Phase 3
Completed N=631
Study to Evaluate the Safety and Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Abacavir/Dolutegravir/Lamivudine in Human Immunodeficiency Virus-1 (HIV-1) Infected, Antiretroviral Treatment-Naive Adults
Source: ClinicalTrials.gov NCT02607930 ↗Enrolled (actual)
631
Serious AEs
12.0%
Results posted
Jul 2018
Primary outcomePrimary: Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm — 92.4; 93.0 percentage of participants — p=0.78
◆ Published Evidence
Highly cited
379citations · ~42 / year
Bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir, abacavir, and lamivudine for initial treatment of HIV-1 infection (GS-US-380-1489): a double-blind, multicentre, phase 3, randomised controlled non-inferiority trial.
Summary
The primary objective of this study is to evaluate the efficacy of a fixed dose combination (FDC) containing bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus a FDC containing abacavir/dolutegravir/lamivudine (ABC/DTG/3TC) in HIV-1 infected, antiretroviral treatment naive-adults.
Linked Publications (5)
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Bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir, abacavir, and lamivudine for initial treatment of HIV-1 infection (GS-US-380-1489): a double-blind, multicentre, phase 3, randomised controlled non-inferiority trial.
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Bictegravir combined with emtricitabine and tenofovir alafenamide versus dolutegravir, abacavir, and lamivudine for initial treatment of HIV-1 infection: week 96 results from a randomised, double-blind, multicentre, phase 3, non-inferiority trial.
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Fixed-dose combination bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir-containing regimens for initial treatment of HIV-1 infection: week 144 results from two randomised, double-blind, multicentre, phase 3, non-inferiority trials.
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Resistance Analysis of Bictegravir-Emtricitabine-Tenofovir Alafenamide in HIV-1 Treatment-Naive Patients through 48 Weeks.
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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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm |
92.4; 93.0 | 0.78 |
| SECONDARY Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 96 as Defined by the US FDA-Defined Snapshot Algorithm |
87.9; 89.8 | 0.45 |
| SECONDARY Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 144 as Defined by the US FDA-Defined Snapshot Algorithm |
81.5; 84.1 | 0.39 |
| SECONDARY Percentage of Participants Who Achieved HIV-1 RNA < 20 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm |
87.6; 87.3 | 0.87 |
| SECONDARY Percentage of Participants Who Achieved HIV-1 RNA < 20 Copies/mL at Week 96 as Defined by the US FDA-Defined Snapshot Algorithm |
83.4; 84.8 | 0.69 |
| SECONDARY Percentage of Participants Who Achieved HIV-1 RNA < 20 Copies/mL at Week 144 as Defined by the US FDA-Defined Snapshot Algorithm |
78.0; 82.2 | 0.19 |
| SECONDARY Change From Baseline in log10 HIV-1 RNA at Week 48 |
-3.11; -3.07 | 0.48 |
| SECONDARY Change From Baseline in log10 HIV-1 RNA at Week 96 |
-3.09; -3.10 | 0.99 |
| SECONDARY Change From Baseline in log10 HIV-1 RNA at Week 144 |
-3.11; -3.10 | 0.88 |
| SECONDARY Change From Baseline in CD4+ Cell Count at Week 48 |
235; 228 | 0.69 |
| SECONDARY Change From Baseline in CD4+ Cell Count at Week 96 |
287; 288 | 0.94 |
| SECONDARY Change From Baseline in CD4+ Cell Count at Week 144 |
299; 317 | 0.30 |
| SECONDARY Percentage Change From Baseline in Hip BMD at Week 48 |
-0.802; -1.148 | 0.092 |
| SECONDARY Percentage Change From Baseline in Hip BMD at Week 96 |
-1.128; -1.262 | 0.59 |
| SECONDARY Percentage Change From Baseline in Hip BMD at Week 144 |
-1.020; -1.291 | 0.39 |
| SECONDARY Percentage Change From Baseline in Spine BMD at Week 48 |
-0.772; -0.552 | 0.41 |
| SECONDARY Percentage Change From Baseline in Spine BMD at Week 96 |
-0.705; -0.219 | 0.14 |
| SECONDARY Percentage Change From Baseline in Spine BMD at Week 144 |
-0.371; 0.035 | 0.26 |
| SECONDARY Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 48 Open-Label as Defined by Missing = Excluded Algorithm |
99.2; 100 | — |
| SECONDARY Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 48 Open-Label as Defined by Missing = Failure Algorithm |
74.8; 83.5 | — |
| SECONDARY Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 96 Open-Label as Defined by Missing = Excluded Algorithm |
97.7; 99.5 | — |
| SECONDARY Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 96 Open-Label as Defined by Missing = Failure Algorithm |
66.2; 85.4 | — |
| SECONDARY Change From Baseline in CD4+ Cell Count at Week 48 Open-Label |
330; -4 | — |
| SECONDARY Change From Baseline in CD4+ Cell Count at Week 96 Open-Label |
339; -15 | — |
Eligibility Criteria
Key Inclusion Criteria
- Antiretroviral treatment naive (≤ 10 days of prior therapy with any antiretroviral agent following a diagnosis of HIV-1 infection) except the use for pre-exposure prophylaxis (PrEP) or post-exposure prophylaxis (PEP), up to one month prior to screening
- Plasma HIV-1 ribonucleic acid (RNA) levels ≥ 500 copies per milliliter (mL) at screening
- Adequate renal function: Estimated glomerular filtration rate ≥ 50 milliliter per minute (mL/min) (≥ 0.83 milliliter per second [mL/sec]) according to the Cockcroft-Gault formula
- Negative screening test for human leukocyte antigen (HLA) -B x 5701 allele provided by Gilead Sciences
Key Exclusion Criteria
- An opportunistic illness indicative of stage 3 HIV diagnosed within the 30 days prior to screening (refer to study protocol)
- Decompensated cirrhosis (e.g, ascites, encephalopathy, or variceal bleeding)
- Current alcohol or substance use judged by the Investigator to potentially interfere with subject study compliance
- Females who are pregnant (as confirmed by positive serum pregnancy test)
- Females who are breastfeeding
- Chronic Hepatitis B Virus (HBV) infection
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT02607930) 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.