Ten years after the signing of ground-breaking licensing agreements between ViiV Healthcare and the Medicines Patent Pool (MPP), as well as ViiV’s direct agreements with Aurobindo Pharma, more than 1 billion packs of generic dolutegravir (DTG) based medicines have reached 24 million people living with HIV in 128 low- and middle-income countries (LMICs), transforming the HIV landscape in those areas of the world.
This means that, as of 2023, over 90% of people on antiretroviral treatment in these countries are estimated to be on DTG-based regimens.
Thanks to this decade-long partnership, WHO-recommended treatment can be developed, produced, and when approved, supplied by 15 generic manufacturers to all low-income, least developed, lower-middle-income and sub-Saharan African countries, as well as some upper middle-income countries, addressing the needs of regions with the highest HIV burdens.
Charles Gore, Executive Director, Medicines Patent Pool, said: “As we reflect on a decade of collaboration with ViiV Healthcare, we are proud to see that public health-oriented voluntary licensing has had tangible impact in the lives of the people we serve, enabling access to affordable versions of innovative HIV treatments in LMICs. We commend ViiV Healthcare for their huge commitment, allowing our partnership to demonstrate that voluntary licensing can serve as a sustainable strategy to enhance affordable production and distribution for more equitable access to essential medicines in underserved territories.”
Deborah Waterhouse, CEO, ViiV Healthcare, said: “The scale and impact of our 10-year collaboration with the Medicines Patent Pool and with Aurobindo Pharma are testament to the power of partnership in advancing global health. We are proud to have played a pivotal role in enabling 24 million people living with HIV access affordable dolutegravir-based treatments, and we look forward to our continued collaboration with MPP and generic partners as we broaden the focus to include innovative preventative HIV medicines.”
Philippe Duneton, Executive Director, Unitaid, said: “When Unitaid established the Medicines Patent Pool in 2010, many doubted whether voluntary licensing was possible. Yet, originator companies came to the negotiating table, proving that this partnership model works. Thanks to MPP and ViiV Healthcare’s licensing agreements, millions of people with HIV in LMICs now have access to affordable treatments that come at a much lower cost. Unitaid is proud to support this decade-long partnership, and we look forward to expanding our efforts to make innovative health solutions accessible to all.”
Nombeko Mpongo, Community Liaison Administrator at the Desmond Tutu HIV Centre in South Africa, said: “What this partnership has done to help expand access to innovative HIV medicines has profoundly impacted my life and the lives of countless others in South Africa. The widespread availability of TLD (tenofovir, lamivudine, dolutegravir – TDF/3TC/DTG) underscores the remarkable progress we’ve made in HIV treatment accessibility and affordability.”
Partnership accelerates access to innovative HIV medicines for paediatrics
As well as enabling widespread access to TLD (a WHO-preferred treatment for adults and adolescents), this 10-year partnership played a foundational role in the development and availability of age-appropriate DTG-based treatment options for children and infants, addressing a key gap as children are disproportionately affected by HIV – with paediatric treatment coverage still lagging behind adults. As a result of MPP and ViiV’s licensing agreement, as well as a novel public-private partnership between ViiV, the Clinton Health Access Initiative (CHAI) and Unitaid providing technology transfer and regulatory support, generic dispersible tablet formulations of DTG have now been supplied to 95 LMICs for children weighing at least 3kg.
Most recently, in 2023, three generic dispersible formulations of paediatric ALD (abacavir, lamivudine, dolutegravir – ABC/3TC/DTG) received approval for infants from three months of age and weighing at least 6kg. This was further to an additional partnership programme which ViiV and CHAI drove with generic partners, in parallel with ViiV’s own paediatric development programme for ABC/3TC/DTG (the first dispersible single-tablet regimen containing dolutegravir). Introduction of this newer combination in LMICs will further support delivery of HIV medication to young children and address unmet needs by offering a reduced pill burden.
Arvind Kanda, Head of ARV/API South Africa and Sub-Saharan Africa at Viatris, said: “We are proud of our partnership with the Medicines Patent Pool and ViiV Healthcare, a collaboration that has enabled us to make a significant impact in the fight against HIV. Our journey began with pioneering the TLD regimen for adults with HIV, where we were the first MPP licensee to receive tentative USFDA approval under the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR). But our commitment doesn’t end there.
“We are equally dedicated to advancing access to the most innovative HIV treatments for children. Through our partnerships to accelerate development and production of paediatric formulations we are addressing the unique needs of children living with HIV. We remain unwavering in our mission: empowering people worldwide to live healthier at every stage of life.”
Sister Tresa Palakudy, Manager, Nyumbani Children’s Home, Kenya, said: “Caring for children living with HIV at Nyumbani, I’m truly grateful that Kenya has had access to paediatric dolutegravir since 2021 through this transformational partnership. I want to offer my heartfelt thanks to ViiV Healthcare, the Medicines Patent Pool, Unitaid, and all the international health partners for making this innovation accessible to our children living with HIV in LMICs.”
Partnership continues with new voluntary licence to include first-of-its-kind preventative medicine
Looking ahead, ViiV Healthcare and MPP are building on this decade-long partnership through furthering access to innovative HIV prevention. The signing of a new licence agreement in 2022 marked a significant step forward in driving access to cabotegravir long-acting for PrEP, and ViiV is supporting all generic sublicensees with technical support and know-how to expedite product development and enable access to this novel prevention tool for people in LMICs.
