Regulatory approvals, pending decisions, and appeals as of October 2024. For product approvals, volumes, implementation, and price comparisons of long-acting PrEP, visit our dashboard on PrEPWatch.org.
Dapivirine Vaginal Ring Regulatory Approval
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.
PrEP Approval Status in Latin America, 2024
Since 2019, rates of HIV acquisition in Latin America have been trending upward, from 110,000 annually in 2019 to approximately 120,000 in 2023. At the same time, Latin America has taken strides to combat this trend, from increasing PrEP initiation rates to preparing for longer acting PrEP products, such as injectable cabotegravir (CAB) and lenacapavir (LEN). Learn more in PxWire.
Moving a Product to the Real World
The rollout of oral PrEP demonstrates that people don’t take PrEP simply because it’s available—there needs to be a demand for it, and it needs to be accessible, acceptable and used effectively by those who need and want it. These are the lessons the field is applying to the rollout of the dapivirine vaginal ring (DVR), and injectable cabotegravir (CAB) and lenacapavir (LEN) for PrEP. To reach the UNAIDS target of 10 million PrEP users by 2025, initiations of oral PrEP alone will not be enough—and this graphic shows that the field is beginning to apply past lessons to accelerate introduction of injectable PrEP options.
This is an updated version of a graphic excerpted from PxWire.
An Overview of Lenacapavir for PrEP Trials
Spotlight on MPTs Addressing STIs
This graphic outlines the development journey of multipurpose technologies (MPTs) that guard against STIs, including HIV, while also preventing pregnancy. It tracks the advancement of various potential products through different trial stages, emphasizing their combined protective roles. Excerpted from our Advocates’ Guide to Multipurpose Technologies.
At A Glance: The MPT R&D Pipeline
This graphic shows the status of products in development. Excerpted from our Advocates’ Guide to Multipurpose Technologies.