Prospective Study to Assess Usage, Adherence, Effectiveness of Cabotegravir LA for Pre-Exposure Prophylaxis in the United States in the OPERA Cohort (219844)

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

  Effectiveness study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medicinal product name:
  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

Population studied

• Short description of the study population:
  People living with HIV (PLWH) aged 18 years and older were included in the study.
• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Estimated number of subjects:
  2500

Study design details

• Study design:
  Observational cohort study utilizing prospectively collected electronic health record (EHR) data up from the OPERA longitudinal healthcare database.; ;
• Main study objective:
  • To describe the baseline characteristics of oral pre-exposure prophylaxis (PrEP) users (Tenofovir Disproxil Fumarate (TDF) / Emtricitabine (FTC) or Tenofovir Alafenamide (TAF) /FTC) users) and LA PrEP users (CAB, with or without oral lead-in (OLI)).; • To describe adherence and usage patterns of CAB OLI and/or LA-PrEP.; • To monitor incidence of Human immunodeficiency virus (HIV) and sexually transmitted infections (STIs) while on CAB OLI and/or LA PrEP.; • To evaluate HIV treatment and virologic suppression after HIV acquisition.; • To describe patterns of HIV testing among CAB LA PrEP users.
• Setting:
  The study population will be derived from PrEP users meeting the inclusion criteria in the OPERA (Observational Pharmaco-Epidemiology Research and Analysis) multisite observational database.
• Comparators:
  Not applicable.
• Outcomes:
  • Demographic and clinical characteristics at baseline; • Adherence and Usage Patterns of CAB Oral Lead in (OLI) and/or LA-PrEP; • HIV testing patterns among CAB LA PrEP users; • Incident diagnoses of HIV and Sexually Transmitted Infections (STIs) while on CAB OLI and/or LA PrEP; • Antiretroviral treatment and virological control following HIV Acquisition; • Number of Participants with Incomplete Initiation of CAB LA for PrEP
• Data analysis plan:
  All data analyses will be computed in a descriptive manner.