HIV-1 Infection
Conditions
Brief summary
The primary objective of the study is to evaluate the efficacy of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) after switching from a stable regimen consisting of emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) or abacavir/lamivudine (ABC/3TC) plus a third antiretroviral (ARV) agent in participants harboring the archived nucleoside/nucleotide reverse transcriptase inhibitor (NRTI) resistance mutation M184V and/or M184I in human immunodeficiency virus (HIV) -1 reverse transcriptase. This is a two part study. If the rate of virologic failure in Part 1 is deemed acceptable, once the internal data monitoring committee officially completes the interim review, the study will continue to Part 2.
Interventions
DRUGE/C/F/TAF
150/150/200/10 mg FDC tablets administered orally once daily
Sponsors
Gilead Sciences
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Documented historical genotype report showing mutation M184V and/or M184I (mixtures are acceptable) in reverse transcriptase. Individuals must not have any primary integrase strand transfer inhibitor (INSTI) or primary protease inhibitor (PI) resistance mutations present on historical genotype; non-nucleoside reverse transcriptase inhibitor (NNRTI) mutations are allowed. * Proviral deoxyribonucleic acid (DNA) test must not have additional exclusion resistance mutations against PIs, NRTIs and INSTIs * Part 1: Historical genotype report must show mutation M184V and/or M184I in reverse transcriptase WITHOUT any other NRTI resistance mutation (including thymidine analogue-associated mutations \[TAMs\] \[TAMs are: M41L, D67N, K70R, L210W, T215Y/F, and K219Q/E/N/R\], K65R, K70E, T69 insertion, and Q151M mutation complex \[A62V, V75I, F77L, F116Y, Q151M\]) * Part 2 (after the interim efficacy review): Historical genotype report must show M184V and/or M184I in reverse transcriptase WITH or WITHOUT 1 or 2 TAMs. Evidence of K65R, K70E, T69 insertion and/or Q151M mutation complex will not be eligible * Currently receiving an ARV regimen consisting of FTC/TDF or ABC/3TC in combination with one third ARV agent for ≥ 6 consecutive months preceding the screening visit * Documented plasma HIV-1 ribonucleic acid (RNA) levels \< 50 copies/mL for ≥ 6 months preceding the screening visit * Plasma HIV-1 RNA levels \< 50 copies/mL at screening visit * Estimated glomerular filtration rate (GFR) ≥ 30 mL/min according to the Cockcroft-Gault formula for creatinine clearance * A female individual is eligible to enter the study if it is confirmed that she is: * not pregnant * of non-childbearing potential * stopped menstruating for ≥ 12 months * of childbearing potential and agrees to utilize the protocol-specified method of contraception or be non-heterosexually active or practice sexual abstinence from screening throughout the duration of study treatment and for 30 days following discontinuation of study drugs * Male individuals must agree to use the protocol-specified method(s) of contraception during heterosexual intercourse or be non-heterosexually active, or practice sexual abstinence from screening throughout the study period and for 30 days following the last study drug dose * Male individuals must agree to refrain from sperm donation from first dose until at least 30 days after the last study drug dose Key
Exclusion criteria
* Individuals will have no evidence of previous virologic failure on a PI/r or INSTI-based regimen (with or without resistance to either class of ARV). Individuals may have evidence of prior virologic failure on only an NNRTI plus 2 NRTI-based regimen * Individuals on a current PI/r-based regimen will have no evidence of previous use of any approved or experimental integrase strand transfer inhibitor (INSTI) (for any length of time) * Hepatitis C infection that would require therapy during the study * Hepatitis B surface antigen (HBsAg) positive * Individuals with clinical evidence of decompensated cirrhosis (eg, ascites, encephalopathy, variceal bleeding) * Have an implanted defibrillator or pacemaker * A history of malignancy within the past 5 years (prior to screening) or ongoing malignancy other than cutaneous Kaposi's sarcoma (KS), basal cell carcinoma, or resected, non invasive cutaneous squamous carcinoma. Individuals with cutaneous KS are eligible, but must not have received any systemic therapy for KS within 30 days of Day 1 and must not be anticipated to require systemic therapy during the study * Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to Day 1 NOTE: Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) < 50 Copies/mL at Week 12 as Defined by Pure Virologic Response (PVR) | Week 12 | The percentage of participants with PVR for HIV-1 RNA cutoff at 50 copies/mL at Week 12 was summarized. PVR was the percentage of participants who did not have a confirmed virologic rebound. Virologic rebound was defined as 2 consecutive HIV-1 RNA values ≥ 50 copies/mL or the last available HIV-1 RNA value ≥ 50 copies/mL during the study followed by premature discontinuation from the study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 Using PVR | Week 24 | The percentage of participants with PVR for HIV-1 RNA cutoff at 50 copies/mL at Week 24 was summarized. PVR was the percentage of participants who did not have a confirmed virologic rebound. Virologic rebound was defined as 2 consecutive HIV-1 RNA values ≥ 50 copies/mL or the last available HIV-1 RNA value ≥ 50 copies/mL during the study followed by premature discontinuation from the study. |
| Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 Using PVR | Week 48 | The percentage of participants with PVR for HIV-1 RNA cutoff at 50 copies/mL at Week 48 was summarized. PVR was the percentage of participants who did not have a confirmed virologic rebound. Virologic rebound was defined as 2 consecutive HIV-1 RNA values ≥ 50 copies/mL or the last available HIV-1 RNA value ≥ 50 copies/mL during the study followed by premature discontinuation from the study. |
| Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 12 Using the FDA Snapshot Analysis | Week 12 | The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 12 was also analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. Week 12 window was between Day 71 and 98 (inclusive). |
| Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 Using the FDA Snapshot Analysis | Week 24 | The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 24 was also analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. Week 24 window was between Day 141 and 210 (inclusive). |
| Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 Using the FDA Snapshot Analysis | Week 48 | The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 48 was also analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. Week 12 window was between Day 295 and 378 (inclusive). |
| Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Week 12 Using the FDA Snapshot Analysis | Week 12 | The percentage of participants with HIV-1 RNA \< 20 copies/mL at Week 12 was also analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. Week 12 window was between Day 71 and 98 (inclusive). |
| Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Week 24 Using the FDA Snapshot Analysis | Week 24 | The percentage of participants with HIV-1 RNA \< 20 copies/mL at Week 24 was also analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. Week 24 window was between Day 141 and 210 (inclusive). |
| Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Week 48 Using the FDA Snapshot Analysis | Week 48 | The percentage of participants with HIV-1 RNA \< 20 copies/mL at Week 48 was also analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. Week 12 window was between Day 295 and 378 (inclusive). |
| Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 12 Using the Missing = Failure (M = F) Approach | Week 12 | The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 12 was analyzed using the M = F approach. In this approach, all missing data was treated as HIV-1 RNA ≥ 50 copies/mL. |
| Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 Using the M = F Approach | Week 24 | The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 24 was analyzed using the M = F approach. In this approach, all missing data was treated as HIV-1 RNA ≥ 50 copies/mL. |
| Percentage of Participants With Emergence of New Mutations in HIV-1 Reverse Transcriptase and Integrase | Day 1 up to 48 weeks | Development of new resistance mutations was assessed in participants who developed virologic failure, defined as 2 consecutive HIV-1 RNA result ≥ 50 copies/mL at any point in the study or with HIV-1 RNA ≥ 50 copies/mL at last visit. |
| Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 12 Using the Missing = Excluded (M = E) Approach | Week 12 | The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 12 was also analyzed using the M = E approach. In this approach, all missing data was excluded in the computation of the proportions. |
| Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 Using the M = E Approach | Week 24 | The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 24 was also analyzed using the M = E approach. In this approach, all missing data was excluded in the computation of the proportions. |
| Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 Using the M = E Approach | Week 48 | The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 48 was also analyzed using the M = E approach. In this approach, all missing data was excluded in the computation of the proportions. |
| Change From Baseline in Cluster Determinant 4+ (CD4+) Cell Count at Week 12 | Baseline (Day 1); Week 12 | — |
| Change From Baseline in CD4+ Cell Count at Week 24 | Baseline (Day 1); Week 24 | — |
| Change From Baseline in CD4+ Cell Count at Week 48 | Baseline (Day 1); Week 48 | — |
| Change From Baseline in CD4 Percentage (%) at Week 12 | Baseline (Day 1); Week 12 | — |
| Change From Baseline in CD4 % at Week 24 | Baseline (Day 1); Week 24 | — |
| Change From Baseline in CD4 % at Week 48 | Baseline (Day 1); Week 48 | — |
| Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 Using the M = F Approach | Week 48 | The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 48 was analyzed using the M = F approach. In this approach, all missing data was treated as HIV-1 RNA ≥ 50 copies/mL. |
Countries
France, Germany, Italy, Spain, United States
Participant flow
Recruitment details
Participants were enrolled at study sites in the United States and Europe. The first participant was screened on 17 December 2015. The last study visit occurred on 11 July 2019.
Pre-assignment details
120 participants were screened.
Participants by arm
| Arm | Count |
|---|---|
| Part 1: E/C/F/TAF Participants with M184V and/or M184I mutations in reverse transcriptase and without any other NRTI-resistance mutation switched from their current human immunodeficiency virus (HIV) treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks. | 37 |
| Part 2: E/C/F/TAF Participants with M184V and/or M184I mutations in reverse transcriptase and with or without 1 or 2 TAMs switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks. | 27 |
| Total | 64 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Death | 0 | 1 |
| Overall Study | Enrolled and Never Treated | 1 | 1 |
| Overall Study | Protocol Violation | 1 | 0 |
| Overall Study | Withdrew Consent | 1 | 0 |
Baseline characteristics
| Characteristic | Part 2: E/C/F/TAF | Part 1: E/C/F/TAF | Total |
|---|---|---|---|
| Age, Continuous | 52 years STANDARD_DEVIATION 9.5 | 50 years STANDARD_DEVIATION 9.2 | 51 years STANDARD_DEVIATION 9.3 |
| CD4+ Cell Count Categories ≥ 200 to < 350 cells/µL | 1 Participants | 3 Participants | 4 Participants |
| CD4+ Cell Count Categories ≥ 350 to < 500 cells/µL | 5 Participants | 4 Participants | 9 Participants |
| CD4+ Cell Count Categories ≥ 500 cells/µL | 19 Participants | 29 Participants | 48 Participants |
| CD4+ Cell Count Categories < 50 cells/µL | 0 Participants | 0 Participants | 0 Participants |
| CD4+ Cell Count Categories ≥ 50 to < 200 cells/µL | 2 Participants | 1 Participants | 3 Participants |
| CD4 Percentage (%) | 31.2 percentage of CD4 cells STANDARD_DEVIATION 11.43 | 32.9 percentage of CD4 cells STANDARD_DEVIATION 10.12 | 32.2 percentage of CD4 cells STANDARD_DEVIATION 10.63 |
| Cluster Determinant 4+ (CD4+) Cell Count | 665 cells/µL STANDARD_DEVIATION 312.7 | 740 cells/µL STANDARD_DEVIATION 319.6 | 708 cells/µL STANDARD_DEVIATION 316.4 |
| HIV-1 RNA | 1.29 log10 copies/mL STANDARD_DEVIATION 0.046 | 1.29 log10 copies/mL STANDARD_DEVIATION 0.056 | 1.29 log10 copies/mL STANDARD_DEVIATION 0.052 |
| HIV-1 RNA Categories < 50 copies/mL | 27 Participants | 37 Participants | 64 Participants |
| HIV-1 RNA Categories ≥ 50 copies/mL | 0 Participants | 0 Participants | 0 Participants |
| HIV Disease Status Acquired Immune Deficiency Syndrome (AIDS) | 3 Participants | 3 Participants | 6 Participants |
| HIV Disease Status Asymptomatic | 23 Participants | 30 Participants | 53 Participants |
| HIV Disease Status Symptomatic HIV Infection | 1 Participants | 4 Participants | 5 Participants |
| Race/Ethnicity, Customized Ethnicity Hispanic or Latino | 4 Participants | 6 Participants | 10 Participants |
| Race/Ethnicity, Customized Ethnicity Not Hispanic or Latino | 21 Participants | 27 Participants | 48 Participants |
| Race/Ethnicity, Customized Ethnicity Not Permitted | 2 Participants | 4 Participants | 6 Participants |
| Race/Ethnicity, Customized Race American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race Asian | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race Black | 8 Participants | 7 Participants | 15 Participants |
| Race/Ethnicity, Customized Race Native Hawaiian or Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race Not Permitted | 2 Participants | 3 Participants | 5 Participants |
| Race/Ethnicity, Customized Race White | 17 Participants | 27 Participants | 44 Participants |
| Region of Enrollment France | 15 Participants | 14 Participants | 29 Participants |
| Region of Enrollment Germany | 1 Participants | 4 Participants | 5 Participants |
| Region of Enrollment Italy | 3 Participants | 2 Participants | 5 Participants |
| Region of Enrollment Spain | 3 Participants | 14 Participants | 17 Participants |
| Region of Enrollment United States | 5 Participants | 3 Participants | 8 Participants |
| Sex: Female, Male Female | 9 Participants | 8 Participants | 17 Participants |
| Sex: Female, Male Male | 18 Participants | 29 Participants | 47 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 64 |
| other Total, other adverse events | 26 / 64 |
| serious Total, serious adverse events | 5 / 64 |
Outcome results
Primary
Percentage of Participants With Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) < 50 Copies/mL at Week 12 as Defined by Pure Virologic Response (PVR)
The percentage of participants with PVR for HIV-1 RNA cutoff at 50 copies/mL at Week 12 was summarized. PVR was the percentage of participants who did not have a confirmed virologic rebound. Virologic rebound was defined as 2 consecutive HIV-1 RNA values ≥ 50 copies/mL or the last available HIV-1 RNA value ≥ 50 copies/mL during the study followed by premature discontinuation from the study.
Time frame: Week 12
Population: The Full Analysis Set included all the randomized participants who received at least one dose of study drug and excluded participants with any major protocol violations.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part 1: E/C/F/TAF | Percentage of Participants With Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) < 50 Copies/mL at Week 12 as Defined by Pure Virologic Response (PVR) | 100.0 percentage of participants |
| Part 2: E/C/F/TAF | Percentage of Participants With Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) < 50 Copies/mL at Week 12 as Defined by Pure Virologic Response (PVR) | 100.0 percentage of participants |
| Total E/C/F/TAF | Percentage of Participants With Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) < 50 Copies/mL at Week 12 as Defined by Pure Virologic Response (PVR) | 100.0 percentage of participants |
Secondary
Change From Baseline in CD4 % at Week 24
Time frame: Baseline (Day 1); Week 24
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1: E/C/F/TAF | Change From Baseline in CD4 % at Week 24 | 0.1 percentage of CD4 cells | Standard Deviation 3.25 |
| Part 2: E/C/F/TAF | Change From Baseline in CD4 % at Week 24 | 1.1 percentage of CD4 cells | Standard Deviation 4.3 |
| Total E/C/F/TAF | Change From Baseline in CD4 % at Week 24 | 0.5 percentage of CD4 cells | Standard Deviation 3.75 |
Secondary
Change From Baseline in CD4 % at Week 48
Time frame: Baseline (Day 1); Week 48
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1: E/C/F/TAF | Change From Baseline in CD4 % at Week 48 | 0.2 percentage of CD4 cells | Standard Deviation 3.12 |
| Part 2: E/C/F/TAF | Change From Baseline in CD4 % at Week 48 | 1.5 percentage of CD4 cells | Standard Deviation 3.64 |
| Total E/C/F/TAF | Change From Baseline in CD4 % at Week 48 | 0.8 percentage of CD4 cells | Standard Deviation 3.39 |
Secondary
Change From Baseline in CD4+ Cell Count at Week 24
Time frame: Baseline (Day 1); Week 24
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1: E/C/F/TAF | Change From Baseline in CD4+ Cell Count at Week 24 | -40 cells/µL | Standard Deviation 162.1 |
| Part 2: E/C/F/TAF | Change From Baseline in CD4+ Cell Count at Week 24 | 28 cells/µL | Standard Deviation 212.5 |
| Total E/C/F/TAF | Change From Baseline in CD4+ Cell Count at Week 24 | -10 cells/µL | Standard Deviation 187.4 |
Secondary
Change From Baseline in CD4+ Cell Count at Week 48
Time frame: Baseline (Day 1); Week 48
Population: Participants in the Full Analysis Set were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1: E/C/F/TAF | Change From Baseline in CD4+ Cell Count at Week 48 | -6 cells/µL | Standard Deviation 131.9 |
| Part 2: E/C/F/TAF | Change From Baseline in CD4+ Cell Count at Week 48 | 27 cells/µL | Standard Deviation 120.4 |
| Total E/C/F/TAF | Change From Baseline in CD4+ Cell Count at Week 48 | 9 cells/µL | Standard Deviation 126.8 |
Secondary
Change From Baseline in CD4 Percentage (%) at Week 12
Time frame: Baseline (Day 1); Week 12
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1: E/C/F/TAF | Change From Baseline in CD4 Percentage (%) at Week 12 | -0.4 percentage of CD4 cells | Standard Deviation 3.37 |
| Part 2: E/C/F/TAF | Change From Baseline in CD4 Percentage (%) at Week 12 | 1.5 percentage of CD4 cells | Standard Deviation 3.01 |
| Total E/C/F/TAF | Change From Baseline in CD4 Percentage (%) at Week 12 | 0.4 percentage of CD4 cells | Standard Deviation 3.33 |
Secondary
Change From Baseline in Cluster Determinant 4+ (CD4+) Cell Count at Week 12
Time frame: Baseline (Day 1); Week 12
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1: E/C/F/TAF | Change From Baseline in Cluster Determinant 4+ (CD4+) Cell Count at Week 12 | -47 cells/µL | Standard Deviation 194.1 |
| Part 2: E/C/F/TAF | Change From Baseline in Cluster Determinant 4+ (CD4+) Cell Count at Week 12 | -6 cells/µL | Standard Deviation 116.1 |
| Total E/C/F/TAF | Change From Baseline in Cluster Determinant 4+ (CD4+) Cell Count at Week 12 | -30 cells/µL | Standard Deviation 165.1 |
Secondary
Percentage of Participants With Emergence of New Mutations in HIV-1 Reverse Transcriptase and Integrase
Development of new resistance mutations was assessed in participants who developed virologic failure, defined as 2 consecutive HIV-1 RNA result ≥ 50 copies/mL at any point in the study or with HIV-1 RNA ≥ 50 copies/mL at last visit.
Time frame: Day 1 up to 48 weeks
Population: Participants in the Full Analysis Set were included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part 1: E/C/F/TAF | Percentage of Participants With Emergence of New Mutations in HIV-1 Reverse Transcriptase and Integrase | 0 percentage of participants |
| Part 2: E/C/F/TAF | Percentage of Participants With Emergence of New Mutations in HIV-1 Reverse Transcriptase and Integrase | 0 percentage of participants |
| Total E/C/F/TAF | Percentage of Participants With Emergence of New Mutations in HIV-1 Reverse Transcriptase and Integrase | 0 percentage of participants |
Secondary
Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Week 12 Using the FDA Snapshot Analysis
The percentage of participants with HIV-1 RNA \< 20 copies/mL at Week 12 was also analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. Week 12 window was between Day 71 and 98 (inclusive).
Time frame: Week 12
Population: Participants in the Full Analysis Set were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part 1: E/C/F/TAF | Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Week 12 Using the FDA Snapshot Analysis | 91.7 percentage of participants |
| Part 2: E/C/F/TAF | Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Week 12 Using the FDA Snapshot Analysis | 96.2 percentage of participants |
| Total E/C/F/TAF | Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Week 12 Using the FDA Snapshot Analysis | 93.5 percentage of participants |
Secondary
Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Week 24 Using the FDA Snapshot Analysis
The percentage of participants with HIV-1 RNA \< 20 copies/mL at Week 24 was also analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. Week 24 window was between Day 141 and 210 (inclusive).
Time frame: Week 24
Population: Participants in the Full Analysis Set were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part 1: E/C/F/TAF | Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Week 24 Using the FDA Snapshot Analysis | 88.9 percentage of participants |
| Part 2: E/C/F/TAF | Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Week 24 Using the FDA Snapshot Analysis | 100.0 percentage of participants |
| Total E/C/F/TAF | Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Week 24 Using the FDA Snapshot Analysis | 93.5 percentage of participants |
Secondary
Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Week 48 Using the FDA Snapshot Analysis
The percentage of participants with HIV-1 RNA \< 20 copies/mL at Week 48 was also analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. Week 12 window was between Day 295 and 378 (inclusive).
Time frame: Week 48
Population: Participants in the Full Analysis Set were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part 1: E/C/F/TAF | Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Week 48 Using the FDA Snapshot Analysis | 88.9 percentage of participants |
| Part 2: E/C/F/TAF | Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Week 48 Using the FDA Snapshot Analysis | 96.2 percentage of participants |
| Total E/C/F/TAF | Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Week 48 Using the FDA Snapshot Analysis | 91.9 percentage of participants |
Secondary
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 12 Using the FDA Snapshot Analysis
The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 12 was also analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. Week 12 window was between Day 71 and 98 (inclusive).
Time frame: Week 12
Population: Participants in the Full Analysis Set were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part 1: E/C/F/TAF | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 12 Using the FDA Snapshot Analysis | 91.7 percentage of participants |
| Part 2: E/C/F/TAF | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 12 Using the FDA Snapshot Analysis | 96.2 percentage of participants |
| Total E/C/F/TAF | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 12 Using the FDA Snapshot Analysis | 93.5 percentage of participants |
Secondary
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 12 Using the Missing = Excluded (M = E) Approach
The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 12 was also analyzed using the M = E approach. In this approach, all missing data was excluded in the computation of the proportions.
Time frame: Week 12
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part 1: E/C/F/TAF | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 12 Using the Missing = Excluded (M = E) Approach | 100.0 percentage of participants |
| Part 2: E/C/F/TAF | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 12 Using the Missing = Excluded (M = E) Approach | 96.2 percentage of participants |
| Total E/C/F/TAF | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 12 Using the Missing = Excluded (M = E) Approach | 98.4 percentage of participants |
Secondary
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 12 Using the Missing = Failure (M = F) Approach
The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 12 was analyzed using the M = F approach. In this approach, all missing data was treated as HIV-1 RNA ≥ 50 copies/mL.
Time frame: Week 12
Population: Participants in the Full Analysis Set were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part 1: E/C/F/TAF | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 12 Using the Missing = Failure (M = F) Approach | 97.2 percentage of participants |
| Part 2: E/C/F/TAF | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 12 Using the Missing = Failure (M = F) Approach | 96.2 percentage of participants |
| Total E/C/F/TAF | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 12 Using the Missing = Failure (M = F) Approach | 96.8 percentage of participants |
Secondary
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 Using PVR
The percentage of participants with PVR for HIV-1 RNA cutoff at 50 copies/mL at Week 24 was summarized. PVR was the percentage of participants who did not have a confirmed virologic rebound. Virologic rebound was defined as 2 consecutive HIV-1 RNA values ≥ 50 copies/mL or the last available HIV-1 RNA value ≥ 50 copies/mL during the study followed by premature discontinuation from the study.
Time frame: Week 24
Population: Participants in the Full Analysis Set were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part 1: E/C/F/TAF | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 Using PVR | 100.0 percentage of participants |
| Part 2: E/C/F/TAF | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 Using PVR | 100.0 percentage of participants |
| Total E/C/F/TAF | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 Using PVR | 100.0 percentage of participants |
Secondary
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 Using the FDA Snapshot Analysis
The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 24 was also analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. Week 24 window was between Day 141 and 210 (inclusive).
Time frame: Week 24
Population: Participants in the Full Analysis Set were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part 1: E/C/F/TAF | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 Using the FDA Snapshot Analysis | 91.7 percentage of participants |
| Part 2: E/C/F/TAF | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 Using the FDA Snapshot Analysis | 100.0 percentage of participants |
| Total E/C/F/TAF | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 Using the FDA Snapshot Analysis | 95.2 percentage of participants |
Secondary
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 Using the M = E Approach
The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 24 was also analyzed using the M = E approach. In this approach, all missing data was excluded in the computation of the proportions.
Time frame: Week 24
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part 1: E/C/F/TAF | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 Using the M = E Approach | 100.0 percentage of participants |
| Part 2: E/C/F/TAF | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 Using the M = E Approach | 100.0 percentage of participants |
| Total E/C/F/TAF | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 Using the M = E Approach | 100.0 percentage of participants |
Secondary
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 Using the M = F Approach
The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 24 was analyzed using the M = F approach. In this approach, all missing data was treated as HIV-1 RNA ≥ 50 copies/mL.
Time frame: Week 24
Population: Participants in the Full Analysis Set were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part 1: E/C/F/TAF | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 Using the M = F Approach | 91.7 percentage of participants |
| Part 2: E/C/F/TAF | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 Using the M = F Approach | 100.0 percentage of participants |
| Total E/C/F/TAF | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 Using the M = F Approach | 95.2 percentage of participants |
Secondary
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 Using PVR
The percentage of participants with PVR for HIV-1 RNA cutoff at 50 copies/mL at Week 48 was summarized. PVR was the percentage of participants who did not have a confirmed virologic rebound. Virologic rebound was defined as 2 consecutive HIV-1 RNA values ≥ 50 copies/mL or the last available HIV-1 RNA value ≥ 50 copies/mL during the study followed by premature discontinuation from the study.
Time frame: Week 48
Population: Participants in the Full Analysis Set were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part 1: E/C/F/TAF | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 Using PVR | 100.0 percentage of participants |
| Part 2: E/C/F/TAF | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 Using PVR | 100.0 percentage of participants |
| Total E/C/F/TAF | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 Using PVR | 100.0 percentage of participants |
Secondary
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 Using the FDA Snapshot Analysis
The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 48 was also analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. Week 12 window was between Day 295 and 378 (inclusive).
Time frame: Week 48
Population: Participants in the Full Analysis Set were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part 1: E/C/F/TAF | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 Using the FDA Snapshot Analysis | 88.9 percentage of participants |
| Part 2: E/C/F/TAF | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 Using the FDA Snapshot Analysis | 96.2 percentage of participants |
| Total E/C/F/TAF | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 Using the FDA Snapshot Analysis | 91.9 percentage of participants |
Secondary
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 Using the M = E Approach
The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 48 was also analyzed using the M = E approach. In this approach, all missing data was excluded in the computation of the proportions.
Time frame: Week 48
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part 1: E/C/F/TAF | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 Using the M = E Approach | 100.0 percentage of participants |
| Part 2: E/C/F/TAF | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 Using the M = E Approach | 100.0 percentage of participants |
| Total E/C/F/TAF | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 Using the M = E Approach | 100.0 percentage of participants |
Secondary
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 Using the M = F Approach
The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 48 was analyzed using the M = F approach. In this approach, all missing data was treated as HIV-1 RNA ≥ 50 copies/mL.
Time frame: Week 48
Population: Participants in the Full Analysis Set were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part 1: E/C/F/TAF | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 Using the M = F Approach | 91.7 percentage of participants |
| Part 2: E/C/F/TAF | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 Using the M = F Approach | 96.2 percentage of participants |
| Total E/C/F/TAF | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 Using the M = F Approach | 93.5 percentage of participants |