Rates of Suspected Hypersensitivity Reaction to Abacavir and Associated Rates of HLA-B*5701 Testing (206206)

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:
  Cohort

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

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  ABACAVIR
• Medical condition to be studied:
  Human immunodeficiency virus transmission

Population studied

• Short description of the study population:
  The study sample will be identified from the OPERA Observational Database for analysis. HIV-1 positive patients initiating abacavir-containing treatment for the first time between 1/1/1999 and 1/1/2016 will be included in the study sample if they meet the following inclusion criteria:; 1) At least 13 years of age at the index date.; 2) Continuous clinical activity in the year prior to abacavir initiation, defined as at least one clinic visit.; 3) Continuous clinical activity in the year following abacavir initiation, defined as at least one clinical contact (visit or telephone contact).
• 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:
  16000

Study design details

• Main study objective:
  To describe the baseline demographic and clinical characteristics of HIV+ patients initiating an abacavir-based ART regimen, the annual incidence rates and cumulative frequencies of HLA-B*5701 testing, and the annual incidence rates and cumulative frequencies of suspected hypersensitivity reaction among abacavir-exposed patients before and after June 15, 2008.
• Outcomes:
  • Diagnosis of suspected hypersensitivity reaction to abacavir (HSR) • Documentation of HLA-B*5701 testing and timing of the test (before or after starting ABC containing regimen)• Exposure to abacavir post positive HLA testing
• Data analysis plan:
  Descriptive analyses will be performed for demographic and clinical variables of interest. Multivariable analyses will be used to produce rates of suspected HSR diagnoses by HLA time period.

Documents

Study results

viiv-206206-clinical-study-report-redact