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Dolutegravir Use During Pregnancy

    Basic Details
    Date Posted
    Status
    Complete
    Medical Product
    dolutegravir
    Health Outcome(s)
    exposure in pregnancy
    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.

    Additional Details
    FDA Center
    CDER
    Time Period
    August 13, 2013 - March 31, 2018
    Analysis Type
    Descriptive
    Population / Cohort
    Pregnant women and women of reproductive age
    Data Sources
    Sentinel Distributed Database (SDD)