FDA One Step Closer To Approving First Drug For HIV Prevention

The battle against AIDS continues, with a favorable review by the Food and Drug Administration of a pill that has been used to treat HIV. The hope is that the pill could be used to prevent people from contracting the virus that causes AIDS.

The FDA said that Truvada appears to be safe and effective for HIV prevention, concluding that taking the pill daily could spare patients “infection with a serious and life-threatening illness that requires lifelong treatment,” reports the Associated Press (via MSNBC).

Tomorrow, a panel of FDA advisers will consider the review when it votes as to whether or not Truvada should be approved as a preventative treatment for anyone at a high risk of getting HIV through sex. The FDA doesn’t have to do what the panel says, but it usually does for the most part.

Needless to say, if Truvada is approved for this use, it’ll have a huge impact on the campaign against the AIDS epidemic. There are no other drugs out there proven to prevent HIV, and a vaccine is still decades away. Truvada has been used since 2004 as a treatment for those already infected with HIV.

If it’s to be used as a preventative measure, the FDA reviewers say Truvada must be taken diligently every day.

“We know that if the person doesn’t take the medication every day they will not be protected,” said Dr. Rodney Wright, director of HIV programs at Montefiore Medical Center in New York and chairman of the AIDS Health Foundation. “So the concern is that there may not be adequate adherence to provide protection in the general population.”

While patient advocacy groups seem to be in favor of its approval, on the down side, Truvada would cost about $900 a month, which works out to around $11,000 per year. Since Medicare and Medicaid generally cover drugs approved by the FDA, they and other insurers might come out against the drug’s approval.

*Thanks for the tip, Matt!

FDA review favors first drug for HIV prevention [Associated Press via MSNBC]

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  1. dwtomek says:

    Thanks, but at that price I think I’ll stick to jimmy caps.

    • Captain Spock says:

      At that price, this will do nothing to prevent the spread of HIV

      Now at 10 dollars a month, spread around amongst enough people we could have an HIV free world at some point.

      • SecretShopper: pours out a lil' liquor for the homies Wasp & Otter says:

        unfortunately I think at that price there’s not enough money in it to be worth the drug co’s time

      • wickedpixel says:

        Agreed. Would love to see a reasonable price and some kind of Truvada/birth control hybrid pill, since many women already take that daily.

  2. FatLynn says:

    I predict this decision won’t be politicized at all!

  3. Torgonius wants an edit button says:

    11k a year to keep someone from getting full-blown AIDS for X years, vs how much per year to treat someone with AIDS for (X-Y) years?

    • SecretShopper: pours out a lil' liquor for the homies Wasp & Otter says:

      Ask Magic

      • Captain Spock says:

        That’s a good point, athletes can afford it!

        Then again, an athlete stupid enough to not use a condom, is probably just as stupid when it came to something like this.

        • SecretShopper: pours out a lil' liquor for the homies Wasp & Otter says:

          well since it’s apparently like “The Pill” in that you have to take it everyday to be effective, I could definitely see some jackass not using it correctly and rendering it pointless

      • cowboyesfan says:

        Magic has had AIDS for 20 years.

    • AustinTXProgrammer says:

      And not having unsafe sex would do the same thing for a whole lot less. And at $11k/year people not engaging in that behavior wouldn’t be taking it so it provides no protection against the other modes of infection.

  4. Cat says:

    “Since Medicare and Medicaid generally cover drugs approved by the FDA…”

    I WILL come out against the drug’s approval if I have to pay $11,000 per year for every bottom dwelling crack ho to get free Truvada.

    • FatLynn says:

      So who do you think should be allowed to have it?

      I imagine that no doctor in his right mind would bother prescribing it to someone who won’t take it on a daily basis.

      • AustinTXProgrammer says:

        People who can pay for it themselves. Again, we aren’t talking about treating people with HIV but treating people so they can maintain their same risky behavior without getting it.

        • FatLynn says:

          What about people who work with high-risk populations and fear needle sticks? What about people in committed relationships with HIV+ partners?

          • Captain Spock says:

            I hadn’t considered that… That would actually be a really good use for it.

          • Awesome McAwesomeness says:

            They can make the choice not to work in those jobs or not to be in a relationship with and HIV infected partner.

            • Awesome McAwesomeness says:

              And, I know that if you get a needle stick, they have a prophylactic protocol that can help greatly reduce your chances of contracting HIV. Much cheaper than an $11,000 a year drug.

            • Such an Interesting Monster says:

              Wow. You’re an ass.

        • Such an Interesting Monster says:

          So if you’re in a committed relationship with someone who is HIV+ and you’re not, you’re just not supposed to ever have sex? Cause every time you do it’s “risky behavior”.

          And before you pull out (see what I did there?) the “wear a condom” snark, condoms break. And I imagine it can’t be too pleasurable trying to be intimate if you’re constantly worried about becoming infected.

          Drugs like this will also be a boon for those whose job puts them at risk of HIV infection — EMTs and healthcare workers to name a few. Oh yeah, right, they should just wear condoms too I guess.

  5. kingofmars says:

    It’s great that it’s getting approved and that it might prevent the spread of HIV, but I can’t imagine who would use it in it’s current form. People who with high risk of infection, but also will spend thousands of dollars to prevent it? Sex workers and porn stars are the only ones that come to mind. Maybe if porn studios and brothels cover the cost while those people are working for them?

    • Hi_Hello says:

      i think porn stars has less chance of getting it than the average person who sleeps around.

      They are require to get tested. I remember reading the news when they found out one porn star tested positive for HIV. Production stopped to make sure everyone else was okay.

      Sex worker…yea. The legal one are safe…too bad it isn’t legal everywhere. I think there’s a lot of background check that need to be done before you can be a client. I might be wrong.

      • kingofmars says:

        I forgot to include hospital workers in my list.

        Pornstars are required to be tested regularly, but that doesn’t prevent them from getting HIV. The case you are talking about the pornstar contracted HIV from some method outside of porn, there is speculation that it was needles or unprotected sex. If I remember correctly there was a least another actor that contracted HIV though that initial person.

        The testing and record keeping helped prevent it from spreading further. This drug could have prevented it from spreading at all.

        • Hi_Hello says:

          i just wanted to point out that they weren’t high risked.

          hospital worker dealing with aids are good group. I heard this nurse got stab with a needle from an HIV patient. She had to go for treatment for 1 year just to lower her chance of getting it.
          Lost her job because of it.

          they probably should just pump the drug into the water supply of Africa.

    • FatLynn says:

      People in committed relationships with a positive partner.

      • kingofmars says:

        Good point, that’s another one I missed. So hospital workers, sex workers, and partners of people with HIV. Are there any others I missed? Aid workers in countries with high infection? Maybe soldiers? Or perhaps people who may have surgery or have recently had surgery and might require a blood transfusion?

    • hmburgers says:

      In addition to people at higher risks due to occupation–nurses, porn stars, prostitutes, etc…

      I think every sexually active person in a non-monogamous relationship is a potential candidate as long as they can get it covered by insurance or keep the costs low.

      It could be like birth control… millions upon millions of woman are on that for a decade+ of their lives.

    • rmorin says:

      Men who have sex with men (MSM) are considered very high risk for HIV infection.

      If you are a MSM this would be practical as so long as it is economically feasible.

      If you think birth control controversy is bad, get ready for that one!

  6. Hi_Hello says:

    I think the HIV is crazy in it’s design. If it was man-made, it has to be a fluke. If it wasn’t a fluke, whoever created is a genius. Maybe evil mad scientist.

    I feel bad for those who got it because of hospital not knowing any better.

    There are three main way the majority of people have HIV.
    1) it sucks for the baby who is born with it because of the mom.

    2) those who share needles… screw them. chances are they are going to die soon any way.

    3) those who have unprotected sex. While I like to say those are who stupid deserved it.. I don’t think stupidity should be a reason people should die… It seems like the majority of people who have unprotected sex and got HIV just doesn’t know better. The rest who knows but don’t care because they don’t think they will get it, screw them.

    I think money should be better spend educating people then trying to cure them.

    There might not be a way to cure HIV but preventing it isn’t that hard.

    • dchs says:

      While I like to say those are who stupid deserved it.. I don’t think stupidity should be a reason people should die…

      Umm yes they should. That’s what Darwin would say. Survival of the fittest. Being dumb means you are not the fittest

      • Bsamm09 says:

        Just an FYI — Darwin didn’t coin the term “survival of the fittest”, Herbert Spencer did after reading his book. Spencer wrote some controversial books too.

    • hmburgers says:

      Accidental needle sticks…

      People in monogamous relationships who have a partner who cheats or lies…

      People who are raped…

      People who have a condom break…

      People who don’t have the condom break, but still get it (it’s not 100% effective)…

      There are a lot of ways for a person to get HIV, you don’t have to be drug user or a moron to get it.

    • JJFIII says:

      Most people who die in car wrecks were from doing something stupid. Those who have lung cancer are mostly those who did something stupid. Those who have heart attacks are usually those who eat like slobs, so they are stupid. I guess we should stop paying for helping people who do stupid things.

    • Clyde Barrow says:

      If it was man-made? Really? Do you want too much science-fiction?

  7. magnetic says:

    Is there really a good reason the drug costs so much? I’ll bet it wold be worth several years’ use of the drug just to see how it plays out in the population until it goes generic. By then we can probably make an informed decision as to whether it’s worth the cost and trouble.

    • nbs2 says:

      Short of a cancer vaccine, a way to prevent the spread of HIV/AIDS has been viewed as the Holy Grail of drugs. While significant sums of public money have been spent on developing this, I suspect that private fund outstrip them. The company has every right to try and recover its R&D costs – otherwise we’ll spend the rest of our lives complaining about how many different drugs there are for ED.

      • Patriot says:

        The holy grail has already been achieved. You can prevent 99% of HIV cases by only having sexual intercourse after you’re married with someone else who’s waited until marriage AND by avoiding the sharing of needles. The remaining 1% will cover the rare blood transfusion acquired HIV and the accidental infection of healthcare workers. It really shows how messed up our priorities are in the US that this easily preventable disease has so much money thrown at it that could instead goto breast cancer or alzheimers.

    • Applekid ┬──┬ ノ( ã‚œ-゜ノ) says:

      Certainly not the most expensive drug I’ve heard of. Remicade costs about $20,000 a year. At least that one has the benefit of having to being expensive because it’s an Honest-to-God Holy-Shit Son-of-a-Bitch I-Can’t-Believe-Humans-Made-This artificial antibody that has to be grown in a lab with mice.

      I’m curious how this stuff is made.

  8. Marlin says:

    Problem is this only protects against HIV, not fully stops HIV let alone other STDs.

    So I can see some taking this and thinking they can do as they please and not worry and end up with other STDs and/or HIV as well.

  9. SkokieGuy says:

    How many people are even aware that AIDS can be cured?

    Discovered accidentally via bone marrow transplant of stem cells in Germany, (treating a leukemia patient). Yes it’s risky and difficult, but you’d think this might get more media attention, huh?

    http://www.popsci.com/scitech/article/2008-11/cure-aids

    • stopNgoBeau says:

      The problem is that bone marrow transplant is extremely expensive, and you’d have to find a bone marrow donor (difficult) that matches (even more difficult) who has the very rare trait of having DNA that makes the donor immune to HIV (extremely difficult).

    • Sound Money Girl says:

      I read about this in Discover recently. However, it was only one person who was cured, and that was by accident during treatment for leukemia. The treatment is expensive, aggressive, and risky. It provides a good lead for researchers looking for a more generally applicable cure, but I would hardly consider the treatment a cure by itself.

    • Round-Eye 外人はコンスマリッストが好きです。 says:

      Also, there’s a very unique set of factors at play when an accidental discovery is made. As a gay dude, I’d love for this to be applicable across the board, but accidental discoveries are just that, accidental. Lots more testing with many other control settings need to be done first. But I’m glad this is a first step.

  10. Sir Winston Thriller says:

    My husband was on Truvada for four days. He developed a raging red rash and lost all feeling and control on the left side of his body and had to be taken to the ER. He recovered. Gilead was no help at all. And we were out over $900 for the prescription he couldn’t use as well as almost $3000 for the ER visit.

    • Applekid ┬──┬ ノ( ã‚œ-゜ノ) says:

      I can see the commercial.

      A couple walking slowly along the bank of a lake, hand in hand.
      Slow Female Announcer Voice: “The first drug proven to stop the spread of HIV.”
      Fast Male Announcer Voice: “side effects include rash, flu like symptoms, hair loss, discoloration of the genitals, tremors, rabies, exploding testicles, spontaneous combustion, alien abduction, eyeballs falling out of their sockets, rivers running red with the blood of the infidel, poltergeists, and diarrhea.”

  11. jojo319 says:

    Knowing the FDA, “One Step Closer” means another decade.

  12. consumed says:

    These treatments are worse than the disease. I know a few people on HAART HIV drugs and they get all these weird side effects. In a few years these people will be on another cocktail to counteract or reverse the damaging effects of the HAART. It is a never ending cycle. Once you start taking these pills you are locked in the pharmacycle for life. It is a lifelong commitment. Going off the drugs will make you get more sick than if you never started taking them in the first place.

    The real reason they want to push this drug out is $$$$. They don’t want to cure the virus. They want to keep everyone sick. Welcome to America land of the corporates and home of the medical pharma industrial complex.

    • failurate says:

      Right now we are trying to find balance in our three part Complex combo; Military Industrial Complex, Housing Gambling Credit Bank Fraud Complex, and the Health Care Pharma Industrial Complex.
      With the wars winding down and the trouble we are having kicking up a new enemy to fight, it looks like Health Care Pharma Industrial Complex will have to pick up some of Military Industrial Compex’s slack.

  13. Important Business Man (Formerly Will Print T-shirts For Food) says:

    I just used control+F to look for the “gay” and “homo” comments, and alas, there are none! Thank you all for finally realizing that HIV/AIDS is not only for us homos. I love you too

    • Applekid ┬──┬ ノ( ã‚œ-゜ノ) says:

      What a gay comment. B)

      I was holding out for a Blame the OP on this one. “It’s their fault they got the HIV in the first place!”

  14. gman863 says:

    Truvada would cost about $900 a month, which works out to around $11,000 per year.

    Correction: Truvada would cost about $900 a month, which works out to around $11,000 per year.in the United States.

    Countries with nationalized health care (Canada, UK) would beat the drug maker down to half that price – and, in Africa, the stuff would damn near be given away.

    Although I don’t have HIV, I am sick and tired of getting raped on prescriptions. American customers and health insurance companies should NOT have to pay more for an identical drug.

    If the Africans want free HIV drugs, great – let billionaires like Bono or Bill Gates subsidize the cost, not American customers.

    • jojo319 says:

      You do realize that you (we) pay more precisely because other countries have caps on pricing, right? If other countries split the bill, we wouldn’t have to pay more. But since countries like Canada FORBID drug companies from charging over a certain dollar amount, they are forced to sell it sometimes at a loss. They can’t just say “we won’t sell you the medicine”, because then they would get hammered for “denying” sick people medicine. I’m not defending the drug companies, but we’re getting screwed more by the other countries wanting to piggyback on our near monopoly on drug development. They reap all of the same benefits and share in almost none of the same costs. you should be angry at those countries, not “envy” them.

      • failurate says:

        I agree, we need the same caps.

      • gman863 says:

        Due to lobbyists and the tens of millions drug companies give to political campaigns and PACs, drug pricing is the 10 Billion Dollar Elephant in health care reform Washington chooses to ignore.

        Although Tea Party members would screamSocialismsm”, I see nothing wrong with enacting a law that states drug companies must sell their products at a price not exceeding the average selling price in Canada and the EU.

  15. dicobalt says:

    $900/month! Southpark was right, injecting cash directly into your bloodstream is a cure for AIDS.

  16. simplekismet says:

    As a pharmacist, I anticipate that Truvada will gecome approved for this indication, but getting insurance companies to pay will be difficult. They cover anti-retroviral therapy for the HIV-infected patient, but why cover it for the HIV-negative? I assume it will be considered similar to Viagra in this case. Besides sex workers, as someone pointed out, the scenario I find this making sense in is an HIV-negative person in a monogamous relationship with an HIV-positive person. Your spouse has HIV and you don’t – might be worth it for couples. There are definitely risks, including long term toxicities and development of resistance – adherence with these drugs has to be like 95%. Doesn’t leave much room for error.

    This is not, however, something that would be given to everyone or combined with birth control. I don’t see enough risk in the general public to justify the potential side effects and costs. It’s more effective to practice safe sex. Drugs can’t replace everything. But for some people who are still at an increased risk of acquiring HIV, this is a great breakthrough.

  17. hmburgers says:

    This is like a Big Pharma wet dream…

    It’s like having the only birth control pill on the market…

    All sexually active people who are in non-monogamous relationships (and even some that are) will want to be on this drug.

    That’s literally billions of potential users.

  18. Telekinesis123 says:

    So are people going to have to pay an arm and a leg for this, or has the billions donated to AIDS research gone to absolutely nothing.

    • damicatz says:

      “Taxpayers” (more like victims, IMHO) have their money stolen at gunpoint to pay for this research. The corporate pirates and their intellectual property shysters then turn around, patent that which was funded by “taxpayers” and then charge the “taxpayers” for using the invention that they paid for to begin with.

      It’s a wonderful racket.

  19. damicatz says:

    This is a perfect reason to eliminate all patents.

    No one has the moral or natural right to claim ownership over an idea and then use guns and violence to enforce a coercive monopoly over it. I reject any claims over “intangibles” like ideas as such “property” is fictitious and does not actually exist in real life.

    No one has the “right” to automatically derive revenue from their ideas; such things are frequently called “liberal entitlements” by faux conservative pro-business types who advocate eliminating things like welfare (and then turn around and want their patent entitlements).

    The only right here that exists is the right to sell a product on the free market without interference provided their product does not harm people or pose an undue risk on the general public. The only legitimate means of restricting someone from using an idea is through voluntary contracts.

    Patents serve no purpose other than to inhibit progress and to enrich the pockets of “Intellectual Property” shysters who operate on a system of legalized extortion.

    • jojo319 says:

      so you would be in favor of eliminating all price caps imposed by most countries? Therefore sharing cost burdens across all countries, and not just the U.S.?

      • damicatz says:

        Yes.

        Government has no business setting prices. Eliminate patents and eliminate government regulation and the market will set prices.

        • jojo319 says:

          That would work for me. Except you will never get the rest of the freeloading countries to agree. There’s no incentive for them.

        • Plasmafox says:

          The market sets prices higher than most people can pay. So those people need insurance. But they can’t get insurance.

          This is what neocons actually believe a healthy, functional system looks like

        • JJFIII says:

          Eliminate regulation? So a drug company can just “test” their product on the public and buyer beware. So be it, if it kills a few million people, that is the cost of doing business. If they get sued and lose, they claim bankruptcy and shareholders can not be held personally liable. Yeah, the free market works really well NOT

    • Bsamm09 says:

      How are patents “liberal entitlements”? Who would ever spend money to develop stuff so that as soon as all their hard work pays off, someone buys product number 1 just so they can copy it and sell it?

      The first item ever produced would have to be sold at astronomical prices. If I couldn’t patent an invention, I would sell the first one for:

      All R&D costs + cost to produce #2 + PV of profit forecast over X years of production + i’m not sure what else as the risk is immense.

      It is risky enough bringing a new product to market now, even with patents. Contrary to your opinion, patents don’t guarantee revenue. There are many things that have been patented which never generate $1.

      • damicatz says:

        Competition drives innovation. Sure, you can choose not to innovate. But then your competitors will and they will be the ones making all the money. Patents are the antithesis of competition. They restrict it. So there is no motivation to continue innovating once you hold a patent.

        Inventors do not benefit from patents (though they may think so, they would be mistaken). Intellectual Property Shysters do. Look at the mobile phone “patent wars”. It’s ridiculous. No one is innovating anything and there is no progress; just a bunch of sore loser lawsuits from a bunch of different mobile phone companies that would rather sue than compete on the free market. And the shysters are laughing all the way to the bank with the billions they made from operating a legalized extortion racket.

        I can’t even release my own software in the US for fear that I will be shaken down by some intellectual property shyster for some ludicrous software patent. Since it costs $5 million on average and takes 5 years to litigate a patent case, the patent could be complete and utter nonsense and I would still be forced at gunpoint to pay them. So I simply chose instead not to release my software.

        People are now being sued for operating wireless networks because some shyster managed to acquire a backroom patent. People have settled with the shyster because it’s cheaper to pay $200 to make them go away than to hire a shyster of your own for millions. iPhone games developers are being sued because someone patented the concept of buying things from within an application and they can’t afford to fight it.

        There are entire companies (e.g Intellectual Vultures) whose sole “business” is buying up patents from bankrupt companies and then waiting for someone to unknowingly “infringe” upon one of the patents. These companies, invariable owned by an intellectual property shyster, contribute nothing, invent nothing and market no products. Intellectual property shysters are bottom-feeding scum suckers who leech off the work of the productive members of society for their own personal gain with a legalized extortion racket.

        • failurate says:

          I think the point was, without patents there is no reason to innovate.
          If you had a company and came up with something brilliant, all I would have to do is re-produce your same brilliant product, and I would be able to do it cheaper than you because I didn’t have to spend any money coming up with a brilliant new thing, because without patents, I don’t have to compensate you for your research or development.

          Now, I am not sure how this works with pharmaceutical companies, since so much medical research is subsidized by We The People.

          • damicatz says:

            The problem with this argument is that it makes fundamental assumptions that simply aren’t true.

            People innovate to outdo their competitor. If you do not innovate, your competitor will. There are also plenty of people who invent because they like inventing and discovering new things rather than simply for profit.

            The concept of the modern patent is only a few hundred years old. Plenty of people innovated before that.

        • Bsamm09 says:

          You think it’s bad with patents in place, tell me how you would sell your software if all patent laws were repealed tomorrow.

          • damicatz says:

            Easily.

            I would easily sell software if there were no patents. Software sold just fine for decades before the intellectual property shysters and corporate pirates bribed the governments to let them patent software.

      • Plasmafox says:

        They’re making an anti-AIDS drug. The possibility of defeating one of the most horrifying epidemics in history trumps their right to earn a profit on it. Especially when they intentionally made it a “take this every day for the rest of your life” drug. I DOUBT that was their only option. Not only is this specifically designed to make as much money as possible, but a medicine people have to take this often is likely to cause resistant strains to develop.

        I can already see the commercials. “YOUR CHILD WILL GET AIDS AND DIE IF YOU DON’T BUY THIS AND KEEP BUYING IT FOREVER OOGA BOOGA” and they’re guaranteed to make billions of dollars until it stops working because of resistances.

  20. Plasmafox says:

    HIV PREVENTION? Seriously? They turned a potential cure into “take this every day for the rest of your life or you might get AIDS.”

  21. HogwartsProfessor says:

    “So the concern is that there may not be adequate adherence to provide protection in the general population.”

    I think this is a pretty valid concern. Not to mention, if you rely on this and don’t practice safe sex, there are a lot of other problems you can end up with also.