HIV, HIV Infections
Conditions
Keywords
HIV, HIV 1 Infected, Virologically-Suppressed
Brief summary
The primary objective of this study is to evaluate the non-inferiority of switching to a tenofovir alafenamide (TAF)-containing fixed dose combination (FDC) relative to maintaining tenofovir disoproxil fumarate (TDF)-containing combination regimens in virologically suppressed HIV-infected participants as determined by having HIV-1 RNA \< 50 copies/mL at Week 48.
Interventions
DRUGE/C/F/TAF
150/150/200/10 mg FDC tablet administered orally once daily
DRUGE/C/F/TDF
150/150/200/300 mg FDC tablet administered orally once daily
DRUGEFV/FTC/TDF
600/200/300 mg FDC tablet administered orally once daily
DRUGRTV
100 mg tablet administered orally once daily
DRUGATV
300 mg capsule administered orally once daily
DRUGFTC/TDF
200/300 mg tablet administered orally once daily
DRUGCOBI
150 mg tablet administered orally once daily
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: * Ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures * Currently receiving antiretroviral therapy consisting of E/C/F/TDF, EFV/FTC/TDF, RTV+ATV+FTC/TDF, or COBI+ATV+FTC/TDF for ≥ 6 consecutive months preceding the final visit in their earlier study * Completion of the Week 144 visit in studies GS-US-236-0102, GS-US-236-0103, GS-US-216-0114, or completion of the Week 96 visit in study GS-US-264-0110 (only participants on an EFV-based regimen), or completion of studies GS-US-236-0104, GS-US-216-0105 * Plasma human immunodeficiency virus type 1-ribonucleic acid (HIV-1 RNA) concentrations at undetectable levels for at least 6 consecutive months prior to the screening visit and have HIV RNA \< 50 copies/mL at the screening visit * Normal echocardiograph (ECG) * Estimated glomerular filtration rate (GFR) ≥ 50 mL/min according to the Cockcroft-Gault formula for creatinine clearance * Hepatic transaminases (aspartate aminotransferase \[AST\] and alanine aminotransferase \[ALT\]) ≤ 5 × upper limit of the normal range (ULN) * Direct bilirubin ≤ 1.5 x ULN * Adequate hematologic function * Serum amylase ≤ 5 × ULN * 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 12 weeks following the last dose of study drug if receiving EFV/FTC/TDF regimen, and 30 days for those assigned to all other regimens. * Female participants 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 * Female participants 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 position * Hepatitis C antibody positive * Participants 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 subject 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 subject unsuitable for the study or unable to comply with dosing requirements * Participation in any other clinical trial without prior approval from the sponsor is prohibited while participating in this trial * Participants receiving ongoing therapy with drugs not to be used with elvitegravir (EVG), COBI, FTC, TDF, ATV, RTV, EFV, and TAF or participants with any known allergies to the excipients of E/C/F/TDF, E/C/F/TAF, EFV/FTC/TDF, ATV, COBI, RTV, or FTC/TDF 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 |
|---|---|---|
| Percent Change From Baseline in Spine BMD at Week 48 | Baseline; Week 48 | Spine BMD was assessed by DXA scan. BMD is calculated as g/cm\^2; the mean (SD) percentage change is presented. |
| Change From Baseline in Serum Creatinine at Week 48 | Baseline; Week 48 | — |
| Change From Baseline in the Overall EFV-related Symptom Assessment Score at Week 48 | Baseline; Week 48 | The mean (SD) change of the overall EFV-related symptom assessment score is presented. The overall symptom score (ranging from 0 to 20) is the sum of the individual symptom scores ranging from 0 (no symptoms) to 4 (most severe symptoms) from the 5 EFV-related symptom assessments (dizziness, trouble sleeping, impaired concentration, sleepiness, and abnormal or vivid dream). A negative change from baseline indicates improvement. EFV-Related Symptom Analysis Set: participants who received EFV/FTC/TDF as prior treatment, received at least 1 dose of study drug, and completed EFV-related symptom assessments at the baseline visit and at least 1 postbaseline visit. |
| 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. |
| 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. BMD is calculated as grams per square centimeter (g/cm\^2); the mean (SD) percentage change is presented. |
| Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Week 96 | 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 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 Cluster Determinant 4 (CD4) Cell Count at Week 48 | Baseline; Week 48 | The analysis of CD4 cell count included values up to 1 day after the last dose date of randomized study drug.The change from baseline in CD4 cell count for the full analysis set was based on observed data (ie, Missing = Excluded) for the total and by the prior treatment regimen. |
| Change From Baseline in CD4 Cell Count at Weeks 96 | Baseline; Week 96 | The analysis of CD4 cell count included values up to 1 day after the last dose date of randomized study drug.The change from baseline in CD4 cell count for the full analysis set was based on observed data (ie, Missing = Excluded) for the total and by the prior treatment regimen. |
| Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Week 48 | 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 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. |
Countries
Australia, Austria, Belgium, Brazil, Canada, Denmark, Dominican Republic, France, Germany, Italy, Mexico, Netherlands, Portugal, Puerto Rico, Spain, Sweden, Switzerland, Thailand, United Kingdom, United States
Participant flow
Recruitment details
Participants were enrolled at study sites in Dominican Republic, Puerto Rico, North America, South America, Europe, Australia, and Asia. The first participant was screened on 27 March 2013. The last study visit occurred on 01 April 2020.
Pre-assignment details
1559 participants were screened.
Participants by arm
| Arm | Count |
|---|---|
| E/C/F/TAF Randomized Phase: Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF)(150/150/200/10 mg) fixed-dose combination (FDC) tablet administered once daily for up to 96 weeks.
Extension Phase: After completing 96 weeks of randomized treatment, all participants were given the opportunity to receive open-label E/C/F/TAF until it became commercially available, or until Gilead elected to terminate the development of E/C/F/TAF. | 959 |
| Stay on Baseline Treatment Regimen (SBR) Randomized Phase: Participants stayed on their baseline emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF)-containing regimen (E/C/F/TDF; efavirenz (EFV)/FTC/TDF; ritonavir (RTV)-boosted atazanavir (ATV)+FTC/TDF; or cobicistat (COBI-boosted ATV+FTC/TDF)) administered according to prescribing information for up to 96 weeks.
Extension Phase: After completing 96 weeks of randomized treatment (SBR), all participants were given the opportunity to receive open-label E/C/F/TAF until it became commercially available, or until Gilead elected to terminate the development of E/C/F/TAF. | 477 |
| Total | 1,436 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Extension Treatment Phase- After Week 96 | Adverse Event | 1 | 1 |
| Extension Treatment Phase- After Week 96 | Death | 1 | 0 |
| Extension Treatment Phase- After Week 96 | Investigator's Discretion | 31 | 15 |
| Extension Treatment Phase- After Week 96 | Lost to Follow-up | 13 | 9 |
| Extension Treatment Phase- After Week 96 | Withdrew Consent | 5 | 1 |
| Randomized Treatment Phase-Up to Week 96 | Adverse Event | 7 | 4 |
| Randomized Treatment Phase-Up to Week 96 | Death | 4 | 0 |
| Randomized Treatment Phase-Up to Week 96 | Investigator's Discretion | 11 | 2 |
| Randomized Treatment Phase-Up to Week 96 | Lack of Efficacy | 1 | 0 |
| Randomized Treatment Phase-Up to Week 96 | Lost to Follow-up | 10 | 9 |
| Randomized Treatment Phase-Up to Week 96 | Participants randomized and never treated | 4 | 3 |
| Randomized Treatment Phase-Up to Week 96 | Pregnancy | 1 | 0 |
| Randomized Treatment Phase-Up to Week 96 | Withdrew Consent | 11 | 17 |
Baseline characteristics
| Characteristic | E/C/F/TAF | Stay on Baseline Treatment Regimen (SBR) | Total |
|---|---|---|---|
| Age, Continuous | 41 Years STANDARD_DEVIATION 10.1 | 41 Years STANDARD_DEVIATION 10.1 | 41 Years STANDARD_DEVIATION 10.1 |
| HIV-1 RNA Category < 50 copies/mL | 943 Participants | 466 Participants | 1409 Participants |
| HIV-1 RNA Category ≥ 50 copies/mL | 16 Participants | 11 Participants | 27 Participants |
| Race/Ethnicity, Customized Ethnicity Hispanic or Latino | 248 Participants | 82 Participants | 330 Participants |
| Race/Ethnicity, Customized Ethnicity Local regulators did not allow collection of race or ethnicity information | 2 Participants | 3 Participants | 5 Participants |
| Race/Ethnicity, Customized Ethnicity Not Hispanic or Latino | 709 Participants | 392 Participants | 1101 Participants |
| Race/Ethnicity, Customized Race American Indian or Alaska Native | 5 Participants | 2 Participants | 7 Participants |
| Race/Ethnicity, Customized Race Asian | 59 Participants | 35 Participants | 94 Participants |
| Race/Ethnicity, Customized Race Black | 169 Participants | 102 Participants | 271 Participants |
| Race/Ethnicity, Customized Race Local regulators did not allow collection of race or ethnicity information | 2 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized Race Native Hawaiian or Pacific Islander | 6 Participants | 1 Participants | 7 Participants |
| Race/Ethnicity, Customized Race Other | 67 Participants | 22 Participants | 89 Participants |
| Race/Ethnicity, Customized Race White | 651 Participants | 314 Participants | 965 Participants |
| Region of Enrollment Australia | 38 participants | 22 participants | 60 participants |
| Region of Enrollment Austria | 16 participants | 8 participants | 24 participants |
| Region of Enrollment Belgium | 14 participants | 8 participants | 22 participants |
| Region of Enrollment Brazil | 14 participants | 5 participants | 19 participants |
| Region of Enrollment Canada | 51 participants | 27 participants | 78 participants |
| Region of Enrollment Denmark | 1 participants | 2 participants | 3 participants |
| Region of Enrollment Dominican Republic | 29 participants | 13 participants | 42 participants |
| Region of Enrollment France | 12 participants | 12 participants | 24 participants |
| Region of Enrollment Germany | 34 participants | 11 participants | 45 participants |
| Region of Enrollment Italy | 13 participants | 6 participants | 19 participants |
| Region of Enrollment Mexico | 19 participants | 6 participants | 25 participants |
| Region of Enrollment Netherlands | 2 participants | 3 participants | 5 participants |
| Region of Enrollment Portugal | 8 participants | 2 participants | 10 participants |
| Region of Enrollment Spain | 5 participants | 3 participants | 8 participants |
| Region of Enrollment Sweden | 1 participants | 0 participants | 1 participants |
| Region of Enrollment Switzerland | 5 participants | 4 participants | 9 participants |
| Region of Enrollment Thailand | 35 participants | 21 participants | 56 participants |
| Region of Enrollment United Kingdom | 14 participants | 8 participants | 22 participants |
| Region of Enrollment United States | 648 participants | 316 participants | 964 participants |
| Sex: Female, Male Female | 103 Participants | 50 Participants | 153 Participants |
| Sex: Female, Male Male | 856 Participants | 427 Participants | 1283 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 / 963 | 0 / 480 | 1 / 905 | 1 / 424 |
| other Total, other adverse events | 620 / 959 | 286 / 477 | 298 / 905 | 144 / 424 |
| serious Total, serious adverse events | 79 / 959 | 39 / 477 | 27 / 905 | 22 / 424 |
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 included participants who were randomized and received at least 1 dose of study drug.~New Drug Application (NDA Data Cut) = participants through the data cut for the E/C/F/TAF NDA; All Participants = participants through the Week 48 Data Cut.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| E/C/F/TAF | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 | NDA Data Cut | 95.6 percentage of participants |
| E/C/F/TAF | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 | All Participants | 97.2 percentage of participants |
| Stay on Baseline Treatment Regimen (SBR) | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 | NDA Data Cut | 92.9 percentage of participants |
| Stay on Baseline Treatment Regimen (SBR) | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 | All Participants | 93.1 percentage of participants |
Comparison: NDA Data Cutp-value: 0.05195.01% CI: [-0.3, 5.6]Cochran-Mantel-Haenszel
Comparison: All Participantsp-value: <0.00195% CI: [1.6, 6.7]Cochran-Mantel-Haenszel
Secondary
Change From Baseline in CD4 Cell Count at Weeks 96
The analysis of CD4 cell count included values up to 1 day after the last dose date of randomized study drug.The change from baseline in CD4 cell count for the full analysis set was based on observed data (ie, Missing = Excluded) for the total and by the prior treatment regimen.
Time frame: Baseline; Week 96
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| E/C/F/TAF | Change From Baseline in CD4 Cell Count at Weeks 96 | Baseline | 701 cells/uL | Standard Deviation 261.8 |
| E/C/F/TAF | Change From Baseline in CD4 Cell Count at Weeks 96 | Change at Week 96 | 60 cells/uL | Standard Deviation 181.6 |
| Stay on Baseline Treatment Regimen (SBR) | Change From Baseline in CD4 Cell Count at Weeks 96 | Change at Week 96 | 42 cells/uL | Standard Deviation 158 |
| Stay on Baseline Treatment Regimen (SBR) | Change From Baseline in CD4 Cell Count at Weeks 96 | Baseline | 689 cells/uL | Standard Deviation 248 |
p-value: 0.07495% CI: [-2, 38]ANOVA
Secondary
Change From Baseline in Cluster Determinant 4 (CD4) Cell Count at Week 48
The analysis of CD4 cell count included values up to 1 day after the last dose date of randomized study drug.The change from baseline in CD4 cell count for the full analysis set was based on observed data (ie, Missing = Excluded) for the total and by the prior treatment regimen.
Time frame: Baseline; Week 48
Population: Participants in the Full Analysis Set with available data were analyzed. NDA Data Cut = participants through the data cut for the E/C/F/TAF NDA; All Participants = participants through the Week 48 Data Cut.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| E/C/F/TAF | Change From Baseline in Cluster Determinant 4 (CD4) Cell Count at Week 48 | Baseline (NDA Data Cut) | 712 cells/uL | Standard Deviation 267.9 |
| E/C/F/TAF | Change From Baseline in Cluster Determinant 4 (CD4) Cell Count at Week 48 | Change at Week 48 (NDA Data Cut) | 33 cells/uL | Standard Deviation 166.6 |
| E/C/F/TAF | Change From Baseline in Cluster Determinant 4 (CD4) Cell Count at Week 48 | Baseline (All Participants) | 701 cells/uL | Standard Deviation 261.8 |
| E/C/F/TAF | Change From Baseline in Cluster Determinant 4 (CD4) Cell Count at Week 48 | Change at Week 48 (All Participants) | 35 cells/uL | Standard Deviation 164.6 |
| Stay on Baseline Treatment Regimen (SBR) | Change From Baseline in Cluster Determinant 4 (CD4) Cell Count at Week 48 | Change at Week 48 (All Participants) | 24 cells/uL | Standard Deviation 156.1 |
| Stay on Baseline Treatment Regimen (SBR) | Change From Baseline in Cluster Determinant 4 (CD4) Cell Count at Week 48 | Baseline (NDA Data Cut) | 690 cells/uL | Standard Deviation 251.4 |
| Stay on Baseline Treatment Regimen (SBR) | Change From Baseline in Cluster Determinant 4 (CD4) Cell Count at Week 48 | Baseline (All Participants) | 689 cells/uL | Standard Deviation 248 |
| Stay on Baseline Treatment Regimen (SBR) | Change From Baseline in Cluster Determinant 4 (CD4) Cell Count at Week 48 | Change at Week 48 (NDA Data Cut) | 27 cells/uL | Standard Deviation 160.2 |
Comparison: NDA Data Cut: Change at Week 48p-value: 0.5695% CI: [-14, 26]ANOVA
Comparison: All Participants: Change at Week 48p-value: 0.2695% CI: [-8, 29]ANOVA
Secondary
Change From Baseline in Serum Creatinine at Week 48
Time frame: Baseline; Week 48
Population: Participants in the Safety Analysis Set (randomized participants who received ≥ 1 dose of study drug) excluding participants with prior treatment of EFV/FTC/TDF.~NDA Data Cut = participants through the data cut for the E/C/F/TAF NDA; All Participants = participants through the Week 48 Data Cut
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| E/C/F/TAF | Change From Baseline in Serum Creatinine at Week 48 | All Participants | 0.00 mg/dL | Standard Deviation 0.115 |
| E/C/F/TAF | Change From Baseline in Serum Creatinine at Week 48 | NDA Data Cut | -0.01 mg/dL | Standard Deviation 0.117 |
| Stay on Baseline Treatment Regimen (SBR) | Change From Baseline in Serum Creatinine at Week 48 | NDA Data Cut | 0.04 mg/dL | Standard Deviation 0.123 |
| Stay on Baseline Treatment Regimen (SBR) | Change From Baseline in Serum Creatinine at Week 48 | All Participants | 0.03 mg/dL | Standard Deviation 0.105 |
Comparison: NDA Data Cutp-value: <0.00195% CI: [-0.07, -0.03]ANCOVA
Comparison: All Participantsp-value: <0.00195% CI: [-0.05, -0.02]ANCOVA
Secondary
Change From Baseline in the Overall EFV-related Symptom Assessment Score at Week 48
The mean (SD) change of the overall EFV-related symptom assessment score is presented. The overall symptom score (ranging from 0 to 20) is the sum of the individual symptom scores ranging from 0 (no symptoms) to 4 (most severe symptoms) from the 5 EFV-related symptom assessments (dizziness, trouble sleeping, impaired concentration, sleepiness, and abnormal or vivid dream). A negative change from baseline indicates improvement. EFV-Related Symptom Analysis Set: participants who received EFV/FTC/TDF as prior treatment, received at least 1 dose of study drug, and completed EFV-related symptom assessments at the baseline visit and at least 1 postbaseline visit.
Time frame: Baseline; Week 48
Population: Participants in EFV-Related Symptom Analysis Set with available data were analyzed.~NDA Data Cut = participants through data cut for E/C/F/TAF NDA; All Participants = participants through Week 48 Data Cut
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| E/C/F/TAF | Change From Baseline in the Overall EFV-related Symptom Assessment Score at Week 48 | All Participants | -1.5 units on a scale | Standard Deviation 3.06 |
| E/C/F/TAF | Change From Baseline in the Overall EFV-related Symptom Assessment Score at Week 48 | NDA Data Cut | -1.6 units on a scale | Standard Deviation 3.06 |
| Stay on Baseline Treatment Regimen (SBR) | Change From Baseline in the Overall EFV-related Symptom Assessment Score at Week 48 | All Participants | -0.1 units on a scale | Standard Deviation 2.39 |
| Stay on Baseline Treatment Regimen (SBR) | Change From Baseline in the Overall EFV-related Symptom Assessment Score at Week 48 | NDA Data Cut | -0.1 units on a scale | Standard Deviation 2.43 |
Comparison: NDA Data Cutp-value: <0.001Wilcoxon (Mann-Whitney)
Comparison: All Participantsp-value: <0.001Wilcoxon (Mann-Whitney)
Secondary
Percentage of Participants With HIV-1 RNA < 20 Copies/mL at 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 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: Participants in the Full Analysis Set were analyzed. NDA Data Cut = participants through the data cut for the E/C/F/TAF NDA; All Participants = participants through the Week 48 Data Cut.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| E/C/F/TAF | Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Week 48 | NDA Data Cut | 92.2 percentage of participants |
| E/C/F/TAF | Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Week 48 | All Participants | 93.5 percentage of participants |
| Stay on Baseline Treatment Regimen (SBR) | Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Week 48 | NDA Data Cut | 90.4 percentage of participants |
| Stay on Baseline Treatment Regimen (SBR) | Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Week 48 | All Participants | 90.4 percentage of participants |
Comparison: NDA Data Cutp-value: 0.2995% CI: [-1.7, 5.3]Cochran-Mantel-Haenszel
Comparison: All Participantsp-value: 0.03195% CI: [0.1, 6.3]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With HIV-1 RNA < 20 Copies/mL at 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 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 < 20 Copies/mL at Week 96 | 90.6 percentage of participants |
| Stay on Baseline Treatment Regimen (SBR) | Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Week 96 | 85.3 percentage of participants |
p-value: 0.00395% CI: [1.6, 9]Cochran-Mantel-Haenszel
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 | 92.8 percentage of participants |
| Stay on Baseline Treatment Regimen (SBR) | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96 | 89.1 percentage of participants |
p-value: 0.01795% CI: [0.4, 7]Cochran-Mantel-Haenszel
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. BMD is calculated as grams per square centimeter (g/cm\^2); the mean (SD) percentage change is presented.
Time frame: Baseline; Week 48
Population: Participants in the Hip DXA Analysis Set (participants who received ≥ 1 dose of study drug and had nonmissing baseline hip BMD) with available data were analyzed.~NDA Data Cut = participants through the data cut for the E/C/F/TAF NDA; All Participants = participants through the Week 48 Data Cut.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| E/C/F/TAF | Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48 | NDA Data Cut | 1.949 percentage change | Standard Deviation 2.9956 |
| E/C/F/TAF | Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48 | All Participants | 1.468 percentage change | Standard Deviation 2.7136 |
| Stay on Baseline Treatment Regimen (SBR) | Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48 | NDA Data Cut | -0.136 percentage change | Standard Deviation 2.989 |
| Stay on Baseline Treatment Regimen (SBR) | Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48 | All Participants | -0.340 percentage change | Standard Deviation 2.828 |
Comparison: NDA Data Cutp-value: <0.00195% CI: [1.697, 2.459]ANOVA
Comparison: All Participantsp-value: <0.00195% CI: [1.488, 2.126]ANOVA
Secondary
Percent Change From Baseline in Spine BMD at Week 48
Spine BMD was assessed by DXA scan. BMD is calculated as g/cm\^2; the mean (SD) percentage change is presented.
Time frame: Baseline; Week 48
Population: Participants in the Spine DXA Analysis Set (participants who received ≥ 1 dose of study drug and had nonmissing baseline spine BMD) with available data were analyzed.~NDA Data Cut = participants through the data cut for the E/C/F/TAF NDA; All Participants = participants through the Week 48 Data Cut.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| E/C/F/TAF | Percent Change From Baseline in Spine BMD at Week 48 | NDA Data Cut | 1.861 percentage change | Standard Deviation 3.0889 |
| E/C/F/TAF | Percent Change From Baseline in Spine BMD at Week 48 | All Participants | 1.557 percentage change | Standard Deviation 3.8441 |
| Stay on Baseline Treatment Regimen (SBR) | Percent Change From Baseline in Spine BMD at Week 48 | NDA Data Cut | -0.110 percentage change | Standard Deviation 3.7415 |
| Stay on Baseline Treatment Regimen (SBR) | Percent Change From Baseline in Spine BMD at Week 48 | All Participants | -0.443 percentage change | Standard Deviation 4.1387 |
Comparison: NDA Data Cutp-value: <0.00195% CI: [1.551, 2.39]ANOVA
Comparison: All Participantsp-value: <0.00195% CI: [1.549, 2.452]ANOVA