Rates of Suspected Hypersensitivity Reaction in HIV infected Adult treatment populations screened HLA-B*5701 negative prior to commencing Abacavir therapy: Meta-analysis of Data from GlaxoSmithKline and ViiV Healthcare Sponsored Clinical Trials (207831)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Effectiveness study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Systematic review and meta-analysis

Study drug and medical condition

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

  LAMIVUDINE

  DOLUTEGRAVIR
• Medical condition to be studied:
  Drug hypersensitivity

Population studied

• Short description of the study population:
  HIV-infected adult subjects will be included in this analysis. Only studies that were completed or for which the primary objective was completed, will be included. This analysis will be based on all treated population defined by subjects who received at least one dose of an ABC- containing product (i.e., ABC/3TC or ABC/DTG/3TC) as either randomized IMP or background medication (i.e., randomization was not based on ABC).
• 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)
• Special population of interest:
  Immunocompromised
• Estimated number of subjects:
  3063

Study design details

• Main study objective:
  To estimate the incidence rate of clinically suspected abacavir hypersensitivity reaction cases (both Investigator diagnosed and MAH adjudicated), reported in HLA-B*5701 negative subjects treated with abacavir-containing anti-retroviral regimens
• Outcomes:
  Investigator diagnosed and MAH adjudicated cases of clinically suspected abacavir hypersensitivity reaction
• Data analysis plan:
  Incidence rates with percentages will be based on the frequency of both: Investigator diagnosed and MAH adjudicated cases of clinically suspected abacavir hypersensitivity reaction occurring during the conduct of clinical trials. 95% CIs will be based on exact binomial 2-sided confidence intervals (CIs). Incidence rate for clinical suspected abacavir hypersensitivity reaction will be repeated in a sub-population of subjects who received TRIUMEQ (or the equivalent components given as the single active preparation of TIVICAY in combination with KIVEXA).