New HIV PrEP Guidelines

The Centers for Disease Control and Prevention (CDC) estimates that 34,800 people were newly infected with HIV in 2019, and 1.2 million people in the country are living with HIV.^[1] CDC released Preexposure Prophylaxis for the Prevention of HIV Infection in the United States — 2021 Update: A Clinical Practice Guideline on December 8, 2021. This update gives healthcare providers the latest guidance on prescribing HIV pre-exposure prophylaxis (PrEP)—a powerful tool for HIV prevention—to their patients.

If you are a licensed provider, you can prescribe PrEP to prevent HIV infection in your patients. CDC estimates that 1.2 million Americans could potentially benefit from PrEP.^[1] Read on to review the new recommendations and key changes in the updated PrEP guidelines.

New Recommendations

Tell all your sexually active adult and adolescent patients that PrEP can protect them from getting HIV (Grade IIIB). This will not only increase the number of people who know about PrEP but may help your patients overcome embarrassment or stigma that could prevent them from talking to you about behaviors that put them at risk of getting HIV. You should also offer PrEP to anyone who asks for it.

Prescribe cabotegravir (CAB) injections — approved by the US Food and Drug Administration (FDA) in 2021 — as PrEP for your sexually active adult and adolescent patients (Grade IA). CAB may be right for your patients who have problems taking oral PrEP as prescribed, who prefer getting a shot every 2 months instead of taking oral PrEP, and/or who have serious kidney disease that prevents their use of other PrEP medications.

You can review the updated PrEP guideline for a complete list of graded recommendations about PrEP.

Selected Key Changes in the Updated PrEP Guideline

1. The updated guideline includes new, easy-to-use flowcharts (Figures 1 and 2) to guide the determination of indications for PrEP use for your sexually active patients and patients who inject drugs.

Figure 1. Assessing indications for PrEP in sexually active people.

Figure 2. Assessing indications for PrEP in people who inject drugs.

2. There are two recommended oral PrEP medications for your patients:

Truvada® (or generic equivalent; emtricitabine [F]/tenofovir disoproxil fumarate [TDF]) is an FDA-approved daily oral PrEP option for healthy adults and adolescents at risk of getting HIV through sex or injection drug use.
Descovy® (emtricitabine [F]/tenofovir alafenamide [TAF]) is an FDA-approved daily oral PrEP option for men and transgender women at risk of getting HIV through sex. The updated guideline adds F/TAF as a PrEP option for these groups.
- Note: F/TAF has not yet been studied in and is not recommended for people assigned female sex at birth who could get HIV through receptive vaginal sex.

3. The updated guideline includes revisions to recommended assessments for your patients taking oral PrEP. The latest recommended assessments are:

Test for HIV every 3 months.
Test patients with signs or symptoms of sexually transmitted infections (STIs) and screen those who are men who have sex with men for STIs every 3 months.
- Screen all sexually active patients for STIs every 6 months.
Assess creatinine clearance once every 12 months for your patients under age 50 or your patients whose estimated creatinine clearance was greater than 90 mL/min when they started oral PrEP.
- For all other patients, assess creatinine clearance every 6 months.
For your patients taking F/TAF, measure their triglyceride and cholesterol levels and weight every 12 months.
Review the list of medications that may interact with F/TAF or F/TDF.

4. The updated guideline includes new recommended assessments for your patients taking injectable PrEP. The recommended assessments are:

Test for HIV every 2 months (at each injection visit).
Screen patients who are men who have sex with men or who are transgender women for STIs every 4 months (at every other injection visit).
- Screen heterosexually active patients for STIs every 6 months (every third injection visit).
Regular kidney function, triglyceride, or cholesterol assessments are not needed for patients taking CAB as they are for patients taking oral PrEP.

5. The guideline update includes two HIV testing algorithms for assessing HIV status for your patients who are starting PrEP, or restarting after an extended stop, and your patients who are taking or have recently taken PrEP. These algorithms can be found on pages 30 and 31 of the updated PrEP guideline and are summarized below.

For patients who are starting or restarting PrEP after a long stop, test using an HIV antigen/antibody test (a laboratory-based test is preferred).
For patients who are taking or have recently taken PrEP (including patients who have taken oral PrEP in the last 3 months or patients who had a CAB injection in the last 12 months), test using an HIV antibody/antigen assay AND a qualitative or quantitative HIV-1 RNA assay.
If a patient has a positive antigen/antibody test and a detectable HIV-1 RNA test confirming the patient has HIV, discontinue PrEP prescription and link the patient to HIV care and treatment.
If a patient has a negative antigen/antibody test and an undetectable HIV-1 RNA test confirming the patient does not have HIV, continue prescribing PrEP.

In addition to the key changes highlighted above, the PrEP guideline update also includes the latest scientific evidence, clarifies aspects of clinical care, discusses considerations for providing PrEP (eg, same-day PrEP, tele-PrEP, 2-1-1 dosing, primary care for PrEP patients), and makes CDC's guidance simpler to follow so that healthcare providers can apply it more easily. For more information about prescribing PrEP for HIV prevention to your patients, including a summary of what's new, access the updated PrEP guideline.

Practice Applying CDC's Latest PrEP Guidance: New Interactive Patient Simulation Continuing Medical Education

In 2020, only 1 in 4 people who may have benefited from PrEP received prescriptions.^[2] You can help change that by implementing CDC's latest PrEP guidance in your practice.

If you are new to prescribing PrEP and/or would like to practice applying CDC's latest PrEP guidance, check out CDC and Medscape Education's newest educational offering.

Individualizing Sexual Health Care: A Virtual Patient Simulation is a program featuring two patient simulations that provide real-world scenarios and patient interactions (see sample on the left) and allow providers to practice and learn in a safe, true-to-life environment.