FDA Approves Groundbreaking Twice-Yearly HIV Prevention Injection
The Food and Drug Administration (FDA) has officially approved Gilead Sciences’ twice-yearly injection, Yeztugo (lenacapavir), for HIV prevention. This long-acting antiviral represents a significant leap forward in HIV prevention, offering a convenient alternative to daily pills or more frequent injections.
A Potential Game-Changer in HIV Prevention
Yeztugo stands out by requiring only two doses per year, in contrast to daily oral medications or bi-monthly injections currently on the market. In clinical trials, the injection demonstrated nearly complete protection against new HIV infections, showcasing its strong potential to curb the decades-long epidemic.
Globally, HIV remains a pressing health concern, with the World Health Organization reporting around 1.5 million new infections and 630,000 deaths in 2023. In the United States alone, there are approximately 700 new HIV cases and 100 deaths weekly, disproportionately affecting people of color, men who have sex with men, and transgender individuals.
Gilead’s CEO emphasized the injection’s potential to transform public health outcomes by simplifying prevention and expanding access.
Cost, Coverage, and Accessibility Concerns
The annual list price of lenacapavir in the U.S. is set at $28,218 before insurance, which aligns with the cost of existing HIV prevention drugs like Truvada and Descovy (around $24,000 yearly), and monthly injections such as GSK's Apretude.
Gilead is proactively working to ensure broad insurance coverage for Yeztugo, including copay assistance programs that could reduce costs to zero for eligible insured patients, and free access for those uninsured.
Moreover, Gilead has committed to making generic versions available in 120 low- and lower-middle-income countries, partnering with manufacturers to provide affordable options. Until then, the company plans to supply up to 2 million doses globally without profit.
Overcoming Barriers Beyond Cost
Despite efforts to widen access, social stigma and cultural challenges continue to hinder uptake of HIV prevention, especially outside the demographic of white men who have sex with men. Black and Hispanic communities, which make up a disproportionate share of new diagnoses, remain underrepresented among PrEP users.
The twice-yearly injection offers privacy and convenience, potentially encouraging more people, especially those deterred by stigma or adherence challenges, to seek prevention.
Clinical Trials Confirm Strong Efficacy
In rigorous late-stage studies, lenacapavir showed remarkable results:
- Among more than 2,000 participants, just two contracted HIV, signifying a 96% risk reduction and outperforming daily oral PrEP by 89%.
- In a separate trial involving cisgender women, the injection demonstrated 100% efficacy, with no participants contracting HIV.
The trials included diverse populations such as cisgender men, transgender women, transgender men, and nonbinary individuals.
Challenges Ahead: Funding Threats and Accessibility
Although the approval marks progress, the introduction of Yeztugo coincides with looming obstacles. Proposed federal funding cuts, including reductions to Medicaid and key HIV prevention programs, could limit access for many, particularly lower-income and underserved communities.
Medicaid, which insures a significant portion of Americans living with HIV, is crucial for maintaining treatment and prevention services. Cuts could destabilize the support networks that enable widespread medication access.
Experts warn that without adequate funding, people currently protected by PrEP might fall out of care, potentially leading to increased infection rates.
Looking Forward
Yeztugo’s FDA approval is a promising milestone in the fight against HIV. Yet, success will depend heavily on making the medication affordable and accessible to the populations that need it most. Gilead’s efforts to expand global availability and local assistance programs aim to bridge this gap, but navigating political and funding challenges remains critical.
