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

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, Canadian, 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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* Drug: 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 in accordance with the product monograph Exclusion Criteria: Participation in any other observational or interventional clinical trial without prior approval from the Medical Monitor

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>Bictegravir/Emtricitabine/Tenofovir alafenamide (B/F/TAF) therapy in HIV-1 infected adults who initiate B/F/TAF therapy | Drug: 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 |
| --- | --- | --- |
| Proportion 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 |
| --- | --- | --- |
| Proportion 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 | 
| Proportion 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 | 
| Proportion of Participants with HIV-1 RNA Suppression (HIV RNA < 50 copies/mL) at 36 Months after initiating or switching to B/F/TAF |  | 36 months | 
| Proportion of Participants with HIV-1 RNA Suppression (HIV RNA < 50 copies/mL) at 48 Months after initiating or switching to B/F/TAF |  | 48 months | 
| Proportion of Participants with HIV-1 RNA Suppression (HIV RNA < 50 copies/mL) at 60 Months after initiating or switching to B/F/TAF |  | 60 months | 
| Change in CD4 Cell Count at 3 Months |  | 3 months | 
| Change in CD4 Cell Count at 6 Months |  | 6 months | 
| Change in CD4 Cell Count at 12 Months |  | 12 months | 
| Change in CD4 Cell Count at 24 Months |  | 24 months | 
| Change in CD4 Cell Count at 36 Months |  | 36 months | 
| Change in CD4 Cell Count at 48 Months |  | 48 months | 
| Change in CD4 Cell Count at 60 Months |  | 60 months | 
| CD4/CD8 Ratio at 3 Months |  | 3 months | 
| CD4/CD8 Ratio at 6 Months |  | 6 months | 
| CD4/CD8 Ratio at 12 Months |  | 12 months | 
| CD4/CD8 Ratio at 24 Months |  | 24 months | 
| CD4/CD8 Ratio at 36 Months |  | 36 months | 
| CD4/CD8 Ratio at 48 Months |  | 48 months | 
| CD4/CD8 Ratio at 60 Months |  | 60 months | 
| Proportion of Participants Experiencing Adverse Events (AEs) |  | 60 months | 
| Proportion of Participants Experiencing and Serious Adverse Events (SAEs) |  | 60 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Observational