Trial Outcomes & Findings for Safety and Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Disoproxil Fumarate in Treatment Naive, HIV-1 and Hepatitis B Co-Infected Adults (NCT NCT03547908)
NCT ID: NCT03547908
Last Updated: 2025-03-19
Results Overview
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. Percentages were rounded-off.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
244 participants
Primary outcome timeframe
Week 48
Results posted on
2025-03-19
Participant Flow
Participants were enrolled at study sites in the North American, Asian, and European regions.
381 participants were screened.
Participant milestones
| Measure |
Blinded Phase: B/F/TAF
Participants who were HIV-1 and HBV co-infected and treatment-naïve received Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) (50/200/25 mg) fixed-dose combination (FDC) tablet orally, once daily without regard to food for 96 weeks. Participants also received placebo to match (PTM) dolutegravir (DTG) tablet and PTM FDC emtricitabine/ tenofovir desoproxil fumarate (F/TDF) tablet orally once daily without regard to food for 96 weeks.
|
Blinded Phase: DTG + F/TDF
Participants who were HIV-1 and HBV co-infected and treatment-naïve received DTG (50 mg) tablet + F/TDF (200/300 mg) FDC tablet, orally, once daily without regard to food for 96 weeks. Participants also received PTM FDC B/F/TAF tablet, orally, once daily without regard to food for 96 weeks.
|
Open-Label Extension Phase: B/F/TAF From B/F/TAF
After Week 96, participants continued their blinded study drug and attended visits every 12 weeks until the End of Blinded Treatment Visit. Following the End of Blinded Treatment Visit, if safety and efficacy of B/F/TAF FDC was demonstrated for the HIV-1 and HBV coinfected participants, in a country where B/F/TAF FDC was not available, participants were given the option to receive 48 weeks of open-label B/F/TAF until the product became accessible through an access program, or until Gilead elected to discontinue the study in that country, whichever occurred first.
|
Open-Label Extension Phase: B/F/TAF From DTG+F/TDF
After Week 96, participants continued their blinded study drug and attended visits every 12 weeks until the End of Blinded Treatment Visit. Following the End of Blinded Treatment Visit, if safety and efficacy of B/F/TAF FDC was demonstrated for the HIV-1 and HBV coinfected participants, in a country where B/F/TAF FDC was not available, participants were given the option to receive 48 weeks of open-label B/F/TAF until the product became accessible through an access program, or until Gilead elected to discontinue the study in that country, whichever occurred first.
|
|---|---|---|---|---|
|
Blinded Phase
STARTED
|
122
|
122
|
0
|
0
|
|
Blinded Phase
COMPLETED
|
111
|
113
|
0
|
0
|
|
Blinded Phase
NOT COMPLETED
|
11
|
9
|
0
|
0
|
|
Open-label Extension Phase
STARTED
|
0
|
0
|
95
|
89
|
|
Open-label Extension Phase
COMPLETED
|
0
|
0
|
91
|
88
|
|
Open-label Extension Phase
NOT COMPLETED
|
0
|
0
|
4
|
1
|
Reasons for withdrawal
| Measure |
Blinded Phase: B/F/TAF
Participants who were HIV-1 and HBV co-infected and treatment-naïve received Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) (50/200/25 mg) fixed-dose combination (FDC) tablet orally, once daily without regard to food for 96 weeks. Participants also received placebo to match (PTM) dolutegravir (DTG) tablet and PTM FDC emtricitabine/ tenofovir desoproxil fumarate (F/TDF) tablet orally once daily without regard to food for 96 weeks.
|
Blinded Phase: DTG + F/TDF
Participants who were HIV-1 and HBV co-infected and treatment-naïve received DTG (50 mg) tablet + F/TDF (200/300 mg) FDC tablet, orally, once daily without regard to food for 96 weeks. Participants also received PTM FDC B/F/TAF tablet, orally, once daily without regard to food for 96 weeks.
|
Open-Label Extension Phase: B/F/TAF From B/F/TAF
After Week 96, participants continued their blinded study drug and attended visits every 12 weeks until the End of Blinded Treatment Visit. Following the End of Blinded Treatment Visit, if safety and efficacy of B/F/TAF FDC was demonstrated for the HIV-1 and HBV coinfected participants, in a country where B/F/TAF FDC was not available, participants were given the option to receive 48 weeks of open-label B/F/TAF until the product became accessible through an access program, or until Gilead elected to discontinue the study in that country, whichever occurred first.
|
Open-Label Extension Phase: B/F/TAF From DTG+F/TDF
After Week 96, participants continued their blinded study drug and attended visits every 12 weeks until the End of Blinded Treatment Visit. Following the End of Blinded Treatment Visit, if safety and efficacy of B/F/TAF FDC was demonstrated for the HIV-1 and HBV coinfected participants, in a country where B/F/TAF FDC was not available, participants were given the option to receive 48 weeks of open-label B/F/TAF until the product became accessible through an access program, or until Gilead elected to discontinue the study in that country, whichever occurred first.
|
|---|---|---|---|---|
|
Blinded Phase
Lost to Follow-up
|
3
|
3
|
0
|
0
|
|
Blinded Phase
Withdrew Consent
|
2
|
3
|
0
|
0
|
|
Blinded Phase
Investigator's Discretion
|
2
|
1
|
0
|
0
|
|
Blinded Phase
Death
|
2
|
0
|
0
|
0
|
|
Blinded Phase
Non-compliance With Study Drug
|
0
|
2
|
0
|
0
|
|
Blinded Phase
Adverse Event
|
1
|
0
|
0
|
0
|
|
Blinded Phase
Randomized But Never Treated
|
1
|
0
|
0
|
0
|
|
Open-label Extension Phase
Lost to Follow-up
|
0
|
0
|
3
|
1
|
|
Open-label Extension Phase
Death
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Safety and Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Disoproxil Fumarate in Treatment Naive, HIV-1 and Hepatitis B Co-Infected Adults
Baseline characteristics by cohort
| Measure |
Blinded Phase: B/F/TAF
n=121 Participants
Participants who were HIV-1 and HBV coinfected and treatment-naïve received Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) (50/200/25 mg) fixed-dose combination (FDC) tablet orally, once daily without regard to food for 96 weeks. Participants also received placebo to match (PTM) dolutegravir (DTG) tablet and PTM FDC emtricitabine/ tenofovir desoproxil fumarate (F/TDF) tablet orally once daily without regard to food for 96 weeks.
|
Blinded Phase: DTG + F/TDF
n=122 Participants
Participants who were HIV-1 and HBV coinfected and treatment-naïve received DTG (50 mg) tablet + F/TDF (200/300 mg) FDC tablet, orally, once daily without regard to food for 96 weeks. Participants also received PTM FDC B/F/TAF tablet, orally, once daily without regard to food for 96 weeks.
|
Total
n=243 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
120 Participants
n=5 Participants
|
121 Participants
n=7 Participants
|
241 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Age, Continuous
|
33 years
STANDARD_DEVIATION 9.2 • n=5 Participants
|
33 years
STANDARD_DEVIATION 9.4 • n=7 Participants
|
33 years
STANDARD_DEVIATION 9.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
112 Participants
n=5 Participants
|
120 Participants
n=7 Participants
|
232 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
114 Participants
n=5 Participants
|
112 Participants
n=7 Participants
|
226 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
108 Participants
n=5 Participants
|
106 Participants
n=7 Participants
|
214 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Black
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
Thailand
|
55 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
94 Participants
n=5 Participants
|
|
Region of Enrollment
China
|
27 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Region of Enrollment
Malaysia
|
15 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Region of Enrollment
Taiwan
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Region of Enrollment
Dominican Republic
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Region of Enrollment
Turkey
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
Hong Kong
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
South Korea
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
Puerto Rico
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
CD4 Cell Count
|
282 cells/µL
STANDARD_DEVIATION 193.1 • n=5 Participants
|
266 cells/µL
STANDARD_DEVIATION 194.3 • n=7 Participants
|
274 cells/µL
STANDARD_DEVIATION 193.5 • n=5 Participants
|
|
CD4 Percentage
|
16.0 percentage of CD4 cells
STANDARD_DEVIATION 8.62 • n=5 Participants
|
14.8 percentage of CD4 cells
STANDARD_DEVIATION 8.25 • n=7 Participants
|
15.4 percentage of CD4 cells
STANDARD_DEVIATION 8.44 • n=5 Participants
|
PRIMARY outcome
Timeframe: Week 48Population: The Full Analysis Set included all participants who were randomized into the study, received at least 1 dose of study drug, and had at least 1 postbaseline HIV-1 RNA or HBV DNA result while on study drug.
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. Percentages were rounded-off.
Outcome measures
| Measure |
Blinded Phase: B/F/TAF
n=119 Participants
Participants who were HIV-1 and HBV co-infected and treatment-naïve received Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) (50/200/25 mg) fixed-dose combination (FDC) tablet orally, once daily without regard to food for 96 weeks. Participants also received placebo to match (PTM) dolutegravir (DTG) tablet and PTM FDC emtricitabine/ tenofovir desoproxil fumarate (F/TDF) tablet orally once daily without regard to food for 96 weeks.
|
Blinded Phase: DTG + F/TDF
n=122 Participants
Participants who were HIV-1 and HBV co-infected and treatment-naïve received DTG (50 mg) tablet + F/TDF (200/300 mg) FDC tablet, orally, once daily without regard to food for 96 weeks. Participants also received PTM FDC B/F/TAF tablet, orally, once daily without regard to food for 96 weeks.
|
|---|---|---|
|
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm (Co-primary Endpoint)
|
95.0 percentage of participants
|
91.0 percentage of participants
|
PRIMARY outcome
Timeframe: Week 48Population: Participants in the Full Analysis Set were analyzed.
This outcome measure was analyzed using a Missing = Failure approach. In this approach, all missing data were treated as HBV DNA ≥ 29 IU/mL. Percentages were rounded-off.
Outcome measures
| Measure |
Blinded Phase: B/F/TAF
n=119 Participants
Participants who were HIV-1 and HBV co-infected and treatment-naïve received Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) (50/200/25 mg) fixed-dose combination (FDC) tablet orally, once daily without regard to food for 96 weeks. Participants also received placebo to match (PTM) dolutegravir (DTG) tablet and PTM FDC emtricitabine/ tenofovir desoproxil fumarate (F/TDF) tablet orally once daily without regard to food for 96 weeks.
|
Blinded Phase: DTG + F/TDF
n=122 Participants
Participants who were HIV-1 and HBV co-infected and treatment-naïve received DTG (50 mg) tablet + F/TDF (200/300 mg) FDC tablet, orally, once daily without regard to food for 96 weeks. Participants also received PTM FDC B/F/TAF tablet, orally, once daily without regard to food for 96 weeks.
|
|---|---|---|
|
Percentage of Participants With Plasma Hepatitis B Virus (HBV) DNA < 29 IU/mL at Week 48 as Defined by Missing = Failure Approach (Co-primary Endpoint)
|
63.0 percentage of participants
|
43.4 percentage of participants
|
SECONDARY outcome
Timeframe: Week 96Population: Participants in the Full Analysis Set were analyzed.
The percentage of participants achieving HIV-1 RNA \< 50 copies/mL at Week 96 was analyzed using the snapshot algorithm, which was defined as 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. Percentages were rounded-off.
Outcome measures
| Measure |
Blinded Phase: B/F/TAF
n=119 Participants
Participants who were HIV-1 and HBV co-infected and treatment-naïve received Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) (50/200/25 mg) fixed-dose combination (FDC) tablet orally, once daily without regard to food for 96 weeks. Participants also received placebo to match (PTM) dolutegravir (DTG) tablet and PTM FDC emtricitabine/ tenofovir desoproxil fumarate (F/TDF) tablet orally once daily without regard to food for 96 weeks.
|
Blinded Phase: DTG + F/TDF
n=122 Participants
Participants who were HIV-1 and HBV co-infected and treatment-naïve received DTG (50 mg) tablet + F/TDF (200/300 mg) FDC tablet, orally, once daily without regard to food for 96 weeks. Participants also received PTM FDC B/F/TAF tablet, orally, once daily without regard to food for 96 weeks.
|
|---|---|---|
|
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96 as Defined by the US FDA-Defined Snapshot Algorithm
|
87.4 percentage of participants
|
87.7 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 48Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
Blinded Phase: B/F/TAF
n=117 Participants
Participants who were HIV-1 and HBV co-infected and treatment-naïve received Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) (50/200/25 mg) fixed-dose combination (FDC) tablet orally, once daily without regard to food for 96 weeks. Participants also received placebo to match (PTM) dolutegravir (DTG) tablet and PTM FDC emtricitabine/ tenofovir desoproxil fumarate (F/TDF) tablet orally once daily without regard to food for 96 weeks.
|
Blinded Phase: DTG + F/TDF
n=116 Participants
Participants who were HIV-1 and HBV co-infected and treatment-naïve received DTG (50 mg) tablet + F/TDF (200/300 mg) FDC tablet, orally, once daily without regard to food for 96 weeks. Participants also received PTM FDC B/F/TAF tablet, orally, once daily without regard to food for 96 weeks.
|
|---|---|---|
|
Change From Baseline in CD4 Cell Count at Week 48
|
200 cells/µL
Standard Deviation 139.3
|
175 cells/µL
Standard Deviation 124.7
|
SECONDARY outcome
Timeframe: Baseline, Week 96Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
Blinded Phase: B/F/TAF
n=109 Participants
Participants who were HIV-1 and HBV co-infected and treatment-naïve received Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) (50/200/25 mg) fixed-dose combination (FDC) tablet orally, once daily without regard to food for 96 weeks. Participants also received placebo to match (PTM) dolutegravir (DTG) tablet and PTM FDC emtricitabine/ tenofovir desoproxil fumarate (F/TDF) tablet orally once daily without regard to food for 96 weeks.
|
Blinded Phase: DTG + F/TDF
n=113 Participants
Participants who were HIV-1 and HBV co-infected and treatment-naïve received DTG (50 mg) tablet + F/TDF (200/300 mg) FDC tablet, orally, once daily without regard to food for 96 weeks. Participants also received PTM FDC B/F/TAF tablet, orally, once daily without regard to food for 96 weeks.
|
|---|---|---|
|
Change From Baseline in CD4 Cell Count at Week 96
|
261 cells/uL
Standard Deviation 161.6
|
229 cells/uL
Standard Deviation 174.0
|
SECONDARY outcome
Timeframe: Baseline, Week 48Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
Blinded Phase: B/F/TAF
n=117 Participants
Participants who were HIV-1 and HBV co-infected and treatment-naïve received Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) (50/200/25 mg) fixed-dose combination (FDC) tablet orally, once daily without regard to food for 96 weeks. Participants also received placebo to match (PTM) dolutegravir (DTG) tablet and PTM FDC emtricitabine/ tenofovir desoproxil fumarate (F/TDF) tablet orally once daily without regard to food for 96 weeks.
|
Blinded Phase: DTG + F/TDF
n=116 Participants
Participants who were HIV-1 and HBV co-infected and treatment-naïve received DTG (50 mg) tablet + F/TDF (200/300 mg) FDC tablet, orally, once daily without regard to food for 96 weeks. Participants also received PTM FDC B/F/TAF tablet, orally, once daily without regard to food for 96 weeks.
|
|---|---|---|
|
Change From Baseline in Percentage of CD4 Cells at Week 48
|
8.43 percentage of CD4 cells
Standard Deviation 4.1
|
7.75 percentage of CD4 cells
Standard Deviation 4.3
|
SECONDARY outcome
Timeframe: Baseline, Week 96Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
Blinded Phase: B/F/TAF
n=108 Participants
Participants who were HIV-1 and HBV co-infected and treatment-naïve received Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) (50/200/25 mg) fixed-dose combination (FDC) tablet orally, once daily without regard to food for 96 weeks. Participants also received placebo to match (PTM) dolutegravir (DTG) tablet and PTM FDC emtricitabine/ tenofovir desoproxil fumarate (F/TDF) tablet orally once daily without regard to food for 96 weeks.
|
Blinded Phase: DTG + F/TDF
n=112 Participants
Participants who were HIV-1 and HBV co-infected and treatment-naïve received DTG (50 mg) tablet + F/TDF (200/300 mg) FDC tablet, orally, once daily without regard to food for 96 weeks. Participants also received PTM FDC B/F/TAF tablet, orally, once daily without regard to food for 96 weeks.
|
|---|---|---|
|
Change From Baseline in Percentage of CD4 Cells at Week 96
|
10.69 percentage of CD4 cells
Standard Deviation 5.047
|
10.42 percentage of CD4 cells
Standard Deviation 5.096
|
SECONDARY outcome
Timeframe: Week 96Population: Participants in the Full Analysis Set were analyzed.
This outcome measure was analyzed using a Missing = Failure approach. In this approach, all missing data were treated as HBV DNA ≥ 29 IU/mL. Percentages were rounded-off.
Outcome measures
| Measure |
Blinded Phase: B/F/TAF
n=119 Participants
Participants who were HIV-1 and HBV co-infected and treatment-naïve received Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) (50/200/25 mg) fixed-dose combination (FDC) tablet orally, once daily without regard to food for 96 weeks. Participants also received placebo to match (PTM) dolutegravir (DTG) tablet and PTM FDC emtricitabine/ tenofovir desoproxil fumarate (F/TDF) tablet orally once daily without regard to food for 96 weeks.
|
Blinded Phase: DTG + F/TDF
n=122 Participants
Participants who were HIV-1 and HBV co-infected and treatment-naïve received DTG (50 mg) tablet + F/TDF (200/300 mg) FDC tablet, orally, once daily without regard to food for 96 weeks. Participants also received PTM FDC B/F/TAF tablet, orally, once daily without regard to food for 96 weeks.
|
|---|---|---|
|
Percentage of Participants With Plasma HBV DNA < 29 IU/mL at Week 96
|
74.8 percentage of participants
|
70.5 percentage of participants
|
SECONDARY outcome
Timeframe: Week 48Population: Participants in the Full Analysis Set with Baseline ALT \> ULN were analyzed.
ALT normalization was defined as an ALT value that changed from above the normal range at baseline to within the normal range at the given post baseline visit. The upper limit of the normal range (ULN) for ALT using the 2018 AASLD normal range was ≤ 25 U/L for females and ≤ 35 U/L for males. The Missing = Failure approach was used for this analysis. Percentages were rounded off.
Outcome measures
| Measure |
Blinded Phase: B/F/TAF
n=60 Participants
Participants who were HIV-1 and HBV co-infected and treatment-naïve received Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) (50/200/25 mg) fixed-dose combination (FDC) tablet orally, once daily without regard to food for 96 weeks. Participants also received placebo to match (PTM) dolutegravir (DTG) tablet and PTM FDC emtricitabine/ tenofovir desoproxil fumarate (F/TDF) tablet orally once daily without regard to food for 96 weeks.
|
Blinded Phase: DTG + F/TDF
n=47 Participants
Participants who were HIV-1 and HBV co-infected and treatment-naïve received DTG (50 mg) tablet + F/TDF (200/300 mg) FDC tablet, orally, once daily without regard to food for 96 weeks. Participants also received PTM FDC B/F/TAF tablet, orally, once daily without regard to food for 96 weeks.
|
|---|---|---|
|
Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Week 48 by American Association for the Study of Liver Diseases (AASLD) Criteria
|
73.3 percentage of participants
|
55.3 percentage of participants
|
SECONDARY outcome
Timeframe: Week 96Population: Participants in the Full Analysis Set with Baseline ALT \> ULN were analyzed.
ALT normalization was defined as an ALT value that changed from above the normal range at baseline to within the normal range at the given post baseline visit. The upper limit of the normal range (ULN) for ALT using the 2018 AASLD normal range was ≤ 25 U/L for females and ≤ 35 U/L for males. The Missing = Failure approach was used for this analysis. Percentages were rounded-off.
Outcome measures
| Measure |
Blinded Phase: B/F/TAF
n=60 Participants
Participants who were HIV-1 and HBV co-infected and treatment-naïve received Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) (50/200/25 mg) fixed-dose combination (FDC) tablet orally, once daily without regard to food for 96 weeks. Participants also received placebo to match (PTM) dolutegravir (DTG) tablet and PTM FDC emtricitabine/ tenofovir desoproxil fumarate (F/TDF) tablet orally once daily without regard to food for 96 weeks.
|
Blinded Phase: DTG + F/TDF
n=47 Participants
Participants who were HIV-1 and HBV co-infected and treatment-naïve received DTG (50 mg) tablet + F/TDF (200/300 mg) FDC tablet, orally, once daily without regard to food for 96 weeks. Participants also received PTM FDC B/F/TAF tablet, orally, once daily without regard to food for 96 weeks.
|
|---|---|---|
|
Percentage of Participants With ALT Normalization at Week 96
|
71.7 percentage of participants
|
57.4 percentage of participants
|
SECONDARY outcome
Timeframe: Week 48Population: The Serologically Evaluable Full Analysis Set for HBsAg loss/seroconversion included all participants who were in the Full Analysis Set and with HBsAg positive and HBsAb negative or missing at baseline.
HBsAg loss was defined as qualitative HBsAg changing from positive at baseline to negative at a post baseline visit. HBsAg seroconversion was defined as HBsAg loss and HBsAb changes from negative or missing at baseline to positive at a post baseline visit. The Missing = Failure approach was used for this analysis. Percentages were rounded-off.
Outcome measures
| Measure |
Blinded Phase: B/F/TAF
n=119 Participants
Participants who were HIV-1 and HBV co-infected and treatment-naïve received Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) (50/200/25 mg) fixed-dose combination (FDC) tablet orally, once daily without regard to food for 96 weeks. Participants also received placebo to match (PTM) dolutegravir (DTG) tablet and PTM FDC emtricitabine/ tenofovir desoproxil fumarate (F/TDF) tablet orally once daily without regard to food for 96 weeks.
|
Blinded Phase: DTG + F/TDF
n=121 Participants
Participants who were HIV-1 and HBV co-infected and treatment-naïve received DTG (50 mg) tablet + F/TDF (200/300 mg) FDC tablet, orally, once daily without regard to food for 96 weeks. Participants also received PTM FDC B/F/TAF tablet, orally, once daily without regard to food for 96 weeks.
|
|---|---|---|
|
Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Week 48
|
12.6 percentage of participants
|
5.8 percentage of participants
|
SECONDARY outcome
Timeframe: Week 96Population: Participants in the Serologically Evaluable Full Analysis Set were analyzed.
HBsAg loss was defined as qualitative HBsAg changing from positive at baseline to negative at a post baseline visit. HBsAg seroconversion was defined as HBsAg loss and HBsAb changes from negative or missing at baseline to positive at a post baseline visit. The Missing = Failure approach was used for this analysis. Percentages were rounded-off.
Outcome measures
| Measure |
Blinded Phase: B/F/TAF
n=119 Participants
Participants who were HIV-1 and HBV co-infected and treatment-naïve received Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) (50/200/25 mg) fixed-dose combination (FDC) tablet orally, once daily without regard to food for 96 weeks. Participants also received placebo to match (PTM) dolutegravir (DTG) tablet and PTM FDC emtricitabine/ tenofovir desoproxil fumarate (F/TDF) tablet orally once daily without regard to food for 96 weeks.
|
Blinded Phase: DTG + F/TDF
n=121 Participants
Participants who were HIV-1 and HBV co-infected and treatment-naïve received DTG (50 mg) tablet + F/TDF (200/300 mg) FDC tablet, orally, once daily without regard to food for 96 weeks. Participants also received PTM FDC B/F/TAF tablet, orally, once daily without regard to food for 96 weeks.
|
|---|---|---|
|
Percentage of Participants With HBsAg Loss at Week 96
|
22.7 percentage of participants
|
14.0 percentage of participants
|
Adverse Events
Blinded Phase: B/F/TAF
Serious events: 17 serious events
Other events: 102 other events
Deaths: 2 deaths
Blinded Phase: DTG + F/TDF
Serious events: 16 serious events
Other events: 98 other events
Deaths: 1 deaths
Open-Label Extension Phase: B/F/TAF From B/F/TAF
Serious events: 4 serious events
Other events: 42 other events
Deaths: 1 deaths
Open-Label Extension Phase: B/F/TAF From DTG+F/TDF
Serious events: 2 serious events
Other events: 40 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Blinded Phase: B/F/TAF
n=121 participants at risk
Participants who were HIV-1 and HBV coinfected and treatment-naïve received Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) (50/200/25 mg) fixed-dose combination (FDC) tablet orally, once daily without regard to food for 96 weeks. Participants also received placebo to match (PTM) dolutegravir (DTG) tablet and PTM emtricitabine/ tenofovir desoproxil fumarate (F/TDF) tablet orally once daily without regard to food for 96 weeks.
|
Blinded Phase: DTG + F/TDF
n=122 participants at risk
Participants who were HIV-1 and HBV coinfected and treatment-naïve received DTG (50 mg) tablet + F/TDF (200/300 mg) FDC tablet, orally, once daily without regard to food for 96 weeks. Participants also received PTM B/F/TAF tablet, orally, once daily without regard to food for 96 weeks.
|
Open-Label Extension Phase: B/F/TAF From B/F/TAF
n=95 participants at risk
After Week 96, participants continued their blinded study drug and attended visits every 12 weeks until the End of Blinded Treatment Visit. Following the End of Blinded Treatment Visit, if safety and efficacy of B/F/TAF FDC was demonstrated for the HIV-1 and HBV coinfected participants, in a country where B/F/TAF FDC was not available, participants were given the option to receive open-label B/F/TAF until the product became accessible through an access program, or until Gilead elected to discontinue the study in that country, whichever occurred first.
|
Open-Label Extension Phase: B/F/TAF From DTG+F/TDF
n=89 participants at risk
After Week 96, participants continued their blinded study drug and attended visits every 12 weeks until the End of Blinded Treatment Visit. Following the End of Blinded Treatment Visit, if safety and efficacy of B/F/TAF FDC was demonstrated for the HIV-1 and HBV coinfected participants, in a country where B/F/TAF FDC was not available, participants were given the option to receive open-label B/F/TAF until the product became accessible through an access program, or until Gilead elected to discontinue the study in that country, whichever occurred first.
|
|---|---|---|---|---|
|
Infections and infestations
Anal abscess
|
0.83%
1/121 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/122 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
1.1%
1/95 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/89 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/121 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.82%
1/122 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/95 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/89 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.83%
1/121 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/122 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/95 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/89 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Eye disorders
Rhegmatogenous retinal detachment
|
0.00%
0/121 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.82%
1/122 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/95 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/89 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Anal fistula
|
0.00%
0/121 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.82%
1/122 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/95 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/89 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/121 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.82%
1/122 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/95 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/89 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/121 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.82%
1/122 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/95 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/89 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/121 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/122 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
2.1%
2/95 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/89 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Haemorrhoids thrombosed
|
0.00%
0/121 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/122 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
1.1%
1/95 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/89 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.00%
0/121 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.82%
1/122 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/95 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/89 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Lumbar hernia
|
0.00%
0/121 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.82%
1/122 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/95 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/89 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
General disorders
Death, not otherwise specified
|
0.83%
1/121 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.82%
1/122 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/95 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/89 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
General disorders
Influenza like illness
|
0.83%
1/121 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/122 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/95 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/89 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Infections and infestations
Appendicitis
|
0.83%
1/121 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.82%
1/122 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/95 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/89 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Infections and infestations
Bacterial sepsis
|
0.00%
0/121 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/122 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/95 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
1.1%
1/89 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Infections and infestations
Covid-19
|
2.5%
3/121 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
4.9%
6/122 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/95 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/89 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Infections and infestations
Cytomegalovirus chorioretinitis
|
0.00%
0/121 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.82%
1/122 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/95 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/89 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Infections and infestations
Dengue haemorrhagic fever
|
0.83%
1/121 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/122 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/95 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/89 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Infections and infestations
Gastroenteritis
|
0.83%
1/121 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/122 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/95 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/89 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Infections and infestations
Groin abscess
|
0.00%
0/121 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/122 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/95 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
1.1%
1/89 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Infections and infestations
Hepatic amoebiasis
|
0.00%
0/121 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.82%
1/122 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/95 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/89 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Infections and infestations
Meningitis cryptococcal
|
0.83%
1/121 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/122 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/95 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/89 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Infections and infestations
Mycotoxicosis
|
0.00%
0/121 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.82%
1/122 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/95 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/89 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Infections and infestations
Orchitis
|
0.83%
1/121 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/122 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/95 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/89 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.00%
0/121 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/122 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/95 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
1.1%
1/89 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Infections and infestations
Pneumonia
|
0.83%
1/121 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/122 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/95 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/89 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Infections and infestations
Pyelonephritis acute
|
0.83%
1/121 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/122 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/95 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/89 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.83%
1/121 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/122 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/95 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/89 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/121 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.82%
1/122 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/95 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/89 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/121 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.82%
1/122 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/95 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/89 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.83%
1/121 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/122 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/95 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/89 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glottis carcinoma
|
0.83%
1/121 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/122 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/95 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/89 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
0.83%
1/121 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/122 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/95 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/89 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal squamous cell carcinoma
|
0.83%
1/121 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/122 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/95 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/89 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Sinonasal papilloma
|
0.00%
0/121 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.82%
1/122 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/95 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/89 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Nervous system disorders
Alcoholic seizure
|
0.00%
0/121 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/122 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/95 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
1.1%
1/89 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/121 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.82%
1/122 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/95 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/89 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.83%
1/121 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/122 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/95 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/89 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/121 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/122 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
1.1%
1/95 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/89 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
Other adverse events
| Measure |
Blinded Phase: B/F/TAF
n=121 participants at risk
Participants who were HIV-1 and HBV coinfected and treatment-naïve received Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) (50/200/25 mg) fixed-dose combination (FDC) tablet orally, once daily without regard to food for 96 weeks. Participants also received placebo to match (PTM) dolutegravir (DTG) tablet and PTM emtricitabine/ tenofovir desoproxil fumarate (F/TDF) tablet orally once daily without regard to food for 96 weeks.
|
Blinded Phase: DTG + F/TDF
n=122 participants at risk
Participants who were HIV-1 and HBV coinfected and treatment-naïve received DTG (50 mg) tablet + F/TDF (200/300 mg) FDC tablet, orally, once daily without regard to food for 96 weeks. Participants also received PTM B/F/TAF tablet, orally, once daily without regard to food for 96 weeks.
|
Open-Label Extension Phase: B/F/TAF From B/F/TAF
n=95 participants at risk
After Week 96, participants continued their blinded study drug and attended visits every 12 weeks until the End of Blinded Treatment Visit. Following the End of Blinded Treatment Visit, if safety and efficacy of B/F/TAF FDC was demonstrated for the HIV-1 and HBV coinfected participants, in a country where B/F/TAF FDC was not available, participants were given the option to receive open-label B/F/TAF until the product became accessible through an access program, or until Gilead elected to discontinue the study in that country, whichever occurred first.
|
Open-Label Extension Phase: B/F/TAF From DTG+F/TDF
n=89 participants at risk
After Week 96, participants continued their blinded study drug and attended visits every 12 weeks until the End of Blinded Treatment Visit. Following the End of Blinded Treatment Visit, if safety and efficacy of B/F/TAF FDC was demonstrated for the HIV-1 and HBV coinfected participants, in a country where B/F/TAF FDC was not available, participants were given the option to receive open-label B/F/TAF until the product became accessible through an access program, or until Gilead elected to discontinue the study in that country, whichever occurred first.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
10.7%
13/121 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
9.0%
11/122 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
2.1%
2/95 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
6.7%
6/89 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastritis
|
6.6%
8/121 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
1.6%
2/122 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/95 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
1.1%
1/89 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Haemorrhoids
|
5.8%
7/121 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
1.6%
2/122 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
1.1%
1/95 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/89 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
General disorders
Influenza like illness
|
5.8%
7/121 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
1.6%
2/122 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
1.1%
1/95 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
1.1%
1/89 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
General disorders
Pyrexia
|
14.0%
17/121 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
13.1%
16/122 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
1.1%
1/95 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
3.4%
3/89 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Infections and infestations
Acute hepatitis C
|
7.4%
9/121 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
1.6%
2/122 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/95 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/89 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Infections and infestations
Covid-19
|
39.7%
48/121 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
42.6%
52/122 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
5.3%
5/95 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
4.5%
4/89 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Infections and infestations
Folliculitis
|
0.83%
1/121 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
5.7%
7/122 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/95 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/89 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Infections and infestations
Latent syphilis
|
5.8%
7/121 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
4.9%
6/122 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
5.3%
5/95 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
1.1%
1/89 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
14.9%
18/121 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
8.2%
10/122 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
7.4%
7/95 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
5.6%
5/89 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Infections and infestations
Secondary syphilis
|
5.8%
7/121 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
5.7%
7/122 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
1.1%
1/95 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
1.1%
1/89 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Infections and infestations
Syphilis
|
6.6%
8/121 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
9.0%
11/122 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
2.1%
2/95 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
1.1%
1/89 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
18.2%
22/121 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
16.4%
20/122 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
7.4%
7/95 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
7.9%
7/89 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Vaccination complication
|
4.1%
5/121 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
5.7%
7/122 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/95 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/89 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Investigations
Alanine aminotransferase increased
|
9.9%
12/121 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
12.3%
15/122 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
1.1%
1/95 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
3.4%
3/89 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
5.8%
7/121 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
8.2%
10/122 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
1.1%
1/95 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
1.1%
1/89 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Investigations
Weight increased
|
10.7%
13/121 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
9.8%
12/122 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
6.3%
6/95 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
6.7%
6/89 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Abnormal weight gain
|
3.3%
4/121 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
2.5%
3/122 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
3.2%
3/95 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
5.6%
5/89 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
4.1%
5/121 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
4.9%
6/122 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
3.2%
3/95 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
5.6%
5/89 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.3%
4/121 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
7.4%
9/122 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
1.1%
1/95 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/89 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Nervous system disorders
Dizziness
|
4.1%
5/121 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
8.2%
10/122 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
1.1%
1/95 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
1.1%
1/89 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
10.7%
13/121 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
7.4%
9/122 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
1.1%
1/95 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/89 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.1%
5/121 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
6.6%
8/122 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
1.1%
1/95 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
1.1%
1/89 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
8.3%
10/121 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
7.4%
9/122 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
2.1%
2/95 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/89 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Vascular disorders
Hypertension
|
6.6%
8/121 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
3.3%
4/122 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
3.2%
3/95 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/89 • Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study 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