In a decision that could fundamentally reshape the fight against HIV, the US Food and Drug Administration (FDA) has given its approval to Gilead Sciences' lenacapavir, a groundbreaking twice-yearly injection for preventing HIV infection in adults and adolescents. Marketed under the brand name Yeztugo in the US, this innovative drug has been eagerly anticipated by both investors and HIV/AIDS activists worldwide.
A New Era for HIV Prevention: Long-Acting PrEP
Current pre-exposure prophylaxis (PrEP) medications, while highly effective, primarily consist of daily pills that necessitate strict adherence for optimal efficacy. Lenacapavir, a capsid inhibitor, offers a significant leap forward in convenience and adherence, having demonstrated nearly 100% effectiveness in large-scale trials last year. This remarkable success has sparked new hope for interrupting the transmission of the virus, which continues to infect approximately 1.3 million people each year.
Gilead CEO Daniel O'Day hailed the approval as a "milestone moment," expressing confidence that lenacapavir is "the most important tool we have yet to bend the arc of the epidemic and move this epidemic into the history books."
Global Accessibility and Affordability: A Crucial Next Step
While Yeztugo will carry a list price of $28,218 per year in the US, Gilead has outlined ambitious plans for a rapid launch across the country and a broader global rollout in collaboration with international partners. Johanna Mercier, Gilead's chief commercial officer, emphasised the company's "end game" of normalising PrEP usage, particularly in low-income African nations where the virus is most prevalent.
Mercier anticipates that around 75% of US insurers, including government health plans, will cover lenacapavir for PrEP within approximately six months of launch, rising to 90% within a year.
Addressing the Global Epidemic: Partnerships and Funding Concerns
Lenacapavir is already available in the US under the brand name Sunlenca as a treatment for patients with advanced HIV disease that has developed resistance to other drugs.
A significant development for global access occurred in December under then-President Joe Biden, when the President’s Emergency Plan for AIDS Relief (PEPFAR) signed an agreement with the Global Fund to Fight AIDS, Tuberculosis, and Malaria. This agreement aims to provide treatment to as many as 2 million people over three years, contingent upon US regulatory approval for the prevention of the condition. This unprecedented move would facilitate early access to this state-of-the-art treatment, as six generic drugmakers, having licensed the product from Gilead, prepare to produce low-cost versions in 120 resource-limited countries.
However, concerns have been raised by HIV/AIDS activists regarding recent cuts to PEPFAR by the Trump administration, questioning the US government's sustained commitment to the global rollout. O'Day acknowledged these "challenging" changes but affirmed ongoing discussions with both the Global Fund and PEPFAR. He expressed belief that "there will be sources of funding for this, and that these organisations will prioritise this type of prevention."
The approval of Yeztugo represents a pivotal moment in HIV prevention, offering a highly effective and convenient option that could significantly impact the global trajectory of the epidemic. The focus now shifts to ensuring equitable and widespread access to this innovative medicine, particularly in communities most affected by HIV.