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Author Topic: FDA weighs in on using Truvada as PrEP on Thursday  (Read 4105 times)

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Offline buginme2

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FDA weighs in on using Truvada as PrEP on Thursday
« on: May 07, 2012, 03:09:20 AM »
So the FDAis going to decide if Truvada should be prescribed to prevent HIV infection in HIV negative individuals who are at risk of Infection.

Apparently there is some disagreement on if this should be approved.  Tuvada costs $14,000 per year, can cause bone and kidney disease.  Treatment with Truvada would also require continued medical care to screen for these issues added to the cost.

While I cannot see this as being practical for the general public, I think it may be useful for HIV negative people who are in a Serodiscordant relationship.

Here's a recent article in the WSJ

http://online.wsj.com/article/SB10001424052702304020104577384502756088234.html

Offline Tim Horn

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Re: FDA weighs in on using Truvada as PrEP on Thursday
« Reply #1 on: May 07, 2012, 07:50:04 AM »
Thus far, the FDA has been very hush-hush on where it stands on the PrEP data yielded thus far. We should have a better sense of things this week, with the anticipated arrival of the agency's "briefing document" submitted to the Antiviral Drugs Advisory Committee ahead of Thursday's yay-or-nay hearing at the FDA campus in Silver Spring.

<<While I cannot see this as being practical for the general public, I think it may be useful for HIV negative people who are in a Serodiscordant relationship.>>

The data definitely seems to be strongest in serodiscordant relationships, yes. But wouldn't highly effective antiretroviral therapy, given to the positive partner, be the most cost-effective strategy in this particular situation? Not only is it good for the HIV-positive person's health, but it also substantially reduces the risk of transmission. And given the high cost of Truvada, wouldn't it make sense to invest in universal treatment coverage for people living with HIV in resource-poor countries as a method of reducing the risk of transmission in serodiscordant relationships worldwide?

 

Online leatherman

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Re: FDA weighs in on using Truvada as PrEP on Thursday
« Reply #2 on: May 07, 2012, 11:10:31 AM »
living in a country (America) where not all HIV+ people have ready-access to medication (ADAP waiting lists) yet, I believe it's wrong to offer a drug up to the wealthier (those with funds and/or insurance) to use for pleasure purposes alone - especially when the cost, side effects, and the effectiveness (about 44%) are all counter-intuitive for it's use and there is another much more effective and less costly mean with greater effectiveness in stopping the transmission of HIV i.e. condoms.

(AHF is sending a member of our statewide HIV task force (SCHACCTF) to testify at the FDA meeting. w00T!)
leatherman (aka mIkIE)


chart from 1992-2013; updated 2/09/13  Reyataz/Norvir/Truvada

Offline jkinatl2

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Re: FDA weighs in on using Truvada as PrEP on Thursday
« Reply #3 on: May 07, 2012, 11:48:31 AM »
living in a country (America) where not all HIV+ people have ready-access to medication (ADAP waiting lists) yet, I believe it's wrong to offer a drug up to the wealthier (those with funds and/or insurance) to use for pleasure purposes alone - especially when the cost, side effects, and the effectiveness (about 44%) are all counter-intuitive for it's use and there is another much more effective and less costly mean with greater effectiveness in stopping the transmission of HIV i.e. condoms.

(AHF is sending a member of our statewide HIV task force (SCHACCTF) to testify at the FDA meeting. w00T!)

Disagree. Firmly.

People do not like to use condoms. People still do not use condoms. To remove ANY weapon in the arsenal against HIV because of it's cost and general availability is giving pharmaceutical companies the very sustained control and power over human health that the Hippocratic Oath was designed to prevent.

I think that rather than try to prevent people from accessing Truvada (or any drug) as PrEP, we should instead be pressuring for fundamental changes in pricing and availability of these drugs.

I am unconvinced of the 44% number you quote, but even if that proves true (and further/expanded research would be necessary) then that's still 44% more protection for a person who otherwise would be unlikely to use a condom consistently and correctly. And in serodiscordant relationships, if the positive partner is on meds and the negative partner chooses to take Truvada, this might even help minimize the fear and stigma associated with HIV.

I am always disturbed that these forums so rarely address the plethora of heterosexual serodiscordant couples who choose to forego condoms when the positive partner is undetectable. Sure, we mention it as a means to conceive (and a successful one at that) but it's naive to think that these couples always leap back into consistent condom use after the fact. There is still a real homophobic stigma about male "barebacking," rooted less and less in science and rational thought and more in bias and stigma.

We have thrown condoms at HIV for three decades. Why not add to the arsenal?

Maybe I am showing my cynicism here, but the most generous assessment of condom promotion as HIV reduction strategies would be that of a mitigated success. Access to HIV meds to ALL infected people would significantly lower the risk of transmission. The promotion of testing, the reduction of stigma, all these things help to lower transmission rates.

I am in the fence, perhaps, about the real-world benefits of Truvada for PrEP pending further study. But disallowing it altogether just seems counter-intuitive.

And dismissing the use of PrEP for "pleasure purposes alone" really sits badly with me. The more I think of that statement, the angrier I get.

It's the same argument that makes it illegal to sell vibrators in parts of the US/world. It's the same argument that keeps genital mutilation alive. It's the sex-negative attitude that makes heterosexual serodiscordant couples who choose to CONCEIVE revered, and makes serodiscordant male couples who choose to eliminate condoms for the undeniable pleasure of sex reviled.

It's part of the problem. No, scratch that. It's a LOT of the problem.





"Many people, especially in the gay community, turn to oral sex as a safer alternative in the age of AIDS. And with HIV rates rising, people need to remember that oral sex is safer sex. It's a reasonable alternative."

-Kimberly Page-Shafer, PhD, MPH

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Online leatherman

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Re: FDA weighs in on using Truvada as PrEP on Thursday
« Reply #4 on: May 07, 2012, 12:41:30 PM »
although in advertising/advocacy I believe, like your premise, that any and all measures should be taken (as in graphic representations and the more soft-sell approach); however when discussing the medical ramifications of HIV transmission, I am a hold-out for stopping as much transmission as possible - which means taking the more hard-lined approach.

I am unconvinced of the 44% number you quote,
well, then consider the upper possibility number of 72% (I think. it's somewhere right at 75%) - which was only that high for those in the study that were given weekly counseling about HIV, safer sex, and condom usage AND were also given condoms to use. That extra 28% effectiveness cannot be easily explained as just daily Truvada use.

Regardless, using that upper number then still leaves people unprotected 1/4 of the time. That's a pretty big problem in my opinion. People having sex on Truvada are still playing Russian roulette like anyone else having unprotected sex, only now the chances are a little more in their favor of not getting infected. But what if you were one that had the misfortune of having sex without any other protection in that 27% hole?

of course, the net result using Truvada would be less HIV transmission, however at a greatly inflated price (daily drugs and monitoring) per effectiveness, not to mention the risk of resistance, and possible side effects to otherwise healthy individuals.

And dismissing the use of PrEP for "pleasure purposes alone" really sits badly with me.
why would an uninfected person take PrEP daily? So that they could have unprotected sex indiscriminately with no thought of consequences. When we're trying to get the uninfected to take responsibility for protecting their own health, giving them the "out" seems counter-intuitive.

makes serodiscordant male couples who choose to eliminate condoms for the undeniable pleasure of sex reviled
as one who has felt little difference when using a condom and not using a condom, I will admit my own experiences often cloud my judgement about these sorts of issues. However, I have often thought it was just a matter of a person finding the right type and right size of condom to obtain their maximum pleasure, rather than falling back onto the trite "sex doesn't feel as good when I use a condom so therefore I hate using condoms".

I also come from a place of working with other agencies concerned with other sexual health care issues in our state which has high rates for other problems. South Carolina is rated as the state with the 8th highest rate of HIV, 1st highest rate of chlamydia and 12th highest rate of teen pregnancy. Cheap effective condom usage will help all of these problems, while Truvada only have the potential to somewhat help with the HIV-issue.
leatherman (aka mIkIE)


chart from 1992-2013; updated 2/09/13  Reyataz/Norvir/Truvada

Offline spacebarsux

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Re: FDA weighs in on using Truvada as PrEP on Thursday
« Reply #5 on: May 07, 2012, 01:29:58 PM »
why would an uninfected person take PrEP daily? So that they could have unprotected sex indiscriminately with no thought of consequences. When we're trying to get the uninfected to take responsibility for protecting their own health, giving them the "out" seems counter-intuitive.....................
as one who has felt little difference when using a condom and not using a condom, I will admit my own experiences often cloud my judgement about these sorts of issues. However, I have often thought it was just a matter of a person finding the right type and right size of condom to obtain their maximum pleasure, rather than falling back onto the trite "sex doesn't feel as good when I use a condom so therefore I hate using condoms".


Leatherman, I’m grappling to grasp the import of your words here. For me, the precise percentage in risk reduction isn’t really the point. The point is that PrEP significantly reduces the risk of onward transmission for serodiscordant couples and should be made available to those interested in availing of this option, provided that the couple is fully informed of the cost-benefit trade off. Whether a serodiscordant couple, straight or gay, has consensual indiscriminate unprotected sex with no PreP or has protected sex alongside PrEP as an overkill, is their business; their private life. It is no reason to limit the options at their disposal. How and which prophylactics they choose to utilize or the manner of employing these preventative measures should be up to them (with the caveat they know have a full understanding of the science), should they not?

Your argument above is strikingly similar to the homophobic arguments people make for banning gay-sex/relationships in toto. They would say ‘why did they have gay sex when they knew of the consequences’ or some such drivel.
Infected-  2005 or early 2006; Diagnosed- Jan 28th, 2011; Feb '11- CD4 754 @34%, VL- 39K; July '11- CD4 907@26%,  VL-81K; Feb '12- CD4 713 @31%, VL- 41K, Nov '12- CD4- 827@31%

Online leatherman

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Re: FDA weighs in on using Truvada as PrEP on Thursday
« Reply #6 on: May 07, 2012, 02:35:07 PM »
Whether a serodiscordant couple, straight or gay, has consensual indiscriminate unprotected sex with no PreP or has protected sex alongside PrEP as an overkill, is their business; their private life. It is no reason to limit the options at their disposal. How and which prophylactics they choose to utilize or the manner of employing these preventative measures should be up to them (with the caveat they know have a full understanding of the science), should they not?
But wouldn't highly effective antiretroviral therapy, given to the positive partner, be the most cost-effective strategy in this particular situation? Not only is it good for the HIV-positive person's health, but it also substantially reduces the risk of transmission. And given the high cost of Truvada, wouldn't it make sense to invest in universal treatment coverage for people living with HIV in resource-poor countries as a method of reducing the risk of transmission in serodiscordant relationships worldwide?
except, as Tim pointed out also, a serodiscordant couple in which the positive partner is properly and effectively treated basically negates the necessity for also treating the negative partner. The couple doesn't really need another option - not when it's effectiveness isn't very high and infected people still need to even receive this medication to fight HIV and stay alive.

Whether a serodiscordant couple, straight or gay, has consensual indiscriminate unprotected sex with no PreP or has protected sex alongside PrEP as an overkill, is their business; their private life.
in general, having "consensual indiscriminate unprotected sex" with an HIV+ person is tantamount to putting oneself at very high risk of becoming infected. Such a couple would obviously need counseling to understand the risk they were assuming.

If Truvada as PrEP had much more of a success rate (much more than 72% and way way better than the 44%), perhaps using it as another option as their disposal would be warranted; but I just believe Truvada as PrEP still leaves much to be desired to be considered "effective". Our goal should be towards educating people about the risks and reducing the risks - not necessarily condoning the risk just because some people consider themselves a "couple".

I italicized the word "couple" above because I think it's getting overused in parts of this discussion. There are many more single people than "coupled" people, so the situation of using Truvada as PrEP won't necessarily be going toward dedicated couples but towards individuals simply coupling for the sake of sex.
leatherman (aka mIkIE)


chart from 1992-2013; updated 2/09/13  Reyataz/Norvir/Truvada

Offline Buckmark

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Re: FDA weighs in on using Truvada as PrEP on Thursday
« Reply #7 on: May 07, 2012, 03:03:52 PM »
My concern about PrEP is that it might lull some people into a false sense of security, and belief that "all I have to do is take this pill and I won't get HIV".  People would need to realize that it doesn't provide complete protection.  And that's where I think the FDA may get hung up on approving Truvada for PrEP.

Still, it's another tool in the arsenal to fight the spread of HIV, and we need more of those.  I can see it being particularly useful for serodiscordant couples, or anyone who has sex regularly.  Our "sex-negative" society in the US generally takes a grim view of people have sex "indiscriminantly" or "for pleasure purposes", even though people do it in this manner all the time.  That's where I think the media coverage on this will focus, portraying PrEP as another tool to promote promiscuity.  Heck, we haven't all found our Mr. or Ms. Right yet   Doesn't everyone deserve the same tools for protection?

I've really come to hate living in a culture that views sex so negatively.  People are constantly passing judgement on *who* has sex, and *why* they have sex.  Jonathan sums it up so well here:

Quote
It's the sex-negative attitude that makes heterosexual serodiscordant couples who choose to CONCEIVE revered, and makes serodiscordant male couples who choose to eliminate condoms for the undeniable pleasure of sex reviled.

I understand about the cost issue.  I really don't know if insurers would pay for this.  Still, I don't see that PrEP would take meds away from infected individuals who need them.  The whole issue of med affordability and accessibility needs to be addressed in the US (but sadly may never be).  But for now the meds will remain just as unaffordable for people who want to use them for PrEP as for treating HIV infection.

Regards,

Henry
"Life in Lubbock, Texas, taught me two things:
     One is that God loves you and you're going to burn in hell.
     The other is that sex is the most awful, filthy thing on earth and you should save it for someone you love."
- Butch Hancock, Musician, The Flatlanders

Offline buginme2

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Re: FDA weighs in on using Truvada as PrEP on Thursday
« Reply #8 on: May 07, 2012, 03:05:09 PM »
I am in a Serodiscordant relationship.  I am also 100% adherent to my medication with an undetectable viral load.  We should be able to use any and all methods that we choose to protect ourselves. 

Online Miss Philicia

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Re: FDA weighs in on using Truvada as PrEP on Thursday
« Reply #9 on: May 07, 2012, 03:09:18 PM »
I am in a Serodiscordant relationship.  I am also 100% adherent to my medication with an undetectable viral load.  We should be able to use any and all methods that we choose to protect ourselves. 

OK I am going to be devil's advocate here. Do you use condoms all of the time?
"I’ve slept with enough men to know that I’m not gay"

Offline Tim Horn

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Re: FDA weighs in on using Truvada as PrEP on Thursday
« Reply #10 on: May 07, 2012, 03:14:20 PM »
I am in the fence, perhaps, about the real-world benefits of Truvada for PrEP pending further study. But disallowing it altogether just seems counter-intuitive.

This, for me, nails it. Withholding FDA approval, as AHF is advocating for, doesn't make any sense at this stage of the game. Given the moderate efficacy that's been reported thus far, it may not even be ethical to conduct yet another placebo-controlled trial of Truvada as PrEP. If, however, approval allows Gilead to become directly involved in feasibility studies to (hopefully) address some of these lingering questions -- I think, perhaps, Gilead is concerned about being directly involved in PrEP without an FDA approval to provide at least some degree of liability protection -- then so be it.


Offline Buckmark

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Re: FDA weighs in on using Truvada as PrEP on Thursday
« Reply #11 on: May 07, 2012, 03:15:18 PM »
...
Our goal should be towards educating people about the risks and reducing the risks - not necessarily condoning the risk just because some people consider themselves a "couple".

I italicized the word "couple" above because I think it's getting overused in parts of this discussion. There are many more single people than "coupled" people, so the situation of using Truvada as PrEP won't necessarily be going toward dedicated couples but towards individuals simply coupling for the sake of sex.
...

Going back to what I said in my previous reply, everyone deserves  to use the tools that are available to prevent HIV infection, regarding of whether or not they are a "couple".

Say what you want about the efficacy of Truvada as PrEP, but your negative view of sex really sucks (pardon the pun), and actually perpetuates the problem of infection.


"Life in Lubbock, Texas, taught me two things:
     One is that God loves you and you're going to burn in hell.
     The other is that sex is the most awful, filthy thing on earth and you should save it for someone you love."
- Butch Hancock, Musician, The Flatlanders

Offline buginme2

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Re: FDA weighs in on using Truvada as PrEP on Thursday
« Reply #12 on: May 07, 2012, 03:27:05 PM »
OK I am going to be devil's advocate here. Do you use condoms all of the time?

No

Online Miss Philicia

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Re: FDA weighs in on using Truvada as PrEP on Thursday
« Reply #13 on: May 07, 2012, 03:35:09 PM »
No

We should be able to use any and all methods that we choose to protect ourselves.

Well then clearly you're not using "any and all methods" (your words, not mine) are you? I'm not trying to be a dick really, but someone somewhere is going to ask why pills should be paid for by some other entity when you're not making use of something with a better cost/benefit analysis.
"I’ve slept with enough men to know that I’m not gay"

Offline jkinatl2

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Re: FDA weighs in on using Truvada as PrEP on Thursday
« Reply #14 on: May 07, 2012, 05:22:02 PM »
We should be able to use any and all methods that we choose to protect ourselves.

Well then clearly you're not using "any and all methods" (your words, not mine) are you? I'm not trying to be a dick really, but someone somewhere is going to ask why pills should be paid for by some other entity when you're not making use of something with a better cost/benefit analysis.

I am unsure whether FDA approval will impact the likelihood or lack thereof insofar as insurance or other "other" entities paying for Truvada. Which is basically what we're talking here. Straight-up approval for PrEP.

Moreover, isn't that the same train of thought that's recently been used to question whether women should get birth control pills via insurance (where other entities are paying into the collective) rather then A) buy them on their own or B) use condoms (which, if I understand correctly, are something with a better cost/benefit analysis?)

We've been nuzzling against this whole dichotomy for years, the "committed couples vs. Sex-Crazy Sluts thing. I daresay a lot of people exist somewhere inside that continuum, and don't have to be one or the other.

In here, perhaps I see it as sweet, married straight (or married/"married" gay) couples versus single - or differently-committed people. In the general public, the standards are, of course, specifically heteronormative. It is that standard/those standards which should be called into question.

Believing a collective illusion to be true doesn't seem to be going a long way insofar as making it true.

"Many people, especially in the gay community, turn to oral sex as a safer alternative in the age of AIDS. And with HIV rates rising, people need to remember that oral sex is safer sex. It's a reasonable alternative."

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Online mecch

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Re: FDA weighs in on using Truvada as PrEP on Thursday
« Reply #15 on: May 07, 2012, 05:41:21 PM »
brass tacks, society should find the resources to provide all HIV+ people the treatment the need before throwing money at this PrEP.
However, if you got the cash yourself, then by all means help yourself. Though a condom would seem more effective and no chemicals required in the body.
“From each, according to his ability; to each, according to his need” 1875 K Marx

Offline Dachshund

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Re: FDA weighs in on using Truvada as PrEP on Thursday
« Reply #16 on: May 07, 2012, 05:54:08 PM »
brass tacks, society should find the resources to provide all HIV+ people the treatment the need before throwing money at this PrEP.
However, if you got the cash yourself, then by all means help yourself. Though a condom would seem more effective and no chemicals required in the body.

Throwing money at this PrEP? It obviously would be more cost effective than a lifetime of paying for someone's treatment. You obviously chose not to use a condom, but I bet you would have jumped at the chance to use PrEP. The post infection morality of some around here is so tedious.

Offline buginme2

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Re: FDA weighs in on using Truvada as PrEP on Thursday
« Reply #17 on: May 07, 2012, 06:33:48 PM »
We should be able to use any and all methods that we choose to protect ourselves.

Well then clearly you're not using "any and all methods" (your words, not mine) are you? I'm not trying to be a dick really, but someone somewhere is going to ask why pills should be paid for by some other entity when you're not making use of something with a better cost/benefit analysis.

If someone has an unprotected sexual encounter we do not withhold PEP from them because they didn't use a condom in the first place. I fail to see how this is any different. 

The reality is sometimes people don't use a condom (for whatever reason).  Having another tool to use in the prevention arsenal doesn't negate that condoms also work too. 

As far as cost.  Well. Currently it may not be the most cost effective way to prevent HIV.  However, that shouldn't prevent it's approval.  Drug prices decrease over time increasing the cost/benefit over time. 


Offline jkinatl2

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Re: FDA weighs in on using Truvada as PrEP on Thursday
« Reply #18 on: May 07, 2012, 07:44:53 PM »
brass tacks, society should find the resources to provide all HIV+ people the treatment the need before throwing money at this PrEP.
However, if you got the cash yourself, then by all means help yourself. Though a condom would seem more effective and no chemicals required in the body.

This isn't about society funding anything.

This is about allowing Truvada to be prescribed for PrEP.

"Many people, especially in the gay community, turn to oral sex as a safer alternative in the age of AIDS. And with HIV rates rising, people need to remember that oral sex is safer sex. It's a reasonable alternative."

-Kimberly Page-Shafer, PhD, MPH

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Offline jkinatl2

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Re: FDA weighs in on using Truvada as PrEP on Thursday
« Reply #19 on: May 07, 2012, 07:45:18 PM »
Throwing money at this PrEP? It obviously would be more cost effective than a lifetime of paying for someone's treatment. You obviously chose not to use a condom, but I bet you would have jumped at the chance to use PrEP. The post infection morality of some around here is so tedious.

Testify.

"Many people, especially in the gay community, turn to oral sex as a safer alternative in the age of AIDS. And with HIV rates rising, people need to remember that oral sex is safer sex. It's a reasonable alternative."

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Online Miss Philicia

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Re: FDA weighs in on using Truvada as PrEP on Thursday
« Reply #20 on: May 07, 2012, 07:58:08 PM »
Just to be clear, I was not moralizing -- I'm just trying to envision how this would be applied if/when it was approved.
"I’ve slept with enough men to know that I’m not gay"

Offline jkinatl2

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Re: FDA weighs in on using Truvada as PrEP on Thursday
« Reply #21 on: May 07, 2012, 08:02:00 PM »
Just to be clear, I was not moralizing -- I'm just trying to envision how this would be applied if/when it was approved.

I understand, and you are absolutely correct. If this thread is any indication, the knee-jerk reaction will be OMG if we even ALLOW it then we'll have to subsidize it.

Which is obviously bullshit. We can't even get mammograms for everyone who needs them.

"Many people, especially in the gay community, turn to oral sex as a safer alternative in the age of AIDS. And with HIV rates rising, people need to remember that oral sex is safer sex. It's a reasonable alternative."

-Kimberly Page-Shafer, PhD, MPH

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Online Miss Philicia

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Re: FDA weighs in on using Truvada as PrEP on Thursday
« Reply #22 on: May 07, 2012, 08:13:21 PM »
I guess, for me, part of it too is that seeing as how only 20% of diagnosed people in the US even stay regularly engaged in specialist HIV care that this is all just a huge waste of time. It just seems impractical on many levels.

Maybe I'm just too cynical.
"I’ve slept with enough men to know that I’m not gay"

Offline jkinatl2

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Re: FDA weighs in on using Truvada as PrEP on Thursday
« Reply #23 on: May 07, 2012, 08:27:30 PM »
I guess, for me, part of it too is that seeing as how only 20% of diagnosed people in the US even stay regularly engaged in specialist HIV care that this is all just a huge waste of time. It just seems impractical on many levels.

Maybe I'm just too cynical.

I don't know if you can ever be TOO cynical. I just think it does no harm to have that option open for those who wish to have Truvada prescribed on-label as PrEP.

I tend to be all Wiccan about that sort of thing.

And think about it. Paying top shelf for that PrEP puts Truvada more into the mainstream. This in turn "subsidizes" the med for those who can't afford it or depend on drug company "compassionate" care.



"Many people, especially in the gay community, turn to oral sex as a safer alternative in the age of AIDS. And with HIV rates rising, people need to remember that oral sex is safer sex. It's a reasonable alternative."

-Kimberly Page-Shafer, PhD, MPH

Welcome Thread

Online mecch

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Re: FDA weighs in on using Truvada as PrEP on Thursday
« Reply #24 on: May 08, 2012, 05:53:42 AM »
This isn't about society funding anything.

This is about allowing Truvada to be prescribed for PrEP.

Hey, I'm all for that.  If the FDA says its useful, then fine. And insurance should cover it.  It should certainly be covered for people trying to have babies naturally, for example.
My argument was in the abstract.  Since there does seem to be a muddy and abstract argument about the total cost of medicine to a society and equitable access to the most important treatments.  (Why would a marginally effective and expensive prevention method be a better cost to society rather than an effective and extremely low cost one - condoms.)  Non stop argument about the "global" concern of health costs, in fact.  And clearly there should be no waiting lists for HIV+ who need HAART in a rich society.   Surely this is apples and oranges in the concrete, but not in the global muddy way people think about such matters.

But I do agree that FDA should act on science, not cost and not morality.
« Last Edit: May 08, 2012, 05:56:39 AM by mecch »
“From each, according to his ability; to each, according to his need” 1875 K Marx

Offline Tim Horn

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Re: FDA weighs in on using Truvada as PrEP on Thursday
« Reply #25 on: May 08, 2012, 09:57:40 AM »
If anyone's interested, here's the background package provided by the FDA to Thursday's Antiviral Drugs Advisory Committee members (David Evans is one of the community representatives).

It doesn't look as if the FDA itself has any major objections to the efficacy or safety data submitted thus far.

Gilead's data set is also available.
« Last Edit: May 08, 2012, 10:02:34 AM by Tim Horn »

Offline emeraldize

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Re: FDA weighs in on using Truvada as PrEP on Thursday
« Reply #26 on: May 08, 2012, 03:38:41 PM »
<http://www.denverpost.com/ci_20573862?source=share_fb&fb_source=message>http://www.denverpost.com/ci_20573862?source=share_fb&fb_source=message


FDA favors first drug for HIV prevention By MATTHEW PERRONE AP Health Writer News Fuze


WASHINGTON­Federal drug regulators on Tuesday affirmed landmark study results showing that a popular HIV-fighting pill can also help healthy people avoid contracting the virus that causes AIDS in the first place. While the pill appears safe and effective for prevention, scientists stressed that it only works when taken on a daily basis.

The Food and Drug Administration will hold a meeting Thursday to discuss whether Truvada should be approved for people who are at risks of contracting HIV through sexual intercourse. The agency's positive review posted Tuesday suggests the daily pill will become the first drug approved to prevent HIV infection in high-risk patients.

FDA reviewers conclude that taking Truvada pre-emptively could spare patients "infection with a serious and life-threatening illness that requires lifelong treatment."

Despite the positive results, reviewers said that patients must be diligent about taking the pill every day. Adherence to the medication was less than perfect in clinical trials, and reviewers said that patients in the real world may forget to take their medication even more than those in clinical studies.

First announced in 2010, Truvada's preventive ability was hailed as a breakthrough in the 30-year campaign against the AIDS epidemic. A three-year study found that daily doses cut the risk of infection in healthy gay and bisexual men by 44 percent, when accompanied by condoms and counseling. Another study found that Truvada reduced infection by 75 percent in heterosexual couples in which one partner was HIV infected and the other was not.

The FDA's panel of advisers will take separate votes on whether Truvada should be approved for:

­ gay and bisexual men

­ other people at risk of acquiring HIV through sexual activity

The FDA is not required to follow the advice of its panels, though it usually does.

An estimated 1.2 million Americans have HIV, which overwhelmingly affects men who have sex with other men, according to the Centers for Disease Control and Prevention. HIV attacks the immune system and, unless treated with antiviral drugs, develops into AIDS, a fatal condition in which the body cannot fight off foreign infections.

Because Truvada is already on the market to manage HIV, some doctors currently prescribe it as a preventive measure. FDA approval would allow the drugmaker Gilead Sciences to formally market its drug for the new use.

But support for FDA approval is not unanimous.
Some researchers stress that condoms remain the best weapon against AIDS, and a prevention pill is not the chemical equivalent.

"We know that if the person doesn't take the medication every day they will not be protected,"
said Dr. Rodney Wright, director of HIV programs at Montefiore Medical Center in New York. "So the concern is that there may not be adequate adherence to provide protection in the general population."

Wright, who is also chairman of the AIDS Health Foundation, added that some upcoming medications may be more effective at preventing infection than Truvada.

Researchers also worry about Truvada's mixed success rate in preventing infection among women.
Last year a study in women was stopped early after researchers found that women taking the drug were more likely to become infected than those taking placebo. Researchers speculated that women may need a higher dose of the drug to prevent infection. They also said the disappointing results may have resulted from women not taking the pills consistently.

Still, many HIV patient advocacy groups say the drug should be a prescribing option to prevent HIV, alongside condoms, counseling and other measures.

"If we're going to reduce the more than 50,000 new HIV infections in this country each year, we need to increase the available options for people," said Ronald Johnson, vice president of AIDS United. He added that more studies are needed to determine the drug's effectiveness in women and other patient subgroups.

"The current state of the data warrants going forward, but we believe additional clinical trials should also go forward to broaden the use of Truvada."

Last month, AIDS United and more than a dozen other advocacy groups sent a letter to the FDA, urging approval of Truvada.

Foster City, Calif.-based Gilead Sciences Inc.
has marketed Truvada since 2004. The drug is a combination of two older HIV drugs, Emtriva and Viread. Doctors usually prescribe the medications as part of a drug cocktail that makes it harder for the virus to reproduce. Patients with low viral levels are far less likely to develop AIDS.

Side effects with Truvada include diarrhea, dizziness, nausea and vomiting. More serious problems can include liver toxicity, kidney problems and bone thinning.

Offline jkinatl2

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Re: FDA weighs in on using Truvada as PrEP on Thursday
« Reply #27 on: May 08, 2012, 04:50:20 PM »
Hey, I'm all for that.  If the FDA says its useful, then fine. And insurance should cover it.  It should certainly be covered for people trying to have babies naturally, for example.
My argument was in the abstract.  Since there does seem to be a muddy and abstract argument about the total cost of medicine to a society and equitable access to the most important treatments.  (Why would a marginally effective and expensive prevention method be a better cost to society rather than an effective and extremely low cost one - condoms.)  Non stop argument about the "global" concern of health costs, in fact.  And clearly there should be no waiting lists for HIV+ who need HAART in a rich society.   Surely this is apples and oranges in the concrete, but not in the global muddy way people think about such matters.

But I do agree that FDA should act on science, not cost and not morality.

I am glad we are on the same page.

Also, it sucks that people will leap directly from the scientific platform to the social/moral one when discussing this.

If you replace "Truvada" with "birth control pills" you will get a real example of how women in the US feel right about now.

"Many people, especially in the gay community, turn to oral sex as a safer alternative in the age of AIDS. And with HIV rates rising, people need to remember that oral sex is safer sex. It's a reasonable alternative."

-Kimberly Page-Shafer, PhD, MPH

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Offline elf

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Re: FDA weighs in on using Truvada as PrEP on Thursday
« Reply #28 on: May 11, 2012, 05:30:31 PM »
So, Truvada is going to be a new orgy drug.
Just like many MSM people take doxycycline and azithromycin as a part of prophylactic ''regime'' before they go to an orgy, they will just add Truvada to it. Up to 30 men can share a bottle of Truvada, and the cost of the pill will be included in the orgy admission fee.
Just wait and see.

To me it's just a message from pharmaceutic companies: we don't really care. More money to us.

And ''party people'' will always find a way to get Truvada w/o prescription.
« Last Edit: May 11, 2012, 05:33:08 PM by elf »
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Offline buginme2

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Re: FDA weighs in on using Truvada as PrEP on Thursday
« Reply #29 on: May 11, 2012, 05:43:59 PM »

Also, it sucks that people will leap directly from the scientific platform to the social/moral one when discussing this.



Kind of like the statement from Elf above?

And Elf? So what? So what if someone takes Truvada before a night of off the wall sex.  If it keeps them from getting HIV who cares?  Would you not people rather take something that could prevent them getting HIV? Is t that the point? Why the concern about how other people conduct their sex life?

Offline jkinatl2

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Re: FDA weighs in on using Truvada as PrEP on Thursday
« Reply #30 on: May 11, 2012, 06:10:35 PM »
Kind of like the statement from Elf above?


Exactly like that statement. And again, it sucks that pozzies are often the worst about judging other people.

HIV is not a character assessment. It is not a punishment for lewd behavior. It's a goddamned virus.

By the fucking way, you don't need an "orgy" to get HIV. You need viral particle A to latch onto vulnerable cell "B."

Harold Tiberious Christ on a popsicle stick, I don't get people.

"Many people, especially in the gay community, turn to oral sex as a safer alternative in the age of AIDS. And with HIV rates rising, people need to remember that oral sex is safer sex. It's a reasonable alternative."

-Kimberly Page-Shafer, PhD, MPH

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Offline Joe K

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Re: FDA weighs in on using Truvada as PrEP on Thursday
« Reply #31 on: May 11, 2012, 06:39:45 PM »
I'm confused on how a post about the FDA approving Truvada, got twisted to become a soapbox for the morality police.  We are talking science here, nothing else and if the science supports it, I hope the FDA approves its use.  As for the moralizing and judgement of some posts, might I suggest you take a portion of your pathology for judging others and direct it to some constructive use.  To think that pozzies would seek to deny a way to prevent infections is very troubling.  Some of you should learn what "tolerance" means.

Joe
Life is what happens, when you are busy making other plans.

Though you may be only one person in the entire world, to one person, you may be the entire world.

I wish to become half the man, that my dog thinks I am.

Remember me with simple acts of kindness and I will live forever.

Offline jkinatl2

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Re: FDA weighs in on using Truvada as PrEP on Thursday
« Reply #32 on: May 11, 2012, 07:15:09 PM »
I'm confused on how a post about the FDA approving Truvada, got twisted to become a soapbox for the morality police.  We are talking science here, nothing else and if the science supports it, I hope the FDA approves its use.  As for the moralizing and judgement of some posts, might I suggest you take a portion of your pathology for judging others and direct it to some constructive use.  To think that pozzies would seek to deny a way to prevent infections is very troubling.  Some of you should learn what "tolerance" means.

Joe

Because some people come into a support forum looking for compassion and honest, science-based support. Yet they are incapable or unwilling to offer the same to others. In England they call them Twats.

And yes, anyone who mentioned not approving Truvada because of a morality/promiscuity issue is a hypocritical twat.

As most of us know, Truvada has been used off-label for Prep for upwards of a decade. Allowing it to be prescribed means people will no longer have to commit a felony to sell or buy it.

This shit makes me extremely angry. And honestly, betrayed when I see it coming from people here. Here, of all places. To those who preached the morality of allowing "promiscuity" or "orgies?" I have only one wish for you, ADAP.

Like that dreadful thread where people piled on a guy who related - turned to US for help with a complicated and agonizing disclosure issue. I am getting to be a little more like my heroes on this site. I am remembering names, and I am less and less inclined to show a great depth of compassion for people who have no compassion to give to others.

Let them see how it feels when people decide THEIR health is not worth "subsidizing" or "condoning."






"Many people, especially in the gay community, turn to oral sex as a safer alternative in the age of AIDS. And with HIV rates rising, people need to remember that oral sex is safer sex. It's a reasonable alternative."

-Kimberly Page-Shafer, PhD, MPH

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Offline madbrain

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Re: FDA weighs in on using Truvada as PrEP on Thursday
« Reply #33 on: May 11, 2012, 08:23:39 PM »
Tim,

If anyone's interested, here's the background package provided by the FDA to Thursday's Antiviral Drugs Advisory Committee members (David Evans is one of the community representatives).

It doesn't look as if the FDA itself has any major objections to the efficacy or safety data submitted thus far.

Gilead's data set is also available.

Thanks ! That is a fairly long package to read. Has anyone in the forum tried to summarize it ?

I heard Anthony Fauci on NPR say today that among people who were adherent to the drug, as evidenced by levels of the drug in the blood, there was a 90% reduction in infections. That seems promising. At the same time, I wonder about the 10% who got infected. Did they get an HIV strain that was resistant to Truvada ? I hope the answer is in that package somewhere. A search on the word "resistant" does find several references.

One quote :

"The risk of developing drug resistant HIV-1 variants may occur in persons who continue to take TRUVADA for a pre-exposure prophylaxis (PrEP) indication following HIV seroconversion. Because of this risk, FDA required the applicant submit a proposed REMS for TRUVADA for a PrEP indication."

Another :
"The importance of regular monitoring of HIV-1 serostatus to avoid continuing to take TRUVADA if seroconversion has occurred, to reduce the risk of development of drug-resistant HIV-1 variants"

Given this, to me, it seems if Prep with Truvada becomes common, there might be a surge in people infected with resistant viral strains. That would certainly seem dangerous to society. As someone who takes a drug regimen that includes Truvada, I can't say that I would be thrilled about the proliferation of resistant virus.

So to me, this brings several additional questions.
1) did those individuals who were taking PrEP and got infected all contract strains that were already resistant to Truvada ?
2)  if not - and someone taking Prep still contracted a strain that was not resistant to Truvada
a) How long does it take for someone to develop a resistant strain if they continue to use Truvada ?
b) how often should individuals taking PrEP get tested for HIV, and what type of test should they use, in order to catch the HIV infection in time, and prevent the virus from becoming resistant to Truvada.

There are other unrelated scientific questions that are hard to answer, such as how many days you need to be on the med before you have sufficient blood levels of the drug to provide protection. I don't know if the paper offers insight on that.

So, IMO, even without even discussing any issue of coverage or payment for the drug, let alone morality, it is not clear when PrEP should be prescribed, to who, if it needs to be taken lifetime or not,  and how often indiduals taking PrEP need to get tested.

Offline Teresa

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Re: FDA weighs in on using Truvada as PrEP on Thursday
« Reply #34 on: May 11, 2012, 10:17:52 PM »
As the HIV- wife of a HIV+ hubby I would not take Truvada. I wouldnt want any of the side effects. We have done just fine using condoms and will continue using them. Its been 6 years and I have tested HIV- every year.

Hugs
Teresa
Hubby HIV+ 5/5/06
CD4:320
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 VL: <20
Atripla (started it 8/24/06)
 

Offline jkinatl2

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Re: FDA weighs in on using Truvada as PrEP on Thursday
« Reply #35 on: May 12, 2012, 12:05:39 AM »
As the HIV- wife of a HIV+ hubby I would not take Truvada. I wouldnt want any of the side effects. We have done just fine using condoms and will continue using them. Its been 6 years and I have tested HIV- every year.

Hugs
Teresa

As an HIV positive person for over 19 years, Truvada has been one of the few drugs with zero side effects. And I have been on just about every non-injectable one. For years plural, and with much research.

SO obviously your mileage may vary.

"Many people, especially in the gay community, turn to oral sex as a safer alternative in the age of AIDS. And with HIV rates rising, people need to remember that oral sex is safer sex. It's a reasonable alternative."

-Kimberly Page-Shafer, PhD, MPH

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Offline J.R.E.

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Re: FDA weighs in on using Truvada as PrEP on Thursday
« Reply #36 on: May 12, 2012, 03:52:15 AM »
I am not sure if this update had already been posted. Update:


FDA Panel Says Yes to HIV Prevention Pill
By Michael Smith, North American Correspondent, MedPage Today

Published: May 10, 2012

An anti-HIV combination pill should be approved to prevent HIV infection in healthy people, an FDA advisory committee agreed overwhelmingly Thursday.

The combination of emtricitabine and tenofovir (Truvada) is safe and well tolerated, the committee decided, and helps prevent HIV infection when used daily by people at high risk.

The panel voted 19-3 that a risk-benefit analysis favored approval of the drug for men who have sex with men, and 19-2, with one abstention, for heterosexuals in couples in which one partner has HIV and the other does not.

The panel was also asked to consider the risk-benefit profile for other people at risk of acquiring HIV through sexual activity; the vote was 12-8 favoring approval, with two abstentions.

The vote marks a departure in the battle to control the HIV/AIDS pandemic – HIV drugs until now have always been approved for therapy, rather than for so-called pre-exposure prophylaxis (PrEP). The FDA is not required to follow the advice of its advisory panels, but it usually does.

The committee was told that two major trials found that -- for healthy people at high risk for infection – taking Truvada daily yields significant protection. The caveat is that the protection was greatest among those who were most consistent about taking the medication.

The drug's maker, Gilead Sciences of Forest City, Calif., asked for the new indication in the wake of the iPrEx and Partners PrEP studies.

Despite the positive votes, there was detailed discussion about ways to prevent potential harms involved in prescribing drugs to people who do not need them for treatment.

A proposed Risk Evaluation and Mitigation Strategy (REMS), which would offer medication guides to patients and would survey physicians and patients about their use of the drug, was characterized as too passive.

A key risk is resistance to the drugs, which can arise if it is used by a person who is actually infected. Panel members worried that the proposed REMS does not include a mechanism to ensure that Truvada would only be given to a person who is HIV-negative.

There was no signal that resistance to either drug was an emerging danger, the committee was told. FDA reviewers noted that there were no cases of resistance mutations found among those who became infected while on treatment in the two trials.

On the other hand, there were several cases of resistance mutations found in participants who had an undetected acute HIV infection when they started the trials.

Several people who testified before the panel – many of them associated with the Los Angeles-based AIDS Healthcare Foundation (AHF) -- opposed approval on the grounds that it is unlikely that healthy people will take the medication properly, exposing them to increased risk since they will believe they are protected.

"People aren't going to take Truvada daily," argued Karen Haughey, RN. "It's not in our nature to take pills when we're not sick."

Indeed, said Catherine Chien, MD, of the AHF, "I have a hard enough time convincing patients with HIV to be adherent to their medication." In the studies, she noted, only a minority of participants were highly adherent to the medication.

Tom Myers, the foundation's general counsel, noted that the benefits seen in the trials were in the context of intensive regular counseling about safe sex and adherence to medication.

But such counseling is rare in the U.S., he said, adding that "absent these interventions (PrEP with Truvada) has not been shown to be safe and effective."

Other participants, however, argued that approving the drug combination for PrEP would add to the available prevention measures, even if it will take some effort to make sure it is used correctly and safely.

"The ifs and the hows are huge and complex, but they are not reasons not to approve this supplemental new drug indication," said Mitchell Warren, executive director of the New York-based advocacy group AVAC. "Approval is the best way to manage the many issues raised here."

Anti-retroviral drugs have for decades been used only for treatment; indeed, emtricitabine/tenofovir is one of the mainstays of modern triple-drug therapy for people already infected with HIV.

One advantage of PrEP would be that control of protection would lie in the hands of the uninfected partner, unlike most current interventions. But the issue has been controversial, if only because anti-retroviral medications are expensive and – in many places – hard to come by.

And a recent trial showed that, in heterosexual couples where only one partner is infected, treating the infection with full-scale triple-drug therapy reduced the risk of transmission by more than 90%.

Many experts, including former International AIDS Society president Julio Montaner, MD, of the University of British Columbia in Vancouver, have argued that, in the light of the evidence, the best use of scarce medications is to get infected people on treatment.

Such an approach is likely to provide a bigger bang for the buck, Montaner told MedPage Today at the Rome meeting of the International AIDS Society in 2011.

"The best, most solid investment in stopping the epidemic is to invest in treatment now, massively, as much as we can," Montaner argued, while PrEP will only have a role as a "very targeted" approach, aimed at people who for one reason or another are at high risk and can't control their exposure to the virus.
Current Meds ; Viramune, Epzicom, 40mg of simvastatin, 12.5mg of Hydrochlorothiazide.
Metoprolol tartrate 25mg



http://forums.poz.com/index.php?topic=40802.0

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http://forums.poz.com/index.php?topic=39414.msg491701#msg491701


 In October of 2003, My t-cell count was 16, Viral load was over 500,000, Percentage at that time was 5%. I started my first  HAART regimen  on October 24th,03.

 As of 6/4/14,  t-cells are at 423, Viral load <40

 Current % is at 13% 

  
 62 years young.

 


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