Welcome to the of the “Get to know the UNIVERSAL project” series! Here we will introduce you to the various work packages and facets that make up the UNIVERSAL project.
Pharmacokinetic study of new DTC, FTC, TAF dose ratio (Work package 3)
Within the UNIVERSAL project, several tablets will be developed for children living with HIV. These tablets combine different medicines in one pill, to make it easier for children to take all their medicines. One of the products to be developed is a tablet with the combination of the medicines dolutegravir, emtricitabine and tenofovir alafenamide (DTG, FTC, TAF). This WP will focus on verifying if the doses of DTG and FTC/TAF that were selected by means of a computer model are sufficient for safe and effective treatment of children living with HIV in Africa.
1. What does the UNIVERSAL project hope to achieve by assessing the dose ratios of DTG, FTC, TAF?
If we are able to determine how these medicines for children living with HIV behave in the body, we can make sure that taking the medicines together is safe and effective. To study this, we perform a clinical trial in children living with HIV and measure the different medicines in the blood. If we can demonstrate that the selected doses are sufficient by means of this study, a single tablet that contains these different medicines can be developed.
2. What contribution does the assessment of DTG, FTC ,TAF ratios bring to the UNIVERSAL project?
If this trial is successful, the combined product of DTG, FTC, TAF fumarate in a single tablet can be developed. The data of this study can be used to register the combination tablet, to optimize treatment for children down to 3 kg. This will contribute to the project’s aim to address the main treatment gaps in poverty-related diseases, specifically for children living with HIV in Sub-Saharan Africa.
3. What impact could UNIVERSAL will have on children and their families?
UNIVERSAL will develop combination tablets which contain drugs already used in adults. This will address the treatment gaps existing between adults and children living with HIV in Africa. Therefore, UNIVERSAL will contribute to the reduction of mortality in Africa and improve public health, which will increase the quality of life of children and their caretakers.