Dolutegravir Use During Pregnancy

Basic Details
Date Posted
Thursday, March 28, 2019
Medical Product
Health Outcome(s)
exposure in pregnancy

This request estimated use of dolutegravir among women of reproductive age and those with a prior human immunodeficiency virus (HIV) diagnosis in the Sentinel Distributed Database (SDD). This request also examined dolutegravir use during pregnancy among women with live-birth deliveries in the SDD.

Data from August 1, 2013 to March 31, 2018 from 16 Data Partners contributing to the SDD were included in the report. This request was distributed to Data Partners on August 21, 2018.

Additional Details
FDA Center
Time Period
August 13, 2013 - March 31, 2018
Study Type
Modular Program
Assessment Type
Exploratory Analyses
Population / Cohort
Pregnant women and women of reproductive age
Data Sources
Sentinel Distributed Database (SDD)