An Observational Drug Utilization Study of Stribild® in Adults with HIV-1 Infection

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation
• Data collection methods:
  Combined primary data collection and secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medical condition to be studied:
  Human immunodeficiency virus transmission

Population studied

• Short description of the study population:
  HIV-1 infected adults who initiate Stribild therapy in 50 participating European clinics participating in the NEAT-ID Foundation across several countries (i.e., Belgium, France, Germany, Italy, Spain, and the United Kingdom). Confirmed diagnosis of HIV-1 infection is required in subjects who are antiretroviral treatment-naïve.
• 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:
  1000

Study design details

• Main study objective:
  To assess the pattern of renal monitoring and patient management in the clinical setting among subjects treated with STB and compare it to key renal messages in the STB SmPC
• Outcomes:
  The rate of proximal renal tubulopathy, The rate of reversibility among subjects with a proximal renal tubulopathy event
• Data analysis plan:
  Baseline information on subject demographics and other clinical characteristics will be summarized using descriptive statistics (ie, sample size, mean, standard deviation, median, interquartile range, minimum and maximum) for continuous data and by the numbers and percentages of subjects for categorical data. Summaries will be provided for subjects overall, and for those with incident PRT and reversibility events. Descriptive analyses also will be performed to assess patient management and monitoring per the STB SmPC at baseline and upon STB discontinuation. The risk factors for PRT associated with the use of STB and potentially nephrotoxic concomitant medications will be evaluated by comparing patients with PRT events to those without events. The number and proportion of subjects with Stribild discontinuation due to PRT will be reported with 95% confidence intervals.