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

• Short description of the study population:
  The study population will include treatment experienced PWH who are 18 years or older, are active in care in OPERA, and received at least one CAB+RPV LA injection between 21JAN2021 and 31DEC2023, 21JAN2021 and 31DEC2024, and 21JAN2021 and 31DEC2025. PWH will be followed from the date of their first CAB+RPV injection until discontinuation of CAB+RPV regimen, death, loss to follow-up (12 months after last clinical contact), or study end (29FEB2024, 28FEB2025, and 28FEB2026).
• Age groups:
  • Paediatric Population (< 18 years)

    • Adolescents (12 to < 18 years)
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 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:
  4000

Study design details

• Study design:
  This is an observational study utilizing prospectively collected electronic health record (EHR) data obtained from the OPERA® cohort.
• 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.; • To compare baseline characteristics and treatment outcomes (persistence/discontinuation, adherence, maintaining virologic suppression, confirmed virologic failure) between oral ART and CAB+RPV LA use in PWH at Year 4 and Year 5 of availability; • To describe baseline characteristics and treatment outcomes (persistence/discontinuation, adherence, virologic effectiveness) among PWH receiving CAB+RPV LA injections at Year 4 and Year 5, in subgroups of interest a) Race/ethnicity (Non-Hispanic Black, Hispanic, Non-Hispanic White) b) Sex/race (Non-Hispanic Black men, Hispanic men, Black women); • Among individuals with confirmed virologic failure (CVF): to describe HIV resistance and proviral testing at the time of CVF, as well as history of resistance and proviral DNA testing prior to CVF at Year 4 and Year 5 of availability; • Among individuals with confirmed virologic failure (CVF): to describe the ART regimens after CVF in OPERA at Year 4 and Year 5 of availability a) To describe the baseline characteristics (demographic, clinical, treatment patterns) of ART regimen after CVF b) To describe virologic response (suppression, non-response, confirmed virologic failure) to ART regimen after CVF
• 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 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.