A generally quiet debate over whether a daily dose of a drug called Truvada can really protect an HIV negative person from contracting the disease that causes AIDS has reached a flash point.
Michael Weinstein, president of AIDS Healthcare Foundation, recently described Truvada as a “party drug” in an interview with the Associated Press. (Weinstein’s full quote was: “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.”)
That prompted an attack on Weinstein by Michael Lucas, a porn performer and adult movie producer, in an article published in Out magazine. Today Eric Paul Leue, recently named Mr. Los Angeles Leather and, coincidentally, a figure in a current AHF ad campaign, says he is launching a petition drive to demand that Weinstein resign from AHF, which he founded in 1987. AHF is the world’s largest non-government provider of HIV/AIDS healthcare services. It is based in Los Angeles and operates in 33 countries.
Truvada, which is manufactured by Gilead Science, is a pill that contains two drugs: tenofovir disoproxil fumarate and emtricitabine. Its use is described as “pre-exposure prophylaxis” (PreP), a term that describes a way to prevent contracting a disease. Truvada was approved by the Food and Drug Administration in 2004 for treatment of HIV infection. In 2012 Gilead won permission to market it as a drug to prevent contracting HIV.
Since 2012 a war has slowly begun between those who see condoms as the only effective way to prevent someone not in a monogamous relationship from contracting HIV and those who argue that PreP is the future in a world where use of condoms is on the decline. Weinstein’s use of the term “party drug,” an allusion to the recreational use by many gay men of dangerous and illegal substances such as GHB and crystal meth, was a flashpoint that will draw wider attention to a fight that largely has been waged on blogs devoted to gay health.
The condom has been pretty much the only form of HIV prevention since the advent of AIDS in the United States in the 1980s. Studies by the U.S. Centers for Disease Control (CDC) describe a latex condom as providing an “impermeable barrier” to the HIV virus and to bacteria associated with other sexually transmitted diseases such as syphilis and gonorrhea.
The effectiveness of condoms in preventing transmission of HIV and other sexually transmitted diseases is often misunderstood because of the way the data is presented. For example, some studies say that condoms are 60 to 70 percent effective in preventing HIV transmission, a statistic that Truvada proponents have used in arguing that the drug is more effective. But those studies include people who don’t use a condom consistently. Studies show condoms are 90 to 95 percent effective in preventing HIV transmission if used consistently, but even those studies don’t account for instances where someone puts a condom on incorrectly so that it slips off or uses it in such a way that it tears.
One study suggests that the best predictor that a gay man will use a condom effectively is the fact that he has had sex at least 10 times a year and thus knows how to put one on. The fact that a latex condom is described as “impermeable” suggests it is 100 percent effective if used consistently and correctly. One indicator of the power of the condom is a study by the UK’s Health Protection Agency that estimated HIV transmission rates in 2000 would have been 400 percent higher if all gay and bisexual men had stopped using them.
The fact is, however, that consistent use of condoms is on the decline among gay men. The CDC reported last November than incidents of gay and bisexual men having unprotected sex with other men increased 20 percent from 2005 to 2011. The reasons aren’t clear. Some speculate that many gay men are willing to risk contracting HIV because it’s no longer viewed as a fatal disease. Others say that a new generation of gay men is unfamiliar with the fatal consequences of HIV in the 1980s and 1990s that led to a dramatic increase in condom use.
Advocates of Truvada as PreP fall into two camps. There are those who support it so long as the men taking the drug also use a condom (the rationale is that someone who is under the influence of alcohol or drugs may forget to use a condom sometimes, and Truvda reduces the risk in those situations). There also are those who see Truvada as a substitute for condoms.
One argument among the latter group is that gay men are going to have unprotected sex anyway, so why not offer Truvada to reduce the risk of HIV transmission (it doesn’t reduce the risk of contracting other sexually transmitted diseases).
Some point to studies that show Truvada’s effectiveness, often misinterpreting the figures. In his essay in Out magazine, Michael Lucas says “the latest research shows that people who take PrEP on a daily basis achieve upwards of 90 percent protection from the virus. That’s a conservative estimate. In the largest study to date, not a single person who took PrEP as prescribed became HIV positive.” Lucas does note, in another essay published in Out in July, that he takes Truvada and that it is important to also use a condom when having sex.
The results of the studies, all of which show daily use of Truvada helps reduce the risk of HIV infection, are complex. The study cited by Lucas actually shows a 99 percent reduction in the risk of contracting HIV in men whose blood shows a level of Truvada that suggests they take it every day. But those men also were offered a package of prevention services that included condoms, monthly HIV testing and counseling to reduce risky sexual behavior and encourage daily use of Truvada. So while Truvada clearly did reduce the risk of HIV infection, it isn’t clear what impact condom use also had on that reduction.
Even some PreP advocates worry that HIV negative gay men may not take a Truvada pill every day. “In a majority of PrEP studies, many or most people did not take it as directed,” noted a writer for BetaBlog.org who was covering a conference on the subject at a San Francisco provider of sexual health services. “Some people are also fearful about PrEP after seeing the debilitating side effects of older antiretroviral drugs.” There is evidence that the drug can cause a reduction in bone density in some people, which has emerged, along with a higher risk of heart disease, as an issue for some people who have been taking antiretroviral medication for HIV over the years.
For some men, a factor in adherence to the daily Truvada regimen may be the cost of the drug, which can be as much as $1,000 a month, although some insurance plans cover much of that. Another is what researchers call the “seasons of risk” for gay men. In those periods when an HIV negative man is in a monogamous relationship with another HIV negative man or is not having sex at all, he may be disinclined to take Truvada every day. But then he may quickly move overnight into a “season of risk” without having the drug on hand or a sufficient amount of it in his system to help protect him.
There’s little chance that Lucas and Leue’s petitions will force Michael Weinstein to leave AHF. But perhaps bringing the debate forward will prompt a deeper look at the potential risks and rewards of Truvada and a deeper look at the scientific studies, whose abstracts often are all that are read, and quoted, by adherents of one approach or another.
Weinstein is against anything that will slow AIDS down and that why he doesn’t do anything about the gay bath houses which are breeding grounds for AIDS. He would be out of his $400,000. a year job if AIDS ended. There’s a lot going on at AHF that this Wehoville is afraid to touch. Weinstein recently fired Dr. Kimberly Sommers who is the Medical Director of the Hollywood Clinic because she did and interview with the LA Times talking about how bad AHF is. Its a true shame that the media cant be trusted to talk about important issues.
Hank, I agree with your last comments 100%, and if Weinstein said something along the lines of “This looks promising but let’s cautiously pursue further and ensure we don’t all just throw condoms out the window, for a variety of reasons,” I don’t think I and many others would be so outraged.
Hank, you are obsessing over a line in the original 2011 study. Numerous people in this thread have directed you to the continuing evaluations of the original data as well as subsequent research.
With your last comment, you are committing another error in understanding. While condoms are 100% effective (ish), that’s only if used. And we know time and time again that’s not the cas, even in those who report consistent use. (“Everyone lies…”) Truvada does’t work that way. Protection — less effective, but still existent — is still there even if doses are missed.
Jody: That line in the 2011 study is a very important one. No one in this thread has directed me to continuing “scientific” evaluations of that study. Also subsequent research hasn’t involved gay men, except for a study of HIV transmission from drug injections. That said, I agree with you that Truvada seems, based on the limited research thus far, to provide additional protection to gay men who might neglect to use a condom. How much protection remains unclear.. And unfortunately many gay men now believe that Truvada is a reliable substitute for condoms (even some of my friends who… Read more »
Hank, I’m glad we agree on some things, and have enjoyed the conversation. 🙂 And your site, in general, which I read several times a week. I think you raise an important point about giving up condoms, and this can be solved through education. I don’t believe condoms are 100% effective either. And when we discuss younger people, I’ve been with a few of them over the last 9 months, and have on more than one occasion been in a situation where they asked me to have sex with them w/o any protection (no condoms, or anything, which usually results… Read more »
Hank, its true that one of the studies Damon referenced involved heterosexual couples. But its also important to note that they were all serodiscordant (where one partner was HIV positive). I would say that represents an even higher risk factor than the iPrex study, which involved homosexuals, as I don’t believe 50% were HIV positive in that study. In that study, “of 404 individuals who received placebo, 14 were infected with HIV whereas of the 750 individuals who received PrEP, none was infected.” I refuse to believe that all 750 individuals were also using condoms, especially 100% of the time.… Read more »
Randy: I agree with pretty much everything you say. My only worry is that some people will think they can use Truvada and not use condoms and be 100% safe. Some of my younger friends tell me that’s their belief. And then, of course, there’s the still unclear risk of kidney and bone damage.
Henry – All 2499 participants in iPrex were randomly assigned to placebo vs. Truvada groups, and were completely blinded. All participants were screened to be at risk for contracting HIV prior to the study based on condomless sex. Everyone received the same amount of condom support and testing. Despite that, many participants, including the ones receiving Truvada, reported condomless encounters. Dr. Robert Grant is much better at explaining this than I am, and why condoms were ultimately not a confounding variable in the analysis of iPrex. Suffice to say, condomless sex was reported in ALL arms of the study. Those… Read more »
Damon: I’m not concerned with what Weinstein does or does not believe. I am concerned about the actual impact of Truvada on men who believe it allows them to forgo condoms. Again, as noted in an earlier comment above, a report by the iPrEx study researchers concluded that “once-daily oral FTC–TDF (Truvada) provided 44% additional protection from HIV among men or transgender women who have sex with men who also received a comprehensive package of prevention services (condoms, counseling and frequent testing and treatment for other sexually transmitted diseases whose presence can increase the likelihood of HIV infection).” “The protective… Read more »
Hank, you simply don’t understand the difference between dependent and independent variables in scientific research studies. I endevour not to get mad about postings on the internet, but it is head-against-table frustrating to see you reporting on science and making such a basic error again and again.
Jody: Then apparently the researchers don’t understand that difference either. What’s clear from the New England Journal of Medicine report on the study — the authoritative report, not a blog post — is that there was no way to factor out the impact of condom use or the possible impact of treatment of other sexually transmitted diseases in such a way as to state definitively the degree to which Truvada made a difference. The assumption is that it did make a difference because HIV transmission was found to be lower than in those who reported only “consistent” condom use and… Read more »
Hank, I appreciate your skepticism. I outlined my reasoning above. It is that I have yet to hear of a single person who has contracted HIV while on PrEP. Whereas, I personally know at least one person who contracted HIV while using a condom. This is after doing a lot of research. I’m sorry, but I don’t agree that condoms are 100 percent effective. Maybe its your definition of “when used properly?” I’ve used condoms my entire life, and that has involved carefully unrolling them, making sure there’s no air in them, making sure they are properly fitted. And on… Read more »
To argue against PrEP because it may lead to more bareback sex is no different than arguing against birth control because it may lead to more unmarried women having sex. Except that a incurable disease is a little worse than an unplanned pregnancy.
I totally agree. To me question isn’t whether it will lead to bareback sex but whether Truvada alone provides sufficient protection against HIV infection. The jury (at least the scientific jury) is still out in that. I hope one day we will know the answer — based on science not anecdotes and blog posts
Flores St., I completely agree with your last paragraph, concerning Weinstein. He really needs to go. Weinstein labeled it as a “party drug” in an AP article, which mislead a lot of people who might be interested in learning more, and an insult and unfair classification of most of us who choose to use it. Regarding the use of PrEP, or any other means of protection, it should come down to personal choice for each individual, and that is somewhat dependent on what options are available, which does include their financial ability to pay for the medication. But we shouldn’t… Read more »
Randy: I guess I’m curious as what leads you to determine “PrEP is more effective than condoms.” A condom, when used properly, is 100 percent effective. The HIV virus has as much chance of penetrating a latex barrier as my Mini Cooper has of driving through a three-foot thick concrete wall. That is to say, no chance at all. If you are basing your assertion that PrEP is more effective on the only study published thus far involving men who have sex with men (the iPrEx study), I again call out that participants in the study also used condoms. We… Read more »
I am not assuming there was no impact. I am assuming that the condom message has reached saturation and there is no reason to think that it had a significantly greater impact this time than the hundreds of times we have heard it in the past. And I think that once PrEP is used by a wider group, you will encounter more people who do not use condoms no matter what you tell them. So, I think it will start to become more clear in our macro level numbers if PrEP works, especially if it works even at an 80… Read more »
The debate on this page is what needs to be happening at the top levels of our healthcare leadership. Is PrEP the answer? Personally, I hope so, but I don’t know. We need to start putting it into practice. My experience is that those who always use condoms will continue to always use condoms until we are all convinced this is the way to go, and therefore it can only help those who presently do not use condoms at all or inconsistently. Therefore, you will either see a drop in total seroconversions or you won’t, because those people are most… Read more »