A multi-site observational study to assess safety and effectiveness of prenatal exposure to Dolutegravir in pregnant individuals living with HIV (212976)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  Retrospective chart review

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Retrospective chart review

Study drug and medical condition

• Medicinal product name:
  TIVICAY
• Study drug International non-proprietary name (INN) or common name:
  DOLUTEGRAVIR
• Anatomical Therapeutic Chemical (ATC) code:
  (J05AX12) dolutegravir

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

Population studied

• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Special population of interest:
  Pregnant women
• Estimated number of subjects:
  2000

Study design details

• Main study objective:
  To describe the demographic and clinical characteristics of pregnant women exposed to DTG, to assess the frequency of birth defects among neonates with prenatal exposure to DTG (categorized by timing of earliest exposure), to describe non-defect pregnancy and neonatal outcomes of the DTG exposed pregnancies, and to assess virologic outcomes among pregnant women on DTG based treatment regimen.
• Outcomes:
  Pregnancy outcomes including spontaneous abortion, induced abortion, still births/live births, preterm births, low birth weight and prevalence of birth defects, maternal VL at delivery (<50 copies/mL & ≥200 copies/mL) and neonatal HIV status.
• Data analysis plan:
  Analyses will be conducted to assess if there are any associations between DTG exposure and outcomes for pregnancy and birth. Logistic regression and Cox proportional-hazards models will be used. Potential confounding factors will be included in a step-wise approach to determine whether they change the odds ratio (OR) or the hazard ratio (HR) for DTG exposure at significance level of 10% in the models. Significant factors modifying the risk of DTG exposure will be retained. Final models will be adjusted on the selected confounders.