New HIV Drug Offers 6-Month Protection, But Faces Backlash Over Price

The latest news regarding the global fight against HIV details that the U.S. Food and Drug Administration (FDA) has approved Gilead Sciences’ long-acting HIV prevention drug, lenacapavir, which will be marketed under the name Yeztugo.

Unlike previous medications, Yeztugo requires only a single injection every six months, marking a significant shift in how HIV prevention can be managed.

Yeztugo is an evolution of lenacapavir, which was previously approved in 2022 under the brand name Sunlenca for patients with treatment-resistant HIV.

The FDA approval was based on two large Phase III trials, PURPOSE I and PURPOSE II. In PURPOSE I, over 2,000 cisgender women using Yeztugo experienced zero HIV infections, demonstrating 100% effectiveness.

PURPOSE II, which included over 2,000 cisgender men and gender-diverse individuals, showed a 99.9% prevention rate with two HIV cases. The trials also confirmed Yeztugo was well-tolerated with no new safety concerns.

Analysts from BMO Capital Markets predict strong adoption of Yeztugo, citing its clean safety profile and convenient twice-yearly regimen aligned with standard physician visits. Mizuho analysts further noted its potential to “redefine the PrEP market.”

Despite its breakthrough status, Yeztugo’s pricing has already sparked controversy. Gilead has set a U.S. list price of $28,218 per person per year. Yet a Lancet HIV study published this week estimates that generic versions of lenacapavir could be produced for as little as $35–$46 per year—and even $25 with large-scale production commitments.

This dramatic price gap prompted a sharp response from UNAIDS Executive Director Winnie Byanyima. “Lenacapavir could be the tool we need to bring new infections under control – but only if it is priced affordably and made available to everyone who could benefit,” she said.

“If this game-changing medicine remains unaffordable, it will change nothing. I urge Gilead to do the right thing. Drop the price, expand production, and ensure the world has a shot at ending AIDS.”

Gilead CEO Daniel O’Day called the approval “a historic day in the decades-long fight against HIV,” emphasizing the importance of innovation in the global effort to end the epidemic. Yet, public health advocates stress that for Yeztugo to fulfill its promise, affordability and access must accompany innovation.