UPDATE: Click here to read the AHF response to this article.
Just in time for gay pride, AIDS Healthcare Foundation published an ad criticizing pre-exposure prophylaxis (PrEP) in various gay publications around the country. The ad, ironically entitled “The War Against Prevention,” is nothing short of a scurrilous attack on Truvada (tenofovir/emtricitabine) as HIV prevention and on gay men’s right to protect themselves against HIV. The missive uses crafty manipulations, and select omissions, of the science behind PrEP to push the agenda of AHF’s notoriously anti-PrEP president, Michael Weinstein.
Below is a fact check of various claims Weinstein makes in the ad. At times his assertions are simply flat-out wrong, if not bald-faced lies (presuming Mr. Weinstein, who has no scientific training, comprehends the science enough to lie about it). POZ’s review was conducted under the assumption that, because AHF placed the ads only in gay publications, this particular missive only addresses the concerns of gay men.
Something of a lone, and ferocious, wolf in the public opposition to PrEP, Weinstein has tinkered with his stance over time as increasing scientific evidence has supported Truvada’s use as a tool to fight the spread of HIV. Currently, he claims not to be against PrEP, saying that he maintains a “nuanced” position by arguing that Truvada may be a worthy option for some individuals, but should not be used as a broad public health intervention.
“Mass PrEP administration is a dangerous experiment that is not supported by medical science and is currently resisted by doctors and patients alike,” he claims in the ad.
Instead, he believes that the best way to prevent HIV transmission is through behavior modification and condoms, as well as through testing for the virus and treating people with HIV in order to render them vastly less infectious. This is a standpoint that dovetails neatly with his position as the leader of the world’s largest provider of treatment for the virus, with more than 420,000 patients in 36 countries.
- Claim: Behavior modification, while never 100 percent effective, has been a remarkable success with gay men.
- This is definitely true when you look at the entire history of the U.S. HIV epidemic. In the 1980s, the use of condoms and other forms of behavior modification among American gay men were highly successful in reducing what was initially a soaring rate of HIV infection in that population. However, in recent years, as memories of the horrors of the early AIDS crisis have faded and a new generation rises that never knew those days, gay men have increasingly shifted their sexual behavior in the opposite direction. Condom use has decreased among the population while the HIV infection rate has risen once again.
- Claim: The ad impliesthatthosesupportingPrEP advocate giving up on condoms.
- The Centers for Disease Control and Prevention (CDC), which recently has become a strong advocate for PrEP, encourages using condoms with Truvada. However, there are certainly PrEP advocates who have quite publicly celebrated Truvada as a tool by which to enjoy condomless intercourse.
- Claim: Truvada has not caught on with medical providers or patients.
- Weinstein relies on Gilead Sciences’ report that only 5,272 PrEP prescriptions were written through 2014. There are many limitations to that estimate that make it a highly unreliable barometer for PrEP use in the United States. It is based on approximately 39 percent of U.S. retail pharmacies and less than 20 percent of Medicaid data, and does not include the many gay men receiving PrEP through a study.
- Research suggests that approximately 4,000 San Franciscans are taking PrEP. In New York State, PrEP prescriptions filed through Medicaid rose 272 percent between June 2014 and February 2015, from 305 to 832. A recent POZ survey found that various medical providers across the country have seen dramatic increases in prescription rates over the past two years. About 400 people currently receive PrEP form the Callen-Lorde Community Health Center in New York City.
- Claim: 95percentofHIV medical providers are “concerned that their patients would not adhere”tothedailyTruvada regimen.
- This refers to a survey of members of American Academy of HIV Medicine, which the AAHIVM published in April. Indeed, 95 percent of the 324 respondents said that “concerns about adherence” to Truvada were “very important” when deciding whether to prescribe PrEP. However, as physicians have argued since Weinstein began publicizing this figure, it is only natural that a clinician should be concerned that patients will not adhere to any drug. This figure, therefore, does not necessarily imply grave reservations about PrEP in particular.
- In the same survey, 79 percent of the clinicians said they were “very likely” to prescribe PrEP to MSM having sex with an HIV-positive partner, while 66 percent said they were very likely to prescribe to MSM at risk for contracting HIV.
- Claim: EverypublishedstudyofPrEP has shown major efficacy problems. For example, thelargeststudyamongMSM (iPrEx) had “only a 42 percent efficacy.”
- By limiting this claim only to published research on PrEP, Weinstein leaves out the results of both the PROUD and IPERGAY studies, which each showed an effectiveness rate of 86 percent among MSM. (Effectiveness, which refers to a drug’s actual, across-the-board success, is the correct term; efficacy only refers to a drug’s potential for success.) PROUD studied PrEP among very high-risk MSM in the United Kingdom and was designed to reflect real-world use of Truvada. IPERGAY tested an intercourse-based dosing protocol of PrEP in which MSM participants in France and Canada were instructed to take Truvada only in the days surrounding a potential HIV exposure.
- The iPrEX study and its open-label extension (OLE) phase, the two published studies of PrEP among MSM, had respective effectiveness rates of 44 percent (not 42 percent) and 50 percent. Weinstein has long characterized these rates as failures. On the contrary, these figures can and should be viewed as successes: The trials succeeded at lowering the rate of HIV by a considerable amount among the high-risk participants taking Truvada. A true failure would have been if PrEP increased or led to no change in HIV rates, or perhaps if the risk reduction was too small to justify a PrEP roll-out. Weinstein also omits the fact that the U.S. participants of the OLE trial adhered at a much higher rate than their international counterparts, suggesting that they enjoyed a greater benefit from PrEP than the study group as a whole.
- Claim: “In the most successful of all the published studies [onPrEP] more than half of the patients did not take the medication as directed.”
- According to AHF spokesperson Christopher Johnson, this claim refers to the Partners PrEP trial, which studied PrEP among heterosexual couples in Kenya and Uganda and had a 67 percent success rate. Since the study did not include MSM, its results are not particularly relevant to a gay male audience.
- Johnson backed up AHF’s claim about the lack of adherence in Partners PrEP with the fact that an estimated 55 percent of the study’s participants had at least one gap of 72 consecutive hours of nonadherence. However, the same analysis showed that just 23 percent of the participants had at least one weeklong adherence gap. According to the head of Partners PrEP, Jared Baeten, MD, PhD, a professor at the University of Washington School of Public Health, Weinstein’s assertion that the study’s participants were highly nonadherent is a “very skewed” interpretation of the research. More than 80 percent of the participants, Baeten points out, had detectable study drug in their blood and 70 percent had concentrations consistent with daily use. Additionally, Baeten states that the Partners PrEP substudy that looked at the adherence gaps measured daily pill-taking through the use of an electronic pill bottle, and that 72-hour gaps may reflect people not taking PrEP while risk was low (perhaps while not having sex) or taking out multiple doses for use while traveling.
- Claim: ThoseinthePartnersPrEP study who were most at risk were also the least likely to adhere properly.
- AHF’s Christopher Johnson refused to provide a citation for this claim. University of Washington’s Jared Baeten asserts the claim is false. He and his colleagues have conducted a number of analyses to determine what factors affected adherence in Partners PrEP (a study which, again, did not include MSM), and found that a consistent factor linked with lower adherence was not having sex. This suggests that, in fact, being low risk was linked to low adherence, and, conversely, that higher risk people adhered at higher rates.
- In iPrEx OLE, the higher-risk participants were more likely to opt to start PrEP in the first place (those who chose not to take Truvada served as a control group), and were then more likely to adhere.
- Claim: Not-yet-published European research on intermittent (also known as intercourse-based) PrEPuseamongMSM has shown very high rates of sexually transmitted infections (STIs) and poor adherence.
- The IPERGAY study indeed showed a very high rate of STIs among the MSM participants—35 percent of the participants contracted one during the study—which is indicative of the fact that they were at high risk for HIV, and therefore good candidates for PrEP. There was no evidence that men increased their sexual risk taking during the study, so PrEP itself cannot be blamed for those STIs.
- With an 86 percent effectiveness rate, the dosing strategy in IPERGAY was actually a great success, indicating that adherence was quite good. It is not clear whether the specifics of the protocol itself led to such a high risk reduction or just the fact that the men wound up taking PrEP often enough to enjoy a significant risk reduction regardless of the exact timing of the pill taking. (The iPrEX OLE results suggest that taking Truvada four times a week offers maximum protection against HIV.) The two participants given Truvada who did contract HIV had apparently stopped taking PrEP several weeks before becoming infected.
- Claim: Concerns about the effectiveness ofPrEP in the clinical trials would be “nonexistent if the patients wore condoms.”
- PrEP is most strongly urged for MSM who are already not using condoms. In a perfect world, all those men would use latex for every potential exposure to the virus. PrEP acknowledges the reality that these men may not be willing or able to change their behavior, but that they may indeed have the capacity to follow a drug regimen that will lower their risk.
- PrEP’s HIV risk reduction benefits can complement those of condoms; the two prevention techniques are not mutually exclusive, and indeed are often used together.
- Claim:AccordingtotheCDC, threeoutoffourMSM used condoms during their last sexual encounter.
- True, but highly misleading. The same 2011 CDC report states that, out of 8,000 MSM in 20 U.S. cities, 57 percent reported having anal sex without a condom during the previous year.
- Claim: “The entire body of scientificdatademonstratesthatTruvada will not be successful as a mass public health intervention.”
- The PROUD study strongly suggests otherwise: It examined PrEP’s use among high-risk MSM in a real-world setting and had an 86 percent success rate.
- Claim: Weinstein insinuates that “the condom culture that has been so hard fought since the [beginning] of AIDS” will disappear.
- This is a worthwhile concern to raise. At this time, none of the studies of PrEP among MSM support the notion that Truvada will lead to a reduction in condom use among that population. However, anecdotal evidence suggests otherwise: that PrEP may indeed contribute an already dropping rate of condom use among MSM. It is possible that one of the reasons that men in the PrEP studies don’t use condoms less while on Truvada is that they already weren’t using them much to begin with; being at high risk for HIV is a qualification for entry into the studies.
- Claim: The condom is the most effective prevention method for an individual who has multiple partners or whose partner has multiple partners.
- If an individual gay man takes PrEP daily, Truvada's 99 percent or greater effectiveness likely offers superior protection against HIV than regular condom use. (And of course he may use condoms in addition to Truvada.) It’s very hard to pin down exactly how effective condoms are when used for anal sex; research is scant, and a recent CDC paper claiming condoms are only 70 percent effective when used consistently and correctly by MSM is based on highly questionable reasoning. But in a nutshell, it’s simpler to use Truvada correctly—you swallow a daily pill—than condoms. Condoms may fail due to putting them on wrong, improper lubrication, or not keeping them on for the entire act of intercourse, a common practice. Psychologists have also argued that it is easier to adhere to a drug that is taken as a part of a daily routine than it is to use a condom during moments when that sense of personal responsibility may be challenged by sexually and emotionally charged experiences.
- Weinstein’s argument here seems to contradict his claim in the previous paragraph that “Truvada can absolutely be the right decision for specific patients.”
- Claim: IfeveryonewithHIV in the United States knew their status, went on treatment and had an undetectable viral load, there wouldbenonewHIV infections.
- This sweeping claim is categorically false because of the impossibility of alerting everyone to their HIV status the instant they contract the virus. During the first few months of infection, viral loads tend to be very high, making an individual highly infectious. Additionally, acutely infected individuals may be engaging in the same high-risk behaviors that led them to contract the virus in the first place, allowing them to transmit the virus to others before they are tested. Estimates vary, but scientists believe a considerable proportion of new HIV cases transmit from people recently infected with the virus.
- Furthermore, as Weinstein points out in the ad, just 30 percent of Americans living with HIV currently have an undetectable viral load. So his vision of treating our way to zero HIV transmissions is a long way off, to say the least. In the meantime, the scale-up of PrEP among high-risk populations will hopefully help reduce infection rates, in particular among MSM.