Up to 2 million people in low- and middle-income countries could access twice-yearly PrEP to prevent HIV in the next three years, according to an agreement announced by drugmaker Gilead Sciences and the Global Fund to Fight AIDS, Tuberculosis and Malaria (Global Fund).
Specifically, Gilead has made a deal to supply the doses of lenacapavir—a pre-exposure prophylaxis (PrEP) given as a shot every six months and recently approved as Yeztugo in the United States. Lenacapavir is the longest-lasting PrEP on the market and is considered a game-changing tool in the fight againt the epidemic. The HIV pharma giant will supply the drug at “no profit” to the Global Fund, which will be responsible for purchasing and delivering the med to its member countries.
Whether the Global Fund has the financial means to procure enough lenacapavir for PrEP remains an active question. Like many health organizations in today’s unstable economy and political landscape, the Global Fund is facing budget concerns. Of note, it has traditionally received a large portion of its funding from the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR), but President Trump has slashed current funding, and his administration plans to cut nearly $2 billion from PEPFAR in the 2026 fiscal year budget. What’s more, Dexex reported July 10 that Global Fund plans to cut $1.4 billion from grants it has already awarded—representing about 11% of its current funding cycle—and that the fund is concerned about donors fulfilling their pledges.
Global Fund executive director Peter Sands alluded to the financial challenges in a press statement about the lenacapavir distribution deal: “For the first time, we have a tool that can fundamentally change the trajectory of the HIV epidemic—but only if we get it to the people who need it most. Our ambition is to reach 2 million people with long-acting PrEP. But we can only do that if the world steps up with the resources required.”
What’s more, the deal with Gilead requires that the Global Fund keep the cost of the med a secret, a condition that advocacy group Health GAP claims in a press statement will undermine transparency and “obstruct civil society activism for lower drug prices and keep prices high in middle-income countries where Gilead will negotiate prices directly. Such secrecy undermines the power of buyers to negotiate affordable prices and violates the human rights of all people to access information and life-saving tools.”
The U.S. Food and Drug Administration (FDA) approved lenacapavir as PrEP under the brand name Yeztugo on June 18. (It was approved under the brand name Sunleca in 2022 as part of treatment for certain people with HIV.) Yeztugo arrived with a U.S. price tag of $28,000 per year, a cost that advocates claim will keep it out of reach for most people.
Given these facts, efforts to make the drug available to those in need are welcome. According to the Global Fund, countries with a high HIV burden—notably those in sub-Saharan Africa—will receive priority access. The hope is that the first deliveries will reach their market by the end of this year, marking the first time that a new HIV prevention med will be simultaneously available in low- and middle-income countries and high-income countries, like the United States.
In its press release, Gilead noted that the collaboration with the Global Fund is one of several actions it is taking “to help ensure supply until licensed generic versions of lenacapavir are available in countries covered by its voluntary licensing program, which is the earliest and most geographically expansive ever developed for an anti-HIV agent.” The drugmaker further explained that in October 2024, it “signed non-exclusive, royalty-free voluntary licensing agreements to manufacture and supply high-quality generic versions of lenacapavir in 120 high-incidence, resource-limited countries, which are primarily low- and lower-middle-income countries.”
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