high, making it a very expensive waste.

    Quite frankly, it's amazing that bizarre 'methods of prevention' like this are being pushed to prevent HIV in this day and age. It's like it's 1912 and not 2002; that's how backward some of the medical "ideas" are about this. What's next, telling people in Africa that the cure to the spread of HIV is cutting off a part of their dicks? (Oh, wait, that's already happening.)

    We're about a few crackpot doctors away from someone suggesting blood letting or leeches -- and mainstream medical science taking them seriously.

    We need free condoms everywhere and education and marketing to get people to use them. We need free HIV tests everywhere and marketing and education to get people to take them regularly, especially if they've had new partners lately and even more so if they did so without a condom or a condom broke.

    We need to remove the shame placed on taking these tests or taking those free condoms. If anything, doing so should be a public display of pride demonstrating how well people are at 'getting some.' :p

    All of that can be had with few, if any, real side effects. All of that can be had at a tiny fraction of the cost of this medication and be much more effective in preventing the spread of the disease.

    If 1 person takes this medication for 1 month, it would pay for 14,000 (or more) free condoms -- something that will be infinitely better at preventing the disease. So, yeah, if this money is going to be spent, it seems like it would be an *opportunity cost* to spend it on the drug instead of condoms and tests.

    This is not rocket science, but it is good medicine... and shame on anyone who tries to convince anyone otherwise.

    Posted by: Ryan | Jul 16, 2012 10:34:56 PM


  22. I have taken Truvada, and it gave me full body hives. It is just toxic.

    Posted by: ChristopherM | Jul 16, 2012 10:35:44 PM


  23. Garst
    I meant I will continue other options to protect myself

    Posted by: GeorgeM | Jul 16, 2012 10:41:26 PM


  24. if any, real side effects. All of that can be had at a tiny fraction of the cost of this medication and be much more effective in preventing the spread of the disease.

    Posted by: Winona Ng | Jul 17, 2012 6:39:45 AM


  25. I find amazing, that according to Business Week in 2010 this drug was selling for less than $ 500 for a years treatment in Africa. Shame!

    Posted by: Rob from cincinnati | Jul 17, 2012 6:49:12 AM


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