Avac Event

PIBA Presents Reimagining the HIV Prevention Blueprint for Black Communities in Arkansas, Mississippi, and Tennessee

PrEP in Black America (PIBA) with regional Partners will host a Virtual Town Hall titled, Reimagining the HIV Prevention Blueprint for Black Communities in Arkansas, Mississippi, and Tennessee.

This is designed to offer a virtual platform for leaders in Mississippi, Tennessee, and Arkansas to share the narrative of PrEP within Black communities. The town hall will concentrate on three main objectives: 1. Motivating the Black public health workforce to spearhead the public health response. 2. Educating the broader Black community about the science and efficacy of PrEP. 3. Advocating for a federally funded national PrEP program.

Local Partners Include:

  • Community Health-PIER (MS)
  • FABRIC, Incorporated (MS)
  • Mississippi AIDS Education and Training Center (MS)
  • WeCare TN
  • Ryan White Part A Program Memphis (TN)

PIBA requests that only residents of Mississippi, Tennessee and Arkansas (US) attend this virtual town hall.

HIVR4P Highlights, Inclusive Prevention Pipeline, Policy Shaping & More

AVAC’s round-up of resources, updates and insights this week includes highlights from HIVR4P, a new vision for an inclusive prevention pipeline, shaping policy and more!

HIVR4P 2024 conference highlights and recap

The 5th HIV Research for Prevention (R4P) conference was held last week in Lima, Peru. The data and discussions centered on accomplishments in HIV prevention, how far the field remains from reaching targets, understanding how choice works and why it matters, and where the research agenda is headed. As AVAC’s Mitchell Warren told Axios, “lenacapavir is on everybody’s lips here at HIVR4P 2024. That’s probably the second-most popular word this week; I think the most popular word is access.

Read more.

Partners and AVAC launched The People’s Research Agenda (PRA), 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. 

Read the report.

Media Highlights

Shaping policy, centering people

AVAC’s Suraj Madoori Joins Developed Country NGO Delegation (DelDev)

Policy Director, Suraj Madoori is one of four new members to join DevDel, one of the 20 voting delegations to the Board of the Global Fund to fight AIDS, Tuberculosis and Malaria. DevDel plays a critical role in the development and evolution of organizational strategy, the funding model, the work of the Secretariat and policy. 

Read more.

AVAC’s Jessica Salzwedel Talks Community Engagement with National Co-ordinating Centre for Public Engagement

In a mini series on community engagement, the National Co-ordinating Centre for Public Engagement interviewed AVAC’s Jessica Salzwedel, Senior Program Manager of Research Engagement on what centering communities truly means.

Listen now.

Avac Event

From Promise to Progress: Overcoming Barriers to Long-Acting PrEP Uptake among Black Gay Men in the US

GBGMC and partners are hosting a webinar on Monday, October 21, titled: “From Promise to Progress: Overcoming Barriers to Long-Acting PrEP Uptake among Black Gay Men in the US.”

This event will delve into the challenges preventing Black gay men from accessing and adopting long-acting PrEP.

By bringing together insights from product developers like ViiV, the CDC, AVAC, healthcare providers, and advocates, the webinar will explore strategies to address these barriers. Key topics include healthcare access, stigma, and the need for culturally competent care.

Our discussion will focus on identifying actionable steps to ensure equitable access to long-acting PrEP, with the goal of improving health outcomes for Black gay men in the US.

Avac Event

An Update on the STI R&D Pipeline and Investments

AVAC and Impact Global Health, previously Policy Cures Research, co-hosted a webinar on the current STI R&D pipeline. This discussion featured leading experts sharing the latest advancements in STI diagnostics and treatments, discussing their potential impact on public health and where investments stand.

Speakers:

  • Mandisa Mdingi, Foundation for Professional Development, South Africa
  • Cécile Ventola, Senior Technical Officer at Impact Global Health
  • Birgitta Gleeson, FIND, Switzerland

Recording / Alison Footman Slides / Mandisa Mdingi Slides / Cécile Ventola Slides / Birgitta Gleeson Slides

People’s Research Agenda

Community & Advocacy Priorities in HIV Prevention Research Development

Led by AVAC alongside a network of partners, the People’s Research Agenda puts forward recommendations to diversify and strengthen the HIV prevention pipeline, enhance investment and financial support for HIV prevention research and development, and guide an advocacy strategy that truly addresses the needs of communities across the prevention pipeline.

The PRA is a living document developed through intentional consultative processes that used multiple modalities, including surveys, focus groups, convenings, to gather insights about the processes and products needed to actualize HIV prevention justice.

In this summary of the People’s Research Agenda, you’ll find the PRA’s core insights into the processes involved in HIV prevention research and implementation, and the types of products that should be developed through these processes.

Download the Report

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

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

Press Release

National PrEP Advocates Applaud CDC PrEP Pilot Launch

For media inquiries contact Michael Chancley at Michael@PrEP4All.org

Thursday, October 4th, 2024- Advocates applaud the announcement of the five jurisdictions to receive funding as part of a first-of-its-kind Centers of Disease Control and Prevention (CDC) PrEP pilot. While the original notification of funding opportunity (NOFO) allocated $7M in funds for four jurisdictions, in the face of overwhelming demand from 17 health departments who applied, the CDC increased the investment to $10M–$2M each for five jurisdictions—a clear sign of the urgent need for more PrEP funding. The initiative has the potential to show how a National PrEP Program, as championed by advocacy organizations all over the US, could transform equitable PrEP access by greatly simplifying cost coverage, expanding access to providers, and creating more effective and community-driven education and awareness initiatives. PrEP4All, PrEP in Black America, HIVMA, and AVAC stand ready to work alongside key stakeholders in the five jurisdictions chosen—Baltimore, Houston, Florida, Oklahoma, and South Carolina—and provide insights from the last three years of multi-stakeholder discussions led by our organizations.

“The fact that so many health departments took the time to apply for this funding with a short one-month submission window shows how badly jurisdictions need more funding for equitable PrEP access,” says PrEP4All Executive Director Jeremiah Johnson. “Unfortunately, this pilot is a one-time funding opportunity that only scratches the surface of what is required to expand PrEP access and end HIV as an epidemic nationally. We urge Members of Congress, the Administration and other key policy makers to find additional funds to address this demonstrated need by broadening this pilot right away and fully funding a National PrEP Program.”

“I think what is particularly exciting here is that the states and cities chosen have a real need for innovative approaches to PrEP access,” explains John Meade, Senior Program Manager for Policy at AVAC and a co-founder of PrEP In Black America. “Four of the five locations have not expanded Medicaid, meaning that a program emphasizing simplified access for un- and underinsured individuals can make a real difference in the lives of people who don’t have the time to navigate broken and fragmented cost-coverage options that make PrEP access impossible for so many individuals.”

“This is an amazing next step in the story of PrEP and ending HIV as an epidemic,” said Michael Chancley, PrEP4All Communications and Mobilization Manager and co-founding organizer of PrEP In Black America. “But one thing that has become clear as we’ve convened multi-stakeholder discussions around the nation, is that funding alone will not lead to equitable access. PrEP in Black America published For Us, By Us: A Master Plan for HIV Prevention in Black America that outlines key strategies for an equity informed response to address disparities in HIV prevention among the Black community as an accompaniment to funding and other investments. In the next few weeks PrEP4All will be releasing a comprehensive report on best implementation practices for PrEP programs that will provide key recommendations and insights from the past three years of community-led discussions. We’re hopeful that these will be useful guidance documents for everyone working on implementation.”

“It’s not lost on us that this announcement comes just as more and promising scientific developments in long-acting injectable forms of PrEP become available,” explains Danielle M. Campbell, Science Equity Activist, researcher, co-founding organizer of PrEP In Black America. “We must acknowledge that in the US, there is a longstanding history of innovative preventive health interventions not reaching the communities who need them the most, in particular Black people. The establishment of this kind of PrEP infrastructure creates an opportunity for greater coordination of access to other essential disease prevention innovations, such as novel PrEP, doxyPEP for the prevention of bacterial STIs, and mpox vaccination and treatment.”

“Our frontline workforce needs this type of support to improve access to PrEP and to ensure that every community has a path toward ending their HIV epidemic. Having simpler, more accessible pathways to cover PrEP services means less time, effort, and money spent on navigating cumbersome, fragmented and inadequate programs,” explains HIVMA Chair Allison Agwu, MD, ScM. “While this is an important step, we still have significant work to do to grow, train and support the public health workforce, and we’re eager to support jurisdictions to make sure that providers have the tools they need to offer and provide PrEP services.”

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.

Press Release

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

New York, NY, October 2, 2024 — 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. 

About AVAC

AVAC is an international non-profit organization that provides an independent voice and leverages global partnerships to accelerate ethical development and equitable delivery of effective HIV prevention options, as part of a comprehensive and integrated pathway to global health equity. Follow AVAC on Twitter @HIVpxresearch; find more at www.avac.org and www.prepwatch.org

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’ CornerIf 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.