HIV-1 Infection
Conditions
Keywords
HIV
Brief 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.
Interventions
DRUGABC/DTG/3TC
600/50/300 milligrams (mg) tablets administered orally, once daily
DRUGB/F/TAF
50/200/25 mg tablets administered orally, once daily, without regard to food
Tablets administered orally, once daily
DRUGB/F/TAF Placebo
Tablets administered orally, once daily
Sponsors
Gilead Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm | Week 48 | The percentage of participants achieving HIV-1 RNA \< 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 144 as Defined by the US FDA-Defined Snapshot Algorithm | Week 144 | The percentage of participants achieving HIV-1 RNA \< 50 copies/mL at Week 144 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. |
| Percentage of Participants Who Achieved HIV-1 RNA < 20 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm | Week 48 | The percentage of participants achieving HIV-1 RNA \< 20 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. |
| Percentage of Participants Who Achieved HIV-1 RNA < 20 Copies/mL at Week 96 as Defined by the US FDA-Defined Snapshot Algorithm | Week 96 | The percentage of participants achieving HIV-1 RNA \< 20 copies/mL at Week 96 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. |
| Percentage of Participants Who Achieved HIV-1 RNA < 20 Copies/mL at Week 144 as Defined by the US FDA-Defined Snapshot Algorithm | Week 144 | The percentage of participants achieving HIV-1 RNA \< 20 copies/mL at Week 144 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. |
| Change From Baseline in log10 HIV-1 RNA at Week 48 | Baseline, Week 48 | — |
| Change From Baseline in log10 HIV-1 RNA at Week 96 | Baseline, Week 96 | — |
| Change From Baseline in log10 HIV-1 RNA at Week 144 | Baseline, Week 144 | — |
| Change From Baseline in CD4+ Cell Count at Week 48 | Baseline, Week 48 | — |
| Change From Baseline in CD4+ Cell Count at Week 96 | Baseline, Week 96 | — |
| Change From Baseline in CD4+ Cell Count at Week 144 | Baseline, Week 144 | — |
| Percentage Change From Baseline in Hip BMD at Week 48 | Baseline, Week 48 | — |
| Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 96 as Defined by the US FDA-Defined Snapshot Algorithm | Week 96 | The percentage of participants achieving HIV-1 RNA \< 50 copies/mL at Week 96 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. |
| Percentage Change From Baseline in Hip BMD at Week 144 | Baseline, Week 144 | — |
| Percentage Change From Baseline in Spine BMD at Week 48 | Baseline, Week 48 | — |
| Percentage Change From Baseline in Spine BMD at Week 96 | Baseline, Week 96 | — |
| Percentage Change From Baseline in Spine BMD at Week 144 | Baseline, Week 144 | — |
| Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 48 Open-Label as Defined by Missing = Excluded Algorithm | Baseline, open-label Week 48 | The percentage of participants with HIV-1 RNA \< 50 copies/mL was analyzed using Missing = Excluded for imputing missing HIV-1 RNA values using the All B/F/TAF Analysis Set. All missing data was excluded in the computation of the percentages (ie, missing data points were excluded from both the numerator and denominator in the computation). The denominator for percentages at a visit was the number of participants in the all B/F/TAF analysis set with non-missing HIV-1 RNA value at that visit. |
| Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 48 Open-Label as Defined by Missing = Failure Algorithm | Baseline, open-label Week 48 | The percentage of participants with HIV-1 RNA \< 50 copies/mL was analyzed using Missing = Failure for imputing missing HIV-1 RNA values using the All B/F/TAF Analysis Set. All missing data was treated as HIV-1 RNA ≥ 50 copies/mL. The denominator for percentages was the number of participants in all B/F/TAF analysis set. |
| Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 96 Open-Label as Defined by Missing = Excluded Algorithm | Baseline, open-label Week 96 | The percentage of participants with HIV-1 RNA \< 50 copies/mL was analyzed using Missing = Excluded for imputing missing HIV-1 RNA values using the All B/F/TAF Analysis Set. All missing data was excluded in the computation of the percentages (ie, missing data points were excluded from both the numerator and denominator in the computation). The denominator for percentages at a visit was the number of participants in the all B/F/TAF analysis set with non-missing HIV-1 RNA value at that visit. |
| Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 96 Open-Label as Defined by Missing = Failure Algorithm | Baseline, open-label Week 96 | The percentage of participants with HIV-1 RNA \< 50 copies/mL was analyzed using Missing = Failure for imputing missing HIV-1 RNA values using the All B/F/TAF Analysis Set. All missing data was treated as HIV-1 RNA ≥ 50 copies/mL. The denominator for percentages was the number of participants in all B/F/TAF analysis set. |
| Change From Baseline in CD4+ Cell Count at Week 48 Open-Label | Baseline, open-label Week 48 | — |
| Change From Baseline in CD4+ Cell Count at Week 96 Open-Label | Baseline, open-label Week 96 | — |
| Percentage Change From Baseline in Hip BMD at Week 96 | Baseline, Week 96 | — |
Countries
Belgium, Canada, Dominican Republic, France, Germany, Italy, Puerto Rico, Spain, United Kingdom, United States
Participant flow
Recruitment details
Participants were enrolled at study centers in Europe, Dominican Republic, and North America. The first participant was screened on 13 November 2015. The last study visit occurred on 02 July 2021.
Pre-assignment details
739 participants were screened.
Participants by arm
| Arm | Count |
|---|---|
| B/F/TAF Blinded Phase: B/F/TAF (50/200/25 mg) FDC tablet + ABC/DTG/3TC placebo orally once daily for at least 144 weeks, without regard to food
Open-Label Extension Phase: After Week 144, participants will continue to take their blinded study drug and attend visits every 12 weeks until the End of Blinded Treatment Visit. Following the End of Blinded Treatment Visit, participants will be given the option to receive open-label (OL) B/F/TAF for 96 weeks. After the Week 96 OL Visit, participants in a country where B/F/TAF is not commercially available will be given the option to continue OL B/F/TAF until the product becomes accessible through an access program or until Gilead elects to discontinue the study in that country, whichever occurs first. | 314 |
| ABC/DTG/3TC Blinded Phase: ABC/DTG/3TC (600/50/300 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 144 weeks, without regard to food
Open-Label Extension Phase: After Week 144, participants will continue to take their blinded study drug and attend visits every 12 weeks until the End of Blinded Treatment Visit. Following the End of Blinded Treatment Visit, participants will be given the option to receive open-label (OL) B/F/TAF for 96 weeks. After the Week 96 OL Visit, participants in a country where B/F/TAF is not commercially available will be given the option to continue OL B/F/TAF until the product becomes accessible through an access program or until Gilead elects to discontinue the study in that country, whichever occurs first. | 315 |
| Total | 629 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Double-Blinded Treatment Phase | Adverse Event | 0 | 4 | 0 | 0 |
| Double-Blinded Treatment Phase | Death | 2 | 1 | 0 | 0 |
| Double-Blinded Treatment Phase | Investigator's discretion | 6 | 3 | 0 | 0 |
| Double-Blinded Treatment Phase | Lost to Follow-up | 25 | 19 | 0 | 0 |
| Double-Blinded Treatment Phase | Non-compliance with study drug | 3 | 5 | 0 | 0 |
| Double-Blinded Treatment Phase | Protocol Violation | 2 | 3 | 0 | 0 |
| Double-Blinded Treatment Phase | Randomized but never treated | 2 | 0 | 0 | 0 |
| Double-Blinded Treatment Phase | Withdrew consent | 14 | 18 | 0 | 0 |
| Open-Label B/F/TAF Extension Phase | Adverse Event | 0 | 0 | 4 | 2 |
| Open-Label B/F/TAF Extension Phase | Death | 0 | 0 | 0 | 1 |
| Open-Label B/F/TAF Extension Phase | Investigator's discretion | 0 | 0 | 2 | 5 |
| Open-Label B/F/TAF Extension Phase | Lack of Efficacy | 0 | 0 | 1 | 1 |
| Open-Label B/F/TAF Extension Phase | Lost to Follow-up | 0 | 0 | 15 | 10 |
| Open-Label B/F/TAF Extension Phase | Non-compliance with study drug | 0 | 0 | 1 | 0 |
| Open-Label B/F/TAF Extension Phase | Protocol Violation | 0 | 0 | 1 | 1 |
| Open-Label B/F/TAF Extension Phase | Withdrew consent | 0 | 0 | 10 | 13 |
Baseline characteristics
| Characteristic | Total | ABC/DTG/3TC | B/F/TAF |
|---|---|---|---|
| Age, Continuous | 34 years STANDARD_DEVIATION 10.8 | 34 years STANDARD_DEVIATION 10.8 | 34 years STANDARD_DEVIATION 10.9 |
| CD4 Cell Count | 464 Cells/µL STANDARD_DEVIATION 226.3 | 476 Cells/µL STANDARD_DEVIATION 231.4 | 453 Cells/µL STANDARD_DEVIATION 220.8 |
| CD4 Cell Count Categories ≥ 200 to < 350 Cells/µL | 127 Participants | 58 Participants | 69 Participants |
| CD4 Cell Count Categories ≥ 350 to < 500 Cells/µL | 178 Participants | 91 Participants | 87 Participants |
| CD4 Cell Count Categories ≥ 500 Cells/µL | 256 Participants | 134 Participants | 122 Participants |
| CD4 Cell Count Categories < 50 Cells/µL | 17 Participants | 10 Participants | 7 Participants |
| CD4 Cell Count Categories ≥ 50 to < 200 Cells/µL | 51 Participants | 22 Participants | 29 Participants |
| Hip Bone Mineral Density (BMD) | 1.052 g/cm^2 STANDARD_DEVIATION 0.1546 | 1.057 g/cm^2 STANDARD_DEVIATION 0.152 | 1.048 g/cm^2 STANDARD_DEVIATION 0.1572 |
| HIV-1 RNA | 4.42 log10 copies/mL STANDARD_DEVIATION 0.665 | 4.42 log10 copies/mL STANDARD_DEVIATION 0.685 | 4.41 log10 copies/mL STANDARD_DEVIATION 0.647 |
| HIV-1 RNA Categories > 100,000 ≤ 400,000 copies/mL | 83 Participants | 38 Participants | 45 Participants |
| HIV-1 RNA Categories ≤ 100,000 copies/mL | 526 Participants | 265 Participants | 261 Participants |
| HIV-1 RNA Categories > 400,000 copies/mL | 20 Participants | 12 Participants | 8 Participants |
| Race/Ethnicity, Customized Ethnicity Hispanic or Latino | 137 Participants | 65 Participants | 72 Participants |
| Race/Ethnicity, Customized Ethnicity Not Hispanic or Latino | 489 Participants | 249 Participants | 240 Participants |
| Race/Ethnicity, Customized Ethnicity Not Permitted | 3 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Race American Indian or Alaska Native | 6 Participants | 4 Participants | 2 Participants |
| Race/Ethnicity, Customized Race Asian | 16 Participants | 10 Participants | 6 Participants |
| Race/Ethnicity, Customized Race Black | 226 Participants | 112 Participants | 114 Participants |
| Race/Ethnicity, Customized Race Native Hawaiian or Pacific Islander | 3 Participants | 2 Participants | 1 Participants |
| Race/Ethnicity, Customized Race Not Permitted | 2 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Race Other | 17 Participants | 8 Participants | 9 Participants |
| Race/Ethnicity, Customized Race White | 359 Participants | 179 Participants | 180 Participants |
| Region of Enrollment Belgium | 6 Participants | 2 Participants | 4 Participants |
| Region of Enrollment Canada | 33 Participants | 15 Participants | 18 Participants |
| Region of Enrollment Dominican Republic | 3 Participants | 1 Participants | 2 Participants |
| Region of Enrollment France | 21 Participants | 10 Participants | 11 Participants |
| Region of Enrollment Germany | 13 Participants | 9 Participants | 4 Participants |
| Region of Enrollment Italy | 18 Participants | 11 Participants | 7 Participants |
| Region of Enrollment Spain | 43 Participants | 23 Participants | 20 Participants |
| Region of Enrollment United Kingdom | 31 Participants | 11 Participants | 20 Participants |
| Region of Enrollment United States | 461 Participants | 233 Participants | 228 Participants |
| Sex: Female, Male Female | 62 Participants | 33 Participants | 29 Participants |
| Sex: Female, Male Male | 567 Participants | 282 Participants | 285 Participants |
| Spine BMD | 1.140 g/cm^2 STANDARD_DEVIATION 0.178 | 1.142 g/cm^2 STANDARD_DEVIATION 0.1713 | 1.139 g/cm^2 STANDARD_DEVIATION 0.1847 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 2 / 316 | 1 / 315 | 2 / 252 | 2 / 254 |
| other Total, other adverse events | 262 / 314 | 276 / 315 | 152 / 252 | 153 / 254 |
| serious Total, serious adverse events | 44 / 314 | 54 / 315 | 19 / 252 | 19 / 254 |
Outcome results
Primary
Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm
The percentage of participants achieving HIV-1 RNA \< 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Time frame: Week 48
Population: Full Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| B/F/TAF | 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 percentage of participants |
| ABC/DTG/3TC | Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm | 93.0 percentage of participants |
95.002% CI: [-4.8, 3.6]
p-value: 0.78Cochran-Mantel-Haenszel
Secondary
Change From Baseline in CD4+ Cell Count at Week 144
Time frame: Baseline, Week 144
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| B/F/TAF | Change From Baseline in CD4+ Cell Count at Week 144 | 299 cells/µL | Standard Deviation 224.9 |
| ABC/DTG/3TC | Change From Baseline in CD4+ Cell Count at Week 144 | 317 cells/µL | Standard Deviation 219.5 |
p-value: 0.395% CI: [-59, 18]ANOVA
Secondary
Change From Baseline in CD4+ Cell Count at Week 48
Time frame: Baseline, Week 48
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| B/F/TAF | Change From Baseline in CD4+ Cell Count at Week 48 | 235 cells/µL | Standard Deviation 185.8 |
| ABC/DTG/3TC | Change From Baseline in CD4+ Cell Count at Week 48 | 228 cells/µL | Standard Deviation 188.7 |
p-value: 0.6995% CI: [-24, 36]ANOVA
Secondary
Change From Baseline in CD4+ Cell Count at Week 48 Open-Label
Time frame: Baseline, open-label Week 48
Population: Participants in the All B/F/TAF Analysis Set with available data were analyzed. For the B/F/TAF group, Week 48 open-label time point refers to Week 192; for Change from Baseline in CD4 Cell Count analysis, it included the available participants at that time point from the Randomized Phase.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| B/F/TAF | Change From Baseline in CD4+ Cell Count at Week 48 Open-Label | 330 cells/µL | Standard Deviation 242.8 |
| ABC/DTG/3TC | Change From Baseline in CD4+ Cell Count at Week 48 Open-Label | -4 cells/µL | Standard Deviation 202 |
Secondary
Change From Baseline in CD4+ Cell Count at Week 96
Time frame: Baseline, Week 96
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| B/F/TAF | Change From Baseline in CD4+ Cell Count at Week 96 | 287 cells/µL | Standard Deviation 206.9 |
| ABC/DTG/3TC | Change From Baseline in CD4+ Cell Count at Week 96 | 288 cells/µL | Standard Deviation 246.8 |
p-value: 0.9495% CI: [-39, 36]ANOVA
Secondary
Change From Baseline in CD4+ Cell Count at Week 96 Open-Label
Time frame: Baseline, open-label Week 96
Population: Participants in the All B/F/TAF Analysis Set with available data were analyzed. For the B/F/TAF group, Week 96 open-label time point refers to Week 240; for Change from Baseline in CD4 Cell Count analysis, it included the available participants at that time point from the Randomized Phase.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| B/F/TAF | Change From Baseline in CD4+ Cell Count at Week 96 Open-Label | 339 cell/µL | Standard Deviation 237.8 |
| ABC/DTG/3TC | Change From Baseline in CD4+ Cell Count at Week 96 Open-Label | -15 cell/µL | Standard Deviation 188.1 |
Secondary
Change From Baseline in log10 HIV-1 RNA at Week 144
Time frame: Baseline, Week 144
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| B/F/TAF | Change From Baseline in log10 HIV-1 RNA at Week 144 | -3.11 log10 copies/mL | Standard Deviation 0.639 |
| ABC/DTG/3TC | Change From Baseline in log10 HIV-1 RNA at Week 144 | -3.10 log10 copies/mL | Standard Deviation 0.681 |
p-value: 0.8895% CI: [-0.08, 0.1]ANOVA
Secondary
Change From Baseline in log10 HIV-1 RNA at Week 48
Time frame: Baseline, Week 48
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| B/F/TAF | Change From Baseline in log10 HIV-1 RNA at Week 48 | -3.11 log10 copies/mL | Standard Deviation 0.641 |
| ABC/DTG/3TC | Change From Baseline in log10 HIV-1 RNA at Week 48 | -3.07 log10 copies/mL | Standard Deviation 0.738 |
p-value: 0.4895% CI: [-0.12, 0.06]ANOVA
Secondary
Change From Baseline in log10 HIV-1 RNA at Week 96
Time frame: Baseline, Week 96
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| B/F/TAF | Change From Baseline in log10 HIV-1 RNA at Week 96 | -3.09 log10 copies/mL | Standard Deviation 0.643 |
| ABC/DTG/3TC | Change From Baseline in log10 HIV-1 RNA at Week 96 | -3.10 log10 copies/mL | Standard Deviation 0.705 |
p-value: 0.9995% CI: [-0.09, 0.09]ANOVA
Secondary
Percentage Change From Baseline in Hip BMD at Week 144
Time frame: Baseline, Week 144
Population: Participants in the Hip DXA Analysis Set with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| B/F/TAF | Percentage Change From Baseline in Hip BMD at Week 144 | -1.020 percentage change | Standard Deviation 3.7638 |
| ABC/DTG/3TC | Percentage Change From Baseline in Hip BMD at Week 144 | -1.291 percentage change | Standard Deviation 3.114 |
p-value: 0.3995% CI: [-0.351, 0.893]ANOVA
Secondary
Percentage Change From Baseline in Hip BMD at Week 48
Time frame: Baseline, Week 48
Population: Participants in the Hip DXA Analysis Set with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| B/F/TAF | Percentage Change From Baseline in Hip BMD at Week 48 | -0.802 percentage change | Standard Deviation 2.328 |
| ABC/DTG/3TC | Percentage Change From Baseline in Hip BMD at Week 48 | -1.148 percentage change | Standard Deviation 2.5126 |
p-value: 0.09295% CI: [-0.057, 0.748]ANOVA
Secondary
Percentage Change From Baseline in Hip BMD at Week 96
Time frame: Baseline, Week 96
Population: Participants in the Hip DXA Analysis Set with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| B/F/TAF | Percentage Change From Baseline in Hip BMD at Week 96 | -1.128 percentage change | Standard Deviation 2.7702 |
| ABC/DTG/3TC | Percentage Change From Baseline in Hip BMD at Week 96 | -1.262 percentage change | Standard Deviation 2.8524 |
p-value: 0.5995% CI: [-0.356, 0.625]ANOVA
Secondary
Percentage Change From Baseline in Spine BMD at Week 144
Time frame: Baseline, Week 144
Population: Participants in the Spine DXA Analysis Set with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| B/F/TAF | Percentage Change From Baseline in Spine BMD at Week 144 | -0.371 percentage change | Standard Deviation 4.4369 |
| ABC/DTG/3TC | Percentage Change From Baseline in Spine BMD at Week 144 | 0.035 percentage change | Standard Deviation 3.5182 |
p-value: 0.2695% CI: [-1.119, 0.307]ANOVA
Secondary
Percentage Change From Baseline in Spine BMD at Week 48
Time frame: Baseline, Week 48
Population: Participants in the Spine DXA Analysis Set with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| B/F/TAF | Percentage Change From Baseline in Spine BMD at Week 48 | -0.772 percentage change | Standard Deviation 3.2228 |
| ABC/DTG/3TC | Percentage Change From Baseline in Spine BMD at Week 48 | -0.552 percentage change | Standard Deviation 3.0956 |
p-value: 0.4195% CI: [-0.741, 0.3]ANOVA
Secondary
Percentage Change From Baseline in Spine BMD at Week 96
Time frame: Baseline, Week 96
Population: Participants in the Spine DXA Analysis Set with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| B/F/TAF | Percentage Change From Baseline in Spine BMD at Week 96 | -0.705 percentage change | Standard Deviation 3.8721 |
| ABC/DTG/3TC | Percentage Change From Baseline in Spine BMD at Week 96 | -0.219 percentage change | Standard Deviation 3.5159 |
p-value: 0.1495% CI: [-1.126, 0.155]ANOVA
Secondary
Percentage of Participants Who Achieved HIV-1 RNA < 20 Copies/mL at Week 144 as Defined by the US FDA-Defined Snapshot Algorithm
The percentage of participants achieving HIV-1 RNA \< 20 copies/mL at Week 144 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Time frame: Week 144
Population: Participants in the Full Analysis Set were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| B/F/TAF | 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 percentage of participants |
| ABC/DTG/3TC | Percentage of Participants Who Achieved HIV-1 RNA < 20 Copies/mL at Week 144 as Defined by the US FDA-Defined Snapshot Algorithm | 82.2 percentage of participants |
95% CI: [-10.5, 2.1]
p-value: 0.19Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Who Achieved HIV-1 RNA < 20 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm
The percentage of participants achieving HIV-1 RNA \< 20 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Time frame: Week 48
Population: Participants in the Full Analysis Set were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| B/F/TAF | 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 percentage of participants |
| ABC/DTG/3TC | Percentage of Participants Who Achieved HIV-1 RNA < 20 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm | 87.3 percentage of participants |
95% CI: [-4.8, 5.6]
p-value: 0.87Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Who Achieved HIV-1 RNA < 20 Copies/mL at Week 96 as Defined by the US FDA-Defined Snapshot Algorithm
The percentage of participants achieving HIV-1 RNA \< 20 copies/mL at Week 96 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Time frame: Week 96
Population: Participants in the Full Analysis Set were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| B/F/TAF | 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 percentage of participants |
| ABC/DTG/3TC | Percentage of Participants Who Achieved HIV-1 RNA < 20 Copies/mL at Week 96 as Defined by the US FDA-Defined Snapshot Algorithm | 84.8 percentage of participants |
95% CI: [-6.9, 4.6]
p-value: 0.69Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 144 as Defined by the US FDA-Defined Snapshot Algorithm
The percentage of participants achieving HIV-1 RNA \< 50 copies/mL at Week 144 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Time frame: Week 144
Population: Participants in the Full Analysis Set were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| B/F/TAF | 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 percentage of participants |
| ABC/DTG/3TC | Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 144 as Defined by the US FDA-Defined Snapshot Algorithm | 84.1 percentage of participants |
95% CI: [-8.5, 3.4]
p-value: 0.39Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 48 Open-Label as Defined by Missing = Excluded Algorithm
The percentage of participants with HIV-1 RNA \< 50 copies/mL was analyzed using Missing = Excluded for imputing missing HIV-1 RNA values using the All B/F/TAF Analysis Set. All missing data was excluded in the computation of the percentages (ie, missing data points were excluded from both the numerator and denominator in the computation). The denominator for percentages at a visit was the number of participants in the all B/F/TAF analysis set with non-missing HIV-1 RNA value at that visit.
Time frame: Baseline, open-label Week 48
Population: Participants in All B/F/TAF Analysis Set (who were randomized into the randomized phase of the study and received at least 1 dose of the B/F/TAF in the randomized phase or at least 1 dose of the B/F/TAF in the open label extension phase) with available data were analyzed. For the B/F/TAF group, Week 48 open-label time point refers to Week 192; for Missing = Excluded analysis, it included the available participants at that time point from the Randomized Phase.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| B/F/TAF | Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 48 Open-Label as Defined by Missing = Excluded Algorithm | 99.2 percentage of participants |
| ABC/DTG/3TC | Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 48 Open-Label as Defined by Missing = Excluded Algorithm | 100 percentage of participants |
Secondary
Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 48 Open-Label as Defined by Missing = Failure Algorithm
The percentage of participants with HIV-1 RNA \< 50 copies/mL was analyzed using Missing = Failure for imputing missing HIV-1 RNA values using the All B/F/TAF Analysis Set. All missing data was treated as HIV-1 RNA ≥ 50 copies/mL. The denominator for percentages was the number of participants in all B/F/TAF analysis set.
Time frame: Baseline, open-label Week 48
Population: Participants in the All B/F/TAF Analysis Set were analyzed. For the B/F/TAF group, Week 48 open-label time point refers to Week 192; for Missing = Failure analysis, it included all participants from the Randomized Phase.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| B/F/TAF | Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 48 Open-Label as Defined by Missing = Failure Algorithm | 74.8 percentage of participants |
| ABC/DTG/3TC | Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 48 Open-Label as Defined by Missing = Failure Algorithm | 83.5 percentage of participants |
Secondary
Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 96 as Defined by the US FDA-Defined Snapshot Algorithm
The percentage of participants achieving HIV-1 RNA \< 50 copies/mL at Week 96 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Time frame: Week 96
Population: Participants in the Full Analysis Set were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| B/F/TAF | 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 percentage of participants |
| ABC/DTG/3TC | Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 96 as Defined by the US FDA-Defined Snapshot Algorithm | 89.8 percentage of participants |
95% CI: [-6.9, 3.1]
p-value: 0.45Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 96 Open-Label as Defined by Missing = Excluded Algorithm
The percentage of participants with HIV-1 RNA \< 50 copies/mL was analyzed using Missing = Excluded for imputing missing HIV-1 RNA values using the All B/F/TAF Analysis Set. All missing data was excluded in the computation of the percentages (ie, missing data points were excluded from both the numerator and denominator in the computation). The denominator for percentages at a visit was the number of participants in the all B/F/TAF analysis set with non-missing HIV-1 RNA value at that visit.
Time frame: Baseline, open-label Week 96
Population: Participants in the All B/F/TAF Analysis Set with available data were analyzed. For the B/F/TAF group, Week 96 open-label time point refers to Week 240; for Missing = Excluded analysis, it included the available participants at that time point from the Randomized Phase.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| B/F/TAF | Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 96 Open-Label as Defined by Missing = Excluded Algorithm | 97.7 percentage of participants |
| ABC/DTG/3TC | Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 96 Open-Label as Defined by Missing = Excluded Algorithm | 99.5 percentage of participants |
Secondary
Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 96 Open-Label as Defined by Missing = Failure Algorithm
The percentage of participants with HIV-1 RNA \< 50 copies/mL was analyzed using Missing = Failure for imputing missing HIV-1 RNA values using the All B/F/TAF Analysis Set. All missing data was treated as HIV-1 RNA ≥ 50 copies/mL. The denominator for percentages was the number of participants in all B/F/TAF analysis set.
Time frame: Baseline, open-label Week 96
Population: Participants in the All B/F/TAF Analysis Set were analyzed. For the B/F/TAF group, Week 96 open-label time point refers to Week 240; for Missing = Failure analysis, it included all participants from the Randomized Phase.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| B/F/TAF | Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 96 Open-Label as Defined by Missing = Failure Algorithm | 66.2 percentage of participants |
| ABC/DTG/3TC | Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 96 Open-Label as Defined by Missing = Failure Algorithm | 85.4 percentage of participants |