October 17, 2013
Poor antiretroviral adherence is widely regarded as a leading cause of HIV treatment failure and the development of drug resistance. What we're less clear on is the precise level of adherence that a patient needs to observe in order to ensure treatment success -- and even that may be beside the point. Adherence, after all, is one of the most important end results of a complex interplay of factors affecting our patients, including the very nature of the HIV care they receive.
To better flesh out the importance of adherence in HIV care today, as well as the steps health care providers can take to increase the likelihood of treatment success in their patients, we spoke with Benjamin Young, M.D., Ph.D., the vice president and chief medical officer of IAPAC, the International Association of Providers of AIDS Care, as well as an adjunct professor at the Korbel School of International Studies at the University of Denver and an assistant clinical professor of medicine at the University of Colorado.
In light of the evolution of HIV treatment over the course of the past several years -- particularly the greater potency of antiretrovirals and, in the U.S., an overall trend of decreasing HIV drug resistance -- how important is adherence at all in the context of HIV care in the U.S. today?
I think that this is a really important observation, and question. Medications over the last 15 years have consistently, and persistently, improved: better side effects; lower doses; lower numbers of pills; and, perhaps more importantly, even with some of the more current regimens, less drug resistance. And, as you said, this has some important implications for pill taking and adherence.
Medications have gotten better, and the frailty of those regimens due to less-than-perfect adherence is less. Drug regimens are less likely to produce treatment failure and drug resistance. I think every provider is uncomfortable saying, "Go ahead and miss a few doses of pills," but our need to berate and stigmatize people for being less than perfect is less than it was five or 10 years ago.
But it still matters?
Yeah, of course. Missing life-saving medication is probably not the best thing. I mean, and that's stating the obvious. But I think that our margin of error now, and the acceptability of a margin of error, is greater than it was before.
The traditional benchmark for optimal adherence has been 95%. Your suggestion, then, is that maybe that's no longer the case? Maybe it's lower?
I think it is. One should remember that the 95% number -- really, the 95% mantra -- was generated by a study that was conducted in the late 1990s. That was a time when regimens were much more complex: more doses; shorter half-life of drugs; more side effects; and so on. In other words, regimens that really had a smaller margin of error, if you will. That number has stuck like a tattoo to our mind's eye, when we think about adherence and we talk to people living with HIV about their adherence.
There have been a number of well-defined studies since that ask what level of adherence is needed with modern antiretroviral treatments. When you do that, the optimal number actually isn't 95%. In fact, with some of the modern regimens, the number is considerably lower. It's almost like we're speaking heresy when we say that 90%, or 85%, or even 80% might be good enough. I don't think that anyone's saying that it's a good idea to miss one in five doses, but I think that it gives us an opportunity to change the dialogue and the language we have with patients about times when they may be a little more human, or a little less than perfect.
What do you mean by "change the dialogue"?
Well, for one, I think too often patients are afraid to admit their shortcomings. So, for example, if I had been taking care of a patient and I'd been hammering them about the 95% number, and they come in and over the last week they missed a bunch of doses -- maybe their calculated number is 80%.
Rather than saying, "You need to stop your treatment until you can get your act together," I can say, "Well, let's look at what's going on. Let's see how we can improve that, and ensure that the overall risk is lowered, and risk of failure is lowered. What are the interventions that we might entertain to do that?"
How can a clinician even really know whether a patient is adhering or not? Viral load monitoring -- you see a blip and you ask that question? Or should you be regularly checking in with a patient to make sure that they're taking their drugs?
I think that the answer's more the latter. In fact, I think that by the time you have a detectable viral load, the horse is out of the barn, as far as medications go -- the virus is out of the cell, if you will.
Monitoring for adherence should happen at multiple levels in the health care system. It's not just a dialogue that happens between patient and doctor; it's a dialogue that happens between patient and case manager; or patient and pharmacist; or patient and support team member; and so on. And it should happen, at some level, at most encounters.
I'm sure we'll touch on this later, but our association published evidence-based guidelines around adherence to medications and care. One of the most strongly rated recommendations was that we should routinely ask all patients about self-reported adherence.
This means that we should be asking people about how they take their pills, understanding that there's reporting bias and error. But the people who are having difficulty will tell you -- at least, some of them will. And that's a reason to act. Conversely, even people who are doing well -- I'm sure that would be an opportunity to reinforce good behaviors.
This sounds like it's going far beyond our traditional understanding of what adherence is all about: "Hey, make sure you take your meds."
Right. It's important because, in fact, there are some studies that suggest poor adherence in those self-reports eventually predicts virologic failure, even if the viral load is suppressed at the time of that inquiry.
Again, viral breakthrough is a late marker of poor adherence. What we want to be doing is to be ahead of the curve and try to do something about it before there's a problem.
What are the steps that a clinician can even take to be on top of a person's adherence? Is this literally just a matter of the health care provider, or the case manager, or some combination thereof, having this regular schedule where they check in and directly ask a person whether they're taking their meds?
There are lots of other interventions. I think it distills back to this idea of individualizing care -- in other words, understanding who the individual is. At one level, understanding what their frailties are, what their risks are. People, for example, who have housing and food security problems, people who have mental health problems, those are people who may be at greater risk. It doesn't mean that they are having adherence problems, per se. But we need to know the warning signs so that we can offer a step -- and then, if necessary, offer greater degrees of support.
Pharmacy refill information is critically important, and it's right in front of us. Pharmacies can provide that information, but don't often communicate it well down the totem pole of care providers. Making sure that information is communicated -- not just to the prescriber, but perhaps to case managers, perhaps to other members of the health care team -- can provide an opportunity for assessment and decision-making long before the patient gets into a lot of difficulty.
Whose responsibility is it to achieve this level of communication?
I think that the answer to that is a very organic one: It depends on what the structure of the care team looks like. That differs from community to community. At a minimum, it's the doctor of the patient -- or the care provider of the patient; many care providers are not physicians.
I think it's an opportunity to strengthen the communications across the care team. Sometimes that's housed in one place; sometimes it's not. In our community in Denver, it's actually housed in multiple places. It can be a challenge to try to coordinate information about a potential warning sign on adherence between a pharmacist, a case manager, a care provider and the patient. But making sure that some sort of dialogue happens around that, I think, is important. And strengthening those communication ties is an opportunity to make it work better for people.
Is that realistic in the context of where we are with health care funding and the general fragmented nature of HIV care generally? We have exactly what you just described: situations where a person is going to a regional clinic to see their doctor, nurse-practitioner or whomever, and that's where they get labs done, that's where they have their three-month check-in, and that's where their meds are prescribed. They've got a case manager at a community-based organization -- maybe nearby, maybe not so nearby -- that checks in with them periodically just to see how they're doing. And then they go to Walgreens to actually fill the prescription.
That's a lot of places, and a lot of potential for cracks in that effort to keep track of the patient and make sure they're OK and taking their meds. But on the flip side, if everybody takes individual responsibility for staying on top of care and ensuring patient adherence, there's potential for a lot of overlap that could end up frustrating a patient.
Yeah. I think this is a story that requires individualized tuning of messages and the messengers. To your first point: It's important to understand that we shouldn't be talking about yet another unfunded mandate to care providers who are already stretched to their limits, and patients who have complex lives and busy activities.
But this can be done inexpensively. If anything, we should be learning lessons from all of the efforts that have been made in East Africa that allow task shifting of responsibilities across a broad spectrum, or bandwidth, of care providers.
The other thing I think that emerges out of East Africa, particularly, is this notion of social investment: The more that the patient understands that there are people invested in their health, the more likely it is that they will stay engaged in care, and the more likely it is that they'll continue taking their medicines when appropriate.
The other piece of it is a bit of redundancy, but it's important: engagement with patients. These organic networks, if you will -- it could be as simple as a phone tree, or an email list with the patient's permission, which allows people to communicate across that network that says, "John Doe missed an appointment," or "John Doe missed a refill. Can we do something to intervene?"
I've seen this work in clinics in rural villages in East Africa. If it can happen there, I'm sure it can happen here in the States.
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