The Human Cost of PEPFAR’s PrEP Restrictions

By Kenyon Farrow

The President’s Emergency Plan for AIDS Relief (PEPFAR) has long been hailed as one of the most successful and bipartisan efforts in global health. Established in 2003 under the Bush Administration, PEPFAR has saved millions of lives by providing critical HIV treatment and prevention services and building partnerships with countries and communities. But this work ground to halt last week, with a chilling pause on all work.

This week, the State Department approved a limited waiver to re-start some treatment and PMTCT programs is a small step forward, but far from a victory at all. And it is especially short-sighted and cruel in it approach (or lack thereof) to primary HIV prevention. One of the most effective tools in the fight against HIV has been Pre-Exposure Prophylaxis (PrEP), a medication regimen that reduces the risk of acquiring HIV by over 99% when taken consistently. Yet, with this new guidance, the Trump Administration is choosing politics over science, discrimination over compassion, and ultimately, death over life.

The February 6th guidance from the Trump Administration stating that “people other than pregnant and breastfeeding women who may be at high risk of HIV infection or were previously initiated on a PrEP option cannot be offered PEPFAR-funded PrEP during this pause of US Foreign Assistance or until further notice” is not only a dangerous deviation from sound public health policy—it is a death sentence for thousands of people at risk of HIV globally.

PrEP is one of the most powerful tools available in the fight against HIV/AIDS. Public health experts and epidemiologists agree that expanding access to PrEP is essential to curbing new infections. The administration’s directive effectively shuts the door on communities around the world, depriving them of life-saving medication and increasing the risk of new HIV transmissions. This move not only contradicts decades of scientific research but also undermines the very mission of PEPFAR: to save lives and reduce the burden of HIV/AIDS worldwide.

The restriction on PrEP access is particularly troubling in regions where the HIV epidemic is most severe, such as sub-Saharan Africa. In these areas, young women account for a disproportionate number of new infections, but so do men who have sex with men (MSM) and transgender individuals—groups that are now explicitly excluded from PEPFAR-funded PrEP under this new policy. By denying these populations access to PrEP, the administration is actively allowing the HIV epidemic to spiral further out of control.

Research has continued to produce newer modalities of PrEP that are long-acting products, which create even more possibilities for people to protect themselves for up to six months per dose. One long-acting prevention tool, injectable lenacapavir, is currently under FDA review and could provide a valuable option for people who have trouble with daily pill-taking or fear the stigma that is sometimes associated with ARVs in their communities. With regulatory approval and WHO guidelines expected by the middle of the year, injectable lenacapavir provides the best chance to drive down the number of new infections. So stopping current PrEP programs makes seizing this new opportunity that much harder.

This decision appears to be less about public health and more about an ideological agenda that seeks to police morality rather than protect lives. The new Trump Administration, just weeks into its second term is demonstrating a careless pattern of undermining global health programs, including cutting funding for international health organizations that provided comprehensive sexual health services. This latest move is yet another example of the administration prioritizing conservative politics over the well-being of vulnerable populations.

By selectively restricting PrEP access to only pregnant and breastfeeding women, the administration is effectively signaling that only certain groups are deemed “worthy” of HIV prevention. This echoes the stigmatizing rhetoric that has long plagued HIV/AIDS policy, one that associates the disease with so-called “immoral” behavior and seeks to punish those who are at highest risk. Such policies not only fail to address the reality of the HIV epidemic but also reinforce dangerous stereotypes that fuel discrimination and stigma.

The repercussions of this policy extend far beyond the immediate communities affected. As the largest funder of global HIV/AIDS programs, the United States has a moral and strategic responsibility—and opportunity—to lead with science and evidence-based solutions. The decision to restrict PrEP access will not only increase new infections but also put added strain on already overburdened healthcare systems. The cost of treating HIV is significantly higher than preventing it, making this policy both a moral and fiscal failure.

Moreover, at a time when the world is grappling with multiple global health crises, the US should be strengthening, not weakening, its commitment to international health initiatives. This policy shift undermines trust in US global health leadership and sends a dangerous message to other nations that discrimination and exclusion are acceptable public health strategies.

Congress, global health advocates, and the public must demand the immediate reversal of this harmful policy.

The fight against HIV/AIDS is far from over. We cannot afford to take steps backward when so many lives are at stake. The Trump Administration’s decision to deny PrEP to those most at risk is a dereliction of duty, a moral failing, and a betrayal of the very principles that PEPFAR was founded upon. The world is watching, and history will not judge kindly those who choose exclusion over compassion, politics over science, and death over life.

PrEP Price Comparison

Comparing the annual price of oral TDF/FTC vs. the dapivirine vaginal ring and injectable cabotegravir. For product approvals, volumes, implementation, and price comparisons of long-acting PrEP, visit our dashboard on PrEPWatch.org.

Gears of Lenacapavir for PrEP Rollout 

The Gears of Lenacapavir for PrEP Rollout outlines a transformative opportunity in the global fight against HIV, coming at a pivotal moment when the scale-up of PrEP has shown remarkable progress but remains insufficient to achieve a transformational impact on HIV incidence and the trajectory of the epidemic. This effort demands a coordinated response from governments, donors, civil society, and the private sector to ensure rapid implementation, equitable access, and sustainable impact. By leveraging lessons from previous PrEP interventions, aligning financing mechanisms, and prioritizing underrepresented regions, stakeholders can overcome systemic barriers and maximize the public health potential of this innovative long-acting prevention tool.

With anticipated regulatory approvals and production scaling, the plan targets over 2.5 million LEN users in low- and middle-income countries by 2027. With a focus on addressing structural barriers like stigma, healthcare inequities, and restrictive policies, alongside integrating generics into national programs, the roadmap aims to build on existing progress while accelerating the pace of HIV prevention. 

The Gears Framework for Lenacapavir for PrEP Rollout

The gears framework for lenacapavir scale-up brings together a coalition of essential stakeholders, each contributing to the successful, sustainable integration of this HIV prevention tool into global health systems.

Excerpted from the Gears of Lenacapavir for PrEP Rollout report.

Oral PrEP Prices in LMICs

This chart tracks pricing for oral PrEP as tenofovir disoproxil and emtricitabine (TDF/FTC) as compared to generic pricing in low- and middle-income countries (LMICs) since 2005.

Avac Event

I Am More Than HIV Prevention – Results from the HPTN 091 Study with Transgender Women

HPTN 091, the I Am study, evaluated the impact of a multicomponent HIV prevention strategy to increase the uptake and adherence of pre-exposure prophylaxis (PrEP) among transgender women. The strategy included HIV prevention services, gender-affirming hormone therapy, and peer health navigation.

This webinar featured Dr. Tonia Poteat, study co-investigator, who will review the study findings and discuss implications.

Speakers:

  • Tonia Poteat, Ph.D., Duke University School of Nursing, Division of Healthcare in Adult Populations

This webinar featured Portuguese and Spanish translation thanks to HPTN.

Video Recording and English Audio / Spanish Audio / Portuguese Audio / Slides / Resources

Introducing the Gears of Lenacapavir Rollout and The People’s Research Agenda

This World AIDS Day, the HIV/AIDS response stands at a crossroads, with injectable lenacapavir set to transform HIV prevention. But as the new UNAIDS report highlights, it also comes at the same time as restrictive policies, economic instability, and geopolitical challenges threaten to frustrate access and rollback so much of the progress that has been achieved over the past two decades. 

AVAC’s 2025 advocacy agenda prioritizes collaboration and strategies for equitable and accelerated product introduction that maximize the public health potential of new prevention options and simultaneously sustains investment in critical research and development. AVAC’s newest publication, The Gears of Lenacapavir for PrEP Rollout, provides a clear pathway for the speed, scale and equity needed to translate exciting science into public health impact, while our recent The People’s Research Agenda (PRA) meets this high-stakes moment for HIV prevention with a clear, concise and collaboratively developed set of priorities for how prevention research should be conducted and what products should be developed in the future. 

Despite the challenges, 2025 holds immense potential for ensuring the equitable rollout of new options and the accelerated development of a pipeline of additional options, the combination of which can help move the field closer to ending HIV/AIDS.  

For the latest information on injectable lenacapavir for PrEP, be sure to join us for our webinar Tuesday, December 3. And read more below about both the Gears of LEN for PrEP Rollout and The People’s Research Agenda

The Gears of Lenacapavir for PrEP Rollout: Driving Speed, Scale, and Equity

Lenacapavir’s rollout is not just about making a new drug available as quickly as possible; it is about ensuring that it reaches the people who need it most, as swiftly and equitably as possible. Gilead has announced its readiness to manufacture up to 10 million doses for 2026, but this potential hinges on coordinated action by governments, donors, and civil society. The roadmap outlines the essential gears driving this effort, from robust demand generation and procurement strategies to equitable distribution and community-driven implementation. Crucially, the roadmap emphasizes lessons learned from previous PrEP interventions: that availability alone is not enough. With global HIV targets still unmet and disparities persisting, this effort demands decisive action and long-term planning.

Download the infographic

The People’s Research Agenda: A Community-Driven Vision

The People’s Research Agenda (PRA) brings the voices of affected communities to the forefront of HIV prevention research and product development. With limited resources, the stakes for decisions about which products to develop and eventually deliver become even higher for funders, communities, policy makers and governments. The PRA offers a bold vision for aligning scientific innovation with community needs. By amplifying the perspectives of those most affected by the epidemic, the PRA is a tool for driving accountability among funders, developers, and policymakers. As a living, adaptable framework, it ensures that evolving needs and challenges in the prevention landscape remain at the center of decision-making.

A Call to Action

The rollout of lenacapavir and the implementation of the PRA come at a critical moment in the global HIV/AIDS response. Achieving their full potential will require sustained collaboration, strategic investments, and unwavering commitment to equity. Together, we can transform this pivotal moment into lasting progress.

PrEP Initiations by Country Worldwide

AVAC tracks global PrEP use by conducting quarterly surveys of ongoing oral PrEP demonstration and implementation projects, and collecting data from manufacturers and government agencies. This graphic shows data on PrEP initiations around the globe. For more trends in oral PrEP uptake, visit PrEPWatch.

PrEP Initiations in Latin America, 2019-2024

Latin American countries account for 306,000 cumulative PrEP initiations in the Global PrEP Tracker as of Q2 2024, which represent 4% of the global total. Since 2019, PrEP initiations across the region continue to increase at a steady rate, with Brazil reaching about 194,000 cumulative PrEP initiations (63% of regional total) since the inception of its National PrEP Program. Read more in PxWire.

PrEP Approval Status in Latin America, 2024

Since 2019, rates of HIV acquisition in Latin America have been trending upward, from 110,000 annually in 2019 to approximately 120,000 in 2023. At the same time, Latin America has taken strides to combat this trend, from increasing PrEP initiation rates to preparing for longer acting PrEP products, such as injectable cabotegravir (CAB) and lenacapavir (LEN). Learn more in PxWire.