Economic conditions & trends

FDA Approves Biannual HIV Prevention Shot

Published JUN 18 2025

Story

Above: A syringe in front of the logo of Gilead Sciences pharmaceutical company on April 4, 2025. Image credit: Nikos Pekiaridis/NurPhoto/Getty Images

The Facts

The U.S. Food and Drug Administration (FDA) approved Lenacapavir — a twice-yearly injectable drug to prevent HIV — on Wednesday, with manufacturer Gilead Sciences marketing it under the brand name Yeztugo.
Reuters
Business Wire
CNBC
The drug works by targeting the capsid protein of HIV, disrupting multiple stages of viral replication. This mechanism is distinct from other antiretrovirals and is designed to reduce the likelihood of resistance development over time.
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Aaas
In clinical trials, lenacapavir showed high efficacy. The Phase 3 PURPOSE 1 trial, presented in June 2024, reported 100% protection against HIV in women and adolescent girls, while PURPOSE 2 showed a 96% reduction in new infections among men and transgender women who have sex with men.
Benzinga
Aaas
NEJM
Gilead
Gilead
Lenacapavir will be priced $28,218 annually in the U.S., comparable to current preventive options. However, researchers from the University of Liverpool say the drug could be manufactured for as little as $25 per year at scale, including a 30% profit margin.
guardian
Benzinga
The New York Times
Gilead stated it is planning for global access “at unprecedented speed,” and pledged last year that it would offer lenacapavir at no-profit prices to 2 million people across 120 low-income countries, until six partner manufacturers can scale up production and provide the drug affordably. The company has submitted applications to the European Medicines Agency to help expedite access in those regions.
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The New York Times
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Bloomberg.com

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The Spin

Narrative A

Gilead's breakthrough represents the closest thing to an HIV vaccine available today. The twice-yearly injection eliminates daily pill adherence challenges that have hindered prevention, particularly among young women in sub-Saharan Africa where HIV rates remain high. Lenacapavir’s near 100% efficacy in preventing infections — and the potential for it to cost just $25 a year — could finally turn off the tap of new HIV cases globally.

guardian

Narrative B

Despite Gilead's breakthrough, the current pricing in the U.S. for lenacapavir remains a barrier to widespread access. While licensing agreements with generics offer some hope, the lack of licensing agreements in key regions like Latin America and parts of Eastern Europe could limit the drug’s global impact, leaving millions at risk and undermining its potential to turn the tide on the HIV epidemic.

Think Global Health

Metaculus Prediction

Editor's Note

This story currently has limited reporting from right-wing sources. We will continue to monitor all major outlets and update our coverage as additional perspectives become available.