14 July 2025
KIGALI, RWANDA – 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 for cabotegravir 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 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 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 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-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, World Health Organization, 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 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.
Jerop Limo, HIV Advocate: “Nobody talks about how frustrating it is to navigate a complicated health system and return home with bottle of pills to hide away, or how hard it is to take those pills every day at the same time without slipping up. Hiding your treatment from classmates or friends because you don’t want to disclose takes a toll. A long-acting injectable ARV isn’t just convenient; it’s a weight lifted off our shoulders. It gives us space to be young, study, and live without hiding or lying. I am excited that what has been a dream for young people living with HIV for so long will soon be reality here in Kenya.”
Nombeko Mpongo, Desmond Tutu Health Foundation South Africa: “Working with young people every day, I see how real the challenges of adherence are—and how urgently we need more options. Long-acting treatment isn’t just a scientific advance, it’s a step toward dignity, privacy, and choice. I hope to see this new WHO recommendation reflected in South Africa’s guidelines soon—and that affordable, generic versions will follow quickly. We cannot let cost be the barrier to freedom and better health.”
Kenly Sikwese, Executive Director, Afrocab Treatment Access Partnership: “Afrocab welcomes the introduction of long-acting CAB + RPV as a significant advancement in HIV treatment. This innovation has the potential to improve adherence, particularly among young people living with HIV who face challenges with daily oral therapy. We urge rapid and equitable scale-up, accompanied by strong pharmacovigilance for RPV, given its resistance profile. We commend the MPP, WHO, and partners for enabling access to long-acting HIV treatment in LMICs.”
Mr. K. Nithyananda Reddy, Vice Chairman & Managing Director, Aurobindo: “We are privileged to be part of the sub-license expansion from MPP and ViiV to develop, manufacture, and distribute generic CAB-LA in select markets for the treatment of HIV-1, in addition to the voluntary licence for PrEP. This is a significant and timely step towards increasing access to advanced long-acting treatment in low- and middle-income countries (LMICs). Aurobindo remains committed to leveraging its global supply capabilities to make this vital combination long-acting injection therapy widely available and affordable. The consideration by ViiV and MPP to include the private market in royalty-bearing countries is a critical step toward expanding access across both public and private sectors.”.
Paul Miller, CEO of Cipla Africa: “At Cipla, we are committed to expanding access to innovative HIV treatments that can transform patient outcomes, particularly in low- and middle-income countries. We welcome the inclusion of long-acting CAB + RPV in the WHO guidelines for HIV treatment, and we are encouraged by ViiV’s expansion of the existing CAB licence to cover treatment. This aligns with our enduring purpose of ‘Caring for Life.’ ”
Arvind Kanda, Head of India and Access Markets (ARV, India, South Africa and Sub-Saharan Africa), Viatris: “With strong expertise in antiretroviral development, manufacturing and distribution, Viatris is looking forward to helping to improve access to this important treatment. Once the updated license takes effect, we will be able to make the treatment widely available in high disease-burden countries where patients need it most.”
Access the licence agreement
The press release is also available in French.
See press release from 2022 – ViiV Healthcare and the Medicines Patent Pool sign new voluntary licensing agreement to expand access to innovative long-acting HIV prevention medicine
Notes to Editors
About ViiV Healthcare
ViiV Healthcare is a global specialist HIV company established in November 2009 by GSK (LSE: GSK) and Pfizer (NYSE: PFE) dedicated to delivering advances in treatment and care for people living with HIV and for people who could benefit from HIV prevention. Shionogi became a ViiV shareholder in October 2012. The company’s aims are to take a deeper and broader interest in HIV and AIDS than any company has done before and take a new approach to deliver effective and innovative medicines for HIV treatment and prevention, as well as support communities affected by HIV.
For more information on the company, its management, portfolio, pipeline, and commitment, please visit viivhealthcare.com.
About GSK
GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at gsk.com/company
About Vocabria (cabotegravir)Vocabria injection is indicated – in combination with rilpivirine injection – for the treatment of Human Immunodeficiency Virus type 1 (HIV-1) infection in adults and adolescents (at least 12 years of age and weighing at least 35kg) who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior virological failure with agents of the non-nucleoside reverse transcriptase inhibitors (NNRTI) and integrase inhibitor (INI) class.Vocabria tablets are indicated – in combination with rilpivirine tablets – for the short-term treatment of HIV-1 infection in adults and adolescents (at least 12 years of age and weighing at least 35kg) who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior virological failure with agents of the NNRTI and INI class for:
Vocabria tablets are only indicated for treatment of HIV-1 in combination with rilpivirine tablets, therefore, the prescribing information for Edurant (rilpivirine) tablets should also be consulted for recommended dosing.
Please consult the full Summary of Product Characteristics for all the safety information: Vocabria 400mg/600 mg prolonged-release suspension for injection and Vocabria 30 mg film-coated tablets
Medicines Patent Pool enquiries:
Gelise McCullough +41 79 685 64 36 (Geneva)
Shihan Liu +41 79 237 87 66 (Geneva)
press@medicinespatentpool.org
Melinda Stubbee
Press and Media
The Medicines Patent Pool (MPP) is a United Nations-backed public health organisation working to increase access to and facilitate the development of life-saving medicines for low- and middle-income countries. Through its innovative business model, MPP partners with civil society, governments, international organisations, industry, patient groups, and other stakeholders to prioritise and license needed medicines and pool intellectual property to encourage generic manufacture and the development of new formulations.
To date, MPP has signed agreements with 22 patent holders for 13 HIV antiretrovirals, one HIV technology platform, three hepatitis C direct-acting antivirals, a tuberculosis treatment, a cancer treatment, four long-acting technologies, a post-partum haemorrhage medicine, three oral antiviral treatments for COVID-19 and 16 COVID-19 technologies.
MPP was founded by Unitaid, which continues to be MPP’s main funder. MPP’s work on access to essential medicines is also funded by the Swiss Agency for Development and Cooperation (SDC), Government of Canada, the World Intellectual Property Organization (WIPO) and the Government of Flanders. MPP’s activities in COVID-19 are undertaken with the financial support of the Japanese Government, the French Ministry for Europe and Foreign Affairs, the German Agency for International Cooperation, and SDC.