Impact of single tablet regimens on adherence and prescription errors? How big an issue and how relevant in both clinical and economic terms (iSTRAP)

Study type

• Study topic:
  Disease /health condition

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

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  ATRIPLA

  EVIPLERA

  STRIBILD
• Medical condition to be studied:
  HIV test positive

Population studied

• Short description of the study population:
  HIV-1 infected adult patients who received antiretroviral treatment (ART) between 1st January 2009 and 31st December 2013 for at least 90 days, recruited from centers in Italy, Portugal, Spain and UK by Investigators that have expertise in the management of HIV infection.
• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 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:
  2215

Study design details

• Main study objective:
  This study aims to determine whether STRs, as SA-free regimens, will (1)improve adherence and generate clinical and economic benefits (2) prevent prescription errors.
• Outcomes:
  To assess the impact of STRs on adherence in HIV-1 infected patients. 1)Assess the efficacy consequences of NA and OIA, overall and STR versus non-STR (2)Assess the effect of NA and OIA on hospital resource utilization, overall and STR versus non-STR (3)Assess the economic consequences of NA and OIA by cohort (STR versus non-STR) (4)Assess the impact of STR in virological failure, hospitalization and ART plus hospitalization costs (5)Quantify ART prescription errors
• Data analysis plan:
  Baseline characteristics will be reported using descriptive statistics. In general, when presenting descriptive statistics the following parameters will be presented:(1) for qualitative data: absolute and relative frequencies. Percentages will be based on the total number of subjects with non-missing values unless specified otherwise. Counts for missing values will be also tabulated but missing values will not be considered in the percentages(2) for quantitative data: use of mean, standard deviation, median, 25th and 75th percentiles, minimum and maximum and number of non-missing cases (95% confidence intervals for parameters of interest).