DRUG SPOTLIGHT: Yeztugo® (lenacapavir)

Manufacturer: Gilead Sciences
FDA Approval Date:  6/18/2025

A new formulation of lenacapavir has been developed for preexposure prophylaxis (PrEP) against HIV-1 infection. Yeztugo provides protection with only two annual injections. Gilead is also in the process of developing a once-yearly formulation of Yeztugo.

Clinical Profile:

Lenacapavir has been available in oral & subcutaneous formulations since 2022 under the brand name SUNLENCA for those with HIV infections that can’t be controlled with current therapies.  For PrEP, Yeztugo demonstrated a 96% efficacy rate as opposed to a common PrEP option, Truvada (89%).

Population:

There are currently 1.2 million people in the U.S. eligible for PrEP. 

Pricing and Availability:

Yeztugo will have a list price of $28,218 per year. This is marginally more than the list price of branded Descovy ($26,400).

Management Strategy:

Due to the nature of how Yeztugo is administered, it would most likely be billed under the medical benefit and administered in clinic. Oral Descovy 200mg/25mg for PrEP is billed under the pharmacy benefit at $0 member cost share. There is the potential for some shift of oral PrEP therapy spend from the pharmacy benefit to the medical benefit if members transition from the oral Descovy to the long-acting Yeztugo shot.

References
BioPharma Dive

Additional Information: 
Press Release Prescribing Information