Multi-country, non-interventional, cohort study of the effectiveness, safety, adherence, and health-related quality of life in HIV-1 infected adult patients receiving Bictegravir/ Emtricitabine/Tenofovir alafenamide (B/F/TAF) (BIC-STaR)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)

  Safety study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Prospective, non-interventional

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  BICTEGRAVIR

  EMTRICITABINE

  TENOFOVIR ALAFENAMIDE
• Anatomical Therapeutic Chemical (ATC) code:
  (J05AR20) emtricitabine, tenofovir alafenamide and bictegravir

  emtricitabine, tenofovir alafenamide and bictegravir
• Medical condition to be studied:
  HIV infection

Population studied

• 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)
• Estimated number of subjects:
  1435

Study design details

• Main study objective:
  The primary objective of this study was to evaluate the effectiveness, safety, adherence, and health-related quality of life in HIV-1 infected adult patients receiving bictegravir/ emtricitabine/tenofovir alafenamide (B/F/TAF).
• Outcomes:
  To evaluate HIV-1 RNA suppression, defined as HIV-1 RNA < 50 copies/mL, at 12 months after initiating or switching to B/F/TAF. ; To evaluate HIV-1 RNA suppression (<50 copies/mL) at Months 3, 6, and 24; To evaluate changes in cluster determinant 4 (CD4) cell count, CD4/CD8 ratio at Months 3, 6, 12, and 24 for all patients after initiating or switiching to B/F/TAF; To assess rates of adverse events (AEs) and serious AEs; To evaluate long-term effectiveness and safety of B/F/TAF in an extension phase through Month 60 in a subgroup of patients in Germany & France
• Data analysis plan:
  For categorical variables, numbers and percentages of patients were reported including the according 95% confidence intervals. ; For continuous variables, mean, standard deviation (SD), minimum, first and third quartile (Q1, Q3), median, maximum and 95% confidence intervals were calculated, together with the total number of observations and the number of missing values. ; Descriptive statistics were summarized demographics and baseline characteristics (including the type of regimen at enrolment). ; Once data is available from more than one country, descriptive analyses by country was done to determine if patient heterogeneity exists across countries and sites. ; The questionnaires scores were calculated according to the algorithms elaborated for these questionnaires.