GSK reinforces access to a paediatric HIV medicine
GSK expands access to dolutegravir via 15 voluntary licences.
paediatric HIV; dolutegravir
Developing access plans for a new HIV medicine while in clinical development
To establish an equitable pricing strategy for a broader patient reach
In collaboration with ViiV Healthcare (a global HIV specialist company majority-owned by GSK, with Pfizer and Shionogi Limited as shareholders), GSK has a strong access plan for the HIV/AIDS medicine dolutegravir (DTG) for paediatric patients, which recently received market approval. Under the voluntary licensing policy, ViiV Healthcare enables generic manufacturers to manufacture and sell versions of paediatric DTG royalty-free in all least developed, low-income, lower middle-income and sub-Saharan African countries and in some upper middle-income countries.
The paediatric DTG formulation is offered under 15 non-exclusive, royalty-free voluntary licences – one licence directly agreed with a generic medicine manufacturer and the other 14 manufacturers as sub-licensees of the agreement with the Medicines Patent Pool (MPP). As a result, they can develop, manufacture and supply the paediatric formulation to a territory covering regions where 99% of all children with HIV live.
Action on the paediatric formulation
ViiV Healthcare formed a public-private partnership with the
Clinton Health Access Initiative (CHAI) funded by Unitaid. Two generic medicine manufacturers which hold paediatric dolutegravir sub-licences from the MPP, Mylan Laboratories Limited (Mylan) and Macleods Pharmaceuticals Limited (Macleods), have been provided with the technical expertise of ViiV Healthcare and a financial incentive from Unitaid via CHAI to accelerate the development, registration, manufacture and supply. The partnership aims to improve the availability of paediatric DTG formulations in resource-limited settings.
In addition, ViiV Healthcare plans a registration strategy and it plans to submit the 5 mg dispersible tablet for WHO prequalification. ViiV Healthcare is funding a major collaborative research study (ODYSSEY) with the Paediatric European Network for Treatment of AIDS (PENTA) Foundation. This will evaluate the role of DTG-based treatment as a first- and second-line therapy for children and adolescents with HIV.