ViiV HEALTHCARE’S COMMITMENTS TO ACCELERATE THE AVAILABILITY OF DOLUTEGRAVIR FOR THE TREATMENT OF HIV IN CHILDREN

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 paediatric 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 paediatric 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 catalyse the development, registration, manufacture and supply of generic formulations of paediatric dolutegravir.