Chronic Hepatitis B
Conditions
Keywords
cHBV, HBV, HBeAg-positive, hepatitis B, vebicorvir, VBR
Brief summary
The purpose of this study is to determine if ABI-H0731 given in combination with a standard of care (SOC) entecavir (ETV) is safe and effective in participants with chronic hepatitis B infection (cHBV)
Detailed description
This is a Phase 2a, multi-center, double-blind, placebo-controlled study evaluating ABI-H0731+ ETV vs ETV alone for the treatment of viremic hepatitis B e antigen (HBeAg)-positive participants with cHBV.
Interventions
DRUGABI-H0731
Participants will receive 300mg QD of ABI-H0731 tablets orally.
DRUGSOC ETV
Participants will receive SOC ETV (0.5 mg QD) orally as per approved package insert.
DRUGPlacebo Oral Tablet
Participants will receive matching QD placebo tablets orally.
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 * HBeAg-positive at screening * In good general health except for cHBV * HBV viral load ≥2×105 IU/mL * Hepatitis B surface antigen (HBsAg) \>1000 IU/mL at screening Key
Exclusion criteria
* Any prior treatment with lamivudine or telbivudine, previous treatment with an investigational agent for HBV other than ABI-H0731; or any other SOC treatment for \>4 weeks * 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: * Platelet count \<100,000/mm3 * Albumin \<lower limit of normal (LLN) * Direct bilirubin \>1.2×upper limit of normal (ULN) * Alanine aminotransferase (ALT) \>10×ULN at screening * Serum alpha fetoprotein (AFP) ≥100 ng/mL. If AFP at Screening is \>ULN but \<100 ng/mL, participant is eligible if a hepatic imaging study prior to the initiation of study drug reveals no lesions suspicious of possible HCC * 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 | Description |
|---|---|---|
| Change in Mean log10 HBV DNA From Baseline (Day 1) to Week 12 or Week 24 on ABI H0731 + SOC ETV as Compared to Placebo + SOC ETV | Baseline, Week 12, and Week 24 | Hepatitis B virus (HBV) DNA was measured using COBAS TaqMan Version 2.0. The lower limit of quantitation (LLOQ) was 20 IU/mL and the limit of detection (LOD) was 10 IU/mL. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Premature Study Discontinuation | Up to Follow-up (maximum up to Week 36) | — |
| 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 + SOC ETV as Compared to Placebo + SOC ETV | Baseline to Week 24 | — |
| Number of Participants With a Decline in Viral DNA to Below Limit of Quantitation on ABI-H0731 + SOC ETV as Compared to Placebo + SOC ETV | Baseline, Weeks 2, 4, 8, 12, 16, 20, and 24 | HBV DNA was measured using COBAS TaqMan Version 2.0. The LLOQ was 20 IU/mL and the LOD was 10 IU/mL. The number of participants with HBV DNA below the limit of quantitation (\<20 IU/mL) and target detected (≥10 IU/mL) was assessed. |
| Number of Participants One or More Adverse Events | Up to Follow-up (maximum up to Week 36) | — |
| Number of Participants With Emergence of Resistant HBV Variants on ABI-H0731 + SOC ETV as Compared to Placebo + SOC ETV | Up to Week 36 | Emergence of a resistant HBV variant was defined as an increase of ≥1 log10 IU/mL from the nadir in HBV DNA. |
| Trough Levels of ABI-H0731 on ABI-H0731 + SOC ETV Therapy | Before dosing at Baseline (Day 1), Weeks 2, 4, 12, and 24 | — |
| Trough Levels of ETV on ABI-H0731 + ETV Therapy as Compared With Placebo + ETV Therapy | Before dosing at Baseline (Day 1), Weeks 2, 4, 12, and 24 | — |
| Trough to Peak Ratios of ABI-H0731 on ABI-H0731 + ETV Therapy | Baseline, Weeks 2, 4, 12, and 24 | — |
| Trough to Peak Ratios of ETV on ABI-H0731 + ETV Therapy as Compared With Placebo + ETV Therapy | Baseline, Weeks 2, 4, 12, 24, and 28 | — |
| Median Time to Viral Suppression, Defined as HBV DNA <20 IU/mL, on ABI-H0731 + ETV as Compared to Placebo + ETV | Baseline, Weeks 2, 4, 8, 12, 16, 20, and 24 | Median time to viral suppression will be calculated and evaluated between participants on ABI-H0731 + ETV as compared to placebo + ETV. |
Countries
Canada, Hong Kong, New Zealand, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ABI-H0731 + SOC ETV Participants with cHBV who are currently not being treated will receive ABI-H0731 along with SOC ETV 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 300mg QD of ABI-H0731 tablets orally.
SOC ETV: Participants will receive SOC ETV (0.5 mg QD) orally as per approved package insert. | 13 |
| Placebo + SOC ETV Participants with cHBV who are currently not being treated will receive matching placebo along with SOC ETV tablets orally 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.
SOC ETV: Participants will receive SOC ETV (0.5 mg QD) orally as per approved package insert.
Placebo Oral Tablet: Participants will receive matching QD placebo tablets orally. | 12 |
| Total | 25 |
Baseline characteristics
| Characteristic | ABI-H0731 + SOC ETV | Placebo + SOC ETV | Total |
|---|---|---|---|
| Age, Continuous | 35.7 years STANDARD_DEVIATION 14.13 | 34.1 years STANDARD_DEVIATION 11.39 | 34.9 years STANDARD_DEVIATION 12.65 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 13 Participants | 12 Participants | 25 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 13 Participants | 11 Participants | 24 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Canada | 1 participants | 2 participants | 3 participants |
| Region of Enrollment Hong Kong | 3 participants | 2 participants | 5 participants |
| Region of Enrollment New Zealand | 1 participants | 0 participants | 1 participants |
| Region of Enrollment United Kingdom | 1 participants | 1 participants | 2 participants |
| Region of Enrollment United States | 7 participants | 7 participants | 14 participants |
| Sex: Female, Male Female | 10 Participants | 7 Participants | 17 Participants |
| Sex: Female, Male Male | 3 Participants | 5 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 13 | 0 / 12 |
| other Total, other adverse events | 7 / 13 | 5 / 12 |
| serious Total, serious adverse events | 0 / 13 | 0 / 12 |
Outcome results
Primary
Change in Mean log10 HBV DNA From Baseline (Day 1) to Week 12 or Week 24 on ABI H0731 + SOC ETV as Compared to Placebo + SOC ETV
Hepatitis B virus (HBV) DNA was measured using COBAS TaqMan Version 2.0. The lower limit of quantitation (LLOQ) was 20 IU/mL and the limit of detection (LOD) was 10 IU/mL.
Time frame: Baseline, Week 12, and Week 24
Population: Intent-to-treat (ITT) population: all randomized participants
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABI-H0731 + SOC ETV | Change in Mean log10 HBV DNA From Baseline (Day 1) to Week 12 or Week 24 on ABI H0731 + SOC ETV as Compared to Placebo + SOC ETV | Baseline | 7.91 Log10 International Units (IU)/mL | Standard Deviation 0.89 |
| ABI-H0731 + SOC ETV | Change in Mean log10 HBV DNA From Baseline (Day 1) to Week 12 or Week 24 on ABI H0731 + SOC ETV as Compared to Placebo + SOC ETV | Change from Baseline at Week 12 | -4.45 Log10 International Units (IU)/mL | Standard Deviation 1.027 |
| ABI-H0731 + SOC ETV | Change in Mean log10 HBV DNA From Baseline (Day 1) to Week 12 or Week 24 on ABI H0731 + SOC ETV as Compared to Placebo + SOC ETV | Change from Baseline at Week 24 | -5.33 Log10 International Units (IU)/mL | Standard Deviation 1.594 |
| Placebo + SOC ETV | Change in Mean log10 HBV DNA From Baseline (Day 1) to Week 12 or Week 24 on ABI H0731 + SOC ETV as Compared to Placebo + SOC ETV | Baseline | 8.03 Log10 International Units (IU)/mL | Standard Deviation 0.999 |
| Placebo + SOC ETV | Change in Mean log10 HBV DNA From Baseline (Day 1) to Week 12 or Week 24 on ABI H0731 + SOC ETV as Compared to Placebo + SOC ETV | Change from Baseline at Week 12 | -3.30 Log10 International Units (IU)/mL | Standard Deviation 1.182 |
| Placebo + SOC ETV | Change in Mean log10 HBV DNA From Baseline (Day 1) to Week 12 or Week 24 on ABI H0731 + SOC ETV as Compared to Placebo + SOC ETV | Change from Baseline at Week 24 | -4.20 Log10 International Units (IU)/mL | Standard Deviation 0.976 |
Comparison: Least Squares (LS) Mean Difference ABI-H0731 + SOC ETV minus Placebo + SOC ETV at Week 12p-value: 0.007795% CI: [-1.986, -0.322]Repeated measures analysis
Comparison: Least Squares Mean Difference ABI-H0731 + SOC ETV minus Placebo + SOC ETV at Week 24p-value: 0.008495% CI: [-1.973, -0.309]Repeated measures analysis
Secondary
Median Time to Viral Suppression, Defined as HBV DNA <20 IU/mL, on ABI-H0731 + ETV as Compared to Placebo + ETV
Median time to viral suppression will be calculated and evaluated between participants on ABI-H0731 + ETV as compared to placebo + ETV.
Time frame: Baseline, Weeks 2, 4, 8, 12, 16, 20, and 24
Population: Median time to viral suppression could not be calculated because fewer than 50% of participants achieved viral suppression within 24 weeks.
Secondary
Number of Participants 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) |
|---|---|---|
| ABI-H0731 + SOC ETV | Number of Participants One or More Adverse Events | 7 Participants |
| Placebo + SOC ETV | Number of Participants One or More Adverse Events | 5 Participants |
Secondary
Number of Participants With Abnormal Alanine Aminotransferase (ALT) at Baseline Who Have Normal ALT at Week 24 on ABI-H0731 + SOC ETV as Compared to Placebo + SOC ETV
Time frame: Baseline to Week 24
Population: Participants in the ITT population with abnormal ALT at Baseline
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ABI-H0731 + SOC ETV | Number of Participants With Abnormal Alanine Aminotransferase (ALT) at Baseline Who Have Normal ALT at Week 24 on ABI-H0731 + SOC ETV as Compared to Placebo + SOC ETV | 4 Participants |
| Placebo + SOC ETV | Number of Participants With Abnormal Alanine Aminotransferase (ALT) at Baseline Who Have Normal ALT at Week 24 on ABI-H0731 + SOC ETV as Compared to Placebo + SOC ETV | 2 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: all randomized participants who received any amount of study drug
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ABI-H0731 + SOC ETV | Number of Participants With a Clinically-significant Change in Vital Signs | 0 Participants |
| Placebo + SOC ETV | 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: all randomized participants who received any amount of study drug
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ABI-H0731 + SOC ETV | Number of Participants With a Clinically-significant Electrocardiogram Abnormality | 0 Participants |
| Placebo + SOC ETV | Number of Participants With a Clinically-significant Electrocardiogram Abnormality | 0 Participants |
Secondary
Number of Participants With a Decline in Viral DNA to Below Limit of Quantitation on ABI-H0731 + SOC ETV as Compared to Placebo + SOC ETV
HBV DNA was measured using COBAS TaqMan Version 2.0. The LLOQ was 20 IU/mL and the LOD was 10 IU/mL. The number of participants with HBV DNA below the limit of quantitation (\<20 IU/mL) and target detected (≥10 IU/mL) was assessed.
Time frame: Baseline, Weeks 2, 4, 8, 12, 16, 20, and 24
Population: ITT population and had viral DNA data available
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ABI-H0731 + SOC ETV | Number of Participants With a Decline in Viral DNA to Below Limit of Quantitation on ABI-H0731 + SOC ETV as Compared to Placebo + SOC ETV | Baseline | 0 Participants |
| ABI-H0731 + SOC ETV | Number of Participants With a Decline in Viral DNA to Below Limit of Quantitation on ABI-H0731 + SOC ETV as Compared to Placebo + SOC ETV | Week 2 | 0 Participants |
| ABI-H0731 + SOC ETV | Number of Participants With a Decline in Viral DNA to Below Limit of Quantitation on ABI-H0731 + SOC ETV as Compared to Placebo + SOC ETV | Week 4 | 0 Participants |
| ABI-H0731 + SOC ETV | Number of Participants With a Decline in Viral DNA to Below Limit of Quantitation on ABI-H0731 + SOC ETV as Compared to Placebo + SOC ETV | Week 8 | 1 Participants |
| ABI-H0731 + SOC ETV | Number of Participants With a Decline in Viral DNA to Below Limit of Quantitation on ABI-H0731 + SOC ETV as Compared to Placebo + SOC ETV | Week 12 | 1 Participants |
| ABI-H0731 + SOC ETV | Number of Participants With a Decline in Viral DNA to Below Limit of Quantitation on ABI-H0731 + SOC ETV as Compared to Placebo + SOC ETV | Week 16 | 2 Participants |
| ABI-H0731 + SOC ETV | Number of Participants With a Decline in Viral DNA to Below Limit of Quantitation on ABI-H0731 + SOC ETV as Compared to Placebo + SOC ETV | Week 20 | 1 Participants |
| ABI-H0731 + SOC ETV | Number of Participants With a Decline in Viral DNA to Below Limit of Quantitation on ABI-H0731 + SOC ETV as Compared to Placebo + SOC ETV | Week 24 | 3 Participants |
| Placebo + SOC ETV | Number of Participants With a Decline in Viral DNA to Below Limit of Quantitation on ABI-H0731 + SOC ETV as Compared to Placebo + SOC ETV | Week 24 | 1 Participants |
| Placebo + SOC ETV | Number of Participants With a Decline in Viral DNA to Below Limit of Quantitation on ABI-H0731 + SOC ETV as Compared to Placebo + SOC ETV | Baseline | 0 Participants |
| Placebo + SOC ETV | Number of Participants With a Decline in Viral DNA to Below Limit of Quantitation on ABI-H0731 + SOC ETV as Compared to Placebo + SOC ETV | Week 12 | 0 Participants |
| Placebo + SOC ETV | Number of Participants With a Decline in Viral DNA to Below Limit of Quantitation on ABI-H0731 + SOC ETV as Compared to Placebo + SOC ETV | Week 2 | 0 Participants |
| Placebo + SOC ETV | Number of Participants With a Decline in Viral DNA to Below Limit of Quantitation on ABI-H0731 + SOC ETV as Compared to Placebo + SOC ETV | Week 20 | 1 Participants |
| Placebo + SOC ETV | Number of Participants With a Decline in Viral DNA to Below Limit of Quantitation on ABI-H0731 + SOC ETV as Compared to Placebo + SOC ETV | Week 4 | 0 Participants |
| Placebo + SOC ETV | Number of Participants With a Decline in Viral DNA to Below Limit of Quantitation on ABI-H0731 + SOC ETV as Compared to Placebo + SOC ETV | Week 16 | 0 Participants |
| Placebo + SOC ETV | Number of Participants With a Decline in Viral DNA to Below Limit of Quantitation on ABI-H0731 + SOC ETV as Compared to Placebo + SOC ETV | Week 8 | 0 Participants |
Secondary
Number of Participants With Emergence of Resistant HBV Variants on ABI-H0731 + SOC ETV as Compared to Placebo + SOC ETV
Emergence of a resistant HBV variant was defined as an increase of ≥1 log10 IU/mL from the nadir in HBV DNA.
Time frame: Up to Week 36
Population: ITT population
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ABI-H0731 + SOC ETV | Number of Participants With Emergence of Resistant HBV Variants on ABI-H0731 + SOC ETV as Compared to Placebo + SOC ETV | Emergence of resistant HBV variants | 1 Participants |
| ABI-H0731 + SOC ETV | Number of Participants With Emergence of Resistant HBV Variants on ABI-H0731 + SOC ETV as Compared to Placebo + SOC ETV | No emergence of resistant HBV variants | 12 Participants |
| Placebo + SOC ETV | Number of Participants With Emergence of Resistant HBV Variants on ABI-H0731 + SOC ETV as Compared to Placebo + SOC ETV | Emergence of resistant HBV variants | 1 Participants |
| Placebo + SOC ETV | Number of Participants With Emergence of Resistant HBV Variants on ABI-H0731 + SOC ETV as Compared to Placebo + SOC ETV | No emergence of resistant HBV variants | 11 Participants |
Secondary
Number of Participants With One or More Abnormal Safety Laboratory Result
Time frame: Up to Week 36
Population: Safety population: all randomized participants who received any amount of study drug
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ABI-H0731 + SOC ETV | Number of Participants With One or More Abnormal Safety Laboratory Result | 8 Participants |
| Placebo + SOC ETV | Number of Participants With One or More Abnormal Safety Laboratory Result | 10 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) |
|---|---|---|
| ABI-H0731 + SOC ETV | Number of Participants With Premature Study Discontinuation | 0 Participants |
| Placebo + SOC ETV | Number of Participants With Premature Study Discontinuation | 0 Participants |
Secondary
Trough Levels of ABI-H0731 on ABI-H0731 + SOC ETV Therapy
Time frame: Before dosing at Baseline (Day 1), Weeks 2, 4, 12, and 24
Population: Results were analyzed and reported only for participants in the safety population who received ABI-H0731 + SOC ETV and had ABI-H0731 pharmacokinetic data assessments available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABI-H0731 + SOC ETV | Trough Levels of ABI-H0731 on ABI-H0731 + SOC ETV Therapy | Baseline (Day 1) | NA ng/mL | — |
| ABI-H0731 + SOC ETV | Trough Levels of ABI-H0731 on ABI-H0731 + SOC ETV Therapy | Week 2 | 1480 ng/mL | Standard Deviation 458 |
| ABI-H0731 + SOC ETV | Trough Levels of ABI-H0731 on ABI-H0731 + SOC ETV Therapy | Week 4 | 1290 ng/mL | Standard Deviation 434 |
| ABI-H0731 + SOC ETV | Trough Levels of ABI-H0731 on ABI-H0731 + SOC ETV Therapy | Week 12 | 1270 ng/mL | Standard Deviation 413 |
| ABI-H0731 + SOC ETV | Trough Levels of ABI-H0731 on ABI-H0731 + SOC ETV Therapy | Week 24 | 1470 ng/mL | Standard Deviation 547 |
Secondary
Trough Levels of ETV on ABI-H0731 + ETV Therapy as Compared With Placebo + ETV Therapy
Time frame: Before dosing at Baseline (Day 1), Weeks 2, 4, 12, and 24
Population: Results were analyzed and reported only for participants in the safety population who had ETV pharmacokinetic data assessments available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABI-H0731 + SOC ETV | Trough Levels of ETV on ABI-H0731 + ETV Therapy as Compared With Placebo + ETV Therapy | Week 2 | 0.432 ng/mL | Standard Deviation 0.126 |
| ABI-H0731 + SOC ETV | Trough Levels of ETV on ABI-H0731 + ETV Therapy as Compared With Placebo + ETV Therapy | Baseline (Day 1) | 0.00325 ng/mL | Standard Deviation 0.0113 |
| ABI-H0731 + SOC ETV | Trough Levels of ETV on ABI-H0731 + ETV Therapy as Compared With Placebo + ETV Therapy | Week 4 | 0.419 ng/mL | Standard Deviation 0.119 |
| ABI-H0731 + SOC ETV | Trough Levels of ETV on ABI-H0731 + ETV Therapy as Compared With Placebo + ETV Therapy | Week 24 | 0.411 ng/mL | Standard Deviation 0.143 |
| ABI-H0731 + SOC ETV | Trough Levels of ETV on ABI-H0731 + ETV Therapy as Compared With Placebo + ETV Therapy | Week 12 | 0.378 ng/mL | Standard Deviation 0.149 |
| Placebo + SOC ETV | Trough Levels of ETV on ABI-H0731 + ETV Therapy as Compared With Placebo + ETV Therapy | Week 24 | 0.408 ng/mL | Standard Deviation 0.131 |
| Placebo + SOC ETV | Trough Levels of ETV on ABI-H0731 + ETV Therapy as Compared With Placebo + ETV Therapy | Week 12 | 0.666 ng/mL | Standard Deviation 0.766 |
| Placebo + SOC ETV | Trough Levels of ETV on ABI-H0731 + ETV Therapy as Compared With Placebo + ETV Therapy | Baseline (Day 1) | 0 ng/mL | Standard Deviation 0 |
| Placebo + SOC ETV | Trough Levels of ETV on ABI-H0731 + ETV Therapy as Compared With Placebo + ETV Therapy | Week 2 | 0.497 ng/mL | Standard Deviation 0.473 |
| Placebo + SOC ETV | Trough Levels of ETV on ABI-H0731 + ETV Therapy as Compared With Placebo + ETV Therapy | Week 4 | 0.618 ng/mL | Standard Deviation 0.736 |
Secondary
Trough to Peak Ratios of ABI-H0731 on ABI-H0731 + ETV 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 ETV on ABI-H0731 + ETV Therapy as Compared With Placebo + ETV Therapy
Time frame: Baseline, Weeks 2, 4, 12, 24, and 28
Population: Trough to peak ratios were not calculated due to an insufficient number of optional peak exposure samples.