The approval of Yeztugo, a twice-yearly injectable medication for HIV prevention, has generated a mix of excitement and concern among health experts. While the innovation is seen as a major advancement in the global fight against HIV, its cost is raising alarms about equitable access, particularly for low-income countries. The United States Food and Drug Administration (FDA) recently gave the green light Lenacapavir, the drug margeted as Yeztugo, which is designed to prevent HIV infection when administered every six months. It has been found highly effective in reducing new infections, offering a simpler alternative to daily oral PrEP pills like Truvada and Descovy, or bimonthly options like Apretude.
Yeztugo's main appeal lies in its convenience. Clinical trials concluded in 2024 showed that taking it twice a year was just as effective, if not more than current prevention methods, making it a promising option for people struggling with the stigma or routine of daily medication.
Gilead CEO Daniel O'Day described the development as a milestone in the effort to curb HIV transmission worldwide. "This really will bend the arc of the epidemic as we roll this out globally," he stated, underscoring the optimism surrounding the drug's global impact.
However, Gilead's announcement of a $28,218 per person annual list price for Yeztugo has drawn criticism from health advocates and international organizations. They argue that such a price tag could make the drug inaccessible to many of the people who need it most, particularly in low-and middle-income countries.
A new research paper published in 'The lance HIV' estimates that generic Lenacapavir could be produced for as little as $35 to $46 per person per year. With strong demand and scale, the cost could drop to around $25, bringing it more in line with existing oral PrEP options and increasing affordability.
Winnie Byanyima, Executive Director of UNAIDS, welcomed the drug's approval but issued a strong rebuke over its pricing. "This is a breakthrough moment... 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 warned.
From the African perspective, Prof. Oyewale Tomori, a top Nigerian virologist, said the development reflects Africa's broader vulnerability in accessing life-saving innovations. He stressed the need for local production and investment in biotechnology. "Only through self-reliance can the continent avoid being perpetually left behind during major health breakthroughs," he said.
In the U.S., Gilead has pledged to offer financial assistance through copay savings and free access for uninsured patients who meet eligibility criteria. The company also anticipates broad insurance coverage similar to that of other HIV prevention drugs.
Globally, Gilead has taken some steps to address access issues by licensing six generic manufacturers to produce low-cost versions of the injection for 120 low-and lower-middle-income countries. Additionally, the company has pledged to supply no-profit doses for up to two million people until generic alternatives become widely available.
While oral PrEP pills have been available for over a decade, their effectiveness has been hindered in many communities by social stigma, daily adherence challenges, and limited outreach. Yeztugo could offer a more practical and discreet option, but only if made widely accessible.
As Gilead prepares for the global rollout of Yeztugo, public health advocates are urging governments, donors, and pharmaceutical companies to act boldly. The goal, they say, should be to ensure that this medical breakthrough promotes inclusion rather than deepening existing health inequalities.
Source: NAN
