Switch Study to Evaluate F/TAF in HIV-1 Infected Adults Who Are Virologically Suppressed on Regimens Containing ABC/3TC

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT02469246

Recruitment Status : Completed

First Posted : June 11, 2015

Results First Posted : June 11, 2018

Last Update Posted : October 25, 2019

Sponsor:

Information provided by (Responsible Party):

Gilead Sciences

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
Condition	HIV-1 Infection
Interventions	Drug: F/TAF Drug: ABC/3TC Drug: ABC/3TC Placebo Drug: F/TAF Placebo Drug: 3rd ARV agent
Enrollment	567

Participant Flow

Recruitment Details	Participants were enrolled at study sites in North America and Europe. The first participant was screened on 29 June 2015. The last study visit occurred on 13 March 2019.
Pre-assignment Details	626 participants were screened.


Arm/Group Title	F/TAF	ABC/3TC
Arm/Group Description	Double-Blind Phase: Emtricitabine/t...	Double-Blind Phase: ABC/3TC (600/30...
Arm/Group Description	Double-Blind Phase: Emtricitabine/tenofovir alafenamide (F/TAF) (200/10 mg) fixed-dose combination (FDC) tablet (with boosted 3rd antiretroviral (ARV) agent) or F/TAF (200/25 mg) FDC tablet (with unboosted 3rd ARV agent) + abacavir/lamivudine (ABC/3TC) placebo tablet once daily for 96 weeks, and continued blinded treatment until unblinding. [Allowed boosted 3rd ARV agents: ritonavir boosted lopinavir (LPV/r), atazanavir (ATV) + ritonavir (RTV), ATV + cobicistat (COBI) or ATV/COBI FDC, darunavir (DRV) + RTV, DRV+COBI or DRV/COBI FDC; Allowed unboosted 3rd ARV agents: efavirenz (EFV), rilpivirine (RPV), raltegravir (RAL), dolutegravir (DTG), maraviroc (MVC), or nevirapine (NVP)]. Open-Label Extension: After the unblinding visit, in countries where F/TAF FDC was not commercially available, participants (except in certain countries) were given the option to receive the open-label F/TAF FDC until it became commercially available, or until Gilead terminated the study in that country.	Double-Blind Phase: ABC/3TC (600/300 mg) FDC tablet + F/TAF placebo tablet once daily + allowed 3rd ARV agent for 96 weeks, and continued blinded treatment until unblinding. (Allowed boosted 3rd ARV agents: LPV/r, ATV + RTV, ATV + COBI or ATV/COBI FDC, DRV + RTV, DRV+COBI or DRV/COBI FDC; Allowed unboosted 3rd ARV agents: EFV, RPV, RAL, DTG, MVC, or NVP) Open-Label Extension: After the unblinding visit, in countries where F/TAF FDC was not commercially available, participants (except in certain countries) were given the option to receive the open-label F/TAF FDC until it became commercially available, or until Gilead terminated the study in that country.
Period Title: Double-Blind Phase
Started	285	282
Completed	218	226
Not Completed	67	56
Reason Not Completed
Randomized and Never Treated	5	6
Adverse Event	12	9
Death	2	0
Lack of Efficacy	2	1
Investigator's Discretion	8	8
Non-Compliance with Study Drug	3	1
Protocol Violation	1	1
Withdrew Consent	25	25
Lost to Follow-up	9	5
Period Title: Open-Label Extension (OLE)
Started	6 ^[1]	5 ^[1]
Completed	6	5
Not Completed	0	0
[1] Only participants in countries where F/TAF was not commercially available were eligible for the OLE.

Baseline Characteristics

Arm/Group Title		F/TAF	ABC/3TC	Total
Arm/Group Description		F/TAF (200/10 mg) FDC tablet (with ...	ABC/3TC (600/300 mg) FDC tablet + F...	Total of all reporting groups
Arm/Group Description		F/TAF (200/10 mg) FDC tablet (with boosted 3rd ARV agent) or F/TAF (200/25 mg) FDC tablet (with unboosted 3rd ARV agent) + ABC/3TC placebo tablet once daily for 96 weeks	ABC/3TC (600/300 mg) FDC tablet + F/TAF placebo tablet once daily + allowed 3rd ARV agent for 96 weeks	Total of all reporting groups
Overall Number of Baseline Participants		280	276	556
Baseline Analysis Population Description		...
Baseline Analysis Population Description		The Safety Analysis Set included all randomized participants who received at least one dose of study drug. Participants were grouped according to the treatment they actually received.
Age, Continuous Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	280 participants	276 participants	556 participants
		51 (9.4)	51 (9.3)	51 (9.3)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	280 participants	276 participants	556 participants
	Female	40	61	101
	Male	240	215	455
Ethnicity (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	280 participants	276 participants	556 participants
	Hispanic or Latino	16	19	35
	Not Hispanic or Latino	264	257	521
	Unknown or Not Reported	0	0	0
Race/Ethnicity, Customized Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	280 participants	276 participants	556 participants
	American Indian or Alaska Native	1	0	1
	Asian	5	5	10
	Black	64	66	130
	White	205	199	404
	Other	5	6	11
Region of Enrollment Measure Type: Count of Participants Unit of measure: Participants	Number Analyzed	280 participants	276 participants	556 participants
Belgium		4	6	10
Canada		9	8	17
Denmark		4	3	7
France		18	17	35
Germany		20	19	39
Ireland		9	8	17
Italy		26	17	43
Spain		32	34	66
Sweden		3	4	7
United Kingdom		50	59	109
United States		105	101	206
HIV-1 RNA Category Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	280 participants	276 participants	556 participants
	< 50 copies/mL	278	273	551
	≥ 50 copies/mL	2	3	5
CD4 Cell Count Mean (Standard Deviation) Unit of measure: cells/µL
	Number Analyzed	280 participants	276 participants	556 participants
		703 (298.7)	727 (275.2)	715 (287.3)
CD4 Cell Count Category Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	280 participants	276 participants	556 participants
	< 50 cells/µL	0	1	1
	≥ 50 to < 200 cells/µL	0	0	0
	≥ 200 to < 350 cells/µL	20	16	36
	≥ 350 to < 500 cells/µL	56	38	94
	≥ 500 cells/µL	204	221	425
HIV Disease Status Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	280 participants	276 participants	556 participants
	Asymptomatic	201	201	402
	Symptomatic HIV Infection	31	24	55
	AIDS	47	50	97
	Unknown	1	1	2

Outcome Measures

1.Primary Outcome


Title	Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Determined by the FDA-Defined Snapshot Algorithm
Description	The percentage of participants achieving HIV-1 RNA < 50 copies/mL a...
Description	The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Time Frame	Week 48

Outcome Measure Data

Analysis Population Description

The Full Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. Participants were grouped according to the treatment to which they were randomized.


Arm/Group Title	F/TAF	ABC/3TC
Arm/Group Description:	F/TAF (200/10 mg) FDC tablet (with ...	ABC/3TC (600/300 mg) FDC tablet + F...
Arm/Group Description:	F/TAF (200/10 mg) FDC tablet (with boosted 3rd ARV agent) or F/TAF (200/25 mg) FDC tablet (with unboosted 3rd ARV agent) + ABC/3TC placebo tablet once daily for 96 weeks	ABC/3TC (600/300 mg) FDC tablet + F/TAF placebo tablet once daily + allowed 3rd ARV agent for 96 weeks
Overall Number of Participants Analyzed	280	276
Measure Type: Number Unit of Measure: percentage of participants
	88.6	92.4

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	F/TAF, ABC/3TC
	Comments	The analysis purpose of the primary efficacy endpoint was to assess the noninferiority of switching to F/TAF+3rd Agent relative to maintaining treatment with ABC/3TC+3rd Agent.
	Type of Statistical Test	Non-Inferiority
	Comments	Non-inferiority was assessed using a 2-sided exact 95% confidence interval (CI) approach, with a non-inferiority margin of 10%.

Statistical Test of Hypothesis	P-Value	0.15
	Comments	[Not Specified]
	Method	Fisher Exact
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Difference in Percentages
	Estimated Value	-3.8
	Confidence Interval	(2-Sided) 95.002% -8.9 to 1.1
	Estimation Comments	The difference in percentages and its 95.002% CI were calculated based on an unconditional exact method using 2 inverted 1-sided tests.

2.Secondary Outcome


Title	Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96 as Determined by the FDA-Defined Snapshot Algorithm
Description	The percentage of participants achieving HIV-1 RNA < 50 copies/mL a...
Description	The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 96 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Time Frame	Week 96

Outcome Measure Data

Analysis Population Description

Participants in the Full Analysis Set were analyzed.


Arm/Group Title	F/TAF	ABC/3TC
Arm/Group Description:	F/TAF (200/10 mg) FDC tablet (with ...	ABC/3TC (600/300 mg) FDC tablet + F...
Arm/Group Description:	F/TAF (200/10 mg) FDC tablet (with boosted 3rd ARV agent) or F/TAF (200/25 mg) FDC tablet (with unboosted 3rd ARV agent) + ABC/3TC placebo tablet once daily for 96 weeks	ABC/3TC (600/300 mg) FDC tablet + F/TAF placebo tablet once daily + allowed 3rd ARV agent for 96 weeks
Overall Number of Participants Analyzed	280	276
Measure Type: Number Unit of Measure: percentage of participants
	82.1	88.4

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	F/TAF, ABC/3TC
	Comments	The analysis purpose of this efficacy endpoint was to assess the non-inferiority of switching to F/TAF+3rd Agent relative to maintaining treatment with ABC/3TC+3rd Agent.
	Type of Statistical Test	Non-Inferiority
	Comments	Non-inferiority was assessed using a 2-sided exact 95% CI approach, with a non-inferiority margin of 4%.

Statistical Test of Hypothesis	P-Value	0.042
	Comments	[Not Specified]
	Method	Fisher Exact
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Difference in Percentages
	Estimated Value	-6.3
	Confidence Interval	(2-Sided) 95% -12.3 to -0.3
	Estimation Comments	The difference in percentages and its 95% CI were calculated based on an unconditional exact method using 2 inverted 1-sided tests.

3.Secondary Outcome


Title	Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 48 as Determined by the FDA-Defined Snapshot Algorithm
Description	The percentage of participants with HIV-1 RNA ≥ 50 copies/mL at ...
Description	The percentage of participants with HIV-1 RNA ≥ 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Time Frame	Week 48

Outcome Measure Data

Analysis Population Description

Participants in the Full Analysis Set were analyzed.


Arm/Group Title	F/TAF	ABC/3TC
Arm/Group Description:	F/TAF (200/10 mg) FDC tablet (with ...	ABC/3TC (600/300 mg) FDC tablet + F...
Arm/Group Description:	F/TAF (200/10 mg) FDC tablet (with boosted 3rd ARV agent) or F/TAF (200/25 mg) FDC tablet (with unboosted 3rd ARV agent) + ABC/3TC placebo tablet once daily for 96 weeks	ABC/3TC (600/300 mg) FDC tablet + F/TAF placebo tablet once daily + allowed 3rd ARV agent for 96 weeks
Overall Number of Participants Analyzed	280	276
Measure Type: Number Unit of Measure: percentage of participants
	1.8	0.7

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	F/TAF, ABC/3TC
	Comments	The analysis purpose of this efficacy endpoint was to assess the non-inferiority of switching to F/TAF+3rd Agent relative to maintaining treatment with ABC/3TC+3rd Agent.
	Type of Statistical Test	Non-Inferiority
	Comments	Non-inferiority was assessed using a 2-sided exact 95% CI approach, with a non-inferiority margin of 4%.

Statistical Test of Hypothesis	P-Value	0.45
	Comments	[Not Specified]
	Method	Fisher Exact
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Difference in Percentages
	Estimated Value	1.1
	Confidence Interval	(2-Sided) 95.002% -1.0 to 3.5
	Estimation Comments	The difference in percentages and its 95.002% CI were calculated based on an unconditional exact method using 2 inverted 1-sided tests.

4.Secondary Outcome


Title	Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 96 as Determined by the FDA-Defined Snapshot Algorithm
Description	The percentage of participants with HIV-1 RNA ≥ 50 copies/mL at ...
Description	The percentage of participants with HIV-1 RNA ≥ 50 copies/mL at Week 96 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Time Frame	Week 96

Outcome Measure Data

Analysis Population Description

Participants in the Full Analysis Set were analyzed.


Arm/Group Title	F/TAF	ABC/3TC
Arm/Group Description:	F/TAF (200/10 mg) FDC tablet (with ...	ABC/3TC (600/300 mg) FDC tablet + F...
Arm/Group Description:	F/TAF (200/10 mg) FDC tablet (with boosted 3rd ARV agent) or F/TAF (200/25 mg) FDC tablet (with unboosted 3rd ARV agent) + ABC/3TC placebo tablet once daily for 96 weeks	ABC/3TC (600/300 mg) FDC tablet + F/TAF placebo tablet once daily + allowed 3rd ARV agent for 96 weeks
Overall Number of Participants Analyzed	280	276
Measure Type: Number Unit of Measure: percentage of participants
	2.5	1.1

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	F/TAF, ABC/3TC
	Comments	The analysis purpose of this efficacy endpoint was to assess the non-inferiority of switching to F/TAF+3rd Agent relative to maintaining treatment with ABC/3TC+3rd Agent.
	Type of Statistical Test	Non-Inferiority
	Comments	Non-inferiority was assessed using a 2-sided exact 95% CI approach, with a non-inferiority margin of 4%.

Statistical Test of Hypothesis	P-Value	0.34
	Comments	[Not Specified]
	Method	Fisher Exact
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Difference in Percentages
	Estimated Value	1.4
	Confidence Interval	(2-Sided) 95% -1.0 to 4.2
	Estimation Comments	The difference in percentages and its 95% CI were calculated based on an unconditional exact method using 2 inverted 1-sided tests.

5.Secondary Outcome


Title	Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Week 48 as Determined by the FDA-Defined Snapshot Algorithm
Description	The percentage of participants achieving HIV-1 RNA < 20 copies/mL a...
Description	The percentage of participants achieving HIV-1 RNA < 20 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Time Frame	Week 48

Outcome Measure Data

Analysis Population Description

Participants in the Full Analysis Set were analyzed.


Arm/Group Title	F/TAF	ABC/3TC
Arm/Group Description:	F/TAF (200/10 mg) FDC tablet (with ...	ABC/3TC (600/300 mg) FDC tablet + F...
Arm/Group Description:	F/TAF (200/10 mg) FDC tablet (with boosted 3rd ARV agent) or F/TAF (200/25 mg) FDC tablet (with unboosted 3rd ARV agent) + ABC/3TC placebo tablet once daily for 96 weeks	ABC/3TC (600/300 mg) FDC tablet + F/TAF placebo tablet once daily + allowed 3rd ARV agent for 96 weeks
Overall Number of Participants Analyzed	280	276
Measure Type: Number Unit of Measure: percentage of participants
	85.7	87.3

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	F/TAF, ABC/3TC
	Comments	The analysis purpose of this efficacy endpoint was to assess the noninferiority of switching to F/TAF+3rd Agent relative to maintaining treatment with ABC/3TC+3rd Agent.
	Type of Statistical Test	Non-Inferiority
	Comments	Non-inferiority was assessed using a 2-sided exact 95% CI approach, with a non-inferiority margin of 10%.

Statistical Test of Hypothesis	P-Value	0.62
	Comments	[Not Specified]
	Method	Fisher Exact
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Difference in Percentages
	Estimated Value	-1.6
	Confidence Interval	(2-Sided) 95% -7.4 to 4.2
	Estimation Comments	The difference in percentages and its 95% CI were calculated based on an unconditional exact method using 2 inverted 1-sided tests.

6.Secondary Outcome


Title	Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Week 96 as Determined by the FDA-Defined Snapshot Algorithm
Description	The percentage of participants achieving HIV-1 RNA < 20 copies/mL a...
Description	The percentage of participants achieving HIV-1 RNA < 20 copies/mL at Week 96 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Time Frame	Week 96

Outcome Measure Data

Analysis Population Description

Participants in the Full Analysis Set were analyzed.


Arm/Group Title	F/TAF	ABC/3TC
Arm/Group Description:	F/TAF (200/10 mg) FDC tablet (with ...	ABC/3TC (600/300 mg) FDC tablet + F...
Arm/Group Description:	F/TAF (200/10 mg) FDC tablet (with boosted 3rd ARV agent) or F/TAF (200/25 mg) FDC tablet (with unboosted 3rd ARV agent) + ABC/3TC placebo tablet once daily for 96 weeks	ABC/3TC (600/300 mg) FDC tablet + F/TAF placebo tablet once daily + allowed 3rd ARV agent for 96 weeks
Overall Number of Participants Analyzed	280	276
Measure Type: Number Unit of Measure: percentage of participants
	80.4	86.2

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	F/TAF, ABC/3TC
	Comments	The analysis purpose of this efficacy endpoint was to assess the noninferiority of switching to F/TAF+3rd Agent relative to maintaining treatment with ABC/3TC+3rd Agent.
	Type of Statistical Test	Non-Inferiority
	Comments	Non-inferiority was assessed using a 2-sided exact 95% CI approach, with a non-inferiority margin of 10%.

Statistical Test of Hypothesis	P-Value	0.069
	Comments	[Not Specified]
	Method	Fisher Exact
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Difference in Percentages
	Estimated Value	-5.9
	Confidence Interval	(2-Sided) 95% -12.2 to 0.4
	Estimation Comments	The difference in percentages and its 95% CI were calculated based on an unconditional exact method using 2 inverted 1-sided tests.

7.Secondary Outcome


Title	Change From Baseline in CD4 Cell Count at Week 48
Description	[Not Specified]
Description	[Not Specified]
Time Frame	Baseline; Week 48

Outcome Measure Data

Analysis Population Description

Participants in the Full Analysis Set with available data were analyzed.


Arm/Group Title	F/TAF	ABC/3TC
Arm/Group Description:	F/TAF (200/10 mg) FDC tablet (with ...	ABC/3TC (600/300 mg) FDC tablet + F...
Arm/Group Description:	F/TAF (200/10 mg) FDC tablet (with boosted 3rd ARV agent) or F/TAF (200/25 mg) FDC tablet (with unboosted 3rd ARV agent) + ABC/3TC placebo tablet once daily for 96 weeks	ABC/3TC (600/300 mg) FDC tablet + F/TAF placebo tablet once daily + allowed 3rd ARV agent for 96 weeks
Overall Number of Participants Analyzed	249	254
Mean (Standard Deviation) Unit of Measure: cells/µL
	-30 (152.3)	2 (171.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	F/TAF, ABC/3TC
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.026
	Comments	P-value was adjusted by the third agent stratum (boosted protease inhibitors vs. others).
	Method	ANOVA
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Difference in LSM
	Estimated Value	-32
	Confidence Interval	(2-Sided) 95% -61 to -4
	Estimation Comments	Difference in LSM and its 95% CI were adjusted by the third agent stratum (boosted protease inhibitors vs. others).

8.Secondary Outcome


Title	Change From Baseline in CD4 Cell Count at Week 96
Description	[Not Specified]
Description	[Not Specified]
Time Frame	Baseline; Week 96

Outcome Measure Data

Analysis Population Description

Participants in the Full Analysis Set with available data were analyzed.


Arm/Group Title	F/TAF	ABC/3TC
Arm/Group Description:	F/TAF (200/10 mg) FDC tablet (with ...	ABC/3TC (600/300 mg) FDC tablet + F...
Arm/Group Description:	F/TAF (200/10 mg) FDC tablet (with boosted 3rd ARV agent) or F/TAF (200/25 mg) FDC tablet (with unboosted 3rd ARV agent) + ABC/3TC placebo tablet once daily for 96 weeks	ABC/3TC (600/300 mg) FDC tablet + F/TAF placebo tablet once daily + allowed 3rd ARV agent for 96 weeks
Overall Number of Participants Analyzed	229	238
Mean (Standard Deviation) Unit of Measure: cells/μL
	-29 (160.7)	10 (178.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	F/TAF, ABC/3TC
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.013
	Comments	P-value was adjusted by the third agent stratum (boosted protease inhibitors vs. others).
	Method	ANOVA
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Difference in LSM
	Estimated Value	-39
	Confidence Interval	(2-Sided) 95% -70 to -8
	Estimation Comments	Difference in LSM and its 95% CI were adjusted by the third agent stratum (boosted protease inhibitors vs. others).

9.Secondary Outcome


Title	Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48
Description	[Not Specified]
Description	[Not Specified]
Time Frame	Baseline; Week 48

Outcome Measure Data

Analysis Population Description

Participants in the Hip Dual-Energy X-Ray Absorptiometry (DXA) Analysis Set (all participants who are randomized and have received at least one dose of study drug, and have nonmissing baseline hip BMD values) with available data were analyzed.


Arm/Group Title	F/TAF	ABC/3TC
Arm/Group Description:	F/TAF (200/10 mg) FDC tablet (with ...	ABC/3TC (600/300 mg) FDC tablet + F...
Arm/Group Description:	F/TAF (200/10 mg) FDC tablet (with boosted 3rd ARV agent) or F/TAF (200/25 mg) FDC tablet (with unboosted 3rd ARV agent) + ABC/3TC placebo tablet once daily for 96 weeks	ABC/3TC (600/300 mg) FDC tablet + F/TAF placebo tablet once daily + allowed 3rd ARV agent for 96 weeks
Overall Number of Participants Analyzed	231	236
Mean (Standard Deviation) Unit of Measure: percent change
	0.246 (2.2914)	0.086 (2.3315)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	F/TAF, ABC/3TC
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.40
	Comments	P-value was adjusted by the third agent stratum (boosted protease inhibitors vs. others).
	Method	ANOVA
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Difference in LSM
	Estimated Value	0.179
	Confidence Interval	(2-Sided) 95% -0.240 to 0.598
	Estimation Comments	Difference in LSM and its 95% CI were adjusted by the third agent stratum (boosted protease inhibitors vs. others).

10.Secondary Outcome


Title	Percent Change From Baseline in Hip BMD at Week 96
Description	[Not Specified]
Description	[Not Specified]
Time Frame	Baseline; Week 96

Outcome Measure Data

Analysis Population Description

Participants in the Hip DXA Analysis Set with available data were analyzed.


Arm/Group Title	F/TAF	ABC/3TC
Arm/Group Description:	F/TAF (200/10 mg) FDC tablet (with ...	ABC/3TC (600/300 mg) FDC tablet + F...
Arm/Group Description:	F/TAF (200/10 mg) FDC tablet (with boosted 3rd ARV agent) or F/TAF (200/25 mg) FDC tablet (with unboosted 3rd ARV agent) + ABC/3TC placebo tablet once daily for 96 weeks	ABC/3TC (600/300 mg) FDC tablet + F/TAF placebo tablet once daily + allowed 3rd ARV agent for 96 weeks
Overall Number of Participants Analyzed	213	221
Mean (Standard Deviation) Unit of Measure: percent change
	0.169 (2.7277)	0.021 (2.7212)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	F/TAF, ABC/3TC
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.53
	Comments	P-value was adjusted by the third agent stratum (boosted protease inhibitors vs. others).
	Method	ANOVA
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Difference in LSM
	Estimated Value	0.165
	Confidence Interval	(2-Sided) 95% -0.348 to 0.678
	Estimation Comments	Difference in LSM and its 95% CI were adjusted by the third agent stratum (boosted protease inhibitors vs. others).

11.Secondary Outcome


Title	Percent Change From Baseline in Spine BMD at Week 48
Description	[Not Specified]
Description	[Not Specified]
Time Frame	Baseline; Week 48

Outcome Measure Data

Analysis Population Description

Participants in the Spine DXA Analysis Set (all participants who are randomized and have received at least one dose of study drug, and have nonmissing baseline spine BMD values) with available data were analyzed.


Arm/Group Title	F/TAF	ABC/3TC
Arm/Group Description:	F/TAF (200/10 mg) FDC tablet (with ...	ABC/3TC (600/300 mg) FDC tablet + F...
Arm/Group Description:	F/TAF (200/10 mg) FDC tablet (with boosted 3rd ARV agent) or F/TAF (200/25 mg) FDC tablet (with unboosted 3rd ARV agent) + ABC/3TC placebo tablet once daily for 96 weeks	ABC/3TC (600/300 mg) FDC tablet + F/TAF placebo tablet once daily + allowed 3rd ARV agent for 96 weeks
Overall Number of Participants Analyzed	232	240
Mean (Standard Deviation) Unit of Measure: percent change
	0.081 (3.0051)	-0.052 (3.7550)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	F/TAF, ABC/3TC
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.63
	Comments	P-value was adjusted by the third agent stratum (boosted protease inhibitors vs. others).
	Method	ANOVA
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Difference in LSM
	Estimated Value	0.151
	Confidence Interval	(2-Sided) 95% -0.465 to 0.767
	Estimation Comments	Difference in LSM and its 95% CI were adjusted by the third agent stratum (boosted protease inhibitors vs. others).

12.Secondary Outcome


Title	Percent Change From Baseline in Spine BMD at Week 96
Description	[Not Specified]
Description	[Not Specified]
Time Frame	Baseline; Week 96

Outcome Measure Data

Analysis Population Description

Participants in the Spine DXA Analysis Set with available data were analyzed.


Arm/Group Title	F/TAF	ABC/3TC
Arm/Group Description:	F/TAF (200/10 mg) FDC tablet (with ...	ABC/3TC (600/300 mg) FDC tablet + F...
Arm/Group Description:	F/TAF (200/10 mg) FDC tablet (with boosted 3rd ARV agent) or F/TAF (200/25 mg) FDC tablet (with unboosted 3rd ARV agent) + ABC/3TC placebo tablet once daily for 96 weeks	ABC/3TC (600/300 mg) FDC tablet + F/TAF placebo tablet once daily + allowed 3rd ARV agent for 96 weeks
Overall Number of Participants Analyzed	217	225
Mean (Standard Deviation) Unit of Measure: percent change
	0.178 (3.8881)	0.235 (4.3066)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	F/TAF, ABC/3TC
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.89
	Comments	P-value was adjusted by the third agent stratum (boosted protease inhibitors vs. others).
	Method	ANOVA
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Difference in LSM
	Estimated Value	-0.056
	Confidence Interval	(2-Sided) 95% -0.825 to 0.713
	Estimation Comments	Difference in LSM and its 95% CI were adjusted by the third agent stratum (boosted protease inhibitors vs. others).

Adverse Events

Time Frame	First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
Adverse Event Reporting Description	The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.

Arm/Group Title	F/TAF (Double-Blind Phase)	ABC/3TC (Double-Blind Phase)	Open-Label F/TAF From F/TAF	Open-Label F/TAF From ABC/3TC
Arm/Group Description	Adverse events reported occurred du...	Adverse events reported occurred du...	Adverse events reported occurred du...	Adverse events reported occurred du...
Arm/Group Description	Adverse events reported occurred during the Double-Blind Phase in participants from the F/TAF group, who received F/TAF (200/10 mg) FDC tablet (with boosted 3rd ARV agent) or F/TAF (200/25 mg) FDC tablet (with unboosted 3rd ARV agent) + ABC/3TC placebo tablet once daily.	Adverse events reported occurred during the Double-Blind Phase in participants from the ABC/3TC group, who received ABC/3TC (600/300 mg) FDC tablet + F/TAF placebo tablet once daily + allowed 3rd ARV agent.	Adverse events reported occurred during the Open-Label Extension Phase in participants who enrolled into the Open-Label Extension Phase from the F/TAF group and received F/TAF (200/10 mg or 200/25 mg) FDC tablet once daily.	Adverse events reported occurred during the Open-Label Extension Phase in participants who enrolled into the Open-Label Extension Phase from the ABC/3TC group and received F/TAF (200/10 mg or 200/25 mg) FDC tablet once daily.
All-Cause Mortality
	F/TAF (Double-Blind Phase)	ABC/3TC (Double-Blind Phase)	Open-Label F/TAF From F/TAF	Open-Label F/TAF From ABC/3TC
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	5/280 (1.79%)	0/276 (0.00%)	0/6 (0.00%)	0/5 (0.00%)
Serious Adverse Events Serious Adverse Events
	F/TAF (Double-Blind Phase)	ABC/3TC (Double-Blind Phase)	Open-Label F/TAF From F/TAF	Open-Label F/TAF From ABC/3TC
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	55/280 (19.64%)	32/276 (11.59%)	0/6 (0.00%)	0/5 (0.00%)
Blood and lymphatic system disorders
Iron deficiency anaemia ^† 1	1/280 (0.36%)	0/276 (0.00%)	0/6 (0.00%)	0/5 (0.00%)
Leukocytosis ^† 1	0/280 (0.00%)	1/276 (0.36%)	0/6 (0.00%)	0/5 (0.00%)
Neutropenia ^† 1	1/280 (0.36%)	0/276 (0.00%)	0/6 (0.00%)	0/5 (0.00%)
Cardiac disorders
Atrial fibrillation ^† 1	0/280 (0.00%)	1/276 (0.36%)	0/6 (0.00%)	0/5 (0.00%)
Cardiac failure congestive ^† 1	1/280 (0.36%)	0/276 (0.00%)	0/6 (0.00%)	0/5 (0.00%)
Cardio-respiratory arrest ^† 1	1/280 (0.36%)	0/276 (0.00%)	0/6 (0.00%)	0/5 (0.00%)
Coronary artery disease ^† 1	1/280 (0.36%)	1/276 (0.36%)	0/6 (0.00%)	0/5 (0.00%)
Coronary artery stenosis ^† 1	1/280 (0.36%)	0/276 (0.00%)	0/6 (0.00%)	0/5 (0.00%)
Myocardial infarction ^† 1	1/280 (0.36%)	1/276 (0.36%)	0/6 (0.00%)	0/5 (0.00%)
Pericarditis ^† 1	0/280 (0.00%)	1/276 (0.36%)	0/6 (0.00%)	0/5 (0.00%)
Gastrointestinal disorders
Abdominal pain ^† 1	1/280 (0.36%)	1/276 (0.36%)	0/6 (0.00%)	0/5 (0.00%)
Diarrhoea ^† 1	1/280 (0.36%)	0/276 (0.00%)	0/6 (0.00%)	0/5 (0.00%)
Faecaloma ^† 1	0/280 (0.00%)	1/276 (0.36%)	0/6 (0.00%)	0/5 (0.00%)
Gastrointestinal haemorrhage ^† 1	0/280 (0.00%)	1/276 (0.36%)	0/6 (0.00%)	0/5 (0.00%)
Haematemesis ^† 1	0/280 (0.00%)	1/276 (0.36%)	0/6 (0.00%)	0/5 (0.00%)
Ileus paralytic ^† 1	1/280 (0.36%)	0/276 (0.00%)	0/6 (0.00%)	0/5 (0.00%)
Intestinal ischaemia ^† 1	0/280 (0.00%)	1/276 (0.36%)	0/6 (0.00%)	0/5 (0.00%)
Large intestine perforation ^† 1	1/280 (0.36%)	0/276 (0.00%)	0/6 (0.00%)	0/5 (0.00%)
Oesophageal ulcer ^† 1	1/280 (0.36%)	0/276 (0.00%)	0/6 (0.00%)	0/5 (0.00%)
Pancreatitis ^† 1	1/280 (0.36%)	0/276 (0.00%)	0/6 (0.00%)	0/5 (0.00%)
Pancreatitis acute ^† 1	1/280 (0.36%)	0/276 (0.00%)	0/6 (0.00%)	0/5 (0.00%)
Rectal haemorrhage ^† 1	1/280 (0.36%)	0/276 (0.00%)	0/6 (0.00%)	0/5 (0.00%)
Small intestinal obstruction ^† 1	0/280 (0.00%)	1/276 (0.36%)	0/6 (0.00%)	0/5 (0.00%)
Umbilical hernia ^† 1	0/280 (0.00%)	1/276 (0.36%)	0/6 (0.00%)	0/5 (0.00%)
General disorders
Asthenia ^† 1	1/280 (0.36%)	0/276 (0.00%)	0/6 (0.00%)	0/5 (0.00%)
Chest pain ^† 1	2/280 (0.71%)	0/276 (0.00%)	0/6 (0.00%)	0/5 (0.00%)
Death ^† 1	1/280 (0.36%)	0/276 (0.00%)	0/6 (0.00%)	0/5 (0.00%)
Sudden cardiac death ^† 1	1/280 (0.36%)	0/276 (0.00%)	0/6 (0.00%)	0/5 (0.00%)
Infections and infestations
Abdominal wall abscess ^† 1	0/280 (0.00%)	1/276 (0.36%)	0/6 (0.00%)	0/5 (0.00%)
Abscess neck ^† 1	1/280 (0.36%)	0/276 (0.00%)	0/6 (0.00%)	0/5 (0.00%)
Acute hepatitis C ^† 1	0/280 (0.00%)	1/276 (0.36%)	0/6 (0.00%)	0/5 (0.00%)
Appendicitis ^† 1	1/280 (0.36%)	1/276 (0.36%)	0/6 (0.00%)	0/5 (0.00%)
Clostridium difficile infection ^† 1	1/280 (0.36%)	0/276 (0.00%)	0/6 (0.00%)	0/5 (0.00%)
Dengue fever ^† 1	1/280 (0.36%)	0/276 (0.00%)	0/6 (0.00%)	0/5 (0.00%)
Diarrhoea infectious ^† 1	1/280 (0.36%)	0/276 (0.00%)	0/6 (0.00%)	0/5 (0.00%)
Diverticulitis ^† 1	1/280 (0.36%)	0/276 (0.00%)	0/6 (0.00%)	0/5 (0.00%)
Erysipelas ^† 1	1/280 (0.36%)	0/276 (0.00%)	0/6 (0.00%)	0/5 (0.00%)
Escherichia pyelonephritis ^† 1	1/280 (0.36%)	0/276 (0.00%)	0/6 (0.00%)	0/5 (0.00%)
Gastroenteritis ^† 1	0/280 (0.00%)	2/276 (0.72%)	0/6 (0.00%)	0/5 (0.00%)
Groin abscess ^† 1	1/280 (0.36%)	0/276 (0.00%)	0/6 (0.00%)	0/5 (0.00%)
Herpes zoster oticus ^† 1	1/280 (0.36%)	0/276 (0.00%)	0/6 (0.00%)	0/5 (0.00%)
Oesophageal candidiasis ^† 1	1/280 (0.36%)	0/276 (0.00%)	0/6 (0.00%)	0/5 (0.00%)
Peritonitis ^† 1	1/280 (0.36%)	0/276 (0.00%)	0/6 (0.00%)	0/5 (0.00%)
Pneumonia ^† 1	5/280 (1.79%)	2/276 (0.72%)	0/6 (0.00%)	0/5 (0.00%)
Pneumonia legionella ^† 1	0/280 (0.00%)	1/276 (0.36%)	0/6 (0.00%)	0/5 (0.00%)
Postoperative wound infection ^† 1	0/280 (0.00%)	1/276 (0.36%)	0/6 (0.00%)	0/5 (0.00%)
Pyelonephritis ^† 1	1/280 (0.36%)	0/276 (0.00%)	0/6 (0.00%)	0/5 (0.00%)
Respiratory tract infection ^† 1	1/280 (0.36%)	0/276 (0.00%)	0/6 (0.00%)	0/5 (0.00%)
Staphylococcal abscess ^† 1	0/280 (0.00%)	1/276 (0.36%)	0/6 (0.00%)	0/5 (0.00%)
Staphylococcal infection ^† 1	1/280 (0.36%)	0/276 (0.00%)	0/6 (0.00%)	0/5 (0.00%)
Urosepsis ^† 1	1/280 (0.36%)	2/276 (0.72%)	0/6 (0.00%)	0/5 (0.00%)
Viral myocarditis ^† 1	0/280 (0.00%)	1/276 (0.36%)	0/6 (0.00%)	0/5 (0.00%)
Injury, poisoning and procedural complications
Fall ^† 1	1/280 (0.36%)	0/276 (0.00%)	0/6 (0.00%)	0/5 (0.00%)
Femoral neck fracture ^† 1	0/280 (0.00%)	1/276 (0.36%)	0/6 (0.00%)	0/5 (0.00%)
Femur fracture ^† 1	0/280 (0.00%)	1/276 (0.36%)	0/6 (0.00%)	0/5 (0.00%)
Fibula fracture ^† 1	1/280 (0.36%)	0/276 (0.00%)	0/6 (0.00%)	0/5 (0.00%)
Meniscus injury ^† 1	1/280 (0.36%)	0/276 (0.00%)	0/6 (0.00%)	0/5 (0.00%)
Poisoning ^† 1	1/280 (0.36%)	0/276 (0.00%)	0/6 (0.00%)	0/5 (0.00%)
Road traffic accident ^† 1	1/280 (0.36%)	0/276 (0.00%)	0/6 (0.00%)	0/5 (0.00%)
Seroma ^† 1	1/280 (0.36%)	0/276 (0.00%)	0/6 (0.00%)	0/5 (0.00%)
Uterine perforation ^† 1	0/280 (0.00%)	1/276 (0.36%)	0/6 (0.00%)	0/5 (0.00%)
Investigations
Blood creatine phosphokinase increased ^† 1	1/280 (0.36%)	0/276 (0.00%)	0/6 (0.00%)	0/5 (0.00%)
Transaminases increased ^† 1	0/280 (0.00%)	1/276 (0.36%)	0/6 (0.00%)	0/5 (0.00%)
Viral load increased ^† 1	1/280 (0.36%)	0/276 (0.00%)	0/6 (0.00%)	0/5 (0.00%)
Metabolism and nutrition disorders
Dehydration ^† 1	0/280 (0.00%)	1/276 (0.36%)	0/6 (0.00%)	0/5 (0.00%)
Diabetic ketoacidosis ^† 1	1/280 (0.36%)	0/276 (0.00%)	0/6 (0.00%)	0/5 (0.00%)
Hyponatraemia ^† 1	0/280 (0.00%)	1/276 (0.36%)	0/6 (0.00%)	0/5 (0.00%)
Type 2 diabetes mellitus ^† 1	2/280 (0.71%)	0/276 (0.00%)	0/6 (0.00%)	0/5 (0.00%)
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion ^† 1	1/280 (0.36%)	1/276 (0.36%)	0/6 (0.00%)	0/5 (0.00%)
Osteonecrosis ^† 1	1/280 (0.36%)	0/276 (0.00%)	0/6 (0.00%)	0/5 (0.00%)
Pathological fracture ^† 1	1/280 (0.36%)	0/276 (0.00%)	0/6 (0.00%)	0/5 (0.00%)
Rhabdomyolysis ^† 1	0/280 (0.00%)	1/276 (0.36%)	0/6 (0.00%)	0/5 (0.00%)
Rotator cuff syndrome ^† 1	0/280 (0.00%)	1/276 (0.36%)	0/6 (0.00%)	0/5 (0.00%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia ^† 1	1/280 (0.36%)	0/276 (0.00%)	0/6 (0.00%)	0/5 (0.00%)
Anal cancer ^† 1	1/280 (0.36%)	0/276 (0.00%)	0/6 (0.00%)	0/5 (0.00%)
Anogenital warts ^† 1	1/280 (0.36%)	0/276 (0.00%)	0/6 (0.00%)	0/5 (0.00%)
Bladder transitional cell carcinoma ^† 1	1/280 (0.36%)	0/276 (0.00%)	0/6 (0.00%)	0/5 (0.00%)
Choroid melanoma ^† 1	1/280 (0.36%)	0/276 (0.00%)	0/6 (0.00%)	0/5 (0.00%)
Colon cancer ^† 1	1/280 (0.36%)	0/276 (0.00%)	0/6 (0.00%)	0/5 (0.00%)
Ganglioneuroma ^† 1	1/280 (0.36%)	0/276 (0.00%)	0/6 (0.00%)	0/5 (0.00%)
Hodgkin's disease ^† 1	2/280 (0.71%)	0/276 (0.00%)	0/6 (0.00%)	0/5 (0.00%)
Lung cancer metastatic ^† 1	1/280 (0.36%)	1/276 (0.36%)	0/6 (0.00%)	0/5 (0.00%)
Ovarian cancer metastatic ^† 1	1/280 (0.36%)	0/276 (0.00%)	0/6 (0.00%)	0/5 (0.00%)
Prostate cancer ^† 1	1/280 (0.36%)	0/276 (0.00%)	0/6 (0.00%)	0/5 (0.00%)
Rectal cancer ^† 1	1/280 (0.36%)	0/276 (0.00%)	0/6 (0.00%)	0/5 (0.00%)
Nervous system disorders
Cerebral haemorrhage ^† 1	1/280 (0.36%)	0/276 (0.00%)	0/6 (0.00%)	0/5 (0.00%)
Cerebral infarction ^† 1	1/280 (0.36%)	0/276 (0.00%)	0/6 (0.00%)	0/5 (0.00%)
Epilepsy ^† 1	1/280 (0.36%)	0/276 (0.00%)	0/6 (0.00%)	0/5 (0.00%)
Hydrocephalus ^† 1	1/280 (0.36%)	0/276 (0.00%)	0/6 (0.00%)	0/5 (0.00%)
Loss of consciousness ^† 1	1/280 (0.36%)	0/276 (0.00%)	0/6 (0.00%)	0/5 (0.00%)
Metabolic encephalopathy ^† 1	1/280 (0.36%)	0/276 (0.00%)	0/6 (0.00%)	0/5 (0.00%)
Presyncope ^† 1	1/280 (0.36%)	0/276 (0.00%)	0/6 (0.00%)	0/5 (0.00%)
Seizure ^† 1	1/280 (0.36%)	0/276 (0.00%)	0/6 (0.00%)	0/5 (0.00%)
Transient ischaemic attack ^† 1	1/280 (0.36%)	0/276 (0.00%)	0/6 (0.00%)	0/5 (0.00%)
Psychiatric disorders
Alcohol abuse ^† 1	0/280 (0.00%)	1/276 (0.36%)	0/6 (0.00%)	0/5 (0.00%)
Bipolar disorder ^† 1	1/280 (0.36%)	0/276 (0.00%)	0/6 (0.00%)	0/5 (0.00%)
Depression ^† 1	0/280 (0.00%)	1/276 (0.36%)	0/6 (0.00%)	0/5 (0.00%)
Drug abuse ^† 1	1/280 (0.36%)	0/276 (0.00%)	0/6 (0.00%)	0/5 (0.00%)
Intentional self-injury ^† 1	0/280 (0.00%)	1/276 (0.36%)	0/6 (0.00%)	0/5 (0.00%)
Psychotic disorder ^† 1	1/280 (0.36%)	1/276 (0.36%)	0/6 (0.00%)	0/5 (0.00%)
Schizophrenia ^† 1	0/280 (0.00%)	1/276 (0.36%)	0/6 (0.00%)	0/5 (0.00%)
Substance abuse ^† 1	1/280 (0.36%)	0/276 (0.00%)	0/6 (0.00%)	0/5 (0.00%)
Suicide attempt ^† 1	2/280 (0.71%)	1/276 (0.36%)	0/6 (0.00%)	0/5 (0.00%)
Renal and urinary disorders
Acute kidney injury ^† 1	3/280 (1.07%)	0/276 (0.00%)	0/6 (0.00%)	0/5 (0.00%)
Nephrolithiasis ^† 1	1/280 (0.36%)	0/276 (0.00%)	0/6 (0.00%)	0/5 (0.00%)
Renal colic ^† 1	1/280 (0.36%)	0/276 (0.00%)	0/6 (0.00%)	0/5 (0.00%)
Reproductive system and breast disorders
Benign prostatic hyperplasia ^† 1	0/280 (0.00%)	1/276 (0.36%)	0/6 (0.00%)	0/5 (0.00%)
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration ^† 1	1/280 (0.36%)	0/276 (0.00%)	0/6 (0.00%)	0/5 (0.00%)
Pulmonary embolism ^† 1	0/280 (0.00%)	3/276 (1.09%)	0/6 (0.00%)	0/5 (0.00%)
Social circumstances
Substance use ^† 1	1/280 (0.36%)	0/276 (0.00%)	0/6 (0.00%)	0/5 (0.00%)
Vascular disorders
Deep vein thrombosis ^† 1	2/280 (0.71%)	3/276 (1.09%)	0/6 (0.00%)	0/5 (0.00%)
Hypertension ^† 1	1/280 (0.36%)	0/276 (0.00%)	0/6 (0.00%)	0/5 (0.00%)
1 Term from vocabulary, MedDRA 21.1 † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	F/TAF (Double-Blind Phase)	ABC/3TC (Double-Blind Phase)	Open-Label F/TAF From F/TAF	Open-Label F/TAF From ABC/3TC
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	190/280 (67.86%)	199/276 (72.10%)	1/6 (16.67%)	2/5 (40.00%)
Gastrointestinal disorders
Diarrhoea ^† 1	30/280 (10.71%)	37/276 (13.41%)	0/6 (0.00%)	0/5 (0.00%)
Nausea ^† 1	14/280 (5.00%)	11/276 (3.99%)	0/6 (0.00%)	0/5 (0.00%)
Vomiting ^† 1	14/280 (5.00%)	10/276 (3.62%)	0/6 (0.00%)	0/5 (0.00%)
General disorders
Fatigue ^† 1	21/280 (7.50%)	15/276 (5.43%)	0/6 (0.00%)	0/5 (0.00%)
Infections and infestations
Bronchitis ^† 1	19/280 (6.79%)	14/276 (5.07%)	0/6 (0.00%)	0/5 (0.00%)
Gastroenteritis ^† 1	11/280 (3.93%)	15/276 (5.43%)	0/6 (0.00%)	0/5 (0.00%)
Influenza ^† 1	12/280 (4.29%)	15/276 (5.43%)	0/6 (0.00%)	0/5 (0.00%)
Nasopharyngitis ^† 1	57/280 (20.36%)	49/276 (17.75%)	0/6 (0.00%)	1/5 (20.00%)
Rhinitis ^† 1	7/280 (2.50%)	6/276 (2.17%)	0/6 (0.00%)	1/5 (20.00%)
Syphilis ^† 1	15/280 (5.36%)	5/276 (1.81%)	0/6 (0.00%)	0/5 (0.00%)
Upper respiratory tract infection ^† 1	36/280 (12.86%)	46/276 (16.67%)	0/6 (0.00%)	0/5 (0.00%)
Urinary tract infection ^† 1	13/280 (4.64%)	18/276 (6.52%)	0/6 (0.00%)	0/5 (0.00%)
Musculoskeletal and connective tissue disorders
Arthralgia ^† 1	28/280 (10.00%)	29/276 (10.51%)	0/6 (0.00%)	0/5 (0.00%)
Back pain ^† 1	24/280 (8.57%)	31/276 (11.23%)	0/6 (0.00%)	0/5 (0.00%)
Musculoskeletal pain ^† 1	11/280 (3.93%)	14/276 (5.07%)	0/6 (0.00%)	0/5 (0.00%)
Pain in extremity ^† 1	22/280 (7.86%)	15/276 (5.43%)	0/6 (0.00%)	0/5 (0.00%)
Spinal pain ^† 1	0/280 (0.00%)	1/276 (0.36%)	1/6 (16.67%)	0/5 (0.00%)
Nervous system disorders
Headache ^† 1	31/280 (11.07%)	25/276 (9.06%)	0/6 (0.00%)	0/5 (0.00%)
Renal and urinary disorders
Renal colic ^† 1	1/280 (0.36%)	0/276 (0.00%)	0/6 (0.00%)	1/5 (20.00%)
Respiratory, thoracic and mediastinal disorders
Cough ^† 1	34/280 (12.14%)	30/276 (10.87%)	0/6 (0.00%)	0/5 (0.00%)
Skin and subcutaneous tissue disorders
Rash ^† 1	14/280 (5.00%)	17/276 (6.16%)	0/6 (0.00%)	0/5 (0.00%)
Vascular disorders
Hypertension ^† 1	15/280 (5.36%)	15/276 (5.43%)	0/6 (0.00%)	0/5 (0.00%)
1 Term from vocabulary, MedDRA 21.1 † Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:

The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or
The study has been completed at all study sites for at least 2 years

Results Point of Contact

Layout table for Results Point of Contact information

Name/Title:	Gilead Clinical Study Information Center
Organization:	Gilead Sciences
Phone:	1-833-445-3230 (GILEAD-0)
EMail:	GileadClinicalTrials@gilead.com

Publications of Results:

Winston A, Post FA, DeJesus E, Podzamczer D, Di Perri G, Estrada V, Raffi F, Ruane P, Peyrani P, Crofoot G, Mallon PWG, Castelli F, Yan M, Cox S, Das M, Cheng A, Rhee MS. Tenofovir alafenamide plus emtricitabine versus abacavir plus lamivudine for treatment of virologically suppressed HIV-1-infected adults: a randomised, double-blind, active-controlled, non-inferiority phase 3 trial. Lancet HIV. 2018 Apr;5(4):e162-e171. doi: 10.1016/S2352-3018(18)30010-9. Epub 2018 Feb 20.

Gupta SK, Post FA, Arribas JR, Eron JJ Jr, Wohl DA, Clarke AE, Sax PE, Stellbrink HJ, Esser S, Pozniak AL, Podzamczer D, Waters L, Orkin C, Rockstroh JK, Mudrikova T, Negredo E, Elion RA, Guo S, Zhong L, Carter C, Martin H, Brainard D, SenGupta D, Das M. Renal safety of tenofovir alafenamide vs. tenofovir disoproxil fumarate: a pooled analysis of 26 clinical trials. AIDS. 2019 Jul 15;33(9):1455-1465. doi: 10.1097/QAD.0000000000002223.

Layout table for additonal information

Responsible Party:	Gilead Sciences
ClinicalTrials.gov Identifier:	NCT02469246 History of Changes
Other Study ID Numbers:	GS-US-311-1717 2015-000871-28 ( EudraCT Number )
First Submitted:	June 9, 2015
First Posted:	June 11, 2015
Results First Submitted:	March 29, 2018
Results First Posted:	June 11, 2018
Last Update Posted:	October 25, 2019

To Top