A new HIV prevention option is changing the rhythm of pre-exposure prophylaxis. In June 2025, the U.S. Food and Drug Administration approved Yeztugo, an injectable form of the antiretroviral drug lenacapavir, for adults and adolescents weighing at least 35 kilograms who are HIV-negative and at risk of sexually acquired HIV.
The significance is practical as much as scientific: Yeztugo is administered every six months. Until now, approved PrEP options in the United States have generally required a daily pill or more frequent injections. A twice-yearly schedule could make prevention easier for people who struggle with daily medication, face stigma around pill bottles, have unstable routines, or cannot reliably return for monthly or bimonthly care.
What the approval means
PrEP is not a treatment for HIV. It is medication taken by people who do not have HIV to reduce the chance of infection before exposure. Patients must receive an HIV test before starting Yeztugo and continue testing during care. The FDA also emphasizes that the drug should be used as part of a broader prevention strategy; it does not protect against other sexually transmitted infections.
Yeztugo’s approval followed results from two large clinical studies known as PURPOSE 1 and PURPOSE 2. In PURPOSE 1, which enrolled cisgender women and adolescent girls in South Africa and Uganda, no participants who received lenacapavir acquired HIV during the study period. In PURPOSE 2, which included cisgender men and gender-diverse people in several countries, no HIV infections occurred among participants assigned to twice-yearly lenacapavir. The studies compared the injection with established PrEP approaches and were designed to measure whether the drug could prevent sexual transmission. For related reading, see Lenacapavir: How a Twice-Yearly Injection Could Change HIV Prevention.
Those results made lenacapavir one of the most closely watched developments in HIV prevention. The medicine works by targeting the HIV capsid, a protein shell that helps the virus reproduce and spread inside cells. Because it acts at multiple stages of the viral life cycle, researchers have investigated it both as a treatment component and as a prevention drug.
Convenience—and the work still ahead
A long-acting option may help address one of PrEP’s persistent challenges: effectiveness depends on receiving the medicine as directed. A person who misses daily pills or clinic visits may lose protection. Six-month dosing cannot eliminate that problem, but it reduces the number of appointments and medication decisions required over a year.
Access will determine how broadly that promise is realized. Patients still need testing, clinical follow-up, and a reliable way to return for the next dose. Cost, insurance coverage, provider availability, and public awareness may shape adoption, particularly in communities that already face barriers to HIV prevention and health care.
The approval is therefore not the end of the HIV-prevention story. It is a new tool—one that could make prevention more durable and discreet for many people. Combined with testing, condoms when appropriate, treatment for people living with HIV, and continued public-health outreach, twice-yearly PrEP gives clinicians another way to move toward fewer new infections.
Use: Approval date, eligibility, dosing, testing requirements, and regulatory context.
Use: Background on PrEP, its purpose, HIV testing, and prevention limitations.
Use: Clinical-trial context and findings from the PURPOSE 1 study.
U.S. Food and Drug Administration — FDA approves first injectable HIV pre-exposure prophylaxis — https://www.fda.gov/news-events/press-announcements/fda-approves-first-injectable-hiv-pre-exposure-prophylaxis — Approval date, eligibility, dosing, testing requirements, and regulatory context.
Centers for Disease Control and Prevention — Preventing HIV with PrEP — https://www.cdc.gov/hiv/basics/prep.html — Background on PrEP, its purpose, HIV testing, and prevention limitations.
The New England Journal of Medicine — Lenacapavir for HIV Prevention in Women — https://www.nejm.org/doi/full/10.1056/NEJMoa2407001 — Clinical-trial context and findings from the PURPOSE 1 study.
