The timeline for generic LEN for PrEP to come to market is expected to be significantly shorter than for CAB for PrEP. Bioequivalence (BE) testing for LEN, which demonstrates a generic product works in the body in the same way as the originator product, is likely to be six months, vs. the 18 months for CAB for PrEP, because of differences in the drug formulation. The rapid granting of voluntary licensing by Gilead also contributes to this shorter timeline. Read more in PxWire.
LEN Generics — Can we go faster?
PrEP Approval Status in Latin America, 2024
Since 2019, rates of HIV acquisition in Latin America have been trending upward, from 110,000 annually in 2019 to approximately 120,000 in 2023. At the same time, Latin America has taken strides to combat this trend, from increasing PrEP initiation rates to preparing for longer acting PrEP products, such as injectable cabotegravir (CAB) and lenacapavir (LEN). Learn more in PxWire.
Avac Event
True Choice in HIV Prevention Involves More than Product Options: Novel strategies in service delivery
The Choice Agenda and presenters from Brazil, Kenya, and South Africa discussed novel strategies for the delivery of HIV prevention interventions. All HIV prevention products have their “Achilles Heels.” Differentiated service delivery supports reaching a wide range of potential users and can overcome challenges with product attributes. Offering different strategies can also make the interface with health care easier and more community friendly.
Speakers:
- Ines Dourado, Universidade Federal da Bahia
- Catherine Verde Hashim, AVAC
- Catherine Martin, Wits RHI
- Katrina Ortblad, Fred Hutch
- Adriano Queiroz, City of São Paulo Municipal Health Secretariat
- Daniel Were, Jhpiego
Thanks to WHO for providing live simultaneous Ukrainian translation and to PAHO for providing live simultaneous translation in Portuguese and Spanish.
Video Recording and English Audio / Ukrainian Audio / Portuguese Audio / Spanish Audio / Slides / Resources

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.

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.
Media Highlights
- Access questions hang over Gilead’s HIV shot, Axios
- What Inspired Me Was to Provide Solutions to People’ – HIV Prevention Advocate Idah Mulala, All Africa
- Argentinian Advocate Gastón Devisich Wins 2024 Omololu Falobi Award at HIVR4P Conference in Lima, Heap News
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.
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.
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
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.
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 [email protected]
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.”