Anniversary of FDA Approval of PrEP

Content From: Robyn Neblett Fanfair, MD, MPH, Captain, USPHS, Acting Director, Division of HIV Prevention, National Center for HIV, Viral Hepatitis, STD, and TB Prevention, Centers for Disease Control and PreventionPublished: July 17, 20233 min read



July 16th marks the anniversary of the U.S. Food and Drug Administration’s (FDA) approval of HIV pre-exposure prophylaxis (PrEP). Truvada was the first medication approved for HIV prevention 11 years ago. In 2019, Descovy was added as a PrEP option, and the first injectable PrEP, Apretude, became available in 2022.

After PrEP’s approval, the CDC’s Division of HIV Prevention (DHP) prioritized PrEP in its HIV prevention toolbox. The Ending the HIV Epidemic in the U.S. (EHE) initiative and the National HIV/AIDS Strategy (NHAS) for the United States (2022-2025) set a bold target to increase PrEP coverage to 50 percent by 2025. EHE and NHAS call for proactive strategies that include the provision of PrEP within primary care settings, pharmacies, and syringe services programs (SSPs). As part of EHE, state and local communities, in partnership with CDC and other federal agencies, employ innovative strategies, including TelePrEP, same-day PrEP delivery, long-acting injectable PrEP, and pharmacy-based access to PrEP. These efforts focus on African American and Latino gay and bisexual men, African American women, people who inject drugs, and other populations disproportionately affected by HIV.

Although we continue to make progress, the progress is uneven. Data show that 30% of the 1.2 million persons eligible for PrEP were prescribed it in 2021, compared to 13% in 2017. However, disparities in PrEP coverage exist across racial and ethnic groups. Only 11% of African American persons and 21% of Hispanic/Latino persons eligible for PrEP were prescribed it compared to 78% of White persons. Deeply entrenched social determinants of health drive these disparities and their outcomes.

As part of EHE, CDC and federal partners continue to implement several strategies to increase access to and use of PrEP, such as:

  • Adding flexibility to core funding requirements that allow communities to provide services related to PrEP.
  • Working with the Health Resources and Services Administration (HRSA) to train healthcare providers on prescribing and managing PrEP.
  • Maintaining the clinical guidelines for prescribing PrEP.
  • Developing and delivering social marketing campaigns to the public and healthcare providers to encourage the use of PrEP and to combat the stigmas associated with PrEP use and HIV.
  • Developing and maintaining the CDC’s Compendium of Evidence-Based Interventions and Best Practices for HIV Prevention.

We have the tools to end the HIV epidemic in the U.S., but our nation will not succeed until people who can benefit most from HIV prevention and care are equitably reached. We must continue researching, implementing, and adopting promising biomedical prevention options.

As we celebrate over a decade of PrEP, we must acknowledge the “Mother of PrEP,” the late Dr. Dawn K. Smith. Her visionary work moved PrEP to the forefront of HIV prevention tools used in the United States and globally. Let’s pause to recognize the anniversary of PrEP while we continue to work for a world free of HIV.