Congenital anomalies following antenatal exposure to dolutegravir: a Canadian surveillance study.

Autor: Money D; Women's Hospital and Health Centre of British Columbia, University of British Columbia, Vancouver, BC, Canada., Lee T; CIHR Canadian HIV Trials Network, Vancouver, BC, Canada., O'Brien C; BC Children's Hospital, University of British Columbia, Vancouver, BC, Canada., Brophy J; Children's Hospital of Eastern Ontario, University of Ottawa, Ottawa, ON, Canada., Bitnun A; Hospital for Sick Children, University of Toronto, Toronto, ON, Canada., Kakkar F; CHU Ste-Justine, Université de Montréal, Montréal, QC, Canada., Boucoiran I; Stollery Children's Hospital, University of Alberta, Edmonton, AB, Canada., Alimenti A; Women's Hospital and Health Centre of British Columbia, University of British Columbia, Vancouver, BC, Canada., Vaudry W; Stollery Children's Hospital, University of Alberta, Edmonton, AB, Canada., Singer J; CIHR Canadian HIV Trials Network, Vancouver, BC, Canada., Sauve LJ; Women's Hospital and Health Centre of British Columbia, University of British Columbia, Vancouver, BC, Canada.; BC Children's Hospital, University of British Columbia, Vancouver, BC, Canada.
Jazyk: angličtina
Zdroj: BJOG : an international journal of obstetrics and gynaecology [BJOG] 2019 Oct; Vol. 126 (11), pp. 1338-1345. Date of Electronic Publication: 2019 Jul 03.
DOI: 10.1111/1471-0528.15838
Abstrakt: Objective: Dolutegravir is recommended worldwide as a first-line antiretroviral therapy (ART) for individuals living with HIV. A recent study reported increased rates of neural tube defects in infants of dolutegravir-treated women. This study examined rates of congenital anomalies in infants born to women living with HIV (WLWH) in Canada.
Design: The Canadian Perinatal HIV Surveillance Programme captures surveillance data on pregnant WLWH and their babies and was analysed to examine the incidence of congenital anomalies.
Setting: Paediatric HIV clinics.
Population: Live-born infants born in Canada to WLWH between 2007 and 2017.
Methods: Data on mother-infant pairs, including maternal ART use at conception and during pregnancy, are collected by participating sites.
Main Outcome Measures: Congenital anomalies.
Results: Of the 2423 WLWH, 85 (3.5%, 95% CI 2.85-4.36%) had non-chromosomal congenital anomalies. There was no evidence of a significant difference in rates of congenital anomalies between women who were on ART in their first trimester (3.9%, CI 1.7-7.6%) or later in the pregnancy (3.9%, 95% CI 2.6-5.6%). Four of the 80 (5.0%, 95% CI 1.4-12.3%) neonates born to WLWH on dolutegravir during the first trimester had congenital anomalies, none were neural tube defects (95% CI 0.00-3.10%).
Conclusion: Despite recent evidence raising a safety concern, this analysis found no signal for increased congenital anomalies.
Tweetable Abstract: Five percent of the infants of Canadian women living with HIV on dolutegravir at conception had congenital anomalies; none had neural tube defects.
(© 2019 Royal College of Obstetricians and Gynaecologists.)
Databáze: MEDLINE