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TO YOUR HEALTH

FDA Approves Truvada, First Drug To Reduce Risk Of HIV Infection

Giving us all a nice start to the week, the FDA has just given the green light to Truvada, the first drug approved to reduce the risk of HIV infection in uninfected individuals.

Taken daily, the drug is being touted as part of a pre-exposure prophylaxis (PrEP) strategy, in combination with safer sex practices, to reduce the risk of HIV infection in high-risk adults, including those with HIV-infected partners. The FDA previously allowed Gilead Sciences to manufacture Truvada (emtricitabine/tenofovir disoproxil fumarate) for use in conjunction with other antiretroviral agents for HIV-positive people.

“Today’s approval marks an important milestone in our fight against HIV,” said FDA Commissioner Dr. Margaret A. Hamburg. “Every year, about 50,000 U.S. adults and adolescents are diagnosed with HIV infection, despite the availability of prevention methods and strategies to educate, test, and care for people living with the disease. New treatments as well as prevention methods are needed to fight the HIV epidemic in this country.”

The medication shouldn’t be perceived as a cure or vaccine: Truvada for PrEP is only prescribed fpr individuals who are confirmed to be HIV-negative prior to using the drug. In double-blind studies of 2,499 HIV-negative men and women in high-risk categories, Truveda was effective in reducing the risk of HIV infection by 42% compared with the placebo. There are also potential side-effects including changes in fat distribution in the body and blood, kidney and liver dysfunction and weakening of the bones.

Today’s approval is heartening sign, definitely, but not a magic bullet.

By:           Dan Avery
On:           Jul 16, 2012
Tagged:
  • 48 Comments
    • Michael
      Michael

      Please don’t take this as a hall pass for debauchery…it is not 100 percent;
      Wrap it up.

      Jul 16, 2012 at 3:25 pm · @ReplyReply to this comment ·
    • Baba Booey
      Baba Booey

      Amazing.

      Jul 16, 2012 at 3:27 pm · @ReplyReply to this comment ·
    • Roxorz
      Roxorz

      O brave new world

      Jul 16, 2012 at 4:25 pm · @ReplyReply to this comment ·
    • Jim H.
      Jim H.

      This seems like a very poor public health decision. Why on earth would we want to encourage people to take a harmful drug test that only offers 1/2 the HIV-preventative benefits of latex and none of the preventative benefits for other STIs? It seems like the only people who will want to take this are people who misunderstand the risks and benefits of the drug to begin with.

      Jul 16, 2012 at 5:01 pm · @ReplyReply to this comment ·
    • Jim H.
      Jim H.

      Please ignore the word “test” in my previous comment. Damned autocorrect.

      Jul 16, 2012 at 5:02 pm · @ReplyReply to this comment ·
    • Oh well
      Oh well

      Great news for serodiscordant couples wishing to add this for extra protection.

      Expect the nanny queens who think they know what’s best for everybody else to throw a giant hissy fit, though :)

      Jul 16, 2012 at 5:06 pm · @ReplyReply to this comment ·
    • Spike
      Spike

      “Truveda was effective in reducing the risk of HIV infection by 42% compared with the placebo. There are also potential side-effects including changes in fat distribution in the body and blood, kidney and liver dysfunction and weakening of the bones.”

      So in other words, you can’t be bothered with practicing safe sex, you can go fuck bare back to your hearts content with a 42% chance that you will remain negative if you don’t mind the side effects that include kidney and liver dysfunction and weakening of the bones. And this is considered a step forward?

      Jul 16, 2012 at 6:19 pm · @ReplyReply to this comment ·
    • Matt
      Matt

      I agree Jim H, it’s just going to encourage or have more people do it raw or they’ll think “It’s a cure for HIV! I don’t need to use condoms or have safer sex!”

      Also HIV meds have horrible side effects.

      Jul 16, 2012 at 6:25 pm · @ReplyReply to this comment ·
    • Liam McG
      Liam McG

      @Oh well —

      It’s certainly an option for serodiscordant couples who choose to go that route with the knowledge that (1) the risk reduction is only 42%, (2) the meds must be taken daily, (3) they may have significant side effects and (4) the meds cost $14,000/year. If you and your partner make an educated choice knowing all the facts, I wish you well.

      The unacceptable risk is for those (most likely single) guys who will see it as a “get out of rubbers free” card. The public tends to perceive every new drug as 100% effective for the indication for which it’s prescribed. Not even close. In addition, my gut is that many if not most non-monogamous users will not stick with the regime but will treat it as a “morning after” pill. If it’s prescribed under strict controls, including a detailed, signed informed consent disclosure, then the risk may be somewhat curtailed. I’m skeptical, though.

      Jul 16, 2012 at 7:02 pm · @ReplyReply to this comment ·
    • Oh well
      Oh well

      @Jim H., @Spike and @Matt, you misrepresent the purpose of this. This is not a perfect drug but it is a good thing by any measure if you are in a relationship with a poz person:

      In one trial involving heterosexual couples where one partner was infected — AND CONDOMS WERE USED ROUTINELY — Truvada reduced the risk of infections by 75 percent, which is a very significant benefit already. (Not everyone was using the drug daily as indicated.)

      Another analysis actually found that the reduction of risk is up to 96% in people who take the drug daily (as confirmed by blood tests).

      The mentioned serious side effects are rare.

      Jul 16, 2012 at 7:06 pm · @ReplyReply to this comment ·
    • Dan
      Dan

      @Oh well: LOL, what serodiscordant couples? Undetectables aren’t infectious. The entire demographic they’ve been advertising this garbage for is imaginary. It’ll be a bareback party pill that will increase infections.

      Jul 16, 2012 at 7:10 pm · @ReplyReply to this comment ·
    • Oh well
      Oh well

      @Liam McG, I understand your concern about people giving up safe sex, but…

      (1) This is not a street drug – people will have to get it from their doctors and have insurance coverage for it, which means that they will get a lot of counseling on its proper use. (I have some experience of being on an expensive rheumatoid arthritis drug, and I keep getting nurses from both the insurance and drug company calling me at home to make sure I use it correctly.)

      (2) Even if some people do not use it as intended, the potential documented benefit to the people who do is so great that it would be criminal to withhold it from them.

      Jul 16, 2012 at 7:15 pm · @ReplyReply to this comment ·
    • Oh well
      Oh well

      @Dan, the studies contradict you.

      Jul 16, 2012 at 7:17 pm · @ReplyReply to this comment ·
    • Dan
      Dan

      What studies sweetheart? The studies indicate that undetectables aren’t infectious. Period.

      Jul 16, 2012 at 7:22 pm · @ReplyReply to this comment ·
    • Oh well
      Oh well

      @Dan, not all poz people are so lucky as to be able to become undetectable. What would you do with them, throw them in camps?

      Also, the UCSF iPrEx study done in men who have high risk sex with men showed that it reduced infections, not increased it as you allege.

      Jul 16, 2012 at 7:25 pm · @ReplyReply to this comment ·
    • Jerry
      Jerry

      You haven’t really read any studies, have you, Dan?

      Jul 16, 2012 at 7:37 pm · @ReplyReply to this comment ·
    • MikeNYC
      MikeNYC

      Dan-Actually people who have an undetectable viral load ARE infectious.

      Jul 16, 2012 at 9:10 pm · @ReplyReply to this comment ·
    • DrewSF
      DrewSF

      Oh Well-People can easily trade or sell this drug as though it’s a street drug. Or people will just pop them before BB/raw orgies.

      Jul 16, 2012 at 9:12 pm · @ReplyReply to this comment ·
    • adam
      adam

      First, a 42% reduction isn’t much, and $14,000 a year sure the hell is.

      Second, having learned nothing through the ’90s and ’00s, we’re now trusting the pharmaceutical establishment?

      I’m glad someone’s making some progress, but for me, pass and pass.

      Jul 16, 2012 at 9:12 pm · @ReplyReply to this comment ·
    • Colin
      Colin

      @Dan:@DrewSF: People who bareback knowing the risks clearly aren’t very concerned about catching disease in the first place. The drug probably will not enable them to be more irresponsible than they already are.

      Jul 16, 2012 at 9:17 pm · @ReplyReply to this comment ·
    • Andrew
      Andrew

      I guess you’d know Colin since you do it raw.

      Jul 16, 2012 at 10:10 pm · @ReplyReply to this comment ·
    • jj
      jj

      It sure as hell doesnt cost 14k per year in Canada. Its something like 1800$ per year. Still, I feel this is just another way for the drug companies to make more money. Sure this would be great for intravenous drug users and prostitutes but good luck trying to get them to take 1 pill every day. Until a prevention method that can be given in quarterly annual shots is developed I agree that this is just going to encourage unsafe behavior.

      Jul 16, 2012 at 10:43 pm · @ReplyReply to this comment ·
    • Tom
      Tom

      @Oh well:

      “Dan, not all poz people are so lucky as to be able to become undetectable. What would you do with them, throw them in camps?”

      Hopefully queerty doesn’t block this one out. We’re all aware that “undetectable” just means “below the level of detection”, right? With infectiousness varying by the amount of virus observed in the bloodstream. For a person to not be infectious, they do not necessarily have to reach “undetectable” status. It would seem that infectiousness requires a certain criticual mass of virus circulating in the body. We don’t know what this magic number is, but we know they’ve reached it by the time they reach undetectable status, usually before. Here’s a source…

      http://www.guttmacher.org/pubs/journals/2620300a.html

      Money quote? “No seroconversions occurred when the HIV-positive partner’s viral load was less than 1,500 copies per milliliter.” For reference, undetectable is currently defined as less than 20 copies per ML.

      We also indirectly proved this with the more well known study, HTPN052. Contrary to popular belief, that study did not measure viral load as it relates to infectiousness. Instead, it sought to triangulate infectiousness against a background of nadir cd4 and other factors that aren’t generally assumed to have anything to do with transmission of the virus. Without even seeing if the meds were working, HTPN052 (the oft misquoted “94%” survey) only observed a 39 transmissions out of nearly 1800 negative parties. Ergo, the drugs don’t even have to be maximally effective or consistently ingested to dramatically reduce infections, they merely have to be taken.

      However, I think we do a disservice to ourselves and the reality of what the medical system has accomplished today by belaboring that “not everyone reaches undetectable”. Well over 80% of newly diagnosed reach undetectable within six months of initiating a first line therapy. The vast majority of those people remain undetectable for a prolonged period afterwards. For those that do experience treatment failure, there are second and third line regimes. Virtually everyone reaches undetectable these days, and almost all of them stay there for an indefinite period.

      @MikeNYC: (sighs) No, mike, actually they aren’t, and until you can scare up some sort of usable data that indicates it, the supposed infectiousness of undetectables is purely theoretical. There are rumours, but I’ve yet to see data that indicate undetectables are infectious. Actually, I’ve yet to personally meet anyone who claims they caught HIV from an undetectable. HTPN052, as I’ve already established, does not measure viral load (the amount of virus in the body) but CD4, meaning that it’s supposed “6% infection rate” is beside the point that I’m making.

      Jul 16, 2012 at 11:03 pm · @ReplyReply to this comment ·
    • Tom
      Tom

      “UCSF iPrEx study done in men who have high risk sex with men showed that it reduced infections, not increased it as you allege.:

      It should also be added that the iprex study was a controlled study. The measured the effective of barebackers on truvada against barebackers on a placebo. I’m not disputing the scientific fact that these drugs, when ingested in a controlled situation, reduce infectiousness. We don’t live in a controlled situation though. I am concerned that they will encourage unprotected sex. I can’t imagine anyone continuing to use condoms in addition to prep. Truvada is indisputably less effective than condom usage, and so any replacement of condoms will invariably correspond with more infections.

      Jul 16, 2012 at 11:10 pm · @ReplyReply to this comment ·
    • MiltonHarvey
      MiltonHarvey

      The whole idea is to encourage unprotected sex so more people will get infected and more people will die. Simple as that. As for Truvada, avoid it. It’s highly toxic. The Side effects alone will kill you way before HIV.

      Jul 17, 2012 at 8:05 am · @ReplyReply to this comment ·
    • Oh well
      Oh well

      Those who oppose this should explain why they don’t consider it unethical to withhold the drug from the subset of people who use it responsibly and whose lives can be saved as a result. For example, almost everybody would agree that it would be unethical to withhold morphine from a cancer patient with intractable pain just because many people abuse morphine. How is this different?

      Jul 17, 2012 at 8:18 am · @ReplyReply to this comment ·
    • Oh well
      Oh well

      @Tom, even if undetectables are uninfectious (promising research I agree, but the jury is still out on that one), one cannot assume every poz partner of a negative person is undetectable, even if they are under treatment. So given the stakes for the negative partner, any additional protective options that are under the control of the negative partner, such as this one, are good to have available.

      As you mention yourself, it can take months to become undetectable once treated. Also, someone who is undetectable may become detectable at some unpredictable time while under treatment, something that may not be discovered until weeks or months later. Also, poz people may sometimes stop or change treatment due to side effects, or they may become forgetful and not take their medicines consistently, and have windows of detectability as a result. Some non-progressors may decide to forgo drug treatment for various reasons.

      Jul 17, 2012 at 8:37 am · @ReplyReply to this comment ·
    • MiltonHarvey
      MiltonHarvey

      @Oh well: How is this different? As a cancer patient, you take morphine to ease the pain when you are dying. By the morphine stage, it’s game over. HIV, on the other hand, can easily be prevented by, among other things, playing it safe. There is no need for this new drug if you play it safe. This drug should not be thought of as a cure because it isn’t and it won’t act the way morphine would for a dying cancer patient. Play it safe and you won’t need this new poison. So, denying a drug which would ease the pain for a dying patient or quite different from a drug which would, in all likelyhood, merely alleviate symptoms for something that could have easily been prevented in the first place. Not the same thing at all.

      Jul 17, 2012 at 8:43 am · @ReplyReply to this comment ·
    • MiltonHarvey
      MiltonHarvey

      @Oh well: Have you lived in a time when there was no HIV? Were you even born when HIV started? I’m hoping you haven’t because if you did live through that period, you obviously have not learned anything. Having lived through it myself, well, it certainly puts things into perspective and I’ve learned a lot. There simply is no excuse for playing it unsafe. “I don’r care if I get HIV ’cause there’s a ton of meds to take care of it”, is a common statement nowadays. Well, that’s stupid. Incredibly stupid.

      Jul 17, 2012 at 8:48 am · @ReplyReply to this comment ·
    • Tom
      Tom

      @Oh well: What a bizarre, misleading analogy. Truvada is not morphine. What is the “chronic, intractable pain?” A lack of cum?

      Let’s cut the through bullshit for just one second and lay down a basic fact about HIV transmission and how this is going to be used. First, HIV is primarily spread between people who do not think they are at risk. This has been true since the early 80s. As common sense would suggest, people who realize they’re at risk usually take steps to change that risk very quickly. Like so much in epidemiology, there are reams of statistical evidence to back this up, but its really just kind of obvious.

      Truvada isn’t going to be used by these people who don’t realize they’re at risk. In their minds, they don’t need to use a drug for a virus they’re not in danger of contracting. In fact, Truvada-a drug which will require a meticulous regime of testing, relatively high financial outlay and countless hours in physician waiting rooms-will be used exclusively by people who are exquisitely aware of the risk they are exposed to.

      This is why the official line loves to reference serodiscordant couples, because these are the only people who actually know they are at risk but aren’t fully empowered to change their behavior. They’re the only group that even makes theoretical sense. They’re politically correct. The problem is, in the western world, transmission between serodiscordant couples is almost nonexistent. As I already established, medicating the positive partner is exceedingly effective at preventing transmission. Partners who reach undetectable status are well known to have no transmissions, despite concerns about “one copy being infectious” that idiots on this website like to repeat. This is why many studies of prep have relied so heavily upon foreign populations, because these are the locations where the positive partner is not medicated, and thus infectious to the negative.

      So who is going to benefit from Truvada as prep? A person who is negative, has access to truvada and has a positive partner that is not on HIV medication. In other words, Truvada’s ideal target demographic is imaginary. This is also why so many people with HIV crapped their pants when they saw this drug roll out, because it literally presumes giving medication to the seronegative instead of the positives who need it to live. This is the elephant in the living room that no one is talking about! The only people who could actually benefit from this drug are fictitous, or worse, they’re diverting access to ARVs from the positive. Realistically though, they’re a marketing ploy dreamed up by Gilead, and they don’t exist in the real world.

      Now, let’s step back for a moment. We have a drug which isn’t going to be used by people who will benefit from it because those people don’t exist. There are very few negative halfs of serodiscordant couples who have access to truvada in spite of a partner not using ARVs. So who will be using PrEP? Well, probably people who realize they’re in serious danger of HIV infection but would like to engage in acts that they know are likely to cause it anyways. In other words, recreational barebackers. The people who get on BBRT and say “DDF UB2″. The people who visit bathhouses and watch from the shadows. This is why it is being called a “bareback party pill”-because thats what it will be. It will facilitate unprotected sex with strangers who are infectious, not partners who are medicated. The problem is, PrEP isn’t nearly as good at preventing HIV infections as the marketing is going to tell us. The actual reduction in transmission is something like 40%. That figure was achieved in a trial setting, and it is well known that in trials, adherence is always better. So, in other words, we are going to see a real world risk reduction of less than 40% amongst PrEP users. We’re going to have people who now feel empowered to use PrEP to bareback who otherwise would not. We’re going to see more people on BBRT. The lurkers at the bathhouse will come out of the shadow and into the sling. Because of this drug’s staggering lack of effectiveness, many of these people who would not otherwise be barebacking strangers will seroconvert.

      The only way PrEP will decrease infections in a casual setting will be if it is used in conjunction with condoms. The idea that someone would invest a copay of up to $200 a month, countless medical visits and blood draws and endless counseling, just to augment the nearly perfect condom, is ludicrous. Instead, PrEP will supplant condoms, and will facilitate risky behavior by creating a false sense of security.

      This will not save any lives. This will increase infections. Witholding prep from potential barebackers is not “withholding morphine from a cancer patient”, it is withholding heroine from a patient with an addictive personality and an ingrown toenail. The fact that so much of the HIV community has fawned over this shit is shameful. It is a low point in the politics of HIV, and if there is a Hell, I’ve no doubt that many of our activist elite will rot in it for their participation in this fiasco.

      Jul 17, 2012 at 9:50 am · @ReplyReply to this comment ·
    • Tom
      Tom

      @Oh well:

      “Tom, even if undetectables are uninfectious (promising research I agree, but the jury is still out on that one), one cannot assume every poz partner of a negative person is undetectable, even if they are under treatment.”

      True, but we don’t need the viral load to get all the way down to “undetectable”. As per the link I previously posted, 1500 does quite nicely.

      “So given the stakes for the negative partner, any additional protective options that are under the control of the negative partner, such as this one, are good to have available.”

      Not when they increase the risk of the broader population. As I’ve already established, this is a drug which isn’t going to benefit people who have positive partners. You may be afraid of infection, but statistically, your risk from your poz partner is almost nonexistent. Instead, this is going to be a sex toy for people who want to fuck strangers. The problem is that in that scenario, a 40% reduction is not nearly good enough.

      “As you mention yourself, it can take months to become undetectable once treated. Also, someone who is undetectable may become detectable at some unpredictable time while under treatment, something that may not be discovered until weeks or months later.”

      This scenario is exceedingly and increasingly rare, especially in situations where the positive partner is motivated towards adherence by a desire to protect the negative.

      “Also, poz people may sometimes stop or change treatment due to side effects, or they may become forgetful and not take their medicines consistently, and have windows of detectability as a result.”

      Windows of detectability do not occur during treatment changes, only during treatment interruptions. While they are infectious at that period, the issue we then face is one of viral resistance. Virtually everyone with HIV uses truvada. For them to stop using it, then pass the virus to a partner who will once again be using truvada, sounds like a recipe for resistance.

      “Some non-progressors may decide to forgo drug treatment for various reasons”

      And virtually all non-progressors have viral loads well below the 1500 mark I previously established, making that a moot concern.

      Jul 17, 2012 at 9:58 am · @ReplyReply to this comment ·
    • Tom
      Tom

      @Oh well: “(promising research I agree, but the jury is still out on that one)”

      Doesn’t the fact that you referred to this as “promising research” sound odd to you? People have been reaching undetectable for the better half of the epidemic, but we still call it “research”, yet this prep shit has been rammed down our collective throats in the last two years, fast tracked by the FDA and rolled out amongst never ending fanfare. Doesn’t that, in and of itself, suggest a high degree of PR manipulation and corruption?

      Jul 17, 2012 at 10:04 am · @ReplyReply to this comment ·
    • MiltonHarvey
      MiltonHarvey

      @Tom: Very well said, Tom. “This will not save lives. This will increase infections”. Exactly, Tom! Exactly!

      Jul 17, 2012 at 10:10 am · @ReplyReply to this comment ·
    • The Real Mike in Asheville
      The Real Mike in Asheville

      @Dan: No Dan, you are wrong. The studies show that undetectable viral loads reduce the risk of infection, but does not eliminate the risk. Of particular note, the viral load in semen DOES NOT automatically track with the viral load in blood. That is, you can have an undetectable blood viral load while having thousands of copies per cc in semen:

      http://www.aidsmap.com/Many-men-with-undetectable-HIV-in-blood-still-have-low-levels-in-their-semen-studies-find/page/2297170/

      Considering the typical adult male has approximately 5000 cc of blood, even a viral load of 20 (undetectable counts are <50 copies/cc; more sophisticated tests can achieve <20 copies/cc), at just 20, there would still be 10,000 copies. A few drops of blood will contain a copy of the virus. Why risk it when a rubber can prevent transmission.

      Jul 17, 2012 at 10:13 am · @ReplyReply to this comment ·
    • Tom
      Tom

      @The Real Mike in Asheville: If there are “studies that show undetectable does not eliminate risk”, please cite a medical observation in which transmission occurred from a stable, undetectable partner. I’ve repeatedly cited mine, and gone into detail to explain them. The fact that there is HIV in semen is immaterial, as it is not sufficient to be infectious. We’ve studied THOUSANDS of serodiscordant couples, and we reach the same conclusion again and again, that there is a certain threshold at which HIV just is not able to be transmittable; undetectables are well below this threshold. Citing scare stories about HIV in semen and imagining data about 10,000 copies does not support your claim, it justifies the serophobes who live on this place, and demonizes those of us who are trying to get on with our lives.

      You really are a nasty troll, you know that? Most of the people on here are clearly idiots, but you do everything under some auspice of personal expertise. You’re the homosexual who argues against gay equality, “from the standpoint of a gay man”. The things you say however are misleading and intentionally scary. We don’t need any more fearmongering. I’m sorry your youth was terrible, please stop trying to rationalize the destruction of any other poz people’s youths.

      Jul 17, 2012 at 11:12 am · @ReplyReply to this comment ·
    • Oh well
      Oh well

      @Tom, @Miltonharvey, the analogy with morphine (and other opioid painkillers) is valid. Many cancer and other pain patients (say, amputees) on opioids are not terminal. Yet most people agree that ethics requires that they should have access to opioids even though many people die each year from opioid abuse. Actually, withholding Truvada will cause some people to die (or live with a bad lifelong infection) who could otherwise have been saved, as shown by the studies. (This is arguably a worse outcome than withholding opioids from a pain patient, which only strengthens my argument.)

      You would prefer these people to take one for the team for what you define as the greater good and just get infected and possibly die, which is not ethically justifiable.

      Jul 17, 2012 at 11:46 am · @ReplyReply to this comment ·
    • Oh well
      Oh well

      @Tom, not everyone lives in your perfectly controlled monogamous gay world. What would you say to the female sex worker who has many clients a day and worries about condom breakage, to give just one of many possible examples? Take one for the team?

      Jul 17, 2012 at 11:57 am · @ReplyReply to this comment ·
    • MiltonHarvey
      MiltonHarvey

      @Oh well: Your persistence is missing a blatantly obvious point indicates you are either completely stupid, unable to see beyond your own little world, or working for a pharmaceutical company. If I have to actually explain the point you missed, it would prove that you really did miss it.

      Jul 17, 2012 at 11:58 am · @ReplyReply to this comment ·
    • Oh well
      Oh well

      @Tom, so now you don’t even have to be undetectable to be uninfectious, and seminal viral load doesn’t even matter? Do you really think spreading this kind of not yet fully substantiated information will be conducive to safe behavior? It is possible that people will take what you are saying regarding uninfectivity as a green light to throw safe sex to the wind as long as their partner says he is being treated (which doesn’t mean he really is, by the way). You are really being very cavalier with other people’s health here, as bad or worse as you accuse the pro-PREP people of being.

      Jul 17, 2012 at 12:03 pm · @ReplyReply to this comment ·
    • Oh well
      Oh well

      @MiltonHarvey, I got your point, but it is moot. Playing it safe does not completely prevent infections, because condoms break or leak, for one thing. Studies showed that even in serodiscordant couples who play it safe, there is a background rate of infections, which PREP reduced. I repeat, because you haven’t bothered to answer it, would you prefer these people to get infected to serve the greater good?

      Jul 17, 2012 at 12:08 pm · @ReplyReply to this comment ·
    • Tom
      Tom

      @Oh well: “You would prefer these people to take one for the team for what you define as the greater good and just get infected and possibly die, which is not ethically justifiable.”

      Who are “these people”? As I said, there are simply no people who will benefit from PrEP. It’s an imaginary demographic, a creation of Gilead’s marketing and a figment of the public’s imagination. It’s not serodiscordant couples, as these people aren’t at risk. It’s not drug users, or abused women who aren’t in a position to coordinate complicated medical care. There just isn’t anyone whose risk of infection will be reduced by adding prep to their medicine cabinet.

      You speak of ethics. I don’t know what school of thought you’re drawing from, but most of us in the west would agree that the lives of tens of thousands of people who will be drawn into reckless behavior are more important than some theoretical demographic which just doesn’t seem to exist. What you’re arguing for is a libertarian philosophy so extreme that it has no grounding in reality. It’s almost like saying that we should sell nuclear weapons to the public, because those who would benefit from them should not have to go without just for the benefit of those who will wind up incinerated.

      Jul 17, 2012 at 12:10 pm · @ReplyReply to this comment ·
    • Tom
      Tom

      @MiltonHarvey:”you are either completely stupid, unable to see beyond your own little world, or working for a pharmaceutical company.”

      Why do I get that feeling too? No one who is this stupid can be able to type, and yet the internet is flooded with pro-prep propaganda. Whenever anyone points out the obvious in clear, easy to understand langauge, they always come back and say the same things, with the same soundbites about “choice” and “tools in our arsenal”.

      I was reading on another forum, and someone pointed out that, almost without fail, he could accurately predict when a new prep study would be released for public consumption-it seemed to follow hot on the heels of virtually every single meaningful advance towards a cure or a vaccine. He worked in PR and said this was a classic tactic, that if a firm couldn’t make debate a point, it would simply eclipse all opposition. I definitely see that here. We keep hearing the same thing, the same bizarre analgies about “morphine” and the same accusations that those of us who are angry just don’t want gay men to have “natural sex”. Blogers work cheap. It’s not unreasonable to think Gilead is paying a few hundred college kids to scour the internet and bury all opposition.

      Jul 17, 2012 at 12:26 pm · @ReplyReply to this comment ·
    • Tom
      Tom

      @Oh well: I would say that rate of an infection occurring from a broken condom with a straight guy is almost nonexistent, as demonstrated by the stunning lack of HIV in places like The Netherlands.

      Jul 17, 2012 at 12:29 pm · @ReplyReply to this comment ·
    • Tom
      Tom

      @Oh well: Don’t be childish. We’ve studied tens of thousands of serodiscordant couples. We’ve spent decades watching undetectables in relationships. We’ve produced exhaustive behavioral inventories. The only reason its “not yet fully substantiated” is because no one has an interest in pointing out the obvious. Saying that this isn’t “fully substantiated” is fucking pedenatic. So is the concern about seminal viral load. There’s always been VL in the semen of undetectables. The critical issue is that it, too, is reduced by ARVs and it, too, is below the level of infection. The level of infection isn’t necessarily undetectable. I agree with Milton, you’re obviously a pawn of the pharmaceutical industry.

      Jul 17, 2012 at 12:36 pm · @ReplyReply to this comment ·
    • Oh well
      Oh well

      @Tom: “As I said, there are simply no people who will benefit from PrEP. […] I would say that rate of an infection occurring from a broken condom with a straight guy is almost nonexistent.”

      Dude, I have tried to be nice, but now you are just being seriously delusional. I may well be the stupid idiot you accuse me of being, but a significant number of scientists, bioethicists, and public health experts disagree with your point of view for essentially the reasons I have stated repeatedly – they must all be stupid idiots too, eh? Fortunately the decision is made, and fortunately those who think like you have lost. I’m not feeding your trollish behavior any longer. Goodbye.

      Jul 17, 2012 at 3:03 pm · @ReplyReply to this comment ·
    • Joshua David Price
      Joshua David Price

      @Spike: you really have no idea of the science behind a drug like this, and the effects it can have for the rest of us. i am a positive guy and my partner is negative, it would be a VERY good idea for him to have this medication to reduce any risk. such a small minded man you are, really.

      Jul 17, 2012 at 5:44 pm · @ReplyReply to this comment ·
    • Trog
      Trog

      @Tom: Tom, you keep referencing the data showing that undetectable viral loads basically translate to no infection risk. But that data is among heterosexuals. Are there any such studies among gay men?

      We all know that anal sex is a much, much higher risk than vaginal sex.

      Plus, the presence of any infections and STIs (perhaps unknown to the person) also increases risk for transmission even when viral load is undetectable.

      I do agree that PrEP isn’t the fabulous hope everyone makes it out to be (for one thing, there’s the cost–it does seem like the perfect product for the worried well and wealthy). However, I do think there are guys out there who are at risk for HIV and who can reduce their risk with PrEP and who will use it as prescribed and possibly remain uninfected as a result. For them, I’m glad it’s an option.

      Jul 17, 2012 at 6:20 pm · @ReplyReply to this comment ·
    • Tom
      Tom

      @Trog:
      “We all know that anal sex is a much, much higher risk than vaginal sex.”
      **You bring up the first good point I’ve seen about the concern that undetectables are infectious. It should be remembered that we’ve studied literally THOUSANDS of straight couples though, over the course of more than a decade. I’m absolutely certain more than a few of them practiced anal sex regularly, so the lack of infections are still applicable to gay couples.

      “Plus, the presence of any infections and STIs (perhaps unknown to the person) also increases risk for transmission even when viral load is undetectable”
      **Please cite the source. I can’t respond to this until I’ve actually seen it. Besides that, I’d be willing to guess that prep’s effectiveness also deminishes considerably with the presence of other STIs.

      “I do think there are guys out there who are at risk for HIV and who can reduce their risk with PrEP and who will use it as prescribed and possibly remain uninfected as a result”
      **And this is where we differ. I just can’t imagine who this person is. Who can shoulder massive copays, weeks of pre planning for the drug to reach therapeutic concentration, endless doctor’s visits, boring counseling and regular HIV testing that CAN’T be bothered to use condoms? It’s an imaginary target audience. Even if these people exist, do they outnumber the people who are going to be infected after they start barebacking thanks to popularization of this pill?

      **Honestly, I truly don’t believe undetectables are infectious. From a personal standpoint, it is not a risk I would want to take with my partners. From a political one however, I’d bet the farm on it. Think about how desperately people grasp at straws to prove that undetectables are infectious. Look at “Mike in Asheville” and his repeated insistence that “one copy of the virus is dangerous” when the facts simply don’t bear him out. Look at the sheer mathematical stupidity of people who would take a “negative” barebacker over an undetectable. Think about all the people on queerty that are utterly terrified of ANY poz partner, even an undetectable. People are searching for a reason to hate those with HIV. “fear of infection” has become a cover for a much dirtier stigma against those deemed sick. If there were ONE verifiable instance of undetectable transmission, it’d be all over the news. It’d be cited in every single “ask the experts” article about safer sex options. People would be citing that every time they wanted to stigmatize poz people, instead of mis-applying data from HTPN052. We’re not hearing about it…because it just hasn’t been observed.

      Jul 17, 2012 at 7:33 pm · @ReplyReply to this comment ·

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