HIV, HIV Infections
Conditions
Keywords
HIV, Treatment Naive, HIV 1 Infected, Female, Women
Brief summary
The primary objective of this study is to evaluate the efficacy of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) versus elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF) FDC in HIV-1 positive, antiretroviral treatment-naive adults.
Interventions
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: * Ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures * Plasma HIV-1 RNA levels ≥ 1,000 copies/mL at screening * No prior use of any approved or investigational antiretroviral drug for any length of time, except the use for pre-exposure prophylaxis (PREP) or post-exposure prophylaxis (PEP), up to 6 months prior to screening * Screening genotype report must show sensitivity to elvitegravir, emtricitabine, tenofovir disoproxil fumarate (tenofovir DF) * Normal electrocardiogram (ECG) * Estimated glomerular filtration rate (eGFR) ≥ 50 mL/min according to the Cockcroft-Gault formula for creatinine clearance * Hepatic transaminases (AST and ALT) ≤ 5 × upper limit of normal (ULN) * Total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin * Adequate hematologic function * Serum amylase ≤ 5 × ULN * Males and females of childbearing potential must agree to utilize highly effective contraception methods or be non-heterosexually active or practice sexual abstinence from screening throughout the duration of study treatment and for 30 days following the last dose of study drug * Females who utilize hormonal contraceptive as one of their birth control methods must have used the same method for at least three months prior to study dosing * Females who have stopped menstruating for ≥ 12 months but do not have documentation of ovarian hormonal failure must have a serum follicle stimulating hormone (FSH) level at screening within the post-menopausal range based on the Central Laboratory reference range Key
Exclusion criteria
* A new acquired immunodeficiency syndrome (AIDS) defining condition diagnosed within the 30 days prior to screening * Hepatitis B surface antigen (HBsAg) positive * Hepatitis C antibody positive * Individuals experiencing decompensated cirrhosis * Females who are breastfeeding * Positive serum pregnancy test * Have an implanted defibrillator or pacemaker * Current alcohol or substance use judged by the Investigator to potentially interfere with study compliance * History of malignancy within the past 5 years or ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, noninvasive cutaneous squamous carcinoma * Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to baseline * Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the individual unsuitable for the study or unable to comply with dosing requirements * Participation in any other clinical trial (including observational trials) without prior approval * Individuals receiving ongoing therapy with drugs not to be used with elvitegravir, cobicistat, emtricitabine, tenofovir DF, and TAF or individuals with any known allergies to the excipients of E/C/F/TDF or E/C/F/TAF single-tablet regimen tablets Note: Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 | 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 patient'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 With HIV-1 RNA < 50 Copies/mL at Weeks 96 and 144 | Weeks 96 and 144 | The percentage of participants achieving HIV-1 RNA \< 50 copies/mL at Weeks 96 and 144 were analyzed using the snapshot algorithm, which defines a patient'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 With HIV-1 RNA < 20 Copies/mL at Weeks 48, 96, and 144 | Weeks 48, 96. and 144 | The percentage of participants achieving HIV-1 RNA \< 20 copies/mL at Weeks 48, 96, and 144 were analyzed using the snapshot algorithm, which defines a patient'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 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 | — |
| Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48 | Baseline; Week 48 | Hip BMD was assessed by dual energy x-ray absorptiometry (DXA) scan. |
| Percent Change From Baseline in Hip BMD at Week 96 | Baseline; Week 96 | Hip BMD was assessed by DXA scan. |
| Percent Change From Baseline in Hip BMD at Week 144 | Baseline; Week 144 | Hip BMD was assessed by DXA scan. |
| Percent Change From Baseline in Spine BMD at Week 48 | Baseline; Week 48 | Spine BMD was assessed by DXA scan. |
| Percent Change From Baseline in Spine BMD at Week 96 | Baseline; Week 96 | Spine BMD was assessed by DXA scan. |
| Percent Change From Baseline in Spine BMD at Week 144 | Baseline; Week 144 | Spine BMD was assessed by DXA scan. |
| Change From Baseline in Serum Creatinine at Week 48 | Baseline; Week 48 | — |
| Change From Baseline in Serum Creatinine at Week 96 | Baseline; Week 96 | — |
| Change From Baseline in Serum Creatinine at Week 144 | Baseline; Week 144 | — |
| Percentage of Participants Experiencing Treatment-emergent Proteinuria Through Week 48 | Up to 48 weeks | Grades 1 (mild), 2 (moderate), and 3 (severe) were the highest treatment-emergent postbaseline grades for urine protein using the dipstick method. The worst postbaseline value is presented for each participant. |
| Percentage of Participants Experiencing Treatment-emergent Proteinuria Through Week 96 | Up to 96 weeks | Grades 1 (mild), 2 (moderate), and 3 (severe) were the highest treatment-emergent postbaseline grades for urine protein using the dipstick method. The worst postbaseline value is presented for each participant. |
| Percentage of Participants Experiencing Treatment-emergent Proteinuria Through Week 144 | Up to 144 weeks | Grades 1 (mild), 2 (moderate), and 3 (severe) were the highest treatment-emergent postbaseline grades for urine protein using the dipstick method. The worst postbaseline value is presented for each participant. |
| Percent Change From Baseline in Urine Retinol Binding Protein (RBP) to Creatinine Ratio at Week 48 | Baseline; Week 48 | Urine RBP is a renal biomarker which is used to detect drug-induced kidney injury. |
| Percent Change From Baseline in Urine RBP to Creatinine Ratio at Week 96 | Baseline; Week 96 | Urine RBP is a renal biomarker which is used to detect drug-induced kidney injury. |
| Percent Change From Baseline in Urine RBP to Creatinine Ratio at Week 144 | Baseline; Week 144 | Urine RBP is a renal biomarker which is used to detect drug-induced kidney injury. |
| Percent Change From Baseline in Urine Beta-2-microglobulin to Creatinine Ratio at Week 48 | Baseline; Week 48 | Urine Beta-2-microglobulin is a renal biomarker which is used to detect drug-induced kidney injury. |
| Percent Change From Baseline in Urine Beta-2-microglobulin to Creatinine Ratio at Week 96 | Baseline; Week 96 | Urine Beta-2-microglobulin is a renal biomarker which is used to detect drug-induced kidney injury. |
| Percent Change From Baseline in Urine Beta-2-microglobulin to Creatinine Ratio at Week 144 | Baseline; Week 144 | Urine Beta-2-microglobulin is a renal biomarker which is used to detect drug-induced kidney injury. |
Countries
Australia, Austria, Belgium, Canada, Italy, Japan, Puerto Rico, Spain, Switzerland, Thailand, United Kingdom, United States
Participant flow
Recruitment details
Participants were enrolled at study sites in North America, Europe, and Asia. The first participant was screened on 26 December 2012. The last study visit occurred on 06 September 2017.
Pre-assignment details
1105 participants were screened.
Participants by arm
| Arm | Count |
|---|---|
| E/C/F/TAF E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks | 435 |
| E/C/F/TDF E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks | 432 |
| Total | 867 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Double-Blind Phase | Adverse Event | 4 | 14 |
| Double-Blind Phase | Death | 1 | 2 |
| Double-Blind Phase | Investigator's Discretion | 5 | 2 |
| Double-Blind Phase | Lack of Efficacy | 1 | 1 |
| Double-Blind Phase | Lost to Follow-up | 23 | 26 |
| Double-Blind Phase | Non-Compliance with Study Drug | 4 | 3 |
| Double-Blind Phase | Pregnancy | 2 | 1 |
| Double-Blind Phase | Protocol Violation | 4 | 3 |
| Double-Blind Phase | Randomized but not Treated | 3 | 2 |
| Double-Blind Phase | Withdrew Consent | 23 | 24 |
| Open-Label Extension Phase | Enrolled but not Treated | 0 | 1 |
Baseline characteristics
| Characteristic | E/C/F/TDF | E/C/F/TAF | Total |
|---|---|---|---|
| Age, Continuous | 36 years STANDARD_DEVIATION 10.5 | 35 years STANDARD_DEVIATION 10 | 35 years STANDARD_DEVIATION 10.3 |
| CD4 Cell Count | 426 cells/µL STANDARD_DEVIATION 212.3 | 437 cells/µL STANDARD_DEVIATION 223.7 | 432 cells/µL STANDARD_DEVIATION 218 |
| CD4 Cell Count Category ≥ 200 to < 350 cells/µL | 111 Participants | 103 Participants | 214 Participants |
| CD4 Cell Count Category ≥ 350 to < 500 cells/µL | 135 Participants | 122 Participants | 257 Participants |
| CD4 Cell Count Category ≥ 500 cells/µL | 133 Participants | 152 Participants | 285 Participants |
| CD4 Cell Count Category < 50 cells/µL | 12 Participants | 10 Participants | 22 Participants |
| CD4 Cell Count Category ≥ 50 to < 200 cells/µL | 41 Participants | 48 Participants | 89 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 70 Participants | 60 Participants | 130 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 362 Participants | 375 Participants | 737 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| HIV-1 RNA Category ≤ 100,000 copies/mL | 336 Participants | 331 Participants | 667 Participants |
| HIV-1 RNA Category > 100,000 to ≤ 400,000 copies/mL | 72 Participants | 79 Participants | 151 Participants |
| HIV-1 RNA Category > 400,000 copies/mL | 24 Participants | 25 Participants | 49 Participants |
| HIV-1 RNA (log10 copies/mL) | 4.55 log10 copies/mL STANDARD_DEVIATION 0.674 | 4.55 log10 copies/mL STANDARD_DEVIATION 0.682 | 4.55 log10 copies/mL STANDARD_DEVIATION 0.678 |
| HIV Disease Status AIDS | 10 Participants | 9 Participants | 19 Participants |
| HIV Disease Status Asymptomatic | 406 Participants | 402 Participants | 808 Participants |
| HIV Disease Status Symptomatic HIV Infection | 15 Participants | 23 Participants | 38 Participants |
| HIV Disease Status Unknown | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 5 Participants | 4 Participants | 9 Participants |
| Race/Ethnicity, Customized Asian | 77 Participants | 76 Participants | 153 Participants |
| Race/Ethnicity, Customized Black | 81 Participants | 94 Participants | 175 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Pacific Islander | 3 Participants | 1 Participants | 4 Participants |
| Race/Ethnicity, Customized Other | 11 Participants | 10 Participants | 21 Participants |
| Race/Ethnicity, Customized White | 255 Participants | 250 Participants | 505 Participants |
| Region of Enrollment Australia | 15 Participants | 19 Participants | 34 Participants |
| Region of Enrollment Austria | 8 Participants | 15 Participants | 23 Participants |
| Region of Enrollment Belgium | 7 Participants | 7 Participants | 14 Participants |
| Region of Enrollment Canada | 23 Participants | 23 Participants | 46 Participants |
| Region of Enrollment Italy | 6 Participants | 3 Participants | 9 Participants |
| Region of Enrollment Japan | 6 Participants | 4 Participants | 10 Participants |
| Region of Enrollment Spain | 42 Participants | 42 Participants | 84 Participants |
| Region of Enrollment Switzerland | 12 Participants | 6 Participants | 18 Participants |
| Region of Enrollment Thailand | 58 Participants | 63 Participants | 121 Participants |
| Region of Enrollment United Kingdom | 5 Participants | 1 Participants | 6 Participants |
| Region of Enrollment United States | 250 Participants | 252 Participants | 502 Participants |
| Sex: Female, Male Female | 56 Participants | 71 Participants | 127 Participants |
| Sex: Female, Male Male | 376 Participants | 364 Participants | 740 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 | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 380 / 435 | 375 / 432 | 16 / 90 | 14 / 94 |
| serious Total, serious adverse events | 73 / 435 | 65 / 432 | 0 / 90 | 1 / 94 |
Outcome results
Primary
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 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 patient'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: participants who were randomized and received at least 1 dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| E/C/F/TAF | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 | 93.1 percentage of participants |
| E/C/F/TDF | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 | 92.8 percentage of participants |
p-value: 0.7895.002% CI: [-3, 4]Cochran-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 on-treatment data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| E/C/F/TAF | Change From Baseline in CD4+ Cell Count at Week 144 | 323 cells/µL | Standard Deviation 213.1 |
| E/C/F/TDF | Change From Baseline in CD4+ Cell Count at Week 144 | 310 cells/µL | Standard Deviation 207.2 |
Secondary
Change From Baseline in CD4+ Cell Count at Week 48
Time frame: Baseline; Week 48
Population: Participants in the Full Analysis Set with on-treatment data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| E/C/F/TAF | Change From Baseline in CD4+ Cell Count at Week 48 | 235 cells/µL | Standard Deviation 183.1 |
| E/C/F/TDF | Change From Baseline in CD4+ Cell Count at Week 48 | 221 cells/µL | Standard Deviation 178.9 |
Secondary
Change From Baseline in CD4+ Cell Count at Week 96
Time frame: Baseline; Week 96
Population: Participants in the Full Analysis Set with on-treatment data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| E/C/F/TAF | Change From Baseline in CD4+ Cell Count at Week 96 | 285 cells/µL | Standard Deviation 203 |
| E/C/F/TDF | Change From Baseline in CD4+ Cell Count at Week 96 | 271 cells/µL | Standard Deviation 208.1 |
Secondary
Change From Baseline in Serum Creatinine at Week 144
Time frame: Baseline; Week 144
Population: Safety Analysis Set. The missing-equals-excluded approach was used, where participants with missing data were excluded from the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| E/C/F/TAF | Change From Baseline in Serum Creatinine at Week 144 | 0.04 mg/dL | Standard Deviation 0.115 |
| E/C/F/TDF | Change From Baseline in Serum Creatinine at Week 144 | 0.08 mg/dL | Standard Deviation 0.133 |
Secondary
Change From Baseline in Serum Creatinine at Week 48
Time frame: Baseline; Week 48
Population: Safety Analysis Set. The missing-equals-excluded approach was used, where participants with missing data were excluded from the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| E/C/F/TAF | Change From Baseline in Serum Creatinine at Week 48 | 0.08 mg/dL | Standard Deviation 0.11 |
| E/C/F/TDF | Change From Baseline in Serum Creatinine at Week 48 | 0.11 mg/dL | Standard Deviation 0.116 |
Secondary
Change From Baseline in Serum Creatinine at Week 96
Time frame: Baseline; Week 96
Population: Safety Analysis Set. The missing-equals-excluded approach was used, where participants with missing data were excluded from the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| E/C/F/TAF | Change From Baseline in Serum Creatinine at Week 96 | 0.05 mg/dL | Standard Deviation 0.109 |
| E/C/F/TDF | Change From Baseline in Serum Creatinine at Week 96 | 0.07 mg/dL | Standard Deviation 0.132 |
Secondary
Percentage of Participants Experiencing Treatment-emergent Proteinuria Through Week 144
Grades 1 (mild), 2 (moderate), and 3 (severe) were the highest treatment-emergent postbaseline grades for urine protein using the dipstick method. The worst postbaseline value is presented for each participant.
Time frame: Up to 144 weeks
Population: Participants in the Safety Analysis Set with at least 1 postbaseline urine protein value were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| E/C/F/TAF | Percentage of Participants Experiencing Treatment-emergent Proteinuria Through Week 144 | Grade 1 | 31.3 percentage of participants |
| E/C/F/TAF | Percentage of Participants Experiencing Treatment-emergent Proteinuria Through Week 144 | Grade 2 | 6.0 percentage of participants |
| E/C/F/TAF | Percentage of Participants Experiencing Treatment-emergent Proteinuria Through Week 144 | Grade 3 | 0.2 percentage of participants |
| E/C/F/TDF | Percentage of Participants Experiencing Treatment-emergent Proteinuria Through Week 144 | Grade 1 | 37.1 percentage of participants |
| E/C/F/TDF | Percentage of Participants Experiencing Treatment-emergent Proteinuria Through Week 144 | Grade 2 | 7.0 percentage of participants |
| E/C/F/TDF | Percentage of Participants Experiencing Treatment-emergent Proteinuria Through Week 144 | Grade 3 | 0.2 percentage of participants |
Secondary
Percentage of Participants Experiencing Treatment-emergent Proteinuria Through Week 48
Grades 1 (mild), 2 (moderate), and 3 (severe) were the highest treatment-emergent postbaseline grades for urine protein using the dipstick method. The worst postbaseline value is presented for each participant.
Time frame: Up to 48 weeks
Population: Participants in the Safety Analysis Set with at least 1 postbaseline urine protein value were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| E/C/F/TAF | Percentage of Participants Experiencing Treatment-emergent Proteinuria Through Week 48 | Grade 2 | 4.6 percentage of participants |
| E/C/F/TAF | Percentage of Participants Experiencing Treatment-emergent Proteinuria Through Week 48 | Grade 1 | 25.8 percentage of participants |
| E/C/F/TAF | Percentage of Participants Experiencing Treatment-emergent Proteinuria Through Week 48 | Grade 3 | 0 percentage of participants |
| E/C/F/TDF | Percentage of Participants Experiencing Treatment-emergent Proteinuria Through Week 48 | Grade 1 | 32.3 percentage of participants |
| E/C/F/TDF | Percentage of Participants Experiencing Treatment-emergent Proteinuria Through Week 48 | Grade 2 | 4.9 percentage of participants |
| E/C/F/TDF | Percentage of Participants Experiencing Treatment-emergent Proteinuria Through Week 48 | Grade 3 | 0.2 percentage of participants |
Secondary
Percentage of Participants Experiencing Treatment-emergent Proteinuria Through Week 96
Grades 1 (mild), 2 (moderate), and 3 (severe) were the highest treatment-emergent postbaseline grades for urine protein using the dipstick method. The worst postbaseline value is presented for each participant.
Time frame: Up to 96 weeks
Population: Participants in the Safety Analysis Set with at least 1 postbaseline urine protein value were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| E/C/F/TAF | Percentage of Participants Experiencing Treatment-emergent Proteinuria Through Week 96 | Grade 1 | 28.8 percentage of participants |
| E/C/F/TAF | Percentage of Participants Experiencing Treatment-emergent Proteinuria Through Week 96 | Grade 2 | 5.1 percentage of participants |
| E/C/F/TAF | Percentage of Participants Experiencing Treatment-emergent Proteinuria Through Week 96 | Grade 3 | 0.2 percentage of participants |
| E/C/F/TDF | Percentage of Participants Experiencing Treatment-emergent Proteinuria Through Week 96 | Grade 1 | 33.9 percentage of participants |
| E/C/F/TDF | Percentage of Participants Experiencing Treatment-emergent Proteinuria Through Week 96 | Grade 2 | 5.8 percentage of participants |
| E/C/F/TDF | Percentage of Participants Experiencing Treatment-emergent Proteinuria Through Week 96 | Grade 3 | 0.2 percentage of participants |
Secondary
Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Weeks 48, 96, and 144
The percentage of participants achieving HIV-1 RNA \< 20 copies/mL at Weeks 48, 96, and 144 were analyzed using the snapshot algorithm, which defines a patient'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: Weeks 48, 96. and 144
Population: Full Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| E/C/F/TAF | Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Weeks 48, 96, and 144 | Week 48 | 86.4 percentage of participants |
| E/C/F/TAF | Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Weeks 48, 96, and 144 | Week 96 | 84.4 percentage of participants |
| E/C/F/TAF | Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Weeks 48, 96, and 144 | Week 144 | 84.6 percentage of participants |
| E/C/F/TDF | Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Weeks 48, 96, and 144 | Week 48 | 87.3 percentage of participants |
| E/C/F/TDF | Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Weeks 48, 96, and 144 | Week 96 | 83.6 percentage of participants |
| E/C/F/TDF | Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Weeks 48, 96, and 144 | Week 144 | 80.1 percentage of participants |
Secondary
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Weeks 96 and 144
The percentage of participants achieving HIV-1 RNA \< 50 copies/mL at Weeks 96 and 144 were analyzed using the snapshot algorithm, which defines a patient'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: Weeks 96 and 144
Population: Full Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| E/C/F/TAF | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Weeks 96 and 144 | Week 96 | 89.2 percentage of participants |
| E/C/F/TAF | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Weeks 96 and 144 | Week 144 | 86.9 percentage of participants |
| E/C/F/TDF | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Weeks 96 and 144 | Week 96 | 88.2 percentage of participants |
| E/C/F/TDF | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Weeks 96 and 144 | Week 144 | 83.1 percentage of participants |
Secondary
Percent Change From Baseline in Hip BMD at Week 144
Hip BMD was assessed by DXA scan.
Time frame: Baseline; Week 144
Population: Hip DXA Analysis Set. Participants were grouped according to the treatment they actually received. The missing-equals-excluded approach was used, where participants with missing data were excluded from the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| E/C/F/TAF | Percent Change From Baseline in Hip BMD at Week 144 | -0.826 percent change | Standard Deviation 4.6786 |
| E/C/F/TDF | Percent Change From Baseline in Hip BMD at Week 144 | -3.475 percent change | Standard Deviation 4.1551 |
Secondary
Percent Change From Baseline in Hip BMD at Week 96
Hip BMD was assessed by DXA scan.
Time frame: Baseline; Week 96
Population: Hip DXA Analysis Set. Participants were grouped according to the treatment they actually received. The missing-equals-excluded approach was used, where participants with missing data were excluded from the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| E/C/F/TAF | Percent Change From Baseline in Hip BMD at Week 96 | -0.951 percent change | Standard Deviation 3.8633 |
| E/C/F/TDF | Percent Change From Baseline in Hip BMD at Week 96 | -3.515 percent change | Standard Deviation 3.9451 |
Secondary
Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48
Hip BMD was assessed by dual energy x-ray absorptiometry (DXA) scan.
Time frame: Baseline; Week 48
Population: Hip DXA Analysis Set: participants who were randomized and received at least 1 dose of study drugs and had nonmissing baseline hip BMD values. Participants were grouped according to the treatment they actually received. The missing-equals-excluded approach was used, where participants with missing data were excluded from the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| E/C/F/TAF | Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48 | -0.865 percent change | Standard Deviation 3.2532 |
| E/C/F/TDF | Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48 | -3.200 percent change | Standard Deviation 3.1759 |
Secondary
Percent Change From Baseline in Spine BMD at Week 144
Spine BMD was assessed by DXA scan.
Time frame: Baseline; Week 144
Population: Spine DXA Analysis Set. Participants were grouped according to the treatment they actually received. The missing-equals-excluded approach was used, where participants with missing data were excluded from the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| E/C/F/TAF | Percent Change From Baseline in Spine BMD at Week 144 | -0.809 percent change | Standard Deviation 4.5041 |
| E/C/F/TDF | Percent Change From Baseline in Spine BMD at Week 144 | -3.023 percent change | Standard Deviation 4.3122 |
Secondary
Percent Change From Baseline in Spine BMD at Week 48
Spine BMD was assessed by DXA scan.
Time frame: Baseline; Week 48
Population: Spine DXA Analysis Set: participants who were randomized and received at least 1 dose of study drugs and had nonmissing baseline spine BMD values. Participants were grouped according to the treatment they actually received. The missing-equals-excluded approach was used, where participants with missing data were excluded from the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| E/C/F/TAF | Percent Change From Baseline in Spine BMD at Week 48 | -1.337 percent change | Standard Deviation 3.0715 |
| E/C/F/TDF | Percent Change From Baseline in Spine BMD at Week 48 | -2.956 percent change | Standard Deviation 3.3524 |
Secondary
Percent Change From Baseline in Spine BMD at Week 96
Spine BMD was assessed by DXA scan.
Time frame: Baseline; Week 96
Population: Spine DXA Analysis Set. Participants were grouped according to the treatment they actually received. The missing-equals-excluded approach was used, where participants with missing data were excluded from the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| E/C/F/TAF | Percent Change From Baseline in Spine BMD at Week 96 | -0.907 percent change | Standard Deviation 4.0039 |
| E/C/F/TDF | Percent Change From Baseline in Spine BMD at Week 96 | -3.053 percent change | Standard Deviation 3.9539 |
Secondary
Percent Change From Baseline in Urine Beta-2-microglobulin to Creatinine Ratio at Week 144
Urine Beta-2-microglobulin is a renal biomarker which is used to detect drug-induced kidney injury.
Time frame: Baseline; Week 144
Population: Participants in the Safety Analysis Set with available data were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| E/C/F/TAF | Percent Change From Baseline in Urine Beta-2-microglobulin to Creatinine Ratio at Week 144 | -24.6 percent change |
| E/C/F/TDF | Percent Change From Baseline in Urine Beta-2-microglobulin to Creatinine Ratio at Week 144 | 60.4 percent change |
Secondary
Percent Change From Baseline in Urine Beta-2-microglobulin to Creatinine Ratio at Week 48
Urine Beta-2-microglobulin is a renal biomarker which is used to detect drug-induced kidney injury.
Time frame: Baseline; Week 48
Population: Participants in the Safety Analysis Set with available data were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| E/C/F/TAF | Percent Change From Baseline in Urine Beta-2-microglobulin to Creatinine Ratio at Week 48 | -32.8 percent change |
| E/C/F/TDF | Percent Change From Baseline in Urine Beta-2-microglobulin to Creatinine Ratio at Week 48 | 18.0 percent change |
Secondary
Percent Change From Baseline in Urine Beta-2-microglobulin to Creatinine Ratio at Week 96
Urine Beta-2-microglobulin is a renal biomarker which is used to detect drug-induced kidney injury.
Time frame: Baseline; Week 96
Population: Participants in the Safety Analysis Set with available data were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| E/C/F/TAF | Percent Change From Baseline in Urine Beta-2-microglobulin to Creatinine Ratio at Week 96 | -33.5 percent change |
| E/C/F/TDF | Percent Change From Baseline in Urine Beta-2-microglobulin to Creatinine Ratio at Week 96 | 32.5 percent change |
Secondary
Percent Change From Baseline in Urine RBP to Creatinine Ratio at Week 144
Urine RBP is a renal biomarker which is used to detect drug-induced kidney injury.
Time frame: Baseline; Week 144
Population: Participants in the Safety Analysis Set with available data were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| E/C/F/TAF | Percent Change From Baseline in Urine RBP to Creatinine Ratio at Week 144 | 37.4 percent change |
| E/C/F/TDF | Percent Change From Baseline in Urine RBP to Creatinine Ratio at Week 144 | 106.9 percent change |
Secondary
Percent Change From Baseline in Urine RBP to Creatinine Ratio at Week 96
Urine RBP is a renal biomarker which is used to detect drug-induced kidney injury.
Time frame: Baseline; Week 96
Population: Participants in the Safety Analysis Set with available data were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| E/C/F/TAF | Percent Change From Baseline in Urine RBP to Creatinine Ratio at Week 96 | 11.3 percent change |
| E/C/F/TDF | Percent Change From Baseline in Urine RBP to Creatinine Ratio at Week 96 | 75.0 percent change |
Secondary
Percent Change From Baseline in Urine Retinol Binding Protein (RBP) to Creatinine Ratio at Week 48
Urine RBP is a renal biomarker which is used to detect drug-induced kidney injury.
Time frame: Baseline; Week 48
Population: Participants in the Safety Analysis Set with available data were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| E/C/F/TAF | Percent Change From Baseline in Urine Retinol Binding Protein (RBP) to Creatinine Ratio at Week 48 | 6.9 percent change |
| E/C/F/TDF | Percent Change From Baseline in Urine Retinol Binding Protein (RBP) to Creatinine Ratio at Week 48 | 51.2 percent change |