Pre-exposure prophylaxis for HIV prevention

Pre-exposure prophylaxis for HIV prevention, commonly known as PrEP, is the use of antiviral drugs as a strategy for the prevention of HIV/AIDS by people that do not have HIV/AIDS.[1] PrEP is one of a number of HIV prevention strategies for people who are HIV-negative but who have a higher risk of acquiring HIV, including sexually active adults who are at increased risk of contracting HIV, people who engage in intravenous drug use (see drug injection), and serodiscordant sexually active couples.[2]

The first form of PrEP for HIV prevention—emtricitabine and tenofovir disoproxil (FTC/TDF; Truvada)—was approved in 2012.[3] In October 2019, the US Food and Drug Administration (FDA) approved the combination of emtricitabine and tenofovir alafenamide (FTC/TAF; Descovy) to be used as PrEP in addition to Truvada, which provides similar levels of protection.[4] Descovy, however, is currently approved only for cisgender males and transgender women as the efficacy has not been assessed in people at risk for HIV through receptive vaginal sex.[2]

In December 2021, the US FDA approved cabotegravir (Apretude), which is an injectable form of PrEP manufactured by Viiv Healthcare. Regulators believe it will improve medication adherence because it has to be taken just once every two months, and it will also widen adoption as it eliminates the need to hide pills or pharmacy visits for discretion.[5]

In its 2021 guidelines, the World Health Organization (WHO) recommends multiple forms of PrEP for HIV prevention:[6]

  • Oral PrEP using TDF-containing compounds for anyone at substantial risk of HIV infection;
  • Event-driven PrEP for men who have sex with men (MSM); and
  • The dapivirine vaginal ring (DPV-VR) for women at substantial risk of HIV infection who do not have access to oral PrEP.[6]

On 18 June 2025, the FDA approved the long-acting HIV prevention antiretroviral lenacapavir in the United States.[7] The drug is branded as Yeztugo by Gilead Sciences and requires only two doses a year demonstrating high efficacy in clinical trials by offering nearly complete protection against HIV infection.[8] As the second PrEP extended-release option following cabotegravir, lenacapavir's simplified dosing schedule could significantly improve patient access and adherence, especially for populations at higher risk of HIV.[9] However, the global rollout may be challenged by recent funding reductions by the Trump Administration in global health funding by the United States that were expected to support lenacapavir access in lower-income countries across sub-Saharan Africa by PEPFAR.[10] The WHO is planning to adopt lenacapavir in global guidelines for resource limited settings as well as for WHO pre-qualification regulatory approval.[11]

  1. ^ "Pre-Exposure Prophylaxis". HIV.gov. 3 December 2019. Retrieved 3 August 2020.
  2. ^ a b Cite error: The named reference :5 was invoked but never defined (see the help page).
  3. ^ "Oral PrEP TDF/FTC". PrEPWatch. 17 February 2023. Retrieved 23 August 2023.
  4. ^ "FDA approves the second drug to prevent HIV infection as part of ongoing efforts to end the HIV epidemic". U.S. Food and Drug Administration (FDA) (Press release). 3 October 2019. Archived from the original on 10 October 2019. Retrieved 10 October 2019. This article incorporates text from this source, which is in the public domain.
  5. ^ "FDA Approves First Injectable Treatment for HIV Pre-Exposure Prevention". U.S. Food and Drug Administration (FDA) (Press release). 20 December 2021. Retrieved 20 April 2022.
  6. ^ a b Consolidated guidelines on HIV prevention, testing, treatment, service delivery and monitoring: recommendations for a public health approach. Geneva: World Health Organization. 2021.
  7. ^ Mandavilli A (18 June 2025). "Regulators Approve a Twice-Yearly Shot to Prevent H.I.V. Infection". The New York Times. ISSN 0362-4331. Retrieved 22 June 2025.
  8. ^ Lambert J (18 June 2025). "HIV prevention drug hailed as a 'breakthrough' gets FDA approval". NPR. Retrieved 22 June 2025.
  9. ^ Silverman Jason Mast, Ed (18 June 2025). "HIV protection with just two shots a year: FDA approves Gilead drug". STAT. Retrieved 22 June 2025.{{cite web}}: CS1 maint: multiple names: authors list (link)
  10. ^ "Gilead Statement on Access Planning for Lenacapavir for HIV Prevention in Low- and Middle-Income Countries". www.gilead.com. Retrieved 22 June 2025.
  11. ^ "FDA approval of injectable lenacapavir marks progress for HIV prevention". www.who.int. Retrieved 22 June 2025.
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