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Trial record 1 of 1 for:    TANGO dolutegravir
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Switch Study to Evaluate Dolutegravir Plus Lamivudine in Virologically Suppressed Human Immunodeficiency Virus Type 1 Positive Adults (TANGO)

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ClinicalTrials.gov Identifier: NCT03446573
Recruitment Status : Active, not recruiting
First Posted : February 27, 2018
Results First Posted : May 4, 2020
Last Update Posted : June 2, 2020
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
ViiV Healthcare

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition HIV Infections
Interventions Drug: DTG + 3TC
Drug: TAF based regimen (TBR)
Enrollment 743
Recruitment Details This non-inferiority study evaluated antiviral activity of switching to dolutegravir (DTG) + lamivudine (3TC) fixed dose combination (FDC) once daily compared to continuation of a Tenofovir alafenamide (TAF)-based regimen (TBR) over 48 weeks in virologically suppressed participants with human immunodeficiency type 1 infection.
Pre-assignment Details 743 participants were enrolled, of which two participants did not receive treatment and hence 741 participants received at least one treatment into the study. The results presented are based on Week 48 primary analysis.
Arm/Group Title DTG+3TC FDC TAF-based Regimen
Hide Arm/Group Description Participants who were on a stable TBR and who had an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at the time of screening, received fixed dose combination of DTG 50 milligrams (mg) + 3TC 300 mg once daily up to 48 weeks. Participants who were on a stable TBR and who had an HIV-1 RNA<50 c/mL at the time of screening, were continued to receive TBR up to 48 weeks. One participant randomized to the this arm received TDF rather than TAF-and was presented within the "TAF-based regimen" arm for efficacy because the efficacy of TAF and TDF are comparable. However the participant was presented separately under "TDF-based regimen" for Safety because the safety profiles of TDF and TAF differ.
Period Title: Overall Study
Started 369 372
Completed 0 0
Not Completed 369 372
Reason Not Completed
Withdrawal by Subject             7             16
Physician Decision             1             1
Lost to Follow-up             3             5
Protocol Violation             3             2
Lack of Efficacy             0             3
Adverse Event             13             2
Ongoing at the time of interim analysis             342             343
Arm/Group Title DTG+3TC FDC TAF-based Regimen Total
Hide Arm/Group Description Participants who were on a stable TBR and who had an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at the time of screening, received fixed dose combination of DTG 50 milligrams (mg) + 3TC 300 mg once daily up to 48 weeks. Participants who were on a stable TBR and who had an HIV-1 RNA<50 c/mL at the time of screening, were continued to receive TBR up to 48 weeks. One participant randomized to the this arm received TDF rather than TAF-and was presented within the "TAF-based regimen" arm for efficacy because the efficacy of TAF and TDF are comparable. However the participant was presented separately under "TDF-based regimen" for Safety because the safety profiles of TDF and TAF differ. Total of all reporting groups
Overall Number of Baseline Participants 369 372 741
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 369 participants 372 participants 741 participants
40.6  (10.76) 40.9  (11.54) 40.8  (11.15)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 369 participants 372 participants 741 participants
Female
25
   6.8%
33
   8.9%
58
   7.8%
Male
344
  93.2%
339
  91.1%
683
  92.2%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 369 participants 372 participants 741 participants
American Indian or Alaska Native
7
   1.9%
8
   2.2%
15
   2.0%
Asian-Central/South Asian Heritage (H)
3
   0.8%
4
   1.1%
7
   0.9%
Asian-Japanese H/East Asian H/South East Asian H
10
   2.7%
9
   2.4%
19
   2.6%
Black or African American
50
  13.6%
58
  15.6%
108
  14.6%
Native Hawaiian or other Pacific Islander
1
   0.3%
3
   0.8%
4
   0.5%
White-Arabic/North African (NA) H
5
   1.4%
2
   0.5%
7
   0.9%
White-Arabic/NA H and white/caucasia/European H
0
   0.0%
1
   0.3%
1
   0.1%
White-White/caucasian/European H
292
  79.1%
286
  76.9%
578
  78.0%
Asian and White
0
   0.0%
1
   0.3%
1
   0.1%
Black or African American and White
1
   0.3%
0
   0.0%
1
   0.1%
Cluster of differentiation 4 plus (CD4+) cell count   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Cells per cubic millimeter (cells/mm^3)
Number Analyzed 369 participants 372 participants 741 participants
682.0
(492.0 to 862.0)
720.0
(531.5 to 901.5)
688.0
(514.0 to 885.0)
[1]
Measure Description: Blood samples were collected to evaluate Baseline CD4+ cell count using flow cytometry. Median along with first and third quartiles are presented for Baseline CD4+ count.
Baseline third agents   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 369 participants 372 participants 741 participants
NNRTI
51
  13.8%
48
  12.9%
99
  13.4%
INSTI
289
  78.3%
296
  79.6%
585
  78.9%
PI
29
   7.9%
28
   7.5%
57
   7.7%
[1]
Measure Description: Blood samples were collected to evaluate Baseline third agents including non-nucleoside reverse transcriptase inhibitors (NNRTI), integrase strand transfer inhibitors (INSTI) and protease inhibitors (PI) based on the antiretroviral medications taken at Baseline.
HIV infection by Centers for Disease Control and Prevention (CDC) classification   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 369 participants 372 participants 741 participants
HIV infection Stage 1
255
  69.1%
259
  69.6%
514
  69.4%
HIV infection Stage 2
94
  25.5%
94
  25.3%
188
  25.4%
HIV infection Stage 3
20
   5.4%
19
   5.1%
39
   5.3%
[1]
Measure Description: CDC classification for human immunodeficiency (HIV) were: Stage 1: No acquired immuno deficiency syndrome (AIDS) defining condition and CD4+ T-lymphocyte count: >=500 cells per microliter (cells/mcL); Stage 2: No AIDS infection and CD4+ lymphocyte count: 200-499 cell/mcL and Stage 3: with HIV infection and CD4+ T-lymphocye count <200 cells/mcL.
1.Primary Outcome
Title Percentage of Participants With Virologic Failure Endpoint as Per Food and Drug Administration (FDA) Snapshot Category at Week 48
Hide Description Percentage of participants with virologic failure (plasma HIV-1 RNA >=50 c/mL) was evaluated using FDA snapshot algorithm at Week 48. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant antiretroviral therapy (ART) prior to the visit of interest. Intent-to-treat exposed (ITT-E) Population comprises of all randomized participants who receive at least one dose of study treatment either DTG + 3TC or TBR. Participants were assessed according to the treatment to which the participant was randomized. Any participant receiving a treatment randomization number was considered to be randomized.
Time Frame Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population. One participant randomized to TBR but received TDF-based regimen and was presented within the "TBR (TAF-based regimen) arm" as efficacy of TAF and TDF are comparable.
Arm/Group Title DTG+3TC FDC TAF-based Regimen
Hide Arm/Group Description:
Participants who were on a stable TBR and who had an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at the time of screening, received fixed dose combination of DTG 50 milligrams (mg) + 3TC 300 mg once daily up to 48 weeks.
Participants who were on a stable TBR and who had an HIV-1 RNA<50 c/mL at the time of screening, were continued to receive TBR up to 48 weeks. One participant randomized to the this arm received TDF rather than TAF-and was presented within the "TAF-based regimen" arm for efficacy because the efficacy of TAF and TDF are comparable. However the participant was presented separately under "TDF-based regimen" for Safety because the safety profiles of TDF and TAF differ.
Overall Number of Participants Analyzed 369 372
Measure Type: Number
Unit of Measure: Percentage of participants
0.3 0.5
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DTG+3TC FDC, TAF-based Regimen
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments Non-inferiority of switching to DTG + 3TC compared to continuation of TBR (as per FDA snapshot algorithm) was to be concluded if the upper bound of a two-sided 95% confidence interval (CI) for the difference in virologic failure rates between the two treatment arms was smaller than 4%.
Method of Estimation Estimation Parameter Adjusted difference in proportion (ADP)
Estimated Value -0.3
Confidence Interval (2-Sided) 95%
-1.2 to 0.7
Estimation Comments ADP was based on Cochran-Mantel Haenszel stratified analysis adjusting for Baseline stratification factor:Baseline third agent (protease inhibitor [PI], non-nucleoside reverse transcriptase inhibitor [NNRTI], and integrase inhibitor [INI]).
2.Secondary Outcome
Title Percentage of Participants With Plasma HIV-1 RNA <50 c/mL as Per Snapshot Algorithm at Week 48
Hide Description Percentage of participants with plasma HIV-1 RNA <50 c/mL (virologic success) was evaluated using FDA snapshot algorithm at Week 48 to demonstrate the non-inferior antiviral activity of switching to DTG +3TC once daily compared to continuation of TBR over 48 weeks. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant ART prior to the visit of interest.
Time Frame Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population. Only those participants with data available at specified time points has been analyzed. One participant randomized to TBR but received TDF-based regimen and was presented within the "TBR (TAF-based regimen) arm" as efficacy of TAF and TDF are comparable.
Arm/Group Title DTG+3TC FDC TAF-based Regimen
Hide Arm/Group Description:
Participants who were on a stable TBR and who had an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at the time of screening, received fixed dose combination of DTG 50 milligrams (mg) + 3TC 300 mg once daily up to 48 weeks.
Participants who were on a stable TBR and who had an HIV-1 RNA<50 c/mL at the time of screening, were continued to receive TBR up to 48 weeks. One participant randomized to the this arm received TDF rather than TAF-and was presented within the "TAF-based regimen" arm for efficacy because the efficacy of TAF and TDF are comparable. However the participant was presented separately under "TDF-based regimen" for Safety because the safety profiles of TDF and TAF differ.
Overall Number of Participants Analyzed 344 346
Measure Type: Number
Unit of Measure: Percentage of participants
93.2 93.0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DTG+3TC FDC, TAF-based Regimen
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments Non-inferiority of switching to DTG + 3TC compared to continuation of TBR (as per FDA snapshot algorithm) was to be concluded when the lower bound of a 2-sided 95% confidence interval for the difference in success rates between the two treatment arms was greater than -8%.
Method of Estimation Estimation Parameter Adjusted difference in proportion
Estimated Value 0.2
Confidence Interval (2-Sided) 95%
-3.4 to 3.9
Estimation Comments ADP was based on Cochran-Mantel Haenszel stratified analysis adjusting for Baseline stratification factor: Baseline third agent (PI, NNRTI, and INSTI).
3.Secondary Outcome
Title Percentage of Participants With Virologic Failure Endpoint as Per FDA Snapshot Category at Week 24
Hide Description Percentage of participants with plasma HIV-1 RNA >=50 c/mL was evaluated using FDA snapshot algorithm at Week 24. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant ART prior to the visit of interest.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population. One participant randomized to TBR but received TDF-based regimen and was presented within the "TBR (TAF-based regimen) arm" as efficacy of TAF and TDF are comparable.
Arm/Group Title DTG+3TC FDC TAF-based Regimen
Hide Arm/Group Description:
Participants who were on a stable TBR and who had an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at the time of screening, received fixed dose combination of DTG 50 milligrams (mg) + 3TC 300 mg once daily up to 48 weeks.
Participants who were on a stable TBR and who had an HIV-1 RNA<50 c/mL at the time of screening, were continued to receive TBR up to 48 weeks. One participant randomized to the this arm received TDF rather than TAF-and was presented within the "TAF-based regimen" arm for efficacy because the efficacy of TAF and TDF are comparable. However the participant was presented separately under "TDF-based regimen" for Safety because the safety profiles of TDF and TAF differ.
Overall Number of Participants Analyzed 369 372
Measure Type: Number
Unit of Measure: Percentage of participants
0.3 0.8
4.Secondary Outcome
Title Percentage of Participants With Plasma HIV-1 RNA <50 c/mL as Per Snapshot Algorithm at Week 24
Hide Description Percentage of participants with plasma HIV-1 RNA <50 c/mL was evaluated using FDA snapshot algorithm at Week 24. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant ART prior to the visit of interest.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population. Only those participants with data available at specified time points has been presented. One participant randomized to TBR but received TDF-based regimen and was presented within the "TBR (TAF-based regimen) arm" as efficacy of TAF and TDF are comparable.
Arm/Group Title DTG+3TC FDC TAF-based Regimen
Hide Arm/Group Description:
Participants who were on a stable TBR and who had an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at the time of screening, received fixed dose combination of DTG 50 milligrams (mg) + 3TC 300 mg once daily up to 48 weeks.
Participants who were on a stable TBR and who had an HIV-1 RNA<50 c/mL at the time of screening, were continued to receive TBR up to 48 weeks. One participant randomized to the this arm received TDF rather than TAF-and was presented within the "TAF-based regimen" arm for efficacy because the efficacy of TAF and TDF are comparable. However the participant was presented separately under "TDF-based regimen" for Safety because the safety profiles of TDF and TAF differ.
Overall Number of Participants Analyzed 350 358
Measure Type: Number
Unit of Measure: Percentage of participants
95 96
5.Secondary Outcome
Title Change From Baseline in CD4+ Cell Count at Weeks 24 and 48
Hide Description CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+. It was evaluated by flow cytometry. Baseline value is defined as the latest pre-dose assessment with a non-missing value (Day 1). Change from Baseline is defined as post-dose visit value minus Baseline value. One participant randomized to TBR but received TDF-based regimen and was presented within the "TBR (TAF-based regimen) arm" as efficacy of TAF and TDF are comparable.
Time Frame Baseline (Day 1) and at Weeks 24 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population. All 741 (369+372) participants were analyzed, however only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Arm/Group Title DTG+3TC FDC TAF-based Regimen
Hide Arm/Group Description:
Participants who were on a stable TBR and who had an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at the time of screening, received fixed dose combination of DTG 50 milligrams (mg) + 3TC 300 mg once daily up to 48 weeks.
Participants who were on a stable TBR and who had an HIV-1 RNA<50 c/mL at the time of screening, were continued to receive TBR up to 48 weeks. One participant randomized to the this arm received TDF rather than TAF-and was presented within the "TAF-based regimen" arm for efficacy because the efficacy of TAF and TDF are comparable. However the participant was presented separately under "TDF-based regimen" for Safety because the safety profiles of TDF and TAF differ.
Overall Number of Participants Analyzed 369 372
Median (Inter-Quartile Range)
Unit of Measure: Cells per cubic millimeter
Week 24, n=351, 359 Number Analyzed 351 participants 359 participants
21.0
(-68.0 to 115.0)
6.0
(-87.0 to 99.0)
Week 48, n=344, 345 Number Analyzed 344 participants 345 participants
22.5
(-71.0 to 121.5)
11.0
(-98.0 to 90.0)
6.Secondary Outcome
Title Change From Baseline in CD4+/CD8+ Cell Count Ratio at Weeks 24 and 48
Hide Description Blood samples were collected at specified time points to assess CD4+/CD8+ cell count ratio. It was assessed by flow cyclometry to evaluate the immunologic activity of switching to DTG+3TC once daily compared to continuation of TBR over 48 Weeks. Baseline (Day 1) values were the actual CD4+ cell count ratio values at pre-dose Day 1. Change from Baseline is defined as post-dose visit value minus Baseline value. One participant randomized to TBR but received TDF-based regimen and was presented within the "TBR (TAF-based regimen) arm" as efficacy of TAF and TDF are comparable .
Time Frame Baseline (Day 1) and at Weeks 24 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population. All 741 (369+372) participants were analyzed, however only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Arm/Group Title DTG+3TC FDC TAF-based Regimen
Hide Arm/Group Description:
Participants who were on a stable TBR and who had an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at the time of screening, received fixed dose combination of DTG 50 milligrams (mg) + 3TC 300 mg once daily up to 48 weeks.
Participants who were on a stable TBR and who had an HIV-1 RNA<50 c/mL at the time of screening, were continued to receive TBR up to 48 weeks. One participant randomized to the this arm received TDF rather than TAF-and was presented within the "TAF-based regimen" arm for efficacy because the efficacy of TAF and TDF are comparable. However the participant was presented separately under "TDF-based regimen" for Safety because the safety profiles of TDF and TAF differ.
Overall Number of Participants Analyzed 369 372
Median (Inter-Quartile Range)
Unit of Measure: Ratio
Baseline (Day 1), n=366, 371 Number Analyzed 366 participants 371 participants
0.950
(0.710 to 1.250)
0.960
(0.730 to 1.310)
Week 24, n=346, 358 Number Analyzed 346 participants 358 participants
0.010
(-0.070 to 0.110)
0.040
(-0.060 to 0.120)
Week 48, n=342, 343 Number Analyzed 342 participants 343 participants
0.030
(-0.050 to 0.110)
0.050
(-0.050 to 0.160)
7.Secondary Outcome
Title Number of Participants With Disease Progression at Weeks 24 and 48
Hide Description HIV-associated conditions were recorded during the study and was assessed according to the 2014 CDC Classification System for HIV Infection in Adults. CDC classification for HIV were: Stage 1: No AIDS defining condition and CD4+ T-lymphocyte count: >=500 cells/mcL; Stage 2: No AIDS infection and CD4+ lymphocyte count: 200-499 cell/mcL and Stage 3: with HIV infection and CD4+ T-lymphocye count <200 cells/mcL. Disease progression summarize participants who had HIV infection stage 3 associated conditions or death. Indicators of clinical disease progression were defined as: CDC Category Stage 1 at enrolment to Stage 3 event; CDC Category Stage 2 at enrolment to Stage 3 event; CDC Category Stage 3 at enrolment to New Stage 3 Event; CDC Category Stage 1, 2 or 3 at enrolment to Death.
Time Frame At Weeks 24 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population. One participant randomized to TBR but received TDF-based regimen and was presented within the "TBR (TAF-based regimen) arm" as efficacy of TAF and TDF are comparable
Arm/Group Title DTG+3TC FDC TAF-based Regimen
Hide Arm/Group Description:
Participants who were on a stable TBR and who had an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at the time of screening, received fixed dose combination of DTG 50 milligrams (mg) + 3TC 300 mg once daily up to 48 weeks.
Participants who were on a stable TBR and who had an HIV-1 RNA<50 c/mL at the time of screening, were continued to receive TBR up to 48 weeks. One participant randomized to the this arm received TDF rather than TAF-and was presented within the "TAF-based regimen" arm for efficacy because the efficacy of TAF and TDF are comparable. However the participant was presented separately under "TDF-based regimen" for Safety because the safety profiles of TDF and TAF differ.
Overall Number of Participants Analyzed 369 372
Measure Type: Count of Participants
Unit of Measure: Participants
From CDC Stage 1 to CDC Stage 3 Event
1
   0.3%
0
   0.0%
From CDC Stage 2 to CDC Stage 3 Event
0
   0.0%
0
   0.0%
From CDC Stage 3 to new CDC Stage 3 Event
0
   0.0%
0
   0.0%
From CDC Stage 1, 2 or 3 to Death
1
   0.3%
0
   0.0%
No HIV-1 disease progression
367
  99.5%
372
 100.0%
8.Secondary Outcome
Title Number of Participants With Any Serious Adverse Events (SAEs) and Common (>=2%) Non-serious Adverse Events (Non-SAEs)
Hide Description An AE is any untoward medical occurrence temporally associated with the use of a study treatment, whether or not considered related to study treatment. A SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, associated with liver injury and impaired liver function or any other situations as per medical or scientific judgment. Safety Population included all participants who received at least one dose of study treatment either DTG + 3TC or TBR. This population was based on the treatment the participant actually received. Number of participants with any SAE and common (>=2%) non-SAEs are presented.
Time Frame Up to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."
Arm/Group Title DTG+3TC FDC TAF-based Regimen
Hide Arm/Group Description:
Participants who were on a stable TBR and who had an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at the time of screening, received fixed dose combination of DTG 50 milligrams (mg) + 3TC 300 mg once daily up to 48 weeks.
Participants who were on a stable TBR and who had an HIV-1 RNA<50 c/mL at the time of screening, were continued to receive TBR up to 48 weeks. One participant randomized to the this arm received TDF rather than TAF-and was presented within the "TAF-based regimen" arm for efficacy because the efficacy of TAF and TDF are comparable. However the participant was presented separately under "TDF-based regimen" for Safety because the safety profiles of TDF and TAF differ.
Overall Number of Participants Analyzed 369 371
Measure Type: Count of Participants
Unit of Measure: Participants
Any non-SAE (>=2%)
222
  60.2%
204
  55.0%
Any SAE
21
   5.7%
16
   4.3%
9.Secondary Outcome
Title Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Any SAEs and Common (>=2%) Non-SAEs
Hide Description An AE is any untoward medical occurrence temporally associated with the use of a study treatment, whether or not considered related to study treatment. A SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, associated with liver injury and impaired liver function or any other situations as per medical or scientific judgment. Number of TDF-based regimen participants with any SAE and common (>=2%) non-SAEs are presented.
Time Frame Up to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."
Arm/Group Title Randomized to TBR But Received TDF-based Regimen
Hide Arm/Group Description:
Participant randomized to TBR arm who had HIV-1 RNA <50 c/mL at the time of screening, received TDF-based regimen instead of TAF-based regimen in error. Participant continued to receive TDF-regimen up to the Week 48 visit (participant withdrew from the study at Week 36)
Overall Number of Participants Analyzed 1
Measure Type: Count of Participants
Unit of Measure: Participants
Any non-SAE (>=2%)
1
 100.0%
Any SAE
0
   0.0%
10.Secondary Outcome
Title Number of Participants With AEs by Their Severity Grades
Hide Description An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Adverse events were evaluated by the investigator and graded according to the Division of Acquired Immunodeficiency Syndrome (DAIDS) toxicity scales from Grade 1 to 5 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening, 5=Death). The higher the grade, the more severe the symptoms. Number of participants with adverse events by maximum grade have been presented.
Time Frame Up to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."
Arm/Group Title DTG+3TC FDC TAF-based Regimen
Hide Arm/Group Description:
Participants who were on a stable TBR and who had an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at the time of screening, received fixed dose combination of DTG 50 milligrams (mg) + 3TC 300 mg once daily up to 48 weeks.
Participants who were on a stable TBR and who had an HIV-1 RNA<50 c/mL at the time of screening, were continued to receive TBR up to 48 weeks. One participant randomized to the this arm received TDF rather than TAF-and was presented within the "TAF-based regimen" arm for efficacy because the efficacy of TAF and TDF are comparable. However the participant was presented separately under "TDF-based regimen" for Safety because the safety profiles of TDF and TAF differ.
Overall Number of Participants Analyzed 369 371
Measure Type: Count of Participants
Unit of Measure: Participants
Grade 1
102
  27.6%
94
  25.3%
Grade 2
170
  46.1%
177
  47.7%
Grade 3
19
   5.1%
15
   4.0%
Grade 4
3
   0.8%
6
   1.6%
Grade 5
1
   0.3%
0
   0.0%
11.Secondary Outcome
Title Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With AEs by Their Severity Grades
Hide Description An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Adverse events were evaluated by the investigator and graded according to the DAIDS toxicity scales from Grade 1 to 5 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening, 5=Death). The higher the grade, the more severe the symptoms. Number of TDF-based regimen participants with adverse events by maximum grade have been presented.
Time Frame Up to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."
Arm/Group Title Randomized to TBR But Received TDF-based Regimen
Hide Arm/Group Description:
Participant randomized to TBR arm who had HIV-1 RNA <50 c/mL at the time of screening, received TDF-based regimen instead of TAF-based regimen in error. Participant continued to receive TDF-regimen up to the Week 48 visit (participant withdrew from the study at Week 36)
Overall Number of Participants Analyzed 1
Measure Type: Count of Participants
Unit of Measure: Participants
Grade 1
0
   0.0%
Grade 2
1
 100.0%
Grade 3
0
   0.0%
Grade 4
0
   0.0%
Grade 5
0
   0.0%
12.Secondary Outcome
Title Number of Participants Who Discontinued the Treatment Due to AEs
Hide Description An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Number of participants who discontinued the treatment due to adverse events have been presented.
Time Frame Up to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."
Arm/Group Title DTG+3TC FDC TAF-based Regimen
Hide Arm/Group Description:
Participants who were on a stable TBR and who had an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at the time of screening, received fixed dose combination of DTG 50 milligrams (mg) + 3TC 300 mg once daily up to 48 weeks.
Participants who were on a stable TBR and who had an HIV-1 RNA<50 c/mL at the time of screening, were continued to receive TBR up to 48 weeks. One participant randomized to the this arm received TDF rather than TAF-and was presented within the "TAF-based regimen" arm for efficacy because the efficacy of TAF and TDF are comparable. However the participant was presented separately under "TDF-based regimen" for Safety because the safety profiles of TDF and TAF differ.
Overall Number of Participants Analyzed 369 371
Measure Type: Count of Participants
Unit of Measure: Participants
13
   3.5%
2
   0.5%
13.Secondary Outcome
Title Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen Who Discontinued the Treatment Due to AEs
Hide Description An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Number of participants who discontinued the treatment due to adverse events have been presented.
Time Frame Up to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."
Arm/Group Title Randomized to TBR But Received TDF-based Regimen
Hide Arm/Group Description:
Participant randomized to TBR arm who had HIV-1 RNA <50 c/mL at the time of screening, received TDF-based regimen instead of TAF-based regimen in error. Participant continued to receive TDF-regimen up to the Week 48 visit (participant withdrew from the study at Week 36).
Overall Number of Participants Analyzed 1
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
14.Secondary Outcome
Title Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities
Hide Description Blood samples were collected up to Week 48 for the analysis of hematology parameters-platelet count, neutrophils, hemoglobin and leukocytes. Any abnormality in hematology parameters were evaluated according to the DAIDS toxicity scale from Grade 1 to 4: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening). The higher the grade, the more severe the symptoms. Only those participants with maximum post-Baseline emergent hematology toxicities in any of the hematology parameters have been presented.
Time Frame Up to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."
Arm/Group Title DTG+3TC FDC TAF-based Regimen
Hide Arm/Group Description:
Participants who were on a stable TBR and who had an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at the time of screening, received fixed dose combination of DTG 50 milligrams (mg) + 3TC 300 mg once daily up to 48 weeks.
Participants who were on a stable TBR and who had an HIV-1 RNA<50 c/mL at the time of screening, were continued to receive TBR up to 48 weeks. One participant randomized to the this arm received TDF rather than TAF-and was presented within the "TAF-based regimen" arm for efficacy because the efficacy of TAF and TDF are comparable. However the participant was presented separately under "TDF-based regimen" for Safety because the safety profiles of TDF and TAF differ.
Overall Number of Participants Analyzed 369 371
Measure Type: Count of Participants
Unit of Measure: Participants
Hemoglobin, Grade 1
3
   0.8%
0
   0.0%
Hemoglobin, Grade 2
0
   0.0%
0
   0.0%
Hemoglobin, Grade 3
0
   0.0%
0
   0.0%
Hemoglobin, Grade 4
0
   0.0%
0
   0.0%
Leukocytes, Grade 1
1
   0.3%
1
   0.3%
Leukocytes, Grade 2
1
   0.3%
0
   0.0%
Leukocytes, Grade 3
0
   0.0%
0
   0.0%
Leukocytes, Grade 4
0
   0.0%
0
   0.0%
Neutrophils, Grade 1
3
   0.8%
4
   1.1%
Neutrophils, Grade 2
2
   0.5%
4
   1.1%
Neutrophils, Grade 3
0
   0.0%
0
   0.0%
Neutrophils, Grade 4
1
   0.3%
0
   0.0%
Platelets, Grade 1
6
   1.6%
5
   1.3%
Platelets, Grade 2
1
   0.3%
1
   0.3%
Platelets, Grade 3
0
   0.0%
0
   0.0%
Platelets, Grade 4
0
   0.0%
0
   0.0%
15.Secondary Outcome
Title Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Hematology Toxicities
Hide Description Blood samples were collected up to the Week 36 visit for the analysis of hematology parameters-platelet count, neutrophils, hemoglobin and leukocytes. Any abnormality in hematology parameters were evaluated according to the DAIDS toxicity scale from Grade 1 to 4: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening). The higher the grade, the more severe the symptoms. Only those TDF-based regimen participants with maximum post-Baseline emergent hematology toxicities in any of the hematology parameters have been presented.
Time Frame Up to Week 36
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."
Arm/Group Title Randomized to TBR But Received TDF-based Regimen
Hide Arm/Group Description:
Participant randomized to TBR arm who had HIV-1 RNA <50 c/mL at the time of screening, received TDF-based regimen instead of TAF-based regimen in error. Participant continued to receive TDF-regimen up to the Week 48 visit (participant withdrew from the study at Week 36).
Overall Number of Participants Analyzed 1
Measure Type: Count of Participants
Unit of Measure: Participants
Hemoglobin, Grade 1
0
   0.0%
Hemoglobin, Grade 2
0
   0.0%
Hemoglobin, Grade 3
0
   0.0%
Hemoglobin, Grade 4
0
   0.0%
Leukocytes, Grade 1
0
   0.0%
Leukocytes, Grade 2
0
   0.0%
Leukocytes, Grade 3
0
   0.0%
Leukocytes, Grade 4
0
   0.0%
Neutrophils, Grade 1
0
   0.0%
Neutrophils, Grade 2
0
   0.0%
Neutrophils, Grade 3
0
   0.0%
Neutrophils, Grade 4
0
   0.0%
Platelets, Grade 1
0
   0.0%
Platelets, Grade 2
0
   0.0%
Platelets, Grade 3
0
   0.0%
Platelets, Grade 4
0
   0.0%
16.Secondary Outcome
Title Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities
Hide Description Blood samples were collected up to Week 48 for the analysis of clinical chemistry parameters: alanine aminotransferase (ALT), albumin, alkaline phosphate (ALP), aspartate aminotransferase (AST), bilirubin, carbon dioxide (CO2), cholesterol, creatinine kinase (CK), creatinine, direct bilirubin, glomerular filtration rate (GFR) from creatinine adjusted for body surface area (BSA), GFR from cystatin C adjusted using chronic kidney disease-epidemiology collaboration (CKD-EPI), hypercalcemia, hyperglycemia, hyperkalemia, hypernatremia, hypocalcemia, hypoglycemia, hypokalemia, hyponatremia, low density lipoprotein (LDL) cholesterol, phosphate and triglycerides. Any abnormality in clinical chemistry parameters were evaluated according to the DAIDS toxicity scale From Grade 1 to 4: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening). The higher the grade, the more severe the symptoms.
Time Frame Up to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."
Arm/Group Title DTG+3TC FDC TAF-based Regimen
Hide Arm/Group Description:
Participants who were on a stable TBR and who had an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at the time of screening, received fixed dose combination of DTG 50 milligrams (mg) + 3TC 300 mg once daily up to 48 weeks.
Participants who were on a stable TBR and who had an HIV-1 RNA<50 c/mL at the time of screening, were continued to receive TBR up to 48 weeks. One participant randomized to the this arm received TDF rather than TAF-and was presented within the "TAF-based regimen" arm for efficacy because the efficacy of TAF and TDF are comparable. However the participant was presented separately under "TDF-based regimen" for Safety because the safety profiles of TDF and TAF differ.
Overall Number of Participants Analyzed 369 371
Measure Type: Count of Participants
Unit of Measure: Participants
ALT, Grade 1
24
   6.5%
18
   4.9%
ALT, Grade 2
6
   1.6%
4
   1.1%
ALT, Grade 3
1
   0.3%
1
   0.3%
ALT, Grade 4
0
   0.0%
0
   0.0%
Albumin, Grade 1
1
   0.3%
0
   0.0%
Albumin, Grade 2
0
   0.0%
0
   0.0%
Albumin, Grade 3
0
   0.0%
0
   0.0%
Albumin, Grade 4
0
   0.0%
0
   0.0%
ALP, Grade 1
2
   0.5%
0
   0.0%
ALP, Grade 2
0
   0.0%
0
   0.0%
ALP, Grade 3
0
   0.0%
0
   0.0%
ALP, Grade 4
0
   0.0%
0
   0.0%
AST, Grade 1
21
   5.7%
29
   7.8%
AST, Grade 2
7
   1.9%
4
   1.1%
AST, Grade 3
1
   0.3%
0
   0.0%
AST, Grade 4
1
   0.3%
0
   0.0%
Bilirubin, Grade 1
17
   4.6%
7
   1.9%
Bilirubin, Grade 2
5
   1.4%
2
   0.5%
Bilirubin, Grade 3
1
   0.3%
1
   0.3%
Bilirubin, Grade 4
0
   0.0%
0
   0.0%
CO2, Grade 1
73
  19.8%
70
  18.9%
CO2, Grade 2
1
   0.3%
1
   0.3%
CO2, Grade 3
0
   0.0%
0
   0.0%
CO2, Grade 4
0
   0.0%
0
   0.0%
Cholesterol, Grade 1
27
   7.3%
52
  14.0%
Cholesterol, Grade 2
12
   3.3%
19
   5.1%
Cholesterol, Grade 3
1
   0.3%
0
   0.0%
Cholesterol, Grade 4
0
   0.0%
0
   0.0%
CK, Grade 1
28
   7.6%
19
   5.1%
CK, Grade 2
4
   1.1%
9
   2.4%
CK, Grade 3
9
   2.4%
8
   2.2%
CK, Grade 4
6
   1.6%
5
   1.3%
Creatinine, Grade 1
16
   4.3%
7
   1.9%
Creatinine, Grade 2
3
   0.8%
1
   0.3%
Creatinine, Grade 3
0
   0.0%
0
   0.0%
Creatinine, Grade 4
0
   0.0%
0
   0.0%
Direct bilirubin, Grade 1
0
   0.0%
0
   0.0%
Direct bilirubin, Grade 2
0
   0.0%
0
   0.0%
Direct bilirubin, Grade 3
8
   2.2%
1
   0.3%
Direct bilirubin, Grade 4
0
   0.0%
0
   0.0%
GFR from creatinine adjusted using CKD EPI,Grade 1
0
   0.0%
0
   0.0%
GFR from creatinine adjusted using CKD EPI,Grade 2
135
  36.6%
83
  22.4%
GFR from creatinine adjusted using CKD EPI,Grade 3
26
   7.0%
13
   3.5%
GFR from creatinine adjusted using CKD EPI,Grade 4
0
   0.0%
0
   0.0%
GFR from cystatin C adjusted using CKD-EPI,Grade 1
0
   0.0%
0
   0.0%
GFR from cystatin C adjusted using CKD-EPI,Grade 2
52
  14.1%
66
  17.8%
GFR from cystatin C adjusted using CKD-EPI,Grade 3
5
   1.4%
4
   1.1%
GFR from cystatin C adjusted using CKD-EPI,Grade 4
1
   0.3%
0
   0.0%
Hypercalcemia, Grade 1
7
   1.9%
3
   0.8%
Hypercalcemia, Grade 2
0
   0.0%
0
   0.0%
Hypercalcemia, Grade 3
0
   0.0%
0
   0.0%
Hypercalcemia, Grade 4
0
   0.0%
0
   0.0%
Hyperglycemia, Grade 1
56
  15.2%
64
  17.3%
Hyperglycemia, Grade 2
21
   5.7%
19
   5.1%
Hyperglycemia, Grade 3
2
   0.5%
2
   0.5%
Hyperglycemia, Grade 4
0
   0.0%
0
   0.0%
Hyperkalemia, Grade 1
0
   0.0%
2
   0.5%
Hyperkalemia, Grade 2
2
   0.5%
0
   0.0%
Hyperkalemia, Grade 3
0
   0.0%
0
   0.0%
Hyperkalemia, Grade 4
0
   0.0%
0
   0.0%
Hypernatremia, Grade 1
1
   0.3%
1
   0.3%
Hypernatremia, Grade 2
0
   0.0%
0
   0.0%
Hypernatremia, Grade 3
0
   0.0%
0
   0.0%
Hypernatremia, Grade 4
0
   0.0%
0
   0.0%
Hypocalcemia, Grade 1
8
   2.2%
1
   0.3%
Hypocalcemia, Grade 2
0
   0.0%
1
   0.3%
Hypocalcemia, Grade 3
0
   0.0%
0
   0.0%
Hypocalcemia, Grade 4
0
   0.0%
0
   0.0%
Hypoglycemia, Grade 1
5
   1.4%
6
   1.6%
Hypoglycemia, Grade 2
3
   0.8%
2
   0.5%
Hypoglycemia, Grade 3
0
   0.0%
0
   0.0%
Hypoglycemia, Grade 4
0
   0.0%
0
   0.0%
Hypokalemia, Grade 1
7
   1.9%
1
   0.3%
Hypokalemia, Grade 2
1
   0.3%
0
   0.0%
Hypokalemia, Grade 3
0
   0.0%
0
   0.0%
Hypokalemia, Grade 4
0
   0.0%
0
   0.0%
Hyponatremia, Grade 1
8
   2.2%
13
   3.5%
Hyponatremia, Grade 2
0
   0.0%
2
   0.5%
Hyponatremia, Grade 3
0
   0.0%
0
   0.0%
Hyponatremia, Grade 4
0
   0.0%
0
   0.0%
LDL cholesterol, Grade 1
28
   7.6%
35
   9.4%
LDL cholesterol, Grade 2
13
   3.5%
15
   4.0%
LDL cholesterol, Grade 3
6
   1.6%
3
   0.8%
LDL cholesterol, Grade 4
0
   0.0%
0
   0.0%
Phosphate, Grade 1
38
  10.3%
47
  12.7%
Phosphate, Grade 2
2
   0.5%
7
   1.9%
Phosphate, Grade 3
0
   0.0%
0
   0.0%
Phosphate, Grade 4
0
   0.0%
0
   0.0%
Triglycerides, Grade 1
34
   9.2%
48
  12.9%
Triglycerides, Grade 2
4
   1.1%
11
   3.0%
Triglycerides, Grade 3
4
   1.1%
4
   1.1%
Triglycerides, Grade 4
4
   1.1%
0
   0.0%
17.Secondary Outcome
Title Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities
Hide Description samples were collected up to the Week 36 visit for the analysis of clinical chemistry parameters: alanine aminotransferase (ALT), albumin, alkaline phosphate (ALP), aspartate aminotransferase (AST), bilirubin, carbon dioxide (CO2), cholesterol, creatinine kinase (CK), creatinine, direct bilirubin, glomerular filtration rate (GFR) from creatinine adjusted for body surface area (BSA), GFR from cystatin C adjusted using chronic kidney disease-epidemiology collaboration (CKD-EPI), hypercalcemia, hyperglycemia, hyperkalemia, hypernatremia, hypocalcemia, hypoglycemia, hypokalemia, hyponatremia, low density lipoprotein (LDL) cholesterol, phosphate and triglycerides. Any abnormality in clinical chemistry parameters were evaluated according to the DAIDS toxicity scale From Grade 1 to 4: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening). The higher the grade, the more severe the symptoms.
Time Frame Up to Week 36
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."
Arm/Group Title Randomized to TBR But Received TDF-based Regimen
Hide Arm/Group Description:
Participant randomized to TBR arm who had HIV-1 RNA <50 c/mL at the time of screening, received TDF-based regimen instead of TAF-based regimen in error. Participant continued to receive TDF-regimen up to the Week 48 visit (participant withdrew from the study at Week 36).
Overall Number of Participants Analyzed 1
Measure Type: Count of Participants
Unit of Measure: Participants
ALT, Grade 1
0
   0.0%
ALT, Grade 2
0
   0.0%
ALT, Grade 3
0
   0.0%
ALT, Grade 4
0
   0.0%
Albumin, Grade 1
0
   0.0%
Albumin, Grade 2
0
   0.0%
Albumin, Grade 3
0
   0.0%
Albumin, Grade 4
0
   0.0%
ALP, Grade 1
0
   0.0%
ALP, Grade 2
0
   0.0%
ALP, Grade 3
0
   0.0%
ALP, Grade 4
0
   0.0%
AST, Grade 1
0
   0.0%
AST, Grade 2
0
   0.0%
AST, Grade 3
0
   0.0%
AST, Grade 4
0
   0.0%
Bilirubin, Grade 1
0
   0.0%
Bilirubin, Grade 2
0
   0.0%
Bilirubin, Grade 3
0
   0.0%
Bilirubin, Grade 4
0
   0.0%
CO2, Grade 1
0
   0.0%
CO2, Grade 2
0
   0.0%
CO2, Grade 3
0
   0.0%
CO2, Grade 4
0
   0.0%
Cholesterol, Grade 1
0
   0.0%
Cholesterol, Grade 2
0
   0.0%
Cholesterol, Grade 3
0
   0.0%
Cholesterol, Grade 4
0
   0.0%
CK, Grade 1
0
   0.0%
CK, Grade 2
0
   0.0%
CK, Grade 3
0
   0.0%
CK, Grade 4
0
   0.0%
Creatinine, Grade 1
0
   0.0%
Creatinine, Grade 2
0
   0.0%
Creatinine, Grade 3
0
   0.0%
Creatinine, Grade 4
0
   0.0%
Direct bilirubin, Grade 1
0
   0.0%
Direct bilirubin, Grade 2
0
   0.0%
Direct bilirubin, Grade 3
0
   0.0%
Direct bilirubin, Grade 4
0
   0.0%
GFR from creatinine adjusted using CKD EPI,Grade 1
0
   0.0%
GFR from creatinine adjusted using CKD EPI,Grade 2
0
   0.0%
GFR from creatinine adjusted using CKD EPI,Grade 3
0
   0.0%
GFR from creatinine adjusted using CKD EPI,Grade 4
0
   0.0%
GFR from cystatin C adjusted using CKD-EPI,Grade 1
0
   0.0%
GFR from cystatin C adjusted using CKD-EPI,Grade 2
0
   0.0%
GFR from cystatin C adjusted using CKD-EPI,Grade 3
0
   0.0%
GFR from cystatin C adjusted using CKD-EPI,Grade 4
0
   0.0%
Hypercalcemia, Grade 1
0
   0.0%
Hypercalcemia, Grade 2
0
   0.0%
Hypercalcemia, Grade 3
0
   0.0%
Hypercalcemia, Grade 4
0
   0.0%
Hyperglycemia, Grade 1
0
   0.0%
Hyperglycemia, Grade 2
0
   0.0%
Hyperglycemia, Grade 3
0
   0.0%
Hyperglycemia, Grade 4
0
   0.0%
Hyperkalemia, Grade 1
0
   0.0%
Hyperkalemia, Grade 2
0
   0.0%
Hyperkalemia, Grade 3
0
   0.0%
Hyperkalemia, Grade 4
0
   0.0%
Hypernatremia, Grade 1
0
   0.0%
Hypernatremia, Grade 2
0
   0.0%
Hypernatremia, Grade 3
0
   0.0%
Hypernatremia, Grade 4
0
   0.0%
Hypocalcemia, Grade 1
0
   0.0%
Hypocalcemia, Grade 2
0
   0.0%
Hypocalcemia, Grade 3
0
   0.0%
Hypocalcemia, Grade 4
0
   0.0%
Hypoglycemia, Grade 1
0
   0.0%
Hypoglycemia, Grade 2
0
   0.0%
Hypoglycemia, Grade 3
0
   0.0%
Hypoglycemia, Grade 4
0
   0.0%
Hypokalemia, Grade 1
0
   0.0%
Hypokalemia, Grade 2
0
   0.0%
Hypokalemia, Grade 3
0
   0.0%
Hypokalemia, Grade 4
0
   0.0%
Hyponatremia, Grade 1
0
   0.0%
Hyponatremia, Grade 2
0
   0.0%
Hyponatremia, Grade 3
0
   0.0%
Hyponatremia, Grade 4
0
   0.0%
LDL cholesterol, Grade 1
0
   0.0%
LDL cholesterol, Grade 2
0
   0.0%
LDL cholesterol, Grade 3
0
   0.0%
LDL cholesterol, Grade 4
0
   0.0%
Phosphate, Grade 1
0
   0.0%
Phosphate, Grade 2
0
   0.0%
Phosphate, Grade 3
0
   0.0%
Phosphate, Grade 4
0
   0.0%
Triglycerides, Grade 1
1
 100.0%
Triglycerides, Grade 2
0
   0.0%
Triglycerides, Grade 3
0
   0.0%
Triglycerides, Grade 4
0
   0.0%
18.Secondary Outcome
Title Change From Baseline in Renal Biomarkers- Urine Albumin/Creatinine (UA/C) Ratio and Urine Protein/Creatinine (UP/C) Ratio at Weeks 24 and 48
Hide Description Urine samples were collected at Baseline, Week 24 and Week 48. Baseline is defined as Day 1. Change from Baseline in UA/C was calculated as UA/C ratio at post-Baseline visit minus UA/C ratio calculated at Baseline. Estimated geometric mean adjusted ratio (each visit over Baseline) and 95% CI have been presented. Change from Baseline in UP/C and UA/C was calculated as UP/C and UA/C ratio at post-Baseline visit minus UP/C and UA/C ratio calculated at Baseline, respectively. Estimated geometric mean adjusted ratio (each visit over Baseline) and 95% CI have been presented. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."
Time Frame Baseline (Day 1) and at weeks 24 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Total of 741 participants were analyzed but 740 participants are presented in this Outcome Measure and 1 participant is presented separately in next Outcome Measure. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Arm/Group Title DTG+3TC FDC TAF-based Regimen
Hide Arm/Group Description:
Participants who were on a stable TBR and who had an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at the time of screening, received fixed dose combination of DTG 50 milligrams (mg) + 3TC 300 mg once daily up to 48 weeks.
Participants who were on a stable TBR and who had an HIV-1 RNA<50 c/mL at the time of screening, were continued to receive TBR up to 48 weeks. One participant randomized to the this arm received TDF rather than TAF-and was presented within the "TAF-based regimen" arm for efficacy because the efficacy of TAF and TDF are comparable. However the participant was presented separately under "TDF-based regimen" for Safety because the safety profiles of TDF and TAF differ.
Overall Number of Participants Analyzed 369 371
Geometric Mean (95% Confidence Interval)
Unit of Measure: Ratio
UA/C, Week 24, n=235, 230 Number Analyzed 235 participants 230 participants
1.080
(1.007 to 1.158)
1.022
(0.956 to 1.091)
UA/C, Week 48, n=230, 224 Number Analyzed 230 participants 224 participants
1.125
(1.036 to 1.222)
1.059
(0.963 to 1.165)
UP/C, Week 24, n=267, 261 Number Analyzed 267 participants 261 participants
0.955
(0.917 to 0.995)
0.976
(0.937 to 1.016)
UP/C, Week 48, n=261, 257 Number Analyzed 261 participants 257 participants
0.971
(0.926 to 1.018)
1.016
(0.964 to 1.070)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DTG+3TC FDC, TAF-based Regimen
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.257
Comments [Not Specified]
Method Mixed Model Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Treatment ratio
Estimated Value 1.057
Confidence Interval (2-Sided) 95%
0.960 to 1.164
Estimation Comments Treatment ratio (DTG+3TC/ TAF based regimen) and 95% CI for UA/C at Week 24 has been presented.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection DTG+3TC FDC, TAF-based Regimen
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.350
Comments [Not Specified]
Method Mixed Model Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Treatment ratio
Estimated Value 1.062
Confidence Interval (2-Sided) 95%
0.936 to 1.205
Estimation Comments Treatment ratio (DTG+3TC/ TAF based regimen) and 95% CI for UA/C at Week 48 has been presented.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection DTG+3TC FDC, TAF-based Regimen
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.473
Comments [Not Specified]
Method Mixed Model Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Treatment ratio
Estimated Value 0.979
Confidence Interval (2-Sided) 95%
0.924 to 1.037
Estimation Comments Treatment ratio (DTG+3TC/ TAF based regimen) and 95% CI for UP/C at Week 24 has been presented.
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection DTG+3TC FDC, TAF-based Regimen
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.212
Comments [Not Specified]
Method Mixed Model Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Treatment ratio
Estimated Value 0.956
Confidence Interval (2-Sided) 95%
0.891 to 1.026
Estimation Comments Treatment ratio (DTG+3TC/ TAF based regimen) and 95% CI for UP/C at Week 48 has been presented.
19.Secondary Outcome
Title Change From Baseline in Renal Biomarkers- UA/C Ratio and UP/C Ratio at Weeks 24 and 48 in Participants Randomized to TBR Receiving TDF-based Regimen
Hide Description Urine samples were collected at Baseline, Week 24 and Week 48 to assess renal biomarkers - urine albumin/creatinine ratio and urine protein/creatinine ratio. Baseline was defined as the latest pre-dose assessment value (Day 1) with a non-missing value. Change from Baseline in UA/C was calculated as UA/C ratio at post-Baseline visit minus UA/C ratio calculated at Baseline. Change from Baseline in UP/C was calculated as UP/C ratio at post-Baseline visit minus UP/C ratio calculated at Baseline. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."
Time Frame Baseline (Day 1) and at weeks 24 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Arm/Group Title Randomized to TBR But Received TDF-based Regimen
Hide Arm/Group Description:
Participant randomized to TBR arm who had HIV-1 RNA <50 c/mL at the time of screening, received TDF-based regimen instead of TAF-based regimen in error. Participant continued to receive TDF-regimen up to the Week 48 visit (participant withdrew from the study at Week 36).
Overall Number of Participants Analyzed 1
Measure Type: Number
Unit of Measure: Ratio
UA/C, Week 24, n=1 Number Analyzed 1 participants
0
UA/C, Week 48, n=0 Number Analyzed 0 participants
UP/C, Week 24, n=1 Number Analyzed 1 participants
0.3
UP/C, Week 48, n=0 Number Analyzed 0 participants
20.Secondary Outcome
Title Change From Baseline in Renal Biomarkers- Urine Beta-2 Microglobulin/Urine Creatinine Ratio
Hide Description Urine biomarker samples were collected at Baseline and Week 48 to assess urine beta-2 microglobulin/urine creatinine. Geometric mean ratio (visit divided by Baseline) and 95% CI of geometric mean ratio has been presented. Baseline (Day 1) value was the value from the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline in urine beta-2-microglobulin/urine creatinine was calculated as urine beta-2-microglobulin/urine creatinine ratio at post-Baseline visit minus urine beta-2-microglobulin/urine creatinine ratio calculated at Baseline. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."
Time Frame Baseline (Day 1) and at weeks 24 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Total of 741 participants were analyzed but 740 participants are presented in this Outcome Measure and 1 participant is presented separately in next Outcome Measure. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Arm/Group Title DTG+3TC FDC TAF-based Regimen
Hide Arm/Group Description:
Participants who were on a stable TBR and who had an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at the time of screening, received fixed dose combination of DTG 50 milligrams (mg) + 3TC 300 mg once daily up to 48 weeks.
Participants who were on a stable TBR and who had an HIV-1 RNA<50 c/mL at the time of screening, were continued to receive TBR up to 48 weeks. One participant randomized to the this arm received TDF rather than TAF-and was presented within the "TAF-based regimen" arm for efficacy because the efficacy of TAF and TDF are comparable. However the participant was presented separately under "TDF-based regimen" for Safety because the safety profiles of TDF and TAF differ.
Overall Number of Participants Analyzed 369 371
Geometric Mean (95% Confidence Interval)
Unit of Measure: Ratio
Week 24, n=136, 141 Number Analyzed 136 participants 141 participants
0.991
(0.899 to 1.093)
1.034
(0.931 to 1.149)
Week 48, n=126, 141 Number Analyzed 126 participants 141 participants
0.973
(0.870 to 1.088)
0.922
(0.832 to 1.022)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DTG+3TC FDC, TAF-based Regimen
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.560
Comments [Not Specified]
Method Mixed Model Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Treatment ratio
Estimated Value 0.958
Confidence Interval (2-Sided) 95%
0.830 to 1.106
Estimation Comments Treatment ratio (DTG+3TC/ TAF based regimen) and 95% CI for Urine beta-2 microglobulin/urine creatinine at Week 24 has been presented.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection DTG+3TC FDC, TAF-based Regimen
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.489
Comments [Not Specified]
Method Mixed Model Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Treatment ratio
Estimated Value 1.055
Confidence Interval (2-Sided) 95%
0.906 to 1.229
Estimation Comments Treatment ratio (DTG+3TC/ TAF based regimen) and 95% CI for Urine beta-2 microglobulin/urine creatinine at Week 48 has been presented.
21.Secondary Outcome
Title Change From Baseline in Renal Biomarkers- Urine Beta-2 Microglobulin/Urine Creatinine Ratio in Participants Randomized to TBR Arm Receiving TDF-based Regimen
Hide Description Urine biomarker samples were collected to assess urine beta-2 microglobulin/urine creatinine. Baseline (Day 1) value was the value from the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline in urine beta-2-microglobulin/urine creatinine was calculated as urine beta-2-microglobulin/urine creatinine ratio at post-Baseline visit minus urine beta-2-microglobulin/urine creatinine ratio calculated at Baseline. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."
Time Frame Baseline (Day 1) and at weeks 24 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Data was not collected for this arm.
Arm/Group Title Randomized to TBR But Received TDF-based Regimen
Hide Arm/Group Description:
Participant randomized to TBR arm who had HIV-1 RNA <50 c/mL at the time of screening, received TDF-based regimen instead of TAF-based regimen in error. Participant continued to receive TDF-regimen up to the Week 48 visit (participant withdrew from the study at Week 36).
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
22.Secondary Outcome
Title Change From Baseline in Renal Biomarkers- Urine Phosphate
Hide Description Urine biomarker samples were collected at Baseline and at Weeks 24 and 48 to assess urine phosphate. Geometric mean ratio (visit divided by Baseline) and 95% CI of geometric mean ratio has been presented. Baseline (Day 1) value was the value from the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline in urine phosphate was calculated as urine phosphate at post-Baseline visit minus urine phosphate calculated at Baseline. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."
Time Frame Baseline (Day 1) and at weeks 24 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Total of 741 participants were analyzed but 740 participants are presented in this Outcome Measure and 1 participant is presented separately in next Outcome Measure. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Arm/Group Title DTG+3TC FDC TAF-based Regimen
Hide Arm/Group Description:
Participants who were on a stable TBR and who had an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at the time of screening, received fixed dose combination of DTG 50 milligrams (mg) + 3TC 300 mg once daily up to 48 weeks.
Participants who were on a stable TBR and who had an HIV-1 RNA<50 c/mL at the time of screening, were continued to receive TBR up to 48 weeks. One participant randomized to the this arm received TDF rather than TAF-and was presented within the "TAF-based regimen" arm for efficacy because the efficacy of TAF and TDF are comparable. However the participant was presented separately under "TDF-based regimen" for Safety because the safety profiles of TDF and TAF differ.
Overall Number of Participants Analyzed 369 371
Geometric Mean (95% Confidence Interval)
Unit of Measure: Ratio
Week 24, n=348, 352 Number Analyzed 348 participants 352 participants
0.955
(0.888 to 1.028)
0.940
(0.871 to 1.014)
Week 48, n=342, 340 Number Analyzed 342 participants 340 participants
0.969
(0.892 to 1.052)
0.970
(0.900 to 1.044)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DTG+3TC FDC, TAF-based Regimen
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.758
Comments [Not Specified]
Method Mixed Model Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Treatment ratio
Estimated Value 1.017
Confidence Interval (2-Sided) 95%
0.915 to 1.130
Estimation Comments Treatment ratio (DTG+3TC/ TAF based regimen) and 95% CI for Urine phosphate at Week 24 has been presented.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection DTG+3TC FDC, TAF-based Regimen
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.985
Comments [Not Specified]
Method Mixed Model Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Treatment ratio
Estimated Value 0.999
Confidence Interval (2-Sided) 95%
0.894 to 1.116
Estimation Comments Treatment ratio (DTG+3TC/ TAF based regimen) and 95% CI for Urine phosphate at Week 48 has been presented.
23.Secondary Outcome
Title Change From Baseline in Renal Biomarkers- Urine Phosphate in Participants Randomized to TBR Arm Receiving TDF-based Regimen
Hide Description Urine biomarker samples were collected to assess urine phosphate. Baseline (Day 1) value was the value from the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline in urine phosphate was calculated as urine phosphate at post-Baseline visit minus urine phosphate calculated at Baseline. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."
Time Frame Baseline (Day 1) and at weeks 24 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Arm/Group Title Randomized to TBR But Received TDF-based Regimen
Hide Arm/Group Description:
Participant randomized to TBR arm who had HIV-1 RNA <50 c/mL at the time of screening, received TDF-based regimen instead of TAF-based regimen in error. Participant continued to receive TDF-regimen up to the Week 48 visit (participant withdrew from the study at Week 36).
Overall Number of Participants Analyzed 1
Measure Type: Number
Unit of Measure: Ratio
Week 24, n=1 Number Analyzed 1 participants
2.9
Week 48, n=0 Number Analyzed 0 participants
24.Secondary Outcome
Title Change From Baseline in Renal Biomarkers- Urine Retinol Binding Protein 4/Urine Creatinine
Hide Description Urine biomarker samples were collected at Baseline and Week 48 to assess urine retinol binding protein 4/urine creatinine. Geometric mean ratio (visit divided by Baseline) and 95% CI of geometric mean ratio has been presented. Baseline (Day 1) value was the value from the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline in Urine retinol binding protein 4/urine creatinine ratio was calculated as Urine retinol binding protein 4/urine creatinine ratio at post-Baseline visit minus Urine retinol binding protein 4/urine creatinine ratio calculated at Baseline. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."
Time Frame Baseline (Day 1) and at weeks 24 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Total of 741 participants were analyzed but 740 participants are presented in this Outcome Measure and 1 participant is presented separately in next Outcome Measure. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Arm/Group Title DTG+3TC FDC TAF-based Regimen
Hide Arm/Group Description:
Participants who were on a stable TBR and who had an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at the time of screening, received fixed dose combination of DTG 50 milligrams (mg) + 3TC 300 mg once daily up to 48 weeks.
Participants who were on a stable TBR and who had an HIV-1 RNA<50 c/mL at the time of screening, were continued to receive TBR up to 48 weeks. One participant randomized to the this arm received TDF rather than TAF-and was presented within the "TAF-based regimen" arm for efficacy because the efficacy of TAF and TDF are comparable. However the participant was presented separately under "TDF-based regimen" for Safety because the safety profiles of TDF and TAF differ.
Overall Number of Participants Analyzed 369 371
Geometric Mean (95% Confidence Interval)
Unit of Measure: Ratio
Week 24, n=344, 343 Number Analyzed 344 participants 343 participants
0.860
(0.790 to 0.936)
0.920
(0.847 to 0.999)
Week 48, n=340, 335 Number Analyzed 340 participants 335 participants
1.063
(0.992 to 1.139)
1.068
(0.996 to 1.144)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DTG+3TC FDC, TAF-based Regimen
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.264
Comments [Not Specified]
Method Mixed Model Reported Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Treatment ratio
Estimated Value 0.935
Confidence Interval (2-Sided) 95%
0.830 to 1.052
Estimation Comments Treatment ratio (DTG+3TC/ TAF based regimen) and 95% CI for Urine retinol binding protein 4/urine creatinine at Week 24 has been presented.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection DTG+3TC FDC, TAF-based Regimen
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.932
Comments [Not Specified]
Method Mixed Model Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Treatment ratio
Estimated Value 0.996
Confidence Interval (2-Sided) 95%
0.903 to 1.098
Estimation Comments Treatment ratio (DTG+3TC/ TAF based regimen) and 95% CI for Urine retinol binding protein 4/urine creatinine at Week 48 has been presented.
25.Secondary Outcome
Title Change From Baseline in Renal Biomarkers- Urine Retinol Binding Protein 4/Urine Creatinine in Participants Randomized to TBR Arm Receiving TDF-based Regimen
Hide Description Urine biomarker samples were collected to assess urine retinol binding protein 4/urine creatinine. Baseline (Day 1) value was the value from the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline in urine retinol binding protein 4/urine creatinine was calculated as urine retinol binding protein 4/urine creatinine ratio at post-Baseline visit minus urine retinol binding protein 4/urine creatinine ratio calculated at Baseline. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."
Time Frame Baseline (Day 1) and at weeks 24 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Arm/Group Title Randomized to TBR But Received TDF-based Regimen
Hide Arm/Group Description:
Participant randomized to TBR arm who had HIV-1 RNA <50 c/mL at the time of screening, received TDF-based regimen instead of TAF-based regimen in error. Participant continued to receive TDF-regimen up to the Week 48 visit (participant withdrew from the study at Week 36).
Overall Number of Participants Analyzed 1
Measure Type: Number
Unit of Measure: Ratio
Week 24, n=1 Number Analyzed 1 participants
1.04
Week 48, n=0 Number Analyzed 0 participants
26.Secondary Outcome
Title Change From Baseline in Fasting Lipids at Weeks 24 and 48
Hide Description Blood samples were collected at Baseline (Day 1), Week 24 and Week 48 to assess fasting lipids which included plasma cholesterol, plasma LDL cholesterol, plasma high density lipoprotein (HDL) cholesterol and plasma triglycerides. Baseline value was the value from the latest pre-dose assessment (Day 1) with a non-missing value. Change from Baseline is defined as post-dose visit value minus Baseline value. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."
Time Frame Baseline (Day 1) and at weeks 24 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Total of 741 participants were analyzed but 740 participants are presented in this Outcome Measure and 1 participant is presented separately in next Outcome Measure. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Arm/Group Title DTG+3TC FDC TAF-based Regimen
Hide Arm/Group Description:
Participants who were on a stable TBR and who had an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at the time of screening, received fixed dose combination of DTG 50 milligrams (mg) + 3TC 300 mg once daily up to 48 weeks.
Participants who were on a stable TBR and who had an HIV-1 RNA<50 c/mL at the time of screening, were continued to receive TBR up to 48 weeks. One participant randomized to the this arm received TDF rather than TAF-and was presented within the "TAF-based regimen" arm for efficacy because the efficacy of TAF and TDF are comparable. However the participant was presented separately under "TDF-based regimen" for Safety because the safety profiles of TDF and TAF differ.
Overall Number of Participants Analyzed 369 371
Median (Inter-Quartile Range)
Unit of Measure: Millimoles per liter
Plasma cholesterol, Week 24, n=282, 264 Number Analyzed 282 participants 264 participants
-0.325
(-0.750 to 0.150)
0.000
(-0.400 to 0.400)
Plasma cholesterol, Week 48, n=275, 263 Number Analyzed 275 participants 263 participants
-0.200
(-0.750 to 0.150)
0.100
(-0.350 to 0.500)
Plasma LDL Cholesterol, Week 24, n=282, 264 Number Analyzed 282 participants 264 participants
-0.210
(-0.570 to 0.130)
-0.060
(-0.340 to 0.410)
Plasma LDL Cholesterol, Week 48, n=275, 263 Number Analyzed 275 participants 263 participants
-0.170
(-0.560 to 0.210)
0.070
(-0.320 to 0.430)
Plasma Triglycerides, Week 24, n=282, 264 Number Analyzed 282 participants 264 participants
-0.100
(-0.460 to 0.160)
0.060
(-0.200 to 0.350)
Plasma Triglycerides, Week 48, n=275, 263 Number Analyzed 275 participants 263 participants
-0.100
(-0.440 to 0.160)
0.100
(-0.280 to 0.380)
Plasma HDL Cholesterol, Week 24, n=282, 264 Number Analyzed 282 participants 264 participants
-0.050
(-0.150 to 0.100)
0.050
(-0.150 to 0.150)
Plasma HDL Cholesterol, Week 48, n=275, 263 Number Analyzed 275 participants 263 participants
0.000
(-0.200 to 0.150)
0.050
(-0.150 to 0.150)
27.Secondary Outcome
Title Change From Baseline in Fasting Lipids at Weeks 24 and 48 in Participants Randomized to TBR Arm Receiving TDF-based Regimen
Hide Description Blood samples were collected up to the Week 48 visit (participant withdrew from the study at Week 36) to assess fasting lipids which included plasma cholesterol, plasma LDL cholesterol, plasma HDL cholesterol and plasma triglycerides. Baseline value was the value from the latest pre-dose assessment (Day 1) with a non-missing value. Change from Baseline is defined as post-dose visit value minus Baseline value. Change from Baseline values for fasting lipids in TDF-based regimen participants has been presented. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."
Time Frame Baseline (Day 1) and at weeks 24 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Arm/Group Title Randomized to TBR But Received TDF-based Regimen
Hide Arm/Group Description:
Participant randomized to TBR arm who had HIV-1 RNA <50 c/mL at the time of screening, received TDF-based regimen instead of TAF-based regimen in error. Participant continued to receive TDF-regimen up to the Week 48 visit (participant withdrew from the study at Week 36).
Overall Number of Participants Analyzed 1
Measure Type: Number
Unit of Measure: Millimoles per liter
Plasma cholesterol, Week 24, n=1 Number Analyzed 1 participants
0
Plasma cholesterol, Week 48, n=0 Number Analyzed 0 participants
Plasma LDL Cholesterol, Week 24, n=1 Number Analyzed 1 participants
-0.67
Plasma LDL Cholesterol, Week 48, n=0 Number Analyzed 0 participants
Plasma Triglycerides, Week 24, n=1 Number Analyzed 1 participants
1.36
Plasma Triglycerides, Week 48, n=0 Number Analyzed 0 participants
Plasma HDL Cholesterol, Week 24, n=1 Number Analyzed 1 participants
0.05
Plasma HDL Cholesterol, Week 48, n=0 Number Analyzed 0 participants
28.Secondary Outcome
Title Number of Participants With Genotypic Resistance
Hide Description Plasma samples were collected for drug resistance testing. Number of participants, who met confirmed virologic withdrawal (CVW) criteria (one plasma HIV-1 RNA >=200 c/mL after Day 1 with immediate prior HIV RNA >=50 c/mL), with emergent genotypic resistance to INSTI, nucleoside reverse transcriptase inhibitor (NRTI), NNRTI and PI was summarized.
Time Frame Up to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
CVW Population comprises all participants in the ITT-E Population who had met the derived CVW criteria. One participant randomized to TBR but received TDF-based regimen and was presented within the "TBR (TAF-based regimen) arm" as efficacy of TAF and TDF are comparable.
Arm/Group Title DTG+3TC FDC TAF-based Regimen
Hide Arm/Group Description:
Participants who were on a stable TBR and who had an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at the time of screening, received fixed dose combination of DTG 50 milligrams (mg) + 3TC 300 mg once daily up to 48 weeks.
Participants who were on a stable TBR and who had an HIV-1 RNA<50 c/mL at the time of screening, were continued to receive TBR up to 48 weeks. One participant randomized to the this arm received TDF rather than TAF-and was presented within the "TAF-based regimen" arm for efficacy because the efficacy of TAF and TDF are comparable. However the participant was presented separately under "TDF-based regimen" for Safety because the safety profiles of TDF and TAF differ.
Overall Number of Participants Analyzed 0 1
Measure Type: Count of Participants
Unit of Measure: Participants
INSTI
0
   0.0%
NRTI
0
   0.0%
NNRTI
0
   0.0%
PI
0
   0.0%
29.Secondary Outcome
Title Number of Participants With Phenotypic Resistance
Hide Description Number of participants, who meet CVW criteria (one plasma HIV-1 RNA >=200 c/mL after Day 1 with immediate prior HIV RNA >=50 c/mL), with emergent phenotypic resistance to INSTI and/or NRTI were summarized. Assessment of antiviral activity of anti-retroviral therapy (ART) using phenotypic test results was interpreted through a proprietary algorithm (from Monogram Biosciences), which provided the overall susceptibility of the drug. Partially sensitive and resistant calls were considered resistant in this analysis. The phenotypic resistance was calculated using binary scoring system, where 0 was considered as sensitive and 1 as resistance. Phenotypic Resistance data for the following INSTI, NNRTI, NRTI and PI drugs in participants Meeting CVW Criteria has been presented.
Time Frame Up to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
CVW Population. One participant randomized to TBR but received TDF-based regimen and was presented within the "TBR (TAF-based regimen) arm" as efficacy of TAF and TDF are comparable.
Arm/Group Title DTG+3TC FDC TAF-based Regimen
Hide Arm/Group Description:
Participants who were on a stable TBR and who had an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at the time of screening, received fixed dose combination of DTG 50 milligrams (mg) + 3TC 300 mg once daily up to 48 weeks.
Participants who were on a stable TBR and who had an HIV-1 RNA<50 c/mL at the time of screening, were continued to receive TBR up to 48 weeks. One participant randomized to the this arm received TDF rather than TAF-and was presented within the "TAF-based regimen" arm for efficacy because the efficacy of TAF and TDF are comparable. However the participant was presented separately under "TDF-based regimen" for Safety because the safety profiles of TDF and TAF differ.
Overall Number of Participants Analyzed 0 1
Measure Type: Count of Participants
Unit of Measure: Participants
INSTI, DTG, Sensitive
1
 100.0%
INSTI, DTG, Resistant
0
   0.0%
INSTI, Bictegravir (BIC), Sensitive
1
 100.0%
INSTI, BIC, Resistant
0
   0.0%
INSTI, Elvitegravir (EVG), Sensitive
1
 100.0%
INSTI, EVG, Resistant
0
   0.0%
INSTI, Raltegravir (RAL), Sensitive
1
 100.0%
INSTI, RAL, Resistant
0
   0.0%
NNRTI, Delavirdine (DLV), Sensitive
1
 100.0%
NNRTI, DLV, Resistant
0
   0.0%
NNRTI, Efavirenz (EFV), Sensitive
1
 100.0%
NNRTI, EFV, Resistant
0
   0.0%
NNRTI, Etravirine (ETR), Sensitive
1
 100.0%
NNRTI, ETR, Resistant
0
   0.0%
NNRTI, Nevirapine (NVP), Sensitive
1
 100.0%
NNRTI, NVP, Resistant
0
   0.0%
NNRTI, Rilpivirine (RPV), Sensitive
1
 100.0%
NNRTI, RPV, Resistant
0
   0.0%
NRTI, 3TC, Sensitive
1
 100.0%
NRTI, 3TC, Resistant
0
   0.0%
NRTI, Abacavir (ABC), Sensitive
1
 100.0%
NRTI, ABC, Resistant
0
   0.0%
NRTI, Zidovudine (AZT), Sensitive
1
 100.0%
NRTI, AZT, Resistant
0
   0.0%
NRTI, Stavudine (D4T), Sensitive
1
 100.0%
NRTI, D4T, Resistant
0
   0.0%
NRTI, Didanosine (DDI), Sensitive
1
 100.0%
NRTI, DDI, Resistant
0
   0.0%
NRTI, Emtricitabine (FTC), Sensitive
1
 100.0%
NRTI, FTC, Resistant
0
   0.0%
NRTI, Tenofovir (TDF), Sensitive
1
 100.0%
NRTI, TDF, Resistant
0
   0.0%
PI, Atazanavir (ATV), Sensitive
1
 100.0%
PI, ATV, Resistant
0
   0.0%
PI, Darunavir (DRV), Sensitive
1
 100.0%
PI, DRV, Resistant
0
   0.0%
PI, Fosamprenavir (FPV), Sensitive
1
 100.0%
PI, FPV, Resistant
0
   0.0%
PI, Indinavir (IDV), Sensitive
1
 100.0%
PI, IDV, Resistant
0
   0.0%
PI, Lopinavir (LPV), Sensitive
1
 100.0%
PI, LPV, Resistant
0
   0.0%
PI, Nelfinavir (NFV), Sensitive
1
 100.0%
PI, NFV, Resistant
0
   0.0%
PI, Ritonavir (RTV), Sensitive
1
 100.0%
PI, RTV, Resistant
0
   0.0%
PI, Saquinavir (SQV), Sensitive
1
 100.0%
PI, SQV, Resistant
0
   0.0%
PI, Tipranavir (TPV), Sensitive
1
 100.0%
PI, TPV, Resistant
0
   0.0%
30.Secondary Outcome
Title Change From Baseline in Bone Biomarkers-serum Bone-specific ALP (Bone-ALP), Osteocalcin, Serum Procollagen 1 N-Terminal Propeptide (P1NP) and Serum Type 1 Collagen C-telopeptides (CTX-1)
Hide Description Serum samples were collected for analysis of bone biomarkers. Baseline was latest pre-dose assessment (Day 1) with a non-missing value. Change from Baseline is post-dose visit value minus Baseline value. Adjusted mean and its corresponding standard error has been presented. Adjusted mean was the estimated mean change from Baseline at each visit in each arm calculated from a repeated measures model adjusting for treatment, visit, Baseline third agent class, CD4+ cell count (continuous), age (continuous), sex, race, body mass index (BMI) (continuous), smoking status, vitamin D use, Baseline biomarker (continuous), treatment by visit interaction, and Baseline value by visit interaction, with visit as repeated factor.One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."
Time Frame Baseline (Day 1) and at Weeks 24 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Total of 741 participants were analyzed but 740 participants are presented in this Outcome Measure and 1 participant is presented separately in next Outcome Measure. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Arm/Group Title DTG+3TC FDC TAF-based Regimen
Hide Arm/Group Description:
Participants who were on a stable TBR and who had an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at the time of screening, received fixed dose combination of DTG 50 milligrams (mg) + 3TC 300 mg once daily up to 48 weeks.
Participants who were on a stable TBR and who had an HIV-1 RNA<50 c/mL at the time of screening, were continued to receive TBR up to 48 weeks. One participant randomized to the this arm received TDF rather than TAF-and was presented within the "TAF-based regimen" arm for efficacy because the efficacy of TAF and TDF are comparable. However the participant was presented separately under "TDF-based regimen" for Safety because the safety profiles of TDF and TAF differ.
Overall Number of Participants Analyzed 369 371
Mean (Standard Error)
Unit of Measure: Micrograms per liter
Bone-ALP, Week 24, n=350, 354 Number Analyzed 350 participants 354 participants
-0.77  (0.112) -1.05  (0.089)
Bone-ALP, Week 48, n=343, 342 Number Analyzed 343 participants 342 participants
-0.03  (0.145) -0.34  (0.117)
Osteocalcin, Week 24, n=350 ,353 Number Analyzed 350 participants 353 participants
-1.08  (0.248) 0.26  (0.229)
Osteocalcin, Week 48, n=343, 342 Number Analyzed 343 participants 342 participants
-1.15  (0.260) 0.69  (0.279)
P1NP, Week24, n=349 ,356 Number Analyzed 349 participants 356 participants
7.0  (0.87) 5.0  (0.72)
P1NP, Week48, n=342, 343 Number Analyzed 342 participants 343 participants
9.3  (1.06) 6.4  (1.00)
CTX-1, Week 24,n=350,356 Number Analyzed 350 participants 356 participants
0.0350  (0.01057) -0.0031  (0.00833)
CTX-1, Week 48, n=343, 343 Number Analyzed 343 participants 343 participants
0.0602  (0.01024) 0.0310  (0.00889)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DTG+3TC FDC, TAF-based Regimen
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.047
Comments [Not Specified]
Method Mixed Model Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.29
Confidence Interval (2-Sided) 95%
0.00 to 0.57
Estimation Comments Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for Bone-ALP at Week 24 has been presented
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection DTG+3TC FDC, TAF-based Regimen
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.094
Comments [Not Specified]
Method Mixed Model Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.31
Confidence Interval (2-Sided) 95%
-0.05 to 0.68
Estimation Comments Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for Bone-ALP at Week 48 has been presented
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection DTG+3TC FDC, TAF-based Regimen
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Model Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.34
Confidence Interval (2-Sided) 95%
-2.01 to -0.68
Estimation Comments Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for Osteocalcin at Week 24 has been presented
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection DTG+3TC FDC, TAF-based Regimen
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Model Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.84
Confidence Interval (2-Sided) 95%
-2.59 to -1.09
Estimation Comments Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for Osteocalcin at Week 48 has been presented
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection DTG+3TC FDC, TAF-based Regimen
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.066
Comments [Not Specified]
Method Mixed Model Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 2.1
Confidence Interval (2-Sided) 95%
-0.1 to 4.3
Estimation Comments Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for P1NP at Week 24 has been presented
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection DTG+3TC FDC, TAF-based Regimen
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.046
Comments [Not Specified]
Method Mixed Model Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 2.9
Confidence Interval (2-Sided) 95%
0.0 to 5.8
Estimation Comments Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for P1NP at Week 48 has been presented
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection DTG+3TC FDC, TAF-based Regimen
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.005
Comments [Not Specified]
Method Mixed Model Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.0381
Confidence Interval (2-Sided) 95%
0.0117 to 0.0646
Estimation Comments Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for CTX-1 at Week 24 has been presented
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection DTG+3TC FDC, TAF-based Regimen
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.032
Comments [Not Specified]
Method Mixed Model Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.0292
Confidence Interval (2-Sided) 95%
0.0025 to 0.0559
Estimation Comments Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for CTX-1 at Week 48 has been presented
31.Secondary Outcome
Title Change From Baseline in Bone Biomarkers-serum Bone-specific ALP (Bone-ALP), Osteocalcin, Serum P1NP and Serum CTX-1 in Participants Randomized to TBR Arm Receiving TDF-based Regimen
Hide Description Serum samples were collected for analysis of bone biomarkers. Baseline was latest pre-dose assessment (Day 1) with a non-missing value. Change from Baseline is post-dose visit value minus Baseline value. Change from Baseline in bone biomarkers-serum bone-specific ALP (Bone-ALP), osteocalcin, serum P1NP and serum CTX-1 in TDF-based regimen participants has been presented. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."
Time Frame Baseline (Day 1) and at Weeks 24 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Arm/Group Title Randomized to TBR But Received TDF-based Regimen
Hide Arm/Group Description:
Participant randomized to TBR arm who had HIV-1 RNA <50 c/mL at the time of screening, received TDF-based regimen instead of TAF-based regimen in error. Participant continued to receive TDF-regimen up to the Week 48 visit (participant withdrew from the study at Week 36).
Overall Number of Participants Analyzed 1
Measure Type: Number
Unit of Measure: Micrograms per liter
Bone-ALP, Week 24, n=1 Number Analyzed 1 participants
0.3
Bone-ALP, Week 48, n=0 Number Analyzed 0 participants
Osteocalcin, Week 24, n=1 Number Analyzed 1 participants
13.4
Osteocalcin, Week 48, n=0 Number Analyzed 0 participants
P1NP, Week24, n=1 Number Analyzed 1 participants
11
P1NP, Week48, n=0 Number Analyzed 0 participants
CTX-1, Week 24,n=1 Number Analyzed 1 participants
0.045
CTX-1, Week 48, n=0 Number Analyzed 0 participants
32.Secondary Outcome
Title Change From Baseline in Bone Biomarker: Serum 25-hydroxyvitamin D
Hide Description Serum samples were collected for analysis of 25-hydroxyvitamin D. Baseline value was latest pre-dose assessment (Day 1) with a non-missing value. Change from Baseline is defined as post-dose visit value minus Baseline value. Adjusted mean and its corresponding standard error has been presented. Adjusted mean was estimated mean change from Baseline at each visit in each arm calculated from a repeated measures model adjusting for treatment, visit, Baseline third agent class, CD4+ cell count (continuous), age (continuous), sex, race, BMI (continuous), smoking status, vitamin D use, Baseline biomarker (continuous), treatment by visit interaction, and Baseline value by visit interaction, with visit as repeated factor.One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."
Time Frame Baseline (Day 1) and at Weeks 24 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Total of 741 participants were analyzed but 740 participants are presented in this Outcome Measure and 1 participant is presented separately in next Outcome Measure. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Arm/Group Title DTG+3TC FDC TAF-based Regimen
Hide Arm/Group Description:
Participants who were on a stable TBR and who had an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at the time of screening, received fixed dose combination of DTG 50 milligrams (mg) + 3TC 300 mg once daily up to 48 weeks.
Participants who were on a stable TBR and who had an HIV-1 RNA<50 c/mL at the time of screening, were continued to receive TBR up to 48 weeks. One participant randomized to the this arm received TDF rather than TAF-and was presented within the "TAF-based regimen" arm for efficacy because the efficacy of TAF and TDF are comparable. However the participant was presented separately under "TDF-based regimen" for Safety because the safety profiles of TDF and TAF differ.
Overall Number of Participants Analyzed 369 371
Mean (Standard Error)
Unit of Measure: Nanomoles per liter
Week 24, n=351, 355 Number Analyzed 351 participants 355 participants
0.0  (1.10) 2.1  (1.15)
Week 48, n=344, 343 Number Analyzed 344 participants 343 participants
-5.8  (1.21) -3.5  (1.13)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DTG+3TC FDC, TAF-based Regimen
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.173
Comments [Not Specified]
Method Mixed Model Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -2.2
Confidence Interval (2-Sided) 95%
-5.3 to 1.0
Estimation Comments Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for serum 25 hydroxyvitamin D at Week 24 has been presented
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection DTG+3TC FDC, TAF-based Regimen
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.168
Comments [Not Specified]
Method Mixed Model Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -2.3
Confidence Interval (2-Sided) 95%
-5.5 to 1.0
Estimation Comments Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for serum 25 hydroxyvitamin D at Week 48 has been presented
33.Secondary Outcome
Title Change From Baseline in Bone Biomarker: Serum 25-hydroxyvitamin D in Participants Randomized to TBR Arm Receiving TDF-based Regimen
Hide Description Serum samples were collected for the analysis of 25-hydroxyvitamin D. Baseline value was the value from latest pre-dose assessment (Day 1) with a non-missing value. Change from Baseline is defined as post-dose visit value minus Baseline value. Change from Baseline values for serum 25-hydroxyvitamin D in TDF-based regimen participants has been presented. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."
Time Frame Baseline (Day 1) and at Weeks 24 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Arm/Group Title Randomized to TBR But Received TDF-based Regimen
Hide Arm/Group Description:
Participant randomized to TBR arm who had HIV-1 RNA <50 c/mL at the time of screening, received TDF-based regimen instead of TAF-based regimen in error. Participant continued to receive TDF-regimen up to the Week 48 visit (participant withdrew from the study at Week 36).
Overall Number of Participants Analyzed 1
Measure Type: Number
Unit of Measure: Nanomoles per liter
Week 24, n=1 Number Analyzed 1 participants
2
Week 48, n=0 Number Analyzed 0 participants
34.Secondary Outcome
Title Change From Baseline in Renal Biomarker- Serum Cystatin C
Hide Description Serum samples were collected to assess renal biomarker. Baseline was latest pre-dose assessment value (Day 1) with non-missing value. Change from Baseline is post-dose visit value minus Baseline value. Adjusted mean and its corresponding standard error has been presented. Adjusted mean was estimated mean change from Baseline at each visit in each arm calculated from a repeated measures model adjusting for following:treatment, visit, Baseline third agent class, CD4+ cell count(continuous), age(continuous), sex, race, BMI(continuous), presence of diabetes mellitus, presence of hypertension, Baseline biomarker(continuous), treatment by visit interaction, and Baseline value by visit interaction, with visit as repeated factor.One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."
Time Frame Baseline (Day 1) and at Weeks 24 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Total of 741 participants were analyzed but 740 participants are presented in this Outcome Measure and 1 participant is presented separately in next Outcome Measure. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Arm/Group Title DTG+3TC FDC TAF-based Regimen
Hide Arm/Group Description:
Participants who were on a stable TBR and who had an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at the time of screening, received fixed dose combination of DTG 50 milligrams (mg) + 3TC 300 mg once daily up to 48 weeks.
Participants who were on a stable TBR and who had an HIV-1 RNA<50 c/mL at the time of screening, were continued to receive TBR up to 48 weeks. One participant randomized to the this arm received TDF rather than TAF-and was presented within the "TAF-based regimen" arm for efficacy because the efficacy of TAF and TDF are comparable. However the participant was presented separately under "TDF-based regimen" for Safety because the safety profiles of TDF and TAF differ.
Overall Number of Participants Analyzed 369 371
Mean (Standard Error)
Unit of Measure: Milligrams per liter
Week 24, n=351, 357 Number Analyzed 351 participants 357 participants
-0.03  (0.005) -0.02  (0.004)
Week 48, n=344, 343 Number Analyzed 344 participants 343 participants
0.00  (0.006) 0.01  (0.005)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DTG+3TC FDC, TAF-based Regimen
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.027
Comments [Not Specified]
Method Mixed Model Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.01
Confidence Interval (2-Sided) 95%
-0.03 to 0.00
Estimation Comments Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for serum cystatin C at Week 24 has been presented
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection DTG+3TC FDC, TAF-based Regimen
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.061
Comments [Not Specified]
Method Mixed Model Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.01
Confidence Interval (2-Sided) 95%
-0.03 to 0.00
Estimation Comments Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for serum cystatin C at Week 48 has been presented
35.Secondary Outcome
Title Change From Baseline in Renal Biomarker- Serum Cystatin C in Participants Randomized to TBR Arm Receiving TDF-based Regimen
Hide Description Serum samples were collected at Baseline, Week 24 and Week 48 to assess renal inflammation biomarker - cystatin C. Baseline was defined as the latest pre-dose assessment value (Day 1) with a non-missing value. Change from Baseline is defined as post-dose visit value minus Baseline value. Change from Baseline values for serum cystatin -C biomarker in TDF based regimen participants has been presented. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."
Time Frame Baseline (Day 1) and at Weeks 24 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Arm/Group Title Randomized to TBR But Received TDF-based Regimen
Hide Arm/Group Description:
Participant randomized to TBR arm who had HIV-1 RNA <50 c/mL at the time of screening, received TDF-based regimen instead of TAF-based regimen in error. Participant continued to receive TDF-regimen up to the Week 48 visit (participant withdrew from the study at Week 36).
Overall Number of Participants Analyzed 1
Measure Type: Number
Unit of Measure: Milligrams per liter
Week 24, n=1 Number Analyzed 1 participants
0
Week 48, n=0 Number Analyzed 0 participants
36.Secondary Outcome
Title Change From Baseline in Renal Biomarker- Serum GFR From Cystatin C Adjusted Using CKD-EPI and Serum GFR From Creatinine Adjusted Using CKD-EPI at Weeks 24 and 48
Hide Description Serum samples were collected to assess serum GFR from cystatin C and from creatinine adjusted using CKD-EPI. Baseline was Day 1 with non-missing value. Change from Baseline is post-dose visit value minus Baseline value. Adjusted mean and standard error has been presented. Adjusted mean was estimated mean change from Baseline at each visit in each arm calculated from a repeated measures model adjusting for treatment, visit, Baseline third agent class, CD4+ cell count(continuous), age(continuous), sex, race, BMI(continuous), presence of diabetes mellitus, presence of hypertension, Baseline biomarker (continuous), treatment by visit interaction, and Baseline value by visit interaction, with visit as repeated factor. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."
Time Frame Baseline (Day 1) and at Weeks 24 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Total of 741 participants were analyzed but 740 participants are presented in this Outcome Measure and 1 participant is presented separately in next Outcome Measure. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Arm/Group Title DTG+3TC FDC TAF-based Regimen
Hide Arm/Group Description:
Participants who were on a stable TBR and who had an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at the time of screening, received fixed dose combination of DTG 50 milligrams (mg) + 3TC 300 mg once daily up to 48 weeks.
Participants who were on a stable TBR and who had an HIV-1 RNA<50 c/mL at the time of screening, were continued to receive TBR up to 48 weeks. One participant randomized to the this arm received TDF rather than TAF-and was presented within the "TAF-based regimen" arm for efficacy because the efficacy of TAF and TDF are comparable. However the participant was presented separately under "TDF-based regimen" for Safety because the safety profiles of TDF and TAF differ.
Overall Number of Participants Analyzed 369 371
Mean (Standard Error)
Unit of Measure: Milliliters/minute/1.73*meter square
GFR from cystatin C CKD-EPI, Week 24, n=351, 357 Number Analyzed 351 participants 357 participants
3.2  (0.52) 1.5  (0.46)
GFR from cystatin C CKD-EPI, Week 48, n=344, 343 Number Analyzed 344 participants 343 participants
0.1  (0.61) -1.6  (0.59)
GFR from creatinine CKD-EPI, Week 24, n=351, 359 Number Analyzed 351 participants 359 participants
-8.8  (0.48) -3.8  (0.47)
GFR from creatinine CKD-EPI, Week 48, n=344, 345 Number Analyzed 344 participants 345 participants
-7.7  (0.48) -2.9  (0.48)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DTG+3TC FDC, TAF-based Regimen
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.012
Comments [Not Specified]
Method Mixed Model Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 1.8
Confidence Interval (2-Sided) 95%
0.4 to 3.1
Estimation Comments Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for serum GFR from cystatin C adjusted using CKD-EPI at Week 24 has been presented
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection DTG+3TC FDC, TAF-based Regimen
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.059
Comments [Not Specified]
Method Mixed Model Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 1.6
Confidence Interval (2-Sided) 95%
-0.1 to 3.3
Estimation Comments Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for serum GFR from cystatin C adjusted using CKD-EPI at Week 48 has been presented
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection DTG+3TC FDC, TAF-based Regimen
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Model Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -5.0
Confidence Interval (2-Sided) 95%
-6.3 to -3.7
Estimation Comments Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for serum GFR from creatinine adjusted using CKD-EPI at Week 24 has been presented
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection DTG+3TC FDC, TAF-based Regimen
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Model Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -4.8
Confidence Interval (2-Sided) 95%
-6.1 to -3.4
Estimation Comments Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for serum GFR from creatinine adjusted using CKD-EPI at Week 48 has been presented
37.Secondary Outcome
Title Change From Baseline in Renal Biomarker- Serum GFR From Cystatin C Adjusted Using CKD-EPI and Serum GFR From Creatinine Adjusted Using CKD-EPI at Weeks 24 and 48 in Participants Randomized to TBR Arm Receiving TDF-based Regimen
Hide Description Serum samples were collected at Baseline, Week 24 and Week 48 to assess renal inflammation biomarkers - serum GFR from cystatin C adjusted using CKD-EPI and serum GFR from creatinine adjusted using CKD-EPI. Baseline was defined as the latest pre-dose assessment value (Day 1) with a non-missing value. Change from Baseline is defined as post-dose visit value minus Baseline value. Change from Baseline in serum GFR from cystatin C adjusted using CKD-EPI and serum GFR from creatinine adjusted using CKD-EPI in TDF-based regimen participants has been presented. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."
Time Frame Baseline (Day 1) and at Weeks 24 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Arm/Group Title Randomized to TBR But Received TDF-based Regimen
Hide Arm/Group Description:
Participant randomized to TBR arm who had HIV-1 RNA <50 c/mL at the time of screening, received TDF-based regimen instead of TAF-based regimen in error. Participant continued to receive TDF-regimen up to the Week 48 visit (participant withdrew from the study at Week 36).
Overall Number of Participants Analyzed 1
Measure Type: Number
Unit of Measure: Milliliters/minute/1.73*meter square
GFR from cystatin C CKD-EPI, Week 24, n=1 Number Analyzed 1 participants
0
GFR from cystatin C CKD-EPI, Week 48, n=0 Number Analyzed 0 participants
GFR from creatinine CKD-EPI, Week 24, n=1 Number Analyzed 1 participants
4
GFR from creatinine CKD-EPI, Week 48, n=0 Number Analyzed 0 participants
38.Secondary Outcome
Title Change From Baseline in Renal Biomarker- Serum Creatinine
Hide Description Serum samples were collected to assess renal inflammation biomarker - serum creatinine. Baseline was Day 1 with a non-missing value. Change from Baseline is post-dose visit value minus Baseline value. Adjusted mean and its corresponding standard error has been presented. Adjusted mean was the estimated mean change from Baseline at each visit in each arm calculated from a repeated measures model adjusting for treatment, visit, Baseline third agent class, CD4+ cell count (continuous), age (continuous), sex, race, BMI (continuous), presence of diabetes mellitus, presence of hypertension, Baseline biomarker (continuous), treatment by visit interaction, and Baseline value by visit interaction, with visit as repeated factor. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."
Time Frame Baseline (Day 1) and at Weeks 24 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Total of 741 participants were analyzed but 740 participants are presented in this Outcome Measure and 1 participant is presented separately in next Outcome Measure. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Arm/Group Title DTG+3TC FDC TAF-based Regimen
Hide Arm/Group Description:
Participants who were on a stable TBR and who had an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at the time of screening, received fixed dose combination of DTG 50 milligrams (mg) + 3TC 300 mg once daily up to 48 weeks.
Participants who were on a stable TBR and who had an HIV-1 RNA<50 c/mL at the time of screening, were continued to receive TBR up to 48 weeks. One participant randomized to the this arm received TDF rather than TAF-and was presented within the "TAF-based regimen" arm for efficacy because the efficacy of TAF and TDF are comparable. However the participant was presented separately under "TDF-based regimen" for Safety because the safety profiles of TDF and TAF differ.
Overall Number of Participants Analyzed 369 371
Mean (Standard Error)
Unit of Measure: Micromoles per liter
Week 24, n=351, 359 Number Analyzed 351 participants 359 participants
7.47  (0.466) 3.11  (0.495)
Week 48, n=344, 345 Number Analyzed 344 participants 345 participants
6.67  (0.493) 2.18  (0.450)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DTG+3TC FDC, TAF-based Regimen
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Model Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 4.37
Confidence Interval (2-Sided) 95%
3.03 to 5.70
Estimation Comments Mean difference (DTG+3TC - TBR) and its 95% CI for serum creatinine at Week 24 has been presented.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection DTG+3TC FDC, TAF-based Regimen
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Model Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 4.49
Confidence Interval (2-Sided) 95%
3.18 to 5.81
Estimation Comments Mean difference (DTG+3TC - TBR) and its 95% CI for serum creatinine at Week 48 has been presented.
39.Secondary Outcome
Title Change From Baseline in Renal Biomarker- Serum Creatinine in Participants Randomized to TBR Arm Receiving TDF-based Regimen
Hide Description Serum samples were collected at Baseline, Week 24 and Week 48 to assess renal inflammation biomarker - serum creatinine. Baseline was defined as the latest pre-dose assessment value (Day 1) with a non-missing value. Change from Baseline is defined as post-dose visit value minus Baseline value. Change from Baseline in serum creatinine in TDF-based regimen participants has been presented. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."
Time Frame Baseline (Day 1) and at Weeks 24 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Arm/Group Title Randomized to TBR But Received TDF-based Regimen
Hide Arm/Group Description:
Participant randomized to TBR arm who had HIV-1 RNA <50 c/mL at the time of screening, received TDF-based regimen instead of TAF-based regimen in error. Participant continued to receive TDF-regimen up to the Week 48 visit (participant withdrew from the study at Week 36).
Overall Number of Participants Analyzed 1
Measure Type: Number
Unit of Measure: Micromoles per liter
Week 24, n=1 Number Analyzed 1 participants
-8
Week 48, n=0 Number Analyzed 0 participants
40.Secondary Outcome
Title Change From Baseline in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Utility Score at Week 24 and 48
Hide Description EQ-5D-5L questionnaire provides a profile of participant function and a global health state rating. The five-item measure has one question assessing each of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and 5 levels for each dimension including 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. The health state is defined by combining the levels of answers from each of the 5 questions. Each health state is referred to in terms of a 5 digit code. Health state 5 digit code is translated into utility score, which is valued up to 1 (perfect health) with lower values meaning worse state. EQ-5D-5L utility score ranges from -0.281 to 1. Higher scores indicate better health.
Time Frame Baseline (Day 1) and at Weeks 24 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population. One participant randomized to TBR but received TDF-based regimen and was presented within the "TBR (TAF-based regimen) arm" as efficacy of TAF and TDF are comparable. Only those participants with data available at the specified data points were analyzed.
Arm/Group Title DTG+3TC FDC TAF-based Regimen
Hide Arm/Group Description:
Participants who were on a stable TBR and who had an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at the time of screening, received fixed dose combination of DTG 50 milligrams (mg) + 3TC 300 mg once daily up to 48 weeks.
Participants who were on a stable TBR and who had an HIV-1 RNA<50 c/mL at the time of screening, were continued to receive TBR up to 48 weeks. One participant randomized to the this arm received TDF rather than TAF-and was presented within the "TAF-based regimen" arm for efficacy because the efficacy of TAF and TDF are comparable. However the participant was presented separately under "TDF-based regimen" for Safety because the safety profiles of TDF and TAF differ.
Overall Number of Participants Analyzed 364 370
Mean (Standard Error)
Unit of Measure: Scores on a scale
Week 24 0.0029  (0.00383) 0.0046  (0.00352)
Week 48 0.0037  (0.00407) 0.0023  (0.00373)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DTG+3TC FDC, TAF-based Regimen
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.741
Comments [Not Specified]
Method Mixed Model Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.0017
Confidence Interval (2-Sided) 95%
-0.0119 to 0.0085
Estimation Comments Week 24. MMRM adjusted for following: Treatment, Visit, Baseline Third Agent Class, Baseline EQ-5D Utility (continuous), Treatment by Visit interaction, and Baseline EQ-5D Utility by Visit interaction, with Visit as the repeated factor.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection DTG+3TC FDC, TAF-based Regimen
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.792
Comments [Not Specified]
Method Mixed Model Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.0015
Confidence Interval (2-Sided) 95%
-0.0094 to 0.0123
Estimation Comments Week 48. MMRM adjusted for following: Treatment, Visit, Baseline Third Agent Class, Baseline EQ-5D Utility (continuous), Treatment by Visit interaction, and Baseline EQ-5D Utility by Visit interaction, with Visit as the repeated factor.
41.Secondary Outcome
Title Change From Baseline in EQ-5D-5L Thermometer Scores at Week 24 and 48
Hide Description EEQ-5D-5L questionnaire provides a profile of participant function and a global health state rating. The five-item measure has one question assessing each of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and 5 levels for each dimension including 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. EQ-5D-5L included EQ visual Analogue scale (EQ VAS) 'Thermometer' which provided Self-rated current health status. Score ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). MMRM was run on the LOCF dataset. Baseline was the latest pre-dose assessment value (Day 1) and change from Baseline=post-dose value minus Baseline value.
Time Frame Baseline (Day 1) and at Weeks 24 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population. One participant randomized to TBR but received TDF-based regimen and was presented within the "TBR (TAF-based regimen) arm" as efficacy of TAF and TDF are comparable. Only those participants with data available at the specified data points were analyzed.
Arm/Group Title DTG+3TC FDC TAF-based Regimen
Hide Arm/Group Description:
Participants who were on a stable TBR and who had an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at the time of screening, received fixed dose combination of DTG 50 milligrams (mg) + 3TC 300 mg once daily up to 48 weeks.
Participants who were on a stable TBR and who had an HIV-1 RNA<50 c/mL at the time of screening, were continued to receive TBR up to 48 weeks. One participant randomized to the this arm received TDF rather than TAF-and was presented within the "TAF-based regimen" arm for efficacy because the efficacy of TAF and TDF are comparable. However the participant was presented separately under "TDF-based regimen" for Safety because the safety profiles of TDF and TAF differ.
Overall Number of Participants Analyzed 364 369
Mean (Standard Error)
Unit of Measure: Scores on a scale
Week 24 1.2  (0.49) 1.3  (0.44)
Week 48 1.1  (0.52) 1.7  (0.43)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DTG+3TC FDC, TAF-based Regimen
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.879
Comments [Not Specified]
Method Mixed Model Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.1
Confidence Interval (2-Sided) 95%
-1.4 to 1.2
Estimation Comments Week 24. MMRM adjusted for following: Treatment, Visit, Baseline Third Agent Class, Baseline EQ-5D Thermometer (continuous), Treatment by Visit interaction, and Baseline EQ-5D Thermometer by Visit interaction, with Visit as the repeated factor.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection DTG+3TC FDC, TAF-based Regimen
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.414
Comments [Not Specified]
Method Mixed Model Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.5
Confidence Interval (2-Sided) 95%
-1.9 to 0.8
Estimation Comments Week 48. MMRM adjusted for following: Treatment, Visit, Baseline Third Agent Class, Baseline EQ-5D Thermometer (continuous), Treatment by Visit interaction, and Baseline EQ-5D Thermometer by Visit interaction, with Visit as the repeated factor.
Time Frame Non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Week 48.
Adverse Event Reporting Description Safety Population. One participant randomized to TBR received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."
 
Arm/Group Title DTG + 3TC TAF Based Regimen Randomized to TBR But Received TDF-based Regimen
Hide Arm/Group Description Participants who were on a stable TBR and who had an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at the time of screening, received fixed dose combination of DTG 50 milligrams (mg) + 3TC 300 mg once daily up to 48 weeks. Participants who were on a stable TBR and who had an HIV-1 RNA<50 c/mL at the time of screening, were continued to receive TBR up to 48 weeks. Participant randomized to TBR arm who had HIV-1 RNA <50 c/mL at the time of screening, received TDF-based regimen instead of TAF-based regimen in error. Participant continued to receive TDF-regimen up to the Week 48 visit (participant withdrew from the study at Week 36).
All-Cause Mortality
DTG + 3TC TAF Based Regimen Randomized to TBR But Received TDF-based Regimen
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/369 (0.27%)      0/371 (0.00%)      0/1 (0.00%)    
Hide Serious Adverse Events
DTG + 3TC TAF Based Regimen Randomized to TBR But Received TDF-based Regimen
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   21/369 (5.69%)      16/371 (4.31%)      0/1 (0.00%)    
Cardiac disorders       
Acute myocardial infarction  1  0/369 (0.00%)  0 1/371 (0.27%)  2 0/1 (0.00%)  0
Atrial fibrillation  1  1/369 (0.27%)  1 0/371 (0.00%)  0 0/1 (0.00%)  0
Atrial flutter  1  1/369 (0.27%)  1 0/371 (0.00%)  0 0/1 (0.00%)  0
Ventricular tachycardia  1  1/369 (0.27%)  1 0/371 (0.00%)  0 0/1 (0.00%)  0
Gastrointestinal disorders       
Inguinal hernia  1  1/369 (0.27%)  1 0/371 (0.00%)  0 0/1 (0.00%)  0
Pancreatitis  1  0/369 (0.00%)  0 1/371 (0.27%)  3 0/1 (0.00%)  0
Hepatobiliary disorders       
Cholecystitis  1  1/369 (0.27%)  1 1/371 (0.27%)  1 0/1 (0.00%)  0
Biliary dyskinesia  1  1/369 (0.27%)  1 0/371 (0.00%)  0 0/1 (0.00%)  0
Cholelithiasis  1  0/369 (0.00%)  0 1/371 (0.27%)  1 0/1 (0.00%)  0
Infections and infestations       
Pneumonia  1  2/369 (0.54%)  2 1/371 (0.27%)  1 0/1 (0.00%)  0
Amniotic cavity infection  1  1/369 (0.27%)  1 0/371 (0.00%)  0 0/1 (0.00%)  0
Anal abscess  1  0/369 (0.00%)  0 1/371 (0.27%)  1 0/1 (0.00%)  0
Escherichia sepsis  1  0/369 (0.00%)  0 1/371 (0.27%)  1 0/1 (0.00%)  0
Labyrinthitis  1  1/369 (0.27%)  1 0/371 (0.00%)  0 0/1 (0.00%)  0
Meningitis pneumococcal  1  0/369 (0.00%)  0 1/371 (0.27%)  1 0/1 (0.00%)  0
Pertussis  1  1/369 (0.27%)  1 0/371 (0.00%)  0 0/1 (0.00%)  0
Pyelonephritis  1  0/369 (0.00%)  0 1/371 (0.27%)  1 0/1 (0.00%)  0
Shigella infection  1  0/369 (0.00%)  0 1/371 (0.27%)  1 0/1 (0.00%)  0
Injury, poisoning and procedural complications       
Femoral neck fracture  1  1/369 (0.27%)  1 0/371 (0.00%)  0 0/1 (0.00%)  0
Gun shot wound  1  1/369 (0.27%)  1 0/371 (0.00%)  0 0/1 (0.00%)  0
Overdose  1  0/369 (0.00%)  0 1/371 (0.27%)  1 0/1 (0.00%)  0
Metabolism and nutrition disorders       
Hypokalaemia  1  1/369 (0.27%)  1 0/371 (0.00%)  0 0/1 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Osteitis  1  0/369 (0.00%)  0 1/371 (0.27%)  1 0/1 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Adenocarcinoma pancreas  1  0/369 (0.00%)  0 1/371 (0.27%)  1 0/1 (0.00%)  0
Diffuse large B-cell lymphoma  1  1/369 (0.27%)  1 0/371 (0.00%)  0 0/1 (0.00%)  0
Lung adenocarcinoma  1  1/369 (0.27%)  1 0/371 (0.00%)  0 0/1 (0.00%)  0
Metastases to liver  1  0/369 (0.00%)  0 1/371 (0.27%)  1 0/1 (0.00%)  0
Penile squamous cell carcinoma  1  1/369 (0.27%)  1 0/371 (0.00%)  0 0/1 (0.00%)  0
Nervous system disorders       
Cerebral haematoma  1  1/369 (0.27%)  1 0/371 (0.00%)  0 0/1 (0.00%)  0
Encephalopathy  1  0/369 (0.00%)  0 1/371 (0.27%)  1 0/1 (0.00%)  0
Facial paresis  1  1/369 (0.27%)  1 0/371 (0.00%)  0 0/1 (0.00%)  0
Pregnancy, puerperium and perinatal conditions       
Amniorrhoea  1  1/369 (0.27%)  1 0/371 (0.00%)  0 0/1 (0.00%)  0
Psychiatric disorders       
Suicidal ideation  1  2/369 (0.54%)  2 0/371 (0.00%)  0 0/1 (0.00%)  0
Anxiety  1  1/369 (0.27%)  1 0/371 (0.00%)  0 0/1 (0.00%)  0
Depression  1  0/369 (0.00%)  0 1/371 (0.27%)  1 0/1 (0.00%)  0
Suicide attempt  1  0/369 (0.00%)  0 1/371 (0.27%)  1 0/1 (0.00%)  0
Reproductive system and breast disorders       
Ovarian cyst  1  0/369 (0.00%)  0 1/371 (0.27%)  1 0/1 (0.00%)  0
Ovarian haematoma  1  0/369 (0.00%)  0 1/371 (0.27%)  1 0/1 (0.00%)  0
Prostatitis  1  0/369 (0.00%)  0 1/371 (0.27%)  1 0/1 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Chronic obstructive pulmonary disease  1  1/369 (0.27%)  1 0/371 (0.00%)  0