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.

Snapshot: Current Status as of June 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/years. MOU signed with Kiara Health to manufacture in South Africa but no clear timeline for local manufacturing	In June 2024, Gilead announced early review of PURPOSE 1 trial data: LEN was safe and effective, with no infections in LEN arm. PURPOSE 2 to readout later in 2024
Regulatory Approval & Normative Guidance	19 regulatory approvals (including EMA); pending in 9 countries; WHO pre-qualification in 2023	Approved in 11 countries, 2 pending review/appeal, 3 submissions in preparation. WHO PQ in 2021	Possible regulatory submissions by early 2025, pending additional data and review
Planning & Budgeting	Total 2023-35 volume: 1.2M doses for non-commercial supply (955k for programs; remainder for studies)	750k rings available 2023-2024, 250k to be manufactured by end of 2025	TBD during 2024
Delivery & Supply Chain	Approximately 12,000 initiations as of Q2 2024	Approximately 1,800 initiations as of Q2 2024
Stakeholder Engagement	Establishment of the Coalition’s Civil Society (CS) Caucus; facilitating reoccurring meetings with product developers; generic manufacturers; funders; and other stakeholders
Research	42 implementation studies ongoing or planned	15 implementation studies ongoing or planned	TBD during 2024
Monitoring & Evaluation	Continued monitoring and assessment of initiations via trackers and think tanks. Understand country-specific product introduction issues to inform programmatic rollout

Proposed Priorities for 2024

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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 transparency on pricing and access, and to grant non-exclusive licenses to multiple generic manufacturers by end of 2024
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; joint CS statement issued in July
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

Comparing Product Approvals, Volume, Implementation, and Price