Lenacapavir Access Campaign

A campaign to expand access to a critical HIV prevention medication

On October 2, 2024, Gilead Sciences announced that it had signed voluntary licensing agreements with six generics manufacturers for its twice-yearly long acting injectable PrEP (pre-exposure prophylaxis) product lenacapavir. However, Gilead excluded most Latin American countries from its license territory and included restrictive agreement terms that will leave many without access. The drug can be produced for as little as $25 per year; the U.S. price is $28,218 per year. In response to these and other barriers, civil society organizations are campaigning to expand access to lenacapavir and to advance the global fight against HIV and AIDS.

Global Week of Action Targets Gilead’s Control of Lifesaving HIV Medicine on World AIDS Day
Public Citizen and allies across the country and around the world launched a coordinated World AIDS Day Global Week of Action (Nov. 24-Dec. 1) to confront the Gilead Sciences over its stranglehold on lenacapavir, a twice-yearly injectable that can prevent HIV or help treat it when combined with other medicines.

Trump Takes Credit for Lenacapavir Deal after His Administration Decimated U.S. International AIDS Prevention Programs (November 18, 2025)
Gilead Sciences, the Global Fund, and the U.S. Department of State announced the delivery of 1000 doses of the new HIV prevention drug lenacapavir to Zambia and Eswatini, as part of an initiative to supply the medicine to two million people in a subset of high-burden developing countries over three years. In a statement, Peter Maybarduk, Access to Medicines Director for Public Citizen, called out the lackluster volume commitment, particularly alongside the U.S. government’s decimation of HIV/AIDS programs. Maybarduk called for greater commitments from the U.S. and other governments, from Gilead Sciences and drugmakers, and from global donors to deliver on the revolutionary promise of long-acting HIV prevention and to rebuild service delivery and community programming. 

Gilead’s Lenacapavir Tablet and Injection Products Prequalified by WHO (October 6, 2025)

Health Groups Announce Global Campaign to Challenge Gilead’s Patent, Registration Barriers and Secure Global Access to Long-Acting PrEP for All (September 24, 2025)
On September 24, 2025, two deals were announced to make long acting lenacapavir available at $40 per person per year in 2027. Dr Reddy’s and Hetero, ​​two Indian generic manufacturers, will offer the price. The same day, a global coalition of health groups announced a global campaign to make this generic price and long-acting PrEP available worldwide by challenging Gilead’s patents, pricing and registration barriers, through legal challenges and advocacy pushing governments and Gilead to make PrEP available and accessible to all.

The Global Fund and the US State Department re-confirm plan with Gilead to reach only 2 million people in 9-12 countries over three years (September 2, 2025)

More than 250 Organizations and Individuals Demand Gilead CEO Commit to Rapid Application for Regulatory Approval of Long-Acting Lenacapavir for PrEP in all Low- and Middle-Income Countries (August 14, 2025)
In an open letter, activists, academics, policy experts, and civil society organizations from around the world called on Gilead to stop delaying applications for regulatory approval for lenacapavir for HIV PrEP across all low- and middle-income countries. The letter is endorsed by Health GAP, Public Citizen, Salud por Derecho, Acción Internacional para la Salud (AIS Perú), Médecins Sans Frontières, Associação Brasileira Inerdisciplinar de AIDS (ABIA Brazil), Health Justice Initiative, Sankalp Rehabilitation Trust, Treatment Action Campaign, and others. On August 28, 2025, Gilead responded to the letter but failed to address many issues raised by the letter. After again urging Gilead for concrete answers regarding plans for regulatory approval of lenacapavir, the company sent another response. Gilead’s letters show that the company does not plan to prioritize broad regulatory authorization for lenacapavir. Track the status of global LEN-LA registration here.

Gilead and the Global Fund Announce Agreement to Supply Lenacapavir (July 9, 2025)
The agreement, like Gilead’s voluntary licenses that authorize generic lenacapavir production, excludes most Latin American countries and other upper-middle income countries. Public Citizen is working with more than 100 health groups across Latin America, the AIDS Healthcare Foundation and the People’s Medicines Alliance to protest this exclusion and support affordable access to HIV prevention for millions of people. The groups called on Gilead to drop evergreening patents and are petitioning many Latin American governments to overcome the patent barrier by authorizing generic competition on their own authority, a mechanism known as compulsory licensing. Colombia recently issued a compulsory license for dolutegravir, another HIV drug. Health advocates also criticized Gilead’s imposition of price secrecy. (Read Public Citizen’s related press release here).

WHO Publishes Global Guidelines Recommending Long-Acting Lenacapavir for All People at Risk of HIV Infection (July 14, 2025)

Statement: Making Long-Acting PrEP Accessible to All Could Help End AIDS (June 17, 2025)

Letter from Civil Society Organizations to the Peruvian Government (June 9, 2025)
Civil society organizations in Peru presented a letter to President Dina Boluarte and other senior government officials, demanding access to lenacapavir for the prevention and treatment of HIV. This letter is part of a broader statement by organizations in Latin America and the Caribbean (LAC), which ask governments to guarantee the availability of this innovative medicine that can definitively control the HIV pandemic.

Dialogue with Gilead (June 2, 2025)
On June 2, 2025, representatives of civil society organizations in Latin America and international allies met with representatives of Gilead Sciences in order to learn about the plans for access to lenacapavir in the region.