Dolutegravir Use During Pregnancy

Project Title Dolutegravir Use During Pregnancy
Date Posted
Thursday, March 28, 2019
Project ID
cder_mpl1r_wp103
Status
Complete
Deliverables
Related Links
Description

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.

Medical Product
dolutegravir
Health Outcome
exposure in pregnancy
Population / Cohort
Pregnant women and women of reproductive age
Time Period
August 13, 2013 - March 31, 2018
Assessment Type
Exploratory Analyses
Study Type
Modular Program
Data Sources
Sentinel Distributed Database (SDD)
FDA Center
CDER