COMPARISON OF HYPERIMMUNE GLOBULIN THERAPY EVERY TWO WEEKS VERSUS EVERY FOUR WEEKS FOR PREGNANT WOMEN WITH PRIMARY CYTOMEGALOVIRUS INFECTION
2Department of Laboratory Medicine, Medical University of Vienna, Vienna
3Department of Pediatrics and Adolescent Medicine, Division of Neonatology, Pediatric Intensive Care and Neuropediatrics, Comprehensive Center for Pediatrics, Medical University of Vienna, Vienna
4Department of Radiology, Division of Neuroradiology and Musculoskeletal Radiology, Medical University of Vienna, Vienna
5Fetal Medicine Unit, St George's University Hospitals NHS Foundation Trust, University of London, London
Problem statement: Cytomegalovirus (CMV) primary infection during pregnancy is linked to an considerable risk for congenital CMV (cCMV) infection, with potentially perinatal as well as long-term morbidity of the newborn. Two randomized controlled trials failed to show a reduction of maternal-fetal transmission with four-weekly hyperimmune globulin (HIG) therapy during pregnancy. Recently published data proposes a benefit of HIG administration every two weeks. Data on directly comparing HIG administration every 2 weeks to HIG administration every 4 weeks in pregnant women with primary CMV infection is lacking.
The aim of this study was the comparison between the two regimens for maternal-fetal transmission rates.
Methods: This retrospective study included pregnant women with primary CMV infection diagnosed in the first or early second trimester at the Department of Obstetrics and feto-maternal Medicine at the Medical University of Vienna between 2010 and 2022. Pregnant individuals were treated with either 300IE HIG/kg every 4 weeks or with 200IE HIG/kg every 2 weeks depending on local protocol. The primary outcome was maternal-fetal CMV transmission rate evaluated by urine CMV PCR of the newborn. Evaluation of adverse pregnancy outcomes, as well as neonatal outcome up to two years of age were undertaken.
Results: Overall, 36 women (4 weeks: n=26; 2 weeks: n=10) and 39 newborns (4 weeks: n=29; 2 weeks: n=10) with a median gestational age at first HIG administration of 13.1 weeks were included. There was no difference in cCMV between the HIG every 4 weeks group and the HIG every 2 weeks group (33.3% vs. 30.0%; p=0.850). Abnormalities in fetal ultrasound was present in three fetuses and fetal MRI anomalies in four fetuses related to cCMV infection with no significant difference between the two groups. Newborn intensive care unit admission (4 weeks: 21.1% vs. 2 weeks: 0.0%; p=0.118) and preterm delivery (4 weeks: 26.3% vs. 2 weeks: 0.0%; p=0.075) were tendentially more frequent in the HIG every four weeks group.
Conclusions: HIG administration every 2 instead of every 4 weeks does not improve maternal-fetal transmission rates. Alternative therapies for the prevention of maternal-fetal transmission rate after cCMV infection such as Valaciclovir therapy, are considerable.
