Ryan Haumschild, PharmD, MS, MBA: At this time, I would like to transition to Mr Driffin. I’d like to get some input from you because the FDA recently approved lencapavir, which is a long-acting injectable medication that we know is designed to be given every 6 months in combination with an appropriate background therapy, which we talked about earlier, for heavily treatment-experienced adults with multidrug-resistant HIV [human immunodeficiency virus]. Mr Driffin, what are some of the considerations for adherence to this new therapy? If you could, please discuss the interplay of patients being required to continue with an optimized background regimen and obtain a twice-yearly injection through a provider’s office.

Daniel Driffin, BS, MPH: I think this is going to start a lot of new conversations around juggling. We are going into some new treatment modalities, some unimaginable, especially not only for people living with HIV, but I also think our medical homes. From seeing someone 3 or 4 times a year to potentially 2 or even 1, I think it’s new conversations. I think it leads a discussion around the fact that all of our medical homes may not be created equally. I say that because certain staff will be able to pick up these different aspects. Going to see someone specifically for HIV treatment only twice a year, but still being mindful of seeing a dietician, or case managers more frequently, I think it actually lends itself to a new relationship. All I can do right now is think about my integration with injectables. I literally am going from receiving a phone call from my pharmacist about 2 weeks prior to my medical appointment, checking insurance status, checking whether am I still on the medication, and if I have any adverse effects or anything. Then my clinical staff at my doctor’s office will give me a call a week out to confirm the date, and usually the day before the appointment, the electronic medical record may send a text to remind me 1 more time. I definitely think there are added time points to ensure that our patient populations are remaining healthy. I think that’s going to be really important as we continue to see more individuals move over to these new modalities of treatment.

Ryan Haumschild, PharmD, MS, MBA: I like what you highlighted. No. 1, you highlighted the interdisciplinary care team. I think that’s so important. Someone who’s monitoring your medication, making sure you have appropriate access, and if you have any questions, the care team confirming the appointment. Because I think with this background regimen that Dr Sension mentioned, it’s so important to be compliant with that. Now as you have a new therapy, how are we making sure we’re solving for transportation vulnerability if it has to be in the provider office? How are we being proactive in reducing that financial toxicity? We’re working together as a team, centered around the patient. That’s when we get those optimal results and outcomes we’re looking for. When I think about this, I know payers are an important piece of this too. Dr Lopes, I want to invite you into the conversation. What are some of the potential payer considerations with respect to the need for continued adherence to an oral regimen and a semiannual provider visit for the injection? Are there any potential benefits to utilizing combination therapy with lencapavir or fostemsavir or ibalizumab?

Maria Lopes, MD, MS: When we look to, especially expensive regimens, we do look to evidence-based care. We usually want to see clinical trials that have been conducted that demonstrate what is the incremental benefit as we look at what combinations constitute the backbone, as Dr Sension was mentioning before. I think that’ll be important. What additional benefit do we have, and with what combinations can we achieve the highest outcome for the value of a treatment? Some of that will also factor in not just cost, but viral suppression, the size of the population we’re talking about. As backbone therapies become also less expensive, especially with patent losses, that’s going to be part of the discussion. Affordability is very much part of the discussion today in the payer environment. I think it’s incumbent as we think about value, which is efficacy, safety as well as cost, and also in the context of shared decision-making, to ensure that we’re getting the best outcomes. That can be, again, consideration of what can that backbone look like as well as maybe other considerations, even predictors of nonadherence can factor into the shared decision-making of what becomes the most appropriate. But real-world data I think will also become very much about how you demonstrate that one combination, especially if it’s a very high-cost combination, is yielding the longer-term results that demonstrate its value.

Ryan Haumschild, PharmD, MS, MBA: You’re right. There’s an equation there, and there’s efficacy and cost for cost-effectiveness. If we do utilize some of these innovative treatments for the backbone, and we get better effectiveness and we get better adherence in the long term, that can really balance out that equation. I appreciate you sharing from a provider’s perspective and a payer’s perspective about the inputs there. Dr Sension, I’m curious from your perspective as we transition, what are some important clinical considerations to account for when deciding on an appropriate therapy for multidrug resistant HIV because we know every patient can be different? If you could, comment on the route of administration, maybe some of the patient preferences, patientcharacteristics, or resistance profiles that would lead you to decide on a unique therapy.

Michael Sension, MD: We have the luxury now in 2023, we have so many regimens that are simpler than what we had 20 years ago. Even with somebody with multidrug resistance, I look at dosing, and I say, is it possible that I can construct a once-a-day regimen? Can I get away from multidosing intervals? Can we do something once a day? Sometimes it involves using a drug off label, out of its indication, but from a pharmacokinetic basis, it may very well work.

Maria Lopes, MD, MS: Cost drives a lot of this, affordability drives a lot of this. Now also when you’re dealing with HIV, and you’re looking at even by commercial Medicare, Medicaid, when you’re dealing with Medicaid, it’s also very state-dependent in terms of prior authorizations, what’s allowed, what your specialty pharmacy’s going to carry. It definitely will help to have some background support in terms of evidence-based that’s been published or abstracts, or we love to see the evolution of science also be a factor in how we think about today’s regimens vs what it can be. Then finally, guidelines. We always appreciate when guidelines are updated. It’s not always instantaneous, we know there’s a journey and a process to that. I think convincing us through clinical literature as well as the data on the outcomes, back to that cost of failure. Sometimes we think we’re saving money, but if there’s literature to support that maybe a different strategy is more appropriate, that it’s leading to better adherence and there’s evidence to show for that, especially in the short term, if you can demonstrate that within 12 to 24 months, payers listen to that.

Transcript edited for clarity.