PxWire Volume 15, Issue 3

With the recent FDA approval of injectable lenacapavir (LEN) for PrEP and the drastic withdrawal of US investment in HIV prevention, the field must reimagine and recommit to getting PrEP rollout right this time AND to sustaining the HIV research pipeline. Research on HIV has brought numerous advances to global health, but controlling, and ultimately ending, the epidemic depends on continued investment in innovation.

This issue of PxWire looks at the scale of shuttered prevention programs for key populations (KPs), the potential market for injectable LEN, and the devastating cuts to research for an HIV vaccine.

Read below or download the PDF version of this issue.

Progress in PrEP Uptake

The PEPFAR stop work orders issued by the US government in January 2025 have devastated the HIV response worldwide, including funding for primary prevention. Sustaining the HIV response and bending the curve of incidence depends on identifying new sources of funding to maintain HIV prevention programs for KPs.

  • Guidance issued in February 2025 indicated that PrEP services funded by the US government are permitted only for pregnant and lactating people—meaning that KPs, such as LGBTQ+ individuals, sex workers, and people who use drugs, have lost access to PrEP, unless they are currently pregnant or lactating.
  • The graphic below shows key findings on the percentage of KP programs terminated by country. Most of the priority African countries for the HIV response report national KP programs are fully or partially terminated.
  • HIV incidence rates amongst KPs are higher than in other populations. Excluding this group from PrEP programming endangers whole communities threatened by HIV, disables the HIV response, and jeopardizes gains made against the epidemic.
  • Research undertaken by Global Black Gay Men Connect (GBGMC) examines the impact of US government funding cuts on KP programs in Africa.
  • Additional research done by AVAC, in the report Impact of PEPFAR Stop Work Orders, shows that KPs are the group most impacted by US government funding reductions to HIV prevention services worldwide. In some cases, such as Panama, national governments are stepping in to fill the gap.

PrEParing for New Products

Stakeholders—including Global Fund, PEPFAR, WHO, UNAIDS, Unitaid, Ministries of Health, advocates and implementing partners—have critical work to do now to ensure doses of LEN hit the ground as quickly as possible. Check out Gears of Lenacapavir for PrEP Rollout and Getting PrEP Rollout Right This Time to get the details.

  • The map shows 16 countries in Africa, Asia and Latin America that have the largest PrEP markets.
  • If total PrEP initiations continue to increase by 20% every year, which is the trend in recent years, and injectables represent 60% of initiations, as seen in implementation studies, 2026 numbers of injectable initiations could be as shown in the map.
  • The exact price and volumes of LEN per country is not yet known.
  • Of those injectable initiations, LEN is expected to be the majority, given the proposed manufacturing projections from Gilead and the stated ambition of the Global Fund to reach two million people with LEN within the first three years of introduction. Additional volumes of injectable cabotegravir would make up the rest.
  • PEPFAR, which in December committed to collaborate with Global Fund, has not yet publicly stated how LEN will fit into their more limited approach to PrEP, which has been restricted to pregnant and breastfeeding women.

The Latest R&D in the Prevention Pipeline

  • In May, NIH’s National Institute of Allergy and Infectious Diseases (NIAID) announced that funding for the Consortia for HIV/AIDS Vaccine Development (CHAVD) would end after the current grant cycle in June 2026. With only one more year of funding before the grants end, current plans for research, clinical trials and progress toward a vaccine are all at risk.
  • First launched in 2005, the CHAVDs led ground-breaking research to develop an HIV vaccine.
  • CHAVD grants currently fund two institutions as consortia leaders—The Scripps Research Institute and Duke University.
  • The quest for an HIV vaccine is gaining momentum with field-changing contributions from the CHAVDs. The institutions are currently researching vaccine designs that rely on the immune system’s broadly neutralizing antibodies (bNAbs) to protect against HIV.
  • The annual funding for the consortia—approximately $67M—represents a significant chunk of the NIH’s funding for HIV vaccine development, and also approximately 10% of all funding for HIV vaccine research globally each year.
  • NIH’s yearly grant total for the CHAVD is larger than any other individual donor’s annual giving for HIV vaccine research. The next closest donor is The Gates Foundation, which donates approximately $64M a year to this research.
  • In 20 years of research, CHAVD discoveries have resulted in new technology to combat HIV, influenza, Zika, COVID, and other novel coronaviruses. The loss of the CHAVD will have a devastating impact on the HIV response and scientific discovery.

Prevention Playlist

AVAC develops a wide range of resources to inform decision making and action. Check out the latest:

Join

  • CHANGE: In response to the unfolding crisis, more than 1,500 people from civil society organizations around the world have launched CHANGE—Community Health & HIV Advocate Navigating Global Emergencies—a coalition formed to support urgent action: [email protected]
  • Subscribe to Global Health Watch: AVAC’s weekly newsletter dedicated to breaking down critical developments in US policies and their impact on global health, at avac.org/global-health-watch
  • Fight For Our Lives” Emergency Townhall: Impact of the Trump Administration Foreign Aid Freeze on KP & LGBTQ Communities, Ongoing convening, Register here

Use

Watch/Listen

Read

Potential Demand for LEN for PrEP

The top 16 PrEP markets, based on 2024 oral PrEP initiations and the possible 2026 injectable market, assuming 60% of new PrEP users choose an injectable, as seen in implementation studies.

Press Release

Important Win for Public Health: Supreme Court Upholds ACA Preventive-Care Protections 

Contact: [email protected]

New York, NY, June 27, 2025 — AVAC welcomes today’s ruling affirming the constitutionality of the Affordable Care Act’s preventive services mandate, including coverage for HIV pre-exposure prophylaxis (PrEP) at no cost to patients. This decision represents a critical victory for public health, health equity, and the millions of people who rely on preventive services to stay healthy and safe. By rejecting efforts to strip away access to PrEP and other essential services based on ideological objections, the court has reaffirmed that public policy must be grounded in science, not stigma. 

Since the original Braidwood decision, AVAC and our partners have worked tirelessly to raise awareness of the case’s far-reaching implications. We joined legal advocates, public health experts, and community leaders to underscore what was at stake: access to evidence-based care and decades of progress in preventing HIV and other serious conditions. Today’s ruling confirms the power of coordinated advocacy and the importance of protecting science-driven health policy from politically motivated attacks. 

This outcome ensures that individuals can continue to access PrEP, both the medication and the clinical services necessary to support its use, without cost barriers. It preserves critical public health gains and sends a strong message that discrimination has no place in our health care system. 

“This ruling is a relief in maintaining the critical role under the Affordable Care Act to cover preventive care services, including HIV pre-exposure prophylaxis (PrEP),” said Mitchell Warren, AVAC’s Executive Director. “Preventive services across healthcare are cost-saving and life-saving, and I am grateful that the Supreme Court found on the side of evidence, logic, public health, and human rights. There has been enormous progress in the fight to end the HIV epidemic, and just last week the FDA approved the newest form of PrEP, injectable lenacapavir. Lenacapavir can be a transformative option, but only if it is available to people who want and need it, and today’s ruling can make that possible.” 

Looking ahead, AVAC will continue working to ensure that PrEP access is not only protected but meaningfully expanded, particularly for the communities that have long faced systemic barriers to care. This includes advocating for a national PrEP program, strengthening provider and patient education, supporting implementation by community-led organizations, and holding insurers accountable for compliance. Today’s ruling offers a strong foundation to build from, and we remain committed to a future where HIV prevention is accessible, equitable, and fully resourced for all. 

Today’s Supreme Court decision does confirm enormous power with the Secretary of Health and Human Services, which under the current administration is cause for significant concern. “In the midst of today’s victory, we must be tempered by what has happened with the CDC’s Advisory Committee on Immunization Practices (ACIP), as it could be a harbinger of what a Secretary of HHS can do to twist committees and task forces that should be composed of technical experts guided by science to ones that are guided by ideology, illogic and political whim,” said Warren.

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About AVAC: Founded in 1995, AVAC is an international non-profit organization that provides an independent voice and leverages global partnerships to accelerate ethical development and equitable delivery of effective HIV prevention options, as part of a comprehensive and integrated pathway to global health equity. Follow AVAC on Bluesky and Instagram. Find more at www.avac.org and www.prepwatch.org. 

The Cruel Irony of Prevention

FDA approves LEN, while the administration destroys USAID

It’s been 22 weeks since the US president issued the executive orders that began the chaotic dismantling of USAID. See recent, remarkable, and much-needed New York Times coverage on the destruction of USAID. And check out this new episode of the This American Life podcast on the aftermath of shutting down USAID.   

We at AVAC took a public stand against this attack on global health and development in our court case, AVAC v. United States Department of State, filed by Public Citizen on February 10. We took this step because we understood the devastation that would come from such drastic and sudden divestment in the HIV response and global health. We also believe it was illegal and unethical.  

In March, US District Court Judge Amir Ali ruled the foreign aid freeze was, indeed, unlawful, and that the administration had “usurped” the authority of Congress. Since that time, some 400 grants have been restored and the government is slowly complying with the Judge’s order to pay all invoices for work conducted through February 13. It’s a mere fraction of USAID’s former self, but each of these restored programs and payments represent an attempt to make America and the world stronger, safer and more prosperous. Just as important, our court case, along with a related one brought by the Global Health Council and colleagues, has forced into the public record the administration’s cynical maneuvers to dismantle global health; information that empowers advocates to fight and, we hope, finally spurs Congress to do its job.

“We cannot cede ground gained against HIV and other global health threats out of fear or paralysis in the face of these reckless actions. It is imperative to hold this administration responsible. And it’s imperative to invest in global health and sustain the gains in HIV. Global health advocates know this better than anyone, and we are fighting back,” said AVAC Executive Director, Mitchell Warren.

Watch AVAC’s Executive Director, Mitchell Warren’s video explaining how this court case is one of many critical steps to safeguard global health and the HIV response.

Nowhere is that fight to safeguard and advance HIV prevention more important than work to rollout injectable lenacapavir (LEN) for PrEP, just approved by the US Food and Drug Administration. LEN approval signals what could be a turning point in the epidemic – but only if the field invests in bold, strategic action. 

“The science is remarkable, and the FDA approval is in. But it’s what happens next that makes the science count. It’s whether or not the technology is made available and becomes truly accessible that will bring impact. Will the world get it right this time? Because for 15 years we’ve squandered the potential of PrEP. That hope depends on fierce and effective advocacy,” said Warren.

HIV prevention advocates around the world are demanding and preparing for injectable LEN to reach the communities that need it most with speed, scale and equity. Watch this video for more on status of LEN rollout and advocacy priorities.

“Scientific progress has been made over the years, and we celebrate them, but without truly having a prevention story to tell…yet. Now it’s time for that story to be told,” said APHA Executive Director Yvette Raphael.

Read this report from Friends of the Global Fight Against AIDS, Tuberculosis and Malaria, Principles of a responsible transition of American leadership to end AIDS: Strategic transition or pandemic resurgence?, on how PEPFAR and US leadership can play an instrumental role in reaching epidemic control.

“There’s much work advocates are doing, and much work ahead. Some donors have come forward, but it’s only a start. We also need to advocate with regulatory authorities at the country level, not to mention pushing for an affordable price, and a big enough supply from Gilead now to support demand creation at scale in order to build a sustainable market, which in turn will support generics and further reductions in price. Advocates are now and will continue to be fighting at the country level and the global level to move all this forward,” said HEPS Uganda Executive Director Kenneth Mwehonge and co-chair of the Civil Society Caucus of the Coalition to Accelerate Access to Long-Acting PrEP.

Check out the Caucus statement on priorities for LEN rollout, and these resources to support our collective advocacy:

Recent news headlines, including the just published New Yorker magazine article by Science reporter Jon Cohen, capture the power of this moment to reshape the HIV response and finally control the epidemic. As advocates, we know the stakes very well.

“What all of us working together have tried to do for years and years and years, is to overcome the barriers from stigma to disinformation, that we’ve seen with oral PrEP, and with treatment 20 years ago. It will take Gilead, working with all of us advocates, to collectively ensure that this drug is accessible to all, so that the success depends not on the politics but on the product. We have to hold everyone, including ourselves, to account for keeping on task and for making sure that we do not squander this opportunity. So, let’s do this together and lay the groundwork for all future innovations to go faster, with speed, with scale and with equity for all,” Warren said.

The field is at a major inflection point, punctuated by both political challenges and scientific opportunity – and we can’t let the former overtake the latter.

Advocates’ Guide to Lenacapavir

Trial results and steps toward ensuring access

This wide-ranging slide deck gives a complete overview of lenacapavir — showing the overall prevention product pipeline, describes lenacapavir, compares it to other options, discusses the trials testing the product, next steps, and links to advocacy resources.

The HIV Prevention Pipeline

This graphic shows currently available options for HIV prevention, newly approved and recommended treatment, and those in development.

Where We Are Now with LEN for PrEP

The chaos in foreign assistance programs (including discontinuation of major PrEP programs), cuts in staffing and new demands on donor commitments will make decisions on the procurement of LEN for PrEP more complex and uncertain.

In December 2024, the Global Fund and PEPFAR announced a plan to reach 2 million people with LEN for PrEP over three years. Exactly how funding to support this unprecedented introduction program will move forward, in the absence of significant US investment, is far from certain. The other stakeholders, including Global Fund, Gilead, CIFF and the Gates Foundation expressed commitments to the deal, but major questions remain.

Moving a Product to the Real World

The rollout of oral PrEP demonstrates that people don’t take PrEP simply because it’s available—there needs to be a demand for it, and it needs to be accessible, acceptable and used effectively by those who need and want it. These are the lessons the field is applying to the rollout of the dapivirine vaginal ring (DVR), and injectable cabotegravir (CAB) and lenacapavir (LEN) for PrEP. To reach the UNAIDS target of 10 million PrEP users by 2025, initiations of oral PrEP alone will not be enough—and this graphic shows that the field is beginning to apply past lessons to accelerate introduction of injectable PrEP options.

For the latest on lenacapavir, visit here.

LEN Generics — Can we go faster?

The timeline for generic LEN for PrEP to come to market is expected to be significantly shorter than for CAB for PrEP. Bioequivalence (BE) testing for LEN, which demonstrates a generic product works in the body in the same way as the originator product, is likely to be six months, vs. the 18 months for CAB for PrEP, because of differences in the drug formulation. The rapid granting of voluntary licensing by Gilead also contributes to this shorter timeline. For the latest on LEN, visit here.

An Overview of Lenacapavir for PrEP Trials

The PURPOSE trials evaluate the safety and efficacy of injectable lenacapavir (LEN), an investigational antiretroviral (ARV) drug being studied as a potential PrEP product. This graphic shows the latest status of all five trials including the groundbreaking results of PURPOSE 1 and PURPOSE 2.