ViiV Healthcare is actively working with the UN-backed Medicines Patent Pool (MPP) to outline a positive path forward for voluntary licensing of long-acting HIV prevention, including assessment of the future demand and necessary manufacturing capacity and capability as well as upstream requirements for potential generic manufacturing partners.
HIV prevention measures, if used appropriately and at scale, have the potential to have a significant impact on the HIV epidemic, particularly for vulnerable and at-risk populations with the highest unmet needs, including women of reproductive age who are disproportionately impacted by HIV in Sub-Saharan Africa.
Voluntary licences would form part of a holistic approach to enable at scale access to cabotegravir LA for HIV pre-exposure prophylaxis (PrEP) in low- and middle-income countries. However, there are complexities and considerations that need to be managed to support the manufacturing and roll out of a generic long-acting injectable. Compared to oral ARVs, cabotegravir LA for PrEP is more complex to manufacture, there may be capital investment needs, and there is an evolving and less well-defined demand for the product. These are challenges not only for ViiV but also for any potential generic partners. Addressing challenges now, in parallel to setting the stage for licensing and getting potential generic manufacturing partners ready, is essential for success.
To support this, consultation with local community organisations who represent the voice of people who could benefit from PrEP will continue to be prioritised. In addition, ViiV and MPP are engaging with a range of interested partners including funders, procurement agencies, and generic manufacturers with a view to forming a coalition focused on finding a workable and sustainable approach as quickly as possible, with a range of stakeholders playing their different and complementary roles.
These efforts build on a long-standing partnership between ViiV and MPP. ViiV has provided voluntary licences both directly to generic manufacturers and via MPP for oral ARVs. By the end of September 2021, generic dolutegravir-based HIV treatment had been supplied to low- and middle-income countries to treat at least 21.3 million people living with HIV.
Cabotegravir LA for PrEP is a long-acting injectable which has recently gained its first regulatory approval for use in the USA. It is not currently approved for use anywhere outside of the USA. ViiV has submitted marketing applications in a number of countries including in sub-Saharan Africa. ViiV is also supporting implementation science projects that will provide critical information on the feasibility, acceptability, and future adoption of cabotegravir LA for PrEP into national programmes, which would contribute towards setting the stage for any future generic version of the product.
ViiV and MPP are confident that active partnership with all stakeholders playing a role would enable progress of voluntary licensing for cabotegravir LA for PrEP, could lead to positive outcomes for the global HIV community and, most importantly, help avert new HIV infections by supporting at-scale access to this long-acting injectable prevention tool.