Lenacapavir for HIV Preexposure Prophylaxis: Guidance from the IAS–USA

This new form of long-acting PrEP is recommended for all persons at risk for sexually acquired HIV.

Sponsoring Organization: International AIDS Society–USA (IAS–USA)

Background

On June 18, 2025, the U.S. Food and Drug Administration approved the first-in-class HIV-1 capsid inhibitor lenacapavir for preexposure prophylaxis (PrEP). The approval was based on trial results demonstrating that twice-yearly injections of lenacapavir dramatically lowered risk for HIV acquisition across diverse populations. Now, the IAS–USA panel has provided recommendations concerning use of lenacapavir for PrEP.

Key Recommendations

Lenacapavir is recommended for all persons at risk for sexual acquisition of HIV.
The drug is administered as two subcutaneous injections every 6 months. At initiation, patients should also receive two lenacapavir tablets immediately and t…

Reviewing Author

Wendy S. Armstrong, MD

Disclosures

Consultant/Advisory BoardNIH Therapeutics and Prevention Data Safety Monitoring Board

Leadership Positions in Professional SocietiesAmerican Board of Internal Medicine Infectious Diseases Subspecialty Board (member), Infectious Diseases Society of America (Vice President)