The long-acting injectable PrEP option is being rolled out at a record pace in sub-Saharan Africa and lower-income countries. Credit: elenavolf/Shutterstock.

ViiV Healthcare has announced plans to triple its annual supply of long-acting cabotegravir for HIV pre-exposure prophylaxis (PrEP) to at least two million doses.

These medicine doses will be supplied to low and middle-income countries (L&MICs) during 2025/26.

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The company’s strategy focuses on maximising rapid access and uptake for populations with the highest unmet needs, in a sustainable manner, through partnerships and integration into existing healthcare services and HIV prevention programmes.

Following the US Food and Drug Administration’s (FDA) approval of the asset under the brand name Apretude in December 2021, ViiV prioritised regulatory submissions in countries with the highest HIV burden.

To date, half of the approvals are in sub-Saharan Africa, and 79% are in L&MICs.

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Apretude is indicated for preventing sexually transmitted HIV-1 infection in adults and adolescents weighing a minimum of 35kg who are at high risk of infection.

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The first long-acting injectable PrEP option is being rolled out at a record pace in sub-Saharan Africa and lower-income countries.

ViiV offers CAB LA for PrEP at a not-for-profit price for roll-out in low-income countries and sub-Saharan Africa through partners such as the United States President’s Emergency Plan For AIDS Relief (PEPFAR) and The Global Fund.

The first rollouts began in Zambia in February 2024, followed by Malawi, Zimbabwe, Eswatini and Ukraine.

By the end of this year, ViiV plans to supply CAB LA for PrEP to 14 countries.

In July 2022, ViiV signed a licensing agreement with the Medicines Patent Pool to enable the development of generic formulations of CAB LA for PrEP.

The company is actively engaged with generic manufacturers, providing technology transfer and expertise to expedite the availability of generic options.

 ViiV Healthcare CEO Deborah Waterhouse said: “The 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.”