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PrEP in Hard-to-Reach Patients
Improving Access to HIV PrEP in Difficult-to-Reach Populations

Released: April 13, 2023

Jona Tanguay
Jona Tanguay, MMSc, PA-C, AAHIVS
Activity Information

Activity

Progress
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Key Takeaways
  • The menu of HIV PrEP options continues to increase, but many eligible patients are being left behind.
  • Use of long-acting injectable therapy and on-demand dosing in appropriate scenarios may improve the appeal of PrEP in patient populations who are historically difficult to reach, such as adolescents, people who inject drugs, and cisgender women.

We are fortunate to have several different forms of HIV pre-exposure prophylaxis (PrEP) suited to different patients, goals, and clinical scenarios. However, one of our biggest challenges is getting all eligible patients equitable access to these important preventive medications.

In 2020, the CDC reported that only 25% of the 1.2 million people in the United States for whom PrEP would be recommended were prescribed it. Although this is an improvement from 2015, we still have a ways to go, especially for key populations. Specifically, disparities in PrEP access exist in people who inject drugs (PWID), people who participate in sex work, people experiencing housing instability, sexual- and gender-diverse communities, adolescents, women, and racial and ethnic minority communities.

Targeting these historically excluded key populations can be difficult, and varied forms of PrEP alone will not be able to close all the gaps. However, having a menu of PrEP options that continues to expand helps us empower patients from varied backgrounds to access preventive sexual healthcare that better suits their needs in individual contexts.

Improving PrEP Access for Historically Difficult-to-Reach Patients

Adolescents
Adolescents are a difficult population to target, especially because of issues with stigma and parental involvement.

Both oral and injectable PrEP are approved for adolescents who weigh at least 35 kg (77 lb) who would benefit from PrEP. A motivated adolescent may do well with oral PrEP, but for those who struggle with managing medication or fear parents or others finding it, injectable PrEP may be a great option.

If considering injectable PrEP, it is important to counsel that in the HPTN 083 trial, 4 incident HIV infections were seen in people who had great adherence and appropriate drug levels. These patients had integrase inhibitor‒resistant HIV and required protease inhibitor‒ or nonnucleoside reverse-transcriptase inhibitor‒based regimens for treatment. More research is needed into cabotegravir (CAB) PrEP failure, but this is important knowledge for people considering long-acting (LA) PrEP.

On-demand 2-1-1 PrEP with oral emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) offers an alternative and perhaps more discreet dosing strategy for patients who prefer an “as-needed” approach rather than taking a pill daily, but its use depends on whether patients and their partners were assigned male or female at birth. Specifically, on-demand 2-1-1 may be an option for patients assigned male at birth who have sex with partners assigned male at birth. There is a potential risk that estrogens may lower TDF levels, so on-demand 2-1-1 may not be a good option for transfeminine young adults receiving estrogens.

In the ANRS IPERGAY trial, more renal and gastrointestinal adverse events (AEs) were observed with on-demand 2-1-1 compared with placebo, so it is important to mention this up front.

Although oral FTC/tenofovir alafenamide (TAF) has not been studied for on-demand use, given its pharmacokinetic profile and improved absorption into the tissues, it is likely an acceptable option. Given the lack of data, it would be best that on-demand FTC/TAF be reserved only for patients assigned male at birth with kidney problems or who, for other reasons, do not tolerate FTC/TDF and are not candidates for other forms of PrEP.

People Who Inject Drugs
When it comes to PWID, FTC/TDF has the most data behind it. FTC/TAF is less studied in this population but could be considered for PWID with bone or kidney issues (with an estimated glomerular filtration rate >30 mL/min) or intolerance to FTC/TDF, such as intractable nausea.

Although injectable CAB theoretically may be a desirable option in PWID, the HPTN 083 and HPTN 084 trials for LA CAB merely included people who were “at high risk for HIV infection”; it did not specifically target PWID. Therefore, in PWID who do not have other behaviors associated with HIV acquisition, FTC/TDF would be the most evidence-based option.

However, pills work only when they are taken. Rather than decide for a patient, it is important to have an honest conversation about adherence. FTC/TDF may be the most studied, but for PWID, if a person does not like taking pills, is concerned about AEs or monitoring, or just prefers an injectable, LA CAB should be offered.

Cisgender Women
FTC/TDF, unlike FTC/TAF, has been studied in people assigned female at birth, and its safety in people who are pregnant is relatively well established. For people looking to become pregnant or who are currently pregnant and want to start PrEP, FTC/TDF would thus be the preferred option if they are able to take pills.

CAB may be a great option for nonpregnant people assigned female at birth with barriers to taking oral PrEP, especially those experiencing AEs with oral FTC/TDF or adherence issues related to stigma. Similar to adolescents, people assigned female at birth may be less likely to understand the risk for HIV acquisition and may fear discrimination. As such, CAB offers an option that can empower patients to sidestep some of these issues and take charge of their own health.

Note that the safety and efficacy of LA CAB for PrEP for people who are pregnant is not well established. In the HPTN 084 trial, CAB did not seem to cause adverse birth effects, but the number of pregnant participants was low. As such, CAB should be reserved only for pregnant people who would not do well on daily oral PrEP.

Studies evaluating FTC/TAF for PrEP in women are underway, so this may become a more supported option in the future.

Conclusions
There is no one right PrEP option for everyone. As the PrEP menu continues to expand, it is essential to counsel patients on the risks and benefits of all the options available to them and ensure proper monitoring and follow-up. LA injectable PrEP is a valuable medication to close gaps in reaching populations with issues taking daily oral PrEP, including those experiencing housing instability, women, or adolescents who are not good candidates for oral PrEP.

People understand their own nature often more than we credit, so it is important to provide the information and let them make their own choice while considering ideal efficacy, their personal real-world efficacy, and the features that are important to them.

Your Thoughts?
In your community, what strategies would be most useful in closing the gaps in PrEP access and acceptability in patient populations that are historically difficult to reach? Join the discussion by posting a comment.