Safety and Efficacy of Bictegravir + Emtricitabine/Tenofo... | NCT02397694

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
BIC + F/TAF	Experimental	Participants will receive BIC + F/TAF FDC + DTG placebo for 48 weeks. Following Week 48, participants will continue to take their blinded treatment and attend visits every 12 weeks until treatment assignments have been unblinded. Participants will return for an unblinding visit and be given the option to participate in an open-label rollover extension and receive bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) until it becomes commercially available, or until Gilead Sciences elects to terminate the development of BIC/F/TAF.	Drug: BIC Drug: F/TAF Drug: DTG Placebo Drug: B/F/TAF
DTG + F/TAF	Active Comparator	Participants will receive DTG + F/TAF FDC + BIC placebo for 48 weeks. Following Week 48, participants will continue to take their blinded treatment and attend visits every 12 weeks until treatment assignments have been unblinded. Participants will return for an unblinding visit and be given the option to participate in an open-label rollover extension and receive B/F/TAF until it becomes commercially available, or until Gilead Sciences elects to terminate the development of BIC/F/TAF.	Drug: F/TAF Drug: DTG Drug: BIC Placebo Drug: B/F/TAF
Open Label Extension Phase	Experimental	After Week 48 participants continued to take their randomized study drug and attended visits every 12 weeks until treatment assignments were unblinded, at which point all participants returned for an unblinding visit and were given the option to participate in an open-label rollover extension to receive an FDC containing B/F/TAF.	Drug: B/F/TAF

Name	Type	Description	Arm Group Labels	Other Names
BIC	Drug	75 mg tablet administered orally once daily	BIC + F/TAF	GS-9883

Measure	Description	Time Frame
Percentage of Participants With HIV-1 RNA < 50 Copies/mL as Determined by the FDA-defined Snapshot Algorithm.	The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 24 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.	Week 24

Measure	Description	Time Frame
Percentage of Participants With HIV-1 RNA < 50 Copies/mL as Determined by the FDA-defined Snapshot Algorithm at Week 12	The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 12 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.

Eligibility Module

Name	Affiliation	Role
Gilead Study Director	Gilead Sciences	Study Director

PubMed Identifier	Type	Citation	Retractions
28219610	Result	Sax PE, DeJesus E, Crofoot G, Ward D, Benson P, Dretler R, Mills A, Brinson C, Peloquin J, Wei X, White K, Cheng A, Martin H, Quirk E. Bictegravir versus dolutegravir, each with emtricitabine and tenofovir alafenamide, for initial treatment of HIV-1 infection: a randomised, double-blind, phase 2 trial. Lancet HIV. 2017 Apr;4(4):e154-e160. doi: 10.1016/S2352-3018(17)30016-4. Epub 2017 Feb 15.
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Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	BIC + F/TAF	Bictegravir (BIC) (75 mg) + emtricitabine/tenofovir alafenamide (F/TAF) (200/25 mg) fixed-dose combination (FDC) + dolutegravir (DTG) placebo tablets orally once daily for 48 weeks. After Week 48 participants continued to take their randomized study drug and attended visits every 12 weeks until treatment assignments were unblinded, at which point all participants returned for an unblinding visit and were given the option to participate in an open-label rollover extension to receive an FDC containing B/F/TAF (50/200/25 mg).

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00034± 11.4 BG00138± 12.9 BG00235± 12.1

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0001 BG0013 BG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0001 BG0010 BG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG00011 BG0014 BG002

HIV-1 RNA

Mean

Standard Deviation

log10 copies/mL

Title

Denominators

Categories

Title	Measurements
	BG0004.39± 0.764 BG0014.38± 0.866 BG002

HIV-1 RNA category

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
≤ 100,000 copies/mL	BG00055 BG00126 BG002

CD4 Cell Count

Mean

Standard Deviation

cells/μL

Title

Denominators

Categories

Title	Measurements
	BG000471± 190.9 BG001507± 271.0 BG002

CD4 Cell Count Category

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
< 200 cells/μL	BG0003 BG0013 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percentage of Participants With HIV-1 RNA < 50 Copies/mL as Determined by the FDA-defined Snapshot Algorithm.

The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 24 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.

Full Analysis Set included all participants who were randomized into the double-blinded phase of study and received at least 1 dose of study drug during the double-blinded phase.

Posted

Number

percentage of participants

Week 24

ID	Title	Description
OG000	BIC + F/TAF	BIC 75 mg + F/TAF (200/25 mg) FDC + DTG placebo tablets orally once daily for 48 weeks. After Week 48 participants continued to take their randomized study drug and attended visits every 12 weeks until treatment assignments were unblinded, at which point all participants returned for an unblinding visit and were given the option to participate in an open-label rollover extension to receive an FDC containing B/F/TAF (50/200/25 mg).
OG001	DTG + F/TAF	DTG 50 mg + F/TAF (200/25 mg) FDC + BIC placebo tablets orally once daily. After Week 48 participants continued to take their randomized study drug and attended visits every 12 weeks until treatment assignments were unblinded, at which point all participants returned for an unblinding visit and were given the option to participate in an open-label rollover extension to receive an FDC containing B/F/TAF (200/50/25 mg).

Units	Counts
Participants	OG00065 OG00133

Title

Denominators

Categories

Title	Measurements
	OG00096.9 OG00193.9

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Cochran-Mantel-Haenszel	Cochran-Mantel Haenszel test stratified by baseline HIV-1 RNA stratum (≤ 100,000 copies/mL vs > 100,000 copies/mL).	0.5		Difference in percentages	2.9			2-Sided	95	-8.5	14.2					Non-Inferiority	Noninferiority of treatment with BIC + F/TAF relative to treatment with DTG + F/TAF. Noninferiority assessed using a conventional 95% confidence interval (CI) approach, with a noninferiority margin of 12%

Secondary

Percentage of Participants With HIV-1 RNA < 50 Copies/mL as Determined by the FDA-defined Snapshot Algorithm at Week 12

The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 12 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.

Participants in the Full Analysis Set were analyzed.

Posted

Number

percentage of participants

Week 12

ID	Title	Description
OG000	BIC + F/TAF	BIC 75 mg + F/TAF (200/25 mg) FDC + DTG placebo tablets orally once daily for 48 weeks. After Week 48 participants continued to take their randomized study drug and attended visits every 12 weeks until treatment assignments were unblinded, at which point all participants returned for an unblinding visit and were given the option to participate in an open-label rollover extension to receive an FDC containing B/F/TAF (50/200/25 mg).
OG001	DTG + F/TAF	DTG 50 mg + F/TAF (200/25 mg) FDC + BIC placebo tablets orally once daily. After Week 48 participants continued to take their randomized study drug and attended visits every 12 weeks until treatment assignments were unblinded, at which point all participants returned for an unblinding visit and were given the option to participate in an open-label rollover extension to receive an FDC containing B/F/TAF (200/50/25 mg).

Secondary

Percentage of Participants With HIV-1 RNA < 50 Copies/mL as Determined by the FDA-defined Snapshot Algorithm at Week 48

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.

Participants in the Full Analysis Set were analyzed.

Posted

Number

percentage of participants

Week 48

ID	Title	Description
OG000	BIC + F/TAF	BIC 75 mg + F/TAF (200/25 mg) FDC + DTG placebo tablets orally once daily for 48 weeks. After Week 48 participants continued to take their randomized study drug and attended visits every 12 weeks until treatment assignments were unblinded, at which point all participants returned for an unblinding visit and were given the option to participate in an open-label rollover extension to receive an FDC containing B/F/TAF (50/200/25 mg).
OG001	DTG + F/TAF	DTG 50 mg + F/TAF (200/25 mg) FDC + BIC placebo tablets orally once daily. After Week 48 participants continued to take their randomized study drug and attended visits every 12 weeks until treatment assignments were unblinded, at which point all participants returned for an unblinding visit and were given the option to participate in an open-label rollover extension to receive an FDC containing B/F/TAF (200/50/25 mg).

Secondary

The Change From Baseline in log10 HIV-1 RNA at Week 12

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

Posted

Mean

Standard Deviation

log10 copies/mL

Baseline; Week 12

ID	Title	Description
OG000	BIC + F/TAF	BIC 75 mg + F/TAF (200/25 mg) FDC + DTG placebo tablets orally once daily for 48 weeks. After Week 48 participants continued to take their randomized study drug and attended visits every 12 weeks until treatment assignments were unblinded, at which point all participants returned for an unblinding visit and were given the option to participate in an open-label rollover extension to receive an FDC containing B/F/TAF (50/200/25 mg).
OG001	DTG + F/TAF	DTG 50 mg + F/TAF (200/25 mg) FDC + BIC placebo tablets orally once daily. After Week 48 participants continued to take their randomized study drug and attended visits every 12 weeks until treatment assignments were unblinded, at which point all participants returned for an unblinding visit and were given the option to participate in an open-label rollover extension to receive an FDC containing B/F/TAF (200/50/25 mg).

Units	Counts
Participants

Secondary

The Change From Baseline in log10 HIV-1 RNA at Week 24

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

Posted

Mean

Standard Deviation

log10 copies/mL

Baseline; Week 24

ID	Title	Description
OG000	BIC + F/TAF	BIC 75 mg + F/TAF (200/25 mg) FDC + DTG placebo tablets orally once daily for 48 weeks. After Week 48 participants continued to take their randomized study drug and attended visits every 12 weeks until treatment assignments were unblinded, at which point all participants returned for an unblinding visit and were given the option to participate in an open-label rollover extension to receive an FDC containing B/F/TAF (50/200/25 mg).
OG001	DTG + F/TAF	DTG 50 mg + F/TAF (200/25 mg) FDC + BIC placebo tablets orally once daily. After Week 48 participants continued to take their randomized study drug and attended visits every 12 weeks until treatment assignments were unblinded, at which point all participants returned for an unblinding visit and were given the option to participate in an open-label rollover extension to receive an FDC containing B/F/TAF (200/50/25 mg).

Units	Counts
Participants

Secondary

The Change From Baseline in log10 HIV-1 RNA at Week 48

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

Posted

Mean

Standard Deviation

log10 copies/mL

Baseline; Week 48

ID	Title	Description
OG000	BIC + F/TAF	BIC 75 mg + F/TAF (200/25 mg) FDC + DTG placebo tablets orally once daily for 48 weeks. After Week 48 participants continued to take their randomized study drug and attended visits every 12 weeks until treatment assignments were unblinded, at which point all participants returned for an unblinding visit and were given the option to participate in an open-label rollover extension to receive an FDC containing B/F/TAF (50/200/25 mg).
OG001	DTG + F/TAF	DTG 50 mg + F/TAF (200/25 mg) FDC + BIC placebo tablets orally once daily. After Week 48 participants continued to take their randomized study drug and attended visits every 12 weeks until treatment assignments were unblinded, at which point all participants returned for an unblinding visit and were given the option to participate in an open-label rollover extension to receive an FDC containing B/F/TAF (200/50/25 mg).

Units	Counts
Participants

Secondary

The Change From Baseline in Cluster of Differentiation 4 Positive (CD4+) Cell Count at Week 12

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

Posted

Mean

Standard Deviation

CD4 Cell Count (/μL)

Baseline; Week 12

ID	Title	Description
OG000	BIC + F/TAF	BIC 75 mg + F/TAF (200/25 mg) FDC + DTG placebo tablets orally once daily for 48 weeks. After Week 48 participants continued to take their randomized study drug and attended visits every 12 weeks until treatment assignments were unblinded, at which point all participants returned for an unblinding visit and were given the option to participate in an open-label rollover extension to receive an FDC containing B/F/TAF (50/200/25 mg).
OG001	DTG + F/TAF	DTG 50 mg + F/TAF (200/25 mg) FDC + BIC placebo tablets orally once daily. After Week 48 participants continued to take their randomized study drug and attended visits every 12 weeks until treatment assignments were unblinded, at which point all participants returned for an unblinding visit and were given the option to participate in an open-label rollover extension to receive an FDC containing B/F/TAF (200/50/25 mg).

Units	Counts
Participants

Secondary

The Change From Baseline in CD4+ Cell Count at Week 24

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

Posted

Mean

Standard Deviation

CD4 Cell Count (/μL)

Baseline; Week 24

ID	Title	Description
OG000	BIC + F/TAF	BIC 75 mg + F/TAF (200/25 mg) FDC + DTG placebo tablets orally once daily for 48 weeks. After Week 48 participants continued to take their randomized study drug and attended visits every 12 weeks until treatment assignments were unblinded, at which point all participants returned for an unblinding visit and were given the option to participate in an open-label rollover extension to receive an FDC containing B/F/TAF (50/200/25 mg).
OG001	DTG + F/TAF	DTG 50 mg + F/TAF (200/25 mg) FDC + BIC placebo tablets orally once daily. After Week 48 participants continued to take their randomized study drug and attended visits every 12 weeks until treatment assignments were unblinded, at which point all participants returned for an unblinding visit and were given the option to participate in an open-label rollover extension to receive an FDC containing B/F/TAF (200/50/25 mg).

Units	Counts
Participants

Secondary

The Change From Baseline in CD4+ Cell Count at Week 48

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

Posted

Mean

Standard Deviation

CD4 Cell Count (/μL)

Baseline; Week 48

ID	Title	Description
OG000	BIC + F/TAF	BIC 75 mg + F/TAF (200/25 mg) FDC + DTG placebo tablets orally once daily for 48 weeks. After Week 48 participants continued to take their randomized study drug and attended visits every 12 weeks until treatment assignments were unblinded, at which point all participants returned for an unblinding visit and were given the option to participate in an open-label rollover extension to receive an FDC containing B/F/TAF (50/200/25 mg).
OG001	DTG + F/TAF	DTG 50 mg + F/TAF (200/25 mg) FDC + BIC placebo tablets orally once daily. After Week 48 participants continued to take their randomized study drug and attended visits every 12 weeks until treatment assignments were unblinded, at which point all participants returned for an unblinding visit and were given the option to participate in an open-label rollover extension to receive an FDC containing B/F/TAF (200/50/25 mg).

Units	Counts
Participants

Secondary

Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) During Double-Blinded Randomized Phase

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

Posted

Number

percentage of participants

First dose date up to last dose (maximum duration: 58 Weeks) plus 30 days (During Double-Blinded Randomized Phase)

ID	Title	Description
OG000	BIC + F/TAF	BIC 75 mg + F/TAF (200/25 mg) FDC + DTG placebo tablets orally once daily for 48 weeks. After Week 48 participants continued to take the study drug and attended visits every 12 weeks until treatment assignments were unblinded, at which point all participants returned for an unblinding visit and were given the option to participate in an open-label rollover extension to receive an FDC containing B/F/TAF (50/200/25 mg).
OG001	DTG + F/TAF	After participants completed their blinded treatment with DTG 50 mg + F/TAF 200/25 mg FDC + BIC placebo, they were given the option to participate in an open-label rollover extension to receive an FDC containing B/F/TAF (200/50/25).

Units	Counts
Participants

Secondary

Percentage of Participants With Treatment Emergent Laboratory Abnormalities During Double-Blind Randomized Phase

Participants in the Safety Analysis Set were analyzed.

Posted

Number

percentage of participants

First dose date up to last dose (maximum duration: 58 Weeks) plus 30 days (During Double-Blinded Randomized Phase)

ID	Title	Description
OG000	BIC + F/TAF	BIC 75 mg + F/TAF (200/25 mg) FDC + DTG placebo tablets orally once daily for 48 weeks. After Week 48 participants continued to take the study drug and attended visits every 12 weeks until treatment assignments were unblinded, at which point all participants returned for an unblinding visit and were given the option to participate in an open-label rollover extension to receive an FDC containing B/F/TAF (50/200/25 mg).
OG001	DTG + F/TAF	After participants completed their blinded treatment with DTG 50 mg + F/TAF 200/25 mg FDC + BIC placebo, they were given the option to participate in an open-label rollover extension to receive an FDC containing B/F/TAF (200/50/25).

Units	Counts
Participants

Secondary

PK Parameter: Cmax for Bictegravir (BIC), Emtricitabine (FTC), Tenofovir Alafenamide (TAF) and Tenofavir (TFV) at Steady-State

Cmax is the maximum observed plasma concentration of the drug.

Pharmacokinetic (PK) Substudy Analysis Set included all participants who (1) were randomized into the double-blinded phase of study, (2) were enrolled into the PK substudy, (3) received at least 1 dose of study drug during the double-blinded phase, and (4) had at least 1 nonmissing intensive PK concentration value.

Posted

Mean

Standard Deviation

ng/mL

0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours postdose at Week 4 or 8

ID	Title	Description
OG000	BIC + F/TAF	BIC 75 mg + F/TAF (200/25 mg) FDC + DTG placebo tablets orally once daily for 48 weeks. After Week 48 participants continued to take their randomized study drug and attended visits every 12 weeks until treatment assignments were unblinded, at which point all participants returned for an unblinding visit and were given the option to participate in an open-label rollover extension to receive an FDC containing B/F/TAF (50/200/25 mg).
OG001	DTG + F/TAF	DTG 50 mg + F/TAF (200/25 mg) FDC + BIC placebo tablets orally once daily. After Week 48 participants continued to take their randomized study drug and attended visits every 12 weeks until treatment assignments were unblinded, at which point all participants returned for an unblinding visit and were given the option to participate in an open-label rollover extension to receive an FDC containing B/F/TAF (200/50/25 mg).

Secondary

PK Parameter: Tmax for BIC, FTC, TAF, and TFV at Steady-State

Tmax was defined as the time to Cmax.

Participants in the PK Substudy Analysis Set were analyzed.

Posted

Median

Inter-Quartile Range

hours

0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours postdose at Week 4 or 8

ID	Title	Description
OG000	BIC + F/TAF	BIC 75 mg + F/TAF (200/25 mg) FDC + DTG placebo tablets orally once daily for 48 weeks. After Week 48 participants continued to take their randomized study drug and attended visits every 12 weeks until treatment assignments were unblinded, at which point all participants returned for an unblinding visit and were given the option to participate in an open-label rollover extension to receive an FDC containing B/F/TAF (50/200/25 mg).
OG001	DTG + F/TAF	DTG 50 mg + F/TAF (200/25 mg) FDC + BIC placebo tablets orally once daily. After Week 48 participants continued to take their randomized study drug and attended visits every 12 weeks until treatment assignments were unblinded, at which point all participants returned for an unblinding visit and were given the option to participate in an open-label rollover extension to receive an FDC containing B/F/TAF (200/50/25 mg).

Units

Secondary

PK Parameter:Ctau for BIC, FTC and TFV

Ctau was defined as the observed drug concentration at the end of the dosing interval.

Participants in the PK Substudy Analysis Set were analyzed.

Posted

Mean

Standard Deviation

ng/mL

0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours postdose at Week 4 or 8

ID	Title	Description
OG000	BIC + F/TAF	BIC 75 mg + F/TAF (200/25 mg) FDC + DTG placebo tablets orally once daily for 48 weeks. After Week 48 participants continued to take their randomized study drug and attended visits every 12 weeks until treatment assignments were unblinded, at which point all participants returned for an unblinding visit and were given the option to participate in an open-label rollover extension to receive an FDC containing B/F/TAF (50/200/25 mg).
OG001	DTG + F/TAF	DTG 50 mg + F/TAF (200/25 mg) FDC + BIC placebo tablets orally once daily. After Week 48 participants continued to take their randomized study drug and attended visits every 12 weeks until treatment assignments were unblinded, at which point all participants returned for an unblinding visit and were given the option to participate in an open-label rollover extension to receive an FDC containing B/F/TAF (200/50/25 mg).

Secondary

PK Parameter: AUCtau for BIC, FTC, TAF, and TFV

AUCtau is defined as the area under the concentration-time curve of the drug over time.

Participants in the PK Substudy Analysis Set were analyzed.

Posted

Mean

Standard Deviation

h*ng/mL

0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours postdose at Week 4 or 8

ID	Title	Description
OG000	BIC + F/TAF	BIC 75 mg + F/TAF (200/25 mg) FDC + DTG placebo tablets orally once daily for 48 weeks. After Week 48 participants continued to take their randomized study drug and attended visits every 12 weeks until treatment assignments were unblinded, at which point all participants returned for an unblinding visit and were given the option to participate in an open-label rollover extension to receive an FDC containing B/F/TAF (50/200/25 mg).
OG001	DTG + F/TAF	DTG 50 mg + F/TAF (200/25 mg) FDC + BIC placebo tablets orally once daily. After Week 48 participants continued to take their randomized study drug and attended visits every 12 weeks until treatment assignments were unblinded, at which point all participants returned for an unblinding visit and were given the option to participate in an open-label rollover extension to receive an FDC containing B/F/TAF (200/50/25 mg).

Secondary

PK Parameter: t1/2 of BIC, FTC, TAF, and TFV

t1/2 was defined as the terminal elimination half-life of the drug

Participants in the PK Substudy Analysis Set were analyzed.

Posted

Median

Inter-Quartile Range

hours

0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours postdose at Week 4 or 8

ID	Title	Description
OG000	BIC + F/TAF	BIC 75 mg + F/TAF (200/25 mg) FDC + DTG placebo tablets orally once daily for 48 weeks. After Week 48 participants continued to take their randomized study drug and attended visits every 12 weeks until treatment assignments were unblinded, at which point all participants returned for an unblinding visit and were given the option to participate in an open-label rollover extension to receive an FDC containing B/F/TAF (50/200/25 mg).
OG001	DTG + F/TAF	DTG 50 mg + F/TAF (200/25 mg) FDC + BIC placebo tablets orally once daily. After Week 48 participants continued to take their randomized study drug and attended visits every 12 weeks until treatment assignments were unblinded, at which point all participants returned for an unblinding visit and were given the option to participate in an open-label rollover extension to receive an FDC containing B/F/TAF (200/50/25 mg).

Units

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	BIC + F/TAF (Double-Blind Randomized)	Adverse events in this reporting group include those that occurred during the double-blind phase by participants randomized to BIC + F/TAF. Participants received BIC (75 mg) + F/TAF (200/25 mg) FDC + DTG placebo tablets orally once daily for 48 weeks.	65	4	65	44	65
EG001	DTG + F/TAF (Double Blind Randomized):	Adverse events in this reporting group include those that occurred during the double-blind phase by participants randomized to DTG + FTC/TAF. Participants received DTG (50 mg) + F/TAF (200/25 mg) FDC + BIC placebo tablets orally once daily.	33	0	33	18	33
EG002	BIC + F/TAF to B/F/TAF (Open-Label Phase)	Adverse events reported occurred during the Open-Label Extension Phase in participants who enrolled into the Extension Phase from the BIC + F/TAF group and received B/F/TAF (50/200/25 mg) FDC tablet.	62	3	62	42	62
EG003	DTG + F/TAF to B/F/TAF (Open-Label Phase)	Adverse events reported occurred during the Open-Label Extension Phase in participants who enrolled into the Extension Phase from the DTG + F/TAF group and received B/F/TAF (50/200/25 mg) FDC tablet.	30	5	30	23	30

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal pain	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected65 at risk EG0010 affected33 at risk EG0020 affected62 at risk EG0031 affected30 at risk
Colitis	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected65 at risk EG0010 affected33 at risk EG0020 affected62 at risk EG003
Umbilical hernia	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected65 at risk EG0010 affected33 at risk EG0020 affected62 at risk EG003
Appendicitis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 affected65 at risk EG0010 affected33 at risk EG0020 affected62 at risk EG003
Pyelonephritis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0000 affected65 at risk EG0010 affected33 at risk EG0021 affected62 at risk EG003
Rib fracture	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0000 affected65 at risk EG0010 affected33 at risk EG0021 affected62 at risk EG003
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected65 at risk EG0010 affected33 at risk EG0020 affected62 at risk EG003
Anal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0000 affected65 at risk EG0010 affected33 at risk EG0021 affected62 at risk EG003
Psychotic disorder	Psychiatric disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected65 at risk EG0010 affected33 at risk EG0020 affected62 at risk EG003
Substance-induced psychotic disorder	Psychiatric disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected65 at risk EG0010 affected33 at risk EG0020 affected62 at risk EG003
Suicidal ideation	Psychiatric disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected65 at risk EG0010 affected33 at risk EG0020 affected62 at risk EG003
Suicide attempt	Psychiatric disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected65 at risk EG0010 affected33 at risk EG0020 affected62 at risk EG003
Bladder mass	Renal and urinary disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected65 at risk EG0010 affected33 at risk EG0020 affected62 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anal fissure	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected65 at risk EG0012 affected33 at risk EG0020 affected62 at risk EG0030 affected30 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0009 affected65 at risk EG0014 affected33 at risk EG0024 affected62 at risk EG003
Flatulence	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected65 at risk EG0012 affected33 at risk EG0020 affected62 at risk EG003
Haemorrhoids	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected65 at risk EG0012 affected33 at risk EG0022 affected62 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0005 affected65 at risk EG0013 affected33 at risk EG0022 affected62 at risk EG003
Chest pain	General disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected65 at risk EG0012 affected33 at risk EG0020 affected62 at risk EG003
Fatigue	General disorders	MedDRA 21.1	Systematic Assessment	EG0004 affected65 at risk EG0012 affected33 at risk EG0023 affected62 at risk EG003
Pain	General disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected65 at risk EG0012 affected33 at risk EG0020 affected62 at risk EG003
Bronchitis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0002 affected65 at risk EG0010 affected33 at risk EG0022 affected62 at risk EG003
Chlamydial infection	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0004 affected65 at risk EG0012 affected33 at risk EG0024 affected62 at risk EG003
Conjunctivitis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0000 affected65 at risk EG0010 affected33 at risk EG0021 affected62 at risk EG003
Furuncle	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0003 affected65 at risk EG0012 affected33 at risk EG0024 affected62 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 affected65 at risk EG0012 affected33 at risk EG0021 affected62 at risk EG003
Gonorrhoea	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0003 affected65 at risk EG0011 affected33 at risk EG0025 affected62 at risk EG003
Influenza	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 affected65 at risk EG0011 affected33 at risk EG0024 affected62 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0003 affected65 at risk EG0011 affected33 at risk EG0023 affected62 at risk EG003
Pharyngitis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0002 affected65 at risk EG0011 affected33 at risk EG0023 affected62 at risk EG003
Proctitis gonococcal	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 affected65 at risk EG0011 affected33 at risk EG0022 affected62 at risk EG003
Sinusitis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0003 affected65 at risk EG0010 affected33 at risk EG0024 affected62 at risk EG003
Syphilis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0003 affected65 at risk EG0011 affected33 at risk EG0028 affected62 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0007 affected65 at risk EG0011 affected33 at risk EG0024 affected62 at risk EG003
Urethritis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0003 affected65 at risk EG0013 affected33 at risk EG0021 affected62 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0000 affected65 at risk EG0011 affected33 at risk EG0020 affected62 at risk EG003
Viral infection	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0000 affected65 at risk EG0012 affected33 at risk EG0022 affected62 at risk EG003
Exposure to communicable disease	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0002 affected65 at risk EG0012 affected33 at risk EG0026 affected62 at risk EG003
Muscle strain	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0001 affected65 at risk EG0011 affected33 at risk EG0025 affected62 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG0004 affected65 at risk EG0012 affected33 at risk EG0023 affected62 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG0004 affected65 at risk EG0010 affected33 at risk EG0025 affected62 at risk EG003
Costochondritis	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected65 at risk EG0012 affected33 at risk EG0020 affected62 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected65 at risk EG0010 affected33 at risk EG0020 affected62 at risk EG003
Headache	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0006 affected65 at risk EG0011 affected33 at risk EG0020 affected62 at risk EG003
Anxiety	Psychiatric disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected65 at risk EG0012 affected33 at risk EG0020 affected62 at risk EG003
Stress	Psychiatric disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected65 at risk EG0012 affected33 at risk EG0020 affected62 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG0003 affected65 at risk EG0011 affected33 at risk EG0027 affected62 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected65 at risk EG0011 affected33 at risk EG0024 affected62 at risk EG003
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected65 at risk EG0012 affected33 at risk EG0020 affected62 at risk EG003
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA 21.1	Systematic Assessment	EG0002 affected65 at risk EG0010 affected33 at risk EG0020 affected62 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected65 at risk EG0012 affected33 at risk EG0020 affected62 at risk EG003
Hypertension	Vascular disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected65 at risk EG0011 affected33 at risk EG0021 affected62 at risk EG003

Facility	Status	City	State	ZIP	Country	Contacts
		Phoenix	Arizona	85012	United States

ID	Title	Description
BG000	BIC + F/TAF	BIC 75 mg + F/TAF (200/25 mg) FDC + DTG placebo tablets orally once daily for 48 weeks. After Week 48 participants continued to take their randomized study drug and attended visits every 12 weeks until treatment assignments were unblinded, at which point all participants returned for an unblinding visit and were given the option to participate in an open-label rollover extension to receive an FDC containing B/F/TAF (50/200/25 mg).
BG001	DTG + F/TAF	DTG 50 mg + F/TAF (200/25 mg) FDC + BIC placebo tablets orally once daily. After Week 48 participants continued to take their randomized study drug and attended visits every 12 weeks until treatment assignments were unblinded, at which point all participants returned for an unblinding visit and were given the option to participate in an open-label rollover extension to receive an FDC containing B/F/TAF (200/50/25 mg).
BG002	Total	Total of all reporting groups

ID	Term
C100119	imidazole mustard
C000620396	bictegravir
C562325	dolutegravir