Data from ODYSSEY increases treatment options for older children living with HIV
05 Aug 2020
Results from a sub-study of the ODYSSEY trial, published today in The Lancet HIV journal, show that children over 20kg in weight can safely have adult doses (50mg) of the anti-HIV drug dolutegravir. As over half of children living with HIV globally are over 20kg, this both expands treatment options and simplifies treatment for children.
Dolutegravir (DTG) is an antiviral drug, which has been shown to be effective and safe as part of once-daily treatment for adults with HIV at a daily dose of 50mg. Smaller dose tablets (25mg and 10mg) have been developed for children but are not widely available in Africa. The ODYSSEY trial is a large ongoing global trial evaluating dolutegravir-based treatment in 700 children, mostly from Africa. In this sub-study, we showed that the adult dose (50mg tablet) provides appropriate drug blood levels for children weighing over 20kg and is safe.
These latest results have already had an impact, with the US Food and Drug Administration approving use of the adult tablets for children weighing at least 20kg in June 2020. They also approved the use of smaller dispersible tablets (5mg) for children aged four weeks or older. This latter decision was also based in part upon data from ODYSSEY (which has been presented and is currently being written up in a paper). Baby tablets for the youngest children will hopefully be available soon. The European Medicines Agency are currently also considering authorising this. The World Health Organisation moved quickly and have already incorporated the data from ODYSSEY into their dosing recommendations for children with HIV (in 2019, when results first became available).
These results are good news, as they will make it simpler for health services to give children living with HIV appropriate doses of dolutegravir. Dolutegravir has a number of advantages over other anti-HIV drugs, as it does not require large doses, is given only once daily and can be given to children as a small tablet rather than an unpleasant tasting syrup.
The results published today are from a pharmacokinetic sub-study of the ODYSSEY trial. In this sub-study, several blood samples were taken from children at different times after they had taken their medicines, and the level of dolutegravir in their blood was measured. This allowed researchers to see whether children taking different doses of dolutegravir had enough of the drug to keep their virus under control, and whether those doses were safe. 62 African children from Uganda and Zimbabwe took part in this sub-study.
The ODYSSEY trial is being carried out in hospitals in the UK, Germany, South Africa, Thailand, Uganda, USA, Zimbabwe, Uganda, France, Argentina, Brazil, Portugal, and Spain. It is comparing treatment combinations with dolutegravir to the current standard treatment combinations for children living with HIV. The results from the main ODYSSEY trial are expected in 2021. ODYSSEY is funded by ViiV Healthcare and the sponsor is the Penta Foundation.