Task Force Recommends PrEP for High-risk Patients

Sept. 7, 2023, News Staff — An updated final recommendation from the U.S. Preventive Services Task Force calls for clinicians to prescribe pre-exposure prophylaxis with effective antiretroviral therapy to people at increased risk of acquiring HIV.

The “A” grade recommendation applies to adolescents and adults who do not have HIV but are at increased risk. To achieve the full benefit of HIV PrEP, the recommendation also stresses that patients should receive counseling about antiretroviral medication adherence and safer sex practices, including condom use and testing.

“PrEP is an essential tool to help reduce rates of HIV in our nation,” task force member John Wong, M.D., said in a USPSTF bulletin. “To prevent HIV, it’s important that health care professionals prescribe PrEP to patients at increased risk and discuss which form of this medication would be best for them.”

The federal government estimates that about 1.2 million people in the United States have HIV and about 13% of those with HIV don’t know they have it. According to the CDC, more than 36,000 diagnoses of HIV infection occurred in 2021, the last year for which data is available.

The updated recommendation, which is consistent with the task force’s 2019 recommendation on the topic, calls for PrEP to be considered for

sexually active adolescents and adults who weigh at least 77 pounds, have engaged in vaginal or anal sex in the past six months, and have a history of inconsistent or no condom use with people whose HIV status is unknown, a bacterial STI in the past six months or a sexual partner who has HIV; and
people who inject drugs and have a partner who also injects drugs and has HIV or shares injection equipment.

The task force said people who engage in transactional sex (including commercial sex workers and people trafficked for sex work), as well as sexually active transgender men and women, should also be considered for PrEP.

The recommendation noted that clinicians need to be aware of local laws and regulations that may apply when providing PrEP to an adolescent minor.

Story Highlights

Several Medications Available

The evidence review found several medications that appeared effective in reducing the risk of sexually acquired HIV infection, including

oral tenofovir disoproxil fumarate (taken alone or with emtricitabine),
oral tenofovir alafenamide plus emtricitabine, and
long-acting injectable cabotegravir.

The FDA has approved these medications to reduce the risk of sexually acquired HIV infection in at-risk adults and adolescents; however, oral tenofovir alafenamide-emtricitabine has not been approved for use in those who are at risk for infection from receptive vaginal sex, as its effectiveness has not been evaluated in these populations.

Findings and Research Gaps

Overall, the evidence review found that oral PrEP with tenofovir disoproxil fumarate, either alone or with emtricitabine, was associated with a significantly decreased risk of acquiring HIV compared with placebo or no PrEP. There was also a strong association between patient adherence and the effectiveness of PrEP.

Oral tenofovir alafenamide-emtricitabine was not inferior to oral tenofovir disoproxil fumarate-emtricitabine in men who have sex with men. The evidence review indicated some positive short-term effects on bone mineral density, but also negative effects on lipid parameters and weight gain.

Long-acting cabotegravir was associated with decreased risk of acquiring HIV compared with oral tenofovir disoproxil fumarate-emtricitabine in men who have sex with men, as well as in transgender women and women at higher risk.

No PrEP medications have received FDA approval for reducing the risk of acquiring HIV from injection drug use. However, CDC clinical practice guidelines indicate that people who inject drugs are likely to benefit from any FDA-approved PrEP medication regardless of whether they have an identified risk from sexual activity.

The USPSTF called for more studies to address research gaps on topics including

tools to identify people at increased risk of acquiring HIV who would benefit from PrEP;
different PrEP drug regimens and dosing strategies;
the safety and effectiveness of PrEP during pregnancy and breastfeeding; and
whether the use of PrEP is associated with an increased risk for other STIs.

Responses to Public Comment

In response to comments on a draft recommendation, the task force

removed the word “infection” to avoid stigmatizing language,
emphasized that adherence support is a key element of providing PrEP,
provided detailed information on the implications of cabotegravir discontinuance, and
clarified that gender-diverse people are one population for which additional research is needed to identify accurate and validated risk-assessment tools.

Supporting Resources

The task force linked to several resources for clinicians and patients, a guide on HIV prevention (available in English and Spanish); a list of PrEP best practices, a clinical practice guideline and a PrEP webpage with mroe resources.

The Academy also offers resources, including an AFP collection of HIV/AIDS content, an adult medicine self-study CME course that features a session on HIV screening and prevention; and familydoctor.org articles on PrEP and HIV medications.