August 17, 2023
7 min read
Source/Disclosures
Published by:
Disclosures:
Krakower reports receiving a research funding from Gilead Sciences paid to the Fenway Institute and receiving other research support from Merck and ViiV Healthcare. Marcus reports no relevant financial disclosures.
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Key takeaways:
- The FDA recently approved an over-the-counter birth control pill.
- Experts argue that HIV prevention medication should be next.
In the wake of the FDA approval of the first over-the-counter birth control pill, two experts argued that the time has come to make another prevention medication available without a prescription.
“Free the PrEP” is the partial title of a commentary recently published in The New England Journal of Medicine — a reference to the yearslong “free the pill” movement. The authors of the commentary, Douglas Krakower, MD, and Julia L. Marcus, PhD, MPH, from the Harvard Pilgrim Health Care Institute’s department of population medicine, argue that making the HIV prevention medication available OTC “could promote access and autonomy in the domain of sexual health.”
HIV PrEP should be available over the counter, two experts argued. Image: Adobe Stock
“Like oral contraception, PrEP is highly effective at preventing an undesired sexual health outcome. Also like oral contraception, it works only if it’s accessible, and there are substantial barriers to access,” they wrote.
We asked Krakower, an infectious diseases physician at Beth Israel Deaconess Medical Center in Boston, about the pros and cons of OTC PrEP and the barriers standing in its way. His responses have been edited for length and clarity.
Healio: Why should PrEP be made available OTC?
Krakower: We know that PrEP is effective but underused. One of the reasons is that people have a lot of challenges accessing PrEP. Making PrEP available over the counter would increase access, particularly for people who have the most challenges in accessing it through current avenues such as clinical care. This would include populations that may not be engaged in health care or don’t feel that the health care system has been trustworthy for them because of stigma, discrimination, transphobia, homophobia and racism, people who find it uncomfortable to discuss sexuality and substance use behaviors with clinicians because they have felt judged, and adolescents who might not want their parents to know.
Douglas Krakower
In terms of over-the-counter readiness, there’s a fair bit of evidence that PrEP is very effective and can be used safely in the vast majority of people. The United States Preventive Services Task Force (USPSTF) has reviewed the safety of PrEP with tenofovir disoproxil fumarate (TDF) and other formulations and given it a grade A recommendation, which is their highest recommendation in terms of benefits outweighing risks.
We’re at a time where we really need to think beyond incremental changes in access to PrEP, which have been very slow and certainly have not been putting us on the trajectory to meet the federal Ending the HIV Epidemic goal of reducing HIV incidence by 90% by 2030.
Healio: What are some of the risks of making PrEP available over the counter?
Krakower: The recent FDA decision to make oral contraceptives available over the counter was one of the ideas that sparked this conversation in our minds, given the similarities between contraception and HIV prevention. The approval for oral contraception was made knowing that there could be some risks, but that the potential public health benefits would be unlikely to be outweighed by the small known risks of making it available over the counter. There’s a similar idea of balancing potential health benefits and risks for over-the-counter PrEP.
There are some risks in terms of health that need to be considered. We know that TDF can lead to decreases in renal function in some people — they tend to be mild and reversible when the medication is stopped, and they tend to occur in people who are older, such as older than the age of 45 or 50 years, and with known renal disease or risk factors. The idea would be to have a label that directs people to consult a clinician before use.
The same type of considerations would be given to people with either osteoporosis or risk factors for low bone mineral density because the medication can also reduce bone density over time. Again, it tends to be mild and reversible.
These medications also have antiviral activity against hepatitis B virus. If the medication is stopped, it can lead to HBV flare ups that can cause hepatic inflammation and, in rare cases, serious hepatic inflammation. People with chronic active HBV or undiagnosed HBV ideally would be monitored if they stop the medication. That’s something that might not happen if people use PrEP over the counter. If people have HBV, ideally, they would seek clinical care before accessing PrEP.
If people with undiagnosed HIV were to use PrEP over the counter, that would pose some risks in that PrEP medications are not fully active regimens against HIV and there is the potential for people to develop HIV drug resistance. We would recommend that over-the-counter PrEP be paired with a home self-test, which has been approved by the FDA and available in the U.S. for many years. Those tests are not as sensitive as laboratory-based tests, so there’s a chance that people have a negative self-test and start PrEP not knowing that they have HIV. People with symptoms that could suggest recent HIV acquisition would ideally obtain more sensitive HIV testing prior to starting PrEP.
Healio: Why is TDF and emtricitabine (TDF/FTC) the “logical” initial choice for OTC PrEP, as you write in the commentary?
Krakower: TDF/FTC can be used in all populations that can benefit from PrEP —all genders, all modes of exposure — and has a long track record of use because it’s been approved since 2012. There have been many studies examining its safety and efficacy. It’s also the only formulation that’s currently available as a generic.
We still need to know people’s willingness to pay because even if it were low cost, the cost of PrEP medications plus HIV self-tests every 3 months as part of OTC PrEP programs still could be cost prohibitive for many people. There are some important policy solutions that could be used to address this. For example, for OTC contraception, a lot of the coalition leaders who have moved that agenda forward have advocated for policies and legislation to ensure that insurance companies would still cover the cost of OTC contraception, and that would make it accessible for many people who are insured. For PrEP, the proposed national PrEP program would provide robust infrastructure and funding for PrEP across the U.S. for people who are either uninsured or have Medicaid, and that kind of PrEP program would ideally include provisions to fund the testing and cost of pills for an OTC PrEP program.
Healio: What are the barriers to moving PrEP toward OTC availability?
Krakower: We need to learn more as to whether populations who would benefit from PrEP would be interested in using it this way. There is something you give up by using medications OTC, which is the counsel and advice of a clinician.
Some of the early studies on contraception found that some people preferred to access contraception OTC because of the convenience and privacy of not having to discuss sexual behaviors with clinicians, whereas other people liked the idea of getting it from a clinician because of the wraparound health care services and counsel they receive from trusted medical professionals. The idea here would be not to make this one or the other but to have another option for accessing PrEP.
We also would need to study whether people can successfully read and understand a label for how to use PrEP over the counter without a clinician present. That would include knowing when to seek clinical advice before using PrEP because of contraindications.
Another potential barrier is the need for pharmaceutical companies to put forth an application for FDA approval of OTC status for TDF/FTC, and as of now, I’m not aware of any conversations or studies that have engaged pharmaceutical companies.
With more rigorous research, I think we can make more intelligent public health decisions about whether this is something that makes good sense to move forward with.
Healio: What are the arguments against making PrEP available OTC?
Krakower: They are primarily about safety. To this, I would mention that there are recent studies from international settings comparing clinic-based access to PrEP and HIV testing with community-based access. Those studies so far suggest that using PrEP with less clinic-based monitoring can be as effective and that people who are using it may see benefits in terms of convenience and it may help them stay engaged in PrEP for a longer duration of time.
PrEP discontinuation is a problem, so convenience and patient-centeredness are important for the long-term effectiveness of PrEP as a population-level intervention.
WHO’s guidance is more permissive of a less clinically intensive approach to PrEP, where it says that renal function monitoring for people aged younger than 50 years can be considered optional. HBV testing before accessing PrEP is strongly encouraged but also optional in places where it can’t be feasibly done.
Another thing that critics might say is that you could potentially have people using PrEP who are at risk for either acquiring or transmitting sexually transmitted infections who aren’t going to have the same level of STI counseling, testing and treatment they would get during clinical care. We think that’s an important consideration, considering the high rates of bacterial STIs in the U.S., and that any OTC PrEP program would ideally include counseling and tools to help people understand when and how to access STI services as an adjunct to their OTC use of PrEP.
It’s important not to let the perfect be the enemy of the good. Even though STIs are a very important consideration in terms of public health, there are people who can use PrEP to decrease their risk of HIV transmission, and I think we should promote that, even if it may require other creative solutions to keeping them engaged in STI preventive care.
Finally, some critics may say there are other aspects of health care that are lost when you’re not getting PrEP from a clinician. Our group and others have done research in the past showing that PrEP can be a gateway to primary care and lead to improvements in things like general preventive health care, immunizations and other things that can help people’s overall health and well-being. That’s something that could be lost with OTC PrEP. But again, we don’t want to have the perfect to be the enemy of the good here. For people who will use PrEP only outside of health care settings, I think it’s very important to consider having as many low-barrier options as possible.
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