A Comprehensive Assessment of Adverse Events and Overall Safety Profile in HIV Positive Patients Treated with Dolutegravir as Compared to Other Integrase Strand Transfer Inhibitors or Darunavir (207832)

Study type

• Study topic:
  Disease /health condition

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

  Safety study (incl. comparative)
• 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:
  Cohort

Study drug and medical condition

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

  ELVITEGRAVIR

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

Population studied

• Short description of the study population:
  The study population consisted of HIV-positive patients at least 13 years of age initiating a core agent of interest prescribed by an OPERA caregiver during the eligibility period (August 1, 2013 to December 31, 2016).; ; The analysis population will be identified from the OPERA Observational Database; according to the inclusion criteria defined below.; Patients initiating any INSTI or DRV between August 01, 2013 and December 31, 2016:; 1) A diagnosis of HIV-1, a positive HIV-1 Western Blot, or a positive HIV-1 enzyme-linked immunosorbent assay (ELISA); and a detectable HIV-1 viral load test.; 2) At least 13 years of age at the index date.; 3) ART naïve or experienced.; 4) Initiation of DTG or EVG or RAL or DRV between August 01, 2013 and December 31, 2016.; ; Subjects with the following criteria will be excluded:; 1) HIV negative; 2) A diagnosis of HIV-2, a positive HIV-1/HIV-2 Multi-spot, a positive HIV-2-specific ELISA, a positive HIV-2 Western Blot or a detectable HIV-2 viral load test; 3) Patients prescribed monotherapy regimens (includes 1 core agent with or without a PK boosting agent); 4) Patients prescribed PEP or PrEP
• 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)
• Special population of interest:
  Immunocompromised
• Estimated number of subjects:
  13000

Study design details

• Main study objective:
  To describe the baseline demographic and clinical characteristics and to quantify and compare the prevalence and incidence of on-label potential and identified risks included in the Dolutegravir Risk Management Plan in HIV+ patients who initiated dolutegravir, elvitegravir or raltegravir as part of an ART regimen
• Outcomes:
  Prevalence and incidence of risks/adverse events of interest detailed in the risk management plan and product label of dolutegravir
• Data analysis plan:
  Descriptive statistics will be used to summarize baseline demographics, clinical characteristics and adverse event history of HIV+ patients initiating an INSTI-based regimen. Adverse events diagnosed will be described as frequencies and classified by the system-organ-class (SOC) hierarchical categorization, and P-values will be calculated to evaluate differences between groups.