Pregnancy and Neonatal Outcomes following Prenatal Exposure to Dolutegravir: Data from the European Pregnancy and Paediatric HIV Cohort Collaboration (EPPICC) (206254)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  Descriptive analysis
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Retrospective analysis

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  DOLUTEGRAVIR

  ABACAVIR

  LAMIVUDINE
• Medical condition to be studied:
  Human immunodeficiency virus transmission

Population studied

• Short description of the study population:
  Pregnant women living with HIV with any exposure to dolutegravir (TIVICAY® & TRIUMEQ®) at any time during the pregnancy and their infants identified from the EPPICC cohort (European Pregnancy and Paediatric HIV Cohort Collaboration) by the end of August 2016.
• Age groups:
  Preterm newborn infants (0 – 27 days)

  Term newborn infants (0 – 27 days)

  Infants and toddlers (28 days – 23 months)

  Children (2 to < 12 years)

  Adolescents (12 to < 18 years)

  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Immunocompromised

  Other

  Pregnant women
• Special population of interest, other:
  Patients with HIV transmission
• Estimated number of subjects:
  65

Study design details

• Main study objective:
  To describe patterns of prenatal use of DTG-containing regimens, maternal characteristics of women taking DTG-based regimens, frequency of adverse pregnancy outcomes in women using DTG in pregnancy, the proportion of women on DTG who achieve viral suppression by the end of pregnancy, and mother-to-child transmission (MTCT) rates in mother-infant pairs with prenatal DTG use.
• Outcomes:
  Pregnancy outcomes (live births, still births, induced abortion, spontaneous abortion, birth defects, low birth weight, very low birth weight and preterm births), maternal viral suppression at end of pregnancy, and infant’s HIV infection status
• Data analysis plan:
  Descriptive statistics will be used to summarize demographic/clinical characteristics and outcomes of interest