Reactions continue to follow the recent approval of Yeztugo, a twice-yearly injectable medication for HIV prevention, with global health experts warning that its high cost could exclude millions of vulnerable people from accessing it.
Speaking in Abuja on Sunday, experts expressed both optimism and caution about the development.
The United States Food and Drug Administration (FDA) recently approved long-acting injectable Lenacapavir for HIV prevention. Administered once every six months, the drug represents a major leap forward in expanding global prevention options for people at high risk of infection.
In two major clinical trials completed in 2024, Gilead’s injection, marketed as Yeztugo, was shown to be highly effective, virtually eliminating new HIV infections when taken twice a year.
Its low-dose frequency makes it a more convenient alternative to existing options like daily oral PrEP pills (Truvada and Descovy) and GSK’s Apretude, which requires a bimonthly injection.
Gilead CEO Daniel O’Day described the approval as a turning point, saying, “This really will bend the arc of the epidemic as we roll this out globally.”
However, global concern erupted following Gilead’s announcement of a $28,218 annual price tag per patient in the United States.
Health advocates and HIV organizations warn that such a price point will put the life-saving drug out of reach for many, particularly in low- and middle-income countries.
A study published in The Lancet HIV this week estimates that generic Lenacapavir could be produced for as little as $35 to $46 per person annually, and potentially as low as $25 with consistent demand. This would make it cost-comparable with existing oral PrEP options.
Winnie Byanyima, Executive Director of UNAIDS and United Nations Under-Secretary-General, welcomed the FDA’s decision but demanded immediate action on access and affordability.
“Lenacapavir could be the tool we need to bring new infections under control, but only if it is priced affordably and made available to everyone who could benefit,” she said.
“This is a breakthrough moment. The approval of Lenacapavir is a testament to decades of public investment, scientific excellence, and the contributions of trial participants and communities. It is beyond comprehension how Gilead can justify a price of $28,218. If this game-changing medicine remains unaffordable, it will change nothing.”
Professor Oyewale Tomori, a virologist and former President of the Nigerian Academy of Science, also praised the scientific advancement but emphasized that the situation underscores Africa’s structural disadvantages in accessing medical innovations.
“Until African countries begin to produce and manufacture their vaccines and treatments, such disparities in access are to be expected,” he said. “We must invest significantly in local research, biotechnology, and pharmaceutical development. Only through self-reliance can the continent avoid being left behind during global health breakthroughs.”
Jeremiah Johnson, Executive Director of PrEP4All, stressed the need to move beyond scientific achievement toward real-world impact.
“It’s not enough to have the science; we need it in the hands of those who need it most,” he said.
Gilead, in response to criticism, announced that it would offer copay assistance to reduce out-of-pocket costs to zero for eligible insured individuals in the United States, and provide free access to qualifying uninsured patients. The company also expects broad insurance coverage for Yeztugo, as with other HIV prevention treatments.
Lenacapavir is already approved for HIV treatment under the brand name Sunlenca, with a list price exceeding $42,000 per year in the U.S.
To support global access, Gilead has licensed six generic manufacturers to produce low-cost versions of Lenacapavir in 120 low- and lower-middle-income countries. The company also pledged to supply up to two million doses at no profit before generic alternatives become widely available.
The company reiterated that HIV knows no boundaries and emphasized its commitment to equitable access.
Despite daily PrEP pills being available for more than a decade, their use has been limited in many communities due to stigma, inconvenience, and adherence challenges—especially outside the demographic of white men who have sex with men.
As Gilead prepares for global rollout of Yeztugo, public health advocates stress the importance of ensuring this innovation becomes a symbol of inclusion and access, rather than a new source of inequality.
