Pregnancy and Neonatal Outcomes following Prenatal Exposure to Cabotegravir: Data from The Antiretroviral Pregnancy Registry (APR) (215325)

Study type

• Study type:
  Non-interventional study

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Observational clinical cohort analysis

Study drug and medical condition

• Name of medicine:
  VOCABRIA
• Study drug International non-proprietary name (INN) or common name:
  CABOTEGRAVIR
• Anatomical Therapeutic Chemical (ATC) code:
  (J05AX) Other antivirals

  Other antivirals
• Medical condition to be studied:
  Human immunodeficiency virus transmission

Population studied

• Age groups:
  Preterm newborn infants (0 – 27 days)

  Term newborn infants (0 – 27 days)

  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:
  Pregnant women
• Estimated number of subjects:
  0

Study design details

• Main study objective:
  • To describe maternal characteristics by timing of first exposure to CAB.; • To estimate frequency of birth defects among neonates, w/prenatal exposure to CAB, by timing of first exposure.; • To estimate frequency of non-defect adverse pregnancy and neonatal outcomes, by timing of first exposure
• Outcomes:
  • Demographic, clinical and immunological characteristics, co-infections, timing of CAB LA initiation, other ARVs used in the regimen ; • Number of participants with live births, induced or spontaneous abortion, or stillbirth ; • Number of neonates with low/very low/extremely low birth weight ; • Number of infants with preterm birth or severe preterm birth ; • Incidence of birth defects
• Data analysis plan:
  Four analyses will be conducted: the first analyses when the number of pregnant women exposed to CAB containing regimen during first trimester in the cohort reaches 25, followed by two more analyses when the study population reaches 100 and 200 pregnancies with first trimester exposures to CAB. A final analysis will be done 12 months after the 3rd analysis. This analysis will be descriptive in nature. Demographic and clinical characteristics of the pregnant women will be tabulated. Frequency assessment of birth defects will be done among all live births. Only singleton births will be included in the analysis of non-defect outcomes, multiple births such as twin and triplet births will be excluded due to the increased risk of adverse outcomes associated with such pregnancies.