• Agreement allows manufacturers to develop, manufacture and supply generic long-acting injectable cabotegravir (CAB LA) for treatment in 133 countries
  • Builds on the voluntary licence 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, today announced an update to their voluntary licensing agreement with the Medicines Patent Pool (MPP) for cabotegravir to include patents relating to its use in a long-acting HIV treatment regimen. The announcement follows updated guidance from 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 being obtained, 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 MPP to continue to increase access and reach those most impacted by HIV.”

Charles Gore, Executive Director at MPP said: “We’re delighted to extend the CAB LA licence to cover HIV treatment, reflecting the latest WHO recommendations. Our previous agreement with ViiV for dolutegravir 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 addition to 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-centred, 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 at World Health Organisation 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.”

The updated MPP-ViiV agreement is an extension of the voluntary license for cabotegravir for HIV 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.

This news release was published by ViiV Healthcare on July 14, 2025.