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 truvadaTruvada 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.