Trial Outcomes & Findings for Safety and Efficacy of Bictegravir + Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected, Antiretroviral Treatment-Naive Adults (NCT NCT02397694)
NCT ID: NCT02397694
Last Updated: 2020-04-07
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
98 participants
Primary outcome timeframe
Week 24
Results posted on
2020-04-07
Participant Flow
Participants were enrolled at 22 centers in the United States of America.The first participant was screened on 23 March 2015 and the last study visit occurred on 27 February 2019.
125 participants were screened.
Participant milestones
| Measure |
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).
|
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 (50/200/25 mg).
|
|---|---|---|
|
Double-Blinded Phase
STARTED
|
65
|
33
|
|
Double-Blinded Phase
COMPLETED
|
62
|
30
|
|
Double-Blinded Phase
NOT COMPLETED
|
3
|
3
|
|
Open Label Extension Phase
STARTED
|
62
|
30
|
|
Open Label Extension Phase
COMPLETED
|
54
|
29
|
|
Open Label Extension Phase
NOT COMPLETED
|
8
|
1
|
Reasons for withdrawal
| Measure |
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).
|
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 (50/200/25 mg).
|
|---|---|---|
|
Double-Blinded Phase
Adverse Event
|
1
|
0
|
|
Double-Blinded Phase
Non-compliance with study drug
|
0
|
2
|
|
Double-Blinded Phase
Withdrawal by Subject
|
1
|
0
|
|
Double-Blinded Phase
Lost to Follow-up
|
1
|
1
|
|
Open Label Extension Phase
Protocol Violation
|
1
|
0
|
|
Open Label Extension Phase
Withdrew Consent
|
3
|
1
|
|
Open Label Extension Phase
Lost to Follow-up
|
4
|
0
|
Baseline Characteristics
Safety and Efficacy of Bictegravir + Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected, Antiretroviral Treatment-Naive Adults
Baseline characteristics by cohort
| Measure |
BIC + F/TAF
n=65 Participants
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).
|
DTG + F/TAF
n=33 Participants
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).
|
Total
n=98 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
34 years
STANDARD_DEVIATION 11.4 • n=5 Participants
|
38 years
STANDARD_DEVIATION 12.9 • n=7 Participants
|
35 years
STANDARD_DEVIATION 12.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
64 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
94 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
24 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
38 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
11 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
54 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
83 Participants
n=5 Participants
|
|
HIV-1 RNA
|
4.39 log10 copies/mL
STANDARD_DEVIATION 0.764 • n=5 Participants
|
4.38 log10 copies/mL
STANDARD_DEVIATION 0.866 • n=7 Participants
|
4.39 log10 copies/mL
STANDARD_DEVIATION 0.795 • n=5 Participants
|
|
HIV-1 RNA category
≤ 100,000 copies/mL
|
55 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
|
HIV-1 RNA category
> 100,000 to ≤ 400,000 copies/mL
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
HIV-1 RNA category
> 400,000 copies/mL
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
CD4 Cell Count
|
471 cells/μL
STANDARD_DEVIATION 190.9 • n=5 Participants
|
507 cells/μL
STANDARD_DEVIATION 271.0 • n=7 Participants
|
483 cells/μL
STANDARD_DEVIATION 220.3 • n=5 Participants
|
|
CD4 Cell Count Category
< 200 cells/μL
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
CD4 Cell Count Category
≥ 200 to < 350 cells/µL
|
17 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
CD4 Cell Count Category
≥ 350 to < 500 cells/µL
|
20 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
CD4 Cell Count Category
≥ 500 cells/µL
|
25 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 24Population: 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.
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.
Outcome measures
| Measure |
BIC + F/TAF
n=65 Participants
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).
|
DTG + F/TAF
n=33 Participants
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).
|
|---|---|---|
|
Percentage of Participants With HIV-1 RNA < 50 Copies/mL as Determined by the FDA-defined Snapshot Algorithm.
|
96.9 percentage of participants
|
93.9 percentage of participants
|
SECONDARY outcome
Timeframe: Week 12Population: Participants in the Full Analysis Set were analyzed.
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.
Outcome measures
| Measure |
BIC + F/TAF
n=65 Participants
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).
|
DTG + F/TAF
n=33 Participants
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).
|
|---|---|---|
|
Percentage of Participants With HIV-1 RNA < 50 Copies/mL as Determined by the FDA-defined Snapshot Algorithm at Week 12
|
93.8 percentage of participants
|
93.9 percentage of participants
|
SECONDARY outcome
Timeframe: Week 48Population: Participants in the Full Analysis Set were analyzed.
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.
Outcome measures
| Measure |
BIC + F/TAF
n=65 Participants
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).
|
DTG + F/TAF
n=33 Participants
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).
|
|---|---|---|
|
Percentage of Participants With HIV-1 RNA < 50 Copies/mL as Determined by the FDA-defined Snapshot Algorithm at Week 48
|
96.9 percentage of participants
|
90.9 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline; Week 12Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
BIC + F/TAF
n=64 Participants
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).
|
DTG + F/TAF
n=31 Participants
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).
|
|---|---|---|
|
The Change From Baseline in log10 HIV-1 RNA at Week 12
|
-3.03 log10 copies/mL
Standard Deviation 0.791
|
-3.15 log10 copies/mL
Standard Deviation 0.731
|
SECONDARY outcome
Timeframe: Baseline; Week 24Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
BIC + F/TAF
n=64 Participants
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).
|
DTG + F/TAF
n=32 Participants
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).
|
|---|---|---|
|
The Change From Baseline in log10 HIV-1 RNA at Week 24
|
-3.09 log10 copies/mL
Standard Deviation 0.740
|
-3.12 log10 copies/mL
Standard Deviation 0.757
|
SECONDARY outcome
Timeframe: Baseline; Week 48Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
BIC + F/TAF
n=63 Participants
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).
|
DTG + F/TAF
n=32 Participants
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).
|
|---|---|---|
|
The Change From Baseline in log10 HIV-1 RNA at Week 48
|
-3.09 log10 copies/mL
Standard Deviation 0.752
|
-3.11 log10 copies/mL
Standard Deviation 0.852
|
SECONDARY outcome
Timeframe: Baseline; Week 12Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
BIC + F/TAF
n=64 Participants
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).
|
DTG + F/TAF
n=31 Participants
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).
|
|---|---|---|
|
The Change From Baseline in Cluster of Differentiation 4 Positive (CD4+) Cell Count at Week 12
|
170 CD4 Cell Count (/μL)
Standard Deviation 150.0
|
173 CD4 Cell Count (/μL)
Standard Deviation 220.5
|
SECONDARY outcome
Timeframe: Baseline; Week 24Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
BIC + F/TAF
n=64 Participants
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).
|
DTG + F/TAF
n=32 Participants
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).
|
|---|---|---|
|
The Change From Baseline in CD4+ Cell Count at Week 24
|
190 CD4 Cell Count (/μL)
Standard Deviation 176.8
|
155 CD4 Cell Count (/μL)
Standard Deviation 165.8
|
SECONDARY outcome
Timeframe: Baseline; Week 48Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
BIC + F/TAF
n=63 Participants
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).
|
DTG + F/TAF
n=30 Participants
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).
|
|---|---|---|
|
The Change From Baseline in CD4+ Cell Count at Week 48
|
258 CD4 Cell Count (/μL)
Standard Deviation 221.7
|
188 CD4 Cell Count (/μL)
Standard Deviation 238.7
|
SECONDARY outcome
Timeframe: First dose date up to last dose (maximum duration: 58 Weeks) plus 30 days (During Double-Blinded Randomized Phase)Population: Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
Outcome measures
| Measure |
BIC + F/TAF
n=65 Participants
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).
|
DTG + F/TAF
n=33 Participants
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).
|
|---|---|---|
|
Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) During Double-Blinded Randomized Phase
|
87.7 percentage of participants
|
72.7 percentage of participants
|
SECONDARY outcome
Timeframe: First dose date up to last dose (maximum duration: 58 Weeks) plus 30 days (During Double-Blinded Randomized Phase)Population: Participants in the Safety Analysis Set were analyzed.
Outcome measures
| Measure |
BIC + F/TAF
n=65 Participants
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).
|
DTG + F/TAF
n=33 Participants
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).
|
|---|---|---|
|
Percentage of Participants With Treatment Emergent Laboratory Abnormalities During Double-Blind Randomized Phase
|
87.5 percentage of participants
|
87.5 percentage of participants
|
SECONDARY outcome
Timeframe: 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours postdose at Week 4 or 8Population: 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.
Cmax is the maximum observed plasma concentration of the drug.
Outcome measures
| Measure |
BIC + F/TAF
n=23 Participants
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).
|
DTG + F/TAF
n=7 Participants
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).
|
|---|---|---|
|
PK Parameter: Cmax for Bictegravir (BIC), Emtricitabine (FTC), Tenofovir Alafenamide (TAF) and Tenofavir (TFV) at Steady-State
BIC
|
9344.3 ng/mL
Standard Deviation 2506.33
|
NA ng/mL
Standard Deviation NA
Participants did not receive BIC
|
|
PK Parameter: Cmax for Bictegravir (BIC), Emtricitabine (FTC), Tenofovir Alafenamide (TAF) and Tenofavir (TFV) at Steady-State
FTC
|
1919.1 ng/mL
Standard Deviation 470.18
|
2157.1 ng/mL
Standard Deviation 486.44
|
|
PK Parameter: Cmax for Bictegravir (BIC), Emtricitabine (FTC), Tenofovir Alafenamide (TAF) and Tenofavir (TFV) at Steady-State
TAF
|
249.1 ng/mL
Standard Deviation 137.40
|
260.8 ng/mL
Standard Deviation 212.44
|
|
PK Parameter: Cmax for Bictegravir (BIC), Emtricitabine (FTC), Tenofovir Alafenamide (TAF) and Tenofavir (TFV) at Steady-State
TFV
|
19.1 ng/mL
Standard Deviation 4.50
|
20.9 ng/mL
Standard Deviation 8.16
|
SECONDARY outcome
Timeframe: 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours postdose at Week 4 or 8Population: Participants in the PK Substudy Analysis Set were analyzed.
Tmax was defined as the time to Cmax.
Outcome measures
| Measure |
BIC + F/TAF
n=23 Participants
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).
|
DTG + F/TAF
n=7 Participants
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).
|
|---|---|---|
|
PK Parameter: Tmax for BIC, FTC, TAF, and TFV at Steady-State
BIC
|
2.00 hours
Interval 1.5 to 3.0
|
NA hours
Participants did not receive BIC
|
|
PK Parameter: Tmax for BIC, FTC, TAF, and TFV at Steady-State
FTC
|
1.50 hours
Interval 1.0 to 2.0
|
1.50 hours
Interval 1.02 to 2.0
|
|
PK Parameter: Tmax for BIC, FTC, TAF, and TFV at Steady-State
TAF
|
1.00 hours
Interval 0.5 to 1.5
|
1.00 hours
Interval 0.5 to 1.0
|
|
PK Parameter: Tmax for BIC, FTC, TAF, and TFV at Steady-State
TFV
|
1.50 hours
Interval 1.5 to 2.0
|
2.00 hours
Interval 1.53 to 2.0
|
SECONDARY outcome
Timeframe: 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours postdose at Week 4 or 8Population: Participants in the PK Substudy Analysis Set were analyzed.
Ctau was defined as the observed drug concentration at the end of the dosing interval.
Outcome measures
| Measure |
BIC + F/TAF
n=23 Participants
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).
|
DTG + F/TAF
n=7 Participants
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).
|
|---|---|---|
|
PK Parameter:Ctau for BIC, FTC and TFV
BIC
|
3508.6 ng/mL
Standard Deviation 1288.85
|
NA ng/mL
Standard Deviation NA
Participants did not receive BIC
|
|
PK Parameter:Ctau for BIC, FTC and TFV
FTC
|
76.6 ng/mL
Standard Deviation 26.35
|
102.6 ng/mL
Standard Deviation 57.60
|
|
PK Parameter:Ctau for BIC, FTC and TFV
TFV
|
10.7 ng/mL
Standard Deviation 2.65
|
12.2 ng/mL
Standard Deviation 5.02
|
SECONDARY outcome
Timeframe: 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours postdose at Week 4 or 8Population: Participants in the PK Substudy Analysis Set were analyzed.
AUCtau is defined as the area under the concentration-time curve of the drug over time.
Outcome measures
| Measure |
BIC + F/TAF
n=23 Participants
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).
|
DTG + F/TAF
n=7 Participants
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).
|
|---|---|---|
|
PK Parameter: AUCtau for BIC, FTC, TAF, and TFV
BIC
|
139778.8 h*ng/mL
Standard Deviation 37810.07
|
NA h*ng/mL
Standard Deviation NA
Participants did not receive BIC
|
|
PK Parameter: AUCtau for BIC, FTC, TAF, and TFV
FTC
|
11605.4 h*ng/mL
Standard Deviation 3241.84
|
14689.8 h*ng/mL
Standard Deviation 5869.37
|
|
PK Parameter: AUCtau for BIC, FTC, TAF, and TFV
TAF
|
247.4 h*ng/mL
Standard Deviation 140.62
|
245.6 h*ng/mL
Standard Deviation 125.03
|
|
PK Parameter: AUCtau for BIC, FTC, TAF, and TFV
TFV
|
316.0 h*ng/mL
Standard Deviation 74.01
|
369.4 h*ng/mL
Standard Deviation 147.96
|
SECONDARY outcome
Timeframe: 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours postdose at Week 4 or 8Population: Participants in the PK Substudy Analysis Set were analyzed.
t1/2 was defined as the terminal elimination half-life of the drug
Outcome measures
| Measure |
BIC + F/TAF
n=23 Participants
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).
|
DTG + F/TAF
n=7 Participants
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).
|
|---|---|---|
|
PK Parameter: t1/2 of BIC, FTC, TAF, and TFV
BIC
|
16.73 hours
Interval 13.79 to 19.28
|
NA hours
Participants did not receive BIC
|
|
PK Parameter: t1/2 of BIC, FTC, TAF, and TFV
FTC
|
5.46 hours
Interval 5.19 to 6.11
|
5.70 hours
Interval 5.3 to 6.38
|
|
PK Parameter: t1/2 of BIC, FTC, TAF, and TFV
TAF
|
0.37 hours
Interval 0.28 to 0.49
|
0.42 hours
Interval 0.4 to 0.45
|
|
PK Parameter: t1/2 of BIC, FTC, TAF, and TFV
TFV
|
37.74 hours
Interval 28.26 to 48.4
|
34.47 hours
Interval 31.97 to 47.57
|
Adverse Events
BIC + F/TAF (Double-Blind Randomized)
Serious events: 4 serious events
Other events: 44 other events
Deaths: 0 deaths
DTG + F/TAF (Double Blind Randomized):
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
BIC + F/TAF to B/F/TAF (Open-Label Phase)
Serious events: 3 serious events
Other events: 42 other events
Deaths: 0 deaths
DTG + F/TAF to B/F/TAF (Open-Label Phase)
Serious events: 5 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
BIC + F/TAF (Double-Blind Randomized)
n=65 participants at risk
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.
|
DTG + F/TAF (Double Blind Randomized):
n=33 participants at risk
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.
|
BIC + F/TAF to B/F/TAF (Open-Label Phase)
n=62 participants at risk
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.
|
DTG + F/TAF to B/F/TAF (Open-Label Phase)
n=30 participants at risk
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.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/65 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/62 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
3.3%
1/30 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/65 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/62 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
3.3%
1/30 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Umbilical hernia
|
1.5%
1/65 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/62 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/30 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Appendicitis
|
1.5%
1/65 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/62 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/30 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/65 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
1.6%
1/62 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/30 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/65 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
1.6%
1/62 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/30 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
1.5%
1/65 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/62 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
3.3%
1/30 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anal cancer
|
0.00%
0/65 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
1.6%
1/62 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/30 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Psychiatric disorders
Psychotic disorder
|
1.5%
1/65 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/62 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/30 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Psychiatric disorders
Substance-induced psychotic disorder
|
0.00%
0/65 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/62 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
3.3%
1/30 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Psychiatric disorders
Suicidal ideation
|
1.5%
1/65 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/62 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/30 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/65 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/62 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
3.3%
1/30 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Bladder mass
|
0.00%
0/65 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/62 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
3.3%
1/30 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
Other adverse events
| Measure |
BIC + F/TAF (Double-Blind Randomized)
n=65 participants at risk
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.
|
DTG + F/TAF (Double Blind Randomized):
n=33 participants at risk
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.
|
BIC + F/TAF to B/F/TAF (Open-Label Phase)
n=62 participants at risk
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.
|
DTG + F/TAF to B/F/TAF (Open-Label Phase)
n=30 participants at risk
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.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Anal fissure
|
1.5%
1/65 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
6.1%
2/33 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/62 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/30 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
13.8%
9/65 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
12.1%
4/33 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
6.5%
4/62 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
13.3%
4/30 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Flatulence
|
1.5%
1/65 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
6.1%
2/33 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/62 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/30 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/65 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
6.1%
2/33 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
3.2%
2/62 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/30 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
7.7%
5/65 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
9.1%
3/33 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
3.2%
2/62 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
10.0%
3/30 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
General disorders
Chest pain
|
0.00%
0/65 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
6.1%
2/33 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/62 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/30 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
General disorders
Fatigue
|
6.2%
4/65 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
6.1%
2/33 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
4.8%
3/62 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/30 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
General disorders
Pain
|
0.00%
0/65 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
6.1%
2/33 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/62 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/30 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Bronchitis
|
3.1%
2/65 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
3.2%
2/62 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
10.0%
3/30 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Chlamydial infection
|
6.2%
4/65 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
6.1%
2/33 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
6.5%
4/62 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
3.3%
1/30 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/65 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
1.6%
1/62 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
6.7%
2/30 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Furuncle
|
4.6%
3/65 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
6.1%
2/33 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
6.5%
4/62 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
6.7%
2/30 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Gastroenteritis
|
1.5%
1/65 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
6.1%
2/33 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
1.6%
1/62 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
6.7%
2/30 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Gonorrhoea
|
4.6%
3/65 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
3.0%
1/33 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
8.1%
5/62 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
6.7%
2/30 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Influenza
|
1.5%
1/65 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
3.0%
1/33 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
6.5%
4/62 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
6.7%
2/30 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
4.6%
3/65 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
3.0%
1/33 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
4.8%
3/62 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
10.0%
3/30 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Pharyngitis
|
3.1%
2/65 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
3.0%
1/33 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
4.8%
3/62 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
6.7%
2/30 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Proctitis gonococcal
|
1.5%
1/65 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
3.0%
1/33 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
3.2%
2/62 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
16.7%
5/30 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Sinusitis
|
4.6%
3/65 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
6.5%
4/62 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
6.7%
2/30 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Syphilis
|
4.6%
3/65 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
3.0%
1/33 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
12.9%
8/62 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
16.7%
5/30 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
10.8%
7/65 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
3.0%
1/33 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
6.5%
4/62 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
3.3%
1/30 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Urethritis
|
4.6%
3/65 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
9.1%
3/33 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
1.6%
1/62 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
3.3%
1/30 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/65 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
3.0%
1/33 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/62 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
6.7%
2/30 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Viral infection
|
0.00%
0/65 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
6.1%
2/33 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
3.2%
2/62 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/30 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Exposure to communicable disease
|
3.1%
2/65 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
6.1%
2/33 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
9.7%
6/62 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
6.7%
2/30 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
1.5%
1/65 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
3.0%
1/33 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
8.1%
5/62 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
3.3%
1/30 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.2%
4/65 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
6.1%
2/33 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
4.8%
3/62 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/30 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.2%
4/65 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
8.1%
5/62 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
3.3%
1/30 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.00%
0/65 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
6.1%
2/33 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/62 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/30 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/65 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/62 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
6.7%
2/30 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
9.2%
6/65 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
3.0%
1/33 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/62 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
3.3%
1/30 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Psychiatric disorders
Anxiety
|
1.5%
1/65 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
6.1%
2/33 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/62 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
3.3%
1/30 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Psychiatric disorders
Stress
|
0.00%
0/65 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
6.1%
2/33 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/62 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/30 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.6%
3/65 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
3.0%
1/33 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
11.3%
7/62 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/30 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
1.5%
1/65 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
3.0%
1/33 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
6.5%
4/62 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
3.3%
1/30 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
1.5%
1/65 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
6.1%
2/33 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/62 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
3.3%
1/30 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
3.1%
2/65 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/62 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
6.7%
2/30 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/65 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
6.1%
2/33 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/62 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
3.3%
1/30 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Vascular disorders
Hypertension
|
1.5%
1/65 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
3.0%
1/33 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
1.6%
1/62 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
6.7%
2/30 • First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
Additional Information
Gilead Clinical Study Information Center
Gilead Sciences
Phone: 1-833-445-3230 (GILEAD-0)
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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
- Publication restrictions are in place
Restriction type: OTHER