HIV-1 Infection
Conditions
Keywords
HIV
Brief 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.
Interventions
DRUGDTG
50 mg tablets administered orally, once daily
DRUGF/TAF
200/25 mg tablets administered orally, once daily
DRUGB/F/TAF
50/200/25 milligrams (mg) FDC tablets administered orally, once daily
DRUGDTG Placebo
Tablets administered orally, once daily
DRUGF/TAF Placebo
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 ≥ 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/
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 | — |
| 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. |
| Change From Baseline in CD4+ Cell Count 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 for the all B/F/TAF analysis. 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 nonmissing 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 for the all B/F/TAF analysis. 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 for the all B/F/TAF analysis. 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 nonmissing 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 for the all B/F/TAF analysis. 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 | — |
| Change From Baseline in CD4+ Cell Count at Week 96 | Baseline, Week 96 | — |
Countries
Australia, Belgium, Canada, Dominican Republic, France, Germany, Italy, Puerto Rico, Spain, United Kingdom, United States
Participant flow
Recruitment details
Participants were enrolled at centers in Australia, Europe, North America, and the Dominican Republic. The first participant was screened on 11 November 2015. The last study visit occurred on 05 July 2021.
Pre-assignment details
742 participants were screened.
Participants by arm
| Arm | Count |
|---|---|
| B/F/TAF Blinded Phase: B/F/TAF (50/200/25 mg) FDC + DTG placebo + F/TAF placebo orally once daily for at least 144 weeks, without regard to food
Open-Label Extension Phase: After Week 144, participants continued to take their blinded study drug and attended visits every 12 weeks until the End of Blinded Treatment Visit. Following the End of Blinded Treatment Visit, participants were given the option to receive OL B/F/TAF for 96 weeks. After the Week 96 OL Visit, participants in a country where B/F/TAF was not commercially available were given the option to continue OL B/F/TAF until the product became accessible through an access program or until Gilead elected to discontinue the study in that country, whichever occured first. | 320 |
| DTG + F/TAF Blinded Phase: DTG (50 mg) + F/TAF (200/25 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 continued to take their blinded study drug and attended visits every 12 weeks until the End of Blinded Treatment Visit. Following the End of Blinded Treatment Visit, participants were given the option to receive OL B/F/TAF for 96 weeks. After the Week 96 OL Visit, participants in a country where B/F/TAF was not commercially available were given the option to continue OL B/F/TAF until the product became accessible through an access program or until Gilead elected to discontinue the study in that country, whichever occured first. | 325 |
| Total | 645 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Double-Blinded Phase | Adverse Event | 4 | 3 | 0 | 0 |
| Double-Blinded Phase | Death | 4 | 4 | 0 | 0 |
| Double-Blinded Phase | Investigator's Discretion | 7 | 2 | 0 | 0 |
| Double-Blinded Phase | Lost to Follow-up | 19 | 16 | 0 | 0 |
| Double-Blinded Phase | Non-Compliance with Study Drug | 0 | 3 | 0 | 0 |
| Double-Blinded Phase | Protocol Violation | 3 | 1 | 0 | 0 |
| Double-Blinded Phase | Randomized but never treated | 7 | 5 | 0 | 0 |
| Double-Blinded Phase | Withdrew Consent | 17 | 19 | 0 | 0 |
| Open-Label Extension Phase | Death | 0 | 0 | 1 | 3 |
| Open-Label Extension Phase | Investigator's Discretion | 0 | 0 | 2 | 2 |
| Open-Label Extension Phase | Lost to Follow-up | 0 | 0 | 14 | 6 |
| Open-Label Extension Phase | Non Compliance with Study Drug | 0 | 0 | 2 | 0 |
| Open-Label Extension Phase | Pregnancy | 0 | 0 | 0 | 1 |
| Open-Label Extension Phase | Protocol Violation | 0 | 0 | 0 | 2 |
| Open-Label Extension Phase | Withdrew Consent | 0 | 0 | 10 | 16 |
Baseline characteristics
| Characteristic | Total | B/F/TAF | DTG + F/TAF |
|---|---|---|---|
| Age, Continuous | 37 years STANDARD_DEVIATION 11.9 | 37 years STANDARD_DEVIATION 12.3 | 37 years STANDARD_DEVIATION 11.6 |
| CD4 Cell Count | 456 Cells/µL STANDARD_DEVIATION 243.4 | 457 Cells/µL STANDARD_DEVIATION 255.3 | 454 Cells/µL STANDARD_DEVIATION 231.5 |
| CD4 Cell Count Categories ≥ 200 to < 350 cells/μL | 144 Participants | 67 Participants | 77 Participants |
| CD4 Cell Count Categories ≥ 350 to < 500 cells/μL | 185 Participants | 91 Participants | 94 Participants |
| CD4 Cell Count Categories ≥ 500 cells/μL | 238 Participants | 118 Participants | 120 Participants |
| CD4 Cell Count Categories < 50 cells/μL | 28 Participants | 15 Participants | 13 Participants |
| CD4 Cell Count Categories ≥ 50 to < 200 cells/μL | 50 Participants | 29 Participants | 21 Participants |
| HIV-1 RNA | 4.41 log10 copies/mL STANDARD_DEVIATION 0.7 | 4.39 log10 copies/mL STANDARD_DEVIATION 0.73 | 4.42 log10 copies/mL STANDARD_DEVIATION 0.669 |
| HIV-1 RNA Categories > 100,000 ≤ 400,000 copies/mL | 95 Participants | 54 Participants | 41 Participants |
| HIV-1 RNA Categories ≤ 100,000 copies/mL | 525 Participants | 254 Participants | 271 Participants |
| HIV-1 RNA Categories > 400,000 copies/mL | 25 Participants | 12 Participants | 13 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 2 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian | 17 Participants | 7 Participants | 10 Participants |
| Race/Ethnicity, Customized Black | 197 Participants | 97 Participants | 100 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 164 Participants | 83 Participants | 81 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Pacific Islander | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 481 Participants | 237 Participants | 244 Participants |
| Race/Ethnicity, Customized Other | 50 Participants | 31 Participants | 19 Participants |
| Race/Ethnicity, Customized White | 378 Participants | 183 Participants | 195 Participants |
| Region of Enrollment Australia | 14 Participants | 4 Participants | 10 Participants |
| Region of Enrollment Belgium | 8 Participants | 4 Participants | 4 Participants |
| Region of Enrollment Canada | 21 Participants | 12 Participants | 9 Participants |
| Region of Enrollment Dominican Republic | 45 Participants | 27 Participants | 18 Participants |
| Region of Enrollment France | 12 Participants | 7 Participants | 5 Participants |
| Region of Enrollment Germany | 48 Participants | 20 Participants | 28 Participants |
| Region of Enrollment Italy | 33 Participants | 15 Participants | 18 Participants |
| Region of Enrollment Spain | 34 Participants | 17 Participants | 17 Participants |
| Region of Enrollment United Kingdom | 44 Participants | 21 Participants | 23 Participants |
| Region of Enrollment United States | 386 Participants | 193 Participants | 193 Participants |
| Sex: Female, Male Female | 77 Participants | 40 Participants | 37 Participants |
| Sex: Female, Male Male | 568 Participants | 280 Participants | 288 Participants |
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 | 4 / 327 | 4 / 330 | 1 / 254 | 3 / 265 |
| other Total, other adverse events | 250 / 320 | 262 / 325 | 165 / 254 | 163 / 265 |
| serious Total, serious adverse events | 64 / 320 | 46 / 325 | 20 / 254 | 32 / 265 |
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 | 89.4 percentage of participants |
| DTG + 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 | 92.9 percentage of participants |
95.002% CI: [-7.9, 1]
p-value: 0.12Cochran-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 | 278 cells/μL | Standard Deviation 236.6 |
| DTG + F/TAF | Change From Baseline in CD4+ Cell Count at Week 144 | 289 cells/μL | Standard Deviation 218.5 |
p-value: 0.4895% CI: [-52, 25]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 | 180 cells/μL | Standard Deviation 166.2 |
| DTG + F/TAF | Change From Baseline in CD4+ Cell Count at Week 48 | 201 cells/μL | Standard Deviation 165.9 |
p-value: 0.09695% CI: [-49, 4]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 | 304 cells/μL | Standard Deviation 249.2 |
| DTG + F/TAF | Change From Baseline in CD4+ Cell Count at Week 48 Open-Label | 9 cells/μL | Standard Deviation 198 |
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 | 237 cells/μL | Standard Deviation 204.2 |
| DTG + F/TAF | Change From Baseline in CD4+ Cell Count at Week 96 | 281 cells/μL | Standard Deviation 209.3 |
p-value: 0.00895% CI: [-81, -12]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 | 336 cells/µL | Standard Deviation 235.1 |
| DTG + F/TAF | Change From Baseline in CD4+ Cell Count at Week 96 Open-Label | -10 cells/µL | Standard Deviation 181.1 |
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 | -3.06 log10 copies/mL | Standard Deviation 0.731 |
| DTG + F/TAF | Change From Baseline in log10 HIV-1 RNA at Week 144 | -3.11 log10 copies/mL | Standard Deviation 0.672 |
p-value: 0.05495% CI: [0, 0.18]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 | -3.07 log10 copies/mL | Standard Deviation 0.719 |
| DTG + F/TAF | Change From Baseline in log10 HIV-1 RNA at Week 48 | -3.12 log10 copies/mL | Standard Deviation 0.672 |
p-value: 0.08195% CI: [-0.01, 0.17]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 | -3.08 log10 copies/mL | Standard Deviation 0.703 |
| DTG + F/TAF | Change From Baseline in log10 HIV-1 RNA at Week 96 | -3.10 log10 copies/mL | Standard Deviation 0.713 |
p-value: 0.1895% CI: [-0.03, 0.15]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 | 77.5 percentage of participants |
| DTG + 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 | 79.1 percentage of participants |
95% CI: [-7.4, 5.3]
p-value: 0.74Cochran-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 | 82.2 percentage of participants |
| DTG + 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 | 87.1 percentage of participants |
95% CI: [-9.4, 1.5]
p-value: 0.16Cochran-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 | 77.5 percentage of participants |
| DTG + 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 | 80.3 percentage of participants |
95% CI: [-8.8, 3.8]
p-value: 0.44Cochran-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 | 81.9 percentage of participants |
| DTG + 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 | 84.0 percentage of participants |
95% CI: [-7.8, 3.9]
p-value: 0.52Cochran-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 for the all B/F/TAF analysis. 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 nonmissing 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 |
| DTG + F/TAF | Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 48 Open-Label as Defined by Missing = Excluded Algorithm | 99.6 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 for the all B/F/TAF analysis. 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 | 75.3 percentage of participants |
| DTG + F/TAF | Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 48 Open-Label as Defined by Missing = Failure Algorithm | 84.5 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 | 84.1 percentage of participants |
| DTG + 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 | 86.5 percentage of participants |
95% CI: [-7.9, 3.2]
p-value: 0.41Cochran-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 for the all B/F/TAF analysis. 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 nonmissing HIV-1 RNA value at that visit.
Time frame: Baseline, open-label Week 96
Population: Participants in 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 | 99.5 percentage of participants |
| DTG + F/TAF | Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 96 Open-Label as Defined by Missing = Excluded Algorithm | 99.1 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 for the all B/F/TAF analysis. 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 | 68.1 percentage of participants |
| DTG + F/TAF | Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 96 Open-Label as Defined by Missing = Failure Algorithm | 87.5 percentage of participants |