Accelerating access to paediatric Dolutegravir for children living with HIV

Accelerating access to paediatric Dolutegravir for children living with HIV

At last, we have what we have been waiting for –  the paediatric Dolutegravir 10 mg dispersible formulation for 1.7 million children living with HIV. It makes treatment easier and cheaper. Therefore, this has the potential to be a game-changer. In this news item, we outline key considerations for community based organisations to support an effective transition.

A unique set of challenges

To improve health and save lives, children living with HIV must have access to timely diagnosis and effective, child-friendly and age-appropriate treatment and care. Children living with HIV are often forgotten and face a unique set of challenges, particularly when HIV medication is hard to swallow or tolerate. Currently, only half of the 1.7 million children living with HIV have access to the lifesaving treatment they need and even fewer are reaching viral suppression.

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Tailored paediatric HIV treatment

WHO has recommended Dolutegravir-based HIV treatment for all children and provided dosing recommendations for children over four weeks of age and more than 3 kg in July 2020. In late 2020, the United States Food and Drug Administration approved one generic version of 10 mg scored dispersible Dolutegravir tablets, further expanding the access of younger children to Dolutegravir, with an additional generic version approved in March 2021. This tailored paediatric HIV treatment will also help meet the urgent needs of these vulnerable children. It comes as a strawberry-flavored tablet that can be dissolved in water, making it easier to give to children too young to swallow tablets.


A pricing agreement

It was developed through a partnership between ViiV Healthcare, generic drug manufacturers, Unitaid and the Clinton Health Access Initiative (CHAI). In 2020, Unitaid and CHAI announced a pricing agreement to make paediatric Dolutegravir available in low- and middle-income countries. Paediatric Dolutegravir will cost $36 per child per year in these countries. But since paediatric Dolutegravir must be taken with other drugs as part of a HIV therapy regimen, the overall cost of treatment under the new pricing agreement will be $120 per child per year (coming down from $480 per child per year).


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Paediatric Dolutegravir paves the way for continued treatment improvement

The introduction and expansion of paediatric Dolutegravir provides clear advantages for children, their caregivers, healthcare providers and the broader health system. Dolutegravir is less likely to cause drug resistance and children are able to suppress their viral load sooner; child-friendly dispersible tablets improve adherence due to a lower pill burden and being easier to administer. Starting on this regimen from infancy reduces the need for changes in treatment for children as they grow older. Fewer regimen changes simplify the daily care for the caregiver, the management of the healthcare provider, and improves stock management. 

A momentous step forward

Approval of paediatric Dolutegravir is a momentous step forward, but meaningless if this new formulation does not quickly reach the children who need it most. There is significant work required at country level to ensure that this becomes available and accessible for all children. Unitaid is partnering with CHAI, PEPFAR, The Global Fund, AfroCAB, EGPAF, WHO and other key stakeholders to ensure that children are able to have widespread access to paediatric Dolutegravir as quickly as possible. National governments, implementing partners, including community based organisations need to work together to find and treat children whose lives can be saved by paediatric Dolutegravir.

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In summary

In summary, the advantages of paediatric Dolutegravir are compelling, and the time for rapid transition is now. That means that we must do all in our power to help accelerate access to paediatric Dolutegravir for all the children who need it. Read more about the practical steps of the rollout of paediatric Dolutegravir in Kenya in the interview with Jacque Wambui.


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