Switching to a Fixed Dose Combination of Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) in Human Immunodeficiency Virus Type 1 (HIV-1) Infected Adults Who Are Virologically Suppressed

Study Overview
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Brief Summary
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The primary objective of this study is to evaluate the efficacy of switching from a regimen of either dolutegravir (DTG) and emtricitabine /tenofovir alafenamide (F/TAF) or DTG and emtricitabine/tenofovir disoproxil fumarate (F/TDF) to a fixed dose combination (FDC) of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus DTG+F/TAF in virologically suppressed HIV-1 infected adults with or without antiretroviral (ARV) resistance.

Official Title
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A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Switching From a Regimen of Dolutegravir and Either Emtricitabine/Tenofovir Alafenamide or Emtricitabine/Tenofovir Disoproxil Fumarate to a Fixed Dose Combination of Bictegravir/ Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected Subjects Who Are Virologically Suppressed

Conditions
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HIV-1-infection

Intervention / Treatment
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* Drug: B/F/TAF
* Drug: F/TAF
* Drug: DTG
* Drug: DTG Placebo
* Drug: F/TAF Placebo
* Drug: B/F/TAF Placebo


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Currently receiving an ARV regimen of DTG+F/TAF or DTG+F/TDF for the following minimum time periods: ≥ 6 months (if there is documented or suspected nucleoside/nucleotide reverse transcriptase inhibitor (NRTI) resistance prior to the screening visit) ≥ 3 months (if there is no documented or suspected NRTI resistance prior to the screening visit) Documented plasma HIV-1 ribonucleic acid (RNA) < 50 copies/mL during treatment with DTG+F/TAF or DTG+F/TDF (for a minimum period of ≥ 6 or ≥ 3 months, as applicable) preceding the screening visit Plasma HIV-1 RNA levels < 50 copies/mL at screening visit Estimated Glomerular Filtration Rate (eGFR) ≥ 30 mL/min according to the Cockcroft-Gault formula for creatinine clearance No documented resistance to integrase stand transfer inhibitors (INSTIs) or confirmed virologic failure Eligible adults with chronic hepatitis B virus (HBV) and/or hepatitis C virus (HCV) infection are permitted to enroll NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: B/F/TAF<br>Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) fixed-dose combination (FDC) tablet + dolutegravir (DTG) placebo tablet + emtricitabine/tenofovir alafenamide (F/TAF) placebo tablet administered without regard to food for at least 48 weeks. | Drug: B/F/TAF<br>* 50/200/25 mg FDC tablet(s) administered orally once daily<br>* Other names: Biktarvy®;Drug: DTG Placebo<br>* Tablet(s) administered orally once daily<br>Drug: F/TAF Placebo<br>* Tablet(s) administered orally once daily<br>|
| Active Comparator: DTG + F/TAF<br>DTG 50 mg tablet + F/TAF FDC tablet + B/F/TAF placebo tablet administered without regard to food for at least 48 weeks. | Drug: F/TAF<br>* 200/25 mg FDC tablet(s) administered orally once daily<br>* Other names: Descovy®;Drug: DTG<br>* 50 mg tablet(s) administered orally once daily<br>* Other names: Tivicay®;Drug: B/F/TAF Placebo<br>* Tablet(s) administered orally once daily<br>|
| Experimental: Open-label Phase B/F/TAF from B/F/TAF<br>Participants who received B/F/TAF in double-blind phase and from a country where B/F/TAF was not available were given the option to receive B/F/TAF orally once daily for up to 96 weeks in the open-label extension phase. | Drug: B/F/TAF<br>* 50/200/25 mg FDC tablet(s) administered orally once daily<br>* Other names: Biktarvy®;|
| Experimental: Open-label Phase B/F/TAF from DTG + F/TAF<br>Participants who received DTG + F/TAF in double-blind phase and from a country where B/F/TAF was not available were given the option to receive B/F/TAF orally once daily for up to 96 weeks in the open-label extension phase. | Drug: B/F/TAF<br>* 50/200/25 mg FDC tablet(s) administered orally once daily<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 ≥ 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm | The percentage of participants with HIV-1 RNA ≥ 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. | Week 48 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm | The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. | Week 48 | 
| Change From Baseline in CD4+ Cell Count at Week 48 |  | Baseline; Week 48 |