Trial Outcomes & Findings for A Study of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Evaluated as a Fixed Dose Combination Regimen in Participants Switching From an Integrase Inhibitor Who Have Experienced Rapid Weight Gain (NCT NCT04442737)
NCT ID: NCT04442737
Last Updated: 2025-03-30
Results Overview
Percent change from baseline in body weight at Week 24 were reported.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
103 participants
Primary outcome timeframe
Baseline and Week 24
Results posted on
2025-03-30
Participant Flow
As per change in planned analysis, data for resistance outcome measures were not collected and analyzed due to insufficient number of participants who met the criteria for virologic rebound/failure.
Participant milestones
| Measure |
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current integrase (INI) inhibitor along with tenofovir alafenamide 10 mg, emtricitabine 200 mg (TAF/FTC) antiretroviral (ARV) (INI + TAF/FTC ARV) regimen switched to receive a fixed-dose combination (FDC) regimen of darunavir 800 milligrams (mg), cobicistat 150 mg, emtricitabine 200 mg, and tenofovir alafenamide 10 mg (D/C/F/TAF), once daily from Day 1 (baseline) up to Week 48.
|
INI + TAF/FTC Delayed Switch (DS): Baseline to Week 48
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen continued to receive baseline integrase (INI) inhibitor along with tenofovir alafenamide 10 mg, emtricitabine 200 mg (TAF/FTC) antiretroviral (ARV) regimen from baseline up to Week 24 per prescribing information (delayed switch 1 \[DS1\]). After Week 24, participants switched to receive D/C/F/TAF FDC once daily from Week 25 to Week 48 (DS2).
|
|---|---|---|
|
Overall Study
STARTED
|
53
|
50
|
|
Overall Study
Treatment Phase IS1: Baseline up to Week 24
|
53
|
0
|
|
Overall Study
Treatment Phase IS2: Week 25 to Week 48
|
49
|
0
|
|
Overall Study
Treatment Phase DS1: Baseline up to Week 24
|
0
|
50
|
|
Overall Study
Treatment Phase DS2: Week 25 to Week 48
|
0
|
49
|
|
Overall Study
COMPLETED
|
45
|
39
|
|
Overall Study
NOT COMPLETED
|
8
|
11
|
Reasons for withdrawal
| Measure |
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current integrase (INI) inhibitor along with tenofovir alafenamide 10 mg, emtricitabine 200 mg (TAF/FTC) antiretroviral (ARV) (INI + TAF/FTC ARV) regimen switched to receive a fixed-dose combination (FDC) regimen of darunavir 800 milligrams (mg), cobicistat 150 mg, emtricitabine 200 mg, and tenofovir alafenamide 10 mg (D/C/F/TAF), once daily from Day 1 (baseline) up to Week 48.
|
INI + TAF/FTC Delayed Switch (DS): Baseline to Week 48
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen continued to receive baseline integrase (INI) inhibitor along with tenofovir alafenamide 10 mg, emtricitabine 200 mg (TAF/FTC) antiretroviral (ARV) regimen from baseline up to Week 24 per prescribing information (delayed switch 1 \[DS1\]). After Week 24, participants switched to receive D/C/F/TAF FDC once daily from Week 25 to Week 48 (DS2).
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
3
|
|
Overall Study
Withdrawal by Subject
|
3
|
2
|
|
Overall Study
Adverse Event
|
3
|
2
|
|
Overall Study
Death
|
0
|
1
|
|
Overall Study
Protocol Violation
|
0
|
2
|
|
Overall Study
Other
|
1
|
1
|
Baseline Characteristics
A Study of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Evaluated as a Fixed Dose Combination Regimen in Participants Switching From an Integrase Inhibitor Who Have Experienced Rapid Weight Gain
Baseline characteristics by cohort
| Measure |
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48
n=53 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current integrase (INI) inhibitor along with tenofovir alafenamide 10 mg, emtricitabine 200 mg (TAF/FTC) antiretroviral (ARV) (INI + TAF/FTC ARV) regimen switched to receive a fixed-dose combination (FDC) regimen of darunavir 800 milligrams (mg), cobicistat 150 mg, emtricitabine 200 mg, and tenofovir alafenamide 10 mg (D/C/F/TAF), once daily from Day 1 (baseline) up to Week 48.
|
INI + TAF/FTC Delayed Switch (DS): Baseline to Week 48
n=50 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen continued to receive baseline integrase (INI) inhibitor along with tenofovir alafenamide 10 mg, emtricitabine 200 mg (TAF/FTC) antiretroviral (ARV) regimen from baseline up to Week 24 per prescribing information (delayed switch 1 \[DS1\]). After Week 24, participants switched to receive D/C/F/TAF FDC once daily from Week 25 to Week 48 (DS2).
|
Total
n=103 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
41.5 years
STANDARD_DEVIATION 12.27 • n=93 Participants
|
46.1 years
STANDARD_DEVIATION 11.7 • n=4 Participants
|
43.7 years
STANDARD_DEVIATION 12.16 • n=27 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
31 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=93 Participants
|
35 Participants
n=4 Participants
|
72 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
16 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
47 Participants
n=93 Participants
|
40 Participants
n=4 Participants
|
87 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
33 Participants
n=93 Participants
|
30 Participants
n=4 Participants
|
63 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=93 Participants
|
19 Participants
n=4 Participants
|
38 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Region of Enrollment
United States of America
|
53 Participants
n=93 Participants
|
50 Participants
n=4 Participants
|
103 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 24Population: The intent-to-treat (ITT) analysis set included all the participants who were randomized and received at least 1 dose of treatment subsequent to randomization in the study. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.
Percent change from baseline in body weight at Week 24 were reported.
Outcome measures
| Measure |
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24
n=49 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen switched to receive a fixed-dose combination (FDC) regimen of darunavir 800 milligrams (mg), cobicistat 150 mg, emtricitabine 200 mg, and tenofovir alafenamide 10 mg (D/C/F/TAF), once daily from Day 1 (baseline) up to Week 24.
|
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24
n=46 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen continued to receive baseline integrase (INI) inhibitor along with tenofovir alafenamide 10 mg, emtricitabine 200 mg (TAF/FTC) antiretroviral (ARV) regimen from Day 1 (baseline) up to Week 24 per prescribing information (delayed switch 1 \[DS1\]).
|
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current integrase (INI) inhibitor along with tenofovir alafenamide 10 mg, emtricitabine 200 mg (TAF/FTC) antiretroviral (ARV) (INI + TAF/FTC ARV) regimen switched to receive a fixed-dose combination (FDC) regimen of darunavir 800 milligrams (mg), cobicistat 150 mg, emtricitabine 200 mg, and tenofovir alafenamide 10 mg (D/C/F/TAF), once daily from Day 1 (baseline) up to Week 48.
|
INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25-Week 48
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen, after Week 24 switched to receive D/C/F/TAF FDC once daily from Week 25 to Week 48 (DS2).
|
|---|---|---|---|---|
|
Percent Change From Baseline in Body Weight at Week 24
|
0.63 Percent Change
Interval -0.435 to 1.698
|
-0.24 Percent Change
Interval -1.354 to 0.874
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline and Week 24Population: The ITT analysis set included all the participants who were randomized and received at least 1 dose of treatment subsequent to randomization in the study. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.
Percent change from baseline in body weight at Week 24 in BMI \>=30 kilograms per square meter (kg/m\^2) subgroup were reported.
Outcome measures
| Measure |
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24
n=26 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen switched to receive a fixed-dose combination (FDC) regimen of darunavir 800 milligrams (mg), cobicistat 150 mg, emtricitabine 200 mg, and tenofovir alafenamide 10 mg (D/C/F/TAF), once daily from Day 1 (baseline) up to Week 24.
|
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24
n=36 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen continued to receive baseline integrase (INI) inhibitor along with tenofovir alafenamide 10 mg, emtricitabine 200 mg (TAF/FTC) antiretroviral (ARV) regimen from Day 1 (baseline) up to Week 24 per prescribing information (delayed switch 1 \[DS1\]).
|
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current integrase (INI) inhibitor along with tenofovir alafenamide 10 mg, emtricitabine 200 mg (TAF/FTC) antiretroviral (ARV) (INI + TAF/FTC ARV) regimen switched to receive a fixed-dose combination (FDC) regimen of darunavir 800 milligrams (mg), cobicistat 150 mg, emtricitabine 200 mg, and tenofovir alafenamide 10 mg (D/C/F/TAF), once daily from Day 1 (baseline) up to Week 48.
|
INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25-Week 48
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen, after Week 24 switched to receive D/C/F/TAF FDC once daily from Week 25 to Week 48 (DS2).
|
|---|---|---|---|---|
|
Percent Change From Baseline in Body Weight at Week 24: Body Mass Index (BMI) >=30 Kilograms Per Square Meter (kg/m^2) Subgroup
|
0.26 Percent Change
Standard Deviation 4.278
|
0.18 Percent Change
Standard Deviation 3.247
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline and Week 24Population: The ITT analysis set included all the participants who were randomized and received at least 1 dose of treatment subsequent to randomization in the study. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here, 'n' (number analyzed) is defined as participants analyzed at specified categories.
Percent change from baseline in body weight at Week 24 in female and male subgroup were reported.
Outcome measures
| Measure |
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24
n=49 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen switched to receive a fixed-dose combination (FDC) regimen of darunavir 800 milligrams (mg), cobicistat 150 mg, emtricitabine 200 mg, and tenofovir alafenamide 10 mg (D/C/F/TAF), once daily from Day 1 (baseline) up to Week 24.
|
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24
n=46 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen continued to receive baseline integrase (INI) inhibitor along with tenofovir alafenamide 10 mg, emtricitabine 200 mg (TAF/FTC) antiretroviral (ARV) regimen from Day 1 (baseline) up to Week 24 per prescribing information (delayed switch 1 \[DS1\]).
|
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current integrase (INI) inhibitor along with tenofovir alafenamide 10 mg, emtricitabine 200 mg (TAF/FTC) antiretroviral (ARV) (INI + TAF/FTC ARV) regimen switched to receive a fixed-dose combination (FDC) regimen of darunavir 800 milligrams (mg), cobicistat 150 mg, emtricitabine 200 mg, and tenofovir alafenamide 10 mg (D/C/F/TAF), once daily from Day 1 (baseline) up to Week 48.
|
INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25-Week 48
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen, after Week 24 switched to receive D/C/F/TAF FDC once daily from Week 25 to Week 48 (DS2).
|
|---|---|---|---|---|
|
Percent Change From Baseline in Body Weight at Week 24: Female and Male Subgroup
Female Subgroup
|
1.26 Percent Change
Standard Deviation 5.361
|
-0.89 Percent Change
Standard Deviation 2.632
|
—
|
—
|
|
Percent Change From Baseline in Body Weight at Week 24: Female and Male Subgroup
Male Subgroup
|
0.46 Percent Change
Standard Deviation 3.939
|
-0.22 Percent Change
Standard Deviation 6.609
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline and Week 24Population: The ITT analysis set included all the participants who were randomized and received at least 1 dose of treatment subsequent to randomization in the study. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here, 'n' (number analyzed) is defined as participants analyzed at specified categories.
Percent change from baseline in body weight at Week 24 in Black/African American and Black/African American- Female subgroups were reported.
Outcome measures
| Measure |
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24
n=30 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen switched to receive a fixed-dose combination (FDC) regimen of darunavir 800 milligrams (mg), cobicistat 150 mg, emtricitabine 200 mg, and tenofovir alafenamide 10 mg (D/C/F/TAF), once daily from Day 1 (baseline) up to Week 24.
|
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24
n=29 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen continued to receive baseline integrase (INI) inhibitor along with tenofovir alafenamide 10 mg, emtricitabine 200 mg (TAF/FTC) antiretroviral (ARV) regimen from Day 1 (baseline) up to Week 24 per prescribing information (delayed switch 1 \[DS1\]).
|
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current integrase (INI) inhibitor along with tenofovir alafenamide 10 mg, emtricitabine 200 mg (TAF/FTC) antiretroviral (ARV) (INI + TAF/FTC ARV) regimen switched to receive a fixed-dose combination (FDC) regimen of darunavir 800 milligrams (mg), cobicistat 150 mg, emtricitabine 200 mg, and tenofovir alafenamide 10 mg (D/C/F/TAF), once daily from Day 1 (baseline) up to Week 48.
|
INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25-Week 48
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen, after Week 24 switched to receive D/C/F/TAF FDC once daily from Week 25 to Week 48 (DS2).
|
|---|---|---|---|---|
|
Percent Change From Baseline in Body Weight at Week 24: Black/African American and Black/African American- Female Subgroups
Black/African American Subgroups
|
0.50 Percent Change
Standard Deviation 5.043
|
-1.36 Percent Change
Standard Deviation 5.925
|
—
|
—
|
|
Percent Change From Baseline in Body Weight at Week 24: Black/African American and Black/African American- Female Subgroups
Black/African American- Female Subgroups
|
0.62 Percent Change
Standard Deviation 5.484
|
-0.82 Percent Change
Standard Deviation 2.894
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline and Week 24Population: The ITT analysis set included all the participants who were randomized and received at least 1 dose of treatment subsequent to randomization in the study. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.
Percent change from baseline in body weight at Week 24 in Non-Black/African American subgroup were reported.
Outcome measures
| Measure |
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24
n=19 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen switched to receive a fixed-dose combination (FDC) regimen of darunavir 800 milligrams (mg), cobicistat 150 mg, emtricitabine 200 mg, and tenofovir alafenamide 10 mg (D/C/F/TAF), once daily from Day 1 (baseline) up to Week 24.
|
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24
n=17 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen continued to receive baseline integrase (INI) inhibitor along with tenofovir alafenamide 10 mg, emtricitabine 200 mg (TAF/FTC) antiretroviral (ARV) regimen from Day 1 (baseline) up to Week 24 per prescribing information (delayed switch 1 \[DS1\]).
|
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current integrase (INI) inhibitor along with tenofovir alafenamide 10 mg, emtricitabine 200 mg (TAF/FTC) antiretroviral (ARV) (INI + TAF/FTC ARV) regimen switched to receive a fixed-dose combination (FDC) regimen of darunavir 800 milligrams (mg), cobicistat 150 mg, emtricitabine 200 mg, and tenofovir alafenamide 10 mg (D/C/F/TAF), once daily from Day 1 (baseline) up to Week 48.
|
INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25-Week 48
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen, after Week 24 switched to receive D/C/F/TAF FDC once daily from Week 25 to Week 48 (DS2).
|
|---|---|---|---|---|
|
Percent Change From Baseline in Body Weight at Week 24: Non-Black/African American Subgroup
|
1.00 Percent Change
Standard Deviation 3.045
|
1.14 Percent Change
Standard Deviation 4.756
|
—
|
—
|
SECONDARY outcome
Timeframe: INI + TAF/FTC Delayed Switch (DS1) and D/C/F/TAF Immediate Switch (IS1): Baseline, Weeks 4, 12, 24; D/C/F/TAF Immediate Switch (IS): Baseline, Week 36 and 48Population: The ITT analysis set included all the participants who were randomized and received at least 1 dose of treatment subsequent to randomization in the study. Here, 'N' (number of participants analyzed) is number of participants evaluable for this outcome measure. Here, 'n' (number analyzed) is defined as participants analyzed at specified timepoints. Here, n=0 signifies that participants were not planned to be analyzed at those timepoints in the respective arms.
Change from baseline in absolute body weight over time were reported.
Outcome measures
| Measure |
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24
n=49 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen switched to receive a fixed-dose combination (FDC) regimen of darunavir 800 milligrams (mg), cobicistat 150 mg, emtricitabine 200 mg, and tenofovir alafenamide 10 mg (D/C/F/TAF), once daily from Day 1 (baseline) up to Week 24.
|
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24
n=53 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen continued to receive baseline integrase (INI) inhibitor along with tenofovir alafenamide 10 mg, emtricitabine 200 mg (TAF/FTC) antiretroviral (ARV) regimen from Day 1 (baseline) up to Week 24 per prescribing information (delayed switch 1 \[DS1\]).
|
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48
n=47 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current integrase (INI) inhibitor along with tenofovir alafenamide 10 mg, emtricitabine 200 mg (TAF/FTC) antiretroviral (ARV) (INI + TAF/FTC ARV) regimen switched to receive a fixed-dose combination (FDC) regimen of darunavir 800 milligrams (mg), cobicistat 150 mg, emtricitabine 200 mg, and tenofovir alafenamide 10 mg (D/C/F/TAF), once daily from Day 1 (baseline) up to Week 48.
|
INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25-Week 48
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen, after Week 24 switched to receive D/C/F/TAF FDC once daily from Week 25 to Week 48 (DS2).
|
|---|---|---|---|---|
|
Change From Baseline in Absolute Body Weight Over Time
Week 4
|
-0.20 Kilograms (kg)
Interval -1.1 to 0.7
|
-0.20 Kilograms (kg)
Interval -1.5 to 0.9
|
—
|
—
|
|
Change From Baseline in Absolute Body Weight Over Time
Week 12
|
0.10 Kilograms (kg)
Interval -1.2 to 2.3
|
0.20 Kilograms (kg)
Interval -2.35 to 1.55
|
—
|
—
|
|
Change From Baseline in Absolute Body Weight Over Time
Week 24
|
0.30 Kilograms (kg)
Interval -2.1 to 2.3
|
0.50 Kilograms (kg)
Interval -2.3 to 2.6
|
—
|
—
|
|
Change From Baseline in Absolute Body Weight Over Time
Week 36
|
—
|
—
|
-0.90 Kilograms (kg)
Interval -3.4 to 2.1
|
—
|
|
Change From Baseline in Absolute Body Weight Over Time
Week 48
|
—
|
—
|
-0.85 Kilograms (kg)
Interval -4.5 to 1.7
|
—
|
SECONDARY outcome
Timeframe: INI + TAF/FTC Delayed Switch (DS1) and D/C/F/TAF Immediate Switch (IS1): Baseline, Weeks 4, 12, 24; D/C/F/TAF Immediate Switch (IS): Baseline, Week 36 and 48Population: The ITT analysis set included all the participants who were randomized and received at least 1 dose of treatment subsequent to randomization in the study. Here, n=0 signifies that participants were not planned to be analyzed at those timepoints in the respective arms.
Percentage of participants with change from baseline \>=3% to \<= 5% in body weight over time was reported.
Outcome measures
| Measure |
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24
n=50 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen switched to receive a fixed-dose combination (FDC) regimen of darunavir 800 milligrams (mg), cobicistat 150 mg, emtricitabine 200 mg, and tenofovir alafenamide 10 mg (D/C/F/TAF), once daily from Day 1 (baseline) up to Week 24.
|
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24
n=53 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen continued to receive baseline integrase (INI) inhibitor along with tenofovir alafenamide 10 mg, emtricitabine 200 mg (TAF/FTC) antiretroviral (ARV) regimen from Day 1 (baseline) up to Week 24 per prescribing information (delayed switch 1 \[DS1\]).
|
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48
n=53 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current integrase (INI) inhibitor along with tenofovir alafenamide 10 mg, emtricitabine 200 mg (TAF/FTC) antiretroviral (ARV) (INI + TAF/FTC ARV) regimen switched to receive a fixed-dose combination (FDC) regimen of darunavir 800 milligrams (mg), cobicistat 150 mg, emtricitabine 200 mg, and tenofovir alafenamide 10 mg (D/C/F/TAF), once daily from Day 1 (baseline) up to Week 48.
|
INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25-Week 48
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen, after Week 24 switched to receive D/C/F/TAF FDC once daily from Week 25 to Week 48 (DS2).
|
|---|---|---|---|---|
|
Percentage of Participants With Change From Baseline Greater Than or Equal to (>=) 3% to <= 5% in Body Weight Over Time
3-5% gain: Week 4
|
2.0 Percentage of Participants
|
3.8 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants With Change From Baseline Greater Than or Equal to (>=) 3% to <= 5% in Body Weight Over Time
3-5% loss: Week 4
|
4.1 Percentage of Participants
|
7.5 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants With Change From Baseline Greater Than or Equal to (>=) 3% to <= 5% in Body Weight Over Time
3-5% gain: Week 12
|
8.9 Percentage of Participants
|
5.8 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants With Change From Baseline Greater Than or Equal to (>=) 3% to <= 5% in Body Weight Over Time
3-5% loss: Week 12
|
4.4 Percentage of Participants
|
17.3 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants With Change From Baseline Greater Than or Equal to (>=) 3% to <= 5% in Body Weight Over Time
3-5% gain: Week 24
|
2.2 Percentage of Participants
|
8.2 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants With Change From Baseline Greater Than or Equal to (>=) 3% to <= 5% in Body Weight Over Time
3-5% loss: Week 24
|
8.7 Percentage of Participants
|
10.2 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants With Change From Baseline Greater Than or Equal to (>=) 3% to <= 5% in Body Weight Over Time
3-5% gain: Week 36
|
—
|
—
|
6.4 Percentage of Participants
|
—
|
|
Percentage of Participants With Change From Baseline Greater Than or Equal to (>=) 3% to <= 5% in Body Weight Over Time
3-5% loss: Week 36
|
—
|
—
|
14.9 Percentage of Participants
|
—
|
|
Percentage of Participants With Change From Baseline Greater Than or Equal to (>=) 3% to <= 5% in Body Weight Over Time
3-5% gain: Week 48
|
—
|
—
|
6.5 Percentage of Participants
|
—
|
|
Percentage of Participants With Change From Baseline Greater Than or Equal to (>=) 3% to <= 5% in Body Weight Over Time
3-5% loss: Week 48
|
—
|
—
|
6.5 Percentage of Participants
|
—
|
SECONDARY outcome
Timeframe: INI + TAF/FTC Delayed Switch (DS1) and D/C/F/TAF Immediate Switch (IS1): Baseline, Weeks 4, 12, 24; D/C/F/TAF Immediate Switch (IS): Baseline, Week 36 and 48Population: The ITT analysis set included all the participants who were randomized and received at least 1 dose of treatment subsequent to randomization in the study. Here, n=0 signifies that participants were not planned to be analyzed at those timepoints in the respective arms.
Percentage of participants with change from baseline \>5% in body weight over time was reported.
Outcome measures
| Measure |
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24
n=50 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen switched to receive a fixed-dose combination (FDC) regimen of darunavir 800 milligrams (mg), cobicistat 150 mg, emtricitabine 200 mg, and tenofovir alafenamide 10 mg (D/C/F/TAF), once daily from Day 1 (baseline) up to Week 24.
|
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24
n=53 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen continued to receive baseline integrase (INI) inhibitor along with tenofovir alafenamide 10 mg, emtricitabine 200 mg (TAF/FTC) antiretroviral (ARV) regimen from Day 1 (baseline) up to Week 24 per prescribing information (delayed switch 1 \[DS1\]).
|
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48
n=53 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current integrase (INI) inhibitor along with tenofovir alafenamide 10 mg, emtricitabine 200 mg (TAF/FTC) antiretroviral (ARV) (INI + TAF/FTC ARV) regimen switched to receive a fixed-dose combination (FDC) regimen of darunavir 800 milligrams (mg), cobicistat 150 mg, emtricitabine 200 mg, and tenofovir alafenamide 10 mg (D/C/F/TAF), once daily from Day 1 (baseline) up to Week 48.
|
INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25-Week 48
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen, after Week 24 switched to receive D/C/F/TAF FDC once daily from Week 25 to Week 48 (DS2).
|
|---|---|---|---|---|
|
Percentage of Participants With Change From Baseline Greater Than (>) 5 Percent (%) in Body Weight Over Time
>5% gain: Week 4
|
4.1 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants With Change From Baseline Greater Than (>) 5 Percent (%) in Body Weight Over Time
>5% loss: Week 4
|
2.0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants With Change From Baseline Greater Than (>) 5 Percent (%) in Body Weight Over Time
>5% gain: Week 12
|
6.7 Percentage of Participants
|
3.8 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants With Change From Baseline Greater Than (>) 5 Percent (%) in Body Weight Over Time
>5% loss: Week 12
|
4.4 Percentage of Participants
|
1.9 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants With Change From Baseline Greater Than (>) 5 Percent (%) in Body Weight Over Time
>5% gain: Week 24
|
10.9 Percentage of Participants
|
14.3 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants With Change From Baseline Greater Than (>) 5 Percent (%) in Body Weight Over Time
>5% loss: Week 24
|
10.9 Percentage of Participants
|
4.1 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants With Change From Baseline Greater Than (>) 5 Percent (%) in Body Weight Over Time
>5% gain: Week 36
|
—
|
—
|
17.0 Percentage of Participants
|
—
|
|
Percentage of Participants With Change From Baseline Greater Than (>) 5 Percent (%) in Body Weight Over Time
>5% loss: Week 36
|
—
|
—
|
14.9 Percentage of Participants
|
—
|
|
Percentage of Participants With Change From Baseline Greater Than (>) 5 Percent (%) in Body Weight Over Time
>5% gain: Week 48
|
—
|
—
|
13.0 Percentage of Participants
|
—
|
|
Percentage of Participants With Change From Baseline Greater Than (>) 5 Percent (%) in Body Weight Over Time
>5% loss: Week 48
|
—
|
—
|
23.9 Percentage of Participants
|
—
|
SECONDARY outcome
Timeframe: INI + TAF/FTC Delayed Switch (DS1) and D/C/F/TAF Immediate Switch (IS1): Baseline, Weeks 4, 12, 24; D/C/F/TAF Immediate Switch (IS): Baseline, Week 36 and 48Population: The ITT analysis set included all the participants who were randomized and received at least 1 dose of treatment subsequent to randomization in the study. Here, 'N' (number of participants analyzed) is number of participants evaluable for this outcome measure. Here, 'n' (number analyzed) is defined as participants analyzed at specified timepoints. Here, n=0 signifies that participants were not planned to be analyzed at those timepoints in the respective arms.
Change from baseline in BMI over time was reported. BMI was calculated as weight (kg)/(height (m\^2).
Outcome measures
| Measure |
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24
n=49 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen switched to receive a fixed-dose combination (FDC) regimen of darunavir 800 milligrams (mg), cobicistat 150 mg, emtricitabine 200 mg, and tenofovir alafenamide 10 mg (D/C/F/TAF), once daily from Day 1 (baseline) up to Week 24.
|
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24
n=53 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen continued to receive baseline integrase (INI) inhibitor along with tenofovir alafenamide 10 mg, emtricitabine 200 mg (TAF/FTC) antiretroviral (ARV) regimen from Day 1 (baseline) up to Week 24 per prescribing information (delayed switch 1 \[DS1\]).
|
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48
n=47 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current integrase (INI) inhibitor along with tenofovir alafenamide 10 mg, emtricitabine 200 mg (TAF/FTC) antiretroviral (ARV) (INI + TAF/FTC ARV) regimen switched to receive a fixed-dose combination (FDC) regimen of darunavir 800 milligrams (mg), cobicistat 150 mg, emtricitabine 200 mg, and tenofovir alafenamide 10 mg (D/C/F/TAF), once daily from Day 1 (baseline) up to Week 48.
|
INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25-Week 48
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen, after Week 24 switched to receive D/C/F/TAF FDC once daily from Week 25 to Week 48 (DS2).
|
|---|---|---|---|---|
|
Change From Baseline in Body Mass Index (BMI) Over Time
Week 4
|
-0.06 Kilograms per meter square (kg/m^2)
Interval -0.35 to 0.22
|
-0.07 Kilograms per meter square (kg/m^2)
Interval -0.51 to 0.27
|
—
|
—
|
|
Change From Baseline in Body Mass Index (BMI) Over Time
Week 12
|
0.03 Kilograms per meter square (kg/m^2)
Interval -0.42 to 0.75
|
0.07 Kilograms per meter square (kg/m^2)
Interval -0.78 to 0.5
|
—
|
—
|
|
Change From Baseline in Body Mass Index (BMI) Over Time
Week 24
|
0.10 Kilograms per meter square (kg/m^2)
Interval -0.66 to 0.77
|
0.20 Kilograms per meter square (kg/m^2)
Interval -0.67 to 0.8
|
—
|
—
|
|
Change From Baseline in Body Mass Index (BMI) Over Time
Week 36
|
—
|
—
|
-0.26 Kilograms per meter square (kg/m^2)
Interval -1.17 to 0.7
|
—
|
|
Change From Baseline in Body Mass Index (BMI) Over Time
Week 48
|
—
|
—
|
-0.26 Kilograms per meter square (kg/m^2)
Interval -1.42 to 0.66
|
—
|
SECONDARY outcome
Timeframe: INI + TAF/FTC Delayed Switch (DS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS): Baseline, Week 48Population: The ITT analysis set included all the participants who were randomized and received at least 1 dose of treatment subsequent to randomization in the study. Here, 'N' (number of participants analyzed) is number of participants evaluable for this outcome measure. Here, 'n' (number analyzed) is defined as participants analyzed at specified timepoints. Here, n=0 signifies that participants were not planned to be analyzed at those timepoints in the respective arms.
Change from baseline in body composition as measured by (DEXA) scan at Weeks 24 and 48 was reported. Body composition included Mass of Fat for Trunk, Lean Body Mass for Trunk, total Mass for Trunk, Mass of Fat for Total Body, Lean Body Mass for Total Body, Total Mass for Total Body, Mass of Fat for Adjusted Total Body, Lean Body Mass for Adjusted Total Body, Total Mass for Adjusted Total Body, Mass of Fat for Appendages, Lean Body Mass for Appendages, total Mass for Appendages, Mass of Visceral Adipose Tissue, and Volume of Visceral Adipose Tissue. Adjusted refers to not including participant's head.
Outcome measures
| Measure |
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24
n=29 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen switched to receive a fixed-dose combination (FDC) regimen of darunavir 800 milligrams (mg), cobicistat 150 mg, emtricitabine 200 mg, and tenofovir alafenamide 10 mg (D/C/F/TAF), once daily from Day 1 (baseline) up to Week 24.
|
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24
n=29 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen continued to receive baseline integrase (INI) inhibitor along with tenofovir alafenamide 10 mg, emtricitabine 200 mg (TAF/FTC) antiretroviral (ARV) regimen from Day 1 (baseline) up to Week 24 per prescribing information (delayed switch 1 \[DS1\]).
|
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48
n=27 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current integrase (INI) inhibitor along with tenofovir alafenamide 10 mg, emtricitabine 200 mg (TAF/FTC) antiretroviral (ARV) (INI + TAF/FTC ARV) regimen switched to receive a fixed-dose combination (FDC) regimen of darunavir 800 milligrams (mg), cobicistat 150 mg, emtricitabine 200 mg, and tenofovir alafenamide 10 mg (D/C/F/TAF), once daily from Day 1 (baseline) up to Week 48.
|
INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25-Week 48
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen, after Week 24 switched to receive D/C/F/TAF FDC once daily from Week 25 to Week 48 (DS2).
|
|---|---|---|---|---|
|
Change From Baseline in Body Composition as Measured by Dual-energy X-ray Absorptiometry (DEXA) Scan at Weeks 24 and 48
Total Mass for Appendages: Week 24
|
0.66 Kilograms (kg)
Interval -1.38 to 1.9
|
0.46 Kilograms (kg)
Interval -0.59 to 1.55
|
—
|
—
|
|
Change From Baseline in Body Composition as Measured by Dual-energy X-ray Absorptiometry (DEXA) Scan at Weeks 24 and 48
Total Mass for Appendages: Week 48
|
—
|
—
|
-0.69 Kilograms (kg)
Interval -1.7 to 0.31
|
—
|
|
Change From Baseline in Body Composition as Measured by Dual-energy X-ray Absorptiometry (DEXA) Scan at Weeks 24 and 48
Mass of Visceral Adipose Tissue: Week 24
|
-0.05 Kilograms (kg)
Interval -0.14 to 0.12
|
0.03 Kilograms (kg)
Interval -0.06 to 0.14
|
—
|
—
|
|
Change From Baseline in Body Composition as Measured by Dual-energy X-ray Absorptiometry (DEXA) Scan at Weeks 24 and 48
Mass of Fat for Trunk: Week 24
|
-0.59 Kilograms (kg)
Interval -1.5 to 0.41
|
0.12 Kilograms (kg)
Interval -0.96 to 1.14
|
—
|
—
|
|
Change From Baseline in Body Composition as Measured by Dual-energy X-ray Absorptiometry (DEXA) Scan at Weeks 24 and 48
Mass of Fat for Trunk: Week 48
|
—
|
—
|
-1.24 Kilograms (kg)
Interval -2.03 to 0.54
|
—
|
|
Change From Baseline in Body Composition as Measured by Dual-energy X-ray Absorptiometry (DEXA) Scan at Weeks 24 and 48
Lean Body Mass for Trunk: Week 24
|
-0.51 Kilograms (kg)
Interval -1.19 to 0.45
|
0.22 Kilograms (kg)
Interval -0.89 to 0.83
|
—
|
—
|
|
Change From Baseline in Body Composition as Measured by Dual-energy X-ray Absorptiometry (DEXA) Scan at Weeks 24 and 48
Lean Body Mass for Trunk: Week 48
|
—
|
—
|
-0.29 Kilograms (kg)
Interval -1.08 to 1.11
|
—
|
|
Change From Baseline in Body Composition as Measured by Dual-energy X-ray Absorptiometry (DEXA) Scan at Weeks 24 and 48
Total Mass for Trunk: Week 24
|
-0.84 Kilograms (kg)
Interval -2.12 to 0.8
|
0.26 Kilograms (kg)
Interval -0.9 to 1.09
|
—
|
—
|
|
Change From Baseline in Body Composition as Measured by Dual-energy X-ray Absorptiometry (DEXA) Scan at Weeks 24 and 48
Total Mass for Trunk: Week 48
|
—
|
—
|
-1.41 Kilograms (kg)
Interval -1.99 to 0.57
|
—
|
|
Change From Baseline in Body Composition as Measured by Dual-energy X-ray Absorptiometry (DEXA) Scan at Weeks 24 and 48
Mass of Fat for Total Body: Week 24
|
-0.88 Kilograms (kg)
Interval -2.75 to 0.62
|
0.29 Kilograms (kg)
Interval -1.45 to 1.77
|
—
|
—
|
|
Change From Baseline in Body Composition as Measured by Dual-energy X-ray Absorptiometry (DEXA) Scan at Weeks 24 and 48
Mass of Visceral Adipose Tissue: Week 48
|
—
|
—
|
-0.05 Kilograms (kg)
Interval -0.11 to 0.04
|
—
|
|
Change From Baseline in Body Composition as Measured by Dual-energy X-ray Absorptiometry (DEXA) Scan at Weeks 24 and 48
Mass of Fat for Total Body: Week 48
|
—
|
—
|
-1.29 Kilograms (kg)
Interval -3.2 to 1.18
|
—
|
|
Change From Baseline in Body Composition as Measured by Dual-energy X-ray Absorptiometry (DEXA) Scan at Weeks 24 and 48
Lean Body Mass for Total Body: Week 24
|
0.22 Kilograms (kg)
Interval -2.44 to 1.5
|
0.52 Kilograms (kg)
Interval -1.27 to 1.76
|
—
|
—
|
|
Change From Baseline in Body Composition as Measured by Dual-energy X-ray Absorptiometry (DEXA) Scan at Weeks 24 and 48
Lean Body Mass for Total Body: Week 48
|
—
|
—
|
-0.42 Kilograms (kg)
Interval -2.18 to 1.16
|
—
|
|
Change From Baseline in Body Composition as Measured by Dual-energy X-ray Absorptiometry (DEXA) Scan at Weeks 24 and 48
Total Mass for Total Body: Week 24
|
0.22 Kilograms (kg)
Interval -3.21 to 2.57
|
0.59 Kilograms (kg)
Interval -0.61 to 2.04
|
—
|
—
|
|
Change From Baseline in Body Composition as Measured by Dual-energy X-ray Absorptiometry (DEXA) Scan at Weeks 24 and 48
Total Mass for Total Body: Week 48
|
—
|
—
|
-1.32 Kilograms (kg)
Interval -3.93 to 0.24
|
—
|
|
Change From Baseline in Body Composition as Measured by Dual-energy X-ray Absorptiometry (DEXA) Scan at Weeks 24 and 48
Mass of Fat for Adjusted Total Body: Week 24
|
-0.88 Kilograms (kg)
Interval -2.71 to 0.68
|
0.41 Kilograms (kg)
Interval -1.44 to 1.76
|
—
|
—
|
|
Change From Baseline in Body Composition as Measured by Dual-energy X-ray Absorptiometry (DEXA) Scan at Weeks 24 and 48
Mass of Fat for Adjusted Total Body: Week 48
|
—
|
—
|
-1.28 Kilograms (kg)
Interval -3.16 to 1.26
|
—
|
|
Change From Baseline in Body Composition as Measured by Dual-energy X-ray Absorptiometry (DEXA) Scan at Weeks 24 and 48
Lean Body Mass for Adjusted Total Body: Week 24
|
0.17 Kilograms (kg)
Interval -2.34 to 1.58
|
0.49 Kilograms (kg)
Interval -1.3 to 2.01
|
—
|
—
|
|
Change From Baseline in Body Composition as Measured by Dual-energy X-ray Absorptiometry (DEXA) Scan at Weeks 24 and 48
Lean Body Mass for Adjusted Total Body: Week 48
|
—
|
—
|
-0.38 Kilograms (kg)
Interval -2.25 to 1.17
|
—
|
|
Change From Baseline in Body Composition as Measured by Dual-energy X-ray Absorptiometry (DEXA) Scan at Weeks 24 and 48
Total Mass for Adjusted Total Body: Week 24
|
-0.01 Kilograms (kg)
Interval -3.23 to 2.42
|
0.56 Kilograms (kg)
Interval -0.66 to 2.03
|
—
|
—
|
|
Change From Baseline in Body Composition as Measured by Dual-energy X-ray Absorptiometry (DEXA) Scan at Weeks 24 and 48
Total Mass for Adjusted Total Body: Week 48
|
—
|
—
|
-1.43 Kilograms (kg)
Interval -3.98 to 0.14
|
—
|
|
Change From Baseline in Body Composition as Measured by Dual-energy X-ray Absorptiometry (DEXA) Scan at Weeks 24 and 48
Mass of Fat for Appendages: Week 24
|
0.00 Kilograms (kg)
Interval -1.3 to 0.45
|
0.34 Kilograms (kg)
Interval -0.14 to 0.69
|
—
|
—
|
|
Change From Baseline in Body Composition as Measured by Dual-energy X-ray Absorptiometry (DEXA) Scan at Weeks 24 and 48
Mass of Fat for Appendages: Week 48
|
—
|
—
|
-0.52 Kilograms (kg)
Interval -1.41 to 0.4
|
—
|
|
Change From Baseline in Body Composition as Measured by Dual-energy X-ray Absorptiometry (DEXA) Scan at Weeks 24 and 48
Lean Body Mass for Appendages: Week 24
|
0.72 Kilograms (kg)
Interval -0.65 to 1.3
|
0.12 Kilograms (kg)
Interval -1.06 to 0.89
|
—
|
—
|
|
Change From Baseline in Body Composition as Measured by Dual-energy X-ray Absorptiometry (DEXA) Scan at Weeks 24 and 48
Lean Body Mass for Appendages: Week 48
|
—
|
—
|
-0.32 Kilograms (kg)
Interval -0.81 to 0.27
|
—
|
SECONDARY outcome
Timeframe: INI + TAF/FTC Delayed Switch (DS1) and D/C/F/TAF Immediate Switch (IS1): Baseline, Weeks 4, 12, 24; D/C/F/TAF Immediate Switch (IS): Baseline, Week 36 and 48Population: The ITT analysis set included all the participants who were randomized and received at least 1 dose of treatment subsequent to randomization in the study. Here, 'N' (number of participants analyzed) is number of participants evaluable for this outcome measure. Here, 'n' (number analyzed) is defined as participants analyzed at specified timepoints. Here, n=0 signifies that participants were not planned to be analyzed at those timepoints in the respective arms.
Change from baseline in waist circumference over time was reported.
Outcome measures
| Measure |
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24
n=49 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen switched to receive a fixed-dose combination (FDC) regimen of darunavir 800 milligrams (mg), cobicistat 150 mg, emtricitabine 200 mg, and tenofovir alafenamide 10 mg (D/C/F/TAF), once daily from Day 1 (baseline) up to Week 24.
|
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24
n=53 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen continued to receive baseline integrase (INI) inhibitor along with tenofovir alafenamide 10 mg, emtricitabine 200 mg (TAF/FTC) antiretroviral (ARV) regimen from Day 1 (baseline) up to Week 24 per prescribing information (delayed switch 1 \[DS1\]).
|
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48
n=47 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current integrase (INI) inhibitor along with tenofovir alafenamide 10 mg, emtricitabine 200 mg (TAF/FTC) antiretroviral (ARV) (INI + TAF/FTC ARV) regimen switched to receive a fixed-dose combination (FDC) regimen of darunavir 800 milligrams (mg), cobicistat 150 mg, emtricitabine 200 mg, and tenofovir alafenamide 10 mg (D/C/F/TAF), once daily from Day 1 (baseline) up to Week 48.
|
INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25-Week 48
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen, after Week 24 switched to receive D/C/F/TAF FDC once daily from Week 25 to Week 48 (DS2).
|
|---|---|---|---|---|
|
Change From Baseline in Waist Circumference Over Time
Week 4
|
0.00 Centimeter (cm)
Interval -3.0 to 0.8
|
0.00 Centimeter (cm)
Interval -2.5 to 1.5
|
—
|
—
|
|
Change From Baseline in Waist Circumference Over Time
Week 12
|
0.20 Centimeter (cm)
Interval -1.0 to 2.5
|
0.00 Centimeter (cm)
Interval -2.0 to 2.7
|
—
|
—
|
|
Change From Baseline in Waist Circumference Over Time
Week 24
|
0.00 Centimeter (cm)
Interval -5.1 to 2.5
|
0.80 Centimeter (cm)
Interval -3.3 to 4.0
|
—
|
—
|
|
Change From Baseline in Waist Circumference Over Time
Week 36
|
—
|
—
|
0.00 Centimeter (cm)
Interval -2.0 to 3.8
|
—
|
|
Change From Baseline in Waist Circumference Over Time
Week 48
|
—
|
—
|
-0.40 Centimeter (cm)
Interval -4.9 to 4.1
|
—
|
SECONDARY outcome
Timeframe: INI + TAF/FTC Delayed Switch (DS1) and D/C/F/TAF Immediate Switch (IS1): Baseline, Weeks 4, 12, 24; D/C/F/TAF Immediate Switch (IS): Baseline, Week 36 and 48Population: The ITT analysis set included all the participants who were randomized and received at least 1 dose of treatment subsequent to randomization in the study. Here, 'N' (number of participants analyzed) is number of participants evaluable for this outcome measure. Here, 'n' (number analyzed) is defined as participants analyzed at specified timepoints. Here, n=0 signifies that participants were not planned to be analyzed at those timepoints in the respective arms.
Change from baseline in SBP and DBP over time was reported.
Outcome measures
| Measure |
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24
n=49 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen switched to receive a fixed-dose combination (FDC) regimen of darunavir 800 milligrams (mg), cobicistat 150 mg, emtricitabine 200 mg, and tenofovir alafenamide 10 mg (D/C/F/TAF), once daily from Day 1 (baseline) up to Week 24.
|
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24
n=53 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen continued to receive baseline integrase (INI) inhibitor along with tenofovir alafenamide 10 mg, emtricitabine 200 mg (TAF/FTC) antiretroviral (ARV) regimen from Day 1 (baseline) up to Week 24 per prescribing information (delayed switch 1 \[DS1\]).
|
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48
n=47 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current integrase (INI) inhibitor along with tenofovir alafenamide 10 mg, emtricitabine 200 mg (TAF/FTC) antiretroviral (ARV) (INI + TAF/FTC ARV) regimen switched to receive a fixed-dose combination (FDC) regimen of darunavir 800 milligrams (mg), cobicistat 150 mg, emtricitabine 200 mg, and tenofovir alafenamide 10 mg (D/C/F/TAF), once daily from Day 1 (baseline) up to Week 48.
|
INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25-Week 48
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen, after Week 24 switched to receive D/C/F/TAF FDC once daily from Week 25 to Week 48 (DS2).
|
|---|---|---|---|---|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time
SBP: Week 36
|
—
|
—
|
-5.0 Milligrams of mercury (mmHg)
Interval -11.0 to 5.0
|
—
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time
SBP: Week 4
|
3.0 Milligrams of mercury (mmHg)
Interval -7.0 to 9.0
|
-2.0 Milligrams of mercury (mmHg)
Interval -10.0 to 7.0
|
—
|
—
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time
SBP: Week 12
|
0.0 Milligrams of mercury (mmHg)
Interval -5.0 to 6.0
|
1.0 Milligrams of mercury (mmHg)
Interval -9.0 to 6.0
|
—
|
—
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time
SBP: Week 24
|
0.5 Milligrams of mercury (mmHg)
Interval -8.0 to 7.0
|
-3.0 Milligrams of mercury (mmHg)
Interval -9.0 to 5.0
|
—
|
—
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time
SBP: Week 48
|
—
|
—
|
-3.0 Milligrams of mercury (mmHg)
Interval -11.0 to 10.0
|
—
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time
DBP: Week 4
|
0.0 Milligrams of mercury (mmHg)
Interval -3.0 to 4.0
|
-2.0 Milligrams of mercury (mmHg)
Interval -8.0 to 3.0
|
—
|
—
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time
DBP: Week 12
|
-1.0 Milligrams of mercury (mmHg)
Interval -5.0 to 4.0
|
-2.0 Milligrams of mercury (mmHg)
Interval -7.0 to 3.5
|
—
|
—
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time
DBP: Week 24
|
0.0 Milligrams of mercury (mmHg)
Interval -4.0 to 4.0
|
0.0 Milligrams of mercury (mmHg)
Interval -6.0 to 4.0
|
—
|
—
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time
DBP: Week 36
|
—
|
—
|
-2.0 Milligrams of mercury (mmHg)
Interval -9.0 to 3.0
|
—
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time
DBP: Week 48
|
—
|
—
|
-2.5 Milligrams of mercury (mmHg)
Interval -8.0 to 2.0
|
—
|
SECONDARY outcome
Timeframe: INI + TAF/FTC Delayed Switch (DS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS): Baseline, Week 48Population: The ITT analysis set included all the participants who were randomized and received at least 1 dose of treatment subsequent to randomization in the study. Here, 'N' (number of participants analyzed) is number of participants evaluable for this outcome measure. Here, 'n' (number analyzed) is defined as participants analyzed at specified timepoints. Here, n=0 signifies that participants were not planned to be analyzed at those timepoints in the respective arms.
Change from baseline in fasting lipids at Weeks 24 and 48 was reported. Fasting lipids included: fasting total cholesterol, fasting high-density lipoprotein (HDLs) and low-density lipoprotein (LDLs), and fasting triglycerides.
Outcome measures
| Measure |
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24
n=41 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen switched to receive a fixed-dose combination (FDC) regimen of darunavir 800 milligrams (mg), cobicistat 150 mg, emtricitabine 200 mg, and tenofovir alafenamide 10 mg (D/C/F/TAF), once daily from Day 1 (baseline) up to Week 24.
|
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24
n=43 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen continued to receive baseline integrase (INI) inhibitor along with tenofovir alafenamide 10 mg, emtricitabine 200 mg (TAF/FTC) antiretroviral (ARV) regimen from Day 1 (baseline) up to Week 24 per prescribing information (delayed switch 1 \[DS1\]).
|
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48
n=44 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current integrase (INI) inhibitor along with tenofovir alafenamide 10 mg, emtricitabine 200 mg (TAF/FTC) antiretroviral (ARV) (INI + TAF/FTC ARV) regimen switched to receive a fixed-dose combination (FDC) regimen of darunavir 800 milligrams (mg), cobicistat 150 mg, emtricitabine 200 mg, and tenofovir alafenamide 10 mg (D/C/F/TAF), once daily from Day 1 (baseline) up to Week 48.
|
INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25-Week 48
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen, after Week 24 switched to receive D/C/F/TAF FDC once daily from Week 25 to Week 48 (DS2).
|
|---|---|---|---|---|
|
Change From Baseline in Fasting Lipids at Weeks 24 and 48
Fasting total cholesterol: Week 24
|
0.11 millimoles per liter (mmol/L)
Standard Deviation 0.847
|
0.86 millimoles per liter (mmol/L)
Standard Deviation 0.790
|
—
|
—
|
|
Change From Baseline in Fasting Lipids at Weeks 24 and 48
Fasting total cholesterol: Week 48
|
—
|
—
|
0.73 millimoles per liter (mmol/L)
Standard Deviation 0.828
|
—
|
|
Change From Baseline in Fasting Lipids at Weeks 24 and 48
Fasting HDL: Week 24
|
-0.13 millimoles per liter (mmol/L)
Standard Deviation 0.337
|
0.04 millimoles per liter (mmol/L)
Standard Deviation 0.269
|
—
|
—
|
|
Change From Baseline in Fasting Lipids at Weeks 24 and 48
Fasting HDL: Week 48
|
—
|
—
|
0.05 millimoles per liter (mmol/L)
Standard Deviation 0.321
|
—
|
|
Change From Baseline in Fasting Lipids at Weeks 24 and 48
Fasting LDL: Week 24
|
0.15 millimoles per liter (mmol/L)
Standard Deviation 0.758
|
0.57 millimoles per liter (mmol/L)
Standard Deviation 0.768
|
—
|
—
|
|
Change From Baseline in Fasting Lipids at Weeks 24 and 48
Fasting LDL: Week 48
|
—
|
—
|
0.59 millimoles per liter (mmol/L)
Standard Deviation 0.791
|
—
|
|
Change From Baseline in Fasting Lipids at Weeks 24 and 48
Fasting triglycerides: Week 24
|
0.16 millimoles per liter (mmol/L)
Standard Deviation 0.575
|
0.49 millimoles per liter (mmol/L)
Standard Deviation 0.902
|
—
|
—
|
|
Change From Baseline in Fasting Lipids at Weeks 24 and 48
Fasting triglycerides: Week 48
|
—
|
—
|
0.28 millimoles per liter (mmol/L)
Standard Deviation 0.832
|
—
|
SECONDARY outcome
Timeframe: INI + TAF/FTC Delayed Switch (DS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS): Baseline, Week 48Population: The ITT analysis set included all the participants who were randomized and received at least 1 dose of treatment subsequent to randomization in the study. Here, 'N' (number of participants analyzed) is number of participants evaluable for this outcome measure. Here, 'n' (number analyzed) is defined as participants analyzed at specified timepoints. Here, n=0 signifies that participants were not planned to be analyzed at those timepoints in the respective arms.
Change from baseline in fasting glucose at Weeks 24 and 48 was reported.
Outcome measures
| Measure |
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24
n=42 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen switched to receive a fixed-dose combination (FDC) regimen of darunavir 800 milligrams (mg), cobicistat 150 mg, emtricitabine 200 mg, and tenofovir alafenamide 10 mg (D/C/F/TAF), once daily from Day 1 (baseline) up to Week 24.
|
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24
n=43 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen continued to receive baseline integrase (INI) inhibitor along with tenofovir alafenamide 10 mg, emtricitabine 200 mg (TAF/FTC) antiretroviral (ARV) regimen from Day 1 (baseline) up to Week 24 per prescribing information (delayed switch 1 \[DS1\]).
|
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48
n=45 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current integrase (INI) inhibitor along with tenofovir alafenamide 10 mg, emtricitabine 200 mg (TAF/FTC) antiretroviral (ARV) (INI + TAF/FTC ARV) regimen switched to receive a fixed-dose combination (FDC) regimen of darunavir 800 milligrams (mg), cobicistat 150 mg, emtricitabine 200 mg, and tenofovir alafenamide 10 mg (D/C/F/TAF), once daily from Day 1 (baseline) up to Week 48.
|
INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25-Week 48
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen, after Week 24 switched to receive D/C/F/TAF FDC once daily from Week 25 to Week 48 (DS2).
|
|---|---|---|---|---|
|
Change From Baseline in Fasting Glucose at Weeks 24 and 48
Week 24
|
0.05 mmol/L
Standard Deviation 0.933
|
-0.08 mmol/L
Standard Deviation 0.697
|
—
|
—
|
|
Change From Baseline in Fasting Glucose at Weeks 24 and 48
Week 48
|
—
|
—
|
0.06 mmol/L
Standard Deviation 0.663
|
—
|
SECONDARY outcome
Timeframe: INI + TAF/FTC Delayed Switch (DS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS): Baseline, Week 48Population: The ITT analysis set included all the participants who were randomized and received at least 1 dose of treatment subsequent to randomization in the study. Here, 'N' (number of participants analyzed) is number of participants evaluable for this outcome measure. Here, 'n' (number analyzed) is defined as participants analyzed at specified timepoints. Here, n=0 signifies that participants were not planned to be analyzed at those timepoints in the respective arms.
Change from baseline in HOMA-IR at Weeks 24 and 48 was reported. HOMA-IR is calculated as fasting insulin \* fasting glucose divided by 405.
Outcome measures
| Measure |
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24
n=43 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen switched to receive a fixed-dose combination (FDC) regimen of darunavir 800 milligrams (mg), cobicistat 150 mg, emtricitabine 200 mg, and tenofovir alafenamide 10 mg (D/C/F/TAF), once daily from Day 1 (baseline) up to Week 24.
|
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24
n=47 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen continued to receive baseline integrase (INI) inhibitor along with tenofovir alafenamide 10 mg, emtricitabine 200 mg (TAF/FTC) antiretroviral (ARV) regimen from Day 1 (baseline) up to Week 24 per prescribing information (delayed switch 1 \[DS1\]).
|
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48
n=44 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current integrase (INI) inhibitor along with tenofovir alafenamide 10 mg, emtricitabine 200 mg (TAF/FTC) antiretroviral (ARV) (INI + TAF/FTC ARV) regimen switched to receive a fixed-dose combination (FDC) regimen of darunavir 800 milligrams (mg), cobicistat 150 mg, emtricitabine 200 mg, and tenofovir alafenamide 10 mg (D/C/F/TAF), once daily from Day 1 (baseline) up to Week 48.
|
INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25-Week 48
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen, after Week 24 switched to receive D/C/F/TAF FDC once daily from Week 25 to Week 48 (DS2).
|
|---|---|---|---|---|
|
Change From Baseline in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) at Weeks 24 and 48
Week 24
|
-0.81 Milligrams per deciliter (mg/dL)
Standard Deviation 7.946
|
-0.05 Milligrams per deciliter (mg/dL)
Standard Deviation 6.699
|
—
|
—
|
|
Change From Baseline in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) at Weeks 24 and 48
Week 48
|
—
|
—
|
0.01 Milligrams per deciliter (mg/dL)
Standard Deviation 7.164
|
—
|
SECONDARY outcome
Timeframe: INI + TAF/FTC Delayed Switch (DS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS): Baseline, Week 48Population: The ITT analysis set included all the participants who were randomized and received at least 1 dose of treatment subsequent to randomization in the study. Here, 'N' (number of participants analyzed) is number of participants evaluable for this outcome measure. Here, 'n' (number analyzed) is defined as participants analyzed at specified timepoints. Here, n=0 signifies that participants were not planned to be analyzed at those timepoints in the respective arms.
Change from baseline in percent of HbA1c at Weeks 24 and 48 was reported.
Outcome measures
| Measure |
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24
n=44 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen switched to receive a fixed-dose combination (FDC) regimen of darunavir 800 milligrams (mg), cobicistat 150 mg, emtricitabine 200 mg, and tenofovir alafenamide 10 mg (D/C/F/TAF), once daily from Day 1 (baseline) up to Week 24.
|
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24
n=46 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen continued to receive baseline integrase (INI) inhibitor along with tenofovir alafenamide 10 mg, emtricitabine 200 mg (TAF/FTC) antiretroviral (ARV) regimen from Day 1 (baseline) up to Week 24 per prescribing information (delayed switch 1 \[DS1\]).
|
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48
n=46 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current integrase (INI) inhibitor along with tenofovir alafenamide 10 mg, emtricitabine 200 mg (TAF/FTC) antiretroviral (ARV) (INI + TAF/FTC ARV) regimen switched to receive a fixed-dose combination (FDC) regimen of darunavir 800 milligrams (mg), cobicistat 150 mg, emtricitabine 200 mg, and tenofovir alafenamide 10 mg (D/C/F/TAF), once daily from Day 1 (baseline) up to Week 48.
|
INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25-Week 48
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen, after Week 24 switched to receive D/C/F/TAF FDC once daily from Week 25 to Week 48 (DS2).
|
|---|---|---|---|---|
|
Change From Baseline in Percent of Hemoglobin A1c (HbA1c) at Weeks 24 and 48
Week 24
|
0.01 Percent of HbA1c
Standard Deviation 0.272
|
-0.07 Percent of HbA1c
Standard Deviation 0.308
|
—
|
—
|
|
Change From Baseline in Percent of Hemoglobin A1c (HbA1c) at Weeks 24 and 48
Week 48
|
—
|
—
|
-0.10 Percent of HbA1c
Standard Deviation 0.313
|
—
|
SECONDARY outcome
Timeframe: INI + TAF/FTC Delayed Switch (DS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS): Baseline, Week 48Population: The ITT analysis set included all the participants who were randomized and received at least 1 dose of treatment subsequent to randomization in the study. Here, 'N' (number of participants analyzed) is number of participants evaluable for this outcome measure. Here, 'n' (number analyzed) is defined as participants analyzed at specified timepoints. Here, n=0 signifies that participants were not planned to be analyzed at those timepoints in the respective arms.
Change from baseline in leptin at Weeks 24 and 48 was reported.
Outcome measures
| Measure |
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24
n=41 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen switched to receive a fixed-dose combination (FDC) regimen of darunavir 800 milligrams (mg), cobicistat 150 mg, emtricitabine 200 mg, and tenofovir alafenamide 10 mg (D/C/F/TAF), once daily from Day 1 (baseline) up to Week 24.
|
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24
n=35 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen continued to receive baseline integrase (INI) inhibitor along with tenofovir alafenamide 10 mg, emtricitabine 200 mg (TAF/FTC) antiretroviral (ARV) regimen from Day 1 (baseline) up to Week 24 per prescribing information (delayed switch 1 \[DS1\]).
|
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48
n=39 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current integrase (INI) inhibitor along with tenofovir alafenamide 10 mg, emtricitabine 200 mg (TAF/FTC) antiretroviral (ARV) (INI + TAF/FTC ARV) regimen switched to receive a fixed-dose combination (FDC) regimen of darunavir 800 milligrams (mg), cobicistat 150 mg, emtricitabine 200 mg, and tenofovir alafenamide 10 mg (D/C/F/TAF), once daily from Day 1 (baseline) up to Week 48.
|
INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25-Week 48
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen, after Week 24 switched to receive D/C/F/TAF FDC once daily from Week 25 to Week 48 (DS2).
|
|---|---|---|---|---|
|
Change From Baseline in Leptin at Weeks 24 and 48
Week 24
|
-6.85 Micrograms per liter (mcg/L)
Standard Deviation 16.077
|
-1.09 Micrograms per liter (mcg/L)
Standard Deviation 10.899
|
—
|
—
|
|
Change From Baseline in Leptin at Weeks 24 and 48
Week 48
|
—
|
—
|
4.11 Micrograms per liter (mcg/L)
Standard Deviation 22.787
|
—
|
SECONDARY outcome
Timeframe: INI + TAF/FTC Delayed Switch (DS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS): Baseline, Week 48Population: The ITT analysis set included all the participants who were randomized and received at least 1 dose of treatment subsequent to randomization in the study. Here, 'N' (number of participants analyzed) is number of participants evaluable for this outcome measure. Here, 'n' (number analyzed) is defined as participants analyzed at specified timepoints. Here, n=0 signifies that participants were not planned to be analyzed at those timepoints in the respective arms.
Change from baseline in adiponectin at Weeks 24 and 48 was reported.
Outcome measures
| Measure |
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24
n=45 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen switched to receive a fixed-dose combination (FDC) regimen of darunavir 800 milligrams (mg), cobicistat 150 mg, emtricitabine 200 mg, and tenofovir alafenamide 10 mg (D/C/F/TAF), once daily from Day 1 (baseline) up to Week 24.
|
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24
n=44 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen continued to receive baseline integrase (INI) inhibitor along with tenofovir alafenamide 10 mg, emtricitabine 200 mg (TAF/FTC) antiretroviral (ARV) regimen from Day 1 (baseline) up to Week 24 per prescribing information (delayed switch 1 \[DS1\]).
|
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48
n=44 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current integrase (INI) inhibitor along with tenofovir alafenamide 10 mg, emtricitabine 200 mg (TAF/FTC) antiretroviral (ARV) (INI + TAF/FTC ARV) regimen switched to receive a fixed-dose combination (FDC) regimen of darunavir 800 milligrams (mg), cobicistat 150 mg, emtricitabine 200 mg, and tenofovir alafenamide 10 mg (D/C/F/TAF), once daily from Day 1 (baseline) up to Week 48.
|
INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25-Week 48
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen, after Week 24 switched to receive D/C/F/TAF FDC once daily from Week 25 to Week 48 (DS2).
|
|---|---|---|---|---|
|
Change From Baseline in Adiponectin at Weeks 24 and 48
Week 24
|
-0.16 Micrograms per liter (mcg/L)
Standard Deviation 1.596
|
-0.11 Micrograms per liter (mcg/L)
Standard Deviation 1.229
|
—
|
—
|
|
Change From Baseline in Adiponectin at Weeks 24 and 48
Week 48
|
—
|
—
|
0.05 Micrograms per liter (mcg/L)
Standard Deviation 1.589
|
—
|
SECONDARY outcome
Timeframe: INI + TAF/FTC Delayed Switch (DS1) and D/C/F/TAF Immediate Switch (IS1): Week 24; D/C/F/TAF Immediate Switch (IS): Week 48Population: The ITT analysis set included all the participants who were randomized and received at least 1 dose of treatment subsequent to randomization in the study. Here, 'N' (number of participants analyzed) is number of participants evaluable for this outcome measure. Here, n=0 signifies that participants were not planned to be analyzed at those timepoints in the respective arms.
Percentage of participants with advanced fibrosis as assessed by NAFLD fibrosis score at Week 24 and 48 was reported. The NAFLD is based on a combination of clinical and laboratory measurements (that is, age, glycemia, BMI, platelet, albumin and AST/ALT ratio). The set cutoffs for this scoring are: NAFLD Score \<-1.455 = F0-F2 (negative), NAFLD Score -1.455 to 0.675 = indeterminate score, NAFLD Score \>0.675 = F3 - F4 (positive). NAFLD score was calculated as: 1.675 + 0.037 \* age (years) + 0.094 \* BMI (kg/m\^2) + 1.13 \* Impaired Fasting Glucose or Diabetes (yes =1; no=0) + 0.99 \* AST/ALT ratio minus 0.013 \* platelet (10\^9/L) minus 0.66 \* albumin (g/dL).
Outcome measures
| Measure |
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24
n=50 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen switched to receive a fixed-dose combination (FDC) regimen of darunavir 800 milligrams (mg), cobicistat 150 mg, emtricitabine 200 mg, and tenofovir alafenamide 10 mg (D/C/F/TAF), once daily from Day 1 (baseline) up to Week 24.
|
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24
n=53 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen continued to receive baseline integrase (INI) inhibitor along with tenofovir alafenamide 10 mg, emtricitabine 200 mg (TAF/FTC) antiretroviral (ARV) regimen from Day 1 (baseline) up to Week 24 per prescribing information (delayed switch 1 \[DS1\]).
|
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48
n=53 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current integrase (INI) inhibitor along with tenofovir alafenamide 10 mg, emtricitabine 200 mg (TAF/FTC) antiretroviral (ARV) (INI + TAF/FTC ARV) regimen switched to receive a fixed-dose combination (FDC) regimen of darunavir 800 milligrams (mg), cobicistat 150 mg, emtricitabine 200 mg, and tenofovir alafenamide 10 mg (D/C/F/TAF), once daily from Day 1 (baseline) up to Week 48.
|
INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25-Week 48
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen, after Week 24 switched to receive D/C/F/TAF FDC once daily from Week 25 to Week 48 (DS2).
|
|---|---|---|---|---|
|
Percentage of Participants With Advanced Fibrosis as Assessed by Non-alcoholic Fatty Liver Disease (NAFLD) Fibrosis Score at Weeks 24 and 48
Negative (F0-F2): Week 24
|
44.0 Percentage of Participants
|
50.9 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants With Advanced Fibrosis as Assessed by Non-alcoholic Fatty Liver Disease (NAFLD) Fibrosis Score at Weeks 24 and 48
Negative (F0-F2): Week 48
|
—
|
—
|
54.7 Percentage of Participants
|
—
|
|
Percentage of Participants With Advanced Fibrosis as Assessed by Non-alcoholic Fatty Liver Disease (NAFLD) Fibrosis Score at Weeks 24 and 48
Indeterminate: Week 24
|
5.7 Percentage of Participants
|
12.0 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants With Advanced Fibrosis as Assessed by Non-alcoholic Fatty Liver Disease (NAFLD) Fibrosis Score at Weeks 24 and 48
Indeterminate: Week 48
|
—
|
—
|
9.4 Percentage of Participants
|
—
|
|
Percentage of Participants With Advanced Fibrosis as Assessed by Non-alcoholic Fatty Liver Disease (NAFLD) Fibrosis Score at Weeks 24 and 48
Positive (F3-F4): Week 24
|
6.0 Percentage of Participants
|
5.7 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants With Advanced Fibrosis as Assessed by Non-alcoholic Fatty Liver Disease (NAFLD) Fibrosis Score at Weeks 24 and 48
Positive (F3-F4): Week 48
|
—
|
—
|
1.9 Percentage of Participants
|
—
|
SECONDARY outcome
Timeframe: INI + TAF/FTC Delayed Switch (DS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS): Baseline, Week 48Population: The ITT analysis set included all the participants who were randomized and received at least 1 dose of treatment subsequent to randomization in the study. Here, 'N' (number of participants analyzed) is number of participants evaluable for this outcome measure. Here, n=0 signifies that participants were not planned to be analyzed at those timepoints in the respective arms.
Percentage of participants at high risk of NASH according to the HAIR score at Weeks 24 and 48 was reported. HAIR score (0-3) is calculated by adding Hypertension = 1, alanine aminotransferase (ALT) \>40 international unit (IU)=1, and Insulin resistance index (IR) \>5.0 = 1. A score of \>=2 is considered as high risk for NASH.
Outcome measures
| Measure |
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24
n=50 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen switched to receive a fixed-dose combination (FDC) regimen of darunavir 800 milligrams (mg), cobicistat 150 mg, emtricitabine 200 mg, and tenofovir alafenamide 10 mg (D/C/F/TAF), once daily from Day 1 (baseline) up to Week 24.
|
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24
n=53 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen continued to receive baseline integrase (INI) inhibitor along with tenofovir alafenamide 10 mg, emtricitabine 200 mg (TAF/FTC) antiretroviral (ARV) regimen from Day 1 (baseline) up to Week 24 per prescribing information (delayed switch 1 \[DS1\]).
|
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48
n=53 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current integrase (INI) inhibitor along with tenofovir alafenamide 10 mg, emtricitabine 200 mg (TAF/FTC) antiretroviral (ARV) (INI + TAF/FTC ARV) regimen switched to receive a fixed-dose combination (FDC) regimen of darunavir 800 milligrams (mg), cobicistat 150 mg, emtricitabine 200 mg, and tenofovir alafenamide 10 mg (D/C/F/TAF), once daily from Day 1 (baseline) up to Week 48.
|
INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25-Week 48
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen, after Week 24 switched to receive D/C/F/TAF FDC once daily from Week 25 to Week 48 (DS2).
|
|---|---|---|---|---|
|
Percentage of Participants at High Risk of Non-alcoholic Fatty Liver Disease (NASH) According to the Hypertension, Age, Insulin, Resistance (HAIR) Score at Weeks 24 and 48
<2: Week 24
|
62.0 Percentage of Participants
|
60.4 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants at High Risk of Non-alcoholic Fatty Liver Disease (NASH) According to the Hypertension, Age, Insulin, Resistance (HAIR) Score at Weeks 24 and 48
<2: Week 48
|
—
|
—
|
56.6 Percentage of Participants
|
—
|
|
Percentage of Participants at High Risk of Non-alcoholic Fatty Liver Disease (NASH) According to the Hypertension, Age, Insulin, Resistance (HAIR) Score at Weeks 24 and 48
>=2: Week 24
|
12.0 Percentage of Participants
|
3.8 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants at High Risk of Non-alcoholic Fatty Liver Disease (NASH) According to the Hypertension, Age, Insulin, Resistance (HAIR) Score at Weeks 24 and 48
>=2: Week 48
|
—
|
—
|
5.7 Percentage of Participants
|
—
|
SECONDARY outcome
Timeframe: D/C/F/TAF Immediate Switch (IS1) and INI + TAF/FTC Delayed Switch (DS1): Baseline up to Week 24; D/C/F/TAF Immediate Switch (IS2) and INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25 up to Week 48Population: The safety analysis set included all randomized participants who received at least 1 dose of study intervention (that is, ITT analysis set).
Percentage of participants with a dose-reduction or complete withdrawal of anti-hypertensive, anti-hyperglycemic, or lipid lowering agents were reported.
Outcome measures
| Measure |
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24
n=53 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen switched to receive a fixed-dose combination (FDC) regimen of darunavir 800 milligrams (mg), cobicistat 150 mg, emtricitabine 200 mg, and tenofovir alafenamide 10 mg (D/C/F/TAF), once daily from Day 1 (baseline) up to Week 24.
|
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24
n=49 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen continued to receive baseline integrase (INI) inhibitor along with tenofovir alafenamide 10 mg, emtricitabine 200 mg (TAF/FTC) antiretroviral (ARV) regimen from Day 1 (baseline) up to Week 24 per prescribing information (delayed switch 1 \[DS1\]).
|
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48
n=50 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current integrase (INI) inhibitor along with tenofovir alafenamide 10 mg, emtricitabine 200 mg (TAF/FTC) antiretroviral (ARV) (INI + TAF/FTC ARV) regimen switched to receive a fixed-dose combination (FDC) regimen of darunavir 800 milligrams (mg), cobicistat 150 mg, emtricitabine 200 mg, and tenofovir alafenamide 10 mg (D/C/F/TAF), once daily from Day 1 (baseline) up to Week 48.
|
INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25-Week 48
n=46 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen, after Week 24 switched to receive D/C/F/TAF FDC once daily from Week 25 to Week 48 (DS2).
|
|---|---|---|---|---|
|
Percentage of Participants With a Dose-reduction or Complete Withdrawal of Anti-hypertensive, Anti-hyperglycemic, or Lipid Lowering Agents
Lipid lowering agents
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With a Dose-reduction or Complete Withdrawal of Anti-hypertensive, Anti-hyperglycemic, or Lipid Lowering Agents
Anti-hypertensive
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With a Dose-reduction or Complete Withdrawal of Anti-hypertensive, Anti-hyperglycemic, or Lipid Lowering Agents
Anti-hyperglycemic agents
|
0 Percentage of Participants
|
0. Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
SECONDARY outcome
Timeframe: D/C/F/TAF Immediate Switch (IS1) and INI + TAF/FTC Delayed Switch (DS1): Baseline up to Week 24; D/C/F/TAF Immediate Switch (IS2) and INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25 up to Week 48Population: The safety analysis set included all randomized participants who received at least 1 dose of study intervention (that is, ITT analysis set).
Percentage of participants initiating an anti-hypertensive, anti-hyperglycemic, or lipid lowering agents were reported.
Outcome measures
| Measure |
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24
n=53 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen switched to receive a fixed-dose combination (FDC) regimen of darunavir 800 milligrams (mg), cobicistat 150 mg, emtricitabine 200 mg, and tenofovir alafenamide 10 mg (D/C/F/TAF), once daily from Day 1 (baseline) up to Week 24.
|
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24
n=49 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen continued to receive baseline integrase (INI) inhibitor along with tenofovir alafenamide 10 mg, emtricitabine 200 mg (TAF/FTC) antiretroviral (ARV) regimen from Day 1 (baseline) up to Week 24 per prescribing information (delayed switch 1 \[DS1\]).
|
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48
n=50 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current integrase (INI) inhibitor along with tenofovir alafenamide 10 mg, emtricitabine 200 mg (TAF/FTC) antiretroviral (ARV) (INI + TAF/FTC ARV) regimen switched to receive a fixed-dose combination (FDC) regimen of darunavir 800 milligrams (mg), cobicistat 150 mg, emtricitabine 200 mg, and tenofovir alafenamide 10 mg (D/C/F/TAF), once daily from Day 1 (baseline) up to Week 48.
|
INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25-Week 48
n=46 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen, after Week 24 switched to receive D/C/F/TAF FDC once daily from Week 25 to Week 48 (DS2).
|
|---|---|---|---|---|
|
Percentage of Participants Initiating an Anti-hypertensive, Anti-hyperglycemic, or Lipid Lowering Agents
Anti-hypertensive
|
7.5 Percentage of Participants
|
5.7 Percentage of Participants
|
18.0 Percentage of Participants
|
12.0 Percentage of Participants
|
|
Percentage of Participants Initiating an Anti-hypertensive, Anti-hyperglycemic, or Lipid Lowering Agents
Anti-hyperglycemic agents
|
0 Percentage of Participants
|
0. Percentage of Participants
|
4.0 Percentage of Participants
|
2.0 Percentage of Participants
|
|
Percentage of Participants Initiating an Anti-hypertensive, Anti-hyperglycemic, or Lipid Lowering Agents
Lipid lowering agents
|
3.8 Percentage of Participants
|
1.9 Percentage of Participants
|
4.0 Percentage of Participants
|
4.0 Percentage of Participants
|
SECONDARY outcome
Timeframe: D/C/F/TAF Immediate Switch (IS1) and INI + TAF/FTC Delayed Switch (DS1): Baseline up to Week 24; D/C/F/TAF Immediate Switch (IS2) and INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25 up to Week 48Population: The safety analysis set included all randomized participants who received at least 1 dose of study intervention (that is, ITT analysis set).
Number of participants with any grade TEAEs was reported. An AE is any untoward medical event that occurs in a participants administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. TEAEs were those AE events that occurred at or after the initial administration of study intervention.
Outcome measures
| Measure |
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24
n=53 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen switched to receive a fixed-dose combination (FDC) regimen of darunavir 800 milligrams (mg), cobicistat 150 mg, emtricitabine 200 mg, and tenofovir alafenamide 10 mg (D/C/F/TAF), once daily from Day 1 (baseline) up to Week 24.
|
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24
n=50 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen continued to receive baseline integrase (INI) inhibitor along with tenofovir alafenamide 10 mg, emtricitabine 200 mg (TAF/FTC) antiretroviral (ARV) regimen from Day 1 (baseline) up to Week 24 per prescribing information (delayed switch 1 \[DS1\]).
|
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48
n=49 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current integrase (INI) inhibitor along with tenofovir alafenamide 10 mg, emtricitabine 200 mg (TAF/FTC) antiretroviral (ARV) (INI + TAF/FTC ARV) regimen switched to receive a fixed-dose combination (FDC) regimen of darunavir 800 milligrams (mg), cobicistat 150 mg, emtricitabine 200 mg, and tenofovir alafenamide 10 mg (D/C/F/TAF), once daily from Day 1 (baseline) up to Week 48.
|
INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25-Week 48
n=46 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen, after Week 24 switched to receive D/C/F/TAF FDC once daily from Week 25 to Week 48 (DS2).
|
|---|---|---|---|---|
|
Number of Participants With Any Grade Treatment-emergent Adverse Events (TEAEs)
|
30 Participants
|
29 Participants
|
26 Participants
|
30 Participants
|
SECONDARY outcome
Timeframe: D/C/F/TAF Immediate Switch (IS1) and INI + TAF/FTC Delayed Switch (DS1): Baseline up to Week 24; D/C/F/TAF Immediate Switch (IS2) and INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25 up to Week 48Population: The safety analysis set included all randomized participants who received at least 1 dose of study intervention (that is, ITT analysis set).
Number of participants with Grade 3 and Grade 4 TEAEs were reported. An AE is any untoward medical event that occurs in a participants administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. TEAEs were those AE events that occurred at or after the initial administration of study intervention. Grades were assessed by Division of Acquired Immunodeficiency Syndrome (DAIDS) grading table: Grade 1: mild event; Grade 2: moderate event; Grade 3: severe event; Grade 4: potentially life-threatening event; Grade 5: death. Higher grades indicated worsening of TEAEs.
Outcome measures
| Measure |
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24
n=50 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen switched to receive a fixed-dose combination (FDC) regimen of darunavir 800 milligrams (mg), cobicistat 150 mg, emtricitabine 200 mg, and tenofovir alafenamide 10 mg (D/C/F/TAF), once daily from Day 1 (baseline) up to Week 24.
|
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24
n=53 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen continued to receive baseline integrase (INI) inhibitor along with tenofovir alafenamide 10 mg, emtricitabine 200 mg (TAF/FTC) antiretroviral (ARV) regimen from Day 1 (baseline) up to Week 24 per prescribing information (delayed switch 1 \[DS1\]).
|
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48
n=49 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current integrase (INI) inhibitor along with tenofovir alafenamide 10 mg, emtricitabine 200 mg (TAF/FTC) antiretroviral (ARV) (INI + TAF/FTC ARV) regimen switched to receive a fixed-dose combination (FDC) regimen of darunavir 800 milligrams (mg), cobicistat 150 mg, emtricitabine 200 mg, and tenofovir alafenamide 10 mg (D/C/F/TAF), once daily from Day 1 (baseline) up to Week 48.
|
INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25-Week 48
n=46 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen, after Week 24 switched to receive D/C/F/TAF FDC once daily from Week 25 to Week 48 (DS2).
|
|---|---|---|---|---|
|
Number of Participants With Grade 3 and Grade 4 TEAEs
Grade 3
|
3 Participants
|
3 Participants
|
3 Participants
|
5 Participants
|
|
Number of Participants With Grade 3 and Grade 4 TEAEs
Grade 4
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: D/C/F/TAF Immediate Switch (IS1) and INI + TAF/FTC Delayed Switch (DS1): Baseline up to Week 24; D/C/F/TAF Immediate Switch (IS2) and INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25 up to Week 48Population: The safety analysis set included all randomized participants who received at least 1 dose of study intervention (that is, ITT analysis set).
Number of participants who discontinued the study drug due to TEAEs were reported. An AE is any untoward medical event that occurs in a participants administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. TEAEs were those AE events that occurred at or after the initial administration of study intervention.
Outcome measures
| Measure |
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24
n=50 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen switched to receive a fixed-dose combination (FDC) regimen of darunavir 800 milligrams (mg), cobicistat 150 mg, emtricitabine 200 mg, and tenofovir alafenamide 10 mg (D/C/F/TAF), once daily from Day 1 (baseline) up to Week 24.
|
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24
n=53 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen continued to receive baseline integrase (INI) inhibitor along with tenofovir alafenamide 10 mg, emtricitabine 200 mg (TAF/FTC) antiretroviral (ARV) regimen from Day 1 (baseline) up to Week 24 per prescribing information (delayed switch 1 \[DS1\]).
|
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48
n=49 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current integrase (INI) inhibitor along with tenofovir alafenamide 10 mg, emtricitabine 200 mg (TAF/FTC) antiretroviral (ARV) (INI + TAF/FTC ARV) regimen switched to receive a fixed-dose combination (FDC) regimen of darunavir 800 milligrams (mg), cobicistat 150 mg, emtricitabine 200 mg, and tenofovir alafenamide 10 mg (D/C/F/TAF), once daily from Day 1 (baseline) up to Week 48.
|
INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25-Week 48
n=46 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen, after Week 24 switched to receive D/C/F/TAF FDC once daily from Week 25 to Week 48 (DS2).
|
|---|---|---|---|---|
|
Number of Participants Who Discontinued the Study Drug Due to TEAEs
|
0 Participants
|
3 Participants
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: D/C/F/TAF Immediate Switch (IS1) and INI + TAF/FTC Delayed Switch (DS1): Baseline up to Week 24; D/C/F/TAF Immediate Switch (IS2) and INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25 up to Week 48Population: The safety analysis set included all randomized participants who received at least 1 dose of study intervention (that is, ITT analysis set).
Number of participants with treatment-emergent SAEs were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important. Treatment-emergent SAEs were those SAE events that occurred at or after the initial administration of study intervention.
Outcome measures
| Measure |
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24
n=50 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen switched to receive a fixed-dose combination (FDC) regimen of darunavir 800 milligrams (mg), cobicistat 150 mg, emtricitabine 200 mg, and tenofovir alafenamide 10 mg (D/C/F/TAF), once daily from Day 1 (baseline) up to Week 24.
|
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24
n=53 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen continued to receive baseline integrase (INI) inhibitor along with tenofovir alafenamide 10 mg, emtricitabine 200 mg (TAF/FTC) antiretroviral (ARV) regimen from Day 1 (baseline) up to Week 24 per prescribing information (delayed switch 1 \[DS1\]).
|
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48
n=49 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current integrase (INI) inhibitor along with tenofovir alafenamide 10 mg, emtricitabine 200 mg (TAF/FTC) antiretroviral (ARV) (INI + TAF/FTC ARV) regimen switched to receive a fixed-dose combination (FDC) regimen of darunavir 800 milligrams (mg), cobicistat 150 mg, emtricitabine 200 mg, and tenofovir alafenamide 10 mg (D/C/F/TAF), once daily from Day 1 (baseline) up to Week 48.
|
INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25-Week 48
n=46 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen, after Week 24 switched to receive D/C/F/TAF FDC once daily from Week 25 to Week 48 (DS2).
|
|---|---|---|---|---|
|
Number of Participants With Treatment-emergent Serious Adverse Events (SAEs)
|
4 Participants
|
3 Participants
|
2 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: INI + TAF/FTC Delayed Switch (DS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS): Baseline, Week 48Population: The safety analysis set included all randomized participants who received at least 1 dose of study intervention (that is, ITT analysis set). Here, 'N' (number of participants analyzed) is number of participants evaluable for this outcome measure. Here, 'n' (number analyzed) is defined as participants analyzed at specified timepoints. Here, n=0 signifies that participants were not planned to be analyzed at those timepoints in the respective arms.
Change from baseline in biochemistry parameters: albumin and protein values at Weeks 24 and 48 were reported.
Outcome measures
| Measure |
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24
n=43 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen switched to receive a fixed-dose combination (FDC) regimen of darunavir 800 milligrams (mg), cobicistat 150 mg, emtricitabine 200 mg, and tenofovir alafenamide 10 mg (D/C/F/TAF), once daily from Day 1 (baseline) up to Week 24.
|
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24
n=46 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen continued to receive baseline integrase (INI) inhibitor along with tenofovir alafenamide 10 mg, emtricitabine 200 mg (TAF/FTC) antiretroviral (ARV) regimen from Day 1 (baseline) up to Week 24 per prescribing information (delayed switch 1 \[DS1\]).
|
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48
n=46 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current integrase (INI) inhibitor along with tenofovir alafenamide 10 mg, emtricitabine 200 mg (TAF/FTC) antiretroviral (ARV) (INI + TAF/FTC ARV) regimen switched to receive a fixed-dose combination (FDC) regimen of darunavir 800 milligrams (mg), cobicistat 150 mg, emtricitabine 200 mg, and tenofovir alafenamide 10 mg (D/C/F/TAF), once daily from Day 1 (baseline) up to Week 48.
|
INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25-Week 48
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen, after Week 24 switched to receive D/C/F/TAF FDC once daily from Week 25 to Week 48 (DS2).
|
|---|---|---|---|---|
|
Change From Baseline in Biochemistry Parameters: Albumin and Protein Values at Weeks 24 and 48
Albumin: Week 24
|
0.1 grams per liter (g/L)
Standard Deviation 3.21
|
0.4 grams per liter (g/L)
Standard Deviation 2.17
|
—
|
—
|
|
Change From Baseline in Biochemistry Parameters: Albumin and Protein Values at Weeks 24 and 48
Albumin: Week 48
|
—
|
—
|
0.1 grams per liter (g/L)
Standard Deviation 2.43
|
—
|
|
Change From Baseline in Biochemistry Parameters: Albumin and Protein Values at Weeks 24 and 48
Protein: Week 24
|
-0.4 grams per liter (g/L)
Standard Deviation 3.88
|
1.8 grams per liter (g/L)
Standard Deviation 3.53
|
—
|
—
|
|
Change From Baseline in Biochemistry Parameters: Albumin and Protein Values at Weeks 24 and 48
Protein: Week 48
|
—
|
—
|
0.6 grams per liter (g/L)
Standard Deviation 3.64
|
—
|
SECONDARY outcome
Timeframe: INI + TAF/FTC Delayed Switch (DS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS): Baseline, Week 48Population: The safety analysis set included all randomized participants who received at least 1 dose of study intervention (that is, ITT analysis set). Here, 'N' (number of participants analyzed) is number of participants evaluable for this outcome measure. Here, 'n' (number analyzed) is defined as participants analyzed at specified timepoints. Here, n=0 signifies that participants were not planned to be analyzed at those timepoints in the respective arms.
Change from baseline in biochemistry parameters: Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase values at Weeks 24 and 48 were reported.
Outcome measures
| Measure |
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24
n=43 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen switched to receive a fixed-dose combination (FDC) regimen of darunavir 800 milligrams (mg), cobicistat 150 mg, emtricitabine 200 mg, and tenofovir alafenamide 10 mg (D/C/F/TAF), once daily from Day 1 (baseline) up to Week 24.
|
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24
n=44 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen continued to receive baseline integrase (INI) inhibitor along with tenofovir alafenamide 10 mg, emtricitabine 200 mg (TAF/FTC) antiretroviral (ARV) regimen from Day 1 (baseline) up to Week 24 per prescribing information (delayed switch 1 \[DS1\]).
|
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48
n=46 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current integrase (INI) inhibitor along with tenofovir alafenamide 10 mg, emtricitabine 200 mg (TAF/FTC) antiretroviral (ARV) (INI + TAF/FTC ARV) regimen switched to receive a fixed-dose combination (FDC) regimen of darunavir 800 milligrams (mg), cobicistat 150 mg, emtricitabine 200 mg, and tenofovir alafenamide 10 mg (D/C/F/TAF), once daily from Day 1 (baseline) up to Week 48.
|
INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25-Week 48
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen, after Week 24 switched to receive D/C/F/TAF FDC once daily from Week 25 to Week 48 (DS2).
|
|---|---|---|---|---|
|
Change From Baseline in Biochemistry Parameters: Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase Values at Weeks 24 and 48
Alkaline Phosphatase: Week 24
|
8.50 units per liter (U/L)
Standard Deviation 1.30
|
0.0 units per liter (U/L)
Standard Deviation 10.84
|
—
|
—
|
|
Change From Baseline in Biochemistry Parameters: Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase Values at Weeks 24 and 48
Alkaline Phosphatase: Week 48
|
—
|
—
|
-2.8 units per liter (U/L)
Standard Deviation 14.33
|
—
|
|
Change From Baseline in Biochemistry Parameters: Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase Values at Weeks 24 and 48
Alanine Aminotransferase: Week 24
|
-4.2 units per liter (U/L)
Standard Deviation 17.15
|
-3.7 units per liter (U/L)
Standard Deviation 10.96
|
—
|
—
|
|
Change From Baseline in Biochemistry Parameters: Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase Values at Weeks 24 and 48
Alanine Aminotransferase: Week 48
|
—
|
—
|
-0.1 units per liter (U/L)
Standard Deviation 29.60
|
—
|
|
Change From Baseline in Biochemistry Parameters: Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase Values at Weeks 24 and 48
Aspartate Aminotransferase: Week 24
|
-4.2 units per liter (U/L)
Standard Deviation 19.35
|
-2.6 units per liter (U/L)
Standard Deviation 6.66
|
—
|
—
|
|
Change From Baseline in Biochemistry Parameters: Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase Values at Weeks 24 and 48
Aspartate Aminotransferase: Week 48
|
—
|
—
|
-1.6 units per liter (U/L)
Standard Deviation 11.77
|
—
|
SECONDARY outcome
Timeframe: INI + TAF/FTC Delayed Switch (DS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS): Baseline, Week 48Population: The safety analysis set included all randomized participants who received at least 1 dose of study intervention (that is, ITT analysis set). Here, 'N' (number of participants analyzed) is number of participants evaluable for this outcome measure. Here, 'n' (number analyzed) is defined as participants analyzed at specified timepoints. Here, n=0 signifies that participants were not planned to be analyzed at those timepoints in the respective arms.
Change from baseline in biochemistry parameters: Bicarbonate, Calcium, Cholesterol, Chloride, Potassium, Phosphate, Sodium, Triglycerides, and Urea Nitrogen values at Weeks 24 and 48 were reported.
Outcome measures
| Measure |
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24
n=43 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen switched to receive a fixed-dose combination (FDC) regimen of darunavir 800 milligrams (mg), cobicistat 150 mg, emtricitabine 200 mg, and tenofovir alafenamide 10 mg (D/C/F/TAF), once daily from Day 1 (baseline) up to Week 24.
|
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24
n=46 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen continued to receive baseline integrase (INI) inhibitor along with tenofovir alafenamide 10 mg, emtricitabine 200 mg (TAF/FTC) antiretroviral (ARV) regimen from Day 1 (baseline) up to Week 24 per prescribing information (delayed switch 1 \[DS1\]).
|
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48
n=46 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current integrase (INI) inhibitor along with tenofovir alafenamide 10 mg, emtricitabine 200 mg (TAF/FTC) antiretroviral (ARV) (INI + TAF/FTC ARV) regimen switched to receive a fixed-dose combination (FDC) regimen of darunavir 800 milligrams (mg), cobicistat 150 mg, emtricitabine 200 mg, and tenofovir alafenamide 10 mg (D/C/F/TAF), once daily from Day 1 (baseline) up to Week 48.
|
INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25-Week 48
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen, after Week 24 switched to receive D/C/F/TAF FDC once daily from Week 25 to Week 48 (DS2).
|
|---|---|---|---|---|
|
Change From Baseline in Biochemistry Parameters: Bicarbonate, Calcium, Cholesterol, Chloride, Potassium, Phosphate, Sodium, Triglycerides, and Urea Nitrogen Values at Weeks 24 and 48
Bicarbonate: Week 24
|
0.70 millimoles per liter (mmol/L)
Standard Deviation 2.624
|
0.09 millimoles per liter (mmol/L)
Standard Deviation 2.661
|
—
|
—
|
|
Change From Baseline in Biochemistry Parameters: Bicarbonate, Calcium, Cholesterol, Chloride, Potassium, Phosphate, Sodium, Triglycerides, and Urea Nitrogen Values at Weeks 24 and 48
Bicarbonate: Week 48
|
—
|
—
|
0.52 millimoles per liter (mmol/L)
Standard Deviation 2.685
|
—
|
|
Change From Baseline in Biochemistry Parameters: Bicarbonate, Calcium, Cholesterol, Chloride, Potassium, Phosphate, Sodium, Triglycerides, and Urea Nitrogen Values at Weeks 24 and 48
Calcium: Week 24
|
0.00 millimoles per liter (mmol/L)
Standard Deviation 0.097
|
0.02 millimoles per liter (mmol/L)
Standard Deviation 0.092
|
—
|
—
|
|
Change From Baseline in Biochemistry Parameters: Bicarbonate, Calcium, Cholesterol, Chloride, Potassium, Phosphate, Sodium, Triglycerides, and Urea Nitrogen Values at Weeks 24 and 48
Calcium: Week 48
|
—
|
—
|
-0.02 millimoles per liter (mmol/L)
Standard Deviation 0.099
|
—
|
|
Change From Baseline in Biochemistry Parameters: Bicarbonate, Calcium, Cholesterol, Chloride, Potassium, Phosphate, Sodium, Triglycerides, and Urea Nitrogen Values at Weeks 24 and 48
Cholesterol: Week 24
|
0.11 millimoles per liter (mmol/L)
Standard Deviation 0.839
|
0.86 millimoles per liter (mmol/L)
Standard Deviation 0.782
|
—
|
—
|
|
Change From Baseline in Biochemistry Parameters: Bicarbonate, Calcium, Cholesterol, Chloride, Potassium, Phosphate, Sodium, Triglycerides, and Urea Nitrogen Values at Weeks 24 and 48
Cholesterol: Week 48
|
—
|
—
|
0.72 millimoles per liter (mmol/L)
Standard Deviation 0.823
|
—
|
|
Change From Baseline in Biochemistry Parameters: Bicarbonate, Calcium, Cholesterol, Chloride, Potassium, Phosphate, Sodium, Triglycerides, and Urea Nitrogen Values at Weeks 24 and 48
Chloride: Week 24
|
-0.4 millimoles per liter (mmol/L)
Standard Deviation 3.13
|
-1.1 millimoles per liter (mmol/L)
Standard Deviation 3.07
|
—
|
—
|
|
Change From Baseline in Biochemistry Parameters: Bicarbonate, Calcium, Cholesterol, Chloride, Potassium, Phosphate, Sodium, Triglycerides, and Urea Nitrogen Values at Weeks 24 and 48
Chloride: Week 48
|
—
|
—
|
-0.8 millimoles per liter (mmol/L)
Standard Deviation 3.05
|
—
|
|
Change From Baseline in Biochemistry Parameters: Bicarbonate, Calcium, Cholesterol, Chloride, Potassium, Phosphate, Sodium, Triglycerides, and Urea Nitrogen Values at Weeks 24 and 48
Potassium: Week 24
|
-0.07 millimoles per liter (mmol/L)
Standard Deviation 0.296
|
-0.03 millimoles per liter (mmol/L)
Standard Deviation 0.421
|
—
|
—
|
|
Change From Baseline in Biochemistry Parameters: Bicarbonate, Calcium, Cholesterol, Chloride, Potassium, Phosphate, Sodium, Triglycerides, and Urea Nitrogen Values at Weeks 24 and 48
Potassium: Week 48
|
—
|
—
|
-0.10 millimoles per liter (mmol/L)
Standard Deviation 0.425
|
—
|
|
Change From Baseline in Biochemistry Parameters: Bicarbonate, Calcium, Cholesterol, Chloride, Potassium, Phosphate, Sodium, Triglycerides, and Urea Nitrogen Values at Weeks 24 and 48
Phosphate: Week 24
|
0.01 millimoles per liter (mmol/L)
Standard Deviation 0.199
|
-0.06 millimoles per liter (mmol/L)
Standard Deviation 0.166
|
—
|
—
|
|
Change From Baseline in Biochemistry Parameters: Bicarbonate, Calcium, Cholesterol, Chloride, Potassium, Phosphate, Sodium, Triglycerides, and Urea Nitrogen Values at Weeks 24 and 48
Phosphate: Week 48
|
—
|
—
|
-0.05 millimoles per liter (mmol/L)
Standard Deviation 0.213
|
—
|
|
Change From Baseline in Biochemistry Parameters: Bicarbonate, Calcium, Cholesterol, Chloride, Potassium, Phosphate, Sodium, Triglycerides, and Urea Nitrogen Values at Weeks 24 and 48
Sodium: Week 24
|
0.1 millimoles per liter (mmol/L)
Standard Deviation 3.47
|
-1.0 millimoles per liter (mmol/L)
Standard Deviation 2.89
|
—
|
—
|
|
Change From Baseline in Biochemistry Parameters: Bicarbonate, Calcium, Cholesterol, Chloride, Potassium, Phosphate, Sodium, Triglycerides, and Urea Nitrogen Values at Weeks 24 and 48
Sodium: Week 48
|
—
|
—
|
-0.7 millimoles per liter (mmol/L)
Standard Deviation 2.68
|
—
|
|
Change From Baseline in Biochemistry Parameters: Bicarbonate, Calcium, Cholesterol, Chloride, Potassium, Phosphate, Sodium, Triglycerides, and Urea Nitrogen Values at Weeks 24 and 48
Triglycerides: Week 24
|
0.13 millimoles per liter (mmol/L)
Standard Deviation 0.593
|
0.47 millimoles per liter (mmol/L)
Standard Deviation 0.898
|
—
|
—
|
|
Change From Baseline in Biochemistry Parameters: Bicarbonate, Calcium, Cholesterol, Chloride, Potassium, Phosphate, Sodium, Triglycerides, and Urea Nitrogen Values at Weeks 24 and 48
Triglycerides: Week 48
|
—
|
—
|
0.26 millimoles per liter (mmol/L)
Standard Deviation 0.826
|
—
|
|
Change From Baseline in Biochemistry Parameters: Bicarbonate, Calcium, Cholesterol, Chloride, Potassium, Phosphate, Sodium, Triglycerides, and Urea Nitrogen Values at Weeks 24 and 48
Urea Nitrogen: Week 24
|
-0.05 millimoles per liter (mmol/L)
Standard Deviation 1.187
|
0.04 millimoles per liter (mmol/L)
Standard Deviation 1.240
|
—
|
—
|
|
Change From Baseline in Biochemistry Parameters: Bicarbonate, Calcium, Cholesterol, Chloride, Potassium, Phosphate, Sodium, Triglycerides, and Urea Nitrogen Values at Weeks 24 and 48
Urea Nitrogen: Week 48
|
—
|
—
|
-0.27 millimoles per liter (mmol/L)
Standard Deviation 1.245
|
—
|
SECONDARY outcome
Timeframe: INI + TAF/FTC Delayed Switch (DS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS): Baseline, Week 48Population: The safety analysis set included all randomized participants who received at least 1 dose of study intervention (that is, ITT analysis set). Here, 'N' (number of participants analyzed) is number of participants evaluable for this outcome measure. Here, 'n' (number analyzed) is defined as participants analyzed at specified timepoints. Here, n=0 signifies that participants were not planned to be analyzed at those timepoints in the respective arms.
Change from baseline in hematology parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils (segmented), Platelets, and Leukocytes values at Weeks 24 and 48 were reported.
Outcome measures
| Measure |
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24
n=43 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen switched to receive a fixed-dose combination (FDC) regimen of darunavir 800 milligrams (mg), cobicistat 150 mg, emtricitabine 200 mg, and tenofovir alafenamide 10 mg (D/C/F/TAF), once daily from Day 1 (baseline) up to Week 24.
|
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24
n=45 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen continued to receive baseline integrase (INI) inhibitor along with tenofovir alafenamide 10 mg, emtricitabine 200 mg (TAF/FTC) antiretroviral (ARV) regimen from Day 1 (baseline) up to Week 24 per prescribing information (delayed switch 1 \[DS1\]).
|
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48
n=45 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current integrase (INI) inhibitor along with tenofovir alafenamide 10 mg, emtricitabine 200 mg (TAF/FTC) antiretroviral (ARV) (INI + TAF/FTC ARV) regimen switched to receive a fixed-dose combination (FDC) regimen of darunavir 800 milligrams (mg), cobicistat 150 mg, emtricitabine 200 mg, and tenofovir alafenamide 10 mg (D/C/F/TAF), once daily from Day 1 (baseline) up to Week 48.
|
INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25-Week 48
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen, after Week 24 switched to receive D/C/F/TAF FDC once daily from Week 25 to Week 48 (DS2).
|
|---|---|---|---|---|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils (Segmented), Platelets, and Leukocytes Values at Weeks 24 and 48
Basophils: Week 24
|
0.00 10^9 cells per liter
Standard Deviation 0.032
|
0.00 10^9 cells per liter
Standard Deviation 0.036
|
—
|
—
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils (Segmented), Platelets, and Leukocytes Values at Weeks 24 and 48
Basophils: Week 48
|
—
|
—
|
-0.01 10^9 cells per liter
Standard Deviation 0.024
|
—
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils (Segmented), Platelets, and Leukocytes Values at Weeks 24 and 48
Eosinophils: Week 24
|
-0.01 10^9 cells per liter
Standard Deviation 0.070
|
-0.01 10^9 cells per liter
Standard Deviation 0.104
|
—
|
—
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils (Segmented), Platelets, and Leukocytes Values at Weeks 24 and 48
Eosinophils: Week 48
|
—
|
—
|
-0.02 10^9 cells per liter
Standard Deviation 0.063
|
—
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils (Segmented), Platelets, and Leukocytes Values at Weeks 24 and 48
Lymphocytes: Week 24
|
0.04 10^9 cells per liter
Standard Deviation 0.631
|
-0.15 10^9 cells per liter
Standard Deviation 0.517
|
—
|
—
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils (Segmented), Platelets, and Leukocytes Values at Weeks 24 and 48
Lymphocytes: Week 48
|
—
|
—
|
-0.17 10^9 cells per liter
Standard Deviation 0.459
|
—
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils (Segmented), Platelets, and Leukocytes Values at Weeks 24 and 48
Monocytes: Week 24
|
-0.02 10^9 cells per liter
Standard Deviation 0.117
|
0.00 10^9 cells per liter
Standard Deviation 0.094
|
—
|
—
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils (Segmented), Platelets, and Leukocytes Values at Weeks 24 and 48
Monocytes: Week 48
|
—
|
—
|
-0.01 10^9 cells per liter
Standard Deviation 0.105
|
—
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils (Segmented), Platelets, and Leukocytes Values at Weeks 24 and 48
Neutrophils (segmented): Week 24
|
0.04 10^9 cells per liter
Standard Deviation 1.254
|
0.11 10^9 cells per liter
Standard Deviation 1.144
|
—
|
—
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils (Segmented), Platelets, and Leukocytes Values at Weeks 24 and 48
Neutrophils (segmented): Week 48
|
—
|
—
|
-0.04 10^9 cells per liter
Standard Deviation 0.759
|
—
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils (Segmented), Platelets, and Leukocytes Values at Weeks 24 and 48
Platelets: Week 24
|
2.0 10^9 cells per liter
Standard Deviation 30.65
|
-9.1 10^9 cells per liter
Standard Deviation 38.58
|
—
|
—
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils (Segmented), Platelets, and Leukocytes Values at Weeks 24 and 48
Platelets: Week 48
|
—
|
—
|
-8.5 10^9 cells per liter
Standard Deviation 41.67
|
—
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils (Segmented), Platelets, and Leukocytes Values at Weeks 24 and 48
Leukocytes: Week 24
|
0.05 10^9 cells per liter
Standard Deviation 1.599
|
-0.06 10^9 cells per liter
Standard Deviation 1.394
|
—
|
—
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils (Segmented), Platelets, and Leukocytes Values at Weeks 24 and 48
Leukocytes: Week 48
|
—
|
—
|
-0.25 10^9 cells per liter
Standard Deviation 1.008
|
—
|
SECONDARY outcome
Timeframe: INI + TAF/FTC Delayed Switch (DS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS): Baseline, Week 48Population: The safety analysis set included all randomized participants who received at least 1 dose of study intervention (that is, ITT analysis set). Here, 'N' (number of participants analyzed) is number of participants evaluable for this outcome measure. Here, 'n' (number analyzed) is defined as participants analyzed at specified timepoints. Here, n=0 signifies that participants were not planned to be analyzed at those timepoints in the respective arms.
Change from baseline in hematology parameter: hemoglobin values at Weeks 24 and 48 were reported.
Outcome measures
| Measure |
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24
n=43 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen switched to receive a fixed-dose combination (FDC) regimen of darunavir 800 milligrams (mg), cobicistat 150 mg, emtricitabine 200 mg, and tenofovir alafenamide 10 mg (D/C/F/TAF), once daily from Day 1 (baseline) up to Week 24.
|
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24
n=42 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen continued to receive baseline integrase (INI) inhibitor along with tenofovir alafenamide 10 mg, emtricitabine 200 mg (TAF/FTC) antiretroviral (ARV) regimen from Day 1 (baseline) up to Week 24 per prescribing information (delayed switch 1 \[DS1\]).
|
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48
n=45 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current integrase (INI) inhibitor along with tenofovir alafenamide 10 mg, emtricitabine 200 mg (TAF/FTC) antiretroviral (ARV) (INI + TAF/FTC ARV) regimen switched to receive a fixed-dose combination (FDC) regimen of darunavir 800 milligrams (mg), cobicistat 150 mg, emtricitabine 200 mg, and tenofovir alafenamide 10 mg (D/C/F/TAF), once daily from Day 1 (baseline) up to Week 48.
|
INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25-Week 48
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen, after Week 24 switched to receive D/C/F/TAF FDC once daily from Week 25 to Week 48 (DS2).
|
|---|---|---|---|---|
|
Change From Baseline in Hematology Parameter: Hemoglobin Values at Weeks 24 and 48
Week 24
|
-0.1 grams per liter (g/L)
Standard Deviation 9.98
|
-1.2 grams per liter (g/L)
Standard Deviation 7.25
|
—
|
—
|
|
Change From Baseline in Hematology Parameter: Hemoglobin Values at Weeks 24 and 48
Week 48
|
—
|
—
|
-2.7 grams per liter (g/L)
Standard Deviation 7.45
|
—
|
SECONDARY outcome
Timeframe: INI + TAF/FTC Delayed Switch (DS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS): Baseline, Week 48Population: The safety analysis set included all randomized participants who received at least 1 dose of study intervention (that is, ITT analysis set). Here, 'N' (number of participants analyzed) is number of participants evaluable for this outcome measure. Here, 'n' (number analyzed) is defined as participants analyzed at specified timepoints. Here, n=0 signifies that participants were not planned to be analyzed at those timepoints in the respective arms.
Change from baseline in hematology parameter: Erythrocytes values at Weeks 24 and 48 were reported.
Outcome measures
| Measure |
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24
n=43 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen switched to receive a fixed-dose combination (FDC) regimen of darunavir 800 milligrams (mg), cobicistat 150 mg, emtricitabine 200 mg, and tenofovir alafenamide 10 mg (D/C/F/TAF), once daily from Day 1 (baseline) up to Week 24.
|
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24
n=42 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen continued to receive baseline integrase (INI) inhibitor along with tenofovir alafenamide 10 mg, emtricitabine 200 mg (TAF/FTC) antiretroviral (ARV) regimen from Day 1 (baseline) up to Week 24 per prescribing information (delayed switch 1 \[DS1\]).
|
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48
n=45 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current integrase (INI) inhibitor along with tenofovir alafenamide 10 mg, emtricitabine 200 mg (TAF/FTC) antiretroviral (ARV) (INI + TAF/FTC ARV) regimen switched to receive a fixed-dose combination (FDC) regimen of darunavir 800 milligrams (mg), cobicistat 150 mg, emtricitabine 200 mg, and tenofovir alafenamide 10 mg (D/C/F/TAF), once daily from Day 1 (baseline) up to Week 48.
|
INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25-Week 48
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen, after Week 24 switched to receive D/C/F/TAF FDC once daily from Week 25 to Week 48 (DS2).
|
|---|---|---|---|---|
|
Change From Baseline in Hematology Parameter: Erythrocytes Values at Weeks 24 and 48
Week 24
|
0.05 10^12 cells per liter
Standard Deviation 0.233
|
-0.06 10^12 cells per liter
Standard Deviation 0.257
|
—
|
—
|
|
Change From Baseline in Hematology Parameter: Erythrocytes Values at Weeks 24 and 48
Week 48
|
—
|
—
|
-0.09 10^12 cells per liter
Standard Deviation 0.273
|
—
|
SECONDARY outcome
Timeframe: INI + TAF/FTC Delayed Switch (DS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS): Baseline, Week 48Population: The safety analysis set included all randomized participants who received at least 1 dose of study intervention (that is, ITT analysis set). Here, 'N' (number of participants analyzed) is number of participants evaluable for this outcome measure. Here, 'n' (number analyzed) is defined as participants analyzed at specified timepoints. Here, n=0 signifies that participants were not planned to be analyzed at those timepoints in the respective arms.
Change from baseline in urinalysis parameter (specific gravity) values at Weeks 24 and 48 were reported.
Outcome measures
| Measure |
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24
n=43 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen switched to receive a fixed-dose combination (FDC) regimen of darunavir 800 milligrams (mg), cobicistat 150 mg, emtricitabine 200 mg, and tenofovir alafenamide 10 mg (D/C/F/TAF), once daily from Day 1 (baseline) up to Week 24.
|
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24
n=46 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen continued to receive baseline integrase (INI) inhibitor along with tenofovir alafenamide 10 mg, emtricitabine 200 mg (TAF/FTC) antiretroviral (ARV) regimen from Day 1 (baseline) up to Week 24 per prescribing information (delayed switch 1 \[DS1\]).
|
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48
n=45 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current integrase (INI) inhibitor along with tenofovir alafenamide 10 mg, emtricitabine 200 mg (TAF/FTC) antiretroviral (ARV) (INI + TAF/FTC ARV) regimen switched to receive a fixed-dose combination (FDC) regimen of darunavir 800 milligrams (mg), cobicistat 150 mg, emtricitabine 200 mg, and tenofovir alafenamide 10 mg (D/C/F/TAF), once daily from Day 1 (baseline) up to Week 48.
|
INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25-Week 48
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen, after Week 24 switched to receive D/C/F/TAF FDC once daily from Week 25 to Week 48 (DS2).
|
|---|---|---|---|---|
|
Change From Baseline in Urinalysis Parameter: Specific Gravity Values at Weeks 24 and 48
Week 24
|
0.00 kg/m^3
Standard Deviation 0.008
|
0.00 kg/m^3
Standard Deviation 0.008
|
—
|
—
|
|
Change From Baseline in Urinalysis Parameter: Specific Gravity Values at Weeks 24 and 48
Week 48
|
—
|
—
|
0.00 kg/m^3
Standard Deviation 0.009
|
—
|
SECONDARY outcome
Timeframe: INI + TAF/FTC Delayed Switch (DS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS): Baseline, Week 48Population: The safety analysis set included all randomized participants who received at least 1 dose of study intervention (that is, ITT analysis set). Here, 'N' (number of participants analyzed) is number of participants evaluable for this outcome measure. Here, 'n' (number analyzed) is defined as participants analyzed at specified timepoints. Here, n=0 signifies that participants were not planned to be analyzed at those timepoints in the respective arms.
Change from baseline in urinalysis parameter: pH values at Weeks 24 and 48 were reported. The pH scale measures how acidic or alkaline a substance is. The scale ranges from 0 to 14. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Higher the pH value, more alkaline is the substance.
Outcome measures
| Measure |
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24
n=43 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen switched to receive a fixed-dose combination (FDC) regimen of darunavir 800 milligrams (mg), cobicistat 150 mg, emtricitabine 200 mg, and tenofovir alafenamide 10 mg (D/C/F/TAF), once daily from Day 1 (baseline) up to Week 24.
|
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24
n=46 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen continued to receive baseline integrase (INI) inhibitor along with tenofovir alafenamide 10 mg, emtricitabine 200 mg (TAF/FTC) antiretroviral (ARV) regimen from Day 1 (baseline) up to Week 24 per prescribing information (delayed switch 1 \[DS1\]).
|
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48
n=45 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current integrase (INI) inhibitor along with tenofovir alafenamide 10 mg, emtricitabine 200 mg (TAF/FTC) antiretroviral (ARV) (INI + TAF/FTC ARV) regimen switched to receive a fixed-dose combination (FDC) regimen of darunavir 800 milligrams (mg), cobicistat 150 mg, emtricitabine 200 mg, and tenofovir alafenamide 10 mg (D/C/F/TAF), once daily from Day 1 (baseline) up to Week 48.
|
INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25-Week 48
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen, after Week 24 switched to receive D/C/F/TAF FDC once daily from Week 25 to Week 48 (DS2).
|
|---|---|---|---|---|
|
Change From Baseline in Urinalysis Parameter: pH Values at Weeks 24 and 48
Week 24
|
0.00 Units on a scale
Standard Deviation 0.463
|
-0.07 Units on a scale
Standard Deviation 0.490
|
—
|
—
|
|
Change From Baseline in Urinalysis Parameter: pH Values at Weeks 24 and 48
Week 48
|
—
|
—
|
-0.06 Units on a scale
Standard Deviation 0.503
|
—
|
SECONDARY outcome
Timeframe: D/C/F/TAF Immediate Switch (IS1) and INI + TAF/FTC Delayed Switch (DS1): Baseline up to Week 24; D/C/F/TAF Immediate Switch (IS2) and INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25 up to Week 48Population: The safety analysis set included all randomized participants who received at least 1 dose of study intervention (that is, ITT analysis set).
Number of participants with grade 3 and grade 4 laboratory abnormalities were reported. Grades were assessed by Division of Acquired Immunodeficiency Syndrome (DAIDS) grading table: Grade 1: mild ; Grade 2: moderate ; Grade 3: severe ; Grade 4: potentially life-threatening ; Grade 5: death. Higher grades indicated worsening of abnormalities.
Outcome measures
| Measure |
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24
n=50 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen switched to receive a fixed-dose combination (FDC) regimen of darunavir 800 milligrams (mg), cobicistat 150 mg, emtricitabine 200 mg, and tenofovir alafenamide 10 mg (D/C/F/TAF), once daily from Day 1 (baseline) up to Week 24.
|
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24
n=53 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen continued to receive baseline integrase (INI) inhibitor along with tenofovir alafenamide 10 mg, emtricitabine 200 mg (TAF/FTC) antiretroviral (ARV) regimen from Day 1 (baseline) up to Week 24 per prescribing information (delayed switch 1 \[DS1\]).
|
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48
n=49 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current integrase (INI) inhibitor along with tenofovir alafenamide 10 mg, emtricitabine 200 mg (TAF/FTC) antiretroviral (ARV) (INI + TAF/FTC ARV) regimen switched to receive a fixed-dose combination (FDC) regimen of darunavir 800 milligrams (mg), cobicistat 150 mg, emtricitabine 200 mg, and tenofovir alafenamide 10 mg (D/C/F/TAF), once daily from Day 1 (baseline) up to Week 48.
|
INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25-Week 48
n=46 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen, after Week 24 switched to receive D/C/F/TAF FDC once daily from Week 25 to Week 48 (DS2).
|
|---|---|---|---|---|
|
Number of Participants With Grade 3 and Grade 4 Laboratory Abnormalities
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: INI + TAF/FTC Delayed Switch (DS1) and D/C/F/TAF Immediate Switch (IS1): Week 24; D/C/F/TAF Immediate Switch (IS): Week 48Population: The ITT analysis set included all the participants who were randomized and received at least 1 dose of treatment subsequent to randomization in the study. Here, 'n' (number analyzed) is defined as participants analyzed at specified timepoints. Here, n=0 signifies that participants were not planned to be analyzed at those timepoints in the respective arms.
Percentage of participants with confirmed virologic rebound at Weeks 24 and 48 was reported. Virologic rebound defined as when 2 consecutive HIV-1 RNA values \>=200 copies/mL at a scheduled or unscheduled visit.
Outcome measures
| Measure |
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24
n=50 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen switched to receive a fixed-dose combination (FDC) regimen of darunavir 800 milligrams (mg), cobicistat 150 mg, emtricitabine 200 mg, and tenofovir alafenamide 10 mg (D/C/F/TAF), once daily from Day 1 (baseline) up to Week 24.
|
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24
n=53 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen continued to receive baseline integrase (INI) inhibitor along with tenofovir alafenamide 10 mg, emtricitabine 200 mg (TAF/FTC) antiretroviral (ARV) regimen from Day 1 (baseline) up to Week 24 per prescribing information (delayed switch 1 \[DS1\]).
|
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48
n=53 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current integrase (INI) inhibitor along with tenofovir alafenamide 10 mg, emtricitabine 200 mg (TAF/FTC) antiretroviral (ARV) (INI + TAF/FTC ARV) regimen switched to receive a fixed-dose combination (FDC) regimen of darunavir 800 milligrams (mg), cobicistat 150 mg, emtricitabine 200 mg, and tenofovir alafenamide 10 mg (D/C/F/TAF), once daily from Day 1 (baseline) up to Week 48.
|
INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25-Week 48
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen, after Week 24 switched to receive D/C/F/TAF FDC once daily from Week 25 to Week 48 (DS2).
|
|---|---|---|---|---|
|
Percentage of Participants With Confirmed Virologic Rebound at Weeks 24 and 48
Week 24
|
4.0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants With Confirmed Virologic Rebound at Weeks 24 and 48
Week 48
|
—
|
—
|
0 Percentage of Participants
|
—
|
SECONDARY outcome
Timeframe: INI + TAF/FTC Delayed Switch (DS1) and D/C/F/TAF Immediate Switch (IS1): Week 24; D/C/F/TAF Immediate Switch (IS): Week 48Population: The ITT analysis set included all the participants who were randomized and received at least 1 dose of treatment subsequent to randomization in the study. Here, 'n' (number analyzed) is defined as participants analyzed at specified timepoints. Here, n=0 signifies that participants were not planned to be analyzed at those timepoints in the respective arms.
Percentage of participants with virologic response (HIV-1 RNA\<50 copies/mL) at Weeks 24 and 48 was reported.
Outcome measures
| Measure |
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24
n=50 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen switched to receive a fixed-dose combination (FDC) regimen of darunavir 800 milligrams (mg), cobicistat 150 mg, emtricitabine 200 mg, and tenofovir alafenamide 10 mg (D/C/F/TAF), once daily from Day 1 (baseline) up to Week 24.
|
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24
n=53 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen continued to receive baseline integrase (INI) inhibitor along with tenofovir alafenamide 10 mg, emtricitabine 200 mg (TAF/FTC) antiretroviral (ARV) regimen from Day 1 (baseline) up to Week 24 per prescribing information (delayed switch 1 \[DS1\]).
|
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48
n=53 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current integrase (INI) inhibitor along with tenofovir alafenamide 10 mg, emtricitabine 200 mg (TAF/FTC) antiretroviral (ARV) (INI + TAF/FTC ARV) regimen switched to receive a fixed-dose combination (FDC) regimen of darunavir 800 milligrams (mg), cobicistat 150 mg, emtricitabine 200 mg, and tenofovir alafenamide 10 mg (D/C/F/TAF), once daily from Day 1 (baseline) up to Week 48.
|
INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25-Week 48
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen, after Week 24 switched to receive D/C/F/TAF FDC once daily from Week 25 to Week 48 (DS2).
|
|---|---|---|---|---|
|
Percentage of Participants With Virologic Response (HIV-1 RNA<50 Copies/mL) at Weeks 24 and 48
Week 24
|
80.0 Percentage of Participants
|
90.6 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants With Virologic Response (HIV-1 RNA<50 Copies/mL) at Weeks 24 and 48
Week 48
|
—
|
—
|
81.1 Percentage of Participants
|
—
|
SECONDARY outcome
Timeframe: INI + TAF/FTC Delayed Switch (DS1) and D/C/F/TAF Immediate Switch (IS1): Week 24; D/C/F/TAF Immediate Switch (IS): Week 48Population: The ITT analysis set included all the participants who were randomized and received at least 1 dose of treatment subsequent to randomization in the study. Here, 'n' (number analyzed) is defined as participants analyzed at specified timepoints. Here, n=0 signifies that participants were not planned to be analyzed at those timepoints in the respective arms.
Percentage of participants with virologic failure (HIV-1 RNA \>=50 copies/mL) at Weeks 24 and 48 was reported.
Outcome measures
| Measure |
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24
n=50 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen switched to receive a fixed-dose combination (FDC) regimen of darunavir 800 milligrams (mg), cobicistat 150 mg, emtricitabine 200 mg, and tenofovir alafenamide 10 mg (D/C/F/TAF), once daily from Day 1 (baseline) up to Week 24.
|
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24
n=53 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen continued to receive baseline integrase (INI) inhibitor along with tenofovir alafenamide 10 mg, emtricitabine 200 mg (TAF/FTC) antiretroviral (ARV) regimen from Day 1 (baseline) up to Week 24 per prescribing information (delayed switch 1 \[DS1\]).
|
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48
n=53 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current integrase (INI) inhibitor along with tenofovir alafenamide 10 mg, emtricitabine 200 mg (TAF/FTC) antiretroviral (ARV) (INI + TAF/FTC ARV) regimen switched to receive a fixed-dose combination (FDC) regimen of darunavir 800 milligrams (mg), cobicistat 150 mg, emtricitabine 200 mg, and tenofovir alafenamide 10 mg (D/C/F/TAF), once daily from Day 1 (baseline) up to Week 48.
|
INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25-Week 48
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen, after Week 24 switched to receive D/C/F/TAF FDC once daily from Week 25 to Week 48 (DS2).
|
|---|---|---|---|---|
|
Percentage of Participants With Virologic Failure (HIV-1 RNA >=50 Copies/mL) at Weeks 24 and 48
Week 24
|
10.0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants With Virologic Failure (HIV-1 RNA >=50 Copies/mL) at Weeks 24 and 48
Week 48
|
—
|
—
|
3.8 Percentage of Participants
|
—
|
SECONDARY outcome
Timeframe: INI + TAF/FTC Delayed Switch (DS1) and D/C/F/TAF Immediate Switch (IS1): Week 24; D/C/F/TAF Immediate Switch (IS): Week 48Population: The ITT analysis set included all the participants who were randomized and received at least 1 dose of treatment subsequent to randomization in the study. Here, 'n' (number analyzed) is defined as participants analyzed at specified timepoints. Here, n=0 signifies that participants were not planned to be analyzed at those timepoints in the respective arms.
Percentage of participants with virologic response (HIV-1 RNA\<200 copies/mL) at Week 24 and 48 was reported.
Outcome measures
| Measure |
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24
n=50 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen switched to receive a fixed-dose combination (FDC) regimen of darunavir 800 milligrams (mg), cobicistat 150 mg, emtricitabine 200 mg, and tenofovir alafenamide 10 mg (D/C/F/TAF), once daily from Day 1 (baseline) up to Week 24.
|
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24
n=53 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen continued to receive baseline integrase (INI) inhibitor along with tenofovir alafenamide 10 mg, emtricitabine 200 mg (TAF/FTC) antiretroviral (ARV) regimen from Day 1 (baseline) up to Week 24 per prescribing information (delayed switch 1 \[DS1\]).
|
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48
n=53 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current integrase (INI) inhibitor along with tenofovir alafenamide 10 mg, emtricitabine 200 mg (TAF/FTC) antiretroviral (ARV) (INI + TAF/FTC ARV) regimen switched to receive a fixed-dose combination (FDC) regimen of darunavir 800 milligrams (mg), cobicistat 150 mg, emtricitabine 200 mg, and tenofovir alafenamide 10 mg (D/C/F/TAF), once daily from Day 1 (baseline) up to Week 48.
|
INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25-Week 48
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen, after Week 24 switched to receive D/C/F/TAF FDC once daily from Week 25 to Week 48 (DS2).
|
|---|---|---|---|---|
|
Percentage of Participants With Virologic Response (HIV-1 RNA<200 Copies/mL) at Weeks 24 and 48
Week 24
|
86.0 Percentage of Participants
|
90.6 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants With Virologic Response (HIV-1 RNA<200 Copies/mL) at Weeks 24 and 48
Week 48
|
—
|
—
|
84.9 Percentage of Participants
|
—
|
SECONDARY outcome
Timeframe: INI + TAF/FTC Delayed Switch (DS1) and D/C/F/TAF Immediate Switch (IS1): Week 24; D/C/F/TAF Immediate Switch (IS): Week 48Population: The ITT analysis set included all the participants who were randomized and received at least 1 dose of treatment subsequent to randomization in the study. Here, 'n' (number analyzed) is defined as participants analyzed at specified timepoints. Here, n=0 signifies that participants were not planned to be analyzed at those timepoints in the respective arms.
Percentage of participants with virologic failure (HIV-1 RNA \>=200 copies/mL) at Weeks 24 and 48 was reported.
Outcome measures
| Measure |
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24
n=50 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen switched to receive a fixed-dose combination (FDC) regimen of darunavir 800 milligrams (mg), cobicistat 150 mg, emtricitabine 200 mg, and tenofovir alafenamide 10 mg (D/C/F/TAF), once daily from Day 1 (baseline) up to Week 24.
|
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24
n=53 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen continued to receive baseline integrase (INI) inhibitor along with tenofovir alafenamide 10 mg, emtricitabine 200 mg (TAF/FTC) antiretroviral (ARV) regimen from Day 1 (baseline) up to Week 24 per prescribing information (delayed switch 1 \[DS1\]).
|
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48
n=53 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current integrase (INI) inhibitor along with tenofovir alafenamide 10 mg, emtricitabine 200 mg (TAF/FTC) antiretroviral (ARV) (INI + TAF/FTC ARV) regimen switched to receive a fixed-dose combination (FDC) regimen of darunavir 800 milligrams (mg), cobicistat 150 mg, emtricitabine 200 mg, and tenofovir alafenamide 10 mg (D/C/F/TAF), once daily from Day 1 (baseline) up to Week 48.
|
INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25-Week 48
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen, after Week 24 switched to receive D/C/F/TAF FDC once daily from Week 25 to Week 48 (DS2).
|
|---|---|---|---|---|
|
Percentage of Participants With Virologic Failure (HIV-1 RNA >=200 Copies/mL) at Weeks 24 and 48
Week 24
|
4.0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants With Virologic Failure (HIV-1 RNA >=200 Copies/mL) at Weeks 24 and 48
Week 48
|
—
|
—
|
0 Percentage of Participants
|
—
|
SECONDARY outcome
Timeframe: INI + TAF/FTC Delayed Switch (DS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS): Baseline, Week 48Population: The safety analysis set included all randomized participants who received at least 1 dose of study intervention (that is, ITT analysis set). Here, 'N' (number of participants analyzed) is number of participants evaluable for this outcome measure. Here, 'n' (number analyzed) is defined as participants analyzed at specified timepoints. Here, n=0 signifies that participants were not planned to be analyzed at those timepoints in the respective arms.
Change from baseline in CD4+ cell count at Weeks 24 and 48 were reported.
Outcome measures
| Measure |
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24
n=43 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen switched to receive a fixed-dose combination (FDC) regimen of darunavir 800 milligrams (mg), cobicistat 150 mg, emtricitabine 200 mg, and tenofovir alafenamide 10 mg (D/C/F/TAF), once daily from Day 1 (baseline) up to Week 24.
|
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24
n=42 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen continued to receive baseline integrase (INI) inhibitor along with tenofovir alafenamide 10 mg, emtricitabine 200 mg (TAF/FTC) antiretroviral (ARV) regimen from Day 1 (baseline) up to Week 24 per prescribing information (delayed switch 1 \[DS1\]).
|
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48
n=43 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current integrase (INI) inhibitor along with tenofovir alafenamide 10 mg, emtricitabine 200 mg (TAF/FTC) antiretroviral (ARV) (INI + TAF/FTC ARV) regimen switched to receive a fixed-dose combination (FDC) regimen of darunavir 800 milligrams (mg), cobicistat 150 mg, emtricitabine 200 mg, and tenofovir alafenamide 10 mg (D/C/F/TAF), once daily from Day 1 (baseline) up to Week 48.
|
INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25-Week 48
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen, after Week 24 switched to receive D/C/F/TAF FDC once daily from Week 25 to Week 48 (DS2).
|
|---|---|---|---|---|
|
Change From Baseline in Cluster of Differentiation-4 (CD4+) Cell Count at Weeks 24 and 48
Week 24
|
9.0 Cells per cubic millimeter (cells/mm^3)
Interval -54.0 to 95.0
|
61.0 Cells per cubic millimeter (cells/mm^3)
Interval 34.0 to 89.0
|
—
|
—
|
|
Change From Baseline in Cluster of Differentiation-4 (CD4+) Cell Count at Weeks 24 and 48
Week 48
|
—
|
—
|
-41.0 Cells per cubic millimeter (cells/mm^3)
Interval -121.0 to 127.0
|
—
|
SECONDARY outcome
Timeframe: INI + TAF/FTC Delayed Switch (DS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS): Baseline, Week 48Population: The ITT analysis set included all the participants who were randomized and received at least 1 dose of treatment subsequent to randomization in the study. Here, n=0 signifies that participants were not planned to be analyzed at those timepoints in the respective arms.
Percentage of participants who had bothersome symptoms (scores of 1, 2, 3 or 4) across all items of the HIV-SI at Weeks 24 and 48 were reported. HIV-SI is a validated PRO instrument to assess 20 common HIV symptoms: fatigue/loss of energy, difficulty sleeping, nervous/anxious, diarrhea/loose bowels, changes in body composition, feeling sad/down/depressed, bloating/pain/gas in stomach, muscle aches/joint pain, problems with sex, trouble remembering, headaches, pain/numbness/tingling in hands/feet, skin problems/rash/itching, cough/trouble breathing, fever/chills/sweats, dizzy/lightheadedness, body weight loss/wasting, nausea/vomiting, hair loss/changes, and loss of appetite/food taste. Symptoms were rated using a 5-point Likert scale: 0: I don't have this symptom; 1: I have this symptom and it doesn't bother me; 2: I have this symptom and it bothers me a little; 3: I have this symptom and it bothers me; 4: I have this symptom and it bothers me a lot. Higher score refers more symptoms.
Outcome measures
| Measure |
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24
n=49 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen switched to receive a fixed-dose combination (FDC) regimen of darunavir 800 milligrams (mg), cobicistat 150 mg, emtricitabine 200 mg, and tenofovir alafenamide 10 mg (D/C/F/TAF), once daily from Day 1 (baseline) up to Week 24.
|
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24
n=44 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen continued to receive baseline integrase (INI) inhibitor along with tenofovir alafenamide 10 mg, emtricitabine 200 mg (TAF/FTC) antiretroviral (ARV) regimen from Day 1 (baseline) up to Week 24 per prescribing information (delayed switch 1 \[DS1\]).
|
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48
n=46 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current integrase (INI) inhibitor along with tenofovir alafenamide 10 mg, emtricitabine 200 mg (TAF/FTC) antiretroviral (ARV) (INI + TAF/FTC ARV) regimen switched to receive a fixed-dose combination (FDC) regimen of darunavir 800 milligrams (mg), cobicistat 150 mg, emtricitabine 200 mg, and tenofovir alafenamide 10 mg (D/C/F/TAF), once daily from Day 1 (baseline) up to Week 48.
|
INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25-Week 48
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen, after Week 24 switched to receive D/C/F/TAF FDC once daily from Week 25 to Week 48 (DS2).
|
|---|---|---|---|---|
|
Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48
Cough or trouble catching your breath?: Baseline
|
36.7 Percentage of Participants
|
—
|
10.9 Percentage of Participants
|
—
|
|
Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48
Fatigue or loss of energy?: Baseline
|
61.2 Percentage of Participants
|
—
|
43.5 Percentage of Participants
|
—
|
|
Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48
Fatigue or loss of energy?: Week 24
|
54.5 Percentage of Participants
|
47.7 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48
Fatigue or loss of energy?: Week 48
|
—
|
—
|
42.9 Percentage of Participants
|
—
|
|
Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48
Fever, chills or sweats?: Baseline
|
26.5 Percentage of Participants
|
—
|
13.0 Percentage of Participants
|
—
|
|
Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48
Fever, chills or sweats?: Week 24
|
20.5 Percentage of Participants
|
11.4 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48
Fever, chills or sweats?: Week 48
|
—
|
—
|
16.7 Percentage of Participants
|
—
|
|
Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48
Feeling dizzy or lightheaded?: Baseline
|
28.6 Percentage of Participants
|
—
|
8.7 Percentage of Participants
|
—
|
|
Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48
Feeling dizzy or lightheaded?: Week 24
|
29.5 Percentage of Participants
|
13.6 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48
Feeling dizzy or lightheaded?: Week 48
|
—
|
—
|
21.4 Percentage of Participants
|
—
|
|
Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48
Pain, numbness or tingling in the hands or feet?: Baseline
|
42.9 Percentage of Participants
|
—
|
30.4 Percentage of Participants
|
—
|
|
Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48
Pain, numbness or tingling in the hands or feet?: Week 24
|
38.6 Percentage of Participants
|
20.5 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48
Pain, numbness or tingling in the hands or feet?: Week 48
|
—
|
—
|
33.3 Percentage of Participants
|
—
|
|
Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48
Trouble remembering? : Baseline
|
53.1 Percentage of Participants
|
—
|
32.6 Percentage of Participants
|
—
|
|
Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48
Trouble remembering? : Week 24
|
38.6 Percentage of Participants
|
34.1 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48
Trouble remembering? : Week 48
|
—
|
—
|
38.1 Percentage of Participants
|
—
|
|
Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48
Nausea or vomiting?: Baseline
|
14.3 Percentage of Participants
|
—
|
4.3 Percentage of Participants
|
—
|
|
Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48
Nausea or vomiting?: Week 24
|
11.4 Percentage of Participants
|
13.6 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48
Nausea or vomiting?: Week 48
|
—
|
—
|
9.5 Percentage of Participants
|
—
|
|
Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48
Diarrhea or loose bowel movements?: Baseline
|
32.7 Percentage of Participants
|
—
|
8.7 Percentage of Participants
|
—
|
|
Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48
Diarrhea or loose bowel movements?: Week 24
|
27.3 Percentage of Participants
|
31.8 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48
Diarrhea or loose bowel movements?: Week 48
|
—
|
—
|
21.4 Percentage of Participants
|
—
|
|
Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48
Felt sad, down or depressed?: Baseline
|
59.2 Percentage of Participants
|
—
|
39.1 Percentage of Participants
|
—
|
|
Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48
Felt sad, down or depressed?: Week 24
|
52.3 Percentage of Participants
|
34.1 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48
Felt sad, down or depressed?: Week 48
|
—
|
—
|
40.5 Percentage of Participants
|
—
|
|
Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48
Felt nervous or anxious?: Baseline
|
55.1 Percentage of Participants
|
—
|
32.6 Percentage of Participants
|
—
|
|
Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48
Felt nervous or anxious?: Week 24
|
43.2 Percentage of Participants
|
38.6 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48
Felt nervous or anxious?: Week 48
|
—
|
—
|
47.6 Percentage of Participants
|
—
|
|
Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48
Difficulty falling or staying asleep? : Baseline
|
59.2 Percentage of Participants
|
—
|
45.7 Percentage of Participants
|
—
|
|
Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48
Difficulty falling or staying asleep?: Week 24
|
56.8 Percentage of Participants
|
52.3 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48
Difficulty falling or staying asleep?: Week 48
|
—
|
—
|
54.8 Percentage of Participants
|
—
|
|
Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48
Skin problems, such as rash, dryness or itching?: Baseline
|
34.7 Percentage of Participants
|
—
|
34.8 Percentage of Participants
|
—
|
|
Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48
Skin problems, such as rash, dryness or itching?: Week 24
|
31.8 Percentage of Participants
|
22.7 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48
Skin problems, such as rash, dryness or itching?: Week 48
|
—
|
—
|
38.1 Percentage of Participants
|
—
|
|
Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48
Cough or trouble catching your breath?: Week 24
|
22.7 Percentage of Participants
|
18.2 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48
Cough or trouble catching your breath?: Week 48
|
—
|
—
|
9.5 Percentage of Participants
|
—
|
|
Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48
Headache? : Baseline
|
36.7 Percentage of Participants
|
—
|
19.6 Percentage of Participants
|
—
|
|
Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48
Headache? : Week 24
|
18.2 Percentage of Participants
|
22.7 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48
Headache? : Week 48
|
—
|
—
|
26.2 Percentage of Participants
|
—
|
|
Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48
Loss of appetite or a change in the taste of food?: Baseline
|
30.6 Percentage of Participants
|
—
|
10.9 Percentage of Participants
|
—
|
|
Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48
Loss of appetite or a change in the taste of food?: Week 24
|
20.5 Percentage of Participants
|
22.7 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48
Loss of appetite or a change in the taste of food?: Week 48
|
—
|
—
|
21.4 Percentage of Participants
|
—
|
|
Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48
Bloating, pain or gas in your stomach?: Baseline
|
40.8 Percentage of Participants
|
—
|
39.1 Percentage of Participants
|
—
|
|
Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48
Bloating, pain or gas in your stomach?: Week 24
|
40.9 Percentage of Participants
|
38.6 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48
Bloating, pain or gas in your stomach?: Week 48
|
—
|
—
|
33.3 Percentage of Participants
|
—
|
|
Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48
Muscle aches or joint pain?: Baseline
|
53.1 Percentage of Participants
|
—
|
34.8 Percentage of Participants
|
—
|
|
Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48
Muscle aches or joint pain?: Week 24
|
45.5 Percentage of Participants
|
38.6 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48
Muscle aches or joint pain?: Week 48
|
—
|
—
|
42.9 Percentage of Participants
|
—
|
|
Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48
Problems with having sex, such as loss of interest or lack of satisfaction?: Baseline
|
42.9 Percentage of Participants
|
—
|
39.1 Percentage of Participants
|
—
|
|
Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48
Problems with having sex, such as loss of interest or lack of satisfaction?: Week 24
|
22.7 Percentage of Participants
|
38.6 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48
Problems with having sex, such as loss of interest or lack of satisfaction?: Week 48
|
—
|
—
|
26.2 Percentage of Participants
|
—
|
|
Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48
Changes in the way your body looks such as fat deposits or weight gain?: Baseline
|
71.4 Percentage of Participants
|
—
|
71.7 Percentage of Participants
|
—
|
|
Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48
Changes in the way your body looks such as fat deposits or weight gain?: Week 24
|
70.5 Percentage of Participants
|
63.6 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48
Changes in the way your body looks such as fat deposits or weight gain?: Week 48
|
—
|
—
|
59.5 Percentage of Participants
|
—
|
|
Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48
Problems with weight loss or wasting?: Baseline
|
32.7 Percentage of Participants
|
—
|
17.4 Percentage of Participants
|
—
|
|
Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48
Problems with weight loss or wasting?: Week 24
|
29.5 Percentage of Participants
|
15.9 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48
Problems with weight loss or wasting?: Week 48
|
—
|
—
|
26.2 Percentage of Participants
|
—
|
|
Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48
Hair loss or changes in the way your hair looks?: Baseline
|
26.5 Percentage of Participants
|
—
|
19.6 Percentage of Participants
|
—
|
|
Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48
Hair loss or changes in the way your hair looks?: Week 24
|
20.5 Percentage of Participants
|
34.1 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48
Hair loss or changes in the way your hair looks?: Week 48
|
—
|
—
|
23.8 Percentage of Participants
|
—
|
SECONDARY outcome
Timeframe: INI + TAF/FTC Delayed Switch (DS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS): Baseline, Week 48Population: The ITT analysis set included all the participants who were randomized and received at least 1 dose of treatment subsequent to randomization in the study. Here, n=0 signifies that participants were not planned to be analyzed at those timepoints in the respective arms.
Percentage of participants who had any symptoms (scores of 1, 2, 3 or 4) across all items of the HIV-SI at Weeks 24 and 48 were reported. HIV-SI is a validated PRO instrument to assess 20 common HIV symptoms: fatigue/loss of energy, difficulty sleeping, nervous/anxious, diarrhea/loose bowels, changes in body composition, feeling sad/down/depressed, bloating/pain/gas in stomach, muscle aches/joint pain, problems with sex, trouble remembering, headaches, pain/numbness/tingling in hands/feet, skin problems/rash/itching, cough/trouble breathing, fever/chills/sweats, dizzy/lightheadedness, body weight loss/wasting, nausea/vomiting, hair loss/changes, and loss of appetite/food taste. Symptoms were rated using a 5-point Likert scale: 0: I don't have this symptom; 1: I have this symptom and it doesn't bother me; 2: I have this symptom and it bothers me a little; 3: I have this symptom and it bothers me; 4: I have this symptom and it bothers me a lot. Higher score refers more symptoms.
Outcome measures
| Measure |
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24
n=49 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen switched to receive a fixed-dose combination (FDC) regimen of darunavir 800 milligrams (mg), cobicistat 150 mg, emtricitabine 200 mg, and tenofovir alafenamide 10 mg (D/C/F/TAF), once daily from Day 1 (baseline) up to Week 24.
|
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24
n=44 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen continued to receive baseline integrase (INI) inhibitor along with tenofovir alafenamide 10 mg, emtricitabine 200 mg (TAF/FTC) antiretroviral (ARV) regimen from Day 1 (baseline) up to Week 24 per prescribing information (delayed switch 1 \[DS1\]).
|
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48
n=46 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current integrase (INI) inhibitor along with tenofovir alafenamide 10 mg, emtricitabine 200 mg (TAF/FTC) antiretroviral (ARV) (INI + TAF/FTC ARV) regimen switched to receive a fixed-dose combination (FDC) regimen of darunavir 800 milligrams (mg), cobicistat 150 mg, emtricitabine 200 mg, and tenofovir alafenamide 10 mg (D/C/F/TAF), once daily from Day 1 (baseline) up to Week 48.
|
INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25-Week 48
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen, after Week 24 switched to receive D/C/F/TAF FDC once daily from Week 25 to Week 48 (DS2).
|
|---|---|---|---|---|
|
Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48
Headache? : Baseline
|
46.9 Percentage of Participants
|
—
|
30.4 Percentage of Participants
|
—
|
|
Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48
Headache? : Week 24
|
29.5 Percentage of Participants
|
29.5 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48
Headache? : Week 48
|
—
|
—
|
38.1 Percentage of Participants
|
—
|
|
Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48
Loss of appetite or a change in the taste of food?: Baseline
|
36.7 Percentage of Participants
|
—
|
21.7 Percentage of Participants
|
—
|
|
Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48
Loss of appetite or a change in the taste of food?: Week 24
|
29.5 Percentage of Participants
|
25.0 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48
Bloating, pain or gas in your stomach?: Baseline
|
46.9 Percentage of Participants
|
—
|
56.5 Percentage of Participants
|
—
|
|
Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48
Bloating, pain or gas in your stomach?: Week 24
|
45.5 Percentage of Participants
|
54.5 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48
Bloating, pain or gas in your stomach?: Week 48
|
—
|
—
|
52.4 Percentage of Participants
|
—
|
|
Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48
Muscle aches or joint pain?: Baseline
|
57.1 Percentage of Participants
|
—
|
43.5 Percentage of Participants
|
—
|
|
Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48
Muscle aches or joint pain?: Week 48
|
—
|
—
|
52.4 Percentage of Participants
|
—
|
|
Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48
Problems with having sex, such as loss of interest or lack of satisfaction?: Baseline
|
51.0 Percentage of Participants
|
—
|
47.8 Percentage of Participants
|
—
|
|
Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48
Problems with having sex, such as loss of interest or lack of satisfaction?: Week 24
|
31.8 Percentage of Participants
|
52.3 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48
Changes in the way your body looks such as fat deposits or weight gain?: Baseline
|
77.6 Percentage of Participants
|
—
|
80.4 Percentage of Participants
|
—
|
|
Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48
Changes in the way your body looks such as fat deposits or weight gain?: Week 24
|
77.3 Percentage of Participants
|
72.7 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48
Changes in the way your body looks such as fat deposits or weight gain?: Week 48
|
—
|
—
|
76.2 Percentage of Participants
|
—
|
|
Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48
Problems with weight loss or wasting?: Baseline
|
36.7 Percentage of Participants
|
—
|
21.7 Percentage of Participants
|
—
|
|
Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48
Hair loss or changes in the way your hair looks?: Baseline
|
34.7 Percentage of Participants
|
—
|
26.1 Percentage of Participants
|
—
|
|
Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48
Hair loss or changes in the way your hair looks?: Week 24
|
27.3 Percentage of Participants
|
38.6 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48
Feeling dizzy or lightheaded?: Baseline
|
34.7 Percentage of Participants
|
—
|
17.4 Percentage of Participants
|
—
|
|
Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48
Feeling dizzy or lightheaded?: Week 24
|
36.4 Percentage of Participants
|
27.3 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48
Feeling dizzy or lightheaded?: Week 48
|
—
|
—
|
28.6 Percentage of Participants
|
—
|
|
Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48
Pain, numbness or tingling in the hands or feet?: Baseline
|
53.1 Percentage of Participants
|
—
|
43.5 Percentage of Participants
|
—
|
|
Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48
Pain, numbness or tingling in the hands or feet?: Week 24
|
47.7 Percentage of Participants
|
34.1 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48
Pain, numbness or tingling in the hands or feet?: Week 48
|
—
|
—
|
42.9 Percentage of Participants
|
—
|
|
Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48
Trouble remembering? : Baseline
|
59.2 Percentage of Participants
|
—
|
47.8 Percentage of Participants
|
—
|
|
Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48
Trouble remembering? : Week 24
|
47.7 Percentage of Participants
|
45.5 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48
Trouble remembering? : Week 48
|
—
|
—
|
47.6 Percentage of Participants
|
—
|
|
Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48
Nausea or vomiting?: Baseline
|
24.5 Percentage of Participants
|
—
|
8.7 Percentage of Participants
|
—
|
|
Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48
Nausea or vomiting?: Week 24
|
15.9 Percentage of Participants
|
18.2 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48
Nausea or vomiting?: Week 48
|
—
|
—
|
16.7 Percentage of Participants
|
—
|
|
Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48
Diarrhea or loose bowel movements?: Baseline
|
46.9 Percentage of Participants
|
—
|
17.4 Percentage of Participants
|
—
|
|
Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48
Diarrhea or loose bowel movements?: Week 24
|
36.4 Percentage of Participants
|
43.2 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48
Diarrhea or loose bowel movements?: Week 48
|
—
|
—
|
35.7 Percentage of Participants
|
—
|
|
Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48
Felt sad, down or depressed?: Baseline
|
73.5 Percentage of Participants
|
—
|
54.3 Percentage of Participants
|
—
|
|
Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48
Felt sad, down or depressed?: Week 24
|
61.4 Percentage of Participants
|
50.0 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48
Felt sad, down or depressed?: Week 48
|
—
|
—
|
47.6 Percentage of Participants
|
—
|
|
Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48
Felt nervous or anxious?: Baseline
|
63.3 Percentage of Participants
|
—
|
63.0 Percentage of Participants
|
—
|
|
Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48
Felt nervous or anxious?: Week 24
|
59.1 Percentage of Participants
|
50.0 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48
Felt nervous or anxious?: Week 48
|
—
|
—
|
54.8 Percentage of Participants
|
—
|
|
Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48
Difficulty falling or staying asleep? : Baseline
|
65.3 Percentage of Participants
|
—
|
50.0 Percentage of Participants
|
—
|
|
Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48
Difficulty falling or staying asleep?: Week 24
|
63.6 Percentage of Participants
|
61.4 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48
Difficulty falling or staying asleep?: Week 48
|
—
|
—
|
64.3 Percentage of Participants
|
—
|
|
Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48
Skin problems, such as rash, dryness or itching?: Baseline
|
42.9 Percentage of Participants
|
—
|
41.3 Percentage of Participants
|
—
|
|
Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48
Skin problems, such as rash, dryness or itching?: Week 24
|
40.9 Percentage of Participants
|
34.1 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48
Skin problems, such as rash, dryness or itching?: Week 48
|
—
|
—
|
45.2 Percentage of Participants
|
—
|
|
Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48
Cough or trouble catching your breath?: Baseline
|
46.9 Percentage of Participants
|
—
|
19.6 Percentage of Participants
|
—
|
|
Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48
Cough or trouble catching your breath?: Week 24
|
29.5 Percentage of Participants
|
31.8 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48
Cough or trouble catching your breath?: Week 48
|
—
|
—
|
21.4 Percentage of Participants
|
—
|
|
Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48
Loss of appetite or a change in the taste of food?: Week 48
|
—
|
—
|
31.0 Percentage of Participants
|
—
|
|
Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48
Muscle aches or joint pain?: Week 24
|
47.7 Percentage of Participants
|
43.2 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48
Problems with having sex, such as loss of interest or lack of satisfaction?: Week 48
|
—
|
—
|
40.5 Percentage of Participants
|
—
|
|
Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48
Problems with weight loss or wasting?: Week 24
|
38.6 Percentage of Participants
|
25.0 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48
Problems with weight loss or wasting?: Week 48
|
—
|
—
|
35.7 Percentage of Participants
|
—
|
|
Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48
Hair loss or changes in the way your hair looks?: Week 48
|
—
|
—
|
35.7 Percentage of Participants
|
—
|
|
Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48
Fatigue or loss of energy?: Baseline
|
73.5 Percentage of Participants
|
—
|
45.7 Percentage of Participants
|
—
|
|
Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48
Fatigue or loss of energy?: Week 24
|
61.4 Percentage of Participants
|
59.1 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48
Fatigue or loss of energy?: Week 48
|
—
|
—
|
47.6 Percentage of Participants
|
—
|
|
Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48
Fever, chills or sweats?: Baseline
|
34.7 Percentage of Participants
|
—
|
17.4 Percentage of Participants
|
—
|
|
Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48
Fever, chills or sweats?: Week 24
|
29.5 Percentage of Participants
|
20.5 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48
Fever, chills or sweats?: Week 48
|
—
|
—
|
26.2 Percentage of Participants
|
—
|
SECONDARY outcome
Timeframe: INI + TAF/FTC Delayed Switch (DS1) and D/C/F/TAF Immediate Switch (IS1): Week 24; D/C/F/TAF Immediate Switch (IS): Week 48Population: The ITT analysis set included all the participants who were randomized and received at least 1 dose of treatment subsequent to randomization in the study. Here, n=0 signifies that participants were not planned to be analyzed at those timepoints in the respective arms. Here, n=0 signifies that participants were not planned to be analyzed at those timepoints in the respective arms.
Number of participants With each bothersome symptom of the HIV-SI adjusting for baseline variables at Weeks 24 and 48 were reported.
Outcome measures
| Measure |
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24
n=50 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen switched to receive a fixed-dose combination (FDC) regimen of darunavir 800 milligrams (mg), cobicistat 150 mg, emtricitabine 200 mg, and tenofovir alafenamide 10 mg (D/C/F/TAF), once daily from Day 1 (baseline) up to Week 24.
|
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24
n=53 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen continued to receive baseline integrase (INI) inhibitor along with tenofovir alafenamide 10 mg, emtricitabine 200 mg (TAF/FTC) antiretroviral (ARV) regimen from Day 1 (baseline) up to Week 24 per prescribing information (delayed switch 1 \[DS1\]).
|
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48
n=53 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current integrase (INI) inhibitor along with tenofovir alafenamide 10 mg, emtricitabine 200 mg (TAF/FTC) antiretroviral (ARV) (INI + TAF/FTC ARV) regimen switched to receive a fixed-dose combination (FDC) regimen of darunavir 800 milligrams (mg), cobicistat 150 mg, emtricitabine 200 mg, and tenofovir alafenamide 10 mg (D/C/F/TAF), once daily from Day 1 (baseline) up to Week 48.
|
INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25-Week 48
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen, after Week 24 switched to receive D/C/F/TAF FDC once daily from Week 25 to Week 48 (DS2).
|
|---|---|---|---|---|
|
Number of Participants With Each Bothersome Symptom of the HIV-SI Adjusting for Baseline Variables at Weeks 24 and 48
Week 24
|
44 Participants
|
44 Participants
|
—
|
—
|
|
Number of Participants With Each Bothersome Symptom of the HIV-SI Adjusting for Baseline Variables at Weeks 24 and 48
Week 48
|
—
|
—
|
42 Participants
|
—
|
SECONDARY outcome
Timeframe: INI + TAF/FTC Delayed Switch (DS1) and D/C/F/TAF Immediate Switch (IS1): Week 24; D/C/F/TAF Immediate Switch (IS): Week 48Population: The ITT analysis set included all the participants who were randomized and received at least 1 dose of treatment subsequent to randomization in the study. Here, 'N' (number of participants analyzed) is number of participants evaluable for this outcome measure. Here, 'n' (number analyzed) is defined as participants analyzed at specified timepoints. Here, n=0 signifies that participants were not planned to be analyzed at those timepoints in the respective arms.
Percentage of participants with PGIC scale score at Weeks 24 and 48 were reported. The PGI-C was a patient reported outcome (PRO) where participants rated using a 7-point scale ranging from 1 to 7 where 1 indicates "very much improved", 2 indicates "much improved', 3 indicates "minimally improved", 4 indicates "No change", 5 indicates "minimally worse", 6 indicates "Much worse" and 7 indicates "Very much worse".
Outcome measures
| Measure |
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24
n=44 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen switched to receive a fixed-dose combination (FDC) regimen of darunavir 800 milligrams (mg), cobicistat 150 mg, emtricitabine 200 mg, and tenofovir alafenamide 10 mg (D/C/F/TAF), once daily from Day 1 (baseline) up to Week 24.
|
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24
n=41 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen continued to receive baseline integrase (INI) inhibitor along with tenofovir alafenamide 10 mg, emtricitabine 200 mg (TAF/FTC) antiretroviral (ARV) regimen from Day 1 (baseline) up to Week 24 per prescribing information (delayed switch 1 \[DS1\]).
|
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48
n=42 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current integrase (INI) inhibitor along with tenofovir alafenamide 10 mg, emtricitabine 200 mg (TAF/FTC) antiretroviral (ARV) (INI + TAF/FTC ARV) regimen switched to receive a fixed-dose combination (FDC) regimen of darunavir 800 milligrams (mg), cobicistat 150 mg, emtricitabine 200 mg, and tenofovir alafenamide 10 mg (D/C/F/TAF), once daily from Day 1 (baseline) up to Week 48.
|
INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25-Week 48
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen, after Week 24 switched to receive D/C/F/TAF FDC once daily from Week 25 to Week 48 (DS2).
|
|---|---|---|---|---|
|
Percentage of Participants With Patient Global Impression of Change (PGIC) Scale Score at Weeks 24 and 48
Very Much Improved: Week 24
|
11.4 Percentage of Participants
|
4.9 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants With Patient Global Impression of Change (PGIC) Scale Score at Weeks 24 and 48
Much Improved: Week 24
|
13.6 Percentage of Participants
|
22.0 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants With Patient Global Impression of Change (PGIC) Scale Score at Weeks 24 and 48
Minimally Improved: Week 24
|
18.2 Percentage of Participants
|
19.5 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants With Patient Global Impression of Change (PGIC) Scale Score at Weeks 24 and 48
No Change: Week 24
|
52.3 Percentage of Participants
|
19.5 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants With Patient Global Impression of Change (PGIC) Scale Score at Weeks 24 and 48
Minimally Worse: Week 24
|
0 Percentage of Participants
|
7.3 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants With Patient Global Impression of Change (PGIC) Scale Score at Weeks 24 and 48
Much Worse: Week 24
|
2.3 Percentage of Participants
|
4.9 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants With Patient Global Impression of Change (PGIC) Scale Score at Weeks 24 and 48
Very Much Worse: Week 24
|
2.3 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants With Patient Global Impression of Change (PGIC) Scale Score at Weeks 24 and 48
Very Much Improved: Week 48
|
—
|
—
|
11.9 Percentage of Participants
|
—
|
|
Percentage of Participants With Patient Global Impression of Change (PGIC) Scale Score at Weeks 24 and 48
Much Improved: Week 48
|
—
|
—
|
16.7 Percentage of Participants
|
—
|
|
Percentage of Participants With Patient Global Impression of Change (PGIC) Scale Score at Weeks 24 and 48
Minimally Improved: Week 48
|
—
|
—
|
26.2 Percentage of Participants
|
—
|
|
Percentage of Participants With Patient Global Impression of Change (PGIC) Scale Score at Weeks 24 and 48
No Change: Week 48
|
—
|
—
|
31.0 Percentage of Participants
|
—
|
|
Percentage of Participants With Patient Global Impression of Change (PGIC) Scale Score at Weeks 24 and 48
Minimally Worse: Week 48
|
—
|
—
|
9.5 Percentage of Participants
|
—
|
|
Percentage of Participants With Patient Global Impression of Change (PGIC) Scale Score at Weeks 24 and 48
Much Worse: Week 48
|
—
|
—
|
2.4 Percentage of Participants
|
—
|
|
Percentage of Participants With Patient Global Impression of Change (PGIC) Scale Score at Weeks 24 and 48
Very Much Worse: Week 48
|
—
|
—
|
2.4 Percentage of Participants
|
—
|
SECONDARY outcome
Timeframe: Weeks 4, 12, 24, 36 and 48Population: The ITT analysis set included all the participants who were randomized and received at least 1 dose of treatment subsequent to randomization in the study. Here, 'N' (number of participants analyzed) is number of participants evaluable for this outcome measure. Here, 'n' (number analyzed) is defined as participants analyzed at specified timepoints. Here, n=0 signifies that participants were not planned to be analyzed at those timepoints in the respective arms.
Adherence rate to treatment at Weeks 4, 12, 24, 36 and 48 were reported. Adherence rates were reported according to the percentage of participants missing 0, 1, 2, 3 or 4 doses as 100%, 75%, 50%, 25%, and 0%, respectively, using participant self-report 4-day recall at Weeks 4, 12, 24, 36, and 48.
Outcome measures
| Measure |
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24
n=43 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen switched to receive a fixed-dose combination (FDC) regimen of darunavir 800 milligrams (mg), cobicistat 150 mg, emtricitabine 200 mg, and tenofovir alafenamide 10 mg (D/C/F/TAF), once daily from Day 1 (baseline) up to Week 24.
|
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24
n=53 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen continued to receive baseline integrase (INI) inhibitor along with tenofovir alafenamide 10 mg, emtricitabine 200 mg (TAF/FTC) antiretroviral (ARV) regimen from Day 1 (baseline) up to Week 24 per prescribing information (delayed switch 1 \[DS1\]).
|
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48
n=47 Participants
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current integrase (INI) inhibitor along with tenofovir alafenamide 10 mg, emtricitabine 200 mg (TAF/FTC) antiretroviral (ARV) (INI + TAF/FTC ARV) regimen switched to receive a fixed-dose combination (FDC) regimen of darunavir 800 milligrams (mg), cobicistat 150 mg, emtricitabine 200 mg, and tenofovir alafenamide 10 mg (D/C/F/TAF), once daily from Day 1 (baseline) up to Week 48.
|
INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25-Week 48
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen, after Week 24 switched to receive D/C/F/TAF FDC once daily from Week 25 to Week 48 (DS2).
|
|---|---|---|---|---|
|
Adherence Rate to Treatment at Weeks 4, 12, 24, 36, and 48
75%: Week 4
|
7.1 Percentage of Participants
|
9.4 Percentage of Participants
|
—
|
—
|
|
Adherence Rate to Treatment at Weeks 4, 12, 24, 36, and 48
50%: Week 4
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
|
Adherence Rate to Treatment at Weeks 4, 12, 24, 36, and 48
25%: Week 4
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
|
Adherence Rate to Treatment at Weeks 4, 12, 24, 36, and 48
0%: Week 4
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
|
Adherence Rate to Treatment at Weeks 4, 12, 24, 36, and 48
100%: Week 12
|
93.0 Percentage of Participants
|
90.4 Percentage of Participants
|
—
|
—
|
|
Adherence Rate to Treatment at Weeks 4, 12, 24, 36, and 48
75%: Week 12
|
4.7 Percentage of Participants
|
7.7 Percentage of Participants
|
—
|
—
|
|
Adherence Rate to Treatment at Weeks 4, 12, 24, 36, and 48
0%: Week 12
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
—
|
—
|
|
Adherence Rate to Treatment at Weeks 4, 12, 24, 36, and 48
100%: Week 24
|
95.2 Percentage of Participants
|
98.0 Percentage of Participants
|
—
|
—
|
|
Adherence Rate to Treatment at Weeks 4, 12, 24, 36, and 48
75%: Week 24
|
2.4 Percentage of Participants
|
4.1 Percentage of Participants
|
—
|
—
|
|
Adherence Rate to Treatment at Weeks 4, 12, 24, 36, and 48
50%: Week 24
|
2.4 Percentage of Participants
|
0.0 Percentage of Participants
|
—
|
—
|
|
Adherence Rate to Treatment at Weeks 4, 12, 24, 36, and 48
25%: Week 24
|
0 Percentage of Participants
|
0.0 Percentage of Participants
|
—
|
—
|
|
Adherence Rate to Treatment at Weeks 4, 12, 24, 36, and 48
0%: Week 24
|
0 Percentage of Participants
|
0.0 Percentage of Participants
|
—
|
—
|
|
Adherence Rate to Treatment at Weeks 4, 12, 24, 36, and 48
100%: Week 4
|
92.9 Percentage of Participants
|
90.6 Percentage of Participants
|
—
|
—
|
|
Adherence Rate to Treatment at Weeks 4, 12, 24, 36, and 48
50%: Week 12
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
—
|
—
|
|
Adherence Rate to Treatment at Weeks 4, 12, 24, 36, and 48
25%: Week 12
|
2.3 Percentage of Participants
|
1.9 Percentage of Participants
|
—
|
—
|
|
Adherence Rate to Treatment at Weeks 4, 12, 24, 36, and 48
100%: Week 36
|
—
|
—
|
93.6 Percentage of Participants
|
—
|
|
Adherence Rate to Treatment at Weeks 4, 12, 24, 36, and 48
75%: Week 36
|
—
|
—
|
6.4 Percentage of Participants
|
—
|
|
Adherence Rate to Treatment at Weeks 4, 12, 24, 36, and 48
50%: Week 36
|
—
|
—
|
0 Percentage of Participants
|
—
|
|
Adherence Rate to Treatment at Weeks 4, 12, 24, 36, and 48
25%: Week 36
|
—
|
—
|
0 Percentage of Participants
|
—
|
|
Adherence Rate to Treatment at Weeks 4, 12, 24, 36, and 48
0%: Week 36
|
—
|
—
|
0 Percentage of Participants
|
—
|
|
Adherence Rate to Treatment at Weeks 4, 12, 24, 36, and 48
100%: Week 48
|
—
|
—
|
93.5 Percentage of Participants
|
—
|
|
Adherence Rate to Treatment at Weeks 4, 12, 24, 36, and 48
75%: Week 48
|
—
|
—
|
2.2 Percentage of Participants
|
—
|
|
Adherence Rate to Treatment at Weeks 4, 12, 24, 36, and 48
50%: Week 48
|
—
|
—
|
0 Percentage of Participants
|
—
|
|
Adherence Rate to Treatment at Weeks 4, 12, 24, 36, and 48
25%: Week 48
|
—
|
—
|
2.2 Percentage of Participants
|
—
|
|
Adherence Rate to Treatment at Weeks 4, 12, 24, 36, and 48
0%: Week 48
|
—
|
—
|
2.2 Percentage of Participants
|
—
|
Adverse Events
D/C/F/TAF Immediate Switch (IS1): Baseline-Week 24
Serious events: 3 serious events
Other events: 10 other events
Deaths: 0 deaths
D/C/F/TAF Immediate Switch (IS2): Week 25-48
Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24
Serious events: 4 serious events
Other events: 13 other events
Deaths: 1 deaths
INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25-Week 48
Serious events: 4 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
D/C/F/TAF Immediate Switch (IS1): Baseline-Week 24
n=53 participants at risk
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen switched to receive a fixed-dose combination (FDC) regimen of darunavir 800 milligrams (mg), cobicistat 150 mg, emtricitabine 200 mg, and tenofovir alafenamide 10 mg (D/C/F/TAF), once daily from Day 1 (baseline) up to Week 24.
|
D/C/F/TAF Immediate Switch (IS2): Week 25-48
n=49 participants at risk
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen switched to receive a fixed-dose combination (FDC) regimen of darunavir 800 milligrams (mg), cobicistat 150 mg, emtricitabine 200 mg, and tenofovir alafenamide 10 mg (D/C/F/TAF), once daily from Day 25 up to Week 48.
|
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24
n=50 participants at risk
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen continued to receive baseline integrase (INI) inhibitor along with tenofovir alafenamide 10 mg, emtricitabine 200 mg (TAF/FTC) antiretroviral (ARV) regimen from Day 1 (baseline) up to Week 24 per prescribing information (delayed switch 1 \[DS1\]).
|
INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25-Week 48
n=46 participants at risk
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen, after Week 24 switched to receive D/C/F/TAF FDC once daily from Week 25 to Week 48 (DS2).
|
|---|---|---|---|---|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/53 • D/C/F/TAF Immediate Switch (IS1) and INI + TAF/FTC Delayed Switch (DS1): Baseline up to Week 24; D/C/F/TAF Immediate Switch (IS2) and INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25 up to Week 48
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (that is, ITT analysis set).
|
0.00%
0/49 • D/C/F/TAF Immediate Switch (IS1) and INI + TAF/FTC Delayed Switch (DS1): Baseline up to Week 24; D/C/F/TAF Immediate Switch (IS2) and INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25 up to Week 48
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (that is, ITT analysis set).
|
0.00%
0/50 • D/C/F/TAF Immediate Switch (IS1) and INI + TAF/FTC Delayed Switch (DS1): Baseline up to Week 24; D/C/F/TAF Immediate Switch (IS2) and INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25 up to Week 48
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (that is, ITT analysis set).
|
2.2%
1/46 • D/C/F/TAF Immediate Switch (IS1) and INI + TAF/FTC Delayed Switch (DS1): Baseline up to Week 24; D/C/F/TAF Immediate Switch (IS2) and INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25 up to Week 48
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (that is, ITT analysis set).
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/53 • D/C/F/TAF Immediate Switch (IS1) and INI + TAF/FTC Delayed Switch (DS1): Baseline up to Week 24; D/C/F/TAF Immediate Switch (IS2) and INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25 up to Week 48
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (that is, ITT analysis set).
|
0.00%
0/49 • D/C/F/TAF Immediate Switch (IS1) and INI + TAF/FTC Delayed Switch (DS1): Baseline up to Week 24; D/C/F/TAF Immediate Switch (IS2) and INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25 up to Week 48
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (that is, ITT analysis set).
|
2.0%
1/50 • D/C/F/TAF Immediate Switch (IS1) and INI + TAF/FTC Delayed Switch (DS1): Baseline up to Week 24; D/C/F/TAF Immediate Switch (IS2) and INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25 up to Week 48
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (that is, ITT analysis set).
|
0.00%
0/46 • D/C/F/TAF Immediate Switch (IS1) and INI + TAF/FTC Delayed Switch (DS1): Baseline up to Week 24; D/C/F/TAF Immediate Switch (IS2) and INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25 up to Week 48
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (that is, ITT analysis set).
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
1.9%
1/53 • D/C/F/TAF Immediate Switch (IS1) and INI + TAF/FTC Delayed Switch (DS1): Baseline up to Week 24; D/C/F/TAF Immediate Switch (IS2) and INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25 up to Week 48
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (that is, ITT analysis set).
|
0.00%
0/49 • D/C/F/TAF Immediate Switch (IS1) and INI + TAF/FTC Delayed Switch (DS1): Baseline up to Week 24; D/C/F/TAF Immediate Switch (IS2) and INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25 up to Week 48
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (that is, ITT analysis set).
|
0.00%
0/50 • D/C/F/TAF Immediate Switch (IS1) and INI + TAF/FTC Delayed Switch (DS1): Baseline up to Week 24; D/C/F/TAF Immediate Switch (IS2) and INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25 up to Week 48
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (that is, ITT analysis set).
|
0.00%
0/46 • D/C/F/TAF Immediate Switch (IS1) and INI + TAF/FTC Delayed Switch (DS1): Baseline up to Week 24; D/C/F/TAF Immediate Switch (IS2) and INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25 up to Week 48
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (that is, ITT analysis set).
|
|
Infections and infestations
COVID-19
|
0.00%
0/53 • D/C/F/TAF Immediate Switch (IS1) and INI + TAF/FTC Delayed Switch (DS1): Baseline up to Week 24; D/C/F/TAF Immediate Switch (IS2) and INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25 up to Week 48
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (that is, ITT analysis set).
|
0.00%
0/49 • D/C/F/TAF Immediate Switch (IS1) and INI + TAF/FTC Delayed Switch (DS1): Baseline up to Week 24; D/C/F/TAF Immediate Switch (IS2) and INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25 up to Week 48
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (that is, ITT analysis set).
|
0.00%
0/50 • D/C/F/TAF Immediate Switch (IS1) and INI + TAF/FTC Delayed Switch (DS1): Baseline up to Week 24; D/C/F/TAF Immediate Switch (IS2) and INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25 up to Week 48
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (that is, ITT analysis set).
|
2.2%
1/46 • D/C/F/TAF Immediate Switch (IS1) and INI + TAF/FTC Delayed Switch (DS1): Baseline up to Week 24; D/C/F/TAF Immediate Switch (IS2) and INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25 up to Week 48
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (that is, ITT analysis set).
|
|
Infections and infestations
Orchitis
|
1.9%
1/53 • D/C/F/TAF Immediate Switch (IS1) and INI + TAF/FTC Delayed Switch (DS1): Baseline up to Week 24; D/C/F/TAF Immediate Switch (IS2) and INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25 up to Week 48
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (that is, ITT analysis set).
|
0.00%
0/49 • D/C/F/TAF Immediate Switch (IS1) and INI + TAF/FTC Delayed Switch (DS1): Baseline up to Week 24; D/C/F/TAF Immediate Switch (IS2) and INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25 up to Week 48
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (that is, ITT analysis set).
|
0.00%
0/50 • D/C/F/TAF Immediate Switch (IS1) and INI + TAF/FTC Delayed Switch (DS1): Baseline up to Week 24; D/C/F/TAF Immediate Switch (IS2) and INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25 up to Week 48
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (that is, ITT analysis set).
|
0.00%
0/46 • D/C/F/TAF Immediate Switch (IS1) and INI + TAF/FTC Delayed Switch (DS1): Baseline up to Week 24; D/C/F/TAF Immediate Switch (IS2) and INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25 up to Week 48
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (that is, ITT analysis set).
|
|
Infections and infestations
Pneumonia
|
0.00%
0/53 • D/C/F/TAF Immediate Switch (IS1) and INI + TAF/FTC Delayed Switch (DS1): Baseline up to Week 24; D/C/F/TAF Immediate Switch (IS2) and INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25 up to Week 48
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (that is, ITT analysis set).
|
2.0%
1/49 • D/C/F/TAF Immediate Switch (IS1) and INI + TAF/FTC Delayed Switch (DS1): Baseline up to Week 24; D/C/F/TAF Immediate Switch (IS2) and INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25 up to Week 48
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (that is, ITT analysis set).
|
0.00%
0/50 • D/C/F/TAF Immediate Switch (IS1) and INI + TAF/FTC Delayed Switch (DS1): Baseline up to Week 24; D/C/F/TAF Immediate Switch (IS2) and INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25 up to Week 48
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (that is, ITT analysis set).
|
0.00%
0/46 • D/C/F/TAF Immediate Switch (IS1) and INI + TAF/FTC Delayed Switch (DS1): Baseline up to Week 24; D/C/F/TAF Immediate Switch (IS2) and INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25 up to Week 48
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (that is, ITT analysis set).
|
|
Infections and infestations
Pneumonia Viral
|
0.00%
0/53 • D/C/F/TAF Immediate Switch (IS1) and INI + TAF/FTC Delayed Switch (DS1): Baseline up to Week 24; D/C/F/TAF Immediate Switch (IS2) and INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25 up to Week 48
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (that is, ITT analysis set).
|
0.00%
0/49 • D/C/F/TAF Immediate Switch (IS1) and INI + TAF/FTC Delayed Switch (DS1): Baseline up to Week 24; D/C/F/TAF Immediate Switch (IS2) and INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25 up to Week 48
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (that is, ITT analysis set).
|
0.00%
0/50 • D/C/F/TAF Immediate Switch (IS1) and INI + TAF/FTC Delayed Switch (DS1): Baseline up to Week 24; D/C/F/TAF Immediate Switch (IS2) and INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25 up to Week 48
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (that is, ITT analysis set).
|
2.2%
1/46 • D/C/F/TAF Immediate Switch (IS1) and INI + TAF/FTC Delayed Switch (DS1): Baseline up to Week 24; D/C/F/TAF Immediate Switch (IS2) and INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25 up to Week 48
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (that is, ITT analysis set).
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/53 • D/C/F/TAF Immediate Switch (IS1) and INI + TAF/FTC Delayed Switch (DS1): Baseline up to Week 24; D/C/F/TAF Immediate Switch (IS2) and INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25 up to Week 48
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (that is, ITT analysis set).
|
0.00%
0/49 • D/C/F/TAF Immediate Switch (IS1) and INI + TAF/FTC Delayed Switch (DS1): Baseline up to Week 24; D/C/F/TAF Immediate Switch (IS2) and INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25 up to Week 48
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (that is, ITT analysis set).
|
2.0%
1/50 • D/C/F/TAF Immediate Switch (IS1) and INI + TAF/FTC Delayed Switch (DS1): Baseline up to Week 24; D/C/F/TAF Immediate Switch (IS2) and INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25 up to Week 48
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (that is, ITT analysis set).
|
0.00%
0/46 • D/C/F/TAF Immediate Switch (IS1) and INI + TAF/FTC Delayed Switch (DS1): Baseline up to Week 24; D/C/F/TAF Immediate Switch (IS2) and INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25 up to Week 48
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (that is, ITT analysis set).
|
|
Injury, poisoning and procedural complications
Upper Limb Fracture
|
1.9%
1/53 • D/C/F/TAF Immediate Switch (IS1) and INI + TAF/FTC Delayed Switch (DS1): Baseline up to Week 24; D/C/F/TAF Immediate Switch (IS2) and INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25 up to Week 48
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (that is, ITT analysis set).
|
0.00%
0/49 • D/C/F/TAF Immediate Switch (IS1) and INI + TAF/FTC Delayed Switch (DS1): Baseline up to Week 24; D/C/F/TAF Immediate Switch (IS2) and INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25 up to Week 48
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (that is, ITT analysis set).
|
0.00%
0/50 • D/C/F/TAF Immediate Switch (IS1) and INI + TAF/FTC Delayed Switch (DS1): Baseline up to Week 24; D/C/F/TAF Immediate Switch (IS2) and INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25 up to Week 48
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (that is, ITT analysis set).
|
0.00%
0/46 • D/C/F/TAF Immediate Switch (IS1) and INI + TAF/FTC Delayed Switch (DS1): Baseline up to Week 24; D/C/F/TAF Immediate Switch (IS2) and INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25 up to Week 48
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (that is, ITT analysis set).
|
|
Musculoskeletal and connective tissue disorders
Lumbar Spinal Stenosis
|
0.00%
0/53 • D/C/F/TAF Immediate Switch (IS1) and INI + TAF/FTC Delayed Switch (DS1): Baseline up to Week 24; D/C/F/TAF Immediate Switch (IS2) and INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25 up to Week 48
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (that is, ITT analysis set).
|
0.00%
0/49 • D/C/F/TAF Immediate Switch (IS1) and INI + TAF/FTC Delayed Switch (DS1): Baseline up to Week 24; D/C/F/TAF Immediate Switch (IS2) and INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25 up to Week 48
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (that is, ITT analysis set).
|
0.00%
0/50 • D/C/F/TAF Immediate Switch (IS1) and INI + TAF/FTC Delayed Switch (DS1): Baseline up to Week 24; D/C/F/TAF Immediate Switch (IS2) and INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25 up to Week 48
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (that is, ITT analysis set).
|
2.2%
1/46 • D/C/F/TAF Immediate Switch (IS1) and INI + TAF/FTC Delayed Switch (DS1): Baseline up to Week 24; D/C/F/TAF Immediate Switch (IS2) and INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25 up to Week 48
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (that is, ITT analysis set).
|
|
Nervous system disorders
Generalised Tonic-Clonic Seizure
|
0.00%
0/53 • D/C/F/TAF Immediate Switch (IS1) and INI + TAF/FTC Delayed Switch (DS1): Baseline up to Week 24; D/C/F/TAF Immediate Switch (IS2) and INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25 up to Week 48
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (that is, ITT analysis set).
|
2.0%
1/49 • D/C/F/TAF Immediate Switch (IS1) and INI + TAF/FTC Delayed Switch (DS1): Baseline up to Week 24; D/C/F/TAF Immediate Switch (IS2) and INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25 up to Week 48
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (that is, ITT analysis set).
|
0.00%
0/50 • D/C/F/TAF Immediate Switch (IS1) and INI + TAF/FTC Delayed Switch (DS1): Baseline up to Week 24; D/C/F/TAF Immediate Switch (IS2) and INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25 up to Week 48
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (that is, ITT analysis set).
|
0.00%
0/46 • D/C/F/TAF Immediate Switch (IS1) and INI + TAF/FTC Delayed Switch (DS1): Baseline up to Week 24; D/C/F/TAF Immediate Switch (IS2) and INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25 up to Week 48
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (that is, ITT analysis set).
|
|
Psychiatric disorders
Drug Abuse
|
0.00%
0/53 • D/C/F/TAF Immediate Switch (IS1) and INI + TAF/FTC Delayed Switch (DS1): Baseline up to Week 24; D/C/F/TAF Immediate Switch (IS2) and INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25 up to Week 48
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (that is, ITT analysis set).
|
0.00%
0/49 • D/C/F/TAF Immediate Switch (IS1) and INI + TAF/FTC Delayed Switch (DS1): Baseline up to Week 24; D/C/F/TAF Immediate Switch (IS2) and INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25 up to Week 48
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (that is, ITT analysis set).
|
2.0%
1/50 • D/C/F/TAF Immediate Switch (IS1) and INI + TAF/FTC Delayed Switch (DS1): Baseline up to Week 24; D/C/F/TAF Immediate Switch (IS2) and INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25 up to Week 48
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (that is, ITT analysis set).
|
0.00%
0/46 • D/C/F/TAF Immediate Switch (IS1) and INI + TAF/FTC Delayed Switch (DS1): Baseline up to Week 24; D/C/F/TAF Immediate Switch (IS2) and INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25 up to Week 48
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (that is, ITT analysis set).
|
|
Reproductive system and breast disorders
Abnormal Uterine Bleeding
|
0.00%
0/53 • D/C/F/TAF Immediate Switch (IS1) and INI + TAF/FTC Delayed Switch (DS1): Baseline up to Week 24; D/C/F/TAF Immediate Switch (IS2) and INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25 up to Week 48
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (that is, ITT analysis set).
|
0.00%
0/49 • D/C/F/TAF Immediate Switch (IS1) and INI + TAF/FTC Delayed Switch (DS1): Baseline up to Week 24; D/C/F/TAF Immediate Switch (IS2) and INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25 up to Week 48
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (that is, ITT analysis set).
|
2.0%
1/50 • D/C/F/TAF Immediate Switch (IS1) and INI + TAF/FTC Delayed Switch (DS1): Baseline up to Week 24; D/C/F/TAF Immediate Switch (IS2) and INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25 up to Week 48
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (that is, ITT analysis set).
|
0.00%
0/46 • D/C/F/TAF Immediate Switch (IS1) and INI + TAF/FTC Delayed Switch (DS1): Baseline up to Week 24; D/C/F/TAF Immediate Switch (IS2) and INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25 up to Week 48
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (that is, ITT analysis set).
|
Other adverse events
| Measure |
D/C/F/TAF Immediate Switch (IS1): Baseline-Week 24
n=53 participants at risk
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen switched to receive a fixed-dose combination (FDC) regimen of darunavir 800 milligrams (mg), cobicistat 150 mg, emtricitabine 200 mg, and tenofovir alafenamide 10 mg (D/C/F/TAF), once daily from Day 1 (baseline) up to Week 24.
|
D/C/F/TAF Immediate Switch (IS2): Week 25-48
n=49 participants at risk
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen switched to receive a fixed-dose combination (FDC) regimen of darunavir 800 milligrams (mg), cobicistat 150 mg, emtricitabine 200 mg, and tenofovir alafenamide 10 mg (D/C/F/TAF), once daily from Day 25 up to Week 48.
|
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24
n=50 participants at risk
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen continued to receive baseline integrase (INI) inhibitor along with tenofovir alafenamide 10 mg, emtricitabine 200 mg (TAF/FTC) antiretroviral (ARV) regimen from Day 1 (baseline) up to Week 24 per prescribing information (delayed switch 1 \[DS1\]).
|
INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25-Week 48
n=46 participants at risk
Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen, after Week 24 switched to receive D/C/F/TAF FDC once daily from Week 25 to Week 48 (DS2).
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
5.7%
3/53 • D/C/F/TAF Immediate Switch (IS1) and INI + TAF/FTC Delayed Switch (DS1): Baseline up to Week 24; D/C/F/TAF Immediate Switch (IS2) and INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25 up to Week 48
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (that is, ITT analysis set).
|
0.00%
0/49 • D/C/F/TAF Immediate Switch (IS1) and INI + TAF/FTC Delayed Switch (DS1): Baseline up to Week 24; D/C/F/TAF Immediate Switch (IS2) and INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25 up to Week 48
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (that is, ITT analysis set).
|
2.0%
1/50 • D/C/F/TAF Immediate Switch (IS1) and INI + TAF/FTC Delayed Switch (DS1): Baseline up to Week 24; D/C/F/TAF Immediate Switch (IS2) and INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25 up to Week 48
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (that is, ITT analysis set).
|
10.9%
5/46 • D/C/F/TAF Immediate Switch (IS1) and INI + TAF/FTC Delayed Switch (DS1): Baseline up to Week 24; D/C/F/TAF Immediate Switch (IS2) and INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25 up to Week 48
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (that is, ITT analysis set).
|
|
Gastrointestinal disorders
Nausea
|
5.7%
3/53 • D/C/F/TAF Immediate Switch (IS1) and INI + TAF/FTC Delayed Switch (DS1): Baseline up to Week 24; D/C/F/TAF Immediate Switch (IS2) and INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25 up to Week 48
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (that is, ITT analysis set).
|
0.00%
0/49 • D/C/F/TAF Immediate Switch (IS1) and INI + TAF/FTC Delayed Switch (DS1): Baseline up to Week 24; D/C/F/TAF Immediate Switch (IS2) and INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25 up to Week 48
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (that is, ITT analysis set).
|
2.0%
1/50 • D/C/F/TAF Immediate Switch (IS1) and INI + TAF/FTC Delayed Switch (DS1): Baseline up to Week 24; D/C/F/TAF Immediate Switch (IS2) and INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25 up to Week 48
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (that is, ITT analysis set).
|
6.5%
3/46 • D/C/F/TAF Immediate Switch (IS1) and INI + TAF/FTC Delayed Switch (DS1): Baseline up to Week 24; D/C/F/TAF Immediate Switch (IS2) and INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25 up to Week 48
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (that is, ITT analysis set).
|
|
General disorders
Oedema Peripheral
|
0.00%
0/53 • D/C/F/TAF Immediate Switch (IS1) and INI + TAF/FTC Delayed Switch (DS1): Baseline up to Week 24; D/C/F/TAF Immediate Switch (IS2) and INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25 up to Week 48
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (that is, ITT analysis set).
|
0.00%
0/49 • D/C/F/TAF Immediate Switch (IS1) and INI + TAF/FTC Delayed Switch (DS1): Baseline up to Week 24; D/C/F/TAF Immediate Switch (IS2) and INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25 up to Week 48
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (that is, ITT analysis set).
|
4.0%
2/50 • D/C/F/TAF Immediate Switch (IS1) and INI + TAF/FTC Delayed Switch (DS1): Baseline up to Week 24; D/C/F/TAF Immediate Switch (IS2) and INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25 up to Week 48
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (that is, ITT analysis set).
|
6.5%
3/46 • D/C/F/TAF Immediate Switch (IS1) and INI + TAF/FTC Delayed Switch (DS1): Baseline up to Week 24; D/C/F/TAF Immediate Switch (IS2) and INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25 up to Week 48
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (that is, ITT analysis set).
|
|
Infections and infestations
COVID-19
|
11.3%
6/53 • D/C/F/TAF Immediate Switch (IS1) and INI + TAF/FTC Delayed Switch (DS1): Baseline up to Week 24; D/C/F/TAF Immediate Switch (IS2) and INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25 up to Week 48
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (that is, ITT analysis set).
|
6.1%
3/49 • D/C/F/TAF Immediate Switch (IS1) and INI + TAF/FTC Delayed Switch (DS1): Baseline up to Week 24; D/C/F/TAF Immediate Switch (IS2) and INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25 up to Week 48
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (that is, ITT analysis set).
|
4.0%
2/50 • D/C/F/TAF Immediate Switch (IS1) and INI + TAF/FTC Delayed Switch (DS1): Baseline up to Week 24; D/C/F/TAF Immediate Switch (IS2) and INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25 up to Week 48
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (that is, ITT analysis set).
|
2.2%
1/46 • D/C/F/TAF Immediate Switch (IS1) and INI + TAF/FTC Delayed Switch (DS1): Baseline up to Week 24; D/C/F/TAF Immediate Switch (IS2) and INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25 up to Week 48
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (that is, ITT analysis set).
|
|
Infections and infestations
Proctitis Gonococcal
|
0.00%
0/53 • D/C/F/TAF Immediate Switch (IS1) and INI + TAF/FTC Delayed Switch (DS1): Baseline up to Week 24; D/C/F/TAF Immediate Switch (IS2) and INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25 up to Week 48
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (that is, ITT analysis set).
|
6.1%
3/49 • D/C/F/TAF Immediate Switch (IS1) and INI + TAF/FTC Delayed Switch (DS1): Baseline up to Week 24; D/C/F/TAF Immediate Switch (IS2) and INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25 up to Week 48
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (that is, ITT analysis set).
|
2.0%
1/50 • D/C/F/TAF Immediate Switch (IS1) and INI + TAF/FTC Delayed Switch (DS1): Baseline up to Week 24; D/C/F/TAF Immediate Switch (IS2) and INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25 up to Week 48
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (that is, ITT analysis set).
|
2.2%
1/46 • D/C/F/TAF Immediate Switch (IS1) and INI + TAF/FTC Delayed Switch (DS1): Baseline up to Week 24; D/C/F/TAF Immediate Switch (IS2) and INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25 up to Week 48
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (that is, ITT analysis set).
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/53 • D/C/F/TAF Immediate Switch (IS1) and INI + TAF/FTC Delayed Switch (DS1): Baseline up to Week 24; D/C/F/TAF Immediate Switch (IS2) and INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25 up to Week 48
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (that is, ITT analysis set).
|
2.0%
1/49 • D/C/F/TAF Immediate Switch (IS1) and INI + TAF/FTC Delayed Switch (DS1): Baseline up to Week 24; D/C/F/TAF Immediate Switch (IS2) and INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25 up to Week 48
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (that is, ITT analysis set).
|
6.0%
3/50 • D/C/F/TAF Immediate Switch (IS1) and INI + TAF/FTC Delayed Switch (DS1): Baseline up to Week 24; D/C/F/TAF Immediate Switch (IS2) and INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25 up to Week 48
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (that is, ITT analysis set).
|
4.3%
2/46 • D/C/F/TAF Immediate Switch (IS1) and INI + TAF/FTC Delayed Switch (DS1): Baseline up to Week 24; D/C/F/TAF Immediate Switch (IS2) and INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25 up to Week 48
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (that is, ITT analysis set).
|
|
Vascular disorders
Hypertension
|
1.9%
1/53 • D/C/F/TAF Immediate Switch (IS1) and INI + TAF/FTC Delayed Switch (DS1): Baseline up to Week 24; D/C/F/TAF Immediate Switch (IS2) and INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25 up to Week 48
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (that is, ITT analysis set).
|
2.0%
1/49 • D/C/F/TAF Immediate Switch (IS1) and INI + TAF/FTC Delayed Switch (DS1): Baseline up to Week 24; D/C/F/TAF Immediate Switch (IS2) and INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25 up to Week 48
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (that is, ITT analysis set).
|
12.0%
6/50 • D/C/F/TAF Immediate Switch (IS1) and INI + TAF/FTC Delayed Switch (DS1): Baseline up to Week 24; D/C/F/TAF Immediate Switch (IS2) and INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25 up to Week 48
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (that is, ITT analysis set).
|
0.00%
0/46 • D/C/F/TAF Immediate Switch (IS1) and INI + TAF/FTC Delayed Switch (DS1): Baseline up to Week 24; D/C/F/TAF Immediate Switch (IS2) and INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25 up to Week 48
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (that is, ITT analysis set).
|
Additional Information
Vice President Medical Affairs Infectious Disease and Vaccines (IDV)
Janssen Scientific Affairs, LLC
Phone: 844-434-4210
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days to allow for filing of a patent application.
- Publication restrictions are in place
Restriction type: OTHER