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ViiV HEALTHCARE TO TRIPLE ANNUAL SUPPLY OF LONG-ACTING HIV PREP FOR LOW- AND MIDDLE-INCOME COUNTRIES
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• At least two million doses of long-acting cabotegravir for PrEP to be made available in 2025-2026 to meet growing demand where HIV burden and unmet need are greatest
• Strong progress made with generic manufacturers through Medicines Patent Pool (MPP) voluntary licensing agreement
• Despite availability of PrEP, an estimated 1.3 million people acquired HIV in 2023, highlighting urgent need to scale up access to innovative new options1
London, 7 October 2024 - ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders, today announced the company's commitment to make at least two million doses of long-acting cabotegravir for HIV pre-exposure prophylaxis (CAB LA for PrEP) available for procurement for low- and middle-income countries (L&MICs) during 2025-2026. The new commitment will triple the company's available supply versus 2024, to accelerate access and meet growing demand where the HIV burden and unmet need are greatest. The announcement was made at the HIV R4P 2024 conference, being held in Lima, Peru from 6 - 10 October.
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; half of the approvals to date are in SSA and 79% are in L&MICs.
ViiV-manufactured CAB LA for PrEP is available at a not-for-profit price for roll-out in low-income 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.
See link for full press release
https://viivhealthcare.com/hiv-news-and-media/news/press-releases/2024/october/triple-annual-supply-of-long-acting-hiv-prep-for-low-and-middle-income-countries/
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