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Act Now: Choice in HIV Prevention -- Let FDA Look at the PrEP Data

By Julie Davids

March 17, 2011

This article was provided by the HIV Prevention Justice Alliance.

Do you believe that we need new tools in our HIV prevention toolbox? At the HIV Prevention Justice Alliance, we support broad and strategic research to explore new methods and interventions for HIV prevention.

Like many of you, we were intrigued by the results of the iPrex trial of pre-exposure prophylaxis (PrEP) that came out late last year. The U.S. Food and Drug Administration (FDA) should review those results and determine if PrEP is safe and effective enough to be approved for widespread use.

Unfortunately, a key HIV health care provider is asking the FDA to deny this choice to gay men and transgender people across the United States. Sign this letter as individuals and/or organizations to support immediate FDA review of PrEP.

The iPrEx trial showed that daily use of the treatment pill TDF/FTC (brand name Truvada) as part of a comprehensive prevention package reduced the risk of HIV infection by 44 percent across the whole group of gay men, other men who have sex with men (MSM) and transgender women who have sex with men (TSM) who volunteered in the study. Half of that group received Truvada and half did not in order to compare whether its use made a difference.

44% may not seem like a home run, but it can have a powerful impact for the people who need it. It's well within the accepted range for many widely used prevention interventions and medical treatments -- and could be the first step towards a true advance in HIV prevention. And it's much better than 0% protection for folks who are unable to use condoms, for whatever reason.

But check this out: for the men and transgender women in the trial who were able to take the drug as prescribed, there were very high levels of protection against HIV. The people who were given Truvada but who did not have detectable levels of drug in their blood (meaning for whatever reason -- and we need to learn more about these reasons -- they weren't taking the pills) were not protected as well. In addition, trial participants used more condoms, and reduced their number of sex partners -- and there was no sign of PrEP treatment increasing drug resistance in this study.

At the HIV PJA, we are disturbed and disheartened to see that a key HIV care provider is misrepresenting these findings and spreading misinformation about PrEP in their quest to get the FDA to ignore the iPrex data. You may have received an invitation from AIDS Healthcare Foundation (AHF) to sign a petition to block FDA consideration of PrEP, which they are mocking as a "magic pill." FDA is one of the world's foremost regulatory bodies that makes decisions on how drugs, like Truvada, can be used.

As part of a growing alliance of national organizations, we are asking you to NOT to sign the AHF letter. Instead, please sign this letter asking for the FDA to do their job and objectively review the data.

The fight against HIV/AIDS is complicated -- and this is no exception. We need vigorous and open dialogue and debate about how to learn more about the best uses of PrEP, to bring down the costs of all prevention and treatment, and include all affected communities are included in deciding if and how to use this intervention. One thing we learned from iPrEx is that adherence to pill-taking matters. In this study, PrEP reduced HIV risk among individuals who took the drug regularly and reported high levels of adherence. Many people weren't able to adhere and, in these people, PrEP didn't have a benefit.

But what we don't need is misinformation, intimidation, or suppression of the data. We can't afford to have the discussion and debate silenced.

For that reason, we're asking you to take a stand on advancing the discussion on PrEP. And part of that involves the Food and Drug Administration (FDA) looking at the data to see if it's time to approve it as preventive therapy for MSM and TSM, or if we need more data first.

FDA approval -- if it is warranted -- could lead towards greater insurance coverage, well-designed pilot-programs, increased public debate and discussion of PrEP, and consideration of approval in countries around the world. To endorse the letter to FDA, click here.

Clearly, we need further studies and pilot programs to help at-risk individuals figure out if and how they will be able to take the drug regularly, and ensure that they use other methods of protection as much as possible but not use PrEP if they are not able to take it consistently and correctly. We need to demand lower drug prices for HIV treatment and preventive therapies. And we need all insurance companies and public programs to remove all barriers to key tools against the epidemic, like HIV testing, medication access, and prevention tools like condoms and sterile syringes.

But in the meantime, we think it is wrong to try to block the FDA from looking at the iPrex data, and to put a roadblock up against something that could make a dent in new infections.

As Jeff Berry wrote in response to the AHF ad,

Of course there is no magic pill. There has never been, and never will be, a one-size-fits-all method to prevent the spread of HIV. And for those populations who may be at higher risk, or who may not have the luxury of having all of the tools at their disposal (for example men or women whose partners are unwilling or unable to use a condom or other form of protection), if they could use a microbicide gel or even a pill to lessen their risk, why would we not want that?

We stand against misrepresentation of the iPrex data, and to any suppression of debate on this possible intervention. We ask you as individuals, as well as representatives as organizations and coalitions, to click here to stand up for the data review and accurate information in our communities. Stand up for truth, and for honest, open debate.

Julie, on behalf of the HIV PJA

P.S. Whether PrEP is something we'd personally use or not, we all should support clear and accurate information on what is and isn't known, and respectful public debate and dialogue. There are people currently considering PrEP use -- including some HIV negative gay men in relationships with HIV+ partners -- who deserve accurate information to aid their decision-making. We'd like to share this story from a PrEP user who posted to a gay blog just this week:

I've been using Truvada for PrEP for about three months now, and I'm thankful that it's available. I'm in an open, serodiscordant relationship; my partner converted after we'd been together for two years. My partner is on medication, and has an undetectable viral load. Even with condoms, however, our sex life plummeted, because he was SO frightened of the possibility of infecting me. This added layer of protection is a huge boon for those like me, who actually DO take their pill every day on a consistent basis. If you take it properly, the success rate is 94% -- not the minimized 44% that this so-called "AIDS Healthcare Foundation" is misrepresenting as the whole story.

My insurance does happen to cover the cost of Truvada, other than the copay I have for any name-brand medication, and they haven't so much as batted an eye. My physician, an expert on HIV care and prevention, monitors me carefully according to the CDC's interim guidelines to ensure that I'm not suffering side effects or toxicity problems.

Again, this is a GREAT TOOL for those who are actually RESPONSIBLE in using it. "AIDS Healthcare Foundation" seems to think that we should toss it aside because SOME won't take it every day, or because it's not 100% effective. The truth is, condoms aren't 100% effective either, but we still promote them. The truth is HIV+ individuals don't always take their meds properly, but we don't dismiss the meds for that reason. I'm personally offended and disturbed at "AIDS Healthcare Foundation's" extreme and irresponsible activism on this.

Please join us in the call for open discussion of PrEP data, and stay tuned for more information as we move forward. And, as always, contact us if you have a story or perspective you'd like to share.

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Reader Comments:

Comment by: Frederick W. (Southern California) Fri., Apr. 29, 2011 at 4:06 pm UTC
This is truly a no brainer to move forward with this prevention tool CDC, NIH and FDA sould move foward to bring forth the truth, NOW. This is what these groups were created for to help the American People. I want talk about taking pills right for we all are driffent. I have been self titrating my ARVS for years, off Atripa for nearly six months, and may go back on them this month. You see for the scientist to say one must take the pills as presribed and then in the same breath say all are driffent, weight, matablizm etc doesn't make sense to me. And for Ryan White Doctors and adminisrator to cut some one off for not taking the pills as they see fit is very strange to me. I wonder if Poz people have any say in their healthcare. You may notice a shampoo bottle states repeat for best resoults and is that about adherance to the manufacture or selling more shampoo. Titration is a process of finding the right doses for a patient and is used though out the Europeon Union and for children. I am going on 25 years of being poz and my first Doctor yelled at me in 1987 to say I will be taking 6 pills and I never return to Dr Eye from Jacksonville Florida and did not take mega doses of AZT either. I will continue to self tirtrate,use my knoledge,instincts and yes if nessccary lie to my Doctor and stock up on the pills, so I can continue to be healthy, for remember ever one is different, then why in the HELL is all be presribed the same doses. P.S no wasting, no kidney problem, no liver problems, no disablity. Which make me think HIV mutation is a marketing plan by Pharma and Labs to keep the bucks coming down the pipe and causes huge side effect as in the over dosing of AZT in the 80's. The question one might ask themselves "am I overdosing my drugs for the happness of the Doctors, Ryan White Case Managers, and Pharma. Titration is a science in some countries and in the USA. I am sure a lot of Poz folks are self tritating their meds but to afraid to speak of it.
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Comment by: Danny (Kansas City) Mon., Apr. 25, 2011 at 1:29 pm UTC
No, "Enraged" is right. We as a society have said we don't have money for a cure, we don't have money for universal treatment, heck, we don't even have money to teach children how to avoid the virus. We do have money to find novel ways for those who already have plenty of options to have "good sex" though. Talk about being forsaken! HIV+ people, our supporters, and anyone with a conscience should be protesting in the streets over this. Our lives matter more than anyone's "good sex". Thats not "fundamentalism" John, thats pragmatism.
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Comment by: Rational (San Bernadino, CA) Sat., Apr. 23, 2011 at 5:49 pm UTC
For whose benefit are we demanding PrEP's approval? Who do we think its going to help? The self-acknowledged semen lovers who will inevitably miss a dose or encounter a resitant strain and wind up infected anyways? Do we think substance abusers will win with this drug which requires nonstop adherence? Maybe prostitutes or third worlders will suddenly find the stuff easily and cheaply dispensed from vending machines!

No, I don't think this drug is going to prevent HIV infection in anyone, at least not for long. I don't think Gilead does either. Maybe its because I don't think they'd bite the hand that feeds them by creating a viable prevention tool. I don't know of any rational model to assume that this profit-minded company would do that. Maybe its because they have not one, but TWO, additional single pill treatments in development with Truvada as an ingredient. That tells me that Gilead doesn't expect any decrease in cocktail consumption in the near future, nor do they expect a substantial rise in Truvada-resistant strains.

Who will benefit? Probably not the average gay man who contracts this disease from trusting the wrong person or making a human mistake. These poor schmucks are going to hear now, more than ever, "I don't know anyone can get this disease these days". Few are going to invest the kind of money that a monthly Truvada copay entails when they don't realize they're at risk. Its not going to do a thing for conscientious serodiscordant couples either. Lets face it, condoms and undectable status already do a darn good job of preserving those people. I think that the people who will benefit from PrEP's approval are the stockholders and employees of Gilead, who are already facing significant problems due to Truvada's looming patent expiration. I think Gilead needs a new application for this drug, so they can re-patent it and maintain their profits on those single pill drugs they have in development.

Well played Gilead.
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Comment by: Neal C. (Indianapolis, IN) Tue., Mar. 29, 2011 at 8:17 am UTC
I agree with John, Zooey and Deepee - my fellow Hoosier has it all wrong. "Enraged's" opinion harkens back to the days of the guilty/innocent trap. PrEP is an essential tool in the kit we need to combat on-going infections, regardless of a person's choices. We are not to judge, but to love, comfort and assist those who are at risk and living with this disease, like myself.
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Comment by: Enraged (Indianapolis) Wed., Mar. 23, 2011 at 2:58 pm UTC
PrEP is ridiculous. WTF are we supposed to do, put Truvada in the water supply? Thats the only way its going to protect normal human beings or people who aren't in a position to protect themselves. The only people who are going to be using it are people who have money to burn and those who are negative but choose to knowingly put themselves at risk. These are not demographics we need to be devoting our resources to protecting. Its absolutely infuriating that we're spending money researching this when pozzies who NEED the drugs still don't have access to them and when so much more needs to be done for our own long term health.

Its great that a handful of neggies can bamboozle their docs and insurance companies into prescribing and paying for the crap to reduce their risk of infection from .0001 to .00005 percent, but I really think that we need to recognize that this is an appalling allocation of resources.
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Replies to this comment:
Comment by: Zooey ((New York, NY)) Wed., Mar. 23, 2011 at 5:01 pm UTC
preach it, brother (or sister)!
Comment by: John E. (St. Louis, MO) Thu., Mar. 24, 2011 at 2:28 pm UTC
Right on, Enraged! If we give 'em condoms, it'll just encourage them to go out and have sex. And if we give them a medication that works almost as well as using a condom, that'll just encourage 'em to go out and have GOOD sex! We should make 'em wait until they actually get HIV to get access to meds. And we should make "pozzes" wait until they actually have AIDS before we let 'em have meds. "These are not demographics we need to be devoting resources to protecting."

Who the f#@k are you, Fred Phelps? Head of the AIDS Wealthcare Foundation? Pat Robertson?
Comment by: Deepee (London, UK) Sun., Mar. 27, 2011 at 5:59 am UTC
I think John E. hit the nail on the head responding to this one - but I would also like to throw in that as a +ve hetro male in a serodiscordant relationship, PrEP is really giving us hope of being able to conceive a child, where previously we thought it would be very difficult. It really is quite a breakthrough, and I for one am happy that the research is being done.
Comment by: Enraged (Indianapolis) Sat., Apr. 23, 2011 at 3:31 pm UTC
John, this isn't anything like the "if they have condoms they'll have sex" arguement. Your attempt to liken my concerns to moralism misses the mark completely. The undeniable fact of the matter is that we already have wildly effective prevention in the form of condoms, and we SHOULD EXPAND ACCESS to PEP for those who have condom failure. We also have a moral imperative to develop a vaccine, if not a cure, for those who don't realize they're at risk or can't protect themselves, or just make normal mistakes like forgetting, getting horny, being tricked, gettting drunk etc.

Sperm washing, and probably undetectable status, already do a far better job of preventing infection in those who want to conceive than even the most wildly optimistic PrEP estimates, so that assertion is moot.

This is about the allocation of resources. We've chosen to spend money and time giving options to a foolhardy few who already have plenty of options while MILLIONS are slated to die, and millions more will become infected even with PrEP. Being repulsed by this doesn't make me "Pat Robertson", it makes me someone who has watched my own health and wealth slip away for a disease I went out of my way to avoid while we put money forward to protecting those who could help themselves but choose not to because they want "good sex". I'm right to be "enraged". Cure funding is almost nonexistant. Vaccines keep hitting brick walls. What are we doing? Spending our money to preserve those who know better but want "good sex" anyways. Every one of us with this virus who didn't get it from outright nihilism or bugchasing should be enraged. Every negative person who realizes this isn't going to protect them if they make any of the normal mistakes which constitute the human condition should be pissed about this. We might as well plug billions into research for seatbelts that will only help people whose speed exceeds 200 mph.

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