DARWIN EU® - Use of antiretroviral therapies in paediatric patients

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology

  Drug utilisation
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (J05AE) Protease inhibitors

  Protease inhibitors

  (J05AF) Nucleoside and nucleotide reverse transcriptase inhibitors

  Nucleoside and nucleotide reverse transcriptase inhibitors

  (J05AG) Non-nucleoside reverse transcriptase inhibitors

  Non-nucleoside reverse transcriptase inhibitors

  (J05AJ) Integrase inhibitors

  Integrase inhibitors

  (J05AR) Antivirals for treatment of HIV infections, combinations

  Antivirals for treatment of HIV infections, combinations

  (J05AX09) maraviroc

  maraviroc

  (J05AX07) enfuvirtide

  enfuvirtide

  (J05AX29) fostemsavir

  fostemsavir

  (J05AX31) lenacapavir

  lenacapavir

  (V03AX03) cobicistat

  cobicistat
• Medical condition to be studied:
  HIV infection

Population studied

• Short description of the study population:
  The study population will include all individuals observed in one of the participating data sources during the study period (1st January 2010 to 31st December 2024) and having at least 1 year of database history. ; For children within the age group of 0-<2 years, the need to have 365 days of prior database history will be dropped.
• Age groups:
  • Infants and toddlers (28 days – 23 months)
  • Children (2 to < 12 years)
  • Adolescents (12 to < 18 years)

Study design details

• Study design:
  This is a descriptive population-level epidemiology study and population-level drug utilisation study (DUS).
• Main study objective:
  1. To describe the prevalence and incidence of HIV in the paediatric general population in a sample of European countries (Spain, Germany and Norway), overall and stratified by sex, age group (0-<1, 1-<2, 2-<5, 5-<12, 12-<18) and calendar year; 2. To describe the prevalence and incidence of use of HIV-specific medication in the paediatric HIV population in a sample of European countries (Germany and Norway) particularly fixed-dose combinations, overall and stratified by sex, age group (0-<1, 1-<2, 2-<5, 5-<12, 12-<18) and calendar year.; 3. To describe the prevalence and incidence of use of HIV-specific medication in the paediatric general population in a sample of European countries (Germany, Norway, and the United Kingdom) particularly fixed-dose combinations, overall and stratified by sex, age group (0-<1, 1-<2, 2-<5, 5-<12, 12-<18) and calendar year.
• Setting:
  This study will use routinely collected health data from 4 databases in the DARWIN EU® network of data ; partners from 4 countries. All databases were previously mapped to the OMOP CDM. ; Data source ; • Base de Datos para la Investigacíon Farmacoepidemiológica en el Ámbito Público (BIFAP), Spain ; (objective 1) ; • InGef Research Database (InGef RDB), Germany (all 3 objectives) ; • Norwegian Linked Health Registry data (all 3 objectives)
• Outcomes:
  The outcome of this study will be the prevalence and incidence of a HIV diagnosis. ; ; In InGef RDB, HIV diagnoses consist of both inpatient and outpatient diagnoses. For outpatient HIV diagnoses in InGef RDB, patients are required to have 2 HIV diagnoses in a year for it to count as an actual diagnosis, since that criterion is commonly used in analyses of German claims data to indicate a higher degree of diagnostic validity compared to patients with a single diagnosis.