Trial Outcomes & Findings for 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 (NCT NCT02269917)

Last Updated: 2021-12-09

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1149 participants

Primary outcome timeframe

Through Week 48

Results posted on

2021-12-09

Participant Flow

Participant milestones

Participant milestones
Measure	D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) 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).	Control (Baseline to Switch) 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.	Switch to D/C/F/TAF 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.
BL to EOE-Test and BL to Switch-Control STARTED	766	383	0
BL to EOE-Test and BL to Switch-Control Treated	763	378	0
BL to EOE-Test and BL to Switch-Control COMPLETED	649	352	0
BL to EOE-Test and BL to Switch-Control NOT COMPLETED	117	31	0
Switch to D/C/F/TAF (Until EOE) STARTED	0	0	352
Switch to D/C/F/TAF (Until EOE) COMPLETED	0	0	314
Switch to D/C/F/TAF (Until EOE) NOT COMPLETED	0	0	38

Reasons for withdrawal

Reasons for withdrawal
Measure	D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) 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).	Control (Baseline to Switch) 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.	Switch to D/C/F/TAF 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.
BL to EOE-Test and BL to Switch-Control Lost to Follow-up	25	7	0
BL to EOE-Test and BL to Switch-Control Other	19	4	0
BL to EOE-Test and BL to Switch-Control Withdrawal by Subject	32	10	0
BL to EOE-Test and BL to Switch-Control Adverse Event	24	4	0
BL to EOE-Test and BL to Switch-Control Non-compliance with study drug	4	0	0
BL to EOE-Test and BL to Switch-Control Physician Decision	4	0	0
BL to EOE-Test and BL to Switch-Control Protocol Violation	2	1	0
BL to EOE-Test and BL to Switch-Control Death	4	0	0
BL to EOE-Test and BL to Switch-Control Randomized but not treated	3	5	0
Switch to D/C/F/TAF (Until EOE) Death	0	0	1
Switch to D/C/F/TAF (Until EOE) Lost to Follow-up	0	0	10
Switch to D/C/F/TAF (Until EOE) Adverse Event	0	0	11
Switch to D/C/F/TAF (Until EOE) Physician Decision	0	0	1
Switch to D/C/F/TAF (Until EOE) Pregnancy	0	0	2
Switch to D/C/F/TAF (Until EOE) Withdrawal by Subject	0	0	5
Switch to D/C/F/TAF (Until EOE) Other	0	0	8

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) n=763 Participants 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).	Control (Baseline to Switch) n=378 Participants 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 n=1141 Participants Total of all reporting groups
Age, Continuous	45.3 years STANDARD_DEVIATION 10.86 • n=5 Participants	44.8 years STANDARD_DEVIATION 10.77 • n=7 Participants	45.1 years STANDARD_DEVIATION 10.83 • n=5 Participants
Sex: Female, Male Female	140 Participants n=5 Participants	65 Participants n=7 Participants	205 Participants n=5 Participants
Sex: Female, Male Male	623 Participants n=5 Participants	313 Participants n=7 Participants	936 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	111 Participants n=5 Participants	59 Participants n=7 Participants	170 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	649 Participants n=5 Participants	317 Participants n=7 Participants	966 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) Asian	17 Participants n=5 Participants	9 Participants n=7 Participants	26 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Black or African American	155 Participants n=5 Participants	82 Participants n=7 Participants	237 Participants n=5 Participants
Race (NIH/OMB) White	573 Participants n=5 Participants	282 Participants n=7 Participants	855 Participants n=5 Participants
Race (NIH/OMB) More than one race	5 Participants n=5 Participants	1 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	6 Participants n=5 Participants	2 Participants n=7 Participants	8 Participants n=5 Participants
Race/Ethnicity, Customized Asian	17 Participants n=5 Participants	9 Participants n=7 Participants	26 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	155 Participants n=5 Participants	82 Participants n=7 Participants	237 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	95 Participants n=5 Participants	56 Participants n=7 Participants	151 Participants n=5 Participants
Race/Ethnicity, Customized Other	20 Participants n=5 Participants	6 Participants n=7 Participants	26 Participants n=5 Participants
Race/Ethnicity, Customized White Non-Hispanic	476 Participants n=5 Participants	225 Participants n=7 Participants	701 Participants n=5 Participants
Region of Enrollment Belgium	32 Participants n=5 Participants	20 Participants n=7 Participants	52 Participants n=5 Participants
Region of Enrollment Canada	45 Participants n=5 Participants	21 Participants n=7 Participants	66 Participants n=5 Participants
Region of Enrollment France	69 Participants n=5 Participants	28 Participants n=7 Participants	97 Participants n=5 Participants
Region of Enrollment Poland	91 Participants n=5 Participants	35 Participants n=7 Participants	126 Participants n=5 Participants
Region of Enrollment Spain	117 Participants n=5 Participants	52 Participants n=7 Participants	169 Participants n=5 Participants
Region of Enrollment Sweden	23 Participants n=5 Participants	5 Participants n=7 Participants	28 Participants n=5 Participants
Region of Enrollment Switzerland	26 Participants n=5 Participants	13 Participants n=7 Participants	39 Participants n=5 Participants
Region of Enrollment United Kingdom	47 Participants n=5 Participants	23 Participants n=7 Participants	70 Participants n=5 Participants
Region of Enrollment United States	313 Participants n=5 Participants	181 Participants n=7 Participants	494 Participants n=5 Participants

PRIMARY outcome

Timeframe: Through Week 48

Population: Intent-to-treat (ITT) analysis set included all the participants who were randomized and received at least 1 dose of study treatment.

Outcome measures

Outcome measures
Measure	D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) n=763 Participants 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).	Switch to D/C/F/TAF n=378 Participants 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.	Switch to D/C/F/TAF 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.
Percentage of Participants With Virologic Rebound (HIV-1 RNA >=50 Copies/mL) Cumulative Through Week 48	2.5 Percentage of participants Interval 1.5 to 3.9	2.1 Percentage of participants Interval 0.9 to 4.1	—

SECONDARY outcome

Timeframe: Through 48 Weeks

Population: ITT analysis set included all participants who were randomized and received at least 1 dose of study treatment.

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.

Outcome measures

Outcome measures
Measure	D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) n=763 Participants 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).	Switch to D/C/F/TAF n=378 Participants 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.	Switch to D/C/F/TAF 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.
Percentage of Participants With Virologic Rebound (Plasma HIV-1 RNA >=20 Copies/mL) Cumulative Through 48 Weeks	10.5 Percentage of Participants Interval 8.4 to 12.9	11.4 Percentage of Participants Interval 8.4 to 15.0	—

SECONDARY outcome

Timeframe: Through 48 Weeks

Population: ITT analysis set included all participants who were randomized and received at least 1 dose of study treatment.

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.

Outcome measures

Outcome measures
Measure	D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) n=763 Participants 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).	Switch to D/C/F/TAF n=378 Participants 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.	Switch to D/C/F/TAF 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.
Percentage of Participants With Virologic Rebound (Plasma HIV-1 RNA >=200 Copies/mL) Cumulative Through 48 Weeks	0.4 Percentage of Participants Interval 0.1 to 1.1	0.0 Percentage of Participants Here NA signifies that the Confidence Interval (CI) was not estimable as no participants had virologic rebound in this group.	—

SECONDARY outcome

Timeframe: Baseline up to Week 48

Population: ITT analysis set included all participants who were randomized and received at least 1 dose of study treatment.

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.

Outcome measures

Outcome measures
Measure	D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) n=763 Participants 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).	Switch to D/C/F/TAF n=378 Participants 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.	Switch to D/C/F/TAF 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.
Percentage of Participants With Non-Virologic Rebound at Week 48 by Kaplan-Meier Estimates	97.7 percentage of participants Interval 96.4 to 98.6	97.8 percentage of participants Interval 95.7 to 98.9	—

SECONDARY outcome

Timeframe: Up to Week 48

Population: ITT analysis set included all the participants who were randomized and received at least 1 dose of study treatment.

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.

Outcome measures

Outcome measures
Measure	D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) n=763 Participants 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).	Switch to D/C/F/TAF n=378 Participants 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.	Switch to D/C/F/TAF 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.
Percentage of Participants Experiencing Grade 3 and 4 Adverse Events (AEs), Serious Adverse Events (SAEs), and Premature Discontinuation Due to AEs Through Week 48 Grade 3 AEs	5.6 Percentage of Participants	6.3 Percentage of Participants	—
Percentage of Participants Experiencing Grade 3 and 4 Adverse Events (AEs), Serious Adverse Events (SAEs), and Premature Discontinuation Due to AEs Through Week 48 Grade 4 AEs	1.2 Percentage of Participants	1.9 Percentage of Participants	—
Percentage of Participants Experiencing Grade 3 and 4 Adverse Events (AEs), Serious Adverse Events (SAEs), and Premature Discontinuation Due to AEs Through Week 48 SAEs	4.6 Percentage of Participants	4.8 Percentage of Participants	—
Percentage of Participants Experiencing Grade 3 and 4 Adverse Events (AEs), Serious Adverse Events (SAEs), and Premature Discontinuation Due to AEs Through Week 48 Premature discontinuations due to AEs	1.4 Percentage of Participants	1.3 Percentage of Participants	—

SECONDARY outcome

Timeframe: Baseline and Weeks 24 and 48

Population: 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.

Change from baseline in serum creatinine levels at Weeks 24 and 48 was assessed.

Outcome measures

Outcome measures
Measure	D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) n=761 Participants 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).	Switch to D/C/F/TAF n=378 Participants 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.	Switch to D/C/F/TAF 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.
Change From Baseline in Serum Creatinine Levels at Weeks 24 and 48 Change at Week 24	1.22 micro mole per liter Standard Error 0.358	0.88 micro mole per liter Standard Error 0.509	—
Change From Baseline in Serum Creatinine Levels at Weeks 24 and 48 Change at Week 48	1.27 micro mole per liter Standard Error 0.368	0.65 micro mole per liter Standard Error 0.530	—

SECONDARY outcome

Timeframe: Baseline, Weeks 24 and 48

Population: 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.

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).

Outcome measures

Outcome measures
Measure	D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) n=761 Participants 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).	Switch to D/C/F/TAF n=378 Participants 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.	Switch to D/C/F/TAF 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.
Change From Baseline in Estimated Glomerular Filtration Rate Based on Serum Creatinine (eGFRcr, by Cockcroft-Gault Formula [eGFRcg]) at Weeks 24 and 48 Change at Week 24	-0.38 milliliter per minute (mL/min) Standard Error 0.502	0.20 milliliter per minute (mL/min) Standard Error 0.715	—
Change From Baseline in Estimated Glomerular Filtration Rate Based on Serum Creatinine (eGFRcr, by Cockcroft-Gault Formula [eGFRcg]) at Weeks 24 and 48 Change at Week 48	-0.94 milliliter per minute (mL/min) Standard Error 0.492	-0.20 milliliter per minute (mL/min) Standard Error 0.708	—

SECONDARY outcome

Timeframe: Baseline, Weeks 24 and 48

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.

Outcome measures

Outcome measures
Measure	D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) n=761 Participants 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).	Switch to D/C/F/TAF n=378 Participants 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.	Switch to D/C/F/TAF 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.
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 Change at Week 24	-1.67 mL/min/1.73 m^2 Standard Error 0.359	-0.75 mL/min/1.73 m^2 Standard Error 0.510	—
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 Change at Week 48	-1.97 mL/min/1.73 m^2 Standard Error 0.369	-0.88 mL/min/1.73 m^2 Standard Error 0.531	—

SECONDARY outcome

Timeframe: Baseline, Weeks 24 and 48

Population: 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.

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).

Outcome measures

Outcome measures
Measure	D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) n=763 Participants 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).	Switch to D/C/F/TAF n=378 Participants 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.	Switch to D/C/F/TAF 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.
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 eGFRcyst: Change at Week 24	0.21 mL/min/1.73 m^2 Standard Error 0.338	-0.93 mL/min/1.73 m^2 Standard Error 0.483	—
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 eGFRcyst: Change at Week 48	-0.42 mL/min/1.73 m^2 Standard Error 0.360	-1.76 mL/min/1.73 m^2 Standard Error 0.517	—

SECONDARY outcome

Timeframe: Baseline, Weeks 24 and 48

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.

Outcome measures

Outcome measures
Measure	D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) n=761 Participants 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).	Switch to D/C/F/TAF n=378 Participants 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.	Switch to D/C/F/TAF 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.
Change From Baseline in Urine Albumin to Creatinine Ratio (UACR) and Urine Protein to Creatinine Ratio (UPCR) at Weeks 24 and 48 UACR: Baseline	6.20 milligram per gram (mg/g) Interval 1.4 to 632.1	7.14 milligram per gram (mg/g) Interval 1.1 to 268.0	—
Change From Baseline in Urine Albumin to Creatinine Ratio (UACR) and Urine Protein to Creatinine Ratio (UPCR) at Weeks 24 and 48 UACR: Change at Week 24	-0.78 milligram per gram (mg/g) Interval -185.4 to 422.2	0.44 milligram per gram (mg/g) Interval -238.5 to 145.0	—
Change From Baseline in Urine Albumin to Creatinine Ratio (UACR) and Urine Protein to Creatinine Ratio (UPCR) at Weeks 24 and 48 UACR: Change at Week 48	-0.76 milligram per gram (mg/g) Interval -195.8 to 344.3	0.40 milligram per gram (mg/g) Interval -121.7 to 110.9	—
Change From Baseline in Urine Albumin to Creatinine Ratio (UACR) and Urine Protein to Creatinine Ratio (UPCR) at Weeks 24 and 48 UPCR: Baseline	61.56 milligram per gram (mg/g) Interval 16.9 to 1158.1	62.90 milligram per gram (mg/g) Interval 14.7 to 870.9	—
Change From Baseline in Urine Albumin to Creatinine Ratio (UACR) and Urine Protein to Creatinine Ratio (UPCR) at Weeks 24 and 48 UPCR: Change at Week 24	-14.63 milligram per gram (mg/g) Interval -509.6 to 734.6	0.07 milligram per gram (mg/g) Interval -359.9 to 400.8	—
Change From Baseline in Urine Albumin to Creatinine Ratio (UACR) and Urine Protein to Creatinine Ratio (UPCR) at Weeks 24 and 48 UPCR: Change at Week 48	-22.25 milligram per gram (mg/g) Interval -520.1 to 386.6	-7.37 milligram per gram (mg/g) Interval -368.7 to 432.3	—

SECONDARY outcome

Timeframe: Baseline, Weeks 24 and 48

Change from baseline in URBPCR and UB2MGCR was assessed at Weeks 24 and 48. Retinol binding protein is a marker of proximal tubular function.

Outcome measures

Outcome measures
Measure	D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) n=748 Participants 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).	Switch to D/C/F/TAF n=371 Participants 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.	Switch to D/C/F/TAF 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.
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 URBPCR: Baseline	126.19 microgram per gram (mcg/g) Interval 20.3 to 116216.2	137.16 microgram per gram (mcg/g) Interval 12.9 to 73958.4	—
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 URBPCR: Change at Week 24	-30.27 microgram per gram (mcg/g) Interval -69873.2 to 2004.4	7.76 microgram per gram (mcg/g) Interval -6040.1 to 60740.4	—
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 URBPCR: Change at Week 48	-27.09 microgram per gram (mcg/g) Interval -67540.0 to 1764.3	19.66 microgram per gram (mcg/g) Interval -5778.3 to 65203.3	—
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 UB2MGCR: Baseline	156.85 microgram per gram (mcg/g) Interval 3.8 to 91216.2	172.25 microgram per gram (mcg/g) Interval 9.8 to 92740.1	—
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 UB2MGCR: Change at Week 24	-72.64 microgram per gram (mcg/g) Interval -72264.6 to 13536.2	12.08 microgram per gram (mcg/g) Interval -20084.8 to 58357.6	—
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 UB2MGCR: Change at Week 48	-67.02 microgram per gram (mcg/g) Interval -72323.4 to 21190.2	20.24 microgram per gram (mcg/g) Interval -22173.5 to 135576.9	—

SECONDARY outcome

Timeframe: Baseline, Weeks 24 and 48

Population: 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.

Percent change from baseline in urine FEPO4 was assessed at Weeks 24 and 48.

Outcome measures

Outcome measures
Measure	D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) n=763 Participants 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).	Switch to D/C/F/TAF n=378 Participants 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.	Switch to D/C/F/TAF 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.
Percent Change From Baseline in Urine Fractional Excretion of Phosphate (FEPO4) at Weeks 24 and 48 Percent change at Week 24	3.58 Percent change Interval -89.4 to 1940.4	8.55 Percent change Interval -78.5 to 281.8	—
Percent Change From Baseline in Urine Fractional Excretion of Phosphate (FEPO4) at Weeks 24 and 48 Percent change at Week 48	8.42 Percent change Interval -97.9 to 1430.3	8.57 Percent change Interval -76.3 to 452.7	—

SECONDARY outcome

Timeframe: Week 48

Population: ITT analysis set included all the participants who were randomized and received at least 1 dose of study treatment.

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).

Outcome measures

Outcome measures
Measure	D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) n=763 Participants 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).	Switch to D/C/F/TAF n=378 Participants 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.	Switch to D/C/F/TAF 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.
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 <20 copies/mL	89.8 Percentage of Participants Interval 87.4 to 91.8	88.4 Percentage of Participants Interval 84.7 to 91.4	—
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 <50 copies/mL	94.9 Percentage of Participants Interval 93.1 to 96.3	93.7 Percentage of Participants Interval 90.7 to 95.9	—
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 <200 copies/mL	95.0 Percentage of Participants Interval 93.2 to 96.5	94.2 Percentage of Participants Interval 91.3 to 96.3	—

SECONDARY outcome

Timeframe: Week 48

Population: ITT analysis set included all the participants who were randomized and received at least 1 dose of study treatment.

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.

Outcome measures

Outcome measures
Measure	D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) n=763 Participants 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).	Switch to D/C/F/TAF n=378 Participants 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.	Switch to D/C/F/TAF 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.
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 <20 copies/mL	86.0 Percentage of Participants Interval 83.3 to 88.4	83.6 Percentage of Participants Interval 79.5 to 87.2	—
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 <50 copies/mL	93.7 Percentage of Participants Interval 91.7 to 95.3	92.9 Percentage of Participants Interval 89.8 to 95.2	—
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 <200 copies/mL	95.4 Percentage of Participants Interval 93.7 to 96.8	94.7 Percentage of Participants Interval 91.9 to 96.7	—

SECONDARY outcome

Timeframe: Baseline, Weeks 24 and 48

Change from baseline in CD4+ cell count was assessed at Weeks 24 and 48.

Outcome measures

Outcome measures
Measure	D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) n=763 Participants 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).	Switch to D/C/F/TAF n=378 Participants 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.	Switch to D/C/F/TAF 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.
Change From Baseline in Cluster of Differentiation 4 Plus (CD4+) Cell Count at Weeks 24 and 48 Baseline	653.3 Cells per cubic millimeter (cells/mm^3) Standard Error 9.12	641.7 Cells per cubic millimeter (cells/mm^3) Standard Error 13.15	—
Change From Baseline in Cluster of Differentiation 4 Plus (CD4+) Cell Count at Weeks 24 and 48 Change at Week 24	14.3 Cells per cubic millimeter (cells/mm^3) Standard Error 5.99	8.5 Cells per cubic millimeter (cells/mm^3) Standard Error 7.76	—
Change From Baseline in Cluster of Differentiation 4 Plus (CD4+) Cell Count at Weeks 24 and 48 Change at Week 48	21.0 Cells per cubic millimeter (cells/mm^3) Standard Error 5.97	9.1 Cells per cubic millimeter (cells/mm^3) Standard Error 8.41	—

SECONDARY outcome

Timeframe: Through Week 48

Population: 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.

Treatment adherence (defined as adherence of \>95%) was assessed by the drug accountability cumulative through Week 48 (Approach 1).

Outcome measures

Outcome measures
Measure	D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) n=215 Participants 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).	Switch to D/C/F/TAF n=102 Participants 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.	Switch to D/C/F/TAF 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.
Percentage of Participants With Treatment Adherence of Greater Than (>)95 Percent (%) (Approach 1) Through Week 48	91.6 Percentage of Participants	85.3 Percentage of Participants	—

SECONDARY outcome

Timeframe: Through Week 48

Population: 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.

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).

Outcome measures

Outcome measures
Measure	D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) n=631 Participants 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).	Switch to D/C/F/TAF n=268 Participants 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.	Switch to D/C/F/TAF 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.
Percentage of Participants With Treatment Adherence of >95% (Approach 2) Through Week 48	82.7 percentage of participants	77.2 percentage of participants	—

SECONDARY outcome

Timeframe: Up to Week 48

Population: The ITT population with confirmed virologic rebound and with HIV-1 RNA value \>=400 copies/mL was analyzed.

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.

Outcome measures

Outcome measures
Measure	D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) n=19 Participants 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).	Switch to D/C/F/TAF n=8 Participants 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.	Switch to D/C/F/TAF 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.
Number of Participants With Resistance to Study Drug	1 Participants	3 Participants	—

SECONDARY outcome

Timeframe: Predose at Weeks 2, 4, 8, 12, 24, 36, and 48

Population: 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.

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.

Outcome measures

Outcome measures
Measure	D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) n=750 Participants 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).	Switch to D/C/F/TAF 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.	Switch to D/C/F/TAF 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.
Predose (Trough) Plasma Concentration (C0h) of Darunavir Week 2	1775.29 Nanogram per milliliter (ng/mL) Standard Deviation 1698.84	—	—
Predose (Trough) Plasma Concentration (C0h) of Darunavir Week 4	1732.00 Nanogram per milliliter (ng/mL) Standard Deviation 1389.44	—	—
Predose (Trough) Plasma Concentration (C0h) of Darunavir Week 8	1910.30 Nanogram per milliliter (ng/mL) Standard Deviation 1501.94	—	—
Predose (Trough) Plasma Concentration (C0h) of Darunavir Week 12	1643.38 Nanogram per milliliter (ng/mL) Standard Deviation 1328.41	—	—
Predose (Trough) Plasma Concentration (C0h) of Darunavir Week 24	2022.99 Nanogram per milliliter (ng/mL) Standard Deviation 1965.64	—	—
Predose (Trough) Plasma Concentration (C0h) of Darunavir Week 36	1806.37 Nanogram per milliliter (ng/mL) Standard Deviation 1669.43	—	—
Predose (Trough) Plasma Concentration (C0h) of Darunavir Week 48	1899.79 Nanogram per milliliter (ng/mL) Standard Deviation 1833.09	—	—

SECONDARY outcome

Timeframe: Baseline, Weeks 24 and 48

Population: 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.

Percent change from baseline in bone biomarkers: P1NP and CTX was assessed at Weeks 24 and 48.

Outcome measures

Outcome measures
Measure	D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) n=209 Participants 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).	Switch to D/C/F/TAF n=108 Participants 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.	Switch to D/C/F/TAF 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.
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 P1NP: Percent change at Week 24	-22.971 Percent Change Standard Error 1.8818	-0.027 Percent Change Standard Error 2.7325	—
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 P1NP: Percent change at Week 48	-26.752 Percent Change Standard Error 1.8960	-3.751 Percent Change Standard Error 2.6988	—
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 CTX: Percent change at Week 24	-16.772 Percent Change Standard Error 2.2575	16.312 Percent Change Standard Error 3.8855	—
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 CTX: Percent change at Week 48	-10.517 Percent Change Standard Error 3.2325	5.433 Percent Change Standard Error 4.1118	—

SECONDARY outcome

Timeframe: Baseline, Weeks 24 and 48

Percent change from baseline in bone biomarker: PTH was assessed at Weeks 24 and 48.

Outcome measures

Outcome measures
Measure	D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) n=209 Participants 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).	Switch to D/C/F/TAF n=108 Participants 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.	Switch to D/C/F/TAF 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.
Percent Change From Baseline in Parathyroid Hormone (PTH) at Weeks 24 and 48 Percent change at Week 24	-3.092 Percent change Standard Error 2.5941	12.034 Percent change Standard Error 4.1777	—
Percent Change From Baseline in Parathyroid Hormone (PTH) at Weeks 24 and 48 Percent change at Week 48	-4.510 Percent change Standard Error 2.5375	9.436 Percent change Standard Error 4.4784	—

SECONDARY outcome

Timeframe: Baseline, Weeks 24 and 48

Percent change from baseline in bone biomarker: 25-hydroxy vitamin D was assessed at Weeks 24 and 48.

Outcome measures

Outcome measures
Measure	D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) n=209 Participants 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).	Switch to D/C/F/TAF n=108 Participants 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.	Switch to D/C/F/TAF 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.
Percent Change From Baseline in 25-hydroxy Vitamin D at Weeks 24 and 48 Percent change at Week 24	-3.0 Percent change Standard Error 5.06	4.2 Percent change Standard Error 6.13	—
Percent Change From Baseline in 25-hydroxy Vitamin D at Weeks 24 and 48 Percent change at Week 48	25.2 Percent change Standard Error 5.51	24.9 Percent change Standard Error 7.46	—

SECONDARY outcome

Timeframe: Baseline, Weeks 24 and 48

Population: 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.

Percent change from baseline in spine and hip BMD was assessed at Weeks 24 and 48.

Outcome measures

Outcome measures
Measure	D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) n=209 Participants 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).	Switch to D/C/F/TAF n=108 Participants 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.	Switch to D/C/F/TAF 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.
Percent Change From Baseline in Spine and Hip Bone Mineral Density (BMD) at Weeks 24 and 48 Spine BMD: Percent change at Week 24	1.55 Percent change Standard Error 0.276	0.18 Percent change Standard Error 0.342	—
Percent Change From Baseline in Spine and Hip Bone Mineral Density (BMD) at Weeks 24 and 48 Spine BMD: Percent change at Week 48	2.06 Percent change Standard Error 0.324	0.01 Percent change Standard Error 0.391	—
Percent Change From Baseline in Spine and Hip Bone Mineral Density (BMD) at Weeks 24 and 48 Hip BMD: Percent change at Week 24	0.91 Percent change Standard Error 0.230	0.00 Percent change Standard Error 0.279	—
Percent Change From Baseline in Spine and Hip Bone Mineral Density (BMD) at Weeks 24 and 48 Hip BMD: Percent change at Week 48	1.62 Percent change Standard Error 0.244	-0.08 Percent change Standard Error 0.288	—

SECONDARY outcome

Timeframe: Baseline, Weeks 24 and 48

Population: 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.

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.

Outcome measures

Outcome measures
Measure	D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) n=209 Participants 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).	Switch to D/C/F/TAF n=108 Participants 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.	Switch to D/C/F/TAF 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.
Change From Baseline in Bone Mineral Density (BMD) T-Score at Weeks 24 and 48 Spine BMD T-score: Baseline	-0.713 Units on a scale Standard Error 0.0850	-0.467 Units on a scale Standard Error 0.1260	—
Change From Baseline in Bone Mineral Density (BMD) T-Score at Weeks 24 and 48 Spine BMD T-score: Change at Week 24	0.102 Units on a scale Standard Error 0.0172	-0.033 Units on a scale Standard Error 0.0253	—
Change From Baseline in Bone Mineral Density (BMD) T-Score at Weeks 24 and 48 Spine BMD T-score: Change at Week 48	0.132 Units on a scale Standard Error 0.0217	-0.063 Units on a scale Standard Error 0.0264	—
Change From Baseline in Bone Mineral Density (BMD) T-Score at Weeks 24 and 48 Hip BMD T-score: Baseline	-0.575 Units on a scale Standard Error 0.0643	-0.484 Units on a scale Standard Error 0.0839	—
Change From Baseline in Bone Mineral Density (BMD) T-Score at Weeks 24 and 48 Hip BMD T-score: Change at Week 24	0.037 Units on a scale Standard Error 0.0108	-0.024 Units on a scale Standard Error 0.0144	—
Change From Baseline in Bone Mineral Density (BMD) T-Score at Weeks 24 and 48 Hip BMD T-score: Change at Week 48	0.095 Units on a scale Standard Error 0.0122	-0.016 Units on a scale Standard Error 0.0139	—
Change From Baseline in Bone Mineral Density (BMD) T-Score at Weeks 24 and 48 Femoral Neck BMD T-score: Baseline	-0.782 Units on a scale Standard Error 0.0625	-0.699 Units on a scale Standard Error 0.0899	—
Change From Baseline in Bone Mineral Density (BMD) T-Score at Weeks 24 and 48 Femoral Neck BMD T-score: Change at Week 24	0.019 Units on a scale Standard Error 0.0128	-0.044 Units on a scale Standard Error 0.0183	—
Change From Baseline in Bone Mineral Density (BMD) T-Score at Weeks 24 and 48 Femoral Neck BMD T-score: Change at Week 48	0.039 Units on a scale Standard Error 0.0146	-0.039 Units on a scale Standard Error 0.0214	—

SECONDARY outcome

Timeframe: Through Week 96 (D/C/F/TAF arm) and from Week 52 to Week 96 (Switch to D/C/F/TAF arm)

Population: Intent-to-treat (ITT) analysis set included all the participants who were randomized and received at least 1 dose of study treatment.

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.

Outcome measures

Outcome measures
Measure	D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) n=763 Participants 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).	Switch to D/C/F/TAF n=352 Participants 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.	Switch to D/C/F/TAF 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.
Percentage of Participants With Virologic Rebound (HIV-1 RNA >=20 Copies/mL) Cumulative Through Week 96	13.8 percentage of participants Interval 11.4 to 16.4	8.8 percentage of participants Interval 6.1 to 12.3	—

SECONDARY outcome

Timeframe: Through Week 96 (D/C/F/TAF arm) and from Week 52 to Week 96 (Switch to D/C/F/TAF arm)

Population: Intent-to-treat (ITT) analysis set included all the participants who were randomized and received at least 1 dose of study treatment.

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.

Outcome measures

Outcome measures
Measure	D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) n=763 Participants 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).	Switch to D/C/F/TAF n=352 Participants 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.	Switch to D/C/F/TAF 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.
Percentage of Participants With Virologic Rebound (HIV-1 RNA >=50 Copies/mL) Cumulative Through Week 96	3.1 percentage of participants Interval 2.0 to 4.6	2.3 percentage of participants Interval 1.0 to 4.4	—

SECONDARY outcome

Timeframe: Through Week 96 (D/C/F/TAF arm) and from Week 52 to Week 96 (Switch to D/C/F/TAF arm)

Population: Intent-to-treat (ITT) analysis set included all the participants who were randomized and received at least 1 dose of study treatment.

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.

Outcome measures

Outcome measures
Measure	D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) n=763 Participants 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).	Switch to D/C/F/TAF n=352 Participants 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.	Switch to D/C/F/TAF 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.
Percentage of Participants With Virologic Rebound (HIV-1 RNA >=200 Copies/mL) Cumulative Through Week 96	0.5 percentage of participants Interval 0.1 to 1.3	0.6 percentage of participants Interval 0.1 to 2.0	—

SECONDARY outcome

Timeframe: Baseline to Week 96 (D/C/F/TAF arm) and from Week 52 to Week 96 (Switch to D/C/F/TAF arm)

Population: ITT analysis set included all the participants who were randomized and received at least 1 dose of study treatment.

Here Kaplan-Meier estimates percentage of participants with non-virologic rebound at Week 96.

Outcome measures

Outcome measures
Measure	D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) n=763 Participants 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).	Switch to D/C/F/TAF n=352 Participants 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.	Switch to D/C/F/TAF 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.
Percentage of Participants With Non-Virologic Rebound at Week 96 by Kaplan-Meier Estimates	96.7 percentage of participants Interval 95.1 to 97.8	97.8 percentage of participants Interval 95.4 to 98.9	—

SECONDARY outcome

Timeframe: 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])

Population: ITT analysis set included all the participants who were randomized and received at least 1 dose of study treatment.

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).

Outcome measures

Outcome measures
Measure	D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) n=763 Participants 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).	Switch to D/C/F/TAF n=352 Participants 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.	Switch to D/C/F/TAF 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.
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 <20 copies/mL	85.3 percentage of participants Interval 82.6 to 87.8	89.8 percentage of participants Interval 86.1 to 92.7	—
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 <50 copies/mL	90.7 percentage of participants Interval 88.4 to 92.7	93.8 percentage of participants Interval 90.7 to 96.0	—
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 <200 copies/mL	91.2 percentage of participants Interval 89.0 to 93.1	95.5 percentage of participants Interval 92.7 to 97.4	—

SECONDARY outcome

Timeframe: 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])

Population: ITT analysis set included all the participants who were randomized and received at least 1 dose of study treatment.

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.

Outcome measures

Outcome measures
Measure	D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) n=763 Participants 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).	Switch to D/C/F/TAF n=352 Participants 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.	Switch to D/C/F/TAF 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.
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 <20 copies/mL	79.6 percentage of participants Interval 76.5 to 82.4	88.1 percentage of participants Interval 84.2 to 91.3	—
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 <50 copies/mL	89.6 percentage of participants Interval 87.3 to 91.7	94.3 percentage of participants Interval 91.4 to 96.5	—
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 <200 copies/mL	91.7 percentage of participants Interval 89.6 to 93.6	95.7 percentage of participants Interval 93.1 to 97.6	—

SECONDARY outcome

Timeframe: 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])

Population: ITT analysis set included all the participants who were randomized and received at least 1 dose of study treatment.

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.

Outcome measures

Outcome measures
Measure	D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) n=763 Participants 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).	Switch to D/C/F/TAF n=352 Participants 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.	Switch to D/C/F/TAF 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.
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 >=20 copies/mL	6.8 percentage of participants Interval 5.1 to 8.8	6.0 percentage of participants Interval 3.7 to 9.0	—
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 >=50 copies/mL	1.2 percentage of participants Interval 0.5 to 2.2	1.7 percentage of participants Interval 0.6 to 3.7	—
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 >=200 copies/mL	0.3 percentage of participants Interval 0.0 to 0.9	0 percentage of participants NA signifies that confidence interval was not calculated as none of the participants had HIV RNA \<200 copies/mL.	—

SECONDARY outcome

Timeframe: 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])

Population: 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).

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).

Outcome measures

Outcome measures
Measure	D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) n=763 Participants 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).	Switch to D/C/F/TAF n=352 Participants 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.	Switch to D/C/F/TAF 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.
Change From Reference in CD4+ Cell Count at Week 96	32.07 cells per cubic millimeter (cells/mm^3) Standard Error 8.0	13.07 cells per cubic millimeter (cells/mm^3) Standard Error 10.7	—

SECONDARY outcome

Timeframe: 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)

Population: 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.

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.

Outcome measures

Outcome measures
Measure	D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) n=9 Participants 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).	Switch to D/C/F/TAF n=3 Participants 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.	Switch to D/C/F/TAF n=7 Participants 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.
Number of Participants With Resistance to Study Drug Through Week 96 DRV resistance-associated mutations (RAMs)	0 Participants	0 Participants	0 Participants
Number of Participants With Resistance to Study Drug Through Week 96 TFV RAMs	0 Participants	0 Participants	0 Participants
Number of Participants With Resistance to Study Drug Through Week 96 FTC RAMs	0 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Through Week 96 (D/C/F/TAF arm) and from Week 52 to Week 96 (Switch to D/C/F/TAF arm)

Population: 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.

Treatment adherence (defined as adherence of \>95%) was assessed by the drug accountability cumulative through Week 96 (Approach 1).

Outcome measures

Outcome measures
Measure	D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) n=379 Participants 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).	Switch to D/C/F/TAF n=236 Participants 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.	Switch to D/C/F/TAF 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.
Percentage of Participants With Treatment Adherence of >95 (Approach 1) Through Week 96	91.6 percentage of participants	87.3 percentage of participants	—

SECONDARY outcome

Timeframe: Through Week 96 (D/C/F/TAF arm) and from Week 52 to Week 96 (Switch to D/C/F/TAF arm)

Outcome measures

Outcome measures
Measure	D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) n=646 Participants 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).	Switch to D/C/F/TAF n=320 Participants 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.	Switch to D/C/F/TAF 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.
Percentage of Participants With Treatment Adherence of >95% (Approach 2) Through Week 96	82.8 percentage of participants	80.9 percentage of participants	—

SECONDARY outcome

Timeframe: Through Week 96 (D/C/F/TAF arm) and from Week 52 to Week 96 (Switch to D/C/F/TAF arm)

Population: ITT analysis set included all the participants who were randomized and received at least 1 dose of study treatment.

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.

Outcome measures

Outcome measures
Measure	D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) n=763 Participants 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).	Switch to D/C/F/TAF n=352 Participants 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.	Switch to D/C/F/TAF 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.
Percentage of Participants Experiencing Grade 3 and Grade 4 AEs, SAEs, and Premature Discontinuation Due to AEs Through Week 96 Grade 3 AEs	10.5 percentage of participants	6.3 percentage of participants	—
Percentage of Participants Experiencing Grade 3 and Grade 4 AEs, SAEs, and Premature Discontinuation Due to AEs Through Week 96 Grade 4 AEs	2.4 percentage of participants	1.1 percentage of participants	—
Percentage of Participants Experiencing Grade 3 and Grade 4 AEs, SAEs, and Premature Discontinuation Due to AEs Through Week 96 SAEs	8.7 percentage of participants	6.0 percentage of participants	—
Percentage of Participants Experiencing Grade 3 and Grade 4 AEs, SAEs, and Premature Discontinuation Due to AEs Through Week 96 Premature discontinuations due to AEs	2.2 percentage of participants	2.0 percentage of participants	—

SECONDARY outcome

Timeframe: 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

Population: 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.

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).

Outcome measures

Outcome measures
Measure	D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) n=692 Participants 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).	Switch to D/C/F/TAF n=336 Participants 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.	Switch to D/C/F/TAF 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.
Change From Reference in Serum Creatinine Levels at Week 96	0.0 micro mole per liter Interval -35.0 to 44.0	0.0 micro mole per liter Interval -45.0 to 29.0	—

SECONDARY outcome

Timeframe: 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

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).

Outcome measures

Outcome measures
Measure	D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) n=692 Participants 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).	Switch to D/C/F/TAF n=336 Participants 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.	Switch to D/C/F/TAF 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.
Change From Reference in Estimated Glomerular Filtration Rate Based on Serum Creatinine (eGFRcr, by Cockcroft-Gault Formula [eGFRcg]) at Week 96	-0.9 milliliter per minute (mL/min) Interval -65.0 to 58.0	0.0 milliliter per minute (mL/min) Interval -44.0 to 157.0	—

SECONDARY outcome

Timeframe: 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

Population: 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.

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).

Outcome measures

Outcome measures
Measure	D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) n=692 Participants 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).	Switch to D/C/F/TAF n=336 Participants 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.	Switch to D/C/F/TAF 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.
Change From Reference in Estimated Glomerular Filtration Rate Based on Serum Creatinine (by CKD-EPI) at Week 96	-1.3 mL/min/1.73 m^2 Interval -37.0 to 35.0	-0.7 mL/min/1.73 m^2 Interval -31.0 to 49.0	—

SECONDARY outcome

Timeframe: 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

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).

Outcome measures

Outcome measures
Measure	D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) n=686 Participants 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).	Switch to D/C/F/TAF n=332 Participants 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.	Switch to D/C/F/TAF 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.
Change From Reference in Estimated Glomerular Filtration Rate Based on Serum Cystatin C (by CKD-EPI) at Week 96	-0.9 mL/min/1.73 m^2 Interval -42.0 to 30.0	1.0 mL/min/1.73 m^2 Interval -30.0 to 105.0	—

SECONDARY outcome

Timeframe: 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

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).

Outcome measures

Outcome measures
Measure	D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) n=694 Participants 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).	Switch to D/C/F/TAF n=334 Participants 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.	Switch to D/C/F/TAF 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.
Change From Reference in UACR at Week 96	-0.63 milligram per gram (mg/g) Interval -209.3 to 2019.7	-0.93 milligram per gram (mg/g) Interval -234.6 to 13230.9	—

SECONDARY outcome

Timeframe: 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

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).

Outcome measures

Outcome measures
Measure	D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) n=675 Participants 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).	Switch to D/C/F/TAF n=331 Participants 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.	Switch to D/C/F/TAF 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.
Change From Reference in URBPCR at Week 96	-25.08 microgram per gram (mcg/g) Interval -61980.5 to 1393.0	-39.07 microgram per gram (mcg/g) Interval -82240.7 to 869.9	—

SECONDARY outcome

Timeframe: 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

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).

Outcome measures

Outcome measures
Measure	D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) n=675 Participants 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).	Switch to D/C/F/TAF n=331 Participants 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.	Switch to D/C/F/TAF 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.
Change From Reference in UPCR at Week 96	-22.23 milligram per gram (mg/g) Interval -533.3 to 2314.7	-12.81 milligram per gram (mg/g) Interval -722.1 to 453.1	—

SECONDARY outcome

Timeframe: 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

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).

Outcome measures

Outcome measures
Measure	D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) n=664 Participants 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).	Switch to D/C/F/TAF n=332 Participants 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.	Switch to D/C/F/TAF 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.
Change From Reference in UB2MGCR at Week 96	-68.22 microgram per gram (mcg/g) Interval -71549.3 to 7433.1	-110.31 microgram per gram (mcg/g) Interval -152500.2 to 12288.4	—

SECONDARY outcome

Timeframe: 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

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).

Outcome measures

Outcome measures
Measure	D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) n=688 Participants 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).	Switch to D/C/F/TAF n=334 Participants 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.	Switch to D/C/F/TAF 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.
Percent Change From Reference in FEPO4 at Week 96	4.15 percent change Interval -88.0 to 524.8	-3.19 percent change Interval -77.9 to 547.8	—

SECONDARY outcome

Timeframe: 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

Population: 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.

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).

Outcome measures

Outcome measures
Measure	D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) n=183 Participants 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).	Switch to D/C/F/TAF n=96 Participants 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.	Switch to D/C/F/TAF 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.
Percent Change From Reference in Levels of Serum P1NP at Week 96	-19.899 percent change Standard Error 2.2151	-18.466 percent change Standard Error 3.1169	—

SECONDARY outcome

Timeframe: 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

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).

Outcome measures

Outcome measures
Measure	D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) n=178 Participants 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).	Switch to D/C/F/TAF n=98 Participants 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.	Switch to D/C/F/TAF 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.
Percent Change From Reference in Levels of Serum CTX at Week 96	-10.192 percent change Standard Error 3.0592	-21.755 percent change Standard Error 3.4926	—

SECONDARY outcome

Timeframe: 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

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).

Outcome measures

Outcome measures
Measure	D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) n=169 Participants 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).	Switch to D/C/F/TAF n=97 Participants 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.	Switch to D/C/F/TAF 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.
Percent Change From Reference in Levels of PTH at Week 96	-17.171 percent change Standard Error 2.6774	-20.466 percent change Standard Error 3.2559	—

SECONDARY outcome

Timeframe: 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

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).

Outcome measures

Outcome measures
Measure	D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) n=141 Participants 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).	Switch to D/C/F/TAF n=98 Participants 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.	Switch to D/C/F/TAF 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.
Percent Change From Reference in Levels of 25-OH Vitamin D at Week 96	24.6 percent change Standard Error 5.16	-1.9 percent change Standard Error 3.33	—

SECONDARY outcome

Timeframe: 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

Population: 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.

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).

Outcome measures

Outcome measures
Measure	D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) n=173 Participants 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).	Switch to D/C/F/TAF n=99 Participants 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.	Switch to D/C/F/TAF 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.
Percent Change From Reference in Hip and Spine BMD at Week 96 Hip region BMD-T score	0.0173 percent change Standard Error 0.00217	0.0108 percent change Standard Error 0.00328	—
Percent Change From Reference in Hip and Spine BMD at Week 96 Spine region BMD-T score	0.0193 percent change Standard Error 0.00286	0.0279 percent change Standard Error 0.00381	—

SECONDARY outcome

Timeframe: 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

Population: 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.

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).

Outcome measures

Outcome measures
Measure	D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) n=173 Participants 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).	Switch to D/C/F/TAF n=99 Participants 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.	Switch to D/C/F/TAF 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.
Change From Reference in BMD T-score of Hip and Spine at Week 96 Hip region BMD	0.122 units on a scale Standard Error 0.0154	0.077 units on a scale Standard Error 0.0230	—
Change From Reference in BMD T-score of Hip and Spine at Week 96 Spine region BMD	0.176 units on a scale Standard Error 0.0259	0.255 units on a scale Standard Error 0.0339	—

SECONDARY outcome

Timeframe: Week 96 to end of extension (at every 6 months, up to 42 months)

Population: 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.

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.

Outcome measures

Outcome measures
Measure	D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) n=671 Participants 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).	Switch to D/C/F/TAF n=323 Participants 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.	Switch to D/C/F/TAF 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.
Percentage of Participants With Non-Virologic Rebound by Kaplan-Meier Estimates Week 96	100 percentage of participants Interval 100.0 to 100.0	100 percentage of participants Interval 100.0 to 100.0	—
Percentage of Participants With Non-Virologic Rebound by Kaplan-Meier Estimates Week 96 + 6 months	99.4 percentage of participants Interval 98.4 to 99.8	100 percentage of participants Interval 100.0 to 100.0	—
Percentage of Participants With Non-Virologic Rebound by Kaplan-Meier Estimates Week 96 + 12 months	98.0 percentage of participants Interval 96.5 to 98.9	98.5 percentage of participants Interval 96.0 to 99.4	—
Percentage of Participants With Non-Virologic Rebound by Kaplan-Meier Estimates Week 96 + 18 months	97.6 percentage of participants Interval 95.9 to 98.6	98.1 percentage of participants Interval 95.4 to 99.2	—
Percentage of Participants With Non-Virologic Rebound by Kaplan-Meier Estimates Week 96 + 24 months	97.1 percentage of participants Interval 94.9 to 98.3	96.5 percentage of participants Interval 92.3 to 98.4	—
Percentage of Participants With Non-Virologic Rebound by Kaplan-Meier Estimates Week 96 + 30 months	95.3 percentage of participants Interval 91.3 to 97.5	96.5 percentage of participants Interval 92.3 to 98.4	—
Percentage of Participants With Non-Virologic Rebound by Kaplan-Meier Estimates Week 96 + 36 months	92.4 percentage of participants Interval 83.0 to 96.7	96.5 percentage of participants Interval 92.3 to 98.4	—
Percentage of Participants With Non-Virologic Rebound by Kaplan-Meier Estimates Week 96 + 42 months	92.4 percentage of participants Interval 83.0 to 96.7	—	—

SECONDARY outcome

Timeframe: Week 96 to end of extension (up to 42 months)

Population: 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.

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 \[ARV\]).

Outcome measures

Outcome measures
Measure	D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) n=680 Participants 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).	Switch to D/C/F/TAF n=326 Participants 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.	Switch to D/C/F/TAF 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.
Percentage of Participants With Non-Treatment Failure by Kaplan-Meier Estimates Week 96	100 percentage of participants Interval 100.0 to 100.0	100 percentage of participants Interval 100.0 to 100.0	—
Percentage of Participants With Non-Treatment Failure by Kaplan-Meier Estimates Week 96 + 6 months	98.1 percentage of participants Interval 96.7 to 98.9	98.5 percentage of participants Interval 96.3 to 99.4	—
Percentage of Participants With Non-Treatment Failure by Kaplan-Meier Estimates Week 96 + 12 months	94.3 percentage of participants Interval 92.2 to 95.9	95.4 percentage of participants Interval 92.3 to 97.2	—
Percentage of Participants With Non-Treatment Failure by Kaplan-Meier Estimates Week 96 + 18 months	91.6 percentage of participants Interval 89.0 to 93.6	92.2 percentage of participants Interval 88.3 to 94.8	—
Percentage of Participants With Non-Treatment Failure by Kaplan-Meier Estimates Week 96 + 24 months	89.4 percentage of participants Interval 86.1 to 91.9	89.7 percentage of participants Interval 85.0 to 93.0	—
Percentage of Participants With Non-Treatment Failure by Kaplan-Meier Estimates Week 96 + 30 months	87.0 percentage of participants Interval 82.7 to 90.4	88.1 percentage of participants Interval 82.0 to 92.2	—
Percentage of Participants With Non-Treatment Failure by Kaplan-Meier Estimates Week 96 + 36 months	84.9 percentage of participants Interval 78.2 to 89.6	82.6 percentage of participants Interval 67.4 to 91.1	—
Percentage of Participants With Non-Treatment Failure by Kaplan-Meier Estimates Week 96 + 42 months	81.7 percentage of participants Interval 71.9 to 88.4	—	—

SECONDARY outcome

Timeframe: Week 96 to end of extension (up to 42 months)

Population: 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.

Percentage of participants with HIV RNA \<50, \<20, \<200 copies/mL post Week 96 to end of extension were reported.

Outcome measures

Outcome measures
Measure	D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) n=688 Participants 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).	Switch to D/C/F/TAF n=334 Participants 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.	Switch to D/C/F/TAF 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.
Percentage of Participants With HIV RNA <50, <20, <200 Copies/mL Post Week 96 to End of Extension Week 96 + 24 months (<200 copies/mL)	99.6 percentage of participants Interval 98.0 to 100.0	99.3 percentage of participants Interval 95.9 to 100.0	—
Percentage of Participants With HIV RNA <50, <20, <200 Copies/mL Post Week 96 to End of Extension Week 96 + 30 months (<200 copies/mL)	100 percentage of participants Interval 97.3 to 100.0	100 percentage of participants Interval 94.4 to 100.0	—
Percentage of Participants With HIV RNA <50, <20, <200 Copies/mL Post Week 96 to End of Extension Week 96 + 36 months (<200 copies/mL)	100 percentage of participants Interval 93.2 to 100.0	100 percentage of participants Interval 86.8 to 100.0	—
Percentage of Participants With HIV RNA <50, <20, <200 Copies/mL Post Week 96 to End of Extension Week 96 + 42 months (<200 copies/mL)	100 percentage of participants Interval 79.4 to 100.0	100 percentage of participants Interval 59.0 to 100.0	—
Percentage of Participants With HIV RNA <50, <20, <200 Copies/mL Post Week 96 to End of Extension Week 96 + 6 months (<20 copies/mL)	91.4 percentage of participants Interval 89.1 to 93.4	93.4 percentage of participants Interval 90.2 to 95.8	—
Percentage of Participants With HIV RNA <50, <20, <200 Copies/mL Post Week 96 to End of Extension Week 96 + 12 months (<20 copies/mL)	93.9 percentage of participants Interval 91.7 to 95.7	91.4 percentage of participants Interval 87.6 to 94.3	—
Percentage of Participants With HIV RNA <50, <20, <200 Copies/mL Post Week 96 to End of Extension Week 96 + 18 months (<20 copies/mL)	96.1 percentage of participants Interval 93.9 to 97.7	92.9 percentage of participants Interval 88.7 to 95.9	—
Percentage of Participants With HIV RNA <50, <20, <200 Copies/mL Post Week 96 to End of Extension Week 96 + 24 months (<20 copies/mL)	96.1 percentage of participants Interval 93.1 to 98.0	95.5 percentage of participants Interval 90.5 to 98.3	—
Percentage of Participants With HIV RNA <50, <20, <200 Copies/mL Post Week 96 to End of Extension Week 96 + 30 months (<20 copies/mL)	95.6 percentage of participants Interval 90.6 to 98.4	92.2 percentage of participants Interval 82.7 to 97.4	—
Percentage of Participants With HIV RNA <50, <20, <200 Copies/mL Post Week 96 to End of Extension Week 96 + 36 months (<20 copies/mL)	94.2 percentage of participants Interval 84.1 to 98.8	96.2 percentage of participants Interval 80.4 to 99.9	—
Percentage of Participants With HIV RNA <50, <20, <200 Copies/mL Post Week 96 to End of Extension Week 96 + 42 months (<20 copies/mL)	93.8 percentage of participants Interval 69.8 to 99.8	100 percentage of participants Interval 59.0 to 100.0	—
Percentage of Participants With HIV RNA <50, <20, <200 Copies/mL Post Week 96 to End of Extension Week 96 + 6 months (<50 copies/mL)	97.8 percentage of participants Interval 96.4 to 98.8	97.9 percentage of participants Interval 95.7 to 99.2	—
Percentage of Participants With HIV RNA <50, <20, <200 Copies/mL Post Week 96 to End of Extension Week 96 + 12 months (<50 copies/mL)	98.4 percentage of participants Interval 97.0 to 99.2	97.4 percentage of participants Interval 94.8 to 98.8	—
Percentage of Participants With HIV RNA <50, <20, <200 Copies/mL Post Week 96 to End of Extension Week 96 + 18 months (<50 copies/mL)	99.6 percentage of participants Interval 98.4 to 99.9	98.7 percentage of participants Interval 96.2 to 99.7	—
Percentage of Participants With HIV RNA <50, <20, <200 Copies/mL Post Week 96 to End of Extension Week 96 + 24 months (<50 copies/mL)	99.3 percentage of participants Interval 97.4 to 99.9	98.5 percentage of participants Interval 94.7 to 99.8	—
Percentage of Participants With HIV RNA <50, <20, <200 Copies/mL Post Week 96 to End of Extension Week 96 + 30 months (<50 copies/mL)	99.3 percentage of participants Interval 95.9 to 100.0	100 percentage of participants Interval 94.4 to 100.0	—
Percentage of Participants With HIV RNA <50, <20, <200 Copies/mL Post Week 96 to End of Extension Week 96 + 36 months (<50 copies/mL)	98.1 percentage of participants Interval 89.7 to 100.0	100 percentage of participants Interval 86.8 to 100.0	—
Percentage of Participants With HIV RNA <50, <20, <200 Copies/mL Post Week 96 to End of Extension Week 96 + 42 months (<50 copies/mL)	100 percentage of participants Interval 79.4 to 100.0	100 percentage of participants Interval 59.0 to 100.0	—
Percentage of Participants With HIV RNA <50, <20, <200 Copies/mL Post Week 96 to End of Extension Week 96 + 6 months (<200 copies/mL)	99.1 percentage of participants Interval 98.1 to 99.7	99.7 percentage of participants Interval 98.3 to 100.0	—
Percentage of Participants With HIV RNA <50, <20, <200 Copies/mL Post Week 96 to End of Extension Week 96 + 12 months (<200 copies/mL)	99.3 percentage of participants Interval 98.3 to 99.8	98.7 percentage of participants Interval 96.6 to 99.6	—
Percentage of Participants With HIV RNA <50, <20, <200 Copies/mL Post Week 96 to End of Extension Week 96 + 18 months (<200 copies/mL)	100 percentage of participants Interval 99.2 to 100.0	99.1 percentage of participants Interval 96.8 to 99.9	—

SECONDARY outcome

Timeframe: Week 96 to end of extension (up to 42 months)

Population: 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

The immunologic change was determined by Cluster of CD4+ cell count. CD4+ cell count post-Week 96 to end of extension were assessed.

Outcome measures

Outcome measures
Measure	D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) n=682 Participants 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).	Switch to D/C/F/TAF n=332 Participants 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.	Switch to D/C/F/TAF 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.
CD4+ Cell Count Post-Week 96 to End of Extension Week 96 + 6 months	706.4 cells/mm^3 Standard Error 10.51	681.3 cells/mm^3 Standard Error 14.99	—
CD4+ Cell Count Post-Week 96 to End of Extension Week 96 + 12 months	707.6 cells/mm^3 Standard Error 11.93	676.2 cells/mm^3 Standard Error 14.57	—
CD4+ Cell Count Post-Week 96 to End of Extension Week 96 + 24 months	712.7 cells/mm^3 Standard Error 15.98	686.4 cells/mm^3 Standard Error 21.20	—
CD4+ Cell Count Post-Week 96 to End of Extension Week 96 + 30 months	730.4 cells/mm^3 Standard Error 23.24	685.8 cells/mm^3 Standard Error 28.61	—
CD4+ Cell Count Post-Week 96 to End of Extension Week 96 + 36 months	732.0 cells/mm^3 Standard Error 33.10	733.3 cells/mm^3 Standard Error 54.73	—
CD4+ Cell Count Post-Week 96 to End of Extension Week 96 + 42 months	714.3 cells/mm^3 Standard Error 56.26	705.6 cells/mm^3 Standard Error 112.99	—
CD4+ Cell Count Post-Week 96 to End of Extension Week 96 + 18 months	713.3 cells/mm^3 Standard Error 12.16	686.1 cells/mm^3 Standard Error 17.05	—

SECONDARY outcome

Timeframe: Week 96 to end of extension (up to 42 months)

Population: 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.

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.

Outcome measures

Outcome measures
Measure	D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) n=363 Participants 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).	Switch to D/C/F/TAF n=216 Participants 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.	Switch to D/C/F/TAF 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.
Percentage of Participants With Treatment Adherence of >95% From Week 96 to End of Extension	89.5 percentage of participants	89.4 percentage of participants	—

SECONDARY outcome

Timeframe: From Week 96 to end of extension (up to 42 months)

Population: ITT analysis set included all the participants who were randomized and received at least 1 dose of study treatment.

Outcome measures

Outcome measures
Measure	D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) n=699 Participants 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).	Switch to D/C/F/TAF n=337 Participants 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.	Switch to D/C/F/TAF 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.
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 Grade 3 AEs	5.7 percentage of participants	5.0 percentage of participants	—
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 Grade 4 AEs	2.1 percentage of participants	1.5 percentage of participants	—
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 SAEs	7.3 percentage of participants	7.7 percentage of participants	—
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 Premature discontinuations due to AEs	1.1 percentage of participants	2.1 percentage of participants	—

Adverse Events

D/C/F/TAF (Test) (Baseline to End of Extension [EOE])

Serious events: 114 serious events

Other events: 584 other events

Deaths: 4 deaths

Control (Baseline to Switch)

Serious events: 18 serious events

Other events: 222 other events

Deaths: 0 deaths

Switch to D/C/F/TAF Group

Serious events: 42 serious events

Other events: 213 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Additional Information

Medical Officer

Janssen Research & Development

Phone: 844-434-4210

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.
Publication restrictions are in place

Restriction type: OTHER

Measure	D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) n=763 participants at risk 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	Control (Baseline to Switch) n=378 participants at risk 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.	Switch to D/C/F/TAF Group n=352 participants at risk 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.
Gastrointestinal disorders Abdominal pain	8.4% 64/763 • Up to 5 years and 4 months 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.	1.9% 7/378 • Up to 5 years and 4 months 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.	2.6% 9/352 • Up to 5 years and 4 months 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.
Gastrointestinal disorders Diarrhoea	13.6% 104/763 • Up to 5 years and 4 months 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.	4.8% 18/378 • Up to 5 years and 4 months 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.	11.4% 40/352 • Up to 5 years and 4 months 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.
Gastrointestinal disorders Nausea	5.4% 41/763 • Up to 5 years and 4 months 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.	2.1% 8/378 • Up to 5 years and 4 months 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.	3.4% 12/352 • Up to 5 years and 4 months 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.
Gastrointestinal disorders Vomiting	5.4% 41/763 • Up to 5 years and 4 months 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.	1.1% 4/378 • Up to 5 years and 4 months 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.	1.7% 6/352 • Up to 5 years and 4 months 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.
General disorders Fatigue	7.1% 54/763 • Up to 5 years and 4 months 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.	3.4% 13/378 • Up to 5 years and 4 months 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.	5.4% 19/352 • Up to 5 years and 4 months 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.
Infections and infestations Bronchitis	9.6% 73/763 • Up to 5 years and 4 months 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.	2.6% 10/378 • Up to 5 years and 4 months 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.	6.0% 21/352 • Up to 5 years and 4 months 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.
Infections and infestations Gastroenteritis	5.8% 44/763 • Up to 5 years and 4 months 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.	3.2% 12/378 • Up to 5 years and 4 months 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.	4.3% 15/352 • Up to 5 years and 4 months 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.
Infections and infestations Influenza	6.9% 53/763 • Up to 5 years and 4 months 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.	1.9% 7/378 • Up to 5 years and 4 months 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.	2.8% 10/352 • Up to 5 years and 4 months 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.
Infections and infestations Nasopharyngitis	18.9% 144/763 • Up to 5 years and 4 months 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.	11.1% 42/378 • Up to 5 years and 4 months 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.	11.9% 42/352 • Up to 5 years and 4 months 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.
Infections and infestations Pharyngitis	7.6% 58/763 • Up to 5 years and 4 months 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.	2.9% 11/378 • Up to 5 years and 4 months 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.	4.0% 14/352 • Up to 5 years and 4 months 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.
Infections and infestations Sinusitis	6.8% 52/763 • Up to 5 years and 4 months 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.	3.2% 12/378 • Up to 5 years and 4 months 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.	3.7% 13/352 • Up to 5 years and 4 months 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.
Infections and infestations Syphilis	7.5% 57/763 • Up to 5 years and 4 months 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.	3.4% 13/378 • Up to 5 years and 4 months 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.	5.7% 20/352 • Up to 5 years and 4 months 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.
Infections and infestations Upper respiratory tract infection	21.4% 163/763 • Up to 5 years and 4 months 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.	10.3% 39/378 • Up to 5 years and 4 months 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.	15.9% 56/352 • Up to 5 years and 4 months 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.
Metabolism and nutrition disorders Vitamin D deficiency	9.7% 74/763 • Up to 5 years and 4 months 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.	7.7% 29/378 • Up to 5 years and 4 months 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.	3.1% 11/352 • Up to 5 years and 4 months 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.
Musculoskeletal and connective tissue disorders Arthralgia	11.0% 84/763 • Up to 5 years and 4 months 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.	2.4% 9/378 • Up to 5 years and 4 months 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.	6.2% 22/352 • Up to 5 years and 4 months 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.
Musculoskeletal and connective tissue disorders Back pain	14.0% 107/763 • Up to 5 years and 4 months 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.	6.1% 23/378 • Up to 5 years and 4 months 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.	8.8% 31/352 • Up to 5 years and 4 months 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.
Musculoskeletal and connective tissue disorders Osteopenia	6.4% 49/763 • Up to 5 years and 4 months 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.	5.8% 22/378 • Up to 5 years and 4 months 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.	0.00% 0/352 • Up to 5 years and 4 months 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.
Musculoskeletal and connective tissue disorders Pain in extremity	6.7% 51/763 • Up to 5 years and 4 months 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.	4.0% 15/378 • Up to 5 years and 4 months 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.	4.0% 14/352 • Up to 5 years and 4 months 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.
Nervous system disorders Headache	12.2% 93/763 • Up to 5 years and 4 months 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.	4.8% 18/378 • Up to 5 years and 4 months 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.	8.2% 29/352 • Up to 5 years and 4 months 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.
Psychiatric disorders Depression	5.4% 41/763 • Up to 5 years and 4 months 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.	3.2% 12/378 • Up to 5 years and 4 months 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.	4.0% 14/352 • Up to 5 years and 4 months 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.
Respiratory, thoracic and mediastinal disorders Cough	9.8% 75/763 • Up to 5 years and 4 months 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.	4.5% 17/378 • Up to 5 years and 4 months 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.	6.0% 21/352 • Up to 5 years and 4 months 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.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	5.6% 43/763 • Up to 5 years and 4 months 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.	3.4% 13/378 • Up to 5 years and 4 months 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.	2.0% 7/352 • Up to 5 years and 4 months 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.
Skin and subcutaneous tissue disorders Rash	5.6% 43/763 • Up to 5 years and 4 months 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.	1.6% 6/378 • Up to 5 years and 4 months 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.	3.4% 12/352 • Up to 5 years and 4 months 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.
Vascular disorders Hypertension	6.2% 47/763 • Up to 5 years and 4 months 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.	1.9% 7/378 • Up to 5 years and 4 months 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.	3.1% 11/352 • Up to 5 years and 4 months 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.