Webinar: PrEP for Primary Care Physicians
Recorded on September 30th, 2024 at 8 pm ET
Faculty: Jonathan Shuter, MD, Uriel Felsen, MD, and Raffaele M. Bernardo, DO
Moderator: Rasika Karnik, MD
Transcript Summary:
Key Highlights:
- Who is PrEP for?
PrEP is recommended for any individual who is HIV-negative and at risk of acquisition through sexual contact or injection drug use. It is not limited to specific populations. - PrEP Options and Efficacy:
Three FDA-approved medications are available:- Truvada (oral)
- Descovy (oral; not approved for vaginal sex)
- Apretude (injectable, given bi-monthly)
All are highly effective when taken as prescribed, with adherence being the strongest predictor of efficacy.
- Clinical Workflow and Screening:
Initiating PrEP involves a comprehensive sexual history, baseline labs (including HIV, STI screening, hepatitis B status), and ongoing monitoring. Renal function should be assessed periodically depending on the medication. - Adherence and Follow-up:
The panel emphasized the importance of adherence counseling and support tools (e.g., reminders, pill organizers). Routine follow-ups every three months include repeat HIV and STI testing. - Side Effects and Safety:
PrEP is generally well-tolerated. Mild nausea may occur initially with oral options, and injection-site pain is common with Apretude. PrEP is safe during pregnancy and should be continued if risk remains. - Special Populations and Scenarios:
- PrEP for people who inject drugs is effective (~75%) but slightly less so than for sexual transmission.
- Discontinuation of PrEP, especially injectable forms, should be done under provider guidance to mitigate risks (e.g., viral resistance, hepatitis B reactivation).
- Practice Integration Tips:
Suggestions included telehealth adoption, staff training, EMR templates, and creating a welcoming clinic environment—especially for LGBTQ+ patients. - Looking Ahead:
Promising developments include twice-yearly injectable agents like lenacapavir and potential subcutaneous implants. Broadening access through pharmacies, EDs, and OB/GYN practices is also being explored.
Takeaway Messages:
- Normalize and routinize discussions of sexual health and HIV prevention.
- PrEP is a simple, safe, and effective tool—primary care providers can and should lead its implementation.
- HIV screening is foundational—both for treatment and prevention strategies.
Transcript:
PrEP for Physicians webinar
Rasika Karnik: Good evening, everyone. Thank you for joining us tonight for our PcMED Connect, where tonight we’re going to focus on learning about PrEP or pre-exposure prophylaxis for HIV. I am joined tonight by three infectious disease and HIV specialists. And my name is Rasika Karnik. By the way, I’m a physician. I do primary care at the University of Chicago. And I’m going to let my panelists, my esteemed panelists, introduce themselves, and we’ll go in alphabetical order. So how about Dr. Bernardo.
Raffaele Bernardo: Hi! Good evening, everyone. My name is Ralph Bernardo. I am an internist and an infectious disease specialist, currently practicing in New Jersey.
Rasika Karnik: All right. Dr. Felson.
Uriel R. Felsen: Hi, everyone! I’m Uriel Felson. I’m an infectious disease doctor. I work at the Montefiore Health System in the Bronx, New York, affiliated with the Albert Einstein College of Medicine, and I work with patients who are living with HIV, and I work with patients who are trying to prevent HIV and I do research on HIV treatment and prevention.
Rasika Karnik: Wonderful! Dr. Shuter.
Jonathan Shuter: Hi, I’m Jon Shuter. I also work at Montefiore Medical Center at Albert Einstein College of Medicine in the Bronx. I think I’m the senior person on this panel, and I have the dubious honor of having seen my first patient with HIV in 1985. So that is close to 40 years ago, and I have been taking care of patients with HIV ever since. I have an active patient panel in our clinic in the Bronx, and I continue to care for patients to this day.
Rasika Karnik: Wow! I’m so glad to have all of you here tonight. And we’re going to do this. This is pretty casual session. We’re going to be having a lot of questions and answers for our panelists from the audience. If you have any questions that pop up, please feel free to shoot them in the in the chat, and we’ll certainly get to them. So let’s get started. And Dr. Felson, who is PrEP for?
Uriel R. Felsen: It’s a great question, Rasika, and I think, you know, for this audience it’s really important to understand that PrEP is for anyone that isn’t already living with HIV, and is at risk for acquiring HIV. So there are some ways to think about some populations who may be more at risk for HIV. But I think the most important take home point for everyone to come home, you know, everyone who’s watching this to understand is that it’s really for anyone that doesn’t already have HIV, and that is interested in protecting themselves from acquiring HIV, either through sex or through intravenous drug use.
Rasika Karnik: Got it. That’s a good overview. So it almost feels like anybody who is interested. And then what about insurance coverage. How does that work out for folks? Because a lot of times people are concerned about payment for and coverage for the medication.
Uriel R. Felsen: The really nice thing about PrEP coverage at this point is that it has a grade A recommendation from the US Preventive Services Task Force, the USPSTF. And so, because there’s a grade A recommendation for it, all insurances are required to cover it without any contributions from the patient. And for those who are uninsured. There are a lot of access programs through the drug companies themselves, and some States also have assistance programs. So pretty much anyone who is interested in being on PrEP should have minimal financial barriers to being able to get it, at this point.
Jonathan Shuter: Can I just chime in.
Rasika Karnik: Please.
Jonathan Shuter: Yes, so we have a very American-centric view here, but it ought to be added that there has been a fairly massive rollout of PrEP internationally, and even though there may not be the range of choices available everywhere that we have in the United States, there’s increasingly improved access to PrEP throughout the world at this point.
Rasika Karnik: Speaking of choices, what options are there for PrEP? Dr. Bernardo.
Raffaele Bernardo: Sure. So there are currently three medications that are FDA approved for HIV pre-exposure prophylaxis. Two of these medications come in the form of an oral tablet that’s taken once daily, and the third is actually the first long-acting injectable for HIV pre-exposure prophylaxis. But all three are FDA approved, and all three, as long as they’re taken as prescribed, are highly effective at preventing HIV infection. The two tablets are single fixed-dose combination tablets of two different medications of the brand names. One is Truvada, the other is Descovy, and the long acting injectable goes by the brand name Apretude. Apretude is given one month back to back for the first two months, and then every other month thereafter.
Rasika Karnik: Are they equal in effectiveness?
Raffaele Bernardo: So, the thing about PrEP is that we know it works. In every study that’s looked at the efficacy of PrEP, there was a direct correlation between adherence and efficacy. So if you take it, it works, and it’s largely up to the patient to determine that. But we know from study after study that there is a direct correlation between the two. So yes, if it’s taken as prescribed, PrEP, all three types, are highly effective at preventing HIV infection.
Rasika Karnik: Gotcha, and how might one decide between the two, you know, like the two pill oral options or the injectable. And that question could be for anybody.
Uriel R. Felsen: I think it’s important to remember that there are three choices, but not all choices are necessarily for all different folks. There’s an option, anybody that’s interested in PrEP, there is an option, but asyou know, Dr. Bernardo mentioned Descovy and Truvada. Both of them contain tenofovir and emtricitabine, but they contain different formulations of the tenofovir.
And currently, it’s really Truvada that is approved for cis men, cis women, and transgender men and transgender women, whereas Descovy is actually not approved for HIV prevention for anyone that’s at risk for acquiring HIV through vaginal sex. So that would be for cis women or potentially trans men.
Rasika Karnik: And is that because there haven’t been studies that have been done in the those populations, or it’s physiologically, does not work for some reason?
Jonathan Shuter: Well, there are ongoing studies looking at Descovy in women. There is some concern that the drug might not accumulate either as much or as rapidly in the vaginal mucosa. So there are concerns about it, although there are ongoing studies to try to prove its efficacy in women.
Rasika Karnik: Got it, that’s good to know. So let’s say, you know, I told you I’m a primary care physician. Let’s say, I’ve got a patient who comes to my office, and brings it up themselves, or I bring it up. What happens next, you know, like, what do I have to do to get them started on PrEP?
Raffaele Bernardo: I can start with that. So anytime someone brings it up in the office, I always take advantage of that opportunity, because we, as providers may may occasionally miss the opportunity to talk about PrEP or other preventative services. So in a when a patient is sort of bringing it up themselves. I really take that as a signal to sort of seize the opportunity and talk about PrEP. I think one of the first things to discuss are any sort of barriers related to PrEP. Be it financial adherence, for example, if there’s any other concurrent issues like mental health issues, for example, substance use, lack of housing, financial coverage, although, as already mentioned earlier, that really shouldn’t be an issue, since PrEP can be obtained at little to no cost for most patients.
The second thing to do is really have a conversation around sexual practices. Who are your sexual partners? What body parts are you using to have sex? And the reason why these questions are important is because, again, as Uri mentioned, not all forms of PrEP are approved for all types of sex. So it’s important to get a sense of who your patients are, who they’re having sex with and what body parts they’re using to have sex. That’s also important. When you talk about testing for sexually transmitted infections, you want to make sure that you’re offering comprehensive testing. And this includes three site testing, perhaps, for gonorrhea and chlamydia, again depending on body parts that a patient may use to have sex. For example, oropharyngeal swabs, rectal swabs which can be self-collected by the patient and/or vaginal swabs, which could also be self-collected by the patient, or urine sample, for example. And then we offer blood work for things like HIV, for example, to make sure that the patient at baseline is not living with HIV. We do testing for syphilis and various forms of hepatitis. But most importantly, we have to test for the preexistence of hepatitis B. And the reason is because some of these medications do have activity against hepatitis B, particularly Truvada and Descovy. And so it’s very important to determine whether or not somebody may have an occult hepatitis B infection, because if you do start one of these oral forms of PrEP and then stop, you can actually cause a rebound hepatitis B viremia, and potentially could cause fulminant liver failure. So that definitely wants to be excluded.
One of the other things that I think is imperative during these conversations is, yes, to talk about HIV prevention, but to talk about other things you can do to keep the patient healthy from a sexual standpoint. So this may include things like discussing vaccines against other sexually transmitted infections, such as hepatitis B and the human papillomavirus, or HPV. And for those patients at risk even the quadrivalent meningococcal vaccine. So I think it’s a great opportunity to discuss and update vaccinations, and then having a conversation around contraception. For example, for your patients who are capable of getting pregnant and who are having sex with sperm producing partners. I think it’s a great opportunity to talk about contraception and family planning, and if you don’t feel comfortable having that conversation to at least know where to refer them, to have those conversations a little bit more comprehensively.
Jonathan Shuter: I think that that’s a great review by Dr. Bernardo, I would just chime in one thing, and that so I agree with all of that. But I would almost lead off with the idea that the only way these medicines work is, if you adhere to them. So someone who is contemplating starting on PrEP. For him or herself, they have to be willing to take the medicine that’s prescribed. If it is sitting in the medicine cabinet, it doesn’t accomplish anything. So so I think that’s an idea to introduce really early to the patient that these pills require one pill every day.Patients have to be reliable and consistent with that and the injectable. They have to show up every two months and get their injection. Otherwise it’s not going to go well. So I think that that’s a good message to start with. And having these conversations.
Raffaele Bernardo: Definitely. And I’ll actually, I’ll even add, I think Dr. Shuter’s point about making sure patients are ready and willing to take their medications as prescribed, talking about things that may prevent that from happening. So, for example, I’ve had patients who have had concerns about disclosure. They have roommates, or maybe they live with family, and they’re worried about having a pill bottle with the label of these medications lying around the house. We talk about things to do there. But that might be a candidate, for example, for Apretude, coming into the office for an injection every other month rather than storing medications at home, just as an example. So when it comes to talking about adherence, trying to really get a sense of what those barriers might be to adhere to these medications, because it might help you steer the conversation toward one medication or another.
Uriel R. Felsen: And I think it’s also important to add, just building off what Doctors Shuter and Bernardo have said that you know a lot of the folks that you may be having this conversation with are people that are have not, don’t already carry other diagnoses, and aren’t necessarily used to being on a chronic medication. So this could be a big change for them. And that’s why, having that conversation is so important upfront.
Rasika Karnik: Yes, there’s a ot to unpack in those responses, you know. And so it sounds like, when the idea of PrEP comes into play, there’s a lot of things that you can address. I mean, it sounds like you can address sexual health, which is health in general and then, talking to people about their social situation as well. And so when taking a sexual history, when bringing that up and trying to glean information from your from your patients, do you have helpful dialogue that you have used in the past? Because sometimes it can be awkward, right there can be generational differences, and perhaps people may not, may feel shy. So what are some of the language? You know some of the ways that you discuss this with patients. If you have any tips for us.
Raffaele Bernardo: Sure I can start with it. So I think there are a few different approaches here, but I think the theme to the takeaway is, you want to be consistent, and I think by doing that it will make having these conversations easier as you have them with patients. These are important conversations we should be having with all of our patients, regardless of age, sex, race gender. Because once you standardize it, it becomes easier, I think, more natural when you’re having these conversations, and how you start off having these conversations is largely a personal preference. I usually will start off by saying something like, the next thing I would like to talk about is your sexual health. I feel like this is a topic that often goes unaddressed, and is just as important as every other part of your health. So if you don’t mind, I’d like to ask you some questions.
And then from there I try to start off with open, ended questions. I try to let the patients lead the conversation themselves, because number one, sometimes it’s more natural that way, and sometimes patients are more comfortable sort of just ad lib talking about their sexual history, but if you find that they are stuttering, or they have a hard time giving you the information you need, you can start asking some more pointed questions, and this could be something as simple as can you tell me a little bit about who you’re having sex with? What are the genders of the people that you’re having sex? With? What body parts are you using to have sex? What methods are you using to prevent pregnancy? What methods are you using to prevent HIV infection?
There’s also a method called the P’s method, I think at one point. It was the Five P’s. Now, it’s probably the Six or Seven P’s to help strategize your sexual history taking. So this is things like, for example, partners practices protection, like I mentioned, from other sexually transmitted infections, past history of STIs, pregnancy, plans. Pleasure, I think, is another one in the expanded P’s history.
There are lots of these different things online that you can look for to help organize your sexual history taking to make it easier. But I think the important thing is that you try to create consistency with having these conversations because they’ll eventually happen more naturally. But it’s important to be comprehensive, because the question you don’t ask leads to the answer you don’t get, and it’s a missed opportunity to perhaps talk about some sort of preventative strategy with your patient.
Rasika Karnik: Absolutely and you know, when you brought up the Five P’s. I was just thinking about from medical school how these acronyms keep on evolving or mnemonic. Sorry, not acronyms.
And so it’s it’s helpful to build templates in your electronic medical record, if you can. If you’re able to do that. So those are those those are great tidbits, for to use in practice.
Raffaele Bernardo: The other thing that I will add as well. The questions you ask are part of it. But I think the environment you create is just as if not more important than the questions you’re asking. Because anyone in this audience can think about perhaps being asked these questions in two very different scenarios, right? A very sort of whitewashed office, very sort of sterile environment versus an environment that perhaps has some signage on the wall sort of promoting sexual health, you know, depending on the population you’re serving. For example, I’m the medical director for a comprehensive LGBTQ-plus practice in New Jersey. So in our office, although we serve all types of individuals, we do have very subtle gestures of support toward the community. So we have, for example, a pride flag in the waiting room. We have nice modern pieces of art that tie-in the LGBTQ-plus colors as well. So these these subtle hints of support, I think, are also very important. You want to create an environment that welcomes these conversations. So I think again, the environment you’re creating is just as important, if not more important, than the actual questions that you’re asking your patients.
Rasika Karnik: That’s very true. So the nonverbal cues.
Raffaele Bernardo: Correct.
Rasika Karnik: And so now you’ll suppose I’ve got a patient that decides to start PrEP. What next? You know, like, we’ve done some of the screening, testing for concomitant STIs. No hepatitis B. What happens after that? Dr. Felson.
Uriel R. Felsen: Like you said, there’s some testing that we would do first. Very importantly, we want to make sure that the person is not already living with HIV. And so as long as you have either a negative, rapid test in front of you, or and you’ve sent off a lab-based HIV test, you can go ahead and you know, counsel the patient about adherence, and you can initiate PrEP. You may have renal function labs pending. That’s okay. For people that are on Truvada, it’s important to monitor their renal function on Truvada or Descovy so you can have that pending. You can always call somebody back if something needs to change based on that result. But then the idea is that people that are on PrEP, that if they’re taking oral PrEP, the general routine is every three month visits, and at those visits you would have repeat HIV testing, and you would do assessments for STI screening and you would repeat STI screening at that point, and repeat an HIV test. And that important thing to remember, once somebody has already been exposed to PrEP, or any other form of antiretroviral therapy, whether they’re coming off of a course of post-exposure prophylaxis, or they’re continuing, this is somebody that’s already been on PrEP pre-exposure prophylaxis. When you are repeating the HIV testing, the CDC at this point recommends sending an HIV viral load along with the antibody test to make sure that you aren’t missing early HIV acquisition.
Raffaele Bernard: One of the things that I think also many offices have implemented as well, which is one of the things for example we do, is same starts for PrEP as well. So actually having patients, for example, leave with a prescription, or even a sample in hand to get started the same day, we find that that often helps with adherence. So some offices do have the availability of doing point of care testing for HIV. There is a slightly longer window period for many of these point of care tests, but if you exclude an acute HIV infection clinically so, people who come in without any recent flu, like syndromes, for example, fevers, chills, swollen lymph nodes rash, etc, and their point of care for HIV is negative. You can actually even start same day PrEP, particularly the oral forms of PrEP.
Rasika Karnik: I’m actually gonna take this question from the chat which applies what we’re talking about. But one of our audience members wants to know, are there any specific side effects to counsel patients on when they start prep? So anything that patients should be aware of.
Jonathan Shuter: These medications are extremely well tolerated.So almost anyone who puts any new pill in their mouth and swallows it could get some nausea. So there is, you know, a certain incidence of nausea and GI upset, associated with the two oral preparations. There were larger earlier concerns with the potential for renal effects and for bone effects with the tenofovir-containing preparations which are both of the oral medications. But most of those fears and concerns have been allayed by the collective experience that that significant renal toxicity or bone toxicity are rare. And so those are really the common side effects with the pills. With the injection, it is basically what you would expect. With the injection, they get injection in site pain, and it is rare that that is severe enough that it causes discontinuation of the medicine, and that tends to get less with subsequent injections.
Raffaele Bernardo: I’ll add, with the nausea that’s occasionally seen, almost always is self limiting, and within a week or so of daily use, the nausea actually goes away without any particular intervention. So I will often counsel my patients and say, while it’s rare, you may experience some nausea in the first few days. If it’s not too uncomfortable, keep taking your pill daily, and almost invariably the nausea self resolves within a couple of days when it happens. But to Dr. Shuter’s point, these side effects are typically very rare.
Rasika Karnik Is it better if patients take it with food?
Raffaele Bernardo: Your patients could take it with or without food. It’s up to them. In my personal experience, I have seen patients prefer taking it with food when they do get some of those Gi side effects. But it’s a personal preference.
Jonathan Shuter: We have learned through painful experience in the HIV treatment world that patients getting any oral medication should always be told not to take the pill dry. So always take every pill. There’s nothing specific about these medicines for that, but always take every pill with adequate water or other liquid.
Rasika Karnik: Gotcha. Thank you for that question, to our audience member. And you had mentioned that, you know, monitoring for renal function. And why is that? Is it just based? I mean, it sounds like there used to be more concerns with potential renal toxicity, but that has kind of gone away as time has gone on, so are there any specific patients that are more at risk for renal toxicity?
Uriel R. Felsen: So Truvada was, was the first approved PrEP medication, and Truvada has the older form of tenofovir. And so the recommendation for Truvada is that people that when prescribing it the eGFR should be above 30 or 60, Ralph. Sorry I’m I’m blanking.
Raffaele Bernardo: For Truvada, 60.
Uriel R. Felsen: 60. I’m sorry. So Truvada is 60, and for Descovy it’s 30, the estimated GFR. And so you know, people that you might be concerned about starting Truvada on are people that have comorbidities that might be affecting their kidneys, diabetics, hypertensives. So you might be more concerned about the effects of Truvada on their kidneys, and consider Descovy, especially if they already have some early CKD.
Rasika Karnik: Got it. And putting my primary care hat on here just another time to sort of tell people how to explain how important blood pressure control is hypertension, and diabetic control is, so we can prevent those kidney side effects. So
Raffaele Bernardo: I’ll also add to that the earlier guidelines for PrEP did recommend three month testing for renal function. But with more and more experience, Truvada was actually found to be safer than was once thought, and so the most recent guidelines for PrEP have actually extended that interval from every three months to every six months, I believe, if not at least annually. So with more real world data, we’re actually finding that it’s actually safer than we once thought the caveat again, being, like Dr. Felson had mentioned, these are individuals who are otherwise healthy, with no other pre-existing comorbidities that may be affecting their kidney function, like uncontrolled hypertension, diabetes, etc.
Rasika Karnik: So monitoring my patients, and they’re coming in regularly. They’re adhering to their the PrEP medication, whichever option they’ve chosen. What happens if you decide you want to come off of PrEP, you know. Like, what is it easy? Can you just stop one day, or is there any specific protocol that needs to be followed.
Raffaele Bernardo: So people’s situations change all the time. There may be a change in one’s perceived risk for HIV infection. So people come on and off PrEP all the time. But it’s important that this is done under the guidance of a provider for a few different reasons. One is, you sort of want to remind the individual that if they do stop PrEP, there is going to be, if they do engage in any risks, any sexual activities or intravenous drug use where they could be exposed to HIV, that they no longer have that medication in their body. And so an alternative form of HIV prevention should be used.
The second thing is, you again want to make sure that you’ve at least addressed the hepatitis B thing at some point, because, again, if there is a missed underlying hepatitis B infection, by stopping these medications abruptly, you can cause a viral rebound, hepatitis B viremia, and potentially fulminant liver failure. For those people who are incidentally found to have chronic hepatitis B, they do have to stay on treatment, at least in the beginning, until they are sort of staged and determine whether or not they need ongoing medication. So we’ll typically narrow them from Truvada, which contains tenofovir and emtricitabine to just tenofovir.
Uriel R. Felsen: I think there’s one other special consideration, which is the folks that are that are on the injectable, for when they want to come off, because it’s a long-acting injectable, and the idea of stopping it would be to sort of let the drug levels peter out. But of course, during that period when the drug levels are petering out, you have some amount of of the medication in you, but not necessarily enough to offer protection. And so there is a small risk during that period, if somebody was to acquire HIV, that their strain of HIV that they’ve acquired could become resistant to the cabotegravir. So some people in that scenario have opted to start an oral medication, one of the oral PrEP options, while the cabotegravir is sort of petering out from their system.
Raffaele Bernardo: And that’s particularly important, because the resistance mutation that occurs sometimes with cabotegravir renders a lot of these single tablet regimens we use to treat HIV ineffective. So not to say that you couldn’t treat somebody now living with HIV. But your options will be somewhat limited. So that’s a great point, Dr. Felson for bringing that up.
Rasika Karnik: Yes, thank you. So it sounds, you know. It seems like there’s certainly a little bit more nuance when you want to stop cabotegravir, want to stop the injectable. And then what if you do develop HIV while you’re on PrEP. So what if what happens then?
Raffaele Bernardo: We like to think that that doesn’t happen. It’s exceedingly rare that that would happen for somebody who has been taking their medication consistently. So we’d like to say that that doesn’t happen, but we know that adherence isn’t always perfect. And so it will happen occasionally that somebody will develop or become infected with HIV while they’re taking PrEP, perhaps intermittently, or you know, maybe missing several doses during the week. That’s not to say that you should stop treating them. But you are going to have to intensify the regimen now to treat them for HIV. One of the things to look out here for, and I’m not sure if this is really for this particular audience. But maybe it is. We often will send an HIV genotype in this case, because we are looking for some resistance mutations that could be associated with the two drugs in the oral formulations of PrEP mor cabotegravir, if that’s what the patient was on., for example. So we do want to look for those resistance mutations, because that may alter the treatment regimen that we ultimately use to treat somebody living with HIV.
Jonathan Shuter: Right. So if we were having this conversation twenty years ago, the idea of becoming resistant to one or two medicines was much more ominous, so there is the potential of becoming resistant to the tenofovir or the emtricitabine or to the cabotegravir. But even in the unlikely event that that happens, there are almost always good regimens that patients can resort to that will suppress their HIV infection very well.
Raffaele Bernardo: I actually think it’s a good opportunity to mention now that you sort of mentioned this, Rasika, is that you know you’re talking about a situation that as long as your patients are taking their medications, this again seldom happens, and I don’t want to scare anyone away from thinking about or going out there and prescribing PrEP.
There are very few things in medicine that we can sort of guarantee patients are 100%. But PrEP, as long as it’s taken as prescribed, is one of those few things in medicine that we can get pretty close, so I don’t want the fear of somebody acquiring HIV while they’re on PrEP to prevent anyone from offering it. As long as patients are taking it every day, the chances of that happening are exceedingly exceedingly exceedingly rare.
Rasika Karnik: Got it. No, that’s very helpful to know. I think I sort of provided this opportunity to discuss a doomsday scenario, so to speak. So. But yes, so people are taking it as prescribed it should. do its job.
I was kind of curious here, and I think it might help our audience members, as well as you know from just from your clinics and your experience. What are what are some of the main hiccups that patients come back to you with, or some complaints or something, just practically speaking, when they start PrEP. What are some of the things that you hear from patients?
Raffaele Bernardo: So for me, I would say, the majority of the patients that, the community that I do serve is a largely a younger population. So one of the things because I think Dr. Felson had mentioned this earlier, a lot of these individuals aren’t on medications for anything else. And now, all of a sudden, you’re entrusting them to take a pill every day. And so one of the big things that comes up during follow up appointments is adherence, and not because they want to miss their medication. They just forget, because it hasn’t been part of their daily routine to take a pill every day. So one of the things we talk about are strategies to remember. We talk about setting daily reminder alarms on their cell phones, for example, or I tell them to put their pill bottle next to something that they will reach for every morning, for example, like their toothbrush or their coffee machine, just to help with adherence. But I think the one most common thing that I will hear from patients in terms of quote unquote issues with PrEP, is just remembering to take their pill.
And, conversely, I do have a handful of patients that have lots of other medical comorbidities, and they have the other problem. They develop what we call the medicine pill fatigue. So now you’re kind of inundating them with another pill they have to take every day, and so it becomes a similar but not so similar conversation. So both ends of the of the spectrum.
Jonathan Shuter: And, needless to say, for folks who are on their first chronic medicine, we shouldn’t assume that they know how to get a refill or know what a refill even is. They should leave the clinic or your office with a phone number to call if they’re having problems, if they lose their pills if they have questions about it, because if you don’t give them that and they have a problem, they’re not going to know what to do if they haven’t been trained in the medical system already.
Raffaele Bernardo: That actually just came up. The other day I sent three refills to a pharmacy, three months worth of PrEP for a patient, and after a month’s supply received the message that they were waiting to have a new script sent for their refill, not realizing that there had been three already sent to the pharmacy. So what you’re mentioning Dr. Shuter is very, very real.
One of the other strategies I mentioned to patients is, I will often offer them if I have available, or I’ll tell them to go pick one up on online, is a little pill key chain, and I will tell my patients to keep one or two. I like to call them emergency pills on them. Put it on their backpack, on their keychain. So, for example, let’s say it’s a night out, they spend the night at a friend’s house, or whatever the case is, they go to work the next day. They forget they have one or two extra pills on them to just sort of take in the event that they forget. But I remind my patients, if you forget, just take it when you remember, never double up on a dose, and then just resume your normal schedule. The following day.
Jonathan Shuter: And I would say that this conversation keeps circling back to adherence, which is absolutely critical. And I think that there’s actually a shocking lack of research that’s been done on factors that promote good adherence to PrEP therapy. But there is a little bit of research and I think that we can extrapolate from what we know from adherence to other medications. So I think it could be summarized as simply this. The more strategies that you employ, the more likely they are to sink in so adherence. Counseling is good. You should tell the patient how important that it is, although that often, or even usually is not enough. So give them other recommendations. There’s a million adherence apps that that could be downloaded for free on people’s phones. There are pill boxes. There are other options, and the weight of the evidence out there is, the more strategies you offer, the more likely they are to adhere. So you know, I think a keychain thing, a pill box, an app, good counseling. All of those things are important, and they should be piled one on top of the other.
Rasika Karnik: Absolutely that’s critical. And I mean, it’s a good lesson, for managing any disease process, or any sort of, counseling your patients about adherence. Those are all great points. We do have another question from the audience. So I want to insert that in here and ask it. So this audience member wants to know., do you have any experience prescribing PrEP for patients whose primary risk factor for HIV acquisition is injection drug use. And how might that change some of the things that we’re talking about.
Raffaele Bernardo: So yes, I think I think we all do to to varying extents. I actually have prescribed PrEP for individuals who actually have had concurrent risk factors for HIV, largely sexual and injection drug use, and suffice to say, the approach remains relatively the same. You’re having the same conversations in terms of adherence, quarterly testing for HIV. But what changes here are the additional tools that you’re going to be giving your patients. You’re going to be talking about risk reduction strategies for other things. So, for example, people whose risk factor for HIV is injection drug use, you want to talk about risk reduction strategies to prevent or minimize risk of other things that can be transmitted through blood like hepatitis C, for example. So here’s an opportunity to talk about needle exchange programs, for example, or to remind your patients never to share needles or other drug paraphernalia, making sure you’re only using needles on yourself. If patients don’t have access to needle exchange programs or new needles, there are protocols online where you can actually use bleach solution to clean needles as well, and those can be found on the Internet pretty readily. But again, suffice to say, you’re still following these patients quarterly. It’s just your conversation is, gonna change a little bit about what else you’re going to be offering them.
Rasika Karnik: Great. Thank you.
Uriel R. Felsen: Just also important to point out that the effectiveness of PrEP in the context of injection drug use is actually different from in the context of sexual acquisition. So Ralph was talking about, you know there are few things that are as effective as PrEP if folks are taking it regularly. And if their risk factor is sexual acquisition, you know, we’re talking about like 99% effectiveness in preventing HIV acquisition. I believe the number in the context of injection drug use is more like 75% effectiveness. So it’s not exactly the same.
Rasika Karnik: And is the, is there knowledge as to why?
Uriel R. Felsen: Not something that I’m aware of. I mean, I think one thing to consider would be the burden of how much virus is introduced, you know, in a single act might have something to do with it.
Jonathan Shuter: And also the journey that the virus has to take to get into the body. So if someone injects 10,000 viral particles into their directly into their bloodstream, that’s a different situation than a viral inoculation that has to cross a mucosal barrier.
Rasika Karnik: And we’ve got another question in the audience. So if a single dose of PrEP is missed, how long should a patient wait before engaging? Is there a timeframe? I’m sort of changing the question a bit, but it sounds like the person wants to know when will the PrEP be as effective as it was, had you not missed the dose? Does that make sense? So at what point can patients still engage in sexual encounters and be protected?
Jonathan Shuter: So we wouldn’t want to advertise this to our patients. But there’s not really an expectation or necessity to be 100% adherent to the pill. So I don’t know these numbers off hand, but I think that the weight of the evidence shows that men who take their PrEP pills, these are just the oral preparations, three or 4 times a week get adequate protection, and the number is a bit higher for women. So more like 5 or 6. Getting 5 or 6 doses in per week is associated with very high levels of protection. So I would think that missing a single dose probably wouldn’t have a negative impact on the level of a patient’s protection, although once again I wouldn’t advertise that to my patients.
Uriel R. Felsen: I think it also does get to a different question, though, that, I think, would be useful. For this audience, which is like, how long after initiating PrEP can somebody expect to be able to enjoy the protection that it offers? And so for those at risk of acquisition through anal sex, it’s about 7 days, for those at risk for acquisition through vaginal sex, it’s more like three weeks. So twenty one days is the idea. So continue using other methods of protection during that period while you’re waiting to achieve the therapeutic levels or the protective levels of PrEP.
Rasika Karnik: A great point. Thank you for bringing that up. So we do have another question from our audience, for your patients who carry a pregnancy. If they get pregnant, what do you tell them about the safety of PrEP, and when to stop, if at all.
Raffaele Bernardo: That’s a great question. And whoever asked that question, I’d like to thank you for not gendering the question. So for patients who can carry a pregnancy, yes, absolutely, patients who have any ongoing risk for HIV, or perceived risk for HIV should continue taking their PrEP as prescribed throughout their pregnancy. We know that these medications are safe in pregnancy both to the mom and the developing fetus and for whatever it’s worth, you know, we do use these medications in combination with other medications, to treat individuals living with HIV throughout their pregnancy as well. So by providing PrEP, I will argue, you’re not only protecting the individual carrying the pregnancy. But you’re also protecting the developing fetus from HIV infection as well.
Jonathan Shuter: So I agree. And the good news is that that there’s not really much of a safety signal with any of these medicines in pregnancy. Someone who is practicing receptive vaginal sex wouldn’t be on Descovy for for PrEP. So really, the discussion of Descovy is irrelevant here. So you’re talking about either Truvada or cabotegravir. So there’s really a mountain of evidence showing that Truvada is a safe drug to take through pregnancy.
Cabotegravir, there’s less data on. There are emerging data from a variety of studies. It is looking to be safe, although I don’t think anyone has made that declaration yet.
Rasika Karnik: Wonderful. We’ve got great questions from our audience tonight, so keep them coming. But while we’re waiting for more questions from our audience, Dr. Bernardo, I wanted to ask you for more tips on, like how to integrate PrEP into your practice. So you had mentioned the welcoming environment. Are there any other things to consider with your practice?
Raffaele Bernardo: So I think a lot of it depends on the practice that you already have established. So if you are working, for example, in a sexual health setting, I think it’s very different than if you’re working in a general primary care setting. You could talk about, for example, scheduling certain days to do PrEP, you can talk about integrating it throughout your regular workday. One of the other nice things about PrEP is that it can also be done through a telemedicine sort of modality as well. And I think that this is particularly important for our younger population for various reasons. So offering PrEP through a telemedicine platform, I think, is very, very helpful. You can even have the patients go to a local laboratory close to their home to perform their STI and HIV testing, and then you can send their prescriptions to their local pharmacy, and it definitely helps with adhering to medical visits in that regard. But there, there’s not a one size fits all on how to integrate a sort of PrEP program into your day to day practice. A lot of it depends on your pre-existing practice. Your providers, if you have help from support staff, for example, some offices are fortunate to also have peer to peer navigators, patient navigators, for example, or peers to help patients navigate the system to sort of take away some of that additional burden from the provider. So a lot of it depends on what you have established already. But the good news is that once you do it, it’s actually very, very easy. PrEP visits can be done very easily, very effectively, and I think can be integrated in anyone’s sort of pre-existing clinical practice.
Rasika Karnik: Great, and then, the hours kind of winding down a bit. So I wanted to, while we had some time, just ask Dr. Shuter what he thought about the future ofPrEP. You know, where are we going? Are we going to once a year? Injectables? What’s next? What’s on the horizon.
Jonathan Shuter: So this is a dynamic field. It is really making progress. And there are exciting possibilities on the horizon. So I just in my mailbox today, with the New England Journal of Medicine paper, the October 3rd 2024 Issue of the New EnglandJjournal publishing the results of the purpose study that looked at lenacapivir, that was given as an every 6-month injection in a population of that included women, including adolescent women, because there’s really been a dearth of research done on adolescents, and they just had spectacular results that were a bit of a tidal wave in in the medical community with with basically, not basically, but exactly 0 cases occurring in patients who were receiving lenacapivir over the course of the study. So unless something catastrophic happens with that drug, I think that that is something that is on the horizon, a realistic possibility of taking an injection every 6 months. And I think that would be a very big improvement over every two months. There’s a great deal of interest in new categories of medicines, oral medicines that can be taken once a month, and there are ongoing trials of that. Those are early. There is interest in developing subcutaneous implants the same way that certain contraceptives are administered with subcutaneous implants that can really last a long time, even potentially, out to a year. So there are a number of studies going on, and I think that we are going to see some of these exciting developments in the years to come.
Uriel R. Felsen: I would just want to add that it’s extremely exciting, what’s happening on the pharmaceutical front. But I think another area of excitement in PrEP is also the different environments or the different clinical settings where patients will be able to get it. And that’s another area of research. And I think, actually, a webinar like this is really important for disseminating the information to primary care physicians. But one of them challenges with PrEP has been, you know., in whose purview does it belong, and who should be providing it? It has sort of ended up with infectious disease doctors in large part, because we are used to using antiretroviral therapy. However, you know, once somebody has acquired HIV, the horse is already out of the barn as far as prevention goes. So I think a really exciting area of research is, where can we start introducing PrEP so that patients have better access to it and don’t have to necessarily find their way to an infectious disease doctor. So primary care physicians are great. There’s been work looking at pharmacists being the ones to prescribe PrEP. I do work about trying to introduce PrEP into emergency department settings where there are high risk populations, urgent care settings. Certainly the Obgyn, there are opportunities for introducing PrEP as well. So I think you know, it doesn’t necessarily sound as novel as some of the pharmaceutical stuff. But it’s a really important way for increasing the footprint that up can have for prevention.
Raffaele Bernardo: And if I can, I also just want to take the opportunity to also remind the audience that none of this, none of these conversations can can happen without an HIV test. We know that HIV testing is the gateway to both treatment and prevention. And similar to how PrEP had been, has been given a grade, a recommendation by the USPSTF, so has HIV testing. So I will implore the members of the audience that if you are not already implementing, screening for all of your patients for HIV at your offices, I would implore you to start doing that at least a one-time test for everyone that you do see.
Rasika Karnik: And you know that sort of brings me to my last question or opportunity for our panelists. Any last minute or last words as our hour comes down, advice that you’d like to give our audience. You know common mistakes. You might see anything you want to add about PrEP. I’ll start with you, Dr. Shuter.
Jonathan Shuter: So this is a bit of a tangent, but I think that it’s an important one that people who work with me know that I’m an anti-smoking zealot, and that all of my research pertains to smoking in people with HIV and people at risk for HIV. So people who show up in clinic to obtain PrEP probably smoke at higher rates than the general population. Although I don’t have evidence to back that up, because I don’t think there is such data, I would suspect that that is the case, and even if they don’t, even if they smoke at the same rate as everyone else, I think that certain medical issues are so weighty that if you ignore them on a comprehensive medical visit, you have to think about what a patient walks away thinking I went to a doctor, and he asked me all kinds of questions, and we spent a long time together. And and I guess smoking is okay, because it never came up. Or the blood pressure came back 160, over 80, and all we talked about was PrEP and STD risk, and the blood pressure got ignored. So my blood pressure is probably not much of a problem, or my cholesterol is probably not much of a problem. Or if I’m at a certain age group, that screening for colon cancer is probably not a priority. I think that everyone on this call is an internist, and also in addition to what they do with their PrEP, and I think that there’s a real effort to normalize sexual health. And I think that that’s a good thing, but normalizing it means that it is in there against the background of all the rest of someone’s health. You have to be really careful about what you what you leave out. And you know to me, since smoking is the most, the most common, preventable cause of death in our society, that’s a really important target. But blood pressure and depression and substance use, none of these things can be ignored, if you’re going to be offering good medical care to somebody.
Rasika Karnik: And just a plug, for you know, primary care providers out there, physicians and advanced practitioners.
So it’s tough to kind of address every single thing at in one go. So, Dr. Shuter, I know I agree with you. All those things are important, but sometimes the 15 minutes just don’t quite cut it. And it helps build patient rapport having those multiple visits.Dr. Felson, I wanted to offer you the same opportunity, any last suggestions, questions, comments.
Uriel R. Felsen: I think something that Ralph was saying earlier sort of struck me, which is you have to just make it routine in order to get good at it and to get comfortable with it. And I think, you know, I think it’s the same sort of mantra for routinizing HIV, testing, normalizing the conversation about sexual health. You’re not going to know unless you ask. And there are some patients that will come and ask you for it, and will start the discussion about their sexual health, and and may ask you about PrEP. But for those that don’t, it’s a really important opportunity for us to to address that aspect of their health, and and many patients are waiting for us to open that door.
Rasika Karnik: Absolutely. And finally, Dr. Bernardo, your turn.
Raffaele Bernardo: So I’ll pretty much reiterate what Dr. Shuter and Dr. Felson already mentioned. A lot of your patients probably want to have these conversations. They just don’t know how to have them so normalize sexual health. Screen all of your patients for HIV. Prescribe PrEP. And don’t forget vaccinations, please. There are catch-up vaccination, there are catch-up vaccination schedules available as well. So even if your patients missed their HPV vaccines, for example, it wasn’t available when they were born, it is available, I think, based on risk up until the age of 46. I think. You can vaccinate your patients, even if they miss those vaccines as younger adults or children.
Jonathan Shuter: And can I just add one last thing. I think that this has been said, but not very directly, in the course of the hour. We’ve talked about a lot of nuance here in the prescribing of these different medicines and a lot of cautionary tales about adherence, and we talked about side effects. But I think particularly for the primary care providers out there who aren’t doing this every day, that it’s really important to point out that in general, in your average patient, particularly if they can be adherent to medicines and follow up, that this is very easy thing to do. You’re just prescribing a simple, very non-toxic medicine one pill once a day, and you’re good. You have to follow the patient up, but it’s extremely easy in most cases.
Rasika Karnik: Thank you for that. So PrEP is easy. So that’s sort of the take home message. But thank you. And any other questions from the audience? I don’t think so. So thank you all for joining us today to our audience members. We hope that you learned something tonight and that you take back the information you have learned and incorporate it into your practice.
Commercial Support
This educational activity is supported by an independent educational grant from Gilead Sciences
Faculty Disclosures
Dr. Shuter has no relevant financial relationships to disclose
Dr. Felsen has no relevant financial relationships to disclose
Dr. Bernardo has no relevant financial relationships to disclose
Dr. Karnik has no relevant financial relationships to disclose
