The U.S. FDA has approved Tivicay PD (dolutegravir), an oral medication from ViiV Healthcare for young children living with HIV, to be used in combination with other antiretroviral agents.
The second-generation integrase strand transfer inhibitor (INSTI) has a higher barrier to resistance than previous generations. Available in tablets for oral use and for oral suspension, it is the first of its kind available to pediatric patients. It will be prescribed to infants weighing at least 2 kg (including newborns) with HIV-1 who are treatment naïve or treatment experienced but INSTI naïve.
Tivicay PD had FDA Priority Review for pediatric patients. Its approval is based on data from the IMPAACT 2023 study funded by the NIH and by pharmacokinetic modeling with additional pediatric data showing that therapeutic drug levels of DTG had a safety profile in neonates consistent with that in older pediatric patients and adults.