Improving Adherence With Long-Acting Antiretroviral Therapy for HIV
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Welcome back to PopHealth Perspectives, a conversation with the Population Health Learning Network where we combine expert commentary and exclusive insight into key issues in population health management and more.
Edmund Pezalla, MD, MPH: I'm Dr. Ed Pezalla and I'm a pediatrician, but I also have a degree in public health, and I did a health service research and health policy fellowship. I have been working in managed care, principally in managed pharmaceuticals, for a number of years. Formerly, I was vice president for pharmaceutical policy and strategy at Aetna from 2007 until 2016. Before that, I was vice president for clinical services at Prescription Solutions which was the pharmacy benefit management arm of PacifiCare.
In these roles, I've had the opportunity to work with a large number of really terrific professionals, pharmacists, statisticians, and others in evaluating pharmaceuticals and pharmacoeconomic work. While at Aetna I became involved in public policy issues regarding pharmaceuticals and other things that are regulated by the Food and Drug Administration. And so that led to being a scholar in residence for a year at the Duke-Margolis Center in Washington, DC, and also several years of affiliation with the NEWDIGS Project, which was originally at MIT and is now at Tufts.
Currently, I'm a consultant to pharma and biotech companies focusing on market access, mostly in the US and US technology assessments, so impact advisor reports, how drugs are evaluated, and how the pharmacoeconomics are evaluated here in the US. And thank you for inviting me today.
What are some of the current challenges that exist in HIV treatment?
Dr Pezalla: So, there are a number of challenges. The first one is identification. It's like, many people are unaware that they have been infected with the HIV, because at first, it's pretty much asymptomatic. And so the difficulty there is they're not receiving treatment, and also they may be infecting others. And it's important to receive treatment early on. Patients who receive treatment earlier have a longer lifespan if we can catch them before their CD4 counts fall below 500. So early identification is important, but that's a challenge because many people, even those at high risk, don't know they're at high risk, but they and they may know, but for various reasons, they don't want to find out, or they don't know where to go. They don't know who to talk to and what can be done. So we still have a challenge in finding the right people to get into treatment. And also there continues to be a stigma associated with HIV. And you just don't want to tell everybody about it and that sort of thing. And so that's really the first part. So it's finding the patients and then getting them into treatment.
And they have to find somebody who can treat them. It may not be, it probably won't be, their primary care doctor if they have one. And oftentimes probably not if they're going to a clinic, probably not at that particular clinic. And so they need to seek out a public health clinic, a Ryan White facility or some other place for care and so they totally don't know where to go. So that's the other thing.
And then once they get into the system in terms of finding a physician who can evaluate them to the proper testing, recommend treatment is we got to keep them on the treatment. And that's hard. I mean, they're taking pills once or twice or sometimes we hope not too often, 3 times a day. Doing something every day like that is really hard just generally for people and it can be doubly hard for people who, you know, perhaps have a sort of more chaotic lifestyle. You know, if they are recovering from using intravenous drugs, for example, and other things, they may be, you know, moving around, they maybe don't have a permanent place to live, a number of other things that can happen to those folks. But even people who have settled life, it can be very difficult just to stick with treatments for such a long time, basically lifelong. And then of course there's the cost of treatment. And so most health plans will pay for HIV drugs and they'll pay for testing, but patients have which can be difficult, you know, many of the products are brandy products. There are generic products, too, but they're not always suitable for everybody because the regimens change, the virus continues to mutate. And we don't think about this too often, but there is a copay for testing, which has to be done frequently to make sure that the patient continues to have viral suppression. So cost continues to be an issue. Now there are government programs, there's Ryan White programs, other things to help patients with those treatment costs. And so anybody who's listening here and you know someone who has HIV, I recommend you check with the CDC website where they have some really great guidance on how to find those resources.
Excellent. It's definitely not one singular aspect of treatment that is causing a lot of issues, it sounds like. It's multifaceted.
Dr Pezalla: That's definitely the case. And it often is in health care, which is a really complicated sort of thing to start with. And, you know, it interacts with the patient's social situation and their attitude towards health, as well as just the ability to access care.
Can you explain the significance of adherence to ART in the treatment of individuals with HIV and how switching to long-acting ART may improve adherence compared to traditional oral therapy?
Dr Pezalla: Because the HIV virus is one of a family of viruses called retroviruses and we don't have to get into the molecular makeup on them to understand that HIV is a serious viral illness and there's been very few people who've ever been cured. So it is a lifelong treatment that's required, but we have really effective therapies these days. And so the importance of adherence is that if you miss a few doses, your blood level of the antiretroviral drugs, the ART drops, and this can allow for wherever the virus is hiding to pop back out. And that does two things. One is that if it's in the bloodstream, it's now exposing some other people. If you have a partner, even people drawing your blood at the laboratory, things like that, could be exposed to the virus. So this can lead to transmission, and that's exactly what we're trying to prevent. You know, this is, we want people to be healthy, but we also don't want them to spread it.
But the other things that go on here is that the lack of consistency can lead to resistant strains. The virus continues to mutate. And one of the ways that it mutates is to change its genetic makeup so that it's no longer susceptible or very susceptible to certain other drugs. And so if you're taking a drug and the drug levels are really varying considerably, then you can end up with a strain that has now become resistant to that drug. And that's the reason for testing is because even if you're doing a good job of taking it, it can still mutate occasionally. So those are kind of the two big issues where that make adherence really important, is avoiding that resistance, but also avoiding having significant blood levels that can be transmitted to some other person.
Long-acting ART helps with adherence because it's not something you have to do every day. You don't have to have a bottle of pills, you don't have to like keep it somewhere you can find it, you don't have to remember to take it whether it's once a day or 2 or 3 times a day because the injection is good for at least a month and some medications probably will be even, you know, less frequent, which is going to be easy. And so with the long-acting ART now, we can get over some of these daily adherence problems and make it much easier for the patient to keep those blood levels up and prevent problems. problems. And so we've seen with long-acting ART now some really positive and important results regarding that versus the daily pill.
For example, in the ABOVE study, 72% of patients were adherent to receiving their injections on time, but only 3% of patients took their pills on time. And so that's a huge, huge difference. And the persistence in treatment that is taking treatment as prescribed over a long period of time was just during the period of the study, 274 days for patients who were receiving the long-acting therapy versus 256 days for those who are taking the pill. So again, that's a difference in adherence that can matter in terms of CD4 counts in terms of the virus itself and how often it pops up and also in preventing that resistant virus from taking hold in that patient.
How has the life expectancy of individuals with HIV who start ART improved over the past 25 years and what factors have contributed to this increase?
Dr Pezalla: That's a really great question. And in 2000, the average life expectancy of a patient with HIV, living with HIV was 37 .6 years. It's now 77 years. So many patients are now getting close to the normal lifespan in the US. And if they are treated before their CD4 counts go below 500, their life span could be even above 83, which is really quite remarkable. And it's a huge, huge improvement in the past 24 or 25 years right now. And so if we can find those patients and we can get them treated, we can get these patients to what is considered a normal lifespan here in the United States.
That is such a significant difference in a relatively short amount of time.
Dr Pezalla: Yeah, we have made some remarkable improvements in a number of areas of medicine. This is clearly one of them. You know, and even though we don't have a cure for HIV, we've made a really big difference here in terms of reducing excess and early mortality.
Absolutely. Were there any other key results from the above study in terms of adherence and persistence to ART compared to oral ART in individuals at HIV that you wanted to touch on?
Dr Pezalla: Yeah, definitely. I mean, the discontinuation likelihood was only 10% in those patients with the long-acting ART versus 26% in those who were taking the daily medication. And also very importantly is the chance of unsuppressed HIV occurring. That is the virus appearing in the bloodstream during testing. And that chance of lack of suppression was only 7% in the long-acting group, versus 25% in the oral daily group. So, again, that's a huge difference because it's that appearance of the virus in the blood that is going to contribute to both resistance strains as well as the potential for transmitting it to a partner or to someone else.
Some really significant numbers there, absolutely. So, how does the above study contribute to the growing evidence supporting immediate initiation of ART following an HIV diagnosis, and what are the potential implications for improving outcomes for patients?
Dr Pezalla: Yeah, so this study really moved things along, but there have been also other studies from NIH and other places as well, really picking up on this, that really matters to be able to improve adherence and that the long-acting does improve adherence. And so one of the things we've seen is that there have been, there has been some consensus guidelines that were published by the American Academy of HIV Medicine and the American College of Clinical Pharmacy along with other national organizations including the Canadian equivalents and European equivalents as well. And they have stated that early treatment can improve longevity and reduce risk of developing HIV-related cancers. And that early ALART will help by reducing the potential for less effective therapy due to adherence issues. So they are supportive of the use of long-acting medications here because of these findings. And hopefully, these findings will lead to an increase in the number of patients receiving long-acting therapy, especially those who are finding it difficult to stick with the regimen every day.
Is there anything else you wanted to touch on? Anything else you thought was important that we didn't get to?
Dr Pezalla: So in closing, I just would like to point out that we still have work to do in HIV. And some of the important work there is to reduce the number of patients who get infected, you know, new cases. Because these are people, they are neighbors, they are people who live in our towns. And so we should care about them. And one way to care about them is to make sure that those patients who are currently infected with the virus are able to get a treatment that prevents them not only from developing resistance and being a problem for them, but also spreading it. But we also have to look at other public health interventions as well, and there are a number of these in order to make sure that we can identify patients, but also so that we can do things that prevent the spread of HIV.
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