PxWire Volume 16, Issue 3

This issue showcases updates presented at the AIDS 2026 conference in Rio de Janeiro, Brazil. As the field continues to grapple with the impact of PEPFAR funding cuts on HIV services, amfAR shared their latest analysis from the PEPFAR Pulse Study. AVAC’s latest infographic unpacks the current status of generic licensing agreements for long-acting PrEP products, including alimatravir (AMI), reflecting significant progress in speeding up access as new products enter the market, while also highlighting persistent and worrying gaps in these agreements. Recent trials on long-acting treatment and broadly neutralizing antibodies (bNAbs) for prevention were also shared at the conference. A new weekly pill for HIV treatment demonstrated non-inferiority, while a combination of two bNAbs did not provide protection from HIV. Both results provided important insights and implications for the current status of the HIV prevention and treatment pipelines.

Read below or download a PDF version of this issue.

Progress in PrEP Uptake

Source: PEPFAR Pulse Study

  • Significant challenges persist in the wake of cuts to PEPFAR programs, as the ripple effects continue to be felt across the field and organizations grapple with how to maintain services with fewer resources.
  • At the start of the conference, amfAR released a report detailing the results from their recent PEPFAR Pulse study. The study provides the first concrete evidence and key details on the impact of PEPFAR cuts: surveying 166 organizations in 46 countries, they found that nearly 2,000 service sites had been forced to shutter. 
  • The results from the study were significant: almost no organizations were able to fill the funding gap with other donors. Services for key populations (KPs) were “decimated”: 73% of implementing partners stopped at least one KP service and 67% stopped outreach services. 
  • HIV prevention services overall took a huge hit: PEPFAR expenditures for condoms and lubricants were almost completely cut, while non-biomedical HIV prevention and VMMC expenditures were cut in half and PrEP expenditures were reduced by 38%. Expenditures for associated services such as violence prevention and response were also cut by two-thirds. 
  • As a result, almost half of respondents reporting that they had halted key prevention activities such as condom or PrEP distribution. Two-thirds reported interruption of PMTCT and nearly one in four stopped providing prevention of mother-to-child transmission services entirely. As outlined in amfAR’s accompanying JIAS article analyzing service delivery data from PEPFAR-supported facilities, these cuts have resulted in drastic reductions in the number of people served.
  • Additionally, the release of UNAIDS’ United to End AIDS special report and a companion KFF-UNAIDS analysis shared results on the global picture of the AIDS epidemic and donor funding landscape.   
  • The report shows HIV financing entering one of its most precarious periods in decades, with international assistance declining 18% between 2024 and 2025. Donor government funding fell by $2.1 billion in 2025—the largest annual decline since global HIV funding began scaling up—and epidemiological progress has stalled, with new HIV infections remaining essentially unchanged for the third consecutive year. 
  • Taken together, these findings underscore the broader challenges facing the field in effectively translating scientific progress into the impact needed to end AIDS as a public health threat by 2030. 

PrEParing for New Products

  • Just before the AIDS 2026 conference, Merck/MSD announced that it had signed bilateral voluntary licenses for their investigational monthly PrEP pill, known as alimatravir (AMI, or MK-8527) with seven generic manufacturers to supply 129 low- and middle-income countries.  
  • Notably, the seven generic manufacturers for AMI include three based in Africa (Kenya, South Africa, and Uganda). This is an important step forward to secure local continuity of supply in high-burden countries. 
  • Merck/MSD’s decision to provide generic manufacturing agreements more than a year out from efficacy trial results is unprecedented. The move reflects the impact of deep engagement with advocates throughout the planning and implementation of the EXPrESSIVE clinical trial program and responsiveness to longstanding calls to accelerate the research to rollout process. 
  • But not all advocacy demands were met. A number of countries – including Brazil, the host country for AIDS 2026 and a site for clinical trials of AMI (and CAB and LEN, previously) – was again left out of the voluntary license territory. (Merck/MSD did subsequently announce they signed a memorandum of understanding with Fiocruz, a Brazilian manufacturer, to supply AMI for Brazil and the region, but the terms, timing and next steps remain unclear.) 
  • As the map above demonstrates, this reflects a broader trend of excluding Latin American countries, as well as some Asian countries, from voluntary licenses despite their participation in clinical trials for the same products, largely due to their World Bank economic categorization, and not their epidemiologic reality.  
  • Furthermore, these agreements do not address the access disparities in high-income countries that disproportionately impact key populations – men who have sex with men, people who use drugs, sex workers, transgender people, and others – especially in the United States where access to prevention products hinges on health insurance coverage. 
  • The World Trade Organization’s TRIPS Agreement does explicitly allow governments compulsory licensing under specific public health crises or anti-competitive practices. This could potentially authorize the production and use of a patented drug without the consent of Merck/MSD, but it can be a lengthy process that further delays access. An extended voluntary license to all low- and middle-income countries would allow for the quickest rollout and maximum impact. 

What is Generic Licensing?

  • Generic drugs are bioequivalent to originator products and are produced by a generic manufacturer. They are sold at much lower prices than the originator drug, usually because they are not manufactured in high-income countries and can make use of economies of scale.
  • Generics manufacturers are allowed to sell their version of the product once the product’s patent and terms of exclusivity expire—usually after 10-20 years. However, a developer can choose to grant a voluntary license before patent expiration, allowing generics to be manufactured and marketed earlier. Original drug developers can either grant this license directly to manufacturers or via the Medicines Patent Pool.
  • The developer decides which countries the license covers; normally high-income countries are excluded, as the developer will continue to sell the brand product in these markets at higher prices for a profit.
  • Countries without a voluntary license to use generic versions of an originator drug may declare the drug to be in the public interest and issue a compulsory license enabling the purchase of the less expensive drug from generic manufacturers.

Time Saved on AMI Generics Licensing

  • The successive introduction of each new PrEP product has gone faster than the previous one, including notable reductions in the amount of time to establish licensing agreements with generic manufacturers. 
  • Granting voluntary licenses while clinical trials for AMI are still enrolling, before it is known if the product is effective, sets a new benchmark for the field, potentially eliminating years of delay between evidence, licensing and generic production.  
  • This accelerated timeline gives the field ample opportunity to plan for broad and rapid access to AMI and should help preempt the supply constraints currently facing LEN and CAB. 
  • Local manufacturing in the three African countries included in the generic licensing agreement should also facilitate faster access in the region with fewer supply constraints. 

The Latest R&D in the Prevention Pipeline

The latest development for long-acting treatment research

  • The HIV treatment pipeline continues to evolve, especially around long-acting options. Over the past year, AVAC has added long-acting treatment (LA-ART) to our pipeline tracking efforts, reflecting the evolving continuum across ARV product development and the need for a comprehensive agenda for the development of novel and longer-acting products that includes PrEP, PEP, and treatment. 
  • At AIDS 2026, Merck and Gilead presented detailed results from the Phase 3 ISLEND trials, showing that an investigational weekly oral single-tablet treatment regimen combining islatravir (ISL) from Merck/MSD and lenacapavir (LEN) from Gilead sustained viral suppression as effectively as daily oral antiretroviral therapy (ART) at week 48; the studies will continue to week 96. 
  • Importantly, trial participants in ISLEND-2 reported strong satisfaction with the ISL/LEN treatment option and felt that it was easier to manage compared to standard HIV treatment options.
  • Given the mechanisms of action of ISL and LEN, which target HIV at multiple stages of the viral life cycle, the combination regimen could offer an important, novel option for people with virologically suppressed HIV. The companies plan to file ISLEND data with regulatory authorities globally, with a potential launch in 2027.  
  • These Phase 3 data are an exciting indication of the evolving HIV treatment landscape, with additional long-acting options in the pipeline and oral options for people who may not prefer an injection. 

Combo bNAbs get even more complicated

  • Broadly neutralizing antibodies (bNAbs) remain at the center of research toward immune-based prevention. In particular, researchers are advancing the concept of “combo AMP,” i.e., passive delivery of a combination of bNAbs targeting multiple sites on the viral envelope, achieving broader and stronger protection than with a single bNAb.   
  • At the conference, the CAPRISA team from Durban, South Africa, announced results from the CAPRISA 012c Phase 2 trial examining a combination of two bNAbs as prevention.
  • The trial, conducted with approximately 1,100 young women in South Africa and Zambia, found that a six-monthly combination of the CAP256 and VRC07 bNAbs was safe, but there was no statistically significant difference in HIV incidence rates between the bNAb and placebo arms, meaning it did not provide protection against HIV acquisition.
  • One reason for the lack of efficacy was the high rate of viruses detected amongst the women who acquired HIV that were resistant to one or both of the bNAbs. This was unexpected, and one conclusion from this trial is that the evolving sensitivity of circulating viruses to the bNAbs manufactured for trials should be carefully considered.
  • Antibody research has always been about more than product development. The CAPRISA 012c study continues to deepen understanding of HIV and the immune system, and will continue to inform vaccine design, cure research and the next generation of prevention strategies. But it is still not clear if bNAbs can be a prevention option on their own.  

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CASPR Impact Report

The Coalition to Accelerate and Support Prevention Research (CASPR) is an Africa-led advocacy network and movement, focused on advancing biomedical HIV prevention research and equitable access to proven HIV prevention products. This report highlights the Coalition’s achievements and key wins over the course of eight years. These include significant impact on elevating community needs, expanding the field of HIV advocacy, promoting inclusive engagement in research, and improving ethical standards in HIV prevention research.

Read the PDF below, or view as a webpage.

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PxWire Volume 16, Issue 2

This issue showcases AVAC’s analysis of the recent PEPFAR data release, assessing how uptake of prevention programs—particularly PrEP initiations—have declined over the last year. As the field grapples with the lasting impact of the US government’s cuts to PEPFAR programs, AVAC takes a closer look at what the data show and what is still missing.

This is especially timely, given the recent announcement from PEPFAR and the Global Fund of their additional commitment to scale-up lenacapavir (LEN) for PrEP. AVAC’s recent infographic unpacks the enduring gap between current donor commitments, LEN volume capacity and potential market size. Lastly, AVAC’s newest infographic depicts the long-acting HIV treatment R&D pipeline. Coupled with research on long-acting prevention and vaccines, long-acting treatment is an important component of an integrated approach to ending HIV as a global health threat.

Read below or download a PDF version of this issue.

Progress in PrEP Uptake

  • On April 17, the US State Department released long-awaited PEPFAR data from the last quarter of Fiscal Year 2025 (FY25), representing the only data available on the status of PEPFAR programs following the US government’s drastic cuts to foreign assistance programs. Only one quarter of data, covering the fourth quarter of FY25 (July-September 2025) was released, and no data are available from the last six months of implementation.
  • While PEPFAR promoted the data release as reflecting significant progress in curbing the epidemic, the data actually reveal stark declines in HIV testing, diagnosis, and treatment. HIV prevention programs were some of the hardest hit by both cuts to PEPFAR programs and the narrowing focus on prevention for pregnant and breastfeeding women (PBFW).
  • In FY25, the number of individuals newly initiated on PrEP decreased by 41% as compared to the same quarter in FY24, with an overall decrease of 54% among all men and 53% among women who are not pregnant or breastfeeding. While PEPFAR touted a 140% increase in PrEP initiation among PBFW, the disaggregated data is historically inconsistent and not available in the latest data release; therefore it cannot be independently verified.
  • Especially worrying was PrEP initiations among adolescent girls and young women (AGYW) aged 15-24, which fell by 39% as compared to a 26% drop among women aged 25-49. AGYW previously benefited from PEPFAR’s DREAMS programs—packages of prevention services to address the high incidence of HIV among AGYW—but the number of program recipients decreased by 86% in FY25 as many of these programs were defunded.
  • Most alarmingly, the data do not include any information on HIV prevention services or PrEP initiation among key populations, including men who have sex with men, transgender people, and sex workers. This lack of data, coupled with the elimination of prevention programs for these populations, reflect an erasure of individuals at high risk for HIV that face life-threatening cuts to services.

Achieving Global 2030 Prevention Targets

The Global HIV Prevention Coalition (GPC) recently launched its HIV Prevention 2030 Global Access Framework, outlining how, by 2030, countries can ensure that 90% of people in need of HIV prevention services have access and that 90% of people living with HIV are virally suppressed. This, in combination, would lead to a 90% reduction in new HIV infections globally. “Innovations, especially lenacapavir, have added to the array of prevention choices. History will judge us harshly if we as a global community fail to meet this scientific moment,” said Mitchell Warren, GPC Co-Chair on a recent webinar. Actions must be country-led, sustainable, people-centered, and rooted in community leadership to achieve these targets.

graphic from UNAIDS report graphic from UNAIDS report

Graphics: HIV Prevention 2030 Global Access Framework

PrEParing for New Products

  • On April 14, the US State Department and the Global Fund announced an increase of their original commitment of LEN for PrEP, from two million to three million people over three years.
  • Gilead has confirmed that it is not supply constrained and can supplement generic supply until it is steady, as long as they receive orders within time, based on their sixto nine-month production lead time needed. Generic supplies are expected to reach the market by the middle of 2027, but their capacity and lead times are not yet known.
  • While this is an important step, it does not go far enough to have meaningful impact on rapid scale-up of LEN, and there are no guarantees that the product will reach those who need it most, including key populations and adolescent girls and young women.
  • AVAC and Access Bridge see more potential to build the market by meeting market demand, leading ultimately to a reduced price, higher annual volumes and significantly increased impact.
  • To achieve this, key priorities over 2026 and 2027 must be advanced:
    • Global Fund and PEPFAR need to raise the floor of their commitment to reach at least four million people in two years.
    • Global Fund must ensure that they have the resources to procure these volumes and meet demand, requiring resource mobilization beyond the recent GC8 replenishment.
    • Global Fund and PEPFAR need to provide clear, transparent LEN access plans, with volumes and countries, ensuring a more comprehensive joint strategy in more countries, as well as volumes and prices with Gilead and generics.
    • All procurers must place orders for 2027 by June 2026 with both Gilead and generics to ensure uninterrupted supply and expanded global access, whether through the Global Fund or directly with manufacturers.
    • Ministries of Health must collaborate with implementation partners and civil society to ensure people-centered approaches to rollout, and to address supply and demand issues as they emerge and develop robust forecasts for 2027.
    • Generic manufacturers must specify their lead-times from order to delivery to coordinate and ensure timely procurement.
    • Gilead must urgently finalize license and supply agreements for middle-income countries, especially in Latin America and Asia.

The Latest in the HIV Research Pipeline

  • AVAC has recently begun to track the research pipeline for long-acting HIV treatment (LA-ART). This focus aligns with AVAC’s work to advance an integrated approach to ending HIV transmission, including a comprehensive agenda for the development of novel and longer-acting products beyond PrEP, inclusive of PEP and treatment.
  • A rapidly expanding pipeline for LA-ART has the potential to introduce new regimens with dosing frequencies that range from weeks to months to, eventually, years. The benefits of LA-ART include reduced drug dosing, frequency, and number of drugs, with the potential for associated decreases in the cost of medications and the burden on health systems. New drug classes could close treatment gaps in children, adolescents, and those with high viremia, comorbidities and resistance.
  • CROI 2026 highlighted the potential future LA-ART landscape beyond today’s 2-month CAB + RPV injections. The range of products in development includes novel characteristics such as new ART classes and monoclonal antibodies, new ARV combinations, delivery via oral, implantable and injectable formulations, and longer regimens—currently up to six-months.
  • Ongoing clinical research will hopefully further demonstrate whether there are trade-offs (treatment failures or resistance) between LA-ART and highly effective daily oral ART. In addition to the new long-acting products, simplified single-tablet daily regimens are also in development.

Building the Market for New Products from the Trial Stage

MK-8527 is currently in Phase III trials (EXPrESSIVE-10 and EXPrESSIVE-11) across 17 countries. To build a supportive environment around the concept of a monthly oral PrEP pill, AVAC supported the development of communications materials for use in the EXPrESSIVE-11 trial which can be adapted for future market entry. AVAC worked with local partners and MSM, transgender, and non-binary communities in 8 trial countries in Africa, Asia, and Latin America to co-create the materials, ensuring that focus populations contributed to the design. The result is a global campaign with a localized feel that is generating awareness on MK-8527 early.

English poster example
Portuguese poster example
Spanish language poster
Swahili language poster

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AVAC Year in Review 2025

2025 underscored the vital role that AVAC plays in the global health ecosystem, and why our work and our partnerships have never been more essential.

This report highlights AVAC’s role as a trusted voice, a translator of science and catalyst for action and advocacy. It reflects an organization ready for the future: supporting African leadership, strengthening bridges from R&D to delivery and preparing for a new chapter as we move forward into our fourth decade as an organization. Read the PDF below or view as a webpage.

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PxWire Volume 16, Issue 1

This issue showcases the status of access to oral PrEP with the best data available since the US foreign aid freeze disrupted PEPFAR operations beginning in January 2025. Stakeholders are digging deep to meet the moment, which includes an unprecedented opportunity to drive down HIV incidence with the rollout of injectable lenacapavir (LEN) for PrEP.

A new AVAC infographic below depicts the accelerated process for delivering LEN to date, and critical next steps. Lastly, our update on the HIV vaccine R&D pipeline documents an evolving and diverse portfolio of products, which remains essential for a durable end to HIV as a global health threat.

Read below or download a PDF version of this issue.

Progress in PrEP Uptake

  • Between the period January-September 2024 to January-September 2025, PrEP initiations fell between 13% and 66% in selected high-volume PrEP countries where ministries of health (MoH) were able to provide data.
  • Among the five countries depicted, four saw significant decline in PrEP uptake. All four relied on PEPFAR PrEP programs and were disrupted by stop work orders (SWO).
  • Brazil does not receive PEPFAR funding for PrEP and was the only country surveyed that saw an increase in initiations, up by 17%.
  • Among the same four African countries, data on initiations of long-acting injectable cabotegravir (CAB) for PrEP show a combined total of 5,709 initiations during this period. With PEPFAR’s original target of 100,000 initiations across ten African countries by the end of 2025, these data reflect an extreme shortfall of CAB uptake, caused by PEPFAR’s discontinuation of CAB procurement and programs.
  • A decline in PrEP uptake represents a serious threat to HIV prevention and to efforts to achieve epidemic control. A recent analysis in The Lancet HIV estimated that stopping PEPFAR’s PrEP programs in Africa for a year could lead to approximately 7,000 additional new HIV acquisitions, and more than 10,000 additional cases of secondary transmission in the next five years. This slowdown also makes the introduction of new options more challenging.
  • For more details on the negative impact of the PEPFAR SWO, including mitigation strategies that ministries of health and program implementers are putting in place, see our SWO Tracker.

PrEParing for New Products

  • The timeline for hitting key milestones in product introduction is moving faster for injectable LEN than for any previous PrEP products, starting from the announcement of efficacy results in Phase III trials.
  • LEN’s accelerated timeline compared to oral PrEP, DVR, and CAB reflects a field-wide effort to learn lessons from previous PrEP rollout and not repeat the mistakes of the past.
  • The developers of LEN, Gilead Sciences, leveraged the EU-M4all process, formerly known as Article 58, and WHO’s Collaborative Registration Procedure (CRP) to speed the process of regulatory review in low-and middle-income (LMIC) countries. This process allows the European Medicines Agency (EMA) and the WHO to provide a scientific opinion on products that address “diseases of major public health interest” in LMICs. EU-M4all and CRP help national regulators accelerate their review.
  • LEN has received 10 African regulatory approvals in only six months since the US Food and Drug Administration granted approval. By comparison, oral PrEP took 3.5 years for the first African approval to be granted after FDA approval, and 6.5 years to reach 10 approvals.

The Latest R&D in the Prevention Pipeline

Despite the challenges posed for research in 2025, and HIV research in particular, two notable vaccine trials launched at the start of 2026:

  • BRILLIANT 011 launched in South Africa. This HIV vaccine trial was cancelled by the US government as part of the dismantling of USAID in early 2025. The South African Medical Research Council and the Gates Foundation, however, provided fund-ing to keep the program going as a smaller, more streamlined version of the trial originally planned under USAID. This groundbreaking African-led and -funded trial is a Phase I study of a bNAb inducing candidate. Learn more about vaccine strategies here.
  • The first vaccinations for the IAVI G004 Phase I clinical trial also took place in January. This early-stage HIV vaccine trial stands out as the first germline-targeting vaccine designed to induce broadly neutralizing antibodies (bNAbs) against more than one major site on the HIV envelope—specifically both the CD4 binding site and the V3 glycan region. Most prior HIV vaccine candidates have focused on the CD4 binding site alone.

Additional developments in the R&D pipeline include:

  • Merck’s Phase 3 trials of the monthly oral PrEP pill MK-8527 – EXPrESSIVE-10 and EXPrESSIVE-11 – are now both underway. EXPrESSIVE-10 officially launched in November 2025 and has since begun recruitment at 19 sites in South Africa, with sites in Kenya and Uganda prepared to launch imminently. EXPrESSIVE-11, which launched last August, is now enrolling participants in 58 sites across 11 countries, with additional sites also launching soon.
  • Sidaction and Aidsfonds announced funding for four projects to inform cure research, investigating the biology of viral persistence, viral control, ethics in cure clinical trials and more.
  • AVAC launched its new Pipeline Tracker that is continuously updated, with comprehensive descriptions and status updates of all products in the HIV R&D pipeline.

A Deep Dive on the People’s Research Agenda

In December AVAC launched our 2025 Update to the People’s Research Agenda (PRA), a people-centered framework for tracking community priorities and progress in the pipeline of HIV prevention research and development. PRA findings include:

The Future of HIV Prevention: A People’s Research Agenda for Speed, Scale and Equity

PRA advertisement

Featured speaker Jeanne Marrazzo of the Infectious Diseases Society of America and AVAC board member explores what the People’s Research Agenda tracks and the advocacy priorities that will shape the future of HIV prevention R&D. View the recording.

“We cannot yell it from the rooftops loud enough that new infections are going to rise and undermine efforts to end AIDS as a public health threat. But this is not a time to despair. It’s a time to fight!” – Jeanne Marrazzo

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People’s Research Agenda

2025 Update

The People’s Research Agenda sets out a people-centered framework for equitable and accelerated R&D and product introduction. It tracks the science, shows where investments align—or fail to align—with community-defined priorities, and spotlights critical gaps in the pipeline of prevention options needed to meet the diverse realities of all populations.

Read the 2025 Update

The original 2024 report is also available.

PxWire Volume 15, Issue 4

This issue provides a range of maps to help orient the field on critical HIV prevention activities: the status of delivering injectable cabotegravir (CAB for PrEP); funders and countries on track for early introduction of injectable lenacapavir (LEN for PrEP); and where new Phase 3 efficacy trials testing MK-8527 as a monthly pill for PrEP are taking place.

Read below or download a PDF version of this issue.

Progress in PrEP Uptake

  • The first supplies of CAB for programmatic use (as opposed to use in implementation studies) began to arrive in countries in 2024.
  • Currently, 16 countries are rolling out CAB for programmatic use, with the majority of supply provided by PEPFAR, and some additional quantities procured by the Global Fund.
  • Stop work orders for PEPFAR programming, issued in January 2025 by the new US administration, led to the cancellation of planned programs to offer CAB before they could start in Namibia and South Africa. Ethiopia’s CAB program was able to move forward with supplies supported by Global Fund.
  • Stop work orders disrupted ongoing CAB programs in other PEPFAR supported countries, too. They were able to resume, though in some cases at a reduced level. Global Fund supported programs were unaffected by stop work orders and are ongoing.
  • The future of PEPFAR and Global Fund supported CAB programs remains uncertain in the context of multiple forms of injectable PrEP entering the market. But lessons and insights being gathered now on delivery of injectable PrEP via these programs can be leveraged to help countries prepare for the introduction of LEN.
  • In the past quarter, CAB for PrEP received additional regulatory approval in Argentina, Chile, Mexico, and Rwanda.

PrEParing for New Products

The Latest R&D in the Prevention Pipeline

  • Seventeen countries are hosting sites for the Phase 3 efficacy trials of a monthly PrEP pill, MK-8527, being developed by Merck (also known as MSD outside of the US and Canada). Merck announced the launch of the Phase 3 trials at IAS 2025 in Kigali. MK-8527 was found to be safe and well-tolerated in Phase 2 clinical trials.
  • A long-acting PrEP pill would offer a unique new option to the existing range of PrEP options and could significantly expand use of HIV prevention, especially among young women, key populations, those facing stigma or access barriers, and those that prefer an oral PrEP option over an injectable.
  • EXPrESSIVE-10, with funding from the Gates Foundation, is expected to launch in Q4. It will enroll about 4,600 cisgender adolescent girls, young women, and other women who could benefit from PrEP across three countries in Eastern and Southern Africa.
  • EXPrESSIVE-11 launched in August 2025, and will enroll about 4,400 cisgender men, MSM, transgender men and women, and gender non-binary persons who could benefit from PrEP in 16 countries. So far, EXPrESSIVE-11 has launched at sites in Dominican Republic, Guatemala, Switzerland, and the US.
  • Merck’s commitment to stakeholder engagement to date contributes an important model of Good Participatory Practice (GPP) to the field, by putting global advocates at the forefront of planning for the program and trial design. Merck has expressed a commitment to sustain this vital engagement throughout the program and next steps.

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The Global Need for Long-Acting PrEP Among Key Populations

Forecasts of Global Demand 2025–2030

The introduction of long-acting PrEP represents a turning point in the global HIV response, especially for key populations who have historically faced persistent barriers to HIV prevention. Despite oral PrEP being introduced more than a decade ago, global uptake remains well below targets. New HIV infections are declining in some regions but are stagnating or rising in others, particularly where key populations are underserved.

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Also available on the GBGMC website.

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.

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  • 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]
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Long-Acting PrEP Market Assessment for Key Populations

Global Access and Readiness

This market assessment supports countries, donors, implementing partners, and advocates in making informed decisions about the introduction, scale-up, and equitable delivery of long-acting PrEP among key populations and other priority groups.

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Also available on the GBGMC website.