High-dose CMV hyperimmune globulin (HIG) and maternal CMV DNAemia independently predict infant outcome in pregnant women with a primary cytomegalovirus (CMV) infection

BACKGROUND: After a primary maternal CMV infection during pregnancy infants are at risk for disease. METHODS: Factors predictive of infant outcome were analyzed in a database of 304 pregnant women with a primary infection. These were enrolled between 2010 and 2017 and delivered 281 infants, of whom 108 were CMV infected. Long term follow-up occurred for 173 uninfected and 106 infected infants at age 4 years (range 1 to 8 years). 157 women were treated with an average of 2 doses (range 1 to 6) of high dose hyperimmune globulin (HIG: 200 mg/kg/infusion). We used a regression model to define predictors of fetal infection, symptoms at birth, and long-term sequelae. 31 covariates were tested. RESULTS: Four factors predicted fetal infection: a 1.8 fold increase (30% vs. 56%) in the rate of congenital infection without HIG (P<0.0001, adjusted odd ratio (AOR) =5.2), a 1.8 fold increase (32% vs. 56%) associated with maternal viral DNAemia prior to HIG administration (P=0.002, AOR=3.0), abnormal ultrasounds (P=0.0002, AOR=54.2), and diagnosis of maternal infection via seroconversion rather than avidity (P=0.007, AOR=3.3). Lack of HIG and abnormal ultrasounds also predicted symptoms (P=0.001). Long term sequelae were predicted by not receiving HIG (P=0.001, AOR=13.2), maternal infection in early gestation (P=0.017, OR = 0.9), and abnormal ultrasounds (P<0.003, OR =7.6). Prevalence and copy/number of DNAemia declined after HIG. CONCLUSIONS: Maternal viremia predicts fetal infection and neonatal outcome. This may help patient counseling. High-dose HIG may prevent fetal infection and disease, and is associated with the resolution of DNAemia.