Pregnancy and Neonatal Outcomes following Prenatal Exposure to Cabotegravir Long Acting (CAB LA): Data from the European Pregnancy and Paediatric HIV Cohort Collaboration (EPPICC) (215163)

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:
  1. Describe maternal characteristics by timing of 1st CAB exposure in relation to estimated date of conception;; 2. Est. frequency of adverse pregnancy and neonatal outcomes, by timing of 1st CAB exposure;; 3. Est. perinatal transmission rates in mother-infant pairs;; 4. Assess proportion of women who achieve viral suppression by the end of pregnancy, by trimester of exposure.
• Outcomes:
  • Demographic, clinical and immunological characteristics, co-infections, timing of CAB LA initiation, other ARVs used in the regimen;; • No. with adverse pregnancy outcome, infants with adverse neonatal outcome, with perinatal transmission rates in mother-infant pairs, percentage achieving viral suppression.
• Data analysis plan:
  Frequency distributions for categorical variables and summary measures for continuous variables will be used for descriptive analyses. For rates, 95% confidence intervals will be calculated. The unit of analysis will vary depending on outcome and multiple gestations will be taken into account where appropriate. Descriptive analyses will include the whole study population. Analyses for preterm and low birth weights will be restricted to live singleton births, birth defects will be estimated among live births, maternal viral suppression estimates will be restricted to women delivering live or stillborn infants, and vertical transmission analyses will be limited to live-born infants. There will be four analyses: the first analyses when the number of pregnant women exposed to CAB containing regimen in the cohorts reaches 25, followed by two more analyses when the study pop reaches 100 and 200 pregnancies. A final analysis will be done 12 months after the 3rd analysis.