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HIV pre-exposure prophylaxis (PrEP) is key to slowing the spread of HIV among individuals at high risk for contracting the condition, yet racial and ethnic disparities and concerns of stigma continue to roadblock its full potential.

The "final recommendation statement" from the United States Preventive Services Task Force (USPSTF) in Aug. 2023 stated that clinicians should offer PrEP to those ("A" rating). High-risk groups were defined as men who have sex with men (MSM) and heterosexually active men and women who either have a serodiscordant sex partner, reported inconsistent condom use during receptive sex, or reported a sexually transmitted infection (STI) such as syphilis, gonorrhea, or chlamydia within the past 6 months. People who inject drugs who share drug equipment or engage in the above sexual behaviors are also at high risk, the USPSTF said.

While the 2019 recommendation referred to "persons at high risk of HIV," released by the USPSTF on Aug. 22, 2023 specifies "adolescents and adults." Otherwise, the strength of the recommendation appears unchanged ("A" rating).

Interestingly, seem to cast the net a bit wider, recommending that "all sexually active adult and adolescent patients should receive information about PrEP."

Three Options, With Caveats

Currently, the FDA has approved three options for HIV PrEP: two oral daily pills and one long-acting injectable to be administered once every 1 to 2 months. All consist of a fixed dose of a combination of antiretroviral therapy (ART) to maximize protection against HIV acquisition.

In the pivotal Preexposure Chemoprophylaxis for HIV Prevention in Men Who Have Sex with Men (iPrEx) trial published in the New England Journal of Medicine, the authors wrote, "the administration of the drug both before and after exposure was important for maximizing the protective benefit."

In 2012, the FDA approved the first PrEP option, an oral daily dose of tenofovir disoproxil fumarate/emtricitabine (TDF/FTC, or Truvada) for individuals ages 12 and older who were at high risk of contracting HIV. Generic TDF/FTC became .

A second daily pill for PrEP was approved in 2019, this time consisting of tenofovir alafenamide/emtricitabine (FTC/TAF, or Descovy). However, this option was approved only for MSM and transgender women who have sex with men, as there was not enough evidence to approve the drug for women who have receptive vaginal sex.

In 2021, the FDA approved the first long-acting injectable form of PrEP, cabotegravir extended-release injectable suspension (CAB-LA, or Apretude) for individuals weighing at least 77 pounds. The medication is administered with two initiation injections 1 month apart and subsequent injections every other month.

CDC does not recommend , but does caution that patients should speak with their healthcare provider if they want to switch from pills to a shot and ensure they test negative for HIV and "have no known allergy to medicines inside the shot."

The 411 on PrEP '2-1-1'

Daily oral PrEP or long-acting injectable PrEP are the only two formulations of the drug regimen specifically approved by the FDA and CDC, though CDC provides information about another off-label form of use called Also called "event-driven PrEP," this type of regimen is for MSM using TDF/FTC only prior to engaging in condomless anal sex. Instead of daily PrEP, patients take:

• 2-24 hours prior to sexual activity: 2 pills

• 24 hours after the first dose: 1 pill

• 24 hours after the second dose: 1 pill

CDC emphasizes that using PrEP in this manner has not been studied in heterosexual men and women, and adds that "taking PrEP as prescribed is currently the only FDA-approved schedule for taking PrEP to prevent HIV."

Disparate Uptake

Of the 1.2 million people who could benefit from PrEP in the U.S. in 2020, 25% were actually prescribed it, according to , which touted the increase from 3% of eligible people in 2015. However, there were marked disparities in prescriptions, especially by race/ethnicity and age.

For example, of the individuals prescribed PrEP, 66% were white, 16% were Hispanic, and 9% were Black.

"Black and Hispanic/Latino people account for the majority of people for whom PrEP is recommended, but have the lowest rates of PrEP use among all racial/ethnic groups," the agency wrote.

CDC also found that similar disparities occurred by age, with 16% of individuals ages 16-24 prescribed PrEP who were recommended for it (vs 27% of adults ages 25-34 and 30% of adults ages 35-44).

Unsurprisingly, data from the CDC's HIV Surveillance Report showed that 69% of new HIV diagnoses in 2019 . Of those, 37% were Black and 32% were Hispanic compared with 25% who were white. Moreover, younger MSM (ages 13-34) made up the majority of diagnoses (with 40% among ages 13-24 and 25% among those ages 25-34).

Barriers to Use

Despite concerted efforts, such as the federal , which attempts to connect people at risk for acquiring HIV to prevention medication through community health centers or STI clinics, there are many reasons uptake continues to be so low. A 2019 study published in AIDS and Behavior examined patients offered PrEP at a community health clinic in Canada, and found patients declined the medication.

The most common reason was perception of risk, with around 42% of patients reporting that they were "not sufficiently at risk to warrant PrEP," while around 25% were "not interested," about 14% said they had an "inability to manage" PrEP use at this time, and about 10% had negative impressions about PrEP.

The researchers added that "stigma seemed to play a strong role in the reason why our patients declined PrEP," writing, "they had preconceived ideas of the 'type of person' who required PrEP (and did not see themselves as such a person) or because they did not want to be viewed as part of a reckless other group of, mostly gay men, who engage in practices that might transmit HIV."

The authors concluded that "the need for more research about people's perceptions of HIV risk and PrEP, and how, when, and why these feel this intervention would be necessary."

Summary

PrEP is highly effective in reducing HIV acquisition and can be administered as oral pills or an injection. However, disparities persist in uptake of PrEP, and these disparities are greatest in racial/ethnic minorities and adolescents. Clinicians should be aware of patient-specific factors that prompt a discussion about PrEP as part of safer sex, the various PrEP options, and screening and monitoring required to begin and continue PrEP.

Read previous installments in this series:

Part 1: The Evolution of HIV: From Death Sentence to Chronic Condition

Part 2: Antiretroviral Therapy for HIV: When Less May Be More

Part 3: Viral Load: HIV's Most Important Disease Marker

Part 4: Case Study: Managing Upper Urinary Tract Kidney Stones in HIV+ Patients