Study of B/F/TAF in Participants Switching From CAB + RPV to B/F/TAF for HIV-1 Infection (EMPOWER)

Study Overview
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Brief Summary
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The goal of this clinical study is to learn how safe and effective it is to switch to an oral therapy of Bictegravir/Emtricitabine/Tenofovir (B/F/TAF) from Cabotegravir + Rilpivirine (CAB+RPV) in participants living with virologically suppressed human immunodeficiency virus type 1 (HIV-1), meaning participants with HIV RNA levels below detectable levels. The primary objective of this study is to assess the safety of switching to B/F/TAF in virologically suppressed participants unable/unwilling to continue on CAB+RPV intramuscular (IM) injections or wishing to switch to oral therapy through Week 12.

Official Title
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A Phase 4 Study to Evaluate the Safety, Pharmacokinetics and Efficacy of Oral B/F/TAF After Discontinuing Injectable CAB + RPV

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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Key Inclusion Criteria: People with HIV-1 (PWH) or provider decision to switch off CAB+RPV IM injections due to intolerance, inconvenience, adverse events (AEs), or willing to switch to (and intention to remain on) daily B/F/TAF Currently virologically suppressed (HIV-1 RNA < 50 copies/mL) on CAB+RPV IM injections every 2 months Currently on CAB+RPV IM injections every 2 months and received at least one dose of CAB+RPV IM injection; no missed CAB+RPV injections Ability to receive B/F/TAF up to 7 days prior to the next scheduled dose of CAB+RPV Documented plasma HIV-1 RNA < 50 copies/mL during treatment for ≥ 6 months preceding the screening visit No documented or suspected resistance to BIC, emtricitabine (FTC), or tenofovir (TFV). Key Exclusion Criteria: History of B/F/TAF intolerance History of previous INSTI virologic failure including CAB+RPV Requirement for ongoing therapy with any prohibited medications listed in local prescribing information for B/F/TAF starting within 30 days prior to screening until 30 days following the last dose of study drug Have been treated within 3 months of study screening or expected to receive during the study immunosuppressant therapies or chemotherapeutic agents (eg, chronic (at least 4 weeks) systemic steroids, immunoglobulins, and other immune- or cytokine-based therapies) Need for oral antiretroviral therapy (ART) bridge or use of other antiretroviral (ARV) agents prior to starting B/F/TAF on Day 1 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: B/F/TAF<br>Participants will receive a fixed dose combination of B/F/TAF 50/200/25 mg once daily for 24 weeks | Drug: B/F/TAF<br>* Tablets administered without regard to food<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 Experiencing Treatment Emergent Grade 3 or 4 Drug-related Adverse Events Through Week 12 (Co-Primary Endpoint) |  | First dose up to Week 12 | 
| Percentage of Participants Experiencing Treatment-emergent Grade 3 or 4 Laboratory Abnormalities Through Week 12 (Co-Primary Endpoint) |  | First dose up to Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma Concentrations of Bictegravir (BIC), Cabotegravir (CAB), and Rilpivirine (RPV) at Day 1 |  | Day 1 | 
| Plasma Concentration of BIC, CAB, and RPV at Week 4 |  | Week 4 | 
| Plasma Concentration of BIC, CAB, and RPV at Week 12 |  | Week 12 | 
| Plasma Concentration of BIC, CAB, and RPV at Week 24 |  | Week 24 | 
| Proportion of Participants with HIV-1 RNA ≥ 50 Copies/mL at Week 12 as Determined by Missing = Excluded Approach | This outcome measure will be analyzed using the Missing = Excluded (M = E) method. In this approach, all missing data will be excluded in the analysis. | Week 12 | 
| Proportion of Participants with HIV-1 RNA ≥ 50 Copies/mL at Week 24 as Determined by Missing = Excluded Approach | This outcome measure will be analyzed using the Missing = Excluded (M = E) method. In this approach, all missing data will be excluded in the analysis. | Week 24 | 
| Proportion of Participants with HIV-1 RNA ≥ 50 Copies/mL at Week 12 as Determined by Discontinuation = Failure Approach | This outcome measure will be analyzed using the Discontinuation = Failure (D = F) method. In this approach, all discontinuation will be treated as HIV-1 RNA >= 50 copies/mL (failure) in the analysis. | Week 12 | 
| Proportion of Participants with HIV-1 RNA ≥ 50 Copies/mL at Week 24 as Determined by Discontinuation = Failure Approach | This outcome measure will be analyzed using the Discontinuation = Failure (D = F) method. In this approach, all discontinuation will be treated as HIV-1 RNA >= 50 copies/mL (failure) in the analysis. | Week 24 | 
| Percentage of Participants with Discontinuation of B/F/TAF by Week 12 |  | Up to 12 Weeks | 
| Percentage of Participants with Discontinuation of B/F/TAF by Week 24 |  | Up to 24 Weeks | 
| Percentage of Participants Experiencing Treatment-emergent Grade 3 or 4 Laboratory Abnormalities Through Week 24 |  | First dose up to Week 24 | 
| HIV Treatment Satisfaction Questionnaire Change (HIVTSQc) Total Score at Week 4 | The HIVTSQc is a 1-12 items questionnaire. Each item is scored -3 to 3. The total score may range from -33 to +33, based on 11 items. Higher the score, greater the improvement in satisfaction with treatment; the lower the score, the greater the deterioration in satisfaction with treatment. A score of 0 will represent no change. | Week 4 |