UNIVERSAL submits data to the FDA to support the dosing of a new drug combination to treat HIV in children 

March 26, 2024

The UNIVERSAL project is proud to announce the submission of a pharmacokinetic modelling and simulation analysis to the US Food and Drug Administration (FDA). This submission aims to support the new dosing of Darunavir/Ritonavir (DRV/r) 120/20mg, combined in one tablet, as the optimal ratio to treat HIV in children across all World Health Organization (WHO) paediatric weight bands. These drugs are already used in combination to treat HIV in both adults and children, but the formulations are not specifically made for children. 

Around 1.5 million children are living with HIV and a large majority of them reside in Africa. These children undergo treatment with a mix of antiretroviral drugs. However, the medicines they are using aren’t exactly child friendly. They tend to be large tablets or bitter syrups that maybe difficult to transport or store because they aren’t always heat stable meaning, they require refrigeration. 

In 2019, the WHO gathered a panel of HIV experts on the Paediatric Antiretroviral Drug Optimisation working group to identify priority products and define research gaps in the development of new HIV drugs and formulations for children in low and middle-income countries. It was deemed as a priority to create a combined tablet of DRV/r for young children due to the growing global need for better HIV treatment options for young children. The submission of the modelling and simulations results to the FDA represents a pivotal step towards the availability of a much-needed combined formulation that ensures the correct dosage and ratio of darunavir and ritonavir for the treatment of advanced HIV in children.  

Marc Lallemant, UNIVERSAL PI, states “The submission of this pharmacokinetic modelling and simulation analysis to the FDA represents not only a major milestone for the UNIVERSAL project. It also brings hope for the millions of children living with HIV in resource-limited settings. By optimising the dosage of Darunavir/Ritonavir in a tablet suitable for children, we are taking a crucial step towards ensuring that young patients receive the precise and effective treatment they deserve. This advance could revolutionise the way we approach paediatric HIV treatment, simplifying dosing regimens and potentially improving adherence and health outcomes for these vulnerable populations 

Penta Child Health Research, the Clinton Health Access Initiative (CHAI), and Laurus Laboratories, Inc. are collaborating to speed up the development and review process for a paediatric fixed-dose combination tablet of DRV/r 120/20mg, aiming to enable quick availability of this life-saving medicine to children living in resource-limited areas. With this data submission, researchers are paving the way for the development of child-friendly, safe, and effective medication that minimises the number of pills children with HIV need to take. Simplifying the dosing regimen may improve treatment adherence and lead to better health outcomes for these children.