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-   -   [Science!] FDA Approves Pill Designed to Prevent HIV Infection (http://www.nuklearforums.com/showthread.php?t=41968)

Shyria Dracnoir 07-17-2012 09:23 AM

[Science!] FDA Approves Pill Designed to Prevent HIV Infection
 
FDA Press Announcement

Quote:

Today, the U.S. Food and Drug Administration approved Truvada (emtricitabine/tenofovir disoproxil fumarate), the first drug approved to reduce the risk of HIV infection in uninfected individuals who are at high risk of HIV infection and who may engage in sexual activity with HIV-infected partners. Truvada, taken daily, is to be used for pre-exposure prophylaxis (PrEP) in combination with safer sex practices to reduce the risk of sexually-acquired HIV infection in adults at high risk.
Quote:

"Today’s approval marks an important milestone in our fight against HIV," said FDA Commissioner Margaret A. Hamburg, M.D. "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."

As a part of this action, the FDA is strengthening Truvada’s Boxed Warning to alert health care professionals and uninfected individuals that Truvada for PrEP must only be used by individuals who are confirmed to be HIV-negative prior to prescribing the drug and at least every three months during use. The drug is contraindicated for PrEP in individuals with unknown or positive HIV status. The FDA strongly recommends against such use
Quote:

Truvada’s safety and efficacy for PrEP were demonstrated in two large, randomized, double-blind, placebo-controlled clinical trials. The iPrEx trial evaluated Truvada in 2,499 HIV-negative men or transgender women who have sex with men and with evidence of high risk behavior for HIV infection, such as inconsistent or no condom use during sex with a partner of positive or unknown HIV status, a high number of sex partners, and exchange of sex for commodities. Results showed Truvada was effective in reducing the risk of HIV infection by 42 percent compared with placebo in this population. Efficacy was strongly correlated with drug adherence in this trial.

The Partners PrEP trial was conducted in 4,758 heterosexual couples where one partner was HIV-infected and the other was not (serodiscordant couples). The trial evaluated the efficacy and safety of Truvada and tenofovir versus placebo in preventing HIV infection in the uninfected male or female partner. Results showed Truvada reduced the risk of becoming infected by 75 percent compared with placebo.
Obviously, it isn't a guaranteed means of protection and not much help for people who are already affected, but given how devastating HIV and AIDS are as diseases, any additional bulwark against infection is a major boon. My only hopes are that this doesn't turn out to have hideous side effects down the line and that it doesn't get bogged down in distribution controversy. Sex education in the United States in general is very inconsistent regarding quality and availability, and healthcare, especially for many of the groups at the highest risk of HIV infection is even more unreliable. My greatest fear is that all these factors will combine to keep this drug out of the hands that need it most.

Aldurin 07-17-2012 09:57 AM

This is a pretty big deal, since for a long time we've been stumped on what to do about the virus that attacks the immune system itself. Having actually made a way to reduce infection risk is a big step.

rpgdemon 07-17-2012 11:52 AM

Am I the only one disturbed by their description of the trials? Like, the fact that they had a double blind test environment wherein they gave a high number of people placebos so that they'd get aids? I mean, I get that double-blind testing is the best testing in general, but situation-specifically here it seems pretty horrible.

Aerozord 07-17-2012 01:12 PM

Now as long as people aren't so stupid as to think "I AM IMMUNE NOW" and disregard usual protection we might be on our way to getting rid of this illness

Quote:

Originally Posted by rpgdemon (Post 1205890)
Am I the only one disturbed by their description of the trials? Like, the fact that they had a double blind test environment wherein they gave a high number of people placebos so that they'd get aids? I mean, I get that double-blind testing is the best testing in general, but situation-specifically here it seems pretty horrible.

I think what they do in situations like that is give it to people already intended to do it. but you are right to prove this it would mean there were people that got infected.

I do however wonder why its nearly twice as effective with heterosexuals though.

Shyria Dracnoir 07-17-2012 01:50 PM

It's possible that the first group was more likely to engage in multiple at-risk behaviors at the same time or engage in at-risk behaviors at a greater frequency than the second group, ultimately increasing the probability of an infection bypassing the medication. I would like to see some profession speculation about that however.

As to RPG's questions about the study, I'm pretty sure that the couples entering the study were reasonably informed that if they participated there was no guarantee that they would be receiving the live drug. Human trials today have to adhere to very stringent ethical standards. If they were explicitly told they would get the drug and were still secretly given the placebo, it would justifiably be a shitstorm.

All the same, I hope for the medical community's sake that everything was done up-front; I dread the possibility that years from now this turns out to be Tuskeegee 2.0.

EDIT: The drug may also be more effective at blocking transmission between genders one way instead of the other. I noticed that the smaller group was largely made up of gay or bisexual male couples, while the larger groups were heterosexual couples with an unspecified ratio of infected man/clean woman and clean man/infected woman pairings. In other words, it may be more effective at stopping a woman from catching it from man or vice versa.

EDIT x2: I'm unclear whether "transgender women" in this case means men who were originally women or women who were originally men. If someone more familiar with the terms can clarify I'd appreciate it; I don't want to be insensitive.

rpgdemon 07-17-2012 03:28 PM

Yeah, I was thinking it might be that the risk of a man contracting aids from a woman could be lowered due to less bodily fluid entering exposed areas during sexual intercourse, whereas anal sex might lead to much more mixing of bodily fluids. I have no scientific evidence to back this up, but I think I remember hearing at some point that anal sex is much more prone to transmitting something like HIV because there is more mixing of fluids.

Aerozord 07-17-2012 04:15 PM

but it was percentage compared to the control group. So it couldn't be because the method was less likely to transfer it. It would have to be a difference in how the drug affected people.

By the sounds of it, its just more effective at keeping women from contracting it. Because they didn't even test homosexual sex between two women by the sounds of it. Is it just really unlikely to transfer between to women or what?

Marelo 07-17-2012 04:38 PM

Quote:

Originally Posted by Shyria Dracnoir (Post 1205903)
EDIT x2: I'm unclear whether "transgender women" in this case means men who were originally women or women who were originally men. If someone more familiar with the terms can clarify I'd appreciate it; I don't want to be insensitive.

Generally speaking, transgender individuals prefer to be referred to by the gender they identify with. So a "transgender woman" is probably a woman whose gender was assigned male at birth.

I've got all those qualifiers in there because usage varies and it can get pretty confusing to people who don't have experience with the community. So it's pretty much always best to ask for clarification at the outset of conversation, like you did!

Also, sidenote, it's kind of rude to refer to transgender individuals as having been "originally" the gender they were assigned. It implies some kind of transformation, whereas the individuals in question probably consider themselves as having always been the gender they identify with. Or at least that's what I've been told by transgender friends when I've asked, and read in things floating around about how to politely discuss transgender issues.

Aerozord 07-17-2012 04:56 PM

I have seen gender issues quickly derail threads here, important thing is they were referring to people who wish to be refereed to as a woman.

rpgdemon 07-17-2012 05:02 PM

Okay, now that that's clarified, it also strikes me as really weird that they have the heterosexual group, and then have a gay men and also trans women who are totally just gay men group. Like, what do trans women have in common with gay men, in terms of sexual intercourse? They were born with a penis and some of them like men?

I mean, having a pill designed to prevent HIV -is- good, don't get me wrong, I just think that the testing is questionable not from a standpoint of being effective, but just from a general, "Hey, that's weird", standpoint.


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