FDA Approves Drug to Treat HIV Infection in Newborns

The U.S. Food and Drug Administration (FDA) has approved Tivicay PD tablets for oral suspension (dolutegravir) to treat HIV infection in babies from birth up to four weeks weighing at least 2 kg, in combination with other antiretroviral agents. Tivicay and Tivicay PD were previously approved for adults and children older than four weeks.

Condition

HIV (human immunodeficiency virus) is a virus that attacks the body's immune system, increasing the chances of developing serious infections or cancer and without treatment can lead to AIDS (acquired immunodeficiency syndrome). There is no cure for HIV, but prevention and treatment options are available.

Data Supporting Tivicay PD in Newborns

Data from the IMPAACT 2023 study and pharmacokinetic modeling data supported the application. In this study (NCT05406583), 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 antiretroviral medications to prevent mother-to-child HIV transmission. The newborns were followed for 16 weeks. Results showed the drug levels of Tivicay PD in newborns were similar to those associated with efficacy in adults. The drug’s safety profile in newborns was also similar to that observed in older pediatric and adult patients.

Safety Information

Patients should not receive Tivicay or Tivicay PD if they had previous allergic reactions to the drug, or if they are also receiving dofetilide. Serious allergic reactions have been reported. Patients should be monitored for liver damage. Immune resconstitution syndrome has been reported in patients treated with combination antiretroviral therapy.

Taking Tivicay or Tivicay PD with certain other medications may cause the drug to stop working against HIV or lead to serious side effects. Patients or their caregivers should tell their healthcare provider about all medications they are taking before starting Tivicay or Tivicay PD.

Tivicay tablets and Tivicay PD tablets for oral suspension are not substitutable on a milligram-per-milligram basis.

Designations

Tivicay PD received priority review for this population.