Safety and Efficacy of Switching From Dolutegravir and ABC/3TC or ABC/DTG/3TC to B/F/TAF in 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 dolutegravir (DTG) and abacavir/lamivudine (ABC/3TC) or a fixed dose combination (FDC) of abacavir/dolutegravir/lamivudine (ABC/DTG/3TC) to a FDC of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus continuing DTG and ABC/3TC as the FDC ABC/DTG/3TC in virologically suppressed Human Immunodeficiency Virus- 1 (HIV-1) infected adults.

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 ABC/3TC, or a Fixed Dose Combination (FDC) of ABC/DTG/3TC to a FDC of GS-9883/F/TAF in HIV-1 Infected Subjects Who Are Virologically Suppressed

Conditions
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HIV-1 Infection

Intervention / Treatment
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* Drug: ABC/DTG/3TC
* Drug: B/F/TAF
* Drug: ABC/DTG/3TC Placebo
* Drug: B/F/TAF Placebo


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Estimated glomerular filtration rate ≥ 50 mL/min (≥ 0.83 mL/sec). Currently receiving an antiretroviral regimen of DTG + ABC/3TC, or ABC/DTG/3TC FDC for ≥ 3 months prior to the screening visit. HIV ribonucleic acid (RNA) < 50 copies/mL at the screening visit. Currently on a stable regimen for ≥ 3 months preceding the screening visit with documented plasma HIV-1 RNA < 50 copies/mL for ≥ 3 months preceding the screening visit (or undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is ≥ 50 copies/mL). Have no documented or suspected resistance to emtricitabine (FTC), tenofovir (TFV), DTG, ABC or 3TC. Key Exclusion Criteria: Current alcohol or substance use judged by the Investigator to potentially interfere with subject study compliance. Active tuberculosis infection. Individuals experiencing decompensated cirrhosis (eg, ascites, encephalopathy, or variceal bleeding). Females who are pregnant. Females who are breastfeeding. Acute hepatitis in the 30 days prior to study entry. Chronic Hepatitis B Virus (HBV) infection. 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: Blinded Phase: B/F/TAF<br>B/F/TAF + ABC/DTG/3TC placebo for at least 48 weeks | Drug: B/F/TAF<br>* 50/200/25 mg FDC tablets administered orally once daily without regard to food<br>* Other names: Biktarvy® [BVY];Drug: ABC/DTG/3TC Placebo<br>* Tablets administered orally once daily without regard to food<br>|
| Active Comparator: Blinded Phase: ABC/DTG/3TC<br>ABC/DTG/3TC + B/F/TAF placebo for at least 48 weeks | Drug: ABC/DTG/3TC<br>* 600/50/300 mg FDC tablets administered orally once daily without regard to food<br>* Other names: Triumeq®;Drug: B/F/TAF Placebo<br>* Tablets administered orally once daily without regard to food<br>|
| Experimental: Open-Label Phase<br>At the End of Blinded Treatment Visit, if safety and efficacy of B/F/TAF is demonstrated following review of unblinded data, participants in a country where B/F/TAF FDC is not available will be given the option to receive B/F/TAF FDC in an open-label extension phase for up to 96 weeks, or until the product becomes accessible to subjects through an access program, or until Gilead Sciences elects to discontinue the study in that country, whichever occurs first. | Drug: B/F/TAF<br>* 50/200/25 mg FDC tablets administered orally once daily without regard to food<br>* Other names: Biktarvy® [BVY];|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Virologic Failure (HIV-1 RNA ≥ 50 Copies/mL) as Defined by the Modified 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With HIV-1 RNA < 50 Copies/mL 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 | 
| Spine Bone Mineral Density (BMD) at Baseline |  | Baseline | 
| Percentage Change From Baseline in Spine BMD at Week 48 |  | Baseline; Week 48 | 
| Hip Bone Mineral Density at Baseline |  | Baseline | 
| Percentage Change From Baseline in Hip BMD at Week 48 |  | Baseline; Week 48 |