Trial Outcomes & Findings for Study to Assess Efficacy and Safety of Bulevirtide in Participants With Chronic Hepatitis Delta (CHD) (NCT NCT03852719)

NCT ID: NCT03852719

Last Updated: 2025-08-22

Results Overview

Combined response was defined as fulfilment of two conditions simultaneously: Undetectable (\< lower limit of quantification (LLOQ, target not detected)) HDV RNA or decrease by ≥ 2 log10 IU/mL from baseline; and ALT normalization.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

150 participants

Primary outcome timeframe

Week 48

Results posted on

2025-08-22

Participant Flow

Participants were enrolled at study sites in Germany, Italy, Russia, and Sweden.

183 participants were screened.

Participant milestones

Participant milestones
Measure
Delayed Treatment/Bulevirtide 10 mg/Day
After an observational period of 48 weeks, participants received bulevirtide 10 mg/day subcutaneous (SC) injection for 96 weeks and were followed for up to 96 weeks (Up to Week 240).
Bulevirtide 2 mg/Day
Participants received bulevirtide 2 mg/day SC injection for 144 weeks and were followed for up to 96 weeks (Up to Week 240).
Bulevirtide 10 mg/Day
Participants received bulevirtide 10 mg/day SC injection for 144 weeks and were followed for up to 96 weeks (Up to Week 240).
Overall Study
STARTED
51
49
50
Overall Study
Did Not Receive Bulevirtide
1
0
0
Overall Study
COMPLETED
28
28
30
Overall Study
NOT COMPLETED
23
21
20

Reasons for withdrawal

Reasons for withdrawal
Measure
Delayed Treatment/Bulevirtide 10 mg/Day
After an observational period of 48 weeks, participants received bulevirtide 10 mg/day subcutaneous (SC) injection for 96 weeks and were followed for up to 96 weeks (Up to Week 240).
Bulevirtide 2 mg/Day
Participants received bulevirtide 2 mg/day SC injection for 144 weeks and were followed for up to 96 weeks (Up to Week 240).
Bulevirtide 10 mg/Day
Participants received bulevirtide 10 mg/day SC injection for 144 weeks and were followed for up to 96 weeks (Up to Week 240).
Overall Study
Withdrawal of consent
8
8
9
Overall Study
Physician Decision
5
4
1
Overall Study
Pregnancy
2
1
0
Overall Study
Death
1
0
0
Overall Study
Reason not Specified
3
3
5
Overall Study
Adverse Event
2
1
4
Overall Study
Progressive disease
1
4
1
Overall Study
Lost to Follow-up
1
0
0

Baseline Characteristics

Study to Assess Efficacy and Safety of Bulevirtide in Participants With Chronic Hepatitis Delta (CHD)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Delayed Treatment/Bulevirtide 10 mg/Day
n=51 Participants
After an observational period of 48 weeks, participants received bulevirtide 10 mg/day SC injection for 96 weeks and were followed for up to 96 weeks (Up to Week 240).
Bulevirtide 2 mg/Day
n=49 Participants
Participants received bulevirtide 2 mg/day SC injection for 144 weeks and were followed for up to 96 weeks (Up to Week 240).
Bulevirtide 10 mg/Day
n=50 Participants
Participants received bulevirtide 10 mg/day SC injection for 144 weeks and were followed for up to 96 weeks (Up to Week 240).
Total
n=150 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
Age, Categorical
Between 18 and 65 years
51 Participants
n=5 Participants
49 Participants
n=7 Participants
50 Participants
n=5 Participants
150 Participants
n=4 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
Age, Continuous
41 years
STANDARD_DEVIATION 7.5 • n=5 Participants
44 years
STANDARD_DEVIATION 9.0 • n=7 Participants
41 years
STANDARD_DEVIATION 8.5 • n=5 Participants
42 years
STANDARD_DEVIATION 8.4 • n=4 Participants
Sex: Female, Male
Female
25 Participants
n=5 Participants
19 Participants
n=7 Participants
20 Participants
n=5 Participants
64 Participants
n=4 Participants
Sex: Female, Male
Male
26 Participants
n=5 Participants
30 Participants
n=7 Participants
30 Participants
n=5 Participants
86 Participants
n=4 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
Race (NIH/OMB)
Asian
11 Participants
n=5 Participants
8 Participants
n=7 Participants
6 Participants
n=5 Participants
25 Participants
n=4 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=5 Participants
0 Participants
n=7 Participants
1 Participants
n=5 Participants
1 Participants
n=4 Participants
Race (NIH/OMB)
White
40 Participants
n=5 Participants
41 Participants
n=7 Participants
43 Participants
n=5 Participants
124 Participants
n=4 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
Region of Enrollment
Germany
7 Participants
n=5 Participants
6 Participants
n=7 Participants
14 Participants
n=5 Participants
27 Participants
n=4 Participants
Region of Enrollment
Italy
7 Participants
n=5 Participants
11 Participants
n=7 Participants
6 Participants
n=5 Participants
24 Participants
n=4 Participants
Region of Enrollment
Russia
29 Participants
n=5 Participants
28 Participants
n=7 Participants
28 Participants
n=5 Participants
85 Participants
n=4 Participants
Region of Enrollment
Sweden
8 Participants
n=5 Participants
4 Participants
n=7 Participants
2 Participants
n=5 Participants
14 Participants
n=4 Participants
Hepatitis Delta Virus (HDV) Ribonucleic Acid (RNA)
5.08 log10 IU/mL
STANDARD_DEVIATION 1.358 • n=5 Participants
5.10 log10 IU/mL
STANDARD_DEVIATION 1.194 • n=7 Participants
4.96 log10 IU/mL
STANDARD_DEVIATION 1.461 • n=5 Participants
5.04 log10 IU/mL
STANDARD_DEVIATION 1.336 • n=4 Participants
Liver stiffness
15.3 kPa
STANDARD_DEVIATION 8.95 • n=5 Participants
14.0 kPa
STANDARD_DEVIATION 8.19 • n=7 Participants
14.8 kPa
STANDARD_DEVIATION 9.26 • n=5 Participants
14.7 kPa
STANDARD_DEVIATION 8.77 • n=4 Participants

PRIMARY outcome

Timeframe: Week 48

Population: The Full Analysis Set included participants randomized to delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. Participants were grouped according to randomized treatment. The arm titles and descriptions in this outcome measure are entered accordingly.

Combined response was defined as fulfilment of two conditions simultaneously: Undetectable (\< lower limit of quantification (LLOQ, target not detected)) HDV RNA or decrease by ≥ 2 log10 IU/mL from baseline; and ALT normalization.

Outcome measures

Outcome measures
Measure
Delayed Treatment
n=51 Participants
Observation period of 48 weeks.
Bulevirtide 2 mg/Day
n=49 Participants
Participants received bulevirtide 2 mg/day SC injection for 48 weeks.
Bulevirtide 10 mg/Day
n=50 Participants
Participants received bulevirtide 10 mg/day SC injection for 48 weeks.
Delayed Treatment / /Bulevirtide 10 mg/Day
Participants received Bulevirtide 10 mg/Day SC for 48 weeks after an observation period of 48 weeks.
Percentage of Participants With Combined Response at Week 48
2.0 percentage of participants
Interval 0.0 to 10.4
44.9 percentage of participants
Interval 30.7 to 59.8
48.0 percentage of participants
Interval 33.7 to 62.6

SECONDARY outcome

Timeframe: Week 48

Population: Participants in the Full Analysis Set were analyzed. Participants were grouped according to randomized treatment. The arm titles and descriptions in this outcome measure are entered accordingly.

Undetectable HDV RNA at Week 48 means undetectable (\< LLOQ, target not detected) HDV RNA at Week 48.

Outcome measures

Outcome measures
Measure
Delayed Treatment
n=51 Participants
Observation period of 48 weeks.
Bulevirtide 2 mg/Day
n=49 Participants
Participants received bulevirtide 2 mg/day SC injection for 48 weeks.
Bulevirtide 10 mg/Day
n=50 Participants
Participants received bulevirtide 10 mg/day SC injection for 48 weeks.
Delayed Treatment / /Bulevirtide 10 mg/Day
Participants received Bulevirtide 10 mg/Day SC for 48 weeks after an observation period of 48 weeks.
Percentage of Participants With Undetectable HDV RNA at Week 48
0 percentage of participants
Interval 0.0 to 7.0
12.2 percentage of participants
Interval 4.6 to 24.8
20.0 percentage of participants
Interval 10.0 to 33.7

SECONDARY outcome

Timeframe: Week 48

Population: Participants in the Full Analysis Set were analyzed. Participants were grouped according to randomized treatment. The arm titles and descriptions in this outcome measure are entered accordingly.

ALT normalization was defined as an ALT value within the normal range, based on the central laboratories \[Russian sites: ≤ 31 U/L for females and ≤ 41 U/L for males; all other sites: ≤ 34 U/L for females and ≤ 49 U/L for males\])

Outcome measures

Outcome measures
Measure
Delayed Treatment
n=51 Participants
Observation period of 48 weeks.
Bulevirtide 2 mg/Day
n=49 Participants
Participants received bulevirtide 2 mg/day SC injection for 48 weeks.
Bulevirtide 10 mg/Day
n=50 Participants
Participants received bulevirtide 10 mg/day SC injection for 48 weeks.
Delayed Treatment / /Bulevirtide 10 mg/Day
Participants received Bulevirtide 10 mg/Day SC for 48 weeks after an observation period of 48 weeks.
Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Week 48
11.8 percentage of participants
Interval 4.4 to 23.9
51.0 percentage of participants
Interval 36.3 to 65.6
56.0 percentage of participants
Interval 41.3 to 70.0

SECONDARY outcome

Timeframe: Baseline (Baseline for Delayed Treatment/Bulevirtide 10 mg/day is reset at Week 48), Week 48

Population: Participants in the Full Analysis Set with available data were analyzed. Data is reported separately for changes from Baseline at Week 48 for the Delayed Treatment arm and for Delayed Treatment/Bulevirtide 10 mg/day arm after 48 weeks of bulevirtide 10 mg treatment. Participants were grouped according to randomized treatment and study design. The arm titles and descriptions in the outcome measure are entered accordingly.

ANCOVA was used for analysis.

Outcome measures

Outcome measures
Measure
Delayed Treatment
n=46 Participants
Observation period of 48 weeks.
Bulevirtide 2 mg/Day
n=48 Participants
Participants received bulevirtide 2 mg/day SC injection for 48 weeks.
Bulevirtide 10 mg/Day
n=42 Participants
Participants received bulevirtide 10 mg/day SC injection for 48 weeks.
Delayed Treatment / /Bulevirtide 10 mg/Day
n=48 Participants
Participants received Bulevirtide 10 mg/Day SC for 48 weeks after an observation period of 48 weeks.
Change From Baseline in Liver Stiffness, as Measured by Elastography at Week 48
0.87 kPa
Interval -0.79 to 2.53
-3.06 kPa
Interval -4.67 to -1.45
-3.16 kPa
Interval -4.88 to -1.43
-3.36 kPa
Interval -4.6 to -2.12

SECONDARY outcome

Timeframe: Baseline (Baseline for Delayed Treatment/Bulevirtide 10 mg/day is reset at Week 48), Week 96

Population: Participants from Full Analysis Set with available data were analyzed. Participants were grouped according to randomized treatment and study design. The arm titles and descriptions in the outcome measure are entered accordingly.

Mixed model for repeated measurements (MMRM) was used for analysis.

Outcome measures

Outcome measures
Measure
Delayed Treatment
n=47 Participants
Observation period of 48 weeks.
Bulevirtide 2 mg/Day
n=47 Participants
Participants received bulevirtide 2 mg/day SC injection for 48 weeks.
Bulevirtide 10 mg/Day
n=48 Participants
Participants received bulevirtide 10 mg/day SC injection for 48 weeks.
Delayed Treatment / /Bulevirtide 10 mg/Day
Participants received Bulevirtide 10 mg/Day SC for 48 weeks after an observation period of 48 weeks.
Change From Baseline in Liver Stiffness, as Measured by Elastography at Week 96
-4.31 kPa
Interval -5.54 to -3.08
-4.88 kPa
Interval -6.11 to -3.65
-4.20 kPa
Interval -5.41 to -2.98

SECONDARY outcome

Timeframe: Baseline, Week 144

Population: Participants from Full Analysis Set with available data were analyzed. Participants were grouped according to randomized treatment and study design. The arm titles and descriptions in the outcome measure are entered accordingly.

MMRM was used for analysis.

Outcome measures

Outcome measures
Measure
Delayed Treatment
n=45 Participants
Observation period of 48 weeks.
Bulevirtide 2 mg/Day
n=43 Participants
Participants received bulevirtide 2 mg/day SC injection for 48 weeks.
Bulevirtide 10 mg/Day
Participants received bulevirtide 10 mg/day SC injection for 48 weeks.
Delayed Treatment / /Bulevirtide 10 mg/Day
Participants received Bulevirtide 10 mg/Day SC for 48 weeks after an observation period of 48 weeks.
Change From Baseline in Liver Stiffness, as Measured by Elastography at Week 144
-5.24 kPa
Interval -6.85 to -3.63
-4.03 kPa
Interval -5.67 to -2.4

SECONDARY outcome

Timeframe: Baseline (Baseline for Delayed Treatment/Bulevirtide 10 mg/day is reset at Week 48), Week 192

Population: Participants from Full Analysis Set with available data were analyzed. Participants were grouped according to randomized treatment and study design. The arm titles and descriptions in the outcome measure are entered accordingly.

MMRM was used for analysis.

Outcome measures

Outcome measures
Measure
Delayed Treatment
n=35 Participants
Observation period of 48 weeks.
Bulevirtide 2 mg/Day
n=34 Participants
Participants received bulevirtide 2 mg/day SC injection for 48 weeks.
Bulevirtide 10 mg/Day
n=35 Participants
Participants received bulevirtide 10 mg/day SC injection for 48 weeks.
Delayed Treatment / /Bulevirtide 10 mg/Day
Participants received Bulevirtide 10 mg/Day SC for 48 weeks after an observation period of 48 weeks.
Change From Baseline in Liver Stiffness, as Measured by Elastography at Week 192
-3.74 kPa
Interval -5.28 to -2.2
-3.70 kPa
Interval -5.27 to -2.14
-1.91 kPa
Interval -3.49 to -0.34

SECONDARY outcome

Timeframe: Baseline (Baseline for Delayed Treatment/Bulevirtide 10 mg/day is reset at Week 48), Week 240

Population: Participants from Full Analysis Set with available data were analyzed. Participants were grouped according to randomized treatment and study design. The arm titles and descriptions in the outcome measure are entered accordingly.

MMRM was used for analysis.

Outcome measures

Outcome measures
Measure
Delayed Treatment
n=28 Participants
Observation period of 48 weeks.
Bulevirtide 2 mg/Day
n=29 Participants
Participants received bulevirtide 2 mg/day SC injection for 48 weeks.
Bulevirtide 10 mg/Day
n=28 Participants
Participants received bulevirtide 10 mg/day SC injection for 48 weeks.
Delayed Treatment / /Bulevirtide 10 mg/Day
Participants received Bulevirtide 10 mg/Day SC for 48 weeks after an observation period of 48 weeks.
Change From Baseline in Liver Stiffness, as Measured by Elastography at Week 240
-1.20 kPa
Interval -3.71 to 1.31
-3.31 kPa
Interval -5.78 to -0.84
-3.59 kPa
Interval -6.14 to -1.04

SECONDARY outcome

Timeframe: Week 168

Population: Participants in the Full Analysis Set were analyzed. Participants were grouped according to randomized treatment and study design. The arm titles and descriptions in the outcome measure are entered accordingly.

Undetectable HDV RNA 24 Weeks after Scheduled End of Treatment means undetectable (\< LLOQ, target not detected) HDV RNA at Week 168

Outcome measures

Outcome measures
Measure
Delayed Treatment
n=49 Participants
Observation period of 48 weeks.
Bulevirtide 2 mg/Day
n=50 Participants
Participants received bulevirtide 2 mg/day SC injection for 48 weeks.
Bulevirtide 10 mg/Day
n=50 Participants
Participants received bulevirtide 10 mg/day SC injection for 48 weeks.
Delayed Treatment / /Bulevirtide 10 mg/Day
Participants received Bulevirtide 10 mg/Day SC for 48 weeks after an observation period of 48 weeks.
Percentage of Participants With Undetectable HDV RNA 24 Weeks After Scheduled End of Treatment (Sustained Virological Response)
18.4 percentage of participants
Interval 8.8 to 32.0
26.0 percentage of participants
Interval 14.6 to 40.3
18.0 percentage of participants
Interval 8.6 to 31.4

SECONDARY outcome

Timeframe: Week 192

Population: Participants in the Full Analysis Set were analyzed. Participants were grouped according to randomized treatment and study design. The arm titles and descriptions in the outcome measure are entered accordingly.

Undetectable HDV RNA 48 Weeks after Scheduled End of Treatment means undetectable (\< LLOQ, target not detected) HDV RNA at Week 192

Outcome measures

Outcome measures
Measure
Delayed Treatment
n=49 Participants
Observation period of 48 weeks.
Bulevirtide 2 mg/Day
n=50 Participants
Participants received bulevirtide 2 mg/day SC injection for 48 weeks.
Bulevirtide 10 mg/Day
n=50 Participants
Participants received bulevirtide 10 mg/day SC injection for 48 weeks.
Delayed Treatment / /Bulevirtide 10 mg/Day
Participants received Bulevirtide 10 mg/Day SC for 48 weeks after an observation period of 48 weeks.
Percentage of Participants With Undetectable HDV RNA 48 Weeks After Scheduled End of Treatment (Sustained Virological Response)
16.3 percentage of participants
Interval 7.3 to 29.7
24.0 percentage of participants
Interval 13.1 to 38.2
16.0 percentage of participants
Interval 7.2 to 29.1

SECONDARY outcome

Timeframe: Delayed Treatment/Bulevirtide 10 mg/day arm: Week 48 up to Week 144; Bulevirtide 2mg/day and 10 mg/day arms: First dose date up to Week 144

Population: Participants in the SAS were analyzed. The SAS included all participants who were randomized into the study and took at least 1 dose of bulevirtide study drug, or who were randomized to the delayed treatment group. Participants were grouped according to actual treatment received for time points Week 0 to 144. The arm titles and descriptions in this outcome measure are entered accordingly.

An AE was defined as any untoward medical occurrence in a participant administered study drug and which did not necessarily have a causal relationship with the study drug. An AE could therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not related to the study drug.

Outcome measures

Outcome measures
Measure
Delayed Treatment
n=49 Participants
Observation period of 48 weeks.
Bulevirtide 2 mg/Day
n=50 Participants
Participants received bulevirtide 2 mg/day SC injection for 48 weeks.
Bulevirtide 10 mg/Day
n=50 Participants
Participants received bulevirtide 10 mg/day SC injection for 48 weeks.
Delayed Treatment / /Bulevirtide 10 mg/Day
Participants received Bulevirtide 10 mg/Day SC for 48 weeks after an observation period of 48 weeks.
Percentage of Participants Who Prematurely Discontinued Study Drug Due to an Adverse Event (AE) by Week 144
0 percentage of participants
0 percentage of participants
0 percentage of participants

Adverse Events

Delayed Treatment (Baseline to Week 48)

Serious events: 1 serious events
Other events: 30 other events
Deaths: 0 deaths

Bulevirtide 2 mg/Day (Baseline to Week 48)

Serious events: 2 serious events
Other events: 35 other events
Deaths: 0 deaths

Bulevirtide 10 mg/Day (Baseline to Week 48)

Serious events: 1 serious events
Other events: 41 other events
Deaths: 0 deaths

Bulevirtide 2 mg/Day (Baseline to Week 144)

Serious events: 3 serious events
Other events: 44 other events
Deaths: 0 deaths

Bulevirtide 10 mg/Day (Baseline to Week 144)

Serious events: 6 serious events
Other events: 46 other events
Deaths: 0 deaths

Delayed Treatment/Bulevirtide 10 mg/Day (Week 48 to Week 144)

Serious events: 3 serious events
Other events: 41 other events
Deaths: 1 deaths

Bulevirtide 2 mg/Day (After EOT (>Week 144 up to Week 240))

Serious events: 7 serious events
Other events: 31 other events
Deaths: 0 deaths

Bulevirtide 10 mg/Day (After EOT (>Week 144 up to Week 240)

Serious events: 7 serious events
Other events: 33 other events
Deaths: 0 deaths

Delayed Treatment/Bulevirtide 10 mg/Day (After EOT (>Week 144 up to Week 240)

Serious events: 8 serious events
Other events: 34 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Delayed Treatment (Baseline to Week 48)
n=51 participants at risk
Observation for 48 weeks.
Bulevirtide 2 mg/Day (Baseline to Week 48)
n=49 participants at risk
Bulevirtide 2 mg/day SC for 48 weeks.
Bulevirtide 10 mg/Day (Baseline to Week 48)
n=50 participants at risk
Bulevirtide 10 mg/day SC for 48 weeks.
Bulevirtide 2 mg/Day (Baseline to Week 144)
n=49 participants at risk
Participants received bulevirtide 2 mg/day SC for 144 weeks.
Bulevirtide 10 mg/Day (Baseline to Week 144)
n=50 participants at risk
Participants received bulevirtide 10 mg/day SC for 144 weeks.
Delayed Treatment/Bulevirtide 10 mg/Day (Week 48 to Week 144)
n=50 participants at risk
After an observational period of 48 weeks, participants received bulevirtide 10 mg/day SC for 96 weeks (Up to Week 144).
Bulevirtide 2 mg/Day (After EOT (>Week 144 up to Week 240))
n=46 participants at risk
After 144 weeks of treatment with bulevirtide 2 mg/day SC, participants were followed for up to 96 weeks (Up to Week 240).
Bulevirtide 10 mg/Day (After EOT (>Week 144 up to Week 240)
n=47 participants at risk
After 144 weeks of treatment with bulevirtide 10 mg/day SC, participants were followed for up to 96 weeks (Up to Week 240).
Delayed Treatment/Bulevirtide 10 mg/Day (After EOT (>Week 144 up to Week 240)
n=49 participants at risk
After 96 weeks of treatment (Up to Week 144) with bulevirtide 10 mg/day SC, participants were followed for up to 96 weeks (Up to Week 240).
Blood and lymphatic system disorders
Anaemia
0.00%
0/51 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
2.2%
1/46 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/47 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
Gastrointestinal disorders
Oesophageal varices haemorrhage
0.00%
0/51 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
2.2%
1/46 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/47 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
Gastrointestinal disorders
Varices oesophageal
0.00%
0/51 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
2.0%
1/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/46 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/47 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
Hepatobiliary disorders
Cholelithiasis
2.0%
1/51 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/46 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/47 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
Hepatobiliary disorders
Hepatic fibrosis
0.00%
0/51 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/46 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/47 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
2.0%
1/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
Hepatobiliary disorders
Hepatic function abnormal
0.00%
0/51 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/46 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/47 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
2.0%
1/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
Hepatobiliary disorders
Hepatitis
0.00%
0/51 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/46 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/47 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
2.0%
1/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
Hepatobiliary disorders
Hepatitis acute
0.00%
0/51 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
2.2%
1/46 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/47 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
Hepatobiliary disorders
Liver injury
0.00%
0/51 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/46 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/47 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
2.0%
1/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
Infections and infestations
Chronic hepatitis B
0.00%
0/51 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/46 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/47 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
2.0%
1/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
Infections and infestations
Coronavirus pneumonia
0.00%
0/51 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
2.0%
1/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/46 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/47 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
Infections and infestations
Covid-19
2.0%
1/51 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
2.0%
1/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/46 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/47 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
2.0%
1/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
Infections and infestations
Covid-19 pneumonia
0.00%
0/51 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
2.0%
1/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
4.0%
2/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/46 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/47 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
Infections and infestations
Hepatitis D
0.00%
0/51 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
8.7%
4/46 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
8.5%
4/47 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
4.1%
2/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
Infections and infestations
Hepatitis E
0.00%
0/51 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
2.0%
1/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/46 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/47 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
Infections and infestations
Urinary tract infection
0.00%
0/51 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
2.0%
1/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/46 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/47 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
2.0%
1/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
Infections and infestations
Yersinia infection
0.00%
0/51 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
2.0%
1/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/46 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/47 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
Injury, poisoning and procedural complications
Foot fracture
0.00%
0/51 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
2.0%
1/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
2.0%
1/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/46 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/47 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
Injury, poisoning and procedural complications
Lumbar vertebral fracture
0.00%
0/51 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
2.0%
1/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/46 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/47 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
Investigations
Alanine aminotransferase increased
0.00%
0/51 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/46 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
2.1%
1/47 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
2.0%
1/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
Investigations
Transaminases increased
0.00%
0/51 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/46 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
2.1%
1/47 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
2.0%
1/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
0.00%
0/51 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
2.2%
1/46 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/47 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Phyllodes tumour
0.00%
0/51 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
2.0%
1/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/46 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/47 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
0.00%
0/51 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
2.0%
1/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/46 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/47 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
Nervous system disorders
Facial paralysis
0.00%
0/51 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/46 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
2.1%
1/47 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
Nervous system disorders
Headache
0.00%
0/51 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
2.0%
1/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
2.0%
1/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/46 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/47 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
Nervous system disorders
Hemiparesis
0.00%
0/51 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
2.0%
1/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
2.0%
1/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/46 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/47 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
Psychiatric disorders
Depression
0.00%
0/51 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
2.0%
1/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
2.0%
1/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/46 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/47 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
Renal and urinary disorders
Urinary retention
0.00%
0/51 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/46 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/47 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
2.0%
1/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.

Other adverse events

Other adverse events
Measure
Delayed Treatment (Baseline to Week 48)
n=51 participants at risk
Observation for 48 weeks.
Bulevirtide 2 mg/Day (Baseline to Week 48)
n=49 participants at risk
Bulevirtide 2 mg/day SC for 48 weeks.
Bulevirtide 10 mg/Day (Baseline to Week 48)
n=50 participants at risk
Bulevirtide 10 mg/day SC for 48 weeks.
Bulevirtide 2 mg/Day (Baseline to Week 144)
n=49 participants at risk
Participants received bulevirtide 2 mg/day SC for 144 weeks.
Bulevirtide 10 mg/Day (Baseline to Week 144)
n=50 participants at risk
Participants received bulevirtide 10 mg/day SC for 144 weeks.
Delayed Treatment/Bulevirtide 10 mg/Day (Week 48 to Week 144)
n=50 participants at risk
After an observational period of 48 weeks, participants received bulevirtide 10 mg/day SC for 96 weeks (Up to Week 144).
Bulevirtide 2 mg/Day (After EOT (>Week 144 up to Week 240))
n=46 participants at risk
After 144 weeks of treatment with bulevirtide 2 mg/day SC, participants were followed for up to 96 weeks (Up to Week 240).
Bulevirtide 10 mg/Day (After EOT (>Week 144 up to Week 240)
n=47 participants at risk
After 144 weeks of treatment with bulevirtide 10 mg/day SC, participants were followed for up to 96 weeks (Up to Week 240).
Delayed Treatment/Bulevirtide 10 mg/Day (After EOT (>Week 144 up to Week 240)
n=49 participants at risk
After 96 weeks of treatment (Up to Week 144) with bulevirtide 10 mg/day SC, participants were followed for up to 96 weeks (Up to Week 240).
Blood and lymphatic system disorders
Anaemia
5.9%
3/51 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
6.1%
3/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
4.0%
2/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
10.2%
5/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
6.0%
3/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
6.0%
3/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
2.2%
1/46 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
2.1%
1/47 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
10.2%
5/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
Blood and lymphatic system disorders
Eosinophilia
0.00%
0/51 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
10.2%
5/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
10.0%
5/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
10.2%
5/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
10.0%
5/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
2.0%
1/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/46 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/47 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
Blood and lymphatic system disorders
Leukopenia
19.6%
10/51 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
14.3%
7/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
10.0%
5/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
20.4%
10/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
18.0%
9/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
14.0%
7/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
4.3%
2/46 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
8.5%
4/47 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
10.2%
5/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
Blood and lymphatic system disorders
Lymphopenia
7.8%
4/51 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
8.2%
4/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
8.0%
4/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
16.3%
8/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
12.0%
6/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
10.0%
5/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
6.5%
3/46 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
8.5%
4/47 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
14.3%
7/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
Blood and lymphatic system disorders
Neutropenia
5.9%
3/51 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
4.1%
2/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
10.0%
5/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
16.3%
8/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
20.0%
10/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
6.0%
3/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
6.5%
3/46 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
8.5%
4/47 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
6.1%
3/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
Blood and lymphatic system disorders
Thrombocytopenia
15.7%
8/51 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
10.2%
5/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
10.0%
5/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
20.4%
10/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
16.0%
8/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
14.0%
7/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
13.0%
6/46 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
10.6%
5/47 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
14.3%
7/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
Cardiac disorders
Bradycardia
0.00%
0/51 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
6.0%
3/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
2.0%
1/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
6.0%
3/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/46 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/47 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
Cardiac disorders
Sinus bradycardia
2.0%
1/51 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
4.1%
2/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
6.0%
3/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
8.0%
4/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
2.2%
1/46 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
4.3%
2/47 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
Gastrointestinal disorders
Abdominal pain
2.0%
1/51 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
2.0%
1/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
8.0%
4/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
4.1%
2/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
8.0%
4/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
4.0%
2/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/46 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
2.1%
1/47 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
Gastrointestinal disorders
Abdominal pain upper
2.0%
1/51 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
10.0%
5/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
4.1%
2/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
10.0%
5/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
4.0%
2/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/46 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
2.1%
1/47 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
Gastrointestinal disorders
Diarrhoea
0.00%
0/51 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
4.0%
2/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
6.0%
3/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
2.0%
1/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/46 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
2.1%
1/47 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
Gastrointestinal disorders
Gastritis
0.00%
0/51 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
6.0%
3/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/46 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
2.1%
1/47 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
Gastrointestinal disorders
Nausea
3.9%
2/51 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
6.1%
3/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
8.0%
4/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
6.1%
3/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
12.0%
6/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
2.0%
1/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/46 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/47 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
2.0%
1/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
General disorders
Asthenia
0.00%
0/51 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
2.0%
1/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
4.0%
2/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
4.1%
2/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
4.0%
2/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
2.0%
1/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
6.5%
3/46 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
8.5%
4/47 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
8.2%
4/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
General disorders
Fatigue
2.0%
1/51 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
10.2%
5/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
14.0%
7/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
14.3%
7/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
18.0%
9/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
6.0%
3/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/46 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
10.6%
5/47 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
8.2%
4/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
General disorders
Injection site erythema
0.00%
0/51 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
4.1%
2/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
10.0%
5/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
6.1%
3/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
10.0%
5/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
4.0%
2/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/46 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/47 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
General disorders
Injection site pruritus
0.00%
0/51 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
4.1%
2/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
6.0%
3/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
4.1%
2/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
6.0%
3/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
2.0%
1/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/46 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/47 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
General disorders
Injection site reaction
0.00%
0/51 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
6.1%
3/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
10.0%
5/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
6.1%
3/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
12.0%
6/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
6.0%
3/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/46 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/47 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
General disorders
Injection site swelling
0.00%
0/51 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
2.0%
1/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
6.0%
3/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
2.0%
1/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
6.0%
3/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/46 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/47 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
General disorders
Oedema peripheral
0.00%
0/51 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
4.0%
2/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
6.0%
3/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/46 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
2.1%
1/47 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
General disorders
Pyrexia
0.00%
0/51 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
2.0%
1/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
4.0%
2/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
6.1%
3/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
8.0%
4/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
2.0%
1/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
2.2%
1/46 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
4.3%
2/47 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
Hepatobiliary disorders
Hepatic fibrosis
2.0%
1/51 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
2.0%
1/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
4.0%
2/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
10.9%
5/46 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
8.5%
4/47 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
6.1%
3/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
Hepatobiliary disorders
Hyperbilirubinaemia
0.00%
0/51 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
4.1%
2/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
4.0%
2/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
8.2%
4/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
4.0%
2/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
6.0%
3/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
2.2%
1/46 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/47 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
2.0%
1/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
Infections and infestations
Covid-19
2.0%
1/51 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
2.0%
1/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
10.2%
5/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
16.0%
8/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
10.0%
5/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
2.2%
1/46 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/47 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
4.1%
2/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
Infections and infestations
Nasopharyngitis
3.9%
2/51 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
8.2%
4/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
10.2%
5/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
4.0%
2/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
6.0%
3/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
4.3%
2/46 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
2.1%
1/47 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
Infections and infestations
Urinary tract infection
2.0%
1/51 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
2.0%
1/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
4.0%
2/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
4.1%
2/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
12.0%
6/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
4.0%
2/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
2.2%
1/46 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
4.3%
2/47 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
2.0%
1/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
Investigations
Activated partial thromboplastin time prolonged
3.9%
2/51 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
2.0%
1/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
2.0%
1/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
4.0%
2/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
4.3%
2/46 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
6.4%
3/47 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
2.0%
1/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
Investigations
Alanine aminotransferase increased
7.8%
4/51 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
4.1%
2/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
6.0%
3/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
10.2%
5/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
8.0%
4/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
41.3%
19/46 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
23.4%
11/47 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
36.7%
18/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
Investigations
Alpha-2 macroglobulin increased
2.0%
1/51 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
8.2%
4/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
6.0%
3/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
4.0%
2/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
4.3%
2/46 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
6.4%
3/47 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
12.2%
6/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
Investigations
Amylase increased
2.0%
1/51 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
2.0%
1/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
6.1%
3/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
2.0%
1/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/46 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
2.1%
1/47 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
Investigations
Aspartate aminotransferase increased
5.9%
3/51 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
2.0%
1/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
2.0%
1/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
4.1%
2/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
2.0%
1/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
2.0%
1/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
37.0%
17/46 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
23.4%
11/47 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
30.6%
15/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
Investigations
Bilirubin conjugated increased
0.00%
0/51 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
8.7%
4/46 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
2.1%
1/47 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
2.0%
1/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
Investigations
Blood bilirubin increased
0.00%
0/51 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
4.1%
2/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
2.0%
1/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
6.1%
3/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
2.0%
1/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
4.3%
2/46 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
2.1%
1/47 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
2.0%
1/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
Investigations
Gamma-glutamyltransferase increased
2.0%
1/51 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
4.0%
2/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
2.0%
1/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
6.0%
3/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
4.0%
2/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
17.4%
8/46 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
8.5%
4/47 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
6.1%
3/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
Investigations
Hepatitis D RNA positive
0.00%
0/51 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/46 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
8.5%
4/47 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
Investigations
Lipase increased
2.0%
1/51 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
4.1%
2/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
2.0%
1/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
6.1%
3/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
2.0%
1/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
4.0%
2/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
2.2%
1/46 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
4.3%
2/47 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
Investigations
Transaminases increased
0.00%
0/51 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
2.0%
1/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
4.3%
2/46 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
14.9%
7/47 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
4.1%
2/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
Investigations
Weight decreased
0.00%
0/51 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
6.5%
3/46 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
2.1%
1/47 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
2.0%
1/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
Metabolism and nutrition disorders
Vitamin D deficiency
25.5%
13/51 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
14.3%
7/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
14.0%
7/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
44.9%
22/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
38.0%
19/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
28.0%
14/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
13.0%
6/46 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
14.9%
7/47 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
14.3%
7/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
Musculoskeletal and connective tissue disorders
Arthralgia
0.00%
0/51 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
6.1%
3/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
8.0%
4/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
12.2%
6/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
16.0%
8/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
2.0%
1/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
4.3%
2/46 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
2.1%
1/47 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
2.0%
1/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
Musculoskeletal and connective tissue disorders
Muscle spasms
0.00%
0/51 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
6.0%
3/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
2.0%
1/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
6.0%
3/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
2.2%
1/46 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/47 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
Musculoskeletal and connective tissue disorders
Myalgia
0.00%
0/51 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
4.0%
2/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
2.0%
1/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
6.0%
3/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
2.0%
1/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/46 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/47 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
Musculoskeletal and connective tissue disorders
Neck pain
0.00%
0/51 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
2.0%
1/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
6.1%
3/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/46 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/47 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
2.0%
1/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
Musculoskeletal and connective tissue disorders
Osteopenia
0.00%
0/51 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
4.1%
2/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
6.1%
3/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
2.0%
1/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/46 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/47 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
Nervous system disorders
Dizziness
0.00%
0/51 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
4.1%
2/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
6.0%
3/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
4.1%
2/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
8.0%
4/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
2.0%
1/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/46 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/47 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
2.0%
1/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
Nervous system disorders
Headache
0.00%
0/51 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
18.4%
9/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
20.0%
10/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
20.4%
10/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
24.0%
12/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
14.0%
7/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/46 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
2.1%
1/47 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
2.0%
1/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
Psychiatric disorders
Sleep disorder
2.0%
1/51 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
6.0%
3/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
6.0%
3/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/46 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
4.3%
2/47 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
Renal and urinary disorders
Proteinuria
3.9%
2/51 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
6.1%
3/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
2.0%
1/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
8.2%
4/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
6.0%
3/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
4.0%
2/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/46 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/47 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
Skin and subcutaneous tissue disorders
Alopecia
0.00%
0/51 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
4.1%
2/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
4.0%
2/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
6.1%
3/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
6.0%
3/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/46 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/47 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
Skin and subcutaneous tissue disorders
Pruritus
0.00%
0/51 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
12.2%
6/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
14.0%
7/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
12.2%
6/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
16.0%
8/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
2.2%
1/46 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
6.4%
3/47 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
2.0%
1/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
Vascular disorders
Hypertension
0.00%
0/51 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
2.0%
1/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
6.0%
3/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
6.1%
3/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
8.0%
4/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
4.0%
2/50 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/46 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
0.00%
0/47 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.
2.0%
1/49 • All-Cause Mortality: Up to Week 240; Adverse Events: Up to Week 48 (first 3 arms); Up to Week 144 (arms 4 and 5); Up to Weeks 48-144 (arm 6); >Week 144 up to Week 240 (arms 7-9). Adverse Event: SAS included all participants randomized (posttreatment SAS required >=1 measurement after EOT) delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. All-cause mortality: Randomized Set included all enrolled and randomized participants.
Participants were grouped according to actual treatment received for time points Week (Wk) 0 to 48, 0 to 144, Wk 48 to 144 and by last treatment received after Wk 144, up to Wk 240. The arm titles and descriptions in this section are entered accordingly. Actual treatment received is defined as randomized treatment except for participants who received treatment that differs from randomized treatment for the entire treatment duration.

Additional Information

Gilead Clinical Study Information Center

Gilead Sciences

Phone: 1-833-445-3230 (GILEAD-0)

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