Trial Outcomes & Findings for Study to Evaluate the Safety and Antiviral Activity of Inarigivir Soproxil (Formerly: GS-9992) Plus Tenofovir Alafenamide (TAF) for 12 Weeks in Adults With Chronic Hepatitis B (CHB) (NCT NCT03434353)
NCT ID: NCT03434353
Last Updated: 2022-04-04
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
123 participants
Primary outcome timeframe
Baseline, Week 12
Results posted on
2022-04-04
Participant Flow
Participants were enrolled at study sites in Hong Kong and South Korea. The first participant was screened on 28 February 2018. The last study visit occurred on 26 January 2021.
161 participants were screened.
Participant milestones
| Measure |
Group 1: Inarigivir Soproxil 50 mg + TAF
Viremic participants were administered inarigivir soproxil 50 mg (2 x 25 mg capsules) once daily orally 1 hour before or 1 hour after a meal plus tenofovir alafenamide (TAF) 25 mg tablet once daily orally with food for 12 weeks followed by TAF 25 mg tablet once daily orally with food for 36 weeks.
|
Group 2: TAF
Viremic participants were administered TAF 25 mg tablet once daily orally with food for 48 weeks.
|
Group 3: Inarigivir Soproxil 200 mg + TAF
Viremic participants were administered inarigivir soproxil 200 mg (2 x 100 mg tablets) once daily orally 1 hour before or 1 hour after a meal plus TAF 25 mg tablet once daily orally with food for 12 weeks followed by TAF 25 mg tablet once daily orally with food for 36 weeks.
|
Group 4: Inarigivir Soproxil 100 mg + Commercially Available NUC(s)
Virally suppressed participants who were receiving commercially available nucleoside/nucleotide (NUC\[s\]) were administered inarigivir soproxil 100 mg tablet once daily orally 1 hour before or 1 hour after a meal for 12 weeks. Participants continued commercially available NUC(s) for 48 weeks.
|
Group 5: Inarigivir Soproxil 400 mg + TAF
Viremic participants were administered inarigivir soproxil 400 mg (2 x 200 mg tablets) once daily orally 1 hour before or 1 hour after a meal plus TAF 25 mg tablet once daily orally with food for 12 weeks followed TAF 25 mg tablet once daily orally with food for 36 weeks.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
30
|
12
|
30
|
21
|
30
|
|
Overall Study
COMPLETED
|
16
|
9
|
16
|
18
|
12
|
|
Overall Study
NOT COMPLETED
|
14
|
3
|
14
|
3
|
18
|
Reasons for withdrawal
| Measure |
Group 1: Inarigivir Soproxil 50 mg + TAF
Viremic participants were administered inarigivir soproxil 50 mg (2 x 25 mg capsules) once daily orally 1 hour before or 1 hour after a meal plus tenofovir alafenamide (TAF) 25 mg tablet once daily orally with food for 12 weeks followed by TAF 25 mg tablet once daily orally with food for 36 weeks.
|
Group 2: TAF
Viremic participants were administered TAF 25 mg tablet once daily orally with food for 48 weeks.
|
Group 3: Inarigivir Soproxil 200 mg + TAF
Viremic participants were administered inarigivir soproxil 200 mg (2 x 100 mg tablets) once daily orally 1 hour before or 1 hour after a meal plus TAF 25 mg tablet once daily orally with food for 12 weeks followed by TAF 25 mg tablet once daily orally with food for 36 weeks.
|
Group 4: Inarigivir Soproxil 100 mg + Commercially Available NUC(s)
Virally suppressed participants who were receiving commercially available nucleoside/nucleotide (NUC\[s\]) were administered inarigivir soproxil 100 mg tablet once daily orally 1 hour before or 1 hour after a meal for 12 weeks. Participants continued commercially available NUC(s) for 48 weeks.
|
Group 5: Inarigivir Soproxil 400 mg + TAF
Viremic participants were administered inarigivir soproxil 400 mg (2 x 200 mg tablets) once daily orally 1 hour before or 1 hour after a meal plus TAF 25 mg tablet once daily orally with food for 12 weeks followed TAF 25 mg tablet once daily orally with food for 36 weeks.
|
|---|---|---|---|---|---|
|
Overall Study
Started commercial Hepatitis B virus therapy
|
10
|
3
|
11
|
3
|
17
|
|
Overall Study
Withdrew consent
|
1
|
0
|
3
|
0
|
0
|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Study to Evaluate the Safety and Antiviral Activity of Inarigivir Soproxil (Formerly: GS-9992) Plus Tenofovir Alafenamide (TAF) for 12 Weeks in Adults With Chronic Hepatitis B (CHB)
Baseline characteristics by cohort
| Measure |
Group 1: Inarigivir Soproxil 50 mg + TAF
n=30 Participants
Viremic participants were administered inarigivir soproxil 50 mg (2 x 25 mg capsules) once daily orally 1 hour before or 1 hour after a meal plus TAF 25 mg tablet once daily orally with food for 12 weeks followed by TAF 25 mg tablet once daily orally with food for 36 weeks.
|
Group 2: TAF
n=12 Participants
Viremic participants were administered TAF 25 mg tablet once daily orally with food for 48 weeks.
|
Group 3: Inarigivir Soproxil 200 mg + TAF
n=30 Participants
Viremic participants were administered inarigivir soproxil 200 mg (2 x 100 mg tablets) once daily orally 1 hour before or 1 hour after a meal plus TAF 25 mg tablet once daily orally with food for 12 weeks followed by TAF 25 mg tablet once daily orally with food for 36 weeks.
|
Group 4: Inarigivir Soproxil 100 mg + Commercially Available NUC(s)
n=21 Participants
Virally suppressed participants who were receiving NUC(s) were administered inarigivir soproxil 100 mg tablet once daily orally 1 hour before or 1 hour after a meal for 12 weeks. Participants continued commercially available NUC(s) for 48 weeks.
|
Group 5: Inarigivir Soproxil 400 mg + TAF
n=30 Participants
Viremic participants were administered inarigivir soproxil 400 mg (2 x 200 mg tablets) once daily orally 1 hour before or 1 hour after a meal plus TAF 25 mg tablet once daily orally with food for 12 weeks followed TAF 25 mg tablet once daily orally with food for 36 weeks.
|
Total
n=123 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Customized
<50 years
|
23 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
19 Participants
n=27 Participants
|
11 Participants
n=483 Participants
|
13 Participants
n=36 Participants
|
71 Participants
n=10 Participants
|
|
Age, Customized
≥50 years
|
7 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
10 Participants
n=483 Participants
|
17 Participants
n=36 Participants
|
52 Participants
n=10 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
9 Participants
n=483 Participants
|
11 Participants
n=36 Participants
|
46 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
19 Participants
n=27 Participants
|
12 Participants
n=483 Participants
|
19 Participants
n=36 Participants
|
77 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
30 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
30 Participants
n=27 Participants
|
21 Participants
n=483 Participants
|
30 Participants
n=36 Participants
|
123 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
30 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
30 Participants
n=27 Participants
|
21 Participants
n=483 Participants
|
30 Participants
n=36 Participants
|
123 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
|
Region of Enrollment
Hong Kong
|
8 participants
n=93 Participants
|
5 participants
n=4 Participants
|
22 participants
n=27 Participants
|
11 participants
n=483 Participants
|
30 participants
n=36 Participants
|
76 participants
n=10 Participants
|
|
Region of Enrollment
South Korea
|
22 participants
n=93 Participants
|
7 participants
n=4 Participants
|
8 participants
n=27 Participants
|
10 participants
n=483 Participants
|
0 participants
n=36 Participants
|
47 participants
n=10 Participants
|
|
Hepatitis B Surface Antigen (HBsAg) Category
≤ 4 log10 IU/mL
|
16 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
23 Participants
n=27 Participants
|
19 Participants
n=483 Participants
|
21 Participants
n=36 Participants
|
83 Participants
n=10 Participants
|
|
Hepatitis B Surface Antigen (HBsAg) Category
> 4 log10 IU/mL
|
14 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
9 Participants
n=36 Participants
|
40 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 12Population: The Full Analysis Set included all participants who were randomized to Groups 1 or 2, or enrolled in Group 3 and 5, and who took at least 1 dose of any study drug.
Outcome measures
| Measure |
Group 1: Inarigivir Soproxil 50 mg + TAF
n=30 Participants
Viremic participants were administered inarigivir soproxil 50 mg (2 x 25 mg capsules) once daily orally 1 hour before or 1 hour after a meal plus TAF 25 mg tablet once daily orally with food for 12 weeks followed by TAF 25 mg tablet once daily orally with food for 36 weeks.
|
Group 2: TAF
n=12 Participants
Viremic participants were administered TAF 25 mg tablet once daily orally with food for 48 weeks.
|
Group 3: Inarigivir Soproxil 200 mg + TAF
n=30 Participants
Viremic participants were administered inarigivir soproxil 200 mg (2 x 100 mg tablets) once daily orally 1 hour before or 1 hour after a meal plus TAF 25 mg tablet once daily orally with food for 12 weeks followed by TAF 25 mg tablet once daily orally with food for 36 weeks.
|
Group 5: Inarigivir Soproxil 400 mg + TAF
n=30 Participants
Viremic participants were administered inarigivir soproxil 400 mg (2 x 200 mg tablets) once daily orally 1 hour before or 1 hour after a meal plus TAF 25 mg tablet once daily orally with food for 12 weeks followed TAF 25 mg tablet once daily orally with food for 36 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants With ≥ 0.5 log10 IU/mL Decline in HBsAg From Baseline at Week 12 (Groups 1-3 and 5)
|
23.3 percentage of participants
Interval 9.9 to 42.3
|
25.0 percentage of participants
Interval 5.5 to 57.2
|
0 percentage of participants
Interval 0.0 to 11.6
|
6.7 percentage of participants
Interval 0.8 to 22.1
|
PRIMARY outcome
Timeframe: Baseline, Week 12Population: The Full Analysis Set (Group 4) included all participants who were enrolled in Group 4, and who took at least 1 dose of any study drug.
Outcome measures
| Measure |
Group 1: Inarigivir Soproxil 50 mg + TAF
n=21 Participants
Viremic participants were administered inarigivir soproxil 50 mg (2 x 25 mg capsules) once daily orally 1 hour before or 1 hour after a meal plus TAF 25 mg tablet once daily orally with food for 12 weeks followed by TAF 25 mg tablet once daily orally with food for 36 weeks.
|
Group 2: TAF
Viremic participants were administered TAF 25 mg tablet once daily orally with food for 48 weeks.
|
Group 3: Inarigivir Soproxil 200 mg + TAF
Viremic participants were administered inarigivir soproxil 200 mg (2 x 100 mg tablets) once daily orally 1 hour before or 1 hour after a meal plus TAF 25 mg tablet once daily orally with food for 12 weeks followed by TAF 25 mg tablet once daily orally with food for 36 weeks.
|
Group 5: Inarigivir Soproxil 400 mg + TAF
Viremic participants were administered inarigivir soproxil 400 mg (2 x 200 mg tablets) once daily orally 1 hour before or 1 hour after a meal plus TAF 25 mg tablet once daily orally with food for 12 weeks followed TAF 25 mg tablet once daily orally with food for 36 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants With ≥ 0.5 log10 IU/mL Decline in HBsAg From Baseline at Week 12 (Group 4)
|
0 percentage of participants
Interval 0.0 to 16.1
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Participants in the Full Analysis Set (Group 1-3 and 5) were analyzed.
Outcome measures
| Measure |
Group 1: Inarigivir Soproxil 50 mg + TAF
n=30 Participants
Viremic participants were administered inarigivir soproxil 50 mg (2 x 25 mg capsules) once daily orally 1 hour before or 1 hour after a meal plus TAF 25 mg tablet once daily orally with food for 12 weeks followed by TAF 25 mg tablet once daily orally with food for 36 weeks.
|
Group 2: TAF
n=12 Participants
Viremic participants were administered TAF 25 mg tablet once daily orally with food for 48 weeks.
|
Group 3: Inarigivir Soproxil 200 mg + TAF
n=30 Participants
Viremic participants were administered inarigivir soproxil 200 mg (2 x 100 mg tablets) once daily orally 1 hour before or 1 hour after a meal plus TAF 25 mg tablet once daily orally with food for 12 weeks followed by TAF 25 mg tablet once daily orally with food for 36 weeks.
|
Group 5: Inarigivir Soproxil 400 mg + TAF
n=30 Participants
Viremic participants were administered inarigivir soproxil 400 mg (2 x 200 mg tablets) once daily orally 1 hour before or 1 hour after a meal plus TAF 25 mg tablet once daily orally with food for 12 weeks followed TAF 25 mg tablet once daily orally with food for 36 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants With ≥ 1 log10 IU/mL Decline in HBsAg From Baseline at Week 12 (Groups 1 Through 3 and 5)
|
0 percentage of participants
Interval 0.0 to 11.6
|
16.7 percentage of participants
Interval 2.1 to 48.4
|
0 percentage of participants
Interval 0.0 to 11.6
|
0 percentage of participants
Interval 0.0 to 11.6
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Participants in the Full Analysis Set (Group 4) were analyzed.
Outcome measures
| Measure |
Group 1: Inarigivir Soproxil 50 mg + TAF
n=21 Participants
Viremic participants were administered inarigivir soproxil 50 mg (2 x 25 mg capsules) once daily orally 1 hour before or 1 hour after a meal plus TAF 25 mg tablet once daily orally with food for 12 weeks followed by TAF 25 mg tablet once daily orally with food for 36 weeks.
|
Group 2: TAF
Viremic participants were administered TAF 25 mg tablet once daily orally with food for 48 weeks.
|
Group 3: Inarigivir Soproxil 200 mg + TAF
Viremic participants were administered inarigivir soproxil 200 mg (2 x 100 mg tablets) once daily orally 1 hour before or 1 hour after a meal plus TAF 25 mg tablet once daily orally with food for 12 weeks followed by TAF 25 mg tablet once daily orally with food for 36 weeks.
|
Group 5: Inarigivir Soproxil 400 mg + TAF
Viremic participants were administered inarigivir soproxil 400 mg (2 x 200 mg tablets) once daily orally 1 hour before or 1 hour after a meal plus TAF 25 mg tablet once daily orally with food for 12 weeks followed TAF 25 mg tablet once daily orally with food for 36 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants With ≥ 1 log10 IU/mL Decline in HBsAg From Baseline at Week 12 (Group 4)
|
0 percentage of participants
Interval 0.0 to 16.1
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 12, 24, 36, and 48Population: Participants in the Full Analysis Set (Group 1-3 and 5) with HBeAg-positive status at baseline were analyzed.
HBeAg loss was defined as qualitative HBeAg result changing from positive at baseline to negative at post-baseline visit. HBeAg seroconversion was defined as HBeAb changing from negative or missing at baseline to positive at any postbaseline visit. Participants who had missing information were assumed to have no HBeAg loss and no HBeAg seroconversion.
Outcome measures
| Measure |
Group 1: Inarigivir Soproxil 50 mg + TAF
n=18 Participants
Viremic participants were administered inarigivir soproxil 50 mg (2 x 25 mg capsules) once daily orally 1 hour before or 1 hour after a meal plus TAF 25 mg tablet once daily orally with food for 12 weeks followed by TAF 25 mg tablet once daily orally with food for 36 weeks.
|
Group 2: TAF
n=7 Participants
Viremic participants were administered TAF 25 mg tablet once daily orally with food for 48 weeks.
|
Group 3: Inarigivir Soproxil 200 mg + TAF
n=14 Participants
Viremic participants were administered inarigivir soproxil 200 mg (2 x 100 mg tablets) once daily orally 1 hour before or 1 hour after a meal plus TAF 25 mg tablet once daily orally with food for 12 weeks followed by TAF 25 mg tablet once daily orally with food for 36 weeks.
|
Group 5: Inarigivir Soproxil 400 mg + TAF
n=16 Participants
Viremic participants were administered inarigivir soproxil 400 mg (2 x 200 mg tablets) once daily orally 1 hour before or 1 hour after a meal plus TAF 25 mg tablet once daily orally with food for 12 weeks followed TAF 25 mg tablet once daily orally with food for 36 weeks.
|
|---|---|---|---|---|
|
Percentage of HBeAg-positive Participants Who Achieved HBeAg Loss and Seroconversion at Weeks 12, 24, 36, and 48 (Groups 1 Through 3 and 5)
Week 12
|
5.6 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of HBeAg-positive Participants Who Achieved HBeAg Loss and Seroconversion at Weeks 12, 24, 36, and 48 (Groups 1 Through 3 and 5)
Week 24
|
5.6 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of HBeAg-positive Participants Who Achieved HBeAg Loss and Seroconversion at Weeks 12, 24, 36, and 48 (Groups 1 Through 3 and 5)
Week 36
|
5.6 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of HBeAg-positive Participants Who Achieved HBeAg Loss and Seroconversion at Weeks 12, 24, 36, and 48 (Groups 1 Through 3 and 5)
Week 48
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 12, 24, 36, and 48Population: Participants in the Full Analysis Set (Group 4) with HBeAg-positive status at baseline were analyzed.
HBeAg loss was defined as qualitative HBeAg result changing from positive at baseline to negative at post-baseline visit. HBeAg seroconversion was defined as HBeAb changing from negative or missing at baseline to positive at any postbaseline visit. Participants who had missing information were assumed to have no HBeAg loss and no HBeAg seroconversion.
Outcome measures
| Measure |
Group 1: Inarigivir Soproxil 50 mg + TAF
n=7 Participants
Viremic participants were administered inarigivir soproxil 50 mg (2 x 25 mg capsules) once daily orally 1 hour before or 1 hour after a meal plus TAF 25 mg tablet once daily orally with food for 12 weeks followed by TAF 25 mg tablet once daily orally with food for 36 weeks.
|
Group 2: TAF
Viremic participants were administered TAF 25 mg tablet once daily orally with food for 48 weeks.
|
Group 3: Inarigivir Soproxil 200 mg + TAF
Viremic participants were administered inarigivir soproxil 200 mg (2 x 100 mg tablets) once daily orally 1 hour before or 1 hour after a meal plus TAF 25 mg tablet once daily orally with food for 12 weeks followed by TAF 25 mg tablet once daily orally with food for 36 weeks.
|
Group 5: Inarigivir Soproxil 400 mg + TAF
Viremic participants were administered inarigivir soproxil 400 mg (2 x 200 mg tablets) once daily orally 1 hour before or 1 hour after a meal plus TAF 25 mg tablet once daily orally with food for 12 weeks followed TAF 25 mg tablet once daily orally with food for 36 weeks.
|
|---|---|---|---|---|
|
Percentage of HBeAg-positive Participants Who Achieved HBeAg Loss and Seroconversion at Weeks 12, 24, 36, and 48 (Group 4)
Week 12
|
14.3 percentage of participants
|
—
|
—
|
—
|
|
Percentage of HBeAg-positive Participants Who Achieved HBeAg Loss and Seroconversion at Weeks 12, 24, 36, and 48 (Group 4)
Week 24
|
14.3 percentage of participants
|
—
|
—
|
—
|
|
Percentage of HBeAg-positive Participants Who Achieved HBeAg Loss and Seroconversion at Weeks 12, 24, 36, and 48 (Group 4)
Week 36
|
14.3 percentage of participants
|
—
|
—
|
—
|
|
Percentage of HBeAg-positive Participants Who Achieved HBeAg Loss and Seroconversion at Weeks 12, 24, 36, and 48 (Group 4)
Week 48
|
14.3 percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 12, 24, 36, and 48Population: Participants in the Full Analysis Set (Groups 1 through 3 and 5) were analyzed.
HBeAg loss was defined as qualitative HBeAg result changing from positive at baseline to negative at post-baseline visit. Participants who had missing information were assumed to have no HBeAg loss.
Outcome measures
| Measure |
Group 1: Inarigivir Soproxil 50 mg + TAF
n=30 Participants
Viremic participants were administered inarigivir soproxil 50 mg (2 x 25 mg capsules) once daily orally 1 hour before or 1 hour after a meal plus TAF 25 mg tablet once daily orally with food for 12 weeks followed by TAF 25 mg tablet once daily orally with food for 36 weeks.
|
Group 2: TAF
n=12 Participants
Viremic participants were administered TAF 25 mg tablet once daily orally with food for 48 weeks.
|
Group 3: Inarigivir Soproxil 200 mg + TAF
n=30 Participants
Viremic participants were administered inarigivir soproxil 200 mg (2 x 100 mg tablets) once daily orally 1 hour before or 1 hour after a meal plus TAF 25 mg tablet once daily orally with food for 12 weeks followed by TAF 25 mg tablet once daily orally with food for 36 weeks.
|
Group 5: Inarigivir Soproxil 400 mg + TAF
n=30 Participants
Viremic participants were administered inarigivir soproxil 400 mg (2 x 200 mg tablets) once daily orally 1 hour before or 1 hour after a meal plus TAF 25 mg tablet once daily orally with food for 12 weeks followed TAF 25 mg tablet once daily orally with food for 36 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants Who Achieved HBsAg Loss at Weeks 12, 24, 36, and 48 (Groups 1 Through 3 and 5)
Week 12
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Who Achieved HBsAg Loss at Weeks 12, 24, 36, and 48 (Groups 1 Through 3 and 5)
Week 24
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Who Achieved HBsAg Loss at Weeks 12, 24, 36, and 48 (Groups 1 Through 3 and 5)
Week 36
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Who Achieved HBsAg Loss at Weeks 12, 24, 36, and 48 (Groups 1 Through 3 and 5)
Week 48
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 12, 24, 36, and 48Population: Participants in the Full Analysis Set (Group 4) were analyzed.
HBeAg loss was defined as qualitative HBeAg result changing from positive at baseline to negative at post-baseline visit.
Outcome measures
| Measure |
Group 1: Inarigivir Soproxil 50 mg + TAF
n=21 Participants
Viremic participants were administered inarigivir soproxil 50 mg (2 x 25 mg capsules) once daily orally 1 hour before or 1 hour after a meal plus TAF 25 mg tablet once daily orally with food for 12 weeks followed by TAF 25 mg tablet once daily orally with food for 36 weeks.
|
Group 2: TAF
Viremic participants were administered TAF 25 mg tablet once daily orally with food for 48 weeks.
|
Group 3: Inarigivir Soproxil 200 mg + TAF
Viremic participants were administered inarigivir soproxil 200 mg (2 x 100 mg tablets) once daily orally 1 hour before or 1 hour after a meal plus TAF 25 mg tablet once daily orally with food for 12 weeks followed by TAF 25 mg tablet once daily orally with food for 36 weeks.
|
Group 5: Inarigivir Soproxil 400 mg + TAF
Viremic participants were administered inarigivir soproxil 400 mg (2 x 200 mg tablets) once daily orally 1 hour before or 1 hour after a meal plus TAF 25 mg tablet once daily orally with food for 12 weeks followed TAF 25 mg tablet once daily orally with food for 36 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants Who Achieved HBsAg Loss at Weeks 12, 24, 36, and 48 (Group 4)
Week 12
|
0 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Who Achieved HBsAg Loss at Weeks 12, 24, 36, and 48 (Group 4)
Week 24
|
0 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Who Achieved HBsAg Loss at Weeks 12, 24, 36, and 48 (Group 4)
Week 36
|
0 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Who Achieved HBsAg Loss at Weeks 12, 24, 36, and 48 (Group 4)
Week 48
|
0 percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 48Population: Participants with at least 12 weeks and 48 weeks of exposure to inarigivir soproxil and TAF, respectively, and with HBV DNA ≥ 69 IU/mL at Week 48 or Early Discontinuation were analyzed.
Outcome measures
| Measure |
Group 1: Inarigivir Soproxil 50 mg + TAF
n=6 Participants
Viremic participants were administered inarigivir soproxil 50 mg (2 x 25 mg capsules) once daily orally 1 hour before or 1 hour after a meal plus TAF 25 mg tablet once daily orally with food for 12 weeks followed by TAF 25 mg tablet once daily orally with food for 36 weeks.
|
Group 2: TAF
n=3 Participants
Viremic participants were administered TAF 25 mg tablet once daily orally with food for 48 weeks.
|
Group 3: Inarigivir Soproxil 200 mg + TAF
n=5 Participants
Viremic participants were administered inarigivir soproxil 200 mg (2 x 100 mg tablets) once daily orally 1 hour before or 1 hour after a meal plus TAF 25 mg tablet once daily orally with food for 12 weeks followed by TAF 25 mg tablet once daily orally with food for 36 weeks.
|
Group 5: Inarigivir Soproxil 400 mg + TAF
n=9 Participants
Viremic participants were administered inarigivir soproxil 400 mg (2 x 200 mg tablets) once daily orally 1 hour before or 1 hour after a meal plus TAF 25 mg tablet once daily orally with food for 12 weeks followed TAF 25 mg tablet once daily orally with food for 36 weeks.
|
|---|---|---|---|---|
|
Number of Participants With Sequence Changes From Baseline Within the HBV Polymerase for Participants Who Had HBV DNA ≥ 69 IU/mL (Groups 1 Through 3 and 5)
|
4 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Baseline up to Week 12Population: Participants in the Full Analysis Set (Group 4) were analyzed.
Virologic breakthrough was defined as HBV deoxyribonucleic acid (DNA) ≥69 IU/mL for 2 consecutive visits
Outcome measures
| Measure |
Group 1: Inarigivir Soproxil 50 mg + TAF
n=21 Participants
Viremic participants were administered inarigivir soproxil 50 mg (2 x 25 mg capsules) once daily orally 1 hour before or 1 hour after a meal plus TAF 25 mg tablet once daily orally with food for 12 weeks followed by TAF 25 mg tablet once daily orally with food for 36 weeks.
|
Group 2: TAF
Viremic participants were administered TAF 25 mg tablet once daily orally with food for 48 weeks.
|
Group 3: Inarigivir Soproxil 200 mg + TAF
Viremic participants were administered inarigivir soproxil 200 mg (2 x 100 mg tablets) once daily orally 1 hour before or 1 hour after a meal plus TAF 25 mg tablet once daily orally with food for 12 weeks followed by TAF 25 mg tablet once daily orally with food for 36 weeks.
|
Group 5: Inarigivir Soproxil 400 mg + TAF
Viremic participants were administered inarigivir soproxil 400 mg (2 x 200 mg tablets) once daily orally 1 hour before or 1 hour after a meal plus TAF 25 mg tablet once daily orally with food for 12 weeks followed TAF 25 mg tablet once daily orally with food for 36 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants Experiencing Hepatitis B Virus (HBV) Virologic Breakthrough During 12 Weeks of Inarigivir Soproxil Treatment (Group 4)
|
0 percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 12, 16, 24, 36, and 48Population: Participants in the Full Analysis Set (Groups 1-3 and 5) with available data were analyzed.
Outcome measures
| Measure |
Group 1: Inarigivir Soproxil 50 mg + TAF
n=30 Participants
Viremic participants were administered inarigivir soproxil 50 mg (2 x 25 mg capsules) once daily orally 1 hour before or 1 hour after a meal plus TAF 25 mg tablet once daily orally with food for 12 weeks followed by TAF 25 mg tablet once daily orally with food for 36 weeks.
|
Group 2: TAF
n=12 Participants
Viremic participants were administered TAF 25 mg tablet once daily orally with food for 48 weeks.
|
Group 3: Inarigivir Soproxil 200 mg + TAF
n=30 Participants
Viremic participants were administered inarigivir soproxil 200 mg (2 x 100 mg tablets) once daily orally 1 hour before or 1 hour after a meal plus TAF 25 mg tablet once daily orally with food for 12 weeks followed by TAF 25 mg tablet once daily orally with food for 36 weeks.
|
Group 5: Inarigivir Soproxil 400 mg + TAF
n=30 Participants
Viremic participants were administered inarigivir soproxil 400 mg (2 x 200 mg tablets) once daily orally 1 hour before or 1 hour after a meal plus TAF 25 mg tablet once daily orally with food for 12 weeks followed TAF 25 mg tablet once daily orally with food for 36 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in HBV DNA at Weeks 12, 16, 24, 36, and 48 (Groups 1 Through 3 and 5)
Baseline
|
7.06 log10 IU/mL
Standard Deviation 1.530
|
7.06 log10 IU/mL
Standard Deviation 1.757
|
6.30 log10 IU/mL
Standard Deviation 1.365
|
6.61 log10 IU/mL
Standard Deviation 1.479
|
|
Change From Baseline in HBV DNA at Weeks 12, 16, 24, 36, and 48 (Groups 1 Through 3 and 5)
Change at Week 12
|
-4.18 log10 IU/mL
Standard Deviation 0.959
|
-4.24 log10 IU/mL
Standard Deviation 1.340
|
-4.02 log10 IU/mL
Standard Deviation 0.854
|
-3.93 log10 IU/mL
Standard Deviation 0.817
|
|
Change From Baseline in HBV DNA at Weeks 12, 16, 24, 36, and 48 (Groups 1 Through 3 and 5)
Change at Week 16
|
-4.58 log10 IU/mL
Standard Deviation 1.023
|
-4.65 log10 IU/mL
Standard Deviation 1.326
|
-4.29 log10 IU/mL
Standard Deviation 0.946
|
-4.23 log10 IU/mL
Standard Deviation 0.869
|
|
Change From Baseline in HBV DNA at Weeks 12, 16, 24, 36, and 48 (Groups 1 Through 3 and 5)
Change at Week 24
|
-5.02 log10 IU/mL
Standard Deviation 1.101
|
-5.25 log10 IU/mL
Standard Deviation 1.510
|
-4.67 log10 IU/mL
Standard Deviation 1.049
|
-4.76 log10 IU/mL
Standard Deviation 1.013
|
|
Change From Baseline in HBV DNA at Weeks 12, 16, 24, 36, and 48 (Groups 1 Through 3 and 5)
Change at Week 36
|
-5.27 log10 IU/mL
Standard Deviation 1.194
|
-5.53 log10 IU/mL
Standard Deviation 1.610
|
-4.78 log10 IU/mL
Standard Deviation 1.207
|
-4.92 log10 IU/mL
Standard Deviation 1.129
|
|
Change From Baseline in HBV DNA at Weeks 12, 16, 24, 36, and 48 (Groups 1 Through 3 and 5)
Change at Week 48
|
-5.36 log10 IU/mL
Standard Deviation 1.225
|
-5.25 log10 IU/mL
Standard Deviation 1.839
|
-4.83 log10 IU/mL
Standard Deviation 1.162
|
-4.93 log10 IU/mL
Standard Deviation 1.370
|
SECONDARY outcome
Timeframe: Baseline, Weeks 12, 16, 24, 36, and 48Population: Participants in the Full Analysis Set (Groups 1-3 and 5) with available data were analyzed.
Outcome measures
| Measure |
Group 1: Inarigivir Soproxil 50 mg + TAF
n=30 Participants
Viremic participants were administered inarigivir soproxil 50 mg (2 x 25 mg capsules) once daily orally 1 hour before or 1 hour after a meal plus TAF 25 mg tablet once daily orally with food for 12 weeks followed by TAF 25 mg tablet once daily orally with food for 36 weeks.
|
Group 2: TAF
n=12 Participants
Viremic participants were administered TAF 25 mg tablet once daily orally with food for 48 weeks.
|
Group 3: Inarigivir Soproxil 200 mg + TAF
n=30 Participants
Viremic participants were administered inarigivir soproxil 200 mg (2 x 100 mg tablets) once daily orally 1 hour before or 1 hour after a meal plus TAF 25 mg tablet once daily orally with food for 12 weeks followed by TAF 25 mg tablet once daily orally with food for 36 weeks.
|
Group 5: Inarigivir Soproxil 400 mg + TAF
n=30 Participants
Viremic participants were administered inarigivir soproxil 400 mg (2 x 200 mg tablets) once daily orally 1 hour before or 1 hour after a meal plus TAF 25 mg tablet once daily orally with food for 12 weeks followed TAF 25 mg tablet once daily orally with food for 36 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in HBsAg at Weeks 12, 16, 24, 36, and 48 (Groups 1 Through 3 and 5)
Baseline
|
3.933 log10 IU/mL
Standard Deviation 0.8058
|
4.118 log10 IU/mL
Standard Deviation 0.6543
|
3.529 log10 IU/mL
Standard Deviation 0.8835
|
3.418 log10 IU/mL
Standard Deviation 0.8075
|
|
Change From Baseline in HBsAg at Weeks 12, 16, 24, 36, and 48 (Groups 1 Through 3 and 5)
Change at Week 12
|
-0.244 log10 IU/mL
Standard Deviation 0.3443
|
-0.435 log10 IU/mL
Standard Deviation 0.5320
|
0.016 log10 IU/mL
Standard Deviation 0.2850
|
-0.026 log10 IU/mL
Standard Deviation 0.3805
|
|
Change From Baseline in HBsAg at Weeks 12, 16, 24, 36, and 48 (Groups 1 Through 3 and 5)
Change at Week 16
|
-0.282 log10 IU/mL
Standard Deviation 0.3954
|
-0.479 log10 IU/mL
Standard Deviation 0.5429
|
0.014 log10 IU/mL
Standard Deviation 0.2916
|
-0.082 log10 IU/mL
Standard Deviation 0.4262
|
|
Change From Baseline in HBsAg at Weeks 12, 16, 24, 36, and 48 (Groups 1 Through 3 and 5)
Change at Week 24
|
-0.310 log10 IU/mL
Standard Deviation 0.4303
|
-0.482 log10 IU/mL
Standard Deviation 0.5119
|
-0.021 log10 IU/mL
Standard Deviation 0.3171
|
-0.104 log10 IU/mL
Standard Deviation 0.5000
|
|
Change From Baseline in HBsAg at Weeks 12, 16, 24, 36, and 48 (Groups 1 Through 3 and 5)
Change at Week 36
|
-0.330 log10 IU/mL
Standard Deviation 0.4363
|
-0.524 log10 IU/mL
Standard Deviation 0.5430
|
-0.055 log10 IU/mL
Standard Deviation 0.4213
|
-0.209 log10 IU/mL
Standard Deviation 0.5319
|
|
Change From Baseline in HBsAg at Weeks 12, 16, 24, 36, and 48 (Groups 1 Through 3 and 5)
Change at Week 48
|
-0.322 log10 IU/mL
Standard Deviation 0.4311
|
-0.517 log10 IU/mL
Standard Deviation 0.5617
|
-0.045 log10 IU/mL
Standard Deviation 0.4778
|
-0.235 log10 IU/mL
Standard Deviation 0.5429
|
SECONDARY outcome
Timeframe: Baseline, Weeks 12, 16, 24, 36, and 48Population: Participants in the Full Analysis Set (Group 4) were analyzed.
Outcome measures
| Measure |
Group 1: Inarigivir Soproxil 50 mg + TAF
n=21 Participants
Viremic participants were administered inarigivir soproxil 50 mg (2 x 25 mg capsules) once daily orally 1 hour before or 1 hour after a meal plus TAF 25 mg tablet once daily orally with food for 12 weeks followed by TAF 25 mg tablet once daily orally with food for 36 weeks.
|
Group 2: TAF
Viremic participants were administered TAF 25 mg tablet once daily orally with food for 48 weeks.
|
Group 3: Inarigivir Soproxil 200 mg + TAF
Viremic participants were administered inarigivir soproxil 200 mg (2 x 100 mg tablets) once daily orally 1 hour before or 1 hour after a meal plus TAF 25 mg tablet once daily orally with food for 12 weeks followed by TAF 25 mg tablet once daily orally with food for 36 weeks.
|
Group 5: Inarigivir Soproxil 400 mg + TAF
Viremic participants were administered inarigivir soproxil 400 mg (2 x 200 mg tablets) once daily orally 1 hour before or 1 hour after a meal plus TAF 25 mg tablet once daily orally with food for 12 weeks followed TAF 25 mg tablet once daily orally with food for 36 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in HBsAg at Weeks 12, 16, 24, 36, and 48 (Group 4)
Baseline
|
3.211 log10 IU/mL
Standard Deviation 0.5536
|
—
|
—
|
—
|
|
Change From Baseline in HBsAg at Weeks 12, 16, 24, 36, and 48 (Group 4)
Change at Week 12
|
-0.017 log10 IU/mL
Standard Deviation 0.0417
|
—
|
—
|
—
|
|
Change From Baseline in HBsAg at Weeks 12, 16, 24, 36, and 48 (Group 4)
Change at Week 16
|
-0.010 log10 IU/mL
Standard Deviation 0.0645
|
—
|
—
|
—
|
|
Change From Baseline in HBsAg at Weeks 12, 16, 24, 36, and 48 (Group 4)
Change at Week 24
|
-0.039 log10 IU/mL
Standard Deviation 0.0925
|
—
|
—
|
—
|
|
Change From Baseline in HBsAg at Weeks 12, 16, 24, 36, and 48 (Group 4)
Change at Week 36
|
-0.037 log10 IU/mL
Standard Deviation 0.0939
|
—
|
—
|
—
|
|
Change From Baseline in HBsAg at Weeks 12, 16, 24, 36, and 48 (Group 4)
Change at Week 48
|
-0.073 log10 IU/mL
Standard Deviation 0.1120
|
—
|
—
|
—
|
Adverse Events
Group 1: Inarigivir Soproxil 50 mg + TAF
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Group 2: TAF
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Group 3: Inarigivir Soproxil 200 mg + TAF
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
Group 4: Inarigivir Soproxil 100 mg + Commercially Available NUC(s)
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Group 5: Inarigivir Soproxil 400 mg + TAF
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1: Inarigivir Soproxil 50 mg + TAF
n=30 participants at risk
Viremic participants were administered inarigivir soproxil 50 mg (2 x 25 mg capsules) once daily orally 1 hour before or 1 hour after a meal plus TAF 25 mg tablet once daily orally with food for 12 weeks followed by TAF 25 mg tablet once daily orally with food for 36 weeks.
|
Group 2: TAF
n=12 participants at risk
Viremic participants were administered TAF 25 mg tablet once daily orally with food for 48 weeks.
|
Group 3: Inarigivir Soproxil 200 mg + TAF
n=30 participants at risk
Viremic participants were administered inarigivir soproxil 200 mg (2 x 100 mg tablets) once daily orally 1 hour before or 1 hour after a meal plus TAF 25 mg tablet once daily orally with food for 12 weeks followed by TAF 25 mg tablet once daily orally with food for 36 weeks.
|
Group 4: Inarigivir Soproxil 100 mg + Commercially Available NUC(s)
n=21 participants at risk
Virally suppressed participants who were receiving NUC(s) were administered inarigivir soproxil 100 mg tablet once daily orally 1 hour before or 1 hour after a meal for 12 weeks. Participants continued commercially available NUC(s) for 48 weeks.
|
Group 5: Inarigivir Soproxil 400 mg + TAF
n=30 participants at risk
Viremic participants were administered inarigivir soproxil 400 mg (2 x 200 mg tablets) once daily orally 1 hour before or 1 hour after a meal plus TAF 25 mg tablet once daily orally with food for 12 weeks followed TAF 25 mg tablet once daily orally with food for 36 weeks.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/30 • All-cause mortality: From randomization/enrollment up to Week 48 + 3 days Adverse events: Groups 1, 2, 3, 5: From first dose up to Week 48 + 3 days Group 4: From first dose up to Week 12 + 30 days (for Group 4, adverse events were planned to be collected only up to Week 12 + 30 days)
All cause mortality: The All Randomized/Enrolled Analysis Set included all participants who were randomized (Group 1 and 2) or enrolled (Group 3-5) in the study. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/12 • All-cause mortality: From randomization/enrollment up to Week 48 + 3 days Adverse events: Groups 1, 2, 3, 5: From first dose up to Week 48 + 3 days Group 4: From first dose up to Week 12 + 30 days (for Group 4, adverse events were planned to be collected only up to Week 12 + 30 days)
All cause mortality: The All Randomized/Enrolled Analysis Set included all participants who were randomized (Group 1 and 2) or enrolled (Group 3-5) in the study. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
3.3%
1/30 • All-cause mortality: From randomization/enrollment up to Week 48 + 3 days Adverse events: Groups 1, 2, 3, 5: From first dose up to Week 48 + 3 days Group 4: From first dose up to Week 12 + 30 days (for Group 4, adverse events were planned to be collected only up to Week 12 + 30 days)
All cause mortality: The All Randomized/Enrolled Analysis Set included all participants who were randomized (Group 1 and 2) or enrolled (Group 3-5) in the study. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/21 • All-cause mortality: From randomization/enrollment up to Week 48 + 3 days Adverse events: Groups 1, 2, 3, 5: From first dose up to Week 48 + 3 days Group 4: From first dose up to Week 12 + 30 days (for Group 4, adverse events were planned to be collected only up to Week 12 + 30 days)
All cause mortality: The All Randomized/Enrolled Analysis Set included all participants who were randomized (Group 1 and 2) or enrolled (Group 3-5) in the study. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/30 • All-cause mortality: From randomization/enrollment up to Week 48 + 3 days Adverse events: Groups 1, 2, 3, 5: From first dose up to Week 48 + 3 days Group 4: From first dose up to Week 12 + 30 days (for Group 4, adverse events were planned to be collected only up to Week 12 + 30 days)
All cause mortality: The All Randomized/Enrolled Analysis Set included all participants who were randomized (Group 1 and 2) or enrolled (Group 3-5) in the study. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Infections and infestations
Campylobacter gastroenteritis
|
3.3%
1/30 • All-cause mortality: From randomization/enrollment up to Week 48 + 3 days Adverse events: Groups 1, 2, 3, 5: From first dose up to Week 48 + 3 days Group 4: From first dose up to Week 12 + 30 days (for Group 4, adverse events were planned to be collected only up to Week 12 + 30 days)
All cause mortality: The All Randomized/Enrolled Analysis Set included all participants who were randomized (Group 1 and 2) or enrolled (Group 3-5) in the study. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/12 • All-cause mortality: From randomization/enrollment up to Week 48 + 3 days Adverse events: Groups 1, 2, 3, 5: From first dose up to Week 48 + 3 days Group 4: From first dose up to Week 12 + 30 days (for Group 4, adverse events were planned to be collected only up to Week 12 + 30 days)
All cause mortality: The All Randomized/Enrolled Analysis Set included all participants who were randomized (Group 1 and 2) or enrolled (Group 3-5) in the study. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/30 • All-cause mortality: From randomization/enrollment up to Week 48 + 3 days Adverse events: Groups 1, 2, 3, 5: From first dose up to Week 48 + 3 days Group 4: From first dose up to Week 12 + 30 days (for Group 4, adverse events were planned to be collected only up to Week 12 + 30 days)
All cause mortality: The All Randomized/Enrolled Analysis Set included all participants who were randomized (Group 1 and 2) or enrolled (Group 3-5) in the study. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/21 • All-cause mortality: From randomization/enrollment up to Week 48 + 3 days Adverse events: Groups 1, 2, 3, 5: From first dose up to Week 48 + 3 days Group 4: From first dose up to Week 12 + 30 days (for Group 4, adverse events were planned to be collected only up to Week 12 + 30 days)
All cause mortality: The All Randomized/Enrolled Analysis Set included all participants who were randomized (Group 1 and 2) or enrolled (Group 3-5) in the study. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/30 • All-cause mortality: From randomization/enrollment up to Week 48 + 3 days Adverse events: Groups 1, 2, 3, 5: From first dose up to Week 48 + 3 days Group 4: From first dose up to Week 12 + 30 days (for Group 4, adverse events were planned to be collected only up to Week 12 + 30 days)
All cause mortality: The All Randomized/Enrolled Analysis Set included all participants who were randomized (Group 1 and 2) or enrolled (Group 3-5) in the study. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/30 • All-cause mortality: From randomization/enrollment up to Week 48 + 3 days Adverse events: Groups 1, 2, 3, 5: From first dose up to Week 48 + 3 days Group 4: From first dose up to Week 12 + 30 days (for Group 4, adverse events were planned to be collected only up to Week 12 + 30 days)
All cause mortality: The All Randomized/Enrolled Analysis Set included all participants who were randomized (Group 1 and 2) or enrolled (Group 3-5) in the study. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/12 • All-cause mortality: From randomization/enrollment up to Week 48 + 3 days Adverse events: Groups 1, 2, 3, 5: From first dose up to Week 48 + 3 days Group 4: From first dose up to Week 12 + 30 days (for Group 4, adverse events were planned to be collected only up to Week 12 + 30 days)
All cause mortality: The All Randomized/Enrolled Analysis Set included all participants who were randomized (Group 1 and 2) or enrolled (Group 3-5) in the study. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/30 • All-cause mortality: From randomization/enrollment up to Week 48 + 3 days Adverse events: Groups 1, 2, 3, 5: From first dose up to Week 48 + 3 days Group 4: From first dose up to Week 12 + 30 days (for Group 4, adverse events were planned to be collected only up to Week 12 + 30 days)
All cause mortality: The All Randomized/Enrolled Analysis Set included all participants who were randomized (Group 1 and 2) or enrolled (Group 3-5) in the study. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/21 • All-cause mortality: From randomization/enrollment up to Week 48 + 3 days Adverse events: Groups 1, 2, 3, 5: From first dose up to Week 48 + 3 days Group 4: From first dose up to Week 12 + 30 days (for Group 4, adverse events were planned to be collected only up to Week 12 + 30 days)
All cause mortality: The All Randomized/Enrolled Analysis Set included all participants who were randomized (Group 1 and 2) or enrolled (Group 3-5) in the study. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
3.3%
1/30 • All-cause mortality: From randomization/enrollment up to Week 48 + 3 days Adverse events: Groups 1, 2, 3, 5: From first dose up to Week 48 + 3 days Group 4: From first dose up to Week 12 + 30 days (for Group 4, adverse events were planned to be collected only up to Week 12 + 30 days)
All cause mortality: The All Randomized/Enrolled Analysis Set included all participants who were randomized (Group 1 and 2) or enrolled (Group 3-5) in the study. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/30 • All-cause mortality: From randomization/enrollment up to Week 48 + 3 days Adverse events: Groups 1, 2, 3, 5: From first dose up to Week 48 + 3 days Group 4: From first dose up to Week 12 + 30 days (for Group 4, adverse events were planned to be collected only up to Week 12 + 30 days)
All cause mortality: The All Randomized/Enrolled Analysis Set included all participants who were randomized (Group 1 and 2) or enrolled (Group 3-5) in the study. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
8.3%
1/12 • All-cause mortality: From randomization/enrollment up to Week 48 + 3 days Adverse events: Groups 1, 2, 3, 5: From first dose up to Week 48 + 3 days Group 4: From first dose up to Week 12 + 30 days (for Group 4, adverse events were planned to be collected only up to Week 12 + 30 days)
All cause mortality: The All Randomized/Enrolled Analysis Set included all participants who were randomized (Group 1 and 2) or enrolled (Group 3-5) in the study. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/30 • All-cause mortality: From randomization/enrollment up to Week 48 + 3 days Adverse events: Groups 1, 2, 3, 5: From first dose up to Week 48 + 3 days Group 4: From first dose up to Week 12 + 30 days (for Group 4, adverse events were planned to be collected only up to Week 12 + 30 days)
All cause mortality: The All Randomized/Enrolled Analysis Set included all participants who were randomized (Group 1 and 2) or enrolled (Group 3-5) in the study. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/21 • All-cause mortality: From randomization/enrollment up to Week 48 + 3 days Adverse events: Groups 1, 2, 3, 5: From first dose up to Week 48 + 3 days Group 4: From first dose up to Week 12 + 30 days (for Group 4, adverse events were planned to be collected only up to Week 12 + 30 days)
All cause mortality: The All Randomized/Enrolled Analysis Set included all participants who were randomized (Group 1 and 2) or enrolled (Group 3-5) in the study. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/30 • All-cause mortality: From randomization/enrollment up to Week 48 + 3 days Adverse events: Groups 1, 2, 3, 5: From first dose up to Week 48 + 3 days Group 4: From first dose up to Week 12 + 30 days (for Group 4, adverse events were planned to be collected only up to Week 12 + 30 days)
All cause mortality: The All Randomized/Enrolled Analysis Set included all participants who were randomized (Group 1 and 2) or enrolled (Group 3-5) in the study. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
Other adverse events
| Measure |
Group 1: Inarigivir Soproxil 50 mg + TAF
n=30 participants at risk
Viremic participants were administered inarigivir soproxil 50 mg (2 x 25 mg capsules) once daily orally 1 hour before or 1 hour after a meal plus TAF 25 mg tablet once daily orally with food for 12 weeks followed by TAF 25 mg tablet once daily orally with food for 36 weeks.
|
Group 2: TAF
n=12 participants at risk
Viremic participants were administered TAF 25 mg tablet once daily orally with food for 48 weeks.
|
Group 3: Inarigivir Soproxil 200 mg + TAF
n=30 participants at risk
Viremic participants were administered inarigivir soproxil 200 mg (2 x 100 mg tablets) once daily orally 1 hour before or 1 hour after a meal plus TAF 25 mg tablet once daily orally with food for 12 weeks followed by TAF 25 mg tablet once daily orally with food for 36 weeks.
|
Group 4: Inarigivir Soproxil 100 mg + Commercially Available NUC(s)
n=21 participants at risk
Virally suppressed participants who were receiving NUC(s) were administered inarigivir soproxil 100 mg tablet once daily orally 1 hour before or 1 hour after a meal for 12 weeks. Participants continued commercially available NUC(s) for 48 weeks.
|
Group 5: Inarigivir Soproxil 400 mg + TAF
n=30 participants at risk
Viremic participants were administered inarigivir soproxil 400 mg (2 x 200 mg tablets) once daily orally 1 hour before or 1 hour after a meal plus TAF 25 mg tablet once daily orally with food for 12 weeks followed TAF 25 mg tablet once daily orally with food for 36 weeks.
|
|---|---|---|---|---|---|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/30 • All-cause mortality: From randomization/enrollment up to Week 48 + 3 days Adverse events: Groups 1, 2, 3, 5: From first dose up to Week 48 + 3 days Group 4: From first dose up to Week 12 + 30 days (for Group 4, adverse events were planned to be collected only up to Week 12 + 30 days)
All cause mortality: The All Randomized/Enrolled Analysis Set included all participants who were randomized (Group 1 and 2) or enrolled (Group 3-5) in the study. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
8.3%
1/12 • All-cause mortality: From randomization/enrollment up to Week 48 + 3 days Adverse events: Groups 1, 2, 3, 5: From first dose up to Week 48 + 3 days Group 4: From first dose up to Week 12 + 30 days (for Group 4, adverse events were planned to be collected only up to Week 12 + 30 days)
All cause mortality: The All Randomized/Enrolled Analysis Set included all participants who were randomized (Group 1 and 2) or enrolled (Group 3-5) in the study. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/30 • All-cause mortality: From randomization/enrollment up to Week 48 + 3 days Adverse events: Groups 1, 2, 3, 5: From first dose up to Week 48 + 3 days Group 4: From first dose up to Week 12 + 30 days (for Group 4, adverse events were planned to be collected only up to Week 12 + 30 days)
All cause mortality: The All Randomized/Enrolled Analysis Set included all participants who were randomized (Group 1 and 2) or enrolled (Group 3-5) in the study. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/21 • All-cause mortality: From randomization/enrollment up to Week 48 + 3 days Adverse events: Groups 1, 2, 3, 5: From first dose up to Week 48 + 3 days Group 4: From first dose up to Week 12 + 30 days (for Group 4, adverse events were planned to be collected only up to Week 12 + 30 days)
All cause mortality: The All Randomized/Enrolled Analysis Set included all participants who were randomized (Group 1 and 2) or enrolled (Group 3-5) in the study. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/30 • All-cause mortality: From randomization/enrollment up to Week 48 + 3 days Adverse events: Groups 1, 2, 3, 5: From first dose up to Week 48 + 3 days Group 4: From first dose up to Week 12 + 30 days (for Group 4, adverse events were planned to be collected only up to Week 12 + 30 days)
All cause mortality: The All Randomized/Enrolled Analysis Set included all participants who were randomized (Group 1 and 2) or enrolled (Group 3-5) in the study. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/30 • All-cause mortality: From randomization/enrollment up to Week 48 + 3 days Adverse events: Groups 1, 2, 3, 5: From first dose up to Week 48 + 3 days Group 4: From first dose up to Week 12 + 30 days (for Group 4, adverse events were planned to be collected only up to Week 12 + 30 days)
All cause mortality: The All Randomized/Enrolled Analysis Set included all participants who were randomized (Group 1 and 2) or enrolled (Group 3-5) in the study. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/12 • All-cause mortality: From randomization/enrollment up to Week 48 + 3 days Adverse events: Groups 1, 2, 3, 5: From first dose up to Week 48 + 3 days Group 4: From first dose up to Week 12 + 30 days (for Group 4, adverse events were planned to be collected only up to Week 12 + 30 days)
All cause mortality: The All Randomized/Enrolled Analysis Set included all participants who were randomized (Group 1 and 2) or enrolled (Group 3-5) in the study. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
6.7%
2/30 • All-cause mortality: From randomization/enrollment up to Week 48 + 3 days Adverse events: Groups 1, 2, 3, 5: From first dose up to Week 48 + 3 days Group 4: From first dose up to Week 12 + 30 days (for Group 4, adverse events were planned to be collected only up to Week 12 + 30 days)
All cause mortality: The All Randomized/Enrolled Analysis Set included all participants who were randomized (Group 1 and 2) or enrolled (Group 3-5) in the study. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
4.8%
1/21 • All-cause mortality: From randomization/enrollment up to Week 48 + 3 days Adverse events: Groups 1, 2, 3, 5: From first dose up to Week 48 + 3 days Group 4: From first dose up to Week 12 + 30 days (for Group 4, adverse events were planned to be collected only up to Week 12 + 30 days)
All cause mortality: The All Randomized/Enrolled Analysis Set included all participants who were randomized (Group 1 and 2) or enrolled (Group 3-5) in the study. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
3.3%
1/30 • All-cause mortality: From randomization/enrollment up to Week 48 + 3 days Adverse events: Groups 1, 2, 3, 5: From first dose up to Week 48 + 3 days Group 4: From first dose up to Week 12 + 30 days (for Group 4, adverse events were planned to be collected only up to Week 12 + 30 days)
All cause mortality: The All Randomized/Enrolled Analysis Set included all participants who were randomized (Group 1 and 2) or enrolled (Group 3-5) in the study. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
General disorders
Influenza like illness
|
0.00%
0/30 • All-cause mortality: From randomization/enrollment up to Week 48 + 3 days Adverse events: Groups 1, 2, 3, 5: From first dose up to Week 48 + 3 days Group 4: From first dose up to Week 12 + 30 days (for Group 4, adverse events were planned to be collected only up to Week 12 + 30 days)
All cause mortality: The All Randomized/Enrolled Analysis Set included all participants who were randomized (Group 1 and 2) or enrolled (Group 3-5) in the study. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/12 • All-cause mortality: From randomization/enrollment up to Week 48 + 3 days Adverse events: Groups 1, 2, 3, 5: From first dose up to Week 48 + 3 days Group 4: From first dose up to Week 12 + 30 days (for Group 4, adverse events were planned to be collected only up to Week 12 + 30 days)
All cause mortality: The All Randomized/Enrolled Analysis Set included all participants who were randomized (Group 1 and 2) or enrolled (Group 3-5) in the study. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
6.7%
2/30 • All-cause mortality: From randomization/enrollment up to Week 48 + 3 days Adverse events: Groups 1, 2, 3, 5: From first dose up to Week 48 + 3 days Group 4: From first dose up to Week 12 + 30 days (for Group 4, adverse events were planned to be collected only up to Week 12 + 30 days)
All cause mortality: The All Randomized/Enrolled Analysis Set included all participants who were randomized (Group 1 and 2) or enrolled (Group 3-5) in the study. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
28.6%
6/21 • All-cause mortality: From randomization/enrollment up to Week 48 + 3 days Adverse events: Groups 1, 2, 3, 5: From first dose up to Week 48 + 3 days Group 4: From first dose up to Week 12 + 30 days (for Group 4, adverse events were planned to be collected only up to Week 12 + 30 days)
All cause mortality: The All Randomized/Enrolled Analysis Set included all participants who were randomized (Group 1 and 2) or enrolled (Group 3-5) in the study. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
3.3%
1/30 • All-cause mortality: From randomization/enrollment up to Week 48 + 3 days Adverse events: Groups 1, 2, 3, 5: From first dose up to Week 48 + 3 days Group 4: From first dose up to Week 12 + 30 days (for Group 4, adverse events were planned to be collected only up to Week 12 + 30 days)
All cause mortality: The All Randomized/Enrolled Analysis Set included all participants who were randomized (Group 1 and 2) or enrolled (Group 3-5) in the study. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/30 • All-cause mortality: From randomization/enrollment up to Week 48 + 3 days Adverse events: Groups 1, 2, 3, 5: From first dose up to Week 48 + 3 days Group 4: From first dose up to Week 12 + 30 days (for Group 4, adverse events were planned to be collected only up to Week 12 + 30 days)
All cause mortality: The All Randomized/Enrolled Analysis Set included all participants who were randomized (Group 1 and 2) or enrolled (Group 3-5) in the study. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
8.3%
1/12 • All-cause mortality: From randomization/enrollment up to Week 48 + 3 days Adverse events: Groups 1, 2, 3, 5: From first dose up to Week 48 + 3 days Group 4: From first dose up to Week 12 + 30 days (for Group 4, adverse events were planned to be collected only up to Week 12 + 30 days)
All cause mortality: The All Randomized/Enrolled Analysis Set included all participants who were randomized (Group 1 and 2) or enrolled (Group 3-5) in the study. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/30 • All-cause mortality: From randomization/enrollment up to Week 48 + 3 days Adverse events: Groups 1, 2, 3, 5: From first dose up to Week 48 + 3 days Group 4: From first dose up to Week 12 + 30 days (for Group 4, adverse events were planned to be collected only up to Week 12 + 30 days)
All cause mortality: The All Randomized/Enrolled Analysis Set included all participants who were randomized (Group 1 and 2) or enrolled (Group 3-5) in the study. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/21 • All-cause mortality: From randomization/enrollment up to Week 48 + 3 days Adverse events: Groups 1, 2, 3, 5: From first dose up to Week 48 + 3 days Group 4: From first dose up to Week 12 + 30 days (for Group 4, adverse events were planned to be collected only up to Week 12 + 30 days)
All cause mortality: The All Randomized/Enrolled Analysis Set included all participants who were randomized (Group 1 and 2) or enrolled (Group 3-5) in the study. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/30 • All-cause mortality: From randomization/enrollment up to Week 48 + 3 days Adverse events: Groups 1, 2, 3, 5: From first dose up to Week 48 + 3 days Group 4: From first dose up to Week 12 + 30 days (for Group 4, adverse events were planned to be collected only up to Week 12 + 30 days)
All cause mortality: The All Randomized/Enrolled Analysis Set included all participants who were randomized (Group 1 and 2) or enrolled (Group 3-5) in the study. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Infections and infestations
Influenza
|
3.3%
1/30 • All-cause mortality: From randomization/enrollment up to Week 48 + 3 days Adverse events: Groups 1, 2, 3, 5: From first dose up to Week 48 + 3 days Group 4: From first dose up to Week 12 + 30 days (for Group 4, adverse events were planned to be collected only up to Week 12 + 30 days)
All cause mortality: The All Randomized/Enrolled Analysis Set included all participants who were randomized (Group 1 and 2) or enrolled (Group 3-5) in the study. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/12 • All-cause mortality: From randomization/enrollment up to Week 48 + 3 days Adverse events: Groups 1, 2, 3, 5: From first dose up to Week 48 + 3 days Group 4: From first dose up to Week 12 + 30 days (for Group 4, adverse events were planned to be collected only up to Week 12 + 30 days)
All cause mortality: The All Randomized/Enrolled Analysis Set included all participants who were randomized (Group 1 and 2) or enrolled (Group 3-5) in the study. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/30 • All-cause mortality: From randomization/enrollment up to Week 48 + 3 days Adverse events: Groups 1, 2, 3, 5: From first dose up to Week 48 + 3 days Group 4: From first dose up to Week 12 + 30 days (for Group 4, adverse events were planned to be collected only up to Week 12 + 30 days)
All cause mortality: The All Randomized/Enrolled Analysis Set included all participants who were randomized (Group 1 and 2) or enrolled (Group 3-5) in the study. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
9.5%
2/21 • All-cause mortality: From randomization/enrollment up to Week 48 + 3 days Adverse events: Groups 1, 2, 3, 5: From first dose up to Week 48 + 3 days Group 4: From first dose up to Week 12 + 30 days (for Group 4, adverse events were planned to be collected only up to Week 12 + 30 days)
All cause mortality: The All Randomized/Enrolled Analysis Set included all participants who were randomized (Group 1 and 2) or enrolled (Group 3-5) in the study. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/30 • All-cause mortality: From randomization/enrollment up to Week 48 + 3 days Adverse events: Groups 1, 2, 3, 5: From first dose up to Week 48 + 3 days Group 4: From first dose up to Week 12 + 30 days (for Group 4, adverse events were planned to be collected only up to Week 12 + 30 days)
All cause mortality: The All Randomized/Enrolled Analysis Set included all participants who were randomized (Group 1 and 2) or enrolled (Group 3-5) in the study. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Infections and infestations
Nasopharyngitis
|
6.7%
2/30 • All-cause mortality: From randomization/enrollment up to Week 48 + 3 days Adverse events: Groups 1, 2, 3, 5: From first dose up to Week 48 + 3 days Group 4: From first dose up to Week 12 + 30 days (for Group 4, adverse events were planned to be collected only up to Week 12 + 30 days)
All cause mortality: The All Randomized/Enrolled Analysis Set included all participants who were randomized (Group 1 and 2) or enrolled (Group 3-5) in the study. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/12 • All-cause mortality: From randomization/enrollment up to Week 48 + 3 days Adverse events: Groups 1, 2, 3, 5: From first dose up to Week 48 + 3 days Group 4: From first dose up to Week 12 + 30 days (for Group 4, adverse events were planned to be collected only up to Week 12 + 30 days)
All cause mortality: The All Randomized/Enrolled Analysis Set included all participants who were randomized (Group 1 and 2) or enrolled (Group 3-5) in the study. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/30 • All-cause mortality: From randomization/enrollment up to Week 48 + 3 days Adverse events: Groups 1, 2, 3, 5: From first dose up to Week 48 + 3 days Group 4: From first dose up to Week 12 + 30 days (for Group 4, adverse events were planned to be collected only up to Week 12 + 30 days)
All cause mortality: The All Randomized/Enrolled Analysis Set included all participants who were randomized (Group 1 and 2) or enrolled (Group 3-5) in the study. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/21 • All-cause mortality: From randomization/enrollment up to Week 48 + 3 days Adverse events: Groups 1, 2, 3, 5: From first dose up to Week 48 + 3 days Group 4: From first dose up to Week 12 + 30 days (for Group 4, adverse events were planned to be collected only up to Week 12 + 30 days)
All cause mortality: The All Randomized/Enrolled Analysis Set included all participants who were randomized (Group 1 and 2) or enrolled (Group 3-5) in the study. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/30 • All-cause mortality: From randomization/enrollment up to Week 48 + 3 days Adverse events: Groups 1, 2, 3, 5: From first dose up to Week 48 + 3 days Group 4: From first dose up to Week 12 + 30 days (for Group 4, adverse events were planned to be collected only up to Week 12 + 30 days)
All cause mortality: The All Randomized/Enrolled Analysis Set included all participants who were randomized (Group 1 and 2) or enrolled (Group 3-5) in the study. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
3.3%
1/30 • All-cause mortality: From randomization/enrollment up to Week 48 + 3 days Adverse events: Groups 1, 2, 3, 5: From first dose up to Week 48 + 3 days Group 4: From first dose up to Week 12 + 30 days (for Group 4, adverse events were planned to be collected only up to Week 12 + 30 days)
All cause mortality: The All Randomized/Enrolled Analysis Set included all participants who were randomized (Group 1 and 2) or enrolled (Group 3-5) in the study. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
25.0%
3/12 • All-cause mortality: From randomization/enrollment up to Week 48 + 3 days Adverse events: Groups 1, 2, 3, 5: From first dose up to Week 48 + 3 days Group 4: From first dose up to Week 12 + 30 days (for Group 4, adverse events were planned to be collected only up to Week 12 + 30 days)
All cause mortality: The All Randomized/Enrolled Analysis Set included all participants who were randomized (Group 1 and 2) or enrolled (Group 3-5) in the study. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
20.0%
6/30 • All-cause mortality: From randomization/enrollment up to Week 48 + 3 days Adverse events: Groups 1, 2, 3, 5: From first dose up to Week 48 + 3 days Group 4: From first dose up to Week 12 + 30 days (for Group 4, adverse events were planned to be collected only up to Week 12 + 30 days)
All cause mortality: The All Randomized/Enrolled Analysis Set included all participants who were randomized (Group 1 and 2) or enrolled (Group 3-5) in the study. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
4.8%
1/21 • All-cause mortality: From randomization/enrollment up to Week 48 + 3 days Adverse events: Groups 1, 2, 3, 5: From first dose up to Week 48 + 3 days Group 4: From first dose up to Week 12 + 30 days (for Group 4, adverse events were planned to be collected only up to Week 12 + 30 days)
All cause mortality: The All Randomized/Enrolled Analysis Set included all participants who were randomized (Group 1 and 2) or enrolled (Group 3-5) in the study. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
10.0%
3/30 • All-cause mortality: From randomization/enrollment up to Week 48 + 3 days Adverse events: Groups 1, 2, 3, 5: From first dose up to Week 48 + 3 days Group 4: From first dose up to Week 12 + 30 days (for Group 4, adverse events were planned to be collected only up to Week 12 + 30 days)
All cause mortality: The All Randomized/Enrolled Analysis Set included all participants who were randomized (Group 1 and 2) or enrolled (Group 3-5) in the study. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/30 • All-cause mortality: From randomization/enrollment up to Week 48 + 3 days Adverse events: Groups 1, 2, 3, 5: From first dose up to Week 48 + 3 days Group 4: From first dose up to Week 12 + 30 days (for Group 4, adverse events were planned to be collected only up to Week 12 + 30 days)
All cause mortality: The All Randomized/Enrolled Analysis Set included all participants who were randomized (Group 1 and 2) or enrolled (Group 3-5) in the study. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
8.3%
1/12 • All-cause mortality: From randomization/enrollment up to Week 48 + 3 days Adverse events: Groups 1, 2, 3, 5: From first dose up to Week 48 + 3 days Group 4: From first dose up to Week 12 + 30 days (for Group 4, adverse events were planned to be collected only up to Week 12 + 30 days)
All cause mortality: The All Randomized/Enrolled Analysis Set included all participants who were randomized (Group 1 and 2) or enrolled (Group 3-5) in the study. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/30 • All-cause mortality: From randomization/enrollment up to Week 48 + 3 days Adverse events: Groups 1, 2, 3, 5: From first dose up to Week 48 + 3 days Group 4: From first dose up to Week 12 + 30 days (for Group 4, adverse events were planned to be collected only up to Week 12 + 30 days)
All cause mortality: The All Randomized/Enrolled Analysis Set included all participants who were randomized (Group 1 and 2) or enrolled (Group 3-5) in the study. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/21 • All-cause mortality: From randomization/enrollment up to Week 48 + 3 days Adverse events: Groups 1, 2, 3, 5: From first dose up to Week 48 + 3 days Group 4: From first dose up to Week 12 + 30 days (for Group 4, adverse events were planned to be collected only up to Week 12 + 30 days)
All cause mortality: The All Randomized/Enrolled Analysis Set included all participants who were randomized (Group 1 and 2) or enrolled (Group 3-5) in the study. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/30 • All-cause mortality: From randomization/enrollment up to Week 48 + 3 days Adverse events: Groups 1, 2, 3, 5: From first dose up to Week 48 + 3 days Group 4: From first dose up to Week 12 + 30 days (for Group 4, adverse events were planned to be collected only up to Week 12 + 30 days)
All cause mortality: The All Randomized/Enrolled Analysis Set included all participants who were randomized (Group 1 and 2) or enrolled (Group 3-5) in the study. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Investigations
Alanine aminotransferase increased
|
13.3%
4/30 • All-cause mortality: From randomization/enrollment up to Week 48 + 3 days Adverse events: Groups 1, 2, 3, 5: From first dose up to Week 48 + 3 days Group 4: From first dose up to Week 12 + 30 days (for Group 4, adverse events were planned to be collected only up to Week 12 + 30 days)
All cause mortality: The All Randomized/Enrolled Analysis Set included all participants who were randomized (Group 1 and 2) or enrolled (Group 3-5) in the study. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
8.3%
1/12 • All-cause mortality: From randomization/enrollment up to Week 48 + 3 days Adverse events: Groups 1, 2, 3, 5: From first dose up to Week 48 + 3 days Group 4: From first dose up to Week 12 + 30 days (for Group 4, adverse events were planned to be collected only up to Week 12 + 30 days)
All cause mortality: The All Randomized/Enrolled Analysis Set included all participants who were randomized (Group 1 and 2) or enrolled (Group 3-5) in the study. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
3.3%
1/30 • All-cause mortality: From randomization/enrollment up to Week 48 + 3 days Adverse events: Groups 1, 2, 3, 5: From first dose up to Week 48 + 3 days Group 4: From first dose up to Week 12 + 30 days (for Group 4, adverse events were planned to be collected only up to Week 12 + 30 days)
All cause mortality: The All Randomized/Enrolled Analysis Set included all participants who were randomized (Group 1 and 2) or enrolled (Group 3-5) in the study. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
4.8%
1/21 • All-cause mortality: From randomization/enrollment up to Week 48 + 3 days Adverse events: Groups 1, 2, 3, 5: From first dose up to Week 48 + 3 days Group 4: From first dose up to Week 12 + 30 days (for Group 4, adverse events were planned to be collected only up to Week 12 + 30 days)
All cause mortality: The All Randomized/Enrolled Analysis Set included all participants who were randomized (Group 1 and 2) or enrolled (Group 3-5) in the study. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/30 • All-cause mortality: From randomization/enrollment up to Week 48 + 3 days Adverse events: Groups 1, 2, 3, 5: From first dose up to Week 48 + 3 days Group 4: From first dose up to Week 12 + 30 days (for Group 4, adverse events were planned to be collected only up to Week 12 + 30 days)
All cause mortality: The All Randomized/Enrolled Analysis Set included all participants who were randomized (Group 1 and 2) or enrolled (Group 3-5) in the study. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/30 • All-cause mortality: From randomization/enrollment up to Week 48 + 3 days Adverse events: Groups 1, 2, 3, 5: From first dose up to Week 48 + 3 days Group 4: From first dose up to Week 12 + 30 days (for Group 4, adverse events were planned to be collected only up to Week 12 + 30 days)
All cause mortality: The All Randomized/Enrolled Analysis Set included all participants who were randomized (Group 1 and 2) or enrolled (Group 3-5) in the study. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
8.3%
1/12 • All-cause mortality: From randomization/enrollment up to Week 48 + 3 days Adverse events: Groups 1, 2, 3, 5: From first dose up to Week 48 + 3 days Group 4: From first dose up to Week 12 + 30 days (for Group 4, adverse events were planned to be collected only up to Week 12 + 30 days)
All cause mortality: The All Randomized/Enrolled Analysis Set included all participants who were randomized (Group 1 and 2) or enrolled (Group 3-5) in the study. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/30 • All-cause mortality: From randomization/enrollment up to Week 48 + 3 days Adverse events: Groups 1, 2, 3, 5: From first dose up to Week 48 + 3 days Group 4: From first dose up to Week 12 + 30 days (for Group 4, adverse events were planned to be collected only up to Week 12 + 30 days)
All cause mortality: The All Randomized/Enrolled Analysis Set included all participants who were randomized (Group 1 and 2) or enrolled (Group 3-5) in the study. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/21 • All-cause mortality: From randomization/enrollment up to Week 48 + 3 days Adverse events: Groups 1, 2, 3, 5: From first dose up to Week 48 + 3 days Group 4: From first dose up to Week 12 + 30 days (for Group 4, adverse events were planned to be collected only up to Week 12 + 30 days)
All cause mortality: The All Randomized/Enrolled Analysis Set included all participants who were randomized (Group 1 and 2) or enrolled (Group 3-5) in the study. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/30 • All-cause mortality: From randomization/enrollment up to Week 48 + 3 days Adverse events: Groups 1, 2, 3, 5: From first dose up to Week 48 + 3 days Group 4: From first dose up to Week 12 + 30 days (for Group 4, adverse events were planned to be collected only up to Week 12 + 30 days)
All cause mortality: The All Randomized/Enrolled Analysis Set included all participants who were randomized (Group 1 and 2) or enrolled (Group 3-5) in the study. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/30 • All-cause mortality: From randomization/enrollment up to Week 48 + 3 days Adverse events: Groups 1, 2, 3, 5: From first dose up to Week 48 + 3 days Group 4: From first dose up to Week 12 + 30 days (for Group 4, adverse events were planned to be collected only up to Week 12 + 30 days)
All cause mortality: The All Randomized/Enrolled Analysis Set included all participants who were randomized (Group 1 and 2) or enrolled (Group 3-5) in the study. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/12 • All-cause mortality: From randomization/enrollment up to Week 48 + 3 days Adverse events: Groups 1, 2, 3, 5: From first dose up to Week 48 + 3 days Group 4: From first dose up to Week 12 + 30 days (for Group 4, adverse events were planned to be collected only up to Week 12 + 30 days)
All cause mortality: The All Randomized/Enrolled Analysis Set included all participants who were randomized (Group 1 and 2) or enrolled (Group 3-5) in the study. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
6.7%
2/30 • All-cause mortality: From randomization/enrollment up to Week 48 + 3 days Adverse events: Groups 1, 2, 3, 5: From first dose up to Week 48 + 3 days Group 4: From first dose up to Week 12 + 30 days (for Group 4, adverse events were planned to be collected only up to Week 12 + 30 days)
All cause mortality: The All Randomized/Enrolled Analysis Set included all participants who were randomized (Group 1 and 2) or enrolled (Group 3-5) in the study. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
4.8%
1/21 • All-cause mortality: From randomization/enrollment up to Week 48 + 3 days Adverse events: Groups 1, 2, 3, 5: From first dose up to Week 48 + 3 days Group 4: From first dose up to Week 12 + 30 days (for Group 4, adverse events were planned to be collected only up to Week 12 + 30 days)
All cause mortality: The All Randomized/Enrolled Analysis Set included all participants who were randomized (Group 1 and 2) or enrolled (Group 3-5) in the study. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
6.7%
2/30 • All-cause mortality: From randomization/enrollment up to Week 48 + 3 days Adverse events: Groups 1, 2, 3, 5: From first dose up to Week 48 + 3 days Group 4: From first dose up to Week 12 + 30 days (for Group 4, adverse events were planned to be collected only up to Week 12 + 30 days)
All cause mortality: The All Randomized/Enrolled Analysis Set included all participants who were randomized (Group 1 and 2) or enrolled (Group 3-5) in the study. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Nervous system disorders
Headache
|
3.3%
1/30 • All-cause mortality: From randomization/enrollment up to Week 48 + 3 days Adverse events: Groups 1, 2, 3, 5: From first dose up to Week 48 + 3 days Group 4: From first dose up to Week 12 + 30 days (for Group 4, adverse events were planned to be collected only up to Week 12 + 30 days)
All cause mortality: The All Randomized/Enrolled Analysis Set included all participants who were randomized (Group 1 and 2) or enrolled (Group 3-5) in the study. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/12 • All-cause mortality: From randomization/enrollment up to Week 48 + 3 days Adverse events: Groups 1, 2, 3, 5: From first dose up to Week 48 + 3 days Group 4: From first dose up to Week 12 + 30 days (for Group 4, adverse events were planned to be collected only up to Week 12 + 30 days)
All cause mortality: The All Randomized/Enrolled Analysis Set included all participants who were randomized (Group 1 and 2) or enrolled (Group 3-5) in the study. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
10.0%
3/30 • All-cause mortality: From randomization/enrollment up to Week 48 + 3 days Adverse events: Groups 1, 2, 3, 5: From first dose up to Week 48 + 3 days Group 4: From first dose up to Week 12 + 30 days (for Group 4, adverse events were planned to be collected only up to Week 12 + 30 days)
All cause mortality: The All Randomized/Enrolled Analysis Set included all participants who were randomized (Group 1 and 2) or enrolled (Group 3-5) in the study. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/21 • All-cause mortality: From randomization/enrollment up to Week 48 + 3 days Adverse events: Groups 1, 2, 3, 5: From first dose up to Week 48 + 3 days Group 4: From first dose up to Week 12 + 30 days (for Group 4, adverse events were planned to be collected only up to Week 12 + 30 days)
All cause mortality: The All Randomized/Enrolled Analysis Set included all participants who were randomized (Group 1 and 2) or enrolled (Group 3-5) in the study. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
6.7%
2/30 • All-cause mortality: From randomization/enrollment up to Week 48 + 3 days Adverse events: Groups 1, 2, 3, 5: From first dose up to Week 48 + 3 days Group 4: From first dose up to Week 12 + 30 days (for Group 4, adverse events were planned to be collected only up to Week 12 + 30 days)
All cause mortality: The All Randomized/Enrolled Analysis Set included all participants who were randomized (Group 1 and 2) or enrolled (Group 3-5) in the study. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/30 • All-cause mortality: From randomization/enrollment up to Week 48 + 3 days Adverse events: Groups 1, 2, 3, 5: From first dose up to Week 48 + 3 days Group 4: From first dose up to Week 12 + 30 days (for Group 4, adverse events were planned to be collected only up to Week 12 + 30 days)
All cause mortality: The All Randomized/Enrolled Analysis Set included all participants who were randomized (Group 1 and 2) or enrolled (Group 3-5) in the study. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
8.3%
1/12 • All-cause mortality: From randomization/enrollment up to Week 48 + 3 days Adverse events: Groups 1, 2, 3, 5: From first dose up to Week 48 + 3 days Group 4: From first dose up to Week 12 + 30 days (for Group 4, adverse events were planned to be collected only up to Week 12 + 30 days)
All cause mortality: The All Randomized/Enrolled Analysis Set included all participants who were randomized (Group 1 and 2) or enrolled (Group 3-5) in the study. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
3.3%
1/30 • All-cause mortality: From randomization/enrollment up to Week 48 + 3 days Adverse events: Groups 1, 2, 3, 5: From first dose up to Week 48 + 3 days Group 4: From first dose up to Week 12 + 30 days (for Group 4, adverse events were planned to be collected only up to Week 12 + 30 days)
All cause mortality: The All Randomized/Enrolled Analysis Set included all participants who were randomized (Group 1 and 2) or enrolled (Group 3-5) in the study. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/21 • All-cause mortality: From randomization/enrollment up to Week 48 + 3 days Adverse events: Groups 1, 2, 3, 5: From first dose up to Week 48 + 3 days Group 4: From first dose up to Week 12 + 30 days (for Group 4, adverse events were planned to be collected only up to Week 12 + 30 days)
All cause mortality: The All Randomized/Enrolled Analysis Set included all participants who were randomized (Group 1 and 2) or enrolled (Group 3-5) in the study. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/30 • All-cause mortality: From randomization/enrollment up to Week 48 + 3 days Adverse events: Groups 1, 2, 3, 5: From first dose up to Week 48 + 3 days Group 4: From first dose up to Week 12 + 30 days (for Group 4, adverse events were planned to be collected only up to Week 12 + 30 days)
All cause mortality: The All Randomized/Enrolled Analysis Set included all participants who were randomized (Group 1 and 2) or enrolled (Group 3-5) in the study. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/30 • All-cause mortality: From randomization/enrollment up to Week 48 + 3 days Adverse events: Groups 1, 2, 3, 5: From first dose up to Week 48 + 3 days Group 4: From first dose up to Week 12 + 30 days (for Group 4, adverse events were planned to be collected only up to Week 12 + 30 days)
All cause mortality: The All Randomized/Enrolled Analysis Set included all participants who were randomized (Group 1 and 2) or enrolled (Group 3-5) in the study. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
8.3%
1/12 • All-cause mortality: From randomization/enrollment up to Week 48 + 3 days Adverse events: Groups 1, 2, 3, 5: From first dose up to Week 48 + 3 days Group 4: From first dose up to Week 12 + 30 days (for Group 4, adverse events were planned to be collected only up to Week 12 + 30 days)
All cause mortality: The All Randomized/Enrolled Analysis Set included all participants who were randomized (Group 1 and 2) or enrolled (Group 3-5) in the study. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/30 • All-cause mortality: From randomization/enrollment up to Week 48 + 3 days Adverse events: Groups 1, 2, 3, 5: From first dose up to Week 48 + 3 days Group 4: From first dose up to Week 12 + 30 days (for Group 4, adverse events were planned to be collected only up to Week 12 + 30 days)
All cause mortality: The All Randomized/Enrolled Analysis Set included all participants who were randomized (Group 1 and 2) or enrolled (Group 3-5) in the study. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/21 • All-cause mortality: From randomization/enrollment up to Week 48 + 3 days Adverse events: Groups 1, 2, 3, 5: From first dose up to Week 48 + 3 days Group 4: From first dose up to Week 12 + 30 days (for Group 4, adverse events were planned to be collected only up to Week 12 + 30 days)
All cause mortality: The All Randomized/Enrolled Analysis Set included all participants who were randomized (Group 1 and 2) or enrolled (Group 3-5) in the study. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/30 • All-cause mortality: From randomization/enrollment up to Week 48 + 3 days Adverse events: Groups 1, 2, 3, 5: From first dose up to Week 48 + 3 days Group 4: From first dose up to Week 12 + 30 days (for Group 4, adverse events were planned to be collected only up to Week 12 + 30 days)
All cause mortality: The All Randomized/Enrolled Analysis Set included all participants who were randomized (Group 1 and 2) or enrolled (Group 3-5) in the study. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/30 • All-cause mortality: From randomization/enrollment up to Week 48 + 3 days Adverse events: Groups 1, 2, 3, 5: From first dose up to Week 48 + 3 days Group 4: From first dose up to Week 12 + 30 days (for Group 4, adverse events were planned to be collected only up to Week 12 + 30 days)
All cause mortality: The All Randomized/Enrolled Analysis Set included all participants who were randomized (Group 1 and 2) or enrolled (Group 3-5) in the study. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/12 • All-cause mortality: From randomization/enrollment up to Week 48 + 3 days Adverse events: Groups 1, 2, 3, 5: From first dose up to Week 48 + 3 days Group 4: From first dose up to Week 12 + 30 days (for Group 4, adverse events were planned to be collected only up to Week 12 + 30 days)
All cause mortality: The All Randomized/Enrolled Analysis Set included all participants who were randomized (Group 1 and 2) or enrolled (Group 3-5) in the study. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
3.3%
1/30 • All-cause mortality: From randomization/enrollment up to Week 48 + 3 days Adverse events: Groups 1, 2, 3, 5: From first dose up to Week 48 + 3 days Group 4: From first dose up to Week 12 + 30 days (for Group 4, adverse events were planned to be collected only up to Week 12 + 30 days)
All cause mortality: The All Randomized/Enrolled Analysis Set included all participants who were randomized (Group 1 and 2) or enrolled (Group 3-5) in the study. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/21 • All-cause mortality: From randomization/enrollment up to Week 48 + 3 days Adverse events: Groups 1, 2, 3, 5: From first dose up to Week 48 + 3 days Group 4: From first dose up to Week 12 + 30 days (for Group 4, adverse events were planned to be collected only up to Week 12 + 30 days)
All cause mortality: The All Randomized/Enrolled Analysis Set included all participants who were randomized (Group 1 and 2) or enrolled (Group 3-5) in the study. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
10.0%
3/30 • All-cause mortality: From randomization/enrollment up to Week 48 + 3 days Adverse events: Groups 1, 2, 3, 5: From first dose up to Week 48 + 3 days Group 4: From first dose up to Week 12 + 30 days (for Group 4, adverse events were planned to be collected only up to Week 12 + 30 days)
All cause mortality: The All Randomized/Enrolled Analysis Set included all participants who were randomized (Group 1 and 2) or enrolled (Group 3-5) in the study. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/30 • All-cause mortality: From randomization/enrollment up to Week 48 + 3 days Adverse events: Groups 1, 2, 3, 5: From first dose up to Week 48 + 3 days Group 4: From first dose up to Week 12 + 30 days (for Group 4, adverse events were planned to be collected only up to Week 12 + 30 days)
All cause mortality: The All Randomized/Enrolled Analysis Set included all participants who were randomized (Group 1 and 2) or enrolled (Group 3-5) in the study. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
8.3%
1/12 • All-cause mortality: From randomization/enrollment up to Week 48 + 3 days Adverse events: Groups 1, 2, 3, 5: From first dose up to Week 48 + 3 days Group 4: From first dose up to Week 12 + 30 days (for Group 4, adverse events were planned to be collected only up to Week 12 + 30 days)
All cause mortality: The All Randomized/Enrolled Analysis Set included all participants who were randomized (Group 1 and 2) or enrolled (Group 3-5) in the study. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/30 • All-cause mortality: From randomization/enrollment up to Week 48 + 3 days Adverse events: Groups 1, 2, 3, 5: From first dose up to Week 48 + 3 days Group 4: From first dose up to Week 12 + 30 days (for Group 4, adverse events were planned to be collected only up to Week 12 + 30 days)
All cause mortality: The All Randomized/Enrolled Analysis Set included all participants who were randomized (Group 1 and 2) or enrolled (Group 3-5) in the study. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/21 • All-cause mortality: From randomization/enrollment up to Week 48 + 3 days Adverse events: Groups 1, 2, 3, 5: From first dose up to Week 48 + 3 days Group 4: From first dose up to Week 12 + 30 days (for Group 4, adverse events were planned to be collected only up to Week 12 + 30 days)
All cause mortality: The All Randomized/Enrolled Analysis Set included all participants who were randomized (Group 1 and 2) or enrolled (Group 3-5) in the study. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/30 • All-cause mortality: From randomization/enrollment up to Week 48 + 3 days Adverse events: Groups 1, 2, 3, 5: From first dose up to Week 48 + 3 days Group 4: From first dose up to Week 12 + 30 days (for Group 4, adverse events were planned to be collected only up to Week 12 + 30 days)
All cause mortality: The All Randomized/Enrolled Analysis Set included all participants who were randomized (Group 1 and 2) or enrolled (Group 3-5) in the study. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/30 • All-cause mortality: From randomization/enrollment up to Week 48 + 3 days Adverse events: Groups 1, 2, 3, 5: From first dose up to Week 48 + 3 days Group 4: From first dose up to Week 12 + 30 days (for Group 4, adverse events were planned to be collected only up to Week 12 + 30 days)
All cause mortality: The All Randomized/Enrolled Analysis Set included all participants who were randomized (Group 1 and 2) or enrolled (Group 3-5) in the study. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
8.3%
1/12 • All-cause mortality: From randomization/enrollment up to Week 48 + 3 days Adverse events: Groups 1, 2, 3, 5: From first dose up to Week 48 + 3 days Group 4: From first dose up to Week 12 + 30 days (for Group 4, adverse events were planned to be collected only up to Week 12 + 30 days)
All cause mortality: The All Randomized/Enrolled Analysis Set included all participants who were randomized (Group 1 and 2) or enrolled (Group 3-5) in the study. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/30 • All-cause mortality: From randomization/enrollment up to Week 48 + 3 days Adverse events: Groups 1, 2, 3, 5: From first dose up to Week 48 + 3 days Group 4: From first dose up to Week 12 + 30 days (for Group 4, adverse events were planned to be collected only up to Week 12 + 30 days)
All cause mortality: The All Randomized/Enrolled Analysis Set included all participants who were randomized (Group 1 and 2) or enrolled (Group 3-5) in the study. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/21 • All-cause mortality: From randomization/enrollment up to Week 48 + 3 days Adverse events: Groups 1, 2, 3, 5: From first dose up to Week 48 + 3 days Group 4: From first dose up to Week 12 + 30 days (for Group 4, adverse events were planned to be collected only up to Week 12 + 30 days)
All cause mortality: The All Randomized/Enrolled Analysis Set included all participants who were randomized (Group 1 and 2) or enrolled (Group 3-5) in the study. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/30 • All-cause mortality: From randomization/enrollment up to Week 48 + 3 days Adverse events: Groups 1, 2, 3, 5: From first dose up to Week 48 + 3 days Group 4: From first dose up to Week 12 + 30 days (for Group 4, adverse events were planned to be collected only up to Week 12 + 30 days)
All cause mortality: The All Randomized/Enrolled Analysis Set included all participants who were randomized (Group 1 and 2) or enrolled (Group 3-5) in the study. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Vascular disorders
Hypertension
|
0.00%
0/30 • All-cause mortality: From randomization/enrollment up to Week 48 + 3 days Adverse events: Groups 1, 2, 3, 5: From first dose up to Week 48 + 3 days Group 4: From first dose up to Week 12 + 30 days (for Group 4, adverse events were planned to be collected only up to Week 12 + 30 days)
All cause mortality: The All Randomized/Enrolled Analysis Set included all participants who were randomized (Group 1 and 2) or enrolled (Group 3-5) in the study. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
8.3%
1/12 • All-cause mortality: From randomization/enrollment up to Week 48 + 3 days Adverse events: Groups 1, 2, 3, 5: From first dose up to Week 48 + 3 days Group 4: From first dose up to Week 12 + 30 days (for Group 4, adverse events were planned to be collected only up to Week 12 + 30 days)
All cause mortality: The All Randomized/Enrolled Analysis Set included all participants who were randomized (Group 1 and 2) or enrolled (Group 3-5) in the study. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
3.3%
1/30 • All-cause mortality: From randomization/enrollment up to Week 48 + 3 days Adverse events: Groups 1, 2, 3, 5: From first dose up to Week 48 + 3 days Group 4: From first dose up to Week 12 + 30 days (for Group 4, adverse events were planned to be collected only up to Week 12 + 30 days)
All cause mortality: The All Randomized/Enrolled Analysis Set included all participants who were randomized (Group 1 and 2) or enrolled (Group 3-5) in the study. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/21 • All-cause mortality: From randomization/enrollment up to Week 48 + 3 days Adverse events: Groups 1, 2, 3, 5: From first dose up to Week 48 + 3 days Group 4: From first dose up to Week 12 + 30 days (for Group 4, adverse events were planned to be collected only up to Week 12 + 30 days)
All cause mortality: The All Randomized/Enrolled Analysis Set included all participants who were randomized (Group 1 and 2) or enrolled (Group 3-5) in the study. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/30 • All-cause mortality: From randomization/enrollment up to Week 48 + 3 days Adverse events: Groups 1, 2, 3, 5: From first dose up to Week 48 + 3 days Group 4: From first dose up to Week 12 + 30 days (for Group 4, adverse events were planned to be collected only up to Week 12 + 30 days)
All cause mortality: The All Randomized/Enrolled Analysis Set included all participants who were randomized (Group 1 and 2) or enrolled (Group 3-5) in the study. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any 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