CAB LA PrEP Cohort: Prospective Cohort Study to Assess Adherence and Effectiveness of, and Monitor for Hepatotoxicity and Resistance to, Cabotegravir for Pre-Exposure Prophylaxis in Europe (221935)

Study type

• Study topic:
  Disease /health condition

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

  Effectiveness study (incl. comparative)

  Safety 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

  Drug-induced liver injury

  Drug hypersensitivity
• Additional medical condition(s):
  No particular condition

Population studied

• Short description of the study population:
  HIV-negative adults and adolescents (at least 12 years of age) ≥35 kgs initiating CAB LA for PrEP initiating OLI or CAB LA injections.
• Age groups:
  • Adolescents (12 to < 18 years)
  • 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:
  500

Study design details

• Study design:
  5-year long prospective cohort study
• Main study objective:
  To describe the population initiating CAB LA for PrEP and to monitor for adherence, HIV incidence, occurrence of drug-induced liver injury (DILI) and hypersensitivity reactions (HSRs) and risk of developing resistance while on CAB LA for PrEP.
• Setting:
  Potential investigational sites within the NEAT-ID Network across Europe will be contacted for feasibility and resistance testing practices as part of their SoC. A formal feasibility assessment questionnaire will be conducted after the protocol is finalized and approved and will be used to determine sites’ eligibility to participate in the study. This formal feasibility assessment will include assessing site’s infrastructure to participate in ; research studies, number of any PrEP prescriptions in the previous year, availability of resistance testing, and HIV testing practices per local standard of care practices. Followup period will start from the date of the first participant enrolled in the study and will end five years after the date of first enrolment.
• Outcomes:
  Incident HIV diagnoses (frequency of diagnosis, proportion of CAB LA PrEP users with diagnosis, time to diagnosis, ART regimen and viral load testing after diagnosis); adherence and durability of regimen, resistance to specific mutations; DILI and HSRs.
• Data analysis plan:
  Descriptive analyses will summarize baseline characteristics of study participants and covariables will be reported as frequencies/median (IQR) at baseline and at follow-up. Time to HIV diagnosis will be assessed using Kaplan-Meier curve. Cox proportional hazards models will be constructed to compare time to HIV diagnosis adjusting for ; participant characteristics. Adherence will be estimated using the date of injections over 6 and 12-month periods. Frequency of resistance will be described among individuals who acquire HIV while on CAB LA for PrEP.