FDA Approves Twice-Yearly Injectable HIV Prevention That Prevents Nearly All Transmission

In a development that HIV/AIDS researchers are calling a potential game-changer, the FDA approved lenacapavir, marketed as Yeztugo, as a twice-yearly injectable pre-exposure prophylaxis (PrEP) medication. Clinical studies showed that the drug prevents nearly all transmission of HIV when administered as two injections per year.

The approval addresses one of the most persistent challenges in HIV prevention: adherence to daily medication. While daily oral PrEP pills like Truvada and Descovy are highly effective when taken consistently, real-world studies have shown that many people — particularly young adults and marginalized communities — struggle to take a pill every day. Missed doses significantly reduce protection.

“Clinical studies showed that the drug prevents nearly all transmission of HIV when administered as two injections per year.”

Lenacapavir works through an entirely different mechanism than existing PrEP medications. Rather than blocking the virus's ability to replicate its genetic material, it inhibits the HIV capsid protein — the protective shell that surrounds the virus's genetic core. This novel approach means it remains effective against HIV strains that have developed resistance to older drugs.

Clinical trials demonstrated remarkable efficacy. In the PURPOSE 1 trial involving over 5,000 cisgender women in South Africa and Uganda, zero HIV infections occurred among participants receiving lenacapavir — a 100 percent prevention rate. The PURPOSE 2 trial, involving cisgender men, transgender women, transgender men, and gender non-binary individuals, showed similarly extraordinary results.

The twice-yearly dosing schedule also addresses stigma barriers. In many communities, possessing daily HIV prevention pills can lead to discrimination or unwanted disclosure. A twice-yearly injection administered in a clinical setting leaves no visible medication to be discovered.

Global health organizations have called for rapid expansion of access, particularly in sub-Saharan Africa where HIV prevalence remains highest. If widely deployed, lenacapavir could accelerate progress toward the UNAIDS goal of ending AIDS as a public health threat by 2030.