The U.S. Food and Drug Administration (FDA) has officially approved Yeztugo, the world’s first twice-yearly HIV prevention injection, developed by Gilead Sciences. The injectable, whose generic name is lenacapavir, is set to revolutionize HIV prevention strategies and could significantly reduce new infections—if widely adopted.
Administered just twice a year by healthcare professionals, Yeztugo provides more than 99.9% protection against HIV in clinical trials, making it one of the most effective pre-exposure prophylaxis (PrEP) methods ever developed.
A Major Leap Beyond Daily Pills
Lenacapavir represents a breakthrough in antiretroviral (ARV) technology. Unlike existing daily pill-based PrEP options such as Truvada, Yeztugo’s six-month injection schedule removes one of the most significant barriers to HIV prevention: adherence.
“This is the single best opportunity in 44 years of HIV prevention,” said Mitchell Warren, executive director of the advocacy group AVAC, speaking to NBC News.
“The promise here is enormous, especially for people who struggle with daily medication.”
The Science Behind Yeztugo
Yeztugo works by blocking HIV from entering and replicating within immune cells. This injectable form of lenacapavir was previously licensed under the name Sunlenca in 2022, as a treatment for highly drug-resistant HIV in combination with other therapies.
In Gilead’s most recent clinical trials:
- Participants were randomly assigned either two injections per year of Yeztugo or a daily Truvada regimen.
- The Yeztugo group had an 89% lower HIV incidence than the Truvada group.
- Compared to those with no PrEP use, the Yeztugo group saw a 96% lower infection rate.
In a separate trial focused on cisgender women in Sub-Saharan Africa, not a single participant who received Yeztugo contracted HIV—a result experts have called “unprecedented.”
A Turning Point in HIV Prevention
For public health officials and HIV advocacy groups, the approval is a long-awaited breakthrough that could accelerate the declining rate of new infections, particularly among communities with limited access to daily medication or high levels of stigma.
Gilead CEO Daniel O’Day called the approval a monumental moment:
“This treatment may help end the HIV epidemic once and for all.”
Challenges Ahead: Cost and Access
While the clinical benefits are clear, questions remain around cost, insurance coverage, and availability, especially in low-income and high-prevalence regions.
In the U.S., access to PrEP remains uneven, and barriers such as medical infrastructure, stigma, and affordability persist. In Africa, despite high demand, rollout of similar HIV prevention technologies has often been slow and fragmented.
Governments, NGOs, and pharmaceutical stakeholders will now need to collaborate to ensure Yeztugo doesn’t become a breakthrough reserved only for the privileged few.
Conclusion: Hope on the Horizon
Yeztugo is not just a new drug—it’s a paradigm shift. By replacing daily pill routines with two clinic visits a year, lenacapavir could finally bridge the gap between HIV prevention science and real-world application.
But with that potential comes responsibility—to make sure that cost, distribution, and equity don’t hinder what could be the biggest step forward in HIV prevention in decades.
