New HIV Drug May Exclude Vulnerable Populations – Experts

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The recent approval of Yeztugo, a twice-yearly injectable medication for HIV prevention, has sparked global debate as health experts warn that its prohibitive cost could render it inaccessible to millions of vulnerable people.

Health professionals and HIV advocates expressed concern that, while the drug represents a significant advancement in HIV prevention, its high price tag could undermine its global impact.

The United States Food and Drug Administration (FDA) recently approved Lenacapavir, marketed as Yeztugo by Gilead Sciences, for use in HIV prevention.

The long-acting injection is administered once every six months, offering a more convenient alternative to existing daily oral PrEP regimens such as Truvada and Descovy, or GSK’s Apretude, taken every two months.

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Gilead’s CEO, Daniel O’Day, hailed the approval as a transformative moment in the global fight against HIV, stating:

“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 (over ₦42 million) per person per year has provoked widespread criticism from public health advocates and global health leaders.

A research paper in The Lancet HIV estimates that generic Lenacapavir could be produced for as little as $35 to $46 per year, with the potential to drop to $25 if there is sufficient demand.

“It is beyond comprehension how Gilead can justify a price of $28,218. If this game-changing medicine remains unaffordable, it will change nothing,” said Winnie Byanyima, Executive Director of UNAIDS and United Nations Under-Secretary-General.

She described the approval as a breakthrough moment, driven by public investment, scientific innovation, and the contributions of trial participants, but insisted that access must not be restricted by price.

In Nigeria, Professor Oyewale Tomori, a renowned virologist and former President of the Nigerian Academy of Science, echoed the concern, stating:

“Until African countries begin to produce and manufacture their own vaccines and treatments, such disparities in access are to be expected.

“We must invest significantly in local research, biotechnology, and pharmaceutical development.”

Jeremiah Johnson, Executive Director of PrEP4All, highlighted the urgency of translating scientific innovation into equitable access:

“It’s not enough to have the science—we need it in the hands of those who need it most.”

Despite the criticism, Gilead has announced plans to offer financial support to reduce out-of-pocket costs for eligible patients in the U.S. and provide free access for qualifying uninsured individuals.

The company also expects broad insurance coverage similar to other HIV prevention drugs.

In a statement, Gilead reiterated its commitment to equity, noting that HIV “knows no boundaries.”

Yeztugo is not Gilead’s first Lenacapavir product. It is already approved for the treatment of HIV under the brand name Sunlenca, which carries a U.S. list price of over $42,200 per year.

To support broader access, Gilead has licensed six generic manufacturers to produce low-cost versions of the injectable for 120 low- and lower-middle-income countries.

The company also pledged to supply up to two million doses at no profit before generics enter the market.

Still, advocates argue that more needs to be done to prevent the medicine from becoming another symbol of inequality in global health.

“Daily PrEP pills have been available for over a decade but remain underutilised in many communities due to stigma, inconvenience, and adherence challenges—particularly outside the demographic of white men who have sex with men,” one public health advocate noted.

As Gilead prepares for global rollout, civil society groups are calling for bold and transparent pricing strategies to ensure Yeztugo becomes a tool for inclusion, not exclusion.

 

 

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