In a major development for global HIV prevention, Gilead Sciences and the Global Fund to Fight AIDS, Tuberculosis and Malaria have finalized plans to provide the long-acting HIV prevention drug lenacapavir to low- and middle-income countries (LMICs). Under the agreement, Gilead will supply up to 2 million doses annually at cost for the next three years to countries supported by the Global Fund. Reuters+2Gilead+2
The initiative moves forward despite ongoing funding cuts from the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR). Although the plan was originally announced in December with PEPFAR’s involvement, the current U.S. administration has scaled back support, limiting access primarily to pregnant and breastfeeding women. A U.S. State Department spokesperson confirmed that most PEPFAR-funded services are under review.
Lenacapavir for HIV Prevention
The FDA approved lenacapavir (brand name: Yeztugo) in June as a twice-yearly injectable to prevent HIV in adults and adolescents. World Health Organization+3Reuters+3Gilead+3 The drug is now under review by other regulators, including the World Health Organization (WHO). World Health Organization+1 AIDS experts have expressed optimism that lenacapavir could help change the trajectory of the global HIV epidemic, which has killed over 42 million people and continues to claim some 1.3 million lives annually, according to WHO.
To expand access, Gilead has signed royalty-free agreements with six generic manufacturers to produce affordable versions of lenacapavir for 120 LMICs, though widespread distribution will take time. theglobalfund.org+3Gilead+3Gilead+3 South Africa is expected to be among the first countries to implement the program, with rollout planned across roughly 10 countries in sub-Saharan Africa by the end of the year. Reuters+2theglobalfund.org+2
“This is the first time that an HIV prevention tool may become available in low-income countries at the same time as in high-income countries,” said Peter Sands, Executive Director of the Global Fund. “That’s never happened before.” Gilead+1
Gilead CEO Daniel O’Day echoed hope for broader U.S. support, saying that long-term investments in prevention will ultimately lower the overall cost of HIV response. Gilead is also collaborating with middle-income countries, including many in Latin America, to accelerate lenacapavir access. theglobalfund.org+3Gilead+3Gilead+3
Meanwhile, the Children’s Investment Fund Foundation (CIFF) has pledged $150 million to the Global Fund to support the lenacapavir initiative — but more donors are still needed.
While there is great excitement surrounding lenacapavir, several challenges remain in ensuring equitable and effective rollout. First, regulatory approval in many LMICs is still pending, and national health agencies must adapt their guidelines, training, and delivery systems to safely administer biannual injections. The WHO formally recommended injectable lenacapavir as an additional PrEP option in July 2025, signaling strong global support. World Health Organization
Second, although Gilead is supplying the drug at cost in the early years, transparency in price setting and long-term sustainability will be crucial. Some advocacy groups have raised concerns about secrecy in pricing arrangements. healthgap.org+2EATG+2 Moreover, many Latin American and upper-middle income countries are currently excluded from the licensing agreements, which may limit lenacapavir access in high-burden nations outside sub-Saharan Africa. theglobalfund.org+3Public Citizen+3Gilead+3
Lenacapavir for HIV Prevention and Global Approval Progress
The FDA approved lenacapavir (brand name: Yeztugo) in June as a twice-yearly injectable to prevent HIV in adults and adolescents. (Reuters) The drug is now under review by other regulators, including the World Health Organization
Third, the global funding environment is uncertain. With reductions in PEPFAR funding, the burden of procurement, distribution, demand generation, and community outreach will increasingly fall on the Global Fund and national governments. PrEPWatch+3aidsmap.com+3EATG+3 To reach the ambitious goal of scaling lenacapavir to millions, sustained donor commitments and innovative financing mechanisms will be required.
Finally, integrating lenacapavir into existing HIV prevention portfolios (oral PrEP, condoms, behavioral interventions) will be important to maximize impact. Some populations may still prefer or require daily or monthly options; others — especially in settings with weak health systems or stigma barriers — may benefit most from the low-maintenance six-month injectable. Early monitoring, community engagement, and flexibility in delivery models (e.g. mobile clinics, community sites) will shape the success of lenacapavir programs.
If these challenges are addressed, the lenacapavir initiative could mark a turning point: offering millions of people in marginalized settings a new, discreet, and long-acting tool to prevent HIV. Over time, widespread uptake could drive down incidence, reduce health system burdens, and accelerate progress toward ending the HIV epidemic.
