A Prospective Observational Cohort Study to Monitor and Compare the Occurrence of Hypersensitivity Reaction and Hepatotoxicity in Patients Receiving Dolutegravir (with and without Abacavir) or other Integrase Inhibitors (with or without Abacavir) (201177)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

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

  Hepatotoxicity

  Rash

Population studied

• Short description of the study population:
  The study population includes HIV positive individuals over the age of 16 years from EuroSIDA clinical sites, who are new users of DTG or users of other integrase inhibitor regimens (RAL and EVG).
• 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)
• Special population of interest:
  Immunocompromised
• Estimated number of subjects:
  10000

Study design details

• Main study objective:
  To describe the incidence of and characteristics of those who develop hypersensitivity skin reactions, hepatotoxicity, and severe skin rash
• Outcomes:
  Hypersensitivity skin reactions, hepatotoxicity, and severe skin rash
• Data analysis plan:
  There are 4 patient groups: A) patients that start DTG and ABC based regimen, B) patients that start DTG based regimen without ABC, C) patients that start other integrase inhibitor based regimen RAL and EGV with ABC, D) patients that start other integrase inhibitor based regimen (RAL and EGV) without ABC. Demographics and clinical history will be collected. Descriptive statistics will be used to describe patient characteristics and event frequency. Logistic regression will be used to assess the risk for the events of interest following use of DTG compared to ABC and other integrase inhibitors.