Curious about PrEP but not sure where to begin? This webinar breaks down everything you need to know—from how PrEP works and how effective it is, to the different medication options, how to get a prescription, and ways to pay for it.
You’ll also get tips for taking it consistently and learn what to expect if you ever decide to stop. Whether you’re just starting to explore or ready to take the next step, this video can help you decide if PrEP is right for you.
Get quick answers to common questions, from doctors who specialize in PrEP care.

Recorded on November 4th, 2024 at 8 pm ET

---

Faculty: Jonathan Shuter, MD, Uriel Felsen, MD, and Raffaele M. Bernardo, DO

---

Full Webinar

Transcript Summary:

Key Highlights:

• What is PrEP? PrEP (pre-exposure prophylaxis) is a medication taken before potential exposure to HIV to prevent infection. It’s recommended for anyone at risk—including people who are sexually active or who inject drugs.
• Effectiveness: When taken as prescribed, PrEP is over 99% effective at preventing HIV.
• Options: There are three FDA-approved PrEP medications—two daily pills (Truvada and Descovy) and one long-acting injectable (Apretude).
• Getting Started: Patients can get PrEP through their primary care provider, local sexual health clinics, or telehealth services. The first visit typically includes a conversation about sexual health and some lab tests.
• Adherence Matters: PrEP only works if it’s taken consistently. Strategies like setting phone reminders or linking the pill with a daily habit can help.
• Side Effects & Safety: Side effects are generally mild and temporary. Truvada may affect kidney or bone health, but this is rare and reversible. Truvada is also safe during pregnancy.
• Access & Cost: PrEP is covered by most insurance plans with no out-of-pocket cost, and assistance programs are available for those who are uninsured or underinsured.
• Empowerment: Choosing PrEP is a proactive step in managing sexual health—not just HIV prevention—and should be seen as part of a broader wellness plan.

Final Takeaway: PrEP is a powerful, underutilized tool in HIV prevention. With multiple options, minimal side effects, and widespread availability, anyone at risk should feel empowered to talk to their provider about whether it’s right for them.

For more information, visit the PrEP for Patients Resource Center at pcmedproject.com or explore CDC materials at https://www.cdc.gov/hiv/prevention/prep.html

---

Transcript:

Moderator: Hello, and welcome to our webinar for people interested in learning more about PrEP medication that can lower your risk of HIV infection. Tonight we’re going to go over the basics of PrEP. What is it? How it works, where to get it, and how to use it?

And we’ll answer any questions you might have. Feel free to put your questions in the chat.

And doctors, if you would please be so kind as to introduce yourselves.

Dr. Jonathan Shuter: So maybe we should go in alphabetical order. So, Dr. Bernardo, why don’t you go first?

Dr. Raffaele Bernardo: Sure. Good evening, everyone. My name is Dr. Bernardo. I am an internist and an infectious disease specialist by training. I’m currently the medical director for a comprehensive LGBTQ plus program located in Northern New Jersey. And I’m excited to be here tonight.

Dr. Jonathan Shuter: Thanks, and Dr. Felsen.

Dr. Uriel R. Felsen: Hi, I’m Uri Felsen. I’m an infectious diseases physician at Montefiore Medical Center in Albert Einstein College of Medicine, and I work with people who are living with HIV and people who are at risk for HIV.

Dr. Jonathan Shuter: And Hello! I am Jonathan Shuter. I’m an infectious disease physician also at Montefiore Medical Center, and the Albert Einstein College of Medicine. I think I’m the oldest person on in this group. And saw my very first patient in 1985, with HIV. And I’ve been involved in HIV medical care going on 40 years.

So I guess we should get started. And let’s start with the basics. Let’s start by asking and answering the question, what is PrEP. And I think that I will send that to Dr. Felsen for the first answer.

Dr. Felsen: Thanks, Dr. Shuter. So PrEP stands for pre-exposure prophylaxis. And the idea is that it is a medicine that you get into your body ahead of time to protect yourself from the risk from acquiring HIV. So this is a medication for anyone who’s not already living with HIV, who may be at risk for HIV, and it’s a medicine that you take to protect yourself from acquiring HIV down the line.

Dr. Shuter: Great. And so I’d like to just dive into that a little bit a little bit more. So. Who is it that should consider using PrEP.

Dr. Felsen: So, you know, PrEP would really be great for anyone who is not currently living with HIV, who wants to protect themselves from it. So some of the people. So anyone who is sexually active should be talking to their provider about PrEP. That’s the recommendation from the CDC. And people who inject drugs as well, should also consider protecting themselves from HIV using PrEP. And can talk to their providers about that.

Dr. Shuter: Great. So I appreciate that answer, and I think if I might even express it more tersely, and say that that anyone who is at more than zero risk for HIV can consider PrEP.

It’s not necessarily for everybody, but a corollary to that statement is that someone who is at zero risk for HIV probably shouldn’t take PrEP. There’s probably no reason to put those chemicals in your body if you’re at zero risk. But assessing whether you are at any risk or zero risk is an equation that you might want to work out with your physician.

Dr. Bernardo: One of the things. I’ll add, Dr. Shuter, that, I think, is also helpful, too, in an effort to get a sense of someone’s perceived risk or actual risk for HIV is to think about the partners that that individual may be having sex with. If they know the HIV status of the partners that they are engaging in sex with, or, for example, if they’ve had a bacterial sexually transmitted infection in the past before, like, for example, syphilis, gonorrhea or chlamydia.

And the thought behind that is in reality, if you’re at risk for one sexually transmitted infection, there is a possible risk for another, and so a good gauge about whether a good gauge for whether or not someone may benefit from PrEP would be to think about history of bacterial, sexually transmitted infections in the past.

Dr. Shuter: Okay. So at this point, we’ve established that there is a treatment option for or there are treatment options for someone who is at risk for HIV, and wants to take measures to prevent acquiring HIV. How well does it work? Let’s let you take that one, Dr. Bernardo.

Dr. Bernardo: Sure. So we have very, very good data that show that HIV preexposure prophylaxis, regardless of its form, is incredibly effective at preventing HIV assuming an individual is taking the medication as prescribed.

We’re looking at 99% plus effectiveness at preventing HIV. Now, there’s a very good correlation between adherence and efficacy, meaning that if you take the medication it works. If you don’t take the medication, it doesn’t work. And so that’s really the driving point here to be made.

Dr. Shuter: So maybe we could now get into the different choices that one might have as far as PrEP medications. Dr. Bernardo.

Dr. Bernardo: Sure. So there are currently three FDA-approved medications for HIV pre-exposure prophylaxis. Two come in the form of pills. Each of those is taken as one pill once a day every day. Whether or not you’re having sex. Those two pills go by the brand names of Discovy and Truvada, and they’re both single tablets that are taken once a day every day.

The third option is the first long acting, injectable medication, called Apretude. Apretude is given in a provider’s office healthcare Provider’s office. It’s given as an injection during one month, one month, two, and then every two months thereafter. So it might be a good option for some people. We’ll talk a little bit later, as far as perhaps, who might benefit from one form over the other. But currently these are the 3 FDA approved medications that are available for HIV pre-exposure prophylaxis.

Dr. Shuter: Okay? And Dr. Felsen, I want to just bring up this question. We are talking to an audience tonight of people who may have never taken a medication regularly before, and aren’t comfortable, or might not be comfortable with the nuts and bolts of starting on a medicine and continuing on it. So might you have any words of wisdom about that about someone who’s starting on a medicine, and might not be accustomed to being on medication over the long term.

Dr. Felsen: Yes, it’s a big change. And for folks that aren’t used to taking a medicine every day, that might be something really new and something to get used to, and as Dr. Bernardo mentioned, you know the effectiveness of pre-exposure prophylaxis is directly correlated to how well you take it. Meaning, are you adherent to it? Are you taking it as it’s prescribed every day? And so a lot of people have come up with ways to integrate taking a medication into their daily routine. Some people will decide to take it every the same time every day, and so they’ll sort of attach it to something that they do on a routine basis, like brushing their teeth at the same time every day. Keep their pill bottle there. Other people might use a pill, might have a medication pack that they carry around with them, and set an alarm on their calendar or on their smartphone to remind them every day. There are lots of different strategies that people have used to remember to do it every day, but it is true that for many people who are starting PrEP, this might be the 1st time that they’re taking a medication every day. So it’s definitely something to be considered.

Dr. Shuter: Yes. And I think that that’s a great point. And and you know, one of the most consistent findings in all studies that PrEP that have been done so far is that the Achilles heel of PrEP. When it doesn’t work, it is almost always when a patient isn’t taking it. Well, so

I’m stating the obvious here, but I’m going to state it, anyway, that that medicine that sits in a bottle in your medicine cabinet and doesn’t go into your mouth and get swallowed doesn’t work. So if this is a decision that one takes, then that it is a decision that one should really stick with and follow the instructions.

And let me just ask another simple question. Either of you jump in, but we’re going to continue along, not assuming that people know how to take medicines chronically. What do you do when there’s only two pills left in the bottle.

Dr. Felsen: You have to make sure to stay on top of getting refills through your physician or your provider, whoever is prescribing PrEP. So PrEP is a medication that will need to be prescribed by a provider, and you’ll get it through a pharmacy. And most likely it’s going to be distributed on a dispensed to you on a monthly basis. And so, as that month’s supply is coming to an end, it’s important to look at your pill bottle and see, is it written on there that there’s any more refills remaining? And if there are, call up your pharmacy, ask them. Let them know that you’re due for a refill, and you’re ready to either pick it up or have it delivered. And if there are no more refills coming, you need to make sure to call your provider so that they can send in the next set of refills for you.

Dr. Bernardo: One of the things I’ll add as well is, many pharmacies also have the option for automatic refills as well, so they’ll keep track of when your last dispense was for your medication, and once they realize that you’re getting down to the last few days of medication, they’ll send an alert via text, or perhaps through a pharmacy app to let you know that you probably are due for a refill, and they’ll ask if you want the medication refilled

So that can serve as an additional reminder. So one of the things I do tell my patients is, if you think you might have issues remembering to ask for refills, see if your pharmacy has this service available. You sign up once and you’ll get reminders as you get toward the end of your month supply of medication. But to Dr. Felsen’s point, once you are reaching that three month mark, and you are due for additional refills, iIt’s important to reconnect with your provider, because you will also require repeat HIV testing at that point as well.

Dr. Shuter: Yes, and so a clear message here is that the patient stands at the center of a healthcare team that includes a physician or other prescribing provider and a pharmacist, and if things come up in the course of taking PrEP. If you lose your medicine, if there’s a fire and your medicines burn up if any kind of accident happens, then the people to call are those people because there are usually remedies for those kinds of urgent situations.

So moving on. If someone were interested in starting in prep, how does that person go about getting it? Who do you call, or who do you, Google? Or with whom do you set up an appointment.

Dr. Bernardo: So I can. I guess I can. I can start. I think the first place to go is if you feel comfortable, is having a conversation with your primary care provider point of contact, somebody, presumably, you know, and trust somebody you can probably have easy access to if you feel comfortable having these conversations, as you should. You can easily bring up this conversation with your primary care provider. Now, having said that, more often than not, I’m getting patients in my office, for example, who are coming to me specifically for sexual health because they don’t feel comfortable having these conversations with their providers. So one of the things you could do if you aren’t comfortable is to go online, see if there are any sexual health clinics nearby. If there are any infectious diseases offices nearby. There are plenty of online resources where you can search for providers.

Now, if there was an issue, for example about disclosure, or perhaps being seen in public, there are also several online services as well that can help set you up for PrEP. These are still run by healthcare providers who will perform an intake visit, and will check in every 3 months or so, and still require testing. But it is an alternative to in-person visits, if there is any limitation in that regard.

So I would start with your PCP, if you already have an established relationship, if not, and you feel more comfortable, you can do some searching online looking for a sexual health clinic or an infectious diseases office nearby. Or there are several online services as available as well, which are accessible through apps as well, that you can download through your phone.

Dr. Shuter: Right. So I I do want to emphasize that last point that we all work in urban centers where usually transportation to various provider settings is fairly easy. But we may have people viewing this webinar who live in rural settings, and it could be a 60 mile drive to get to their providers. So I think you mentioned this already. But might you say another word or two about availability of telehealth, and whether that’s a viable way of securing access to PrEP.

Dr. Bernardo: Absolutely so. One of the other options as well, is, if you do find a local provider or your provider that you’ve already established with, they may offer the opportunity to do telemedicine services as well. So what’s nice about telemedicine is that you can obtain medical care without leaving home. There are some limitations. You, as a patient, need to be located in the state that your provider is licensed. But it is an option to expand availability if distance is an issue.

We in our office do provide telemedicine for PrEP as well. We do recommend that patients come in at least once a year to be seen in person, because I think and I’m sure we’ll discuss this a little bit later, PrEP. Is more than just HIV prevention. And there’s some other topics and vaccines and things like that that we do prefer to talk about in person. But when it comes to PrEP, we do offer the opportunity to do telemedicine as well, and it has improved access to care.

Dr. Shuter: Okay, so let’s let’s move along here. You’ve identified the provider that you want to speak to about PrEP. What does someone who is going to start PrEP. Or is considering it? What should they expect at the initial doctor visit? Maybe Dr. Felsen can chime in on that.

Dr. Felsen: Sure. So you know when, at your first appointment, where you might be speaking to a provider about PrEP, I’m sure that the provider is going to have questions for you about what kind of sex you have, who you’re having sex with, to try to get a sense of what is your risk for HIV, and how can and whether PrEP might be a good option for you to protect yourself against HIV. It’s also going to be important to know just more about you as a person, and whether you have other medical issues, because that might have an impact on which PrEP medication is appropriate for you.

So a lot of questions about yourself, and about your sex life. Some questions about your

about your medical history. And you’re also going to – one thing that Dr. Bernardo was mentioning that is another challenge in telehealth is the fact that there are some routine labs that you’re going to get during your first provider visit. So remember that PrEP is really for anyone that’s not already living with HIV. So one of the most important things is to have an HIV test before you start PrEP, to make sure that you don’t already have HIV.

Some of the other tests that are going to be done are looking for other sexually transmitted infections, just routine care, so gonorrhea, chlamydia, syphilis. Some of these infections might cause sort of infections of the genitals, but sometimes they can also cause infections of the throat or infections of the rectum. So your provider may be asking you, maybe collecting specimens, you know, from your throat a throat swab as well as a rectal swab. Rectal swabs are things that patients can even do by themselves. It’s really just a Q-tip where you get a little swab in the area and it gets sent off to the lab. So some some blood tests, some swabs. We talked about syphilis, which would be a blood test. And another important one is going to be hepatitis B. So people that are starting on PrEP, we need to know whether you have hepatitis B or not, because some of the medicines for PrEP will also treat hepatitis B. And so, there is a small risk, that if somebody with hepatitis B were to stop their PrEP medication, it could cause a flare of the hepatitis B virus, which is something that affects the liver. So there’s just some routine labs that are going to be done at your first visit, along with getting a thorough history.

Dr. Shuter: Yes, so just to just to summarize, medical issues in the background. That could be important. Particularly, if there is significant renal or kidney disease, and also a history of hepatitis B, those would be of some importance.

Dr. Bernardo, I’m going to ask you to answer this question in a second, but I will also give my poor man’s answer to it before I ask you, what if a person who’s thinking about PrEP is embarrassed to go to the doctor? So my routine answer is that I’ve been a doctor a long time, and there’s nothing you could tell me that I haven’t heard, you know, many, many times before, and probably way more embarrassing than what than what you’re going to tell me. But I’d like to hear your insight. What would you advise? Someone who, where the impediment is embarrassment.

Dr. Bernardo: Sure. One of the things that I often tell my patients is that most people probably want to have these conversations, and probably many providers are ready to have them. But it’s always awkward who’s going to start the conversation, so I generally tell my patients to be open and honest with their providers, because these are conversations that are very important. They are on most people’s minds when they come into the doctor’s office.

And we try to normalize the conversation, because I often say to my patients, Look, your overall health is not just about your physical health. Right? You come in. You get vitals. We check your blood pressure. We do blood work, we do. X Y and Z. But your overall health is also about your mental health. It’s about your sexual health, and each one is just as important as the next. And so I do try to normalize these conversations. I often tell my patients these are routine questions that I often will ask of all, and if I will ask all of all of my patients, and if my patients don’t feel comfortable bringing them up, I will bring it up myself. And more often than not, when I bring up those questions they also start opening up to me and say something to the effect of you know I, I wanted to ask you those questions, but I was, I was nervous. I wasn’t sure if you were prepared to answer them.

And so I try to normalize these conversations, and I think the more we do that, number one as providers, I think it definitely helps from the patient experience, but from the patient side of things, I think it’s important that we remember that our sexual health is just as important as the rest of our overall health.

And these are questions that you need to ask in conversations you have to have with your healthcare provider.

Dr. Shuter: Thank you, Dr. Felsen. A very, a very simple, straightforward question. We talked about what to expect at the initial doctor visit, and it sounds like there is going to be a bunch of questions and question answer session, and there’s going to be some blood draw done. When do I expect to have pills in my hand?

Dr. Felsen: So you can walk out that day with a prescription for PrEP. So as long as you know, we do want to make sure that that HIV test is negative, but you might have had been able to have a rapid test on site. And at this point, very often, even if it’s not a what’s called a rapid test that you’re seeing, you know the little line on the strip in front of you, even if it’s sent to the lab, you may have the answer by the next day. So, most providers, at this point, in the absence of any suspicion that you might already have HIV, would feel comfortable sending you out with a prescription that day.

Dr. Shuter: Great, so I hope I don’t get in trouble by saying that it’s actually faster than Amazon Prime. You go to the doctor, you will probably have, and you go to the pharmacist, you will probably have treatment in your hand that day.

Next, Dr. Bernardo. I think that the audience knows that these medicines are not necessarily cheap, and some of them are quite expensive. So how do you pay for it? Or how does it get paid for.

Dr. Bernardo: Sure. So one of the messages I like to convey to both patients and providers, healthcare providers who may be offering PrEP services, that anyone who needs PrEP, whoever wants PrEP can get PrEP, and finances should never be an issue. Whether you’re insured, uninsured, underinsured. There’s a mechanism to get some form of PrEP.

Now, the USPSTF, that’s the United States Preventative Services Task Force, this is the Federal organization that makes recommendations for certain screening tests. For example, when we’re supposed to get our colonoscopies, our mammograms, pap smears, etc. The same organization has given PrEP a grade A recommendation. Now, this is important for many reasons. But one reason in particular is that any recommendation that’s given a grade A, those services are supposed to be provided to patients with no cost-sharing on the side of the patient. In other words, if a patient wants or needs PrEP and is insured, they should have no out-of-pocket when they go to the pharmacy to pick up these medications. Now this is particularly true of the generic version of Truvada. That medication is available at no cost to people who are currently insured.

Other medications, or, for example, if a patient is under or uninsured, are available through various support programs, either locally through the city, the State, or even through the pharmaceutical company itself. There are programs that are available to assist people in obtaining these medications.

For people who do have coverage, but, let’s say, have a large out-of-pocket, the pharmaceutical companies also have what’s referred to as Copay Assistance. So let’s say your insurance does cover PrEP whatever form it is. But you have a large out-of-pocket. These pharmaceutical companies do offer Copay Assistance up to a certain amount per year, which very often will cover the bulk, if not the entire, out of pocket cost for the year.

So, in other words, ability to pay should not be a limitation for getting HIV pre-exposure prophylaxis. It is available at little to no cost in one way, shape or form.

Dr. Shuter: Thank you, and this also is for you, Dr. Bernardo. The conversation that we are having this evening has been dominated by a discussion of pills. There are two different pills available for PrEP. And it’s appropriate to spend most of our time on that, because that that is something like 99% of the PrEP prescriptions that are written in this country. But I don’t want to ignore the fact that there’s an injectable option. So I wonder if you could just say a few words about the injectable option.

Dr. Bernardo: Sure, so the injectable aptitude is the first ever long-acting injectable for HIV preexposure prophylaxis, and I think it does have some benefits over the pills, and vice versa, of course. But in terms of the pros with the injectable, one of the situations that comes up not infrequently is, for example, the issue with pill fatigue. So patients who already on several other medications and now adding another medication, it becomes daunting.

The second situation I often come across is an issue surrounding disclosure. So patients who may live with family, or, let’s say, close friends who are concerned about having a pill bottle around that may be found by whoever they’re cohabitating with. Or in the situation I think Dr. Felsen mentioned earlier. Somebody who’s new to pills, and now all of a sudden has to remember to take a pill every day, that can also be daunting as well. These have been three situations where I have found injectable Cabotegravir to be, or injectable Apretude, to be incredibly helpful.

It reduces the need to remember to take a pill every day. It helps around the situation of disclosure, since you don’t have to, you don’t have to keep a medicine bottle around the house, and it minimizes the need for additional medications you have to take every day for those who are already taking several different medications. So it is a great option.

The injectable is very well tolerated. There are minimal to. If any side effects. The big thing that occasionally we will see is injection, site pain. This is an injection that does have to be given in the provider’s office. It is an intramuscular injection, and, like was mentioned earlier. The 1st 2 injections are given back to back month one and month 2 for what we refer to as a loading dose, and then every 2 months thereafter for maintenance dosing.

So there are some people who have some injection site pain, although it isn’t limiting, for I would say, the overwhelming majority of people. And typically that injection site pain gets better with each subsequent injection. So I think injectable Apretude definitely has its place in the HIV pre-exposure prophylaxis realm for certain subsets of individuals.

Dr. Shuter: Okay. So at this point I’ve identified a provider. I’ve made an appointment. I kept that appointment. I answered all the questions, I had my blood drawn, I received the prescription. I went to the pharmacy. I have the bottle of pills in my hand.

And I’m taking the first one, so I’m very interested to know what kinds of side effects to anticipate, and whether there are any significant dangers associated with these pills or with the injectable. So, Dr. Felsen, could you address that.

Dr. Felsen: Sure. So for PrEP, all three of the options are really well tolerated. Like any medications, though, anything that you put in your body, there’s always the potential for side effects. So with both of the pill options, both of the oral options, the most common side effects are going to be gastrointestinal. So people with some GI upset usually will sort of pass. People will sort of get used to it over the first couple of weeks of being on the medication. Sometimes people have headache as well. That also usually passes

Like Dr. Bernardo mentioned for Apretude for the injectable form, by far the most common side effect is the injection site pain that he was talking about.

So as far as other side effects that one might want to know about and consider for the pills, for Truvada, the most common one, the one that people might have heard about, are that some people can have some effect on their kidney function, which is usually very mild, and your doctor, it’s something that would be recognized by checking blood tests and looking at your kidney function. And if it’s something that’s happening, if your physician or your provider finds that Truvada is affecting your kidneys, then you would most likely stop it, and at which point your kidney function would go back to where it was. So it’s reversible.

That’s with Truvada.

For Descovy, which is the other pill option, the impact on your kidney is less so. Even with people who have underlying kidney disease for whom Truvada might not be an option, Descovy might be an option. So kidney is one thing. The other thing that people talk about is bone health.

So Truvada also can decrease sort of the density of your bones. It has not been shown to be very clinically significant, meaning it’s not like people are developing new fractures. Once they start Truvada, it’s more of a lab finding or an imaging finding. And again, like the kidney function, if one were to stop the medication, the bones go back to their baseline health.

Dr. Shuter: Yes, thank you. So in summary, one could expect maybe a little bit of nausea with the pills. A bit of pain at the injection site with the injectable, and those usually get better over time.

As someone who’s been in this field for many, many years, I can say that at the outset when we began using Truvada -it’s over a decade ago already, when we started using it for PrEP – there was significant concern that kidney issues and bone issues would come up, and by and large those concerns have not materialized. And not to say that there’s no effect. But the effect that’s been observed is very, very mild, and usually reverses after you stop the medicine. So I think we have to take all potential side effects seriously. But the side effect profile of all of these medicines is very, very favorable.

Dr. Shuter: Next question, how about someone who is pregnant, or is anticipating pregnancy? What’s the track record of safety of these medications in pregnancy?

Dr. Felsen: So Truvada is safe in pregnancy and can be used, you know. Certainly there’s the situation in a zero discordant relationship. So that’s a situation where one partner is living with HIV and the other partner is not living with HIV, and sometimes a couple like that might be trying to conceive, and so Truvada is an option in that situation to help prevent acquisition by the person who’s not living with HIV, and also to protect the fetus. So Truvada is safe in pregnancy.

Cabotegravir, or Apretude, the injectable, is relatively new. We don’t really have enough information about cabotegravir in pregnancy at this point. If you are on cabotegravir and you become pregnant, you’d want to discuss with your provider the options of either staying on it or potentially switching to Truvada. That would be a discussion to have. But people who are on Truvada can continue that through pregnancy.

Dr. Shuter: Yes, so then all of that is valuable information, and I think it’s worth pointing out that, as far as Descovy and cabotegravir, Apretude, go, as far as I know, there is no worrisome safety signal with regard to pregnancy or effects adverse effects on the fetus. But what you said is true. There’s not enough data to really rely on that, at this point.

Dr. Felsen: Lots of years of experience with Truvada.

Dr. Bernardo: Right. So the two things I was going to add, one is these are medications like Truvada, for example, that we’ve been using for a very long time, particularly with people living with HIV who get pregnant. So we have a lot of good data showing its safety profile in the setting of pregnancy. The other thing I will add to what Dr. Felsen mentioned is that while Descovy is safe in pregnancy, it typically is not, or it should not be a medication that we would be giving for HIV pre-exposure prophylaxis in somebody who is capable of getting pregnant. And the reason is because it is not FDA-approved for people who engage in receptive vaginal sex. So again, while it is safe in terms of the fetus, it is not a medication that somebody in that situation would be prescribed prior to getting pregnant. Presumably.

Dr. Shuter: Right, so that probably is worth repeating. The pill Truvada is is approved for pretty much every population who would be interested in PrEP. Whereas Descovy is not

approved for those practicing receptive vaginal intercourse.

Dr. Shuter: okay. Next question. How quickly after I start does it begin to work? How soon does protection kick in.

Dr. Bernardo: So this is a this is a very important question, and not something that routinely patients bring to the table. So I think it’s important that we do discuss. So we do have some data that show that for Truvada in particular, it does take about 7 days of continuous use before it achieves levels within rectal tissue that are considered protective against HIV in vaginal tissue. We think this is closer to 3 weeks or 21 days or so.

In my practice, I extend that data to include Descovy, although there’s probably a difference between the two. But just for precautionary measures, we typically will also generally recommend the same amount of time, 7 and 21 days, with the rectal and vaginal tissue respectively.

For penile tissue, oropharyngeal tissue, or the throat, for example, we don’t have as good data, but largely, I would recommend closer to a 2 or 3-week mark in that regard. But the data that we do have rectal tissue 7 days vaginal tissue, approximately 21 days for injectable Apretude. We believe there is about a 7 to 14-day window before the drug achieves protective levels in the blood after your first injection.

So I often will inform my patients, who are already on some form of oral PrEP, to continue their oral PrEP for approximately 14 days after their 1st injection, to ensure that the injectable Apretude has reached levels that are protective against HIV.

Dr. Shuter: Dr. Bernardo, I want to follow that question up with a question about event-driven PrEP. And I suspect that some people on the call will be familiar with the idea or the concept of 211 dosing. We have to be careful about what we say here and really disclaim our statements and the content that’s going to follow by saying that this is not an FDA=approved indication of the medication as of yet, but it is something that is done very widely. It is approved by a number of very authoritative medical boards, and it might be coming, you know, in an official way, in the United States. So I suspect that people are doing it already. So what about you had just said that it takes, anyway, anywhere from a week to 3 weeks to build up a protective level when you use Truvada or Descovy the correct way. What about this 211 dosing? Tell us about that, and tell us how quickly protection is thought to kick in.

Dr. Bernardo: So 211 PrEP. Also known as on demand, PrEP, or event driven PrEP, is a way to reduce your pill burden – the number of pills you’re taking over the course of the month. This is particularly beneficial for individuals who are having sex with a perceived risk for HIV relatively infrequently throughout the month. It is currently recommended particularly for men who have sex with men.

The idea behind it is that you take and I will also mention that this is particular to Truvada, both the brand Truvada and generic Truvada. This is not currently recommended with Descovy. So again, Truvada generic, Truvada, 211 on demand or event-driven PrEP.

So the idea is you take two pills 2 to 24 hours before anticipated sex. So this is one of the downsides of this form of taking PrEP, because there is some anticipation that is required. So you take two pills, 2 to 24 hours before sex. Assuming you have sex during that time period, you take one pill 24 hours after the two pills, and then one pill 24 hours after that pill.

So two pills, 2 to 24 hours before sex, one pill 24 hours later, and then one more pill 24 hours after that.

The idea is that you are achieving protective levels within two hours after taking that loading dose of two pills. But it is important to follow with that 48 hour tail of medication. So one pill every 24 hours for 48 hours.

Here’s the caveat. If you were to have sex within that 48 hour tail, you have to take one pill every 24 hours for 48 hours after the last time you had sex. So you can imagine if you had sex two or three times in that week, you effectively are taking daily PrEP.

So again, this is a great idea for someone who has a perceived or actual risk for HIV, relatively, infrequently, for also for someone who’s looking to reduce or minimize their pill exposure.

Dr. Shuter: Dr. Felsen, I’m just going to present a couple of real world scenarios with regard to adherence and taking the medication properly. So I think we’ve tried to hammer home the idea that this medicine only works if you take it and take it as you’re supposed to. But what happens if my routine is to take it at 8 am every morning. And then one day at dinner time, I realized I didn’t take my 8 am dose. That’s scenario number one.

Scenario number 2 is, what if I miss a whole day? You know I missed my Thursday dose. And here’s Friday, and am I still protected? And what should I do? Should I double dose? Or what’s the correct approach, then?

Dr. Felsen: Yes, that’s a great question. And you can imagine that this comes up all the time, and nobody’s perfect, and nobody is going to be expected to take their medication at the exact same time every day 365 days a year. So this definitely comes up and we have to have real world expectations of our patients. And so the idea is, you want to do the very best that you can. So let’s say you take your pill. Let’s say you’re on Descovy or Truvada, and you take your pill every day at the same time at 8 am. And come that evening, you realize you haven’t taken it yet? Go ahead and take it, and you’re going to be just fine. You’re within the same 24 hours. It’s just fine, and you’ll be able to take your next pill at 8 am the next day without having to worry about it. That would be for the 1st situation that you said so like it it is. Let me just be very clear, it’s better to take it late than to skip it entirely. If you realize in the same day that you missed a dose, just take it later in the day, and you’ll be fine.

If you entirely missed a day, don’t double up on your meds. So if you missed your Monday dose, and now you wake up on Tuesday and said, Oh, my God! I forgot to take it. Take your Tuesday dose and forget about the Monday dose. It should be all right. Everyone is, you know, the idea is to take it as consistently as you can. We want to make sure that you take it almost every day. But if you miss a day. It’s not worth the potential risk of having too much medication on board by doubling up that day.

Dr. Shuter: We don’t encourage anyone to miss doses, but there are a great deal of data available to show that if you get six doses in a week rather than seven, that the protection should last throughout the week. So try to take every pill. But if you miss one dose, there’s nothing to panic about. And your protection probably continues.

Dr. Shuter: So, Dr. Bernardo, people’s circumstances change sometimes. So what if someone’s relationships change or they leave a relationship and aren’t in a new relationship, and their risk for HIV acquisition does, in fact, go to zero for a period of time. What is the story on whether you could start and stop PrEP. And if that is possible, then how do you go about doing it?

Dr. Bernardo: So obviously things, life, circumstances, change, relationships come and go, and so can PrEP. People can stop and start PrEP as they feel is necessary. However, we do recommend it is done under the guidance of a healthcare provider, for a couple of reasons.

In terms of discontinuing PrEP. Dr. Felsen had alluded earlier about checking for underlying hepatitis B infection prior to starting PrEP. The same is true when you stop PrEP. If it was missed initially and again, just to remind everyone, the reason is because these oral forms of PrEP do have activity against hepatitis B as well. And if an infection is missed, and these oral forms are stopped, you can actually have a rebound infection and can develop fulminant liver failure. And so we do have to screen. If it wasn’t screened for initially, if someone does have chronic hepatitis B, they do need to remain on at least one form of hepatitis B medication that that individual can discuss with their provider.

In terms of restarting PrEP, again, similarly, things change and people can definitely restart. However, prior to restarting PrEP, you do need an HIV test to make sure that you are, in fact, HIV-negative before restarting PrEP. So you should never just keep the pills at home, decide to stop for a month or two and then pick it up, you know, two, three months down the road without discussing with the healthcare provider, because those tests do need to be repeated, and to make sure we aren’t missing anything.

When it comes to the injectable form of Apretude, there is an additional concern. Apretude does have a very long what we refer to as a tail, meaning that after the injection it does take a while before the medication is completely eradicated from the body. And the reason this is concerned is because if someone does have an HIV exposure during this quote unquote tail period, they may still get infected, they may still get HIV. But now, because you have that low level drug available in your system, the HIV virus can become resistant to that medication, and not that we couldn’t treat the HIV infection. But we have to be a little bit more creative with our medications. So that’s an additional nuance in terms of starting and stopping PrEP when it comes to the injectable. Not that someone would do this at home, since it has to be done in the healthcare provider’s office, but something to keep in mind. If you do stop PrEP, or if you do stop injectable PrEP, if you feel that there may be a potential risk for HIV acquisition, make sure you’re using some other form of HIV prevention like condoms, for example, until you are able to return to your doctor’s office to discuss restarting injectable Apretude.

Dr. Felsen: And I would just add also that when you do restart, the same sort of timeframes that we’ve talked about earlier come into play again. So if you stopped PrEP, but now you’ve restarted again, it’s seven days before, if you’re on oral PrEP, it’s seven days before the protection in the rectal tissue, and about 3 weeks in the vaginal tissue.

Dr. Shuter: Thank you. So I I’d like to move on from the somewhat scientific discussion that we’ve had to maybe a bit of a philosophical view. And this is for Dr. Bernardo. We started off by talking about how patients might be embarrassed when they begin to approach this topic, and the topic is wrapped up in the idea of vulnerability that someone is vulnerable to being exposed to HIV and potentially acquiring HIV.

But those are kind of negative takes – embarrassment, vulnerability. Can you say a couple of words about how the decision to start PrEP can be empowering in an expression of a person’s power.

Dr. Bernardo: I like to refer to PrEP as a part of someone’s sexual health toolbox. Right? So when we talk about sexual health, there’s lots of different things we talk about. So we talk about contraception. We talk about vaccinations against certain sexually transmitted infections. Sure, we talk about condom use. We talk about PrEP, we talk about family planning. There’s a lot that goes on there, and I feel that PrEP and HIV risk is just a small part of that.

So whenever I have conversations regarding sexual health with my patients, I’m not just focusing in on that one thing. I’m not. Because then what happens is you’re equating sex and HIV. It becomes this direct link, this direct association, when sex is more than just about your risk for HIV. It’s a small part of it. And so I make that conversation part of a larger conversation, and again, by normalizing the conversation to your point earlier. Anyone who’s having I forgot how exactly how you phrased it. Non zero percent risk.

These conversations should be brought to the table. So by normalizing the conversations around PrEP. And I ask it. I usually ask it in a very sort of non-discriminating, non-offensive way. I say, so tell me what you’re doing to keep yourself that you’re enjoying sex you’re doing in a way that’s keeping you safe. Talk to me about the tools you’re using for prevention against sexually transmitted infections. Right? And I might not even mention HIV right away. And sometimes condoms come up. Sometimes patients will say, Well, I try to use condoms as often as I can, but sometimes I forget, and then I’ll use that as an opportunity and say, Well, have you heard about HIV? Pre-exposure prophylaxis? And sometimes that’s a way to sort of drive the conversation. But to get back to your original question. I think the big point to be made here is that we have to get away from associating sex and HIV, that it’s more than just that. It’s not just about HIV prevention when we’re having these conversations, both on the side of the healthcare provider and the side of the patient. These are part of much larger conversations as we normalize conversations around sexual health. So that’s that’s one way that I try to strategize.

I bring these conversations to the table, and patients should not feel uncomfortable having these conversations, because, like I said earlier, many, many people want to have these conversations. They just don’t know how to have them. So let’s normalize the conversation. Let’s talk about it.

Dr. Shuter: Thank you. And you know. So both my patients and my colleagues know that I’m something of a zealot about general health care. And I also want to make the point, and I think what Dr. Bernardo just said is a good segue into it, that we want to normalize sexual health, but that implies that it becomes part of your overall health care. And for anyone out there who is contemplating looking into PrEP and contacting a provider, it would be a tremendous missed opportunity to not pull other health issues into that conversation. Because, yes, this is important. But if you smoke cigarettes, that’s really important also. And if you have hypertension, that’s really important, and if your lipids aren’t good, or if you’re diabetic, or you’re suffering with obesity, or you’re struggling with depression or anxiety. These are all major major medical issues, and they are all very common.

And to me it would be something of a tragic error to interact in an intensive way with the medical community and to leave that stuff out. Now, the truth is that your PrEP provider may very well not have time in the visit that’s allocated to you to deal with those things.

But at the very least they should enter the conversation because he or she might feel comfortable dealing with them at future visits, or might feel comfortable referring you to a different provider. Because if you’re going to get this part of your health in order, go ahead and get all the parts of your health in order, it’s a great opportunity to do that, and a great way of getting started and being healthy from A to Z. So I do want to make that point.

Dr. Shuter: At this point I would like to invite Dr. Felsen and Dr. Bernardo to contribute any final thoughts. Is there anything we left out anything niggling at you that we ought to say.

Dr. Bernardo: I I guess the one thing I will add is to remember and forgive me for being repetitive, but I think it’s important that talking about sexual health isn’t just about HIV prevention, and I think it’s important to have conversations about other ways to improve your sexual health toolbox, and these are things like, for example, talking about contraception. If you’re capable of getting pregnant, talk about vaccinations that are available against certain sexually transmitted infections, like, for example, hepatitis B, or the human papillomavirus.

So these lead to sort of broader conversations, and if your healthcare provider doesn’t bring it up, I encourage you as patients to bring those things, those topics to the table as well.

Dr. Felsen: I think that’s a that’s a great point. I I just want to add that PrEP is a really important tool of that toolbox. And right now it’s being underutilized. Not enough people who would benefit from it are using it. And so we need to keep thinking of ways to make sure that those who have the most to benefit from this advance can get their hands on it. And can, you know benefit from its effectiveness.

Dr. Shuter: Thank you, and I would like to circle back also to adherence, because, as I said at the beginning, that is really the Achilles heel of the pills that patients take. So it is adherence, adherence, adherence, and we are talking to an audience of smart people.

We can’t understand and advise you about every circumstance in your life, so I don’t know what adherence strategies are going to work for you. It might be putting your pill next to your toothbrush every day.

It might be putting it next to the coffee maker, as a reminder to take it every day. But you have to also anticipate other situations. What are you going to do when you go on vacation? The time to think about it is not when you’re running to the gate in the airport. The time to think about that is the day before. What should I do? Where should I pack this?

Or, if you’re going to go sleep at a friend’s house for the night, and be out of your house for 24 hours. How can you take the pill along in a way that works for you, because if you don’t think of those things in advance, they’re not going to happen, and your adherence is going to fall down, and when PrEP fails, it is because patients don’t take their pills. Right? So please give that some thought. If you’re contemplating starting PrEP, or you’re on it now, think about how to stay on it really, really, reliably, over the course of time.

Moderator: Thank you very much, Dr. Bernardo, Dr. Felsen, Dr. Shooter, for participating tonight. And thank you to our audience for joining us.

If you want more information, you can visit our PrEP for Patients Resource Center at pcmedproject.com, where there’s written material, podcasts, and infographics.

The CDC also has excellent materials for consumers at CDC.gov. They call it “Let’s Stop HIV together.”

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

Related PcMed Topics: