Safety and Efficacy of Switching to a FDC of B/F/TAF From E/C/F/TAF, E/C/F/TDF, or ATV+RTV+FTC/TDF in Virologically Suppressed HIV-1 Infected Women

• Sponsor: Gilead Sciences (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02652624
• Collaborator: (none)
• Enrollment: 472
• Locations: 56
• Arms: 3
• Actual Duration (Months): 33.2
• Patients Per Site: 8.4
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

The primary objective of this study is to evaluate the efficacy of switching to a fixed-dose combination (FDC) of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus continuing on a regimen consisting of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF), elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF), or atazanavir (ATV) + ritonavir (RTV) + emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) in virologically suppressed HIV-1 infected women.

Condition or Disease	Intervention/Treatment	Phase
HIV-1 Infection	Drug: E/C/F/TAF; Drug: E/C/F/TDF; Drug: ATV; Drug: RTV; Drug: FTC/TDF; Drug: B/F/TAF	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 472 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 3, Randomized, Open Label Study to Evaluate the Safety and Efficacy of Switching to a Fixed Dose Combination (FDC) of GS-9883/Emtricitabine/Tenofovir Alafenamide (GS-9883/F/TAF) From Elvitegravir/Cobicistat/Emtricitabine/ Tenofovir Alafenamide (E/C/F/TAF), Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate (E/C/F/TDF) or Atazanavir + Ritonavir + Emtricitabine/Tenofovir Disoproxil Fumarate (ATV+RTV+FTC/TDF) in Virologically Suppressed HIV-1 Infected Women
• Actual Study Start Date: Feb 19, 2016
• Actual Primary Completion Date: Oct 9, 2017
• Actual Study Completion Date: Nov 26, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: B/F/TAF Participants will switch to B/F/TAF FDC and receive treatment for 48 weeks.	Drug: B/F/TAF; 50/200/25 mg FDC tablet administered orally once daily without regard to food; Other Names: Biktarvy®
Active Comparator: Baseline Regimen Participants will remain on their baseline regimen of E/C/F/TAF, E/C/F/TDF, or ATV+RTV+FTC/TDF for 48 weeks.	Drug: E/C/F/TAF; 150/150/200/10 mg FDC tablet administered orally once daily with food; Other Names: Genvoya® ; Drug: E/C/F/TDF; 150/150/200/300 mg FDC administered orally once daily with food; Other Names: Stribild® ; Drug: ATV; ATV 300 mg capsules administered orally once daily with food; Other Names: Reyataz® ; Drug: RTV; RTV 100 mg tablets administered orally once daily with food; Other Names: Norvir® ; Drug: FTC/TDF; 200/300 mg tablet administered orally once daily with food; Other Names: Truvada®
Experimental: Extension Phase Following Week 48, participants in countries where B/F/TAF is not available may have the option to receive B/F/TAF for up to 48 additional weeks.	Drug: B/F/TAF; 50/200/25 mg FDC tablet administered orally once daily without regard to food; Other Names: Biktarvy®

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 48 as Determined by the US FDA-Defined Snapshot Algorithm [Week 48]

   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.

Secondary Outcome Measures

1. Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Determined by the US FDA-Defined Snapshot Algorithm [Week 48]

   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.

2. Change From Baseline in CD4+ Cell Count at Week 48 [Baseline; Week 48]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Key Inclusion Criteria

Medically stable HIV-1 infected women who meet the following criteria:

• Completion of the Week 48 open-label extension (OLE) visit or any post Week 48 OLE visits in Gilead-sponsored study GS-US-236-0128, or Completion of the Week 96 visit or any post Week 96 visits in Gilead-sponsored study GS-US-292-0109 or completion of the Week 144 visit or any post Week 144 visits in Gilead sponsored studies GS-US-292-0104 or GS-US-292-0111.

• Currently on a stable antiretroviral regimen consisting of E/C/F/TAF, E/C/F/TDF, or ATV+RTV+FTC/TDF continuously for ≥ 12 consecutive weeks preceding the Screening visit

• Documented plasma HIV-1 RNA levels < 50 copies/mL for ≥ 12 weeks preceding the Screening visit. After reaching HIV-1 RNA < 50 copies/mL, single values of HIV-1 RNA

≥ 50 copies/mL followed by re-suppression to < 50 copies/mL is allowed

• HIV-1 RNA <50 copies/mL at screening

• Estimated glomerular filtration rate (eGFR) ≥ 50 mL/min (≥ 0.83 mL/sec) according to the Cockcroft-Gault formula at the Screening visit

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Stamford	Connecticut	United States	6902
2		Washington	District of Columbia	United States	20009
3		Washington	District of Columbia	United States	20037
4		Fort Lauderdale	Florida	United States	33308
5		Fort Pierce	Florida	United States	34982
6		Miami	Florida	United States	33133
7		Miami	Florida	United States	33136
8		Orlando	Florida	United States	32803-1851
9		Tampa	Florida	United States	33607
10		Tampa	Florida	United States	33614
11		West Palm Beach	Florida	United States	33401
12		Atlanta	Georgia	United States	30308
13		Decatur	Georgia	United States	30033
14		Macon	Georgia	United States	31201
15		Savannah	Georgia	United States	31401
16		Springfield	Massachusetts	United States	01105
17		Saint Louis	Missouri	United States	63110
18		Newark	New Jersey	United States	07102
19		Bronx	New York	United States	10467
20		Great Neck	New York	United States	11021
21		Charlotte	North Carolina	United States	28207
22		Durham	North Carolina	United States	27710
23		Huntersville	North Carolina	United States	28078
24		Bellaire	Texas	United States	77401
25		Dallas	Texas	United States	75208
26		Dallas	Texas	United States	75219
27		Fort Worth	Texas	United States	76104
28		Harlingen	Texas	United States	78550
29		Houston	Texas	United States	77004
30		Santo Domingo		Dominican Republic	10514
31		Santo Domingo		Dominican Republic
32		San Juan		Puerto Rico	00909-1711
33		Barnaul		Russian Federation	656010
34		Ekaterinburg		Russian Federation	620102
35		Irkutsk		Russian Federation	664043
36		Khabarovsk		Russian Federation	680031
37		Koltsovo		Russian Federation	630559
38		Krasnodar		Russian Federation	350015
39		Krasnoyarsk		Russian Federation	660049
40		Lipetsk		Russian Federation	398043
41		Moscow		Russian Federation	105275
42		Moscow		Russian Federation	129110
43		Nizhniy Novgorod		Russian Federation	603950
44		Saint Petersburg		Russian Federation	190103
45		Saint Petersburg		Russian Federation	196645
46		Saint-Petersberg		Russian Federation	190020
47		Saint-Petersburg		Russian Federation	191167
48		Volgograd		Russian Federation	400010
49		Voronezh		Russian Federation	394065
50		Bangkok		Thailand	10330
51		Bangkok		Thailand	10400
52		Bangkok		Thailand	10700
53		Chiang Mai		Thailand	50200
54		Khon Kaen		Thailand	40002
55		Nonthaburi		Thailand	11000
56		Kampala		Uganda

Sponsors and Collaborators

• Gilead Sciences

Investigators

• Study Director: Gilead Study Director, Gilead Sciences

Study Documents (Full-Text)

• Study Protocol: Original - Nov 20, 2015
• Study Protocol: Amendment 1 - Jun 30, 2016
• Study Protocol: Amendment 2 - Nov 10, 2016
• Statistical Analysis Plan: Week 48 Statistical Analysis Plan - Oct 19, 2017
• Statistical Analysis Plan: Final Statistical Analysis Plan - Dec 21, 2018

More Information

Publications

None provided.

• Responsible Party: Gilead Sciences
• ClinicalTrials.gov Identifier: NCT02652624
• Other Study ID Numbers: GS-US-380-1961
• First Posted: Jan 12, 2016
• Last Update Posted: Mar 4, 2020
• Last Verified: Nov 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination

Study Results

Participant Flow

Recruitment Details	Participants were enrolled at study sites in the United States, Russian Federation, Thailand, Dominican Republic, and Uganda. The first participant was screened on 19 February 2016. The last study visit occurred on 26 November 2018.
Pre-assignment Detail	491 participants were screened.

Arm/Group Title	B/F/TAF	Stay on Baseline Regimen (SBR)
Arm/Group Description	Randomized Phase: Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) (50/200/25 mg) fixed-dose combination (FDC) tablet once daily for at least 48 weeks, without regard to food. Extension Phase: After Week 48, participants in countries where B/F/TAF was not available were given the option to receive B/F/TAF (50/200/25 mg) FDC tablet once daily for up to 48 additional weeks, or until the product became accessible to participants through an access program, or until Gilead elected to discontinue the study in that country, whichever occurred first.	Randomized Phase: Participants remained on their baseline regimen of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) tablet, elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF) (150/150/200/300 mg) tablet, or atazanavir (ATV) 300 mg capsule + ritonavir (RTV) 100 mg tablet + emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300 mg) tablet for at least 48 weeks with food. Extension Phase: After Week 48, participants in countries where B/F/TAF was not available were given the option to receive B/F/TAF (50/200/25 mg) FDC tablet once daily for up to 48 additional weeks, or until the product became accessible to participants through an access program, or until Gilead elected to discontinue the study in that country, whichever occurred first.
Period Title: Randomized Phase
STARTED	234	236
COMPLETED	231	231
NOT COMPLETED	3	5
Period Title: Randomized Phase
STARTED	231	228
COMPLETED	227	224
NOT COMPLETED	4	4

Baseline Characteristics

Arm/Group Title	B/F/TAF	Stay on Baseline Regimen	Total
Arm/Group Description	B/F/TAF (50/200/25 mg) FDC tablet once daily without regard to food for 48 weeks.	Participants remained on their baseline regimen of E/C/F/TAF (150/150/200/10 mg) tablet, E/C/F/TDF (150/150/200/300 mg) tablet, or ATV 300 mg capsule + RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet for 48 weeks.	Total of all reporting groups
Overall Participants	234	236	470
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	40 (9.5)	40 (9.1)	40 (9.3)
Sex: Female, Male (Count of Participants)
Female	234 100%	236 100%	470 100%
Male	0 0%	0 0%	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	36 15.4%	38 16.1%	74 15.7%
Not Hispanic or Latino	198 84.6%	198 83.9%	396 84.3%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race/Ethnicity, Customized (Count of Participants)
Asian	48 20.5%	54 22.9%	102 21.7%
Black	91 38.9%	83 35.2%	174 37%
White	66 28.2%	67 28.4%	133 28.3%
Other	29 12.4%	32 13.6%	61 13%
Region of Enrollment (Count of Participants)
United States	36 15.4%	36 15.3%	72 15.3%
Dominican Republic	28 12%	30 12.7%	58 12.3%
Uganda	65 27.8%	62 26.3%	127 27%
Thailand	47 20.1%	54 22.9%	101 21.5%
Russia	58 24.8%	54 22.9%	112 23.8%
HIV-1 RNA Category (Count of Participants)
< 50 copies/mL	234 100%	233 98.7%	467 99.4%
≥ 50 copies/mL	0 0%	3 1.3%	3 0.6%
CD4 Cell Count (cells/µL) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [cells/µL]	712 (268.1)	738 (268.4)	725 (268.3)
CD4 Cell Count Category (Count of Participants)
≥ 50 to < 200 cells/µL	1 0.4%	1 0.4%	2 0.4%
≥ 200 to < 350 cells/µL	10 4.3%	9 3.8%	19 4%
≥ 350 to < 500 cells/µL	33 14.1%	25 10.6%	58 12.3%
≥ 500 cells/µL	190 81.2%	201 85.2%	391 83.2%
Prior Antiretroviral (ARV) Regimen (Count of Participants)
E/C/F/TAF	124 53%	125 53%	249 53%
E/C/F/TDF	99 42.3%	98 41.5%	197 41.9%
RTV + ATV + FTC/TDF	11 4.7%	13 5.5%	24 5.1%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 48 as Determined by the US FDA-Defined Snapshot Algorithm
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

The Full Analysis Set included participants who were randomized and received at least 1 dose of study drug.

Arm/Group Title	B/F/TAF	Stay on Baseline Regimen
Arm/Group Description	B/F/TAF (50/200/25 mg) FDC tablet once daily without regard to food for 48 weeks.	Participants remained on their baseline regimen of E/C/F/TAF (150/150/200/10 mg) tablet, E/C/F/TDF (150/150/200/300 mg) tablet, or ATV 300 mg capsule + RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet for 48 weeks.
Measure Participants	234	236
Number [percentage of participants]	1.7 0.7%	1.7 0.7%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	B/F/TAF, Stay on Baseline Regimen
	Comments	The null hypothesis was that the percentage of participants with HIV-1 RNA ≥ 50 copies/mL at Week 48 in the B/F/TAF group was at least 4% higher than the rate in the SBR group; the alternative hypothesis was that the percentage of participants with HIV-1 RNA ≥ 50 copies/mL in the B/F/TAF group was less than 4% higher than that in the SBR group.
	Type of Statistical Test	Non-Inferiority
	Comments	A sample size of 470 participants (~235 participants per treatment group) would provide at least 87% power to detect a non-inferiority margin of 4% difference in the percentage of participants with HIV-1 RNA ≥ 50 copies/mL at Week 48 between the 2 treatment groups. This was based on the assumptions that both treatment groups have 2% of participants with HIV-1 RNA ≥ 50 copies/mL (based on Gilead Genvoya and Stribild studies) and that the significance level of the test is at a 1-sided 0.025 level.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference in percentages
	Estimated Value	0.0
	Confidence Interval	(2-Sided) 95.001%; -2.9 to 2.9
	Parameter Dispersion	Type: Value:
	Estimation Comments	The difference in percentages between treatment groups and their 95.001% confidence intervals (CI) were calculated based on an unconditional exact method using 2 inverted 1-sided tests.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	B/F/TAF, Stay on Baseline Regimen
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	1.00
	Comments
	Method	Fisher Exact
	Comments

2. Secondary Outcome

Title	Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Determined by the US FDA-Defined Snapshot Algorithm
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	B/F/TAF	Stay on Baseline Regimen
Arm/Group Description	B/F/TAF (50/200/25 mg) FDC tablet once daily without regard to food for 48 weeks.	Participants remained on their baseline regimen of E/C/F/TAF (150/150/200/10 mg) tablet, E/C/F/TDF (150/150/200/300 mg) tablet, or ATV 300 mg capsule + RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet for 48 weeks.
Measure Participants	234	236
Number [percentage of participants]	95.7 40.9%	95.3 40.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	B/F/TAF, Stay on Baseline Regimen
	Comments
	Type of Statistical Test	Non-Inferiority
	Comments	The non-inferiority of B/F/TAF would be established if the lower bound of the 2-sided 95.001% CI of the difference between the treatment groups (B/F/TAF group - SBR group) in the percentage of participants with HIV-1 RNA < 50 copies/mL is greater than -10%.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference in percentages
	Estimated Value	0.4
	Confidence Interval	(2-Sided) 95.001%; -3.7 to 4.5
	Parameter Dispersion	Type: Value:
	Estimation Comments	The difference in percentages between treatment groups and their 95.001% CIs were calculated based on an unconditional exact method using 2 inverted 1-sided tests.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	B/F/TAF, Stay on Baseline Regimen
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	1.00
	Comments
	Method	Fisher Exact
	Comments

3. Secondary Outcome

Title	Change From Baseline in CD4+ Cell Count at Week 48
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	B/F/TAF	Stay on Baseline Regimen
Arm/Group Description	B/F/TAF (50/200/25 mg) FDC tablet once daily without regard to food for 48 weeks.	Participants remained on their baseline regimen of E/C/F/TAF (150/150/200/10 mg) tablet, E/C/F/TDF (150/150/200/300 mg) tablet, or ATV 300 mg capsule + RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet for 48 weeks.
Measure Participants	225	225
Mean (Standard Deviation) [cells/µL]	29 (159.4)	26 (170.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	B/F/TAF, Stay on Baseline Regimen
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.84
	Comments
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	Difference in least square means
	Estimated Value	3
	Confidence Interval	(2-Sided) 95%; -27 to 34
	Parameter Dispersion	Type: Value:
	Estimation Comments	Difference in least squares means and its 95% CI were from ANOVA model with treatment group as a fixed effect in the model.

Adverse Events

Time Frame	First dose date to last dose date (maximum duration: 128.4 weeks) plus 30 days
Adverse Event Reporting Description	The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
Arm/Group Title	B/F/TAF (Randomized Phase)		Stay on Baseline Regimen (Randomized Phase)		Extension Phase B/F/TAF From B/F/TAF		Extension Phase B/F/TAF From Stay on Baseline Regimen
Arm/Group Description	Adverse events reported occurred during the Randomized Phase in participants from the B/F/TAF group, who received B/F/TAF (50/200/25 mg) FDC tablet once daily without regard to food for 48 weeks.		Adverse events reported occurred during the Randomized Phase in participants from the SBR group, who remained on their baseline regimen of E/C/F/TAF (150/150/200/10 mg) tablet, E/C/F/TDF (150/150/200/300 mg) tablet, or ATV 300 mg capsule + RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet for 48 weeks.		Adverse events reported occurred during the Extension Phase in participants who enrolled into the Extension Phase from the B/F/TAF group and received B/F/TAF (50/200/25 mg) FDC tablet for up to 48 additional weeks, or until the product became accessible to participants through an access program, or until Gilead elected to discontinue the study in that country, whichever occurred first.		Adverse events reported occurred during the Extension Phase in participants who enrolled into the Extension Phase from the SBR group and received B/F/TAF (50/200/25 mg) FDC tablet for up to 48 additional weeks, or until the product became accessible to participants through an access program, or until Gilead elected to discontinue the study in that country, whichever occurred first.
All Cause Mortality
	B/F/TAF (Randomized Phase)		Stay on Baseline Regimen (Randomized Phase)		Extension Phase B/F/TAF From B/F/TAF		Extension Phase B/F/TAF From Stay on Baseline Regimen
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/234 (0%)		0/236 (0%)		0/231 (0%)		1/228 (0.4%)
Serious Adverse Events
	B/F/TAF (Randomized Phase)		Stay on Baseline Regimen (Randomized Phase)		Extension Phase B/F/TAF From B/F/TAF		Extension Phase B/F/TAF From Stay on Baseline Regimen
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	7/234 (3%)		9/236 (3.8%)		8/231 (3.5%)		10/228 (4.4%)
Cardiac disorders
Acute myocardial infarction	0/234 (0%)		0/236 (0%)		0/231 (0%)		1/228 (0.4%)
Angina pectoris	0/234 (0%)		0/236 (0%)		1/231 (0.4%)		0/228 (0%)
Supraventricular tachycardia	0/234 (0%)		0/236 (0%)		1/231 (0.4%)		0/228 (0%)
Congenital, familial and genetic disorders
Urachal abnormality	0/234 (0%)		0/236 (0%)		1/231 (0.4%)		0/228 (0%)
Gastrointestinal disorders
Colitis	0/234 (0%)		2/236 (0.8%)		0/231 (0%)		0/228 (0%)
General disorders
Non-cardiac chest pain	0/234 (0%)		0/236 (0%)		0/231 (0%)		1/228 (0.4%)
Hepatobiliary disorders
Cholecystitis acute	0/234 (0%)		0/236 (0%)		0/231 (0%)		1/228 (0.4%)
Hepatitis	1/234 (0.4%)		0/236 (0%)		0/231 (0%)		0/228 (0%)
Infections and infestations
Abdominal wall abscess	0/234 (0%)		1/236 (0.4%)		0/231 (0%)		0/228 (0%)
Diverticulitis	1/234 (0.4%)		0/236 (0%)		1/231 (0.4%)		0/228 (0%)
Influenza	0/234 (0%)		1/236 (0.4%)		0/231 (0%)		0/228 (0%)
Malaria	1/234 (0.4%)		1/236 (0.4%)		0/231 (0%)		0/228 (0%)
Pneumonia	1/234 (0.4%)		1/236 (0.4%)		0/231 (0%)		0/228 (0%)
Pyelonephritis acute	0/234 (0%)		0/236 (0%)		1/231 (0.4%)		0/228 (0%)
Salpingo-oophoritis	1/234 (0.4%)		0/236 (0%)		0/231 (0%)		0/228 (0%)
Viral infection	0/234 (0%)		0/236 (0%)		0/231 (0%)		1/228 (0.4%)
Injury, poisoning and procedural complications
Joint dislocation	0/234 (0%)		0/236 (0%)		0/231 (0%)		1/228 (0.4%)
Metabolism and nutrition disorders
Hyperglycaemia	0/234 (0%)		0/236 (0%)		0/231 (0%)		1/228 (0.4%)
Musculoskeletal and connective tissue disorders
Osteoarthritis	0/234 (0%)		1/236 (0.4%)		0/231 (0%)		1/228 (0.4%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer	0/234 (0%)		0/236 (0%)		0/231 (0%)		1/228 (0.4%)
Invasive ductal breast carcinoma	0/234 (0%)		0/236 (0%)		1/231 (0.4%)		0/228 (0%)
Metastases to liver	0/234 (0%)		0/236 (0%)		1/231 (0.4%)		0/228 (0%)
Nervous system disorders
Headache	1/234 (0.4%)		0/236 (0%)		0/231 (0%)		0/228 (0%)
Migraine	0/234 (0%)		1/236 (0.4%)		0/231 (0%)		0/228 (0%)
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous	0/234 (0%)		1/236 (0.4%)		0/231 (0%)		0/228 (0%)
Foetal death	0/234 (0%)		0/236 (0%)		0/231 (0%)		1/228 (0.4%)
Retained products of conception	1/234 (0.4%)		0/236 (0%)		0/231 (0%)		0/228 (0%)
Product Issues
Device issue	1/234 (0.4%)		0/236 (0%)		0/231 (0%)		0/228 (0%)
Psychiatric disorders
Depression	0/234 (0%)		0/236 (0%)		0/231 (0%)		1/228 (0.4%)
Suicide attempt	0/234 (0%)		0/236 (0%)		1/231 (0.4%)		0/228 (0%)
Respiratory, thoracic and mediastinal disorders
Pneumothorax spontaneous	0/234 (0%)		0/236 (0%)		0/231 (0%)		1/228 (0.4%)
Pulmonary embolism	0/234 (0%)		0/236 (0%)		0/231 (0%)		1/228 (0.4%)
Social circumstances
Substance use	0/234 (0%)		0/236 (0%)		1/231 (0.4%)		0/228 (0%)
Vascular disorders
Hypertensive crisis	0/234 (0%)		0/236 (0%)		1/231 (0.4%)		0/228 (0%)
Other (Not Including Serious) Adverse Events
	B/F/TAF (Randomized Phase)		Stay on Baseline Regimen (Randomized Phase)		Extension Phase B/F/TAF From B/F/TAF		Extension Phase B/F/TAF From Stay on Baseline Regimen
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	61/234 (26.1%)		47/236 (19.9%)		52/231 (22.5%)		41/228 (18%)
Infections and infestations
Nasopharyngitis	18/234 (7.7%)		15/236 (6.4%)		19/231 (8.2%)		13/228 (5.7%)
Upper respiratory tract infection	15/234 (6.4%)		14/236 (5.9%)		19/231 (8.2%)		15/228 (6.6%)
Urinary tract infection	16/234 (6.8%)		4/236 (1.7%)		8/231 (3.5%)		5/228 (2.2%)
Vulvovaginal candidiasis	12/234 (5.1%)		9/236 (3.8%)		9/231 (3.9%)		9/228 (3.9%)
Nervous system disorders
Headache	12/234 (5.1%)		13/236 (5.5%)		13/231 (5.6%)		8/228 (3.5%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

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