Descriptive Analysis of Neuropsychiatric Diagnoses in Patients taking Dolutegravir in the OPERA® Observational Database (205846)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  Observational cohort analysis
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Descriptive analysis

Study drug and medical condition

• Name of medicine:
  STRIBILD
• Name of medicine, other:
  Complera
• Study drug International non-proprietary name (INN) or common name:
  DOLUTEGRAVIR

  EFAVIRENZ

  RALTEGRAVIR

  DARUNAVIR

  ABACAVIR

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

Population studied

• Short description of the study population:
  HIV-positive patients who have been prescribed DTG-based, efavirenz (EFV)-based, ralutegravir (RAL)-based, or darunavir (DRV)-based regimens by an OPERA caregiver including both treatment naïve and treatment experienced patients.
• 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)
• Special population of interest:
  Immunocompromised
• Estimated number of subjects:
  2000

Study design details

• Main study objective:
  To summarize neuropsychiatric tolerability diagnoses in a population of HIV-positive males and females who have been prescribed DTG-based, EFV-based, RAL-based, DRV-based, Complera, and Stribild regimens including both antiretroviral (ART) naïve and ART experienced patients
• Outcomes:
  Neuropsychiatric diagnoses of interest and time to discontinuation
• Data analysis plan:
  Patient demographics, baseline clinical characteristics and neuropsychiatric diagnoses will be described using frequency distributions. Medians with interquartile ranges will be used to describe time to neuropsychiatric events. Frequency of events distributions will be generated for: DTG-based, EFV-based, RAL-based, DRV-based, Complera, and Stribild regimens. Comparison of demographics will be conducted for patients on DTG with and without neuropsychiatric events.