Prospective Non-Interventional Real-Life Study of Effectiveness, Safety, Adherence, and Health-Related Quality of Life in Adult Patients receiving Elvitegravir/Cobicistat/Emtricitabine/Tenofovir alafenamide (E/C/F/TAF) or Rilpivirine/Emtricitabine/Tenofovir alafenamide (R/F/TAF) for HIV-1 Infection in France (TARANIS)

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:
  Efficacy
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medical condition to be studied:
  HIV infection

Population studied

• Short description of the study population:
  The study will enroll approximately 300 adult (age ≥ 18) treatment-naïve and treatment-experienced HIV-1 infected patients initiating treatment with E/C/F/TAF in; accordance with the approved SmPC in routine care.; Participating study sites are specialized on treating HIV patients. All study sites are located in France.; ; Inclusion Criteria; Subjects must meet all of the following inclusion criteria to be eligible for documentation in this study:; 1) HIV-1 infection; 2) Initiating treatment with E/C/F/TAF in accordance with the E/C/F/TAF SmPC; 3) ≥ 18 years old; 4) Signed informed consent
• 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:
  649

Study design details

• Main study objective:
  To assess effectiveness, safety, adherence, health care resource utilization, and patient reported outcomes (PROs) for quality of life of E/C/F/TAF or R/F/TAF use in routine care.
• Outcomes:
  To evaluate HIV-1 RNA and CD4 cell count changes for patients using E/C/F/TAF or R/F/TAF within a time period of 24 months, Rates of ADRs and serious ADRs, motivation for ART initiation in treatment-naïve subjects and factors driving the ART switch to E/C/F/TAF or R/F/TAF in treatment-experienced subjects, adherence and reasons for E/C/F/TAF or R/F/TAF discontinuation during the study, quality of life, health status, treatment satisfaction using standardized questionnaires, health care resource utilization
• Data analysis plan:
  For categorical variables, numbers and percentages of patients were reported. For continuous variables, mean, standard deviation (SD), minimum, first and third quartile (Q1, Q3), median, and maximum were calculated, together with the total number of observations and the number of missing values. Multivariate analyses were conducted to compare treatment naïve and non-naïve treatment groups. Demographics and baseline measures were potential confounders/effect modifiers for multivariate analyses. Confounders/effect modifiers and respective adjustments will be addressed in the Statistical Analysis Plan. AEs/SAEs and comorbidities were coded using the Medical Dictionary for Regulatory Activities (MedDRA).