USA – ViiV Healthcare has announced plans to increase its supply of long-acting cabotegravir (CAB LA) for HIV pre-exposure prophylaxis (PrEP), aiming to triple its annual production to at least two million doses by 2025/26.
This bold move targets low- and middle-income countries (L&MICs) to help populations facing high HIV infection rates and limited access to prevention resources.
The initiative will play a crucial role in expanding access to this long-acting HIV prevention method where the need is greatest.
This commitment is part of ViiV Healthcare’s ongoing efforts to help end the HIV epidemic by making long-acting PrEP more accessible in regions where resources are limited, and the burden of HIV is particularly high.
Following the U.S. Food and Drug Administration’s (FDA) approval of cabotegravir under the brand name Apretude in December 2021, ViiV Healthcare prioritized regulatory submissions in countries with the highest HIV burdens.
To date, 79% of regulatory approvals have been in L&MICs, with half occurring in sub-Saharan Africa, where the epidemic remains the most severe.
Apretude is the first long-acting injectable PrEP and is used to prevent sexually transmitted HIV-1 infection in individuals at high risk.
It is indicated for adults and adolescents weighing at least 35 kg, offering a durable, bi-monthly alternative to daily oral PrEP.
Expanding global access to HIV prevention
In her statement, ViiV Healthcare CEO Deborah Waterhouse emphasized the importance of expanding access to CAB LA: “This 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.
Long-acting PrEP provides a crucial option for populations disproportionately affected by HIV, including young women and girls in sub-Saharan Africa.”
To ensure affordable access, ViiV Healthcare is working in partnership with global health organizations such as the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) and The Global Fund.
These collaborations allow CAB LA to be supplied at a not-for-profit price in low-income countries, with the first rollouts having begun in Zambia in early 2024.
Additional rollouts have followed in Malawi, Zimbabwe, Eswatini, and Ukraine, and by the end of this year, ViiV plans to have expanded the drug’s availability to 14 countries.
In addition to increasing production and supply, ViiV has taken significant steps to ensure the sustainability of access to CAB LA for PrEP.
In July 2022, the company signed a licensing agreement with the Medicines Patent Pool to enable the development of generic formulations of CAB LA.
This agreement ensures that generic manufacturers can work with ViiV to expedite the availability of lower-cost versions of the drug, further widening access across L&MICs.
As part of its broader mission, ViiV has been actively engaged with local partners, providing grants, supporting fellowships, and launching a coalition aimed at strengthening community-based HIV prevention programs.
