Chronic Hepatitis B
Conditions
Keywords
Chronic hepatitis B, HBV, HBeAg-positive, hepatitis B, HBeAg-negative, vebicorvir, VBR
Brief summary
The purpose of this study is to determine if ABI-H0731 given in combination with a standard of care (SOC) hepatitis B virus (HBV) nucleos(t)ide reverse transcriptase inhibitor (NUC) medication is safe and effective in participants with chronic hepatitis B virus infection (cHBV).
Detailed description
This is a Phase 2a, Multi-center, Double-blind, Placebo-controlled Study Evaluating ABI-H0731 as Adjunctive Therapy in Virally-suppressed Participants with cHBV.
Interventions
DRUGABI-H0731
Participants will receive ABI-H0731 300 mg tablets orally once daily (QD).
DRUGSOC NUC
Participants will continue on their SOC NUC (ETV, TDF or TAF) tablet orally as per approved package insert.
DRUGPlacebo Oral Tablet
Participants will receive placebo matching ABI-0731 tablets orally QD.
Sponsors
Assembly Biosciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Male or female between ages 18 and 70 years * Virologically-suppressed (defined as HBV DNA ≤limit of quantitation (LOQ) for at least 6 months before screening on SOC NUC therapy * HBeAg-positive or HBeAg-negative at screening * In good general health except for cHBV Key
Exclusion criteria
* Co-infection with HIV, hepatitis C virus (HCV), hepatitis E virus (HEV) or hepatitis D virus (HDV) * History or evidence of hepatic decompensation (including gastrointestinal bleeding or esophageal varices) at any time prior to or at time of screening * Clinically significant cardiac or pulmonary disease, chronic or recurrent renal or urinary tract disease, liver disease other than HBV, endocrine disorder, autoimmune disorder, diabetes mellitus requiring treatment with insulin or hypoglycemic agents, neuromuscular, musculoskeletal, or mucocutaneous conditions requiring frequent treatment, seizure disorders requiring treatment, or other medical conditions requiring frequent medical management or pharmacologic or surgical treatment that in the opinion of the Investigator or the Sponsor makes the participant unsuitable for the study * Previous treatment with an investigational agent for HBV other than ABI-H0731 in the last 6 months before screening * History of hepatocellular carcinoma (HCC) * Females who are lactating or pregnant or wish to become pregnant are excluded from the study * Exclusionary laboratory parameters at screening include: * Platelet count \<100,000/mm3 * Albumin \<lower limit of normal (LLN) * Direct bilirubin \>1.2×upper limit of normal (ULN) * Alanine aminotransferase (ALT) \>5×ULN at screening * International Normalized Ratio (INR) \>1.5×ULN * Glomerular filtration rate (GFR) \<60 mL/min/1.73 m2 by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Mean log10 Serum HBsAg From Baseline (Day 1) to Week 24 on ABI-H0731 + SOC NUC as Compared to Placebo + SOC NUC | Baseline to Week 24 |
| Change in Mean log10 Serum HBeAg From Baseline (Day 1) to Week 24 on ABI-H0731 + SOC NUC as Compared to Placebo + SOC NUC | Baseline to Week 24 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With One or More Abnormal Safety Laboratory Result | Up to Week 36 | — |
| Number of Participants With a Clinically-significant Electrocardiogram Abnormality | Up to Week 24 | — |
| Number of Participants With a Clinically-significant Change in Vital Signs | Baseline and up to Week 24 | Vital signs assessed were body temperature, respiratory rate, and pulse rate |
| Number of Participants With Abnormal Alanine Aminotransferase (ALT) at Baseline Who Have Normal ALT at Week 24 on ABI-H0731 + NUC Therapy as Compared With Placebo + NUC Therapy | Baseline to Week 24 | Abnormal ALT was defined as ≥1.25 x upper limit of normal (34 Units/L for female and 43 Units/L for male participants). |
| Trough Levels of ABI-H0731 on ABI-H0731 + SOC NUC Therapy | Before dosing at Baseline (Day 1), Weeks 2, 4, 12, and 24 | — |
| Number of Participants With One or More Adverse Events | Up to Follow-up (maximum up to Week 36) | — |
| Trough Levels of Tenofovir Alafenamide (TAF) on ABI-H0731 + SOC NUC Therapy as Compared With Placebo + SOC NUC Therapy | Before dosing at Baseline (Day 1), Weeks 2, 4, 12, and 24 | — |
| Trough Levels of Tenofovir Disoproxil Fumarate (TDF) on ABI-H0731 + SOC NUC Therapy as Compared With Placebo + SOC NUC Therapy | Before dosing at Baseline (Day 1), Weeks 2, 4, 12, and 24 | — |
| Trough to Peak Ratios of ABI-H0731 on ABI-H0731 + SOC NUC Therapy | Baseline, Weeks 2, 4, 12, and 24 | — |
| Trough to Peak Ratios of SOC NUC on ABI-H0731 + SOC NUC Therapy as Compared With Placebo + SOC NUC Therapy | Baseline, Weeks 2, 4, 12, and 24 | — |
| Trough Levels of Entecavir (ETV) on ABI-H0731 + SOC NUC Therapy as Compared With Placebo + SOC NUC Therapy | Before dosing at Baseline (Day 1), Weeks 2, 4, 12, and 24 | — |
| Number of Participants With Premature Study Discontinuation | Up to Follow-up (maximum up to Week 36) | — |
Countries
Canada, New Zealand, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ABI-H0731 + SOC NUC Virologically suppressed participants will receive ABI-H0731 along with SOC NUC (ETV, TDF or TAF) tablets orally for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to continue open-label ABI-H0731 for up to an additional year if necessary.
ABI-H0731: Participants will receive 300 mg QD ABI-H0731 tablets orally.
SOC NUC: Participants will continue on their SOC NUC (ETV, TDF or TAF) tablet orally (QD frequency) as per approved package insert. | 45 |
| Placebo + SOC NUC Virologically suppressed participants will receive matching placebo tablets and continue their SOC NUC (ETV, TDF or TAF) for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to start treatment on open-label ABI-H0731 for up to a year if necessary.
Placebo Oral Tablet: Participants will receive matching QD placebo tablets orally.
SOC NUC: Participants will receive SOC NUC (ETV, TDF or TAF) tablet orally as per approved package insert. | 28 |
| Total | 73 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Noncompliance with study drug | 0 | 1 |
Baseline characteristics
| Characteristic | Placebo + SOC NUC | Total | ABI-H0731 + SOC NUC |
|---|---|---|---|
| Age, Continuous | 46.4 years STANDARD_DEVIATION 11.32 | 45.3 years STANDARD_DEVIATION 10.63 | 44.6 years STANDARD_DEVIATION 10.26 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 2 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 27 Participants | 71 Participants | 44 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Hepatitis B e Antigen (HBeAg) status HBeAg Negative | 10 Participants | 26 Participants | 16 Participants |
| Hepatitis B e Antigen (HBeAg) status HBeAg Positive | 18 Participants | 47 Participants | 29 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 24 Participants | 61 Participants | 37 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 5 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 0 Participants | 4 Participants | 4 Participants |
| Region of Enrollment Canada | 4 participants | 10 participants | 6 participants |
| Region of Enrollment Hong Kong | 0 participants | 1 participants | 1 participants |
| Region of Enrollment New Zealand | 0 participants | 1 participants | 1 participants |
| Region of Enrollment United States | 24 participants | 61 participants | 37 participants |
| Sex: Female, Male Female | 13 Participants | 26 Participants | 13 Participants |
| Sex: Female, Male Male | 15 Participants | 47 Participants | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 45 | 0 / 28 |
| other Total, other adverse events | 24 / 45 | 8 / 28 |
| serious Total, serious adverse events | 0 / 45 | 0 / 28 |
Outcome results
Primary
Change in Mean log10 Serum HBeAg From Baseline (Day 1) to Week 24 on ABI-H0731 + SOC NUC as Compared to Placebo + SOC NUC
Time frame: Baseline to Week 24
Population: ITT population. Results were analyzed and reported only for participants who were HBeAg positive at Baseline and had available data at Baseline, Week 24, or both.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HBeAg-positive Participants: ABI-H0731 + SOC NUC | Change in Mean log10 Serum HBeAg From Baseline (Day 1) to Week 24 on ABI-H0731 + SOC NUC as Compared to Placebo + SOC NUC | Baseline | 0.55 Log10 International Units (IU)/mL | Standard Deviation 0.98 |
| HBeAg-positive Participants: ABI-H0731 + SOC NUC | Change in Mean log10 Serum HBeAg From Baseline (Day 1) to Week 24 on ABI-H0731 + SOC NUC as Compared to Placebo + SOC NUC | Change from baseline | -0.05 Log10 International Units (IU)/mL | Standard Deviation 0.191 |
| HBeAg-positive Participants: Placebo + SOC NUC | Change in Mean log10 Serum HBeAg From Baseline (Day 1) to Week 24 on ABI-H0731 + SOC NUC as Compared to Placebo + SOC NUC | Baseline | 0.43 Log10 International Units (IU)/mL | Standard Deviation 0.964 |
| HBeAg-positive Participants: Placebo + SOC NUC | Change in Mean log10 Serum HBeAg From Baseline (Day 1) to Week 24 on ABI-H0731 + SOC NUC as Compared to Placebo + SOC NUC | Change from baseline | -0.10 Log10 International Units (IU)/mL | Standard Deviation 0.193 |
Comparison: Least squares (LS) mean difference in HBeAg-positive participants: ABI-H0731 + SOC NUC minus placebo + SOC NUC at Week 24p-value: 0.2916Repeated measures analysis
Primary
Change in Mean log10 Serum HBsAg From Baseline (Day 1) to Week 24 on ABI-H0731 + SOC NUC as Compared to Placebo + SOC NUC
Time frame: Baseline to Week 24
Population: Intention-to-treat (ITT) population: all randomized participants. Results were analyzed and reported based on Baseline HBeAg status: positive or negative, for available data at Baseline, Week 24, or both.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HBeAg-positive Participants: ABI-H0731 + SOC NUC | Change in Mean log10 Serum HBsAg From Baseline (Day 1) to Week 24 on ABI-H0731 + SOC NUC as Compared to Placebo + SOC NUC | Baseline | 3.48 Log10 International Units (IU)/mL | Standard Deviation 0.401 |
| HBeAg-positive Participants: ABI-H0731 + SOC NUC | Change in Mean log10 Serum HBsAg From Baseline (Day 1) to Week 24 on ABI-H0731 + SOC NUC as Compared to Placebo + SOC NUC | Change from baseline | 0.03 Log10 International Units (IU)/mL | Standard Deviation 0.138 |
| HBeAg-positive Participants: Placebo + SOC NUC | Change in Mean log10 Serum HBsAg From Baseline (Day 1) to Week 24 on ABI-H0731 + SOC NUC as Compared to Placebo + SOC NUC | Change from baseline | 0.03 Log10 International Units (IU)/mL | Standard Deviation 0.054 |
| HBeAg-positive Participants: Placebo + SOC NUC | Change in Mean log10 Serum HBsAg From Baseline (Day 1) to Week 24 on ABI-H0731 + SOC NUC as Compared to Placebo + SOC NUC | Baseline | 3.57 Log10 International Units (IU)/mL | Standard Deviation 0.516 |
| HBeAg-negative Participants: ABI-H0731 + SOC NUC | Change in Mean log10 Serum HBsAg From Baseline (Day 1) to Week 24 on ABI-H0731 + SOC NUC as Compared to Placebo + SOC NUC | Baseline | 2.99 Log10 International Units (IU)/mL | Standard Deviation 0.555 |
| HBeAg-negative Participants: ABI-H0731 + SOC NUC | Change in Mean log10 Serum HBsAg From Baseline (Day 1) to Week 24 on ABI-H0731 + SOC NUC as Compared to Placebo + SOC NUC | Change from baseline | 0.09 Log10 International Units (IU)/mL | Standard Deviation 0.133 |
| HBeAg-negative Participants: Placebo + SOC NUC | Change in Mean log10 Serum HBsAg From Baseline (Day 1) to Week 24 on ABI-H0731 + SOC NUC as Compared to Placebo + SOC NUC | Baseline | 3.35 Log10 International Units (IU)/mL | Standard Deviation 0.648 |
| HBeAg-negative Participants: Placebo + SOC NUC | Change in Mean log10 Serum HBsAg From Baseline (Day 1) to Week 24 on ABI-H0731 + SOC NUC as Compared to Placebo + SOC NUC | Change from baseline | -0.00 Log10 International Units (IU)/mL | Standard Deviation 0.021 |
Comparison: Least squares (LS) mean difference in HBeAg-positive participants: ABI-H0731 + SOC NUC minus placebo + SOC NUC at Week 24p-value: 0.6855Repeated measures analysis
Comparison: LS mean difference in HBeAg-negative participants: ABI-H0731 + SOC NUC minus placebo + SOC NUC at Week 24p-value: 0.175Repeated measures analysis
Secondary
Number of Participants With Abnormal Alanine Aminotransferase (ALT) at Baseline Who Have Normal ALT at Week 24 on ABI-H0731 + NUC Therapy as Compared With Placebo + NUC Therapy
Abnormal ALT was defined as ≥1.25 x upper limit of normal (34 Units/L for female and 43 Units/L for male participants).
Time frame: Baseline to Week 24
Population: Participants in the ITT population with abnormal ALT at Baseline
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HBeAg-positive Participants: ABI-H0731 + SOC NUC | Number of Participants With Abnormal Alanine Aminotransferase (ALT) at Baseline Who Have Normal ALT at Week 24 on ABI-H0731 + NUC Therapy as Compared With Placebo + NUC Therapy | 1 Participants |
| HBeAg-positive Participants: Placebo + SOC NUC | Number of Participants With Abnormal Alanine Aminotransferase (ALT) at Baseline Who Have Normal ALT at Week 24 on ABI-H0731 + NUC Therapy as Compared With Placebo + NUC Therapy | 0 Participants |
Secondary
Number of Participants With a Clinically-significant Change in Vital Signs
Vital signs assessed were body temperature, respiratory rate, and pulse rate
Time frame: Baseline and up to Week 24
Population: Safety population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HBeAg-positive Participants: ABI-H0731 + SOC NUC | Number of Participants With a Clinically-significant Change in Vital Signs | 0 Participants |
| HBeAg-positive Participants: Placebo + SOC NUC | Number of Participants With a Clinically-significant Change in Vital Signs | 0 Participants |
Secondary
Number of Participants With a Clinically-significant Electrocardiogram Abnormality
Time frame: Up to Week 24
Population: Safety population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HBeAg-positive Participants: ABI-H0731 + SOC NUC | Number of Participants With a Clinically-significant Electrocardiogram Abnormality | 0 Participants |
| HBeAg-positive Participants: Placebo + SOC NUC | Number of Participants With a Clinically-significant Electrocardiogram Abnormality | 0 Participants |
Secondary
Number of Participants With One or More Abnormal Safety Laboratory Result
Time frame: Up to Week 36
Population: Safety population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HBeAg-positive Participants: ABI-H0731 + SOC NUC | Number of Participants With One or More Abnormal Safety Laboratory Result | 27 Participants |
| HBeAg-positive Participants: Placebo + SOC NUC | Number of Participants With One or More Abnormal Safety Laboratory Result | 20 Participants |
Secondary
Number of Participants With One or More Adverse Events
Time frame: Up to Follow-up (maximum up to Week 36)
Population: Safety population: all randomized participants who received any amount of study drug
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HBeAg-positive Participants: ABI-H0731 + SOC NUC | Number of Participants With One or More Adverse Events | 24 Participants |
| HBeAg-positive Participants: Placebo + SOC NUC | Number of Participants With One or More Adverse Events | 8 Participants |
Secondary
Number of Participants With Premature Study Discontinuation
Time frame: Up to Follow-up (maximum up to Week 36)
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HBeAg-positive Participants: ABI-H0731 + SOC NUC | Number of Participants With Premature Study Discontinuation | 0 Participants |
| HBeAg-positive Participants: Placebo + SOC NUC | Number of Participants With Premature Study Discontinuation | 1 Participants |
Secondary
Trough Levels of ABI-H0731 on ABI-H0731 + SOC NUC Therapy
Time frame: Before dosing at Baseline (Day 1), Weeks 2, 4, 12, and 24
Population: Safety population. Results were analyzed and reported only for participants who received ABI-H0731 + SOC NUC and had ABI-H0731 pharmacokinetic data assessments available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HBeAg-positive Participants: ABI-H0731 + SOC NUC | Trough Levels of ABI-H0731 on ABI-H0731 + SOC NUC Therapy | Week 24 | 1330 ng/mL | Standard Deviation 526 |
| HBeAg-positive Participants: ABI-H0731 + SOC NUC | Trough Levels of ABI-H0731 on ABI-H0731 + SOC NUC Therapy | Baseline (Day 1) | 0.436 ng/mL | Standard Deviation 2.92 |
| HBeAg-positive Participants: ABI-H0731 + SOC NUC | Trough Levels of ABI-H0731 on ABI-H0731 + SOC NUC Therapy | Week 2 | 1390 ng/mL | Standard Deviation 647 |
| HBeAg-positive Participants: ABI-H0731 + SOC NUC | Trough Levels of ABI-H0731 on ABI-H0731 + SOC NUC Therapy | Week 4 | 1390 ng/mL | Standard Deviation 632 |
| HBeAg-positive Participants: ABI-H0731 + SOC NUC | Trough Levels of ABI-H0731 on ABI-H0731 + SOC NUC Therapy | Week 12 | 1330 ng/mL | Standard Deviation 560 |
Secondary
Trough Levels of Entecavir (ETV) on ABI-H0731 + SOC NUC Therapy as Compared With Placebo + SOC NUC Therapy
Time frame: Before dosing at Baseline (Day 1), Weeks 2, 4, 12, and 24
Population: Safety population. Results were analyzed and reported only for participants who received ETV as their SOC NUC and had ETV pharmacokinetic data assessments available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HBeAg-positive Participants: ABI-H0731 + SOC NUC | Trough Levels of Entecavir (ETV) on ABI-H0731 + SOC NUC Therapy as Compared With Placebo + SOC NUC Therapy | Week 24 | 1.04 ng/mL | Standard Deviation 1.57 |
| HBeAg-positive Participants: ABI-H0731 + SOC NUC | Trough Levels of Entecavir (ETV) on ABI-H0731 + SOC NUC Therapy as Compared With Placebo + SOC NUC Therapy | Week 2 | 0.554 ng/mL | Standard Deviation 0.261 |
| HBeAg-positive Participants: ABI-H0731 + SOC NUC | Trough Levels of Entecavir (ETV) on ABI-H0731 + SOC NUC Therapy as Compared With Placebo + SOC NUC Therapy | Week 4 | 0.872 ng/mL | Standard Deviation 1.04 |
| HBeAg-positive Participants: ABI-H0731 + SOC NUC | Trough Levels of Entecavir (ETV) on ABI-H0731 + SOC NUC Therapy as Compared With Placebo + SOC NUC Therapy | Week 12 | 0.583 ng/mL | Standard Deviation 0.363 |
| HBeAg-positive Participants: ABI-H0731 + SOC NUC | Trough Levels of Entecavir (ETV) on ABI-H0731 + SOC NUC Therapy as Compared With Placebo + SOC NUC Therapy | Baseline (Day 1) | 1.10 ng/mL | Standard Deviation 1.88 |
| HBeAg-positive Participants: Placebo + SOC NUC | Trough Levels of Entecavir (ETV) on ABI-H0731 + SOC NUC Therapy as Compared With Placebo + SOC NUC Therapy | Week 2 | 0.346 ng/mL | Standard Deviation 0.124 |
| HBeAg-positive Participants: Placebo + SOC NUC | Trough Levels of Entecavir (ETV) on ABI-H0731 + SOC NUC Therapy as Compared With Placebo + SOC NUC Therapy | Baseline (Day 1) | 1.78 ng/mL | Standard Deviation 1.77 |
| HBeAg-positive Participants: Placebo + SOC NUC | Trough Levels of Entecavir (ETV) on ABI-H0731 + SOC NUC Therapy as Compared With Placebo + SOC NUC Therapy | Week 12 | 0.704 ng/mL | Standard Deviation 0.403 |
| HBeAg-positive Participants: Placebo + SOC NUC | Trough Levels of Entecavir (ETV) on ABI-H0731 + SOC NUC Therapy as Compared With Placebo + SOC NUC Therapy | Week 24 | 0.739 ng/mL | Standard Deviation 0.0902 |
| HBeAg-positive Participants: Placebo + SOC NUC | Trough Levels of Entecavir (ETV) on ABI-H0731 + SOC NUC Therapy as Compared With Placebo + SOC NUC Therapy | Week 4 | 0.621 ng/mL | Standard Deviation 0.46 |
Secondary
Trough Levels of Tenofovir Alafenamide (TAF) on ABI-H0731 + SOC NUC Therapy as Compared With Placebo + SOC NUC Therapy
Time frame: Before dosing at Baseline (Day 1), Weeks 2, 4, 12, and 24
Population: Safety population. Results were analyzed and reported only for participants who received TAF as their SOC NUC and had TAF pharmacokinetic data assessments available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HBeAg-positive Participants: ABI-H0731 + SOC NUC | Trough Levels of Tenofovir Alafenamide (TAF) on ABI-H0731 + SOC NUC Therapy as Compared With Placebo + SOC NUC Therapy | Week 2 | 13.1 ng/mL | Standard Deviation 4.73 |
| HBeAg-positive Participants: ABI-H0731 + SOC NUC | Trough Levels of Tenofovir Alafenamide (TAF) on ABI-H0731 + SOC NUC Therapy as Compared With Placebo + SOC NUC Therapy | Week 12 | 18.4 ng/mL | Standard Deviation 14.3 |
| HBeAg-positive Participants: ABI-H0731 + SOC NUC | Trough Levels of Tenofovir Alafenamide (TAF) on ABI-H0731 + SOC NUC Therapy as Compared With Placebo + SOC NUC Therapy | Week 4 | 21.3 ng/mL | Standard Deviation 25.3 |
| HBeAg-positive Participants: ABI-H0731 + SOC NUC | Trough Levels of Tenofovir Alafenamide (TAF) on ABI-H0731 + SOC NUC Therapy as Compared With Placebo + SOC NUC Therapy | Week 24 | 18.9 ng/mL | Standard Deviation 18.2 |
| HBeAg-positive Participants: ABI-H0731 + SOC NUC | Trough Levels of Tenofovir Alafenamide (TAF) on ABI-H0731 + SOC NUC Therapy as Compared With Placebo + SOC NUC Therapy | Baseline (Day 1) | 9.67 ng/mL | Standard Deviation 3.43 |
| HBeAg-positive Participants: Placebo + SOC NUC | Trough Levels of Tenofovir Alafenamide (TAF) on ABI-H0731 + SOC NUC Therapy as Compared With Placebo + SOC NUC Therapy | Week 24 | 13.3 ng/mL | Standard Deviation 3.26 |
| HBeAg-positive Participants: Placebo + SOC NUC | Trough Levels of Tenofovir Alafenamide (TAF) on ABI-H0731 + SOC NUC Therapy as Compared With Placebo + SOC NUC Therapy | Baseline (Day 1) | 12.2 ng/mL | Standard Deviation 6.52 |
| HBeAg-positive Participants: Placebo + SOC NUC | Trough Levels of Tenofovir Alafenamide (TAF) on ABI-H0731 + SOC NUC Therapy as Compared With Placebo + SOC NUC Therapy | Week 2 | 14.1 ng/mL | Standard Deviation 6.95 |
| HBeAg-positive Participants: Placebo + SOC NUC | Trough Levels of Tenofovir Alafenamide (TAF) on ABI-H0731 + SOC NUC Therapy as Compared With Placebo + SOC NUC Therapy | Week 4 | 11.8 ng/mL | Standard Deviation 4.52 |
| HBeAg-positive Participants: Placebo + SOC NUC | Trough Levels of Tenofovir Alafenamide (TAF) on ABI-H0731 + SOC NUC Therapy as Compared With Placebo + SOC NUC Therapy | Week 12 | 11.7 ng/mL | Standard Deviation 3.66 |
Secondary
Trough Levels of Tenofovir Disoproxil Fumarate (TDF) on ABI-H0731 + SOC NUC Therapy as Compared With Placebo + SOC NUC Therapy
Time frame: Before dosing at Baseline (Day 1), Weeks 2, 4, 12, and 24
Population: Safety population. Results were analyzed and reported only for participants who received TDF as their SOC NUC and had TDF pharmacokinetic data assessments available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HBeAg-positive Participants: ABI-H0731 + SOC NUC | Trough Levels of Tenofovir Disoproxil Fumarate (TDF) on ABI-H0731 + SOC NUC Therapy as Compared With Placebo + SOC NUC Therapy | Week 2 | 85.5 ng/mL | Standard Deviation 49.3 |
| HBeAg-positive Participants: ABI-H0731 + SOC NUC | Trough Levels of Tenofovir Disoproxil Fumarate (TDF) on ABI-H0731 + SOC NUC Therapy as Compared With Placebo + SOC NUC Therapy | Week 12 | 79.3 ng/mL | Standard Deviation 68.1 |
| HBeAg-positive Participants: ABI-H0731 + SOC NUC | Trough Levels of Tenofovir Disoproxil Fumarate (TDF) on ABI-H0731 + SOC NUC Therapy as Compared With Placebo + SOC NUC Therapy | Week 4 | 86.8 ng/mL | Standard Deviation 58.2 |
| HBeAg-positive Participants: ABI-H0731 + SOC NUC | Trough Levels of Tenofovir Disoproxil Fumarate (TDF) on ABI-H0731 + SOC NUC Therapy as Compared With Placebo + SOC NUC Therapy | Week 24 | 79.3 ng/mL | Standard Deviation 45.3 |
| HBeAg-positive Participants: ABI-H0731 + SOC NUC | Trough Levels of Tenofovir Disoproxil Fumarate (TDF) on ABI-H0731 + SOC NUC Therapy as Compared With Placebo + SOC NUC Therapy | Baseline (Day 1) | 77.5 ng/mL | Standard Deviation 52.1 |
| HBeAg-positive Participants: Placebo + SOC NUC | Trough Levels of Tenofovir Disoproxil Fumarate (TDF) on ABI-H0731 + SOC NUC Therapy as Compared With Placebo + SOC NUC Therapy | Week 24 | 78.3 ng/mL | Standard Deviation 44.4 |
| HBeAg-positive Participants: Placebo + SOC NUC | Trough Levels of Tenofovir Disoproxil Fumarate (TDF) on ABI-H0731 + SOC NUC Therapy as Compared With Placebo + SOC NUC Therapy | Baseline (Day 1) | 89.1 ng/mL | Standard Deviation 71.4 |
| HBeAg-positive Participants: Placebo + SOC NUC | Trough Levels of Tenofovir Disoproxil Fumarate (TDF) on ABI-H0731 + SOC NUC Therapy as Compared With Placebo + SOC NUC Therapy | Week 2 | 76.2 ng/mL | Standard Deviation 21.5 |
| HBeAg-positive Participants: Placebo + SOC NUC | Trough Levels of Tenofovir Disoproxil Fumarate (TDF) on ABI-H0731 + SOC NUC Therapy as Compared With Placebo + SOC NUC Therapy | Week 4 | 84.1 ng/mL | Standard Deviation 60.3 |
| HBeAg-positive Participants: Placebo + SOC NUC | Trough Levels of Tenofovir Disoproxil Fumarate (TDF) on ABI-H0731 + SOC NUC Therapy as Compared With Placebo + SOC NUC Therapy | Week 12 | 86.7 ng/mL | Standard Deviation 47.4 |
Secondary
Trough to Peak Ratios of ABI-H0731 on ABI-H0731 + SOC NUC Therapy
Time frame: Baseline, Weeks 2, 4, 12, and 24
Population: Trough to peak ratios were not calculated due to an insufficient number of optional peak exposure samples.
Secondary
Trough to Peak Ratios of SOC NUC on ABI-H0731 + SOC NUC Therapy as Compared With Placebo + SOC NUC Therapy
Time frame: Baseline, Weeks 2, 4, 12, and 24
Population: Trough to peak ratios were not calculated due to an insufficient number of optional peak exposure samples.