ViiV Healthcare statement on voluntary license in enabling access to cabotegravir LA for PrEP in low- and middle-income countries

ViiV Healthcare is 100% focused on the needs of people living with and those at risk of acquiring HIV. We seek to make our medicines widely available to those in need – regardless of income or where they live – through innovative access mechanisms and partnerships including voluntary licensing.

We are proud that through our voluntary licences for dolutegravir, both directly with generic manufacturers and via the UN-backed Medicines Patent Pool, we have successfully broadened access to this WHO-recommended 1st and 2nd line treatment, with at least 21.3 million people living with HIV taking a generic dolutegravir-based regimen in low- and middle-income countries by the end of September 2021.¹

We are equally committed to supporting access to cabotegravir LA for HIV Pre-Exposure Prophylaxis (PrEP), for populations with highest unmet needs. We are excited about the potential impact that cabotegravir LA for PrEP can have on the HIV epidemic, especially for women of reproductive age who are disproportionately impacted by HIV in Sub-Saharan Africa. We are clear that this must be achieved in a sustainable way, centred on partnership and integration into existing healthcare services and HIV prevention programmes.

Voluntary licenses have helped enable access for some oral ARVs through partnerships with generic manufacturers. ViiV Healthcare has conducted a rigorous assessment, with inputs from several generic manufacturers and contract manufacturing organisations, to evaluate the feasibility of voluntary licenses to enable broader access to cabotegravir LA for PrEP with the goal of being able to enable lower prices and/or increased capacity. The conclusion was that, for this product, we are currently unable to secure a generic partner as voluntary licenses will not achieve the objectives of enabling access in resource-limited settings, in the short to medium term, due to the complexities of manufacturing, regulatory requirements, capital investment needs and unpredictable demand.

Therefore, we will be the sole supplier of cabotegravir LA for PrEP globally, including in resource-limited settings at least during the initial years of introduction of the medicine. We are continuing to work with the Medicines Patent Pool and other partners and remain open to the potential for voluntary licenses for cabotegravir LA for PrEP in the future.

We will focus on collaborations to enable implementation science projects that will provide critical information on the feasibility, acceptability, and future adoption of cabotegravir LA for PrEP into national programmes, in line with WHO recommendations and the recent summary from the WHO-led Conference on Antiretroviral Drug Optimization (CADO).

We will continue to work with partners and consortia to ensure clinical-need driven access to cabotegravir LA for PrEP is possible outside of voluntary licenses in developing countries and that sufficient supply is available to meet these important goals. We remain open to proposals from external partners to find innovative and sustainable access mechanisms to enable access to cabotegravir LA for PrEP.

References

1. ViiV Healthcare Data on File