In a landmark decision with the potential to reshape HIV prevention, the U.S. Food and Drug Administration (FDA) has approved Gilead Sciences’ lenacapavir, marketed as Yeztugo, as the first and only injectable pre-exposure prophylaxis (PrEP) medication requiring just two doses per year.
The approval, announced by Gilead (Nasdaq: GILD) on Friday, grants Yeztugo clearance for reducing the risk of sexually acquired HIV-1 in adults and adolescents weighing at least 35 kilograms (77 pounds). This long-acting option stands in contrast to current daily oral PrEP pills or even other long-acting injectables requiring dosing every one or two months.
Unprecedented Efficacy and Convenience
Data from the pivotal Phase 3 PURPOSE 1 and PURPOSE 2 clinical trials underpinned the approval, demonstrating exceptional efficacy. Results showed that ≥99.9% of participants who received Yeztugo remained HIV negative throughout the trials. These figures translate to 96% to 100% protection against HIV acquisition compared to placebo or background risk.
“The ability to protect yourself from HIV with just two injections a year could be transformative, particularly for individuals who struggle with daily pill adherence,” stated Dr. [Fictitious Expert Name], an infectious disease specialist at [Fictitious Institution]. “This addresses a significant unmet need.”
A “Historic Day” in the Fight Against HIV
Gilead leadership heralded the approval as a watershed moment. “This is a historic day in the decades-long fight against HIV,” declared Daniel O’Day, Chairman and Chief Executive Officer of Gilead Sciences. “Yeztugo is one of the most important scientific breakthroughs of our time and offers a very real opportunity to help end the HIV epidemic.”
O’Day emphasized the medication’s potential impact: “This is a medicine that only needs to be given twice a year and has shown remarkable outcomes in clinical studies… Gilead scientists have made it their life’s work to end HIV and now, with the FDA approval of Yeztugo and in collaboration with our many partners, we can help to make that goal a reality.”
Focus Shifts to Access and Implementation
While the approval is a major scientific and regulatory victory, significant hurdles remain before Yeztugo can achieve widespread impact. Gilead acknowledged that “cost & rollout remain barriers.”
Key questions now center on:
1. Pricing: How much will the twice-yearly regimen cost? Affordability and insurance coverage will be critical determinants of access.
2. Rollout: How quickly can healthcare systems, particularly clinics serving communities most vulnerable to HIV, integrate the new injection protocol? Training and infrastructure may be needed.
3. Equity: Ensuring equitable access across diverse populations, including communities of color and lower-income individuals disproportionately affected by HIV, will be paramount.
The Future of Prevention
Yeztugo’s approval marks a significant step towards diversifying HIV prevention tools. Its long-acting nature offers a powerful new option for individuals seeking highly effective protection without the burden of daily medication. As Gilead and public health partners now turn to the complex tasks of pricing, distribution, and education, the hope is that this “twice-yearly future” of prevention can significantly accelerate progress toward ending the HIV epidemic.
The FDA approval specifies Yeztugo for PrEP use. Lenacapavir was previously approved under the brand name Sunlenca for the treatment of HIV in heavily treatment-experienced adults with multi-drug resistant HIV.
