The treatment landscape for HIV is discussed by a panel led by Dr Welch.
Adam C. Welch, PharmD, MBA: Let’s get into some of those treatments. Shauna, can you provide an overview of how we treat HIV?
Shauna Applin, A-NP, CNM, AAHIVS: Sure. We really have 2 categories: for most patients and for certain populations. They’ve changed the language from recommended for most patients and then for certain populations. The backbone for most people is the integrase inhibitors. I’ll run down the list. There are just a few. The first is an integrase inhibitor partnered with 2 nucleosides. It’s in a single tablet called Biktarvy [bictegravir, emtricitabine, tenofovir, alafenamide]. The integrase is Bictegravir, and the 2 nucleosides are tenofovir and emtricitabine. This is a single-tablet regimen, an all-in-1 taken once a day. Another 1 recommended is also integrase based, but the integrase is dolutegravir. That can be partnered with Descovy [emtricitabine, tenofovir] or Truvada [emtricitabine, tenofovir], and the difference between those 2 agents is the tenofovir component. But that regimen is 2 pills taken once a day. Instead of a single tablet, it’s 2 tablets. It still has a high barrier to resistance, which is critical to how we treat people.
The third regimen is also integrase based. The integrase is dolutegravir. It’s a single tablet that combines 2 different nucleosides, Abacavir and lamivudine, in a single tablet. There are a few caveats with this product. You need to do genetic testing before you use it. You need to have that test done before it’s used. This isn’t a treatment that we use in rapid treatment initiation. You also need to ensure they’re not coinfected with hepatitis B. If that fits your patient, it’s a great regimen. If it doesn’t, then we’ll use a different 1 that’s individualized.
There’s a 2-medication regimen that has been called out, but it would work for a different population. It’s dolutegravir with lamivudine. The trade name is Dovato. It’s only 2 pills in combination, which is different from the historical thinking that 3 agents combined are needed. It has a lot of caveats. You want to have a patient who will be adherent to it because you lack that third drug, the cushion drug. You also want to make sure they’re not coinfected with hepatitis B. It didn’t perform as well in high viral load, so they need to have a viral load that’s less than 500,000. When we do rapid treatment initiation, sometimes we treat before resistance testing is back. Dovato isn’t a product you want to do that on. You want to have the resistance testing back so that you know the 2 agents are fully active.
The last 1 I’ll call out, because it’s newer in the guidelines, is a protease-based regimen that’s combined with 2 nucleosides. It has been called out recently in the guidelines for people who were previously on Apretude [cabotegravir], which is the long-acting injectable for PrEP [pre-exposure prophylaxis]. The recommendation, while you’re waiting on integrase resistance testing, is to start a patient on a PI [protease inhibitor]–based regimen to ensure they didn’t get integrase resistance because of that long-acting injectable and then seroconverting to HIV.
Adam C. Welch,PharmD, MBA:I found it interesting that in all the medications you were listing, you mentioned the number of pills and the pill burden that exists with this. It’s very important in the treatment of patients. Ann, can you talk a little about pill burden and what it means to have to take these dosage forms. I apologize to the pharmaceutics folks out there. A pill is a tablet or a capsule, but we use the term pill generically. Talk to me about pill burden.
Ann Khalsa, MD, MSEd, FAAFP, AAHIVS: Back in the day, we had very high pill burdens. Each medication could be 1 pill twice a day, up to 6 pills 3 times a day. Luckily, nowadays, almost everything can be prescribed once a day, but when our hands are forced, based on payer coverage, sometimes we’ll separate the combined ingredients into 2 separate pills. The protease, which could be Symtuza combined, might be Prezcobix and Descovy separated. Even though it’s not commonly used for initial guidance, you can do abacavir lamivudine with dolutegravir, which would be Triumeq [abacavir dolutegravir, lamivudine], but sometimes we have to separate that. If we’re going to use Truvada [emtricitabine, tenofovir] or Descovy [emtricitabine, tenofovir, and alafenamide] with dolutegravir, those are separate pills.
Taking 2 pills vs 1, what’s the big deal in swallowing? Not a lot, except when you have disconnects at the pharmacies and disconnects with the patients, they don’t realize, “I got only 1 of them in. That’s good enough.” No, it’s not. I have to specifically advise patients: if you don’t have your full regimen, don’t take any of it. In the case of HIV or any infectious disease, some treatment is worse than none. You take the full treatment but never partial, because partial in a living organism allows it to mutate and become resistant. I see insurance and pharmacy disconnects constantly. Anyone who takes medications and gets prescriptions at the pharmacy knows that you go there the first time with all your scripts, and several years later they’re all on different refill dates. I don’t know how it happens, but it does. But our patients, many of whom are not savvy consumers, sometimes don’t realize the importance no matter how much I emphasize it. It will lead to resistance. I frequently tell patients, “Don’t take just 1 of those 2 pills. If you don’t have both, don’t take them. Call us immediately.”
Christian B. Ramers, MD, MPH, FIDSA, AAHIVS: The only setting where it’s OK to split things up is a setting where you directly observe therapy. For patients in institutional settings where you have a nurse watching you swallow the pill, that would be acceptable to save some money, cut corners, and give them the same drugs in a couple of different pills. Outside that situation, the literature supports that when you split things up, bad things happen. Patients lose prescriptions, and the adherence isn’t as good. As we’ve already talked about, poor adherence can penalize a patient for a lifetime because once resistance develops in the virus, it’s there forever. Then you have to move on to more expensive and burdensome second- and third-line treatment regimens.
Adam C. Welch, PharmD, MBA: Even in the best-case scenario, someone who is the best educated and has the best coverage from an insurance standpoint can still find hiccups navigating health care system.
Ann Khalsa, MD, MSEd, FAAFP, AAHIVS: Absolutely.
Adam C. Welch, PharmD, MBA: With adherence so critical to outcomes in patient care, we’re not even talking about individuals who may experience homelessness or who have other types of inequities that would limit their access to the health care system.
Ann Khalsa, MD, MSEd, FAAFP, AAHIVS: Another big 1 I saw this year is patients’ formularies changed and their health insurance. They go in to get a prescription the day before they’re going to run out of medications only to find it’s no longer on formulary. That’s been very problematic, and I’ve got some patients whose insurance co-pays for their medications are unaffordable. With commercial plans, there are pharmaceutical co-pay cards. Thank you very much. But they’ll go through that co-pay in 3 or 4 months. I’m switching between different brands of medicines to make it affordable. That’s not optimal.
Alina Orozco, RN: I’m representing a Medicaid health plan with an HIV specialty focus. From the beginning, we learned that with a single-tablet regimen, the ease of taking these medications is very valuable. We’ve developed a working relationship with the pharmacy where obviously it’s the drug utilization review and the drug-to-drug interactions. But we have medical directors who are well versed in HIV treatment, who do peer-to-peer. We have referrals coming in from the pharmacy department to our case-management department help members who aren’t picking up on time or have lapsed. We try, with the different fill dates coming in at different times. I don’t know how to get those more cohesively at the same time, because it helps. There’s a continual burden to educate and see the preferred drug list that’s out there. In Florida, we only have prior authorization for Selzentry [maraviroc], because of Trofile, and Fuzeon [enfuvirtide]. Everything else is an auto prior authorization. As long as the diagnosis is on there at the point of sale, it should go through. But it’s a huge part of the management of HIV, and the payers are the central part of it. Working collaboratively and bringing in that pharmacy piece is critical because it’s a huge part of the treatment and the health outcomes for our membership.
Transcript edited for clarity.