Dr. Jenell Stewart (University of Minnesota, Hennepin Healthcare) joined The Choice Agenda to discuss and analyze recent research on HIV PrEP and implications for event driven PrEP across sex and gender.

Avac Event
Dr. Jenell Stewart (University of Minnesota, Hennepin Healthcare) joined The Choice Agenda to discuss and analyze recent research on HIV PrEP and implications for event driven PrEP across sex and gender.
Dear Advocate,
How do we translate recent scientific advances in long-acting HIV prevention and therapy into public health impact? Read answers in this new The Lancet HIV commentary from a distinguished group of authors including our Executive Director, Mitchell Warren, AVAC board members, Linda-Gail Bekker, Solange Baptiste Simon, with partners Francois Venter, Kenly Sikwese, and others: The long wait for long-acting HIV prevention and treatment formulations.
Major advances in long-acting HIV treatment and prevention, including the latest PURPOSE 1 results of lenacapavir for PrEP, hold great promise for achieving global targets. However, planning to coordinate among stakeholders, including pharmaceutical companies, governments, and multilateral organizations to deploy and ensure equitable access to these products, particularly in low- and middle-income countries, requires immediate action.
“Civil society organisations and HIV activists have been instrumental in holding pharmaceutical companies, financial donors, governments, and international organisations accountable for commitments to the international HIV treatment response for decades,” the authors write. “These organisations and activists are needed to promote transparency in pricing, challenge restrictive patent practices, advocate for affordable and widespread availability of drug innovations, prevent companies from restricting broad access to medications, and require funding to allow this work to be done independently.”
The Lens on LEN: this primer for advocates shares the basics on injectable lenacapavir as PrEP.
Long-Acting PrEP Status Update: this webpage shares graphics and information synthesizing the current status of long-acting PrEP products. It’s updated quarterly.
PrEP Products Overview: this page on PrEPWatch shares the status of PrEP products in development and approved.
Injectable Cabotegravir Evidence Gap Tracker: this webpage 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.
Years Ahead in HIV Prevention Research: Time to Market: this downloadable graphic shows the potential time points when the next-generation of HIV prevention options might find their way into new programs.
Among 134 countries reviewed, 42 have comprehensive anti-discrimination policies covering a broad range of populations, while 24 lack any such policies. The remaining countries have adopted partial measures. Nations with comprehensive anti-discrimination policies, document significantly higher rates of PrEP initiation compared to those without such protections. Key studies show a strong link between supportive policies (which can enable PrEP eligibility, HIV self-testing, and lower age of consent for treatment, for example) and higher PrEP initiations.
As CAB for PrEP is a long-acting, extended-release injection, bioequivalence (BE) testing takes time to determine whether the generic drug functions in the body similarly to the original drug. As shown in this timeline graphic, the BE study (as determined by WHO guidance) is the longest part of the development process for generic CAB. But other steps, such as selecting and licensing generic manufacturers and technology transfer could be done faster.
PxWire is AVAC’s quarterly update covering the latest in the field of biomedical HIV prevention research and development, implementation and advocacy. Each issue includes updates, emerging issues and upcoming events. A PDF version of this report is also available.
Oral PrEP initiations in Uganda were among the highest in the region, with sizable increases each quarter, until the enactment of the Anti-Homosexuality Act (AHA) in March 2023. Since then, the number of new PrEP initiations plummeted, and have since struggled to sustain rates seen in 2023. Public policies clearly matter.
Among 134 countries reviewed, 42 have comprehensive anti-discrimination policies covering a broad range of populations, while 24 lack any such policies. The remaining countries have adopted partial measures. Nations with comprehensive anti-discrimination policies, document significantly higher rates of PrEP initiation compared to those without such protections. Key studies show a strong link between supportive policies (which can enable PrEP eligibility, HIV self-testing, and lower age of consent for treatment, for example) and higher PrEP initiations.
An analysis presented at AIDS 2024, HIV Pre-Exposure Prophylaxis Policies Worldwide, by the Georgetown University Center for Global Health Policy & Politics and AVAC found that 69% of the 194 countries reviewed have approved at least one PrEP product. However, only 52% of these countries adhere to WHO guidance on PrEP eligibility, with regulatory approvals and national policies that support PrEP use for all populations or people at risk. This data reinforces the critical need for policies that support PrEP uptake.
Advocacy to accelerate licensing for new products can speed the process of generics manufacturing.
Three generic manufacturers—Aurobindo, Cipla, and Viatris—have licenses via the Medicinces Patent Pool to develop generic versions of injectable cabotegravir (CAB) for PrEP. These generic products are currently in development and expected to be submitted to regulatory authorities in the second half of 2026, with possible approval in 2027.
As CAB for PrEP is a long-acting, extended-release injection, bioequivalence (BE) testing takes time to determine whether the generic drug functions in the body similarly to the original drug. As shown on the timeline graphic below, the BE study (as determined by WHO guidance) is the longest part of the development process for generic CAB. But other steps, such as selecting and licensing generic manufacturers and technology transfer could be done faster. It is critical that generic manufacturers for new PrEP products, such as lenacapavir, star as soon as possible. This requires Gilead to pursue licensing even before regulatory submission, and to accelerate technology transfer and API development.
See AVAC’s Planning Matrix for more!
Results from the PURPOSE 1 trial of injectable lenacapavir showing 100% efficacy in preventing HIV among cisgender women and adolescent girls dominated headlines at the AIDS 2024 conference. This Phase 3 trial, conducted by Gilead Sciences, involved over 5,000 participants from South Africa and Uganda and demonstrated superior results compared to daily oral PrEP options. See the New England Journal of Medicine publication, accompanying Editorial and our advocates’ primer to learn more about the results and what needs to happen next: Lens on LEN: The basics on injectable lenacapavir as PrEP.
Gilead’s PURPOSE 2 Phase 3 trial is ongoing and testing injectable lenacapavir as PrEP in the US, South Africa, Peru, Brazil, Mexico, Argentina, and Thailand, among cisgender men who have sex with men, transgender women, transgender men, and gender non-binary individuals. With 3,000 participants enrolled, initial results are anticipated in late 2024 or early 2025. Two other trials (PURPOSE 3 & 4) are currently recruiting in the United States, enrolling cisgender women and people who inject drugs, respectively. Enrollment for PURPOSE 5 in France and the UK is expected to commence in the latter half of this year. For more information about the lenacapavir trials, visit: An Overview of Lenacapavir for PrEP Trials.
Meanwhile, the bioequivalence study for the Dual Prevention Pill (DPP), designed to prevent both HIV and pregnancy, has concluded successfully, with each of the drugs functioning together in the body in a similar way to how they function alone. The promising results pave the way for regulatory submission and potential large-scale adoption, offering another significant tool in the fight against HIV and unintended pregnancies. Learn more about the DPP and find resources for your advocacy.
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Press Release
For media inquiries contact Michael Chancley at [email protected]
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.
Avac Event
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
Avac Event
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.
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.
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.
The resources on PrEPWatch come from projects and partners from around the world; if you have information to share or resource needs, please email [email protected]. 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.