Valganciclovir Use in Children with Congenital Cytomegalovirus Disease (cCMV) or Cytomegalovirus (CMV) Infection: A Descriptive Analysis

    Basic Details
    Date Posted
    Friday, March 25, 2022
    Status
    Complete
    Medical Product
    valganciclovir
    Health Outcome(s)
    congenital cmv
    Description

    This analysis includes two reports:

    • Report 1: We examined the trends in diagnosis of congenital cytomegalovirus disease (cCMV) or cytomegalovirus infection (CMV). We also assessed clinical characteristics, laboratory tests performed for CMV diagnosis, hearing loss and hematologic outcomes among infants with CMV and those who used valganciclovir/ganciclovir treatment.
    • Report 2: We assessed follow-up time and distribution of valganciclovir or ganciclovir treatment in infants with cCMV. We also assessed clinical characteristics, laboratory tests performed for CMV diagnosis, hearing loss and hematologic outcomes among infants with CMV who used valganciclovir/ganciclovir treatment. 

    The study period includes data from January 1, 2008 through May 31, 2021. We distributed this request to 12 Sentinel Data Partners on December 9, 2021.

    Additional Details
    FDA Center
    CDER
    Time Period
    January 1, 2008 - May 31, 2021
    Study Type
    Modular Program
    Assessment Type
    Exploratory Analyses
    Population / Cohort
    Individuals 5 years of age and younger
    Data Sources
    Sentinel Distributed Database (SDD)