On This Day in Health: June 18, 2025
On June 18, 2025, the U.S. Food and Drug Administration approved lenacapavir, sold as Yeztugo by California-based Gilead Sciences, for preventing sexually acquired HIV in eligible adults and adolescents. The decision introduced the first HIV pre-exposure prophylaxis option with injections given every six months. Known as PrEP, preventive medication helps people without HIV reduce their chance of acquiring the virus. The approval covered adults and adolescents weighing at least 35 kilograms who were at risk of infection. It marked a major extension of prevention choices, especially for people who found it difficult to maintain a daily pill routine.
HIV prevention medicines were already highly effective when used as intended, but access and consistent use remained persistent challenges. Daily oral PrEP required an ongoing medication habit, while an earlier injectable option involved visits more frequently than twice a year. Lenacapavir offered a different schedule because its long-lasting formulation could maintain drug exposure between six-month visits. It inhibits the HIV capsid, the protein structure that encloses the virus's genetic material, interfering with stages of viral replication. The approval did not turn the medicine into a vaccine or a cure for existing infection. It authorized a preventive use within a continuing clinical service.
Evidence came from two large randomized studies, PURPOSE 1 and PURPOSE 2, involving different populations and settings. At the primary analysis, no HIV infections occurred among women receiving lenacapavir in PURPOSE 1. PURPOSE 2 found a substantial reduction in infections among men and gender-diverse participants, although infections did occur in the lenacapavir group. Those results supported strong protection without establishing that infection was impossible. The studies also compared the new approach with existing oral prevention options. Injection-site reactions were common, including small lumps that could persist, and continued observation was needed to understand the experience of using the medicine over longer periods.
The six-month interval reduced the frequency of dosing but did not remove the need for testing and follow-up. Confirming that someone did not have HIV before starting and before subsequent injections was particularly important because using a single preventive medicine during an unrecognized infection could select resistant virus. Starting treatment also involved oral loading doses alongside the initial injections. The approval opened a U.S. regulatory pathway; it did not automatically provide worldwide access or resolve questions of cost, insurance and clinic capacity. The milestone's lasting significance was the addition of a powerful prevention method with a schedule suited to different lives. Turning that scientific advance into fewer infections still depended on affordable delivery, informed choice and dependable health services.
PrEP prevents HIV acquisition in people who do not have HIV. Before lenacapavir's preventive approval, options already included daily oral medicines and an injectable medicine administered more frequently.
Lenacapavir is a capsid inhibitor. Its long-acting formulation made a six-month injection schedule possible, offering an additional choice rather than eliminating the need for other prevention methods.
PURPOSE 1 and PURPOSE 2 supplied the main evidence for approval. Strong trial results did not mean that every infection could be prevented in every circumstance or that follow-up could stop.
Testing for HIV remained a central safeguard because undetected infection during preventive use could lead to drug resistance. Injection-site reactions and practical arrangements for repeat visits also mattered.
The June 18 decision authorized use in the United States. Approval, insurance coverage, international regulatory decisions and actual delivery to communities were separate developments.
The advance broadened the range of prevention schedules available to patients and clinicians. Its public-health impact depended on making that choice accessible and supporting people throughout continued use.
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