First Full Day of AIDS 2024

Lenacapavir for PrEP has taken center stage at the 25th International AIDS Conference, #AIDS2024, which opened Monday with many highlighting its potential for long-acting PrEP for HIV prevention. Some advocates took to the halls in protest calling on LEN’s maker to price the product low. Leaders across HIV voiced the need for urgency in galvanizing support for the introduction of lenacapavir. “It is gobsmackingly exciting to see zero in a clinical trial” AVAC’s Mitchell Warren told Forbes. The potential to bend the curve of the epidemic depends on speeding access to prevention options like LEN, that show high efficacy. 

At the same time, it’s imperative to remember that neither lenacapavir, nor any other single product, now or in the future, will ever be a ‘miracle drug’, and LEN must not be equated with a vaccine, as seen in some conference media reports.  

Ongoing investment in the pipeline for HIV prevention must be founded on the principle of choice, offering a range of products to meet diverse needs among people facing the risk of HIV. We hope that vaccines will one day be among those choices, as will long and short-acting products, and topical and systemic products. Clear communication that allows product users to understand how products are different supports widespread adoption of HIV prevention and moves the world toward finally ending the epidemic.  

See AVAC’s statement calling for early planning to accelerate LEN’s regulatory review and for ambitious introduction plans, and the joint civil society call to action with specific priorities about what needs to happen next. Our primer, the Lens on LEN, also offers advocates a guide in explaining the findings from the Purpose 1 trial and next steps for advocacy. 

As Albert Liu from UCSF’s Center for AIDS Research told delegates in the symposium on breakthrough and insights in long-acting technologies, “It’s never just the ‘product.’ New options can’t solve everything.” Atul Gawande of USAID reiterated a similar message at the satellite focused on women’s prevention, “The critical message to understand is that there isn’t going to be a magic bullet for prevention. What we have to understand is that there are also considerations that affect the likelihood that women will have what they want and what they’re likely to use.”

People First

The conference theme, “Put People First,” is the main message we all must hear. Lillian Mworeko of the International Community of Women living with HIV/AIDS East Africa (ICWEA) captured the essence of the meeting: “I am not just a recipient of care. I need a seat at the table to meaningfully engage and tell people what I need and how I need it.” 

Monday’s opening session underscored the vital role of community engagement and the necessity for inclusive policies that address disparities affecting marginalized populations. Jay Mulucha of Fem Alliance, Uganda, the first trans man to speak at the International AIDS Conference, delivered a compelling message to the 12,000+ delegates attending both in person and online: “As a trans man living in Uganda, I am asking you to stop leaving us behind. Nothing about us, without us.”

New UNAIDS Report

UNAIDS released a report, The Urgency of Now, AIDS at a Crossroads calling out funding disparities and the need to dismantle the discrimination and stigma that are pushing the most marginalized people away from health care. The report warned of the peril in delayed funding decisions; investment needs to happen urgently for long-acting treatment and prevention options to reach all low- and middle-income countries and meet 2025 targets.

Money, Money, Money

Making the most of investment in HIV prevention fundamentally depends on political will, but the field needs the right data, too. Monday’s satellite session, Money, money, money: Building towards a sustainable end state for HIV prevention, called for better data that goes beyond PrEP initiation numbers. “[PrEP initiations] alone do not tell us how much product is needed or how long people stay on PrEP. We are not collecting the right data,” said Katherine Kripke of Avenir Health. AVAC’s Mitchell Warren described the vicious cycle of small pilot projects generating limited data on PrEP use, resulting in unpredictable demand and cautious investment. “We have lots of small examples, and then we don’t scale it up because governments don’t know what it will cost. And still the world has 1.3 million new infections. We have to break the cycle.”

The Future of Women’s Prevention

At the session organized by CASPR (Coalition to Accelerate & Support Prevention Research) and MATRIX (Microbicide R&D to Advance HIV Prevention Technologies through Responsive Innovation and Excellence), New ways for the next wave: Innovative R&D for the future of women’s prevention, MATRIX laid out their innovative approach that involves very early engagement of all stakeholders in the research, development and delivery of new products for HIV prevention. The session emphasized the equitable inclusion of women in all phases and in every aspect of R&D—as researchers, potential users, and advocates.

Sharon Hillier of Magee-Women’s Research Institute noted, “What we’ve learned in our research is that women care about efficacy, but it’s just one element of what they consider when they decide on prevention. They’re quite interested in safety, ease of use, discretion, price, availability, and accessibility.”  

Stay tuned for more highlights from AIDS 2024 and visit our curated conference webpage, which includes new resources and summaries of the preconference sessions.

PrEP Justice

Updates on the US v. Gilead case and the fight for equitable PrEP access

In a major twist that could potentially result in as much as $1B for equitable PrEP access in the US, the government has just made the decision to appeal last year’s jury verdict in the US v. Gilead case. The Choice Agenda and PrEP4All discussed the origin of US v. Gilead, the reasons for the government appeal, and what the case means for PrEP users in the United States.

Recording / Slides / Resources

The Future of ARV-Based Prevention and More

The pipeline of non-vaccine HIV prevention products includes oral pills, vaginal rings, vaginal and rectal gels, vaginal films, long-acting injectable antiretrovirals and more. Also pictured are the range of MPTs in development that aim to reduce the risk of HIV and STIs and/or provide effective contraception for women.

Click here for a view of all large-scale prevention trials.

Avac Event

PrEP Justice: Updates on the US v. Gilead case and the fight for equitable PrEP access


In a major twist that could potentially result in as much as $1B for equitable PrEP access in the US, the government has just made the decision to appeal last year’s jury verdict in the US v. Gilead case. Following pressure from PrEP4All and HIV/AIDS advocates, the US government originally brought the case in 2019, alleging that Gilead had infringed on PrEP patents held by the Centers for Disease Control and Prevention and owed royalties to the government. While a jury verdict in May of last year went against the government, the judge in the case overturned a key part of that verdict just this March, setting the stage for a government appeal.

The stakes for communities in need of PrEP access could not be higher. Gilead’s patent infringement and price gouging have sabotaged equitable PrEP access in America. Royalties paid to the government could and should form the basis for a National PrEP Program that would help erase those disparities. Join The Choice Agenda and PrEP4All to discuss the origin of US v. Gilead, the reasons for the government appeal, and what the case means for PrEP users in the United States.

Moderator:

  • Michael Chancley, PrEP4All

Speakers:

  • Chris Morten, Columbia Law School
  • Jeremiah Johnson, PrEP4All

Recording / Slides / Resources

Global HIV Prevention Advocates Call for Accelerated Timeline for Widespread Access to Injectable Lenacapavir for PrEP

A global cadre of HIV prevention advocates is calling for an accelerated timeline for access to the HIV prevention drug lenacapavir. Gilead, the developer of the drug, announced topline results from a large study among cisgender African women on 20 June, followed shortly thereafter with a statement about access. 

The Lens on LEN

The Basics on Injectable Lenacapavir as PrEP

In late June 2024, Gilead Sciences announced an early review of the data of the PURPOSE 1 trial by an independent monitoring board, which found that injectable lenacapavir (LEN) provided as prevention was safe and highly effective against HIV. The product is being tested among 5,300 HIV-negative cisgender women ages 16-25 in Uganda and South Africa. No infections were seen among those receiving LEN. This advocates’ primer provides further background on the product and trials, raises key questions, and explores next steps.

Download the report.

Upcoming Webinars and a Roundup of New Resources

Last week’s interim result of the PURPOSE 1 HIV prevention study of injectable lenacapavir is captivating headlines. Check out AVAC’s statement here and one from the PURPOSE 1 Global Community Accountability Board and the African Women’s Prevention Community Accountability Board here. But there are LOTS of other things also happening in HIV prevention, and we’re delighted to share this roundup.

Upcoming Webinars

Responding to Project 2025’s Threats to Science, Rights and Resources

Project 2025 is part of an ongoing multi-pronged backlash to the sexual and reproductive health, gender and LGBTQ+ movements. Building on the experience of the HIV movement in fighting these same far-right forces, join this Choice Agenda webinar discussing potential responses through the lens of HIV affected communities and programs. Register here

You Get What You Measure: Why Monitoring for PrEP Choice Helps Tell Our Story

The data collected on a program determines its path and priorities. This Choice Agenda webinar will cover the current state of PrEP monitoring and evaluation, and efforts to improve and simplify data-gathering to better reflect how people use PrEP and to support choice amongst the growing array of PrEP methods. And the discussion will also focus on how data can be used to enhance the stories we tell about PrEP program implementation. Register here

Recordings and Resources

From The Lab To The Jab Webinar and Issue Briefs

Earlier this month, AVAC hosted a webinar highlighting our series of issue briefs, From The Lab To The Jab, covering research and development, mRNA technology, vaccine production, issues relevant to equitable global access to vaccines. The webinar featured panelists from the International Vaccine Institute, International Treatment Preparedness Coalition, and æqua, a think tank focused on equity and economic justice for health. Panelists discussed international initiatives for vaccine development, the current state of vaccine research and access, and how they can be improved. Read more

The GPP Body of Evidence: GPP Monitoring and Evaluation Frameworks, REAL and REAL2

GPP is an essential part of clinical trials research, and an ethical imperative to creating equitable and effective clinical trials. GPP is created by and for communities, so it looks different and takes multiple forms in different cultural contexts. This kind of responsiveness is inherent to GPP, but it also makes it difficult to measure and evaluate. In this webinar, participants will learn from the Realist Review of Community Engagement and the REAL2 review of participatory research. Each examined frameworks for evaluating community engagement efforts. We’ll also learn about the Global Health Network’s new course on evaluation, and other efforts in the field to evaluate the impact of GPP. View the recording

It’s Not Just about the Trial: GPP from discovery to delivery in TB research

GPP enhances every stage of the research lifecycle. In this webinar, our partners at TB Alliance, SMART4TB, and THINK shared experiences, lessons learned, and innovative approaches in integrating GPP at the organizational, network and situational level, from drug development through delivery. View the recording

Advocates’ Guide to Doxycycline to Prevent Bacterial STIs (DoxyPEP)

Doxycycline, an oral antibiotic, can be used as a post-exposure prophylaxis, commonly referred to as DoxyPEP, when used to prevent the acquisition of some bacterial STIs after sex. Doxycycline is inexpensive, easily tolerated, and widely available. However, questions remain regarding who will benefit most from DoxyPEP and how to implement this strategy broadly to ensure equitable access and minimize antimicrobial resistance. This guide seeks to explore and address these critical questions. Read the guide

Episode 3: The Promising Science

Our Mitchell Warren speaks to ViiV’s Kimberly Smith in this episode of the Foreign Policy podcast series ‘can we end epidemics?’ about the future of HIV science and the challenges we need to overcome on our journey to finding a cure. Listen

We hope these conversations and resources are helpful in your advocacy. Stay tuned for our upcoming advocates’ primer on lenacapavir and our roadmap to the AIDS 2024 conference in Munich.

Avac Event

AIDS 2024: New Ways for the Next Wave: Innovative R&D for the future of women’s prevention

This session will be 9:30AM to 11:00AM Munich time.

Women need a range of HIV prevention options to meet different needs, preferences and life circumstances. Currently available pills, rings and injectables are necessary but insufficient. How might we accelerate the delivery of methods we have while developing additional ones – including systemic and non-systemic methods, short-acting and on-demand products, to complement longer-acting ones? Product developers and advocates are collaborating on new approaches to expedite R&D of additional HIV prevention options. Notably, MATRIX is taking a unique approach, endorsed by the CASPR network of advocates, that aims to improve the odds of success of new products – through development, delivery and use.

This session will focus on new efforts to identify and develop promising options, strategically engage all stakeholders, decolonize R&D and involve potential users in all their diversities throughout the process.

Speakers:

  • Jeanne Marrazzo, National Institute of Allergy and Infectious Diseases
  • Sharon Hillier, University of Pittsburgh / Magee-Womens Research Institute
  • Thesla Palanee-Phillips, Wits RHI

Followed by a moderated panel with:

  • Chimwemwe Chamdimba, African Medicines Regulatory Harmonization (AMRH) initiative- AUDA/NEPAD
  • Kelly Chibale, Holistic Drug Discovery and Development Centre -H3D, University of Cape Town
  • Nyaradzo Mgodi, University of Zimbabwe- Harare Health Research Centre
  • Jerop Ruth Limo, Ambassador for Youth and Adolescents Reproductive Health Program (AYARHEP)

Moderators:

  • Navita Jain, AVAC
  • Kenneth Ngure, Jomo Kenyatta University of Agriculture and Technology

Session Chairs:

  • Sharon Hillier, University of Pittsburgh / Magee-Womens Research Institute
  • Imelda Mahaka, Pangaea Zimbabwe

This satellite session will be co-hosted by CASPR and MATRIX, with support from USAID and PEPFAR.

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. Read more here.

Landmark Trial in South Africa and Uganda Finds Twice Yearly HIV Prevention Injection Safe and Highly Effective

AVAC Calls for Accelerated Regulatory Review and Ambitious Introduction Plans

AVAC welcomes the groundbreaking results of the PURPOSE 1 HIV prevention study among adolescent girls and young women in South Africa and Uganda. Preliminary safety and efficacy results were reported today by Gilead Sciences, the developer of the lenacapavir, one of the HIV prevention drugs that was being studied in the trial. An independent data and safety monitoring board (DSMB), at a scheduled review of the trial data, found the regimen to be safe and highly effective, with no infections seen among trial participants who received injectable lenacapavir. 

“This is one of the most important results we’ve seen to date in an HIV prevention study,” said Mitchell Warren, AVAC’s executive director. “Adding additional HIV prevention options means more people may find an option that is right for them. Beyond expanded choice, a twice-yearly injection has the potential to transform the way we deliver HIV prevention to people who need and want it most – from an easier to follow regimen for individuals to a decreased burden on healthcare systems that are stretched to the limit.” 

“We are incredibly excited about this result, especially about what it can mean for women in Africa,” says Nandisile Sikwana, Regional Stakeholder Engagement Manager for AVAC, and a member of the PURPOSE 1 Global Community Advisory Group. “We applaud Gilead’s commitment to Good Participatory Practice in this and the other PURPOSE studies. While we wait for full data from the study, including adherence data of oral F/TAF, it is imperative that planning for rollout of lenacapavir be accelerated. We know that even with the most ambitious timeline, it will take time for lenacapavir to be rolled out,” says Sikwana.

The PURPOSE 1 study enrolled over 5,300 cisgender adolescent girls and young women ages 16-26 in South Africa and Uganda. The study is evaluating injectable lenacapavir for PrEP and daily oral emtricitabine/tenofovir alafenamide (F/TAF) for PrEP. A companion trial, PURPOSE 2, is underway in Argentina, Brazil, Mexico, Peru, South Africa, Thailand and the US, testing twice-yearly lenacapavir for PrEP among cisgender men who have sex with men, transgender women, transgender men, and gender non-binary people. Results from PURPOSE 2 are expected by early 2025. Additional studies in critical populations, including PURPOSE 3 among cisgender women in the US and PURPOSE 4 among people who use injection drugs, are also underway, and it will be imperative to understand how today’s results influence these trials. A schematic of the suite of studies is here.

Gilead’s plans for submission to regulatory agencies and future access, including the US Food and Drug Administration (FDA), are not yet clear. But the results reported today make this urgent. “We expect to see a timeline that takes into account a full analysis of PURPOSE 1 data and the coming data from PURPOSE 2 from Gilead as soon as possible, and we urge regulatory agencies to prepare to fast track regulatory review,” Warren said. “We also call on WHO to be prepared to quickly include lenacapavir, if approved by regulatory agencies, in HIV prevention guidelines. There is no time to waste if we are to translate these exciting clinical trial results into actual public health impact and expand the toolbox of HIV prevention choices.”

“We now know that lenacapivir for PrEP is safe and highly effective among women,” Sikwana added. “Even as we await the results of the trial among other essential populations and for regulatory submission and review, there is urgent work to be done now by communities, policy makers, funders and program implementers to design and build HIV prevention programs and prepare health systems to deliver the growing array of biomedical PrEP options, including the addition of twice-yearly injectable lenacapavir. The full range of PrEP products – including oral PrEP – must be made feasible choices for all people who need and want HIV prevention options.”

Lessons learned from roll out of daily oral PrEP, and more recently the dapivirine vaginal ring and injectable cabotegravir, can help speed regulatory approval and guideline development in key countries, design of effective programs, and community understanding of and acceptance of lenacapavir for PrEP.

“AVAC and a cadre of international partners have been working together to plan for successful, accelerated introduction of lenacapavir. Since oral PrEP was first shown to be safe and effective 14 years ago, the global health community has failed in delivering PrEP at scale and with equity – and we have, therefore, not seen the impact that we need. The lessons from the past are clear, and we now must act on them and move with speed, scale and urgency. There can be no excuses and no delays,” said Warren. “We look forward to working with civil society partners, Gilead, international donors, normative agencies and national governments to ensure that this groundbreaking HIV prevention option is made available as quickly as possible and that we don’t squander this opportunity to drive down new HIV infections.”