Challenges to Monitoring PrEP Adherence and Persistence

A multidisciplinary panel of experts discuss challenges to monitoring patient adherence and persistence to HIV PrEP.

Neil Minkoff, MD: In my practice and in the payer community, there’s this idea that if you shoot for 7 days a week, you might get 5, and if you shoot for 5, you might get 3, and so on. I don’t mean to minimize pill burden. I’m not minimizing it at all. One of the things I hear a lot is that the relaxation of the daily pill burden, for example, could lead to potential downstream consequences. I don’t know the answer to that. I’m asking it very forthrightly based on the conversation we’re having. 

Jeffrey Crowley, MPH: I think the world is changing, and a lot of what we know is based on the first product that came along, and that I still say is forgivable. But we talk about an intermittent [dosing] model, which is 2-1-1, but that in some ways requires people to predict effectively when they’re going to have sex, and I think that’s hard. But I think as we see more products come along, there’ll be more room for error, and I think there’s space for future intermittent models where it’s about taking 1 pill once a week, and then if you have sex on a day you take a pill and different things like that, that’ll create more room for error.

Neil Minkoff, MD: Fair enough. Dr. Frank?

Ian Frank, MD: Well, it’s certain that things are going to get more complicated in the future.

Neil Minkoff, MD: Yes.

Ian Frank, MD: If we look at the French model, though, when somebody in Paris starts on pre-exposure prophylaxis [PrEP], they’re told that there are 2 different approaches here. If they’re having frequent sex, take the pill every day. If they’re having intermittent sex, maybe just a couple of times a month, they’re instructed to take 2 pills before having sex, 1 the next day, and 1 the day after that if they haven’t had sex. If they’ve had an additional day of sex, they keep going until they’re 48 hours beyond their last sexual encounter. If people are having sex less frequently, not taking a pill every day may diminish the risk of pill fatigue and of not doing it the right way at all. People are instructed that they can switch back and forth. If people are having sex more frequently, they transition to taking it every day. If you’re working on a project and you’re not going to be out socializing for the next couple of weeks, then you can stop. If you have 1 intermittent contact, you can do it this intermittent way. They’re taught how to take the medication in a more flexible way. In the large real-world studies that are accumulating the experience here, the rate of HIV acquisition is the same if people are doing it every day or if they’re doing it intermittently, and it’s a fraction of a percent of people who are at risk of acquiring HIV. Thus, both strategies are effective. 

In the United States, there is only 1 FDA-approved way to give PrEP, and that is every day. I am not trying to encourage, recommend, whatever word you want, I’m not doing that. I’m not recommending that we go to an intermittent PrEP strategy.

Neil Minkoff, MD: No, we’re just realistically accepting that the way people do things in the real world is not necessarily the way it was done from a regulatory point of view, and that’s patient choice, and so on.

Ian Frank, MD: OK. Ryan?

Ryan Bitton, PharmD, MBA: Yes, I’m not 100% sure what the question is.

Neil Minkoff, MD: Given that there’s such variability in the way patients and clinicians are using the product for PrEP in the real world, how does that interfere or make it more difficult to try to do warning systems like you might do for patients in other chronic diseases who have gone a certain amount of time without doing a refill, indicating they might be falling off therapy? Does it make it challenging to measure where the persistence problems are?

Ryan Bitton, PharmD, MBA: Yes, in pharmacy today that’s always complicated. Because all you have got to go off of is, did it pay? We don’t know if they picked it up, but we know that if the pharmacy reversed it, then the patient didn’t pick it up. You’ve got pay claims, claims that were reversed, and then you can see how long; was it a 30-day, was it a 90-day, etc. You’ve got to create an algorithm to say, OK, I don’t want to bug people if they’re just 1 day late, and how many, is it 7 days, is it 30 days? I think there’s delay, and there’s severe delay, in how people can approach this, and I think understanding those tolerance levels is important. But from a pharmacy claims perspective, we’ve only really got 2 things to go off of: whether it paid, and then if it got reversed. You can definitely still see a great story there, but you can only go so far into the story because all you’ve got are those 2 pieces of data. It is tough, but we can tell great things. It’s virtually almost real-time. For example, you can tell that it was picked up yesterday, and the PBM [pharmacy benefit manager] sends the claims data over to a health plan. Thus, there are tools that can be used, but it’s tough to build a program just based on that, because what if it’s reversed in 2 weeks and the patient never picked it up? There are some constraints with pharmacy there.

Jeffrey Crowley, MPH: If I could suggest something, and you as a payer might say this is harder to do than I realize, but my sense generally of the research is that people aren’t middle adherers, they either take their pills largely every day or they don’t adhere at all. I think we need to step back and look at who we really see have the most indications for PrEP and what’s some of the difference in the population. Roughly two-thirds of our new transmissions are gay and bisexual men, concentrated in gay and bisexual men of color. We’re all white men of a certain age, and the health system probably works better for us, and daily pill-taking might be one way. A large part of our target population are young Black and Latino, gay and bisexual men who maybe their experience with taking pills daily is very different. I think we need to think about building systems that are more effective at supporting them, and it may include peer supports, and text messages to remind them. But this specific population might need a different type of intervention than other patients.

Neil Minkoff, MD: Carl, you look like you’re nodding in agreement to that. 

Carl Schmid, MBA: Yes. I think that’s one of the issues, the barriers to PrEP uptake, is to make sure we’re getting PrEP to the right people who need it. Right now, a lot of maybe white gay men and more affluent people are able to access it. But as Jeff said, where we’re seeing the growth of HIV is in the Black and Latino, particularly the younger gay men, particularly in the South as well. It’s important to have the payer system, and we talk about that and the importance. But it’s really that a lot more counseling is needed, more outreach is needed, and more holding of hands. Just as Dr. Frank talked about earlier, the need to take the sexual health history, it’s hard to discuss some of these issues in certain communities. There’s still so much stigma associated with HIV. I think those are some of the barriers to increasing PrEP uptake.

Transcript edited for clarity.

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