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Tuesday, November 23, 2010

Daily Pill—Taken Without Fail (No Screwing Up)—Reduces HIV Infection Rates By 90%

Posted by on Tue, Nov 23, 2010 at 9:21 AM

NYT:

In a development that could change the battle against AIDS, researchers have found that taking a daily antiretroviral pill greatly lowers the chances of getting infected with the virus. In the study, published Tuesday by the New England Journal of Medicine, researchers found that the hundreds of gay men randomly assigned to take the drugs were 44 percent less likely to get infected than the equal number assigned to take a placebo.

But when only the men whose blood tests showed they had taken their pill faithfully every day were considered, the pill was more than 90 percent effective, said Dr. Anthony S. Fauci, head of the division of the National Institutes of Health, which paid for the study along with the Bill and Melinda Gates Foundation.

“That’s huge,” Dr. Fauci said. “That says it all for me.”

First: thanks, Bill; thanks, Melinda. Moving on:

Also, the antiretroviral pill—Truvada, a combination of two drugs, tenofovir and emtricitabine—is available by prescription in many countries right now.... The protection, known as “pre-exposure prophylaxis” or “PreP,” is also the first new form available to men, especially men who cannot use condoms because they sell sex, are in danger of prison rape, are under pressure from partners or lose their inhibitions when drunk or high.

This pill—is "the pill" taken?—will be popular among gay men who want to have unprotected sex with their partners because it feels better, because condoms are the wrong sort of pain the ass, because fucking without condoms is more intimate. And it may change the mental calculus around negotiated safety for gay men in stable relationships. (Gay men in LTRs may decide to go condom-free a little sooner: a high level of trust used to be required before a couple could go condom-free. But if men can go on an effective pill when they first stop using condoms with a new partners—one that lessens their risk if their trust was misplaced—they're likelier to stop using condoms sooner.) But I doubt that the pill, if it becomes available, will stem the tide of HIV infections in the gay community. The men most in need of the drug—the significant chunk of gay men out there who aren't using condoms with random and/or anonymous partners—those guys just don't give a shit. They don't give a shit about themselves, about their partners, about contracting HIV or other STIs, about their health, about the health of their community. These guys are unlikely to take a pill "faithfully."

And the pill? It has significant side effects—what is going to happen to someone who takes the pill for decades? And the pill costs $14,000 a year—who's going to pay? There are currently long and growing waiting lists for drugs that mean the difference between life and death for people who have full-blown AIDS. And if guys taking the pill come to see themselves as invincible and/or immune, what are the odds that some—many?—will take more risks, expose themselves to HIV more often, and by so doing wipe out whatever protections the pill provides?

Color me skeptical, but I'm not sure it's practical to suggest that all gay men everywhere be placed on an expensive drug regimen all of our adult lives—along with "other high-risk groups," like "sex workers... drug users and uninfected people married to infected people."

UPDATE: Andrew is a lot more upbeat: "massive breakthrough," "best news in a long time." I remain skeptical. Yes, this is big news. But who are the gay men most likely to use this drug? Health-conscious gay men with access to health care who self-select to take the drug. In other words, gay men—negative and positive—who are already protecting themselves and/or their partners. And this made me roll my eyes...

This could have real implications especially in those subcultures where using condoms is rare, where the closet or the DL make any candid discussion of HIV before sex taboo.

Asking your doctor to write you a prescription for a drug that makes it possible for you to have tons of unprotected gay buttsex will require the mother of all candid discussions.

Closeted guys and guys on the DL—and "DL" is just another way of saying "closeted"—are unlikely to regard the gay pill as any less taboo than a candid discussion about HIV or a condom. Closeted guys avoid those discussions and refuse to use condoms because having them or using them implicates them as gay. How will getting and taking the gay pill be any less of a taboo?

 

Comments (42) RSS

Oldest First Unregistered On Registered On Add a comment
1
Great point as always, Dan. Still, let's celebrate this discovery, given that we were too wary to celebrate the discovery of anti-retrovirals 15ish years ago. This may/will pave the way towards more practical cures.
Posted by yisheng on November 23, 2010 at 9:29 AM · Report this
2
I wonder how much of the benefits of new treatments for HIV is conteracted by people being less safe. In the late '90s people were saying that by now half of all gay men would be HIV+. That didn't quite happen.
Posted by Ken Mehlman on November 23, 2010 at 9:40 AM · Report this
Vince 3
Gee, all those Christians who scream "I hope you get AIDS and die!," at Gay Pride parades are going to be so disappointed.
Posted by Vince on November 23, 2010 at 9:52 AM · Report this
Fifty-Two-Eighty 4
Yes, @2 - how reassuring that it's "only" 20%. Or maybe not.
Posted by Fifty-Two-Eighty http://www.nra.org on November 23, 2010 at 9:53 AM · Report this
5
In the name of being responsible, being sure, being risk-adverse, being the kind of guy who cares about me, my partners and my community...I use condoms even when I know they are probably not necessary...like in that relationship that's just not quite there yet! But I draw the line at taking retro-virals that I don't need. And I'm not looking forward to the day where porno's are contentious of showing Mason Wyler take his daily pill! Not...that...into...this...development!

But like the NYT write up states, some people can't get buy in from their partners to use condoms; some people are at risk of violence if they try. I hope those people can get this drug.
Posted by LukeJoe on November 23, 2010 at 10:00 AM · Report this
6
Americans can't finish out their damn antibiotic regimens, let alone an EVERY.DAY.PILL.

Sure, people who need pills to survive take them every day, but even then, there are missed days.

I call bullshit, and I am skeptical with you Dan.
Posted by Taller Than You on November 23, 2010 at 10:02 AM · Report this
7
5: Bad news: Mason Wyler is already POZ.

http://www.advocate.com/News/News_Featur…
Posted by Taller Than You on November 23, 2010 at 10:07 AM · Report this
8
Dan, sadly your skepticism is about right. The only real cure will be some kind of vaccine. If that was as feasable it should be we would have had one by now.
Posted by wl on November 23, 2010 at 10:12 AM · Report this
BEG 9
Yeah, that was pretty much my take on it too.

Not to mention shiny new national health care picking up the tab... oh wait.

I think it's important in terms of progress made in figuring this disease out. I can see based on the knowledge that this works, and going through *how* and *why* it works, we'd be that much closer to finding a cure.

But the practical application of this particular bit of knowledge? Um, yeah. I get why Sullivan's happy -- but as you say, he's part of a pretty small slice of the already small gay male population...
Posted by BEG http://twitter.com/#!/browneyedgirl65 on November 23, 2010 at 10:15 AM · Report this
Stiny 10
I wonder...women who want reliable hormonal contraception and who don't like taking a daily pill have patches, rings and even small implantable devices that release hormones over time. In the case of the implant, it's good for three years. So, what are the odds that an implantable device could be developed to deliver antiretroviral therapy? It would be more discreet, perhaps, than a pill, and if you can snag a high risk-don't care person even once, you could give them (and their partners) some protection.
Posted by Stiny on November 23, 2010 at 10:17 AM · Report this
monkey 11
And then for some gay men HIV is just another suicide method. Probably the stupidest suicide method you could choose but a method none the less.
Posted by monkey on November 23, 2010 at 10:18 AM · Report this
12
@7 Oh that's a shame. But really I just pulled his name at random. Since I guess he will be taking daily retro-virals, if he keeps preforming that make actually be a meaningful thing to portray. But they should keep it in the DVD extras.
Posted by LukeJoe on November 23, 2010 at 10:20 AM · Report this
BEG 13
I take that back. The porn industry makes way enough on profits to supply every one of their employees with this stuff as needed and maybe that's what they should do. Of course, then we'll see employees being coerced into doing more bareback work. Gotta love human nature.

@10 -- Huh, not a bad idea. Though I have no idea whether these retrovirals are amenable to such approaches.
Posted by BEG http://twitter.com/#!/browneyedgirl65 on November 23, 2010 at 10:35 AM · Report this
14
"Also, many men in the study failed to take all their pills, and some clearly lied about it. For example, some who claimed to take them 90 percent of the time had little or no drug in their bloodstreams."

So are homosexuals the stupidest lyingest assholes on the planet?
or what......
Posted by whát on November 23, 2010 at 10:52 AM · Report this
15
One small correction - the statistic for higher effectiveness is that those who took the pill 90% were 72.8% protected.
I think this is fantastic news. I understand the concerns, but the more tools we have the better we can fight this. The vaccine studies are still underway and will be the best answer when one is found, in the meantime we should prevent as many infections as we can with the tools at hand.
Posted by EMR on November 23, 2010 at 10:53 AM · Report this
blip 16
there will never, ever be an HIV vaccine. you can quote me on that. this is as close as we can get.

this breakthrough is only the beginning; they are doing off-label research for an existing drug, and these results open up an entirely new path for research: drugs designed specifically for a prophylactic effect. just look at how far ARV treatments have come in the 13 years we've had them. perhaps now all the billions of dollars wasted on pointless vaccine research can be directed towards something that might actually work.
Posted by blip on November 23, 2010 at 11:00 AM · Report this
17
"The protection, known as “pre-exposure prophylaxis” or “PreP,” is also the first new form available to men, especially men who cannot use condoms because they sell sex, are in danger of prison rape..."

First of all, why is that gay man who sell sex "cannot" use condoms. Last I checked sex workers are perfectly within their rights to set guidelines for their clients.

Second of all, what are the chances that the prison system would be willing to provide all of the inmates in the country with this pill because they may be "in danger of prison rape?" Seems to me that that would be akin to admitting that there are flaws in the system.
Posted by nyker on November 23, 2010 at 11:04 AM · Report this
18
Good news, I suppose, but I'll stick with rubbers.
Posted by Smell on November 23, 2010 at 11:09 AM · Report this
19
Do we know that the pill alone is what reduced the infection rates? People who are willing/able to take a pill every day for a study might also be the people who are more willing/able to practice other safer behaviors.

Even if someone tried to argue that any such positive secondary effects were worth it from a $14,000 pill, I would think this would suggest that there might be cheaper methods that can be implemented as alternatives that could address at least part of the issue.
Posted by fetch on November 23, 2010 at 11:09 AM · Report this
Canadian Nurse 20
It's true that closeted men won't likely be the consumers of a medication like this, but who knows about other high-risk people. This pill is unlikely to be in wide use, but as patents wear out, we might find more convenient methods of having the right amount of these drugs in the bloodstream.

The BCP used to need to be taken every day, but now we've got 3 month injections and weekly patches. Hopefully researchers will be able to figure out how to create methods of benefiting from this drug that aren't a daily pill.
Posted by Canadian Nurse on November 23, 2010 at 11:12 AM · Report this
Canadian Nurse 21
@10: This is what I get for opening the tab and then getting distracted for an hour. Completely repeated your post.
Posted by Canadian Nurse on November 23, 2010 at 11:22 AM · Report this
22
@16 blip,

You're awfully sure of yourself. History is lettered with people who said X will never happen. If the internet had existed 100 years ago, someone would have posted that a polio vaccine will never happen.

Are you an expert? What makes you so confident it will never happen? Considering the resources being thrown at this problem -- and the progress that has already been made -- I think it's more likely to be a matter of when than if. The When might be 50 or 100 years from now, but some things take time.
Posted by ML77 on November 23, 2010 at 11:49 AM · Report this
23
@19, that's kind of what I thought too and posted on AmericaBlog. Unless everyone in the study is having unprotected receptive with POZ guys, how do you know the value of the pill if that's what you're doing?
Posted by LukeJoe on November 23, 2010 at 11:51 AM · Report this
24
@20 Been thinking along those lines since I heard about the study this morning. The cynic in me sees this as a crapcause/effect study. It stands to reason that the people who are dilligent about taking a pill every single day to protect their health are far more likely to embrace other strategies to protect their health.

But releasing the results might get some to pony up $14,000 a year and open a new market/revenue stream for the pharmeceutical industry.

I suspect that if a future study is done on who dillegently took the drug daily as a SOLE means of protection will approach infection rates of people who did very little. There's a giant variable missing in the write-ups of this study.
Posted by BornAgainInBellevue on November 23, 2010 at 11:59 AM · Report this
25
PEP has been around alot longer...it works too but few seem to know about it or use it either.
Posted by timetotry on November 23, 2010 at 12:07 PM · Report this
Kevin_BGFH 26
Excellent analysis, Dan. My first question when I first heard about this was about the side effects, and my second was about the cost and feasibility of widespread usage. Should have also thought about the risk high usage resulting of drug-resistant strains.

Posted by Kevin_BGFH http://biggayfrathouse.typepad.com/blog/ on November 23, 2010 at 12:11 PM · Report this
blip 27
@22 HIV (or any retrovirus) integrates itself into the genome of the cell it infects, immortalizing itself by becoming a part of its host. an effective vaccine would have to neutralize the virus before it had an opportunity to infect a CD4+ cell. given the high variability of the virus itself, it is next to impossible to engineer a vaccine that would be able to recognize every possible variant of the virus AND do so within minutes of infection. ask anyone involved in HIV vaccine research and they will tell you: this will almost certainly never happen. but in research, you learn as much (if not more) from your failures as your successes, so these studies continue even though they are all expected to fail.

but yes, in 50 or 100 years, maybe scientists could figure out how to create an effective HIV vaccine, but it's much more likely they will develop other, more effective approaches to prophylaxis and treatment long before that happens.
Posted by blip on November 23, 2010 at 12:15 PM · Report this
28
Thanks for what feels like the only sensible commentary on this story out there.
Posted by Alice Dreger http://www.alicedreger.com on November 23, 2010 at 12:19 PM · Report this
kerfuffle 29
$14,000 a year? That's $38 a day! Thats fucking expensive, but here's the deal...it's a major step forward. Major. It's not perfect, and there will be people who take advantage of, or abuse it...but this is a step in the right direction. Twenty years ago when I started volunteering with NW AIDS Foundation, this seemed like a pipe dream. HIV was a death sentence.
This is a big deal.
Please keep using condoms.
Posted by kerfuffle on November 23, 2010 at 12:38 PM · Report this
30
Absolutely agree with Dan on all points. Look at the birth control pill, and then think of having to take that tiny pill EVERYDAY forever to avoid getting pregnant. The same applies. Condoms are better, and you can't lie and say, "Oh, I took my pill this morning, don't worry about it," because they have no proof. But they can always sit there and watch you put on a condom. Now here's to hoping people actually follow Dan's advice.
Posted by dakoneko on November 23, 2010 at 1:53 PM · Report this
venomlash 31
@27: You are incorrect.
Sure, HIV, like all retroviruses, splices itself into the genetic code by using reverse transcriptase. But how does it get into the cell in the first place? The same way any virus gets into the cell; it binds to a receptor protein embedded in the cell membrane, causing it to be internalized. If you create a vaccine that causes the pertinent T cells not to express the protein (and we do know which protein it is), which could be done by delivering an engineered gene to the bone marrow by way of an adenovirus, then HIV would have no way of infecting the patient. There's actually research currently going on in that direction.
Read the literature, blip.
Posted by venomlash on November 23, 2010 at 4:23 PM · Report this
32
Something I think that stands out?

What do you do when you have partners where one partner is poz, and the other partner is not?

Wear your condoms, yeah, but if it drops the risk that much more...that's a big improvement in life.
Posted by slinky on November 23, 2010 at 5:19 PM · Report this
blip 33
@venomlash -- first, i'm not a fucking retard.

second, scientists may be researching what you're talking about, but that is ridiculously more complicated and waaaaay further past the horizon than chemical prophylaxis. we are nowhere near the point of being able to insert genes into adult human's cells, and eons from even grappling with the ethical considerations of such endeavors. what's currently being researched does not necessarily equal what is most likely to be available in the next decade or 2, which is my point. path of least resistance, yo.

did you seriously just call me a fucking retard?
Posted by blip on November 23, 2010 at 6:55 PM · Report this
eclexia 34
It would make sense to give this drug to any gay man in substance abuse situations. That includes everything from tweakers to newly-out college students who get blackout drunk on weekends.

Sure, a rehab program would be a better choice. But in the meantime, maybe the side effects of taking the pill for a year are less important when weighted against having one night of blackout sex followed by a lifetime of HIV meds.
Posted by eclexia on November 23, 2010 at 7:27 PM · Report this
venomlash 35
@33: I don't think you're a fucking retard. I just like Bill Nye, and have spent perhaps too much time in the shadier parts of the Interwebs lately. No offense on the personal front.
And actually, we HAVE performed gene therapy, using adenoviruses to insert a functional copy of a gene in people who bear a defective copy. Sadly, human trials were set back a great deal in 1999, when a participant in an early clinical trial died due to a massive immune reaction to the adenovirus used.
Read the literature on gene therapy; it may be a new and fairly hit-or-miss science, but it has bore fruit.
Posted by venomlash on November 23, 2010 at 8:23 PM · Report this
watchout5 36
Why is aids research seemingly 100% targeted, and spoken about, in the context of gay sex? Did strait people gain immunity and I missed the memo? Or maybe women? All the commercials on the radio are like, "if you're a young gay male we want your help for an AIDS cure". Now this article, what the fuck?
Posted by watchout5 http://www.overclockeddrama.com on November 24, 2010 at 4:15 AM · Report this
37
36

20% of all homosexuals have AIDS

44X as much as normal Americans.

more than street whores and crack addicts.

what the fuck indeed
Posted by . what. the. fuck...... on November 24, 2010 at 6:38 AM · Report this
38
This medicine costs $14,000 a year in the US, but in developing countries with generic versions, it costs about $132 dollars a year. Sex workers in developing nations almost never have the options to use condoms, and most married women in sub-Saharan Africa who get infected by husbands who have sex with prostitutes while working away from the home also do not have the option to use condoms. So this new discovery could potentially be of great help outside the US, if (and this is a big if) AIDS service organizations can figure out a cost-effective way to get these daily pills to vulnerable populations.
Posted by SunGirl on November 26, 2010 at 11:03 AM · Report this
39
What we can do, is thank the beautiful gay boys that paved the way for a drug that (if it can ever go generic) that will undoubtedly help women (and men) in parts of the world where women have no cultural or legal right to say no. Like Women in Africa, Or the wives of long distance truckers in India (by far the biggest population spreading HIV to their unsuspecting wives). Heck, if I could afford it I'd use it in combination with Condoms. I'm poly, pansexual and Alergic to latex and not all guys fit into the unstudied non-latex alternatives, thank you, Side effects or not, it beats possibly spreading something to myself or someone i care about.
Posted by g.k.sushi on February 11, 2011 at 5:01 PM · Report this
Sandiai 40
@31. I was going to pipe up with that idea as well. Except I was thinking of just blocking the CD4 receptor with a specific drug (that hasn't been developed yet). That would be easier than gene therapy or even antisense therapy. It would dumb down the immune system a bit, but done right it might be worth it. And I believe that there are other receptors involved as well. People lacking any one of these receptors I believe are essentially immune to HIV.
And @36 and @39, yes, around the world AIDS is basically a heterosexual disease, something the bigots/trolls always conveniently forget. In some African countries 30% of HETEROsexuals are infected, and we don't judge them as amoral just because of an unlucky encounter with a virus. BTW, As far as Africa, I heard it was long-distance truckers and prostitutes there too. Also there, occasionally and sadly, you can pick up the virus if you go into a hospital for surgery.
Posted by Sandiai on May 24, 2011 at 8:28 PM · Report this
41
This isn't really news. People who have unexpected exposures, such as health care workers who get needle sticks from HIV+ patients and victims of sexual assault by people whose HIV status is unknown or known to be positive, are put on antiretroviral prophylaxis. HIV+ pregnant women are put on antiretrovirals to protect the fetuses, and it works. The problem is that the more you use the drugs, the more the virus adapts to them.

Currently, people who are judged to be compliance risks – i.e., people who are considered unlikely to take a pill "faithfully" every day – are often not prescribed these medications, even though they are HIV+ or may even be symptomatic with AIDS, because taking the drugs irregularly increases the spread of antiretroviral resistance. It's hard to imagine a whole population whose only qualification is high-risk behavior being given the meds.
Posted by SAH on August 23, 2011 at 6:04 PM · Report this
42
@10 et seq.:
I, too, hope that there are more automated delivery systems for these drugs or others, but consider a simple hurdle: the drug will have to be stable at about 37C for the life of the implant.

I don't doubt that "they" will be able to come up with this*---speaking as a beneficiary of shelf-stable, time-released insulin preparations unavailable until about a decade ago---but it might take some doing.

*pretty easy for me to say, as I'm not one of them, yet.
Posted by Gerald Fnord on May 10, 2012 at 2:50 PM · Report this

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