New Treatment Option Helps Address Nonadherence Among Patients With HIV
Christopher Blackwell, PhD, UCF College of Nursing, discusses the HIV treatment option Cabenuva, and explains why this is a more convenient way to deliver long-acting antiretroviral therapy to patients who either do not want to take a daily pill, or who are just wanting to break the cycle of having to take a pill every day.
Read the full transcript:
Dr Christopher Blackwell: My name is Dr Christopher Blackwell and I'm an associate professor, and I'm also the program director for the Adult Gerontology Acute Care Nurse Practitioner program in the College of Nursing at the University of Central Florida.
I've been at UCF as a faculty member for 20 years, and I continue to practice as a nurse practitioner in the area of pulmonary critical care, and my scholarship and research areas are in the field of LGBTQ health.
I think the article that we're going to be talking about today is one that I wrote that looks specifically at long-acting antiretroviral therapies, which was an injectable form called Cabenuva, which it's only available as a brand name.
What existing data led you and your co-investigators to conduct your research?
Dr Christopher Blackwell: Yeah, so it wasn't so much a revelation of needing to do groundbreaking research on these drugs, as much as it was that we felt like there was a need to get the information out there for clinicians. This agent was approved by, or these agents I should say, were approved by the FDA, and we really wanted to let clinicians know that this was a viable option for HIV management in their patients.
So, we really dove into the literature and we dove into the long manufacturer's insert on this particular drug, and we wanted to make sure that we covered all the bases, so that anybody that was thinking about prescribing this drug or the ... I say this drug, because again, Cabenuva is the brand name, but it actually is two agents that ... we can talk about the separate agents as well and I'll explain what those agents are and how they work.
But the real mission of writing this article and getting that research and scholarship out there was so that clinicians would know that, hey, this is a viable option for your patients who are living with HIV who have met viral suppression, but who don't want to take a pill, or maybe they're at risk for being non-compliant, which I hate that term.
So, non-compliant is a term we use in the literature or clinically for a patient that fails to take therapy, whatever that therapy may be. Nonadherence is another way of saying it sometimes. But the good thing about this particular drug is that it's only injected now every two months, right?
When we wrote the article, I wanted to focus on the monthly injection of this drug, but now it's an every two month regimen. So, it's even more of a convenient way to deliver long-acting antiretroviral therapy to patients who either just don't want to take a daily pill who are just wanting to break that cycle of having to take a pill every day, or like I said, may be at risk for missing doses of an oral agent or not being compliant with an oral agent. So, we wanted to make sure that clinicians knew how to prescribe this.
What are some of these real world applications that doctors can take into clinical practice?
Dr Christopher Blackwell: Yeah, well, any provider, right? Nurse practitioners, physicians, physician assistants who work in this area. The other thing is that HIV management used to belong to the field of infectious disease, and we've now taken this area of practice kind of out of infectious disease and it's now a primary care managed process.
We see nurse practitioners working in primary care settings managing HIV, and physicians, PAs, same thing. So really learning how to deliver this medication, learning who's right for this medication, learning what the adverse effects of this medication are. All those things are really important, because this is a real significant tool in our arsenal against HIV.
Let me explain briefly how it works and then we'll get into some of these applications that you're asking about. So, the way Cabenuva works is it's two agents, okay? It's an integrase inhibitor and an NNRTI. They both basically work from two different perspectives of stopping HIV replication. A patient that would be suitable for this particular drug would be already virally suppressed, so that individual already has an undetectable viral load or what we say less than 50 copies of HIV RNA.
Then once that is established, that viral suppression is established, that person would get a month of an oral lead in of Cabenuva, so these two agents that we're talking about. They would take that for 30 days, and if they were stable on that regimen for 30 days, they didn't have significant adverse events that occurred, then we could get them on the every other month regimen at the last day of that 30-day period. So the implications of that are phenomenal, because like I said before, you no longer have to worry about taking a daily pill for these patients.
The other thing that we avoid a lot of times by doing that is what we call first pass effect metabolism. So there is still some interactions with these agents, but the good news is for patients with renal disease, for patients with hepatic disease, as long as it's mild hepatic disease or moderate hepatic disease, we don't see any real significant adverse events, and so it's a really good agent to be using for patients who want a long-acting substitute for that daily oral regimen. So, it's really, really a powerful tool in our arsenal.
Like I said, especially when we get somebody that, let's say, has maybe a mental health disorder where they're not able to remember to take their daily medication, or maybe they don't have home security, so maybe they're going in and out of homelessness, and so they don't have the ability to store medications and bring them with them. So again, a longer-acting agent is more appropriate for those people who might fall into that noncompliant or non-adherent category. So, there's really great implications for delivering this agent to people who it's appropriate for.
Once a patient gets on Cabenuva, the research shows that only about 4% will actually stop taking the medication because of side effects or adverse effects, so that's also very promising. It's a very low number of patients who go off the drug as a consequence of adverse effects, and then also it's very effective. So, it's about 95% to 98% effective at maintaining that viral suppression.
If we can keep patients virally suppressed, they can live essentially a normal lifespan. So, that's one of the beautiful things that's happened with antiretroviral therapies over the years is that patients who had poor outcomes before with HIV infection, now these people are living with HIV for normal lifespans.
If you look at the CDC data, they're looking at all cause mortality now from patients with HIV, meaning that these patients are living long enough now that they're dying from the disease processes that aren't necessarily associated with AIDS or HIV. So we're not looking at opportunistic infection deaths, but maybe we're looking at heart disease or complications from pneumonia or cancers, or things like that that everybody in the population gets, not just those who have AIDS.
What do you hope to do in the future with your research?
Dr Christopher Blackwell: Right now, I've done a lot of research on vaccinations, and I've done some data on COVID-19 implications, getting vaccinated to help prevent COVID-19 spread, particularly in men who have sex with men or gay bisexual men, and I'd like to kind of keep going down that route. The same partner that actually wrote this particular article with me, he's been an amazing colleague over the years.
His name is Dr Lopez Castillo, and he is a physician and he also has a PhD in public health. Very, very smart individual, he's an amazing colleague to be able to work with. He and I developed an intervention a few years ago called The Sex Café Podcast. It was a podcast, it's still out there, you can listen to it, little shameless plug here. You can get it on Apple Podcasts, and we used that platform as a way to teach people about stigmatized sexual topics.
So, we went into everything. We went into how to be safe, what vaccinations are out there, what are some ways that we can prevent not only HIV infection, but other sexually transmitted infections as well. So, I'd like to keep going down that path. I like the use of social media as a way to engage people, and I like the use of newer technologies like podcasts and the things that you're doing yourself to really reach out to people in ways that we've never done before, right?
Traditional ways have been through maybe television or radio or written brochures, things like that. Whereas now we have the opportunity to reach new audiences who are using different platforms to educate themselves on different topics. So with The Sex Café Podcast, we were able to do that, and so I'd like to keep going that way.
One of the things that I think would be really great to study and utilize in terms of the same kind of approach is prevention from hepatitis, and really educating people about hepatitis A prevention, hepatitis B prevention, and what are the treatment options for patients who get hepatitis C, because hepatitis C is essentially curable now.
So, educating patients in the population about what is available in terms of vaccination, how to prevent hepatitis infection, and then getting into curing hepatitis C infection if that were to ever occur. That's kind of where I'd like to go.
Is there anything else you would like to add about this research on Cabenuva?
Dr Christopher Blackwell: Yeah, I do. I think that any clinician who is working in the area of HIV ... well, let's actually back up for a second. Even if you're not working in HIV, you've probably seen the commercials for Cabenuva on TV. So that being said, read my article or read somebody else's article. The good thing about my article is it's pretty short and concise and covers pretty much everything, right?
It covers how to start a patient on the regimen, it covers adverse events, it covers the clinical trials that were done on the two agents involved with that regimen, and it does a really good job of just kind of presenting everything concisely. So even if you don't work in HIV, you're going to be managing patients clinically who might be taking this medication, so it's not a bad idea to educate yourself on the particulars of this drug.
The other thing I would say is that those who are working in HIV who are kind of probably comfortable and set in their ways with either using a two drug or three drug regimen orally, this might be a really good option for your patients. So talking to your patients about injectable Cabenuva, these two particular drugs that are in that brand name agent, really, really a great option for people.
So, there are some cost issues that come up, but there is also some resources, and I've actually got that in the article too, where clinicians can turn to for financial assistance for their patients. So I really would just encourage, even if you're not working in HIV, just get a little bit of background about this drug and its two agents and learn what it entails, just so you're aware when a patient comes in what agents they're on, and what the particular regimen is and what are some of the expectations of care for a patient that's on Cabenuva.
Then those who are managing patients who have HIV and are living with HIV, maybe look into offering this to them and seeing if this is a viable option for them. Do they meet some of the criteria that we look at to say a patient is appropriate for this, or it's okay if they're not. Keeping a patient on a PO regimen that's working good is fine too, but giving patients choices, especially with HIV management is always a good thing.
So, I think that learning about this drug and learning about how to onboard patients with it, watch for adverse effects, and then manage them long-term on an every other month basis is really a positive thing that clinicians can do on their own.