New conversations are starting in HIV care as phase III trials have shown that monthly injections of cabotegravir and rilpivirine (Edurant) are non-inferior to a three-drug pill regimen. In 2018, TheBody asked a range of people living with HIV about their willingness to switch to an injectible, and most had mixed feelings. But even if there's widespread interest in this new way of taking antiretroviral therapy (and most likely also prevention, not too far away), it's important to consider not just the willingness of people to move to this new form of treatment, but whether health care systems and providers in the U.S. are ready to support this innovation.
That was part of the message that Melanie Thompson, M.D., principal investigator with the AIDS Research Consortium of Atlanta, imparted to the American Conference for the Treatment of HIV (ACTHIV 2019) on April 11 in Miami, Florida. While a majority of her presentation focused on educating the room of HIV care providers about the state of the pipeline of long-acting antiretroviral therapy for prevention and treatment, she also raised a series of questions about whether health care systems, including doctors and nurses, are ready to build this into their existing routines of providing care.
Monthly Injections May Require More Staff and Training
As of now, the monthly injectable of cabotegravir/rilpivirine is the only long-acting antiretroviral therapy that has both reached Phase 3 study and been found non-inferior to standard pill therapy. But ViiV and Janssen (ViiV owns cabotegravir; Janssen owns rilpivirine) have yet to file an application for U.S. Food and Drug Administration (FDA) approval. Thompson presented details on not only this regimen, but others in the pipeline. As we await the FDA application and approval of cabotegravir/rilpivirine, questions remain about what the approval of a single injectable treatment means for any future products.
Cabotegravir/rilpivirine must initially be administered in four injections, then as two injections every month, in the gluteus medius (a buttock muscle to the side of the hip). This will require staff training -- it entails a specific technique called "Z-tracking," which is used to ensure the injection goes all the way into the muscle and doesn't leak out into the skin layer. And since it's a shot in the butt and not in the arm, clinicians will need to figure out a private space where the shots can be administered.
This new approach to administration may also require additional staffing. If you have a clinical practice with hundreds of patients with HIV who want the injectable, that may impact the flow of your day and increase the number of visits. And if a bimonthly pre-exposure prophylaxis (PrEP) injectable is approved soon as well, that could mean even more patient visits.
"We're going to have to staff up for retention, because people are going to have to come back monthly for these injections," said Thompson.
Thompson also made note that cabotegravir/rilpivirine had not been tested in people with buttock implants, which can impact whether some people are able to take the shots. Such implants are popular among many transgender women -- and, in some parts of the country, cisgender women as well. Some older people living with HIV also may have buttock implants as a result of prior HIV- or medication-related fat loss.
What about keeping appointments? Thompson noted that for many people who take daily pills, if their prescription runs out, that can be an impetus to schedule an appointment with their provider. But without that reminder, a person getting a monthly shot may forget to make their appointments.
Given how taxing this could be on already stretched HIV care systems, Thompson raised the possibility of other kinds of delivery systems, like pharmacies (many of whom already administer flu shots), home health visits, and mobile heath units that go into communities (such as HIV testing vans).
We Don't Know About the Costs
Given that this is a new paradigm in HIV treatment delivery, Thompson also detailed more considerations for costs -- whether the cost to patients, to providers, or to the health care system. For instance: How will the drugs be priced? Considering the debates about high antiretroviral drug costs, the price for a new product has Thompson and other providers wondering whether it will be lower, similar, or higher than pill-based antiretroviral therapy. We don't know whether patients will pay for the drugs, as with a standard prescription, or whether the provider will pay. Many medicines that have to be given as a shot are procured by the health care provider, and the cost is rolled into the bill sent to the patient's insurance company. We are unsure about how this will work with injectable antiretrovirals.
If injectables are procured by the health care facility, managing the stocks of drugs will be a new consideration. Inevitably, there will be patients who will need to be seen as walk-ins to get their treatment if they've missed an appointment, or if they have to travel and can't be seen when they originally planned. Clinics will have to manage stocks of drugs to ensure they have enough to keep up with both planned visits and unscheduled appointments.
Another challenge to the current system of care is patient-assistance programs. Currently, many patients can apply for copay cards to help cover the balance of out-of-pocket costs. But if the injectables are not purchased by the patient, copay cards cannot be used -- they do not cover drugs purchased and administered by clinics, Thompson said.
Then there's the question of how payers -- public or private insurance -- will cover injectable treatment. Will they reimburse providers above, at, or below the cost of the drug? Thompson talked about benzathine penicillin G, an antibiotic that is reimbursed below drug costs. This situation could make providing patients with the injectable option impossible.
Lastly, Thompson discussed the total costs on the health system: the cost of the drug will matter to state AIDS Drug Assistance Program formularies, she said, and the related costs of monthly care provider visits have yet to be addressed.
While some patients are actively awaiting the possibility of switching to an injectable treatment, it's clear from Thompson's presentation that there are still more details to be worked out.
Until the FDA application is filed and ultimately approved for cabotegravir/rilpivirine, there's still time to address these questions for people with HIV who wish to take monthly shots instead of pills.
"Fifty percent of our patients in America are not retained in care and are not virally suppressed," Thompson warned. "While it's exciting to hear about new drugs, really it's the extent to which any of these new drugs might help this care continuum that we should get excited about any of them. But we have a lot of work to do."