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Study to Evaluate Efficacy and Safety of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Regimen Versus Boosted Protease Inhibitor (bPI) Along With Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) Regimen in Virologically-Suppressed, HIV-1 Infected Participants

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ClinicalTrials.gov Identifier: NCT02269917
Recruitment Status : Completed
First Posted : October 21, 2014
Results First Posted : November 9, 2018
Last Update Posted : December 9, 2021
Sponsor:
Information provided by (Responsible Party):
Janssen R&D Ireland

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Human Immunodeficiency Virus Type 1
Interventions Drug: D/C/F/TAF
Drug: Boosted Protease Inhibitor (bPI)
Drug: FTC/TDF
Enrollment 1149
Recruitment Details  
Pre-assignment Details  
Arm/Group Title D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) Control (Baseline to Switch) Switch to D/C/F/TAF
Hide Arm/Group Description Participants received a single fixed dose combination (FDC) tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF tablet), orally once daily up to Week 48. After Week 48, all participants continued to receive D/C/F/TAF treatment (that is, initial switch to D/C/F/TAF group) up to Week 96. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until D/C/F/TAF became commercially available up to 42 months (end of extension). Participants received a boosted protease inhibitor (bPI) (limited to darunavir [DRV] or atazanavir with low-dose ritonavir [rtv] or cobicistat [COBI], or lopinavir with rtv) combined with emtricitabine/tenofovir disoproxil fumarate (F/TDF) up to Week 48. After Week 52, participants earlier receiving treatment with bPI+F/TDF switched to D/C/F/TAF treatment up to Week 96. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until D/C/F/TAF became commercially available for up to 42 months.
Period Title: BL to EOE-Test and BL to Switch-Control
Started 766 383 0
Treated 763 378 0
Completed 649 352 0
Not Completed 117 31 0
Reason Not Completed
Lost to Follow-up             25             7             0
Other             19             4             0
Withdrawal by Subject             32             10             0
Adverse Event             24             4             0
Non-compliance with study drug             4             0             0
Physician Decision             4             0             0
Protocol Violation             2             1             0
Death             4             0             0
Randomized but not treated             3             5             0
Period Title: Switch to D/C/F/TAF (Until EOE)
Started 0 0 352
Completed 0 0 314
Not Completed 0 0 38
Reason Not Completed
Death             0             0             1
Lost to Follow-up             0             0             10
Adverse Event             0             0             11
Physician Decision             0             0             1
Pregnancy             0             0             2
Withdrawal by Subject             0             0             5
Other             0             0             8
Arm/Group Title D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) Control (Baseline to Switch) Total
Hide Arm/Group Description Participants received a single fixed dose combination (FDC) tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF tablet), orally once daily up to Week 48. After Week 48, all participants continued to receive D/C/F/TAF treatment (that is, initial switch to D/C/F/TAF group) up to Week 96. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until D/C/F/TAF became commercially available up to 42 months (end of extension). Participants received a boosted protease inhibitor (bPI) (limited to darunavir [DRV] or atazanavir with low-dose ritonavir [rtv] or cobicistat [COBI], or lopinavir with rtv) combined with emtricitabine/tenofovir disoproxil fumarate (F/TDF) up to Week 48. Total of all reporting groups
Overall Number of Baseline Participants 763 378 1141
Hide Baseline Analysis Population Description
Intent-to-treat (ITT) analysis set included all the participants who were randomized and received at least 1 dose of study treatment.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 763 participants 378 participants 1141 participants
45.3  (10.86) 44.8  (10.77) 45.1  (10.83)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 763 participants 378 participants 1141 participants
Female
140
  18.3%
65
  17.2%
205
  18.0%
Male
623
  81.7%
313
  82.8%
936
  82.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 763 participants 378 participants 1141 participants
Hispanic or Latino
111
  14.5%
59
  15.6%
170
  14.9%
Not Hispanic or Latino
649
  85.1%
317
  83.9%
966
  84.7%
Unknown or Not Reported
3
   0.4%
2
   0.5%
5
   0.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 763 participants 378 participants 1141 participants
American Indian or Alaska Native
5
   0.7%
2
   0.5%
7
   0.6%
Asian
17
   2.2%
9
   2.4%
26
   2.3%
Native Hawaiian or Other Pacific Islander
2
   0.3%
0
   0.0%
2
   0.2%
Black or African American
155
  20.3%
82
  21.7%
237
  20.8%
White
573
  75.1%
282
  74.6%
855
  74.9%
More than one race
5
   0.7%
1
   0.3%
6
   0.5%
Unknown or Not Reported
6
   0.8%
2
   0.5%
8
   0.7%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 763 participants 378 participants 1141 participants
Asian
17
   2.2%
9
   2.4%
26
   2.3%
Black or African American
155
  20.3%
82
  21.7%
237
  20.8%
Hispanic or Latino
95
  12.5%
56
  14.8%
151
  13.2%
Other
20
   2.6%
6
   1.6%
26
   2.3%
White Non-Hispanic
476
  62.4%
225
  59.5%
701
  61.4%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 763 participants 378 participants 1141 participants
Belgium
32
   4.2%
20
   5.3%
52
   4.6%
Canada
45
   5.9%
21
   5.6%
66
   5.8%
France
69
   9.0%
28
   7.4%
97
   8.5%
Poland
91
  11.9%
35
   9.3%
126
  11.0%
Spain
117
  15.3%
52
  13.8%
169
  14.8%
Sweden
23
   3.0%
5
   1.3%
28
   2.5%
Switzerland
26
   3.4%
13
   3.4%
39
   3.4%
United Kingdom
47
   6.2%
23
   6.1%
70
   6.1%
United States
313
  41.0%
181
  47.9%
494
  43.3%
1.Primary Outcome
Title Percentage of Participants With Virologic Rebound (HIV-1 RNA >=50 Copies/mL) Cumulative Through Week 48
Hide Description Virologic rebound was defined as: confirmed plasma human immunodeficiency virus - 1 (HIV-1) Ribonucleic Acid (RNA) level greater than or equal to (>=)50 copies per milliliter (copies/mL) up to, and including the upper bound of the Week 48 window (ie, 54 weeks) and last available on-treatment (single) HIV-1 RNA >=50 copies/mL at premature discontinuation (irrespective of reason). Percentage of participants with virologic rebound were reported.
Time Frame Through Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) analysis set included all the participants who were randomized and received at least 1 dose of study treatment.
Arm/Group Title D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) Control (Baseline to Switch)
Hide Arm/Group Description:
Participants received a single fixed dose combination (FDC) tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF tablet), orally once daily up to Week 48. After Week 48, all participants continued to receive D/C/F/TAF treatment (that is, initial switch to D/C/F/TAF group) up to Week 96. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until D/C/F/TAF became commercially available up to 42 months (end of extension).
Participants received a boosted protease inhibitor (bPI) (limited to darunavir [DRV] or atazanavir with low-dose ritonavir [rtv] or cobicistat [COBI], or lopinavir with rtv) combined with emtricitabine/tenofovir disoproxil fumarate (F/TDF) up to Week 48.
Overall Number of Participants Analyzed 763 378
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
2.5
(1.5 to 3.9)
2.1
(0.9 to 4.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]), Control (Baseline to Switch)
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments 4
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Stratum-adjusted Mantel-Haenszel (MH)
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 0.4
Confidence Interval (2-Sided) 95%
-1.5 to 2.2
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants With Virologic Rebound (Plasma HIV-1 RNA >=20 Copies/mL) Cumulative Through 48 Weeks
Hide Description Virologic rebound was defined as: confirmed plasma HIV-1 RNA >=20 copies/mL up to, and including the upper bound of the Week 48 window (ie, 54 weeks) and last available on-treatment (single) HIV-1 RNA >=20 copies/mL at premature discontinuation (irrespective of reason). Percentage of participants with virologic rebound were reported.
Time Frame Through 48 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set included all participants who were randomized and received at least 1 dose of study treatment.
Arm/Group Title D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) Control (Baseline to Switch)
Hide Arm/Group Description:
Participants received a single fixed dose combination (FDC) tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF tablet), orally once daily up to Week 48. After Week 48, all participants continued to receive D/C/F/TAF treatment (that is, initial switch to D/C/F/TAF group) up to Week 96. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until D/C/F/TAF became commercially available up to 42 months (end of extension).
Participants received a boosted protease inhibitor (bPI) (limited to darunavir [DRV] or atazanavir with low-dose ritonavir [rtv] or cobicistat [COBI], or lopinavir with rtv) combined with emtricitabine/tenofovir disoproxil fumarate (F/TDF) up to Week 48.
Overall Number of Participants Analyzed 763 378
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
10.5
(8.4 to 12.9)
11.4
(8.4 to 15.0)
3.Secondary Outcome
Title Percentage of Participants With Virologic Rebound (Plasma HIV-1 RNA >=200 Copies/mL) Cumulative Through 48 Weeks
Hide Description Virologic rebound was defined as: confirmed plasma HIV-1 RNA >=200 copies/mL up to, and including the upper bound of the Week 48 window (ie, 54 weeks) and last available on-treatment (single) HIV-1 RNA >=200 copies/mL at premature discontinuation (irrespective of reason). Percentage of participants with virologic rebound were reported.
Time Frame Through 48 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set included all participants who were randomized and received at least 1 dose of study treatment.
Arm/Group Title D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) Control (Baseline to Switch)
Hide Arm/Group Description:
Participants received a single fixed dose combination (FDC) tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF tablet), orally once daily up to Week 48. After Week 48, all participants continued to receive D/C/F/TAF treatment (that is, initial switch to D/C/F/TAF group) up to Week 96. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until D/C/F/TAF became commercially available up to 42 months (end of extension).
Participants received a boosted protease inhibitor (bPI) (limited to darunavir [DRV] or atazanavir with low-dose ritonavir [rtv] or cobicistat [COBI], or lopinavir with rtv) combined with emtricitabine/tenofovir disoproxil fumarate (F/TDF) up to Week 48.
Overall Number of Participants Analyzed 763 378
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
0.4
(0.1 to 1.1)
0.0 [1] 
(NA to NA)
[1]
Here NA signifies that the Confidence Interval (CI) was not estimable as no participants had virologic rebound in this group.
4.Secondary Outcome
Title Percentage of Participants With Non-Virologic Rebound at Week 48 by Kaplan-Meier Estimates
Hide Description Virologic rebound was defined as: confirmed plasma HIV-1 RNA >=50 copies/mL up to, and including the upper bound of the Week 48 window (ie, 54 weeks) and last available on-treatment (single) HIV-1 RNA >=50 copies/mL at premature discontinuation (irrespective of reason). Here Kaplan-Meier estimates percentage of participants with non-virologic rebound at week 48.
Time Frame Baseline up to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set included all participants who were randomized and received at least 1 dose of study treatment.
Arm/Group Title D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) Control (Baseline to Switch)
Hide Arm/Group Description:
Participants received a single fixed dose combination (FDC) tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF tablet), orally once daily up to Week 48. After Week 48, all participants continued to receive D/C/F/TAF treatment (that is, initial switch to D/C/F/TAF group) up to Week 96. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until D/C/F/TAF became commercially available up to 42 months (end of extension).
Participants received a boosted protease inhibitor (bPI) (limited to darunavir [DRV] or atazanavir with low-dose ritonavir [rtv] or cobicistat [COBI], or lopinavir with rtv) combined with emtricitabine/tenofovir disoproxil fumarate (F/TDF) up to Week 48.
Overall Number of Participants Analyzed 763 378
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
97.7
(96.4 to 98.6)
97.8
(95.7 to 98.9)
5.Secondary Outcome
Title Percentage of Participants Experiencing Grade 3 and 4 Adverse Events (AEs), Serious Adverse Events (SAEs), and Premature Discontinuation Due to AEs Through Week 48
Hide Description An AE is any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Grade 3 (Severe) events were symptoms causing inability to perform usual social & functional activities. Grade 4 (Life-threatening) events were symptoms causing inability to perform basic self-care functions or medical or operative intervention indicated to prevent permanent impairment, persistent disability, or death.
Time Frame Up to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set included all the participants who were randomized and received at least 1 dose of study treatment.
Arm/Group Title D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) Control (Baseline to Switch)
Hide Arm/Group Description:
Participants received a single fixed dose combination (FDC) tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF tablet), orally once daily up to Week 48. After Week 48, all participants continued to receive D/C/F/TAF treatment (that is, initial switch to D/C/F/TAF group) up to Week 96. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until D/C/F/TAF became commercially available up to 42 months (end of extension).
Participants received a boosted protease inhibitor (bPI) (limited to darunavir [DRV] or atazanavir with low-dose ritonavir [rtv] or cobicistat [COBI], or lopinavir with rtv) combined with emtricitabine/tenofovir disoproxil fumarate (F/TDF) up to Week 48.
Overall Number of Participants Analyzed 763 378
Measure Type: Number
Unit of Measure: Percentage of Participants
Grade 3 AEs 5.6 6.3
Grade 4 AEs 1.2 1.9
SAEs 4.6 4.8
Premature discontinuations due to AEs 1.4 1.3
6.Secondary Outcome
Title Change From Baseline in Serum Creatinine Levels at Weeks 24 and 48
Hide Description Change from baseline in serum creatinine levels at Weeks 24 and 48 was assessed.
Time Frame Baseline and Weeks 24 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set included all participants randomized and received at least 1 dose of study treatment. Here, N (number of participants analyzed) indicates number of participants evaluable for this endpoint; and 'n' specifies participants analyzed for this endpoint at given time point.
Arm/Group Title D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) Control (Baseline to Switch)
Hide Arm/Group Description:
Participants received a single fixed dose combination (FDC) tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF tablet), orally once daily up to Week 48. After Week 48, all participants continued to receive D/C/F/TAF treatment (that is, initial switch to D/C/F/TAF group) up to Week 96. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until D/C/F/TAF became commercially available up to 42 months (end of extension).
Participants received a boosted protease inhibitor (bPI) (limited to darunavir [DRV] or atazanavir with low-dose ritonavir [rtv] or cobicistat [COBI], or lopinavir with rtv) combined with emtricitabine/tenofovir disoproxil fumarate (F/TDF) up to Week 48.
Overall Number of Participants Analyzed 761 378
Least Squares Mean (Standard Error)
Unit of Measure: micro mole per liter
Change at Week 24 Number Analyzed 735 participants 362 participants
1.22  (0.358) 0.88  (0.509)
Change at Week 48 Number Analyzed 725 participants 350 participants
1.27  (0.368) 0.65  (0.530)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]), Control (Baseline to Switch)
Comments Change at Week 24
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.580
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Square (LS) Mean Difference
Estimated Value 0.34
Confidence Interval (2-Sided) 95%
-0.88 to 1.57
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.623
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]), Control (Baseline to Switch)
Comments Change at Week 48
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.340
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Square (LS) Mean Difference
Estimated Value 0.62
Confidence Interval (2-Sided) 95%
-0.65 to 1.88
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.646
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Change From Baseline in Estimated Glomerular Filtration Rate Based on Serum Creatinine (eGFRcr, by Cockcroft-Gault Formula [eGFRcg]) at Weeks 24 and 48
Hide Description Change from baseline in eGFRcr (by Cockcroft-Gault formula) was assessed at Weeks 24 and 48. eGFRcr according to the Cockcroft Gault formula- Male: (140 - age in years)*(weight in kilogram [kg])/72*(serum creatinine in milligram per deciliter [mg/dL])=eGFRcr (milliliter per minute [mL/min]); Female: (140 - age in years)*(weight in kg)/72*(serum creatinine in mg/dL)*0.85=eGFRcr (mL/min).
Time Frame Baseline, Weeks 24 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set included all the participants who were randomized and received at least 1 dose of study treatment. Here, N (number of participants analyzed) indicates number of participants evaluable for this endpoint; and 'n' specifies those participants who were analyzed for this endpoint at given time point.
Arm/Group Title D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) Control (Baseline to Switch)
Hide Arm/Group Description:
Participants received a single fixed dose combination (FDC) tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF tablet), orally once daily up to Week 48. After Week 48, all participants continued to receive D/C/F/TAF treatment (that is, initial switch to D/C/F/TAF group) up to Week 96. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until D/C/F/TAF became commercially available up to 42 months (end of extension).
Participants received a boosted protease inhibitor (bPI) (limited to darunavir [DRV] or atazanavir with low-dose ritonavir [rtv] or cobicistat [COBI], or lopinavir with rtv) combined with emtricitabine/tenofovir disoproxil fumarate (F/TDF) up to Week 48.
Overall Number of Participants Analyzed 761 378
Least Squares Mean (Standard Error)
Unit of Measure: milliliter per minute (mL/min)
Change at Week 24 Number Analyzed 735 participants 362 participants
-0.38  (0.502) 0.20  (0.715)
Change at Week 48 Number Analyzed 725 participants 350 participants
-0.94  (0.492) -0.20  (0.708)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]), Control (Baseline to Switch)
Comments Change at Week 24
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.506
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.58
Confidence Interval (2-Sided) 95%
-2.30 to 1.13
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.874
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]), Control (Baseline to Switch)
Comments Change Week 48
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.392
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.74
Confidence Interval (2-Sided) 95%
-2.43 to 0.95
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.862
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Change From Baseline in Estimated Glomerular Filtration Rate Based on Serum Creatinine (eGFRcr, by Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI]) at Weeks 24 and 48
Hide Description Change from baseline in eGFRcr (by CKD-EPI) was assessed at Weeks 24 and 48. eGFRcr per CKD-EPI formula - Female: 1) Serum creatinine (Scr) less than or equal to (<=)0.7 mg/dL: 144*(Scr/0.7)^-0.329*0.993age; 2) Scr greater than (>)0.7 mg/dL: 144*(Scr/0.7)^-1.209*0.993age. Male: 1) Scr <=0.9 mg/dL: 141*(Scr/0.9)^-0.411*0.993age; 2) Scr >0.9 mg/dL: 141*(Scr/0.9)^-1.209*0.993age.
Time Frame Baseline, Weeks 24 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set included all the participants who were randomized and received at least 1 dose of study treatment. Here, N (number of participants analyzed) indicates number of participants evaluable for this endpoint; and 'n' specifies those participants who were analyzed for this endpoint at given time point.
Arm/Group Title D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) Control (Baseline to Switch)
Hide Arm/Group Description:
Participants received a single fixed dose combination (FDC) tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF tablet), orally once daily up to Week 48. After Week 48, all participants continued to receive D/C/F/TAF treatment (that is, initial switch to D/C/F/TAF group) up to Week 96. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until D/C/F/TAF became commercially available up to 42 months (end of extension).
Participants received a boosted protease inhibitor (bPI) (limited to darunavir [DRV] or atazanavir with low-dose ritonavir [rtv] or cobicistat [COBI], or lopinavir with rtv) combined with emtricitabine/tenofovir disoproxil fumarate (F/TDF) up to Week 48.
Overall Number of Participants Analyzed 761 378
Least Squares Mean (Standard Error)
Unit of Measure: mL/min/1.73 m^2
Change at Week 24 Number Analyzed 735 participants 362 participants
-1.67  (0.359) -0.75  (0.510)
Change at Week 48 Number Analyzed 725 participants 350 participants
-1.97  (0.369) -0.88  (0.531)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]), Control (Baseline to Switch)
Comments Change at Week 24
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.143
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.92
Confidence Interval (2-Sided) 95%
-2.14 to 0.31
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.624
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]), Control (Baseline to Switch)
Comments Change at Week 48
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.092
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.09
Confidence Interval (2-Sided) 95%
-2.36 to 0.18
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.646
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Change From Baseline in Estimated Glomerular Filtration Rate Based on Serum Cystatin C (eGFRcyst, by Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI]) at Weeks 24 and 48
Hide Description Change from baseline in eGFRcyst (by CKD-EPI) was assessed at Weeks 24 and 48. eGFRcyst according to the CKD-EPI formula - 1) Serum Cystatin C (Scyst) <=0.8 mg/L: 133*(Scyst/0.8)^-0.499*0.996age (*0.932 if female); 2) Scyst >0.8 mg/L: 133*(Scyst/0.8)^-1.328*0.996age (*0.932 if female).
Time Frame Baseline, Weeks 24 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set included all the participants who were randomized and received at least 1 dose of study treatment. Here, 'n' specifies those participants who were analyzed for this endpoint at given time point.
Arm/Group Title D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) Control (Baseline to Switch)
Hide Arm/Group Description:
Participants received a single fixed dose combination (FDC) tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF tablet), orally once daily up to Week 48. After Week 48, all participants continued to receive D/C/F/TAF treatment (that is, initial switch to D/C/F/TAF group) up to Week 96. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until D/C/F/TAF became commercially available up to 42 months (end of extension).
Participants received a boosted protease inhibitor (bPI) (limited to darunavir [DRV] or atazanavir with low-dose ritonavir [rtv] or cobicistat [COBI], or lopinavir with rtv) combined with emtricitabine/tenofovir disoproxil fumarate (F/TDF) up to Week 48.
Overall Number of Participants Analyzed 763 378
Least Squares Mean (Standard Error)
Unit of Measure: mL/min/1.73 m^2
eGFRcyst: Change at Week 24 Number Analyzed 734 participants 360 participants
0.21  (0.338) -0.93  (0.483)
eGFRcyst: Change at Week 48 Number Analyzed 724 participants 351 participants
-0.42  (0.360) -1.76  (0.517)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]), Control (Baseline to Switch)
Comments Change at Week 24
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.054
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 1.14
Confidence Interval (2-Sided) 95%
-0.02 to 2.29
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.590
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]), Control (Baseline to Switch)
Comments Change at Week 48
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.034
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 1.34
Confidence Interval (2-Sided) 95%
0.10 to 2.57
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.630
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Change From Baseline in Urine Albumin to Creatinine Ratio (UACR) and Urine Protein to Creatinine Ratio (UPCR) at Weeks 24 and 48
Hide Description Change from baseline in UACR and UPCR was assessed at Weeks 24 and 48. Lower levels of albumin or protein in the urine indicates better proximal tubular function.
Time Frame Baseline, Weeks 24 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set included all the participants who were randomized and received at least 1 dose of study treatment. Here, N (number of participants analyzed) indicates number of participants evaluable for this endpoint; and 'n' specifies those participants who were analyzed for this endpoint at given time point.
Arm/Group Title D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) Control (Baseline to Switch)
Hide Arm/Group Description:
Participants received a single fixed dose combination (FDC) tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF tablet), orally once daily up to Week 48. After Week 48, all participants continued to receive D/C/F/TAF treatment (that is, initial switch to D/C/F/TAF group) up to Week 96. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until D/C/F/TAF became commercially available up to 42 months (end of extension).
Participants received a boosted protease inhibitor (bPI) (limited to darunavir [DRV] or atazanavir with low-dose ritonavir [rtv] or cobicistat [COBI], or lopinavir with rtv) combined with emtricitabine/tenofovir disoproxil fumarate (F/TDF) up to Week 48.
Overall Number of Participants Analyzed 761 378
Median (Full Range)
Unit of Measure: milligram per gram (mg/g)
UACR: Baseline Number Analyzed 761 participants 378 participants
6.20
(1.4 to 632.1)
7.14
(1.1 to 268.0)
UACR: Change at Week 24 Number Analyzed 735 participants 362 participants
-0.78
(-185.4 to 422.2)
0.44
(-238.5 to 145.0)
UACR: Change at Week 48 Number Analyzed 723 participants 351 participants
-0.76
(-195.8 to 344.3)
0.40
(-121.7 to 110.9)
UPCR: Baseline Number Analyzed 758 participants 375 participants
61.56
(16.9 to 1158.1)
62.90
(14.7 to 870.9)
UPCR: Change at Week 24 Number Analyzed 727 participants 357 participants
-14.63
(-509.6 to 734.6)
0.07
(-359.9 to 400.8)
UPCR: Change at Week 48 Number Analyzed 710 participants 347 participants
-22.25
(-520.1 to 386.6)
-7.37
(-368.7 to 432.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]), Control (Baseline to Switch)
Comments UACR - Change at Week 24
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Van Elteren Test
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]), Control (Baseline to Switch)
Comments UACR - Change at Week 48
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Van Elteren Test
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]), Control (Baseline to Switch)
Comments UPCR - Change at Week 24
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Van Elteren Test
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]), Control (Baseline to Switch)
Comments UPCR - Change at Week 48
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Van Elteren Test
Comments [Not Specified]
11.Secondary Outcome
Title Change From Baseline in Urine Retinol Binding Protein to Creatinine Ratio (URBPCR) and Urine Beta-2 Microglobulin to Creatinine Ratio (UB2MGCR) at Weeks 24 and 48
Hide Description Change from baseline in URBPCR and UB2MGCR was assessed at Weeks 24 and 48. Retinol binding protein is a marker of proximal tubular function.
Time Frame Baseline, Weeks 24 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set included all the participants who were randomized and received at least 1 dose of study treatment. Here, N (number of participants analyzed) indicates number of participants evaluable for this endpoint; and 'n' specifies those participants who were analyzed for this endpoint at given time point.
Arm/Group Title D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) Control (Baseline to Switch)
Hide Arm/Group Description:
Participants received a single fixed dose combination (FDC) tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF tablet), orally once daily up to Week 48. After Week 48, all participants continued to receive D/C/F/TAF treatment (that is, initial switch to D/C/F/TAF group) up to Week 96. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until D/C/F/TAF became commercially available up to 42 months (end of extension).
Participants received a boosted protease inhibitor (bPI) (limited to darunavir [DRV] or atazanavir with low-dose ritonavir [rtv] or cobicistat [COBI], or lopinavir with rtv) combined with emtricitabine/tenofovir disoproxil fumarate (F/TDF) up to Week 48.
Overall Number of Participants Analyzed 748 371
Median (Full Range)
Unit of Measure: microgram per gram (mcg/g)
URBPCR: Baseline Number Analyzed 748 participants 371 participants
126.19
(20.3 to 116216.2)
137.16
(12.9 to 73958.4)
URBPCR: Change at Week 24 Number Analyzed 721 participants 356 participants
-30.27
(-69873.2 to 2004.4)
7.76
(-6040.1 to 60740.4)
URBPCR: Change at Week 48 Number Analyzed 710 participants 344 participants
-27.09
(-67540.0 to 1764.3)
19.66
(-5778.3 to 65203.3)
UB2MGCR: Baseline Number Analyzed 736 participants 366 participants
156.85
(3.8 to 91216.2)
172.25
(9.8 to 92740.1)
UB2MGCR: Change at Week 24 Number Analyzed 702 participants 348 participants
-72.64
(-72264.6 to 13536.2)
12.08
(-20084.8 to 58357.6)
UB2MGCR: Change at Week 48 Number Analyzed 693 participants 338 participants
-67.02
(-72323.4 to 21190.2)
20.24
(-22173.5 to 135576.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]), Control (Baseline to Switch)
Comments URBPCR: Change at Week 24
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Van Elteren Test
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]), Control (Baseline to Switch)
Comments URBPCR: Change at Week 48
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Van Elteren Test
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]), Control (Baseline to Switch)
Comments UB2MGCR: Change at Week 24
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Van Elteren Test
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]), Control (Baseline to Switch)
Comments UB2MGCR: Change at Week 48
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Van Elteren Test
Comments [Not Specified]
12.Secondary Outcome
Title Percent Change From Baseline in Urine Fractional Excretion of Phosphate (FEPO4) at Weeks 24 and 48
Hide Description Percent change from baseline in urine FEPO4 was assessed at Weeks 24 and 48.
Time Frame Baseline, Weeks 24 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set included all the participants who were randomized and received at least 1 dose of study treatment. Here 'n' specifies those participants who were analyzed for this endpoint at given time point.
Arm/Group Title D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) Control (Baseline to Switch)
Hide Arm/Group Description:
Participants received a single fixed dose combination (FDC) tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF tablet), orally once daily up to Week 48. After Week 48, all participants continued to receive D/C/F/TAF treatment (that is, initial switch to D/C/F/TAF group) up to Week 96. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until D/C/F/TAF became commercially available up to 42 months (end of extension).
Participants received a boosted protease inhibitor (bPI) (limited to darunavir [DRV] or atazanavir with low-dose ritonavir [rtv] or cobicistat [COBI], or lopinavir with rtv) combined with emtricitabine/tenofovir disoproxil fumarate (F/TDF) up to Week 48.
Overall Number of Participants Analyzed 763 378
Median (Full Range)
Unit of Measure: Percent change
Percent change at Week 24 Number Analyzed 729 participants 358 participants
3.58
(-89.4 to 1940.4)
8.55
(-78.5 to 281.8)
Percent change at Week 48 Number Analyzed 719 participants 346 participants
8.42
(-97.9 to 1430.3)
8.57
(-76.3 to 452.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]), Control (Baseline to Switch)
Comments FEPO4 - Change at Week 24
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.288
Comments [Not Specified]
Method Van Elteren Test
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]), Control (Baseline to Switch)
Comments FEPO4 - Change at Week 48
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.148
Comments [Not Specified]
Method Van Elteren Test
Comments [Not Specified]
13.Secondary Outcome
Title Percentage of Participants With Virologic Response Based on HIV-1 RNA Less Than (<)20, <50, and <200 Copies/mL Threshold at Week 48 as Defined by the Food and Drug Administration (FDA) Snapshot Approach
Hide Description Percentage of participants with virologic response based on HIV-1 RNA <20, <50, and <200 copies/mL threshold were analyzed at Week 48 using FDA snapshot approach. FDA Snapshot approach analysis was based on the last observed viral load data: virologic response was defined as HIV-1 RNA <20/50/200 copies/mL (observed case).
Time Frame Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set included all the participants who were randomized and received at least 1 dose of study treatment.
Arm/Group Title D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) Control (Baseline to Switch)
Hide Arm/Group Description:
Participants received a single fixed dose combination (FDC) tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF tablet), orally once daily up to Week 48. After Week 48, all participants continued to receive D/C/F/TAF treatment (that is, initial switch to D/C/F/TAF group) up to Week 96. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until D/C/F/TAF became commercially available up to 42 months (end of extension).
Participants received a boosted protease inhibitor (bPI) (limited to darunavir [DRV] or atazanavir with low-dose ritonavir [rtv] or cobicistat [COBI], or lopinavir with rtv) combined with emtricitabine/tenofovir disoproxil fumarate (F/TDF) up to Week 48.
Overall Number of Participants Analyzed 763 378
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
<20 copies/mL
89.8
(87.4 to 91.8)
88.4
(84.7 to 91.4)
<50 copies/mL
94.9
(93.1 to 96.3)
93.7
(90.7 to 95.9)
<200 copies/mL
95.0
(93.2 to 96.5)
94.2
(91.3 to 96.3)
14.Secondary Outcome
Title Percentage of Participants With Virologic Response Based on HIV-1 RNA <20, <50, and <200 Copies/mL Threshold at Week 48 as Defined by the Time to Loss of Virologic Response (TLOVR) Algorithm
Hide Description Percentage of participants with virologic response based on HIV-1 RNA <20, <50, and <200 copies/mL threshold were analyzed at Week 48 using TLOVR algorithm approach. TLOVR was defined as sustained HIV-1 RNA <20/50/200 copies/mL.
Time Frame Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set included all the participants who were randomized and received at least 1 dose of study treatment.
Arm/Group Title D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) Control (Baseline to Switch)
Hide Arm/Group Description:
Participants received a single fixed dose combination (FDC) tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF tablet), orally once daily up to Week 48. After Week 48, all participants continued to receive D/C/F/TAF treatment (that is, initial switch to D/C/F/TAF group) up to Week 96. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until D/C/F/TAF became commercially available up to 42 months (end of extension).
Participants received a boosted protease inhibitor (bPI) (limited to darunavir [DRV] or atazanavir with low-dose ritonavir [rtv] or cobicistat [COBI], or lopinavir with rtv) combined with emtricitabine/tenofovir disoproxil fumarate (F/TDF) up to Week 48.
Overall Number of Participants Analyzed 763 378
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
<20 copies/mL
86.0
(83.3 to 88.4)
83.6
(79.5 to 87.2)
<50 copies/mL
93.7
(91.7 to 95.3)
92.9
(89.8 to 95.2)
<200 copies/mL
95.4
(93.7 to 96.8)
94.7
(91.9 to 96.7)
15.Secondary Outcome
Title Change From Baseline in Cluster of Differentiation 4 Plus (CD4+) Cell Count at Weeks 24 and 48
Hide Description Change from baseline in CD4+ cell count was assessed at Weeks 24 and 48.
Time Frame Baseline, Weeks 24 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set included all the participants who were randomized and received at least 1 dose of study treatment. Here 'n' specifies those participants who were analyzed for this endpoint at given time point.
Arm/Group Title D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) Control (Baseline to Switch)
Hide Arm/Group Description:
Participants received a single fixed dose combination (FDC) tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF tablet), orally once daily up to Week 48. After Week 48, all participants continued to receive D/C/F/TAF treatment (that is, initial switch to D/C/F/TAF group) up to Week 96. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until D/C/F/TAF became commercially available up to 42 months (end of extension).
Participants received a boosted protease inhibitor (bPI) (limited to darunavir [DRV] or atazanavir with low-dose ritonavir [rtv] or cobicistat [COBI], or lopinavir with rtv) combined with emtricitabine/tenofovir disoproxil fumarate (F/TDF) up to Week 48.
Overall Number of Participants Analyzed 763 378
Mean (Standard Error)
Unit of Measure: Cells per cubic millimeter (cells/mm^3)
Baseline Number Analyzed 763 participants 378 participants
653.3  (9.12) 641.7  (13.15)
Change at Week 24 Number Analyzed 731 participants 362 participants
14.3  (5.99) 8.5  (7.76)
Change at Week 48 Number Analyzed 722 participants 351 participants
21.0  (5.97) 9.1  (8.41)
16.Secondary Outcome
Title Percentage of Participants With Treatment Adherence of Greater Than (>)95 Percent (%) (Approach 1) Through Week 48
Hide Description Treatment adherence (defined as adherence of >95%) was assessed by the drug accountability cumulative through Week 48 (Approach 1).
Time Frame Through Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set included all the participants who were randomized and received at least 1 dose of study treatment. Here, N (number of participants analyzed) indicates the number of participants evaluable for this endpoint.
Arm/Group Title D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) Control (Baseline to Switch)
Hide Arm/Group Description:
Participants received a single fixed dose combination (FDC) tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF tablet), orally once daily up to Week 48. After Week 48, all participants continued to receive D/C/F/TAF treatment (that is, initial switch to D/C/F/TAF group) up to Week 96. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until D/C/F/TAF became commercially available up to 42 months (end of extension).
Participants received a boosted protease inhibitor (bPI) (limited to darunavir [DRV] or atazanavir with low-dose ritonavir [rtv] or cobicistat [COBI], or lopinavir with rtv) combined with emtricitabine/tenofovir disoproxil fumarate (F/TDF) up to Week 48.
Overall Number of Participants Analyzed 215 102
Measure Type: Number
Unit of Measure: Percentage of Participants
91.6 85.3
17.Secondary Outcome
Title Percentage of Participants With Treatment Adherence of >95% (Approach 2) Through Week 48
Hide Description Treatment adherence (defined as adherence of >95%) was assessed by the drug accountability cumulative treatment adherence up to time point where not more than one bottle was missing, or if available, through Week 48, whichever came sooner (Approach 2).
Time Frame Through Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set included all the participants who were randomized and received at least 1 dose of study treatment. Here, 'N' (number of participants analyzed) indicates the number of participants evaluable for this endpoint.
Arm/Group Title D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) Control (Baseline to Switch)
Hide Arm/Group Description:
Participants received a single fixed dose combination (FDC) tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF tablet), orally once daily up to Week 48. After Week 48, all participants continued to receive D/C/F/TAF treatment (that is, initial switch to D/C/F/TAF group) up to Week 96. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until D/C/F/TAF became commercially available up to 42 months (end of extension).
Participants received a boosted protease inhibitor (bPI) (limited to darunavir [DRV] or atazanavir with low-dose ritonavir [rtv] or cobicistat [COBI], or lopinavir with rtv) combined with emtricitabine/tenofovir disoproxil fumarate (F/TDF) up to Week 48.
Overall Number of Participants Analyzed 631 268
Measure Type: Number
Unit of Measure: percentage of participants
82.7 77.2
18.Secondary Outcome
Title Number of Participants With Resistance to Study Drug
Hide Description HIV-1 genotypes were analyzed from samples of participants with confirmed virologic rebound (virologic rebound was defined as: confirmed HIV-1 RNA >=50 copies/mL up to, and including the upper bound of the Week 48 window) and with HIV-1 RNA value >=400 copies/mL or who discontinued with last HIV-1 RNA >=400 copies/mL. Number of participants who developed resistance to any of the study drug was determined.
Time Frame Up to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population with confirmed virologic rebound and with HIV-1 RNA value >=400 copies/mL was analyzed.
Arm/Group Title D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) Control (Baseline to Switch)
Hide Arm/Group Description:
Participants received a single fixed dose combination (FDC) tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF tablet), orally once daily up to Week 48. After Week 48, all participants continued to receive D/C/F/TAF treatment (that is, initial switch to D/C/F/TAF group) up to Week 96. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until D/C/F/TAF became commercially available up to 42 months (end of extension).
Participants received a boosted protease inhibitor (bPI) (limited to darunavir [DRV] or atazanavir with low-dose ritonavir [rtv] or cobicistat [COBI], or lopinavir with rtv) combined with emtricitabine/tenofovir disoproxil fumarate (F/TDF) up to Week 48.
Overall Number of Participants Analyzed 19 8
Measure Type: Count of Participants
Unit of Measure: Participants
1
   5.3%
3
  37.5%
19.Secondary Outcome
Title Predose (Trough) Plasma Concentration (C0h) of Darunavir
Hide Description Predose (trough) plasma concentration (C0h) of darunavir was determined. Pharmacokinetic (PK) data was only analyzed for participants in the D/C/F/TAF group as per planned analysis.
Time Frame Predose at Weeks 2, 4, 8, 12, 24, 36, and 48
Hide Outcome Measure Data
Hide Analysis Population Description
The PK analysis set included all participants randomized to D/C/F/TAF group and received at least 1 dose of study drug in study, and for whom plasma concentration data of any analytes of interest were available. Here 'n' specifies participants who were analyzed for this endpoint at given time point.
Arm/Group Title D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE])
Hide Arm/Group Description:
Participants received a single fixed dose combination (FDC) tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF tablet), orally once daily up to Week 48. After Week 48, all participants continued to receive D/C/F/TAF treatment (that is, initial switch to D/C/F/TAF group) up to Week 96. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until D/C/F/TAF became commercially available up to 42 months (end of extension).
Overall Number of Participants Analyzed 750
Mean (Standard Deviation)
Unit of Measure: Nanogram per milliliter (ng/mL)
Week 2 Number Analyzed 130 participants
1775.29  (1698.84)
Week 4 Number Analyzed 110 participants
1732.00  (1389.44)
Week 8 Number Analyzed 104 participants
1910.30  (1501.94)
Week 12 Number Analyzed 114 participants
1643.38  (1328.41)
Week 24 Number Analyzed 112 participants
2022.99  (1965.64)
Week 36 Number Analyzed 100 participants
1806.37  (1669.43)
Week 48 Number Analyzed 126 participants
1899.79  (1833.09)
20.Secondary Outcome
Title Percent Change From Baseline in Serum Procollagen 1 N-Terminal Propeptide (P1NP) and Serum Collagen Type 1 Beta Carboxy Telopeptide (CTX) Levels at Weeks 24 and 48
Hide Description Percent change from baseline in bone biomarkers: P1NP and CTX was assessed at Weeks 24 and 48.
Time Frame Baseline, Weeks 24 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
The bone investigation substudy (BIS) analysis set included all participants who were randomized and received at least 1 dose of study drug in the study, and had at least one postbaseline value for biomarker data. Here 'n' specifies participants who were analyzed for this endpoint at given time point.
Arm/Group Title D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) Control (Baseline to Switch)
Hide Arm/Group Description:
Participants received a single fixed dose combination (FDC) tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF tablet), orally once daily up to Week 48. After Week 48, all participants continued to receive D/C/F/TAF treatment (that is, initial switch to D/C/F/TAF group) up to Week 96. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until D/C/F/TAF became commercially available up to 42 months (end of extension).
Participants received a boosted protease inhibitor (bPI) (limited to darunavir [DRV] or atazanavir with low-dose ritonavir [rtv] or cobicistat [COBI], or lopinavir with rtv) combined with emtricitabine/tenofovir disoproxil fumarate (F/TDF) up to Week 48.
Overall Number of Participants Analyzed 209 108
Mean (Standard Error)
Unit of Measure: Percent Change
P1NP: Percent change at Week 24 Number Analyzed 195 participants 99 participants
-22.971  (1.8818) -0.027  (2.7325)
P1NP: Percent change at Week 48 Number Analyzed 191 participants 98 participants
-26.752  (1.8960) -3.751  (2.6988)
CTX: Percent change at Week 24 Number Analyzed 190 participants 97 participants
-16.772  (2.2575) 16.312  (3.8855)
CTX: Percent change at Week 48 Number Analyzed 185 participants 98 participants
-10.517  (3.2325) 5.433  (4.1118)
21.Secondary Outcome
Title Percent Change From Baseline in Parathyroid Hormone (PTH) at Weeks 24 and 48
Hide Description Percent change from baseline in bone biomarker: PTH was assessed at Weeks 24 and 48.
Time Frame Baseline, Weeks 24 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
The bone investigation substudy (BIS) analysis set included all participants who were randomized and received at least 1 dose of study drug in the study, and had at least one postbaseline value for biomarker data. Here 'n' specifies participants who were analyzed for this endpoint at given time point.
Arm/Group Title D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) Control (Baseline to Switch)
Hide Arm/Group Description:
Participants received a single fixed dose combination (FDC) tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF tablet), orally once daily up to Week 48. After Week 48, all participants continued to receive D/C/F/TAF treatment (that is, initial switch to D/C/F/TAF group) up to Week 96. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until D/C/F/TAF became commercially available up to 42 months (end of extension).
Participants received a boosted protease inhibitor (bPI) (limited to darunavir [DRV] or atazanavir with low-dose ritonavir [rtv] or cobicistat [COBI], or lopinavir with rtv) combined with emtricitabine/tenofovir disoproxil fumarate (F/TDF) up to Week 48.
Overall Number of Participants Analyzed 209 108
Mean (Standard Error)
Unit of Measure: Percent change
Percent change at Week 24 Number Analyzed 199 participants 102 participants
-3.092  (2.5941) 12.034  (4.1777)
Percent change at Week 48 Number Analyzed 193 participants 103 participants
-4.510  (2.5375) 9.436  (4.4784)
22.Secondary Outcome
Title Percent Change From Baseline in 25-hydroxy Vitamin D at Weeks 24 and 48
Hide Description Percent change from baseline in bone biomarker: 25-hydroxy vitamin D was assessed at Weeks 24 and 48.
Time Frame Baseline, Weeks 24 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
The bone investigation substudy (BIS) analysis set included all participants who were randomized and received at least 1 dose of study drug in the study, and had at least one postbaseline value for biomarker data. Here 'n' specifies participants who were analyzed for this endpoint at given time point.
Arm/Group Title D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) Control (Baseline to Switch)
Hide Arm/Group Description:
Participants received a single fixed dose combination (FDC) tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF tablet), orally once daily up to Week 48. After Week 48, all participants continued to receive D/C/F/TAF treatment (that is, initial switch to D/C/F/TAF group) up to Week 96. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until D/C/F/TAF became commercially available up to 42 months (end of extension).
Participants received a boosted protease inhibitor (bPI) (limited to darunavir [DRV] or atazanavir with low-dose ritonavir [rtv] or cobicistat [COBI], or lopinavir with rtv) combined with emtricitabine/tenofovir disoproxil fumarate (F/TDF) up to Week 48.
Overall Number of Participants Analyzed 209 108
Mean (Standard Error)
Unit of Measure: Percent change
Percent change at Week 24 Number Analyzed 146 participants 72 participants
-3.0  (5.06) 4.2  (6.13)
Percent change at Week 48 Number Analyzed 142 participants 72 participants
25.2  (5.51) 24.9  (7.46)
23.Secondary Outcome
Title Percent Change From Baseline in Spine and Hip Bone Mineral Density (BMD) at Weeks 24 and 48
Hide Description Percent change from baseline in spine and hip BMD was assessed at Weeks 24 and 48.
Time Frame Baseline, Weeks 24 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
The bone investigation substudy (BIS) analysis set included all participants who were randomized and received at least 1 dose of study drug in the study, and had at least one postbaseline value for bone mineral density (BMD) data. Here 'n' specifies participants who were analyzed for this endpoint at given time point.
Arm/Group Title D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) Control (Baseline to Switch)
Hide Arm/Group Description:
Participants received a single fixed dose combination (FDC) tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF tablet), orally once daily up to Week 48. After Week 48, all participants continued to receive D/C/F/TAF treatment (that is, initial switch to D/C/F/TAF group) up to Week 96. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until D/C/F/TAF became commercially available up to 42 months (end of extension).
Participants received a boosted protease inhibitor (bPI) (limited to darunavir [DRV] or atazanavir with low-dose ritonavir [rtv] or cobicistat [COBI], or lopinavir with rtv) combined with emtricitabine/tenofovir disoproxil fumarate (F/TDF) up to Week 48.
Overall Number of Participants Analyzed 209 108
Least Squares Mean (Standard Error)
Unit of Measure: Percent change
Spine BMD: Percent change at Week 24 Number Analyzed 192 participants 97 participants
1.55  (0.276) 0.18  (0.342)
Spine BMD: Percent change at Week 48 Number Analyzed 192 participants 101 participants
2.06  (0.324) 0.01  (0.391)
Hip BMD: Percent change at Week 24 Number Analyzed 184 participants 93 participants
0.91  (0.230) 0.00  (0.279)
Hip BMD: Percent change at Week 48 Number Analyzed 188 participants 97 participants
1.62  (0.244) -0.08  (0.288)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]), Control (Baseline to Switch)
Comments Spine BMD: Percent change at Week 24
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 1.37
Confidence Interval (2-Sided) 95%
0.697 to 2.037
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.340
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]), Control (Baseline to Switch)
Comments Spine BMD: Percent change at Week 48
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 2.05
Confidence Interval (2-Sided) 95%
1.277 to 2.814
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.390
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]), Control (Baseline to Switch)
Comments Hip BMD: Percent change at Week 24
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.90
Confidence Interval (2-Sided) 95%
0.366 to 1.436
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.272
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]), Control (Baseline to Switch)
Comments Hip BMD: Percent change at Week 48
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 1.70
Confidence Interval (2-Sided) 95%
1.144 to 2.248
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.280
Estimation Comments [Not Specified]
24.Secondary Outcome
Title Change From Baseline in Bone Mineral Density (BMD) T-Score at Weeks 24 and 48
Hide Description Change from baseline in spine, hip, and femoral neck BMD T-Score was assessed at Week 24 and 48. T-score values >= -1.0 were considered normal, T-score values < -1.0 to -2.5 indicate osteopenia and T-score values < -2.5 indicate osteoporosis.
Time Frame Baseline, Weeks 24 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
The bone investigation substudy (BIS) analysis set included all participants who were randomized and received at least 1 dose of study drug in the study, and had at least one postbaseline value for BMD data. Here 'n' specifies those participants who were analyzed for this endpoint at given time point.
Arm/Group Title D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) Control (Baseline to Switch)
Hide Arm/Group Description:
Participants received a single fixed dose combination (FDC) tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF tablet), orally once daily up to Week 48. After Week 48, all participants continued to receive D/C/F/TAF treatment (that is, initial switch to D/C/F/TAF group) up to Week 96. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until D/C/F/TAF became commercially available up to 42 months (end of extension).
Participants received a boosted protease inhibitor (bPI) (limited to darunavir [DRV] or atazanavir with low-dose ritonavir [rtv] or cobicistat [COBI], or lopinavir with rtv) combined with emtricitabine/tenofovir disoproxil fumarate (F/TDF) up to Week 48.
Overall Number of Participants Analyzed 209 108
Mean (Standard Error)
Unit of Measure: Units on a scale
Spine BMD T-score: Baseline Number Analyzed 206 participants 107 participants
-0.713  (0.0850) -0.467  (0.1260)
Spine BMD T-score: Change at Week 24 Number Analyzed 192 participants 97 participants
0.102  (0.0172) -0.033  (0.0253)
Spine BMD T-score: Change at Week 48 Number Analyzed 192 participants 101 participants
0.132  (0.0217) -0.063  (0.0264)
Hip BMD T-score: Baseline Number Analyzed 204 participants 104 participants
-0.575  (0.0643) -0.484  (0.0839)
Hip BMD T-score: Change at Week 24 Number Analyzed 184 participants 93 participants
0.037  (0.0108) -0.024  (0.0144)
Hip BMD T-score: Change at Week 48 Number Analyzed 188 participants 97 participants
0.095  (0.0122) -0.016  (0.0139)
Femoral Neck BMD T-score: Baseline Number Analyzed 204 participants 104 participants
-0.782  (0.0625) -0.699  (0.0899)
Femoral Neck BMD T-score: Change at Week 24 Number Analyzed 184 participants 93 participants
0.019  (0.0128) -0.044  (0.0183)
Femoral Neck BMD T-score: Change at Week 48 Number Analyzed 188 participants 97 participants
0.039  (0.0146) -0.039  (0.0214)
25.Secondary Outcome
Title Percentage of Participants With Virologic Rebound (HIV-1 RNA >=20 Copies/mL) Cumulative Through Week 96
Hide Description Virologic rebound was defined as: confirmed plasma HIV-1 RNA level >=20 copies/mL up to and including Week 96, last available on-treatment (single) HIV-1 RNA >=20 copies/mL at premature discontinuation (irrespective of reason), and last available on-treatment HIV-1 RNA >=20 copies/mL at the study cutoff of Week 96 (that is, any last viral load [re]test having occurred no later than 6 weeks after Week 96). Percentage of participants with virologic rebound were reported.
Time Frame Through Week 96 (D/C/F/TAF arm) and from Week 52 to Week 96 (Switch to D/C/F/TAF arm)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) analysis set included all the participants who were randomized and received at least 1 dose of study treatment.
Arm/Group Title D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) Switch to D/C/F/TAF
Hide Arm/Group Description:
Participants received a single fixed dose combination (FDC) tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF tablet), orally once daily up to Week 48. After Week 48, all participants continued to receive D/C/F/TAF treatment (that is, initial switch to D/C/F/TAF group) up to Week 96. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until D/C/F/TAF became commercially available up to 42 months (end of extension).
After Week 52, participants earlier receiving treatment with bPI+F/TDF switched to D/C/F/TAF treatment up to Week 96. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until D/C/F/TAF became commercially available for up to 42 months.
Overall Number of Participants Analyzed 763 352
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
13.8
(11.4 to 16.4)
8.8
(6.1 to 12.3)
26.Secondary Outcome
Title Percentage of Participants With Virologic Rebound (HIV-1 RNA >=50 Copies/mL) Cumulative Through Week 96
Hide Description Virologic rebound was defined as: confirmed plasma HIV-1 RNA level >=50 copies/mL up to and including Week 96, last available on-treatment (single) HIV-1 RNA >=50 copies/mL at premature discontinuation (irrespective of reason), and last available on-treatment HIV-1 RNA >=50copies/mL at the study cutoff of Week 96 (that is, any last viral load [re]test having occurred no later than 6 weeks after Week 96). Percentage of participants with virologic rebound were reported.
Time Frame Through Week 96 (D/C/F/TAF arm) and from Week 52 to Week 96 (Switch to D/C/F/TAF arm)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) analysis set included all the participants who were randomized and received at least 1 dose of study treatment.
Arm/Group Title D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) Switch to D/C/F/TAF
Hide Arm/Group Description:
Participants received a single fixed dose combination (FDC) tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF tablet), orally once daily up to Week 48. After Week 48, all participants continued to receive D/C/F/TAF treatment (that is, initial switch to D/C/F/TAF group) up to Week 96. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until D/C/F/TAF became commercially available up to 42 months (end of extension).
After Week 52, participants earlier receiving treatment with bPI+F/TDF switched to D/C/F/TAF treatment up to Week 96. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until D/C/F/TAF became commercially available for up to 42 months.
Overall Number of Participants Analyzed 763 352
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
3.1
(2.0 to 4.6)
2.3
(1.0 to 4.4)
27.Secondary Outcome
Title Percentage of Participants With Virologic Rebound (HIV-1 RNA >=200 Copies/mL) Cumulative Through Week 96
Hide Description Virologic rebound was defined as: confirmed plasma HIV-1 RNA level >=200 copies/mL up to and including Week 96, last available on-treatment (single) HIV-1 RNA >=200 copies/mL at premature discontinuation (irrespective of reason), and last available on-treatment HIV-1 RNA >=200 copies/mL at the study cutoff of Week 96 (that is, any last viral load [re]test having occurred no later than 6 weeks after Week 96). Percentage of participants with virologic rebound were reported.
Time Frame Through Week 96 (D/C/F/TAF arm) and from Week 52 to Week 96 (Switch to D/C/F/TAF arm)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) analysis set included all the participants who were randomized and received at least 1 dose of study treatment.
Arm/Group Title D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) Switch to D/C/F/TAF
Hide Arm/Group Description:
Participants received a single fixed dose combination (FDC) tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF tablet), orally once daily up to Week 48. After Week 48, all participants continued to receive D/C/F/TAF treatment (that is, initial switch to D/C/F/TAF group) up to Week 96. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until D/C/F/TAF became commercially available up to 42 months (end of extension).
After Week 52, participants earlier receiving treatment with bPI+F/TDF switched to D/C/F/TAF treatment up to Week 96. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until D/C/F/TAF became commercially available for up to 42 months.
Overall Number of Participants Analyzed 763 352
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
0.5
(0.1 to 1.3)
0.6
(0.1 to 2.0)
28.Secondary Outcome
Title Percentage of Participants With Non-Virologic Rebound at Week 96 by Kaplan-Meier Estimates
Hide Description Here Kaplan-Meier estimates percentage of participants with non-virologic rebound at Week 96.
Time Frame Baseline to Week 96 (D/C/F/TAF arm) and from Week 52 to Week 96 (Switch to D/C/F/TAF arm)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set included all the participants who were randomized and received at least 1 dose of study treatment.
Arm/Group Title D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) Switch to D/C/F/TAF
Hide Arm/Group Description:
Participants received a single fixed dose combination (FDC) tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF tablet), orally once daily up to Week 48. After Week 48, all participants continued to receive D/C/F/TAF treatment (that is, initial switch to D/C/F/TAF group) up to Week 96. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until D/C/F/TAF became commercially available up to 42 months (end of extension).
After Week 52, participants earlier receiving treatment with bPI+F/TDF switched to D/C/F/TAF treatment up to Week 96. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until D/C/F/TAF became commercially available for up to 42 months.
Overall Number of Participants Analyzed 763 352
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
96.7
(95.1 to 97.8)
97.8
(95.4 to 98.9)
29.Secondary Outcome
Title Percentage of Participants With Virologic Response Based on HIV-1 RNA <20, <50, and <200 Copies/mL Threshold at Week 96 as Defined by the FDA Snapshot Approach
Hide Description Percentage of participants with virologic response based on HIV-1 RNA <20, <50, and <200 copies/mL threshold were analyzed at Week 96 using FDA snapshot approach. FDA Snapshot approach analysis was based on the last observed viral load data: virologic response was defined as having last available HIV-1 RNA <20/50/200 copies/mL (observed case).
Time Frame Week 96 (Comprising up to Week 96 for D/C/F/TAF and 44 weeks of D/C/F/TAF exposure [that is, from the switch to D/C/F/TAF at Week 52 up to Week 96])
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set included all the participants who were randomized and received at least 1 dose of study treatment.
Arm/Group Title D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) Switch to D/C/F/TAF
Hide Arm/Group Description:
Participants received a single fixed dose combination (FDC) tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF tablet), orally once daily up to Week 48. After Week 48, all participants continued to receive D/C/F/TAF treatment (that is, initial switch to D/C/F/TAF group) up to Week 96. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until D/C/F/TAF became commercially available up to 42 months (end of extension).
After Week 52, participants earlier receiving treatment with bPI+F/TDF switched to D/C/F/TAF treatment up to Week 96. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until D/C/F/TAF became commercially available for up to 42 months.
Overall Number of Participants Analyzed 763 352
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
<20 copies/mL
85.3
(82.6 to 87.8)
89.8
(86.1 to 92.7)
<50 copies/mL
90.7
(88.4 to 92.7)
93.8
(90.7 to 96)
<200 copies/mL
91.2
(89.0 to 93.1)
95.5
(92.7 to 97.4)
30.Secondary Outcome
Title Percentage of Participants With Virologic Response Based on HIV-1 RNA <20, <50, and <200 Copies/mL Threshold at Week 96 as Defined by the TLOVR Algorithm
Hide Description Percentage of participants with virologic response based on HIV-1 RNA <20, <50, and <200 copies/mL threshold were analyzed at Week 96 using TLOVR algorithm approach. TLOVR was defined as sustained HIV-1 RNA <20/50/200 copies/mL.
Time Frame Week 96 (Comprising up to Week 96 for D/C/F/TAF and 44 weeks of D/C/F/TAF exposure [that is, from the switch to D/C/F/TAF at Week 52 up to Week 96])
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set included all the participants who were randomized and received at least 1 dose of study treatment.
Arm/Group Title D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) Switch to D/C/F/TAF
Hide Arm/Group Description:
Participants received a single fixed dose combination (FDC) tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF tablet), orally once daily up to Week 48. After Week 48, all participants continued to receive D/C/F/TAF treatment (that is, initial switch to D/C/F/TAF group) up to Week 96. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until D/C/F/TAF became commercially available up to 42 months (end of extension).
After Week 52, participants earlier receiving treatment with bPI+F/TDF switched to D/C/F/TAF treatment up to Week 96. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until D/C/F/TAF became commercially available for up to 42 months.
Overall Number of Participants Analyzed 763 352
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
<20 copies/mL
79.6
(76.5 to 82.4)
88.1
(84.2 to 91.3)
<50 copies/mL
89.6
(87.3 to 91.7)
94.3
(91.4 to 96.5)
<200 copies/mL
91.7
(89.6 to 93.6)
95.7
(93.1 to 97.6)
31.Secondary Outcome
Title Percentage of Participants With Virologic Failure Based on HIV-1 RNA >=20, >=50, and >=200 Copies/mL Threshold at Week 96 as Defined by the FDA Snapshot Approach
Hide Description Percentage of participants with virologic failure based on HIV-1 RNA >=20, >=50, and >=200 copies/mL threshold were analyzed at Week 96 using FDA snapshot approach. FDA Snapshot approach analysis was based on the last observed viral load data: virologic failure was defined by the FDA snapshot approach as having last available HIV-1 RNA >=20/50/200 copies/mL at Week 96; virologic failure - leading to discontinuation; virologic failure - discontinued due to other reason and last available HIV-1 RNA >=20/50/200 copies/mL.
Time Frame Week 96 (Comprising up to Week 96 for D/C/F/TAF and 44 weeks of D/C/F/TAF exposure [that is, from the switch to D/C/F/TAF at Week 52 up to Week 96])
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set included all the participants who were randomized and received at least 1 dose of study treatment.
Arm/Group Title D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) Switch to D/C/F/TAF
Hide Arm/Group Description:
Participants received a single fixed dose combination (FDC) tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF tablet), orally once daily up to Week 48. After Week 48, all participants continued to receive D/C/F/TAF treatment (that is, initial switch to D/C/F/TAF group) up to Week 96. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until D/C/F/TAF became commercially available up to 42 months (end of extension).
After Week 52, participants earlier receiving treatment with bPI+F/TDF switched to D/C/F/TAF treatment up to Week 96. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until D/C/F/TAF became commercially available for up to 42 months.
Overall Number of Participants Analyzed 763 352
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
>=20 copies/mL
6.8
(5.1 to 8.8)
6.0
(3.7 to 9.0)
>=50 copies/mL
1.2
(0.5 to 2.2)
1.7
(0.6 to 3.7)
>=200 copies/mL
0.3
(0.0 to 0.9)
0 [1] 
(NA to NA)
[1]
NA signifies that confidence interval was not calculated as none of the participants had HIV RNA <200 copies/mL.
32.Secondary Outcome
Title Change From Reference in CD4+ Cell Count at Week 96
Hide Description Change from reference in CD4+ cell count was assessed at Week 96. The change from reference in CD4+ count at a given time point is defined as: CD4+ at a given time point minus reference CD4+. For the D/C/F/TAF group, reference is the comparative treatment phase baseline as in Week 48 analysis (reference 1). For the Switch to D/C/F/TAF (late switch) group, the last value prior to the switch was used as reference (reference 2).
Time Frame From Reference 1 to Week 96 for D/C/F/TAF+ F/TDF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF (Comprising 44 weeks of D/C/F/TAF exposure [that is, from the switch to D/C/F/TAF at Week 52])
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set included all the participants who were randomized and received at least 1 dose of study treatment. Based on non-completing=failure (NC=F) analysis with values after discontinuation imputed with the reference value. Other (intermittent) missing values are imputed using last observation carried forward (LOCF).
Arm/Group Title D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) Switch to D/C/F/TAF
Hide Arm/Group Description:
Participants received a single fixed dose combination (FDC) tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF tablet), orally once daily up to Week 48. After Week 48, all participants continued to receive D/C/F/TAF treatment (that is, initial switch to D/C/F/TAF group) up to Week 96. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until D/C/F/TAF became commercially available up to 42 months (end of extension).
After Week 52, participants earlier receiving treatment with bPI+F/TDF switched to D/C/F/TAF treatment up to Week 96. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until D/C/F/TAF became commercially available for up to 42 months.
Overall Number of Participants Analyzed 763 352
Least Squares Mean (Standard Error)
Unit of Measure: cells per cubic millimeter (cells/mm^3)
32.07  (8.0) 13.07  (10.7)
33.Secondary Outcome
Title Number of Participants With Resistance to Study Drug Through Week 96
Hide Description HIV-1 genotypes were analyzed from samples of participants with confirmed virologic rebound in case they had HIV-1 RNA values >=400 copies/mL at failure or at later time points, including participants who discontinued with last HIV-1 RNA >=400 copies/mL. Virologic rebound was defined as: confirmed plasma HIV-1 RNA level >=20 copies/mL up to and including Week 96, last available on-treatment (single) HIV-1 RNA >=20 copies/mL at premature discontinuation (irrespective of reason), and last available on-treatment HIV-1 RNA >=20 copies/mL at the study cutoff of Week 96 (that is, any last viral load [re]test having occurred no later than 6 weeks after Week 96). Number of participants who developed resistance to any of the study drug (DRV, FTC, and TFV/TAF) were reported.
Time Frame Through Week 96 (D/C/F/TAF arm), up to Week 48 (Control arm) and from Week 52 to Week 96 (Switch to D/C/F/TAF arm)
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study. Here, N (number of participants analyzed) signifies total number of participants with screening/baseline and endpoint genotype. Due to the low proportion of rebounders of which the majority had low viral load values, few samples were eligible for postbaseline genotyping.
Arm/Group Title D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) Control (Baseline to Switch) Switch to D/C/F/TAF
Hide Arm/Group Description:
Participants received a single fixed dose combination (FDC) tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF tablet), orally once daily up to Week 48. After Week 48, all participants continued to receive D/C/F/TAF treatment (that is, initial switch to D/C/F/TAF group) up to Week 96. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until D/C/F/TAF became commercially available up to 42 months (end of extension).
Participants received a boosted protease inhibitor (bPI) (limited to darunavir [DRV] or atazanavir with low-dose ritonavir [rtv] or cobicistat [COBI], or lopinavir with rtv) combined with emtricitabine/tenofovir disoproxil fumarate (F/TDF) up to Week 48.
After Week 52, participants earlier receiving treatment with bPI+F/TDF switched to D/C/F/TAF treatment up to Week 96. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until D/C/F/TAF became commercially available for up to 42 months.
Overall Number of Participants Analyzed 9 3 7
Measure Type: Count of Participants
Unit of Measure: Participants
DRV resistance-associated mutations (RAMs)
0
   0.0%
0
   0.0%
0
   0.0%
TFV RAMs
0
   0.0%
0
   0.0%
0
   0.0%
FTC RAMs
0
   0.0%
0
   0.0%
1
  14.3%
34.Secondary Outcome
Title Percentage of Participants With Treatment Adherence of >95 (Approach 1) Through Week 96
Hide Description Treatment adherence (defined as adherence of >95%) was assessed by the drug accountability cumulative through Week 96 (Approach 1).
Time Frame Through Week 96 (D/C/F/TAF arm) and from Week 52 to Week 96 (Switch to D/C/F/TAF arm)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set included all the participants who were randomized and received at least 1 dose of study treatment. Here, N (number of participants analyzed) indicates the number of participants evaluable for this outcome measure.
Arm/Group Title D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) Switch to D/C/F/TAF
Hide Arm/Group Description:
Participants received a single fixed dose combination (FDC) tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF tablet), orally once daily up to Week 48. After Week 48, all participants continued to receive D/C/F/TAF treatment (that is, initial switch to D/C/F/TAF group) up to Week 96. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until D/C/F/TAF became commercially available up to 42 months (end of extension).
After Week 52, participants earlier receiving treatment with bPI+F/TDF switched to D/C/F/TAF treatment up to Week 96. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until D/C/F/TAF became commercially available for up to 42 months.
Overall Number of Participants Analyzed 379 236
Measure Type: Number
Unit of Measure: percentage of participants
91.6 87.3
35.Secondary Outcome
Title Percentage of Participants With Treatment Adherence of >95% (Approach 2) Through Week 96
Hide Description Treatment adherence (defined as adherence of >95%) was assessed by the drug accountability cumulative treatment adherence up to time point where not more than one bottle was missing, or if available, through Week 96, whichever came sooner (Approach 2).
Time Frame Through Week 96 (D/C/F/TAF arm) and from Week 52 to Week 96 (Switch to D/C/F/TAF arm)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set included all the participants who were randomized and received at least 1 dose of study treatment. Here, 'N' (number of participants analyzed) indicates the number of participants evaluable for this outcome measure.
Arm/Group Title D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) Switch to D/C/F/TAF
Hide Arm/Group Description:
Participants received a single fixed dose combination (FDC) tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF tablet), orally once daily up to Week 48. After Week 48, all participants continued to receive D/C/F/TAF treatment (that is, initial switch to D/C/F/TAF group) up to Week 96. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until D/C/F/TAF became commercially available up to 42 months (end of extension).
After Week 52, participants earlier receiving treatment with bPI+F/TDF switched to D/C/F/TAF treatment up to Week 96. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until D/C/F/TAF became commercially available for up to 42 months.
Overall Number of Participants Analyzed 646 320
Measure Type: Number
Unit of Measure: percentage of participants
82.8 80.9
36.Secondary Outcome
Title Percentage of Participants Experiencing Grade 3 and Grade 4 AEs, SAEs, and Premature Discontinuation Due to AEs Through Week 96
Hide Description AE is any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Grade 3 (Severe) events were symptoms causing inability to perform usual social & functional activities. Grade 4 (Life-threatening) events were symptoms causing inability to perform basic self-care functions or medical or operative intervention indicated to prevent permanent impairment, persistent disability, or death. SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above.
Time Frame Through Week 96 (D/C/F/TAF arm) and from Week 52 to Week 96 (Switch to D/C/F/TAF arm)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set included all the participants who were randomized and received at least 1 dose of study treatment.
Arm/Group Title D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) Switch to D/C/F/TAF
Hide Arm/Group Description:
Participants received a single fixed dose combination (FDC) tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF tablet), orally once daily up to Week 48. After Week 48, all participants continued to receive D/C/F/TAF treatment (that is, initial switch to D/C/F/TAF group) up to Week 96. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until D/C/F/TAF became commercially available up to 42 months (end of extension).
After Week 52, participants earlier receiving treatment with bPI+F/TDF switched to D/C/F/TAF treatment up to Week 96. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until D/C/F/TAF became commercially available for up to 42 months.
Overall Number of Participants Analyzed 763 352
Measure Type: Number
Unit of Measure: percentage of participants
Grade 3 AEs 10.5 6.3
Grade 4 AEs 2.4 1.1
SAEs 8.7 6.0
Premature discontinuations due to AEs 2.2 2.0
37.Secondary Outcome
Title Change From Reference in Serum Creatinine Levels at Week 96
Hide Description Change from reference in serum creatinine levels at Week 96 was assessed. For the D/C/F/TAF group, reference is the comparative treatment phase baseline as in Week 48 analysis (Reference 1). For the Switch to D/C/F/TAF (late switch) group, the last value prior to the switch was used as reference (reference 2).
Time Frame From Reference 1 to Week 96 for D/C/F/TAF+ F/TDF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment. Here, N (number of participants analyzed) signifies participants evaluated for this outcome measure.
Arm/Group Title D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) Switch to D/C/F/TAF
Hide Arm/Group Description:
Participants received a single fixed dose combination (FDC) tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF tablet), orally once daily up to Week 48. After Week 48, all participants continued to receive D/C/F/TAF treatment (that is, initial switch to D/C/F/TAF group) up to Week 96. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until D/C/F/TAF became commercially available up to 42 months (end of extension).
After Week 52, participants earlier receiving treatment with bPI+F/TDF switched to D/C/F/TAF treatment up to Week 96. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until D/C/F/TAF became commercially available for up to 42 months.
Overall Number of Participants Analyzed 692 336
Median (Full Range)
Unit of Measure: micro mole per liter
0.0
(-35 to 44)
0.0
(-45 to 29)
38.Secondary Outcome
Title Change From Reference in Estimated Glomerular Filtration Rate Based on Serum Creatinine (eGFRcr, by Cockcroft-Gault Formula [eGFRcg]) at Week 96
Hide Description Change from reference in eGFRcr (by Cockcroft-Gault formula) was assessed at Week 96. eGFRcr according to the Cockcroft Gault formula- Male: (140 - age in years)*(weight in kilogram [kg])/72*(serum creatinine in milligram per deciliter [mg/dL])=eGFRcr (milliliter per minute [mL/min]); Female: (140 - age in years)*(weight in kg)/72*(serum creatinine in mg/dL)*0.85=eGFRcr (mL/min). For the D/C/F/TAF group, reference is the comparative treatment phase baseline as in Week 48 analysis (Reference 1). For the Switch to D/C/F/TAF (late switch) group, the last value prior to the switch was used as reference (reference 2).
Time Frame From Reference 1 to Week 96 for D/C/F/TAF+ F/TDF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study. Here, N (number of participants analyzed) signifies participants evaluated for this outcome measure.
Arm/Group Title D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) Switch to D/C/F/TAF
Hide Arm/Group Description:
Participants received a single fixed dose combination (FDC) tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF tablet), orally once daily up to Week 48. After Week 48, all participants continued to receive D/C/F/TAF treatment (that is, initial switch to D/C/F/TAF group) up to Week 96. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until D/C/F/TAF became commercially available up to 42 months (end of extension).
After Week 52, participants earlier receiving treatment with bPI+F/TDF switched to D/C/F/TAF treatment up to Week 96. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until D/C/F/TAF became commercially available for up to 42 months.
Overall Number of Participants Analyzed 692 336
Median (Full Range)
Unit of Measure: milliliter per minute (mL/min)
-0.9
(-65 to 58)
0.0
(-44 to 157)
39.Secondary Outcome
Title Change From Reference in Estimated Glomerular Filtration Rate Based on Serum Creatinine (by CKD-EPI) at Week 96
Hide Description Change from reference in eGFRcr (by CKD-EPI) was assessed at Week 96. eGFRcr per CKD-EPI formula - Female: 1) Serum creatinine (Scr) less than or equal to (<=)0.7 mg/dL: 144*(Scr/0.7)^-0.329*0.993^age; 2) Scr greater than (>)0.7 mg/dL: 144*(Scr/0.7)^-1.209*0.993^age. Male: 1) Scr <=0.9 mg/dL: 141*(Scr/0.9)^-0.411*0.993^age; 2) Scr >0.9 mg/dL: 141*(Scr/0.9)^-1.209*0.993^age. . For the D/C/F/TAF group, reference is the comparative treatment phase baseline as in Week 48 analysis (Reference 1). For the Switch to D/C/F/TAF (late switch) group, the last value prior to the switch was used as reference (reference 2).
Time Frame From Reference 1 to Week 96 for D/C/F/TAF+ F/TDF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT analysis set included all the participants who were randomized and participants at least one dose of study treatment. Here, N (number of participants analyzed) signifies participants evaluated for this outcome measure.
Arm/Group Title D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) Switch to D/C/F/TAF
Hide Arm/Group Description:
Participants received a single fixed dose combination (FDC) tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF tablet), orally once daily up to Week 48. After Week 48, all participants continued to receive D/C/F/TAF treatment (that is, initial switch to D/C/F/TAF group) up to Week 96. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until D/C/F/TAF became commercially available up to 42 months (end of extension).
After Week 52, participants earlier receiving treatment with bPI+F/TDF switched to D/C/F/TAF treatment up to Week 96. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until D/C/F/TAF became commercially available for up to 42 months.
Overall Number of Participants Analyzed 692 336
Median (Full Range)
Unit of Measure: mL/min/1.73 m^2
-1.3
(-37 to 35)
-0.7
(-31 to 49)
40.Secondary Outcome
Title Change From Reference in Estimated Glomerular Filtration Rate Based on Serum Cystatin C (by CKD-EPI) at Week 96
Hide Description Change from reference in eGFRcyst (by CKD-EPI) was assessed at Week 96. eGFRcyst according to the CKD-EPI formula - 1) Serum Cystatin C (Scyst) <=0.8 mg/L: 133*(Scyst/0.8)^-0.499*0.996^age (*0.932 if female); 2) Scyst >0.8 mg/L: 133*(Scyst/0.8)^-1.328*0.996^age (*0.932 if female). For the D/C/F/TAF group, reference is the comparative treatment phase baseline as in Week 48 analysis (Reference 1). For the Switch to D/C/F/TAF (late switch) group, the last value prior to the switch was used as reference (reference 2).
Time Frame From Reference 1 to Week 96 for D/C/F/TAF+ F/TDF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT analysis set included all the participants who were randomized and participants at least one dose of study treatment. Here, N (number of participants analyzed) signifies participants evaluated for this outcome measure.
Arm/Group Title D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) Switch to D/C/F/TAF
Hide Arm/Group Description:
Participants received a single fixed dose combination (FDC) tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF tablet), orally once daily up to Week 48. After Week 48, all participants continued to receive D/C/F/TAF treatment (that is, initial switch to D/C/F/TAF group) up to Week 96. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until D/C/F/TAF became commercially available up to 42 months (end of extension).
After Week 52, participants earlier receiving treatment with bPI+F/TDF switched to D/C/F/TAF treatment up to Week 96. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until D/C/F/TAF became commercially available for up to 42 months.
Overall Number of Participants Analyzed 686 332
Median (Full Range)
Unit of Measure: mL/min/1.73 m^2
-0.9
(-42 to 30)
1.0
(-30 to 105)
41.Secondary Outcome
Title Change From Reference in UACR at Week 96
Hide Description Change from reference in UACR was assessed at Week 96. For the D/C/F/TAF group, reference is the comparative treatment phase baseline as in Week 48 analysis (Reference 1). For the Switch to D/C/F/TAF (late switch) group, the last value prior to the switch was used as reference (reference 2).
Time Frame From Reference 1 to Week 96 for D/C/F/TAF+ F/TDF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment. Here, N (number of participants analyzed) signifies participants evaluated for this outcome measure.
Arm/Group Title D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) Switch to D/C/F/TAF
Hide Arm/Group Description:
Participants received a single fixed dose combination (FDC) tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF tablet), orally once daily up to Week 48. After Week 48, all participants continued to receive D/C/F/TAF treatment (that is, initial switch to D/C/F/TAF group) up to Week 96. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until D/C/F/TAF became commercially available up to 42 months (end of extension).
After Week 52, participants earlier receiving treatment with bPI+F/TDF switched to D/C/F/TAF treatment up to Week 96. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until D/C/F/TAF became commercially available for up to 42 months.
Overall Number of Participants Analyzed 694 334
Median (Full Range)
Unit of Measure: milligram per gram (mg/g)
-0.63
(-209.3 to 2019.7)
-0.93
(-234.6 to 13230.9)
42.Secondary Outcome
Title Change From Reference in URBPCR at Week 96
Hide Description Change from reference in URBPCR was assessed at Week 96. For the D/C/F/TAF group, reference is the comparative treatment phase baseline as in Week 48 analysis (Reference 1). For the Switch to D/C/F/TAF (late switch) group, the last value prior to the switch was used as reference (reference 2).
Time Frame From Reference 1 to Week 96 for D/C/F/TAF+ F/TDF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment. Here, N (number of participants analyzed) signifies participants evaluated for this outcome measure.
Arm/Group Title D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) Switch to D/C/F/TAF
Hide Arm/Group Description:
Participants received a single fixed dose combination (FDC) tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF tablet), orally once daily up to Week 48. After Week 48, all participants continued to receive D/C/F/TAF treatment (that is, initial switch to D/C/F/TAF group) up to Week 96. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until D/C/F/TAF became commercially available up to 42 months (end of extension).
After Week 52, participants earlier receiving treatment with bPI+F/TDF switched to D/C/F/TAF treatment up to Week 96. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until D/C/F/TAF became commercially available for up to 42 months.
Overall Number of Participants Analyzed 675 331
Median (Full Range)
Unit of Measure: microgram per gram (mcg/g)
-25.08
(-61980.5 to 1393.0)
-39.07
(-82240.7 to 869.9)
43.Secondary Outcome
Title Change From Reference in UPCR at Week 96
Hide Description Change from reference in UPCR was assessed at Week 96. For the D/C/F/TAF group, reference is the comparative treatment phase baseline as in Week 48 analysis (Reference 1). For the Switch to D/C/F/TAF (late switch) group, the last value prior to the switch was used as reference (reference 2).
Time Frame From Reference 1 to Week 96 for D/C/F/TAF+ F/TDF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment. Here, N (number of participants analyzed) signifies participants evaluated for this outcome measure.
Arm/Group Title D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) Switch to D/C/F/TAF
Hide Arm/Group Description:
Participants received a single fixed dose combination (FDC) tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF tablet), orally once daily up to Week 48. After Week 48, all participants continued to receive D/C/F/TAF treatment (that is, initial switch to D/C/F/TAF group) up to Week 96. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until D/C/F/TAF became commercially available up to 42 months (end of extension).
After Week 52, participants earlier receiving treatment with bPI+F/TDF switched to D/C/F/TAF treatment up to Week 96. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until D/C/F/TAF became commercially available for up to 42 months.
Overall Number of Participants Analyzed 675 331
Median (Full Range)
Unit of Measure: milligram per gram (mg/g)
-22.23
(-533.3 to 2314.7)
-12.81
(-722.1 to 453.1)
44.Secondary Outcome
Title Change From Reference in UB2MGCR at Week 96
Hide Description Change from reference in UB2MGCR was assessed at Week 96. For the D/C/F/TAF group, reference is the comparative treatment phase baseline as in Week 48 analysis (Reference 1). For the Switch to D/C/F/TAF (late switch) group, the last value prior to the switch was used as reference (reference 2).
Time Frame From Reference 1 to Week 96 for D/C/F/TAF+ F/TDF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment. Here, N (number of participants analyzed) signifies participants evaluated for this outcome measure.
Arm/Group Title D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) Switch to D/C/F/TAF
Hide Arm/Group Description:
Participants received a single fixed dose combination (FDC) tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF tablet), orally once daily up to Week 48. After Week 48, all participants continued to receive D/C/F/TAF treatment (that is, initial switch to D/C/F/TAF group) up to Week 96. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until D/C/F/TAF became commercially available up to 42 months (end of extension).
After Week 52, participants earlier receiving treatment with bPI+F/TDF switched to D/C/F/TAF treatment up to Week 96. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until D/C/F/TAF became commercially available for up to 42 months.
Overall Number of Participants Analyzed 664 332
Median (Full Range)
Unit of Measure: microgram per gram (mcg/g)
-68.22
(-71549.3 to 7433.1)
-110.31
(-152500.2 to 12288.4)
45.Secondary Outcome
Title Percent Change From Reference in FEPO4 at Week 96
Hide Description Percent change from reference in FEPO4 at Week 96 was reported. For the D/C/F/TAF group, reference is the comparative treatment phase baseline as in Week 48 analysis (Reference 1). For the Switch to D/C/F/TAF (late switch) group, the last value prior to the switch was used as reference (reference 2).
Time Frame From Reference 1 to Week 96 for D/C/F/TAF+ F/TDF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment. Here, N (number of participants analyzed) signifies participants evaluated for this outcome measure.
Arm/Group Title D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) Switch to D/C/F/TAF
Hide Arm/Group Description:
Participants received a single fixed dose combination (FDC) tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF tablet), orally once daily up to Week 48. After Week 48, all participants continued to receive D/C/F/TAF treatment (that is, initial switch to D/C/F/TAF group) up to Week 96. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until D/C/F/TAF became commercially available up to 42 months (end of extension).
After Week 52, participants earlier receiving treatment with bPI+F/TDF switched to D/C/F/TAF treatment up to Week 96. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until D/C/F/TAF became commercially available for up to 42 months.
Overall Number of Participants Analyzed 688 334
Median (Full Range)
Unit of Measure: percent change
4.15
(-88.0 to 524.8)
-3.19
(-77.9 to 547.8)
46.Secondary Outcome
Title Percent Change From Reference in Levels of Serum P1NP at Week 96
Hide Description Percent change from reference in serum P1NP levels at Week 96 was reported. For the D/C/F/TAF group, reference is the comparative treatment phase baseline as in Week 48 analysis (Reference 1). For the Switch to D/C/F/TAF (late switch) group, the last value prior to the switch was used as reference (reference 2).
Time Frame From Reference 1 to Week 96 for D/C/F/TAF+ FTC/TDF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF
Hide Outcome Measure Data
Hide Analysis Population Description
BIS analysis set included all participants who were randomized, received at least 1 dose of study drug in study and had at least one post-baseline value for either biomarker/BMD data. Here, N (number of participants analyzed) signifies participants evaluated for this outcome measure.
Arm/Group Title D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) Switch to D/C/F/TAF
Hide Arm/Group Description:
Participants received a single fixed dose combination (FDC) tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF tablet), orally once daily up to Week 48. After Week 48, all participants continued to receive D/C/F/TAF treatment (that is, initial switch to D/C/F/TAF group) up to Week 96. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until D/C/F/TAF became commercially available up to 42 months (end of extension).
After Week 52, participants earlier receiving treatment with bPI+F/TDF switched to D/C/F/TAF treatment up to Week 96. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until D/C/F/TAF became commercially available for up to 42 months.
Overall Number of Participants Analyzed 183 96
Mean (Standard Error)
Unit of Measure: percent change
-19.899  (2.2151) -18.466  (3.1169)
47.Secondary Outcome
Title Percent Change From Reference in Levels of Serum CTX at Week 96
Hide Description Percent change from reference in serum CTX at Week 96 was reported. For the D/C/F/TAF group, reference is the comparative treatment phase baseline as in Week 48 analysis (Reference 1). For the Switch to D/C/F/TAF (late switch) group, the last value prior to the switch was used as reference (reference 2).
Time Frame From Reference 1 to Week 96 for D/C/F/TAF+ FTC/TDF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF
Hide Outcome Measure Data
Hide Analysis Population Description
BIS analysis set included all participants who were randomized, received at least 1 dose of study drug in study and had at least one post-baseline value for either biomarker/BMD data. Here, N (number of participants analyzed) signifies participants evaluated for this outcome measure.
Arm/Group Title D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) Switch to D/C/F/TAF
Hide Arm/Group Description:
Participants received a single fixed dose combination (FDC) tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF tablet), orally once daily up to Week 48. After Week 48, all participants continued to receive D/C/F/TAF treatment (that is, initial switch to D/C/F/TAF group) up to Week 96. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until D/C/F/TAF became commercially available up to 42 months (end of extension).
After Week 52, participants earlier receiving treatment with bPI+F/TDF switched to D/C/F/TAF treatment up to Week 96. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until D/C/F/TAF became commercially available for up to 42 months.
Overall Number of Participants Analyzed 178 98
Mean (Standard Error)
Unit of Measure: percent change
-10.192  (3.0592) -21.755  (3.4926)
48.Secondary Outcome
Title Percent Change From Reference in Levels of PTH at Week 96
Hide Description Percent change from reference in PTH at Week 96 was reported. For the D/C/F/TAF group, reference is the comparative treatment phase baseline as in Week 48 analysis (Reference 1). For the Switch to D/C/F/TAF (late switch) group, the last value prior to the switch was used as reference (reference 2).
Time Frame From Reference 1 to Week 96 for D/C/F/TAF+ FTC/TDF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF
Hide Outcome Measure Data
Hide Analysis Population Description
BIS analysis set included all participants who were randomized, received at least 1 dose of study drug in study and had at least one post-baseline value for either biomarker/BMD data. Here, N (number of participants analyzed) signifies participants evaluated for this outcome measure.
Arm/Group Title D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) Switch to D/C/F/TAF
Hide Arm/Group Description:
Participants received a single fixed dose combination (FDC) tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF tablet), orally once daily up to Week 48. After Week 48, all participants continued to receive D/C/F/TAF treatment (that is, initial switch to D/C/F/TAF group) up to Week 96. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until D/C/F/TAF became commercially available up to 42 months (end of extension).
After Week 52, participants earlier receiving treatment with bPI+F/TDF switched to D/C/F/TAF treatment up to Week 96. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until D/C/F/TAF became commercially available for up to 42 months.
Overall Number of Participants Analyzed 169 97
Mean (Standard Error)
Unit of Measure: percent change
-17.171  (2.6774) -20.466  (3.2559)
49.Secondary Outcome
Title Percent Change From Reference in Levels of 25-OH Vitamin D at Week 96
Hide Description Percent change from reference in 25-OH Vitamin D at Week 96 were reported. For the D/C/F/TAF group, reference is the comparative treatment phase baseline as in Week 48 analysis (Reference 1). For the Switch to D/C/F/TAF (late switch) group, the last value prior to the switch was used as reference (reference 2).
Time Frame From Reference 1 to Week 96 for D/C/F/TAF+ FTC/TDF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF
Hide Outcome Measure Data
Hide Analysis Population Description
BIS analysis set included all participants who were randomized, received at least 1 dose of study drug in study and had at least one post-baseline value for either biomarker/BMD data. Here, N (number of participants analyzed) signifies participants evaluated for this outcome measure.
Arm/Group Title D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) Switch to D/C/F/TAF
Hide Arm/Group Description:
Participants received a single fixed dose combination (FDC) tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF tablet), orally once daily up to Week 48. After Week 48, all participants continued to receive D/C/F/TAF treatment (that is, initial switch to D/C/F/TAF group) up to Week 96. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until D/C/F/TAF became commercially available up to 42 months (end of extension).
After Week 52, participants earlier receiving treatment with bPI+F/TDF switched to D/C/F/TAF treatment up to Week 96. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until D/C/F/TAF became commercially available for up to 42 months.
Overall Number of Participants Analyzed 141 98
Mean (Standard Error)
Unit of Measure: percent change
24.6  (5.16) -1.9  (3.33)
50.Secondary Outcome
Title Percent Change From Reference in Hip and Spine BMD at Week 96
Hide Description The BMD is the amount of mineral in gram per square centimeter of bone, which was assessed by DXA scan. Positive values are "best values" and negative values are "worst values" of change. Percent change from reference in hip and spine BMD was assessed. For the D/C/F/TAF group, reference is the comparative treatment phase baseline as in Week 48 analysis (Reference 1). For the Switch to D/C/F/TAF (late switch) group, the last value prior to the switch was used as reference (reference 2).
Time Frame From Reference 1 to Week 96 for D/C/F/TAF+ FTC/TDF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF
Hide Outcome Measure Data
Hide Analysis Population Description
BIS analysis set included all participants who were randomized, received at least 1 dose of study drug in study and had at least one post-baseline value for either biomarker/BMD data. Here, N (number of participants analyzed) indicates number of participants evaluable for this outcome measure; and 'n' specifies participants analyzed for specified categories.
Arm/Group Title D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) Switch to D/C/F/TAF
Hide Arm/Group Description:
Participants received a single fixed dose combination (FDC) tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF tablet), orally once daily up to Week 48. After Week 48, all participants continued to receive D/C/F/TAF treatment (that is, initial switch to D/C/F/TAF group) up to Week 96. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until D/C/F/TAF became commercially available up to 42 months (end of extension).
After Week 52, participants earlier receiving treatment with bPI+F/TDF switched to D/C/F/TAF treatment up to Week 96. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until D/C/F/TAF became commercially available for up to 42 months.
Overall Number of Participants Analyzed 173 99
Mean (Standard Error)
Unit of Measure: percent change
Hip region BMD-T score Number Analyzed 164 participants 96 participants
0.0173  (0.00217) 0.0108  (0.00328)
Spine region BMD-T score Number Analyzed 173 participants 99 participants
0.0193  (0.00286) 0.0279  (0.00381)
51.Secondary Outcome
Title Change From Reference in BMD T-score of Hip and Spine at Week 96
Hide Description BMD status was assessed using BMD T-scores; normal bone status was defined by a BMD T-score >= -1, osteopenia by a T-score >= -2.5 to <-1.0, and osteoporosis by a T-score <-2.5. For the D/C/F/TAF group, reference is the comparative treatment phase baseline as in Week 48 analysis (Reference 1). For the Switch to D/C/F/TAF (late switch) group, the last value prior to the switch was used as reference (reference 2).
Time Frame From Reference 1 to Week 96 for D/C/F/TAF+ FTC/TDF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF
Hide Outcome Measure Data
Hide Analysis Population Description
BIS analysis set included all participants who were randomized, received at least 1 dose of study drug in study and had at least one post-baseline value for either biomarker/BMD data. Here, N (number of participants analyzed) indicates number of participants evaluable for this outcome measure; and 'n' specifies participants analyzed for specified categories.
Arm/Group Title D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) Switch to D/C/F/TAF
Hide Arm/Group Description:
Participants received a single fixed dose combination (FDC) tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF tablet), orally once daily up to Week 48. After Week 48, all participants continued to receive D/C/F/TAF treatment (that is, initial switch to D/C/F/TAF group) up to Week 96. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until D/C/F/TAF became commercially available up to 42 months (end of extension).
After Week 52, participants earlier receiving treatment with bPI+F/TDF switched to D/C/F/TAF treatment up to Week 96. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until D/C/F/TAF became commercially available for up to 42 months.
Overall Number of Participants Analyzed 173 99
Mean (Standard Error)
Unit of Measure: units on a scale
Hip region BMD Number Analyzed 164 participants 96 participants
0.122  (0.0154) 0.077  (0.0230)
Spine region BMD Number Analyzed 173 participants 99 participants
0.176  (0.0259) 0.255  (0.0339)
52.Secondary Outcome
Title Percentage of Participants With Non-Virologic Rebound by Kaplan-Meier Estimates
Hide Description Virologic rebound is defined as participants who show confirmed HIV-1 RNA >=50 copies/mL, or for which the last available (single) HIV-1 RNA value on treatment was >=50 copies/mL. Here, Kaplan-Meier estimates (%) of non-virologic rebound at every 6 months interval are presented.
Time Frame Week 96 to end of extension (at every 6 months, up to 42 months)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set included all the participants who were randomized and received at least 1 dose of study treatment. Here, N (number of participants analyzed) indicates number of participants evaluable for this outcome measure; and 'n' specifies participants analyzed for specified timepoints.
Arm/Group Title D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) Switch to D/C/F/TAF
Hide Arm/Group Description:
Participants received a single fixed dose combination (FDC) tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF tablet), orally once daily up to Week 48. After Week 48, all participants continued to receive D/C/F/TAF treatment (that is, initial switch to D/C/F/TAF group) up to Week 96. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until D/C/F/TAF became commercially available up to 42 months (end of extension).
After Week 52, participants earlier receiving treatment with bPI+F/TDF switched to D/C/F/TAF treatment up to Week 96. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until D/C/F/TAF became commercially available for up to 42 months.
Overall Number of Participants Analyzed 671 323
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Week 96 Number Analyzed 671 participants 323 participants
100
(100 to 100)
100
(100 to 100)
Week 96 + 6 months Number Analyzed 638 participants 308 participants
99.4
(98.4 to 99.8)
100
(100 to 100)
Week 96 + 12 months Number Analyzed 515 participants 248 participants
98.0
(96.5 to 98.9)
98.5
(96.0 to 99.4)
Week 96 + 18 months Number Analyzed 325 participants 159 participants
97.6
(95.9 to 98.6)
98.1
(95.4 to 99.2)
Week 96 + 24 months Number Analyzed 150 participants 68 participants
97.1
(94.9 to 98.3)
96.5
(92.3 to 98.4)
Week 96 + 30 months Number Analyzed 55 participants 28 participants
95.3
(91.3 to 97.5)
96.5
(92.3 to 98.4)
Week 96 + 36 months Number Analyzed 26 participants 8 participants
92.4
(83 to 96.7)
96.5
(92.3 to 98.4)
Week 96 + 42 months Number Analyzed 2 participants 0 participants
92.4
(83.0 to 96.7)
53.Secondary Outcome
Title Percentage of Participants With Non-Treatment Failure by Kaplan-Meier Estimates
Hide Description Percentage of participants with non-treatment failure by Kaplan-Meier Estimates were reported. Treatment failure was defined as having either protocol-defined virologic rebound or having discontinued for reasons other than alternate access to D/C/F/TAF (or other antiretroviral [ARV]).
Time Frame Week 96 to end of extension (up to 42 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment. Here, N (number of participants analyzed) indicates number of participants evaluable for this outcome measure; and 'n' specifies participants analyzed for specified timepoints.
Arm/Group Title D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) Switch to D/C/F/TAF
Hide Arm/Group Description:
Participants received a single fixed dose combination (FDC) tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF tablet), orally once daily up to Week 48. After Week 48, all participants continued to receive D/C/F/TAF treatment (that is, initial switch to D/C/F/TAF group) up to Week 96. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until D/C/F/TAF became commercially available up to 42 months (end of extension).
After Week 52, participants earlier receiving treatment with bPI+F/TDF switched to D/C/F/TAF treatment up to Week 96. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until D/C/F/TAF became commercially available for up to 42 months.
Overall Number of Participants Analyzed 680 326
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Week 96 Number Analyzed 680 participants 326 participants
100
(100 to 100)
100
(100 to 100)
Week 96 + 6 months Number Analyzed 646 participants 311 participants
98.1
(96.7 to 98.9)
98.5
(96.3 to 99.4)
Week 96 + 12 months Number Analyzed 532 participants 261 participants
94.3
(92.2 to 95.9)
95.4
(92.3 to 97.2)
Week 96 + 18 months Number Analyzed 348 participants 177 participants
91.6
(89.0 to 93.6)
92.2
(88.3 to 94.8)
Week 96 + 24 months Number Analyzed 163 participants 71 participants
89.4
(86.1 to 91.9)
89.7
(85.0 to 93.0)
Week 96 + 30 months Number Analyzed 62 participants 32 participants
87.0
(82.7 to 90.4)
88.1
(82.0 to 92.2)
Week 96 + 36 months Number Analyzed 32 participants 12 participants
84.9
(78.2 to 89.6)
82.6
(67.4 to 91.1)
Week 96 + 42 months Number Analyzed 2 participants 0 participants
81.7
(71.9 to 88.4)
54.Secondary Outcome
Title Percentage of Participants With HIV RNA <50, <20, <200 Copies/mL Post Week 96 to End of Extension
Hide Description Percentage of participants with HIV RNA <50, <20, <200 copies/mL post Week 96 to end of extension were reported.
Time Frame Week 96 to end of extension (up to 42 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study. Here, N (number of participants analyzed) indicates number of participants evaluable for this outcome measure and 'n' specifies participants analyzed for specified timepoints.
Arm/Group Title D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) Switch to D/C/F/TAF
Hide Arm/Group Description:
Participants received a single fixed dose combination (FDC) tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF tablet), orally once daily up to Week 48. After Week 48, all participants continued to receive D/C/F/TAF treatment (that is, initial switch to D/C/F/TAF group) up to Week 96. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until D/C/F/TAF became commercially available up to 42 months (end of extension).
After Week 52, participants earlier receiving treatment with bPI+F/TDF switched to D/C/F/TAF treatment up to Week 96. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until D/C/F/TAF became commercially available for up to 42 months.
Overall Number of Participants Analyzed 688 334
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Week 96 + 6 months (<50 copies/mL) Number Analyzed 688 participants 334 participants
97.8
(96.4 to 98.8)
97.9
(95.7 to 99.2)
Week 96 + 12 months (<50 copies/mL) Number Analyzed 611 participants 302 participants
98.4
(97.0 to 99.2)
97.4
(94.8 to 98.8)
Week 96 + 18 months (<50 copies/mL) Number Analyzed 461 participants 225 participants
99.6
(98.4 to 99.9)
98.7
(96.2 to 99.7)
Week 96 + 24 months (<50 copies/mL) Number Analyzed 280 participants 134 participants
99.3
(97.4 to 99.9)
98.5
(94.7 to 99.8)
Week 96 + 30 months (<50 copies/mL) Number Analyzed 135 participants 64 participants
99.3
(95.9 to 100)
100
(94.4 to 100)
Week 96 + 36 months (<50 copies/mL) Number Analyzed 52 participants 26 participants
98.1
(89.7 to 100)
100
(86.8 to 100)
Week 96 + 42 months (<50 copies/mL) Number Analyzed 16 participants 7 participants
100
(79.4 to 100)
100
(59.0 to 100)
Week 96 + 6 months (<200 copies/mL) Number Analyzed 688 participants 334 participants
99.1
(98.1 to 99.7)
99.7
(98.3 to 100)
Week 96 + 12 months (<200 copies/mL) Number Analyzed 611 participants 302 participants
99.3
(98.3 to 99.8)
98.7
(96.6 to 99.6)
Week 96 + 18 months (<200 copies/mL) Number Analyzed 461 participants 225 participants
100
(99.2 to 100)
99.1
(96.8 to 99.9)
Week 96 + 24 months (<200 copies/mL) Number Analyzed 280 participants 134 participants
99.6
(98.0 to 100)
99.3
(95.9 to 100)
Week 96 + 30 months (<200 copies/mL) Number Analyzed 135 participants 64 participants
100
(97.3 to 100)
100
(94.4 to 100)
Week 96 + 36 months (<200 copies/mL) Number Analyzed 52 participants 26 participants
100
(93.2 to 100)
100
(86.8 to 100)
Week 96 + 42 months (<200 copies/mL) Number Analyzed 16 participants 7 participants
100
(79.4 to 100)
100
(59 to 100)
Week 96 + 6 months (<20 copies/mL) Number Analyzed 688 participants 334 participants
91.4
(89.1 to 93.4)
93.4
(90.2 to 95.8)
Week 96 + 12 months (<20 copies/mL) Number Analyzed 611 participants 302 participants
93.9
(91.7 to 95.7)
91.4
(87.6 to 94.3)
Week 96 + 18 months (<20 copies/mL) Number Analyzed 461 participants 225 participants
96.1
(93.9 to 97.7)
92.9
(88.7 to 95.9)
Week 96 + 24 months (<20 copies/mL) Number Analyzed 280 participants 134 participants
96.1
(93.1 to 98.0)
95.5
(90.5 to 98.3)
Week 96 + 30 months (<20 copies/mL) Number Analyzed 135 participants 64 participants
95.6
(90.6 to 98.4)
92.2
(82.7 to 97.4)
Week 96 + 36 months (<20 copies/mL) Number Analyzed 52 participants 26 participants
94.2
(84.1 to 98.8)
96.2
(80.4 to 99.9)
Week 96 + 42 months (<20 copies/mL) Number Analyzed 16 participants 7 participants
93.8
(69.8 to 99.8)
100
(59 to 100)
55.Secondary Outcome
Title CD4+ Cell Count Post-Week 96 to End of Extension
Hide Description The immunologic change was determined by Cluster of CD4+ cell count. CD4+ cell count post-Week 96 to end of extension were assessed.
Time Frame Week 96 to end of extension (up to 42 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study. Here, N (number of participants analyzed) signifies participants evaluated for this outcome measure and n (number analyzed) signifies participants analyzed at specified timepoints
Arm/Group Title D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) Switch to D/C/F/TAF
Hide Arm/Group Description:
Participants received a single fixed dose combination (FDC) tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF tablet), orally once daily up to Week 48. After Week 48, all participants continued to receive D/C/F/TAF treatment (that is, initial switch to D/C/F/TAF group) up to Week 96. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until D/C/F/TAF became commercially available up to 42 months (end of extension).
After Week 52, participants earlier receiving treatment with bPI+F/TDF switched to D/C/F/TAF treatment up to Week 96. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until D/C/F/TAF became commercially available for up to 42 months.
Overall Number of Participants Analyzed 682 332
Mean (Standard Error)
Unit of Measure: cells/mm^3
Week 96 + 6 months Number Analyzed 682 participants 332 participants
706.4  (10.51) 681.3  (14.99)
Week 96 + 12 months Number Analyzed 606 participants 298 participants
707.6  (11.93) 676.2  (14.57)
Week 96 + 18 months Number Analyzed 459 participants 225 participants
713.3  (12.16) 686.1  (17.05)
Week 96 + 24 months Number Analyzed 278 participants 128 participants
712.7  (15.98) 686.4  (21.20)
Week 96 + 30 months Number Analyzed 134 participants 63 participants
730.4  (23.24) 685.8  (28.61)
Week 96 + 36 months Number Analyzed 52 participants 25 participants
732.0  (33.10) 733.3  (54.73)
Week 96 + 42 months Number Analyzed 16 participants 7 participants
714.3  (56.26) 705.6  (112.99)
56.Secondary Outcome
Title Percentage of Participants With Treatment Adherence of >95% From Week 96 to End of Extension
Hide Description Treatment adherence (defined as adherence of >95%) was assessed by the drug accountability and was calculated cumulative from start of treatment/switch to last study drug intake by determination of the cumulative treatment adherence in participants who returned all dispensed bottles prior to or at the last visit in the study from Week 96 to end of extension.
Time Frame Week 96 to end of extension (up to 42 months)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set included all the participants who were randomized and received at least 1 dose of study treatment. Here, N (number of participants analyzed) indicates the number of participants evaluable for this outcome measure.
Arm/Group Title D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) Switch to D/C/F/TAF
Hide Arm/Group Description:
Participants received a single fixed dose combination (FDC) tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF tablet), orally once daily up to Week 48. After Week 48, all participants continued to receive D/C/F/TAF treatment (that is, initial switch to D/C/F/TAF group) up to Week 96. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until D/C/F/TAF became commercially available up to 42 months (end of extension).
After Week 52, participants earlier receiving treatment with bPI+F/TDF switched to D/C/F/TAF treatment up to Week 96. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until D/C/F/TAF became commercially available for up to 42 months.
Overall Number of Participants Analyzed 363 216
Measure Type: Number
Unit of Measure: percentage of participants
89.5 89.4
57.Secondary Outcome
Title Percentage of Participants Experiencing Grade 3 and 4 AEs, Serious Adverse Events (SAEs), and Premature Discontinuation Due to AEs Post-Week 96 to End of Extension
Hide Description AE is any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Grade 3 (Severe) events were symptoms causing inability to perform usual social & functional activities. Grade 4 (Life-threatening) events were symptoms causing inability to perform basic self-care functions or medical or operative intervention indicated to prevent permanent impairment, persistent disability, or death. SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above.
Time Frame From Week 96 to end of extension (up to 42 months)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set included all the participants who were randomized and received at least 1 dose of study treatment.
Arm/Group Title D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) Switch to D/C/F/TAF
Hide Arm/Group Description:
Participants received a single fixed dose combination (FDC) tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF tablet), orally once daily up to Week 48. After Week 48, all participants continued to receive D/C/F/TAF treatment (that is, initial switch to D/C/F/TAF group) up to Week 96. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until D/C/F/TAF became commercially available up to 42 months (end of extension).
After Week 52, participants earlier receiving treatment with bPI+F/TDF switched to D/C/F/TAF treatment up to Week 96. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until D/C/F/TAF became commercially available for up to 42 months.
Overall Number of Participants Analyzed 699 337
Measure Type: Number
Unit of Measure: percentage of participants
Grade 3 AEs 5.7 5.0
Grade 4 AEs 2.1 1.5
SAEs 7.3 7.7
Premature discontinuations due to AEs 1.1 2.1
Time Frame Up to 5 years and 4 months
Adverse Event Reporting Description Safety was performed using intent-to-treat (ITT) analysis set included all the participants who were randomized and received at least one dose of study treatment in the study.
 
Arm/Group Title D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) Control (Baseline to Switch) Switch to D/C/F/TAF Group
Hide Arm/Group Description Participants received a single fixed dose combination (FDC) tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF tablet), orally once daily up to Week 48. After Week 48, all participants continued to receive D/C/F/TAF treatment (that is, initial switch to D/C/F/TAF group) up to Week 96. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until the D/C/F/TAF became commercially available up to 42 months Participants received a boosted protease inhibitor (bPI) (limited to darunavir [DRV] or atazanavir with low-dose ritonavir [rtv] or cobicistat [COBI], or lopinavir with rtv) combined with emtricitabine/tenofovir disoproxil fumarate (F/TDF) up to Week 48. After Week 52, participants earlier receiving treatment with bPI+F/TDF switched to D/C/F/TAF up to Week 96. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until the D/C/F/TAF became commercially available for up to 42 months.
All-Cause Mortality
D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) Control (Baseline to Switch) Switch to D/C/F/TAF Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   4/763 (0.52%)   0/378 (0.00%)   1/352 (0.28%) 
Hide Serious Adverse Events
D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) Control (Baseline to Switch) Switch to D/C/F/TAF Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   114/763 (14.94%)   18/378 (4.76%)   42/352 (11.93%) 
Blood and lymphatic system disorders       
Leukocytosis * 1  1/763 (0.13%)  0/378 (0.00%)  0/352 (0.00%) 
Lymphadenopathy * 1  1/763 (0.13%)  0/378 (0.00%)  0/352 (0.00%) 
Cardiac disorders       
Acute myocardial infarction * 1  1/763 (0.13%)  0/378 (0.00%)  0/352 (0.00%) 
Angina pectoris * 1  1/763 (0.13%)  0/378 (0.00%)  0/352 (0.00%) 
Angina unstable * 1  1/763 (0.13%)  0/378 (0.00%)  1/352 (0.28%) 
Atrial fibrillation * 1  1/763 (0.13%)  0/378 (0.00%)  1/352 (0.28%) 
Atrial flutter * 1  0/763 (0.00%)  0/378 (0.00%)  1/352 (0.28%) 
Atrioventricular block complete * 1  0/763 (0.00%)  0/378 (0.00%)  1/352 (0.28%) 
Bradycardia * 1  1/763 (0.13%)  0/378 (0.00%)  0/352 (0.00%) 
Cardiac failure congestive * 1  0/763 (0.00%)  0/378 (0.00%)  1/352 (0.28%) 
Coronary artery disease * 1  1/763 (0.13%)  0/378 (0.00%)  1/352 (0.28%) 
Myocardial infarction * 1  4/763 (0.52%)  1/378 (0.26%)  1/352 (0.28%) 
Ventricular tachycardia * 1  1/763 (0.13%)  0/378 (0.00%)  0/352 (0.00%) 
Endocrine disorders       
Cushing's syndrome * 1  0/763 (0.00%)  0/378 (0.00%)  1/352 (0.28%) 
Gastrointestinal disorders       
Abdominal adhesions * 1  1/763 (0.13%)  0/378 (0.00%)  0/352 (0.00%) 
Abdominal pain upper * 1  1/763 (0.13%)  0/378 (0.00%)  0/352 (0.00%) 
Anal fissure * 1  1/763 (0.13%)  0/378 (0.00%)  0/352 (0.00%) 
Anal fistula * 1  1/763 (0.13%)  0/378 (0.00%)  0/352 (0.00%) 
Colitis * 1  1/763 (0.13%)  0/378 (0.00%)  1/352 (0.28%) 
Diarrhoea * 1  1/763 (0.13%)  0/378 (0.00%)  0/352 (0.00%) 
Gastric ulcer * 1  1/763 (0.13%)  0/378 (0.00%)  0/352 (0.00%) 
Gastritis * 1  1/763 (0.13%)  0/378 (0.00%)  0/352 (0.00%) 
Gastrointestinal inflammation * 1  1/763 (0.13%)  0/378 (0.00%)  0/352 (0.00%) 
Haemorrhoids * 1  0/763 (0.00%)  0/378 (0.00%)  1/352 (0.28%) 
Hiatus hernia * 1  0/763 (0.00%)  0/378 (0.00%)  1/352 (0.28%) 
Inflammatory bowel disease * 1  0/763 (0.00%)  0/378 (0.00%)  1/352 (0.28%) 
Inguinal hernia * 1  1/763 (0.13%)  0/378 (0.00%)  0/352 (0.00%) 
Intestinal obstruction * 1  0/763 (0.00%)  1/378 (0.26%)  0/352 (0.00%) 
Nausea * 1  0/763 (0.00%)  1/378 (0.26%)  0/352 (0.00%) 
Oesophageal rupture * 1  1/763 (0.13%)  0/378 (0.00%)  0/352 (0.00%) 
Pancreatitis * 1  1/763 (0.13%)  0/378 (0.00%)  0/352 (0.00%) 
Pancreatitis acute * 1  1/763 (0.13%)  0/378 (0.00%)  0/352 (0.00%) 
Peptic ulcer * 1  1/763 (0.13%)  0/378 (0.00%)  0/352 (0.00%) 
Rectal perforation * 1  1/763 (0.13%)  0/378 (0.00%)  0/352 (0.00%) 
Small intestinal obstruction * 1  1/763 (0.13%)  0/378 (0.00%)  0/352 (0.00%) 
Vomiting * 1  0/763 (0.00%)  1/378 (0.26%)  0/352 (0.00%) 
General disorders       
Brain death * 1  1/763 (0.13%)  0/378 (0.00%)  0/352 (0.00%) 
Chest pain * 1  1/763 (0.13%)  0/378 (0.00%)  1/352 (0.28%) 
Fatigue * 1  1/763 (0.13%)  0/378 (0.00%)  0/352 (0.00%) 
Hernia * 1  1/763 (0.13%)  0/378 (0.00%)  0/352 (0.00%) 
Non-cardiac chest pain * 1  2/763 (0.26%)  0/378 (0.00%)  2/352 (0.57%) 
Pyrexia * 1  1/763 (0.13%)  0/378 (0.00%)  1/352 (0.28%) 
Surgical failure * 1  0/763 (0.00%)  0/378 (0.00%)  1/352 (0.28%) 
Hepatobiliary disorders       
Cholelithiasis * 1  0/763 (0.00%)  0/378 (0.00%)  1/352 (0.28%) 
Hepatitis acute * 1  0/763 (0.00%)  1/378 (0.26%)  0/352 (0.00%) 
Immune system disorders       
Jarisch-Herxheimer reaction * 1  0/763 (0.00%)  0/378 (0.00%)  1/352 (0.28%) 
Infections and infestations       
Abdominal abscess * 1  0/763 (0.00%)  0/378 (0.00%)  1/352 (0.28%) 
Abscess limb * 1  0/763 (0.00%)  1/378 (0.26%)  0/352 (0.00%) 
Abscess oral * 1  1/763 (0.13%)  0/378 (0.00%)  0/352 (0.00%) 
Anal abscess * 1  1/763 (0.13%)  0/378 (0.00%)  0/352 (0.00%) 
Appendicitis * 1  2/763 (0.26%)  0/378 (0.00%)  3/352 (0.85%) 
Appendicitis perforated * 1  0/763 (0.00%)  0/378 (0.00%)  1/352 (0.28%) 
Cellulitis * 1  2/763 (0.26%)  1/378 (0.26%)  2/352 (0.57%) 
Colon gangrene * 1  0/763 (0.00%)  0/378 (0.00%)  1/352 (0.28%) 
Diarrhoea infectious * 1  1/763 (0.13%)  0/378 (0.00%)  0/352 (0.00%) 
Diverticulitis * 1  4/763 (0.52%)  0/378 (0.00%)  0/352 (0.00%) 
Epididymitis * 1  0/763 (0.00%)  1/378 (0.26%)  0/352 (0.00%) 
Escherichia sepsis * 1  0/763 (0.00%)  0/378 (0.00%)  1/352 (0.28%) 
Fournier's gangrene * 1  0/763 (0.00%)  0/378 (0.00%)  1/352 (0.28%) 
Gastroenteritis * 1  4/763 (0.52%)  0/378 (0.00%)  0/352 (0.00%) 
Gastroenteritis shigella * 1  1/763 (0.13%)  0/378 (0.00%)  0/352 (0.00%) 
Groin abscess * 1  1/763 (0.13%)  0/378 (0.00%)  0/352 (0.00%) 
Hepatitis A * 1  1/763 (0.13%)  0/378 (0.00%)  1/352 (0.28%) 
Herpes simplex meningitis * 1  1/763 (0.13%)  0/378 (0.00%)  0/352 (0.00%) 
Infection * 1  0/763 (0.00%)  1/378 (0.26%)  0/352 (0.00%) 
Infectious pleural effusion * 1  1/763 (0.13%)  0/378 (0.00%)  0/352 (0.00%) 
Influenza * 1  1/763 (0.13%)  0/378 (0.00%)  0/352 (0.00%) 
Lower respiratory tract infection * 1  1/763 (0.13%)  0/378 (0.00%)  0/352 (0.00%) 
Lymphogranuloma venereum * 1  1/763 (0.13%)  0/378 (0.00%)  0/352 (0.00%) 
Malaria * 1  0/763 (0.00%)  0/378 (0.00%)  1/352 (0.28%) 
Orchitis * 1  0/763 (0.00%)  0/378 (0.00%)  1/352 (0.28%) 
Perineal abscess * 1  0/763 (0.00%)  1/378 (0.26%)  1/352 (0.28%) 
Peritonitis * 1  1/763 (0.13%)  0/378 (0.00%)  0/352 (0.00%) 
Pneumonia * 1  10/763 (1.31%)  0/378 (0.00%)  3/352 (0.85%) 
Pneumonia respiratory syncytial viral * 1  1/763 (0.13%)  0/378 (0.00%)  0/352 (0.00%) 
Pyelonephritis * 1  1/763 (0.13%)  0/378 (0.00%)  0/352 (0.00%) 
Secondary syphilis * 1  0/763 (0.00%)  0/378 (0.00%)  1/352 (0.28%) 
Sepsis * 1  0/763 (0.00%)  0/378 (0.00%)  2/352 (0.57%) 
Septic shock * 1  1/763 (0.13%)  0/378 (0.00%)  1/352 (0.28%) 
Subcutaneous abscess * 1  1/763 (0.13%)  0/378 (0.00%)  0/352 (0.00%) 
Syphilis * 1  0/763 (0.00%)  1/378 (0.26%)  0/352 (0.00%) 
Tooth infection * 1  1/763 (0.13%)  0/378 (0.00%)  0/352 (0.00%) 
Upper respiratory tract infection * 1  1/763 (0.13%)  0/378 (0.00%)  0/352 (0.00%) 
Urinary tract infection * 1  0/763 (0.00%)  0/378 (0.00%)  1/352 (0.28%) 
Urosepsis * 1  1/763 (0.13%)  0/378 (0.00%)  0/352 (0.00%) 
Viral infection * 1  0/763 (0.00%)  0/378 (0.00%)  1/352 (0.28%) 
Injury, poisoning and procedural complications       
Alcohol poisoning * 1  1/763 (0.13%)  0/378 (0.00%)  0/352 (0.00%) 
Ankle fracture * 1  3/763 (0.39%)  0/378 (0.00%)  0/352 (0.00%) 
Eye injury * 1  0/763 (0.00%)  0/378 (0.00%)  1/352 (0.28%) 
Fibula fracture * 1  1/763 (0.13%)  0/378 (0.00%)  0/352 (0.00%) 
Foot fracture * 1  1/763 (0.13%)  0/378 (0.00%)  0/352 (0.00%) 
Foreign body in gastrointestinal tract * 1  1/763 (0.13%)  0/378 (0.00%)  0/352 (0.00%) 
Hip fracture * 1  1/763 (0.13%)  0/378 (0.00%)  0/352 (0.00%) 
Ligament injury * 1  1/763 (0.13%)  0/378 (0.00%)  0/352 (0.00%) 
Lumbar vertebral fracture * 1  1/763 (0.13%)  0/378 (0.00%)  0/352 (0.00%) 
Meniscus injury * 1  0/763 (0.00%)  1/378 (0.26%)  0/352 (0.00%) 
Multiple fractures * 1  1/763 (0.13%)  0/378 (0.00%)  0/352 (0.00%) 
Musculoskeletal injury * 1  1/763 (0.13%)  0/378 (0.00%)  0/352 (0.00%) 
Overdose * 1  3/763 (0.39%)  0/378 (0.00%)  1/352 (0.28%) 
Postoperative ileus * 1  1/763 (0.13%)  0/378 (0.00%)  0/352 (0.00%) 
Skull fracture * 1  1/763 (0.13%)  0/378 (0.00%)  0/352 (0.00%) 
Subdural haematoma * 1  1/763 (0.13%)  0/378 (0.00%)  0/352 (0.00%) 
Tendon rupture * 1  0/763 (0.00%)  0/378 (0.00%)  1/352 (0.28%) 
Toxicity to various agents * 1  1/763 (0.13%)  0/378 (0.00%)  0/352 (0.00%) 
Upper limb fracture * 1  1/763 (0.13%)  0/378 (0.00%)  0/352 (0.00%) 
Investigations       
Amylase increased * 1  0/763 (0.00%)  1/378 (0.26%)  0/352 (0.00%) 
Biopsy lymph gland * 1  1/763 (0.13%)  0/378 (0.00%)  0/352 (0.00%) 
Oxygen saturation decreased * 1  1/763 (0.13%)  0/378 (0.00%)  0/352 (0.00%) 
Metabolism and nutrition disorders       
Dehydration * 1  0/763 (0.00%)  1/378 (0.26%)  0/352 (0.00%) 
Diabetic ketoacidosis * 1  1/763 (0.13%)  0/378 (0.00%)  0/352 (0.00%) 
Hyperglycaemia * 1  0/763 (0.00%)  0/378 (0.00%)  1/352 (0.28%) 
Hyperglycaemic hyperosmolar nonketotic syndrome * 1  1/763 (0.13%)  0/378 (0.00%)  0/352 (0.00%) 
Hypokalaemia * 1  1/763 (0.13%)  0/378 (0.00%)  0/352 (0.00%) 
Type 2 diabetes mellitus * 1  1/763 (0.13%)  0/378 (0.00%)  0/352 (0.00%) 
Musculoskeletal and connective tissue disorders       
Osteoarthritis * 1  0/763 (0.00%)  0/378 (0.00%)  1/352 (0.28%) 
Osteonecrosis * 1  1/763 (0.13%)  0/378 (0.00%)  0/352 (0.00%) 
Polyarthritis * 1  1/763 (0.13%)  0/378 (0.00%)  0/352 (0.00%) 
Rhabdomyolysis * 1  1/763 (0.13%)  0/378 (0.00%)  0/352 (0.00%) 
Seronegative arthritis * 1  0/763 (0.00%)  0/378 (0.00%)  1/352 (0.28%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Anal squamous cell carcinoma * 1  2/763 (0.26%)  0/378 (0.00%)  0/352 (0.00%) 
Anogenital warts * 1  0/763 (0.00%)  0/378 (0.00%)  1/352 (0.28%) 
Breast cancer * 1  1/763 (0.13%)  0/378 (0.00%)  0/352 (0.00%) 
Cholangiocarcinoma * 1  0/763 (0.00%)  0/378 (0.00%)  1/352 (0.28%) 
Enchondromatosis * 1  0/763 (0.00%)  0/378 (0.00%)  1/352 (0.28%) 
Hodgkin's disease * 1  1/763 (0.13%)  0/378 (0.00%)  0/352 (0.00%) 
Lymphoma * 1  1/763 (0.13%)  0/378 (0.00%)  0/352 (0.00%) 
Non-Hodgkin's lymphoma * 1  1/763 (0.13%)  0/378 (0.00%)  0/352 (0.00%) 
Pancreatic carcinoma metastatic * 1  1/763 (0.13%)  0/378 (0.00%)  0/352 (0.00%) 
Prostate cancer * 1  2/763 (0.26%)  0/378 (0.00%)  0/352 (0.00%) 
Retinal melanoma * 1  0/763 (0.00%)  1/378 (0.26%)  0/352 (0.00%) 
Spinal cord neoplasm * 1  1/763 (0.13%)  0/378 (0.00%)  0/352 (0.00%) 
Uterine leiomyoma * 1  1/763 (0.13%)  0/378 (0.00%)  0/352 (0.00%) 
Nervous system disorders       
Carotid artery aneurysm * 1  1/763 (0.13%)  0/378 (0.00%)  0/352 (0.00%) 
Carotid artery stenosis * 1  1/763 (0.13%)  0/378 (0.00%)  1/352 (0.28%) 
Cerebrovascular accident * 1  2/763 (0.26%)  0/378 (0.00%)  0/352 (0.00%) 
Epilepsy * 1  1/763 (0.13%)  0/378 (0.00%)  0/352 (0.00%) 
Essential tremor * 1  1/763 (0.13%)  0/378 (0.00%)  0/352 (0.00%) 
Headache * 1  3/763 (0.39%)  0/378 (0.00%)  0/352 (0.00%) 
Hemiparesis * 1  1/763 (0.13%)  0/378 (0.00%)  0/352 (0.00%) 
Loss of consciousness * 1  2/763 (0.26%)  0/378 (0.00%)  0/352 (0.00%) 
Paraparesis * 1  1/763 (0.13%)  0/378 (0.00%)  0/352 (0.00%) 
Radiculopathy * 1  1/763 (0.13%)  0/378 (0.00%)  0/352 (0.00%) 
Syncope * 1  1/763 (0.13%)  0/378 (0.00%)  1/352 (0.28%) 
Transient ischaemic attack * 1  1/763 (0.13%)  0/378 (0.00%)  0/352 (0.00%) 
Pregnancy, puerperium and perinatal conditions       
Ectopic pregnancy * 1  0/763 (0.00%)  1/378 (0.26%)  0/352 (0.00%) 
Product Issues       
Device breakage * 1  0/763 (0.00%)  1/378 (0.26%)  0/352 (0.00%) 
Device loosening * 1  1/763 (0.13%)  0/378 (0.00%)  0/352 (0.00%) 
Psychiatric disorders       
Adjustment disorder * 1  0/763 (0.00%)  0/378 (0.00%)  1/352 (0.28%) 
Anxiety * 1  1/763 (0.13%)  0/378 (0.00%)  0/352 (0.00%) 
Completed suicide * 1  1/763 (0.13%)  0/378 (0.00%)  0/352 (0.00%) 
Delirium * 1  1/763 (0.13%)  0/378 (0.00%)  0/352 (0.00%) 
Depression * 1  1/763 (0.13%)  0/378 (0.00%)  3/352 (0.85%) 
Drug abuse * 1  2/763 (0.26%)  0/378 (0.00%)  0/352 (0.00%) 
Major depression * 1  0/763 (0.00%)  1/378 (0.26%)  1/352 (0.28%) 
Personality disorder * 1  1/763 (0.13%)  0/378 (0.00%)  0/352 (0.00%) 
Schizophrenia * 1  1/763 (0.13%)  0/378 (0.00%)  0/352 (0.00%) 
Suicidal ideation&nbs