The US Food and Drug Administration approved dolutegravir (Tivicay PD) tablets for oral suspension, in combination with other antiretroviral agents, to treat HIV infection in newborns from birth through 4 weeks of age who weigh at least 2 kg, according to an agency press release. Previously, Tivicay and Tivicay PD were approved for adults and pediatric patients older than 4 weeks.
HIV attacks the immune system, increasing the risk of serious infections or cancer and potentially progressing to AIDS without treatment, noted the US Food and Drug Administration (FDA). HIV has no cure, although preventive and therapeutic options are available.
The application was supported by data from the IMPAACT 2023 study and pharmacokinetic modeling. The study included 48 newborns exposed to HIV-1 who weighed at least 2 kg. Participants received dolutegravir tablets for oral suspension from birth for up to 6 weeks in combination with standard-of-care antiretroviral medications to prevent mother-to-child HIV transmission. Participants were followed for 16 weeks.
Dolutegravir levels in newborns were comparable with those associated with efficacy in adults. The safety profile in newborns was similar to that observed in older pediatric and adult patients.
The agency noted that patients should not receive dolutegravir if they have previously had an allergic reaction to the drug or are receiving dofetilide. Serious allergic reactions have been reported with treatment. Patients receiving dolutegravir should be monitored for liver damage. Immune reconstitution syndrome has also been reported in patients receiving combination antiretroviral therapy.
Taking dolutegravir with certain medications may cause the drug to stop working against HIV or result in serious adverse effects. Patients or caregivers should inform their health care provider about all medications being taken prior to initiating dolutegravir.
The FDA noted that Tivicay tablets and Tivicay PD tablets for oral suspension are not substitutable on a milligram-per-milligram basis.
Dolutegravir tablets for oral suspension received priority review for this population.
Source: US Food and Drug Administration
