Bollen PDJ, Moore CL, Mujuru HA, et al. - Until recently, 25 mg and 10 mg film-coated tablets are required for pediatric dolutegravir doses approved by stringent regulatory authorities (SRAs) for children weighing 20 kg to less than 40 kg. Low-resource settings, where the burden of HIV is highest, have no easy availability of these tablets. In patients enrolled in the ODYSSEY-trial, they performed nested pharmacokinetic substudies to examine simplified dosing in children with HIV. In four research centers in Uganda and Zimbabwe, eligible children with HIV were randomized to dolutegravir in ODYSSEY and weighed 20 kg to less than 40 kg children. In children weighing 20 kg to less than 25 kg, pharmacokinetics of dolutegravir was determined in children given once daily 25 mg film-coated tablets (approved by the SRAs at the time of the study) in part one of the study, and 50 mg film-coated tablets (adult dose) or 30 mg dispersible tablets in part two of the study. In children weighing 25 kg to less than 40 kg, they further examined the pharmacokinetics of dolutegravir within-subject on film-coated tablet doses of 25 mg or 35 mg once daily, which SRAs approved for the children's weight band; then switching was done to 50 mg film-coated tablets once daily. Per outcomes, adult dolutegravir 50 mg film-coated tablets provided once daily yielded suitable pharmacokinetic profiles in these children, with no safety signal, allowing simplified practical dosing and rapid access to dolutegravir. Results thereby are informative to the WHO 2019 dolutegravir pediatric dosing guidelines and have resulted in US Food and Drug Administration approval of adult dosing down to 20 kg.