Daily Pill Lowers H.I.V. Infection Risk

[wammt]

http://www.nytimes.com/2010/11/24/health/research/24aids.html?_r=1&ref=global-home

Daily Pill Lowers H.I.V. Infection Risk, Study Finds

By DONALD G. McNEIL Jr.

Published: November 23, 2010

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.”

The large study, nicknamed iPrEx, included nearly 2,500 men in six countries and was coordinated by the Gladstone Institutes of the University of California, San Francisco.

The results are the best news in the AIDS field in years, even better than this summer’s revelation that a vaginal microbicide protected 39 percent of all the women testing it and 54 percent of those who used it faithfully.

Also, the antiretroviral pill — Truvada, a combination of two drugs, tenofovir and emtricitabine — is available by prescription in many countries right now, while the microbicide gel is made only in small amounts for clinical trials.

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.

It is a form of protection “that does not involve getting permission from the other partner, and that’s important,” said Phill Wilson, president of the Black AIDS Institute, which focuses on the epidemic among blacks.

Michel Sidibé, the head of UNAIDS, the United Nations AIDS-fighting agency, called it “a breakthrough that will accelerate the prevention revolution.”

Because Truvada is available now, some clinicians already prescribe it for prophylaxis, Dr. Fauci said, but whether doing so becomes official policy will depend on discussions by the Centers for Disease Control and Prevention, the Food and Drug Administration, medical societies and others, which could take months.

Although the C.D.C. would prefer that doctors wait for further studies, more probably will prescribe it now that this study is out, said Dr. Kevin Fenton, chief of the agency’s AIDS division, so the C.D.C. will soon release suggested guidelines.

The agency will encourage that the drug be prescribed only with close medical supervision and used only with other safe-sex practices, treatment for venereal diseases and counseling.

“The results are encouraging, but it’s not time for gay men to throw away their condoms,” Dr. Fenton said.

AIDS advocacy groups were very excited by the results.

“If you comply with it, this works really well,” said Chris Collins, policy director of amfAR, the Foundation for AIDS Research. “This is too big to walk away from.”

Mitchell Warren, executive director of AVAC, which lobbies for AIDS prevention, called the study “a great day for the fight against AIDS” and said gay men and others at risk needed to be consulted on the next steps.

AIDS experts and the researchers issued several caveats about the study’s limitations.

It was only of gay men and only of one drug combination. More studies, now under way, are needed to see if they duplicate these results and to see whether Truvada also protects heterosexual men and women, prostitutes and drug users who share needles, and whether other drugs will work, too.

There is no medical reason to think the pill would not work in everyone, since it attacks the virus in the blood, rather than in the vaginal wall as a microbicide does.

Different regimens, like taking the pills only when sex is anticipated instead of daily, also need testing.

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.

Although the pills caused no major side effects in the study, some men disliked the relatively minor ones, like nausea and headaches. Also, as is common in clinical trials, some stopped bothering once they suspected they might be taking a placebo.

“People have their own reasons,” Mr. Collins said. “People don’t take their Lipitor every day either.”

A major question now is who will pay for the drug.

In the United States, Truvada, made by Gilead Sciences, costs $12,000 to $14,000 a year. In very poor countries, generic versions costs as little as 40 cents a pill.

Globally, only about 5 million of the 33 million people with AIDS are on antiretrovirals, and, in an era of tight foreign-aid budgets, that number is not expected to rise quickly.

Hundreds of millions of Africans, eastern Europeans and Asians are at risk and could benefit from prophylaxis, but that would cost tens of billions of dollars.

If he had the money, Mr. Sidibé of UNAIDS said, he would target high-risk groups like sex workers, gay men, drug users and uninfected people married to infected people.

In this country, insurers and Medicare normally pay for the drugs, and the Ryan White Act covers the cost for the poor — but none of these payers yet have policies on supplying the drugs to healthy people.

One fear some scientists have is that putting more people on the drugs will speed the evolution of drug-resistant strains.

None of the 2,499 participants developed resistance to tenofovir. Three were found to have strains resistant to emtricitabine, but investigators believe all three were infected before the study began, but at levels low enough to have been missed by their first H.I.V. tests.

Because participants were tested monthly and those who got infected were put on triple therapy cocktails, it was unlikely any were on two-drug Truvada long enough to develop drug resistant strains.

Another fear was that the participants would become so fearless that they would stop using condoms, but the opposite effect was seen — they used condoms more often and had fewer sex partners. But that can also be a function of simply being enrolled in a study and getting a steady diet of safe sex advice and free condoms, the investigators said.

The study took place at 11 sites in the United States, South Africa, Brazil, Thailand, Ecuador and Peru. Other trials of pre-exposure prophylaxis have about 20,000 volunteers enrolled around the world. Their results are expected to arrive in a steady stream over the next two years.

[JoshLandaleXXX]

Interesting... very simlar to the news out of Switzerland 3-4 years ago.

Edited November 23, 2010 by JoshLandaleXXX
general editing

[wammt]

This the one you are referring to ( Jan.2008)?:

Swiss experts say individuals with undetectable viral load and no STI cannot transmit HIV during sex

http://www.aidsmap.com/page/1429357/

[Belfast-Bottom]

Many thanks for posting this Wammt! This is probably the best news since the success of the vaginal gels.

I'm a non discriminating cumdump. I NEVER ask status, but I'd prefer not to become infected with HIV. I want to be able to take ALL loads - with less anxiety.

[rawTOP]

It's called PrEP and IMHO it's a horrible idea... Over a year ago I wrote a whole blog post on how bad of an idea I thought it was...

http://www.rawtop.com/blog/2009-09/prep-is-a-really-horrible-idea

Short version - I'm not in favor of giving healthy people powerful toxic drugs that have serious side effects. If the person doesn't take the meds properly they can build up a resistance to medication they made need later. I also think the impetus for it comes out of a place of fear shame and guilt.

Of course it's a personal decision, but after literally 2+ decades of doctors wanting to treat me for a condition I didn't have (including powerful drugs with side effects and two life threatening operations) - I don't trust any doctor who wants to aggressively treat people who are perfectly healthy.

I hope the insurance companies will refuse to pay for the medications... That would put a quick stop to the idea.

[JoshLandaleXXX]

This the one you are referring to ( Jan.2008)?:

Swiss experts say individuals with undetectable viral load and no STI cannot transmit HIV during sex

http://www.aidsmap.com/page/1429357/

Thats the one fella.. think the initial research came out in 2007 or something like that... lost track of time lol

Very interesting though isnt it...

[JoshLandaleXXX]

It's called PrEP and IMHO it's a horrible idea... Over a year ago I wrote a whole blog post on how bad of an idea I thought it was...

http://www.rawtop.com/blog/2009-09/prep-is-a-really-horrible-idea

Short version - I'm not in favor of giving healthy people powerful toxic drugs that have serious side effects. If the person doesn't take the meds properly they can build up a resistance to medication they made need later. I also think the impetus for it comes out of a place of fear shame and guilt.

Of course it's a personal decision, but after literally 2+ decades of doctors wanting to treat me for a condition I didn't have (including powerful drugs with side effects and two life threatening operations) - I don't trust any doctor who wants to aggressively treat people who are perfectly healthy.

I hope the insurance companies will refuse to pay for the medications... That would put a quick stop to the idea.

I read this way differently than PEP.. post exposure prophylaxis.

PEP is to be taken in the event of someone having known exposure to HIV and has to be taken within 72 TOPS of exposure. It's been available free here in the UK on the NHS for about 2 years, and is proven to have saved many hundreds of people from contracting HIV.

I didnt read this as being PEP at all... rather than a pill which is taken ALL the time to reduce the risk of infection.. kinda like taking vitamin C tablets to try and stave off a cold.

[JoshLandaleXXX]

Sorry... totally misread (its 2am here!) I agree its a bad idea... i thought you'd misundestood it for PEP (post exposure)... upon re-reading it i see it actually says PRE exposure... so yes.. i had read it right, and everyone else had too... haha.. sorry totally my bad.

I agree, its a terrible idea. PEP is a great idea, but PRE is a bad bad one... it's not been discussed here, and i doubt it will...

[rawTOP]

I agree, its a terrible idea. PEP is a great idea, but PRE is a bad bad one... it's not been discussed here, and i doubt it will...

PEP is only a good idea sometimes... I'm in favor of it for health care professionals who get stuck with dirty needles. I'm in favor of it when guys are trying to be safe and the condom breaks when there's a poz top involved. But I'm not in favor of it when the bottom made a premeditated choice to bareback 'cause they're going to make the same choice again and it's stupid to keep running to the emergency room in a panic every time they have sex.

But agreed - PrEP is always a bad idea.

[tin]

I think idea of PreP would be good for couples where one person is HIV+ and the other is HIV-, or for high-risk people in third world countries where (especially females) don't always have as much control over their sexual-safety as they would like.

But being used as a 'chemical condom' for your average bare-backer - I don't think it's a great idea. The meds can have some nasty long-term side effects, you might not tolerate them well.

Also, you do need to be pretty strict on adhering to taking them regularly - start missing doses / etc - and you could quickly find yourself ending up HIV+ and having your strain become resistant to the medication your taking and complicating your future treatment options.

So, in some select cases - this can be a good thing. Having a HIV+ who is on meds and undetectable, and a HIV- doing a daily pill - the combination could greatly reduce the risk of transmission in that relationship, and would probably be a huge weight off of the minds of those involved.

[rawTOP]

I think idea of PreP would be good for couples where one person is HIV+ and the other is HIV-, or for high-risk people in third world countries where (especially females) don't always have as much control over their sexual-safety as they would like.

So, in some select cases - this can be a good thing. Having a HIV+ who is on meds and undetectable, and a HIV- doing a daily pill - the combination could greatly reduce the risk of transmission in that relationship, and would probably be a huge weight off of the minds of those involved.

If the poz partner is on meds and undetectable that alone is more effective than using condoms (and not being on meds). I still wouldn't suggest it in that case - just too much risk in side effects to the neg guy. I'd recommend condoms actually... Condoms plus meds for the poz guy is pretty much bullet proof. I'd only really suggest it if they desperately want to bareback and the poz guy is the top in the relationship.

And the problem with the 3rd world is getting a constant supply of meds to the neg woman. IF that can be achieved (it's unlikely in the 3rd world) then it's a good idea. Prostitutes in urban areas would be a good group for PrEP - they're very high risk and being in an urban area means they probably have access to adequate healthcare and can get the meds on a regular basis. Rural women are a much bigger challenge.

[kinkyfucker]

If the poz partner is on meds and undetectable that alone is more effective than using condoms (and not being on meds). I still wouldn't suggest it in that case - just too much risk in side effects to the neg guy. I'd recommend condoms actually... Condoms plus meds for the poz guy is pretty much bullet proof. I'd only really suggest it if they desperately want to bareback and the poz guy is the top in the relationship.

rawTOP-

You're wrong that barebacking with a poz top on meds is safer than having sex with a condom who isn't on meds. I believe what you are trying to do is take the Swiss Statement and distort it for your own purposes. Originally, the only thing the Swiss Statement was intended to do was to address whether a neg woman could safely be impregnated "naturally" by a poz top who had an undetectable viral load. Yet from there people have gone and extrapolated so far as to say it is safer to have sex with someone who is UD raw than someone who is NOT UD with a condom. This is simply not true. In fact, pretty much all other studies have shown otherwise. In fact, recently the authors of the Swiss Statement came out and recanted much of their original work after finding it did not apply much further than the laboratory and was leading people to do unsafe things. So, rawTOP, be careful what you post, people are relying on you for accurate information as the moderator of the board!

[HungLatinDom]

Kinkyfucker,

Can you please point me to that retraction? I am very interested.

Thanks

[kinkyfucker]

Kinkyfucker,

Can you please point me to that retraction? I am very interested.

Thanks

I hope I didn't imply that it was a full retraction, but rather a revision of their statement. Maybe it was a poor choice of words on my part. Well, here is the link to the latest study out of Switzerland. Hope it helps clarify things!

http://aids-clinical-care.jwatch.org/cgi/content/full/2010/1115/1

[HungLatinDom]

Ehhh.

That is not what I was expecting, based on your commentary. The single author of the opinion you sent, Dr. Albrecht, is not part of the original Swiss study, so not sure where did you get the "original authors recanted" bit.

Ironically, he says:

"Although ART is a promising avenue for preventing the spread of HIV, we need data, not opinions, before we encourage serodiscordant couples to skip the condoms."

Despite he himself gives no data at all.

Sure, infections might happen, but the amount of risk reduction is huge and Rawtop is probably right, plus, the original study addressed the fact that people with other STDs might harbor the virus on their genital tract, despite being UD. However, you are right that the study was only about hetero couples.

This is a science and health debate, so pointing fingers, making up motives and being uncivil won't help anyone.