The Pediatric infectious disease journal · 2025
The Effects on the Growth of HIV-exposed Uninfected Infants of Initiating Dolutegravir-based Versus Efavirenz-based cART in Late Pregnancy (DolPHIN-2).
СтатьяРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Hagens Lisa, Bevers Lisanne A H, Malaba Thokozile R, Nassiwa Sylvia Cornelia, Mrubata Megan, Theunissen Helene, Reynolds Helen, He Nengjie, Read Jim, Burger David M, Lamorde Mohammed, Myer Landon, Wang Duolao, Khoo Saye, Waitt Catriona, Colbers Angela
Аннотация
BACKGROUND: In 2019, the World Health Organization (WHO) changed its recommendations for pregnant women living with HIV from efavirenz-based to dolutegravir-based therapy due to its superior efficacy, tolerability and resistance profile. Perinatal exposure to antiretrovirals may influence infant growth, but limited data exist on the effects of specific regimens over time.
AIM: This study aimed to compare growth trajectories over the first 72 weeks of life among infants exposed to dolutegravir-based versus efavirenz-based therapy during late pregnancy.
METHODS: The DolPHIN-2 trial was a randomized, open-label trial conducted in South Africa and Uganda, researching the efficacy of dolutegravir-based versus efavirenz-based therapy in pregnant women living with HIV, initiating treatment in the third trimester. In this secondary analysis, we compared growth trajectories until 72 weeks postpartum between HIV-exposed uninfected infants perinatally exposed to dolutegravir-based versus efavirenz-based therapy. Measures of infant weight, length and head circumference were converted to WHO-defined weight-for-age, weight-for-length, length-for-age and head circumference-for-age Z-scores. Subsequently, Z-scores were compared across treatment arms, using linear mixed-effect models.
RESULTS: After exclusions, 232 infants remained (dolutegravir: n = 116; efavirenz: n = 116). In both crude models and models adjusted for study site and maternal height, length-for-age Z-scores were 0.277 units higher in the dolutegravir arm. No statistically significant impact of treatment was observed for other outcomes. In both study arms, a decline in mean length-for-age Z-scores occurred over the first 72 weeks, while mean weight-for-age Z-scores declined between weeks 48 and 72.
CONCLUSION: Our data support the WHO in recommending dolutegravir-based therapy over efavirenz-based therapy in pregnant women living with HIV.
AIM: This study aimed to compare growth trajectories over the first 72 weeks of life among infants exposed to dolutegravir-based versus efavirenz-based therapy during late pregnancy.
METHODS: The DolPHIN-2 trial was a randomized, open-label trial conducted in South Africa and Uganda, researching the efficacy of dolutegravir-based versus efavirenz-based therapy in pregnant women living with HIV, initiating treatment in the third trimester. In this secondary analysis, we compared growth trajectories until 72 weeks postpartum between HIV-exposed uninfected infants perinatally exposed to dolutegravir-based versus efavirenz-based therapy. Measures of infant weight, length and head circumference were converted to WHO-defined weight-for-age, weight-for-length, length-for-age and head circumference-for-age Z-scores. Subsequently, Z-scores were compared across treatment arms, using linear mixed-effect models.
RESULTS: After exclusions, 232 infants remained (dolutegravir: n = 116; efavirenz: n = 116). In both crude models and models adjusted for study site and maternal height, length-for-age Z-scores were 0.277 units higher in the dolutegravir arm. No statistically significant impact of treatment was observed for other outcomes. In both study arms, a decline in mean length-for-age Z-scores occurred over the first 72 weeks, while mean weight-for-age Z-scores declined between weeks 48 and 72.
CONCLUSION: Our data support the WHO in recommending dolutegravir-based therapy over efavirenz-based therapy in pregnant women living with HIV.
Предметные рубрики MeSH
HumansFemalePyridonesPiperazinesOxazinesPregnancyHeterocyclic Compounds, 3-RingHIV InfectionsAlkynesCyclopropanesBenzoxazinesPregnancy Complications, InfectiousUgandaInfantInfant, NewbornAdultSouth AfricaMaleAnti-HIV AgentsInfectious Disease Transmission, VerticalChild DevelopmentHIV Integrase InhibitorsDolutegravir