Friday, September 22, 2023
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Assistant Professor of Clinical Medicine
University of Miami Miller School of Medicine
Miami, Florida
This activity is intended for infectious disease/HIV specialists, primary care physicians, pharmacists, and nurses.
The goal of this activity is that learners will be better able to educate clinicians on how to implement long-acting injectables (LAIs) for HIV into clinical practice, including clinician-patient communication to optimize both patient outcomes and satisfaction.
Upon completion of this activity, participants will:
Medscape, LLC requires every individual in a position to control educational content to disclose all financial relationships with ineligible companies that have occurred within the past 24 months. Ineligible companies are organizations whose primary business is producing, marketing, selling, re-selling, or distributing healthcare products used by or on patients.
All relevant financial relationships for anyone with the ability to control the content of this educational activity are listed below and have been mitigated according to Medscape policies. Others involved in the planning of this activity have no relevant financial relationships.
Assistant Professor of Clinical Medicine
University of Miami Miller School of Medicine
Miami, Florida
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Physician: Your labs look fantastic, Shane. Your viral load is undetectable, and your T cells are at 500.
Patient: That's what's up.
Physician: How are you doing otherwise?
Patient: I'm doing well; really well; almost too well.
Physician: Okay. What does that mean?
Patient: So, I got offered this job. Something I've been dreaming of since -- forever. Still doesn't seem real.
Physician: Yes. Well, that sounds amazing. You've worked really hard. Is it here in the city? Are you gonna take it?
Patient: I'd be crazy not to . . . but . . .
Physician: Then what's the matter?
Patient: It’s just, there's travel. Short stints -- like a month or less -- but, I'll never fully know what to expect until I get there. I do know that it'll be close quarters. And I'll probably have to share a hotel room. I'm openly gay. But I'm not openly HIV positive. I know I should be. I know I could be. But I'm not.
Laura Beauchamps, MD: My name is Dr Laura Beauchamps and I work at the University of Miami Miller School of Medicine. This video is a very good example of the conversations that we have on a daily basis with our patients coming to clinic and the decisions that we have to make sometimes about switching antiretrovirals. Many people may not bring their medication with them when they travel, possibly because there's a lot of stigma behind medications that are used to treat HIV.
The conversation starts usually with the patient -- both those who have been on ART for a long time and those who could be newly diagnosed with HIV and have already achieved undetectable viral loads. Some patients could be very young without comorbidities and might not be used to taking medications every day (even vitamins). So for them, it would be a good option to use long-acting antiretrovirals. It's good also in a way that they don't have to dwell on being HIV positive or living with HIV when they see that they have to take a pill every day as a constant reminder.
On the other hand, we could see patients that have lived with HIV for 20+ years, and they're basically tired of taking medications every day; they would want the option of coming to the clinic every 2 months for an ARV injection.
Key clinical and patient-specific criteria should be considered when selecting this injectable antiretroviral regimen in the context of switching and/or initiating this treatment. The majority of people living with HIV could qualify for it if they have undetectable viral loads.
Why is this case patient a good candidate for this treatment? He has undetectable viral loads, which also means that he is compliant, adherent, reliable. If patients are not like he is in his appointments, they could encounter problems with viral escape; issues with resistance, although rare, could happen as well. Basically, his adherence and for other reasons, like we said, that he has to travel and he has to be always with people, sharing rooms, he would rather not take a pill every day.
So who would you consider not a good candidate? It would be somebody that basically [is] giving us some red flags, right? Somebody who is not picking up their medications in the pharmacy, somebody that is missing appointments. For those patients, we'd rather not basically start with this treatment unless we know that they will be changing or sticking to the schedule.
We should review considerations when identifying these patients who might be on long-acting injectables treatment. There are relevant data and clinical experience from the studies that have tried this new regimen. We know that it is convenient and that it is increasing privacy and confidentiality and [helps to] reduce internalized stigma. This treatment is more discreet and with less potential for unintended disclosures of one's HIV status.
The trials -- ATLAS and FLAIR -- found that continued injection dosing schedule after bridging maintained the virologic suppression; there were no safety events of concern in the people that participated in these studies.
The next segment will emphasize the important role of the pharmacist in incorporating a long-acting injectable into the clinic.
Pharmacist: Hi, Shane. My name's Abigail. I'm the pharmacist for the clinic. I hear you might be interested in switching to a long-acting treatment option.
Patient: Yes. Possibly.
Pharmacist: All right. Well, I'm here to walk you through what that would look like, answer any of your questions.
Patient: Okay, great.
Pharmacist: What are you most curious about?
Patient: I guess how it works. Mostly if it works as well as what I take now. We've been pretty successful. I've been suppressed for a little over 2 years.
Pharmacist: Got it. So instead of taking a daily pill, this is an injection that you'd receive every 2 months. It's given here in the clinic, usually by Amy the nurse practitioner, or it could be Dr Jacobs. It's a combination of 2 medications that release slowly into the bloodstream -- on a daily basis -- for about 60 days, and it is effective; it's been tested in clinical studies in around 2000 patients and was shown to maintain viral suppression for years.
Patient: If I switch, would I stay suppressed? Or could there be a "blip?" I'm in a relationship, and I can't expose him.
Pharmacist: It's possible, but it's rare. To stay suppressed, you can't miss an injection. The best way to protect him would be to keep your appointments. The medication will help to keep you suppressed for up to 2 months. So timing is crucial. I can't stress that enough.
Patient: All right. So, then I would come into the clinic for the shot. You guys would give it?
Pharmacist: Yes, during your appointment, you'd receive 2 injections, 1 in each side of the glute. Each injection contains 1 of the 2 medicines.
Patient: Does it hurt?
Pharmacist: The injection goes into the muscle, so there can be mild discomfort: pain, swelling, some tenderness and bruising around the area.
Patient: What happens if I can't make an appointment? I mean . . . I know I can't just skip treatment, but you were stressing the timing. I've got a new job offer. I really want to take it. And there's travel. I just . . . um . . .
Pharmacist: Totally understand. There just needs to be communication between you and the clinic. There's about 7 days flexibility in scheduling -- that's 7 days before to 7 days after your treatment date.
Patient: That helps. How long does the appointment take?
Pharmacist: The actual injection takes only minutes, but we ask that you stick around afterward for about 10 minutes. Otherwise, you're free to go about your day as usual.
Patient: Are there any side effects?
Pharmacist: The most common are injection-site reactions, the things I mentioned -- like tenderness or swelling -- around the injection site.
Patient: All right, thanks for all this. If I were going to switch, would I start, like, today?
Dr Beauchamps: This video is a great example of the conversations that we might have between patients and pharmacists that are working in clinic. Engaging these patients in discussion of injectable treatment options is very, very important. We will be talking about treatment goals, concerns (eg, the efficacy of this long-acting injectable ART vs a standard oral therapy), the side effects that the person might experience, the number of clinic visits that is going to be changing from the regular schedule they had before, whether they have any fear of needles, or if they have any previous history with the injection, so side effects, problems with the injection-site side effects. We will be also talking about the number and frequency of injections that will happen at every visit and the bodily location where we're going to be injecting the medication.
We will make sure to go over compliance. It is very important to make sure that [the patient] knows that they should be adherent to this medication, the same as they were with the medications that were taking on a daily basis. Then we'll discuss overall treatment satisfaction at every visit. We want to make sure that we address the practical considerations of the patient and mitigate the challenges. So we will discuss where the injection will take place here in the clinic. We want to make sure to discuss with them what happens if there is a planned missed injection. For example, if somebody knows that they're not going to be here, we will give them the options of a 7-day flexibility or an oral substitution. [The choice depends on] when they will travel or not be able to come to clinic; we'll make sure that they're covered with antiviral therapy during that time to make sure that there is no long period without treatment that could lead to a viral blip, or [an increase in] viral load that could cause problems with their health. In addition, they could be transmitting HIV; this is very important.
We want to make sure that they know that they cannot start the injection right away. They have to start with a lead-in [course of] oral therapy. This is to ensure that the medication is not causing any side effects or allergies that we could not treat or stop after the patient starts a long-acting injectable, but which can be managed when they're taking just the oral medication every day.
In addition, we will discuss lower dose volume and lower-gauge needle use. We want to make sure that they understand all the logistics of the prevention of errors and making sure that they feel comfortable with the injection itself. Let's go to the next video to see the conclusion of this case.
Physician: All right, so Abigail says that you'd like to make the switch to a long-acting option.
Patient: Yeah. I'm ready.
Physician: Okay. And you're able to commit to coming to the clinic every 2 months for your injection? It's imperative that we stick to this schedule.
Patient: Yes. I can manage it. Abigail was very clear on the expectations. And who wouldn't want an excuse to visit you guys every 2 months, anyway?
Physician: I know, right? It's a win-win.
Pharmacist: I'll connect with you about your insurance in a minute. Every insurance company has different requirements to approve the medication. We've mapped out the approval process for most of them. So, we'll work with your insurance to get the medication approved. And then have it here in the clinic for you, ready to go.
Physician: I don't know if you guys already spoke about this, but once we have the medicine approved, we'll get you started on the pill form at home.
Pharmacist: That's right. We start you off with 2 pills that contain the same 2 medicines that are in the injection. This way we can see how your body might respond to the treatment before launching into a long-acting injection.
You'll take the pills once a day with a meal, for about a month. I'll call and check on you along the way. We'll be on the lookout for any side effects, including allergies. You'll take the last pill on the same day as your first injection.
Physician: Either me or the nurse practitioner will give you the injection. Your first and second injection appointments will be 1 month apart. After that, you will begin your every-2-months regimen. Sound like a plan?
Patient: Sounds like a plan.
Dr Beauchamps: In this last video, we were able to see how we concluded with this case scenario. We reviewed practical considerations that are very important for the clinic to incorporate long-acting injectable ART.
We went over the steps that we have to take to make sure that the patient's insurance will cover this medication. We went over how we need to store the medication. It needs to be refrigerated; if it is taken out to provide to the patient and they don't show up, we know when to discard it. We know how to administer it and where in the body to administer it.
We went over the important points of compliance. It is very important to make sure that the patients follow up with the follow-up injection visits. For example, in my clinic, we will be sending them a text reminder at least 1 week before the visit so that we could have maybe some time to talk. We send them a text and see if they could talk about the next visit: when it's going to happen, the time that it's going to happen, and to make sure that everything is in order, that the medication has arrived and that we're waiting for them.
The last part would be the importance of team-based care. A pharmacist, a nurse, and the doctor, we are a team that is working together. With our skills, we're making sure that we can make this new treatment possible and that it could be successfully given and it could work for these patients. I'm truly a believer in team-based care as the best way to provide care for our patients in general. We're happy that we have this new modality for treatment of HIV.
Thank you for your attention. I hope this program was able to provide you with key information for long-acting injectable treatment for HIV. Thank you so much.
This transcript has been edited for style and clarity.
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