Deborah Waterhouse, Chief Executive Officer at ViiV Healthcare and President, Global Health at GSK, said: “Today’s announcement marks another important milestone in our efforts to accelerate access to the only long-acting PrEP available now -- CAB LA -- where it’s needed most. We know long-acting PrEP provides a crucial option to suit the needs and circumstances of populations disproportionately affected by HIV, including young women and girls in Sub-Saharan Africa. We are committed to working at pace with our partners and the community -- globally, regionally, and locally -- to continue enabling sustainable access to CAB LA for PrEP as a key part of our mission to help end the HIV epidemic.”
ViiV’s strategy for CAB LA for PrEP in L&MICs is to maximise rapid access and uptake for populations with highest unmet needs, in a sustainable way, centred on partnership and integration into existing healthcare services and HIV prevention programmes.
The roll-out of CAB LA for PrEP -- the first long-acting injectable PrEP option -- is progressing at record pace in Sub-Saharan Africa (SSA) and lower income countries. Following the first approval of CAB LA for PrEP by the U.S. FDA in December 2021, under the brand name Apretude, regulatory submissions have been prioritised in countries where the HIV burden is greatest; almost half of the approvals to date are in SSA and 79% are in low, lower-middle and upper-middle income countries.
ViiV-manufactured CAB LA for PrEP is available at a not-for-profit price for roll-out in low-income, least developed, and SSA countries, via partners including the United States President's Emergency Plan For AIDS Relief (PEPFAR), and The Global Fund. The first of these rollouts was in Zambia in February 2024, just two years after the U.S.; since then, initiations have started in Malawi, Zimbabwe, Eswatini and Ukraine. By the end of 2024, ViiV will have supplied CAB LA for PrEP to key partners for roll-out to a total of 14 countries (13 countries in SSA and Ukraine).
Expanding capacity and improving affordability in resource-limited settings is critical to ensuring sustainable access to innovative medicines. In addition to providing CAB LA for PrEP at a non-profit price, ViiV announced the signing of a licensing agreement with the Medicines Patent Pool in July 2022, to enable the development of generic formulations. ViiV is actively engaged with the generic manufacturers, providing technology transfer and expertise, to expedite this process and the availability of generic CAB LA for PrEP.
Apretude (CAB LA for PrEP) has received marketing authorisation from 24 regulatory agencies, covering 53 countries. For more information on approvals and submissions around the world, click here.
