ViiV Healthcare and Medicines Patent Pool extends voluntary licensing agreement to enable access to long-acting injectable HIV treatment
Agreement allows generic manufacturers to develop, manufacture and supply long-acting injectable cabotegravir for treatment (CAB LA) in 133 countries
It builds on the voluntary license for CAB LA for HIV pre-exposure prophylaxis (PrEP), enabling increased access to innovative long-acting injectables for HIV treatment
ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders, and the Medicines Patent Pool (MPP), today announced an update to their voluntary licensing agreement to include patents relating to its use in a long-acting regimen. The announcement follows updated guidance from the WHO recommending long-acting injectable cabotegravir + rilpivirine as an HIV treatment option.
Existing generic licensees for prevention will be able to develop, manufacture and supply generic CAB LA, for use in combination with long-acting rilpivirine, subject to required regulatory approvals, to help enable access to the long-acting treatment in 133 countries worldwide.
This includes all least-developed, low-income, lower middle-income, and Sub-Saharan African countries, as well as countries where ViiV does not have patent rights for cabotegravir. Deborah Waterhouse, CEO at ViiV Healthcare said: “As leaders in long-acting innovation we’re proud to be expanding our voluntary licence with the MPP to now include treatment of HIV in addition to prevention. Long-acting injectables have the potential to transform HIV treatment and we welcome the latest recommendations from WHO to expand treatment options. In line with our mission to ensure no one living with HIV is left behind, we’re committed to working with partners like the MPP to continue to increase access and reach those most impacted by HIV.”
Charles Gore, Executive Director MPP said: “We’re delighted to extend the CAB LA licence to cover treatment, reflecting the latest WHO recommendations. Our dolutegravir licence with ViiV has already enabled the supply of generic DTG-based HIV treatments in 129 countries and we hope that over time a similar coverage can be achieved for CAB LA. CAB LA is a vital additional tool in the HIV treatment toolbox—especially for people facing adherence challenges with oral regimens. Expanding access to long-acting options like this supports a more person-centered, choice- and needs-driven approach, which is exactly what an equitable and effective HIV response requires.”
Dr Meg Doherty, Director Global HIV, Hepatitis and STI Programmes said: "The World Health Organization welcomes the expansion of the voluntary licence agreement for long-acting cabotegravir to include HIV treatment. This step is closely aligned with WHO’s new recommendation of long-acting injectable antiretrovirals as an alternative for people who are virologically suppressed but face adherence challenges with daily oral regimens. It reflects our commitment to expanding access to innovative, person-centered treatment options that improve outcomes—particularly in underserved regions. This agreement aligns with our global goals to ensure equitable access to essential medicines and improve health outcomes for all. We are committed to supporting countries in implementing these new guidelines and ensuring that no one is left behind.”
Dr Philippe Duneton, Executive Director of Unitaid said: “Expanding access to long-acting injectable cabotegravir for HIV treatment is a major milestone in the global HIV response. This updated licensing agreement is a crucial step toward making innovative treatment options more accessible to people in countries most affected by HIV. Long-acting regimens can be transformative for people who face challenges with taking daily medication, and this progress reflects the power of strong partnerships to drive equitable access and advance our shared goal of ending the HIV epidemic.”
The updated MPP-ViiV agreement is an extension of the voluntary licensing agreement for cabotegravir long-acting (CAB LA) for HIV pre-exposure prophylaxis (PrEP). ViiV Healthcare has been supporting the generic manufacturers with technical know-how to enable development and access to CAB LA as soon as possible.
Through the agreement, the existing licensees, Aurobindo, Cipla and Viatris, will be able to develop, manufacture and supply generic versions of CAB LA, for use in combination with long-acting rilpivirine, for the treatment of HIV-1 infection in adults and adolescents weighing at least 35kg, subject to required regulatory approvals being obtained.
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