Patient characteristics, Adherence, and Clinical Outcomes among People Living with HIV (PLWH), Initiating Cabotegravir + Rilpivirine LA Regimen in the OPERA Cohort

Study type

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

  Effectiveness study (incl. comparative)

  Other

  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, other:
  CABENUVA
• 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:
  HIV infection

Population studied

• Age groups:
  Adolescents (12 to < 18 years)

  Adults (18 to < 65 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:
  4000

Study design details

• Main study objective:
  To assess the utilization patterns, durability, adherence and discontinuation, virologic effectiveness and safety of Cabotegravir (CAB) + Rilpivirine (RPV) Long Acting (LA) Regimen among adult PLWH.
• Outcomes:
  • To describe demographics, clinical characteristics, patterns of use, persistence, adherence, discontinuation, virologic effectiveness and factors associated with confirmed virologic failure among PWH receiving CAB+RPV LA at Year 3, Year 4, and Year 5 of availability.; • Sub-group analyses by viral load, BMI and age at initiation to assess characteristics, adherence, persistence, discontinuation and virologic effectiveness.; • To estimate the frequency of documented injection site reactions and hypersensitivity reactions among PWH receiving CAB+RPV LA injections at Year 3, Year 4, and Year 5 of availability.
• Data analysis plan:
  Baseline characteristics and outcomes will be described using counts and relative frequencies for categorical variables and medians with interquartile ranges (IQR) for continuous variables. For 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). Analyses will be stratified by viral load (<50 copies/mL vs. 50 - <200 copies/mL vs. ≥200 copies/mL), BMI (<30 kg/m2 vs. ≥30 kg/m2) and age (<18, 18-50, 50-64, ≥65 years) at initiation of CAB+RPV regimen. Factors associated with confirmed virologic failure will be assessed using multiple logistic regression.