An Evaluation of Weight Gain in Patients Treated with Dolutegravir vs. Other Core Agents (208943)

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

Study drug and medical condition

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

Population studied

• Short description of the study population:
  The analysis population will be identified from the OPERA Observational Database according to the inclusion criteria defined below.; Primary population; 1) A diagnosis of HIV-1, a positive HIV-1 Western Blot, or a positive HIV-1-specific ELISA; and a detectable HIV-1 viral load test; 2) At least 18 years of age at the index date; 3) Male or female patients; 4) Prescribed DTG, RPV, RAL, BIC, EVG/c and DRV(/r/c) as part of a 3-drug regimen for the first time between 01AUG2013 and 31DEC2017; 5) Not exposed to >1 core agent of interest concurrently; Subjects with the following criteria will be excluded from the study sample:; 1) HIV-negative; 2) A diagnosis of HIV-2, a positive HIV-1/HIV-2 Multispot, a positive HIV-2-specific ELISA, a positive HIV-2 Western Blot or a detectable HIV-2 viral load test; 3) Women who are considered pregnant at the index date; 4) Transgender patients (potential for weight changes due to hormone use); ; Secondary population; The study population for the secondary objectives will be a subset of the primary study population meeting the following additional inclusion criteria:; 1) Patients switching to DTG, RPV, RAL, BIC, EVG/c or DRV(/r/c) as part of a 3-drug regimen for the first time between 01AUG2013 and 31DEC2017 (excluding ARTnaïve patients); 2) Patients with a viral load <200 copies/mL at last viral load test prior to switch to core agent of interest
• 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:
  15000

Study design details

• Main study objective:
  To describe BMI categories, weight, lipid levels, and lipodystrophy among new users of DTG and other INSTIs at core agent initiation and at 6, 12, and 24 months after core agent initiation (stratified by ART- naïve and ART experienced) and to estimate the association between specific core agent initiation and changes in BMI at 6, 12, and 24 months after core agent initiation
• Data analysis plan:
  Descriptive statistics will be used to summarize baseline demographic and clinical characteristics, as well as weight, lipid, and lipodystrophy outcomes at each time point (6,12, and 24 months). Pairwise comparisons will be made between DTG and other core agents. Adjusted linear regression models will be used to assess the association between core agent and mean changes in BMI at 6, 12, and 24 months. Baseline variables meeting the definition of a confounder will be included in the adjusted models, and will be selected a priori. The analysis will be stratified by baseline BMI categories (underweight, normal weight, overweight, obese).