FDA approves HIV treatment for newborns - Takeaways - MDSpire

FDA approves HIV treatment for newborns

Study and pharmacokinetic data supported the application.

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The FDA approved dolutegravir (Tivicay PD) for treating HIV in newborns from birth to 4 weeks who weigh at least 2 kg.
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Dolutegravir was previously approved for adults and children older than 4 weeks.
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The approval was supported by data from the IMPAACT 2023 study involving 48 HIV-exposed newborns.
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The safety profile of dolutegravir in newborns was similar to that in older pediatric and adult patients.
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Patients should be monitored for liver damage and inform healthcare providers about all medications before starting dolutegravir.