Adult dolutegravir could offer a practical and accessible treatment for children living with HIV
Adult doses of an antiviral drug could offer a practical and accessible option for children weighing 20-25kg living with HIV. The results of the pharmacokinetic sub-study (measuring levels of drug in the blood to check if doses are correct), part of the ODYSSEY trial, were presented today at the Conference on Retroviruses and Opportunistic Infections, in Seattle, Washington.
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 have been developed for children (e.g. 25mg) 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 a previous pharmacokinetic sub-study, we showed that the adult dose (50mg) provides appropriate drug blood levels for children weighing over 25kg; this practical dosing has been included in the World Health Organization (WHO) dosing guidelines.
The current presentation focuses on children in the 20-25kg weight bracket, around one in four of all children living with HIV worldwide. This sub-study compared the standard 25mg film-coated tablet with a higher-dose film-coated tablet (50mg), and 30mg of dispersible tablets (which provide the same levels of drug in the blood as the 50mg film-coated tablet).
The study showed that the 50mg film-coated and 30mg of dispersible tablets gave very similar and appropriate drug levels of dolutegravir in the blood and were better than the 25mg film-coated tablet. The short-term safety data in the sub-study was also reassuring.
The sub-study concluded that either the 50mg film-coated tablet or 30mg (six 5-milligram) dispersible tablets should be used in children weighing 20-25kg. This conclusion has already been incorporated into the updated tables of antiretroviral drugs produced by WHO, and means that treatment for children heavier than 20kg can be the same as for adults.
A very thin layer of a safe ingredient placed around the tablet. The film can hide the flavour of an unpleasantly flavoured drug, and protect the drug from exposure to the environment.
The tablet can be dissolved in water or other liquid before consumption.