Press Release

Heeding Community Advocates’ Calls, CDC Funds PrEP Pilot Program, Allows Funds to Pay for Generic Medications

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

Tuesday, August 6th, 2024 – For the first time ever, the U.S. Centers for Disease Control and Prevention will allow for funding to pay for generic PrEP medications as part of a new supplemental funding opportunity aimed at quickly scaling up equitable PrEP access in four jurisdictions. Advocates have been calling for such an initiative to serve as a pilot for a National PrEP Program for un- and underinsured individuals; a key component of which would involve the implementation of a user-friendly PrEP Pass that could eliminate cost and complexity as a barrier to medications, HIV testing, necessary lab work, and provider visits. 

Along with a previous decision by CDC allowing for grant funds to go toward ancillary PrEP services, this initiative marks the first time that jurisdictions will be able to purchase affordable, high quality generic medications– priced at less than $20 per month– to create a common sense public health approach to PrEP scale up that avoids navigating complex, fragmented coverage options. 

The initiative will also fund coordinators within health departments to advance the project in partnership with community partners and empower them to conduct a comprehensive review of insurance barriers to PrEP coverage.   

Leading advocacy organizations for a National PrEP Program, including PrEP4All, AVAC, HIVMA, and the PrEP in Black America coalition, enthusiastically support the initiative and urge eligible health departments to apply before the August 31st deadline. 

“This is a real opportunity to make an impact in our national efforts to scale up PrEP and end HIV as an epidemic. The entire advocacy community, after years of building an evidence base for this sort of approach to equitable uptake, is ready to take the successes and lessons learned from this initiative to Congress to advocate for a national program.” explains John Meade, Senior Program Manager for Policy at AVAC and co-founding member of PrEP In Black America.

Although both the application and project implementation timelines are short, advocates are hopeful that health departments will apply to be part of this historic initiative. 

“We think it’s important for any department thinking of applying to note that the notification of funding opportunity (NOFO) specifically includes selection criteria prioritizing jurisdictions in the Deep South and states that have not expanded Medicaid- meaning that it’s well worth it for those priority jurisdictions to get an application in. Also, there is flexibility on the timeline for grant implementation through 2026, so the short window shouldn’t discourage anyone.” says Michael Chancley, Communications and Mobilization Manager for PrEP4All and co-founding member of PrEP In Black America. 

“Our organizations want to sincerely thank the CDC for listening to our advocacy for this pilot and for also affirming that expanding PrEP infrastructure can help scale up novel sexual health interventions like doxy PEP. In particular, we really appreciate the efforts of Dr. Robyn Neblett Fanfair, who as the Director of the Division of HIV Prevention has undoubtedly worked hard to get this NOFO released after Congressional delays in passing the FY24 complicated matters further,” added Colleen Kelley, MD, MPH, FIDSA, HIVMA Chair-Elect.

In addition to the PrEP Pass, advocates have called for the initiative to expand prescriber access points throughout communities, including through leveraging innovative use of telehealth, and to develop campaigns made by and for PrEP users and potential PrEP users from underserved communities. 

“This initiative aligns squarely with what the PrEP advocacy community has identified as what’s needed. Our organizations are ready to work with health departments to help provide context on how this grant opportunity came to be and why it is so important in advancing our movement for a National PrEP Program. We look forward to doing everything we can to support the innovative public health leaders who are ready to take full advantage of this opportunity.” says Jeremiah Johnson, MPH, PrEP4All Executive Director.

Read the full press release in PDF format here.

Avac Event

PrEP Your Booty – The Launch of HPTN 106 “Rev Up”

HPTN 106 (REV UP) is an innovative clinical trial from the HIV Prevention Trials Network that will investigate the safety and acceptability of a tenofovir-based rectal douche for HIV prevention among cisgender men and transgender women who have sex with men. This webinar featured researchers leading the study.

Speakers:
Dr. Craig Hendrix, Johns Hopkins University School of Medicine
Dr. Mark Marzinke, Johns Hopkins University School of Medicine

Moderator:
Jim Pickett, The Choice Agenda

Co-sponsor:
HIV Prevention Trials Network

Recording  / Webinar Slides / Resources

Avac Event

Let’s Talk LEN: What global advances in HIV prevention mean for Black communities in the US

Groundbreaking results from the PURPOSE 1 trial conducted among cisgender Ugandan and South African women have changed the injectable PrEP global landscape. This webinar explored the implications of these findings for US Black populations.

This webinar was co-hosted by PrEP in Black America, Black Public Health, Federal AIDS Policy Partnership (FAPP), AVAC, and APHA.

Recording / Bekker Resource / Campbell Resource

Navigating the PrEP Landscape—PrEPWatch is here to help!

With a growing number of PrEP products in development and approved for use in various countries, and an increase in PrEP initiations worldwide, the future of PrEP has never been more exciting. Check out our newly redesigned PrEPWatch website to help navigate the latest research, policy developments, implementation strategies, and advocacy efforts worldwide.

Navigating the PrEP Landscape

PrEPWatch is here to help!

With a growing number of PrEP products in development and approved for use in various countries, and an increase in PrEP initiations worldwide, the future of PrEP has never been more exciting. Check out our newly redesigned PrEPWatch website to help navigate the latest research, policy developments, implementation strategies, and advocacy efforts worldwide. The updated site features an array of expanded PrEP resources and improved navigation. We hope PrEPWatch and its resources will be helpful in your advocacy. 

Explore the Latest on PrEPWatch

  • Enhanced Resource Library: An extensive collection of updated tools, research, and guidelines, making it easier than ever for users to access the latest information on PrEP implementation and best practices. Check out some of the most used resources like the Integrated Study Dashboard.
  • Interactive Global PrEP Tracker: Provides up-to-date information on PrEP initiations by country and delivery model, offering insights into the progress and impact of PrEP programs around the world.
  • Country Planning Tracker: Navigable matrix showing where PrEP products are currently approved and where approval is pending. It also tracks key indicators for the introduction of new PrEP options by country, including late-stage clinical trials and implementation research, procurement plans, and more.
  • CAB for PrEP Evidence Tracker: Summarizes the latest insights from the Biomedical Prevention Implementation Collaborative (BioPIC) on injectable CAB for PrEP, links to learn more, and information on where evidence is still needed, mapped against priority evidence gaps.
  • Updated Product Pages: Updated product information addressing frequently asked questions about PrEP options that are currently available and those in late-stage clinical development – including updates on the latest news related to injectable lenacapavir.
  • Long-Acting PrEP Status Update: Quarterly dashboard produced on behalf of the Coalition to Accelerate Access to Long-Acting PrEP with graphics on regulatory approvals, volumes, ongoing and planned implementation science studies, and non-profit prices for currently available long-acting PrEP products.

The resources on PrEPWatch come from projects and partners from around the world; if you have information to share or resource needs, please email PrEPWatch@avac.org. And we are grateful for support to AVAC from the Gates Foundation via BioPIC and from PEPFAR via USAID and the Maximizing Options to Advance Informed Choice for HIV Prevention (MOSAIC) project that makes PrEPWatch possible. 

Avac Event

Opportunities to Expand Equitable Access to HIV Prevention Services through Community Pharmacies

RxEACH is a national coalition effort working to expand and sustain access to HIV prevention and linkage to care services in community pharmacies. Community pharmacies are poised to unlock access to HIV prevention services, particularly in areas where it is most needed, and can play a crucial role in achieving equitable PrEP access.

With over half of the 70,000 pharmacies in the U.S. in medically underserved areas and 90% of the U.S. population living within 5 miles of a pharmacy, community pharmacies can serve as vital entry points for essential HIV prevention and linkage to care services – and ensure people can access services in their communities. Broader pharmacy access for prevention services, can empower choice for individuals to choose to receive PrEP and other prevention services in a location that best suits their needs. This webinar discussed the opportunity to expand equitable access to HIV prevention services, including PrEP, and what is needed to grow and sustain community-based HIV prevention service programs in pharmacies.

Moderator:

  • Mike Elizabeth, Equality Federation

Speakers:

  • Natalie Crawford, Emory University
  • Noelle Esquire, Elton John AIDS Foundation
  • Juan Carlos Loubriel, Whitman-Walker Health
  • Tamara McCants, National Pharmaceutical Association
  • Michael Murphy, American Pharmacists Association
  • Sara Zeigler, Courage Forward Strategies

Recording in English / Webinar Slides / Resources

HIV Pre-Exposure Prophylaxis Policies Worldwide

An analysis presented at IAS2024, HIV Pre-Exposure Prophylaxis Policies Worldwide, by the Georgetown University Center for Global Health Policy & Politics has found 69% of 194 countries reviewed have approved at least one PrEP product. But only 52% of the countries reviewed follow WHO guidance on PrEP eligibility with regulatory approvals and national policies that support PrEP eligibility for all populations or people at risk.

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

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