The Associated Press – about as mainstream as you can get – has an article out this week about a very marginalized medication:
It’s the Truvada conundrum: A drug hailed as a lifesaver for many people infected by HIV is at the heart of a rancorous debate among gay men, AIDS activists and health professionals over its potential for protecting uninfected men who engage in gay sex without using condoms.
Many doctors and activists see immense promise for such preventive use of Truvada, and are campaigning hard to raise awareness of it as a crucial step toward reducing new HIV infections, which now total about 50,000 a year in the U.S. Recent efforts range from think-tank forums and informational websites to a festive event at a New York City bar featuring popular drag queens.
Yet others — despite mounting evidence of Truvada’s effectiveness — say such efforts are reckless, tempting some condom users to abandon that layer of protection and exposing them to an array of other sexually transmitted infections aside from HIV. “If something comes along that’s better than condoms, I’m all for it, but Truvada is not that,” said Michael Weinstein, president of the AIDS Healthcare Foundation. “Let’s be honest: It’s a party drug.”
I have to say I’m aghast by that attempt to stigmatize – yes, stigmatize – a medication that could prevent countless men from being infected with HIV. Think about it: if it were 1990 and the news emerged that – just by taking one pill a day – you could avoid ever getting infected with HIV, do you think there would be any debate at all? There would be lines around the block for it, huge publicity campaigns to get the amazing news out, celebrations in the streets, and huge relief for anyone not infected with the virus. Fast forward a quarter century, and those taking this medication are actually demonized as “Truvada Whores“.
Whore? Why are some now channeling Rush Limbaugh’s sex-phobia? I mean: are women who are on the contraceptive pill “whores” as well? All they’re doing is protecting themselves from the consequences of sex in terms of pregnancy. And all gay men on Truvada are doing is protecting themselves from HIV. Why on earth would we want to prevent or marginalize that? As Peter Staley, one of the true heroes of ACT-UP, has put it:
It breaks my heart that the worst of HIV stigma comes from my own community: gay men.
Mine too. The reason, it appears, is that being free from the fear of HIV infection could lead gay men to have lots of sex again with lots of partners. (One study we have examining this did not bear this out.) But here’s some breaking news: for vast numbers of gay men, lots of sex is already the case. Now that HIV is not a death sentence but a chronic disease like diabetes, the terror is long gone. But the virus isn’t. And rates of infection remain stubbornly high, especially in this demographic. Because, well, men are men. Betting against their testosterone in a sub-population without women is a mug’s game. Add to this that fact that for many men – spoiler alert – condoms make sex less pleasurable, less intimate and less intense, and you have the current high rates of infection. Given where we are, we have a choice, it seems to me. We can either use our medical knowledge to prevent infections, or we can allow them to continue.
What about side-effects? Yes, they exist with Truvada, as with any drug. But this pill must be prescribed by a doctor who can monitor quickly for any early adverse reaction in the liver and end the drug if necessary. One possible effect on bone-density takes a very long time to occur and again can be monitored and the drug ended if that’s the case. And compared with the side-effects of getting infected and having to take the full spectrum of anti-HIV drugs? Let’s just say your liver prefers Truvada. What about getting people to take it every day? Yes, that’s vital – just like contraception. If you are not taking it regularly, and you get infected, there’s a chance that the virus could mutate in the presence of Truvada to foil similar drugs in a future cocktail. But since the Truvada regimen requires blood work every three months, the resistance is unlikely to go on for long. And there are, mercifully, plenty of other classes of anti-HIV drugs that can replace it in a cocktail if you go on to get infected. So, yes, it might not be the best option for a tiny minority. But for the vast majority? It’s a complete no-brainer.
Can gay men be relied upon to take a pill once a day? Please. Why would they be regarded as less capable of protecting themselves than millions of women? And the cost we have already incurred by not aggressively promoting this drug as a preventative is huge. I wrote about this option as far back as 2006, when it first appeared on the horizon. 400,000 people have been infected since then. Back in 2010, in a thread called “A Massive HIV Breakthrough“, I noted that the trials concluded that the pill was more than 90 percent effective. Truvada was subsequently approved by the FDA in 2012 and continued to have high rates of success in clinical trials. From another Dish thread last summer:
According to the C.D.C., when study results are adjusted to include only participants who took their pills most of the time, the protective effects are 92 percent for gay men, nearly 90 percent for couples in which only one partner is infected, 84 percent for heterosexual men and women, and about 70 percent for drug injectors.
Think of how that can change the dynamic in a sero-discordant couple where one man is negative and the other positive. Think of how it can also help end the barriers between HIV-positive and HIV-negative gay men, with far, far less chance of infecting one another. But, in a felicitous medical coincidence, it also raises the tantalizing prospect of wiping HIV out of the gay community in our lifetime.
If you’re my age and remember the horror and the trauma and the paralyzing terror of the plague, that is not something you can feel indifferent about.
Here’s why it is now perhaps possible in ways that have never existed before. If all HIV-negative gay men are on Truvada, they cannot get infected with the virus. And if all HIV-positive gay men are on retrovirals, then they cannot effectively transmit the virus. Bingo! Epidemiologically, HIV is facing extinction. But is it true that those of us on anti-retrovirals with undetectable levels of virus in our blood and semen cannot infect others? Well, we just got pretty amazing news on that front. A two-year PARTNER study – with more than a thousand sero-different couples, gay and straight – found that no-one was infected with HIV. (The results are available on aidsmap here.)
The bottom line: if we can get a critical mass of gay men on either Truvada or retrovirals, we could soon reach a tipping point in which this virus could be wiped out in a generation.
When we are still having 50,000 infections a year – and gay men remain a resiliently vulnerable population – this should be an urgent goal. We have a chance our predecessors long dreamed of: to have great and enjoyable sex lives without this paralyzing fear and this dehumanizing stigma. We owe it to them and to ourselves to do all we can to make this scenario possible.
Why on earth are we hesitating?
During a recent “Ask Anything” taping with Dave Cullen, to discuss his book Columbine for the 15th anniversary this month, he opened up about his experience with Truvada, which he’s been taking for almost a year now:
Meanwhile, the in-tray is starting to fill up with responses to my post:
Thank you so much for your writing on Truvada and celebrating it for the godsend that it is. I’m in a serodiscordant couple, so to hear it described as a “party drug” makes me feel ill. If eliminating fear at the heart of a relationship is a party, then, yeah, that’s a party I’ll go to. If wanting to fuck the person I love safely makes me a whore, well then I suppose I’m a whore. The names can’t hurt our community as much as HIV has. So if takes being called names to finally end this virus, then let them call us whatever they want.
Your blog has been one of the few places I can go for reassurance about PrEP ever since going on it six months ago. I am 28 years old and have grown up in a generation of gay men that has been taught that not using condoms is tantamount to instantaneous seroconversion. When I first started taking Truvada, I was excited to share my experiences with friends and loved ones. But since that time, I have decided to no longer disclose my use of prep, since I have experienced a significant amount of backlash from friends as well as prospective sex partners. It can sometimes be a passive remark, like a friend telling me that this is a “lifestyle choice.” Other times, it is a more brash statement, like “truvada whore”. They assume I am on the pill because of a sex life that is somehow more licentious than my counterparts that are not on prep, which isn’t true.
The advent of PrEP has created a unique relationship between those who are taking steps to prevent HIV seroconversion and those who already have HIV: a shared interest in treating and eradicating a devastating health threat. But in our own community, we continue to face backlash thanks in no small part to misinformation propagated by groups like AIDS Healthcare Foundation. On one side we see a group looking toward effective treatment options built on a foundation of openness. On the opposite side is a swath of gay men who stigmatize those who have HIV, and yet, are simultaneously wary of those men who take pills to prevent getting the HIV disease. A paradox, if ever there was one.
OMFG you spoke the truth here, thank you. What’s frustrating is that so few people are speaking it. Unfortunately, I am recently (December 2013) HIV positive. (Don’t date pathological liars.) However, the drug cocktail (Complera in my case) is amazing, and I’m already undetectable with no side effects, but it would of course be better if I weren’t on it in the first place.
I’d been active in HIV/AIDS related work heavily 15-20 years ago, when I was much younger, and fell out of it for various reasons, so it’s been an education diving back into the weeds of it. Because of highly effective treatment options, HIV is a fundamentally different disease than it was in 1999, when I was last in a job working with mostly HIV+ patients. It’s now a treatable, chronic condition and not a terminal illness, and one that’s harder for treated patients to transmit and one for which it’s possible for non-patients to get a pretty effective prevention drug for.
Yet it feels like the public health and prevention strategies are still stuck in 1992, when the disease was still a death sentence. No wonder HIV infection rates amongst gay men are rebounding. We need to fight the disease as it exists today. That disease profile includes the current prognosis, transmission risks and prevention tools, each of which has changed dramatically since current HIV public health measures came into place. It’s happening, but not fast enough, and that slow pace is causing more people (like me) to get infected unnecessarily.
Andrew, you can sometimes be a pain in the ass, riding your hobby horses, and sometimes I want to slap you. It’s your best AND your worst quality, and it can be infuriating, even when I agree with you. But it’s moved the needle before (gay marriage, anyone?), and I think you have an opportunity to move the needle here to save lives and reduce the infection rate. Agree or disagree with you, when you get passionate on a topic, you’re hard to ignore and you force the conversation into the open, and this is a conversation that’s not being had in the open enough.
So please make this the first of many posts on the subject, and infuriate and annoy the hell out of us. You’ll do a world of good.
The idea that gay sex requires more justification than straight sex is deeply embedded in the culture – even within gay culture. Two other themes have emerged as well in talking about this with my fellow homos. The first is that taking a Truvada pill means, for some, the taking of an HIV pill. And being HIV-negative is sometimes defined as not having to take an HIV pill. So taking Truvada as a preventative means, for some, crossing the HIV divide, when they have spent an entire adult life-time keeping their distance from HIV culture. This makes no logical sense – taking Truvada as well as using safer sex helps you stay free of HIV more effectively than any other method (think of it as combination therapy). But it does make psychological sense for the countless who remain traumatized by the memory of the plague.
I think there’s also a resistance to the good news in the same way that there was intense resistance to the good news of the cocktail therapy eighteen years ago. Perhaps the most controversial piece I’ve ever written was my “When Plagues End” cover-essay for the New York Times magazine. It was assailed as empirically wrong, dangerous and complacent. But every single factual claim in it has been borne out – and then some. The truth is: we become wedded to the status quo, even if that status quo is terrifying. Camus grasped this in his great novel, “The Plague.” He showed how no one wanted to believe the good news that the plague was ending – because they were too scared to hope, too terrified of getting their hopes up, too conditioned by terror to change quickly. That psychological insight is invaluable – even as the truth now is that no one with undetectable virus can infect anyone, and no one on Truvada can get infected. Instead of embracing that, we shy from it.
Meanwhile, readers are responding in droves via Facebook and the in-tray:
Thank you so much for your writing on Truvada and celebrating it for the godsend that it is. I’m in a serodiscordant couple and to hear it described as a “party drug” makes me feel ill. If eliminating fear at the heart of a relationship is a party, then, yeah, that’s a party I’ll go to. If wanting to fuck the person I love safely makes me a whore, well then I suppose I’m a whore. The names can’t hurt our community as much as HIV has. So if takes being called names to finally end this virus, then let them call us whatever they want.
I’m a married straight guy. I had known somewhat vaguely about Truvada before your posts – though I didn’t really know anything about the drug and had no idea about the reputation. That said, the backlash is absolutely mind-boggling. There is a drug that would prevent the transmission of a drug that has killed millions over the past three decades, and people are called whores for taking it? I mean it literally when I call it mind-boggling; I simply cannot wrap my mind around that logic.
I have to say, I almost physically attacked my computer screen when I read the quote from the AIDS Healthcare Foundation president, Michael Weinstein, who called Truvada a “party drug.” I have sex. I’m human. Condoms come off. It happens. I’m a working professional, not a raver on molly who dabbles in the gay meth scene. But I am single, in my 20s, sexually active, gay, live in San Francisco and I am HIV-. Why isn’t this the simple litmus test for potentially being prescribed Truvada?
After an “HIV scare” last year when a partner of mine tested positive (he was the first person I’d been with since moving to San Francisco), I raced to the doctor to get an RNA HIV test. I was fortunate. Tests came back negative. So next week, I will be going into to consult an HIV/AIDs specialist at my HMO about Truvada. I’ve passed all the blood/urine pre-screens, so I think it’s mainly for me to understand the importance of taking it daily, sign an agreement to get my blood work done every three months, still use condoms, etc. If I don’t keep up with the blood work, I’d imagine they may remove me from their PrEP program, which is completely reasonable to me, considering the potential side effects and needing to know the HIV status of the patient.
My general practitioner is the reason why I haven’t done this sooner. He may share the same views of Mr. Weinstein. After my HIV scare, which he helped me through, he was reluctant to recommend the drug for me. When I brought it up, the conversation was just shot down with “it’s not like a contraceptive pill” with a shake of the head. Ironically, during in the same conversation he mentioned that many people don’t know or lie about their HIV status. His other concern seemed to be there’s only been one solid, long-term study on Truvada in regards to effectiveness and side effects. This may be a valid concern.
But I have one life to live. Spare me the lectures and finger wagging.
I was infected in 1985. Those were the days of no available treatments and the best you could hope for was eighteen months – if you were lucky. Anybody remember drinking aloe vera juice? How about melting down a pound of butter and mixing in lecithin powder and then freezing it in ice cube trays to be mixed into juice? I do.
How about going to a bar and no longer looking for the tell-tale KS lesions but the cheap digital watches that beeped every four hours screaming “take your AZT!” I do, and that is why I do not wish this illness on anybody.
I am open to any and all available treatments, and the hateful rhetoric and name-calling on both sides is not doing either side any good. All I can do is be honest and tell my story and try to explain my fears, but I get immediately shouted at as some old guy who does not know anything about modern treatments. If you want to sell me something, educate me and try to understand my fears; don’t lecture me. Truvada, as well as a whole host of drugs, exist because my friends died. Don’t belittle my loss.
My biggest fear is maintenance. All I can say is that I have been taking pills since 1987 when AZT came out. There have been many, I am sad to say, times in the almost 30 years that I skipped a dose. Sometimes even weeks would go by. I can’t tell you why. You just get tired. You have a headache, you take an aspirin and it goes away. You take a handful of drugs and you do not have that immediate payoff and it just gets hard to keep up. I am clean and sober, have great insurance, and a long-term and loving relationship for support and it is still hard.
We don’t know the long-term effects, especially for the post-HAART infected. Even though the virus may not be detectable in your bloodstream, it can be quite active in your brain fluid. I have just been diagnosed with AVN and will need to have both of my hips and shoulders replaced. Google AIDS and aging and see what is happening. Most of the time it is not the virus, but the medicine that is responsible.
So do whatever it takes. Life is far too short to be worried about what anybody thinks of you.
Another round of emails focuses on the high cost of PrEP drugs like Truvada:
I was just turning 30 when the AIDS epidemic struck. I spent the next 13 or so years caring for, then burying, my friends and loved ones. Somehow a few friends and I escaped infection; I don’t know how.
In the intervening years, I’ve gone through periods of promiscuity (10 years) and celibacy (another 10). Now, at 62 years of age, I’m still HIV-negative and “back out there” seeing a couple of guys regularly. I’m not sure of their HIV status. We do not practice safe sex. I’m not proud of that, but just being truthful here.
My internist is part of New York’s main gay health clinic. He also knows that I’m sexually active and “at risk.” I request twice-yearly HIV testing and have been treated for other STDs. Truvada has never been mentioned as an option.
I don’t ask for it because of the expense. What is it, ten grand a year? I work for a small law firm and the heavy users of the health insurance plan seem to get laid off (read: fired) at much higher rates. Perhaps I am immune to the HIV virus. I hope so. But I wish my health insurance wasn’t handled by my employer.
To my knowledge, most health insurance covers Truvada – as well it should. It could save insurance companies a small fortune if it cuts down on the need for far more expensive anti-retrovirals. Here’s a site that monitors insurance coverage of PrEP. Money quote:
We have not heard of any insurance company or any Medicaid program outright denying coverage of Truvada as PrEP. Some companies and programs are requiring prior-authorization, however, which requires paperwork to be filled out. And the type of insurance coverage you have, including prescription drug benefits, will determine the cost to you as the consumer. To date, we have seen the biggest barrier to obtaining PrEP from providers who are unwilling to write a prescription.
Let them know if your insurance is denying coverage. Another reader:
You ask why aren’t gay men on Truvada? Uh, cost??? I have a gold-level insurance plan and the Truvada manufacturer’s coupon (good for up to $200 per month), but it’s still costing me $469 per month. Truvada, like every other anti-retroviral, is a “non-preferred” drug on the formulary of every insurance plan that I could find in my state. I guess they’d “prefer” that we just drop dead. I’m starting to wonder if I shouldn’t fly to India and try to arrange a generic supply. How many gay men are going to go ask their doctors for prescriptions if they’ll still have to fork over almost $500 per month to get it?
Is it being prescribed as preventative medicine? Several more readers sound off:
I am a sexually active HIV-negative gay man who started taking Truvada as a preventative four months ago. I’m in my mid-40s, and during my 25 years of sexual activity I have been a spotty practitioner of safer sex. That I have remained HIV-neg is probably a combination of luck and the fact that I am an exclusive top. (I am also circumcised – no idea if that is a factor).
So am I a Truvada whore? I have no idea. In the gay community, a whore is anyone who gets laid more than you do
I have great health insurance, and when I heard about research showing Truvada’s efficacy as an HIV preventative, I thought, “Why the hell not?” My luck could run out one day, and if Truvada boosts my chances of remaining negative with minimal cost to me, why wouldn’t I take it? I also thought about my partners, many of whom I care about beyond their heavenly posteriors. Testing positive for HIV would be bad enough; knowing that I might have unwittingly spread the bug to someone else would be too much to handle.
Getting the drug is not without hassle. I asked my primary care physician for a prescription when I went for my annual physical. She seemed unaware of the Truvada-as-preventative research. Even after I showed her CDC/NIH recommendations (which I had printed out and brought with me), she was uneasy about giving me a prescription and referred me to an infectious disease specialist. I finally got the drug, but only after seeing the other doctor and subjecting myself to another round of blood work.
Also, it is my understanding that not all health insurers cover Truvada for the HIV-negative. If mine didn’t, there is no way I could afford the medication on my own.
The optimist in me hopes that once other drug companies develop similar PrEP drugs, prices will come down. I’ve also read they are looking into a long-term injection method that would last three months which would help with any “taking it daily” problems. And perhaps way down the road generics will be made available. Let’s hope.
This reader could use some:
I found your post regarding Truvada so timely – as in today, when I went to a NYC pharmacy to fill my own prescription to start PreP, an HIV-negative guy of no particularly promiscuous lifestyle, deciding the medical benefits of Truvada for PreP were unassailable.
Last year, before news of its efficacy for for PreP really began hitting the mainstream press, I’d learned about it from Facebook posts about the FDA’s then-new guidance posted by more informed gay pals, some of whom were health advocates. Learning quickly of the controversy and so-called shaming from some gays didn’t faze me in the slightest; I’m not a peer pressure guy and rationally considering the medical science made it a no-brainer: I wanted this drug in my arsenal.
Still, it took several months from thinking about it to acting on this knowledge at my annual physical exam. My doctor was 100% supportive, explained how I would need to strictly adhere to daily use and regular monitoring in his office, wrote me a prescription and, warning that my insurance company probably wouldn’t cover it, gave me a manufacturer’s “co-pay assistance program” card, essentially a discount club, with which I duly registered. (The Gilead program’s customer support person, who had not yet encountered anyone calling to register for the assistance intending to use it for PreP, had to check with her supervisor that their program would apply, but it turned out this was ok.)
So far so good. Until I reached the drugstore counter though, just today here in NYC. At $1,320 for a month’s supply, the cost was breathtaking, at least to one who has never faced the bills of someone with a chronic disease. Just as my doctor suspected, my AETNA plan won’t cover PreP, everyone knows there is no generic alternative, and Gilead Sciences, the manufacturer, is selling it at at what they are selling it for. Were I already HIV positive, my insurance company would cover Truvada much more cheaply, but AETNA knows I am not trying to get it for HIV, because my doctor prescribed it alone, not in a three-drug combination “cocktail” that signifies an HIV prescription.
The pharmacist helpfully gave me the printout explaining the cost breakdown from ATENA’ drugs formulary. The cost for a 30-day supply was $1,539, the fact I was an AETNA member got me a contracted discount price of $218.96 off (14.22%), but there was no coverage or partial coverage by AETNA, no manageable co-pay for me. Rather, it was all-pay. I walked out of the drugstore and realized I will need to reassess. And then I got home to see your Dish post, which only strengthened my conviction this drug should be available widely as a prudent personal and public health measure.
It took me a couple of minutes to discover that Aetna does indeed cover Truvada. Money quote:
A documented diagnosis of human immunodeficiency virus (HIV) OR
A documented diagnosis of initiating therapy for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults at high risk AND documentation of all of the following:
A negative HIV antibody test taken:
Immediately before starting Truvada for PrEP AND
Every 3 months thereafter while on therapy
Confirmation that creatinine clearance value >/=60 mL/min before initiating Truvada for PrEP AND
Serum creatinine and calculate creatinine clearance checks performed at 3 months after initiation and then every 6 months thereafter
NOTE: Members may receive a 30 days’ supply of medication upon initial request of Truvada for PrEP diagnosis. After 30 days, above criteria must be met.
Update from a reader:
You might be interested to know that, at least in Illinois, many ACA plans have very poor coverage for Truvada. In fact, Illinois ACA plans generally have poor coverage for all HIV drugs. I’d highly recommend taking a look at this study [pdf] done by the AIDS Foundation of Chicago on coverage for HIV drugs by ACA plans in Illinois. For example, under Aetna’s Illinois plan, Truvada is a “non-preferred” drug that usually requires out-of-pocket costs of $733.99 a month, effectively putting it out of any normal person’s reach.
Of course this reader focuses on The Horror! of paying $734/month for Truvada – instead of doing us the service of pointing out that in the very same PDF we learn that BCBS has it available at a $50 copay for silver plans; $35 for gold. Likewise, even at $734, the cost is still subject to the plan’s deductible and out-of-pocket max, meaning almost exactly nobody is going to be paying $734/month for the entire year on these plans.
When asked about the risks of Truvada, Dave Cullen answered in three quick parts: healthcare costs (discussed by readers here), side effects, and people not taking the drug consistently:
A New Yorker piece backs up Cullen on the side effects:
Taking Truvada to prevent H.I.V. comes with very few risks. In the N.I.H. study, one in two hundred people had to temporarily go off the pill owing to kidney issues, but even those people were able to resume treatment after a couple of weeks. While bone-density loss occasionally occurs in Truvada takers who are already infected with the virus, no significant bone issues have emerged in the PrEP studies. And though about one in ten PrEP takers suffer from nausea at the onset of treatment, it usually dissipates after a couple of weeks. According to the U.N. panel’s Karim, Truvada’s side-effects profile is “terrific,” and Grant said that common daily medications like aspirin and birth control, as well as drugs to control blood pressure and cholesterol, are all arguably more toxic than Truvada.
A reader is still worried about the indirect risks of PrEP:
I’m sympathetic to your position; I will probably take Truvada when I’m at Bear Pride in Chicago. I plan on using condoms anyway, but … you know. Alcohol and all that. Sometimes you don’t pay attention.
But for the record, I do think the points that those concerned about Truvada raise regarding substituting it for a general sexual health strategy are reasonable in some ways. Case-in-point: gonorrhea. I can tell you right now, I am much, much more afraid of drug-resistant gonorrhea than I am of HIV.
One criticism I’ve read of Truvada is that if lots of gay men start taking it, but even a small subset of them do not take it as directed, i.e. once a day, that it could lead to different resistant strains and a strengthening of the virus? Is that at all true?
[Jim Pickett, the director of advocacy for the AIDS Foundation of Chicago] told me he believes drug resistance is “something to be watchful for,” but not a huge concern of his for a few reasons. One is that resistance is common in the world of HIV medications. He said he’s HIV positive himself, and has been on various meds since 1997, building up resistance to “a whole bunch of drugs over the years.” And because maintaining a Truvada prescription requires a comprehensive HIV test every three months, Pickett suggested that there would be opportunity to keep a mutant strain of the virus contained:
And if you were going in for your refill and it was found out that you were actually positive, they could immediately determine what kind of strain of HIV you have. If it has any kind of genetic alterations due to it being exposed to a certain drug, suboptimal levels of drug, that could be determined. It could also be determined that you don’t have any drug in your system. And if you don’t have drug in your system, you can’t be resistant.
You also can’t be resistant if you don’t become HIV positive. People get confused about that a little bit, like the drug itself can create resistance. Well, the drug has to be at suboptimal levels and come into contact with HIV. If you don’t come into contact with HIV, no resistance. If you come into contact with HIV and you don’t have any drug in your system, no resistance. It’s just that suboptimal part. But it’s a harder thing to happen than I think people think about.
Another reader notes an obvious way to lower such risks:
I wish the discussion would remember that many gay guys – I think I once heard Dan Savage say as many as 30 percent – spend their entire lives without having anal sex, and that a lot are also in situations where they’re already at extremely low risk of contracting HIV, such as men who aren’t as active sexually or prefer practices that don’t involve intercourse. While the current safe sex rhetoric is obsessed around condoms, it is so because it is also obsessed around equating male homosexuality with anal intercourse, and sexual expression shouldn’t just be about one act.
Another risk-averse reader wrings his hands:
I’m a 38-year-old gay man, young enough that none of my friends died of AIDS but old enough that I have spent virtually my entire conscious life worrying that I would die from it. I’m a rarity: a fully condom-compliant gay man. I’ve never had difficulty using them and have never had sex without them, except with my husband.
Plus, I’ve always tried to avoid having sex with guys who don’t use condoms regularly for casual sex. Avoiding barebackers is a rule that has served me well; I’ve never had an STD, despite a huge number of partners.
PrEP – while undeniably a good thing – is very disorienting. Do I avoid barebackers who use PrEP? Just continue using condoms with them? Start taking PreP myself and forgo condoms altogether? What a wonderful, frightening thought that is.
I know I should be celebrating. Instead I’m still worrying … about a new set of issues.
Those two adjectives – “wonderful” and “frightening” – say it all. Fear is a terribly difficult thing to leave behind, especially when you have lived your entire life in its shadow.
A straight female reader chimes in:
As I was listening to Dave Cullen discuss Truvada I could only think … well, welcome to my world! The birth control pill was “unleashed” on women in 1960. I graduated from college in 1967 and moved to Chicago to work. When I went to my doctor to get a prescription for them, boy did I get a lecture. “Now, you aren’t going to have an affair with a married man are you?” At that point I was dating a divorced man, so maybe that was the same? But the feelings about the pill and women were almost exactly the same as Cullen was talking about and which Limbaugh expressed when Sandra Fluke testified about the contraceptive requirement in the ACA. We were going to be irresponsible; we were sluts – all because we wanted to protect ourselves from getting pregnant when we had sex, just like Cullen wants to protect himself and others from HIV when he has sex.
We haven’t gotten very far, have we?
The comparison to the birth control pill brings to mind this great quote from Jim Pickett, the director of advocacy for the AIDS Foundation of Chicago:
You’re here because people barebacked. Your grandmother was a barebacker. That secretary in your office, when you’re invited to her baby shower, she’s a barebacker. You’re bringing gifts for someone who engaged in risky fucking behavior. What the fuck are you doing? She’s a bad person. We would never [say] that. We’re like, ‘Yay! You’re pregnant! What is it? Woohoo!’ With a gay man, it’s like, ‘Oh my God. You’re reckless, you’re careless, you’re insane, you’re self-destructive, you want to hurt yourself and others.’ And we ignore the fact that gay men have the same needs to feel close and intimate and pleasure.
Another reader asks:
How is Gardasil – an intervention to prevent a potentially incurable disease – somehow morally correct and non-contributory to increased sexual activity, and yet Truvada is not? In the name of prevention and facing the realities of sexual behavior, we have railed against Christianists’ opposition to sex education, condoms for teens and now a vaccine. It’s time we are consistent about ourselves.
Another responds to this video from Dave Cullen:
As a straight female, I have real issues with the whole “it feels better bare so why not do it that way.” My late husband and I had a good marriage, but one area in which he was difficult was birth control. He didn’t like condoms and didn’t want to use them. He didn’t want to go to the store and ask the pharmacist for condoms. He refused to have a vasectomy when he didn’t want more kids, so I got a tubal ligation.
All the things he feared and resented I had to take on. I had to go to the store and ask the pharmacist for birth control pills (and deal with the side effects); I had to research and decide on an IUD and a doctor to insert it; I had to have a tubal ligation after my last pregnancy. And yes, I had to do those things because we didn’t want and couldn’t afford a large family. If we had not both been products of the 1950s, the marriage probably wouldn’t have happened, because I would not have been as subservient and the relationship would not have progressed with his issues about birth control.
Although I like sex without condoms better if I’m protected from disease and pregnancy, being a widow means condoms are in my future if I meet a guy who wants to fill them. I don’t think censoring opinions about “bare is better” works. But anyone who exalts barebacking should do so while communicating that there’s no good mutual sexual experience – one that is good at the moment and also good in memory forever – that leaves one partner worried or angry about pregnancy, disease, or discomfort. Bare isn’t better if it isn’t the best mutual choice, and it isn’t a decision that should be made on the basis of penile nerve endings alone.
(Video: A brief history of the birth control pill)
Dissents Of The Day
A reader quotes me:
Even as the truth now is that no one with undetectable virus can infect anyone, and no one on Truvada can get infected. Instead of embracing that, we shy from it.
This seems optimistic to me in a way that borders on foolish. Where did you learn this? I’d love to read the scientific papers or studies that come to that conclusion. My memory of articles I have read about Truvada say that in the study group, it prevented infection at a percentage in the high 90s, which is pretty darn good. But that doesn’t mean “no one on Truvada can get infected.” I have no beef with anyone who wants to take it to reduce their risk, but you can’t make the claim that a very effective pharmaceutical can protect a person from infection in the same way that a physical latex barrier can. (I’ve never agreed with your hatred of condoms and side with Dan Savage: If condoms break without people noticing, they can’t make that much of a difference.)
Not to mention that saying a person with undetectable viral load cannot infect anyone also sounds irresponsible at best. From the CDC website: “However, sexual transmission of HIV from an infected partner who was on ART with a repeatedly undetectable plasma viral load has been documented.”
All that said, wider use of PrEP should be considered, but honesty and facts are called for in discussing its potential. I think if it were true that no one on Truvada could get infected, you’d see every public health department clamoring to offer it to high-risk populations.
We’ve covered this ground already. Here’s the key study on the impact of undetectable viral loads in preventing transmission. Money quote:
Statistical analysis shows that the maximum likely chance of transmission via anal sex from someone on successful HIV treatment was 1% a year for any anal sex and 4% for anal sex with ejaculation where the HIV-negative partner was receptive; but the true likelihood is probably much nearer to zero than this. When asked what the study tells us about the chance of someone with an undetectable viral load transmitting HIV, presenter Alison Rodger said: “Our best estimate is it’s zero.”
In over 40,000 unprotected sex acts, no negative partner was infected by a positive partner with undetectable viral loads. A key Truvada study found more than 90 percent effectiveness in preventing HIV infection even among those not fully compliant with the one-pill-a-day regimen. Another study showed that “participants could reduce their risk of HIV by 76 percent taking two doses per week, 96 percent by taking four doses per week, and 99 percent by taking seven doses per week.” 99 percent may not be 100 percent, but it’s pretty damn close. And it’s not that different from condom use in HIV prevention. Condoms are not 100 percent effective either; you need to use them correctly; they can break; and so on. Moreover, stopping sex and putting on a rubber in the heat of the moment may not be as easy as taking one pill a day outside the experience of sex.
Another reader is “horrified that you are using your influence to pass off opinion as science in regards to the prophylactic use of Truvada”:
I’m not an expert, a patient, an advocate, or a physician – I just work for the pharmaceutical industry and I sat through the FDA Advisory Committee hearing on Truvada PrEP in May 2012. I assure you that experts on that panel were concerned about Truvada and resistance – particularly when not taken as prescribed. Furthermore, the claim that “maintaining a Truvada prescription requires a comprehensive HIV test every three months” is simply false. This is recommended by FDA, but there is no process in place to ensure that prescribers test patients every three months. We must depend upon physicians to follow these recommendations – and even the most conscientious prescriber might fill a prescription for the patient who is about to leave on vacation and needs a refill “just this once.” Contrast this to a drug like thalidomide, for which FDA requires the prescriber to submit a negative pregnancy test result before the drug is dispensed.
Finally, no one knows what side effects might result from long-term use of Truvada – or what will happen when the drug is not taken as recommended. The FDA approval was based on results seen in a small number of patients in carefully controlled clinical trials. Oftentimes it takes years after approval before dangerous side effects of drugs are discovered. This is particularly true for drugs taken long term.
Celebrate that Truvada is on the market. Celebrate that Truvada represents a major development in HIV-prevention, but please don’t pass off opinion and conjecture as scientific fact. You have so much influence, please be careful!
Here [pdf] is the FDA’s Risk Evaluation and Mitigation Strategy for Truvada for PrEP. It describes many of the concerns about Truvada. And here [pdf] is a transcript of the advisory committee hearing. It’s really long, but search this for “resistance” – and you’ll see that it was a major concern among the experts on the panel.
I’ve noted that resistance is a worry. But insurance companies won’t cover the drug outside the three-month protocol, require an HIV test to start it, can catch an HIV infection before it has a chance to mutate, and the small chance of resistance if the patient is not taking it regularly in those three months can be overcome by other HIV drugs in a different class than Truvada. As for side-effects, it is not true that we know nothing about it. Truvada has been around for quite a while. No drug is without side effects. But the side-effects of HIV are brutal and the side-effects of the full cocktail much more punishing to the body. The truth is: the risks of Truvada are minimal compared with the risk of HIV and the toll of the cocktail. No of course it isn’t fail-safe. But the actual risks of this are trivial, when you abandon the irrational fear and panic inherited from the past and look at the entire picture. Another reader:
In the past I have found your attitude toward HIV to be a little cavalier, to be honest. So when you talk about Truvada, I take it with a grain of salt. I am 29, of the generation that was a little child when the worst was happening and was basically taught to fear sex, condom or not, ESPECIALLY GAY SEX. This was of course on top of all the traditional moralizing against sex, coupled with “abstinence only” sex ed. To this day, even after learning the truths, I can’t have sex without the worry in the back of my mind of whether this will be it. I had resigned myself to it for the rest of my life.
So now I am hearing that that there’s a drug that could be almost the vaccine we have all been hoping for. The first thing that happens is massive amounts of moralizing (on both sides), judgement and a big heaping spoon of FUD [fear, uncertainty, doubt]. What I need are trusted, independent, verifiable facts. And right now, I don’t know who the fuck to believe.
So my question is: Where the hell are the doctors? Why aren’t we hearing from independent medical professionals? Where is the Surgeon General issuing a recommendation? The AMA? All I have to go on right now is figures from one side, figures from the other side, and all the screaming in between.
My attitude is not cavalier. It comes from two and a half decades of study and more than two decades with the virus. My attitude is based simply on taking seriously the value of intimate, gay sex as a human good, not a lamentable evil. And on trying to see the actual, practical ways we can deploy to reduce infection and transmission. From sero-sorting to Truvada, I’ve been thinking about this for a long time – in part out of a duty to my friends and lovers who died agonizing deaths. I don’t think they would want us infecting each other at the rates we are, or would regard this breakthrough as anything other than a Holy Grail of sorts. And don’t throw up your hands at arguments back and forth. I’ve offered the data and the facts. Check out the links I’ve provided and ask your doctor if it works for you.
Malkin Award Nominee
“In the last few days in terms of the people who have been yelling the loudest about [Truvada], they’ve all been associated with bareback porn. They’re all associated with bareback porn, which kind of makes my point that it’s a party drug,” – Michael Weinstein, president of the Los Angeles-based AIDS Healthcare Foundation, the largest HIV/AIDS medical care provider in the U.S.