HIV-1 Infection
Conditions
Brief summary
The primary objective of this study is to evaluate the efficacy of switching from a regimen of 2 nucleos(t)Ide reverse transcriptase inhibitors (NRTIs) and a third agent to a fixed dose combination (FDC) of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus continuing their baseline regimen in HIV-1 infected, virologically suppressed African American participants.
Interventions
DRUGB/F/TAF
50/200/25 mg FDC tablets administered orally once daily without regard to food
DRUGNRTIs
The following NRTIs will be administered as prescribed until Week 24 without regard to food: abacavir (ABC), emtricitabine (FTC), lamivudine (3TC), tenofovir alafenamide (TAF), tenofovir disoproxil fumarate (TDF), zidovudine (ZDV or AZT)
DRUGThird Agent
Any one of the following third agents will be administered as prescribed. Protease inhibitors and EVG will be administered with the appropriate pharmacologic booster cobicistat or ritonavir. : * Non-nucleoside reverse transcriptase inhibitors (NNRTIs) * delavirdine (DLV) * efavirenz (EFV) * nevirapine (NVP) * rilpivirine (RPV) * doravirine (DOR) * Integrase inhibitors * dolutegravir (DTG) * elvitegravir (EVG) * raltegravir (RAL) * Protease inhibitors (PIs) * atazanavir (ATV) * darunavir (DRV) * lopinavir (LPV) * nelfinavir NFV) * saquinavir (SQV) * tipranavir (TPV) * Chemokine co-recptor 5 (CCR5) antagonist --maraviroc (MVC)
Sponsors
Gilead Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Self-describes as Black, African American, or mixed race, including Black * Currently receiving an antiretrovirals (ARV) regimen other than FDC of B/F/TAF that consists of any two NRTIs + allowed 3rd agent for ≥ 6 months * Allowed 3rd agents include any FDA-approved INSTI, with the exception of bictegravir, any FDA-approved NNRTI with the exception of etravirine, protease inhibitors or the CCR5 antagonist, maraviroc * If the baseline 3rd agent is dolutegravir, dosing other than 50 mg once daily is excluded * Baseline regimens containing investigational drugs or \> 2 classes of ARVs are not permitted, with the exception of the pharmacologic enhancers cobicistat (taken with elvitegravir or a PI), or ritonavir (taken with a PI) * Have no documented or suspected resistance to INSTIs and no history of virologic failure on an INSTI containing regimen (2 consecutive HIV-1 RNA ≥ 50 copies/mL after achieving \<50 copies/mL while on an INSTI-containing regimen) * History of 1-2 thymidine analogue mutations (TAMs), M184V/I, and any other RT substitutions are allowed, with the following exceptions: History of 3 or more TAMs (M41L, D67N, K70R, L210W, T215F/Y, and K219Q/E/N/R), T69-insertions, or K65R/E/N in RT will be excluded * Documented plasma HIV-1 RNA \< 50 copies/mL during treatment with the baseline regimen for a minimum period of 6 months and at least the last two HIV-1 RNA measurements prior to the Screening visit * HIV-1 RNA levels \< 50 copies/mL at Screening * Estimated glomerular filtration rate (eGFR) ≥ 50 mL/min according to the Cockcroft-Gault formula for creatinine clearance Key
Exclusion criteria
* History of 3 or more TAMs (M41L, D67N, K70R, L210W, T215F/Y, and K219Q/E/N/R),T69-insertions, or K65R/E/N in RT * No desire to switch from current ARVs * An opportunistic illness indicative of stage 3 HIV diagnosed within the 30 days prior to screening * Participants experiencing decompensated cirrhosis (e.g., ascites, encephalopathy, or variceal bleeding) * Have been treated with immunosuppressant therapies or chemotherapeutic agents within 3 months of study screening, or expected to receive these agents or systemic steroids during the study (eg, corticosteroids, immunoglobulins, and other immune- or cytokine-based therapies) * Malignancy within 5 years of screening other than cutaneous Kaposi's sarcoma, completely resected non -melanoma skin cancer (basal cell carcinoma or non-invasive cutaneous squamous carcinoma), or completely resected carcinoma in-situ of the cervix (CIN 3) or anus (AIN 3). A prior malignancy treated with curative therapy and for which there has been no evidence of disease for at least five years prior to screening is allowed * Current alcohol or substance use judged by the Investigator to potentially interfere with participant study compliance * Active, serious infections (other than HIV-1 infection) requiring antibiotic or antifungal therapy within 30 days prior to Day 1 * Participation in any other clinical trial, including observational studies, without prior approval from the sponsor is prohibited while participating in this trial * Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the participant unsuitable for the study or unable to comply with the dosing requirements * Known hypersensitivity to FDC of B/F/TAF tablets, their metabolites, or formulation excipient * Females who are pregnant (as confirmed by positive serum pregnancy test) * Females who are breastfeeding * Acute hepatitis in the 30 days prior to randomization * Active tuberculosis infection. Note: Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Had HIV-1 RNA ≥ 50 Copies/mL at Week 24 as Defined by the US FDA-Defined Snapshot Algorithm: Full Analysis Set | Week 24 | The percentage of participants who had HIV-1 RNA ≥ 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defined 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 Had HIV-1 RNA < 50 Copies/mL at Week 24 as Defined by the US FDA-Defined Snapshot Algorithm: Full Analysis Set | Week 24 | The percentage of participants who had HIV-1 RNA \< 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defined 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 Had HIV-1 RNA < 50 Copies/mL at Week 24 as Defined by the US FDA-Defined Snapshot Algorithm: Week 24 Per Protocol Analysis Set | Week 24 | The percentage of participants who had HIV-1 RNA \< 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defined 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 Had HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm: Full Analysis Set | Week 48 | The percentage of participants who had HIV-1 RNA \< 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defined 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. By Week 48, participants in B/F/TAF had received 48 weeks of treatment with B/F/TAF, while those in the Delayed B/F/TAF group had received only 24 weeks of treatment with B/F/TAF. |
| Change From Baseline in CD4+ Cell Count at Week 24: Full Analysis Set | Baseline to Week 24 | The analysis includes values up to 1 day after permanent discontinuation of study treatment. |
| Percentage of Participants Who Had HIV-1 RNA ≥ 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm: Full Analysis Set | Week 48 | The percentage of participants who had HIV-1 RNA ≥ 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defined 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. By Week 48, participants in B/F/TAF had received 48 weeks of treatment with B/F/TAF, while those in the Delayed B/F/TAF group had received only 24 weeks of treatment with B/F/TAF. |
| Change From Baseline in CD4+ Cell Count at Week 48: Full Analysis Set | Baseline to Week 48 | The analysis includes values up to 1 day after permanent discontinuation of study treatment. By Week 48, participants in B/F/TAF had received 48 weeks of treatment with B/F/TAF, while those in the Delayed B/F/TAF group had received only 24 weeks of treatment with B/F/TAF. |
| Percentage of Participants Experiencing Treatment-Emergent Adverse Events | First B/F/TAF dose date up to Week 72 plus 30 days | An adverse event (AE) was any untoward medical occurrence in a clinical study participant administered a medicinal product, which did not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A treatment-emergent adverse event was defined as any adverse event with onset date on or after the study treatment start date and no later than 30 days after the study drug stop date; or any adverse event leading to study drug discontinuation. |
| Percentage of Participants Experiencing Treatment-Emergent Graded Laboratory Abnormalities | First B/F/TAF dose date up to Week 72 plus 30 days | Treatment-emergent laboratory abnormalities were defined as values that increase at least one toxicity grade from baseline. The most severe graded abnormality from all tests was counted for each participant. Severity grades were defined by 'Gilead Grading Scale for Severity of AEs and Laboratory Abnormalities'. |
| Change From Baseline in CD4+ Cell Count at Week 24: Week 24 Per Protocol Analysis Set | Baseline to Week 24 | The analysis includes values up to 1 day after permanent discontinuation of study treatment. |
Countries
United States
Participant flow
Recruitment details
Participants were enrolled at study centers in the United States. The first participant was screened on 28 August 2018. The last study visit occurred on 19 August 2020.
Pre-assignment details
The following NRTIs & 3rd agents were allowed: NRTIs:abacavir, emtricitabine, lamivudine, tenofovir alafenamide, tenofovir disoproxil fumarate, zidovudine; 3rd agents:delavirdine,efavirenz, nevirapine, rilpivirine,dolutegravir, elvitegravir,raltegravir, doravirine, atazanavir, darunavir, lopinavir, nelfinavir, saquinavir, tipranavir, maraviroc
Participants by arm
| Arm | Count |
|---|---|
| B/F/TAF Participants received B/F/TAF (50/200/25 mg) FDC tablet orally once daily for 48 weeks, without regard to food. At Week 48, participants who wished to continue on B/F/TAF were given the option to receive B/F/TAF FDC for up to an additional 24 weeks or until they had access to B/F/TAF, whichever occurred first. | 330 |
| Stay on Baseline Regimen/ Delayed B/F/TAF Participants stayed on baseline regimen consisting of 2 NRTIs and a third agent (each taken as prescribed) for 24 weeks with a delayed switch to B/F/TAF (50/200/25 mg) FDC tablet administered orally, once daily until Week 48 without regard to food. At Week 48, participants who wished to continue on B/F/TAF were given the option to receive B/F/TAF FDC for up to an additional 24 weeks or until they had access to B/F/TAF, whichever occurred first. | 165 |
| Total | 495 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| B/F/TAF Treatment Phase (After Week 24) | Adverse Event | 4 | 1 |
| B/F/TAF Treatment Phase (After Week 24) | Death | 1 | 0 |
| B/F/TAF Treatment Phase (After Week 24) | Investigator's discretion | 1 | 0 |
| B/F/TAF Treatment Phase (After Week 24) | Lack of Efficacy | 1 | 0 |
| B/F/TAF Treatment Phase (After Week 24) | Lost to Follow-up | 6 | 1 |
| B/F/TAF Treatment Phase (After Week 24) | Withdrew Consent | 3 | 3 |
| Randomized Phase Up to Week 24 | Adverse Event | 2 | 0 |
| Randomized Phase Up to Week 24 | Lost to Follow-up | 3 | 0 |
| Randomized Phase Up to Week 24 | Randomized but not treated | 1 | 0 |
| Randomized Phase Up to Week 24 | Withdrew Consent | 1 | 2 |
Baseline characteristics
| Characteristic | B/F/TAF | Stay on Baseline Regimen/ Delayed B/F/TAF | Total |
|---|---|---|---|
| Age, Continuous | 47 years STANDARD_DEVIATION 12.3 | 48 years STANDARD_DEVIATION 12.2 | 47 years STANDARD_DEVIATION 12.2 |
| CD4+ Cell Count | 765 cells/µL STANDARD_DEVIATION 313.4 | 757 cells/µL STANDARD_DEVIATION 323 | 763 cells/µL STANDARD_DEVIATION 316.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 15 Participants | 5 Participants | 20 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 315 Participants | 160 Participants | 475 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| HIV-1 RNA Category < 50 copies/mL | 325 Participants | 163 Participants | 488 Participants |
| HIV-1 RNA Category ≥ 50 copies/mL | 5 Participants | 2 Participants | 7 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Black or African American | 285 Participants | 154 Participants | 439 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Other | 45 Participants | 11 Participants | 56 Participants |
| Race/Ethnicity, Customized White | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 101 Participants | 55 Participants | 156 Participants |
| Sex: Female, Male Male | 229 Participants | 110 Participants | 339 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 | 1 / 331 | 0 / 165 | 2 / 319 | 0 / 163 |
| other Total, other adverse events | 38 / 330 | 13 / 165 | 53 / 319 | 26 / 163 |
| serious Total, serious adverse events | 13 / 330 | 7 / 165 | 20 / 319 | 7 / 163 |
Outcome results
Primary
Percentage of Participants Who Had HIV-1 RNA ≥ 50 Copies/mL at Week 24 as Defined by the US FDA-Defined Snapshot Algorithm: Full Analysis Set
The percentage of participants who had HIV-1 RNA ≥ 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defined 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 24
Population: Participants in the Full Analysis Set \[included all participants who were randomized into the study, and had received at least 1 dose of study treatment (either B/F/TAF or baseline regimen on Day 1), and did not have pre-existing integrase strand transfer inhibitor resistance-associated mutations (based on historical data)\] in B/F/TAF and SBR groups were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| B/F/TAF | Percentage of Participants Who Had HIV-1 RNA ≥ 50 Copies/mL at Week 24 as Defined by the US FDA-Defined Snapshot Algorithm: Full Analysis Set | 0.6 percentage of participants |
| Stay on Baseline Regimen (SBR) | Percentage of Participants Who Had HIV-1 RNA ≥ 50 Copies/mL at Week 24 as Defined by the US FDA-Defined Snapshot Algorithm: Full Analysis Set | 1.8 percentage of participants |
95% CI: [-4.8, 0.9]
p-value: 0.3399Fisher Exact
Secondary
Change From Baseline in CD4+ Cell Count at Week 24: Full Analysis Set
The analysis includes values up to 1 day after permanent discontinuation of study treatment.
Time frame: Baseline to Week 24
Population: Participants in the Full Analysis Set in the B/F/TAF and SBR groups with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| B/F/TAF | Change From Baseline in CD4+ Cell Count at Week 24: Full Analysis Set | 13 cells/uL | Standard Deviation 209.3 |
| Stay on Baseline Regimen (SBR) | Change From Baseline in CD4+ Cell Count at Week 24: Full Analysis Set | 1 cells/uL | Standard Deviation 171.2 |
p-value: 0.561895% CI: [-27, 49]ANOVA
Secondary
Change From Baseline in CD4+ Cell Count at Week 24: Week 24 Per Protocol Analysis Set
The analysis includes values up to 1 day after permanent discontinuation of study treatment.
Time frame: Baseline to Week 24
Population: Participants in the Week 24 Per Protocol Analysis Set in the B/F/TAF and SBR groups with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| B/F/TAF | Change From Baseline in CD4+ Cell Count at Week 24: Week 24 Per Protocol Analysis Set | 13 cells/uL | Standard Deviation 210.1 |
| Stay on Baseline Regimen (SBR) | Change From Baseline in CD4+ Cell Count at Week 24: Week 24 Per Protocol Analysis Set | 4 cells/uL | Standard Deviation 171.3 |
p-value: 0.663295% CI: [-31, 48]ANOVA
Secondary
Change From Baseline in CD4+ Cell Count at Week 48: Full Analysis Set
The analysis includes values up to 1 day after permanent discontinuation of study treatment. By Week 48, participants in B/F/TAF had received 48 weeks of treatment with B/F/TAF, while those in the Delayed B/F/TAF group had received only 24 weeks of treatment with B/F/TAF.
Time frame: Baseline to Week 48
Population: Participants in the Full Analysis Set in the B/F/TAF and the Delayed B/F/TAF groups with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| B/F/TAF | Change From Baseline in CD4+ Cell Count at Week 48: Full Analysis Set | 7 cells/uL | Standard Deviation 188.6 |
| Stay on Baseline Regimen (SBR) | Change From Baseline in CD4+ Cell Count at Week 48: Full Analysis Set | -8 cells/uL | Standard Deviation 159.2 |
Secondary
Percentage of Participants Experiencing Treatment-Emergent Adverse Events
An adverse event (AE) was any untoward medical occurrence in a clinical study participant administered a medicinal product, which did not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A treatment-emergent adverse event was defined as any adverse event with onset date on or after the study treatment start date and no later than 30 days after the study drug stop date; or any adverse event leading to study drug discontinuation.
Time frame: First B/F/TAF dose date up to Week 72 plus 30 days
Population: The B/F/TAF (BVY) Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of BVY study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| B/F/TAF | Percentage of Participants Experiencing Treatment-Emergent Adverse Events | 83.3 percentage of participants |
| Stay on Baseline Regimen (SBR) | Percentage of Participants Experiencing Treatment-Emergent Adverse Events | 69.3 percentage of participants |
Secondary
Percentage of Participants Experiencing Treatment-Emergent Graded Laboratory Abnormalities
Treatment-emergent laboratory abnormalities were defined as values that increase at least one toxicity grade from baseline. The most severe graded abnormality from all tests was counted for each participant. Severity grades were defined by 'Gilead Grading Scale for Severity of AEs and Laboratory Abnormalities'.
Time frame: First B/F/TAF dose date up to Week 72 plus 30 days
Population: Participants in the BVY Safety Analysis Set with available data were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| B/F/TAF | Percentage of Participants Experiencing Treatment-Emergent Graded Laboratory Abnormalities | 87.8 percentage of participants |
| Stay on Baseline Regimen (SBR) | Percentage of Participants Experiencing Treatment-Emergent Graded Laboratory Abnormalities | 80.4 percentage of participants |
Secondary
Percentage of Participants Who Had HIV-1 RNA < 50 Copies/mL at Week 24 as Defined by the US FDA-Defined Snapshot Algorithm: Full Analysis Set
The percentage of participants who had HIV-1 RNA \< 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defined 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 24
Population: Participants in the Full Analysis Set in the B/F/TAF and SBR groups were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| B/F/TAF | Percentage of Participants Who Had HIV-1 RNA < 50 Copies/mL at Week 24 as Defined by the US FDA-Defined Snapshot Algorithm: Full Analysis Set | 96.3 percentage of participants |
| Stay on Baseline Regimen (SBR) | Percentage of Participants Who Had HIV-1 RNA < 50 Copies/mL at Week 24 as Defined by the US FDA-Defined Snapshot Algorithm: Full Analysis Set | 94.5 percentage of participants |
95% CI: [-2, 6.8]
p-value: 0.3532Fisher Exact
Secondary
Percentage of Participants Who Had HIV-1 RNA < 50 Copies/mL at Week 24 as Defined by the US FDA-Defined Snapshot Algorithm: Week 24 Per Protocol Analysis Set
The percentage of participants who had HIV-1 RNA \< 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defined 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 24
Population: Participants in the Week 24 Per Protocol Analysis Set \[included all participants who were randomized into the study and had received at least 1 dose of study treatment (either B/F/TAF or baseline regimen on Day 1), and had not committed any major protocol violation, including the violation of key entry criteria\] in the B/F/TAF and SBR groups were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| B/F/TAF | Percentage of Participants Who Had HIV-1 RNA < 50 Copies/mL at Week 24 as Defined by the US FDA-Defined Snapshot Algorithm: Week 24 Per Protocol Analysis Set | 99.3 percentage of participants |
| Stay on Baseline Regimen (SBR) | Percentage of Participants Who Had HIV-1 RNA < 50 Copies/mL at Week 24 as Defined by the US FDA-Defined Snapshot Algorithm: Week 24 Per Protocol Analysis Set | 98.0 percentage of participants |
95% CI: [-1, 5.3]
p-value: 0.3356Fisher Exact
Secondary
Percentage of Participants Who Had HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm: Full Analysis Set
The percentage of participants who had HIV-1 RNA \< 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defined 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. By Week 48, participants in B/F/TAF had received 48 weeks of treatment with B/F/TAF, while those in the Delayed B/F/TAF group had received only 24 weeks of treatment with B/F/TAF.
Time frame: Week 48
Population: Participants in the Full Analysis Set in the B/F/TAF and the Delayed B/F/TAF groups with available data were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| B/F/TAF | Percentage of Participants Who Had HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm: Full Analysis Set | 94.5 percentage of participants |
| Stay on Baseline Regimen (SBR) | Percentage of Participants Who Had HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm: Full Analysis Set | 96.9 percentage of participants |
Secondary
Percentage of Participants Who Had HIV-1 RNA ≥ 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm: Full Analysis Set
The percentage of participants who had HIV-1 RNA ≥ 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defined 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. By Week 48, participants in B/F/TAF had received 48 weeks of treatment with B/F/TAF, while those in the Delayed B/F/TAF group had received only 24 weeks of treatment with B/F/TAF.
Time frame: Week 48
Population: Participants in the Full Analysis Set in the B/F/TAF and the Delayed B/F/TAF groups with available data were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| B/F/TAF | Percentage of Participants Who Had HIV-1 RNA ≥ 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm: Full Analysis Set | 0.9 percentage of participants |
| Stay on Baseline Regimen (SBR) | Percentage of Participants Who Had HIV-1 RNA ≥ 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm: Full Analysis Set | 0 percentage of participants |