February 15, 2012

FDA Gives Priority Review of Truvada as PrEP

The U.S. Food and Drug Administration (FDA) has accepted Gilead Sciences’ application to give priority review of Truvada (emtricitabine and tenofovir) as pre-exposure prophylaxis (PrEP), according to a Gilead statement. This PrEP is when an HIV-negative person takes a daily dose of Truvada as a means to lower the chance of contracting the virus during sex. The FDA grants fast-track appraisal to drug applicants that demonstrate major advances in treatment or provide a treatment where no adequate or current therapy exists. Approval of the supplemental New Drug Application (sNDA) will be discussed at the FDA Antiviral Drugs Advisory Committee in May. The target review date is June 15.

To read the Gilead statement, click here.

Search: U.S. Food and Drug Administration, FDA, Gilead Sciences, Truvada, pre-exposure prophylaxis, PrEP, supplemental New Drug Application, sNDA, Antiviral Drugs Advisory Committee

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Previous Comments:

DJ, New Orleans, LA, 2012-02-22 18:43:45
I see no wrong with having an additional option to prevent an already wild-fire like disease. The guys that have POZ boyfriends and husbands should be able to enjoy the intimate act of bare sex if given the option. I can agree that the "party boys" will most likely try and use this drug as an excuse to have sex with anyone they want, and not mention their status. I feel this preventative drug can have both a positive, and negative impact. Only time will tell the outcome, but we have the option.

Afroshawty, , 2012-02-17 23:27:41
We all know that the available treatments to manage the disease work. Now its time to move on and rather focus on a CURE. All new funds shuld target companies that work on a cure. It doesn't make a difference to make a long list of what this or that treatment med can do. Poz people have given up natural sex, compromised it and use a condom willingly, This story of Truvada for PerP seems to be saying, we want everyone to enjoy sex naturally, neg or poz, shuld all enjoy it the same.

Jeton Ademaj, Harlem, NYC, 2012-02-17 13:48:36
as i read the comments here, i'm glad i've limited myself from getting sucked into online arguments about this too much...unlike the Internet, when u go before the FDA to complain, u had better have ur arguments prepared well. "Truvada will cost 10k a month!"..."there partyboys will create SUPERAIDS so they can bareback!"..."Big Pharma doesn't care about a CURE!" (of course they dont!)...NONE of this infantilism means much to a Government agency. PrEP will reduce HIV-infection, period.

Gene, San Francisco, 2012-02-17 03:41:41
They rather find ways to have more people buying there pills then work for a cure. i take truvada and it keeps me healthy, but do you ever feel like there focus is more about making money then helping the human race? Do these companies want a cure? I am not anti-meds, they saved my life, but as we reflect on lives lost in the past 30 years, it is always good to question if everything is being done that can be or is profitable biz keeps us hooked for the rest of our lives?

Mario, , 2012-02-16 23:50:52
Hope ya'll love paying 10k a month for your truvada, cuz thats what we're gonna get stuck paying so that a handful of partyboys can enjoy taking loads!

Daniel, , 2012-02-16 23:43:28
who the f***k can use an expensive pill but not a rubber? This isn't going to stop any infections. This drug is a joke, and the bareback fetish prep crazies-and the hordes of HIV "activists" who are bending over to backwards to support it, make me sick.

Ima supizous, USA, 2012-02-16 17:05:17
I have to question the validity of a course of action such as this, from a distribution standpoint it will become a popular (Party favor) used to the point that it might well become less effective in the population, what happens, when the virus eventually becomes active, then you would have a resistant, incubator, that person could then easily pass it on to any number of individuals after that time, thinking all the while that they were safe but in reality they would be creating horror story

Mark, SD, 2012-02-16 14:37:19
Is this really a good idea with the latest study showing the increase adverse risks? "The nucleotide reverse transcriptase inhibitor tenofovir is associated with an increased risk of kidney damage and chronic kidney disease that increases over time and doesn’t appear to be immediately reversible, according to a new analysis by University of California at San Francisco (UCSF) researchers that’s published online ahead of print by the journal AIDS. I am all for safe alernatives.

Ken, Los Angeles, 2012-02-16 14:32:40
. . .and AHF spends thousands lobbying against FDA approval of Truvada as a PREP - more misguided and shameful behavior from the egomaniac Weinstein.

Jeton Ademaj, Harlem, NYC, 2012-02-16 04:40:23
this is excellent news. it appears that the "all-heat and no light" anti-PrEP strategy pursued by the AHF and some on this site has backfired. i'm glad that the FDA looked past sanctimony and sexual jealousy and focused on the real issue, preventing new infections among subgroups that don't use rubber. no one deserves to die of a deadly illness bcuz they prefer natural sex. fund condom access, eroticize n improve them...but stop pretending they're the total solution to HIV. that lie is stale.