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 Emtricitabine/Tenofovir alafenamide (F/TAF) or Rilpivirine/Emtricitabine/Tenofovir alafenamide (R/F/TAF) for HIV-1 Infection in Germany (TAFNES)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

  Effectiveness study (incl. comparative)
• 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 carrier

Population studied

• Short description of the study population:
  The study will enroll approximately 900 adult (age ≥ 18) treatment-naïve and treatment-experienced HIV-1 infected subjects initiating treatment with E/C/F/TAF, F/TAF or R/F/TAF (300 subjects per arm) in accordance with the respective SmPC in routine care. To evenly represent treatment-naive and treatment-experienced patients the study will enroll in each arm approximately 150 treatment-naive and 150 treatment-experienced subjects.; Subjects must meet all of the following inclusion criteria to be eligible for documentation in this study:; Arm 1 (E/C/F/TAF); 1. HIV-1 infection; 2. Signed informed consent; 3. ≥ 18 years old; 4. Initiating treatment with E/C/F/TAF in accordance with the E/C/F/TAF SmPC; Arm 2 (F/TAF); 1. HIV-1 infection; 2. Signed informed consent; 3. treatment-naïve subjects ≥ 18 years old; 4. treatment-experienced subjects ≥ 50 years old; 5. Initiating treatment with F/TAF (in combination with other ARV medication) in accordance with the F/TAF SmPC; Arm 3 (R/F/TAF); 1. HIV-1 infection; 2. Signed informed consent; 3. ≥ 18 years old; 4. Initiating treatment with R/F/TAF in accordance with the R/F/TAF SmPC
• 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:
  900

Study design details

• Main study objective:
  To evaluate HIV-1 RNA and CD4 cell count changes for patients using E/C/F/TAF, F/TAF or R/F/TAF within a time period of 24 months.
• Outcomes:
  To evaluate HIV-1 RNA and CD4 cell count changes for patients using E/C/F/TAF, F/TAF or R/F/TAF within a time period of 24 months, To describe the following: rates of ADRs, motivation for ART initiation in treatment-naïve subjects and factors driving the ART switch to E/C/F/TAF, F/TAF or R/F/TAF in treatment-experienced subjects, adherence and reasons for drug discontinuation during study, physical and mental health related quality of life, health status, and treatment satisfaction, and healthcare resource utilization.
• Data analysis plan:
  For categorical variables: numbers and percentages of patients. For continuous variables: mean, standard deviation (SD), minimum, first and third quartile, median, and maximum. Descriptive statistics summarized demographics and baseline characteristics. The questionnaires scores were calculated according to the algorithms elaborated for these questionnaires. Visit windows were defined to group data in order to generate descriptive statistics across time to assess potential trends in patient reported outcome questionnaires, safety data or CD4. P-values and/or confidence intervals (95% two-sided) were calculated when considered relevant. Multivariate analyses were conducted to compare the treatment naïve and non naïve treatment groups. Longitudinal analysis were done using mixed models.

Documents

Study results

GS-DE-292-1912-csr-body final_f-redact