Long-Acting PrEP Status Update

This long-acting PrEP status update is revised on a quarterly basis by AVAC, Secretariat to the Coalition to Accelerate Access to Long-Acting PrEP, to synthesize the current status of long-acting PrEP products. This is done in service to the wider ecosystem. It is not a deliverable of the Coalition nor representative of the views of the individual institutions that make up the Coalition.

Below you will find graphics pertaining to the regulatory approvals, volumes, ongoing and planned implementation science studies, and non-profit prices for currently available long-acting PrEP products (currently injectable cabotegravir and dapivirine vaginal ring).

The Pathway to Access and Impact

This graphic outlines the critical steps for rolling out long-acting injectable PrEP products.

The Pathway to Access and Impact graphic

Snapshot: Current Status as of October 2024

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	CAB	DVR	LEN
Product (pricing, manufacturing, generics)	Current price form ViiV made public: £23.50/vial (approximately $180/year). Voluntary license granted from MPP to 3 generics—expected to market by 2027	Current price from PopCouncil is approx. $156/year. MOU signed with Kiara Health to manufacture in South Africa but no clear timeline for local manufacturing	Gilead announced early review of PURPOSE 1 and 2 trial data in June and September. LEN was safe and effective in both trials, with no infections shown (PURPOSE 1) and a 96% lower HIV rate (PURPOSE 2). Gilead licensed six generic manufacturers to produce LEN for 120 countries
Regulatory Approval & Normative Guidance	25 regulatory approvals (including EMA); pending in 8 countries; WHO pre-qualification in 2023	Approved in 11 countries; 2 pending review/appeal; WHO pre-qualification in 2021	Possible regulatory submissions by early 2025, pending additional data and review
Planning & Budgeting	Total 2023-2026 volume: updated to 2.64M doses available (study and programmatic supply)	677k rings available 2022-2024, 323k to be manufactured by end of 2026. CIFF and Global Fund committed up to USD$2 million over 2024-2025, for purchase of approx. 150k DVRs	Gilead has stated capacity to manufacture up to ten million doses of lenacapavir by 2026—enough for 2.5 million potential lenacapavir users
Delivery & Supply Chain	Approx. 15,500 initiations as of Q3 2024	Approx 1,860 initiations as of Q3 2024	TBD during 2024/5, pending regulatory approvals and Gilead supplies
Stakeholder Engagement	Establishment of the Coalition’s Civil Society (CS) Caucus; facilitating reoccurring meetings with product developers; generic manufacturers; funders; and other stakeholders
Research	39 implementation studies completed, ongoing or planned in 22 countries; findings from two US real-world evidence studies showed more than 99% effectiveness of CAB	14 implementation studies completed, ongoing or planned in 9 countries. Positive data on 3-monthly ring presented at R4P	PURPOSE 3, 4 & 5 ongoing; develop additional implementation science agenda, as needed
Monitoring & Evaluation	Continued monitoring and assessment of initiations via trackers and think tanks. Understand country-specific product introduction issues to inform programmatic rollout		TBD during 2024/5

Proposed Priorities for H2 2024 to H1 2025

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	CAB	DVR	LEN
Product (pricing, manufacturing, generics)	Collaborate with ViiV to understand procurement plans, build demand and accelerate generics progress	Collaborate with PopCouncil on price/volume for 2024/25 & plans for local mfg with Kiara; track development of 3-monthly & dual-purpose rings	Engage with Gilead now to encourage continued inclusivity and transparency on pricing and access. Work with six generic manufacturers with haste and in parallel to regulatory submissions.
Regulatory Approval & Normative Guidance	Monitor progress on the need to remove oral CAB development and registration from sublicence agreements	Advocate for additional submission in high-burden countries	Engage with Gilead to ensure timely sharing of PURPOSE 1 data and begin submission to WHO and regulatory agencies. WHO and national agencies to review data ASAP
Planning & Budgeting	Build demand in country and develop long-term demand forecast	Build demand in country and develop long-term demand forecast; understand what data PEPFAR may need to consider programmatic procurement	PEPFAR and the Global Fund to work with other donors and MoH to negotiate price and volume guarantees. MoHs to integrate into national guidelines ASAP
Delivery & Supply Chain	Track current implementation studies and share early insights; continue to identify and address evidence gaps	Track current implementation studies and share early insights; continue to identify and address evidence gaps	MoHs, policy makers and donors to collaboratively design a comprehensive introduction strategy to speed up introduction
Stakeholder Engagement	Create collective advocacy strategies, continue to integrate civil society perspectives and support implementation of HIV Prevention Choice Manifesto		Create collective commitment to expedite comprehensive access strategy by engaging in open conversations and engagement in Plan for LEN and upcoming documents
Research	Ensure further studies are planned to research long-term effects, and continue to identify gaps in product introduction by country	Advocate for further research on long-term effects and use in conjunction with other prevention methods	Identify implementation science priorities that can be embedded in programmatic rollout and/or run in parallel in anticipation of approval & recommendations
Monitoring & Evaluation	Continue to coordinate modeling exercises; assess gaps in in product introduction by country. Push to advance a learning agenda for programmatic rollout	Continue to assess gaps in in product introduction by country. Push to advance a learning agenda for programmatic rollout	Anticipate gaps in in product introduction by country; push to advance a learning agenda for programmatic rollout