Pre-conference Highlights from HIVR4P 2024 🌟

The HIV Research for Prevention 2024 (R4P) conference in Lima, Peru began with a suite of satellites that put the HIV prevention pipeline in context and pulled out key priorities from upstream research to gaps in PrEP coverage today, to progress toward connecting excluded populations with an array of choices.  

Read on for highlights!  

Upstream Research

Key discussions in Lima focused on the promise of early phase research for next-generation HIV prevention, and priorities for future research. A satellite, Creating a Menu of Options: Early R&D of HIV prevention products for women, the MATRIX way showcased innovation such as a dapivirine vaginal film and on-demand options for vaginal or rectal use. Presenter Thesla Palanee-Phillips of Wits RHI emphasized that product success depends on providing options that fit into people’s lives. “Unless people use a product, they’re not going to take us anywhere.” Presenters talked about the importance of human-centered design to inform the research agenda, and Nyaradzo Mgodi from the University of Zimbabwe pointed to the need for dual prevention technologies that address both HIV and pregnancy. 

All these discussions inform and advance the just launched People’s Research Agenda, a global initiative driven by communities and advocates to envision an inclusive HIV prevention pipeline and ensure the voices of those most affected by HIV are integrated into HIV prevention research and development. 

PrEP in Latin America and the Caribbean

The satellite, Enhancing service providers’ engagement in PrEP delivery, uptake, and retention in Latin America & the Caribbean, featured data from the PrEPWatch PrEP tracker on Latin America and the Caribbean (LAC), and highlighted the region’s role in the lenacapavir PURPOSE 2 study that included sites from across South America. AVAC’s Catherine Verde Hashim, Kelika Konda of USC/Universidad Peruana Cayetano Heredia, Mayara Secco Torres da Silva of Fiocruz and Jared Baeten from Gilead discussed the ongoing challenge to reach young people in the region with PrEP services and the vital role that both industry and community partnerships play in closing the gaps.

Expanding Inclusion

Advocates, researchers and regulatory authorities each have unique contributions to ensure pregnant and lactating populations are included in research. Critical conversations between these stakeholders was the focus of the satellite, Catalyzing Progress in the Inclusion of Pregnant and Lactating People in HIV Prevention Research.  

Renowned researcher and AVAC board member, Linda-Gail Bekker explored the historical exclusion of women from research, where outcomes from trials among men were wrongly assumed to apply to women. Advocates called for deep collaboration to close this gap and Bekker pointed to the ground broken by the PURPOSE 1 trial that included PLP and other populations who have historically been excluded from clinical trials. “This is now a benchmark—we must move forward, not back. The key is teamwork, collaboration, and amplifying voices.” 

PrEP and Choice for Adolescent Girls and Young Women

Yes, Girls DO wanna have fun! But adolescent girls and young women (AGYW) also want to be in control of their sexual and reproductive health options. The presentations on the satellite session co-chaired by AVAC’s Director of Research Engagement, Stacey Hannah, What’s Really Going to Work in the Lives of AGYW? Innovations in Acceptability and Mobile Health Support Interventions for HIV Prevention, focused on choice for AGYW in HIV prevention. Presentations covered how AGYW respond to various PrEP options and tools for adherence, except long-acting injectable PrEP, which faces challenges in daily oral PrEP efficacy trials. Studies explored preferences between F/TAF and F/TDF, the vaginal ring’s role, the acceptability of injectables, and adherence tools. The key takeaway? There’s no one-size-fits-all solution—just like other groups, AGYW need different PrEP options tailored to their lives and circumstances. 

Update on the Dual Prevention Pill

The Dual Prevention Pill (DPP) is our next big opportunity to expand the HIV prevention toolbox. But it’s not just about the product, it’s also the delivery of the product that makes the difference in the end. At a satellite on how best to deliver the DPP, Delivering on the promise: Defining optimal implementation strategies and service delivery packages for the Dual Prevention Pill, AVAC’s Kate Segal said the next product close to seeking regulatory approval will prevent both HIV and pregnancy and bring a much-desired product to young women. “Research found that the DPP was a tool that helped women navigate the unpredictability of life and supported them to take control of their sexual health,” said Segal. Users also resonated with messaging that celebrated their individuality, life goals, enjoyment and self care. Incorporating the DPP into adolescent youth services and busting myths about both PrEP and contraception are some of the considerations for delivering this option effectively. The DPP could reach the market as early as 2026. 

Advocates Corner

Stay tuned for more from AVAC at HIVR4P 2024 and be sure to visit us in the Advocates’ Corner on Level 1 if you are in Lima. And join us for our daily virtual debriefs from 7:00–8:00 am PET to reflect on key discussions and ask questions. Register here.

Introducing the People’s Research Agenda

As the HIV Research for Prevention (HIVR4P) conference opens in Lima, Peru, AVAC and partners are thrilled to introduce the People’s Research Agenda: Community & Advocacy Priorities in HIV Prevention Research and Development to help guide what will be—and should be—discussed at the meeting and beyond.

The People’s Research Agenda (PRA) is a global initiative driven by communities and advocates to envision an inclusive HIV prevention pipeline and ensure the voices of those most affected by HIV are integrated into HIV prevention research and development. 

Download the Report

As the global community gathers, in person and virtually, this week in Peru (check out our conference guide here), the field is at a critical juncture—with a range of new ARV-based prevention products approved and in delivery, HIV vaccine and antibody studies in complex stages, and HIV incidence still far too high to hit global targets for ending the epidemic.  

As options have increased, resources for research, implementation science and delivery have flattened or dwindled. And even as new ARV-based PrEP options have entered the market, the majority of next-generation prevention options are in upstream safety, dosing and immunogenicity trials.  

This context intensifies the stakes for decisions about which products to develop—and how to develop them. The PRA meets this high-stakes moment for HIV prevention with a clear, concise and collaboratively developed set of priorities for how prevention research should be conducted and what products should be developed.  

Developed through a collaborative community-inclusive process, supported by AVAC, CASPR, PEPFAR and USAID, the PRA is a living document, to be used as a tool for communities to amplify their priorities and for funders, product developers and policy leaders to keep at hand as crucial decision are made about what to invest in, where and why.  

Tell us what you think! Email [email protected].

A Plan for LEN Access and New LEN Resources!

We learned of progress this week in building a sustainable market for choice in prevention with the news of generic licensing agreements for lenacapavir as injectable PrEP. We are moving faster than the first decade of oral PrEP and the beginning rollout of injectable cabotegravir, which is an example of advocacy at its best, but making lenacapavir and new prevention options available to all who need it, requires even greater speed, scale and equity. Coordination and strategic actions among numerous and varied stakeholders are urgently needed, as outlined in this article from the New York Times.

See AVAC’s updated Lens on LEN, our new Plan for Accelerating Access to Injectable Lenacapavir for PrEP, along with additional resources on LEN!

From Clinical Trial Efficacy to Public Health Impact: A Plan for Accelerating Access to Injectable Lenacapavir for PrEP

This plan provides a comprehensive view of all the moving parts and identifies priority actions and actors responsible for ensuring time is not wasted and opportunity not squandered.

Read the Plan

The Lens on LEN: The basics on injectable lenacapavir as PrEP

This updated advocates’ primer with the PURPOSE 2 data provides background on lenacapavir and its trials, raises key questions, and explores next steps.

Read the Primer

Lenacapavir: The case for investing in delivering HIV prevention

This episode of PxPulse goes deep on LEN for PrEP. Recorded just days before Gilead’s announcement that PURPOSE 2 also found very high efficacy, Dr. Flavia Kiweewa, a principal investigator of PURPOSE 1, the first trial to announce efficacy, lays out the research findings and what they mean. And Chilufya Kasanda Hampongo of Zambia’s Treatment Advocacy and Literacy Campaign and Mitchell Warren of AVAC talk about how to change a long history of squandered opportunities to get rollout right.

Listen Now

Breaking Ground: Expanding Access to Lenacapavir

This webinar hosted by UNITAID brought together global health experts, community advocates, and civil society organizations to discuss the challenges and opportunities in ensuring equitable access to Lenacapavir.

View the Recording

An Overview of Lenacapavir 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.

Gilead Agrees to Allow Generic Version of Groundbreaking HIV Shot in Poor Countries

This news New York Times article raises key questions on access and pricing of lenacapavir. “Mr. Warren said he hoped the major global health agencies would work together to place orders large enough to have at least a million people on lenacapavir by the end of 2026, which would help send a clear signal to generics makers about the potential market for the product.”

Read More

AVAC Calls on Gilead and Global Stakeholders to Accelerate Access to Generic Lenacapavir Following License Agreements

AVAC welcomes Gilead Sciences’ announcement in granting multiple, non-exclusive licenses to generic manufacturers to produce lenacapavir, their investigational twice-a-year injectable for PrEP, while it is still in clinical trials. This reflects longstanding community advocates’ calls to speed up access to PrEP options immediately following regulatory approval.  

On October 2, Gilead Sciences announced their plan to work with six generic medicines manufacturers to produce and market injectable lenacapavir for PrEP in 120 countries. This process of granting licensing agreements with generic manufacturers prior to regulatory submissions could reduce the time to market for generic products by up to three years.  

“Today’s announcement from Gilead is positive momentum in moving forward with injectable lenacapavir for PrEP. But while voluntary licenses are essential, they are not sufficient on their own to translate exciting science into public health impact,” said Mitchell Warren, AVAC’s executive director. “The six licenses announced today demonstrate that the field is learning what needs to go faster, and pharmaceutical companies are listening and acting.”  

“This is notable improvement both in timelines for licensing and in geographic coverage, with LEN licenses being granted before regulatory approval, compared to the two-year gap after approval for injectable cabotegravir. Additionally, the six generics for LEN come from three different countries, whereas the three cabotegravir licenses were concentrated in one country. Expanding manufacturing across multiple regions can hopefully further enhance efforts to accelerate global access,” Warren added. 

However, key countries with significant HIV incidence, including several of those hosting the PURPOSE 2 trials of lenacapavir, are left out of the license geographies. This challenges the field’s ability to use this new option at the scale needed to drive down HIV incidence as quickly as possible to meet global targets. In addition, the price of lenacapavir for prevention – for both the originator product and the future generics – is still unknown, another critical piece of information in building a sustainable, impactful market. 

Various cost-effectiveness analyses have shown that injectable PrEP must be priced in the range of generic daily oral TDF/FTC to be considered cost-effective. Modeling studies suggest that the generic price of LEN for PrEP could be as low as $100 per person year of protection, but only when the number of vials produced is equivalent to those needed for one million LEN users.  

This represents a significant increase in the current PrEP market and would require scaling up additional investment in product procurement and programming by donors and governments. While this may not be possible at product launch, the field needs to collaborate to reach this price point as quickly as possible and then move to the price of daily oral PrEP, as the number of LEN for PrEP users rises to over ten million people per year.  

To reach these price points, it is essential to build volume in the global market with supplies from Gilead at close to $100 per person per year of protection beginning next year. Simultaneously, donors must procure and program large quantities and support generic manufacturers to prepare for production at scale, with market entry by 2027 to catalyze even lower prices.    

“Advocates must push for equitable and speedy PrEP access, including pricing transparency from Gilead and generics, accelerated investments by donors to design and implement integrated programs that offer LEN as part of choice of product and service delivery models, for everyone, everywhere, based on public health imperatives, and not on World Bank country classifications or geographical location,” said Wawira Nyagah, AVAC’s director of product introduction and access.  

AVAC will continue to monitor the research, approval processes and product implementation of lenacapavir as part of its quarterly Long-Acting PrEP Status Updates. Please read our Lens On LEN Advocates’ Guide, which will be updated as the process toward lenacapavir access moves forward and stay tuned for our forthcoming comprehensive plan to accelerate introduction and access.

AVAC’s Guide to HIVR4P 2024 in Lima

We are looking ahead to the biennial HIV Research for Prevention 2024 conference  in Lima, Peru next week, 6-10 October. HIVR4P is a space where biomedical HIV prevention research, policy and programs takes center stage. Whether you’ll be in Lima or are following from afar, AVAC will keep you connected!

Read on for information on AVAC sessions, a sortable roadmap, the Advocates’ Corner (open all week) and more!  

Resources

  • Use AVAC’s Prevention Roadmap of conference sessions and satellites to find what interests you the most. You can download it as a sortable spreadsheet or PDF.
  • Advocates’ Corner: If you plan to be in Lima, be sure to join us and our CASPR partners at the Advocates’ Corner to take the conversations and themes deeper. The Advocates’ Corner will be open throughout the conference hosting a program of activities along with materials displays and opportunities for informal networking. Be sure to check the events page for updates on programming.
  • AVAC’s Coverage: From the latest news on injectable lenacapavir, to updates on the development of next generation prevention options, to the complex work of implementing the tools that exist today and all the advocacy needed to get it all done, our email dispatches to the Advocates’ Network keep you informed. Follow events in real time on Twitter at #HIVR4P2024 and Instagram.
  • People’s Research Agenda: During HIVR4P, we’ll be releasing the new People’s Research Agenda, a global initiative driven by communities and advocates to define the most urgent priorities, research questions and recommendations for HIV prevention research. We hope it serves as a guide to what is – and should be – discussed at HIVR4P and beyond.

Satellites and Sessions Featuring AVAC and Partners

Sunday, 6 October

Monday, 7 October

Tuesday, 8 October

Wednesday, 9 October

  • Symposium: Reducing burdens and barriers to expand the use of HIV prevention options, 13:30 – 15:00
    This session will explore the promise, potential and risks of using remote tools, such as telemedicine, virtual tools, apps and self-testing and the impact of other tools used to expand access and uptake of HIV prevention modalities. It will also review approaches to overcome misinformation and mistrust.

Thursday, 10 October

Find these resources, conference highlights and more at AVAC’s dedicated HIVR4P 2024 page. And watch this space for new opportunities to come together and shape what happens next.

SRH + HIV integration advocacy, Pandemic Accord, GPP and more!

AVAC’s round-up of resources, updates and insights this week includes a new roadmap for sexual and reproductive health (SRH) and HIV integration, resources to support an equitable Pandemic Accord, innovations in Good Participatory Practices (GPP) and more!

The power of choice in contraception, sexual health and HIV prevention this World Contraception Day

Roadmap: Sexual and Reproductive Health (SRH) Integration Roadmap

Copper Rose Zambia, as a part of CASPR and AVAC launched a new resource addressing the critical need for integrated SRH and HIV services. This roadmap provides key steps for success, focusing on collaboration, strategic mapping and targeted advocacy.

Read the roadmap

Advocate’s Guide: Advocates’ Guide to Multipurpose Prevention Technologies (MPTs)

MPTs are products designed to simultaneously address more than one sexual and reproductive health concern. This advocates’ guide shows the pipeline of products in development, discusses why MPTs are needed, investment, and what advocates can do to push for MPT development and introduction.

Read more

What will it take for an equitable Pandemic Accord?

Call to Action: Pandemic Accord Priorities from the Coalition of Advocates for Global Health and Pandemic Preparedness

A group of organizations advocating for an integrated and holistic approach to preparedness that emphasizes equity, inclusion, and synergies of multiple global health programs in advancing preparedness, shares five priorities in Pandemic Accord negotiations.

Read more

UNGA Side Event: Restrategizing Civil Society Engagement for Pandemic and Global Governance

AVAC’s Sam Rick moderated CISDI’s event alongside Nina Schwalbe, Lawrence Gostin, Eloise Todd and others, reminding the audience that for pandemic prevention, preparedness and response (PPPR) to succeed, lessons from the HIV response must be integrated into the architecture being built for PPPR.

Read the summary

Good Participatory Practices in action

Call for Applications: Now Accepting Applications for the 2024 Good Participatory Practice Online Course

The 2024 Good Participatory Practice Online Course is now accepting applications for 30 spots! This course offering will run 14 October – 20 December 2024. The application deadline is 9 October.

Apply now

Recording: Innovations in GPP

Recording / Clever Chilende Slides / Sarah Read Slides / Ntando Yola Slides

Restrategizing Civil Society Engagement for Pandemic and Global Governance 

Ministries of health, researchers, advocates, academics and civil society members came together on the sidelines of UNGA79 to discuss strategies for more meaningful and impactful engagement of civil society in global governance for health, climate, and other development sectors, particularly in the context of the Pandemic Accord negotiations at Center for Indonesia’s Strategic Development Initiatives’ (CISDI) event, Restrategizing Civil Society Engagement for Pandemic and Global Governance. 

After two years of negotiations, countries did not reach an agreement around the Pandemic Accord and therefore agreed to continue negotiations for up to one year. The Pandemic Accord is meant to represent a global agreement on coordination, equity principles, financing expectations, and a range of capacity areas, including disease surveillance, healthcare workforce, lab facilities, and resources for non-pandemic related healthcare.  

However, “there’s been no other process where they so systematically ignored civil society,” said Nina Schwalbe, CEO of Spark Street Advisors. AVAC’s Sam Rick who moderated the event reminded the audience that for pandemic prevention, preparedness and response (PPPR) to succeed, lessons from the HIV response must be integrated into the architecture being built for PPPR. Meaning, the principles of equity must be embedded into every level of these agreements, and governments and civil society must be empowered to hold them accountable.

Schwalbe and colleagues expressed their deep concern and dissatisfaction with the ongoing Pandemic Accord negotiations. See the recent statement from the Coalition of Advocates for Global Health and Pandemic Preparedness. “With decades of experience in the global HIV and NTD movements, we have demonstrated through our work the crucial role that civil society and communities play in advancing multilateral governance and their impact on health outcomes, as pandemics start and end with community and as such, communities and civil society must be at the center of, and included in all pandemic negotiations… We urge Member States to agree to a governance structure for the Accord moving forward that institutionalizes meaningful civil society and community engagement.” 

The panel highlighted the disparities in vaccine distribution and the necessity for self-reliance in health systems. They emphasized the need for a unified message and strategic coordination among civil society organizations to influence global health policies effectively. 

“You need global health, that is, you need the highest possible health outcomes for as many people around the world, and you need all of those benefits to be equitably distributed… And I think it’s up to us in civil society, pressing our governments, pressing the WHO, pressing the United Nations to actually make this happen.” – Lawrence Gostin, Faculty Director of the O’Neill Institute for National and Global Health Law 

The panel made clear calls to action:  

  • Read and provide comments on the draft pandemic agreement text to identify gaps and push for stronger civil society participation. 
  • Engage with national authorities responsible for pandemic preparedness and response to ensure meaningful civil society participation at the country level. 
  • Support a unified message that can be widely endorsed by civil society organizations. 
  • Advocate for the establishment of formal, funded, and representative civil society engagement mechanisms in the pandemic agreement negotiations and other global health governance processes. 
  • Explore opportunities to leverage upcoming events like the COP meetings to amplify civil society voices and push for greater inclusion. 

For More on Pandemic Accord Negotiations, Read:  

Anna Miti Joins The Choice Agenda (TCA) as Co-Moderator

AVAC and The Choice Agenda (TCA) are delighted to welcome Anna Miti as the TCA’s new co-moderator. Based in Harare, Zimbabwe, Anna is a seasoned journalist, advocate for gender equality, an AVAC Cure Fellow, former AVAC Advocacy Fellow and co-convener of the Zimbabwe Media Science Cafe, who brings her passion for amplifying community voices to this role. 

Launched by AVAC with Jim Pickett in April 2022, TCA is a global forum for advocacy on the latest in HIV prevention. With monthly webinars hosting informed discussions and a moderated listserv of nearly 3,000 subscribers from 40+ countries, TCA offers the HIV prevention community a platform to come together, learn from one another and chart the way forward.  Anna will work alongside Jim and the AVAC team to foster inclusive advocacy around efforts to expand equitable access to HIV prevention tools around the world. 

“As a long-time member of the TCA, I have valued it as a place for robust discussions and a vital platform to access new, timely and relevant information. I am excited to now contribute to this platform as co-moderator. Together with other advocates, I aim to strengthen the TCA’s impact and contribute even more to HIV and science advocacy.” – Anna Miti, TCA co-moderator

“On behalf of the TCA community, I am thrilled to welcome Anna into the brand-new role of co-moderator. Her dedication to HIV prevention research advocacy, her deep well of experience, and her exceptional communication skills will help us improve and expand our work to support HIV prevention research literacy and advocacy. The sun never sets on TCA, and I couldn’t be happier to have such a savvy, partner to help us take TCA to the next level.” – Jim Pickett, AVAC senior consultant and TCA moderator.

Join our Q&A with Anna, September 24

As part our webinar, Do Vaginas Demand Perfection? Implications for Event-Driven PrEP, we’ll host a 30-minute Q&A with Anna. We hope you’ll join us!

For more information about The Choice Agenda, upcoming events, or to join the listserv, visit AVAC’s The Choice Agenda page. 

Brand-new PxPulse Podcast on LEN’s Impact on HIV Prevention

The promise of long-acting PrEP has been super-charged this year by studies showing the powerful efficacy of an injectable antiretroviral known as lenacapavir (LEN). 

PxPulse’s new episode, Lenacapavir: The case for investing in delivering HIV prevention, goes deep on LEN. Recorded just days before Gilead’s announcement that PURPOSE 2, its second major trial of LEN as injectable PrEP, also found very high efficacy, Dr. Flavia Kiweewa, a principal investigator of PURPOSE 1, the first trial to announce efficacy, lays out the research findings and what they mean. And Chilufya Kasanda Hampongo of Zambia’s Treatment Advocacy and Literacy Campaign and Mitchell Warren of AVAC talk about how to change a long history of squandered opportunities to get rollout right. 

The PURPOSE 1 trial announced findings in June that a twice-yearly injection of LEN was 100% effective among cisgender women, with zero new cases of HIV. And the PURPOSE 2 trial among cisgender men, and trans and non-binary people, was shown to reduce the risk of HIV by 96%.  

LEN now enters a select category, one of five ARV-based options for PrEP that all protect against HIV if you take them. But many of the people applauding the results from PURPOSE 1 and 2 will tell you that breakthrough science like this, as hard as it is, is still the easy part. Breaking the back of the HIV epidemic demands overcoming an altogether different challenge — coordinating and accelerating every step in rolling out new products so that everyone who needs HIV prevention can get it.   

Listen to this podcast to learn what must be done to finally deliver on the promise of highly effective HIV prevention, from pills to rings to injectable PrEP and beyond. 

Explore STIWatch.org and get the latest resources to navigate the IUSTI & STI Prevention meetings!

Dear Advocate, 

AVAC is delighted to share its all-new STIWatch.org website just as advocates, clinicians, researchers and partners convene in Atlanta, GA for the Centers for Disease Control and Prevention STI Prevention Conference, and in Sydney, Australia for the 25th International Union Against Sexually Transmitted Infections (IUSTI) World Congress.  

Rates of sexually transmitted infections (STIs) continue to rise globally with too little public health intervention and investment. While many STIs are curable, they often go undiagnosed and untreated because they tend to cause few or no initial symptoms. Available diagnostics are often too costly to use for routine screening and testing in many low to middle-income countries (LMICs), and few vaccines exist to address the most common STIs. 

Discover STIWatch.org!

STIWatch.org is an updated platform designed to enhance understanding and advocacy for STI vaccine and diagnostics research, development, and rollout. It offers comprehensive information on common STIs, a clinical trials dashboard, advocacy priorities, and a range of resources and tools to support STI prevention and treatment efforts. 

Scroll down for more STI prevention resources advocates need to navigate these two conferences.

Resources

Follow the STI Prevention Conference events in real time in Atlanta on Twitter at #STIConf24 and on AVAC’s feed at @HIVpxresearch

STI Clinical Trial Dashboard: shares the latest STI research on diagnostics and vaccines

STIs: A Review of the 2022 Vaccine and Diagnostic R&D Pipeline and Investments: provides an annual analysis of global funding trends for STI prevention research

Advocates’ Guide to Doxycycline to Prevent Bacterial STIs (DoxyPEP): explores and addresses the explore and address the critical questions around who will benefit most from DoxyPEP and how to implement this strategy broadly to ensure equitable access. 

STIWatch.org is an initiative of AVAC with funding and support from the World Health Organization, the Bill & Melinda Gates Foundation and the National Institutes of Allergy and Infectious Diseases.  

Contact [email protected] for more information. To receive email updates from AVAC, signup here.