Phase 3
Completed N=567
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
Source: ClinicalTrials.gov NCT02603120 ↗Enrolled (actual)
567
Serious AEs
7.2%
Results posted
Jul 2018
Primary outcomePrimary: Percentage of Participants With Virologic Failure (HIV-1 RNA ≥ 50 Copies/mL) as Defined by the Modified US FDA-defined Snapshot Algorithm — 1.1; 0.4 percentage of participants — p=0.62
◆ Published Evidence
Highly cited
201citations · ~25 / year
Switching to fixed-dose bictegravir, emtricitabine, and tenofovir alafenamide from dolutegravir plus abacavir and lamivudine in virologically suppressed adults with HIV-1: 48 week results of a randomised, double-blind, multicentre, active-controlled, phase 3, non-inferiority trial.
Summary
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.
Linked Publications (5)
-
Switching to fixed-dose bictegravir, emtricitabine, and tenofovir alafenamide from dolutegravir plus abacavir and lamivudine in virologically suppressed adults with HIV-1: 48 week results of a randomised, double-blind, multicentre, active-controlled, phase 3, non-inferiority trial.
-
Switching to bictegravir/emtricitabine/tenofovir alafenamide maintained HIV-1 RNA suppression in participants with archived antiretroviral resistance including M184V/I.
-
Patient-Reported Symptoms Over 48 Weeks Among Participants in Randomized, Double-Blind, Phase III Non-inferiority Trials of Adults with HIV on Co-formulated Bictegravir, Emtricitabine, and Tenofovir Alafenamide versus Co-formulated Abacavir, Dolutegravir, and Lamivudine.
-
Efficacy and safety of switching to bictegravir, emtricitabine, and tenofovir alafenamide in virologically suppressed Asian adults living with HIV: A pooled analysis from three international phase III randomized trials.
-
Efficacy and safety of switch to bictegravir/emtricitabine/tenofovir alafenamide from dolutegravir/abacavir/lamivudine: Results from an open-label extension of a phase 3 randomized, double-blind, multicenter, active-controlled, non-inferiority study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Virologic Failure (HIV-1 RNA ≥ 50 Copies/mL) as Defined by the Modified US FDA-defined Snapshot Algorithm |
1.1; 0.4 | 0.62 |
| SECONDARY Percentage of Participants With HIV-1 RNA < 50 Copies/mL as Defined by the US FDA-defined Snapshot Algorithm |
93.6; 95.0 | .59 |
| SECONDARY Change From Baseline in CD4+ Cell Count at Week 48 |
-31; 4 | 0.031 sig |
| SECONDARY Spine Bone Mineral Density (BMD) at Baseline |
1.124; 1.103 | — |
| SECONDARY Percentage Change From Baseline in Spine BMD at Week 48 |
0.692; 0.416 | 0.33 |
| SECONDARY Hip Bone Mineral Density at Baseline |
1.006; 0.996 | — |
| SECONDARY Percentage Change From Baseline in Hip BMD at Week 48 |
0.156; 0.299 | 0.47 |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02603120) 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.