Harnessing private sector strategies for family planning to deliver the Dual Prevention Pill, the first multipurpose prevention technology with pre-exposure prophylaxis, in an expanding HIV prevention landscape

Working with colleagues, AVACers Cat Verde Hashim and Kate Segal published this research article in the Journal of the International AIDS Society. The researchers undertook qualitative research in Kenya, South Africa and Zimbabwe to prioritize private sector service delivery approaches for the introduction of the DPP.

Impact of the Anti-Homosexuality Act on PrEP Uptake Rates in Uganda Compared to Other Countries

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.

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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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.

PxPulse: The Advocacy Chronicles with Ruth Akulu

On this episode of the Advocacy Chronicles: a look at advocacy in Uganda for the Dual Prevention Pill (DPP), a new product combining oral PrEP and oral contraception.

Ruth Akulu is a Youth Representative of the Uganda Country Coordinating Mechanism Board for Global Fund, member of the DPP Civil Society Advisory Group, and a 2022 AVAC Advocacy Fellow. Akulu talks about her work to mobilize regulatory authorities to prepare for the DPP. And while she was at it, the establishment of a groundbreaking new initiative, the Product Regulator’s Engagement Committee, which is supporting ongoing engagement between government regulators and young women representing their communities.  

Listen to learn why the DPP is a priority for young women and HIV prevention, the challenges Ruth confronted and tactics that supported the success of this advocacy.

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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

Global HIV Prevention Advocates Call for Accelerated Timeline for Widespread Access to Injectable Lenacapavir for PrEP

A global cadre of HIV prevention advocates is calling for an accelerated timeline for access to the HIV prevention drug lenacapavir. Gilead, the developer of the drug, announced topline results from a large study among cisgender African women on 20 June, followed shortly thereafter with a statement about access. 

From The Lab To The Jab: Lessons learned and what’s next in HIV vaccine research

On 3 June 2024, AVAC hosted a webinar highlighting its Lab to Jab issue briefs on research and development, production and equitable global access to vaccines.

Platforms, Not Pathogens

“[Our approach to access and equity] has to be intentional, not incidental, and it has to be empowered, not vulnerable.” — Dr. Jerome Kim, International Vaccine Institute

Panelists stressed an intentional, rather than incidental approach to ensuring global vaccine access and equity, going from pathogens to platforms, and having LMICs move from consumers to actors. They described ways to transform vaccine R & D from a financial imperative of pharmaceutical corporations into a system that addresses health needs through medical innovation. They underscored the importance of new, equity-based models to move low- and middle-income countries from being recipients of vaccine technology to co-creators from the very beginning of the R & D process. These models can work through in-country partnerships for vaccine development and production, shared technology and know-how, use of TRIPS flexibilities, intellectual property waivers and access conditions, and establishing a local production ecosystems.

The webinar featured Dr Jerome Kim, Director General of the International Vaccine Institute, Othoman Mellouk, Access to Diagnostics and Medicines Lead at the International Treatment Preparedness Coalition, and Dr Els Torreele, Founding Director of æqua, a recently created think tank on equity and economic justice for health. The panelists discussed international initiatives for vaccine development, the current state of vaccine research and access, and how they can be improved. 

From Consumers to Actors

“Driving innovation at the regional R&D hubs means creating access to the technology platforms that can be adapted to new pathogens or the local health needs.” — Dr. Els Torreele, æqua

As of December 2023, only 56% of the world’s population received a complete series of COVID-19 vaccines, and only 28% had at least one booster dose. Many low- and middle-income countries (LMIC) were last in line to purchase overpriced vaccines. Lack of access to Mpox vaccines in Africa, where it is endemic, continues. These inequities are driven by the current profit-driven model and intellectual property barriers—but there could be a different way.  

One major initiative discussed is being spearheaded by the International Vaccine Initiative (IVI), a UN-chartered organization dedicated to accelerating vaccine R&D for global health. Through its robust partnerships, and funding from the Gates Foundation, it has developed two approved vaccines (for cholera and thyphoid)–for less than $30 million each. The IVI also hosts the Advancing Vaccine End-to-End Capabilities in Africa (AVEC) Initiative, which aims to accelerate the development of the African ecosystem for vaccine R&D. Its aim is to support a powerhouse of continental manufacturing through a sustainable pan-African alliance that executes on the ground. 

For more information, see:

On Access and Equity

“The problem is, until now, our countries are thinking mostly as consumers, not as actors. We only heard a little bit about some initiatives during COVID, because everybody woke up.” — Othoman Mellouk, International Treatment Preparedness Coalition