Phase 3
Completed N=86
Study to Evaluate Switching From an E/C/F/TAF Fixed-Dose Combination (FDC) Regimen or a TDF Containing Regimen to B/F/TAF FDC in Human Immunodeficiency Virus-1 (HIV-1) Infected Participants Aged ≥ 65 Years
Source: ClinicalTrials.gov NCT03405935 ↗Enrolled (actual)
86
Serious AEs
10.5%
Results posted
Dec 2019
Primary outcomePrimary: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 as Defined by the Food and Drug Administration (FDA)-Defined Snapshot Algorithm — 97.7 percentage of participants
◆ Published Evidence
Established
50citations · ~10 / year
Bictegravir/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed People with HIV Aged ≥ 65 Years: Week 48 Results of a Phase 3b, Open-Label Trial.
Summary
The primary objective of this study is to characterize the virologic efficacy of switching virologically suppressed participants on an elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) regimen or a tenofovir disoproxil fumarate (TDF) containing regimen to bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) FDC.
Linked Publications (2)
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Bictegravir/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed People with HIV Aged ≥ 65 Years: Week 48 Results of a Phase 3b, Open-Label Trial.
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Bictegravir/emtricitabine/tenofovir alafenamide in older individuals with HIV: Results of a 96-week, phase 3b, open-label, switch trial in virologically suppressed people ≥65 years of age.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 as Defined by the Food and Drug Administration (FDA)-Defined Snapshot Algorithm |
97.7 | — |
| SECONDARY Percentage of Participants Experiencing Adverse Events (AEs) Through Week 24 |
62.8 | — |
| SECONDARY Percentage of Participants Experiencing AEs Through Week 48 |
81.4 | — |
| SECONDARY Percentage of Participants Experiencing AEs Through Week 72 |
94.2 | — |
| SECONDARY Percentage of Participants Experiencing AEs Through Week 96 |
95.3 | — |
| SECONDARY Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the FDA-Defined Snapshot Algorithm |
90.7 | — |
| SECONDARY Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 72 as Defined by the FDA-Defined Snapshot Algorithm |
94.2 | — |
| SECONDARY Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96 as Defined by the FDA-Defined Snapshot Algorithm |
74.4 | — |
| SECONDARY Change From Baseline in CD4 Cell Count at Week 24 |
20 | — |
| SECONDARY Change From Baseline in CD4 Cell Count at Week 48 |
8 | — |
| SECONDARY Change From Baseline in CD4 Cell Count at Week 72 |
36 | — |
| SECONDARY Change From Baseline in CD4 Cell Count at Week 96 |
22 | — |
| SECONDARY Change From Baseline in CD4 Percentage at Week 24 |
0.1 | — |
| SECONDARY Change From Baseline in CD4 Percentage at Week 48 |
0.1 | — |
| SECONDARY Change From Baseline in CD4 Percentage at Week 72 |
-0.1 | — |
| SECONDARY Change From Baseline in CD4 Percentage at Week 96 |
-0.1 | — |
| SECONDARY Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24, as Analyzed by Missing = Failure Approach |
97.7 | — |
| SECONDARY Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48, as Analyzed by Missing = Failure Approach |
90.7 | — |
| SECONDARY Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 72, as Analyzed by Missing = Failure Approach |
94.2 | — |
| SECONDARY Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96, as Analyzed by Missing = Failure Approach |
79.1 | — |
| SECONDARY Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24, as Analyzed by Missing = Excluded Approach |
100.0 | — |
| SECONDARY Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48, as Analyzed by Missing = Excluded Approach |
100.0 | — |
| SECONDARY Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 72, as Analyzed by Missing = Excluded Approach |
100.0 | — |
| SECONDARY Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96, as Analyzed by Missing = Excluded Approach |
100.0 | — |
Eligibility Criteria
Key Inclusion Criteria
- Currently receiving an antiretroviral regimen of E/C/F/TAF FDC (or emtricitabine [FTC]/TDF + 3rd agent if currently or previously participated in Study GS-US-292-1826 [NCT02616783]) for ≥ 3 months
- Documented plasma HIV-1 ribonucleic acid (RNA) < 50 copies/mL during treatment with E/C/F/TAF (or FTC/TDF + 3rd agent if currently or previously participated in Study GS-US-292-1826 [NCT02616783]) for the last 2 visits 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)
- Adequate renal function, an estimated glomerular filtration rate (eGFR) ≥ 30 mL/min according to the Cockcroft-Gault formula for creatinine clearance
Key Exclusion Criteria
- An opportunistic illness indicative of stage 3 HIV diagnosed within the 30 days prior to screening
- Decompensated cirrhosis (eg, ascites, encephalopathy, or variceal bleeding)
- Current alcohol or substance use judged by the investigator to potentially interfere with participant study compliance
Note: Other protocol defined Inclusion/ Exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT03405935) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.