Pharmacy Times interviewed Stephanie Kirk, PharmD, CDCES, BCACP, AAHIVP, clinical associate professor at Medical University of South Carolina (MUSC), division of infectious diseases, about HIV and the treatment options available to those with HIV. Kirk also discusses the REPRIEVE trial and its influence on patients with HIV, what treatment options are on the horizon, the significance of reducing stigma, and how pharmacists can help with the efficiency of care.
Key Takeaways
- REPRIEVE Trial’s Impact on Statin Use: The REPRIEVE trial emphasized the importance of statin use for patients aged 40-75 who are living with HIV, indicating a clinically meaningful reduction in cardiovascular events. The trial supported the notion of considering HIV as a cardiovascular risk equivalent, leading to increased discussions between health care providers and patients about statin therapy.
- Long-Acting Treatment Options and Challenges in HIV Care: Long-acting cabotegravir plus rilpivirine, administered through injections every 2 months, offer an alternative to daily oral therapy for HIV patients, showing benefits for patients who struggle with adherence to daily pills or face stigma associated with HIV. Other social determinants of health—trauma, low health literacy, cultural misunderstandings, and cost of medicine—present significant obstacles for individuals seeking HIV treatment.
- Pharmacist's Evolving Role and the Future: Pharmacists play a key role in HIV prevention, with a focus on pre-exposure prophylaxis (PrEP) and addressing the stigma associated with HIV testing. The evolving role of pharmacists involves prescribing and monitoring PrEP, managing metabolic complications, and collaborating with healthcare providers to ensure access to necessary medications. Looking forward, long-acting therapies and advancements in HIV care have improved the quality of life for individuals living with HIV, and the goal is to continue reducing HIV prevalence through prevention, stigma reduction, increased testing, and prompt initiation of treatment.
Pharmacy Times: Can you introduce yourself?
Stephanie Kirk: Thank you so much for having me. I'm Stephanie Kirk, and I call myself a pharmacy doctor because my training is in ambulatory care management and in pharmacy care. So, we have a lot of different roles as pharmacists, and I'm a pharmacy doctor here at the HIV clinic at Medical University of South Carolina in Charleston. I've been here since 2017. Before that, I was with the college of pharmacy here and [I worked in] internal medicine and family medicine, and [I] really was focusing on ambulatory care management of patients. When I took this job in 2017, [I] really self-educated [myself] to become an HIV expert.
I love my job. I love my 2 girls and I love being a mom…Before [I worked at] the college of pharmacy, I was with the VA where I did my residency, so my home has been in Charleston, South Carolina since 2007. So yeah, that's me in a nutshell.
Pharmacy Times: How did the REPRIEVE trial influence statin use, and how did it impact individuals living with HIV who are seeking care?
Kirk: So the REPRIEVE trial—just super quick summary—was about 7700 patients and it was over 5 years of patients living with HIV from 2015 to 2019. They followed him for about 5 years, and [patients were] either taking pitavastatin [at] 4 mg or placebo. And so it's a moderate intensity statin that reduces LDL cholesterol by about 35%. So, the median LDL of patients on this trial ages 40 to 75 living with HIV, started out at [around] 108, so that's not something that we typically would start a statin on. And their ASCVD risk scores were not in the category that we would typically start with on a statin. So, patients living with HIV—in my mind—I have for a very long time consider HIV a cardiovascular risk equivalent, but a lot of the guidelines don't really necessarily say that and say that we need statins. So, this REPRIEVE trial came out and really said for patients who are between the ages of 40 and 75, living with HIV need a statin because the number needed to treat was 108 patients to reduce an event over the course of 5 years. That number is pretty significant, so it just gives more evidence and use for statins and it gives us that push as providers to have that conversation with patients.
I think too, it gives you know retail pharmacists, primary care pharmacists, ambulatory care pharmacists, kind of that incentive to really discuss cardiovascular health with patients who are living with HIV, and I think that that trial was really, really exciting. We actually did a study with a resident a while back before this trial was even thought in anybody's brain, but we looked at how often we're prescribing statins. I'm really excited to see how that the REPRIEVE trial data is going to impact how often we're prescribing statins because we can see a push. The 1 thing I wish it had looked at is the younger population living with HIV, because we do have, unfortunately—probably in the next couple of years—we're going to see a higher incidence of new diagnoses in the age range of like 13 to 24, and I think we need to know that that answer to that question. What do we do when they're 20 to 40?
Pharmacy Times: Other thandaily pills, what treatment options do you see—or would like to see—HIV care shifting toward? What are their benefits? Disadvantages?
Kirk: Right now, the only FDA-approved complete non-oral regimen is long-acting cabotegravir [plus] rilpivirine, so it's a 2-drug combination [that is] injected once monthly for the first 2 months, and then every 2 months thereafter. I think a lot of people have in their brain [that] it's 1 injection, it's actually 2 [injections] into the gluteal muscles. And so, we at MUSC actually have [been] pushing about 100 patients out of our 1400 patients on this already, and I've seen a huge swing of patients struggling with adherence to their oral therapy.
Oral daily therapy is not for everybody. My personal thing is I'm a busy mom, I don't want to have to come in and see somebody every 2 months, I'd rather take a pill every day. But a lot of people, unfortunately, because of that horrible stigma associated with HIV, that pill every day reminds them, whether it's a trauma that they experienced with the transmission of HIV, being told about their diagnosis, not wanting to share their diagnosis with other people and they don't want people seeing them take medicine…there's so many reasons why a pill a day does not work for everyone. So, I love that we have this 1 long-acting option.
What's coming in the pipeline—what I'm really excited about—there's a nexplanon implant for contraceptive, and so, they're designing—hopefully, fingers crossed it will come in the next decade or so—HIV regimens that will be implantable every year. They're also working on patches; however, right now, it's probably the size of a mattress, so we can't really do that yet. But I love the fact that when I sit with a patient who's newly diagnosed, and maybe they're having a lot of emotions, maybe they're not, maybe they're just like, “My life is such a mess and I cannot envision [myself] taking a pill every day, I don't know how I'm going to do this.” I can look them in the eyes and say, “Listen, there's hope. Hang on with me, get suppressed.” because the long-acting therapies are not ideally for the unsuppressed patients. There is the direct to inject, or the JAB study, that did show some really good evidence for unsuppressed patients, but right now, it's mostly for suppressed patients and I've seen great results
Advantages or benefits of this, I would say is right now, the therapy that we have that's injectable every 2 months is directly-observed therapy. [Patients are] coming in, I know that I'm not sitting there racking my brain going, “Why is this therapy not working? Why are they not taking it? Are they taking it, I don't really know if I should believe them.” That's taken out of the picture. The other benefit is, it really takes these patients who are struggling to remember to refill their medicine, take their medicine, [patients who are] moving, [have] unstable housing…it takes that out of it. It also has been really beneficial for some of my patients with GI absorption issues. [As an example,] I have 1 patient, and he has such a super high ostomy output, by no fault of his own, he cannot take oral pills, and we now have a therapy for him and I'm so excited…
[As far as] the disadvantages, there is that 1% failure rate for unknown reasons [which] we're trying to figure out. So, I have that conversation with patients and say, “Look, I've got other options if you do fail.” And there’s the close monitoring, I have to make them go to labs…We also find ourselves chasing people down, like, it's your target time, I don’t get them on the phone…so, it's a lot of behind the scenes work to make sure that the medicines [are] covered, paid for, [that it is] here when [patients] get here to inject it, training for nurses…[This] has been my life for the last, how many ever years…it's really good for select patients. But other disadvantages [include] the coverage, the coverage is hard [for patients.]
Pharmacy Times: You note that there is a lot of stigma when it comes to people living with HIV seeking out care. Other than stigma, what are the most common obstacles this population faces when seeking out treatment options?
Kirk: There are so many social determinants of health {SDOH} in this population, that just cause my heart to bleed, whether it be they have been through so much trauma in their life [that prevents] them from either truly accepting the diagnosis, understanding the diagnosis, or it might be also, unfortunately, just a low literacy level in general—not just literacy level, but health literacy, sometimes too—some cultural misunderstandings of maybe what HIV is, or the fact that it is a chronic disease state, the fact that [HIV] can't be treated with natural medicine or anything like that.
I would say the 1 thing though that I want to be out of the obstacles is the cost of medicine. You know, the beautiful part about my job is that when I do meet with those patients, we have a rapid access clinic and anybody that's diagnosed with HIV can call and get an appointment that week if they want it, and they come in and I get to give them their medicines starting [that day.] Like, I get to give [them their] pill, [they’re] taking it in clinic, the first scary dose is done. And I get to tell them, look them in the face and say, “Take the worry about the cost of medicine, or these visits, off your shoulders.” All around the country, there are Ryan White clinics dedicated to treating patients and helping them stay in care and take medications. Very rarely…free HIV medication is for all patients, no matter if you have a higher income versus not. We'll find a way, we'll switch your therapies and get the copay cards going. I think cost of medicines should be removed.
But otherwise, though, transportation issues or living conditions, unstable housing, and I have to say, 1 obstacle I feel like that we can't underestimate is the lack of health care professional time to truly devote to these patients who may not be able to understand it within a 5-minute timeframe. And then we have to devote that time, and that's hard for all of us.
Pharmacy Times: What is the pharmacists’ role in HIV care, and is there anything that pharmacists should know about treatment options and providing care to patients?
Kirk: Luckily, in America, HIV is not as prevalent is diabetes, obesity, heart disease…and so, I don't feel that as pharmacists that we have to have this, “I know all the HIV medicines and how to pronounce them all.” That's not the typical pharmacist’s role in HIV care. I think what our role really should be focused on prevention, focus on pre-exposure prophylaxis (PrEP). We’ve got to get this going, we've got to help remove that stigma and help understand that 1 in 7 people don't know their diagnosis, and they're responsible for 50% of the new cases. We've got to get to a point where we as pharmacists—because you never know when you're that person that’s seeing that patient—could just be like, “Oh, you’re never had a test? Well, they're free and you can even…get an at-home oral test if you're nervous and you can get on treatment…” I think that's more of the role, pharmacists, as providers have got to continue to get move forward in America, and so, I think that the pharmacist’s role will be more prescribing, monitoring PrEP, I think that's going to be huge.
Ideally, I would love to see some of these injections being able to be given in retail pharmacies that are close by to patients’ homes, I'm kind of stuck there…but overall, I know, HIV is a chronic disease state, so the pharmacist’s role is going to be pushed more towards managing those metabolic complications, cardiovascular risk, statins, blood pressure, diabetes, smoking cessation for these patients, and so, we can all work together to move the mark there. But prevention is key.
For any retail pharmacists, hospital pharmacists, anybody that sees, an HIV medicine, and [is] like, “I don't know what this is,” it's fine. But I think our role as pharmacists needs to be making sure that we don't see that [a treatment] is going to cost the patient $4000 because they're uninsured, and saying, “Sorry, you can't get it.” I think that we all need to work together…your job as a pharmacist is to contact that clinic, so that we can do our due diligence and figure out a way to get that patient that medicine.
Pharmacy Times: Final thoughts?
Kirk: I think that would be a closing thought…if you're a pharmacist working on the front lines [and you] realize that this patient's insurance doesn't cover this medicine, and the patient presents and they can't pick it up, it's not always a fault of their own that they don't have the avenues or understand how to get back into the care, and it's just it's a struggle. So, if you can help us with that struggle, that would be amazing.
…And then number 2 is that HIV care has come such a long way, from literally a handful of pills multiple times a day, to 1 pill once a day, and now long-acting injectables…we've got a long way to go, though, in terms of prevention. I do think, ideally, I would love to see no more HIV when my kids are my age. I would love to see that. I think part of the goal there is reducing the stigma, helping people get tested and getting treatment.
I just I think World AIDS Day [on] December 1, their theme [this year] was let communities lead, and I think that's the key, the more that we help—prevention is key as well. But at the same time, just because [a patient is] on PrEP doesn't mean [they] shouldn't be using condoms because we're seeing an uptake of syphilis, chlamydia, and gonorrhea. But yeah, I think prevention, reducing the stigma, helping people get meds, getting them connected into a clinic, and we'll go from there.
