Phase 3
Completed N=657
Study to Evaluate the Safety and Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Alafenamide in Human Immunodeficiency Virus (HIV-1) Infected, Antiretroviral Treatment-Naive Adults
Source: ClinicalTrials.gov NCT02607956 ↗Enrolled (actual)
657
Serious AEs
13.9%
Results posted
Jun 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 — 89.4; 92.9 percentage of participants — p=0.12
◆ Published Evidence
Highly cited
394citations · ~44 / year
Coformulated bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir with emtricitabine and tenofovir alafenamide, for initial treatment of HIV-1 infection (GS-US-380-1490): a randomised, double-blind, multicentre, phase 3, non-inferiority trial.
Summary
This 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 dolutegravir (DTG) + a FDC containing emtricitabine/tenofovir alafenamide (F/TAF) in HIV-1 infected, antiretroviral treatment-naive adults.
Linked Publications (5)
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Coformulated bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir with emtricitabine and tenofovir alafenamide, for initial treatment of HIV-1 infection (GS-US-380-1490): a randomised, double-blind, multicentre, phase 3, non-inferiority trial.
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Renal safety of tenofovir alafenamide vs. tenofovir disoproxil fumarate: a pooled analysis of 26 clinical trials.
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Co-formulated bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir with emtricitabine and tenofovir alafenamide 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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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 |
89.4; 92.9 | 0.12 |
| SECONDARY Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 96 as Defined by the US FDA-Defined Snapshot Algorithm |
84.1; 86.5 | 0.41 |
| SECONDARY Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 144 as Defined by the US FDA-Defined Snapshot Algorithm |
81.9; 84.0 | 0.52 |
| SECONDARY Percentage of Participants Who Achieved HIV-1 RNA < 20 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm |
82.2; 87.1 | 0.16 |
| SECONDARY Percentage of Participants Who Achieved HIV-1 RNA < 20 Copies/mL at Week 96 as Defined by the US FDA-Defined Snapshot Algorithm |
77.5; 80.3 | 0.44 |
| SECONDARY Percentage of Participants Who Achieved HIV-1 RNA < 20 Copies/mL at Week 144 as Defined by the US FDA-Defined Snapshot Algorithm |
77.5; 79.1 | 0.74 |
| SECONDARY Change From Baseline in log10 HIV-1 RNA at Week 48 |
-3.07; -3.12 | 0.081 |
| SECONDARY Change From Baseline in log10 HIV-1 RNA at Week 96 |
-3.08; -3.10 | 0.18 |
| SECONDARY Change From Baseline in log10 HIV-1 RNA at Week 144 |
-3.06; -3.11 | 0.054 |
| SECONDARY Change From Baseline in CD4+ Cell Count at Week 48 |
180; 201 | 0.096 |
| SECONDARY Change From Baseline in CD4+ Cell Count at Week 96 |
237; 281 | 0.008 sig |
| SECONDARY Change From Baseline in CD4+ Cell Count at Week 144 |
278; 289 | 0.48 |
| 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; 99.6 | — |
| SECONDARY Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 48 Open-Label as Defined by Missing = Failure Algorithm |
75.3; 84.5 | — |
| SECONDARY Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 96 Open-Label as Defined by Missing = Excluded Algorithm |
99.5; 99.1 | — |
| SECONDARY Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 96 Open-Label as Defined by Missing = Failure Algorithm |
68.1; 87.5 | — |
| SECONDARY Change From Baseline in CD4+ Cell Count at Week 48 Open-Label |
304; 9 | — |
| SECONDARY Change From Baseline in CD4+ Cell Count at Week 96 Open-Label |
336; -10 | — |
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 ≥ 30 mL per minute (min) (≥ 0.50 mL per second (sec)) according to the Cockcroft-Gault formula
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 subject study compliance
- Females who are pregnant (as confirmed by positive serum pregnancy test)
- Females who are breastfeeding
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT02607956) 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.