ISL/LEN Phase 3 Development Program

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. This infographic features data from Gilead’s AIDS 2026 presentations on ISLEND-1 and ISLEND-2 trials.

Long-Acting HIV Treatment Pipeline

AVAC has begun to track the research pipeline for long-acting HIV treatment (LA-ART). 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. 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.

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.

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.

Prevention Playlist

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

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PxPulse: An Advocacy Chronicle on U=U in South Africa with Mandisa Dukashe

On this episode of PxPulse: The Advocacy Chronicles, Mandisa Tyadi Dukashe, Treatment Technical Lead at the South African National AIDS Council (SANAC) describes her work in helping to inspire and launch a National U=U Campaign in South Africa in 2024.

What is U=U? Undetectable equals Untransmittable refers to a major breakthrough in the science and understanding of HIV treatment. From data published in 2019, researchers confirmed that people living with HIV who have an undetectable viral load and take medication as prescribed have zero risk of transmitting HIV to their sexual partners.

This evidence galvanized a worldwide campaign, with the hope that spreading the word, Undetectable equals Untransmittable, would reduce stigma around HIV and inspire people to maintain their treatment.

The WHO released guidance in 2023 on how to monitor viral load, which provided supportive global policy for ministries of health. But WHO action is not enough to set public health policy or fulfill the promise of U=U.

Mandisa has long list of credentials behind her: She’s the co-founder of the U=U Africa Forum, part of the U=U Global Community Advisory Board, an alumnus of the AVAC Cure Research program and the AVAC Advocacy Fellows Program. Among many accolades, she has also been recognized as a 2021 Amazing People Living with HIV by HIV Plus Magazine.

Listen

Listen to the full podcast (12:02)

Resources

Expanding HIV Self-Testing Impact and Innovations from the STAR Initiative

BMC Infectious Diseases Supplement

This supplement presents major achievements and insights gained from the introduction, scale-up, and optimization of self-testing. Full details here.

Avac Event

HIV, Viral Hepatitis and Sexually Transmitted Infections: Progress and gaps

13:00 – 14:30 CEST PM

Please join this webinar being held in the run up to the 77th World Health Assembly.

The World Health Organization (WHO) will launch a publication, which describes progress and gaps identified during the first two years of implementing the global health sector strategies on HIV, viral hepatitis and sexually transmitted infections (STIs) for 2022-2030.

Moderators will ask key leaders in the responses to HIV, viral hepatitis and STIs how we can increase visibility, political will and community activism to accelerate action.

Panelists include:

Jérôme Salomon, WHO, Switzerland
Jessica Hicks, World Hepatitis Alliance, United Kingdom
Maureen Luba, AVAC, Malawi
Meg Doherty, WHO, Switzerland
Patty Garcia, Cayetano Heredia University, Peru
Philippe Duneton, Unitaid, Switzerland
Sabin Nsanzimana, Ministry of Health, Rwanda (TBC)

The conversation will be moderated by Charles Gore from the Medicines Patent Pool (MPP) and Birgit Poniatowski from IAS – the International AIDS Society.

The webinar is organized by IAS – the International AIDS Society – and its partners, WHO, Medicines Patent Pool and Unitaid.

Bahati Thomas Haule

Bahati is a rising advocate from Tanzania, advancing the rights and well-being of people living with HIV (PLHIV), women, youth and marginalized communities. She has professional experience in the HIV response as a programs officer. She is also community representative in several spaces, including Tanzania Commission for AIDS, Medicines Patent Pool, AfroCAB and UNITAID. As an AVAC 2024 Advocacy Fellow, Bahati will focus on the scale-up of U=U for better health outcomes for those living with HIV as well as lower rates of HIV transmission among their sexual partners. She believes in a future where health, gender equity, and social justice intersect to create a world of inclusivity and empowerment.

Media & Advocacy

You can call it U=U campaign, ITV-the TV Station (Swahili)
Under CSOs resort to new Anti-HIV drive amid USAID funding suspension, Daily News
Mwitikio wa VVU: Fursa katika teknolojia na usawa, Mwananchi

Elina Mwasinga

Elina is an experienced advocate focused on HIV/AIDS and Sexual Reproductive Health & Rights (SRHR). She wears many hats as an expert and as an advocate. Her positions include national coordinator for the National Association for Young People Living with HIV, a member of AVAC’s Cure ROAR program, a fellow alumni of the Advocacy for Cure Academy, a member of the board of trustees for the Baylor College of Medicine Children’s Foundation, a member of the Coalition of Women Living with HIV (COWLHA) the Youth Forum for National Transformation (YOFONAT). As an AVAC 2024 Advocacy Fellow, Elina’s focus is on U=U and viral load suppression in children as a pathway to an HIV cure.

Media

When the Funding Stops, the Virus Doesn’t: Why cure research matters even more, The Atlas
When Funding Stops, HIV Doesn’t, Malawi Nation
Elizabeth Glaser Pediatric AIDS Foundation Kitchen Table, Facebook
Voice for a Cure, video for the Elizabeth Glaser Pediatric AIDS Foundation

Advocacy

Press Release

Funding for HIV Survives Extreme Cuts Proposed By House Republicans

Final FY24 Bill Includes Calls for HHS/CDC to Increase PrEP Access

21 March 2024 – PrEP4All, AVAC, HIVMA, and the PrEP in Black America coalition celebrate Congress’ decision to both fund domestic HIV programs at the same level as last year and to lift up calls for a National PrEP Program. The final 2024 Health and Human Services bill rejects extreme cuts to HIV funding proposed by House Republicans in July of last year. The organizations have led the charge on the #SaveHIVFunding campaign following efforts to eliminate $767M in critical funds to end HIV as an epidemic. We additionally thank House and Senate LHHS Appropriations Subcommittee leaders Senators Tammy Baldwin (D-WI) and Shelley Moore Capito (R-WV) and Representatives Robert Aderholt (R-AL) and Rosa DeLauro (D-CT) for working to ensure an effective and ultimately bipartisan outcome.

“Our movement for a National PrEP Program and to end HIV as an epidemic remains strong,” says PrEP4All Executive Director Jeremiah Johnson. “The final bill ultimately shows strong bipartisan support for HIV funding, including PrEP, and rejects the flawed effort by some House Republicans to zero out the Ending the HIV Epidemic Program. We created the #SaveHIVFunding campaign in collaboration with AVAC, HIVMA, and PrEP in Black America knowing that everyone in Congress needed to hear from community advocates in order to be successful in fighting these unnecessary deep cuts. Without this work and the concerted and brilliant efforts of so many HIV organizations within the Federal AIDS Policy Partnership, this win would not have been possible.”

The outcome means that a previous $25M increase going toward CDC’s efforts to improve equitable PrEP access will be preserved, which is critical as advocates continue to engage with CDC on ways to establish a foundation for a National PrEP Program using existing funds. Congress also included final report language directing CDC to increase access to PrEP and cited previous calls from the Senate to establish the “building blocks of a national program to increase awareness of PrEP, increase access to PrEP medication, [and] laboratory services…”

“This outcome is a win for Black communities across the nation who are disproportionately impacted by HIV. Making life-saving treatment and prevention a reality for Black Americans is a possibility because of our relentless advocacy work to #SaveHIVFunding,” says Raniyah Copeland, Founding member of the PrEP in Black America Coalition and Founder of Equity Impact Solutions.

“This has been a long process, and we are grateful to have an outcome that leaves us on firm footing to realize the vision of a National PrEP Program,” says Andrea Weddle of HIVMA. “However, the fight for FY25 is already upon us following this prolonged budget process; meaning that advocates will have to remain vigilant, fight to protect our existing funding, and continue to ensure a clear, immediate, and fully funded pathway toward equitable PrEP access.”

“This is very encouraging news for PrEP advocates, especially following the President’s reintroduction of his proposal for a National PrEP Program last week.” Explains John Meade, Senior Program Manager for Policy at AVAC . “Combined with HIV/AIDS housing advocates’ victory in achieving an FY24 funding increase, I am so proud of our movement and our ability to rally in the face of these threats.”

A National PrEP Program would be a cost effective means to achieve our national goal of Ending the HIV Epidemic by 2030. Pre-Exposure Prophylaxis (PrEP) is a 99% effective use of medication to prevent HIV. Unfortunately 64% of people who could benefit from PrEP do not have access to it. A new study shows that states with the highest PrEP coverage showed an annual percentage decrease in HIV diagnoses of 8% from 2012 – 2021. In contrast, states with low PrEP coverage increased 2% annually. A National PrEP Program will increase access among people who could benefit and address major disparities in access related to race, gender and geographic location. “In the current political environment, this Congressional action is especially noteworthy. But we must never confuse this progress with success; our fights for funding, equity and impact in treating and preventing this epidemic must continue, and funding and implementing a national PrEP program at scale and with urgency remains a huge priority,” said Mitchell Warren, Executive Director of AVAC.

Read the full press release here.

New issue of POSITIVELY AWARE points the way towards a more equitable future

By Kenyon Farrow

In many ways the world is entering an era of HIV prevention that many of us have spent the last 40 years fighting for— there now exists multiple options for preventing HIV that are safe, highly effective and easy to use. 2012 saw the introduction of the first ARV-based prevention option—daily oral PrEP. And over the past two years, WHO recommended, and several national regulatory agencies have approved, injectable ARVs for treatment and prevention, as well as the dapvirine vaginal ring.

While these advances are something to celebrate, this is far from the end of the road. Technological gains only go as far as people’s awareness of them, desire to use them, and access to them. And this is where we — as a public health community and as a planet of humans — struggle. Just like with the first ARV therapies in the mid 1990s, and the first PrEP pill for prevention a decade ago, we’re now four years into the FDA approval of the first long-acting ARV therapy and we are several years away from scaling up these long-acting medications and truly seeing the impact they can have on the lives of people (whether living with HIV or in need of PrEP), and on the HIV epidemic itself.

It takes the HIV response far too long to move these innovative inventions to the point where they become medical miracles, experienced by everyone who needs and wants them, regardless of race, ethnicity, national origin, religion, sexual orientation, gender identity, sex assigned at birth, pregnancy status or income.

There is a new special issue of the magazine POSITIVELY AWARE, co-edited by Kenyon Farrow, AVAC’s communications director, and Jim Pickett, AVAC’s senior advisor and lead of the Choice Agenda, that explores the impact of long-acting injectable treatment and PrEP. The articles, including a piece co-authored by John Meade, AVAC’s senior policy manager, and Danielle Campbell of PrEP in Black America and longtime AVAC partner, speak to the humans involved in downstream research, and what their experiences as patients, researchers, advocates and medical providers of long-acting treatment and PrEP teach us about how these products could be transformative. These stories make clear how far we still have to go to change our health systems so that they can meet their maximum potential.

AVAC will continue our work to advocate for global equity in access to prevention and treatment in all their current and future forms. We celebrate this issue of POSITIVELY AWARE as one collection of voices helping to point the way towards a more equitable future.