Gilead Sciences Inc GILD is facing mounting pressure to price its long-acting HIV prevention drug, lenacapavir, affordably as it prepares for U.S. regulatory approval on June 19.
In December 2022, the FDA approved Lenacapavir in combination with other antiretrovirals to treat HIV-1 infection in heavily treatment-experienced adults with multi-drug resistant HIV-1 infection.
Researchers and global health leaders are urging the company to ensure widespread access, especially in low- and middle-income countries, given the drug’s potential to significantly curb the HIV pandemic.
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In June 2024, Gilead Sciences shared topline results from an interim analysis of its Phase 3 PURPOSE 1 trial, indicating its twice-yearly lenacapavir demonstrated 100% efficacy for the investigational use of HIV prevention in cisgender women, marking a major shift from daily oral pre-exposure prophylaxis (PrEP) regimens. However, concerns are rising about affordability.
While Gilead has not yet disclosed the price, it is expected to align with existing preventive medications at approximately $25,000 annually. As a treatment for those already living with HIV, the drug costs around $39,000 per year.
Citing a new analysis from the University of Liverpool, the Guardian report suggests that if produced at a large scale, lenacapavir could be manufactured for as little as $25 annually, even with a 30% profit margin.
Dr. Andrew Hill, one of the study’s authors, argued that charging over $20,000 a year would make widespread use unfeasible, even in wealthy countries.
He added that updated production estimates show lenacapavir could be made for $35 to $46 per year at 2 million doses annually and as low as $25 at volumes between 5 million and 10 million doses.
Earlier, Hill estimated that a generic version of lenacapavir could be produced for $40 a year, assuming 10 million people used it annually.
In October 2024, Gilead partnered with six generic manufacturers to supply low-cost versions in 120 low-income countries.
The Guardian report added that the company has pledged to deliver doses to about 2 million people at no profit ahead of generic availability.
Despite these commitments, advocates have criticized the exclusion of key countries with high HIV burdens, such as Brazil, Argentina, and parts of Eastern Europe, from Gilead’s licensing agreements.
Last week, the U.S. Food and Drug Administration placed a clinical hold on Gilead’s HIV treatment trials of GS-1720 (an investigational integrase strand transfer inhibitor) and/or GS-4182 (an investigational capsid inhibitor).
The clinical hold is due to the identification of a safety signal of decreases in CD4+T-cell (CD4) and absolute lymphocyte counts in a subset of participants receiving the combination of GS-1720 and GS-4182.
Price Action: GILD stock is trading lower by 2.22% to $108.37 at last check Tuesday.
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