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Truvada Approved to Reduce the Risk of Sexually Transmitted HIV in People Who Are Not Infected With the Virus

July 16, 2012

On July 16, 2012, the Food and Drug Administration approved Truvada (a fixed dose combination of emtricitabine/tenofovir disoproxil fumarate) 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 is to be used for pre-exposure prophylaxis (PrEP) in combination with safer sex practices to prevent sexually-acquired HIV infection in adults at high risk. Truvada is the first drug approved for this indication.

Truvada for PrEP is meant to be used as part of a comprehensive HIV prevention plan that includes risk reduction counseling consistent and correct condom use, regular HIV testing, and screening for and treatment of other sexually-transmitted infections. Truvada is not a substitute for safer sex practices

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Visit the FDA's website to find out more about their activities and publications.
See Also
More on HIV Medications
More News on Truvada (Tenofovir/FTC)

Reader Comments:

Comment by: michael (los angeles) Sat., Jul. 21, 2012 at 4:29 am UTC
that's a very expensive supplemental protection. i guess it's all about the benjamins. i doubt the majority of insurance companies will approve spending nearly a thousand dollars for a preparation/prevention drug when they can easily tell you to wear a condom and if you get sick, kick you off their plan.

this move makes no real sense, unless they remove the patent and allow for the formulation of generics so that it is easily accessible.

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Comment by: Anonymous (st.louis,Mo) Tue., Jul. 17, 2012 at 11:34 pm UTC
We have come a long way!!!!!
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Comment by: Tom (Fairfield, Ca) Tue., Jul. 17, 2012 at 12:49 pm UTC
Hmmm...a prevention pill that isn't half as good as condoms and will probably replace them. Wonder how much the bribes for this one totalled?
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Comment by: Nick R (Toronto) Mon., Jul. 16, 2012 at 7:38 pm UTC
A question,

If "safe sex" practices (i.e. condom use) prevents HIV anyway, why does it recommend using safe sex practices along with Truvada? In other words, this "news" sort of implies that if you are already having safe sex with HIV infected persons, you should also be taking Truvada. Can someone clear this up for me?

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Replies to this comment:
Comment by: Cole (Detroit, MI) Fri., Jul. 20, 2012 at 3:39 pm UTC
Hey Nick,

I think the purpose of the Truvada PrEP, at least in theory, is to provide *SUPPLEMENTAL* protection against HIV for when condoms fail. As I'm sure you know, condoms are highly effective against spreading HIV, but they are not 100% effective, and the efficacy declines with improper use.

Of course, there is, as Tom pointed out above, a high risk that some patients will be irresponsible and use Truvada as a replacement for condom use, which is extremely dangerous and wreckless, and will greatly increase their likelihood of getting infected, sadly.

I hope that people will choose to act responsibly and always use condoms first, but I know that will not always be the case. :-(

Comment by: Tom (Fairfield, Ca) Sun., Jul. 22, 2012 at 9:34 am UTC
We shouldn't refer to PrEP's victims as "irresponsible". Think of how they're seeing it; an HIV prevention pill. This is what the news has been calling it. This is what the ads they'll be seeing will refer to it as. Remember that until you've lived with HIV, this virus is binary. Things work or they don't. Things are risky or safe. You're infected, or you're not. This is why we gave up qualifying "safe" sex as "safER". This is why HAART has existed for more than half of the epidemic, but it still means nothing to tell the average neg that you're undetectable. They just blink and say "but you still have virus in your blood, right?". It really is a quantum leap to go from the general public's understanding of HIV to that of an educated patient. It's not just an intellectual jump, but an intuitive one. Of course most of PrEP's users are going to trash condoms. Virtually no one is going to keep using rubbers-which are nearly 100% effective-and go through the acrobatics of getting & using PrEP. A person would have to be a hypochondriac to do that.

When these people have unprotected sex, they'll wind up infected. They'll find themselves caught up in the same cycle of self blame that characterizes everyone who winds up infected, probably magnified. They'll have to hear how it was their fault because they weren't sufficiently adherent. They'll never hear how, even in clinical trials, only a small minority was adherent enough for this drug to be reasonably protective.

I think we as lay poz people need to re-examine the activists, news organizations, regulatory panels and service organizations who've moved for this. These are the groups who knew better, but enabled it. This is their fault, and it will be their hands which are covered in blood. Granted, they apparently had reason to fear retaliation, but that doesn't excuse anything. Ask ourselves, do we want these people with us going forward? I think the answer is clearly no.

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