Press Release

New AVAC Plan Lays Out Priorities for Swift and Equitable Rollout of Injectable Cabotegravir for PrEP


Kay Marshall, +1 (347) 249-6375,

June 9, 2022 — As the HIV prevention field is poised to introduce two promising new options: the dapivirine vaginal ring (DVR) and injectable cabotegravir (CAB), AVAC lays out a Plan for Accelerating Access and Introduction of Injectable CAB for PrEP. The plan identifies immediate priorities to support the swift rollout of CAB for PrEP and calls on stakeholders to ensure that it’s delivered to programs at scale at the lowest price possible.

In December 2021, the US FDA approved CAB as PrEP, making it the first injectable PrEP option to be added to a growing range of proven prevention methods. Eight additional applications have been filed for regulatory approval in priority countries with decisions expected later this year. In addition, WHO guidelines for injectable PrEP are expected later this year.

“COVID-19 has shown us that the field can compress timelines and new technologies can be developed, tested and distributed quickly and with urgency, at least for wealthier nations,” said Mitchell Warren, AVAC Executive Director. “The challenge now is to learn these lessons from COVID-19. Can the world respond just as urgently for HIV prevention? Can we speed up the process, with delivery happening in parallel to further research that may be needed? Can access be scaled and programs designed so that injectable PrEP truly impacts the HIV epidemic and is delivered with equity, reaching those who need it most? The answer to all these questions must be yes. But will take all of us, doing our part.”

AVAC’s plan comes on the heels of months-long discussions between advocates and other stakeholders who participated in a series of meetings with ViiV Healthcare, the maker of injectable CAB for PrEP, and in the World Health Organization (WHO) Guidelines Review Group. These discussions prioritized the imperative to make good on the promise of injectable cabotegravir to advance HIV prevention and global health—a number of important statements from advocates emerged from these discussions. In response, ViiV announced last month that it is “actively negotiating voluntary licensing terms” of CAB for PrEP to the Medicines Patent Pool (MPP) and is “committed to supplying” CAB for PrEP at a non-profit price for public programs in low-income and all sub-Saharan African countries until a generic is available.

“This is an example of advocacy at its best, but while this commitment is hugely important, advocates have much more work ahead to ensure that all stakeholders do their part to support swift and equitable access to injectable CAB for PrEP,” Warren added.

AVAC’s plan provides a comprehensive view of all the moving parts involved in delivering CAB for PrEP and identifies priorities for ensuring time is not wasted and opportunity is not squandered in making CAB for PrEP available to all who need and want it. 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.

“Injectable CAB for PrEP gives us an important opportunity to advance HIV prevention for populations most at risk. We are committed to ensuring we get rollout right so that a broad range of options are available to people who want and need them, especially young women,” wrote a group of Southern African Women Advocates in a March 2022 statement. “We… will work with all stakeholders, including ViiV, to make a real impact in HIV prevention.”

Members of this group along with colleagues in East Africa, with support from AVAC, Advocacy for Prevention of HIV and AIDS (APHA) and International Community of Women living with HIV Eastern Africa (ICWEA,) have formed the African Women Community Prevention Accountability Board to serve as an ongoing, independent mechanism for stakeholder engagement to provide input into CAB for PrEP planning and implementation among cisgender women in Africa.

Oral PrEP was first shown to be safe and effective in 2010 and first approved in 2012, but the field moved too slowly—and now 10 years since first approved, fewer than 2 million people have used this option, while an estimated 120 million could benefit from it.

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, on a cost-effective and affordable price and volume for 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 manufacturer(s), including technology transfer as required.
  • Donor investments in generic manufacturing capacity.
  • National Programs in priority countries complete CAB for PrEP registration or secure relevant waivers.
  • 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 an independent coordination mechanism.

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

“We welcome the recent announcement by ViiV to start negotiations with the MPP to potentially open the door for generic injectable CAB- LA. While it’s notable progress, this is NOT a license agreement,” said Kenly Sikwese, Executive Director at the Afrocab Treatment Access Partnership and a member of AVAC’s board of directors. “New HIV prevention options, in particular injectable cabotegravir for PrEP, hold the promise to transform HIV prevention in our communities. For years, communities have advocated for diverse HIV prevention options that respond to the needs, lifestyles, and unique experiences of our community members at greatest risk for HIV infection. Affordable, widespread access to injectable CAB can represent a step change for HIV prevention, if we can collectively move faster and more strategically.”

In the days to come, advocates will continue to engage with ViiV, WHO, donors and other decision-making bodies focused on the future of CAB for PrEP. AVAC will be tracking the progress, investing support, and putting a spotlight on the key priorities as information becomes available.

AVAC has worked on PrEP advocacy and introduction since the design of the earliest studies on the efficacy of oral PrEP beginning in 2004. In 2007, AVAC partnered with UNAIDS to develop the Good Participatory Practice Guidelines, offering a roadmap and principles to effectively engage with all stakeholders in the design and conduct of biomedical HIV prevention trials. Nearly 15 years later, with growing advocacy calling for greater political and financial support to introduce and rollout the dapivirine vaginal ring, or PrEP ring, along with injectable CAB for PrEP, many of the initial principles of GPP—transparency, accountability, community stakeholder autonomy, and mutual understanding—continue to be more important than ever.


About AVAC: Founded in 1995, AVAC is a non-profit organization that uses education, policy analysis, advocacy and a network of global collaborations to accelerate the ethical development and global delivery of HIV prevention options as part of a comprehensive response to the pandemic. Follow AVAC on Twitter @HIVpxresearch and find more at and