A prospective observational cohort study to monitor for hepatotoxicity and regimen discontinuation due to liver related adverse events among People with HIV, initiating Cabotegravir + Rilpivirine regimens (215162)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Drug utilisation

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  CABOTEGRAVIR

  RILPIVIRINE
• Anatomical Therapeutic Chemical (ATC) code:
  (J05AG05) rilpivirine

  rilpivirine

  (J05AJ04) cabotegravir

  cabotegravir
• Medical condition to be studied:
  Human immunodeficiency virus transmission

Population studied

• Age groups:
  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:
  0

Study design details

• Main study objective:
  Characterize the rates & risks of hepatotoxicity by estimating incidence of alanine aminotransferase (ALT) elevation & risk factor for elevation, estimating incidence of cases of combined ALT & total bilirubin elevation & risk factor for elevation Estimate number of individuals discontinuing CAB+RPV, DTG+RPV or DTG+3TC due to any reason & discontinuation due to liver-related related adverse events.
• Outcomes:
  • Monitor for hepatotoxicity ; • Regimen discontinuations due to liver-related AEs
• Data analysis plan:
  Descriptive analyses will summarize the individuals exposed to each of the three proposed ART regimens. Incidence rates of discontinuation of the regimens and hepatotoxicity will be calculated and where sufficient events accrue, multivariate regression will investigate factors associated with the endpoint of interest.