PAHO deal to expand access to twice-yearly HIV prevention drug in 14 countries

Fourteen countries in Latin America and the Caribbean will gain a new pathway to access lenacapavir, a twice-yearly injectable medication for HIV prevention, under an agreement between the Pan American Health Organization (PAHO) and Gilead Sciences.

PAHO announced Monday that Argentina, Brazil, Chile, Colombia, Costa Rica, Ecuador, El Salvador, Guatemala, Mexico, Panama, Paraguay, Peru, Uruguay and Venezuela will be able to procure the long-acting medication through the organization's Regional Revolving Funds, subject to national regulatory and program requirements.

The agreement comes as approximately 140,000 new HIV infections continue to occur annually across Latin America and the Caribbean.

Lenacapavir is a long-acting injectable form of pre-exposure prophylaxis, or PrEP, administered once every six months.

The World Health Organization recommended lenacapavir as an additional HIV prevention option in 2025 following clinical trials that demonstrated nearly 100% efficacy in preventing HIV infection.

Its twice-yearly dosing offers an alternative to other forms of PrEP, particularly for people who may have difficulty adhering to more frequent prevention regimens.

“Today, the Americas have increasingly effective tools to prevent HIV, but these innovations will have an impact only if they reach the people who need them,” PAHO Director Dr. Jarbas Barbosa said.

“This initiative is an important step toward reducing gaps in access to lenacapavir, expanding the prevention options available to countries and advancing efforts to end HIV as a public health problem,” he added.

The new arrangement complements voluntary licensing agreements that already cover 24 countries in Latin America and the Caribbean as part of a broader global access framework covering 120 countries.

PAHO's Regional Revolving Funds pool demand from participating countries to support procurement of medicines and other health technologies under favorable conditions.

As part of the agreement, Gilead has also committed to advancing a technology-transfer process in Brazil aimed at allowing local production of lenacapavir in the future.

PAHO said the process remains under development and no specific timeline or mechanism has yet been established. Increased regional production could eventually improve availability and contribute to more sustainable procurement conditions.

“The agreement between Gilead and PAHO reflects our shared commitment to help countries move as quickly as possible from scientific innovation to real-world access to HIV prevention and public health impact,” said Johanna Mercier, Gilead's chief commercial and corporate affairs officer.

The introduction of lenacapavir into national HIV programs will occur progressively and depend on regulatory approvals, clinical protocols, health worker training and planning within individual countries.

PAHO said it will provide technical assistance to countries on areas including needs assessments, guidelines, monitoring and health system preparedness.

Lenacapavir joins several existing HIV prevention options, including daily or event-driven oral PrEP, long-acting cabotegravir and condoms, alongside early diagnosis and access to antiretroviral treatment.

PAHO said expanding access to prevention, diagnostic and treatment tools will be critical to the region's goal of ending HIV as a public health problem by 2030.