New H.I.V. Prevention Shot Gets FDA Approval

The US Food and Drug Administration has approved a twice-yearly injection to prevent H.I.V. infection, offering a promising new tool in the fight against AIDS. The shot, called lenacapavir, was shown to provide near-perfect protection in clinical trials.

However, its availability is uncertain due to deep cuts to global health programs that were expected to purchase and distribute the drug in low-income countries. Advocacy organizations worry that insurance companies may raise barriers to widespread access, while proposed cuts to Medicaid could restrict access for Americans at risk of H.I.V. infection.

Gilead Sciences has announced plans to make lenacapavir available to 120 low-income nations at affordable prices, but the agreement does not extend to middle-income countries. The company will also provide the drug as a preventative at “no-profit costs” to two million people in those countries until demand can be met.

The approval of lenacapavir is seen as a significant development in H.I.V. prevention, with many experts believing it has the potential to transform the epidemic. However, its high price and uncertain availability raise concerns about accessibility.

Source: https://www.nytimes.com/2025/06/18/health/hiv-fda-lenacapavir.html