Announcer

Welcome to the Academy Exchange: HIV Today and Tomorrow. In this podcast, we discuss the latest advances in HIV prevention, care and treatment, as well as examine the societal and systemic issues facing people with HIV. Thank you for joining us.

Bruce

Hello, everyone, and welcome to episode two of this new podcast we're calling the Academy Exchange HIV in 2022 and beyond, hosted by my organization, the American Academy of HIV Medicine. Once again, my name is Bruce Packett, and I'm the executive director of the Academy. And I'll be guiding our listenership through what's basically an interview or a series of probing questions from some of our key members who serve as faculty for our medical education programing and are otherwise affiliated with the organization.

The point of the podcast, as I mentioned in our opening episode, is really to take this great clinical education content and repurpose it in a conversation for a wider audience. So with that in mind, we're very lucky today to have Dr. Carly Floyd with us. Carly Floyd is a clinical pharmacist at Southwest Care Center, SCC, and the clinical director at the University of New Mexico AIDS Education and Training Center. So that's the UNMAETC. She attended the University of New Mexico College of Pharmacy in Albuquerque, New Mexico. Upon graduation, she completed her PGY-1 residency in El Paso, Texas, and at the UTEP at Austin Community Pharmacy Residency Program with a focus on HIV primary care. In 2012, she returned to her home in New Mexico and eventually became the pharmacy manager for the Southwest Care Center location in Albuquerque and obtained her certification in HIV.

She transitioned to her current role as a clinical pharmacist educator and provider of HIV treatment prevention hepatitis C, transgender medicine, diabetes and smoking cessation. Carly was awarded the New Mexico Pharmacists Association’s Distinguished Pharmacist of the Year Award in 2018. At the end of 2019, she accepted an additional role as a clinical director with the UNMAETC to continue educating New Mexico in El Paso, Texas communities to help end the HIV epidemic.

So Dr. Floyd did a talk for our members and other clinicians about getting pre-exposure prophylaxis, or PrEP, and post-exposure prophylaxis, or PEP, to some of the harder to reach populations in the country. And she is self-evidently very passionate about prep access and talking about PrEP with her clients and talking to other providers about doing the same. Welcome to the podcast, Dr. Floyd.

Dr. Floyd

Thank you so much for having me today, Bruce.

Bruce

Absolutely. I just want to back up and say we're not going to assume a lot of medical or scientific or biologic knowledge of HIV as a disease state. So let's start by backing up and just defining our terms. So PrEP, or pre-exposure prophylaxis, has been a huge development in the fight against HIV over the last decade. And I'm hoping that you can start and tell us what pre-exposure prophylaxis is and how it differs from post-exposure prophylaxis or prep. And then maybe tell us how PrEP originated or how it came into clinical use for HIV prevention and ultimately how it works. I think, if I'm not mistaken, this is right around the ten year anniversary of the Food and Drug Administration approving the first oral prep medication for HIV prevention. So maybe this is a good time to reflect on those early days of development. I'll stop there.

Dr. Floyd

Yeah, absolutely. We're right at the ten year anniversary, it was approved in 2012.  It was the first oral PrEP medication that we had. So like you said, pre-exposure prophylaxis. I like to tell people when I'm talking to patients, clients that I say that it's similar to birth control. Right? We take, women and people who are of childbearing potential take a daily pill sometimes to prevent pregnancy. And so it's very similar to an oral pill that was approved initially. And then since then, over the last ten years, we've had  two oral agents and even a generic, and then most recently an injectable. And so I think your question was, let's talk about what it is in general and how does it work, correct?

Bruce

That's right.

Dr. Floyd

Yep. Okay. So in general, what happens is that these medications, usually either two medications and one pill or one active medication in an injection, work to prevent HIV in people who might be exposed to HIV. Now, they may not know that they're going to be exposed, but they think that they could be exposed and that would be exposure through blood, sexual exposure or injection. So if somebody is potentially sharing a needle or any kind of injection equipment that is another exposure. And so going on these medications is the way that we actually can prevent that person from acquiring HIV.

Bruce

Right. Great for that. Thanks for that explanation. I want to kind of shift here and move over to discussing the National Strategic Plan, because obviously PrEP and prevention is a big part of that hope to end HIV in the U.S. by 2030, which is what the strategic plan lays out. You know, and many of us working in HIV, you're very familiar with what we call MVC, where everything has acronyms, the NHAS, the National HIV AIDS Strategic Plan, for Ending the HIV epidemic in the U.S..

So for our listeners who may not be aware of the details of the national plan to eradicate HIV or more likely may not even know it exists, can you share a brief overview of sort of the general pillars of the plan and where it comes from? Who devised it? And I'm hoping you can also do kind of a brief overview of what part HIV prevention specifically plays in the ending the epidemic plan.

Dr. Floyd

Yeah. So we just recently passed 40 years of having HIV and AIDS in in our country and being aware of it. So, we're 40 years in and we don't have we haven't ended it. Right? We were hoping to have done this. And so that the HIV National Strategic Plan is something that's coming from the federal government, where we're trying to focus on, like you said, these pillars.

So these four kind of key things to really stop having new diagnoses of HIV. We really want to be done with HIV across our country and in the world, If we're able to. And this is specific, you know, the Ending the HIV epidemic I'm specifically referring to in the United States.

So the first pillar is diagnosing people with HIV as early as possible. And so that means increasing testing, having people be screened routinely, not just putting it for people we think might have it, but just part of routine care. You get an HIV screening. When was your last HIV screen? And then once somebody is, we determine that they're positive. We have it as soon as they, what we call ,seroconvert or where their blood turns to have the HIV antibody. So that's the first pillar.

The second pillar is treating people. So you get the people who are diagnosed with HIV, hopefully as soon as possible within the HIV timeline. And then we're going to treat them. And we want to treat them rapidly, meaning usually same day, but generally within the first two weeks of diagnosis. So that we can get their virus to become completely undetectable in their blood. We call that viral suppression. And that is a way to prevent the spread to other people.

The third pillar and the pillar that we're kind of focusing on the most is the prevention pillar. And so this is really getting people on pre-exposure prophylaxis, syringe service programs, but it also includes post-exposure prophylaxis. And so post-exposure prophylaxis is kind of more of an emergency where within a few days, 72 hours is our rule, of an exposure, a potential exposure to HIV. We can put somebody on a regimen to decrease that seroconversion where their blood goes from antibody negative to antibody positive. And so that's another piece that's in there in that prevention pillar.

And then the fourth pillar is really responding to potential HIV outbreaks, getting prevention and treatment services out to people who need them. And so this is kind of the strategic plan, and those are the pillars that you mentioned. And I think one of the best things that most people can do is that prevention piece. Right? And also diagnosing because a screening test is very easy to do, but it's so easy for us to start getting prevention out there and making it widely available. And available to all people. Right? Not just in certain areas, but anyone can get it. And so that's what I hope to help people feel really comfortable with by the end of this talk.

Bruce

Yeah, that's great. So just to getting a little bit into the differences between PrEP and PEP. PrEP is sort of commonly known as something where you are taking a one pill once a day or an injection every month or two, sort of in perpetuity.  but the same is not true of PEP, this for a finite amount of time. Can you sort of hash that out for us?

Dr. Floyd

Yeah. So PEP is something that you do for a month. So, for example, if somebody comes into my clinic and they tell me, hey, you know, it's Monday morning, on Saturday night, they were at a party and something happened. They woke up and there was maybe sexual assault or some sort of questionable thing that happened. And they're really concerned about potentially getting sexually transmitted infections, HIV, any of the things that could be transmitted sexually or by blood. They can come in and we can give them a month's worth. Technically, for the guidelines, it's 28 days, but about a month of a fully active HIV regimen because we know that that has significantly decreased risk in people if it started within 72 hours. And the reason for that is the virus,iIf the person was exposed to the HIV or to the human immunodeficiency virus, it takes about 72 hours to get that wide spread dissemination or just getting throughout all the body, getting into the organs and beyond just that kind of initial exposure.

And so if we can give somebody a fully active HIV treatment regimen, we can actually prevent that full dissemination through the body, prevent the antibody from converting over from negative to positive. And as long as there's no continuing exposure for that month, then that person, after a month goes by, they test them again, they should be considered to be fine from that exposure.

And part of the reason why we do just one month is because once they've been on it for a long period of time, if that virus isn't replicating and there's no other exposure, there's no need to go on it longer. But we could talk about prevention after that. Like continued daily prevention or injectable prevention as well.

Bruce

Yeah, seems like a good entry point to sort of talk about a transition potentially from PEP to PrEP in that instance. And I want to get into some of those risk factors and conversations that lead to a PrEP prescription in a moment. But you alluded to, and so did I actually, the new injectable formulation of PrEP, which is something we focused on in the first Academy Exchange podcast, specifically new treatment and prevention modalities. How is this different than your typical traditional PrEP using oral medications or pills?

Dr. Floyd

Yeah, it's a really exciting new area for preventing, even treating, but especially for preventing HIV. And so one of the differences I think, is just in the way that it's formulated, right? So we're giving somebody this very potent, good prevention option, not in an oral pill that has to be taken every 24 hours, but in an injection that needs to be given initially, you do a month apart and then you go two months.

So what's really cool about that is that people don't have to remember to take a pill every day. I'm a pharmacist. I struggle to remember my daily medications. So I think it's so cool that we can say, “Hey, come in and get an injection”. And for the next two months we feel pretty comfortable because this has really good data that you're not going to get HIV.

Obviously it's not 100%, but it's going to be better than you remembering to take a pill every day and forgetting it maybe three or four days out of the week, which is where it's going to significantly decrease protection from HIV for the oral medication. So it's really great. It's been something we've been anticipating for quite some time as we've been seeing the studies come out.

COVID did kind of delay its release, but it's finally here and it's really a great option for people wanting to prevent HIV.

Bruce

Yeah, it really is an exciting new prevention modality in addition to being an exciting new treatment modality as well. I want to move into the communications side of things and I want to pose kind of two different scenarios. The first is when a patient or client specifically comes into a clinic, asks their prescriber, their health care provider, their clinical pharmacist, about PrEP specifically at that point, what kinds of questions would that provider ask to determine if this patient is, in fact, or this client is, in fact, an appropriate candidate for PrEP?

So I guess a different way of looking at this question might be we start to think about, quote unquote, risky sex for men, women and transgender clients or injection drug use and all the other things you mentioned being the risk factors that make someone the candidate for starting PrEP. You might think that this applies to a large proportion of your patient population.

So what are those key questions that you might ask and what kind of response are you looking for to generate that prescription?

Dr. Floyd

Now, this is a great question. I think it's really interesting to talk about, too, because we used to be really particular about who actually qualifies for PrEP, where it was like, you know, we really needed to show a certain risk. And I remember at one point years ago where we would kind of calculate their risk rate for is there something that they should go on? We would ask questions about the number of sexual partners, risk factors that they may have, prior sexual transmitted history, a lot of questions and all our really important questions as a clinician. However, there can be some contribution or furthering of stigma around stigma around sex, especially when we're quantifying number of partners.

And so this is something that's kind of going away, although you absolutely could ask, you know, what lifetime when you're thinking about the number of partners that you've had, what's your lifetime number of partners? You know, and if somebody says one that's very different than somebody who says 100 or more, and we have lots of different numbers in between, but really trying to remove the stigma around that. Right? Being sexually healthy is super important for all people. Maybe just asking about the different types of behaviors somebody engages in. 

And what's really cool is that the CDC guidelines for PrEP, which if the listeners aren't familiar with, they are available online free. And they were just recently updated in December 2021. So fresh hot off the press, but they now recommend to offer it to everyone. It didn't used to be like that and now you pretty much can go in there and it's either give them PrEP or consider PrEP and offer it. Basically to all people. So my perspective is that everyone is a candidate unless proven otherwise.

So really, I think the big thing is like let's talk about those types of behaviors you might be engaging in and really talking about what's a high risk behavior and what's not a high risk behavior. And so when we kind of look at this, there are ways of stratifying. What's the highest risk? What's a lower risk? What's the lowest risk?

Obviously, if we think about blood transfusions, prior to us being able to test, that's going to be the highest risk like nine out of ten people are going to get HIV that way. So thankfully, we screen now and so it's not an issue, but that's going to be our highest. 

But when we're thinking about things that might be a more common for people, right? Condom-less sex is a big thing. Right? And then there's different stratification between the types of sex that people are having. And this is where I think as health care providers we've done, we're not doing great here. We're kind of afraid to talk about sex. We don't get good training on it. There's lots of research out there that shows that there might be some training, but it's not very great, it's not adequate.

And as we get out into practice, we start to lower prioritize taking a sexual history. So it is really important, but it's very hard to do. And so you have to start talking about, well, what kind of sex are you having and really removing the stigma around that. So condom less receptive anal sex you can hear this being called I bottom, being the receptive partner they'll say bottom.

But this is not just for gay men. I think that this is a big stigma that only gay men have receptive anal sex. And I think it's really important to remember that all types of people have anal sex. If you have an anus, you can use it for sex, right? So it's really important to normalize that and ask everybody. Not just, oh, well, I know that this person is gay or trans or whatever so they might engage in anal sex. No. Just ask people, make it normal. Talking about that and then talking about maybe they're the sort of partner. And so there is a risk they're lower than being the bottom or the receptive partner.

And then asking about, have you ever shared injection needles or supplies maybe that you've shared cookers or cottons or any of the things that go with preparing injection of substances. Right? Those things can pass on HIV generally. We're more concerned about Hep C with that because it lives on surfaces much longer than HIV. But we want to know about that.

And then the last thing I think that's really important to think about is if somebody has sexual partners who are HIV positive, who are either not taking HIV medication, so then their virus is replicating in their blood, or somebody who is on HIV medication but has a detectable viral load, meaning either they're not taking their medication daily as they're supposed to, or if the virus is somewhat resistant to their medications and they have replicating virus in their blood.

So those categories, for the most part, are going to be people who would be considered high risk. And I will even say when we talk about sex, even oral sex can be at risk. Very much lower when we're comparing it to all of the things. But that is a risk. And so what I like to do is sit down with people and say, Hey, here are your risks. There's a really great chart that I'll send to you the links. You can put it in the show notes for the podcast. It's from 2015, but the data is still the same. It's really great. And it talks about like your odds of getting HIV, so one in 200 and whatever, one in 2000, basically negligible. And I let people look at that and say, okay, I engage in these types of behaviors and we're normalizing it, right? We're not stigmatizing it. 

And then they can say, I'm comfortable with these risks or I'm not. They ask me? Generally, I'll say, Yeah, they might be a good thing for you, but we also want to think about what would the side effects of the medication be? So if we give somebody oral PrEP and they already have a predisposition to having some of the side effects then it might be more risky to give them the PrEP than the HIV.

But if they’re really wanting PrEP? I try to give them PrEP because that is a really important part of ending the HIV epidemic. We need to prevent transmission. And some people really feel that their risks are low. And we know in the studies and the data that's out there that people who actually do end up getting HIV really think that their risks are low and so they might opt not to. So there's also a piece of education as well of talking about how this is a high risk behavior. And I would really encourage you to be on something like PrEP to prevent, especially if you're not using condoms, which are another way to prevent STIs and HIV. 

So lots of lots of things to talk about in a visit. And we're in a world where we have very little time. But if you have the time and are able to just having a brief 3 to 5 minute conversation without going into all the details of, okay, you're here for you want PrEP? All right. Well, let's look at this chart here really quickly and see, okay. Point to the the different types of sex that you engage in or practices or whatever. And let's look at your risks. And yeah, it looks like you would be a good candidate. Let's talk about the medication.

Bruce

Yeah, those are all really great points. And what a comprehensive answer. There's a lot to unpack there. I think you did touch on possible side effects or maybe even drug interactions or other medication considerations that a patient or client should discuss or think about before starting PrEP. And I have to say, whenever I'm out in the world, just kind of talking about PrEP, for people who don't really know about it, who may think it's, you know, a pretty good idea, their first question is, what are the side effects of being on that long term? Do we know that yet? Do we know if I'm on this other medication that interacts with it? What does it mean? I've heard that bone density decreases when you take PrEP. What would you say in those kinds of situations regarding side effects?

Dr. Floyd

Yeah, I know, side effects for anything you put in your body. Right. There are always side effects if it doesn't naturally come in your body. And even if it does, you can have a side effect when you inject it or you take it by mouth. Right? That is a very normal thing. The nice thing about PrEP is overall it is very well tolerated.

So let's look at oral PrEP first. We have a couple of options and even a generic option that's available. Generally speaking, side effects from taking it are going to be kind of GI, nausea, vomiting and diarrhea, some gas and usually those are early on. So when somebody starts PrEP, they might start noticing the side effects, but then it tends to go away.

One of the options for oral PrEP, Truvada or the generic, it has a type of tenofovir in it, which is one of the active ingredients, that is more prone to causing problems with bones and kidney. So like you mentioned that decreasing bone mineral density. So if somebody has a history of fractures, we might be more concerned about using that particular medication for somebody or somebody who might have decreased kidney function. We might want to avoid the one that can affect the kidneys more negatively. 

The other oral option tends to be safer overall on bones and kidneys and has less nausea, vomiting, GI side effects but still can have that happen. So overall really safe. 

But one thing to know about these medications is, and this is kind of a tangent, but I promise I'll bring it back to injectable PrEP, is that if you put somebody on oral PrEP, you need to know if they have hepatitis B and the reason for that is that one of the medications in oral PrEP, there's two medications in each pill, tenofovir, is active in treating hepatitis B.

So if you give somebody PrEP and you don't know if they have hepatitis B, but they have it, what's going to happen is it's going to treat the virus in their blood, which is really great. Hepatitis B is a chronic blood borne illness. So we give them a medication that will suppress the virus, which is awesome. The problem with that is, and this is something we have to know about before they start, is that if they start it and then maybe down the road, let's say this person was not in a monogamous relationship and now they're in a monogamous relationship, their risks are zero. They feel comfortable stopping PrEP, but they have hepatitis B. What's going to happen is that virus in their blood of hepatitis B is going to flare up and they're going to be put at risk for what's called fulminant hepatitis and potentially could kill this person. So that is a really big concern. So something we check for always is hepatitis B.

It's not necessarily a side effect of the med, it's a very good benefit. But we have to know that upfront and have that conversation. If somebody does have hepatitis B because we want them to stay on this medication lifelong or at least go get consult for a different treatment that they could go on as well if they opt not to be on PrEP.

Okay. So that's oral, oral PrEP. And injectable PrEP considerations really, if we're talking about the medication specifically, we're really going to be thinking about injection site reactions because it's injected and we're going to be thinking about headaches. So the injectable PrEP is a category of medication for HIV that we've had for a while. While it is the newest prevention medication, it's not, this category of meds have been around for some time, so they're not totally new.

And we know long term that that they're really powerful, good medications. We don't have long term studies specifically for PrEP and what might happen, but we know that the way it's metabolized is not the same as it would be for the oral PrEP options to affect the bones and kidney. So that's kind of a bonus of it. 

And I don't know, I think I might have skipped over. But one of the common side effects of injectable PrEP is a headache, so some people might notice a headache when they're on it. Most people for this injection feel this the side effects at the time when they get it, they have soreness where they get the injection and then it goes away. 

Overall, though, injections are really well tolerated for PrEP, there were a couple of big studies that were done. One only had about a 2.2% discontinuation rate, meaning most people chose to stay on it even if they had side effects. And then in the other one, there were almost 3300 participants in the second one and they had no discontinuations due to injection site reactions. So depending on how people can tolerate it, it may be a really great option for them. 

However, I would say a side effect or something we should consider is cost because these aren't covered as widely, the injectable, as oral PrEP is at this point. So definitely a consideration that's not really specific to the med in the person's body, but something to think about because that can really impact access for sure.

Bruce

Absolutely. And I want to kind of wade into that murky sort of waters of access, because it's such an important consideration when you're talking about the dispensation of PrEP. So we've covered the clinical side of things right? You've talked to the patient, you've talked about PrEP. You determine that they're a good candidate. They've decided to go on PrEP. They agree this is a good choice for them. What does it look like for that patient to then actually access PrEP? And I know this probably impacted some probably I know there is definitely a gulf of difference right now between, for example, generic Truvada and injectable PrEP, it being the first year, however exciting the data is on it. The access the access points are still pretty difficult with regard to injectable PrEP, but I wonder if you can talk about that process from written prescription to the patient actually accessing that medication and sustaining them.

Dr. Floyd

Yeah, totally. I'd like to start with the oral PrEP because that's the one we have more experience with and kind of better access, I would say, at this point. So what happens is a patient comes in, we determine they're good, a prescription is sent. Usually that’s sent to wherever the patient pharmacy is, sometimes it's an in-house pharmacy. In my situation here at Southwest Care Center where I work, we have an in-house pharmacy. We're really fortunate, they can walk down the hall, pick it up and walk out. So the prescription is going to get sent and then depending on their insurance, there are going to be some things that happen. So first thing is maybe the brand that was sent in isn't covered on their insurance.

So there are two brands and then there's the generic. So if one brand is sent in that doesn't have a generic it might need a prescription change. So if there's a pharmacy maybe down the road that doesn't have access to the provider very easily, that can delay things a little bit. But there's also it could require a prior authorization.

Most plans are pretty good. They'll cover one or the other without a prior authorization. But there are times where we're seeing prior authorization. It shouldn't be like that because it's supposed to be covered across the board for everybody. But occasionally we do see that. Generally it's just for a specific brand. So one thing I will say here is just for the even like the very first part, it's really important to have dedicated team members if you're able to if you're prescribing a lot of PrEP or want to prescribe a lot of PrEP, there are people, peer navigators or PrEP navigators who are able to assist where, you know, if you go to the pharmacy and they tell you it's not covered and they're sending a request to the doctor or the prescriber for a change, maybe that that patient could call that person directly and then they could facilitate that change faster, as opposed to it sitting in a long line of faxes to the provider where it just sits for a few days. In my clinic, we do have a PrEP navigator, which is immensely helpful, and we also are fortunate to have pharmacy technicians to our prior authorization specialists who have access to the medical records and help with the prior authorization process. And so that really helps get PrEP out there. 

But that's not always the case. It's just important to know, okay, if this isn't covered, what tell the patient what to do next and not just to wait, because that can really slow down the process.

But the other thing that I would say with that is making sure that wherever you are and like in my state, I know what Medicaid covers, which plans. I know what most of my primary commercial plans that I tend to see cover and prefer. So, for example, I know that my Medicaid plans are going to be okay with Descovy. But one particular insurance that's coming to mind, United Healthcare is going to be really particular with generic Truvada. 

And so kind of having that list really readily available, you see someone, you determine that they're a candidate. Look at the list. If you have their insurance on there and prescribe that med, that will speed it up really, really well. 

The other piece that can really slow things down is the co-pay. Generally, people should not have co-pays. You know, that's what it's supposed to be across our country as it is a grade A recommendation for oral PrEP, but that's not exactly what we're seeing in practice. We still see co-pays. 

So if you are a prescriber and you're sending them out to a pharmacy down the street, have them walk out with a copay card. This can be something you get directly from the manufacturer. You go online and they can sign up for it before they leave your office. Super easy. They print it and they walk in and they hand it to the pharmacy and say, Please put this on.

And that will bring their co-pays down to zero. These copay cards are, I think, up to $7500 annually in copay assistance, which is amazing. We have our PrEP navigator who helps patients lead with those when they need them And then our internal pharmacy is actually very great at putting those copay cards on for patients so that it's a very, very smooth process.

So that's for oral PrEP insured patients. Actually, I skipped Medicare. Let me add in Medicare there.

Medicare can be tricky. They'll get the prescription sent out and depending on where they fall in the donut hole, they might have a higher cost of medication. And so this can be challenging. Sometimes we're able to use generic Truvada for these people with Medicare. But one of the challenging things is as we age and we go on Medicare, our kidneys slow down. And so we might not be able to use generic Truvada, which is very cheap across the board. I think for the most part, you can get it for like 20 bucks, 20 to 30 bucks depending on where you go, but it's pretty cheap across the board.

And so if that's not an option, really, you have to look into getting brand name of Descovy and may need to look into Medicare Part D medication foundations. And there's a couple and Bruce I'll be happy to share those links so we can put in the show notes. But yeah, that's a key part for people with Medicare. 

And I did fail to mention this earlier, but it's really important that older people have sex, too. And we really need to remember that because I have in my clinic here, I can think of a really good percentage of my population are 75 and up and they're very sexually active. And so we need to not have that age stigma as well or ageism. 

Okay. And last thing for oral PrEP, I want to say is the uninsured. So if somebody is uninsured or they can still get PrEP, we can always look at doing generic generally at a federally qualified health center. We can get it pretty cheap. Or you can apply them for a program called the Advancing Access Program, which is where they, depending on their income, they'll qualify and get medication through the program. Generally, I've seen approvals from three months to six months to up to a year of being able to get the medication covered.

If that doesn't work, there are state PrEP programs that may be available in various areas. And then there's also the readysetprep.hiv.gov. That's a great way to try to find something for somebody for oral PrEP. So all this is for oral PrEP.

Bruce

I'm sorry. Just to clarify for our listeners, the Advancing Access Program, does that include Descovy or is that just for generic Truvada?

Dr. Floyd

Both Descovy and Truvada. So Advancing Access is actually a program through Gilead. Gilead is the company that makes both Descovy and Truvada. So it actually doesn't even cover the generics. It's just the brand names. And so generally, if you’re going to put somebody on Advancing Access, you can easily go with Descovy, the smaller pill with fewer side effects because it will get covered. You don't have to go with Truvada, but it will cover Truvada if needed. If there's a reason, somebody doesn't tolerate Descvoy we do that. And that's through the drug manufacturer.

Bruce

Great. Well, thanks for that explanation. And obviously, we've touched on some of those access barriers with things like prior authorization, patient copays. But here's where I think the conversation gets interesting, because when we look at the national estimates that say that nationwide, only about a quarter of US population who are considered to be at risk of HIV infections are actually receiving PrEP.

So beyond the things you've already mentioned, what are, in your experience, the specific factors that are keeping this percentage so low? Yeah, we touched on some of the provider communication aspects of this question, taking a robust, a robust non-stigmatizing sexual history, for example. But thinking more broadly, what changes to our health care system would help increase this percentage?

And then sorry to make a compund question, but the question is what disparities do we observe when we look at PrEP coverage overall? So you're talking about your usual disparities in the health care space, right? Looking at social determinants of health, minority and disenfranchised communities and so on. What are those disparities you see and how much how might they be addressed in terms of PrEP access?

Dr. Floyd

Yeah, yeah. So there are so many factors, I think, that are keeping the percentage of PrEP, giving PrEP out to the people who actually need it, who are at risk. I think there's a lot of changes to our health care system that we need to help with this. But when you look at, the data that there is for this is from 2019, it’s the most recent that I've seen.  Maybe some 2020 coming out haven't seen it yet, but most states aren’t doing great.

Some states are doing better than others, but no state is getting PrEP to 50% or more of people who are at risk of HIV. No state is above that. So some are doing better than others. Some have a lot of work to do. But I think there's you know, you mentioned, the sexual health history training.

We need to be better trained. I when I think about it and I go back to some of the providers that I've had over my lifetime, it's very infrequent that people ask me about sex and usually or my risk factors, right? Injecting. Usually it's are you sexually active, yes or no? And then we move on.

And so that is a problem. We need to be talking about this because we know if somebody's sexually active, they're at risk for depending on if they are able to bear child but they may be able to be a parent of a child. Right. They may be at risk for a sexually transmitted infection, HIV, Hepatitis B is bloodborne. So just so many different things. And there's so much packed into that. And we're just kind of glossing over that. Right? I think that's a big problem. And I really think we need to be talking more about sex. 

There are some, the I think it's the American Sexual Health Association, ASHA, they really talk about what does it mean to be sexually healthy? And there's a lot of stuff that's in there. But where there's no stigma, you're having open conversations, you feel comfortable. You can have pleasure within sex as opposed to just making it like, Oh, well, are you having problems, right? Like, well, we should be talking about it in a much better way. So removing a lot of that I think is really big, but that is a big thing to change and that's just one thing, right?

I also think I've found that people, some health care providers, though this is happening less and less often, at least in my experience, is that some people see Truvada, Descovy, generic Truvada and they think HIV treatment, right. And so we have to change that, that just because you see those meds that look like they could be in HIV treatment and they are used in HIV treatment, does it necessarily that's what it is.

And so when somebody comes in, we have to be staying up to date on the information. So that's one of the big things I'm passionate about is making sure people know what is PrEP to begin with and you can prescribe it. You don't need to go to a specialist to do it. The guidelines have really good algorithms and ways to do it. Yeah, there are nuances, but we need to understand it better. And instead of waiting for patients to ask us, we should be asking them, you know, have you ever been on PrEP? Do you need PrEP? Let's talk about it. So I think that's really important. 

And then the other part of why I think it's really low is so when we look at the data from 2019, you see that and I can't remember 63% or so of people who are White are accessing PrEP. But when you look at Latinx, Black. And just when you compare those three races, we're seeing huge disparities there. And is it because maybe our education is targeting only certain ethnicities or races? Is it because certain people have access to insurance or health care in general?. And so we have so many disparities in health care just across the board, but we are clearly seeing that in PrEP uptake.

We need to be focusing on hardly rich populations, not that they're hard to reach. They're there. We can reach them. They're just hardly reached. And that's, again, where I think it's so important to get out there and educate and target people who we know are at risk, but then making sure that we're hitting Black people, Latinx people, Asian people, all people, not just certain areas where people might have better access to health care or have better insurance or whatever the case may be. We need to figure out ways to reach people. 

And so I think that there's  so much within that I can probably talk about it for forever, but we have a lot of work to do there.

But I think one other thing, and this is starting to show more is and I didn't talk about this with your previous question, but with injectable PrEP. That is such a great medication, we're seeing even better reduction in HIV acquisition with these injectable PrEP, injectable prevention medications. But it is so hard to get and I work in the specialty clinic that deals with this and we're having a hard time doing it. And so we have a lot of problems in our health care system with things like where you have to go through a specific specialty pharmacy. I may call that white bagging where you can't just go to any pharmacy. You have to work with this specific one and then they might ship it and it may not make it or you know, it's so cumbersome and all the administrative procedures just trying to figure out if it's even covered. Right. We need to be doing better as a health care system across the board in making this available to all. And I think that's a huge problem. 

And we're finding out now, too, with injectable PrEP, and this is one of the big struggles that we're having here, even as one of the bigger HIV treatment and prevention providers in my state, we're having a hard time getting paid for it, and that doesn't make sense. If we're buying this medication and getting it out to people, that's great. But if it puts organizations out thousands of dollars, every single injection, that's not sustainable and those places are going to be closed. And so we have to do better. 

And so I think part of that has to do with just the way we have kind of specialty medications set up. And I, you know, again, I probably talk about that for a long time, but also just kind of limiting how we access it. I think that we're doing a disservice to everybody by doing that. So yeah, that's a really complicated answer. But a lot of where I fall and how I think we can we can do better as a country and states. Some states are good.  Mine is not doing great yet.

Bruce

Just so many important issues in there. And it's really important that we think through all of them because there's not one magic bullet or one simple answer to answer all of these disparity and access issues. It really is a complicated nexus of things happening. And I want to kind of pivot that into a question about, what can we as advocates or if there's a call to action for our listeners, for example, who may also be similarly motivated by their passion to see HIV eradicated in their communities, what would be their call to action to try to encourage policymakers and lawmakers to adopt policies to increase PrEP and other prevention uptake? I mean, what are some of the key, I guess you call them political issues?

Dr. Floyd

Yeah, I think I've been seeing a lot more lately from the pharmacy perspective of trying to remove, like I said, white bagging, which is really forcing people to use a specific pharmacy to access medication. And so what's happening is that pharmacy benefit and pharmacy benefit manager are saying, well, we have our own specialty pharmacy and that's the only place that you can access this medication. And it's usually mail order. 

And there's so many issues with that, delays in getting medication, lost medication, not shipping it out at all. I mean, I've had so many problems. We deal with this for so many variety of specialty meds. And so I've been seeing advocacy work being done in various states, I think two in the last week who have just put into place legislation laws that were approved that will eliminate, in that state, white bagging. Meaning if I need to go get my PrEP and it's better for me to use my local pharmacy that I'm comfortable with and they can get it, I should be able to go there and get it. I shouldn't be told where I have to go. 

Because what's happening is medications are going to a pharmacy that insurance and payers and they own. And so they're getting all of this. They're keeping the money in-house and it's a big money game. And for me that's a problem, right? Where it's supposed to be about access, not about who gets all the money. And of course, you know, there's so much packed into that politically, right? Of, you know, people are who have a lot of money or are making a lot more money from that. But I think if we're really trying to get it out there, we really have to push some of those laws and say people have a right to choose what pharmacy, for whatever med.  There are white bagging laws is what I've heard them, right to choose. 

I know in New Mexico, we've had those go up multiple years in a row. I can't tell you the number, maybe five, six, seven and they get shut down every year, get tabled because, you know, people with the money don't want that because that's less money for them. But it's decreasing access. And if we're really trying to end the HIV epidemic, we have to change those things. And really, I think that's where we can we can advocate. And that's my perspective as a pharmacist. I'm sure there's plenty of other ways that we can be involved in change, but I think that's one big one.

Bruce

I'm sure, again, all really important points and it can feel a little daunting, right? I mean, I always try to end these podcasts on a positive note. It's my usual M.O., you know, but it's I think it's hard to do when you're talking about the policies and politics around health care access in this country in general, you know, especially for poor, underserved and uninsured populations. So maybe we can end by trying to delve into something that the division of HIV Prevention at CDC is now calling HIV status neutral. And this is kind of a new paradigm, a new sort of watch phrase that's being discussed in the community and really seems to be a positive intervention in terms of the prevention of transmission and in ending the epidemic.

So maybe you can talk for a second just to close this out about what HIV status neutral means and what does this new paradigm mean for our efforts to end the pandemic?

Dr. Floyd

Yeah, yeah. Status neutral. So essentially what it's saying is all people, regardless of their HIV status, are going to be treated the same way from the start, positive or negative, right? So we're going to test everybody for HIV. One of those things I was saying, we need to increase screening. And regardless of the results, we get them either into the HIV prevention path or the HIV treatment path.

And maybe their HIV prevention path is not the same. You know, maybe they don't get PrEP that way, but there may be other ways, behavioral ways. Right? The whole idea is to really everyone's health, regardless of whether they're positive or negative. I think what's so great about it is we're increasing that education and knowledge and people are talking about HIV more. It'll remove stigma, right? If we're talking about it, it's normalized. We're not saying, oh, HIV positive or, you know, any of the things that people might kind of bristle at. 

And it really focuses on that continuum of care where we're really getting people into treatment, keeping them in treatment, keeping their viral load down. And then for those who are negative, really getting them on that prevention side so that we're really working to end the HIV epidemic.

And so I think it's a great new approach. I encourage people to, no matter what their practice is, start to educate themselves on what that looks like and how to talk to people regardless of their HIV status. And maybe learning a little bit about HIV, studying it a little bit more, learning how to counsel people who might be positive, but then we treat everybody the same.

And I think that that's something we try to do in health care, but we know it definitely isn't happening. And so we can do that ourselves. Right? It just takes one person in a clinic, in an organization to start a movement where we can really start to see that everyone is treated the same and it doesn't matter. And we're going to put them in either HIV prevention or HIV treatment, and that's normal. The more we normalize it, I think the better off we're going to do as a whole. And so I think it's a really great thing. I'm really excited about it. I love teaching and educating, so it fits right in my wheelhouse for HIV education.

Bruce

Great. Dr. Floyd, thank you for coming on here to the Academy Exchange to talk about HIV prevention today. Some really, really important messages. And I just thank you again.

Dr. Floyd

Thank you so much for having me. It was my pleasure.