I have been a bit slow on blogging recently due to moving to a new house at the start of a semester (remind me why I thought *that* would be an OK idea again?) but I did want to share this very interesting piece from the New Yorker by Christopher Glazek “Why Is No One On the First Treatment To Prevent H.I.V.?“
At Petrie-Flom we held a great panel discussion right when this PrEP (pre-exposure prohylaxis) treatment (and the OraQuick home HIV test) came out, and you can watch it here. (The event featured Robert Greenwald, Director of the Center for Health Law and Policy Innovation; Douglas A. Michels, President and CEO, OraSure Technologies, Inc; David Piontkowsky, Senior Director for Medical Affairs, HIV and HIV Global Medical Director, Gilead Sciences, Inc; Kenneth H. Mayer, Medical Research Director, Co-Chair of The Fenway Institute; Kevin Cranston, Director, Bureau of Infectious Disease, Massachusetts Department of Public Health; Mark Barnes, Partner, Ropes Gray, Lecturer in Law, Harvard Law School.)
As the New Yorker Article describes (and full disclosure, I sat on an IRB that oversaw a good chunk of this research at Fenway Health at one point in my career, so I am not a disinterested observe) the use of of the drug Truvada for PrEP has some pretty impressive figures from the clinical studies:
while adherence is a concern, as it is with condoms, Truvada offers H.I.V. protection that is more effective than any other method short of abstinence. In the N.I.H. study, for example, 5.2 per cent of the placebo group “seroconverted,” or became H.I.V. positive, compared with 2.9 per cent of the Truvada group. That’s a forty-four-per-cent added protection over-all—better than inconsistent condom use. More impressively, patients who maintained a detectable amount of the drug in their system were protected at a rate of ninety-five per cent. (A later statistical analysis estimated that the drug would need to be taken four times a week to offer protection in that range.) Grant said that people in the study who took the drug four to seven days a week “were absolutely protected. We didn’t have anyone seroconvert in our cohort in the United States.”
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.
Perhaps more important, drug resistance has not been observed in people who were H.I.V.-negative when they began treatment. “We’re not seeing people getting infected who are actually taking the drug,” said Grant. “There are people who take the drug home with them and choose not to take it; they get infected, but you’re not going to get drug resistance from something that stays in a drawer.” Some patients who entered the trials turned out to already have an H.I.V. infection that was too recent to be caught by a blood test. These subjects showed a small amount of drug resistance, which is why the F.D.A. now requires doctors to conduct an H.I.V. test before putting their patients on PrEP. The larger resistance threat, though, comes from the ten million H.I.V.-positive people around the world who take antiretrovirals for treatment, including, in some cases, Truvada. “The best way to prevent drug resistance is to prevent H.I.V. infection entirely,” said Grant. “We know that when we prevent a case of H.I.V., we’re preventing a lifelong risk of drug resistance.”
But that just prompts the mystery, why aren’t more people taking the drug?
As the New Yorker article notes “adoption of the drug has been slow. According to Dawn Smith, a biomedical interventions implementation officer in the C.D.C.’s epidemiology branch, at least half a million Americans are good candidates for PrEP—meaning that they are at high risk for contracting H.I.V. through sexual activity—yet only a few thousand Americans are receiving the treatment.”
Had you told me this fact, my best guess would have been insurers as the gatekeeper blocking it. But in fact the New Yorker article reports that:
Cost, at least in the United States, has also turned out to be a smaller concern than initially predicted. Smith said, “We were very surprised to find out the insurance companies said, ‘Yes, we’ll pay for it. It’s much more expensive to treat people who have H.I.V. infections.’ ” While a lot of people at high risk for contracting H.I.V. currently lack health insurance, after January 1st many of them will be able to get coverage through Obamacare. And for those who still don’t have insurance or who have unmanageable co-pays, Gilead provides assistance to purchase the drug, which has a sticker price of thirteen thousand dollars a year.
So what has been the problem? If the New Yorker is to be believed, it appears that initial negative publicity on the drug trials have poisoned the well among potential prescribing physicians. Again from the article:
Regan Hofmann, the former editor-in-chief of Poz, a magazine for people living with AIDS, called PrEP a “profit-driven sex toy for rich Westerners.” Michael Weinstein, the head of the AIDS Healthcare Foundation (A.H.F.), the world’s largest AIDS organization and the primary-care provider for more than two hundred thousand patients around the world, predicted a public-health catastrophe. “The applause for this approach shows just how disposable we consider the lives of gay men,” he wrote. When I interviewed Weinstein, he claimed the studies were “rigged” and that PrEP was essentially a plot by Gilead to force young people into buying unnecessary medication, and that it was going badly because A.H.F. wasn’t letting the company get away with it.
There is also, if the article is to be believed, a whiff of “slutshaming” (my word not the author’s) going on, wherein those who “need” a drug like Truvada and cannot be trusted to use condoms are treated as “sluts” or irresponsible or meth heads.
Here is my own take on these concerns:
Do I think we need to do more to further the goals of getting affordable HIV medications and prevention to the developing world. Absolutely. Do I think widespread use of PrEP among high risk populations is in conflict with that goal? Absolutely not.
Do I think those non-monogamously sexually active should use condoms every time? Absolutely. Do I think that is likely? Absolutely not. The key question is whether PrEP leads to behavioral dis-inhibition on condom use that is so great it outweighs the benefits in protection and preventing new infections from PrEP. I have seen no data thus far that supports that claim and all the data I have seen suggests the opposite, but I am happy to be educated that I have the epidemiology wrong. There is, in my mind, a harder question about the effect of such dis-inhibition on non-HIV STD/STIs. Here, though, I think what is hard is how to balance the outcomes from a public policy perspective. How many new cases of HPV or Syphillis would one trade for one fewer case of HIV in a given year? Perhaps QALYs or other health policy tools can help us answer that question, but it is exactly these thoughtful data-driven we should be focused on, not slutshaming and conspiracy theories.
So let me end with a question: If you had a friend, or child, who was engaged in non-monogamous sexual activity that had a significant risk of HIV infection, what would you tell them? To use condoms every time? Absolutely. But would you not also suggest they look into PrEP as an extra bulwark?