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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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.

African Networks of People Living with HIV Seek Resource Commitments in the Fight to End HIV

A coalition of African People Living and Affected with HIV released a statement during the 25th International AIDS Conference to extend gratitude to the international community for their contributions in ending the epidemic globally, but also highlighted several concerns including the need for sustained investment, efforts to push for a 5-year PEPFAR reauthorization, and advocating for key populations as they face increased discrimination.

Read the full statement here.

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.

Choice, Access and Equity at AIDS 2024

Choice, access, and equity were central themes during the sessions and discussions at #AIDS2024 on Wednesday and Thursday. Highlights included new data on long-acting cabotegravir, a plenary calling out the need to move with speed, scale and equity in the rollout of new PrEP options, updated guidelines to improve access to post-exposure prophylaxis (PEP), a renewed commitment to the African Women’s Choice Manifesto, new data highlighting the omission of key populations from sustainability planning, and much more.

AIDS 2024 Preconference Highlights

AIDS2024, this year’s annual conference of the International AIDS Society opened with a spotlight on troubling trends. A series of preconferences took on critical topics including supporting key populations in a time of increasing discrimination; new and novel research and implementation of STI prevention and treatment, witnessing a soaring rise in incidence; and the importance of implementing new PrEP options to create more choice for people who need HIV prevention most.

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. “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.

LEN in the Spotlight at AIDS 2024

Midpoint at #AIDS2024 in Munich, one of the most significant advances in HIV prevention in the history of the response, the efficacy of lenacapavir as PrEP, was presented at the Co-Chair’s Choice session. The findings, zero infections and 100% efficacy among the trial participants in the PURPOSE 1 trial, brought a standing ovation.