Trial Outcomes & Findings for A Study Evaluating Treatment Regimens Containing Vebicorvir (ABI-H0731) in Participants With Chronic Hepatitis B Infection (NCT NCT04820686)
NCT ID: NCT04820686
Last Updated: 2023-11-14
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
65 participants
Primary outcome timeframe
AEs were collected from the time of signing the informed consent until the final follow-up visit, up to 96 weeks.
Results posted on
2023-11-14
Participant Flow
Participant milestones
| Measure |
VBR + AB-729 + SOC NrtI
Participants with cHBV received VBR + AB-729 + SOC NrtI for 48 weeks followed by 48 weeks in follow-up or until the study was early terminated
VBR: VBR is an HBV core protein inhibitor. Participants received VBR 300 mg tablets orally once daily (QD).
AB-729: AB-729 is a small interfering ribonucleic acid (siRNA) inhibitor of HBV. Participants received a 60-mg subcutaneous injection of AB-729 once every 8 weeks.
SOC NrtI: Participants received their SOC NrtI (ETV, TDF or TAF) tablet orally as per approved package insert.
|
VBR + SOC NrtI
Participants with cHBV received VBR + SOC NrtI for 48 weeks followed by 48 weeks in follow-up or until the study was early terminated. This treatment was used as a reference regimen.
VBR: VBR is an HBV core protein inhibitor. Participants received VBR 300 mg tablets orally once daily (QD).
SOC NrtI: Participants received their SOC NrtI (ETV, TDF or TAF) tablet orally as per approved package insert.
|
AB-729 + SOC NrtI
Participants with cHBV received AB-729 + SOC NrtI for 48 weeks followed by 48 weeks in follow-up or until the study was early terminated. This treatment was used as a reference regimen.
AB-729: AB-729 is a small interfering ribonucleic acid (siRNA) inhibitor of HBV. Participants received a 60-mg subcutaneous injection of AB-729 once every 8 weeks.
SOC NrtI: Participants received their SOC NrtI (ETV, TDF or TAF) tablet orally as per approved package insert.
|
|---|---|---|---|
|
Overall Study
STARTED
|
32
|
16
|
17
|
|
Overall Study
COMPLETED
|
2
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
30
|
16
|
17
|
Reasons for withdrawal
| Measure |
VBR + AB-729 + SOC NrtI
Participants with cHBV received VBR + AB-729 + SOC NrtI for 48 weeks followed by 48 weeks in follow-up or until the study was early terminated
VBR: VBR is an HBV core protein inhibitor. Participants received VBR 300 mg tablets orally once daily (QD).
AB-729: AB-729 is a small interfering ribonucleic acid (siRNA) inhibitor of HBV. Participants received a 60-mg subcutaneous injection of AB-729 once every 8 weeks.
SOC NrtI: Participants received their SOC NrtI (ETV, TDF or TAF) tablet orally as per approved package insert.
|
VBR + SOC NrtI
Participants with cHBV received VBR + SOC NrtI for 48 weeks followed by 48 weeks in follow-up or until the study was early terminated. This treatment was used as a reference regimen.
VBR: VBR is an HBV core protein inhibitor. Participants received VBR 300 mg tablets orally once daily (QD).
SOC NrtI: Participants received their SOC NrtI (ETV, TDF or TAF) tablet orally as per approved package insert.
|
AB-729 + SOC NrtI
Participants with cHBV received AB-729 + SOC NrtI for 48 weeks followed by 48 weeks in follow-up or until the study was early terminated. This treatment was used as a reference regimen.
AB-729: AB-729 is a small interfering ribonucleic acid (siRNA) inhibitor of HBV. Participants received a 60-mg subcutaneous injection of AB-729 once every 8 weeks.
SOC NrtI: Participants received their SOC NrtI (ETV, TDF or TAF) tablet orally as per approved package insert.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
5
|
2
|
3
|
|
Overall Study
Study Termination
|
25
|
13
|
14
|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
Baseline Characteristics
A Study Evaluating Treatment Regimens Containing Vebicorvir (ABI-H0731) in Participants With Chronic Hepatitis B Infection
Baseline characteristics by cohort
| Measure |
VBR + AB-729 + SOC NrtI
n=32 Participants
Participants with cHBV received VBR + AB-729 + SOC NrtI for 48 weeks followed by 48 weeks in follow-up or until the study was early terminated.
VBR: VBR is an HBV core protein inhibitor. Participants received VBR 300 mg tablets orally once daily (QD).
AB-729: AB-729 is a small interfering ribonucleic acid (siRNA) inhibitor of HBV. Participants received a 60-mg subcutaneous injection of AB-729 once every 8 weeks.
SOC NrtI: Participants received their SOC NrtI (ETV, TDF or TAF) tablet orally as per approved package insert.
|
VBR + SOC NrtI
n=16 Participants
Participants with cHBV received VBR + SOC NrtI for 48 weeks followed by 48 weeks in follow-up or until the study was early terminated. This treatment was used as a reference regimen.
VBR: VBR is an HBV core protein inhibitor. Participants received VBR 300 mg tablets orally once daily (QD).
SOC NrtI: Participants received their SOC NrtI (ETV, TDF or TAF) tablet orally as per approved package insert.
|
AB-729 + SOC NrtI
n=17 Participants
Participants with cHBV received AB-729 + SOC NrtI for 48 weeks followed by 48 weeks in follow-up or until the study was early terminated. This treatment was used as a reference regimen.
AB-729: AB-729 is a small interfering ribonucleic acid (siRNA) inhibitor of HBV. Participants received a 60-mg subcutaneous injection of AB-729 once every 8 weeks.
SOC NrtI: Participants received their SOC NrtI (ETV, TDF or TAF) tablet orally as per approved package insert.
|
Total
n=65 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
40 years
STANDARD_DEVIATION 6.1 • n=5 Participants
|
41 years
STANDARD_DEVIATION 6.4 • n=7 Participants
|
42 years
STANDARD_DEVIATION 5.9 • n=5 Participants
|
41 years
STANDARD_DEVIATION 6.1 • n=4 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
32 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
65 Participants
n=4 Participants
|
|
Ethnicity (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
|
|
Race/Ethnicity, Customized
White
|
10 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
American Indian / Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
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/Ethnicity, Customized
Asian
|
17 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Body Weight
|
73.8 kg
STANDARD_DEVIATION 15.77 • n=5 Participants
|
74.2 kg
STANDARD_DEVIATION 15.38 • n=7 Participants
|
69.2 kg
STANDARD_DEVIATION 12.22 • n=5 Participants
|
72.7 kg
STANDARD_DEVIATION 14.75 • n=4 Participants
|
|
Body Mass Index
|
25.6 kg/m^2
STANDARD_DEVIATION 4.21 • n=5 Participants
|
26.1 kg/m^2
STANDARD_DEVIATION 4.67 • n=7 Participants
|
24.1 kg/m^2
STANDARD_DEVIATION 3.26 • n=5 Participants
|
25.3 kg/m^2
STANDARD_DEVIATION 4.12 • n=4 Participants
|
|
Years positive for HBV
|
14.5 years
STANDARD_DEVIATION 7.75 • n=5 Participants
|
13.1 years
STANDARD_DEVIATION 11.01 • n=7 Participants
|
15.4 years
STANDARD_DEVIATION 8.78 • n=5 Participants
|
14.4 years
STANDARD_DEVIATION 8.80 • n=4 Participants
|
|
HBV Genotype
A
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
HBV Genotype
B
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
HBV Genotype
B/C
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
HBV Genotype
C
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
HBV Genotype
C/B
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
HBV Genotype
C/E
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
HBV Genotype
D
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
HBV Genotype
D/B
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
HBV Genotype
E
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
HBV Genotype
Unable to Genotype
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
NrtI at Baseline
Tenofovir Alafenamide (TAF)
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
NrtI at Baseline
Tenofovir disoproxil fumarate (TDF)
|
18 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
|
NrtI at Baseline
Entecavir (ETV)
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Years on current HBV treatment
|
6.9 years
STANDARD_DEVIATION 3.92 • n=5 Participants
|
4.8 years
STANDARD_DEVIATION 2.67 • n=7 Participants
|
5.9 years
STANDARD_DEVIATION 3.52 • n=5 Participants
|
6.1 years
STANDARD_DEVIATION 3.61 • n=4 Participants
|
|
HBV DNA (log10 IU/mL)
|
0.7 Log10 IU/mL
STANDARD_DEVIATION 0 • n=5 Participants
|
0.7 Log10 IU/mL
STANDARD_DEVIATION 0 • n=7 Participants
|
0.7 Log10 IU/mL
STANDARD_DEVIATION 0 • n=5 Participants
|
0.7 Log10 IU/mL
STANDARD_DEVIATION 0 • n=4 Participants
|
|
HBV RNA (log10 U/mL)
|
1.2 Log10 IU/mL
STANDARD_DEVIATION .88 • n=5 Participants
|
1.1 Log10 IU/mL
STANDARD_DEVIATION .69 • n=7 Participants
|
1.4 Log10 IU/mL
STANDARD_DEVIATION .88 • n=5 Participants
|
1.2 Log10 IU/mL
STANDARD_DEVIATION .83 • n=4 Participants
|
|
HBV TNA Quantitative (Log10 U/mL)
|
1.2 Log10 IU/mL
STANDARD_DEVIATION .41 • n=5 Participants
|
1.1 Log10 IU/mL
STANDARD_DEVIATION .32 • n=7 Participants
|
1.2 Log10 IU/mL
STANDARD_DEVIATION .49 • n=5 Participants
|
1.1 Log10 IU/mL
STANDARD_DEVIATION .41 • n=4 Participants
|
|
HBcrAg (Log10 U/mL)
|
3.3 Log10 U/mL
STANDARD_DEVIATION 1.22 • n=5 Participants
|
3.3 Log10 U/mL
STANDARD_DEVIATION 1.43 • n=7 Participants
|
3.2 Log10 U/mL
STANDARD_DEVIATION .89 • n=5 Participants
|
3.3 Log10 U/mL
STANDARD_DEVIATION 1.19 • n=4 Participants
|
|
HBsAg (Log10 IU/mL)
|
3.4 Log10 IU/mL
STANDARD_DEVIATION .57 • n=5 Participants
|
3.3 Log10 IU/mL
STANDARD_DEVIATION .62 • n=7 Participants
|
3.3 Log10 IU/mL
STANDARD_DEVIATION .56 • n=5 Participants
|
3.3 Log10 IU/mL
STANDARD_DEVIATION .57 • n=4 Participants
|
|
ALT (U/L)
|
29 U/L
STANDARD_DEVIATION 19.8 • n=5 Participants
|
27 U/L
STANDARD_DEVIATION 12.8 • n=7 Participants
|
28 U/L
STANDARD_DEVIATION 17.3 • n=5 Participants
|
28 U/L
STANDARD_DEVIATION 17.4 • n=4 Participants
|
|
Baseline HBeAb
Negative
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Baseline HBeAb
Positive
|
25 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
56 Participants
n=4 Participants
|
|
Baseline HBsAb
Negative
|
32 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
65 Participants
n=4 Participants
|
|
Baseline HBsAb
Positive
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Fibroscan Result (kPa)
|
5.2 kPa
STANDARD_DEVIATION 1.22 • n=5 Participants
|
5.6 kPa
STANDARD_DEVIATION 1.04 • n=7 Participants
|
5.0 kPa
STANDARD_DEVIATION 1.13 • n=5 Participants
|
5.3 kPa
STANDARD_DEVIATION 1.16 • n=4 Participants
|
|
Metavir Fibrosis Stage
F0-F2
|
32 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
65 Participants
n=4 Participants
|
|
Metavir Fibrosis Stage
F3
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Metavir Fibrosis Stage
F4
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: AEs were collected from the time of signing the informed consent until the final follow-up visit, up to 96 weeks.Outcome measures
| Measure |
VBR + AB-729 + SOC NrtI
n=32 Participants
Participants with cHBV received VBR + AB-729 + SOC NrtI for 48 weeks followed by 48 weeks in follow-up or until study was early terminated.
VBR: VBR is an HBV core protein inhibitor. Participants received VBR 300 mg tablets orally once daily (QD).
AB-729: AB-729 is a small interfering ribonucleic acid (siRNA) inhibitor of HBV. Participants received a 60-mg subcutaneous injection of AB-729 once every 8 weeks.
SOC NrtI: Participants received their SOC NrtI (ETV, TDF or TAF) tablet orally as per approved package insert.
|
VBR + SOC NrtI
n=16 Participants
Participants with cHBV received VBR + SOC NrtI for 48 weeks followed by 48 weeks in follow-up or until study was early terminated. This treatment was used as a reference regimen.
VBR: VBR is an HBV core protein inhibitor. Participants received VBR 300 mg tablets orally once daily (QD).
SOC NrtI: Participants received their SOC NrtI (ETV, TDF or TAF) tablet orally as per approved package insert.
|
AB-729 + SOC NrtI
n=17 Participants
Participants with cHBV received AB-729 + SOC NrtI for 48 weeks followed by 48 weeks in follow-up or until the study was early terminated. This treatment was used as a reference regimen.
AB-729: AB-729 is a small interfering ribonucleic acid (siRNA) inhibitor of HBV. Participants received a 60-mg subcutaneous injection of AB-729 once every 8 weeks.
SOC NrtI: Participants received their SOC NrtI (ETV, TDF or TAF) tablet orally as per approved package insert.
|
VBR + SOC Nrtl (Continued NrtI Only)
Participants with cHBV received VBR + SOC NrtI for 48 weeks followed by 48 weeks in follow-up or until study was early terminated. This treatment was used as a reference regimen.
VBR: VBR is an HBV core protein inhibitor. Participants received VBR 300 mg tablets orally once daily (QD).
SOC NrtI: Participants received their SOC NrtI (ETV, TDF or TAF) tablet orally as per approved package insert.
|
AB-729 + SOC NrtI (Discontinued All)
Participants with cHBV received AB-729 + SOC NrtI for 48 weeks followed by 48 weeks in follow-up or until the study was early terminated. This treatment was used as a reference regimen.
AB-729: AB-729 is a small interfering ribonucleic acid (siRNA) inhibitor of HBV. Participants received a 60-mg subcutaneous injection of AB-729 once every 8 weeks.
SOC NrtI: Participants received their SOC NrtI (ETV, TDF or TAF) tablet orally as per approved package insert.
|
AB-729 + SOC NrtI (Continued NrtI Only)
Participants with cHBV received AB-729 + SOC NrtI for 48 weeks followed by 48 weeks in follow-up or until the study was early terminated. This treatment was used as a reference regimen.
AB-729: AB-729 is a small interfering ribonucleic acid (siRNA) inhibitor of HBV. Participants received a 60-mg subcutaneous injection of AB-729 once every 8 weeks.
SOC NrtI: Participants received their SOC NrtI (ETV, TDF or TAF) tablet orally as per approved package insert.
|
|---|---|---|---|---|---|---|
|
Number of Participants With One or More Adverse Events (AEs)
|
26 Participants
|
12 Participants
|
12 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: AEs were collected from the time of signing the informed consent until the final follow-up visit, up to 96 weeks.Population: Subjects in the arm receiving only AB-720 and SOC NrtL were not evaluated for VBR discontinuation. Subjects in the arm reviewing only VBR and SOC NrtI were not evaluated for AB-720 discontinuation.
Outcome measures
| Measure |
VBR + AB-729 + SOC NrtI
n=32 Participants
Participants with cHBV received VBR + AB-729 + SOC NrtI for 48 weeks followed by 48 weeks in follow-up or until study was early terminated.
VBR: VBR is an HBV core protein inhibitor. Participants received VBR 300 mg tablets orally once daily (QD).
AB-729: AB-729 is a small interfering ribonucleic acid (siRNA) inhibitor of HBV. Participants received a 60-mg subcutaneous injection of AB-729 once every 8 weeks.
SOC NrtI: Participants received their SOC NrtI (ETV, TDF or TAF) tablet orally as per approved package insert.
|
VBR + SOC NrtI
n=16 Participants
Participants with cHBV received VBR + SOC NrtI for 48 weeks followed by 48 weeks in follow-up or until study was early terminated. This treatment was used as a reference regimen.
VBR: VBR is an HBV core protein inhibitor. Participants received VBR 300 mg tablets orally once daily (QD).
SOC NrtI: Participants received their SOC NrtI (ETV, TDF or TAF) tablet orally as per approved package insert.
|
AB-729 + SOC NrtI
n=17 Participants
Participants with cHBV received AB-729 + SOC NrtI for 48 weeks followed by 48 weeks in follow-up or until the study was early terminated. This treatment was used as a reference regimen.
AB-729: AB-729 is a small interfering ribonucleic acid (siRNA) inhibitor of HBV. Participants received a 60-mg subcutaneous injection of AB-729 once every 8 weeks.
SOC NrtI: Participants received their SOC NrtI (ETV, TDF or TAF) tablet orally as per approved package insert.
|
VBR + SOC Nrtl (Continued NrtI Only)
Participants with cHBV received VBR + SOC NrtI for 48 weeks followed by 48 weeks in follow-up or until study was early terminated. This treatment was used as a reference regimen.
VBR: VBR is an HBV core protein inhibitor. Participants received VBR 300 mg tablets orally once daily (QD).
SOC NrtI: Participants received their SOC NrtI (ETV, TDF or TAF) tablet orally as per approved package insert.
|
AB-729 + SOC NrtI (Discontinued All)
Participants with cHBV received AB-729 + SOC NrtI for 48 weeks followed by 48 weeks in follow-up or until the study was early terminated. This treatment was used as a reference regimen.
AB-729: AB-729 is a small interfering ribonucleic acid (siRNA) inhibitor of HBV. Participants received a 60-mg subcutaneous injection of AB-729 once every 8 weeks.
SOC NrtI: Participants received their SOC NrtI (ETV, TDF or TAF) tablet orally as per approved package insert.
|
AB-729 + SOC NrtI (Continued NrtI Only)
Participants with cHBV received AB-729 + SOC NrtI for 48 weeks followed by 48 weeks in follow-up or until the study was early terminated. This treatment was used as a reference regimen.
AB-729: AB-729 is a small interfering ribonucleic acid (siRNA) inhibitor of HBV. Participants received a 60-mg subcutaneous injection of AB-729 once every 8 weeks.
SOC NrtI: Participants received their SOC NrtI (ETV, TDF or TAF) tablet orally as per approved package insert.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Premature Treatment Discontinuation Due to AEs
VBR discontinuation due to AE
|
3 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Premature Treatment Discontinuation Due to AEs
AB-729 discontinuation due to AE
|
1 Participants
|
—
|
0 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Laboratory results were collected from the time of signing the informed consent until the study was early terminated, up to 96 weeks.Outcome measures
| Measure |
VBR + AB-729 + SOC NrtI
n=32 Participants
Participants with cHBV received VBR + AB-729 + SOC NrtI for 48 weeks followed by 48 weeks in follow-up or until study was early terminated.
VBR: VBR is an HBV core protein inhibitor. Participants received VBR 300 mg tablets orally once daily (QD).
AB-729: AB-729 is a small interfering ribonucleic acid (siRNA) inhibitor of HBV. Participants received a 60-mg subcutaneous injection of AB-729 once every 8 weeks.
SOC NrtI: Participants received their SOC NrtI (ETV, TDF or TAF) tablet orally as per approved package insert.
|
VBR + SOC NrtI
n=16 Participants
Participants with cHBV received VBR + SOC NrtI for 48 weeks followed by 48 weeks in follow-up or until study was early terminated. This treatment was used as a reference regimen.
VBR: VBR is an HBV core protein inhibitor. Participants received VBR 300 mg tablets orally once daily (QD).
SOC NrtI: Participants received their SOC NrtI (ETV, TDF or TAF) tablet orally as per approved package insert.
|
AB-729 + SOC NrtI
n=17 Participants
Participants with cHBV received AB-729 + SOC NrtI for 48 weeks followed by 48 weeks in follow-up or until the study was early terminated. This treatment was used as a reference regimen.
AB-729: AB-729 is a small interfering ribonucleic acid (siRNA) inhibitor of HBV. Participants received a 60-mg subcutaneous injection of AB-729 once every 8 weeks.
SOC NrtI: Participants received their SOC NrtI (ETV, TDF or TAF) tablet orally as per approved package insert.
|
VBR + SOC Nrtl (Continued NrtI Only)
Participants with cHBV received VBR + SOC NrtI for 48 weeks followed by 48 weeks in follow-up or until study was early terminated. This treatment was used as a reference regimen.
VBR: VBR is an HBV core protein inhibitor. Participants received VBR 300 mg tablets orally once daily (QD).
SOC NrtI: Participants received their SOC NrtI (ETV, TDF or TAF) tablet orally as per approved package insert.
|
AB-729 + SOC NrtI (Discontinued All)
Participants with cHBV received AB-729 + SOC NrtI for 48 weeks followed by 48 weeks in follow-up or until the study was early terminated. This treatment was used as a reference regimen.
AB-729: AB-729 is a small interfering ribonucleic acid (siRNA) inhibitor of HBV. Participants received a 60-mg subcutaneous injection of AB-729 once every 8 weeks.
SOC NrtI: Participants received their SOC NrtI (ETV, TDF or TAF) tablet orally as per approved package insert.
|
AB-729 + SOC NrtI (Continued NrtI Only)
Participants with cHBV received AB-729 + SOC NrtI for 48 weeks followed by 48 weeks in follow-up or until the study was early terminated. This treatment was used as a reference regimen.
AB-729: AB-729 is a small interfering ribonucleic acid (siRNA) inhibitor of HBV. Participants received a 60-mg subcutaneous injection of AB-729 once every 8 weeks.
SOC NrtI: Participants received their SOC NrtI (ETV, TDF or TAF) tablet orally as per approved package insert.
|
|---|---|---|---|---|---|---|
|
Number of Participants With One or More Abnormal Laboratory Result
|
30 Participants
|
16 Participants
|
16 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and 56.Population: The number analyzed differs from the overall number analyzed due to early terminated and/or withdrawn subjects.
Subjects remained on their assigned oral agents (ie, VBR+NrtI for Groups 1 and 2; NrtI for Group 3) until Week 48 laboratory results required for Treatment Stopping Criteria assessment were available so there are some results past Week 48.
Outcome measures
| Measure |
VBR + AB-729 + SOC NrtI
n=32 Participants
Participants with cHBV received VBR + AB-729 + SOC NrtI for 48 weeks followed by 48 weeks in follow-up or until study was early terminated.
VBR: VBR is an HBV core protein inhibitor. Participants received VBR 300 mg tablets orally once daily (QD).
AB-729: AB-729 is a small interfering ribonucleic acid (siRNA) inhibitor of HBV. Participants received a 60-mg subcutaneous injection of AB-729 once every 8 weeks.
SOC NrtI: Participants received their SOC NrtI (ETV, TDF or TAF) tablet orally as per approved package insert.
|
VBR + SOC NrtI
n=16 Participants
Participants with cHBV received VBR + SOC NrtI for 48 weeks followed by 48 weeks in follow-up or until study was early terminated. This treatment was used as a reference regimen.
VBR: VBR is an HBV core protein inhibitor. Participants received VBR 300 mg tablets orally once daily (QD).
SOC NrtI: Participants received their SOC NrtI (ETV, TDF or TAF) tablet orally as per approved package insert.
|
AB-729 + SOC NrtI
n=17 Participants
Participants with cHBV received AB-729 + SOC NrtI for 48 weeks followed by 48 weeks in follow-up or until the study was early terminated. This treatment was used as a reference regimen.
AB-729: AB-729 is a small interfering ribonucleic acid (siRNA) inhibitor of HBV. Participants received a 60-mg subcutaneous injection of AB-729 once every 8 weeks.
SOC NrtI: Participants received their SOC NrtI (ETV, TDF or TAF) tablet orally as per approved package insert.
|
VBR + SOC Nrtl (Continued NrtI Only)
Participants with cHBV received VBR + SOC NrtI for 48 weeks followed by 48 weeks in follow-up or until study was early terminated. This treatment was used as a reference regimen.
VBR: VBR is an HBV core protein inhibitor. Participants received VBR 300 mg tablets orally once daily (QD).
SOC NrtI: Participants received their SOC NrtI (ETV, TDF or TAF) tablet orally as per approved package insert.
|
AB-729 + SOC NrtI (Discontinued All)
Participants with cHBV received AB-729 + SOC NrtI for 48 weeks followed by 48 weeks in follow-up or until the study was early terminated. This treatment was used as a reference regimen.
AB-729: AB-729 is a small interfering ribonucleic acid (siRNA) inhibitor of HBV. Participants received a 60-mg subcutaneous injection of AB-729 once every 8 weeks.
SOC NrtI: Participants received their SOC NrtI (ETV, TDF or TAF) tablet orally as per approved package insert.
|
AB-729 + SOC NrtI (Continued NrtI Only)
Participants with cHBV received AB-729 + SOC NrtI for 48 weeks followed by 48 weeks in follow-up or until the study was early terminated. This treatment was used as a reference regimen.
AB-729: AB-729 is a small interfering ribonucleic acid (siRNA) inhibitor of HBV. Participants received a 60-mg subcutaneous injection of AB-729 once every 8 weeks.
SOC NrtI: Participants received their SOC NrtI (ETV, TDF or TAF) tablet orally as per approved package insert.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Mean log10 Serum Hepatitis B Surface Antigen (HBsAg) On-Treatment
Week 2
|
-0.3 log10 IU/mL
Standard Deviation .42
|
0 log10 IU/mL
Standard Deviation 0.07
|
-0.2 log10 IU/mL
Standard Deviation .26
|
—
|
—
|
—
|
|
Change From Baseline in Mean log10 Serum Hepatitis B Surface Antigen (HBsAg) On-Treatment
Week 4
|
-.3 log10 IU/mL
Standard Deviation .35
|
0 log10 IU/mL
Standard Deviation 0.05
|
-0.3 log10 IU/mL
Standard Deviation .39
|
—
|
—
|
—
|
|
Change From Baseline in Mean log10 Serum Hepatitis B Surface Antigen (HBsAg) On-Treatment
Week 8
|
-0.7 log10 IU/mL
Standard Deviation .62
|
0 log10 IU/mL
Standard Deviation .06
|
-0.6 log10 IU/mL
Standard Deviation .42
|
—
|
—
|
—
|
|
Change From Baseline in Mean log10 Serum Hepatitis B Surface Antigen (HBsAg) On-Treatment
Week 12
|
-1.2 log10 IU/mL
Standard Deviation .65
|
0 log10 IU/mL
Standard Deviation .07
|
-1.1 log10 IU/mL
Standard Deviation .5
|
—
|
—
|
—
|
|
Change From Baseline in Mean log10 Serum Hepatitis B Surface Antigen (HBsAg) On-Treatment
Week 16
|
-1.5 log10 IU/mL
Standard Deviation .56
|
0 log10 IU/mL
Standard Deviation .08
|
-1.3 log10 IU/mL
Standard Deviation .53
|
—
|
—
|
—
|
|
Change From Baseline in Mean log10 Serum Hepatitis B Surface Antigen (HBsAg) On-Treatment
Week 20
|
-1.7 log10 IU/mL
Standard Deviation .55
|
0 log10 IU/mL
Standard Deviation .07
|
-1.6 log10 IU/mL
Standard Deviation .53
|
—
|
—
|
—
|
|
Change From Baseline in Mean log10 Serum Hepatitis B Surface Antigen (HBsAg) On-Treatment
Week 24
|
-1.7 log10 IU/mL
Standard Deviation .52
|
0 log10 IU/mL
Standard Deviation .07
|
-1.6 log10 IU/mL
Standard Deviation .42
|
—
|
—
|
—
|
|
Change From Baseline in Mean log10 Serum Hepatitis B Surface Antigen (HBsAg) On-Treatment
Week 28
|
-1.7 log10 IU/mL
Standard Deviation .54
|
0 log10 IU/mL
Standard Deviation .12
|
-1.7 log10 IU/mL
Standard Deviation .49
|
—
|
—
|
—
|
|
Change From Baseline in Mean log10 Serum Hepatitis B Surface Antigen (HBsAg) On-Treatment
Week 32
|
-1.8 log10 IU/mL
Standard Deviation .5
|
0 log10 IU/mL
Standard Deviation 0.1
|
-1.7 log10 IU/mL
Standard Deviation .43
|
—
|
—
|
—
|
|
Change From Baseline in Mean log10 Serum Hepatitis B Surface Antigen (HBsAg) On-Treatment
Week 36
|
-1.9 log10 IU/mL
Standard Deviation .53
|
0 log10 IU/mL
Standard Deviation .11
|
-1.9 log10 IU/mL
Standard Deviation .45
|
—
|
—
|
—
|
|
Change From Baseline in Mean log10 Serum Hepatitis B Surface Antigen (HBsAg) On-Treatment
Week 40
|
-1.8 log10 IU/mL
Standard Deviation .54
|
0 log10 IU/mL
Standard Deviation .11
|
-1.8 log10 IU/mL
Standard Deviation .5
|
—
|
—
|
—
|
|
Change From Baseline in Mean log10 Serum Hepatitis B Surface Antigen (HBsAg) On-Treatment
Week 44
|
-1.9 log10 IU/mL
Standard Deviation .54
|
0 log10 IU/mL
Standard Deviation .11
|
-1.9 log10 IU/mL
Standard Deviation .47
|
—
|
—
|
—
|
|
Change From Baseline in Mean log10 Serum Hepatitis B Surface Antigen (HBsAg) On-Treatment
Week 48
|
-1.9 log10 IU/mL
Standard Deviation .52
|
0 log10 IU/mL
Standard Deviation .12
|
-1.9 log10 IU/mL
Standard Deviation .51
|
—
|
—
|
—
|
|
Change From Baseline in Mean log10 Serum Hepatitis B Surface Antigen (HBsAg) On-Treatment
Week 52
|
-1.8 log10 IU/mL
Standard Deviation .53
|
0 log10 IU/mL
Standard Deviation .09
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Mean log10 Serum Hepatitis B Surface Antigen (HBsAg) On-Treatment
Week 56
|
-1.5 log10 IU/mL
Standard Deviation .35
|
-0.1 log10 IU/mL
Standard Deviation .14
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-specified time points up to 96 weeksPopulation: Due to early termination of the study, data was not collected or analyzed for secondary outcomes.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 48Population: Due to early termination of the study, data was not collected or analyzed for secondary outcomes.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 48Population: Due to early termination of the study, data was not collected or analyzed for secondary outcomes.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and 56.Population: The number analyzed differs from the overall number analyzed due to early terminated and/or withdrawn subjects.
Subjects remained on their assigned oral agents (ie, VBR+NrtI for Groups 1 and 2; NrtI for Group 3) until Week 48 laboratory results required for Treatment Stopping Criteria assessment were available so there are some results past Week 48.
Outcome measures
| Measure |
VBR + AB-729 + SOC NrtI
n=32 Participants
Participants with cHBV received VBR + AB-729 + SOC NrtI for 48 weeks followed by 48 weeks in follow-up or until study was early terminated.
VBR: VBR is an HBV core protein inhibitor. Participants received VBR 300 mg tablets orally once daily (QD).
AB-729: AB-729 is a small interfering ribonucleic acid (siRNA) inhibitor of HBV. Participants received a 60-mg subcutaneous injection of AB-729 once every 8 weeks.
SOC NrtI: Participants received their SOC NrtI (ETV, TDF or TAF) tablet orally as per approved package insert.
|
VBR + SOC NrtI
n=16 Participants
Participants with cHBV received VBR + SOC NrtI for 48 weeks followed by 48 weeks in follow-up or until study was early terminated. This treatment was used as a reference regimen.
VBR: VBR is an HBV core protein inhibitor. Participants received VBR 300 mg tablets orally once daily (QD).
SOC NrtI: Participants received their SOC NrtI (ETV, TDF or TAF) tablet orally as per approved package insert.
|
AB-729 + SOC NrtI
n=17 Participants
Participants with cHBV received AB-729 + SOC NrtI for 48 weeks followed by 48 weeks in follow-up or until the study was early terminated. This treatment was used as a reference regimen.
AB-729: AB-729 is a small interfering ribonucleic acid (siRNA) inhibitor of HBV. Participants received a 60-mg subcutaneous injection of AB-729 once every 8 weeks.
SOC NrtI: Participants received their SOC NrtI (ETV, TDF or TAF) tablet orally as per approved package insert.
|
VBR + SOC Nrtl (Continued NrtI Only)
Participants with cHBV received VBR + SOC NrtI for 48 weeks followed by 48 weeks in follow-up or until study was early terminated. This treatment was used as a reference regimen.
VBR: VBR is an HBV core protein inhibitor. Participants received VBR 300 mg tablets orally once daily (QD).
SOC NrtI: Participants received their SOC NrtI (ETV, TDF or TAF) tablet orally as per approved package insert.
|
AB-729 + SOC NrtI (Discontinued All)
Participants with cHBV received AB-729 + SOC NrtI for 48 weeks followed by 48 weeks in follow-up or until the study was early terminated. This treatment was used as a reference regimen.
AB-729: AB-729 is a small interfering ribonucleic acid (siRNA) inhibitor of HBV. Participants received a 60-mg subcutaneous injection of AB-729 once every 8 weeks.
SOC NrtI: Participants received their SOC NrtI (ETV, TDF or TAF) tablet orally as per approved package insert.
|
AB-729 + SOC NrtI (Continued NrtI Only)
Participants with cHBV received AB-729 + SOC NrtI for 48 weeks followed by 48 weeks in follow-up or until the study was early terminated. This treatment was used as a reference regimen.
AB-729: AB-729 is a small interfering ribonucleic acid (siRNA) inhibitor of HBV. Participants received a 60-mg subcutaneous injection of AB-729 once every 8 weeks.
SOC NrtI: Participants received their SOC NrtI (ETV, TDF or TAF) tablet orally as per approved package insert.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Mean log10 HBV RNA On-Treatment
Week 4
|
-.7 log10 U/mL
Standard Deviation .76
|
0.2 log10 U/mL
Standard Deviation .77
|
-.6 log10 U/mL
Standard Deviation .86
|
—
|
—
|
—
|
|
Change From Baseline in Mean log10 HBV RNA On-Treatment
Week 8
|
-.7 log10 U/mL
Standard Deviation 1.01
|
0 log10 U/mL
Standard Deviation .59
|
-0.5 log10 U/mL
Standard Deviation .65
|
—
|
—
|
—
|
|
Change From Baseline in Mean log10 HBV RNA On-Treatment
Week 12
|
-.6 log10 U/mL
Standard Deviation 1.0
|
0 log10 U/mL
Standard Deviation .55
|
-0.7 log10 U/mL
Standard Deviation .78
|
—
|
—
|
—
|
|
Change From Baseline in Mean log10 HBV RNA On-Treatment
Week 16
|
-0.6 log10 U/mL
Standard Deviation .94
|
0 log10 U/mL
Standard Deviation .58
|
-0.8 log10 U/mL
Standard Deviation .6
|
—
|
—
|
—
|
|
Change From Baseline in Mean log10 HBV RNA On-Treatment
Week 20
|
-0.7 log10 U/mL
Standard Deviation 1.01
|
.1 log10 U/mL
Standard Deviation .59
|
-0.8 log10 U/mL
Standard Deviation .56
|
—
|
—
|
—
|
|
Change From Baseline in Mean log10 HBV RNA On-Treatment
Week 24
|
-0.5 log10 U/mL
Standard Deviation .89
|
.2 log10 U/mL
Standard Deviation .54
|
-0.7 log10 U/mL
Standard Deviation .64
|
—
|
—
|
—
|
|
Change From Baseline in Mean log10 HBV RNA On-Treatment
Week 28
|
-0.9 log10 U/mL
Standard Deviation 1.0
|
.2 log10 U/mL
Standard Deviation .65
|
-0.8 log10 U/mL
Standard Deviation .59
|
—
|
—
|
—
|
|
Change From Baseline in Mean log10 HBV RNA On-Treatment
Week 32
|
-0.7 log10 U/mL
Standard Deviation .89
|
.1 log10 U/mL
Standard Deviation .55
|
-0.7 log10 U/mL
Standard Deviation .68
|
—
|
—
|
—
|
|
Change From Baseline in Mean log10 HBV RNA On-Treatment
Week 2
|
-.6 log10 U/mL
Standard Deviation .75
|
-.2 log10 U/mL
Standard Deviation .7
|
-.4 log10 U/mL
Standard Deviation .48
|
—
|
—
|
—
|
|
Change From Baseline in Mean log10 HBV RNA On-Treatment
Week 36
|
-0.7 log10 U/mL
Standard Deviation .88
|
.1 log10 U/mL
Standard Deviation .5
|
-0.7 log10 U/mL
Standard Deviation .78
|
—
|
—
|
—
|
|
Change From Baseline in Mean log10 HBV RNA On-Treatment
Week 40
|
-0.6 log10 U/mL
Standard Deviation .88
|
.1 log10 U/mL
Standard Deviation .68
|
-0.6 log10 U/mL
Standard Deviation .57
|
—
|
—
|
—
|
|
Change From Baseline in Mean log10 HBV RNA On-Treatment
Week 44
|
-0.6 log10 U/mL
Standard Deviation .87
|
0 log10 U/mL
Standard Deviation .51
|
-0.8 log10 U/mL
Standard Deviation .69
|
—
|
—
|
—
|
|
Change From Baseline in Mean log10 HBV RNA On-Treatment
Week 48
|
-0.7 log10 U/mL
Standard Deviation 1.03
|
-0.1 log10 U/mL
Standard Deviation .6
|
-0.7 log10 U/mL
Standard Deviation .46
|
—
|
—
|
—
|
|
Change From Baseline in Mean log10 HBV RNA On-Treatment
Week 52
|
-0.7 log10 U/mL
Standard Deviation .89
|
-0.1 log10 U/mL
Standard Deviation .6
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Mean log10 HBV RNA On-Treatment
Week 56
|
-1.0 log10 U/mL
Standard Deviation 1.37
|
.2 log10 U/mL
Standard Deviation .62
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 48Population: The number analyzed differs from the overall number analyzed due to early terminated and/or withdrawn subjects.
Outcome measures
| Measure |
VBR + AB-729 + SOC NrtI
n=32 Participants
Participants with cHBV received VBR + AB-729 + SOC NrtI for 48 weeks followed by 48 weeks in follow-up or until study was early terminated.
VBR: VBR is an HBV core protein inhibitor. Participants received VBR 300 mg tablets orally once daily (QD).
AB-729: AB-729 is a small interfering ribonucleic acid (siRNA) inhibitor of HBV. Participants received a 60-mg subcutaneous injection of AB-729 once every 8 weeks.
SOC NrtI: Participants received their SOC NrtI (ETV, TDF or TAF) tablet orally as per approved package insert.
|
VBR + SOC NrtI
n=16 Participants
Participants with cHBV received VBR + SOC NrtI for 48 weeks followed by 48 weeks in follow-up or until study was early terminated. This treatment was used as a reference regimen.
VBR: VBR is an HBV core protein inhibitor. Participants received VBR 300 mg tablets orally once daily (QD).
SOC NrtI: Participants received their SOC NrtI (ETV, TDF or TAF) tablet orally as per approved package insert.
|
AB-729 + SOC NrtI
n=17 Participants
Participants with cHBV received AB-729 + SOC NrtI for 48 weeks followed by 48 weeks in follow-up or until the study was early terminated. This treatment was used as a reference regimen.
AB-729: AB-729 is a small interfering ribonucleic acid (siRNA) inhibitor of HBV. Participants received a 60-mg subcutaneous injection of AB-729 once every 8 weeks.
SOC NrtI: Participants received their SOC NrtI (ETV, TDF or TAF) tablet orally as per approved package insert.
|
VBR + SOC Nrtl (Continued NrtI Only)
Participants with cHBV received VBR + SOC NrtI for 48 weeks followed by 48 weeks in follow-up or until study was early terminated. This treatment was used as a reference regimen.
VBR: VBR is an HBV core protein inhibitor. Participants received VBR 300 mg tablets orally once daily (QD).
SOC NrtI: Participants received their SOC NrtI (ETV, TDF or TAF) tablet orally as per approved package insert.
|
AB-729 + SOC NrtI (Discontinued All)
Participants with cHBV received AB-729 + SOC NrtI for 48 weeks followed by 48 weeks in follow-up or until the study was early terminated. This treatment was used as a reference regimen.
AB-729: AB-729 is a small interfering ribonucleic acid (siRNA) inhibitor of HBV. Participants received a 60-mg subcutaneous injection of AB-729 once every 8 weeks.
SOC NrtI: Participants received their SOC NrtI (ETV, TDF or TAF) tablet orally as per approved package insert.
|
AB-729 + SOC NrtI (Continued NrtI Only)
Participants with cHBV received AB-729 + SOC NrtI for 48 weeks followed by 48 weeks in follow-up or until the study was early terminated. This treatment was used as a reference regimen.
AB-729: AB-729 is a small interfering ribonucleic acid (siRNA) inhibitor of HBV. Participants received a 60-mg subcutaneous injection of AB-729 once every 8 weeks.
SOC NrtI: Participants received their SOC NrtI (ETV, TDF or TAF) tablet orally as per approved package insert.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Mean log10 Hepatitis B Core-related Antigen (HBcrAg) On-Treatment
|
-0.4 log10 U/mL
Standard Deviation .7
|
0 log10 U/mL
Standard Deviation .58
|
-0.3 log10 U/mL
Standard Deviation .53
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 48Population: Due to early termination of the study, data was not collected or analyzed for secondary outcomes.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and at pre-specified time points up to 96 weeksPopulation: Due to early termination of the study, data was not collected or analyzed for secondary outcomes.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Before dosing at Baseline (Day 1) and at pre-specified time points up to 48 weeks, and at Week 52Population: Due to early termination of the study, data were not collected and analyzed for secondary outcomes.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 hours after dosing at pre-specified time points up to 40 weeksPopulation: Due to early termination of the study, data were not collected and analyzed for secondary outcomes.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Before dosing at Baseline (Day 1) and at pre-specified time points up to 48 weeksPopulation: Due to early termination of the study, data was not collected or analyzed for secondary outcomes.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Weeks 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92 and 96.Population: Not all subjects reached Week 96 due to study termination.
Outcome measures
| Measure |
VBR + AB-729 + SOC NrtI
n=12 Participants
Participants with cHBV received VBR + AB-729 + SOC NrtI for 48 weeks followed by 48 weeks in follow-up or until study was early terminated.
VBR: VBR is an HBV core protein inhibitor. Participants received VBR 300 mg tablets orally once daily (QD).
AB-729: AB-729 is a small interfering ribonucleic acid (siRNA) inhibitor of HBV. Participants received a 60-mg subcutaneous injection of AB-729 once every 8 weeks.
SOC NrtI: Participants received their SOC NrtI (ETV, TDF or TAF) tablet orally as per approved package insert.
|
VBR + SOC NrtI
n=11 Participants
Participants with cHBV received VBR + SOC NrtI for 48 weeks followed by 48 weeks in follow-up or until study was early terminated. This treatment was used as a reference regimen.
VBR: VBR is an HBV core protein inhibitor. Participants received VBR 300 mg tablets orally once daily (QD).
SOC NrtI: Participants received their SOC NrtI (ETV, TDF or TAF) tablet orally as per approved package insert.
|
AB-729 + SOC NrtI
Participants with cHBV received AB-729 + SOC NrtI for 48 weeks followed by 48 weeks in follow-up or until the study was early terminated. This treatment was used as a reference regimen.
AB-729: AB-729 is a small interfering ribonucleic acid (siRNA) inhibitor of HBV. Participants received a 60-mg subcutaneous injection of AB-729 once every 8 weeks.
SOC NrtI: Participants received their SOC NrtI (ETV, TDF or TAF) tablet orally as per approved package insert.
|
VBR + SOC Nrtl (Continued NrtI Only)
n=12 Participants
Participants with cHBV received VBR + SOC NrtI for 48 weeks followed by 48 weeks in follow-up or until study was early terminated. This treatment was used as a reference regimen.
VBR: VBR is an HBV core protein inhibitor. Participants received VBR 300 mg tablets orally once daily (QD).
SOC NrtI: Participants received their SOC NrtI (ETV, TDF or TAF) tablet orally as per approved package insert.
|
AB-729 + SOC NrtI (Discontinued All)
n=7 Participants
Participants with cHBV received AB-729 + SOC NrtI for 48 weeks followed by 48 weeks in follow-up or until the study was early terminated. This treatment was used as a reference regimen.
AB-729: AB-729 is a small interfering ribonucleic acid (siRNA) inhibitor of HBV. Participants received a 60-mg subcutaneous injection of AB-729 once every 8 weeks.
SOC NrtI: Participants received their SOC NrtI (ETV, TDF or TAF) tablet orally as per approved package insert.
|
AB-729 + SOC NrtI (Continued NrtI Only)
n=4 Participants
Participants with cHBV received AB-729 + SOC NrtI for 48 weeks followed by 48 weeks in follow-up or until the study was early terminated. This treatment was used as a reference regimen.
AB-729: AB-729 is a small interfering ribonucleic acid (siRNA) inhibitor of HBV. Participants received a 60-mg subcutaneous injection of AB-729 once every 8 weeks.
SOC NrtI: Participants received their SOC NrtI (ETV, TDF or TAF) tablet orally as per approved package insert.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Mean log10 Serum Hepatitis B Surface Antigen (HBsAg) Off-Treatment
Off-Treatment Week 40
|
—
|
-1.7 log10 IU/mL
Standard Deviation .68
|
—
|
—
|
-1.2 log10 IU/mL
Standard Deviation NA
Only 1 participant, SD is not applicable.
|
-2.9 log10 IU/mL
Standard Deviation NA
Only 1 participant, SD is not applicable.
|
|
Change From Baseline in Mean log10 Serum Hepatitis B Surface Antigen (HBsAg) Off-Treatment
Off-Treatment Week 4
|
-1.9 log10 IU/mL
Standard Deviation .51
|
-1.6 log10 IU/mL
Standard Deviation .53
|
—
|
0 log10 IU/mL
Standard Deviation .09
|
-1.8 log10 IU/mL
Standard Deviation .75
|
-1.8 log10 IU/mL
Standard Deviation .62
|
|
Change From Baseline in Mean log10 Serum Hepatitis B Surface Antigen (HBsAg) Off-Treatment
Off-Treatment Week 8
|
-1.9 log10 IU/mL
Standard Deviation .54
|
-1.4 log10 IU/mL
Standard Deviation .32
|
—
|
0 log10 IU/mL
Standard Deviation .08
|
-1.8 log10 IU/mL
Standard Deviation .7
|
-1.8 log10 IU/mL
Standard Deviation .56
|
|
Change From Baseline in Mean log10 Serum Hepatitis B Surface Antigen (HBsAg) Off-Treatment
Off-Treatment Week 12
|
-1.8 log10 IU/mL
Standard Deviation .54
|
-1.4 log10 IU/mL
Standard Deviation .54
|
—
|
-0.1 log10 IU/mL
Standard Deviation .1
|
-1.7 log10 IU/mL
Standard Deviation .62
|
-2.0 log10 IU/mL
Standard Deviation .18
|
|
Change From Baseline in Mean log10 Serum Hepatitis B Surface Antigen (HBsAg) Off-Treatment
Off-Treatment Week 16
|
-1.7 log10 IU/mL
Standard Deviation .24
|
-1.5 log10 IU/mL
Standard Deviation .64
|
—
|
-0.1 log10 IU/mL
Standard Deviation .09
|
-1.4 log10 IU/mL
Standard Deviation .55
|
-1.6 log10 IU/mL
Standard Deviation .62
|
|
Change From Baseline in Mean log10 Serum Hepatitis B Surface Antigen (HBsAg) Off-Treatment
Off-Treatment Week 20
|
-1.8 log10 IU/mL
Standard Deviation .18
|
-1.7 log10 IU/mL
Standard Deviation .85
|
—
|
0 log10 IU/mL
Standard Deviation .06
|
-1.2 log10 IU/mL
Standard Deviation .96
|
-2.1 log10 IU/mL
Standard Deviation .28
|
|
Change From Baseline in Mean log10 Serum Hepatitis B Surface Antigen (HBsAg) Off-Treatment
Off-Treatment Week 24
|
-1.7 log10 IU/mL
Standard Deviation .13
|
-2.0 log10 IU/mL
Standard Deviation .78
|
—
|
0 log10 IU/mL
Standard Deviation .01
|
-1.3 log10 IU/mL
Standard Deviation .69
|
-2.9 log10 IU/mL
Standard Deviation NA
Only 1 participant
|
|
Change From Baseline in Mean log10 Serum Hepatitis B Surface Antigen (HBsAg) Off-Treatment
Off-Treatment Week 28
|
-1.8 log10 IU/mL
Standard Deviation .13
|
-2.0 log10 IU/mL
Standard Deviation .73
|
—
|
0 log10 IU/mL
Standard Deviation NA
Only 1 participant
|
-1.6 log10 IU/mL
Standard Deviation .06
|
-3.0 log10 IU/mL
Standard Deviation NA
Only 1 participant
|
|
Change From Baseline in Mean log10 Serum Hepatitis B Surface Antigen (HBsAg) Off-Treatment
Off-Treatment Week 32
|
-1.7 log10 IU/mL
Standard Deviation .2
|
-1.9 log10 IU/mL
Standard Deviation .72
|
—
|
0.0 log10 IU/mL
Standard Deviation NA
Only 1 participant, SD is not applicable.
|
-1.5 log10 IU/mL
Standard Deviation NA
Only 1 participant, SD is not applicable.
|
-3.2 log10 IU/mL
Standard Deviation NA
Only 1 participant, SD is not applicable.
|
|
Change From Baseline in Mean log10 Serum Hepatitis B Surface Antigen (HBsAg) Off-Treatment
Off-Treatment Week 36
|
-1.6 log10 IU/mL
Standard Deviation .04
|
-1.8 log10 IU/mL
Standard Deviation .63
|
—
|
0 log10 IU/mL
Standard Deviation NA
Only 1 participant, SD is not applicable.
|
-1.2 log10 IU/mL
Standard Deviation NA
Only 1 participant, SD is not applicable.
|
-3.0 log10 IU/mL
Standard Deviation NA
Only 1 participant, SD is not applicable.
|
|
Change From Baseline in Mean log10 Serum Hepatitis B Surface Antigen (HBsAg) Off-Treatment
Off-Treatment Week 44
|
—
|
-1.6 log10 IU/mL
Standard Deviation .56
|
—
|
—
|
—
|
-2.8 log10 IU/mL
Standard Deviation NA
Only 1 participant, SD is not applicable.
|
|
Change From Baseline in Mean log10 Serum Hepatitis B Surface Antigen (HBsAg) Off-Treatment
Off-Treatment Week 48
|
—
|
-2.2 log10 IU/mL
Standard Deviation NA
Only 1 participant, SD is not applicable.
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92 and 96.Population: Due to study early termination, not all subjects reached week 96.
Outcome measures
| Measure |
VBR + AB-729 + SOC NrtI
n=12 Participants
Participants with cHBV received VBR + AB-729 + SOC NrtI for 48 weeks followed by 48 weeks in follow-up or until study was early terminated.
VBR: VBR is an HBV core protein inhibitor. Participants received VBR 300 mg tablets orally once daily (QD).
AB-729: AB-729 is a small interfering ribonucleic acid (siRNA) inhibitor of HBV. Participants received a 60-mg subcutaneous injection of AB-729 once every 8 weeks.
SOC NrtI: Participants received their SOC NrtI (ETV, TDF or TAF) tablet orally as per approved package insert.
|
VBR + SOC NrtI
n=11 Participants
Participants with cHBV received VBR + SOC NrtI for 48 weeks followed by 48 weeks in follow-up or until study was early terminated. This treatment was used as a reference regimen.
VBR: VBR is an HBV core protein inhibitor. Participants received VBR 300 mg tablets orally once daily (QD).
SOC NrtI: Participants received their SOC NrtI (ETV, TDF or TAF) tablet orally as per approved package insert.
|
AB-729 + SOC NrtI
Participants with cHBV received AB-729 + SOC NrtI for 48 weeks followed by 48 weeks in follow-up or until the study was early terminated. This treatment was used as a reference regimen.
AB-729: AB-729 is a small interfering ribonucleic acid (siRNA) inhibitor of HBV. Participants received a 60-mg subcutaneous injection of AB-729 once every 8 weeks.
SOC NrtI: Participants received their SOC NrtI (ETV, TDF or TAF) tablet orally as per approved package insert.
|
VBR + SOC Nrtl (Continued NrtI Only)
n=12 Participants
Participants with cHBV received VBR + SOC NrtI for 48 weeks followed by 48 weeks in follow-up or until study was early terminated. This treatment was used as a reference regimen.
VBR: VBR is an HBV core protein inhibitor. Participants received VBR 300 mg tablets orally once daily (QD).
SOC NrtI: Participants received their SOC NrtI (ETV, TDF or TAF) tablet orally as per approved package insert.
|
AB-729 + SOC NrtI (Discontinued All)
n=7 Participants
Participants with cHBV received AB-729 + SOC NrtI for 48 weeks followed by 48 weeks in follow-up or until the study was early terminated. This treatment was used as a reference regimen.
AB-729: AB-729 is a small interfering ribonucleic acid (siRNA) inhibitor of HBV. Participants received a 60-mg subcutaneous injection of AB-729 once every 8 weeks.
SOC NrtI: Participants received their SOC NrtI (ETV, TDF or TAF) tablet orally as per approved package insert.
|
AB-729 + SOC NrtI (Continued NrtI Only)
n=4 Participants
Participants with cHBV received AB-729 + SOC NrtI for 48 weeks followed by 48 weeks in follow-up or until the study was early terminated. This treatment was used as a reference regimen.
AB-729: AB-729 is a small interfering ribonucleic acid (siRNA) inhibitor of HBV. Participants received a 60-mg subcutaneous injection of AB-729 once every 8 weeks.
SOC NrtI: Participants received their SOC NrtI (ETV, TDF or TAF) tablet orally as per approved package insert.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Mean log10 HBV RNA Off-Treatment
Off-Treatment Week 4
|
-0.6 log10 U/mL
Standard Deviation .83
|
-0.8 log10 U/mL
Standard Deviation 1.03
|
—
|
-0.1 log10 U/mL
Standard Deviation .57
|
-1.1 log10 U/mL
Standard Deviation .61
|
-0.9 log10 U/mL
Standard Deviation 1.05
|
|
Change From Baseline in Mean log10 HBV RNA Off-Treatment
Off-Treatment Week 8
|
-0.5 log10 U/mL
Standard Deviation .93
|
-0.5 log10 U/mL
Standard Deviation 1.02
|
—
|
0 log10 U/mL
Standard Deviation .36
|
-0.8 log10 U/mL
Standard Deviation .63
|
-0.9 log10 U/mL
Standard Deviation .56
|
|
Change From Baseline in Mean log10 HBV RNA Off-Treatment
Off-Treatment Week 12
|
-0.7 log10 U/mL
Standard Deviation 1.11
|
-0.6 log10 U/mL
Standard Deviation 1.24
|
—
|
-0.2 log10 U/mL
Standard Deviation .28
|
-0.8 log10 U/mL
Standard Deviation .66
|
-1.0 log10 U/mL
Standard Deviation .78
|
|
Change From Baseline in Mean log10 HBV RNA Off-Treatment
Off-Treatment Week 16
|
0 log10 U/mL
Standard Deviation 1.25
|
-0.5 log10 U/mL
Standard Deviation .55
|
—
|
0.3 log10 U/mL
Standard Deviation .31
|
-0.8 log10 U/mL
Standard Deviation .66
|
-0.9 log10 U/mL
Standard Deviation .93
|
|
Change From Baseline in Mean log10 HBV RNA Off-Treatment
Off-Treatment Week 20
|
.7 log10 U/mL
Standard Deviation .77
|
-0.3 log10 U/mL
Standard Deviation 1.45
|
—
|
-0.2 log10 U/mL
Standard Deviation .01
|
-0.6 log10 U/mL
Standard Deviation .9
|
-0.7 log10 U/mL
Standard Deviation .65
|
|
Change From Baseline in Mean log10 HBV RNA Off-Treatment
Off-Treatment Week 24
|
.5 log10 U/mL
Standard Deviation .41
|
-0.4 log10 U/mL
Standard Deviation 1.09
|
—
|
-0.4 log10 U/mL
Standard Deviation .25
|
-0.5 log10 U/mL
Standard Deviation .2
|
0.7 log10 U/mL
Standard Deviation NA
Only 1 participant, standard deviation is not applicable.
|
|
Change From Baseline in Mean log10 HBV RNA Off-Treatment
Off-Treatment Week 28
|
0 log10 U/mL
Standard Deviation 0
|
-0.8 log10 U/mL
Standard Deviation .17
|
—
|
-0.7 log10 U/mL
Standard Deviation NA
Only 1 participant, standard deviation is not applicable.
|
-0.6 log10 U/mL
Standard Deviation .03
|
-0.6 log10 U/mL
Standard Deviation NA
Only 1 participant, standard deviation is not applicable.
|
|
Change From Baseline in Mean log10 HBV RNA Off-Treatment
Off-Treatment Week 32
|
.2 log10 U/mL
Standard Deviation .3
|
-1.0 log10 U/mL
Standard Deviation 1.26
|
—
|
-0.2 log10 U/mL
Standard Deviation NA
Only 1 participant, standard deviation is not applicable.
|
-0.1 log10 U/mL
Standard Deviation NA
Only 1 participant, standard deviation is not applicable.
|
-0.3 log10 U/mL
Standard Deviation NA
Only 1 participant, standard deviation is not applicable.
|
|
Change From Baseline in Mean log10 HBV RNA Off-Treatment
Off-Treatment Week 36
|
0 log10 U/mL
Standard Deviation 0
|
-1.0 log10 U/mL
Standard Deviation .51
|
—
|
0 log10 U/mL
Standard Deviation NA
Only 1 participant, standard deviation is not applicable.
|
.5 log10 U/mL
Standard Deviation NA
Only 1 participant, standard deviation is not applicable.
|
-0.1 log10 U/mL
Standard Deviation NA
Only 1 participant, standard deviation is not applicable.
|
|
Change From Baseline in Mean log10 HBV RNA Off-Treatment
Off-Treatment Week 40
|
—
|
-0.9 log10 U/mL
Standard Deviation .37
|
—
|
—
|
-0.4 log10 U/mL
Standard Deviation NA
Only 1 participant, standard deviation is not applicable.
|
-0.6 log10 U/mL
Standard Deviation NA
Only 1 participant, standard deviation is not applicable.
|
|
Change From Baseline in Mean log10 HBV RNA Off-Treatment
Off-Treatment Week 44
|
—
|
-1.0 log10 U/mL
Standard Deviation .39
|
—
|
—
|
—
|
.1 log10 U/mL
Standard Deviation NA
Only 1 participant, standard deviation is not applicable.
|
|
Change From Baseline in Mean log10 HBV RNA Off-Treatment
Off-Treatment Week 48
|
—
|
-1.2 log10 U/mL
Standard Deviation NA
Only 1 participant, standard deviation is not applicable.
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92 and 96.Population: Due to study early termination, not all subjects reached week 96.
Outcome measures
| Measure |
VBR + AB-729 + SOC NrtI
n=12 Participants
Participants with cHBV received VBR + AB-729 + SOC NrtI for 48 weeks followed by 48 weeks in follow-up or until study was early terminated.
VBR: VBR is an HBV core protein inhibitor. Participants received VBR 300 mg tablets orally once daily (QD).
AB-729: AB-729 is a small interfering ribonucleic acid (siRNA) inhibitor of HBV. Participants received a 60-mg subcutaneous injection of AB-729 once every 8 weeks.
SOC NrtI: Participants received their SOC NrtI (ETV, TDF or TAF) tablet orally as per approved package insert.
|
VBR + SOC NrtI
n=11 Participants
Participants with cHBV received VBR + SOC NrtI for 48 weeks followed by 48 weeks in follow-up or until study was early terminated. This treatment was used as a reference regimen.
VBR: VBR is an HBV core protein inhibitor. Participants received VBR 300 mg tablets orally once daily (QD).
SOC NrtI: Participants received their SOC NrtI (ETV, TDF or TAF) tablet orally as per approved package insert.
|
AB-729 + SOC NrtI
Participants with cHBV received AB-729 + SOC NrtI for 48 weeks followed by 48 weeks in follow-up or until the study was early terminated. This treatment was used as a reference regimen.
AB-729: AB-729 is a small interfering ribonucleic acid (siRNA) inhibitor of HBV. Participants received a 60-mg subcutaneous injection of AB-729 once every 8 weeks.
SOC NrtI: Participants received their SOC NrtI (ETV, TDF or TAF) tablet orally as per approved package insert.
|
VBR + SOC Nrtl (Continued NrtI Only)
n=12 Participants
Participants with cHBV received VBR + SOC NrtI for 48 weeks followed by 48 weeks in follow-up or until study was early terminated. This treatment was used as a reference regimen.
VBR: VBR is an HBV core protein inhibitor. Participants received VBR 300 mg tablets orally once daily (QD).
SOC NrtI: Participants received their SOC NrtI (ETV, TDF or TAF) tablet orally as per approved package insert.
|
AB-729 + SOC NrtI (Discontinued All)
n=7 Participants
Participants with cHBV received AB-729 + SOC NrtI for 48 weeks followed by 48 weeks in follow-up or until the study was early terminated. This treatment was used as a reference regimen.
AB-729: AB-729 is a small interfering ribonucleic acid (siRNA) inhibitor of HBV. Participants received a 60-mg subcutaneous injection of AB-729 once every 8 weeks.
SOC NrtI: Participants received their SOC NrtI (ETV, TDF or TAF) tablet orally as per approved package insert.
|
AB-729 + SOC NrtI (Continued NrtI Only)
n=4 Participants
Participants with cHBV received AB-729 + SOC NrtI for 48 weeks followed by 48 weeks in follow-up or until the study was early terminated. This treatment was used as a reference regimen.
AB-729: AB-729 is a small interfering ribonucleic acid (siRNA) inhibitor of HBV. Participants received a 60-mg subcutaneous injection of AB-729 once every 8 weeks.
SOC NrtI: Participants received their SOC NrtI (ETV, TDF or TAF) tablet orally as per approved package insert.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Mean log10 Hepatitis B Core-related Antigen (HBcrAg) Off-Treatment
Off-Treatment Week 48
|
—
|
-0.1 log10 U/mL
Standard Deviation .14
|
—
|
—
|
—
|
0 log10 U/mL
Standard Deviation NA
Only 1 participant, standard deviation is not applicable.
|
|
Change From Baseline in Mean log10 Hepatitis B Core-related Antigen (HBcrAg) Off-Treatment
Off-Treatment Week 12
|
-0.3 log10 U/mL
Standard Deviation .46
|
-0.5 log10 U/mL
Standard Deviation .81
|
—
|
.1 log10 U/mL
Standard Deviation .48
|
-0.1 log10 U/mL
Standard Deviation .18
|
-0.6 log10 U/mL
Standard Deviation .70
|
|
Change From Baseline in Mean log10 Hepatitis B Core-related Antigen (HBcrAg) Off-Treatment
Off-Treatment Week 24
|
-0.3 log10 U/mL
Standard Deviation .17
|
-0.2 log10 U/mL
Standard Deviation .15
|
—
|
.8 log10 U/mL
Standard Deviation 1.13
|
-0.2 log10 U/mL
Standard Deviation .06
|
-0.2 log10 U/mL
Standard Deviation .07
|
|
Change From Baseline in Mean log10 Hepatitis B Core-related Antigen (HBcrAg) Off-Treatment
Off-Treatment Week 36
|
-0.3 log10 U/mL
Standard Deviation .07
|
-0.2 log10 U/mL
Standard Deviation .07
|
—
|
0 log10 U/mL
Standard Deviation NA
Only 1 participant, standard deviation is not applicable.
|
-0.2 log10 U/mL
Standard Deviation NA
Only 1 participant, standard deviation is not applicable.
|
0 log10 U/mL
Standard Deviation NA
Only 1 participant, standard deviation is not applicable.
|
Adverse Events
VBR + AB-729 + SOC NrtI
Serious events: 1 serious events
Other events: 31 other events
Deaths: 0 deaths
VBR + SOC NrtI
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
AB-729 + SOC NrtI
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
VBR + AB-729 + SOC NrtI
n=32 participants at risk
Participants with cHBV received VBR + AB-729 + SOC NrtI for 48 weeks followed by 48 weeks in follow-up or until the study was early terminated.
VBR: VBR is an HBV core protein inhibitor. Participants received VBR 300 mg tablets orally once daily (QD).
AB-729: AB-729 is a small interfering ribonucleic acid (siRNA) inhibitor of HBV. Participants received a 60-mg subcutaneous injection of AB-729 once every 8 weeks.
SOC NrtI: Participants received their SOC NrtI (ETV, TDF or TAF) tablet orally as per approved package insert.
|
VBR + SOC NrtI
n=16 participants at risk
Participants with cHBV received VBR + SOC NrtI for 48 weeks followed by 48 weeks in follow-up or until the study was early terminated. This treatment was used as a reference regimen.
VBR: VBR is an HBV core protein inhibitor. Participants received VBR 300 mg tablets orally once daily (QD).
SOC NrtI: Participants received their SOC NrtI (ETV, TDF or TAF) tablet orally as per approved package insert.
|
AB-729 + SOC NrtI
n=17 participants at risk
Participants with cHBV received AB-729 + SOC NrtI for 48 weeks followed by 48 weeks in follow-up or until the study was early terminated. This treatment was used as a reference regimen.
AB-729: AB-729 is a small interfering ribonucleic acid (siRNA) inhibitor of HBV. Participants received a 60-mg subcutaneous injection of AB-729 once every 8 weeks.
SOC NrtI: Participants received their SOC NrtI (ETV, TDF or TAF) tablet orally as per approved package insert.
|
|---|---|---|---|
|
Infections and infestations
Covid-19 Pneumonia
|
3.1%
1/32 • Baseline and at pre-specified time points up to 96 weeks
Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.
|
0.00%
0/16 • Baseline and at pre-specified time points up to 96 weeks
Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.
|
0.00%
0/17 • Baseline and at pre-specified time points up to 96 weeks
Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.
|
Other adverse events
| Measure |
VBR + AB-729 + SOC NrtI
n=32 participants at risk
Participants with cHBV received VBR + AB-729 + SOC NrtI for 48 weeks followed by 48 weeks in follow-up or until the study was early terminated.
VBR: VBR is an HBV core protein inhibitor. Participants received VBR 300 mg tablets orally once daily (QD).
AB-729: AB-729 is a small interfering ribonucleic acid (siRNA) inhibitor of HBV. Participants received a 60-mg subcutaneous injection of AB-729 once every 8 weeks.
SOC NrtI: Participants received their SOC NrtI (ETV, TDF or TAF) tablet orally as per approved package insert.
|
VBR + SOC NrtI
n=16 participants at risk
Participants with cHBV received VBR + SOC NrtI for 48 weeks followed by 48 weeks in follow-up or until the study was early terminated. This treatment was used as a reference regimen.
VBR: VBR is an HBV core protein inhibitor. Participants received VBR 300 mg tablets orally once daily (QD).
SOC NrtI: Participants received their SOC NrtI (ETV, TDF or TAF) tablet orally as per approved package insert.
|
AB-729 + SOC NrtI
n=17 participants at risk
Participants with cHBV received AB-729 + SOC NrtI for 48 weeks followed by 48 weeks in follow-up or until the study was early terminated. This treatment was used as a reference regimen.
AB-729: AB-729 is a small interfering ribonucleic acid (siRNA) inhibitor of HBV. Participants received a 60-mg subcutaneous injection of AB-729 once every 8 weeks.
SOC NrtI: Participants received their SOC NrtI (ETV, TDF or TAF) tablet orally as per approved package insert.
|
|---|---|---|---|
|
Infections and infestations
COVID-19
|
18.8%
6/32 • Baseline and at pre-specified time points up to 96 weeks
Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.
|
31.2%
5/16 • Baseline and at pre-specified time points up to 96 weeks
Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.
|
35.3%
6/17 • Baseline and at pre-specified time points up to 96 weeks
Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.
|
|
Nervous system disorders
Headache
|
25.0%
8/32 • Baseline and at pre-specified time points up to 96 weeks
Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.
|
43.8%
7/16 • Baseline and at pre-specified time points up to 96 weeks
Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.
|
5.9%
1/17 • Baseline and at pre-specified time points up to 96 weeks
Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.
|
|
Infections and infestations
Nasopharyngitis
|
12.5%
4/32 • Baseline and at pre-specified time points up to 96 weeks
Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.
|
6.2%
1/16 • Baseline and at pre-specified time points up to 96 weeks
Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.
|
17.6%
3/17 • Baseline and at pre-specified time points up to 96 weeks
Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.
|
|
General disorders
Fatigue
|
6.2%
2/32 • Baseline and at pre-specified time points up to 96 weeks
Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.
|
12.5%
2/16 • Baseline and at pre-specified time points up to 96 weeks
Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.
|
11.8%
2/17 • Baseline and at pre-specified time points up to 96 weeks
Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.
|
|
Gastrointestinal disorders
Nausea
|
3.1%
1/32 • Baseline and at pre-specified time points up to 96 weeks
Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.
|
31.2%
5/16 • Baseline and at pre-specified time points up to 96 weeks
Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.
|
0.00%
0/17 • Baseline and at pre-specified time points up to 96 weeks
Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.2%
2/32 • Baseline and at pre-specified time points up to 96 weeks
Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.
|
12.5%
2/16 • Baseline and at pre-specified time points up to 96 weeks
Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.
|
11.8%
2/17 • Baseline and at pre-specified time points up to 96 weeks
Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.
|
|
Investigations
Alanine Aminotransferase Increased
|
3.1%
1/32 • Baseline and at pre-specified time points up to 96 weeks
Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.
|
6.2%
1/16 • Baseline and at pre-specified time points up to 96 weeks
Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.
|
17.6%
3/17 • Baseline and at pre-specified time points up to 96 weeks
Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.
|
|
Gastrointestinal disorders
Diarrhoea
|
6.2%
2/32 • Baseline and at pre-specified time points up to 96 weeks
Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.
|
12.5%
2/16 • Baseline and at pre-specified time points up to 96 weeks
Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.
|
5.9%
1/17 • Baseline and at pre-specified time points up to 96 weeks
Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.
|
|
Nervous system disorders
Dizziness
|
3.1%
1/32 • Baseline and at pre-specified time points up to 96 weeks
Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.
|
18.8%
3/16 • Baseline and at pre-specified time points up to 96 weeks
Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.
|
5.9%
1/17 • Baseline and at pre-specified time points up to 96 weeks
Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.
|
|
General disorders
Injection Site Pain
|
9.4%
3/32 • Baseline and at pre-specified time points up to 96 weeks
Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.
|
0.00%
0/16 • Baseline and at pre-specified time points up to 96 weeks
Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.
|
11.8%
2/17 • Baseline and at pre-specified time points up to 96 weeks
Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.1%
1/32 • Baseline and at pre-specified time points up to 96 weeks
Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.
|
25.0%
4/16 • Baseline and at pre-specified time points up to 96 weeks
Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.
|
0.00%
0/17 • Baseline and at pre-specified time points up to 96 weeks
Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.
|
Additional Information
Director of Clinical Operations
Assembly BioSciences Inc.
Phone: 415-366-5172
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60