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Getting Practical About PrEP

| 15 Comments
Time to bring in the referees: a U.S. Food and Drug Administration (FDA) panel has voted to approve the first HIV prevention medication for adults in the history of the epidemic--and some people are not at all happy about it.

On May 10, 2012, an FDA advisory panel recommended with near unanimity that the antiretroviral (ARV) drug Truvada (tenofovir plus emtricitabine) may be used not only by HIV-positive people to treat their HIV, but also by some HIV-negative people to prevent them from acquiring the virus. The panel's recommendation, which the FDA will likely follow, should have been an occasion for great joy--the triumph of the first new prevention tool in the 30-year history of the epidemic--but the hearing, just like the public discussions that led up it, was marred by apprehension, misinformation and controversy. 

In my capacity as Director of Research Advocacy for Project Inform I attended the marathon twelve-and-a-half hour FDA advisory meeting, one that highlighted a schism among the audience members and some of the panelists, and suggests contentious public discussions about resource allocation and on PrEP's efficacy and safety are still to come. 

Since the vote, several prominent activists and researchers have expressed their displeasure, citing concerns about side effects and drug resistance and worries that people will throw out their condoms. While it's understandable that tempers are running hot as we dissect the science, pragmatism, from all sides, is what's truly needed.

AIDSmeds' very own Tim Horn gives an excellent overview of the full hearing and its outcome here (so I won't go into a blow-by-blow account), but I do want to draw attention to a presentation given at the beginning of the hearing by Susan Buchbinder of the San Francisco Department of Public Health, who made one of the most compelling cases for PrEP that I've heard yet.

Buchbinder described how condoms and behavior change alone have failed to put even a small dent in the epidemic for some time. There are myriad reasons for this, but at the heart of it is that lots of people struggle to use condoms consistently for vaginal or anal sex and our efforts to fix that have been only modestly successful. We are going on 16 years of flat HIV numbers overall--more than 50,000 new cases per year in the United States--and HIV rates are rising in young men who have sex with men (MSM), particularly young MSM of color. In fact, in some cities nearly 80 percent of young black men could become infected by the age of 60 if something doesn't change--not because of greater risk-taking behavior, but simply because HIV is so prevalent among their sex partners that even one or two slip-ups can have devastating consequences.

On top of that, Buchbinder explained, our best interventions to help reduce HIV risk through behavior change have rarely demonstrated long-lasting effects in most people, nor have those studies ever documented an actual reduction in new HIV infections. Lastly, for many people condom use means risking the loss of a relationship or safe housing, or in some cases physical violence. Such people desperately need prevention tools that take such risks into account and that don't require the consent and cooperation of their sex partners. PrEP fully meets those conditions.

Given the stigma and emotional hardship of an HIV diagnosis, the risk of discrimination and prosecution, the reduced life expectancy and astronomical cost of health care, allowing 50,000 more people to become infected each year is an unfolding moral and financial catastrophe.

Like condoms, PrEP can be a highly effective technology--more than 90 percent effective when used correctly. And just like condoms, PrEP only works if it is used. Unlike condoms, however, which are cheap, abundant and safe, Truvada for PrEP is expensive, and carries the risk of side effects and of causing those who become infected while taking Truvada to develop drug resistance. This is a substantial point of controversy. But as Buchbinder and others have pointed out so eloquently, for tens of thousands of people each year the choice won't be one of PrEP versus condoms, but PrEP versus nothing at all.

It's fair to assume that most people share the same goal at heart: to end the AIDS epidemic in a way that respects the rights and wellbeing of those living with HIV and those at risk for becoming infected. PrEP, I believe, is a critical step toward that aim, if we apply it properly. Here's how: 

Give people the facts--the whole picture--and let them decide whether PrEP is right for them

Let's tell people how effective the drug is when they actually take it as prescribed--over 90 percent effective--and stop quoting statistics from the clinical trials where they averaged all of the people together whether or not they were actually taking the drugs. People are going to need motivation to adhere well to PrEP and telling them that it will only cut their chance of becoming infected by 42 percent (the iPrEx study) or 75 percent (Partners PrEP) is not only dishonest, it could significantly undercut their willingness to take a pill every day. How would people feel if we said that condoms were only 30 or 40 percent effective and never revealed that this figure is true only because we counted all of the people who never used condoms in the first place?

Let's also stress that in the clinical studies, PrEP was used with condoms, at least some of the time by some of the participants, and that it shouldn't be seen as a complete substitute. That said, the fear that people will forgo condoms for PrEP is a reasonable one. Therefore, I believe strongly that we should be targeting PrEP to those who are struggling most with condom use, for whatever reason.

Let's also emphasize that while side effects were rare, and not immediately serious in the vast majority of PrEP-takers in trials, we honestly don't know what long-term side effects will look like. People who ultimately end up taking PrEP for more than two years are entering new territory, as are people who might have greater underlying risks for kidney or bone disease. 

PrEP is not benign, but neither is HIV; let's strive for balance and accuracy in describing both. We all have a responsibility to correct inaccurate information where we find it, whether in our community publications or blogs, local planning meetings or in our groups of friends. We can never know who's in most desperate need of PrEP and who might be swayed inappropriately one way or the other by misleading or cherry-picked information.

Speaking of correct information, let's also spread the message far and wide that "disco dosing," whereby people only take Truvada during sex, is completely untested and that there are reasons to fear it won't work. Misuse of PrEP is a realistic concern, and we should do what we can to discourage it, but prohibiting PrEP for everyone out of fear that some will misuse it is the worst kind of paternalism.

At the beginning of the AIDS epidemic a group of HIV-positive men and women assembled in Denver and produced what's called the Denver Principles: a manifesto that demands the rights of people with HIV to make their own healthcare decisions based on the best possible scientific knowledge available; that health care providers stop treating people with HIV like ignorant children who aren't capable of being full partners in their own health care. 

We should afford the same rights and respect to HIV-negative men and women seeking to protect themselves from becoming infected.

Advocate fiercely for demonstration projects, where we test how best to use PrEP in real-world settings

We know how PrEP works in the artificial confines of a clinical trial (efficacy), but we don't yet know how it works in the real world (effectiveness). Understanding the difference is crucial and the only way we'll learn this will be in the multiple demonstration projects that will be slowly rolling out over the coming months and years. Yet, paradoxically, one prominent HIV organization tried to shut down two large demonstration projects in California this spring for reasons that were never entirely clear, but were apparently due to out-and-out opposition to PrEP altogether. Right-wingers spew enough anti-science rhetoric around HIV as it is (e.g. opposition to needle exchange and promotion of abstinence only education). We certainly don't need that coming from within our community.

Here are the things that each of us can do to support these demonstration projects:

  • Insist that our local, state and federal AIDS organizations are advocating for demonstration projects in our communities. We'll never learn how to use PrEP safely and effectively if we don't. The AIDS Vaccine Advocacy Coalition (AVAC) will be helping us keep tabs on demonstration projects and the target communities of those projects on their website (www.avac.org).
  • Let's do what we can to reduce the stigma associated with participating in these kinds of trials. If we hear our peers or our community leaders denigrating HIV-negative people who struggle with safer sex or who might be considering PrEP, or claim that people can't be trusted with this technology let's call them on the carpet. 

Turn down the emotion on conversations regarding resources for PrEP

At a time when we still have thousands of people with HIV who don't have health care, and when we still have waiting lists for the AIDS Drug Assistance Programs (ADAPs), it's completely understandable that people would fear anything that might further stretch resources. Still, we don't have to let that fear shut down reasonable and necessary discussions, or cause us to neglect the facts.

Some have expressed fears that if public or private health insurers choose to cover PrEP it will lead to a reduction in resources for people with HIV. Health insurance plans aren't generally set up that way, however, and extending services to one group rarely results in reduced services to another.

So if PrEP won't take resources away from HIV-positive people on Medicaid, Medicare or private health insurance, what about Ryan White or the AIDS Drug Assistance Programs, which provide healthcare and HIV drugs to low-income HIV-positive people who don't have insurance? By law, no money from these programs can ever be spent on HIV-negative individuals' health care. What's more, we have never had federal budget discussions where an increase in prevention funds at the CDC had to be offset by cuts to Ryan White, and that has been true throughout the last five years of extreme shortages in ADAP funding. At the state and local level, the reverse has actually been true.

Moreover, Truvada's maker, Gilead Sciences, has promised to offer PrEP for free to lower-income individuals who don't have health insurance, as well as to provide vouchers to cover HIV testing and condoms. That's a massive reduction in the likely costs for PrEP to cash-strapped state and local HIV prevention programs. We'll still need to find money from our HIV and STD prevention funds for doctor visits, adherence support and tests to monitor a person's bone and kidney health, but that's a more manageable task given that awareness of PrEP among those at high risk for HIV is quite low and so we aren't expecting a huge and immediate upswing in demand for it.

If PrEP uptake is as low and slow as many expect it to be, we will have plenty of time for the hoped-for demonstration projects to reveal how effective it is in real-world settings. Armed with that information a couple of years down the road, we can then have reasonable conversations about the resources required to reach those who need PrEP most. We can also figure out where PrEP will be most cost effective. Given that PrEP itself will be free to some of those who need it most, experts have already estimated that this will be incredibly cost saving when compared to a lifetime spent on ARVS if they become infected.

HIV-positive and HIV-negative activists have partnered hand-in-hand for nearly thirty years to advocate for both care and treatment for people with HIV and prevention services for those not living with the virus. It's been a winning, effective combination. I hope when it comes to PrEP we can overcome fear, suspicion and rancor and ensure that this partnership stays strong.

15 Comments

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Comments on David Evans's blog entry "Getting Practical About PrEP"

Hi. There are side effects with everything. Breathing during rush hour outside for asthmatics. We need everything we can get right now because hiv is the tip with many populations. We must prepare now and act on multiple diagnoses. Seeing "Denial" as a Disease. So much we've done let's keep workin toward the goal.

BRAVO for that brilliant declamation of the issues surrounding PrEP! As an HIV+ man, I'm all too aware that the 100% consistency with which i take a large number of meds today would be better spent on PrEP if it had been available years ago. As a result i have found myself swept up in some of the rhetorical battles about it in our community.

I do not regret this at all, for i'm also all too aware of how much PrEP is needed by some today who could never afford it. more rhetorical skirmishes are probably inevitable, as the PrEP-approval controversy has truly laid bare some underlying fault lines in the HIV+ community.

however, your call for unity is much appreciated...in my heart i hope we can all come together around the promise of new HIV-prevention tools. You have effectively defanged many of the anti-PrEP arguments in a fairly diplomatic way.

i hope we can all use more of that well-informed diplomacy in our community's discussion.

"30 for 30" is a campaign organized last year by HIV/AIDS and women's reproduce health groups to insure that HIV+ women and at risk women are not left behind in federal policy, funding or emerging programs. Given the less than promising results for women in FemPrep trials, what should we be telling young, high risk women and girls about PrEP?

One word, or two actually: terrific article. Thank you, Mr. Evans.

Thank you David for this smart, clear, sober, strategic and very forward thinking piece on PrEP. As you mention, the scientific evidence is clear - if one uses PrEP as directed, the protection is quite high. New prevention technologies have been decades in the making - and Truvada as PrEP, being first out of the box, isn't perfect by any stretch - but it gives us a desperately needed new tool and it will reduce new HIV infections if we deploy it well. And that is what we need to rally around. The necessity of getting ARVs to the people who need them - whether they are HIV positive like myself, or HIV negative and at high risk of acquiring HIV - should be something we all can work on together. Meanwhile, we need to continue to support vaginal and rectal microbicide research, vaccine research, and the quest for new formulations and delivery mechanisms - like films, long acting injectables, etc.... We are in the "1970"s boombox, 1980's car phone" era of biomedical prevention at the moment - kinda big, kinda clunky. We need to keep working to make new prevention technologies easier, safer, and sexier to use - think the latest version of the iPhone or iPod.

We certainly need to think out-of-the-box concerning prevention. Unfortunately, it seems many people have become fatalistic about HIV infection. It should never be an "either-or" situation. It should be "and" all the way.

There have been some valid points made on both sides. I do have a question. Do all of you honestly expect the public health programs to pay for this?
I certainly do not. More now than ever. Many politcos already consider this as a want instead of a need. Unfortunately, it will be classified under Medicare as Viagra, and benzos that are currently not covered.

If someone who needs the drug to live is paying Gilead 2k a month, but Gilead is giving the drug away for free as PrEP, it reasonably follows that for Gilead to remain solvent, we and these programs are already destined to pay for it, either directly or indirectly.

Thank you for such an informative, honest, well-reasoned and sensible article. What a shame that so many people I once respected have chosen to take the wrong side of this issue. The rest of us are moving forward.

Wonderful article David. I certainly hope that people on all sides of this issue will step back, take a deep breath, and rationally observe the results of the demonstration projects that are essential to determine the ultimate effectiveness of PREP and the issues associated with it. As a gay man with HIV, I've come to believe that unconscious fear and unconscious anti-HIV/AIDs, and anti-gay sex, bigotry tends to color so much of the debate on issues like this.

I feel Prep Is ludicrous at best. Very expensive, plus it does nothing to stop the many other STDs that are running rampant. I say, wrap that rascal for much less money and much more protection against STDs and dont feed the pharms more money, they are rich enough.

Oh please, can we stop pretending that there's some serious opposition to this pill? It has been obvious since day one that PrEP was inevitable. Already we're seeing phrases like "we won't end the epidemic without PrEP". LOL what? I'm sorry, have we forgotten about a cure, which is the only working model we have, or a vaccine, which has historically been the only economical way to eradicate a disease? WTF???

No one with a brain thinks PrEP is going to decrease HIV infections. Not straight people, not seronegative gay men, and not people who are poz and are honest about how they came to be infected. One literally has to grasp at straws to imagine this as something other than a recreational drug. Despite this, it is politically incorrect to point out what Gilead is doing here: finding a new use for an old drug to renew its patent, just like we saw happen with Norvir.

All of this noise about "resistance" is a red herring. We don't see any evidence of that happening and Gilead clearly doesn't expect it, evidenced by the fact that it's just introduced two more fixed dose treatments containing Truvada. The response that this drug won't take away from existing HIV programs is a straw man, and a pretty poor one at that since any rational observer should now be asking how Gilead can afford to give the stuff away as Prep while gouging insurance companies and public assistance.

The real issue is that this drug is an indictment against our pharmaceutical system, and an embarassment to our so called "activists" who've spread their legs for it in exchange for god-only-knows what compensation and a death sentence for hundreds of thousands of gay men who are going to be seeing ads for this in periodicals within the next year. If you're not angry about this, you're not paying attention.

How dare you admonish us to "turn down the emotion of conversations regarding prep". We've reached a sad day when people who make their living as "HIV advocates" tell people living with the virus to sit down and shut up.

one has to wonder if you believe in editing. that first sentence is utterly contradicted by the depth of fury in your tone...unless your tone is meant as a lampoon of Michael Weinstein, head of the AHF and someone who would probably be called "seriously opposed to PrEP" by most astute observers...tho one can always make the ninja-case (and some people have) that he's always been in the pocket of Gilead and only attacked PrEP to discourage widespread use of it and thus avoid any downward-pricing pressure upon Gilead.

if your screed was meant to lampoon Weinstein's over-ripe, preposterously sex-negative tone, kudos. have a biscuit or a scone.

i especially liked the supposition that trying to avoid a potentially deadly infection while engaging in physically unencumbered, natural sex is some sort of "recreational" activity. zomglulz that can be deconstructed sooooo many ways...it gets me EVERY time!

bravo! i'm glad you're not "serious opposition"!

Tell them that compliance is critical, regardless of "how they feel," and as long as the risk persists, keep their future in the front of their thinking.

PrEP - or, if that is too elaborate or expensive, PEP for post-exposure - raises consciousness far better than condoms, and it's consciousness which will cure the epidemic well before science has better solutions.

Fine on PrEP, although we've known about it in general terms for at least 2 years. What about PEP, "community infectivity" due to higher levels of safe testing, and the sharp drop in new cases where there is close to universal health care? Together they suggest an real end to the epidemic, even without a cure.

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This page contains a single entry by David Evans published on May 23, 2012 3:49 PM.

HIV Treatment Guidelines Change: But Who Cares? was the previous entry in this blog.

AIDS 2012: Did It Matter That 23,767 People Came to D.C. to Talk About AIDS? is the next entry in this blog.

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