Gilead statement on new CDC guidelines on twice-yearly Yeztugo® (lenacapavir) for HIV prevention

Foster City, Calif., September 18, 2025 – The U.S. Centers for Disease Control and Prevention (CDC) today issued new guidelines for the use of twice-yearly injectable lenacapavir as pre-exposure prophylaxis (PrEP) for HIV prevention. The guidelines strongly recommend twice-yearly lenacapavir for PrEP, marketed in the United States as Yeztugo®. They also recommend that individuals be tested for HIV the day of their first Yeztugo injections and with follow-up injections, which are administered every six months. Yeztugo is an injectable HIV-1 capsid inhibitor manufactured by Gilead Sciences and approved by the U.S. Food and Drug Administration (FDA) to reduce the risk of sexually acquired HIV in adults and adolescents weighing ≥35kg.

The guidelines are based on data from Gilead’s Phase 3 PURPOSE 1 and PURPOSE 2 clinical trials, which showed ≥99.9% of participants who received twice-yearly lenacapavir remained HIV negative.

“Yeztugo represents a transformative scientific advancement in HIV prevention—delivering high efficacy across broad, representative populations in clinical trials and approved as the first and only twice-yearly injectable option in the U.S.,” said Dietmar Berger, MD, PhD, Chief Medical Officer at Gilead Sciences. “As we strive to reimagine the future of HIV prevention, the CDC’s endorsement of Yeztugo offers healthcare providers, public health leaders and communities clear guidance on an innovation that could help shift the trajectory of the HIV epidemic.”

The endorsement by the CDC comes on the heels of the World Health Organization (WHO) issuing guidelines in July that recommend twice-yearly lenacapavir as a PrEP option for HIV prevention. Additionally, in June, the International Antiviral Society-USA Panel updated its PrEP guidelines to recommend twice-yearly lenacapavir for PrEP.

Read the full company statement here.