Reactions have continued to trail the approval of Yeztugo, a twice-yearly injectable medication for HIV prevention, with experts warning that its high cost could shut out millions of vulnerable people worldwide.
The concerns were raised by experts in an interview with the News Agency of Nigeria (NAN) on Sunday in Abuja.
NAN reports that the United States Food and Drug Administration (FDA) recently approved long-acting injectable Lenacapavir for HIV prevention.
The medicine, to be administered once every six months, represents a significant advancement in expanding prevention options for people at risk of HIV infection across the globe.
In two major clinical trials concluded in 2024, Gilead’s injection, marketed as Yeztugo proved highly effective in virtually eliminating new HIV infections when taken twice a year.
Its low-dose frequency makes it more convenient than existing prevention options, including daily oral PrEP pillslike Truvada and Descovy, and GSK’s Apretude, taken every other month.
According to Gilead CEO, Daniel O’Day, this really will bend the arc of the epidemic as we roll this out globally,”
However, Gilead’s announcement of a U.S. list price of 28,218 dollars per person per year has drawn global criticism.
Health leaders and HIV advocates warn that the pricing risks making the life-saving medication inaccessible to those most in need.
A research paper published in the Lancet HIV this week estimated that generic Lenacapavir could be produced for as little as 35dollars to 46 dollars per person per year.
The research said that it had the potential of dropping to 25 dollars with committed demand, making it comparable to existing oral PrEP.
Winnie Byanyima, Executive Director of UNAIDS and United Nations Under-Secretary-General, welcomed the FDA approval but demanded urgent action on pricing and access.
According to her, 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.
“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 dollars. If this game-changing medicine remains unaffordable, it will change nothing,” she said.
Prof. Oyewale Tomori, a renowned virologist and former President of the Nigerian Academy of Science, also commended the scientific milestone but said that the situation reflected a deeper problem for the African continent.
“Until African countries begin to produce and manufacture their vaccines and treatments, such disparities in access are to be expected.
“We must invest significantly in local research, biotechnology, and pharmaceutical development.
“Only through self-reliance can the continent avoid being perpetually left behind during major health breakthroughs,” Tomori said.
Mr Jeremiah Johnson, Executive Director of PrEP4All, highlighted the urgent need to bridge the access gap.
“It’s not enough to have the science, we need it in the hands of those who need it most, “ he said.
NAN recalls that Gilead has pledged to provide copay savings to reduce out-of-pocket costs to zero for eligible insured patients and to offer free access to qualifying uninsured individuals in the U.S.
The company also expects broad insurance coverage, similar to existing HIV prevention therapies.
Lenacapavir is already approved for treating HIV under the brand name Sunlenca, which has a U.S. price list exceeding 42,200 per year.
To support global access, Gilead has licensed six generic manufacturers to produce and sell low-cost versions of the injection in 120 low- and lower-middle-income countries.
The company also pledged to supply doses for up to two million people at no profit before generic versions reach the market.
Gilead said that HIV knows no boundaries, reinforcing its commitment to equitable access.
Meanwhile, daily PrEP pills have been available for over a decade.
However, their effectiveness has been limited in many communities due to stigma, inconvenience, and adherence challenges, particularly outside the demographic of white men who have sex with men.
As Gilead prepares to roll out Yeztugo globally, public health advocates seek bold steps to ensure that the innovation becomes a symbol of inclusion and equity, not exclusion and disparity.
NAN
