Fact Check: FDA approves world's only twice-a-year HIV prevention shot.

Fact Check: "FDA 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, marketed as Yeztugo, as the first and only twice-a-year injectable medication for HIV pre-exposure prophylaxis (PrEP) (Pharmacy Times, Gilead Sciences). This approval marks a significant advancement in HIV prevention, as it provides a highly effective option for individuals at risk of HIV infection. Clinical trials, including the PURPOSE 1 and PURPOSE 2 studies, demonstrated that lenacapavir resulted in a 100% reduction in HIV infections among participants (Pharmacy Times, USA Today).

The drug's efficacy is underscored by its requirement of only two injections per year, which is a notable improvement over existing PrEP options that typically require daily dosing (Gilead Sciences, Stat News). This development is seen as a potential game-changer in the fight against HIV, providing a more convenient and effective method for prevention (NBC News).

Analysis

The claim that the FDA has approved the world's only twice-a-year HIV prevention shot is supported by multiple credible sources. The FDA's official announcement and subsequent reports from major news outlets such as NBC News, USA Today, and CNBC confirm the approval of lenacapavir as a twice-yearly injection for HIV prevention (Pharmacy Times, Gilead Sciences, CNBC).

The clinical trials backing this approval are particularly noteworthy. In the PURPOSE 1 trial, there were no HIV infections reported among participants receiving lenacapavir, indicating its high efficacy (Pharmacy Times). The trials also showed high adherence rates, with over 90% of participants receiving their injections on time (Pharmacy Times).

The sources reporting this information are reputable and include peer-reviewed articles and official press releases from Gilead Sciences, which is the manufacturer of lenacapavir. While Gilead has faced scrutiny in the past regarding drug pricing, the scientific data presented in support of lenacapavir's efficacy appears robust and is corroborated by independent news outlets (Gilead Sciences, Stat News).

Overall, the evidence from these sources indicates that the FDA's approval of lenacapavir as a twice-a-year HIV prevention shot is accurate and reflects a significant advancement in HIV prevention strategies.

Conclusion

Verdict: True
The claim that the FDA has approved the world's only twice-a-year HIV prevention shot is true. The approval of lenacapavir (Yeztugo) as an injectable PrEP option represents a major breakthrough in HIV prevention, supported by clinical trial data demonstrating its effectiveness and adherence rates. The sources consulted provide reliable and consistent information confirming this development.

Sources

1. Gilead Sciences - Wikipedia
2. Regulators Approve Lenacapavir for H.I.V. Prevention
3. FDA Approves Twice-Yearly Lenacapavir for HIV Preexposure ...
4. FDA approves twice-a-year injection for HIV prevention
5. Yeztugo Lenacapavir Is Now the First and Only FDA ...
6. FDA approves Gilead HIV prevention injection lenacapavir
7. FDA approves new twice-yearly HIV shot. What to know
8. HIV protection with just two shots a year: FDA approves Gilead ...