FDA Expands Label of Oral HIV Drug to Newborns

The U.S. Food and Drug Administration (FDA) has recently expanded the usage of oral HIV drug dolutegravir tablets for newborns under four weeks old. This extension permits the once-daily medication, when used alongside other antiretroviral therapies (ARTs), for infants weighing at least 2 kg (~4.4 lbs) who have not been previously treated with an integrase strand transfer inhibitor (INSTI).

The FDA's approval of the expanded label for dolutegravir was based on data from the phase I IMPAACT 2023 study and pharmacokinetic modeling. The trial involved 48 newborns who were given dolutegravir alongside standard ART for up to six weeks. At 16 weeks post-treatment, researchers discovered that dolutegravir levels in the infants were comparable to those found in adults, and the drug's safety profile was consistent with its use in older patients.

Diana Clarke, PharmD, a researcher from Boston University School of Medicine, highlighted the significance of this approval, stating that too many newborns living with HIV have had limited treatment options tailored to their unique requirements. Early treatment with highly effective therapies significantly improves outcomes, Clarke emphasized.

First approved in 2013 for adults and children aged 12 and above, dolutegravir has since received an indication for children as young as four weeks old. The World Health Organization recommends the second-generation INSTI as part of first- or second-line ART regimens for children with HIV. It's important to note that the adult oral suspension tablets and the pediatric oral suspension tablets for newborns are not bioequivalent and cannot be interchanged based on milligram-to-milligram dosage.

The most frequently reported moderate to severe adverse events in adult study participants included insomnia, fatigue, and headache. The FDA's drug labeling includes contraindications such as coadministration with dofetilide and prior allergic reactions to dolutegravir, as well as hypersensitivity reactions like rash and liver injury. Some patients on combination ART regimens have experienced immune reconstitution syndrome.