Fact Check: U.S. Approves World's Only Twice-a-Year HIV Prevention Shot
What We Know
On June 18, 2025, the U.S. Food and Drug Administration (FDA) approved lenacapavir, a twice-yearly injection for the prevention of HIV infection. This drug is marketed under the name Yeztugo and is noted for providing near-complete protection against HIV in clinical trials, with participants receiving just two shots a year remaining HIV negative (New York Times, NPR). Lenacapavir is the second long-acting option for HIV prevention, following cabotegravir (Apretude), which is administered every two months (Reuters).
The approval is seen as a significant milestone in HIV prevention, especially given that over 39,000 individuals contracted HIV in the U.S. in 2023 alone (NPR). Lenacapavir's efficacy was highlighted in clinical trials, where it demonstrated an impressive efficacy rate of 96% (NPR).
However, the rollout of lenacapavir faces challenges, particularly in low-income countries where funding cuts to global health programs may limit access to the drug. Advocacy groups express concern that the high cost of the drug, approximately $28,218 per year, could hinder widespread adoption (New York Times, CBS News).
Analysis
The claim that the U.S. has approved the world's only twice-a-year HIV prevention shot is partially true. While it is accurate that lenacapavir is the first drug approved in the U.S. for this specific regimen, it is important to note that cabotegravir (Apretude) is already available as a two-month injection. Thus, lenacapavir is not the only long-acting option; it is simply the first to offer a twice-yearly dosing schedule (NPR, CBS News).
The sources used in this analysis are credible, with the New York Times and NPR being reputable news organizations known for their thorough reporting. The FDA's approval is a verified fact, and the clinical trial results are backed by peer-reviewed studies, lending further credibility to the claims about lenacapavir's efficacy (NPR, Reuters). However, the concerns raised by advocacy groups about access and affordability highlight significant barriers that could affect the drug's impact on the HIV epidemic, particularly in low-income regions (New York Times, CBS News).
Conclusion
The claim that the U.S. has approved the world's only twice-a-year HIV prevention shot is partially true. While lenacapavir is indeed a new option for HIV prevention with a twice-yearly dosing schedule, it is not the only long-acting option available, as cabotegravir also exists. The approval of lenacapavir represents a significant advancement in HIV prevention, but the challenges regarding access and affordability may limit its effectiveness in combating the epidemic, particularly in low-income countries.
Sources
- Regulators Approve Lenacapavir for H.I.V. Prevention - New York Times
- HIV prevention drug hailed as a 'breakthrough' gets FDA approval - NPR
- US FDA approves Gilead's twice-yearly injection for HIV - Reuters
- HIV prevention drug lenacapavir approved by FDA as twice - CBS News
- FDA approves new twice-yearly HIV shot. What to know - USA Today
