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ViiV Healthcare's commitments to accelerate the availability of dolutegravir for the treatment of HIV in children
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As a specialist HIV company, ViiV Healthcare (ViiV) is committed to addressing the ongoing challenges and gaps in treatment options and management of HIV treatment in children and adolescents.
We recognise that peadiatric dolutegravir is a high priority for children living with HIV. We continue to actively engage with global paediatric stakeholders, including Médecins Sans Frontières, to understand the challenges and progress our efforts towards solutions to accelerate development and subsequent access.
Building on our successful track-record, we are focusing efforts on accelerating the development and availability of age-appropriate HIV treatment options, with dolutegravir in particular. Through a series of novel solutions and interventions, we are working with global partners to deliver industry-leading, sustainable solutions that can be successfully implemented across the developing world, where the burden of HIV in infants and children is highest.
ViiV continues to prioritise the research and development and global registration of paediatric formulations of dolutegravir across age and weight bands. We continue to make progress on the programme, working with the IMPAACT and PENTA clinical trial networks and in accordance with the requirements of the regulatory authorities and have committed to more transparency about the submission of regulatory files for paediatric dolutegravir.
Beyond our own formulation development, we have just announced an innovative public-private partnership initiative with Unitaid and CHAI to accelerate development of optimal pediatric formulations of dolutegravir. The initiative provides two generic manufacturers who hold paediatric dolutegravir sub-licences from the Medicines Patent Pool, Mylan and Macleods with a financial incentive award from Unitaid via CHAI, as well as the technical expertise of ViiV Healthcare, to catalyze the development, registration, manufacture and supply of generic formulations of pediatric dolutegravir.
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Innovative public-private partnership initiative to accelerate development of optimal pediatric formulations of dolutegravir to improve the lives of CLHIV
We are delighted to announce the joint launch of a partnership to speed up development and introduction of optimized pediatric formulations of dolutegravir for children living with HIV in resource-limited settings.
The new initiative includes an incentive program and is a key feature of Unitaid's US$34 million Optimal Antiretroviral (ARV) grant to CHAI. The optimal ARV grant aims to bring optimized HIV drugs to market more quickly than in the past and integrate them into treatment programs in communities that need them most. As part of this, CHAI is also working closely with health ministries, community leaders and other partners to support introduction in resource-limited settings.
Accelerating the development of pediatric ARVs and increasing access to HIV testing for children in resource-limited settingsis a strategic investment priority for Unitaid. As part of this program, and with funding from Unitaid, CHAI and ViiV Healthcare will work together to improve the availability of pediatric formulations of dolutegravir. A key aspect of the initiative to-date has been the competitive selection of two generic manufacturers, Mylan Laboratories Limited and Macleods Pharmaceuticals Limited. The initiative provides Mylan and Macleods with a financial incentive award from Unitaid via CHAI, as well as the technical expertise of ViiV Healthcare, to catalyze the development, manufacture and supply of generic formulations of pediatric dolutegravir.
ViiV Healthcare, the company that researched and developed dolutegravir, continues to press ahead with the clinical development and registration of its own pediatric formulations of dolutegravir. ViiV Healthcare is also enabling generic pharmaceutical companies to manufacture and sell generic versions of the medicine in resource-limited settings through existing royalty-free licensing agreements that have been granted both directly and via the Medicines Patent Pool.
This initiative is an important step towards our commitments under the Rome Action Plan agreed in November 2017 at the Vatican, to ramp up access to pediatric HIV treatment with innovative medicines like dolutegravir.
We look forward to sharing updates as the program progresses.
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