Gears of Lenacapavir for PrEP Rollout 

The Gears of Lenacapavir for PrEP Rollout outlines a transformative opportunity in the global fight against HIV, coming at a pivotal moment when the scale-up of PrEP has shown remarkable progress but remains insufficient to achieve a transformational impact on HIV incidence and the trajectory of the epidemic. This effort demands a coordinated response from governments, donors, civil society, and the private sector to ensure rapid implementation, equitable access, and sustainable impact. By leveraging lessons from previous PrEP interventions, aligning financing mechanisms, and prioritizing underrepresented regions, stakeholders can overcome systemic barriers and maximize the public health potential of this innovative long-acting prevention tool.

With anticipated regulatory approvals and production scaling, the plan targets over 2.5 million LEN users in low- and middle-income countries by 2027. With a focus on addressing structural barriers like stigma, healthcare inequities, and restrictive policies, alongside integrating generics into national programs, the roadmap aims to build on existing progress while accelerating the pace of HIV prevention. 

Oral PrEP Prices in LMICs

This chart tracks pricing for oral PrEP as tenofovir disoproxil and emtricitabine (TDF/FTC) as compared to generic pricing in low- and middle-income countries (LMICs) since 2005.

PrEP Initiations by Country Worldwide

AVAC tracks global PrEP use by conducting quarterly surveys of ongoing oral PrEP demonstration and implementation projects, and collecting data from manufacturers and government agencies. This graphic shows data on PrEP initiations around the globe. For more trends in oral PrEP uptake, visit PrEPWatch.

An Advocate’s Guide to Research in Pregnant and Lactating Populations

A resource that provides background on the need for research in pregnant and lactating populations and how advocates can advance inclusion.

Moving a Product to the “Real World”

A visual roadmap illustrating the key stages transitioning a product from clinical trials to large-scale real-world implementation.

PxPulse: The Votes are In — What’s next for the US’ role in global health and HIV prevention

KFF’s Jen Kates and AVAC’s Suraj Madoori lay out the challenges and the priorities in 2025 and beyond. 

In the days, months and years ahead under a new US Presidential Administration, advocacy for choice, freedom, science, and rights will require intentional strategies to protect hard fought gains in HIV treatment and prevention and in global health generally, and to safeguard policies and programs that advance it. And there will be major implications for the global AIDS response.

Navigating through the work ahead involves assessing the potential impact on PEPFAR and Global Fund support; on USAID, NIH, CDC and the FDA; on the US relationship to WHO and other UN agencies; and on evidence- and rights-based policies and programs generally. Joining us to begin those efforts and better understand the landscape for advocacy are Jen Kates from KFF and our own Suraj Madoori.

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Resources

Years Ahead in HIV Prevention Research: Time to Market

This timeline shows the potential time points when the next-generation of HIV prevention options might find their way into new programs.

People’s Research Agenda: New dimensions to the “3D” pathway

Launched at HIVR4P in Lima, Peru in October 2024, the People’s Research Agenda (PRA) is a collaboratively developed framework for aligning the needs and priorities of affected communities with the agenda for HIV prevention research. 130 advocates from more than 20 countries contributed to the framework, which offers guidance on both research conduct and what products to develop. Read more in PxWire.

LEN Generics — Can we go faster?

The timeline for generic LEN for PrEP to come to market is expected to be significantly shorter than for CAB for PrEP. Bioequivalence (BE) testing for LEN, which demonstrates a generic product works in the body in the same way as the originator product, is likely to be six months, vs. the 18 months for CAB for PrEP, because of differences in the drug formulation. The rapid granting of voluntary licensing by Gilead also contributes to this shorter timeline. Read more in PxWire.

PrEP Initiations in Latin America, 2019-2024

Latin American countries account for 306,000 cumulative PrEP initiations in the Global PrEP Tracker as of Q2 2024, which represent 4% of the global total. Since 2019, PrEP initiations across the region continue to increase at a steady rate, with Brazil reaching about 194,000 cumulative PrEP initiations (63% of regional total) since the inception of its National PrEP Program. Read more in PxWire.