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News
A new treatment option for the tiniest HIV patients just got the green light. The FDA approved dolutegravir (Tivicay PD) for newborns under 4 weeks old weighing at least 2 kg — making it the first second-generation integrase inhibitor available for this age group. Experts say it's simpler to administer, highly effective, and offers a higher barrier to drug resistance than existing options.
A new treatment option for the tiniest HIV patients just got the green light.
The FDA approved dolutegravir (Tivicay PD, ViiV Healthcare) on August 26 for use in newborns under 4 weeks old weighing at least 2 kg — making it the first second-generation integrase strand transfer inhibitor (INSTI) available for this age group. Previously, dolutegravir was only approved for children 4 weeks and older. The approval is based on the IMPAACT 2023 trial, which enrolled 48 newborns and showed efficacy and safety comparable to that seen in adults. Federal pediatric HIV guidelines had already been updated in June to make two NRTIs plus dolutegravir the preferred regimen for full-term infants under 1 month old.
Clinicians are calling it a meaningful step forward. The drug comes in a dispersible tablet formulation that's easy to prepare and administer, replacing more complex dosing regimens. It also carries a high barrier to resistance — critical for children who will need lifelong treatment.
By the Numbers:
Why it matters: Untreated HIV progresses rapidly in newborns, with devastating outcomes. Having a more potent, easier-to-use option from day one of life could improve viral suppression, reduce disease progression, and preserve future treatment options for children who will need lifelong HIV care.
