The debate over pre-exposure prophylaxis (PrEP) -- the daily use of the antiretroviral medication Truvada in conjunction with other prevention measures to avoid HIV infection -- has been raging for a few years now. However, in recent weeks the back-and-forth over this little blue pill has reached a fever pitch, with pundits, health providers, and patients expressing rather entrenched opinions on a matter that is still laden with many unanswered questions.
As a primary-care physician with a particular focus on HIV/AIDS, I find that the issue of PrEP frequently comes up in my conversations with patients, revealing that many gay men are still scratching their heads over whether this intervention is right for them.
The most recent dispute over PrEP was initially sparked by a mainstream piece by the Associated Press (AP) earlier this month. The author delved deeply into this volatile debate in the gay community, billing it as our "Truvada conundrum." Notably, AIDS Healthcare Foundation President Michael Weinstein struck a nerve with many gay men, with some even calling for his resignation, after he was quoted in the AP article saying, "If something comes along that's better than condoms, I'm all for it, but Truvada is not that. Let's be honest: It's a party drug."
While there is much to unpack in Weinstein's statement, he provided a necessary counterpoint to this discussion, which to date has been largely unbalanced in favor of expanded PrEP use among gay men -- with those offering a different, cautionary perspective being unfairly branded as sex-negative or ignorant of the realities of sex among gay men today.
Andrew Sullivan has weighed in heavily on the matter alongside several other writers, including Michael Lucas, a well-known gay erotica producer. Many of these pieces have been thoughtful, often first-hand accounts of the author's experience with PrEP. However, in a singular voice the commentary has overwhelmingly bemoaned the slow adoption of this new and promising intervention by gay men and framed the debate as a missed opportunity to eradicate HIV -- posing the questions "'Why on earth are [gay men] hesitating?'" and "Why are we not 'shouting from the roof tops' about this new 'wonder drug'?"
I would offer that there is plenty of reason at least to hesitate, that many important details have been glossed over in the recent discussion about PrEP, and that the relatively meager uptake of PrEP by gay men is perhaps prudent -- an appropriate response in light of the many unanswered questions that remain about its use in the real world.
Most of us with an opinion on the matter are quite aware of the sexual reality of gay men and are equally concerned about the increasing rates of HIV transmission within our community. However, some take issue with PrEP because of the reasonable concerns that it misses the point on why HIV continues to spread among men who have sex with men (MSM) and might distract us from many other worrisome sexually transmitted diseases such syphilis and multi-drug-resistant gonorrhea, which continue to spread rapidly within our community. Also troubling is how the discussion to date has both overstated what we know about the effectiveness of PrEP and repeatedly mischaracterized it as a simple once-a-day blue pill, when in reality it involves so much more.
PrEP was studied as a complete "prevention package" that entailed rigorous monthly risk-reduction counseling, testing and treatment for sexually transmitted infections, provision of condoms, and regular safety lab work. The Food and Drug Administration (FDA) recommendations detailed this "prevention package" in its interim guidance issued for PrEP use in 2012. However, if you look at the recent debate, you will find repeated suggestion that PrEP be used in lieu of condoms, since gay men are just going to have bareback sex anyway.
The ultimate concern is not that gay men would be unable to adhere faithfully to the daily dosing regimen and otherwise use PrEP as it was intended under a health provider's care. Rather, it is a fear that some of us -- for one reason or another -- simply will not do so, and that some might indeed use Truvada as a "party drug," taken like candy before crystal meth binges or indiscriminate bareback sex parties. That said, it is clear that many responsible gay men already take PrEP because they are in a serodiscordant relationship or some other "high-risk" situation, know the risks associated, agree to the regular checkups and lab work, and have made a conscious decision with their provider.
But with all of this excitement over PrEP, we still risk blinding ourselves to the pervasive HIV stigma still rampant in our community. Arguably, for some PrEP may even worsen stigma by further absolving both HIV-positive and HIV-negative gay men of the responsibility to openly discuss their status -- because why bother if everyone is taking his pills? The hope is that PrEP instead fosters a more open conversation, evidenced by how this recent debate has much engaged the community. Time will tell whether the PrEP effect will open up the discussion about HIV among gay men or silence us further.
Silence is dangerous, as it only fuels the further spread of the disease. And while Andrew Sullivan is "aghast at attempts to stigmatize [PrEP]," equating Weinstein's comments to the often-cited "Truvada Whore" meme (a term I'm convinced is born from an ironic and provocative way to confront stigma rather than perpetuate it), the resulting debate has forced us to talk openly about many of the concerns that still underlie PrEP. That conversation only gives us strength in the face of HIV and should not be stifled.
Fighting amongst ourselves does nothing to advance the discussion and bring greater clarity to ending HIV. Weinstein's comments about Truvada being a "party drug" may have been flippant and imprecise, but in that sense he is no guiltier than those who flatly promote PrEP as "90- to 99-percent effective" without clarifying that such rates of risk reduction are hypothetical -- obtained from a subsequent subgroup analysis that cherry-picked only those cases that were able to fully adhere to their dosing. The "99 percent" figure came from the later STRAND study in which men were directly observed taking their medication on a daily basis. Neither of these scenarios reflects reality. In truth, the original iPrEx study, on which the FDA recommendations for PrEP use in MSM were made, demonstrated that adherence among gay men was actually quite dismal when they were left to their own devices.
As such, while many advocates for broader use of PrEP scoff at the notion that gay men might struggle with daily drug compliance, the iPrEx study's findings throw water in the face of their claim. Importantly, in the wake of the FDA recommendation, the CDC expressed caution about PrEP, stating that "sexual risk behavior and adherence ... among MSM taking [Truvada] for PrEP outside of a trial setting, and with awareness of trial results, might be different from what was observed for men in the iPrEx trial."
And that difference may have a profound impact not just for the individuals taking PrEP but for the rest of us as well.
PrEP holds tremendous promise, but its true impact in the real world -- whether ultimately positive, negative, or equivocal -- has yet to be elucidated. In the meantime, we bear the onus of seeking a more realistic perspective on PrEP, making a decision informed by the evidence but also tempered by reservation when evidence is lacking. And so far, despite some overzealous writers suggesting that most every HIV-negative gay man get with the PrEP program, the evidence does not support such a blanket recommendation.
Instead of speculating about the impact of PrEP, we should promote further discussion and focus on educating each other about the intervention and what questions about it still remain. The righteous anger aimed at forcing Weinstein to renege on his statements and resign from his post distracts from this effort. Just consider that for many of us, Weinstein's statement does not apply, while for some it certainly may. Silencing that discussion denies gay men their human fallibility and may provide cover for the flagrant misuse of PrEP to justify irresponsible behavior.
So let's take a breath, save our indignation for ourselves, and critically examine the use of PrEP in the real world. In this vein, I'm encouraged to see websites such as PrEPwatch.org and My PrEP Experience that aim both to inform and tap into the authentic, shared experiences of those using PrEP.
This is an exciting time, and PrEP represents very promising progress in the prevention of HIV. We owe it to ourselves and future generations of gay men not to squander but to seize the opportunity that PrEP offers to prevent further transmission of HIV, while also mitigating its potential risks. So let's work together to get the word out about PrEP and engage in the debate, but in a more balanced, accurate, and incremental way that is informed by the evidence as it comes.