https://avac.org/resource/len-generics/PxWire is AVAC’s quarterly update covering the latest in the field of biomedical HIV prevention research, development, implementation and advocacy. Each issue includes updates, emerging issues and upcoming events.
The full issue is available online as a webpage and PDF.
Progress in PrEP Uptake
The HIVR4P 2024 conference, hosted this year in Lima, Peru, put a spotlight on PrEP delivery in Latin America. Since 2019, rates of HIV acquisition in the region 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).
- At least 15 Latin American countries have approved oral PrEP. Brazil and Peru also approved CAB for PrEP, and it is under review in Chile, Mexico, and Colombia.
- Four countries and one territory in the region, Argentina, Brazil, Mexico, Peru, and Puerto Rico, have trial sites participating in the PURPOSE 2 trial, which showed LEN reduced HIV incidence by 96% compared to a background incidence. There were two incident cases of HIV among 2,180 participants receiving LEN.
- 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.
Latest Trends in PrEP Uptake?
Find the latest trends on 2024 data in AVAC’s Global PrEP Tracker. Watch for the next update on November 22.
PrEParing for New Products
LEN generics may submit for regulatory approval around the same time as CAB generics (Q3-4 2026), primarily because LEN has been licensed even before regulatory submission / approval, is already moving towards tech transfer to generic manufacturers (as of Q4 2024) and because BE timelines are expected to be much shorter for LEN than for CAB.
LEN Generics - Can we go faster?
- On October 2, Gilead Sciences announced six licenses to generic manufacturers in Egypt, India, and Pakistan to produce and market lenacapavir (LEN) for PrEP in 120 countries.
- What’s new about this announcement? This marks both an increase in geographic coverage and speed, as compared to generic licenses for injectable CAB for PrEP. Gilead awarded these licenses even before submitting LEN for PrEP for regulatory approval in any country, and these awards cover an additional 35 countries. But even as these licenses for generic LEN for PrEP cover more countries than those granted for injectable CAB for PrEP, many countries with high HIV incidence have been left out of the licensing deal; notably Argentina, Brazil, Mexico, and Peru, countries in which the PURPOSE 2 Phase III trials took place. In addition, Gilead’s licenses are more restrictive than ViiV’s, in terms of where generics can be marketed.
- 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, versus 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.
- Generic regulatory approval submission for LEN for PrEP may begin as early as the second half off 2026, two years after Gilead announced positive trial results. Generic CAB for PrEP is on track to submit for regulatory approval around the same time, approximately six years after the announcement of trial results.
Product Updates
CAB for PrEP has been approved in Cote d’Ivoire, Kenya, Myanmar, Namibia, and Ukraine. See AVAC’s Planning Matrix for more!
The Latest R&D in the Prevention Pipeline
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.
PRA priorities include:
- Support a choice-based prevention agenda with clear and realistic target product profiles that reflect the current and future landscape of HIV prevention.
- Begin with the end in mind by identifying and anticipating trial design issues (feasibility, cost, size, regulatory pathways) and implementation science questions so that the timeline from evidence to impact and to widespread access is as short as possible. Initiate access planning during efficacy trials to ensure expeditious rollout.
- Center and invest in social and behavioral science that explores end users’ needs and preferences, informs target product profiles, and identifies and addresses social and structural barriers in HIV prevention.
- Maintain advocacy across product categories to fill important gaps in a comprehensive HIV prevention toolbox. We must make newly efficacious products accessible, and vaccines, bnAbs, implants, and other products in early-phase development will also play an important role for a sustainable end to the epidemic.
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