The FDA has approved dolutegravir (Tivicay PD; ViiV Healthcare) tablets for oral suspension for the treatment of HIV infection in newborns from birth to younger than four weeks – who weigh at least 2 kg – when used in combination with other antiretroviral agents.
Previously, Tivicay and Tivicay PD were approved for adults and paediatric patients aged four weeks and older.
The expanded indication moves dolutegravir treatment into the first weeks of life, a period in which age-appropriate antiretroviral options have historically been limited
Data from the IMPAACT 2023 study and pharmacokinetic modelling data supported the application.
In this study, 48 newborns exposed to HIV 1 and weighing at least 2 kg received Tivicay PD from birth for up to six weeks, in combination with standard-of-care ARV medications to prevent mother-to-child HIV transmission. The newborns were followed for 16 weeks. Results showed the drug levels of Tivicay PD in the infants were similar to those associated with efficacy in adults.
The drug’s safety profile in the newborns was also similar to that observed in older paediatric and adult patients.
See more from MedicalBrief archives:
FDA paediatric version of dolutegravir to treat children
Dolutegravir for younger children: results from the ODYSSEY trial