Trial Outcomes & Findings for Study to Evaluate Switching to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Fixed Dose Combination (FDC) in Virologically-Suppressed HIV-1 Infected Adults Harboring the Archived Isolated NRTI Resistance Mutation M184V/M184I (NCT NCT02616029)
NCT ID: NCT02616029
Last Updated: 2020-07-23
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
66 participants
Primary outcome timeframe
Week 12
Results posted on
2020-07-23
Participant Flow
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.
120 participants were screened.
Participant milestones
| Measure |
Part 1: E/C/F/TAF
Participants with M184V and/or M184I mutations in reverse transcriptase and without any other nucleos(t)ide reverse transcriptase inhibitor (NRTI)-resistance mutation switched from their current human immunodeficiency virus (HIV) treatment regimen consisting of emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) or abacavir/lamivudine (ABC/3TC) plus a third antiretroviral agent to elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablet orally once daily for 48 weeks.
|
Part 2: E/C/F/TAF
Participants with M184V and/or M184I mutations in reverse transcriptase and with or without 1 or 2 thymidine analog-associated mutations (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.
|
|---|---|---|
|
Overall Study
STARTED
|
38
|
28
|
|
Overall Study
COMPLETED
|
34
|
26
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
Reasons for withdrawal
| Measure |
Part 1: E/C/F/TAF
Participants with M184V and/or M184I mutations in reverse transcriptase and without any other nucleos(t)ide reverse transcriptase inhibitor (NRTI)-resistance mutation switched from their current human immunodeficiency virus (HIV) treatment regimen consisting of emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) or abacavir/lamivudine (ABC/3TC) plus a third antiretroviral agent to elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablet orally once daily for 48 weeks.
|
Part 2: E/C/F/TAF
Participants with M184V and/or M184I mutations in reverse transcriptase and with or without 1 or 2 thymidine analog-associated mutations (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.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Death
|
0
|
1
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Withdrew Consent
|
1
|
0
|
|
Overall Study
Enrolled and Never Treated
|
1
|
1
|
Baseline Characteristics
Study to Evaluate Switching to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Fixed Dose Combination (FDC) in Virologically-Suppressed HIV-1 Infected Adults Harboring the Archived Isolated NRTI Resistance Mutation M184V/M184I
Baseline characteristics by cohort
| Measure |
Part 1: E/C/F/TAF
n=37 Participants
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.
|
Part 2: E/C/F/TAF
n=27 Participants
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.
|
Total
n=64 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50 years
STANDARD_DEVIATION 9.2 • n=113 Participants
|
52 years
STANDARD_DEVIATION 9.5 • n=163 Participants
|
51 years
STANDARD_DEVIATION 9.3 • n=160 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=113 Participants
|
9 Participants
n=163 Participants
|
17 Participants
n=160 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=113 Participants
|
18 Participants
n=163 Participants
|
47 Participants
n=160 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Hispanic or Latino
|
6 Participants
n=113 Participants
|
4 Participants
n=163 Participants
|
10 Participants
n=160 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Not Hispanic or Latino
|
27 Participants
n=113 Participants
|
21 Participants
n=163 Participants
|
48 Participants
n=160 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Not Permitted
|
4 Participants
n=113 Participants
|
2 Participants
n=163 Participants
|
6 Participants
n=160 Participants
|
|
Race/Ethnicity, Customized
Race · American Indian or Alaska Native
|
0 Participants
n=113 Participants
|
0 Participants
n=163 Participants
|
0 Participants
n=160 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
0 Participants
n=113 Participants
|
0 Participants
n=163 Participants
|
0 Participants
n=160 Participants
|
|
Race/Ethnicity, Customized
Race · Black
|
7 Participants
n=113 Participants
|
8 Participants
n=163 Participants
|
15 Participants
n=160 Participants
|
|
Race/Ethnicity, Customized
Race · Native Hawaiian or Pacific Islander
|
0 Participants
n=113 Participants
|
0 Participants
n=163 Participants
|
0 Participants
n=160 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
27 Participants
n=113 Participants
|
17 Participants
n=163 Participants
|
44 Participants
n=160 Participants
|
|
Race/Ethnicity, Customized
Race · Not Permitted
|
3 Participants
n=113 Participants
|
2 Participants
n=163 Participants
|
5 Participants
n=160 Participants
|
|
Region of Enrollment
United States
|
3 Participants
n=113 Participants
|
5 Participants
n=163 Participants
|
8 Participants
n=160 Participants
|
|
Region of Enrollment
Italy
|
2 Participants
n=113 Participants
|
3 Participants
n=163 Participants
|
5 Participants
n=160 Participants
|
|
Region of Enrollment
France
|
14 Participants
n=113 Participants
|
15 Participants
n=163 Participants
|
29 Participants
n=160 Participants
|
|
Region of Enrollment
Germany
|
4 Participants
n=113 Participants
|
1 Participants
n=163 Participants
|
5 Participants
n=160 Participants
|
|
Region of Enrollment
Spain
|
14 Participants
n=113 Participants
|
3 Participants
n=163 Participants
|
17 Participants
n=160 Participants
|
|
HIV-1 RNA
|
1.29 log10 copies/mL
STANDARD_DEVIATION 0.056 • n=113 Participants
|
1.29 log10 copies/mL
STANDARD_DEVIATION 0.046 • n=163 Participants
|
1.29 log10 copies/mL
STANDARD_DEVIATION 0.052 • n=160 Participants
|
|
HIV-1 RNA Categories
< 50 copies/mL
|
37 Participants
n=113 Participants
|
27 Participants
n=163 Participants
|
64 Participants
n=160 Participants
|
|
HIV-1 RNA Categories
≥ 50 copies/mL
|
0 Participants
n=113 Participants
|
0 Participants
n=163 Participants
|
0 Participants
n=160 Participants
|
|
Cluster Determinant 4+ (CD4+) Cell Count
|
740 cells/µL
STANDARD_DEVIATION 319.6 • n=113 Participants
|
665 cells/µL
STANDARD_DEVIATION 312.7 • n=163 Participants
|
708 cells/µL
STANDARD_DEVIATION 316.4 • n=160 Participants
|
|
CD4+ Cell Count Categories
< 50 cells/µL
|
0 Participants
n=113 Participants
|
0 Participants
n=163 Participants
|
0 Participants
n=160 Participants
|
|
CD4+ Cell Count Categories
≥ 50 to < 200 cells/µL
|
1 Participants
n=113 Participants
|
2 Participants
n=163 Participants
|
3 Participants
n=160 Participants
|
|
CD4+ Cell Count Categories
≥ 200 to < 350 cells/µL
|
3 Participants
n=113 Participants
|
1 Participants
n=163 Participants
|
4 Participants
n=160 Participants
|
|
CD4+ Cell Count Categories
≥ 350 to < 500 cells/µL
|
4 Participants
n=113 Participants
|
5 Participants
n=163 Participants
|
9 Participants
n=160 Participants
|
|
CD4+ Cell Count Categories
≥ 500 cells/µL
|
29 Participants
n=113 Participants
|
19 Participants
n=163 Participants
|
48 Participants
n=160 Participants
|
|
HIV Disease Status
Asymptomatic
|
30 Participants
n=113 Participants
|
23 Participants
n=163 Participants
|
53 Participants
n=160 Participants
|
|
HIV Disease Status
Symptomatic HIV Infection
|
4 Participants
n=113 Participants
|
1 Participants
n=163 Participants
|
5 Participants
n=160 Participants
|
|
HIV Disease Status
Acquired Immune Deficiency Syndrome (AIDS)
|
3 Participants
n=113 Participants
|
3 Participants
n=163 Participants
|
6 Participants
n=160 Participants
|
|
CD4 Percentage (%)
|
32.9 percentage of CD4 cells
STANDARD_DEVIATION 10.12 • n=113 Participants
|
31.2 percentage of CD4 cells
STANDARD_DEVIATION 11.43 • n=163 Participants
|
32.2 percentage of CD4 cells
STANDARD_DEVIATION 10.63 • n=160 Participants
|
PRIMARY outcome
Timeframe: Week 12Population: 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.
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.
Outcome measures
| Measure |
Part 1: E/C/F/TAF
n=36 Participants
Participants with M184V and/or M184I mutations in reverse transcriptase and without any other NRTI-resistance mutation 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.
|
Part 2: E/C/F/TAF
n=26 Participants
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.
|
Total E/C/F/TAF
n=62 Participants
Participants 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.
|
|---|---|---|---|
|
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
Interval 90.3 to 100.0
|
100.0 percentage of participants
Interval 86.8 to 100.0
|
100.0 percentage of participants
Interval 94.2 to 100.0
|
SECONDARY outcome
Timeframe: Day 1 up to 48 weeksPopulation: Participants in the Full Analysis Set were included in the analysis.
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.
Outcome measures
| Measure |
Part 1: E/C/F/TAF
n=36 Participants
Participants with M184V and/or M184I mutations in reverse transcriptase and without any other NRTI-resistance mutation 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.
|
Part 2: E/C/F/TAF
n=26 Participants
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.
|
Total E/C/F/TAF
n=62 Participants
Participants 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.
|
|---|---|---|---|
|
Percentage of Participants With Emergence of New Mutations in HIV-1 Reverse Transcriptase and Integrase
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Week 24Population: Participants in the Full Analysis Set were analyzed.
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.
Outcome measures
| Measure |
Part 1: E/C/F/TAF
n=36 Participants
Participants with M184V and/or M184I mutations in reverse transcriptase and without any other NRTI-resistance mutation 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.
|
Part 2: E/C/F/TAF
n=26 Participants
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.
|
Total E/C/F/TAF
n=62 Participants
Participants 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.
|
|---|---|---|---|
|
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 Using PVR
|
100.0 percentage of participants
Interval 90.3 to 100.0
|
100.0 percentage of participants
Interval 86.8 to 100.0
|
100.0 percentage of participants
Interval 94.2 to 100.0
|
SECONDARY outcome
Timeframe: Week 48Population: Participants in the Full Analysis Set were analyzed.
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.
Outcome measures
| Measure |
Part 1: E/C/F/TAF
n=36 Participants
Participants with M184V and/or M184I mutations in reverse transcriptase and without any other NRTI-resistance mutation 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.
|
Part 2: E/C/F/TAF
n=26 Participants
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.
|
Total E/C/F/TAF
n=62 Participants
Participants 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.
|
|---|---|---|---|
|
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 Using PVR
|
100.0 percentage of participants
Interval 90.3 to 100.0
|
100.0 percentage of participants
Interval 86.8 to 100.0
|
100.0 percentage of participants
Interval 94.2 to 100.0
|
SECONDARY outcome
Timeframe: Week 12Population: Participants in the Full Analysis Set were analyzed.
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).
Outcome measures
| Measure |
Part 1: E/C/F/TAF
n=36 Participants
Participants with M184V and/or M184I mutations in reverse transcriptase and without any other NRTI-resistance mutation 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.
|
Part 2: E/C/F/TAF
n=26 Participants
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.
|
Total E/C/F/TAF
n=62 Participants
Participants 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.
|
|---|---|---|---|
|
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 12 Using the FDA Snapshot Analysis
|
91.7 percentage of participants
Interval 77.5 to 98.2
|
96.2 percentage of participants
Interval 80.4 to 99.9
|
93.5 percentage of participants
Interval 84.3 to 98.2
|
SECONDARY outcome
Timeframe: Week 24Population: Participants in the Full Analysis Set were analyzed.
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).
Outcome measures
| Measure |
Part 1: E/C/F/TAF
n=36 Participants
Participants with M184V and/or M184I mutations in reverse transcriptase and without any other NRTI-resistance mutation 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.
|
Part 2: E/C/F/TAF
n=26 Participants
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.
|
Total E/C/F/TAF
n=62 Participants
Participants 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.
|
|---|---|---|---|
|
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 Using the FDA Snapshot Analysis
|
91.7 percentage of participants
Interval 77.5 to 98.2
|
100.0 percentage of participants
Interval 86.8 to 100.0
|
95.2 percentage of participants
Interval 86.5 to 99.0
|
SECONDARY outcome
Timeframe: Week 48Population: Participants in the Full Analysis Set were analyzed.
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).
Outcome measures
| Measure |
Part 1: E/C/F/TAF
n=36 Participants
Participants with M184V and/or M184I mutations in reverse transcriptase and without any other NRTI-resistance mutation 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.
|
Part 2: E/C/F/TAF
n=26 Participants
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.
|
Total E/C/F/TAF
n=62 Participants
Participants 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.
|
|---|---|---|---|
|
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 Using the FDA Snapshot Analysis
|
88.9 percentage of participants
Interval 73.9 to 96.9
|
96.2 percentage of participants
Interval 80.4 to 99.9
|
91.9 percentage of participants
Interval 82.2 to 97.3
|
SECONDARY outcome
Timeframe: Week 12Population: Participants in the Full Analysis Set were analyzed.
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).
Outcome measures
| Measure |
Part 1: E/C/F/TAF
n=36 Participants
Participants with M184V and/or M184I mutations in reverse transcriptase and without any other NRTI-resistance mutation 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.
|
Part 2: E/C/F/TAF
n=26 Participants
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.
|
Total E/C/F/TAF
n=62 Participants
Participants 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.
|
|---|---|---|---|
|
Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Week 12 Using the FDA Snapshot Analysis
|
91.7 percentage of participants
Interval 77.5 to 98.2
|
96.2 percentage of participants
Interval 80.4 to 99.9
|
93.5 percentage of participants
Interval 84.3 to 98.2
|
SECONDARY outcome
Timeframe: Week 24Population: Participants in the Full Analysis Set were analyzed.
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).
Outcome measures
| Measure |
Part 1: E/C/F/TAF
n=36 Participants
Participants with M184V and/or M184I mutations in reverse transcriptase and without any other NRTI-resistance mutation 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.
|
Part 2: E/C/F/TAF
n=26 Participants
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.
|
Total E/C/F/TAF
n=62 Participants
Participants 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.
|
|---|---|---|---|
|
Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Week 24 Using the FDA Snapshot Analysis
|
88.9 percentage of participants
Interval 73.9 to 96.9
|
100.0 percentage of participants
Interval 86.8 to 100.0
|
93.5 percentage of participants
Interval 84.3 to 98.2
|
SECONDARY outcome
Timeframe: Week 48Population: Participants in the Full Analysis Set were analyzed.
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).
Outcome measures
| Measure |
Part 1: E/C/F/TAF
n=36 Participants
Participants with M184V and/or M184I mutations in reverse transcriptase and without any other NRTI-resistance mutation 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.
|
Part 2: E/C/F/TAF
n=26 Participants
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.
|
Total E/C/F/TAF
n=62 Participants
Participants 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.
|
|---|---|---|---|
|
Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Week 48 Using the FDA Snapshot Analysis
|
88.9 percentage of participants
Interval 73.9 to 96.9
|
96.2 percentage of participants
Interval 80.4 to 99.9
|
91.9 percentage of participants
Interval 82.2 to 97.3
|
SECONDARY outcome
Timeframe: Week 12Population: Participants in the Full Analysis Set were analyzed.
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.
Outcome measures
| Measure |
Part 1: E/C/F/TAF
n=36 Participants
Participants with M184V and/or M184I mutations in reverse transcriptase and without any other NRTI-resistance mutation 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.
|
Part 2: E/C/F/TAF
n=26 Participants
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.
|
Total E/C/F/TAF
n=62 Participants
Participants 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.
|
|---|---|---|---|
|
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
Interval 85.5 to 99.9
|
96.2 percentage of participants
Interval 80.4 to 99.9
|
96.8 percentage of participants
Interval 88.8 to 99.6
|
SECONDARY outcome
Timeframe: Week 24Population: Participants in the Full Analysis Set were analyzed.
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.
Outcome measures
| Measure |
Part 1: E/C/F/TAF
n=36 Participants
Participants with M184V and/or M184I mutations in reverse transcriptase and without any other NRTI-resistance mutation 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.
|
Part 2: E/C/F/TAF
n=26 Participants
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.
|
Total E/C/F/TAF
n=62 Participants
Participants 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.
|
|---|---|---|---|
|
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 Using the M = F Approach
|
91.7 percentage of participants
Interval 77.5 to 98.2
|
100.0 percentage of participants
Interval 86.8 to 100.0
|
95.2 percentage of participants
Interval 86.5 to 99.0
|
SECONDARY outcome
Timeframe: Week 48Population: Participants in the Full Analysis Set were analyzed.
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.
Outcome measures
| Measure |
Part 1: E/C/F/TAF
n=36 Participants
Participants with M184V and/or M184I mutations in reverse transcriptase and without any other NRTI-resistance mutation 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.
|
Part 2: E/C/F/TAF
n=26 Participants
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.
|
Total E/C/F/TAF
n=62 Participants
Participants 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.
|
|---|---|---|---|
|
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 Using the M = F Approach
|
91.7 percentage of participants
Interval 77.5 to 98.2
|
96.2 percentage of participants
Interval 80.4 to 99.9
|
93.5 percentage of participants
Interval 84.3 to 98.2
|
SECONDARY outcome
Timeframe: Week 12Population: Participants in the Full Analysis Set with available data were analyzed.
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.
Outcome measures
| Measure |
Part 1: E/C/F/TAF
n=35 Participants
Participants with M184V and/or M184I mutations in reverse transcriptase and without any other NRTI-resistance mutation 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.
|
Part 2: E/C/F/TAF
n=26 Participants
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.
|
Total E/C/F/TAF
n=61 Participants
Participants 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.
|
|---|---|---|---|
|
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
Interval 90.0 to 100.0
|
96.2 percentage of participants
Interval 80.4 to 99.9
|
98.4 percentage of participants
Interval 91.2 to 100.0
|
SECONDARY outcome
Timeframe: Week 24Population: Participants in the Full Analysis Set with available data were analyzed.
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.
Outcome measures
| Measure |
Part 1: E/C/F/TAF
n=33 Participants
Participants with M184V and/or M184I mutations in reverse transcriptase and without any other NRTI-resistance mutation 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.
|
Part 2: E/C/F/TAF
n=26 Participants
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.
|
Total E/C/F/TAF
n=59 Participants
Participants 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.
|
|---|---|---|---|
|
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 Using the M = E Approach
|
100.0 percentage of participants
Interval 89.4 to 100.0
|
100.0 percentage of participants
Interval 86.8 to 100.0
|
100.0 percentage of participants
Interval 93.9 to 100.0
|
SECONDARY outcome
Timeframe: Week 48Population: Participants in the Full Analysis Set with available data were analyzed.
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.
Outcome measures
| Measure |
Part 1: E/C/F/TAF
n=33 Participants
Participants with M184V and/or M184I mutations in reverse transcriptase and without any other NRTI-resistance mutation 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.
|
Part 2: E/C/F/TAF
n=25 Participants
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.
|
Total E/C/F/TAF
n=58 Participants
Participants 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.
|
|---|---|---|---|
|
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 Using the M = E Approach
|
100.0 percentage of participants
Interval 89.4 to 100.0
|
100.0 percentage of participants
Interval 86.3 to 100.0
|
100.0 percentage of participants
Interval 93.8 to 100.0
|
SECONDARY outcome
Timeframe: Baseline (Day 1); Week 12Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
Part 1: E/C/F/TAF
n=33 Participants
Participants with M184V and/or M184I mutations in reverse transcriptase and without any other NRTI-resistance mutation 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.
|
Part 2: E/C/F/TAF
n=25 Participants
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.
|
Total E/C/F/TAF
n=58 Participants
Participants 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.
|
|---|---|---|---|
|
Change From Baseline in Cluster Determinant 4+ (CD4+) Cell Count at Week 12
|
-47 cells/µL
Standard Deviation 194.1
|
-6 cells/µL
Standard Deviation 116.1
|
-30 cells/µL
Standard Deviation 165.1
|
SECONDARY outcome
Timeframe: Baseline (Day 1); Week 24Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
Part 1: E/C/F/TAF
n=33 Participants
Participants with M184V and/or M184I mutations in reverse transcriptase and without any other NRTI-resistance mutation 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.
|
Part 2: E/C/F/TAF
n=26 Participants
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.
|
Total E/C/F/TAF
n=59 Participants
Participants 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.
|
|---|---|---|---|
|
Change From Baseline in CD4+ Cell Count at Week 24
|
-40 cells/µL
Standard Deviation 162.1
|
28 cells/µL
Standard Deviation 212.5
|
-10 cells/µL
Standard Deviation 187.4
|
SECONDARY outcome
Timeframe: Baseline (Day 1); Week 48Population: Participants in the Full Analysis Set were analyzed.
Outcome measures
| Measure |
Part 1: E/C/F/TAF
n=31 Participants
Participants with M184V and/or M184I mutations in reverse transcriptase and without any other NRTI-resistance mutation 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.
|
Part 2: E/C/F/TAF
n=25 Participants
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.
|
Total E/C/F/TAF
n=56 Participants
Participants 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.
|
|---|---|---|---|
|
Change From Baseline in CD4+ Cell Count at Week 48
|
-6 cells/µL
Standard Deviation 131.9
|
27 cells/µL
Standard Deviation 120.4
|
9 cells/µL
Standard Deviation 126.8
|
SECONDARY outcome
Timeframe: Baseline (Day 1); Week 12Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
Part 1: E/C/F/TAF
n=33 Participants
Participants with M184V and/or M184I mutations in reverse transcriptase and without any other NRTI-resistance mutation 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.
|
Part 2: E/C/F/TAF
n=25 Participants
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.
|
Total E/C/F/TAF
n=58 Participants
Participants 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.
|
|---|---|---|---|
|
Change From Baseline in CD4 Percentage (%) at Week 12
|
-0.4 percentage of CD4 cells
Standard Deviation 3.37
|
1.5 percentage of CD4 cells
Standard Deviation 3.01
|
0.4 percentage of CD4 cells
Standard Deviation 3.33
|
SECONDARY outcome
Timeframe: Baseline (Day 1); Week 24Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
Part 1: E/C/F/TAF
n=33 Participants
Participants with M184V and/or M184I mutations in reverse transcriptase and without any other NRTI-resistance mutation 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.
|
Part 2: E/C/F/TAF
n=26 Participants
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.
|
Total E/C/F/TAF
n=59 Participants
Participants 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.
|
|---|---|---|---|
|
Change From Baseline in CD4 % at Week 24
|
0.1 percentage of CD4 cells
Standard Deviation 3.25
|
1.1 percentage of CD4 cells
Standard Deviation 4.30
|
0.5 percentage of CD4 cells
Standard Deviation 3.75
|
SECONDARY outcome
Timeframe: Baseline (Day 1); Week 48Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
Part 1: E/C/F/TAF
n=31 Participants
Participants with M184V and/or M184I mutations in reverse transcriptase and without any other NRTI-resistance mutation 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.
|
Part 2: E/C/F/TAF
n=25 Participants
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.
|
Total E/C/F/TAF
n=56 Participants
Participants 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.
|
|---|---|---|---|
|
Change From Baseline in CD4 % at Week 48
|
0.2 percentage of CD4 cells
Standard Deviation 3.12
|
1.5 percentage of CD4 cells
Standard Deviation 3.64
|
0.8 percentage of CD4 cells
Standard Deviation 3.39
|
Adverse Events
Total E/C/F/TAF
Serious events: 5 serious events
Other events: 26 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Total E/C/F/TAF
n=64 participants at risk
Participants 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.
|
|---|---|
|
General disorders
Death
|
1.6%
1/64 • First dose date up to the last dose date (maximum: 48 Weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Safety data for overall study population is presented in this section as all participants received same treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
1.6%
1/64 • First dose date up to the last dose date (maximum: 48 Weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Safety data for overall study population is presented in this section as all participants received same treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostatic adenoma
|
1.6%
1/64 • First dose date up to the last dose date (maximum: 48 Weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Safety data for overall study population is presented in this section as all participants received same treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tonsil cancer
|
1.6%
1/64 • First dose date up to the last dose date (maximum: 48 Weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Safety data for overall study population is presented in this section as all participants received same treatment.
|
|
Renal and urinary disorders
Acute kidney injury
|
1.6%
1/64 • First dose date up to the last dose date (maximum: 48 Weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Safety data for overall study population is presented in this section as all participants received same treatment.
|
|
Renal and urinary disorders
Proteinuria
|
1.6%
1/64 • First dose date up to the last dose date (maximum: 48 Weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Safety data for overall study population is presented in this section as all participants received same treatment.
|
|
Renal and urinary disorders
Renal failure
|
1.6%
1/64 • First dose date up to the last dose date (maximum: 48 Weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Safety data for overall study population is presented in this section as all participants received same treatment.
|
Other adverse events
| Measure |
Total E/C/F/TAF
n=64 participants at risk
Participants 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.
|
|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
7.8%
5/64 • First dose date up to the last dose date (maximum: 48 Weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Safety data for overall study population is presented in this section as all participants received same treatment.
|
|
General disorders
Asthenia
|
10.9%
7/64 • First dose date up to the last dose date (maximum: 48 Weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Safety data for overall study population is presented in this section as all participants received same treatment.
|
|
Infections and infestations
Bronchitis
|
10.9%
7/64 • First dose date up to the last dose date (maximum: 48 Weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Safety data for overall study population is presented in this section as all participants received same treatment.
|
|
Infections and infestations
Nasopharyngitis
|
10.9%
7/64 • First dose date up to the last dose date (maximum: 48 Weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Safety data for overall study population is presented in this section as all participants received same treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.8%
5/64 • First dose date up to the last dose date (maximum: 48 Weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Safety data for overall study population is presented in this section as all participants received same treatment.
|
|
Nervous system disorders
Dizziness
|
6.2%
4/64 • First dose date up to the last dose date (maximum: 48 Weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Safety data for overall study population is presented in this section as all participants received same treatment.
|
|
Nervous system disorders
Headache
|
9.4%
6/64 • First dose date up to the last dose date (maximum: 48 Weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Safety data for overall study population is presented in this section as all participants received same treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.8%
5/64 • First dose date up to the last dose date (maximum: 48 Weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Safety data for overall study population is presented in this section as all participants received same treatment.
|
Additional Information
Gilead Clinical Study Information Center
Gilead Sciences
Phone: 1-833-445-3230 (GILEAD-0)
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: * The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or * The study has been completed at all study sites for at least 2 years
- Publication restrictions are in place
Restriction type: OTHER