July 1, 2025: In a groundbreaking step toward ending the global HIV epidemic, the U.S. Food and Drug Administration (FDA) has approved lenacapavir, marketed as Yeztugo by Gilead Sciences, as the world’s first twice-yearly injectable pre-exposure prophylaxis (PrEP) for HIV prevention. This long-acting injection, administered every six months, offers a highly effective and convenient alternative to daily oral PrEP pills or bimonthly injections, potentially transforming HIV prevention efforts worldwide.
A New Era in HIV Prevention
Lenacapavir, previously approved in 2022 as Sunlenca for treating multidrug-resistant HIV, is a capsid inhibitor that disrupts multiple stages of the HIV lifecycle. As Yeztugo, it is now approved for adults and adolescents (weighing at least 77 lbs) to prevent sexually acquired HIV. The drug is administered as two subcutaneous injections in the abdomen every six months, creating a slow-release “depot” that provides sustained protection.
Clinical trials demonstrated remarkable efficacy. In the PURPOSE 1 trial in sub-Saharan Africa, zero HIV infections were recorded among 2,134 cisgender women receiving lenacapavir, compared to some infections in the group taking daily oral Truvada. Across PURPOSE 1 and PURPOSE 2 trials, lenacapavir achieved 99.9% effectiveness, nearly eliminating HIV transmission. A July 2024 study in the New England Journal of Medicine reported zero infections in one trial arm, earning lenacapavir Science magazine’s 2024 “Breakthrough of the Year” designation.
Why It Matters
“This is a game changer,” said Gilead CEO Daniel O’Day. “Lenacapavir’s twice-yearly dosing could improve adherence and reduce the burden of daily pills, especially for those with limited healthcare access or facing stigma.” Experts, including Dr. Joe Eron of the University of North Carolina, see it as the closest thing to an HIV vaccine yet, with the potential to curb the 1.3 million new HIV infections reported annually.
The injection’s discretion and long-lasting protection could particularly benefit women in high-prevalence areas, where carrying pills may invite stigma. “This could empower communities and help end the 44-year AIDS epidemic,” said Dr. Linda-Gail Bekker, a leading HIV researcher.
Challenges Ahead
Despite its promise, challenges remain. Yeztugo’s U.S. list price is $28,218 per year, raising concerns about affordability. Gilead has pledged “no-profit” pricing for up to two million people in low-income countries, but middle-income nations like Brazil, which account for nearly 25% of new infections, are excluded. Proposed U.S. federal funding cuts for HIV prevention under the Trump administration could further limit domestic access.
Two rare cases of HIV resistance to lenacapavir in trials underscore the need for regular monitoring. Additionally, lenacapavir does not protect against other sexually transmitted infections, so condoms and STI screenings remain essential.
Global Rollout and Future Impact
Gilead is seeking regulatory approval in multiple countries, with World Health Organization (WHO) guidelines expected on July 14, 2025, at the International AIDS Conference in Kigali. The WHO’s prequalification program aims to accelerate approvals in high-burden regions. However, experts stress that robust supply chains, political will, and community engagement are critical to ensuring equitable access.
Social media reactions on X highlight widespread excitement, with users calling Yeztugo a “revolutionary” step toward ending AIDS. Yet, some express concern that high costs and limited access could hinder its global impact.
A Step Toward Ending AIDS
The FDA’s approval of lenacapavir marks a historic milestone in HIV prevention. If cost and access barriers are addressed, this twice-yearly injection could redefine the fight against HIV, bringing the world closer to ending the epidemic. For now, stakeholders await global rollout plans and hope for a future where HIV transmission is a thing of the past.
