The Academy Exchange: HIV Today & Tomorrow

A New Day for HIV Treatment

September 06, 2022 American Academy of HIV Medicine Season 1 Episode 1
The Academy Exchange: HIV Today & Tomorrow
A New Day for HIV Treatment
Show Notes Transcript

Academy Executive Director, Bruce Packett, is joined by clinical HIV Pharmacist™ Dr. Brooke Stevens to discuss new and novel antiretroviral therapies including single pill regimens and long-acting injectables. These new regimens allow antiretroviral therapy to be administered less frequently, making it potentially easier for patients to remain adherent.

They discuss who might be good candidates to consider switching to novel formulations and modalities, as well as trends in which patients are interested in switching.  But there are some barriers to uptake of these novel treatments, including prior authorization requirements and challenges with rolling out new therapies. 

About Dr. Stevens:

Dr. Brooke Stevens is the specialty pharmacy clinical manager at Indiana University Health in Indianapolis, Indiana and a clinical pharmacist at LifeCare Clinic at Methodist Hospital as well as the Ryan White Center for Pediatric Infectious Disease and Global Health at Riley Hospital for Children at Indiana University Health.

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Questions about this topic? E-mail podcast@aahivm.org to get connected with Bruce or any of our guests.

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To learn more about the Academy, visit www.aahivm.org


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 and welcome to our listeners. This is the Academy Exchange: HIV Today and Tomorrow. And here we are with another new podcast in the world. My name is Bruce Packett. I'm the Executive Director of an organization called the American Academy of HIV Medicine, hence, the Academy Exchange moniker, and I'm joined here today by Dr. Brooke Stevens, who is a pharmacist and a clinical HIV specialist and who has some really interesting things to talk to us about today, which we'll get into.

We'll also do a more formal introduction of Dr. Stevens in just a moment. But since this is a brand new podcast, the first episode of the new podcast, I wanted, Dr. Stevens, with your permission, to do a very brief background on who I am, what my organization is, and why we think we need another podcast in the world.

So as I said, my organization is the American Academy of HIV Medicine, and it's, first of all, a 501(c)(3) charity nonprofit. But really, we function as a kind of trade association for clinicians who are seeing HIV, treating HIV, caring for people with HIV and hopefully preventing new HIV transmissions. Our core members are prescribers, so we're talking about the physicians, obviously, but also the nurse practitioners, physician assistants, those advanced practice providers, and also clinical pharmacists who are obviously a critical part of the HIV care team as well.

And we know that through federal programs like Ryan White and other federally qualified health centers, the HIV care team is really doing primary care, which is to say caring for the entire patient. So this isn't like another infectious disease where you treat the disease itself and then send that patient back to their primary care provider for the rest of their whole person health needs.

You're treating this person's HIV. And then also all the comorbidities, any opportunistic infections and even other normal conditions of someone who is aging like with, say, diabetes, hypertension and so on. And then on top of that, HIV is a disease very dependent on what we call the social determinants of health. So things like demographics, race, economics, mental health, homelessness can all influence a person's risk profile for contracting HIV and have a strong bearing on their access to health care in general and to some of the pricey medications to treat the HIV itself.

So it's a clinically complicated, socially complicated, probably under reimbursed profession that our members are in. And we see our organization as a resource to these hero clinicians who choose to work in the space.

Briefly, what we do for our members, we represent them to policymakers and legislators. So we have an advocacy and policy side of the organization that develops relationships with the health policymakers on the state and federal scenes to try to impart to those policymakers and legislators what those clinicians need to do their jobs and to, we hope, ultimately end the HIV epidemic.

We also have a certification program to recognize the HIV specialist. And so a lot of people in there may not realize this, but there is no medical subspecialty in medical school for HIV, which usually gets housed under infectious disease but doesn't have a specialty designation of its own. Although I think I could be wrong. But there's a there's a newish track, I think, for HIV under the American Board of Internal Medicine certification, if I'm not mistaken.

So we have that HIV specialist credential that clinicians and pharmacists can earn through our organization. And then on top of that, we do all these great continuing medical education programs to offer training and education opportunities in HIV and all of the clinical things that go along with HIV for our members and other providers of care.

So we're talking about things like workshops, We have a textbook online curricula, webinars.  And our thinking here is that with all of the great clinical information that we're putting out into the world, we could really use an opportunity like this to get that information out to a broader lay audience, to patients, to maybe primary care providers and providers in other fields. Maybe this is optimistic, but maybe even to lawmakers and hopefully to the public at large, really to increase the understanding and awareness around HIV and what's new in the HIV clinic at what's coming down the pike.

So that hopefully kind of sets the stage for this series of Academy podcasts. And I think it's great that we have Dr. Stevens with us today to talk about what's new in HIV treatments and what's coming in the near future in this space of antiretroviral therapies. Because I really think the common public perception of HIV these days is the whole one pill once a day approach to keeping the virus in check.  And, beyond some research into vaccines and maybe even cures, that's basically that. But really that's kind of far from true as there are some new exciting treatments for HIV available that we want to talk about today. So let me go ahead and take a moment and introduce my interlocutor today, Dr. Brooke Stevens.

Dr. Stevens is the Specialty Pharmacy Clinical Manager at Indiana University Health in Indianapolis, Indiana. She also works as an HIV Clinical Pharmacist at the Life Care Clinic at Methodist Hospital and the Ryan White Center for Pediatric Infectious Disease and Global Health at Riley Hospital for Children at IU Health. She is credentialed as a Board Certified Pharmacotherapy Specialist as well as an HIV Pharmacist through the American Academy of HIV Medicine.

Dr. Stevens, welcome.

Dr. Stevens

Thank you so much for having me. This is a really exciting topic and I look forward to chatting about it.

Bruce

Yeah, absolutely. Thanks for being here. You gave a talk for the Academy on one of our clinical update webinars and I love the title of that talk, “The Roaring 2020s: New Ways of Working in HIV in 2021 and Beyond”. I think from a clinical perspective, these actually are exciting times to work in HIV. But before we get into some of that, can you maybe just generally introduce your background how you got into this work, specifically HIV and then talk a little bit about your practice setting and kind of your day to day work that you do as an HIV clinical pharmacist.

Dr. Stevens

Absolutely. So when I graduated from pharmacy school, I really wanted to go into infectious diseases as my residency training. And during that residency, I decided it was really important for me to get a general understanding of HIV as well, because I knew that I would see that while I was working in the hospital. So on a rotation, actually at the clinic that I currently work at, I saw how our pharmacists interacted with patients, had developed really strong relationships with them and were really contributing to their lives.

And on the first day of my rotation, I went home and said, “this is what I'm going to do”. So I spent the rest of my two years of residency rotating through this clinic and learning what I could. And then this was my first job outside of residency. So I've been working with this clinic overall since 2014. So it is the Life Care Clinic at IU Health in Indianapolis, Indiana, and we are the largest provider of HIV medical services in the state of Indiana.

We have about 1,500 patients or so. And then we also see people who are prescribed PrEPp as well as post-exposure prophylaxis. We are a nurse practitioner based clinic and we actually have three pharmacists and a pharmacy technician that work in our clinic. Our day to day, we see new patients just to introduce ourselves. We talk to patients about new medications that they may be starting.

We help develop regimens based on resistance mutations, drug interactions, plan formularies. We work with insurance companies to get medications approved for the patients and coordinate that with pharmacies. And we spend a lot of time working with people who have difficulties taking their medicine based on a variety of barriers in their lives.

Bruce

Yeah, that's great. We want to get into some of those barriers that you mentioned and then maybe before we dive into the details on some of today and tomorrow's novel treatments, can you tell us a little bit about how you chose this topic to present and why it's interesting to you as a clinical pharmacist in practice?

Dr. Stevens

The Academy approached me about this topic because I think it's, you know, it's what's coming down the pipeline. It's what we can get excited about. It's the things that we can share with our patients to give them hope. One pill once a day is amazing and we've come so far, even in the last several years since I've been working in the field, things have changed a lot and this is really a game changer for patients.

We work every day to try to help patients incorporate their medicine into their lives so they can live normal, healthy lives and are not hindered by a diagnosis. And these long acting medications and new formulations of medications just make their lives easier and allow them to do all of the things that they want to do.

Bruce

Great. And we're going to drill down into some of that. So when we talk about treating HIV, we're talking about what's called antiretroviral therapy (ART) for those who don't know. And when we talk about new or novel ART, we're talking, as you point out, largely about these new injectable formulations of longer acting antiretroviral agents. Could you explain to our listeners how do these longer acting agents work and what sort of changed in the research, in the science that allows us to go from, as we said, taking one pill daily for HIV treatment or prevention to taking injections monthly or even every two months as it's looking we might be able to do.

Dr. Stevens

Yeah. So there are several different classes of medications to treat HIV. And each of those classes has a different mechanism of action. So each of the injectables or other formulations will, the actual way that they work, will vary based on the mechanism of action. But if we're thinking about a long acting, these contain higher doses of medications than oral formulations.

And if we're thinking about an intramuscular suspension, such as cabotegravir/rilpivirine, which is the one that we're currently using, Cabenuva, it creates a depot. So it has a slow, prolonged, sustained action and hangs around in the body for a longer than an oral medicine. So, for example, cabotegravir, which is one of the medications in that formulation, it's half life.

So when we think about half life, it is the amount of time to clear half of the medicine from the body.  For the oral formulation it's 40 hours, but for the intramuscular it's 40 days. So much longer, it hangs around for a much longer time to allow us to administer it less frequently.

Bruce

Right. Thanks for that detailed explanation. So. So let's say you have most of your HIV patients in care who are taking one pill once a day, primarily. Right? And maybe they're happy with that regimen. Or maybe it's really onerous for some people with HIV. Who are these injectable options for and what are some of the experiences and I guess emotional challenges of patients that might motivate them to want to switch from a daily pill for HIV treatment to receiving these periodic injections of the longer acting medications that you just described?

Dr. Stevens

Some of the medications that are coming down the pipeline will be specifically for either treatment naïve, so they've never been on medicine before, or treatment heavily treatment experience who don't have a lot of options. But if we think about the intramuscular Cabenuva that we're using now, what's really great is it's essentially equivalent to the oral medicine. So it gives patients the choice.

If they like taking an oral medicine, that's great. They can continue on that as long as it's working for them. But, if taking an oral medicine is really difficult for them for a variety of reasons that I can touch on, we can switch it up and make it easier by giving them an injection. So unfortunately, despite advancements in science and improved knowledge, we know that our patients living with HIV are still highly stigmatized.

So just in my clinic, I hear patients tell me that taking an oral medicine every single day is a reminder of their diagnosis every day. And so they would really prefer to do something that's less frequent so they don't have to necessarily think about it as often. Sometimes patients also don't feel comfortable sharing their diagnosis with people around them, and this may lead to them needing to hide their medications for their confidentiality.

And that can be that can cause a lot of stress on them, as well as it can impact their ability to be adherent to their medicine if it's hidden in a closet or not right in front of them every day where they remember to take it. 

I also work with pediatric patients and I've had some adolescents tell me that they just want to feel like a normal kid. And I think, you know, as adults, we more commonly talk about being on medication, but kids don't often talk about that. And even though we know kids take medications for a variety of diagnoses, a lot of my pediatric patients just feel different than their peers. And so this is a way that they can kind of mitigate that by just coming to get an injection in the doctor's office.

I will say that on the flip side, there are individuals who coming to a clinic every month or every other month is what reminds them of their diagnosis. And that's not of interest to them. Or maybe they work a couple of jobs and they have a family and they just don't have the time to come in that often.

So it may not be a good option for them. So this it's really great that we have more options that allow flexibility for our patients to really incorporate it into their lives and what works best for them.

Bruce

That's great. So it's really all about tailoring the treatments or the medications for these patients to what suits them personally, ultimately. Do you have a good percentage or good number of patients that you're seeing in your practice who are requesting these injectable therapies?

Dr. Stevens

We do have a lot. So I think we currently have about 70 individuals that are receiving an injection now and we're talking about it with our patients every single day. Even our new diagnoses, we're talking to them about it. They don't necessarily qualify right now because patients do need to have a suppressed viral load. So their viral load needs to be less than 50 to qualify, but it's something for them to think about and it's something for them to look forward to or kind of wrap their mind around if that would be something that's of interest to them.

Bruce

Sure, that makes sense. I also want to talk about access barriers a little bit, because I think, suffice to say, we don't really have to go into details here, the rollout of cabotegravir, since its FDA approval for treatment and now for PrEP, has been a little bit rocky, a little bit difficult. Right? But regardless of benefit coverage or sourcing, many health plans require prior authorization for these newer ARTs.

And that's proving to be a little bit confounding, I think, or a little bit laborious or onerous for some of our members. Can you share with us a little bit about how prior authorization requirements for antiretroviral therapy impact a health care provider’s work and how they can impact patients or clients living with HIV?

Dr. Stevens

Yes, absolutely. So we've done prior authorizations for medications for a long time. You know, our medicines are very expensive. So this is not something that has been uncommon. But what is new is this is the first injection for HIV. So that's kind of new for all of us. And prior authorizations in general can be really time consuming for health care providers, especially when the medication that we're working towards is brand new.

So a lot of times health plans have not yet evaluated criteria for use or they may not have the correct codes in place. And so there is extra labor associated with working through that, or they may just not be able to review it at all until the company reviews the criteria for use.

So essentially with a prior authorization, we submit an initial form that is specific to the insurance company. Sometimes this can be electronically, but sometimes they do require it via fax or over the phone. And then we provide additional medical information indicating why somebody might need this medicine.

If it's not approved, then we need to move into an appeal process which requires extra documentation. Oftentimes, a letter written from the provider, including additional medical information. It could include guideline excerpt, it could include relevant studies, anything to help show the insurance company that this truly is the best medication for the patient.

So it is very time consuming on the health care provider. Fortunately, it's not as burdensome on the patient, but the process can take a long time and I know that can be discouraging to patients. They hear about these new agents and they're ready to get started right away, and we certainly are ready for them to get started as well. But we're also we're often hindered by the insurance companies and their processes. 

And ultimately the decision lies on the insurance company. So we may be able to provide all of the documentation and the medical necessity, but they may not approve it, which is really unfortunate. I think also sometimes it can be confusing for patients because the insurance companies, if they are originally denied before we get to an appeal process, they will send a letter to the patient indicating that it has been denied. And so the patient thinks that it's kind of over with and doesn't know that we're still working in the background on trying to get it approved.

Bruce

Sure. Have you had any instances of patients who see that sort of gap and are waiting for their prior authorization approval from the payer, just sort of back out of the process and say, “you know what, I'm kind of sick of waiting for this approval. I'm just going to and we're going to continue doing the one pill once a day”, or whatever regimen they're currently taking or an alternate regimen if they're not on one currently. Have you had any patients sort of back out?

Dr. Stevens

I personally haven't had anybody back out. It kind of seems, we've been talking about this medication for a long time, even before it was approved. And so we have a lot of patients who have kind of just been waiting on this and they're doing very well on their oral medicine. And so they kind of just stick with it through the process with us.

But it's certainly it's certainly a concern that we could lose patients in the process due to frustrations with the laborious process with insurance companies.

Bruce

Sure. Sure. And what do you think, generally, we hear a lot about these egregious gaps in the health care system in this country. We don't have a system of universalized care for everybody. It's sort of a patchwork of state funded, federally funded, employer funded plans, things along those lines. What gaps in the U.S. system would you say have been revealed or kind of underscored by the rollout of this new treatment modality? Specifically, the injectable ARTs.

Dr. Stevens

It's obvious that the prior authorization process for each company is not standardized, each of them once different information, different forms. And that can be really challenging for providers who are already limited on time and are wanting to spend the majority of their time seeing patients. It's hard to navigate those processes oftentimes, and it's hard to figure out who to get on the phone to talk about the struggles that you're having.

It's also become very apparent how different the deductibles, and co-pays, programs, and all how all of these different insurance companies run. And so it could be cost prohibitive for patients. So it's really unfortunate that we don't have just a a single way to go about all of these processes to make it easier for us and easier for patients as well.

Bruce

Right. That makes sense. And maybe if we can kind of stay behind the scenes on your side of things, on the provider side, can you talk us through what happens specifically in your clinic, let's say, when a provider prescribes that new treatment, an injectable treatment. So just kind of describe to me what happens in terms of turning that prescription, sort of pen to a pad, into an actual administered treatment for that patient. Can you kind of walk us through that process?

Dr. Stevens

Sure, so we have developed a standardized process that works for our staff and our clinic. So when a patient expresses interest in one of these medications, we approach it as a multidisciplinary team. So each patient is assigned a nurse practitioner, a social worker and a pharmacist. And we as a team work to ensure that the patient qualifies for the medication.

So not only is it appropriate based on their other medications that they're taking on comorbid conditions, on their viral suppression. But will the patient have access to transportation to come to the clinic every 1 to 2 months? Do they have options for copay assistance? That kind of thing. So once we all decide as a team with the patient that this is appropriate to move forward and the patient will sign a release of information and that allows us to submit an application to the manufacturer because they have their own benefits investigation process.

So the company will actually contact the insurance company with the information that we provide, and they will determine if the medication is covered. Does it need to be billed through pharmacy or medical benefit, what the deductible and co-pays look like, and if a prior authorization is needed. And they oftentimes include the phone number for the prior authorization department and they send all that information back to us so that we can proceed with a prior authorization.

I will say, even if we are told that a prior authorization is not required, we do go ahead and submit a predetermination just to ensure that we have documentation from the insurance company that it will be covered because we never want our patient to end up with a large bill that they were not expecting to have.

At that point we move forward the prior authorization process, as we normally would with any other medication. And this can take anywhere from 24 to 72 hours to be reviewed, but it can take longer. And sometimes we have to follow up with insurance companies to make sure that they have all of the documentation and that they're still moving forward with the process.

Like I mentioned earlier, if it's denied, we may need to move through the appeal process. And that again requires the prescriber to write a letter on the patient's behalf. After the medication is approved and we know which way we should be obtaining it, through the medical benefit or pharmacy benefit, we reach out to the patient to kind of discuss where we're at.

Historically, we've used the oral lead-in. So that is the oral version of the injectable medicine. And it was used for four weeks prior to starting the injection to make sure the patient tolerates it and everything goes okay. Recently that has become an option. So that's also now a shared decision making with the patient and the prescriber to see if it's appropriate to do that or not.

If it is the oral lead and medications are coordinated with the actual manufacturer and they ship the medication to the patient's house and we follow up with them as far as tolerability and getting all their appointments scheduled. If it is not required or we are not going to have the patient do it, we can immediately schedule them for their first injection.

We've just done some in the last week or so that when we got it approved they actually came in for their injection the next day. So once we work through that prior authorization process, it actually can move pretty quickly after that.

Bruce

Great. I certainly don't want to spend too much time on process and barriers. This is definitely an exciting treatment option for, as you pointed out, a number of patients. Can you talk a little bit, you sort of glossed over some of the pharmacy benefit versus medical benefit and how it's sourced. And there's also this notion of brown bagging and white bagging. Maybe you can get into some of those differences and what they means or listeners can understand that process a little better.

Dr. Stevens

Sure. So I'll start with the medical benefit. So this is different from what patients might normally be used to because most medications go through the pharmacy benefit. So if the insurance is telling us that we can bill through the medical benefit that involves the prescribers office purchasing the medication, and then we have a stored supply in our clinic for use when a patient needs it.

So it's not a patient specific medicine. We just have our own supply, the clinic bills for that and then the patient receives a bill just as they would for any other medical visit. Copay assistance is still available through the medical benefit. It's billed a little bit differently and involves saving explanation of benefits or EOBs and kind of doing some work on the back end. But it's definitely an option. 

Not all clinics may choose to bill through the medical benefit if they have an option. Inventory can be really expensive. The medications must be refrigerated, so you want to make sure that you have adequate space for that. So that really may not be feasible for all clinics, but it is an option. 

The alternative is to bill through the pharmacy benefit. So this is what patients are used to, their normal pharmacy coverage that they use when they go to a local retail pharmacy and pick up other medications. But this can be done kind of in a couple of different ways. So the white bagging refers to the distribution of a patient specific medication from a pharmacy to the clinic for administration.

So this is used in other scenarios like oncology, they do this often times. So providers have to stock and store the medication for each patient and keep it separate from any additional stocks that they might have, which could prove to be logistically challenging.

Brown bagging refers to dispensing the medicine from a pharmacy directly to the patient, who then brings their medication to the clinic for administration. So that prevents us from needing to store it. But it's also, another challenge is that we can't confirm how the medication was handled from the time it left the pharmacy to the time it came to our office. So some organizations also may not want to go that route.

Fortunately, a lot of insurance companies are giving you the option to bill either the pharmacy benefit or the medical benefit so you can really work with your patient to see which one is best for your clinic and is also the best cost wise for the patient.

Bruce

Right. I want to switch gears a little bit and talk about the virus specifically. We hear a lot in HIV about multidrug resistance or MDR virus. And I'm wondering how some of these newer antiretroviral therapies might help us mitigate the phenomenon of multidrug resistance in HIV? And can you talk a little bit about what that is and how these treatments may be able to help with that?

Dr. Stevens

Absolutely. So a multidrug resistant virus means that the HIV contains multiple mutations that reduce the susceptibility or the effects of various different medications. So it can oftentimes be multiple classes of medications that the patient can no longer use, which really limits their treatment option. Oftentimes, or most of the time this occurs due to non-adherence, so that the patient struggling to be able to take the medicine at the same time every day, but there can be transmission of mutations when someone acquires the virus.

These mutations can cause treatment failure, and it makes it really difficult to treat, often requiring many different medications. They often will have worse side effect profiles than the medications that we prefer to use and can be more than one time a day dosing, which makes it difficult for individuals to be adherent, especially with everything else going on in their lives.

So long, acting injectables could potentially prevent patients from getting these resistance mutations because we're really relying less on the patient to take their medicine daily since we are administering it to them in the office. It is still very important that they're able to keep their clinical appointments on a scheduled basis so that they don't miss their injection. But it takes the day to day kind of away from the patient. It makes it a little bit easier for them. 

We also have new agents, fostemsavir has been approved and we have a couple of others in the pipeline that have novel mechanisms of action. So because those are new ways that the medicine works, the patient has never been exposed to them before and so they won't have resistance. So these are new treatment options to kind of give them relief from the more complicated regimens.

Bruce

Thanks for that explanation. I want to get into some of those other, newer treatments that have novel mechanisms of action, as you pointed out. So other than these long acting injectables, can you talk a little bit about some of the other novel treatment modalities out there? For example, what can you say about implants or vaginal rings? What's sort of coming down the pike in those areas?

Dr. Stevens

Yes. So there was a vaginal ring that was studied. It contains dapivirine. So that is a class of medication, an NNRTI, which is already widely used and this was specifically used for PrEP. And this may still be used in other countries, but unfortunately the company producing this product voluntarily withdrew their application from the FDA. So it won't actually be used in the United States, which is disappointing for the PrEP community.

But fortunately, we have other options that we can use as well.  Islatravir is one of the other medicines that's in the pipeline that has not only a novel mechanism of action, but it also was being studied as a subdermal implant. In December of 2021 all of those studies were kind of placed on hold by the FDA. There was one particular combination with islatravir and another investigational agent where they observed decreases in total lymphocyte and CD4 counts. And so they put all of the studies on hold until they can figure out what is actually causing that decrease. Is it significant to patients and kind of regroup on what they want to do moving forward. So those are things that have kind of been in the pipeline and are not really available to us now.

But I think that it's it brings us hope that there are alternative formulations. And this is kind of the way of the future. We have plenty of oral medications, plenty of tablets that we can give patients. But these new ways of administering medications is really, I think, where the research is headed.

Bruce

Right. That makes sense. I also want to get into leronlimab a little bit and I wanted to ask you, for what patients might that be a good treatment option? And maybe you can talk about how it's different from some of these other investigational or novel injectable medications.

Dr. Stevens

So I'll start by kind of talking about its mechanism of action, which is a little bit different. So it is a monoclonal antibody, so it works a little bit differently than most of our other medications. We do have one other monoclonal antibody, ibalizumab, for treatment of HIV, but it blocks the HIV from entering and infecting immune cells by binding to CCR5.

So that's a receptor on our human CD4 cells. And by blocking that, the HIV is unable to essentially fuse with the cell and enter. So this medication has a really high genetic barrier to resistance, which ultimately means it's difficult to develop resistance to the medication. It's a once weekly subcutaneous injection, so it's not an every day, but it is subcutaneous, which is different from the intramuscular medication that we have in Cabenuva right now.

And this is being studied for individuals with multidrug resistance, as well as a monotherapy maintenance for people who are already suppressed. So one thing to know about this medication is they do have to be CCR5 tropic. So like I mentioned, it works specifically on that type of receptor on the human CD4 cell. But the CD4 cell also has another receptor. So we need to make sure that that is the receptor that the cell is using to make sure that the medication will be effective. 

So like I mentioned, it's been being studied in two different populations. So it's being studied as a single agent for people who are suppressed and has shown good results at the higher doses to maintain virologic suppression.

And it's been used in multidrug resistant HIV. So it is effective against viruses that are even resistant to another medication that works on the same receptor called maraviroc, and it works synergistically with maraviroc. So those two things can be used together to work against HIV. 

So these antibody based strategies are not new. They're used in other disease states, but they give us a unique mechanism of action. They have a decreased potential for development of resistance. They're generally really well tolerated. And so it's really a great new option for patients who may have limited options.

Bruce

And would you say that similar to the monoclonal antibody treatments for COVID, the mechanism of action is very similar there?

Dr. Stevens

It is a monoclonal antibody. I won't say that the mechanism of action is exactly the same, but. But that's similar.

Bruce

Got it. And because we are because it did mention COVID and because we're talking about the Roaring Twenties, it's difficult to sort of skip over the coronavirus pandemic. So I want to touch on that just a little bit. How might the pandemic, the current pandemic, and these sort of global campaigns for vaccination affect the patients’ attitudes around injectable ART?

I would imagine it's probably a sort of a positive a sort of adjustment of attitude in patient populations. But I'm curious to get your take on it.

Dr. Stevens

Yeah, I think patients are really used to us now talking about vaccines and injections. And this is just kind normal language that we're using in our appointments. I will say, there has been widespread misinformation about vaccination during the COVID pandemic. And, even in our clinic, we've had patients who are hesitant to get vaccinated because of the various information that they've heard out in the community.

What I think is oftentimes unique with our situation is that we see these patients, could be for decades. They're living long, healthy lives and we see them and we recreate these really trusting relationships with them. So we've had many patients who are only open to receiving vaccines from us because they trust us, that we are providing the best care for them and what they need to stay healthy.

So I think that's the same thing with injectables. If we have that relationship and we're open and honest about the benefits and the downsides of these medications, I think patients will be trusting of us and our recommendations along the way. I will say that something that I heard a lot talking about COVID vaccines was that it came to market very quickly.

And so I wonder sometimes when we talk about novel medications, if patients are concerned that that means experimental. So I think when patients are having concerns, we really just need to take the time to dive into that and see where their concerns are coming from and make sure that we can have an honest conversation about that so that they know that these are well studied and that we would only be recommending things that would be safe for them to use.

Bruce

That's a really important point thanks for saying that. I think a good way to start to kind of conclude here is to talk about the state of HIV treatment. I think our general listening public may be thinking all of these new treatment advances, treatment options, new modalities, new mechanisms of action from all of these new agents coming to market is definitely, undeniably a good thing. It provides more options. It deals with issues of adherence and some of the other things you mentioned. 

But I would imagine a lot of people are thinking where the cure is the cure coming. And I guess my question is, what are the implications of these particular advances on what might be an eventual HIV cure, from your perspective? A little bit speculative, but I'm keen to get your thoughts on that.

Dr. Stevens

Yeah, all of my providers are always telling our patients that we will be happy to give up our jobs if there is an HIV cure. And I think that it is being heavily researched as well. So while the way that they're studying it is quite different from these medications, these advancements surely give us hope. I have a lot of patients who were diagnosed in the 1980s and to hear their experiences of the handfuls of medications that they were taking when they were originally diagnosed and seeing their friends and family members passing away to where we are now for a one pill once a day or an injectable every other month is really incredible how far we've come. 

So we're not quite there yet with a cure. But these new agents give our patients a little bit more freedom as we continue to work towards a cure. And it really sets them up for success by keeping the virus controlled and their immune system healthy while we wait for those future advancements.

Bruce

Sure. And I think just to follow up on that last point, it's important to remind our listeners that while there is not an HIV cure or a vaccine necessarily on the horizon, we do have the tools, the clinical tools, to effectively end new transmissions and end the epidemic, especially in this country where we have all of these great treatment options.

And I think that's just an important thing to remind folks that even if there isn't a cure, we can eradicate new transmissions and ultimately the virus itself through what we have on the table currently. Any last thoughts before we break today?

Dr. Stevens

Just to add to that, we are absolutely talking about undetectable equals one, transmittable (U=U) to all of our patients. And that is really powerful messaging. It makes them feel comfortable. It makes other people around them feel comfortable knowing that if you take your medicine every day, you will not transmit the virus. And I think that that is really great and comforting for our patients who may be receiving a new diagnosis that they didn't know much about before.

Bruce

What a great sort of optimistic way to conclude our podcast today. Thank you, Dr. Stevens, so much for being here and for explaining all of these great treatment options that are available out there.

Dr. Stevens

Thank you again for having me.