Effectiveness, Safety, Adherence, and Health-related Quality of Life in HIV-1 Infected Adults Receiving Bictegravir/ Emtricitabine/Tenofovir Alafenamide (B/F/TAF)

Study Overview
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Brief Summary
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The primary objective of this study is to evaluate HIV-1 RNA suppression, defined as HIV-1 RNA < 50 copies/mL, at 12 months after initiating or switching to bictegravir/ emtricitabine/tenofovir alafenamide (B/F/TAF).

Official Title
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Multi-center, Israeli, 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)

Conditions
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HIV-1-infection

Intervention / Treatment
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* Other: B/F/TAF


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: HIV-1 infection Signed informed consent Initiating treatment with B/F/TAF Exclusion Criteria: Participation in any interventional clinical trial

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| B/F/TAF<br>HIV-1 infected adults who initiate B/F/TAF therapy | Other: B/F/TAF<br>* B/F/TAF administered in accordance with the approved product monograph<br>* Other names: Biktarvy®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants with HIV-1 RNA Suppression (HIV RNA < 50 copies/mL) at 12 Months after Initiating or Switching to B/F/TAF |  | 12 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants with HIV-1 RNA Suppression (HIV RNA < 50 copies/mL) at 3 Months After Initiating or Switching to B/F/TAF |  | 3 Months | 
| Proportion of Participants with HIV-1 RNA Suppression (HIV RNA < 50 copies/mL) at 6 Months After Initiating or Switching to B/F/TAF |  | 6 Months | 
| Percentage of Participants with HIV-1 RNA Suppression (HIV RNA < 50 copies/mL) at 24 Months After Initiating or Switching to B/F/TAF |  | 24 Months | 
| Change in CD4 Cell Count at 3 Months After Initiating or Switching to B/F/TAF |  | 3 Months | 
| Change in CD4 Cell Count at 6 Months After Initiating or Switching to B/F/TAF |  | 6 Months | 
| Change in CD4 Cell Count at 12 Months After Initiating or Switching to B/F/TAF |  | 12 Months | 
| Change in CD4 Cell Count at 24 Months After Initiating or Switching to B/F/TAF |  | 24 Months | 
| CD4/CD8 Ratio at 3 Months After Initiating or Switching to B/F/TAF |  | 3 Months | 
| CD4/CD8 Ratio at 6 Months After Initiating or Switching to B/F/TAF |  | 6 Months | 
| CD4/CD8 Ratio at 12 Months After Initiating or Switching to B/F/TAF |  | 12 Months | 
| CD4/CD8 Ratio at 24 Months After Initiating or Switching to B/F/TAF |  | 24 Months | 
| Percentage of Participants Experiencing Adverse Events and Serious Adverse Events |  | 24 Months |