PAHO provides new opportunity for Latin America and the Caribbean to access HIV drugs 

WASHINGTON, Sept 16, CMC – The Pan American Health Organization (PAHO) says it is providing new opportunities for Latin America and the Caribbean (LAC) to access lenacapavir as part of the preventative medicine to curb the spread of HIV throughout the region.

PAHO said that the medication will be made available through its Regional Revolving Funds, under an agreement with Gilead Sciences and that the initiative will make the long-acting HIV prevention medicine available to 14 countries.

“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, chief commercial & corporate affairs officer, Gilead Sciences.

“Strategic partnerships are essential to our ambition to help end the HIV epidemic. This agreement demonstrates how collaboration between governments, public health organisations and industry can expand access, accelerate implementation and create the conditions for sustainable scale.”

PAHO said that approximately 140,000 new HIV infections occur each year in Latin America and the Caribbean, underscoring the need to expand access to effective and acceptable prevention options.

Lenacapavir is a long-acting injectable pre-exposure prophylaxis (PrEP) administered twice a year. In 2025, the World Health Organization (WHO) recommended lenacapavir as an additional HIV prevention option following clinical trials that demonstrated almost 100 per cent efficacy in preventing HIV infection. Its twice-yearly dosing provides an alternative for people who may face challenges with more frequent prevention regimens.

Under the new agreement, the 14 countries will be able to procure lenacapavir through PAHO’s Regional Revolving Funds, subject to applicable national regulatory and programmatic processes.

The new pathway complements voluntary licensing agreements that already cover 24 countries in Latin America and the Caribbean under a broader global access framework covering 120 countries worldwide. Together, these mechanisms provide complementary routes for countries in the region to access lenacapavir.

“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,” said PAHO director Dr Jarbas Barbosa.

“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.

Countries will be able to procure lenacapavir through the established procedures of PAHO’s Regional Revolving Funds, which pool demand and support efficient and reliable procurement for member states under favourable conditions.

As part of this initiative, Gilead has also committed to advance a technology-transfer process in Brazil with the aim of facilitating local production of lenacapavir in the future. The process is still under development, and specific timelines and mechanisms have yet to be defined. In the longer term, increased regional production capacity could contribute to greater availability of lenacapavir and more sustainable procurement conditions.

PAHO said the introduction of lenacapavir into national HIV programmes will take place progressively and will depend on national regulatory processes, clinical protocols, health-worker training and programmatic planning.

PAHO said it is providing technical cooperation to support countries with needs assessment and quantification, guideline development, monitoring and health-system preparedness, helping to ensure that introduction is evidence-based and adapted to national contexts.

The agreement forms part of PAHO’s broader efforts to accelerate access to new HIV prevention technologies and strengthen regional capacity to produce health technologies. It is also aligned with the Alliance for the Elimination of HIV, a regional coordination platform within PAHO’s Disease Elimination Initiative.

PAHO said lenacapavir adds to a growing range of HIV prevention options, including daily or event-driven oral PrEP, long-acting cabotegravir and condoms, alongside early diagnosis and timely access to antiretroviral treatment. Providing people with a range of prevention options can help respond to different needs and preferences and support more person-centred approaches to HIV prevention.

“Expanding access to effective prevention, diagnostic and treatment tools, and ensuring they reach everyone who needs them, will remain essential to reducing new HIV infections and advancing toward the goal of ending HIV as a public health problem by 2030,” PAHO added.