For a long time, the most common way to describe pre-exposure prophylaxis (PrEP) was that it is a daily pill taken to prevent acquiring HIV. But now, New York City is tackling what might be a barrier to PrEP uptake with its new on-demand PrEP initiative.
"On-demand" PrEP has been tested in trials like IPERGAY and other recent studies and has been shown to be highly effective. To that end, and following the International Antiviral Society–USA and the San Francisco Department of Public Health releasing on-demand PrEP guidelines, New York City's Department of Health and Mental Hygiene (DOHMH) has released its own guidelines to providers who need education on this new way to deliver this still relatively new HIV prevention intervention.
TheBodyPRO spoke to Demetre Daskalakis, M.D., M.P.H., deputy commissioner for the Division of Disease Control of the DOHMH, about the guidelines and why it was time to introduce them in New York.
Mathew Rodriguez: Tell us, in your words, what "PrEP on demand" is.
Demetre Daskalakis, M.D., M.P.H.: So PrEP on demand is a non–FDA [Food and Drug Administration] approved dosing schedule that has really good clinical evidence in terms of studies for gay and bisexual men and other men who have sex with men as an alternative to daily dosing. The idea is that there is a loading dose a couple of days -- ideally 24 hours, or as little as two hours -- before sexual activity, and then a dose a day after that, and another a day after that, and then a discontinuation of PrEP.
It's an event-driven option for people who may not want to take PrEP every day. Or people who cannot. There are people who have issues that make it hard for them to take PrEP every day, like a medical issue, renal insufficiency, or kidney problems. There are people who may have barriers for payment and provider flexibility and, without spilling the beans, it could provide some interesting public-health strategies for people who need episodic versus long-term pre-exposure prophylaxis.
MR: Scientists have known about the efficacy of on-demand PrEP since the IPERGAY trial in 2014. What do you think has stopped on-demand PrEP from becoming a standard practice in U.S.-based PrEP care?
DD: There's a couple of things. It's not part of current CDC [Centers for Disease Control and Prevention] guidelines for PrEP, so that makes it hard for folks to adopt. The good news is that there are other guidelines that have come out that talk about on-demand PrEP. The International [Antiviral] Society–USA guidelines are the first example of domestic guidelines saying that this is an option. New York has been monitoring that closely. San Francisco has also released guidelines about using it this way. We wanted to make sure we support our providers and make sure folks in New York have more options. This is like contraceptive conversations. The more options people have, the more people buy in. We wanted to say that this is evidence based and safe -- and providers don't have to guess if they don't know. We want to make sure they have guidance to do this right.
The New York City Bureau of HIV assistant commissioner [Oni Blackstock, M.D.] -- she and I had conversations about accelerating this, and we wanted people to know this around Pride Month, at this time around New York City. The combination of IPERGAY, the IPERGAY open-label extension, all that data makes us comfortable. We're always going to say we like daily PrEP. We like daily PrEP; it's easier in some ways. But with daily PrEP, you're just on it. If a scenario emerges where you will have sex, you're not making any decision about HIV prevention, because you made that decision when you started PrEP. On-demand has this other bit where you have to make a plan, or a guess. Some people can guess when they have sex, so it adds a dimension. For some people, it might be the right way to go -- for others, a daily pill is easier.
I think it's good public health to demand options, as long they're evidence based.
In my practice, we call it the "Berlin syndrome," if my patients are going to Berlin. It's the, "I'm traveling, I'm going to do this," or "I'm going to some party, and I know I'm going to have sex," so some of those folks may not necessarily have consistent sexual exposure. I've definitely encountered patients in my personal practice who say they don't want to go on PrEP because they say they only have crazy sex when they go to Provincetown! That's what it's like. They don't want to put that pill in their body every day, because they don't need it. For those folks, this is an interesting option.
MR: Ever since IPERGAY, the line has kinda been like, "On-demand PrEP might be best for people who have fun on the weekends," while daily PrEP is better for people who are having fun during the weekday, too. As DOHMH, how do you speak to providers about the distinction?
DD: This goes to one of our core values, which is, Talk to your patients about sex and what they want. We want people to have frank conversations with their providers. The fact that my patient can look at me and say, "I'm going to Berlin," and I say, "Let's talk about that." That distinction you made is sort of the thumbnail view, but I have people who don't have a lot of HIV exposure opportunity in terms of having a lot of sex all the time but who feel more confident in taking that pill every day and being able to be spontaneous. People pick options for a lot of reasons that are not always obvious and apparent to people who are sitting in an office making public-health decisions. What's important is if it works, it works.
As long as it's clear that the data are really only for cisgender men who have sex with men, it's really specific who these studies have been with. It's not for women, yet. But at the end of the day, it's just the idea that you should have more options and flexibility if it's evidence based.
It takes time to figure out exactly how to roll out guidance. In San Francisco, they win at the horse race with this one. We modeled a lot of our New York City guidance on what they did, because it's nice and clear, in a universe where there was only an option for daily PrEP, trying to see what other guidelines did before we ventured out on our own. But when we saw that IAS and SF jumped on board, it felt good for NYC to have a similar commitment.
When PrEP was first approved, we moved really quick to get guidance in place. This is a bit more of a nuance, but it's a nuance that I think is appropriate.
MR: What do you think might indicate someone for on-demand PrEP instead of daily PrEP, if you were seeing them?
DD: What a good question. I would start by presenting daily PrEP to someone I'm talking to. But there are folks who could benefit from PrEP, but they have an unwillingness to go on daily, so I have the option of another strategy. It's about giving the full range of what's available. It's funny, actually. Whenever I've done PrEP daily versus on demand, which, let's not pretend -- I was doing on-demand PrEP before New York City thought it was something good to do. There are people I'd meet and tell them about daily PrEP, and they'd turn it down, and then when I say, "There's another option where you don't have to take it every day," they'd say, "Yeah, that fits my lifestyle better." So having the option means more people might be willing to take up the intervention.
MR: If it were to change in a few months that emtricitabine/tenofovir disoproxil fumarate (Truvada) is not the only drug combination approved for PrEP, and we add emtricitabine/tenofovir alafenamide (Descovy), would you say to wait on this method of PrEP usage until Descovy has been properly tested?
DD: I predict that there's probably already a trial coming, if not already getting enrolled. In general, we tend to be very conservative about new drugs, so I think we would stick to Truvada as on-demand, unless we had evidence that said otherwise. Or if there was an extrapolation where we had conversations with other thought leaders in the area to see if it's a feasible extension of what Descovy could do. I'm going to be gun shy about it until I have some data for it. In theory, it seems to make sense, but there are a lot of things we seem to think in theory would biologically work, but they don't. I would wait before I jump too fast.
MR: Scenario: Someone Googles "on-demand PrEP." Recently, there was a case in Australia about a person acquiring HIV while using on-demand PrEP. Should that worry someone who is thinking about using that method?
DD: Since they called me the day after that case to comment publicly, I'll say what I said then: Neither PrEP daily or on demand are completely foolproof. It's important to get tested on the schedule that's required for PrEP so if you get an HIV infection, you can get treated quickly. The good thing is people who seroconvert from PrEP, they tend to get to undetectable very quickly and do very well.