The State of PrEP in the U.S.: A Confusing Decision for Many
Oni Blackstock: For national trends in terms of PrEP utilization, for the most recent data we have, which I believe is through 2018, there have been year over year increases in the number of PrEP users—which is very encouraging. However, the data also highlights the inequities that exist in PrEP use across different groups.
We know that PrEP use is greatest among white gay men. However, we know that Black and Latinx men who have sex with men are at an incredibly high risk for HIV. Seeing increases in those groups would be reassuring. But we’re not seeing the increases that we necessarily want to.
Also, use among cisgender women, particularly Black and Latina cisgender women, remains low as well. And there’s less data available, unfortunately, for trans women, who we know bear a very high burden of HIV and are at high risk for HIV due to a number of factors. We don’t have national data that I’m aware of for trans women.
So, overall, encouraging to see these increases year over year, but also acknowledging that a lot of work needs to be done to address the inequities that we see in who is using PrEP.
Wilder: In October 2019, the FDA [U.S. Food and Drug Administration] announced the approval of Descovy in certain at-risk adults and adolescents to reduce the risk of HIV-1 infection from sex, excluding those who have receptive vaginal sex. Can you talk about what has happened since it was approved, in terms of awareness?
Blackstock: We have this second option for PrEP—Descovy—that has been approved by the FDA for men who have sex with men and transgender women. In contrast to Truvada, which was approved for PrEP in 2012, Descovy, pretty soon after approval, was being advertised on TV, online, and in various other ads. Also, when individuals go to the [official] Truvada for PrEP landing page, it actually opens up a window that takes them to Descovy. So, there’s been a push, at least on the manufacturer end, to get people started on Descovy if they’re new to PrEP, or switched to Descovy if they’ve previously been on Truvada.
There has also been a spate of both TV and social media ads about a class action lawsuit against the manufacturer of Descovy and Truvada, accusing it of holding back Descovy until the patent on Truvada ran out, knowing that Descovy had less adverse outcomes when it comes to kidney and bone health. Those ads are focused on Truvada and Descovy for HIV treatment, but because they are also available as PrEP, it has sown a lot of confusion among potential and actual PrEP users about which of these medications they should be taking, and which is safer.
So, we’ve seen a shift—many patients being switched off of Truvada onto Descovy, and then having patients coming in and asking if they should be switched, and if Descovy is a safer alternative.
Wilder: What are some of the questions that you’ve received from your patients who are on PrEP with Truvada but are kind of curious about Descovy?
Blackstock: Many patients have heard that Descovy is quote-unquote safer. And so, the main question is whether they need to switch from Truvada to Descovy. We have a conversation about that, which I can talk about in more detail.
Very rarely are there patients who maybe might have another medical condition, which makes being on one or the other a potential contraindication, or relative contraindication. In those cases, sometimes it’s a little clearer in terms of which medication to provide.
But, yes, there’s lots of consternation and confusion about whether patients should continue on Truvada—because they’ve heard all these horrible things about it—or whether they should be switching to Descovy.
The Case for Shared Decision-Making in HIV Prevention
Wilder: In your presentation at IDWeek 2020, you talked about the specific ways in which patients receive information from their medical providers and are involved in their health care decisions. Can you recap the differences between paternalistic decision-making, informed decision-making, and shared decision-making?
Blackstock: A paternalistic model is probably the most extreme, and involves the clinician giving not just information, but their own recommendations to the patient, without the patient’s input. That’s the most extreme version of what a clinician-patient therapeutic relationship could look like.
Then there’s informed medical decision-making, where the clinician is giving the patient information, and then it’s up to the patient to then come up with what they want for themselves and to choose the best option. That’s obviously in collaboration with the clinician.
Then there’s, lastly, shared decision-making. This is more of a process that involves both the clinician and the patient in selecting, in this case, what is the best prevention or treatment option. It involves the bidirectional flow of information, where the clinician is providing information about benefits, alternatives, and potential risks of different options. Also, the patient is providing their preferences and values. Then, together, the clinician and patient come up with a decision based on the pros and cons that they’ve heard about, the options available, and the patient’s values and preferences.
We know shared decision-making is associated with a number of positive outcomes, including higher patient satisfaction and communication, in terms of the patient-clinician interaction. There’s also some data to suggest it reduces health inequities among underserved and marginalized populations. This is one recommended approach particularly when we’re dealing with talking about these two PrEP options, and thinking about the communities that are most impacted.
Wilder: Take me through the shared decision-making model with an example of someone who is trying to make a decision around staying on Truvada as PrEP or switching to Descovy.
Blackstock: The more common example is having someone come in who’s been taking, let’s say, Truvada daily. They saw one of these commercials and they are saying maybe they need to switch from Truvada to Descovy because of Truvada’s potential harm.
The model that I used for the presentation was developed by Dr. Glyn Elwyn and a team of clinicians. It basically involves this process of the clinician working with the patient to deliberate about the different options and then have the patient develop informed preferences that then allow them–with the clinician–to come up with a decision.
The model starts with something called “choice talk,” which refers to the step of making sure that patients know that reasonable options are available. This situation involving Descovy and Truvada is a little different because patients are coming in knowing that they’ve been advertised to and that there is a choice. But some may not know, so saying that there’s information that you can provide to the patient about these two PrEP options, about how they’re similar and how they’re different, is really important–but so is emphasizing why choice is important.
We want to make sure that we’re respecting our patients’ individual preferences and that we also recognize that there is some level of uncertainty with medications. It’s possible that one patient may have a different reaction to a medication than another.
Recognizing all of those factors, you then work with the patient to go into what’s called “option talk,” where you provide more detailed information about the two options.
A lot of the conversation is also understanding what the patient may already know about the two options. Then there’s a much deeper dialogue and exploration of the differences between the pros and cons of the different options and the different implications that they may have for the patient. That’s all discussed.
For PrEP, we would talk about the robustness of the evidence base. For Truvada, we have lots more studies on it as PrEP than we do for Descovy, which has only been studied in MSM and trans women. We would talk about what we know about safety, differences in cost, and how Truvada can be taken on demand. There’s data to support Truvada being taken on demand for PrEP—we don’t have that data for Descovy.
Then, just summarizing back with the patient, assessing their understanding of what was discussed, asking them, “OK. What’s your understanding? Can you repeat back to me your understanding of the conversation so far?”
The next step is “decision talk,” where you’re basically supporting the patient and the work of considering their preferences and deciding what’s best.
You’re asking them, “From what we’ve discussed, from what your preferences are, what matters most to you in terms of looking at these two options?” You’re eliciting from them a preference, asking if they’re ready to make a decision, and then coming to a decision with them.
For the patient who came in asking about whether they should switch to Descovy from Truvada, the patient may say, “Well, for me, I want to be on a medication that has been tested or studied in lots of different people, where there’s a lot of experience behind it. I know Truvada has been around for eight years, at least as PrEP, and longer for treatment.”
They may be worried about some of the side effects of one versus the other. Then together you figure out, based on what information has been provided, what the preferences are and what choice makes the most sense.
Answering a Patient’s PrEP Questions: Share What You Know—And What You Don’t
Wilder: What’s the first question a medical provider should ask a patient if the patient says they’re thinking about switching their PrEP medication?
Blackstock: At that point, they know that there is an option. I would say something affirming. “Thank you for asking that question. There is good information about how these two options are different that I’d like to discuss with you.”
Then, again, emphasize the reasons why there might be a choice: There may be differences in safety or differences in the patient’s preferences. And also, ask what they have heard or read about PrEP; just get a sense of their understanding and work through the pros and cons with them.
Wilder: How important is it to include data in these conversations—for example, information about efficacy, safety, and even the cost of the drugs?
Blackstock: A lot of times patients may not have a clear understanding of what the data is and what the differences are. So part of the conversation is describing the data that’s available in a way that is accessible and understandable and digestible by the patient.
We can talk with our patients about the relative effectiveness, the fact that we have seen in studies a 99%, almost 100%, reduction in the risk of acquiring HIV in people who used Truvada versus a sugar pill, or whatever.
There’s no difference from the studies we have—and we don’t have to get all into the weeds, but one option is not more effective than the other. There are small changes in kidney health and bone health with, for instance, Truvada, and small increases in cholesterol and body weight for Descovy, but we don’t know the long-term impact.
Sharing what we do know, what we don’t know, the magnitude of the differences that we see are important as patients weigh for themselves a very important decision, in terms of what medication they’re going to put into their bodies every day.
How to Provide Patients With Tools to Make Their Own PrEP Decisions
Wilder: At the end of your presentation, you talked about decision aids or decision tools. What are those and how they could be useful to patients?
Blackstock: They’re basically designed to help patients understand the options that are available to them and the different attributes of the options that would probably matter very much to patients. What is the difference in cost? How is it administered? Potential side effects?
They can then choose, using this decision tool, what matters most to them. They’re able to sort of rank those things that matter most and think about: What are the benefits? How much do those matter? Then, what are the risks? How much do those matter to them? Then this tool says, “OK. It looks like from what your preferences are, this option seems to fit the best with the information you’ve provided.”
It’s just another way of complementing a conversation with a provider; another support to have in the conversation with the patient to ensure they have a clear understanding of what the options are and how they may be similar or different, and how they may align or not align with the patient’s preferences.
Wilder: The example you gave was a diabetes decision aid. It sounds like we definitely need one for PrEP.
Blackstock: Yes, and one may exist that I may not know of. This one for diabetes medication was very clear. It looked at: How much does your blood sugar decrease by? What’s your daily routine like? Does it require an injection or not? Does it cause low blood sugar? Does it cause weight change? All those things would be important to many patients.
Getting to What Matters Most in a PrEP Choice
Wilder: In the shared decision-making model, do you include information about on-demand PrEP or event-driven use?
Blackstock: That’s one of the big differences between Truvada and Descovy: Truvada has been studied in several large studies, in terms of being used on-demand, or event-driven, or pericoital. It’s been found to be really effective for men who have sex with men. So, we have data that supports its use in this dosing strategy.
We don’t have that for Descovy. In the absence of any efficacy data on-demand for Descovy, it would be far afield of guidelines to prescribe event-driven Descovy. There’s no reason why one would necessarily want to do that, given the abundance of information we have on Truvada. Again, perhaps if there was a patient with renal issues, for instance, who was taking Descovy daily and for whatever reason wanted to take it on-demand, that would be a really important discussion to have, in terms of what evidence we have or what evidence we don’t have.
I’m not aware of providers recommending on-demand Descovy, but that’s something that may be happening.
Wilder: As you’re having this conversation with your patient, how do you as the clinician assess if the patient is actually ready to make the decision?
Blackstock: That’s when you go to the decision talk. You try to get from the discussion what matters most. Then elicit from them what is their preference from what they’ve heard. If patients seem unready, you can ask, “Are you ready to decide? Do you want more time? What questions do you have?” You want to keep the doors of communication open. “Are there more things we should discuss?”
It may be that the patient wants more time to think about it, and so scheduling a follow-up appointment makes sense. Maybe they want to talk more with friends. They want to look up more information—whatever it is. You definitely want to sort of push them in a certain direction, while checking in to see whether they’re ready to make a decision or not based on the whole conversation that you’ve had.
Wilder: Some medical providers might say they don’t have time to go through this model with their patients. About how much time in the visit do you think it would take to move through this model?
Blackstock: Honestly, I have conversations like this all the time with patients. It does not take long. I would say 10 or 15 minutes. Many times, it’s pretty much a slam dunk. There is just such an abundance of data to support Truvada. And when you can offer evidence-based information to patients in a way that’s very clear, it’s much easier for them to work with you to come up with a decision.
So, these conversations actually are pretty brief with patients. Patients, first of all, appreciate you taking time to talk to them about the differences—this robustness of the evidence for Truvada, the fact that one is not more effective than the other.
Though, the safety issue is the issue that people are most concerned about: When you talk to patients about the fact that one is not necessarily safer, but they have different safety profiles, that makes a huge difference. The fact that they have different safety profiles, and one has much more data behind its use, that gets patients choosing one over the other. And then the on-demand aspect, the flexibility of that, is also really important to patients.
When you explain all of those attributes, and what’s similar and what’s different, it’s a lot easier for patients to come to a decision—and it does not take long at all.
Wilder: Lastly, can you summarize why is it important that patients are involved in shared decision-making about their body and their health?
Blackstock: The experience that patients can have in the health care setting can be sometimes off-putting, where they’re not necessarily seen as an expert in their own experience. Many times it can feel very unidirectional, the information that they’re getting from a clinician or health care provider.
But we know that when we are able to work hand in hand with our patients—when they are able to fully understand what is going on, when their preferences and values are elicited in part of that conversation—that results for the patient in a much better overall experience, and it’s much more likely for patients to then adhere to whatever strategy or option they’ve then chosen in collaboration with you. It allows patients to have more ownership, more of a sense of agency—and, I think, a greater investment in their health and whatever strategies that they’ve decided are best for them.