Study to Assess Switching to B/F/TAF in Treatment Experienced People With HIV Who Are at Least 65 Years of Age

Study Overview
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Brief Summary
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To assess patient reported treatment satisfaction and medication tolerability in virologically suppressed HIV-1 infected adults who are at least 65 years of age who switch to a bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) fixed-dose combination regimen.

Official Title
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Switching to a Fixed Dose Combination of Biktarvy in Treatment Experienced People With HIV Who Are Currently Virologically Suppressed and at Least 65 Years of Age

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: Be at least 65 years of age at the time of signing the informed consent form. Be currently receiving an antiretroviral regimen for ≥ 3 months prior to the screening visit. Have documented plasma HIV-1 RNA < 50 copies/mL for a minimum of 3 months on current ART regimen. Have a plasma HIV-1 RNA < 50 copies/mL at screening visit. Key Exclusion Criteria: Have resistance to tenofovir (K65R/E/N, ≥3 thymidine analogue mutations or T69-insertions), primary INSTI-resistance, or a history of failure on an INSTI-based regimen. Have been treated with B/F/TAF Participants with CrCl <30 mL/min Known or suspected severe hepatic impairment (Child-Pugh Class C)

Ages Eligible for Study
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Minimum Age: 65 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>B/F/TAF for 48 weeks | Drug: B/F/TAF<br>* 50/200/25 mg fixed-dose combination administered orally once daily 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 |
| --- | --- | --- |
| Improvement in treatment satisfaction by a change in total satisfaction scale as measured by the HIVTSQ survey. | Improvement in treatment satisfaction by a change in total satisfaction scale as measured by the HIVTSQ survey. The range of scores is between -33 and +33. The higher the score, the greater the improvement in satisfaction. Satisfaction may be positive or negative. | 48 weeks | 
| Improvement in overall quality of life as characterized by a change in total satisfaction scale as measured by the HIVDQoL survey. | Improvement in overall quality of life as characterized by a change in total satisfaction scale as measured by the HIVDQoL survey. The range of scores is between -9 to +3. The higher the score the greater the impact. Impacts may be positive or negative. | 48 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of all participants who have plasma HIV-1 RNA Viral Load < 50 c/mL at W24 | Percentage of all participants who have plasma HIV-1 RNA Viral Load < 50 c/mL at W24 using FDA snapshot analysis, which defined a participant's virologic response status using only the viral load at the predefined timepoint within a certain window of time, along with study drug discontinuation. | Week 24 | 
| Percentage of all participants who have plasma HIV-1 RNA Viral Load < 50 c/mL at end of study | Percentage of all participants who have plasma HIV-1 RNA Viral Load < 50 c/mL at end of study (Week 48) using FDA snapshot analysis, which defined a participant's virologic response status using only the viral load at the predefined timepoint within a certain window of time, along with study drug discontinuation. | Week 48 | 
| Percentage of Participants experiencing Adverse Events (AEs) through End of Study (Week 48) | An Adverse Event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related . An AE can be any unfavorable and unintended sign, symptom, or disease associated with the use of a study intervention. | Week 48 | 
| Percentage of patients who reduced their number of total medications from baseline. | Percentage of patients who reduced their number of total medications from baseline. Polypharmacy is defined as 5 or more prescription medications and the Beers Criteria is utilized as a tool to evaluate potentially inappropriate prescriptions in this population. | Week 48 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, QOL, Elderly