Pregnancy and neonatal outcomes after prenatal exposure to dolutegravir: Data from a European cohort collaboration

Objective We aimed to assess ‘real‐world’ pregnancy and neonatal outcomes following prenatal dolutegravir (DTG) use in a European setting. Methods We conducted a pooled analysis of individual‐patient data from seven observational studies. Pregnancies with DTG exposure any time from the periconception period (≤6 completed gestational weeks) were included. Congenital anomalies were assessed using criteria defined by the World Health Organization International Classification of Diseases: Tenth Revision (ICD‐10) and the European Network of population‐based registries for the epidemiological surveillance of congenital anomalies (EUROCAT). Results Of 827 pregnancies, there were 764 live births, 37 miscarriages, 21 terminations and five stillbirths. No congenital anomalies were identified in the five stillborn infants. One termination was due to an identified congenital anomaly. Excluding four infants with chromosomal abnormalities, 34 live‐born infants had 37 anomalies. There were no central nervous system abnormalities. Live birth prevalence of congenital anomalies was 4.4% (95% CI 3.0, 6.1) according to ICD‐10; for infants with earliest DTG exposure in the periconception period, later in the first trimester and in the second/third trimester, prevalence was 4.7% (22/470), 2.6% (1/38) and 4.1% (11/265), respectively. Prevalence according to EUROCAT classification was 3.5% (95% CI 2.3, 5.0) overall. In live‐born singletons with earliest exposure at periconception/first trimester and second/third trimesters, 13.6% (66/485) and 13.7% (32/255) were preterm and 9.7% (46/474) and 6.5% (16/246) were small for gestational age, respectively. Conclusions Our data on prenatal DTG use do not demonstrate increased risk of congenital anomalies compared to expected rates. Ongoing monitoring is needed to exclude association with rare anomalies.