Welcome to 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.
Assessing the long-term safety of ART drugs (Work package 5)
Prompt treatment of children living with HIV with antiretroviral therapy (ART) saves lives and improves health. However there is often a delay in children being given new ART drugs, and we don’t know if these drugs are safe and effective to take over a number of years. Two large paediatric randomised controlled trials are investigating which new and existing drugs are the most effective for children, and they measure outcomes up to around 2 years after the children start taking these drugs. In UNIVERSAL WP5, the follow-up period for these trials has been extended so we can measure safety and effectiveness over a longer period of time.
1. What does the UNIVERSAL project hope to achieve by assessing the long-term safety of ART drugs?
We hope the results from the extended follow-up will show that the drugs are safe and effective for children to take for a number of years.
2. What contribution does the assessment of long-term safety of ART drugs bring to the UNIVERSAL project?
Long-term safety assessment involves looking at the safety and effectiveness of drugs which are already in use. This provides important evidence on the long term safety and effectiveness of new and existing drugs. It will also provide important data for the other work packages for their work on finding the best dose for some drugs for younger children for the first time. As a whole this work package has a similar contribution as the other work packages as they all help fill gaps in evidence, and results will be useful to policy makers to ensure that children get the best drugs.
3. What impact could UNIVERSAL will have on children and their families?
The whole motivation behind UNIVERSAL is to make sure that children living with HIV, and in particular younger children, have access to the best available treatment. We hope that as a result of UNIVERSAL, children will have more treatment options, which are easier to take, and which are safe and effective. Our goal is that this in turn will improve children’s health and their families’ lives.