Accelerating Access and Introduction of Injectable CAB for PrEP

Late last month, ViiV Healthcare, the maker of injectable cabotegravir (CAB) announced that it is "actively negotiating voluntary licensing terms'' of CAB for PrEP to the Medicines Patent Pool (MPP) and is “committed to supplying” the product at a non-profit price for public programs in low-income and all sub-Saharan African countries until a generic is available. This announcement comes after months-long pressure from advocates and others, demanding that ViiV does its part to make good on the promise of injectable CAB for PrEP to advance HIV prevention and global health equity – see a number of important statements from advocates emerging from these discussions.

While this is an important step forward, and an example of advocacy at its best, this is only one piece of the puzzle that will make CAB for PrEP available to all who need and want it. Advocates have much more work ahead to ensure swift and equitable access to CAB.

And AVAC has a plan.

AVAC’s Plan for Accelerating Access and Introduction of Injectable CAB for PrEP provides a comprehensive view of all the moving parts involved in delivering this new PrEP option and identifies priorities for ensuring time is not wasted and opportunity is not squandered. The plan focuses on learning the lessons from the first ten years of delivering oral PrEP and how to move faster, more strategically, and with greater coordination to maximize the impact of injectable CAB for PrEP.

AVAC’s plan calls on ViiV, policy makers, normative agencies, donors, program implementers, researchers, civil society, advocates and communities to act on a range of key activities, which include:

• A transparent commitment from ViiV, and a negotiated guarantee from donors, to a cost-effective and affordable price and volume of CAB for PrEP to support early launch, introduction and rollout.
• Inclusion of injectable CAB for PrEP in WHO guidelines, which are expected ahead of AIDS 2022.
• National programs in priority countries complete CAB for PrEP registration or secure relevant waivers.
• Voluntary licensing from ViiV to select generic manufacturers, including technology transfer as required.
• Donor investments in generic manufacturing capacity.
• Market assessments and demand forecasts are updated with data from initial projects, to inform programming, manufacturing and cost.
• Operational research and implementation science studies identify successful, scalable delivery channels; a testing algorithm that balances resistance risk with the needs of users and providers; ongoing engagement with communities and civil society; and a mechanism for independent coordination.

The plan also lays out advocacy priorities and calls on advocates to hold decision-makers accountable, for the rollout of CAB for PrEP – and on prevention generally. Is there clarity about next steps? Are there targets and milestones in place? Is there adequate funding to support strategic and accelerated rollout? How might decisions be made about who would get the product first, if it’s licensed and introduced through phased rollout?

In the days, weeks and months to come, advocates will continue to engage with ViiV, WHO, donors and other decision-making bodies focused on the future of CAB for PrEP and HIV prevention at large. Read our full statement here. AVAC hopes this plan will be the guide. As always, we will be tracking the progress, investing support, and keeping you informed.