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

  Safety study (incl. comparative)

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
• 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:
  1500

Study design details

• Main study objective:
  The primary objective of this study is 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. Evaluate HIV-1 RNA suppression (<50 copies/mL) at Months 3, 6, and 24, changes in cluster determinant 4 (CD4) cell count, CD4/CD8 ratio at Months 3, 6, 12, and 24 for all patients, assess rates of adverse events (AEs) and serious AEs, Evaluate long-term effectiveness at Month 36, 48, and 60 and safety for patients in Germany & France (in an extension phase).
• Data analysis plan:
  For categorical variables, numbers and percentages of patients will be 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 will be calculated, together with the total number of observations and the number of missing values. Descriptive statistics will summarize demographics and baseline characteristics (including the type of regimen at enrolment). Once data is available from more than one country, descriptive analyses by country will be done to determine if patient heterogeneity exists across countries and sites. The questionnaires scores will be calculated according to the algorithms elaborated for these questionnaires.