Switching to a Fixed Dose Combination of Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) in HIV-1 Infected Marginalized Populations Who Are Virologically Suppressed

Study Overview
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Brief Summary
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In an effort to engage more HIV-infected PWUD into care, and ensure treatment adherence and efficacy, simplification of older, multi-tablet regimens is required. Newer, more potent molecules can also overcome resistant that has persisted with previous regimens, while simultaneously providing a high barrier to resistance. The co-formulation of B/F/TAF is a viable switch-option for patients who have experienced lower adherence with previous regimens due to high pill burden, or for those requiring a more potent regimen due to emergent resistances. The formal evaluation of B/F/TAF in this context will allow us to optimize care for HIV-infected PWUD.

Official Title
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Switching to a Fixed Dose Combination of Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) in HIV-1 Infected Marginalized Populations Who Are Virologically Suppressed

Conditions
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Human Immunodeficiency Virus I Infection, Drug Use

Intervention / Treatment
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* Drug: Bictegravir/emtricitabine/tenofovir alafenamide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participant is ≥19 years of age infected with HIV-1 Participant has an undetectable viral load <40 copies/mL at screening with any CD4 count and has exhibited any, or all of the following: Transient HIV viremia (episodes of HIV viral load between 40-1000 copies/mL) in the past 12 months, OR Virologic breakthrough (HIV viral load > 1000 copies/mL) in the past 12 months, OR Documented instances of non-adherence for a period of more than 7 days or… Participant is currently on multi-tablet HIV antiretroviral therapy, including multi-tablet regimens and/or two drug combinations (dual therapy) Participant has a history or current indication of illicit drug use. Patients infected with HCV and or HBV can be included in this study. If female, participant must have a negative pregnancy test and agree to use, for the duration of the study, a method of birth control that has a history of proven reliability as judged by the investigator. Exclusion Criteria: They have any documented history of integrase inhibitor resistance They exhibit any of the following: Creatinine Clearance Rate < 30 ml/min Hemoglobin < 10.0 g/dL Absolute neutrophil count <750 cells/mL Platelet count < 50,000 /mL ALT or AST >5x upper limit of normal (ULN) Creatinine > 1.5x ULN They are taking medication that is contraindicated with any component of B/F/TAF. They are pregnant or breastfeeding. They do not/have not ever used any form of illicit drug use.

Ages Eligible for Study
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Minimum Age: 19 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: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: B/F/TAF<br>Switching participants who are currently on multi-tablet HIV antiretroviral therapy, including multi-tablet regimens and/or two drug combinations (dual therapy) to one oral tablet of B/F/TAF once-daily for 72 weeks | Drug: Bictegravir/emtricitabine/tenofovir alafenamide<br>* Taking one oral tablet of B/F/TAF once-daily for 72 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of subjects that remain virally suppressed at week 48 | The proportion of subjects with HIV RNA <40 copies/mL | Interim analysis of efficacy will be done at 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of subjects with viral blips | Viral blips defined as detectable HIV viral load between 40-1000 copies/mL at week 72 | Analysis will be done at 72 weeks | 
| Changes of adherence | Changes of adherence from baseline at week 2, 8, 24, 48, and 72 with an adherence questionnaire | Analysis will be done at 72 weeks | 
| Proportion of patients that achieved >90% adherence | Proportion of patients that achieved >90% adherence | Analysis will be done at 72 weeks | 
| The proportion of viral blips on regimens pre-switch compared to the blips on B/F/TAF | The proportion of viral blips on regimens pre-switch compared to the blips on B/F/TAF | Analysis will be done at 72 weeks | 
| The proportion of participants that discontinued B/F/TAF due to side-effects at weeks 36 and72 | The proportion of participants that discontinued B/F/TAF due to side-effects at weeks 36 and72 | Analysis will be done at 72 weeks | 
| Changes to baseline quality of life at week 4, 12, 36, 60, and 72 using the HIV Symptoms Distress Module | Changes to baseline quality of life at week 4, 12, 36, 60, and 72 using the HIV Symptoms Distress Module | Analysis will be done at 72 weeks |