Safety and pharmacokinetics of dolutegravir in pregnant mothers with HIV infection and their neonates: A randomised trial (DolPHIN-1 study)

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dc.contributor.authorWaitt, Catriona
dc.contributor.authorOrrell, Catherine
dc.contributor.authorWalimbwa, Stephen
dc.contributor.authorSingh, Yashna
dc.contributor.authorKintu, Kenneth
dc.contributor.authorSimmons, Bryony
dc.contributor.authorKaboggoza, Julian
dc.contributor.authorSihlangu, Mary
dc.contributor.authorCoombs, Julie- Anne
dc.contributor.authorMalaba, Thoko
dc.contributor.authorByamugisha, Josaphat
dc.contributor.authorAmara, Alieu
dc.contributor.authorGini, Joshua
dc.contributor.authorElse, Laura
dc.contributor.authorHeiburg, Christie
dc.contributor.authorHodel, Eva Maria
dc.contributor.authorReynolds, Helen
dc.contributor.authorMehta, Ushma
dc.contributor.authorByakika-Kibwika, Pauline
dc.contributor.authorHill, Andrew
dc.contributor.authorMyer, Landon
dc.contributor.authorLamorde, Mohammed
dc.contributor.authorKhoo, Saye
dc.date.accessioned2022-01-14T08:00:26Z
dc.date.available2022-01-14T08:00:26Z
dc.date.issued2019
dc.description.abstractThe global transition to use of dolutegravir (DTG) in WHO-preferred regimens for HIV treatment is limited by lack of knowledge on use in pregnancy. Here we assessed the relationship between drug concentrations (pharmacokinetics, PK), including in breastmilk, and impact on viral suppression when initiated in the third trimester (T3). Methods and findings In DolPHIN-1, HIV-infected treatment-naïve pregnant women (28–36 weeks of gestation, age 26 (19–42), weight 67kg (45–119), all Black African) in Uganda and South Africa were randomised 1:1 to dolutegravir (DTG) or efavirenz (EFV)-containing ART until 2 weeks post-partum (2wPP), between 9th March 2017 and 16th January 2018, with follow-up until six months postpartum. The primary endpoint was pharmacokinetics of DTG in women and breastfed infants; secondary endpoints included maternal and infant safety and viral suppression. Intensive pharmacokinetic sampling of DTG was undertaken at day 14 and 2wPP following administration of a medium-fat breakfast, with additional paired sampling between maternal plasma and cord blood, breastmilk and infant plasma.en_US
dc.identifier.citationWaitt C, Orrell C, Walimbwa S, Singh Y, Kintu K, Simmons B, et al. (2019) Safety and pharmacokinetics of dolutegravir in pregnant mothers with HIV infection and their neonates: A randomised trial (DolPHIN-1 study). PLoS Med 16(9): e1002895. https://doi.org/10.1371/journal. pmed.1002895en_US
dc.identifier.urihttps://doi.org/10.1371/journal. pmed.1002895
dc.identifier.urihttps://nru.uncst.go.ug/xmlui/handle/123456789/1276
dc.language.isoenen_US
dc.publisherPLoS Meden_US
dc.subjectPharmacokineticsen_US
dc.subjectDolutegraviren_US
dc.subjectPregnant mothersen_US
dc.subjectHIV infectionen_US
dc.subjectNeonatesen_US
dc.titleSafety and pharmacokinetics of dolutegravir in pregnant mothers with HIV infection and their neonates: A randomised trial (DolPHIN-1 study)en_US
dc.typeArticleen_US
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