HIV, HIV Infections
Conditions
Keywords
HIV, Treatment Naive, HIV 1 Infected, Women, Female
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) 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 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 * Age ≥ 18 years Key
Exclusion criteria
* A new 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 * Receiving ongoing therapy with drugs not to be used with elvitegravir, cobicistat, emtricitabine, tenofovir DF, and TAF or participants with any known allergies to the excipients of E/C/F/TDF or E/C/F/TAF Note: Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving 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 < 20 Copies/mL at Weeks 48 and 96 | Weeks 48 and 96 | The percentage of participants achieving HIV-1 RNA \< 20 copies/mL at Weeks 48 and 96 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. |
| 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 | — |
| 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 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. |
| Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96 | 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 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 Serum Creatinine at Week 96 | Baseline; Week 96 | — |
| Percentage of Participants With Treatment-emergent Proteinuria Through Week 48 | Baseline to 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. |
| Percentage of Participants With Treatment-emergent Proteinuria Through Week 96 | Baseline to 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. |
| 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 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. |
| Change From Baseline in Serum Creatinine at Week 48 | Baseline; Week 48 | — |
Countries
Canada, Dominican Republic, France, Italy, Mexico, Netherlands, Portugal, Puerto Rico, Sweden, United Kingdom, United States
Participant flow
Recruitment details
Participants were enrolled at study sites in North America and Europe. The first participant was screened on 12 March 2013. The last study visit occurred on 03 October 2018.
Pre-assignment details
1070 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 | 431 |
| 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 | 435 |
| Total | 866 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Double-Blind Phase | Adverse Event | 3 | 0 |
| Double-Blind Phase | Death | 5 | 4 |
| Double-Blind Phase | Investigator's Discretion | 15 | 17 |
| Double-Blind Phase | Lack of Efficacy | 1 | 2 |
| Double-Blind Phase | Lost to Follow-up | 34 | 26 |
| Double-Blind Phase | Noncompliance with Study Drug | 5 | 1 |
| Double-Blind Phase | Pregnancy | 0 | 1 |
| Double-Blind Phase | Protocol Violation | 0 | 1 |
| Double-Blind Phase | Randomized but Not Treated | 4 | 2 |
| Double-Blind Phase | Withdrew Consent | 20 | 35 |
| Open-Label Extension Phase | Investigator's Discretion | 1 | 0 |
Baseline characteristics
| Characteristic | E/C/F/TDF | Total | E/C/F/TAF |
|---|---|---|---|
| Age, Continuous | 36 years STANDARD_DEVIATION 10.9 | 36 years STANDARD_DEVIATION 10.9 | 35 years STANDARD_DEVIATION 10.8 |
| CD4 Cell Count | 431 cells/µL STANDARD_DEVIATION 226.8 | 423 cells/µL STANDARD_DEVIATION 217.1 | 414 cells/µL STANDARD_DEVIATION 206.8 |
| CD4 Cell Count Category ≥ 200 to < 350 cells/μL | 89 Participants | 204 Participants | 115 Participants |
| CD4 Cell Count Category ≥ 350 to < 500 cells/μL | 149 Participants | 283 Participants | 134 Participants |
| CD4 Cell Count Category ≥ 500 cells/μL | 133 Participants | 260 Participants | 127 Participants |
| CD4 Cell Count Category < 50 cells/μL | 15 Participants | 29 Participants | 14 Participants |
| CD4 Cell Count Category ≥ 50 to < 200 cells/μL | 49 Participants | 89 Participants | 40 Participants |
| CD4 Cell Count Category Missing | 0 Participants | 1 Participants | 1 Participants |
| HIV-1 RNA | 4.50 log10 copies/mL STANDARD_DEVIATION 0.69 | 4.52 log10 copies/mL STANDARD_DEVIATION 0.669 | 4.53 log10 copies/mL STANDARD_DEVIATION 0.647 |
| HIV-1 RNA Category ≤ 100,000 copies/mL | 336 Participants | 675 Participants | 339 Participants |
| HIV-1 RNA Category > 100,000 to ≤ 400,000 copies/mL | 82 Participants | 150 Participants | 68 Participants |
| HIV-1 RNA Category > 400,000 copies/mL | 17 Participants | 41 Participants | 24 Participants |
| HIV Disease Status AIDS | 19 Participants | 41 Participants | 22 Participants |
| HIV Disease Status Asymptomatic | 394 Participants | 771 Participants | 377 Participants |
| HIV Disease Status Symptomatic HIV Infection | 19 Participants | 49 Participants | 30 Participants |
| HIV Disease Status Unknown | 3 Participants | 5 Participants | 2 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 3 Participants | 4 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian | 12 Participants | 27 Participants | 15 Participants |
| Race/Ethnicity, Customized Black | 132 Participants | 261 Participants | 129 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 97 Participants | 204 Participants | 107 Participants |
| Race/Ethnicity, Customized Missing | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Pacific Islander | 1 Participants | 5 Participants | 4 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 336 Participants | 659 Participants | 323 Participants |
| Race/Ethnicity, Customized Not Permitted | 1 Participants | 2 Participants | 1 Participants |
| Race/Ethnicity, Customized Other | 44 Participants | 91 Participants | 47 Participants |
| Race/Ethnicity, Customized White | 243 Participants | 478 Participants | 235 Participants |
| Region of Enrollment Canada | 22 Participants | 41 Participants | 19 Participants |
| Region of Enrollment Dominican Republic | 35 Participants | 65 Participants | 30 Participants |
| Region of Enrollment France | 18 Participants | 34 Participants | 16 Participants |
| Region of Enrollment Italy | 8 Participants | 18 Participants | 10 Participants |
| Region of Enrollment Mexico | 12 Participants | 28 Participants | 16 Participants |
| Region of Enrollment Netherlands | 8 Participants | 14 Participants | 6 Participants |
| Region of Enrollment Portugal | 16 Participants | 37 Participants | 21 Participants |
| Region of Enrollment Sweden | 3 Participants | 11 Participants | 8 Participants |
| Region of Enrollment United Kingdom | 31 Participants | 56 Participants | 25 Participants |
| Region of Enrollment United States | 282 Participants | 562 Participants | 280 Participants |
| Sex: Female, Male Female | 71 Participants | 133 Participants | 62 Participants |
| Sex: Female, Male Male | 364 Participants | 733 Participants | 369 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 | 5 / 431 | 4 / 435 | 0 / 141 | 0 / 119 |
| other Total, other adverse events | 374 / 431 | 366 / 435 | 32 / 141 | 27 / 119 |
| serious Total, serious adverse events | 54 / 431 | 68 / 435 | 4 / 141 | 2 / 119 |
Outcome results
Primary
Percentage of Participants Achieving 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: The Full Analysis Set included participants who were randomized and received at least 1 dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| E/C/F/TAF | Percentage of Participants Achieving HIV-1 RNA < 50 Copies/mL at Week 48 | 91.6 percentage of participants |
| E/C/F/TDF | Percentage of Participants Achieving HIV-1 RNA < 50 Copies/mL at Week 48 | 88.5 percentage of participants |
Comparison: Null hypothesis: the E/C/F/TAF group was ≥ 12% worse than the E/C/F/TDF group with respect to the percentage of participants achieving HIV-1 RNA \< 50 copies/mL at Week 48; alternative hypothesis: the E/C/F/TAF group was \< 12% worse than the E/C/F/TDF group.p-value: 0.1395.002% CI: [-1, 7.1]Cochran-Mantel-Haenszel
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 |
|---|---|---|---|
| E/C/F/TAF | Change From Baseline in CD4+ Cell Count at Week 48 | 225 cells/µL | Standard Deviation 171.2 |
| E/C/F/TDF | Change From Baseline in CD4+ Cell Count at Week 48 | 200 cells/µL | Standard Deviation 162.5 |
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 |
|---|---|---|---|
| E/C/F/TAF | Change From Baseline in CD4+ Cell Count at Week 96 | 274 cells/µL | Standard Deviation 184 |
| E/C/F/TDF | Change From Baseline in CD4+ Cell Count at Week 96 | 260 cells/µL | Standard Deviation 179.6 |
Secondary
Change From Baseline in Serum Creatinine at Week 48
Time frame: Baseline; Week 48
Population: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. The missing-equals-excluded approach 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 0.136 |
| E/C/F/TDF | Change From Baseline in Serum Creatinine at Week 48 | 0.12 mg/dL | Standard Deviation 0.283 |
Secondary
Change From Baseline in Serum Creatinine at Week 96
Time frame: Baseline; Week 96
Population: Participants in the Safety Analysis Set were analyzed. The missing-equals-excluded approach 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 | 0.04 mg/dL | Standard Deviation 0.119 |
| E/C/F/TDF | Change From Baseline in Serum Creatinine at Week 96 | 0.07 mg/dL | Standard Deviation 0.122 |
Secondary
Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Weeks 48 and 96
The percentage of participants achieving HIV-1 RNA \< 20 copies/mL at Weeks 48 and 96 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: Weeks 48 and 96
Population: Participants in the Full Analysis Set were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| E/C/F/TAF | Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Weeks 48 and 96 | Week 48 | 82.4 percentage of participants |
| E/C/F/TAF | Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Weeks 48 and 96 | Week 96 | 78.7 percentage of participants |
| E/C/F/TDF | Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Weeks 48 and 96 | Week 48 | 80.7 percentage of participants |
| E/C/F/TDF | Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Weeks 48 and 96 | Week 96 | 76.8 percentage of participants |
Secondary
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 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 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 96
Population: Participants in the Full Analysis Set were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| E/C/F/TAF | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96 | 84.0 percentage of participants |
| E/C/F/TDF | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96 | 82.3 percentage of participants |
Secondary
Percentage of Participants With 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: Baseline to Week 48
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 With Treatment-emergent Proteinuria Through Week 48 | Grade 1 | 27.3 percentage of participants |
| E/C/F/TAF | Percentage of Participants With Treatment-emergent Proteinuria Through Week 48 | Grade 2 | 4.7 percentage of participants |
| E/C/F/TAF | Percentage of Participants With Treatment-emergent Proteinuria Through Week 48 | Grade 3 | 0 percentage of participants |
| E/C/F/TDF | Percentage of Participants With Treatment-emergent Proteinuria Through Week 48 | Grade 1 | 31.6 percentage of participants |
| E/C/F/TDF | Percentage of Participants With Treatment-emergent Proteinuria Through Week 48 | Grade 2 | 4.6 percentage of participants |
| E/C/F/TDF | Percentage of Participants With Treatment-emergent Proteinuria Through Week 48 | Grade 3 | 0 percentage of participants |
Secondary
Percentage of Participants With 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: Baseline to Week 96
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 With Treatment-emergent Proteinuria Through Week 96 | Grade 1 | 31.8 percentage of participants |
| E/C/F/TAF | Percentage of Participants With Treatment-emergent Proteinuria Through Week 96 | Grade 2 | 5.4 percentage of participants |
| E/C/F/TAF | Percentage of Participants With Treatment-emergent Proteinuria Through Week 96 | Grade 3 | 0 percentage of participants |
| E/C/F/TDF | Percentage of Participants With Treatment-emergent Proteinuria Through Week 96 | Grade 1 | 36.9 percentage of participants |
| E/C/F/TDF | Percentage of Participants With Treatment-emergent Proteinuria Through Week 96 | Grade 2 | 5.1 percentage of participants |
| E/C/F/TDF | Percentage of Participants With Treatment-emergent Proteinuria Through Week 96 | Grade 3 | 0 percentage of participants |
Secondary
Percent Change From Baseline in Hip BMD at Week 96
Hip BMD was assessed by DXA scan.
Time frame: Baseline; Week 96
Population: Participants in the Hip DXA Analysis Set were analyzed. Participants were grouped according to the treatment they actually received. The missing-equals-excluded approach 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 | -0.364 percent change | Standard Deviation 3.899 |
| E/C/F/TDF | Percent Change From Baseline in Hip BMD at Week 96 | -3.023 percent change | Standard Deviation 3.9796 |
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: The Hip DXA Analysis Set included all participants who were randomized and received at least 1 dose of study drug, and have nonmissing baseline hip BMD values. Participants were grouped according to the treatment they actually received. The missing-equals-excluded approach 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 | -0.420 percent change | Standard Deviation 3.2268 |
| E/C/F/TDF | Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48 | -2.603 percent change | Standard Deviation 3.1482 |
Secondary
Percent Change From Baseline in Spine BMD at Week 48
Spine BMD was assessed by DXA scan.
Time frame: Baseline; Week 48
Population: The Spine DXA Analysis Set included all participants who were randomized and received at least 1 dose of study drug, and have nonmissing baseline spine BMD values. Participants were grouped according to the treatment they actually received. The missing-equals-excluded approach 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 | -1.278 percent change | Standard Deviation 3.0098 |
| E/C/F/TDF | Percent Change From Baseline in Spine BMD at Week 48 | -2.759 percent change | Standard Deviation 3.0024 |
Secondary
Percent Change From Baseline in Spine BMD at Week 96
Spine BMD was assessed by DXA scan.
Time frame: Baseline; Week 96
Population: Participants in the Spine DXA Analysis Set were analyzed. Participants were grouped according to the treatment they actually received. The missing-equals-excluded approach 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 | -1.017 percent change | Standard Deviation 3.3957 |
| E/C/F/TDF | Percent Change From Baseline in Spine BMD at Week 96 | -2.516 percent change | Standard Deviation 3.8612 |
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 | -29.3 percent change |
| E/C/F/TDF | Percent Change From Baseline in Urine Beta-2-microglobulin to Creatinine Ratio at Week 48 | 32.3 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 | -31.0 percent change |
| E/C/F/TDF | Percent Change From Baseline in Urine Beta-2-microglobulin to Creatinine Ratio at Week 96 | 35.2 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 | 16.9 percent change |
| E/C/F/TDF | Percent Change From Baseline in Urine RBP to Creatinine Ratio at Week 96 | 73.7 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 | 13.3 percent change |
| E/C/F/TDF | Percent Change From Baseline in Urine Retinol Binding Protein (RBP) to Creatinine Ratio at Week 48 | 51.7 percent change |