HIV Prevention Breakthrough Faces Access Bottlenecks Despite Clinical Success

A new injectable medication capable of preventing HIV with just two doses per year has been hailed as a major scientific advance, yet access remains uneven across the globe. Lenacapavir, developed by US pharmaceutical giant Gilead Sciences, demonstrated 100% efficacy in preventing the virus during a 2024 clinical trial involving over 2,000 young women in South Africa and Uganda.

“It’s the closest thing to an HIV vaccine,” said Carlota Baptista da Silva, global HIV lead at Doctors Without Borders (MSF), describing the drug as the most innovative tool in the fight against HIV in the past decade. The World Health Organization (WHO) has endorsed the long-acting injectable as an additional form of pre-exposure prophylaxis (PrEP).

The introduction of lenacapavir arrives during a critical period for global health. According to UNAIDS, international HIV funding dropped by 18% in 2025 to $7.3 billion, the lowest level in nearly twenty years. Consequently, the number of people receiving preventive medication fell from 1.4 million in 2024 to 1.1 million in 2025, making equitable access to this new option urgently important.

While the scientific viability of lenacapavir is established, questions surrounding manufacturing rules, pricing, and supply chains remain unresolved. In the United States, the drug costs approximately $28,000 annually per person, whereas generic versions are projected to cost around $40 a year.

The US Food and Drug Administration approved lenacapavir for HIV prevention in June 2025. However, large-scale access to cheaper generic alternatives is not anticipated in many low- and middle-income countries until 2027.

Gilead is currently supplying its branded version at no profit to programs supported by the Global Fund and the US President’s Emergency Plan for AIDS Relief (PEPFAR). Rollouts are underway in nations including South Africa, Kenya, Zambia, Nigeria, and Eswatini. The company has licensed six manufacturers to produce generic versions, with widespread availability expected in 2027.

Despite these efforts, MSF reports that at least 26 middle-income countries are excluded from the generic licensing agreement. These include Brazil, Mexico, Argentina, and Peru, nations that have seen rising HIV infections and even participated in early trials. Da Silva criticized this exclusion, stating, “People should not really help generate the evidence for breakthrough medicine and then find that their country is excluded from affordable generic access.” MSF noted that these excluded countries accounted for nearly 23% of new HIV infections globally in 2023.

In response, Gilead announced a separate agreement with the Pan American Health Organization to create an access pathway for 14 Latin American and Caribbean nations. However, MSF argues that this arrangement leaves these countries dependent on Gilead’s pricing rather than allowing them to purchase cheaper generics directly.

Furthermore, MSF has reported that it has been unable to purchase lenacapavir directly from Gilead for its medical programs for over a year, despite not requesting a discount. Da Silva emphasized the urgency for humanitarian settings, noting that displaced populations and victims of sexual violence are particularly vulnerable and may struggle with daily pill adherence. “People living through conflict and humanitarian crises cannot be the last in line for medical innovation,” she said.

Gilead declined to grant an interview, citing scheduling constraints. In a statement, the company highlighted its strategy of no-profit supplies and royalty-free licensing but did not address why it refuses direct sales to MSF or why certain nations were excluded from the generic deal. The company plans to supply enough medication for up to three million people by 2028.

MSF contends this scale is insufficient, projecting that nearly 20 million people worldwide need access to PrEP to significantly curb new infections. The organization is urging governments excluded from Gilead’s agreements to consider using World Trade Organization (WTO) flexibilities, such as compulsory licensing, to bypass patent barriers.

Brazil utilized similar measures in 2007 to access cheaper generic HIV drugs after price negotiations with Merck failed. Activists are now urging Brazil and other nations to apply these legal safeguards again if patent obstacles persist.

For MSF, the precedent set by lenacapavir’s distribution is crucial. “For a humanitarian medical organisation, we should not have to spend more than a year trying to find a way to buy a WHO-recommended medicine,” Da Silva concluded. “The way the drug is made available could determine whether one of the greatest advances in HIV prevention in decades reaches people based on need, rather than where they live or what their health systems can afford.”