The U.S. Food and Drug Administration (FDA) has approved the first and only twice-yearly injectable HIV prevention treatment, Yeztugo, developed by Gilead Sciences. This groundbreaking development marks a significant leap in the ongoing battle against HIV, offering a convenient alternative to traditional daily oral medications. The drug, known as lenacapavir, has been shown to be nearly 100% effective in preventing sexually transmitted HIV infections in adult and adolescent populations.
“This is a historic day in the decades-long fight against HIV,” said Daniel O’Day, chairman and CEO of Gilead Sciences, in a press release. The approval comes after extensive clinical trials that demonstrated lenacapavir’s efficacy, with results surpassing those of current once-daily oral medications like Truvada, another Gilead product.
Yeztugo is administered as an injectable that is slowly absorbed by the body, requiring only two doses per year. Patients must undergo a negative HIV-1 test before starting treatment. The drug’s unique mechanism targets multiple stages of the HIV lifecycle, distinguishing it from traditional antiviral medications that typically act on a single stage. This multi-stage approach is a key factor in its impressive clinical results.
The drug’s effectiveness has been highlighted by its designation as the 2024 “Breakthrough of the Year” by the journal Science. While the benefits of Yeztugo are significant, patients should be aware of potential side effects, including injection site reactions, headaches, and nausea, which were commonly reported during clinical trials. Despite these, the FDA has deemed the drug safe and effective, marking a major advancement in HIV prevention strategies.
Gilead Sciences has emphasized that this treatment could play a crucial role in reducing the global HIV epidemic, offering a more practical solution for long-term prevention. As the first of its kind, Yeztugo represents a transformative shift in the way HIV is prevented, potentially improving adherence and accessibility for at-risk populations.