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Knowing the Ins and Outs of Injectable PrEP

Frank J. Palella Jr, MD, and Carl Schmid continue the discussion of patient selection for long-acting injectable PrEP and its cost effectiveness in comparison with other PrEP modalities.

Frank J. Palella Jr, MD: Injectable PrEP is given in outpatient care settings by clinic staff. The dispensing pharmacy, retail pharmacy, or otherwise directly dispenses the medication to the clinic—not to the patient, to him or herself—so we don't have to rely upon the patients bringing the medication to the clinic. The medication is given in the gluteal area, and it cannot be self-administered. It must be administered by a health care professional, usually a nurse in most settings, and it requires a pact between the health care delivery site and the patient to keep on a schedule for those every 2-month visits when the medication will be given. The success of such programs are reliant upon our ability to have fluid communication with patients regarding the scheduling of their visits and adaptability and flexibility if rescheduling is necessary because they can't make it. When a visit is missed, there is wiggle room, at least a week before or a week after the scheduled every 2-month dose, but if we know that more than a month is going to lapse between a scheduled visit and the next available visit, we then have to talk about other strategies. Temporarily covering that period of time with oral PrEP alternatives is one, including in some cases the oral version of the injectable PrEP, the oral version of the cabotegravir. The ability to communicate, respond, and be adaptive and flexible with patients regarding their scheduling within pre-established time limits between doses and having the ability to offer, when necessary, temporary, daily oral PrEP to cover any substantial lags in IM doses is essential.

My patients who have received injectable therapy for the prevention of HIV, as well as injectable therapy for the treatment of HIV, are sold on it. They like the idea of not being tethered to daily pill-taking for HIV prevention in this case. They feel liberated, and many of them travel for work or for other reasons, of having to have a bottle of pills, which can get lost, which may need to be taken out at times in front of people that they would rather not be in front of. The acceptance has been extraordinarily good overall. The tolerability has been good. As the studies like HBTN 083 and 084 evidenced, the success has been magnificent.

In general, cost-effectiveness analyses, depending upon what the endpoint is to define effectiveness, are valuable to undertake and can illustrate challenges or even shortcomings of different approaches to therapy because, ultimately, what they are looking at is the amount of money spent per HIV-free year of life. These are good exercises to undertake. Some of these, and one in particular, that very recently demonstrates that using long-acting therapy might cost more per year of HIV-free life achieved. However, I think that really needs to be taken into consideration in the context that with the data from HPTN 083 and 084, you're much more likely to have HIV-free years of life, many more of them with such therapy than without. I think cost-effective analyses are important to undertake and can be of value, but the bottom line is how effective and how adherable and tolerable are the therapies being used. Most effectiveness is good when we're talking about therapies that are equivalent in their effectiveness or in their adherence. That's not the case with cabotegravir and its oral competitors. We've demonstrated the superiority in very important high-risk groups of injectable therapy with the HBTN studies.

Carl Schmid: I'm always looking at these studies, and it is just one model. The outcomes of a model are only as good as the inputs in that model. When they looked at the cost of the drug, they looked at the list price of the drug, and we know that there are significant rebates that manufacturers provide both to private insurers and to the Medicaid programs. You have to look at the window of how many infections HIV averted because of PrEP. They just looked at a 10-year window. It's important to look at the whole lifetime. You're saving a lifetime of treatment costs, and you shouldn't just look at 10 years. I've seen other models as well, that show the new long-acting drug to prevent HIV can be as cost-effective. What really matters is what's best for the patient, for the person, and that's a decision that should be made between the provider and the patient. Some people, it may be beneficial to take a daily oral, but for others, it may not. As the FDA said, it's superior to take in the long-acting. I think models are models. It's really predicated on the input, but I think what's most important is how many lives will be saved, and how much fewer HIV there will be in the future, as well as what's the preference for that patient?

Transcript edited for clarity.

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