MEDPAGE TODAY reported: The FDA expanded the approval of dolutegravir tablets for oral suspension (Tivicay PD) to include newborns with HIV infections younger than 4 weeks of age, the agency announced on Tuesday.

In combination with other antiretroviral therapies (ARTs), the once-daily treatment is indicated for babies weighing at least 2 kg (~4.4 lbs) who are naive to an integrase strand transfer inhibitor (INSTI).

The approval was supported by the phase I IMPAACT 2023 study and pharmacokinetic modeling data. The open-label trial included 48 newborns who received dolutegravir in addition to standard ART for up to 6 weeks. With 16 weeks of follow-up, data showed that dolutegravir levels among the babies were similar to levels linked to efficacy in adults, along with a safety profile consistent with treatment in older patients.

"For too long, newborns living with HIV have had too few treatment options designed and studied to meet their unique needs, despite the importance of starting treatment as early as possible," said investigator Diana Clarke, PharmD, of Boston University School of Medicine, in a press release from manufacturer ViiV Healthcare.

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