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Author Topic: FDA delays decision on drug to prevent HIV  (Read 1336 times)

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Offline leatherman

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  • Google and HIV meds are Your Friends
FDA delays decision on drug to prevent HIV
« on: June 11, 2012, 10:15:54 AM »
FDA delays decision on Truvada

‎"The Food and Drug Administration is delaying by three months a decision on whether to approve a drug for preventing infection with HIV, the virus that causes AIDS."

"During the May meeting, FDA advisers wrestled with safety concerns, including fears that men taking the drug would see it as an excuse to stop using condoms, and worries that healthy people would not take the drug daily as prescribed.

The biggest safety worry: that people already diagnosed with HIV will take the drug, a scenario that can trigger drug-resistant, difficult-to-treat HIV."

http://ow.ly/bu3j7 The Washington Post
leatherman (aka mIkIE)


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

Offline vaguesbleues

  • Member
  • Posts: 93
Re: FDA delays decision on drug to prevent HIV
« Reply #1 on: June 11, 2012, 02:50:28 PM »
I have also been a bit apprehensive in how I view the use of PEP long term.  I mean, it has been shown to work for those after exposure, but for long term use, wouldn't it be "better" to use a full drug regiment as opposed to only 2 NRTIs?  I'd also be a bit worried about a potential resistance. 
03/10/2011 - Tested HIV negative
04/26/2011 - Inconclusive WB result
05/19/2011 - Confirmed HIV positive
                    VL < 50, T-Cell 747 (30%)
06/13/2011 - VL 345, T-Cell 841 (30%)
08/23/2011 - VL 50,100, T-Cell 1155 (19%) - CMV
09/18/2011 - Started Atripla!!
11/07/2011 - VL 489, T-Cell 881 (31%)
02/08/2012 - VL Undetectable!!, T-Cell 772 (34%)
08/08/2012 - VL UD, T-Cell 1070 (42%)
11/05/2012 - VL UD, T-Cell 1174 (35%)
03/18/2013 - VL UD, T-Cell 972 (28%)
10/04/2013 - VL UD, T-Cell 1025 (34%)

Offline leatherman

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Re: FDA delays decision on drug to prevent HIV
« Reply #2 on: June 11, 2012, 03:41:43 PM »
as it was being debated, we actually had a discussion about this that you might be interested in reading
FDA weighs in on using Truvada as PrEP on Thursday
leatherman (aka mIkIE)


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

Offline jkinatl2

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  • Doo. Dah. Dipp-ity.
Re: FDA delays decision on drug to prevent HIV
« Reply #3 on: June 11, 2012, 05:19:56 PM »
FDA delays decision on Truvada

"During the May meeting, FDA advisers wrestled with safety concerns, including fears that men taking the drug would see it as an excuse to stop using condoms, and worries that healthy people would not take the drug daily as prescribed.

The biggest safety worry: that people already diagnosed with HIV will take the drug, a scenario that can trigger drug-resistant, difficult-to-treat HIV."

http://ow.ly/bu3j7 The Washington Post

Like people use condoms 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

Welcome Thread

Offline denb45

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Re: FDA delays decision on drug to prevent HIV
« Reply #4 on: June 11, 2012, 05:31:59 PM »
Like people use condoms now?

LOL, I haven't used a condom in 20 yrs. 1990 was the last  time  ;D
"it's so nice to be insane, cause no-one ask you to explain" Helen Reddy cc 1974

Offline newt

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  • the one and original newt
Re: FDA delays decision on drug to prevent HIV
« Reply #5 on: June 11, 2012, 05:47:08 PM »
So, 2 straw dogs to tilt at. Disinhibition has never really been proven with any sex related prevention technology. As for resistance, read the bloody studies FDA. Almost certainly, today, the contracetive pill would be deferred for 3+ months for similar concerns (albeit not an exact match).

License the f******g drug.

- matt
"The object is to be a well patient, not a good patient"

Offline phildinftlaudy

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  • sweet Ann what you think babe...
Re: FDA delays decision on drug to prevent HIV
« Reply #6 on: June 11, 2012, 06:20:28 PM »
My ID doc at University of Miami is actually the co-PI on another study that is currently enrolling men who have sex with men but who are HIV - and want to take Truvada as PREP...

She is very excited about it. She told me to let others who might be interested in participating and who might be eligible to know about it.

September 13, 2008 - diagnosed +
Labs:
Date    CD4    %   VL     Date  CD4  %   VL
10/08  636    35  510   9/09 473  38 2900  12/4/09 Atripla
12/09  540    30    60   
12/10  740    41  <48   
8/11    667    36  <20  
03/12  1,041  42  <20
05/12  1,241  47  <20
08/12   780    37  <20
11/12   549    35  <20
02/12  1,102  42  <20
11/12   549    35  <20

Offline denb45

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  • "1987 Classic Old School POZ+"
Re: FDA delays decision on drug to prevent HIV
« Reply #7 on: June 11, 2012, 06:35:31 PM »

License the f******g drug.

- matt[/font]

Sure couldn't hurt  :)
"it's so nice to be insane, cause no-one ask you to explain" Helen Reddy cc 1974

Offline leatherman

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Re: FDA delays decision on drug to prevent HIV
« Reply #8 on: June 11, 2012, 08:24:58 PM »
Like people use condoms now?
sure. many people use condoms. Drug stores sell them all the time and agencies give them away, with people coming in to request them. The problem has always been that not enough people use them  ;)
leatherman (aka mIkIE)


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

Offline denb45

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  • "1987 Classic Old School POZ+"
Re: FDA delays decision on drug to prevent HIV
« Reply #9 on: June 11, 2012, 09:31:57 PM »
sure. many people use condoms. Drug stores sell them all the time and agencies give them away, with people coming in to request them. The problem has always been that not enough people use them  ;)

 ::) a day late and a dollar short for most of us, wouldn't you say....
« Last Edit: June 11, 2012, 09:33:47 PM by denb45 »
"it's so nice to be insane, cause no-one ask you to explain" Helen Reddy cc 1974

Offline leatherman

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  • Google and HIV meds are Your Friends
Re: FDA delays decision on drug to prevent HIV
« Reply #10 on: June 11, 2012, 11:38:11 PM »
::) a day late and a dollar short for most of us, wouldn't you say....
then this whole subject of Truvada as PrEP is a day late and a dollar short for all of us too ::)

are you implying that you're against condoms being used as prevention?
are you implying that you're against Truvada used for prevention?

although, it can be said that if pozzies use condoms and/or take Truvada they can reduce their chances of spreading HIV, so maybe condoms and Truvada are current and right on the money for us too. ;)
leatherman (aka mIkIE)


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

 


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