The US Food and Drug Administration (FDA) has approved lenacapavir, the first injectable HIV prevention therapy that patients receive only twice a year and that has shown almost complete protection against infection in clinical trials. The decision, announced on June 20, 2025, follows years of research and marks a pivotal moment in the effort to curb new HIV cases.
How Lenacapavir Works
Lenacapavir blocks HIV’s ability to reproduce by targeting its capsid protein, a crucial structure the virus needs to multiply. Rather than stimulating the immune system, the drug halts the virus at its earliest stage, stopping it before it can take hold. Clinical trials demonstrated a 99.9 percent reduction in sexual transmission of HIV among participants weighing more than 35 kilograms when they received injections every six months.
Comparison with Daily PrEP Pills
Until now, pre‑exposure prophylaxis (PrEP) pills taken daily have been the standard preventive measure for people at risk of HIV. These pills require strict daily adherence, and missed doses can reduce protection. By contrast, lenacapavir’s twice‑yearly schedule removes the burden of daily pills, which may help more people maintain continuous protection.
Global and Treatment Background
Before its preventive use, lenacapavir earned approval in several countries as a treatment for people with HIV strains resistant to other drugs. However, this marks the first time any country has approved the drug for prophylaxis. Its dual role underscores lenacapavir’s versatility but also raises questions about prioritizing supply for treatment versus prevention.
Gilead Sciences, the developer of lenacapavir, plans to market the injection under the brand name Yeztugo. The company has pledged to produce 10 million doses by the end of 2026.
Cost and Access Challenges
Despite its promise, the drug’s $28,218 annual list price in the United States presents a significant obstacle for many potential users. In sub‑Saharan Africa—home to roughly two‑thirds of the world’s people living with HIV—the cost could put the therapy out of reach for those who need it most⁴. UNAIDS Executive Director Winnie Byanyima has warned that high prices could limit the impact of what might otherwise be a game‑changer in regions hardest hit by the epidemic.
Implications for Public Health
Public health experts say lenacapavir could transform prevention efforts by reducing new infections and easing the burden on healthcare systems. By removing the daily pill requirement, the injection could reach populations that struggle with pill fatigue, stigma, or irregular access to healthcare services. Yet, rolling out a twice‑yearly injection will require investment in clinic infrastructure and patient follow‑up to ensure on‑schedule dosing.
Personal Analysis
In my view, lenacapavir represents a meaningful step forward in HIV prevention because it simplifies treatment and directly addresses adherence challenges that have long hampered PrEP success. However, without aggressive pricing negotiations and support programs, the injection risks deepening inequalities between wealthy and low‑income countries. Policymakers and global health bodies must work quickly to subsidize costs, expand manufacturing, and train medical staff to administer injections, ensuring this innovation benefits everyone at risk.
