C2C: COMBINE-2 for Cabotegravir+Rilpivirine LA Regimen - A Prospective Cohort Study to Monitor Effectiveness, Adherence and Resistance (215160)

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medicinal product name:
  EDURANT

  REKAMBYS

  REKAMBYS

  REKAMBYS

  VOCABRIA

  VOCABRIA

  VOCABRIA

  VOCABRIA
• Study drug International non-proprietary name (INN) or common name:
  CABOTEGRAVIR

  RILPIVIRINE
• Anatomical Therapeutic Chemical (ATC) code:
  (J05AG05) rilpivirine

  rilpivirine

  (J05AJ04) cabotegravir

  cabotegravir

  (J05AX) Other antivirals

  Other antivirals
• Medical condition to be studied:
  Human immunodeficiency virus transmission

Population studied

• Short description of the study population:
  The study population will consist of HIV positive male or female aged 18 years or over from NEAT ID Network clinical sites who are prescribed CAB+RPV LA regimen and: ; • Virologically suppressed (HIV-1 RNA <50 copies/mL) at the time of regimen initiation. ; • No evidence of prior virological failure with agents of the NNRTI and INI class ; • No evidence of present or past documented viral resistance to, agents of the NNRTI and INI class
• Age groups:
  • 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:
  0

Study design details

• Study design:
  A prospective cohort study using data from individual medical records from participating ; clinical sites will be conducted to meet the study objectives.
• Main study objective:
  • Describe study population initiating CAB+RPV LA regimen ; • Assess adherence, durability and discontinuation for individuals starting the regimen ; • Assess the clinical effectiveness among individuals who initiate the regimen and had suppressed viral load at regimen initiation ; • Monitor for resistance in case of virologic failure while on the regimen or after switching over the follow-up period
• Setting:
  Only clinical sites whose standard of care guidance includes HIV subtype testing and resistance testing among individuals with virologic failure will be include in the study to ensure collecting resistance data.
• Outcomes:
  • Clinical effectiveness ; • Regimen discontinuation ; • Adherence ; • Resistance testing at virologic failure and next treatment response
• Data analysis plan:
  Descriptive analyses will summarize the study population exposed to CAB+RPV LA. Proportions and multivariable regression models will be used to assess the factors associated with virologic failure, non-adherence, discontinuation of CAB+RPV LA regimen and resistance among participants with virologic failure.