CABFIDENCE: Global Real-World Evidence Cohort Study to evaluate Utilization, Clinical and Patient-Reported Outcomes among CAB+RPV LA users (224047)

Study type

• Study topic:
  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

  Effectiveness study (incl. comparative)

  Evaluation of patient-reported outcomes

  Other

  Safety study (incl. comparative)
• If ‘other’, further details on the scope of the study:
  Persistence, Adherence
• Data collection methods:
  Combined primary data collection and secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  VOCABRIA

  EDURANT
• Name of medicine, other:
  Cabenuva
• Study drug International non-proprietary name (INN) or common name:
  CABOTEGRAVIR

  RILPIVIRINE
• Anatomical Therapeutic Chemical (ATC) code:
  (J05AJ04) cabotegravir

  cabotegravir

  (J05AG05) rilpivirine

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

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)

      • Adults (18 to < 46 years)
      • Adults (46 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:
  1000

Study design details

• Study design:
  This observational study will assess the utilization patterns, adherence, persistence, discontinuation, virologic effectiveness, and patient-reported outcomes of CAB+RPV LA in a real-world clinical setting.
• Main study objective:
  • To describe baseline demographics, clinical characteristics and patterns of use among individuals receiving CAB+RPV LA; • To assess the persistence, discontinuation, and adherence among individuals receiving CAB+RPV LA; • To assess virologic effectiveness among individuals receiving CAB+RPV LA; • To assess factors associated with confirmed virologic failure (CVF) among individuals receiving CAB+RPV LA regimen
• Outcomes:
  • Persistence; • Discontinuation; • Adherence; • Virologic effectiveness; • Resistance; • ART regimen after discontinuation /CVF; • Safety outcomes (ISR and HSR); • Health-related quality of life; • Treatment-related stigma, and benefits; • Reasons for initiating CAB+RPV LA; • Reasons for discontinuing CAB+RPV LA; • Reasons for missed injection(s)
• Data analysis plan:
  Baseline characteristics and outcomes will be described using counts and relative frequencies for categorical variables. Continuous variables will be summarized using summary statistics (means, standard deviations, medians, minimums, maximums, and quartiles 1 and 3). ; For event outcomes assessed at any point during follow-up, incidence rates will be estimated using unadjusted Poisson regression, accounting for person-time since index (i.e., first CAB+RPV LA injection). ; Additional analytic approaches may also be considered (e.g., Kaplan-Meir estimator/curve). Analyses will be stratified by BMI (< 30 kg/m^2 vs. ≥ 30 kg/m^2), age (18-50, 50-64, ≥ 65 years), sex assigned at birth (female, male) and race and ethnicity, and country, if sample sizes allow, at initiation of CAB+RPV LA regimen. ; Factors associated with CVF will be assessed using a logistic regression model. Participant surveys will be summarized descriptively for item and summary score (where applicable). ; The World Health Organization Quality of Life-Human Immunodeficiency Virus BREF (WHOQOL-HIV BREF) will be scored according to instrument scoring guidelines and derived scores will be summarized descriptively.