Two new agreements from Gilead Sciences, the developer of lenacapavir, this week could expand access to lenacapavir for HIV PrEP (LEN), both for the current every six month injectable and a potential once-yearly option still in development. Gilead and the Pan American Health Organization (PAHO) announced new steps to establish a procurement pathway through PAHO’s Regional Revolving Funds that will allow 14 countries in Latin America and the Caribbean – including Argentina, Brazil, Peru and Mexico (all of which participated in one of the pivotal efficacy trials) – to procure twice-yearly LEN. This mechanism complements the 24 countries already covered in the region by Gilead’s existing voluntary licensing agreements. Gilead also committed to advance a technology-transfer process in Brazil, although timelines, prices, and volumes were not defined in the release. Separately, Gilead expanded its six royalty-free voluntary licenses for lenacapavir to include the investigational once-yearly formulation being studied in the Phase 3 PURPOSE 365 trial. This would extend once-yearly LEN generic plans for 120 high-incidence, resource-limited countries before efficacy results or regulatory approval. 
 
IMPLICATIONS: These LEN announcements are a step forward in rolling out new HIV prevention options with speed and scale, but equity continues to remain a central issue. Advocacy partners, ITPC Global and Make Medicines Affordable, welcomed the PAHO mechanism as an important step for countries that were initially excluded from Gilead’s voluntary licenses. However, they warned that important details including price, volumes, supply commitments and delivery timelines remain unknown and that governments cannot plan national scale-up without that information.  
 
At the same time, expanding voluntary licenses to the prospective once-yearly formulation while it is still in Phase 3 development is an important step forward in early access planning and could shorten the gap between approval and generic supply, should the once-yearly formulation prove safe and effective. This early licensing approach mirrors Merck/MSD’s recent licensing agreements for their investigational monthly oral PrEP option, alimatravir. AVAC’s projections of potential LEN supply and demand through 2028 illustrate the scale of the opportunity—and the gap that remains between potential demand and current commitments. Whether these two LEN access agreements translate into affordable, predictable supply that countries can actually finance and deliver at scale and speed will be the true test of equity. 

READ:  

• PAHO opens a new pathway to access lenacapavir for HIV prevention in Latin America and the Caribbean—PAHO  
• Unique partnership commits €32.5 million to EmpowHER Fund to expand HIV prevention for women and girls—Aidsfonds 
• Sign the letters for alimatravir's access in Perú—Public Citizen 
• Why do women make up 71% of South Africa’s new lenacapavir users?—IOL 
• Want the six-monthly HIV jab? Here’s your nine-step clinic cheat sheet—Bhekisisa  
• Gilead Accelerates Global Access Planning for Investigational Once-Yearly Lenacapavir for HIV Prevention—Gilead  
• A pathway is not access: ITPC and MMA call for transparency on the Gilead–PAHO lenacapavir agreement—Make Medicines Affordable 
• Gilead and PAHO Announce Milestone Partnership to Accelerate Access to Twice-Yearly Lenacapavir for HIV Prevention Across Latin America and the Caribbean—Gilead  

Advocates led by the Save HIV Funding campaign, founded by PrEP4All, HIVMA and AVAC, are demanding more transparency and a withdrawal of the proposed restructuring of the National Institute of Allergy and Infectious Diseases (NIAID) to allow time for meaningful opportunities for the HIV community to provide input on the reorganization proposal. Last week, the National Institutes of Health (NIH) released a proposed reorganizational chart with public comments due today, September 18. The proposal would eliminate NIAID’s Division of Clinical Research and redistribute clinical research functions across the Institute. Little accompanying detail has been provided about the rationale for the changes, how responsibilities would be reassigned or what the restructuring could mean for NIAID’s domestic and international clinical research infrastructure.  
 
The Save HIV Funding campaign developed a template for comments for individuals and organizations that would like to comment on the NIH proposed reorganization of NIAID.

IMPLICATIONS: The proposed restructuring comes at a particularly uncertain moment for the HIV research infrastructure NIAID has built over decades. The long-delayed announcement for the next seven-year cycle of the trial networks creates the possibility of funding gaps that could disrupt ongoing trials, research sites, staff and study participants; infectious-disease groups have warned that lapses could destabilize research capacity that has contributed to advances across HIV, TB, hepatitis and other infectious diseases. With fundamental questions about the reorganization still unanswered, advocates are pressing NIH not to restructure that system without greater transparency and meaningful community input. The uncharacteristically shortened timeline for public comment and scant details available about the proposed reorganization has been criticized as obfuscating meaningful community engagement and involvement in NIAID processes. Furthermore, NIAID has provided little justification for eliminating pertinent divisions such the Division of Clinical Research – which provides substantial clinical and regulatory support for NIAID-funded studies.  

READ: 

• Action Alert: Urge Congress to Protect & Fund Federal HIV Programs—Save HIV Funding  
• The NIH funding crisis that could reshape biotech for years to come—Drug Discovery News  
• New NIH research center on vaccine harms takes shape—Science  
• NIH Budget Cuts Threaten HIV Research—Think Global Health 

The Global Fund to Fight AIDS, TB and Malaria released its 2026 Results Report, which positions sustained progress against all three diseases in 2025 despite the decimation of global health foreign assistance and financing. In Global Fund invested countries, the report shows that 26.9 million people received antiretroviral therapy for HIV, which is an increase from 25.6 million in 2024. However, despite sustainability of treatment, the report also documents the effects on prevention where programs were scaled back or suspended altogether in some countries. Notably, the number of people receiving PrEP in Global Fund-supported countries fell from 1.4 million in 2024 to 1.1 million in 2025. 

IMPLICATIONS: These findings suggest a similar pattern across recent analyses of the global HIV response, including the recent UNAIDS report and latest PEPFAR data. HIV treatment programs have so far proved relatively resilient to the funding pitfalls, while HIV prevention has been much more severely disrupted. AmfAR’s Brian Honerman and co-authors, Jirair Ratevosian, KFF and AVAC’s own analysis of the latest PEPFAR data, all sound the alarm that the front end of the HIV response is weakening.

READ: 

• Results Report 2026—Global Fund  
• Despite Funding Cuts, Global Fund Sustains Progress Against HIV, TB and Malaria—Health Policy Watch 
• New report: Global Fund partnership has saved 72 million lives since 2002—Friends of the Global Fight 
• Aid cuts hit disease prevention harder than treatment, Global Fund chief says—Reuters  

Seventeen US researchers filed a class-action lawsuit challenging a new National Institutes of Health (NIH) grant-screening process that they say unlawfully allows political considerations to override scientific merit. According to the complaint, NIH is using a computational tool to flag at least 235 terms—including “gender,” “health disparities,” “racist” and “climate change”—in new and existing grants, and in some cases requiring researchers to remove or change flagged language before funding can proceed. The lawsuit alleges that the process violates First Amendment protections against viewpoint discrimination as well as federal requirements governing how NIH awards and terminates grants. They are asking the court to halt the screening policy, restore terminated grants and reconsider applications denied under the process.  

IMPLICATIONS: The lawsuit represents a new legal challenge to the Administration’s efforts to reshape federally funded research. Following the mass grant terminations in early 2025, this evolution of political overstep is being played out in a new way. The 17 researchers argue that requiring scientists to remove terms related to populations or subjects they are studying can alter how research is described and, in some cases, undermine its scientific design. Because this lawsuit is filed as a class action, its implications could extend beyond their specific grants and to researchers around the country affected by the screening policy. This new challenge follows AVAC’s lawsuit, which unlocked the payment of millions of dollars of development assistance for work that was done in January and February 2025. 

READ:

• Researchers file First Amendment challenge to NIH grant screening—Science  
• Researchers Challenge NIH Screening of Grants for Disfavored Viewpoints—ACLU  
• NSF memo implementing Trump’s ‘golden age’ of science unsettles researchers—Science