CAB LA PrEP Cohort: Prospective Cohort Study to Assess Adherence and Effectiveness of, and Monitor for Hepatotoxicity and Resistance to, Cabotegravir for Pre-Exposure Prophylaxis in Europe (221935)

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Safety study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  APRETUDE
• Study drug International non-proprietary name (INN) or common name:
  CABOTEGRAVIR
• Anatomical Therapeutic Chemical (ATC) code:
  (J05AJ04) cabotegravir

  cabotegravir
• Medical condition to be studied:
  HIV infection

  Drug-induced liver injury

  Drug hypersensitivity
• Additional medical condition(s):
  No particular condition

Population studied

• Age groups:
  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)
• Estimated number of subjects:
  500

Study design details

• Main study objective:
  To describe the population initiating CAB LA for PrEP and to monitor for adherence, HIV incidence, occurrence of drug-induced liver injury (DILI) and hypersensitivity reactions (HSRs) and risk of developing resistance while on CAB LA for PrEP.
• Outcomes:
  Incident HIV diagnoses (frequency of diagnosis, proportion of CAB LA PrEP users with diagnosis, time to diagnosis, ART regimen and viral load testing after diagnosis); adherence and durability of regimen, resistance to specific mutations; DILI and HSRs.