DOLOMITE EPPICC Study: Pregnancy and Neonatal Outcomes following Prenatal Exposure to Dolutegravir: Data from the European Pregnancy and Paediatric HIV Cohort Collaboration (EPPICC) (208613)

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:
  Observational cohort analysis
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

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

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  DOLUTEGRAVIR
• Medical condition to be studied:
  Human immunodeficiency virus transmission

Population studied

• Short description of the study population:
  The study population included all pregnant women living with HIV exposed to any DTG (TIVICAY®, TRIUMEQ®, JULUCA and D3) at any time during the pregnancy and their infants identified from the EPPICC network.
• Age groups:
  Preterm newborn infants (0 – 27 days)

  Term newborn infants (0 – 27 days)

  Infants and toddlers (28 days – 23 months)

  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:
  150

Study design details

• Main study objective:
  To describe trends and patterns of use of dolutegravir (DTG)-containing regimens in pregnancy in Europe, to describe frequency of adverse pregnancy outcomes in women using DTG in pregnancy, to describe the proportion of women on DTG who achieve viral suppression by the end of pregnancy, and to describe mother-to-child transmission (MTCT) rates in mother-infant pairs with prenatal DTG use.
• Outcomes:
  Pregnancy outcomes including spontaneous abortion, induced abortion, live birth, and still birth by trimester of exposure to DTG, adverse pregnancy outcomes including birth defects, preterm and severely preterm births, low birth weight, very low birth weight, and extremely low birth weight infants, maternal virological suppression at the end of pregnancy and MTCT rates.
• Data analysis plan:
  Statistical analysis will be carried out using STATA® v12.0 software (StataCorp, College Station, Texas). Standard descriptive statistics will be used to summarize the data. For continuous variables, the sample size, median and interquartile range will be provided. Frequency distributions will be provided for categorical variables. For rates, 95% confidence intervals will be calculated.

Documents

Study results

Study Report DOLOMITE EPPIC_Pregnancy_Final Report Anonymized 03 Nov 2023