What Happens to PrEP Initiations in Countries with Anti-Discrimination Policies?

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.

Generic Cabotegravir Timelines

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 Volume 14, Issue No. 3

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.

Progress in PrEP Uptake

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.

PrEParing for New Products

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.

Does the Timeline Have to be this Long?

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.

Product Updates

  • Data from HPTN 084 show that CAB for PrEP was generally well tolerated and safe for both pregnant cisgender women and their babies.
  • China has approved CAB for PrEP.
  • With PEPFAR support, Eswatini, Nigeria, and Ukraine are poised to introduce CAB for PrEP into their national PrEP programmes this quarter, and the South African government announced CAB supplies from PEPFAR will be launched in Q1/Q2 2025.

See AVAC’s Planning Matrix for more!

The Latest R&D in the Prevention Pipeline

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

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

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.

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 [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. 

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.