Gilead’s Greed Imperils Access to Newly FDA-Approved Breakthrough HIV Prevention Shot

PRESS STATEMENT
FOR IMMEDIATE RELEASE: July 18 2025
Contact for more information: Asia Russell | +1 267 475 2645 asia@healthgap.org 

Gilead’s Greed Imperils Global Access to Newly FDA-Approved Breakthrough HIV Prevention Shot While Estimates of HIV Infections Rise Sharply Due to Trump Administration’s HIV Cuts  

Today, the U.S. Food and Drug Administration (FDA) approved Gilead Sciences’ long-acting injectable lenacapavir (LEN-LA) for HIV pre-exposure prophylaxis (PrEP), at a U.S. price of of $28,218 per person per year. By contrast, a recent academic study estimates lenacapavir could be produced generically for $25–$40 per person per year at scale, a price comparable with oral PrEP. 

In clinical trials, LEN-LA, a shot given every six months, confers virtually complete protection against HIV acquisition. For communities most at risk of acquiring HIV, such as sex workers, LGBTQ+ people, people who use drugs, and cisgender straight women in sub-Saharan African countries, existing HIV prevention tools such as oral PrEP and condoms have shown limited effectiveness. Aggressive and widespread rollout of LEN-LA is urgently needed–in May, global estimates of new HIV infections rose sharply from 3500 to 5800 HIV infections daily, due to the Trump Administration’s abandonment of many HIV prevention programs. 

Gilead’s global lenacapavir access strategy has been widely criticized. Gilead has issued voluntary licenses to only six generic manufacturers and restricted countries eligible for that supply to 120 low- and middle-income countries (LMICs). While that may sound like an impressive number of LMICs, 23% of new HIV acquisitions occur in the 26 excluded countries, including Argentina, Brazil, Mexico, and Peru, countries where Gilead carried out pivotal lenacapavir clinical trials. Gilead intends to maximize profit in those excluded countries through opaque, inflated “tiered pricing” deals that will be unaffordable for individuals and the health systems that serve them. Other regions with excluded countries include Eastern Europe, the Middle East, and Asia, including China and Malaysia—have also been left out.

“Lenacapavir has once-in-a-generation potential to prevent millions of new HIV infections. Accelerating global access to affordable injectable lenacapavir should be Gilead Sciences’ CEO Daniel O’Day’s top priority,” said Fatima Hassan, Director of Health Justice Initiative. “But it will only be rolled out effectively if all LMICs are included and there is a single affordable access price, comparable with oral PrEP.”

While Gilead has not shared its price for other countries, it is rumoured Gilead’s lowest price will be approximately $100 per person per year for limited subset of the world’s most impoverished countries, with other countries charged a tiered price activists fear will be unaffordable, increasing HIV prevention inequities among the very communities most in need of injectable PrEP. At $100 per year, widespread rollout of this breakthrough prevention tool will be impossible given unprecedented and sudden HIV funding cuts, and the Trump Administration’s attacks on HIV prevention. Moreover, Gilead is demanding complete price secrecy, pushing for non-disclosure agreements not only from big funders such as the Global Fund but also from the country governments that will introduce LEN-LA, in a move that will further undermine efforts to secure affordable access.  

Civil society organisations call on Gilead to immediately amend its restrictive voluntary license to allow wider generic production and supply.

“While we wait, vulnerable people remain at risk. We cannot let corporate control and excessive pricing decide who stays HIV-free,” said Susana van der Ploeg, the coordinator of the Working Group on Intellectual Property, and project assistant at the Brazilian Interdisciplinary Association on AIDS (ABIA). “Governments in Latin America must act urgently—including rejecting frivolous patents and using compulsory licensing—to ensure equitable access to this breakthrough prevention tool. Brazil in particular needs to be cautious as any voluntary licensing deal Gilead offers to its public manufacturers could in fact have hidden restrictions that could delay and undermine affordable supply,” she adds. 

Activists called on governments, funders, and global health agencies to:

• • Prioritize domestic and international funding for the introduction and equitable rollout of lenacapavir; 
  • Support countries excluded from Gilead’s licensing territory to make use of all available legal tools, such as patent oppositions and compulsory licenses, to overcome patent and other intellectual property barriers; 

• Remove unnecessary and restrictive clauses from Gilead’s voluntary license, such as the ‘non-diversion’ clause, which would have the effect of preventing excluded countries that issue a compulsory license from purchasing lenacapavir made by one of the licensed generic companies;    

• Lower Gilead’s ‘access price’ to a price comparable with oral PrEP in all LMICs 25-40 per person per year; 

• Demand full price and supply transparency from Gilead and its procurement partners.

ENDS