So some panel at the FDA just approved this antiretroviral drug, Truvada-- they say its okay to prescribe this drug for HIV negative people to keep them from getting HIV.
Im going to this news the nicest way possible:
I think there were a lot of MDs, and very few PhDs, on this FDA review panel. If you know what I mean.
I have been over this before--
--Prescribing an antiretroviral to negative individuals to prevent HIV is a neat idea. When it comes to this particular antiretroviral, it appears to be a very stupid idea. It has life threatening side effects, it has been shown to have a positive effect on some populations in one study, it has been show to have absolutely no effect in others. And then its ridiculously expensive-- $11K a year.
Know what we *know* works, has no adverse effects, and is dirt cheap?
So we are going to give these drugs to people who dont need them (wear a goddamn condom), while people who *do* need them (HIV+ individuals) are having their coverage cut domestically and abroad, and then there is this minor thing we have to deal with with HIV... DRUG RESISTANCE.
You have to take drugs like this *religiously* for them to have the best chance of working (and even then, drug resistance develops). Ask any chick on The Pill, anyone who has to take blood pressure meds every day, or hell, even when you are on antibiotics for a week for a UTI or something-- everyone forgets a pill now and then. Lets imagine what happens if you forget a pill if youre taking antiretrovirals to prevent HIV infection-- you forget one pill, take one the next day, whatevs. Not whatevs. If youre exposed to the virus, it will be replicating in non-therapeutic levels of the antiviral. You will be selecting for variants of the HIV quasispecies that are resistant to the virus. In the mean time, youre thinking 'IM TAKING ANTIRETROVIRALS! IM FINE!!!' and not regularly getting tested for HIV. So HIV gets to thrive and have a great time, even in the presence of Truvada. And then you have sex with someone else "IM ON THE HIV PILL WE CAN TOTALLY BAREBACK IT!!! **HIGH-FIVE**" and you transmit a highly fit, drug resistant variant of HIV to someone else. And now they cant use some kinds of antiretrovirals because they wont work.
There is *one* instance where I think this is a good idea-- if you have got a genetically vain HIV discordant heterosexual couple who have threatened to kill themselves/everyone if they dont conceive a child together. And even then, only when they are trying to conceive. And even then, only with an antiretroviral that is proven to work for these purposes (the Truvada trials that were stopped were with heterosexual women).
In all other instances, this is a TERRIBLE idea.
JUST WEAR CONDOMS.
JUST WEAR GODDAMN CONDOMS, PEOPLE.
And its not just me--
"Truvada needs to be taken every day, 100 percent of the time, and my experience as a registered nurse tells me that won't happen," Karen Haughey told the panel. "In my eight years, not one patient that I've cared for has been 100 percent adherent."
The AIDS Healthcare Foundation, which opposes approval of Truvada, estimates that 20 HIV-positive patients could be treated for the cost of treating one patient with preventive Truvada.
This is stupid.
Condoms are great -- if your main worry is sexual transmission.
I've been in enough emergency-medicine scenes to know that maintaining adequate BSI can be challenging even when you're not digging people out of collapsed buildings in Haiti, though, and for cases like that the answer may not be quite so clear.
Abby, on this issue you are letting your emotions blind you. "I CAN'T DO PREVENTION, I HAS THE JUDGMENTAL."
Re:#2 That's not a very convincing counter-argument, Mr. Reeders. Abbi makes a very strong argument within the context she's assuming.
Condoms suck though :/
Tyler, if you were a microbiologist, you would wear condoms. Even if you know that you and your partner have had clean STI bills of health - what about the unknown nasties we haven't discovered yet, but which are presumably out there (the next HPV/HepC/HTLV)? Can't test for those, but you can certainly wear a condom and give yourself the best chance of avoiding them.
Additionally - if, as a hetero bloke, you use a condom, you're ensuring no woman will slap you with a child support bill at some future date because she forgot to take the Pill/'forgot' to take the Pill/had the Pill fail cos she was on antibiotics.
Basically, man the fuck up Tyler.
Condoms are not 100% effective; even when used properly there is a small rate of failure due to tears, slippage, etc. In people at high-risk of HIV infection, supplementing condom use with an anti-retroviral may be add a viable layer of protection on top of that offered by condoms alone.
I'd agree that as a primary prevention, it is an idea beyond stupid...
Condom flame war!
Sure condoms protect, but condoms have been around for a long time and yet somehow people still transmit HIV sexually aaall the tiiime. Being all "why can't you use condoms" often comes off sounding not that different from "why can't you just abstain".
The prophylactic art trials gave mixed results, but i think you're painting them in an unnecessarily pessimistic light. Did you see the summary talks Wafaa El-Sadr, Sharon Hillier, and the Karims gave at CROI this year? i think optimistic for good reason - there's lots to be figured out about in which settings this works best, but it definitely does appear to work in some.
eg - Did any of the trials yield evidence of poor adherence leading to development of resistant strains? From memory, i thought there was none - and if not, why do you think that was?
Also, on adherence: Realistically, it's unlikely that there will be long-term prescription of these drugs to anyone who doesn't participate in very regular screening. Additionally very little is yet known about i) the physiology of the various transmission routes or ii) the tissue or cell-type specific bioavailabilities of the trialed drugs. This stuff will probably allow administration to be tailored.
I agree totally, and one of the main problems of contraceptive use/uptake that is leading to the propagation of aids (among other problems) is....... CATHOLICISM!. I don't want to be over simplistic, or judgemental-but much of Africa (one of the most AIDS/HIV prone areas) has a high level of Catholicism and I truly feel that if the Pope wanted to do one good thing for humanity (and the planet in general) it would be to promote rather than prevent contraceptives.
It will only be a matter of time until a wide variety of short-term side effects of Truvida, and probably multiple long term side-effects are discovered to a drug like this.
It is also totally impracticable, do you prescribe the entire adult HIV-negative population with the drug?-where do you begin or end.
If vaccination where possible (which perhaps in the far far future it will) then you could run vaccination programs. But this is an evolving virus, all over the world so Truvida frankly seems rather a waste of space as how on earth do you even begin to start deciding who should use it?
Until we either find a cure, or a vaccination to HIV, which at this point we are no where near then the only prevention is contraception!
Are you suggesting that a second possible use for Truvada would be for medical first responders? Or would it, in that case, be better used as part of a drug cocktail after the fact of a needle stick or other suspect injury?
Tyler, just turn them inside out . . .
One would think MDs should be more familiar with non-adherence and side effects than PhDs.
In the scenario you propose might be a good idea (the sero-discordant couple wanting to conceive) there's a far better solution than Truvada PrEP - put the HIV positive partner on treatment until his/her viral load is undetectable.
HIV positive partner on treatment = 96% reduction in transmission rate.
MDs should be more familiar with non-adherence and side effects than PhDs.
Yeah, they do such a good job not ever prescribing antibiotics for viral infections, they clearly have an excellent understanding of selection for resistance.
They probably understand selection for resistance in the antibiotics for viral infections case but their psychological need to prescribe something overpowers it. Like obese people don't keep eating because they don't understand the connection between eating and weight.
how amusing. many of us will *never* use condoms, and we simply don't care about bloggers and their indignation...many of us find these rants to be hilarious, actually. 30 years into the pandemic, the level of new infections remains a disaster...exclusively throwing condoms at the problem has FAILed, and continues to FAIL. what is it about condom-advocates and FAILURE seeming to go together so well?
you folks have had your chance, and then some. now it's time to expand the prevention arsenal.
ahem, here's a far more diplomatic and comprehensively reasoned response from David Evans of Project Inform, posted recently to his own blog at poz.com:
You sound so dated with your "Use Condoms!" shtick. Shaming people to use condoms didn't work in the 80's and 90's and still doesn't 20 years later. Way to ignore socio-economic factors, addiction issues and mental health issues that strongly contribute to HIV transmission.
What about people in relationships where 1 person is HIV positive and the other is negative. This offers an added value of protection. What about sub-saharan african countries where there is a stigma in condom usage and HIV infection is rampant? What if someone is in an abusive relationship / marriage and is forced to have unprotected sex on a regular basis? This "use condoms" mantra is great, but making the issue far too simple than it actually is. And this article is condescending to top it all off.
We tried this therapy in Africa-- we *wanted* to use it for women in abusive relationships and stigma of condom usage is rampant.
So now we are giving (or want to give) this drug to people in the US who have plenty of access to free/low-cost condoms (which do work) because they just dont want to use condoms. They would rather take an antiretroviral that people in other parts of the world (including the US) NEED to stay alive, the only reason for which is they want to maximize their sexual pleasure. While others are dying.
I think *that* is condescending.
uhm, ERV? is this really a science blog? if it is, would you be so kind as to note at least SOME of the widely-acknowledged flaws in the PrEP study done on African women? like that most of them never took the drug to any measurable level? that they had to promise to avoid getting pregnant lest the medicine damage their offspring and ruin the study results? that the meds they were given were quite valuable on the black market?
studies have shown that Truvada is at least as effective as condoms when actually taken as directed, and about as good as condoms when taken with over 90% adherence.
as a 100% openly HIV+ man who only has 100% condom-free sex and takes many medications with exactly 100% adherence, i scoff at the sexual attacks on PrEP...including the lie that people who decline using condoms must by definition be unlikely to take medication faithfully. i also know and have sex with HIV- men who faithfully take PrEP that they pay for out of pocket...some by purchasing it cheaper from overseas. done at this level of adherence, chemoprophylaxis works extremely well at preventing infections.
Sexual pleasure is a human right and primordial expression of living...irrespective of any given culturally-based bias or shame. not all people can be expected to give up that expression to prevent an infection that can also be prevented without giving up sexual pleasure...and make no mistake: for many people, condoms are not a minor change in sexual pleasure, they are the very death of it.
YES, that includes whatever personal favorite you have, whether it's the female condom, the ribbed one, the polyurethane one, or the various "baggy" ones. Perhaps some of the effort expended on pushing condom-use would be better spent creating and distributing cheap and effective condoms that actually feel far better than present versions? why not design them to feel BETTER than natural ("bareback") sex? it's 2012, forget about flying cars...where are the nanotech condoms?
somebody is always dying somewhere...that you would invoke that to shame people out of their sexual proclivities is hilarious, especially for its...impotence. you're not going to stop myself or anyone else from having the sex we legally choose for ourselves. to even try is to essentially bleat defeat. no one deserves to get HIV, not even those nasty barebackers you've read about and maybe even argued with online...
btw Truvada is not uranium, more can always be made...it's spurious to pretend that using it to protect an HIV- person somehow leaves an HIV+ person without medication.
PLEASE, read David Evans much more friendly and medically salient piece i linked to above. let go of your own sexual issues and recognize the limits of the circa-1985 safe-sex vision you have embraced. after several decades of continued infections, it's about time...your Rubber Religion needs reinforcements if HIV is be halted and defeated..
it's time for PrEP.
San Francisco Mayor Ed Lee was just put in the difficult position of backfilling funding due to expire at the end of June.
I am not one of the smart people who are posting on here. There seems to be serious science supporting PrEP. But until we have reasonable stability in our healthcare system and zero people on wait lists in our country due to exhausted CARE/HIP - Ryan White - ADAP monies... NO PrEP for negative people! There are over 8,000 people in the U.S. right this second who have arrived at a point with their illness where ARV intervention is necessary and has been prescribed by a doctor.
They have arrived but with nowhere to go.
Help them first.
HIV- people can wait.
so, uh, James...? why don't we close all the restaurants until World Hunger is ended? why not ban all birth control until all orphans are adopted, and/or until all human sexual activity is done in the context of monogamy?
funds for hiv-prevention are not funds for hiv-treatment, tho indeed treatment can serve a preventative function. no HIV- person should have to become HIV+, especially not for the sexual sanctimony or healthcare-access-anxiety of others.
(of course no one who invokes this particular PrEP bogeyman (the claim that giving HIV-meds to HIV- people will take away meds from HIV+ people) has EVER provided a single example of where this switcheroo has even been contemplated, let alone actually proposed. it's a giant red herring.)
hint: the people fighting for PrEP are not the people creating ADAP waiting lists...in fact, the latter are enemies of the former. pretending otherwise is incredibly shortsighted...the truth is that the funding of both Treatment and Prevention requires battling homophobia, racism, sexism and social Darwinism.
Prevention is not the enemy of Treatment. Ignorance and Bigotry are the enemies of both.
Of all the things one could die from, dying from sex seems the least objectionable. Condoms suck!
This decision needs to be based on data, not judgmentalism. Writing on your blog in all caps that people should use condoms with a "goddamn it" for good measure won't actually cause people do it.
There are downsides as you mention, ie, possibility of resistance, possible increase in risky behavior due to people knowing they are taking the pill, etc. Plus the cost and side effects of the pills. Hard to tell how those negatives will play out. It will require data on the pros versus cons of this measure to really assess whether it's a good idea and whether it will help improve the situation with this crisis. However one thing that I am fairly sure will not help is writing in all caps on a blog that people should "USE CONDOMS GODDAMN IT".
Condoms suck? The alternative are far worse... Condoms keeps shit from getting on your dick.. feces can irritate it badly. And nobody mentions here that new antibiotic resistant gonorrhea.... "condoms suck" sounds like the most childish, immature, irresponsible complaint...
Vaccine. Doesn't have to be perfect and at this point anything will do. Anything
I'm glad this author so generously finds a way to justify a situation in which heterosexuals should be allowed to use this drug. But never for gays? Homosexual men are disproportionately infected (here in America, anyway.) But her narrow, sarcastic, jaded view of the world can't imagine a single reason for gay men to want or need the drug.
How about giving people options? Condoms have been around for *thousands* of years, but we still have lots of STI's that affect our species. Maybe it's time we use science to find a variety of preventative tools for people. Condom-only expectations are like abstinence-only sex ed programs.
so the FDA has approved this today...BRAVO. now it's time for the complaints to cease and for all interested parties to focus effort on making PrEP work in the real world...we can expect the number of viable prevention options to now multiply and improve in all aspects. once monthly injections are already in the near future, and even a Cure is a realistic goal once more.
it's a beautiful. day today.
People have heard the message about wearing condoms and yet HIV is still being transmitted. Your novel insertion of the word "GODDAMN" is sure to do the trick. No one ever thought of swearing before. Your latent between-the-lines homophobia is disgusting and unprofessional.
To the people reading this blog who desperately want to take antiretrovirals that might prevent HIV (there is evidence that it will not) which will put others at risk of contracting drug resistant HIV, rather than wearing a condom that will prevent HIV infection and will not put others in danger:
This is a very bad move made by people who dont understand basic viral evolution. Not a huge surprise considering the way evolution is taught (rather, not taught) in this country. It will be another mess that I have to clean up in 10 years. It will be another mess that *others* pay the price for in 10 years. It contributes to a mess we have currently for antiretroviral availability.
And Im not straight. Ive never been straight. You would think that supposed 'homosexuals' would be less heteronormative. You would also think that the issues homosexuals have to deal with on a daily basis would make them more aware of their privilege-- in this case living in a part of the world where they have access to food, clean water, high-speed internet connections, unnecessary medications-- they would be more aware of how their privilege looks to someone needs those unnecessary medications to live.
But no, by all means, try to talk down to the 'heterosexual' actually doing something about HIV, to make yourself feel better about taking drugs that others cant have.
*That* is disgusting, 'Sam'.
Sam (from one Sam to another),
I'm hetero and not necessarily attuned enough to between-the-lines homophobia to pick it up here. But I still think you're right about the tone of this post. Education is only ever going to go so far in encouraging condom use, and beyond that point additional exasperated moralizing will probably be right around 0% effective. ARVs don't protect against a huge range of STDs or prevent pregnancy, and given the side-effects of the drugs it's hard for me to imagine people giving up condom use to get on meds. But for people who don't and won't use condoms consistently, you know who you are. And now you have an option you didn't have before.
Hmm. Compliance is a problem. Compliance with wearing condoms is a problem.
Seems there is a problem.
But I agree, a simple sleeve is a less invasive solution than taking a drug that can affect your whole body and the ecology therein and thereon,
"You will be selecting for variants of the HIV quasispecies that are resistant to the virus."
I think that's supposed to be "... resistant to the antiviral drug".
To all those people who complain about condoms sucking and wondering why the nasty blogger doesn't want you to take the magic pill: it's because, as she writes, the drug would quickly lose its mojo. It's like prescribing antibiotics for the common cold or putting them in animal feed; pretty soon, bacteria will become resistant to those antibiotics.
Oh, wait, we're actually doing that. Crap.
Dan, i'll repeat to you what so many condom advocates seem deaf to: condoms have proven insufficient in stemming new infections, and more tools are needed. behavioral interventions in general have limited success...condoms especially suffer in popularity due to the way they reliably diminish sex.
keep ignoring that fact, keep talking around it, and i suppose it becomes easy to simply lament and feel superior...but the cost of that is 50,000 new HIV infections a year in the USA, and 2.5 million a year globally.
stop pretending that everyone can be convinced or guilt-tripped into using a device that either attenuates, inhibits or fully destroys the act it is meant to facilitate in a safER manner. we must drastically reduce/eliminate the flaws that cause condoms to be so unappealing, or get out of the way of new tools in the arsenal.