23 Mar, 2022
The results of an ODYSSEY pharmacokinetic sub-study investigating dolutegravir (DTG) based antiretroviral (ARV) treatments for children weighing 3 to less than 20kg have recently been published in The Lancet HIV as an Open Access article.
DTG has been available for treating HIV in adults globally for many years with paediatric formulations only developed in recent years. Very little pharmacokinetic data were available in young children when the ODYSSEY trial was opened to young children. With this in mind, the team nested a sub-study to evaluate pharmacokinetics and safety and confirm the optimal dosing in children weighing 3 to less than 20kg.
72 children between the ages of 3 months and 11 years were enrolled into the sub-study. Children weighing 3 kg to less than 14 kg received 5 mg dispersible tablets of dolutegravir according to WHO weight bands and children weighing 14 kg to less than 20 kg received a 25 mg film-coated tablet once per day early in the trial or 25 mg dispersible tablets (five 5 mg tablets once per day) later in the trial.
Based on the findings of the study, children given dolutegravir dispersible tablets had appropriate dolutegravir exposures, whereas children weighing 14 kg to less than 20 kg given 25mg DTG in film-coated tablets had suboptimal drug levels. Overall, DTG was well tolerated, and the study identified no new safety issues in children. These results showed that dolutegravir dispersible tablets dosed in WHO weight bands is a suitable treatment option for children 3 to less than 20kg, making it possible for children of 4 weeks and older to receive dolutegravir treatment. The dispersible tablets are easily stored and transported and the dosing can be adapted to meet the needs of a growing child.
The data from this study have contributed to the recent decisions to license 5mg DTG dispersible tablets for use in children from 4 weeks of age weighing at least 3kg to less than 20kg by the US FDA and the EMA and informed current WHO antiretroviral guidelines which adopted FDA dosing. The sub-study has laid an important stepping stone towards alignment of treatment for children with adult recommendations.
Read the full article here