Evidence · Randomised trial
Safety and pharmacokinetics of dolutegravir in pregnant mothers with HIV infection and their neonates: A randomised trial (DolPHIN-1 study).
- Breast milk and breastfeeding
- Congenital infections
- Infection
- Medical
- Nutrition and gastrointestinal
This paper is from 2019, more than five years ago. Newer evidence may have been published since.
Summary
DolPHIN-1 is a randomised trial in Uganda and South Africa comparing dolutegravir with efavirenz-based antiretroviral therapy started in the third trimester in treatment-naïve pregnant women with HIV. It assessed pharmacokinetics in mothers and their breastfed infants, including placental transfer, breastmilk transfer and infant plasma exposure, alongside maternal and infant safety and viral suppression. Dolutegravir crossed the placenta and entered breastmilk, with persistent infant exposure attributed to slower neonatal clearance. Both regimens were well tolerated, no congenital abnormalities were observed, and dolutegravir achieved faster viral suppression.
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- Licence:
- Open (Creative Commons)
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