Chronic Hepatitis B
Conditions
Keywords
cHBV, HBV, vebicorvir, VBR
Brief summary
The purpose of this study is to evaluate the safety, antiviral activity, and pharmacokinetics of ABI-H0731 in combination with entecavir (ETV) and with ETV plus pegylated-interferon alpha (Peg-IFNα) in Chinese participants with chronic hepatitis B virus infection (cHBV)
Interventions
Sponsors
Assembly Biosciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Body mass index (BMI) 18 to 36 kg/m\^2 and a minimum body weight of 45 kg (inclusive) * Female subjects must be non-pregnant and have a negative serum pregnancy test * Chronic hepatitis B infection, defined as HBV infection for ≥6 months documented, for example, by at least 2 measurements of HBsAg positivity and/or detectable HBV DNA ≥6 months apart (inclusive of Screening). For subjects without clear documentation of CHB, serum immunoglobulin M (IgM) antibody to the HBV core antigen (HBcAb) must be negative at Screening to exclude acute HBV infection. * HBeAg positive with HBV DNA ≥2 × 10\^4 IU/mL at Screening * Lack of cirrhosis or advanced liver disease * A candidate for interferon-based therapy * Agreement to comply with protocol-specified contraceptive requirements * Agreement to abstain from alcohol abuse and the use of illicit substances from Screening through the duration of the study * In good general health, except for cHBV, in the opinion of the Investigator * Able to take oral medication and be willing to receive subcutaneous injections of Peg-IFNα.
Exclusion criteria
* Current or prior treatment for CHB with * A nucleos(t)ide reverse transcriptase inhibitor of the HBV polymerase (NrtI) (ETV, tenofovir disoproxil fumarate or tenofovir alafenamide) for \>4 weeks at any time. Note, NrtI treatment of ≤4 weeks duration cannot be within 6 months prior to Screening * Interferon-based therapy within 6 months prior to Screening * Liver-protecting and/or ALT-lowering treatment including traditional Chinese medicine within 1 month of Screening * Lamivudine, telbivudine or adefovir (of any duration) * Previous treatment with siRNA within 9 months prior to Screening * HBV core inhibitors (any duration) * Previous treatment with any other investigational agent for HBV infection within 6 months prior to Screening * Co-infection with human immunodeficiency virus (HIV), hepatitis A virus (HAV) hepatitis C virus (HCV), hepatitis E virus (HEV), or hepatitis D virus (HDV) * Females who are lactating, or wish to become pregnant during the course of the study * History or evidence of advanced liver disease or hepatic decompensation at any time prior to, or at the time of Screening * History of persistent alcohol abuse or illicit drug abuse within 3 years prior to Screening * Clinically significant psychiatric disease, including severe depression, history of suicidal ideation or suicide attempt * Clinically significant cardiac disease including poorly controlled or unstable hypertension; pulmonary disease; chronic or recurrent renal or urinary tract disease; liver disease other than cHBV; endocrine disorder; autoimmune disorder; poorly controlled diabetes mellitus; neuromuscular, musculoskeletal, or mucocutaneous conditions requiring frequent treatment; seizure disorders requiring treatment; ongoing infection 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 subject unsuitable for study participation * History of hepatocellular carcinoma (HCC) * History of malignancy other than HCC unless the subject's malignancy has been in complete remission off chemotherapy and without additional medical or surgical interventions during the 3 years before Screening * History or presence at Screening of electrocardiogram (ECG) abnormalities deemed clinically significant, in the opinion of the Investigator * History of hypersensitivity or idiosyncratic reaction to any components or excipients of the investigational drug * History of any significant food or drug-related allergic reactions such as, anaphylaxis or Stevens-Johnson syndrome * Exclusionary laboratory results at Screening: * Hemoglobin \<12g/dL for males or \<11g/dL for females * Platelet count \<100,000/mm\^3 * White blood cell count \<2,500/mm\^3 * Absolute neutrophil count \<1,500/mm\^3 * Albumin \<lower limit of normal * History of thyroid disease poorly controlled on prescribed medications, with thyroid-stimulating hormone (TSH), free triiodothyronine or free thyroxine (T4) outside the normal limits * Total bilirubin \>1.2 × upper limit of normal (ULN) * Direct bilirubin \>1.2 × ULN * ALT ≤1 x ULN or ≥10 × ULN * Serum alpha fetoprotein (AFP) ≥100 ng/mL. If AFP at Screening is \>ULN but \<100 ng/mL, the participant is eligible if a hepatic imaging trial prior to initiation of study drug reveals no lesions indicative of possible HCC. * International Normalized Ratio \>1.5 × ULN unless on a stable anticoagulant regimen * Glomerular filtration rate \<60 mL/min/1.73 m\^2 by Chronic Kidney Disease Epidemiology Collaboration equation * Serum creatinine \>1.5 x ULN * Any other laboratory abnormality deemed clinically significant by the Sponsor or the Investigator. * Subjects receiving prohibited concomitant medications or medications that should be avoided within 7 days or 5 half-lives (if known), whichever is longer, prior to administration of the first dose of study drug (Day 1) and for the duration of the study period. Please refer to Exclusion Criterion #1 for criteria regarding liver protecting and/or ALT lowering agents * Participation in another clinical study of any non-HBV-related drug or device whereby the last investigational drug/device administration is within 60 days or 5 half-lives prior to the first study drug administration (Day 1), whichever is longer. * Subjects who have received, in the previous 4 weeks, a treatment likely to alter the immune response (intravenous immunoglobulins, blood-derived products, or high-dose steroids, or other immunosuppressants).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants With an Adverse Event | Up to 60 weeks |
| Number of Participants With Premature Discontinuation of Treatment | Up to 60 weeks |
| Number of Participants With a Laboratory Abnormality | Up to 60 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Mean Change From Baseline in HBcrAg | Baseline and at pre-specified time points up to 60 weeks |
| Mean Change From Baseline in HBsAg | Baseline and at pre-specified time points up to 60 weeks |
| Mean Change From Baseline in HBV pgRNA | Baseline and at pre-specified time points up to 60 weeks |
| Plasma Concentration of ABI-H0731 | Predose on Day 1, Week 4, and Week 24 and at pre-specified time points postdose up to Week 24 |
| Incidence of HBV Variants With Reduced Susceptibility to ABI-H0731 | Pre-specified time points up to 60 weeks |
| Number of Participants With Normalized Alanine Aminotransferase (ALT) | Baseline and at pre-specified time points up to 60 weeks |
| Mean Change From Baseline HBV DNA | Baseline and at pre-specified time points up to 60 weeks |
| Mean Change From Baseline in HBeAg | Baseline and at pre-specified time points up to 60 weeks |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ABI-H0731 + ETV Participants with cHBV received ABI-H0731 with ETV for 48 weeks, followed by ETV alone for 12 weeks or until the study was early terminated
ABI-H0731: Participants received ABI-H0731 300 mg tablets orally once daily
ETV: Participants received ETV 0.5 mg tablets orally once daily | 20 |
| ABI-H0731 + ETV + Peg-IFNα Participants with cHBV received ABI-H0731 with ETV and Peg-IFNα for 24 weeks, followed by ABI-H0731 with ETV for 24 weeks, followed by ETV alone for 12 weeks or until the study was early terminated
ABI-H0731: Participants received ABI-H0731 300 mg tablets orally once daily
ETV: Participants received ETV 0.5 mg tablets orally once daily
Peg-IFNα: Participants received Peg-IFNα with a starting dose of 180 µg solution by subcutaneous injection once weekly | 17 |
| ETV + Peg-IFNα Participants with cHBV received ETV and Peg-IFNα for 24 weeks, followed by ABI-H0731 with ETV for 24 weeks, followed by ETV alone for 12 weeks or until the study was early terminated
ETV: Participants received ETV 0.5 mg tablets orally once daily
Peg-IFNα: Participants received Peg-IFNα with a starting dose of 180 µg solution by subcutaneous injection once weekly | 17 |
| Total | 54 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 | 1 |
| Overall Study | Pregnancy | 0 | 0 | 1 |
| Overall Study | Protocol Violation | 1 | 0 | 0 |
| Overall Study | Study terminated by Sponsor | 11 | 9 | 9 |
| Overall Study | Virology rebounded | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 2 | 0 |
Baseline characteristics
| Characteristic | Total | ABI-H0731 + ETV | ABI-H0731 + ETV + Peg-IFNα | ETV + Peg-IFNα |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 54 Participants | 20 Participants | 17 Participants | 17 Participants |
| Age, Continuous | 32 years STANDARD_DEVIATION 6.7 | 33 years STANDARD_DEVIATION 6.6 | 31 years STANDARD_DEVIATION 5.8 | 34 years STANDARD_DEVIATION 7.8 |
| ALT (U/L) | 137 U/L STANDARD_DEVIATION 84.3 | 149 U/L STANDARD_DEVIATION 65 | 138 U/L STANDARD_DEVIATION 121.2 | 123 U/L STANDARD_DEVIATION 58.5 |
| Body Mass Index | 22.93 kg/m^2 STANDARD_DEVIATION 2.843 | 22.51 kg/m^2 STANDARD_DEVIATION 2.683 | 22.90 kg/m^2 STANDARD_DEVIATION 2.407 | 23.44 kg/m^2 STANDARD_DEVIATION 3.457 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 54 Participants | 20 Participants | 17 Participants | 17 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| HBcrAg (Log10 kU/mL) | 5.3 Log10 kU/mL STANDARD_DEVIATION 0.62 | 5.5 Log10 kU/mL STANDARD_DEVIATION 0.59 | 5.0 Log10 kU/mL STANDARD_DEVIATION 0.71 | 5.4 Log10 kU/mL STANDARD_DEVIATION 0.46 |
| HBeAg (Log10 IU/mL) | 2.6 Log10 IU/mL STANDARD_DEVIATION 0.79 | 2.7 Log10 IU/mL STANDARD_DEVIATION 0.81 | 2.4 Log10 IU/mL STANDARD_DEVIATION 0.89 | 2.7 Log10 IU/mL STANDARD_DEVIATION 0.64 |
| HBsAg (Log10 IU/mL) | 4.3 Log10 IU/mL STANDARD_DEVIATION 0.58 | 4.5 Log10 IU/mL STANDARD_DEVIATION 0.39 | 4.1 Log10 IU/mL STANDARD_DEVIATION 0.76 | 4.3 Log10 IU/mL STANDARD_DEVIATION 0.53 |
| HBV DNA (Log10 IU/mL) | 8.0 Log 10 IU/mL STANDARD_DEVIATION 0.96 | 8.2 Log 10 IU/mL STANDARD_DEVIATION 1.02 | 7.7 Log 10 IU/mL STANDARD_DEVIATION 1.11 | 8.1 Log 10 IU/mL STANDARD_DEVIATION 0.63 |
| HBV Genotype Genotype A | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| HBV Genotype Genotype B | 25 Participants | 9 Participants | 8 Participants | 8 Participants |
| HBV Genotype Genotype C | 29 Participants | 11 Participants | 9 Participants | 9 Participants |
| HBV Genotype Genotype D | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| HBV Genotype Other Genotype | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| HBV pgRNA (Log10 U/mL) | 6.3 Log10 U/mL STANDARD_DEVIATION 1.3 | 6.5 Log10 U/mL STANDARD_DEVIATION 1.33 | 5.8 Log10 U/mL STANDARD_DEVIATION 1.43 | 6.5 Log10 U/mL STANDARD_DEVIATION 1.05 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 54 Participants | 20 Participants | 17 Participants | 17 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment China | 54 participants | 20 participants | 17 participants | 17 participants |
| Sex: Female, Male Female | 39 Participants | 15 Participants | 14 Participants | 10 Participants |
| Sex: Female, Male Male | 15 Participants | 5 Participants | 3 Participants | 7 Participants |
| Years positive for HBV | 11.3 years STANDARD_DEVIATION 9 | 11.3 years STANDARD_DEVIATION 9.23 | 11.2 years STANDARD_DEVIATION 9.43 | 11.2 years STANDARD_DEVIATION 8.91 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 17 | 0 / 17 |
| other Total, other adverse events | 14 / 20 | 17 / 17 | 17 / 17 |
| serious Total, serious adverse events | 0 / 20 | 1 / 17 | 0 / 17 |
Outcome results
Primary
Number of Participants With a Laboratory Abnormality
Time frame: Up to 60 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ABI-H0731 + ETV | Number of Participants With a Laboratory Abnormality | 19 Participants |
| ABI-H0731 + ETV + Peg-IFNα | Number of Participants With a Laboratory Abnormality | 16 Participants |
| ETV + Peg-IFNα | Number of Participants With a Laboratory Abnormality | 17 Participants |
Primary
Number of Participants With an Adverse Event
Time frame: Up to 60 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ABI-H0731 + ETV | Number of Participants With an Adverse Event | 14 Participants |
| ABI-H0731 + ETV + Peg-IFNα | Number of Participants With an Adverse Event | 17 Participants |
| ETV + Peg-IFNα | Number of Participants With an Adverse Event | 17 Participants |
Primary
Number of Participants With Premature Discontinuation of Treatment
Time frame: Up to 60 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ABI-H0731 + ETV | Number of Participants With Premature Discontinuation of Treatment | 18 Participants |
| ABI-H0731 + ETV + Peg-IFNα | Number of Participants With Premature Discontinuation of Treatment | 17 Participants |
| ETV + Peg-IFNα | Number of Participants With Premature Discontinuation of Treatment | 11 Participants |
Secondary
Incidence of HBV Variants With Reduced Susceptibility to ABI-H0731
Time frame: Pre-specified time points up to 60 weeks
Population: No cases met the criteria for resistance analysis.
Secondary
Mean Change From Baseline HBV DNA
Time frame: Baseline and at pre-specified time points up to 60 weeks
Population: Due to early termination of the study, not all subjects reached Week 48.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABI-H0731 + ETV | Mean Change From Baseline HBV DNA | Week 6 | -3.6 log10 IU/mL | Standard Deviation 1.07 |
| ABI-H0731 + ETV | Mean Change From Baseline HBV DNA | Week 44 | -6.5 log10 IU/mL | Standard Deviation 1.15 |
| ABI-H0731 + ETV | Mean Change From Baseline HBV DNA | Week 36 | -6.2 log10 IU/mL | Standard Deviation 1.05 |
| ABI-H0731 + ETV | Mean Change From Baseline HBV DNA | Week 4 | -3.2 log10 IU/mL | Standard Deviation 0.92 |
| ABI-H0731 + ETV | Mean Change From Baseline HBV DNA | Week 1 | -2.1 log10 IU/mL | Standard Deviation 0.64 |
| ABI-H0731 + ETV | Mean Change From Baseline HBV DNA | Week 32 | -6.2 log10 IU/mL | Standard Deviation 0.93 |
| ABI-H0731 + ETV | Mean Change From Baseline HBV DNA | Week 2 | -2.5 log10 IU/mL | Standard Deviation 0.76 |
| ABI-H0731 + ETV | Mean Change From Baseline HBV DNA | Week 20 | -5.8 log10 IU/mL | Standard Deviation 0.99 |
| ABI-H0731 + ETV | Mean Change From Baseline HBV DNA | Week 12 | -4.9 log10 IU/mL | Standard Deviation 1.18 |
| ABI-H0731 + ETV | Mean Change From Baseline HBV DNA | Week 28 | -6.2 log10 IU/mL | Standard Deviation 0.82 |
| ABI-H0731 + ETV | Mean Change From Baseline HBV DNA | Week 24 | -6.0 log10 IU/mL | Standard Deviation 0.94 |
| ABI-H0731 + ETV | Mean Change From Baseline HBV DNA | Week 48 | -6.7 log10 IU/mL | Standard Deviation 1.27 |
| ABI-H0731 + ETV | Mean Change From Baseline HBV DNA | Week 8 | -4.2 log10 IU/mL | Standard Deviation 1.21 |
| ABI-H0731 + ETV | Mean Change From Baseline HBV DNA | Week 40 | -6.2 log10 IU/mL | Standard Deviation 1.17 |
| ABI-H0731 + ETV | Mean Change From Baseline HBV DNA | Week 16 | -5.5 log10 IU/mL | Standard Deviation 1.06 |
| ABI-H0731 + ETV + Peg-IFNα | Mean Change From Baseline HBV DNA | Week 16 | -5.2 log10 IU/mL | Standard Deviation 1.13 |
| ABI-H0731 + ETV + Peg-IFNα | Mean Change From Baseline HBV DNA | Week 12 | -4.4 log10 IU/mL | Standard Deviation 1 |
| ABI-H0731 + ETV + Peg-IFNα | Mean Change From Baseline HBV DNA | Week 20 | -5.6 log10 IU/mL | Standard Deviation 1.05 |
| ABI-H0731 + ETV + Peg-IFNα | Mean Change From Baseline HBV DNA | Week 36 | -6.2 log10 IU/mL | Standard Deviation 1.15 |
| ABI-H0731 + ETV + Peg-IFNα | Mean Change From Baseline HBV DNA | Week 40 | -6.0 log10 IU/mL | Standard Deviation 1.1 |
| ABI-H0731 + ETV + Peg-IFNα | Mean Change From Baseline HBV DNA | Week 44 | -5.8 log10 IU/mL | Standard Deviation 1.4 |
| ABI-H0731 + ETV + Peg-IFNα | Mean Change From Baseline HBV DNA | Week 1 | -2.1 log10 IU/mL | Standard Deviation 0.53 |
| ABI-H0731 + ETV + Peg-IFNα | Mean Change From Baseline HBV DNA | Week 2 | -2.6 log10 IU/mL | Standard Deviation 0.81 |
| ABI-H0731 + ETV + Peg-IFNα | Mean Change From Baseline HBV DNA | Week 4 | -2.9 log10 IU/mL | Standard Deviation 0.7 |
| ABI-H0731 + ETV + Peg-IFNα | Mean Change From Baseline HBV DNA | Week 6 | -3.6 log10 IU/mL | Standard Deviation 0.99 |
| ABI-H0731 + ETV + Peg-IFNα | Mean Change From Baseline HBV DNA | Week 8 | -4.1 log10 IU/mL | Standard Deviation 1.13 |
| ABI-H0731 + ETV + Peg-IFNα | Mean Change From Baseline HBV DNA | Week 24 | -6.0 log10 IU/mL | Standard Deviation 0.92 |
| ABI-H0731 + ETV + Peg-IFNα | Mean Change From Baseline HBV DNA | Week 28 | -6.3 log10 IU/mL | Standard Deviation 0.87 |
| ABI-H0731 + ETV + Peg-IFNα | Mean Change From Baseline HBV DNA | Week 32 | -6.2 log10 IU/mL | Standard Deviation 0.94 |
| ABI-H0731 + ETV + Peg-IFNα | Mean Change From Baseline HBV DNA | Week 48 | -5.9 log10 IU/mL | Standard Deviation 1.16 |
| ETV + Peg-IFNα | Mean Change From Baseline HBV DNA | Week 6 | -4.0 log10 IU/mL | Standard Deviation 0.94 |
| ETV + Peg-IFNα | Mean Change From Baseline HBV DNA | Week 36 | -6.9 log10 IU/mL | Standard Deviation 0.5 |
| ETV + Peg-IFNα | Mean Change From Baseline HBV DNA | Week 32 | -6.7 log10 IU/mL | Standard Deviation 0.52 |
| ETV + Peg-IFNα | Mean Change From Baseline HBV DNA | Week 8 | -4.5 log10 IU/mL | Standard Deviation 0.97 |
| ETV + Peg-IFNα | Mean Change From Baseline HBV DNA | Week 24 | -6.5 log10 IU/mL | Standard Deviation 0.67 |
| ETV + Peg-IFNα | Mean Change From Baseline HBV DNA | Week 20 | -6.1 log10 IU/mL | Standard Deviation 0.75 |
| ETV + Peg-IFNα | Mean Change From Baseline HBV DNA | Week 12 | -5.1 log10 IU/mL | Standard Deviation 0.89 |
| ETV + Peg-IFNα | Mean Change From Baseline HBV DNA | Week 1 | -2.2 log10 IU/mL | Standard Deviation 0.51 |
| ETV + Peg-IFNα | Mean Change From Baseline HBV DNA | Week 28 | -6.7 log10 IU/mL | Standard Deviation 0.67 |
| ETV + Peg-IFNα | Mean Change From Baseline HBV DNA | Week 2 | -2.7 log10 IU/mL | Standard Deviation 0.61 |
| ETV + Peg-IFNα | Mean Change From Baseline HBV DNA | Week 44 | -6.6 log10 IU/mL | Standard Deviation 0.68 |
| ETV + Peg-IFNα | Mean Change From Baseline HBV DNA | Week 16 | -5.6 log10 IU/mL | Standard Deviation 0.74 |
| ETV + Peg-IFNα | Mean Change From Baseline HBV DNA | Week 4 | -3.4 log10 IU/mL | Standard Deviation 0.72 |
| ETV + Peg-IFNα | Mean Change From Baseline HBV DNA | Week 40 | -6.7 log10 IU/mL | Standard Deviation 0.63 |
| ETV + Peg-IFNα | Mean Change From Baseline HBV DNA | Week 48 | -6.8 log10 IU/mL | Standard Deviation 0.75 |
Secondary
Mean Change From Baseline in HBcrAg
Time frame: Baseline and at pre-specified time points up to 60 weeks
Population: Due to early termination of the study, not all subjects reached Week 48.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABI-H0731 + ETV | Mean Change From Baseline in HBcrAg | Week 4 | -.4 log10 kU/mL | Standard Deviation 0.49 |
| ABI-H0731 + ETV | Mean Change From Baseline in HBcrAg | Week 8 | -.6 log10 kU/mL | Standard Deviation 0.59 |
| ABI-H0731 + ETV | Mean Change From Baseline in HBcrAg | Week 12 | -.9 log10 kU/mL | Standard Deviation 0.68 |
| ABI-H0731 + ETV | Mean Change From Baseline in HBcrAg | Week 16 | -1.0 log10 kU/mL | Standard Deviation 0.68 |
| ABI-H0731 + ETV | Mean Change From Baseline in HBcrAg | Week 20 | -1.1 log10 kU/mL | Standard Deviation 0.76 |
| ABI-H0731 + ETV | Mean Change From Baseline in HBcrAg | Week 24 | -1.2 log10 kU/mL | Standard Deviation 0.81 |
| ABI-H0731 + ETV | Mean Change From Baseline in HBcrAg | Week 28 | -1.2 log10 kU/mL | Standard Deviation 0.86 |
| ABI-H0731 + ETV | Mean Change From Baseline in HBcrAg | Week 32 | -1.3 log10 kU/mL | Standard Deviation 0.87 |
| ABI-H0731 + ETV | Mean Change From Baseline in HBcrAg | Week 36 | -1.5 log10 kU/mL | Standard Deviation 0.85 |
| ABI-H0731 + ETV | Mean Change From Baseline in HBcrAg | Week 40 | -1.6 log10 kU/mL | Standard Deviation 0.97 |
| ABI-H0731 + ETV | Mean Change From Baseline in HBcrAg | Week 44 | -2.0 log10 kU/mL | Standard Deviation 0.83 |
| ABI-H0731 + ETV | Mean Change From Baseline in HBcrAg | Week 48 | -2.0 log10 kU/mL | Standard Deviation 0.93 |
| ABI-H0731 + ETV + Peg-IFNα | Mean Change From Baseline in HBcrAg | Week 48 | -1.2 log10 kU/mL | Standard Deviation 0.59 |
| ABI-H0731 + ETV + Peg-IFNα | Mean Change From Baseline in HBcrAg | Week 4 | -.4 log10 kU/mL | Standard Deviation 0.43 |
| ABI-H0731 + ETV + Peg-IFNα | Mean Change From Baseline in HBcrAg | Week 28 | -1.3 log10 kU/mL | Standard Deviation 0.75 |
| ABI-H0731 + ETV + Peg-IFNα | Mean Change From Baseline in HBcrAg | Week 36 | -1.2 log10 kU/mL | Standard Deviation 0.55 |
| ABI-H0731 + ETV + Peg-IFNα | Mean Change From Baseline in HBcrAg | Week 8 | -.8 log10 kU/mL | Standard Deviation 0.57 |
| ABI-H0731 + ETV + Peg-IFNα | Mean Change From Baseline in HBcrAg | Week 24 | -1.3 log10 kU/mL | Standard Deviation 0.73 |
| ABI-H0731 + ETV + Peg-IFNα | Mean Change From Baseline in HBcrAg | Week 44 | -1.3 log10 kU/mL | Standard Deviation 0.55 |
| ABI-H0731 + ETV + Peg-IFNα | Mean Change From Baseline in HBcrAg | Week 12 | -.9 log10 kU/mL | Standard Deviation 0.48 |
| ABI-H0731 + ETV + Peg-IFNα | Mean Change From Baseline in HBcrAg | Week 32 | -1.2 log10 kU/mL | Standard Deviation 0.65 |
| ABI-H0731 + ETV + Peg-IFNα | Mean Change From Baseline in HBcrAg | Week 20 | -1.2 log10 kU/mL | Standard Deviation 0.66 |
| ABI-H0731 + ETV + Peg-IFNα | Mean Change From Baseline in HBcrAg | Week 16 | -1.0 log10 kU/mL | Standard Deviation 0.57 |
| ABI-H0731 + ETV + Peg-IFNα | Mean Change From Baseline in HBcrAg | Week 40 | -1.3 log10 kU/mL | Standard Deviation 0.6 |
| ETV + Peg-IFNα | Mean Change From Baseline in HBcrAg | Week 16 | -1.2 log10 kU/mL | Standard Deviation 0.82 |
| ETV + Peg-IFNα | Mean Change From Baseline in HBcrAg | Week 20 | -1.3 log10 kU/mL | Standard Deviation 0.86 |
| ETV + Peg-IFNα | Mean Change From Baseline in HBcrAg | Week 40 | -1.9 log10 kU/mL | Standard Deviation 0.93 |
| ETV + Peg-IFNα | Mean Change From Baseline in HBcrAg | Week 24 | -1.4 log10 kU/mL | Standard Deviation 0.88 |
| ETV + Peg-IFNα | Mean Change From Baseline in HBcrAg | Week 28 | -1.5 log10 kU/mL | Standard Deviation 0.84 |
| ETV + Peg-IFNα | Mean Change From Baseline in HBcrAg | Week 32 | -1.7 log10 kU/mL | Standard Deviation 0.83 |
| ETV + Peg-IFNα | Mean Change From Baseline in HBcrAg | Week 44 | -2.0 log10 kU/mL | Standard Deviation 1.04 |
| ETV + Peg-IFNα | Mean Change From Baseline in HBcrAg | Week 4 | -.3 log10 kU/mL | Standard Deviation 0.36 |
| ETV + Peg-IFNα | Mean Change From Baseline in HBcrAg | Week 8 | -.8 log10 kU/mL | Standard Deviation 0.8 |
| ETV + Peg-IFNα | Mean Change From Baseline in HBcrAg | Week 36 | -1.9 log10 kU/mL | Standard Deviation 0.83 |
| ETV + Peg-IFNα | Mean Change From Baseline in HBcrAg | Week 12 | -1.1 log10 kU/mL | Standard Deviation 0.85 |
| ETV + Peg-IFNα | Mean Change From Baseline in HBcrAg | Week 48 | -2.0 log10 kU/mL | Standard Deviation 1.01 |
Secondary
Mean Change From Baseline in HBeAg
Time frame: Baseline and at pre-specified time points up to 60 weeks
Population: Due to early termination of the study, not all subjects reached Week 48.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABI-H0731 + ETV | Mean Change From Baseline in HBeAg | Week 36 | -1.5 log10 IU/mL | Standard Deviation 0.97 |
| ABI-H0731 + ETV | Mean Change From Baseline in HBeAg | Week 24 | -1.1 log10 IU/mL | Standard Deviation 0.91 |
| ABI-H0731 + ETV | Mean Change From Baseline in HBeAg | Week 44 | -1.8 log10 IU/mL | Standard Deviation 0.83 |
| ABI-H0731 + ETV | Mean Change From Baseline in HBeAg | Week 32 | -1.4 log10 IU/mL | Standard Deviation 0.87 |
| ABI-H0731 + ETV | Mean Change From Baseline in HBeAg | Week 28 | -1.2 log10 IU/mL | Standard Deviation 0.93 |
| ABI-H0731 + ETV | Mean Change From Baseline in HBeAg | Week 8 | -.6 log10 IU/mL | Standard Deviation 0.59 |
| ABI-H0731 + ETV | Mean Change From Baseline in HBeAg | Week 16 | -1.0 log10 IU/mL | Standard Deviation 0.78 |
| ABI-H0731 + ETV | Mean Change From Baseline in HBeAg | Week 12 | -.8 log10 IU/mL | Standard Deviation 0.66 |
| ABI-H0731 + ETV | Mean Change From Baseline in HBeAg | Week 40 | -1.5 log10 IU/mL | Standard Deviation 0.95 |
| ABI-H0731 + ETV | Mean Change From Baseline in HBeAg | Week 20 | -1.1 log10 IU/mL | Standard Deviation 0.83 |
| ABI-H0731 + ETV | Mean Change From Baseline in HBeAg | Week 48 | -1.9 log10 IU/mL | Standard Deviation 0.88 |
| ABI-H0731 + ETV + Peg-IFNα | Mean Change From Baseline in HBeAg | Week 28 | -1.2 log10 IU/mL | Standard Deviation 0.71 |
| ABI-H0731 + ETV + Peg-IFNα | Mean Change From Baseline in HBeAg | Week 8 | -.8 log10 IU/mL | Standard Deviation 0.61 |
| ABI-H0731 + ETV + Peg-IFNα | Mean Change From Baseline in HBeAg | Week 12 | -.8 log10 IU/mL | Standard Deviation 0.46 |
| ABI-H0731 + ETV + Peg-IFNα | Mean Change From Baseline in HBeAg | Week 16 | -.9 log10 IU/mL | Standard Deviation 0.5 |
| ABI-H0731 + ETV + Peg-IFNα | Mean Change From Baseline in HBeAg | Week 20 | -1.1 log10 IU/mL | Standard Deviation 0.68 |
| ABI-H0731 + ETV + Peg-IFNα | Mean Change From Baseline in HBeAg | Week 24 | -1.2 log10 IU/mL | Standard Deviation 0.73 |
| ABI-H0731 + ETV + Peg-IFNα | Mean Change From Baseline in HBeAg | Week 32 | -1.2 log10 IU/mL | Standard Deviation 0.7 |
| ABI-H0731 + ETV + Peg-IFNα | Mean Change From Baseline in HBeAg | Week 36 | -1.1 log10 IU/mL | Standard Deviation 0.61 |
| ABI-H0731 + ETV + Peg-IFNα | Mean Change From Baseline in HBeAg | Week 40 | -1.2 log10 IU/mL | Standard Deviation 0.65 |
| ABI-H0731 + ETV + Peg-IFNα | Mean Change From Baseline in HBeAg | Week 44 | -1.1 log10 IU/mL | Standard Deviation 0.57 |
| ABI-H0731 + ETV + Peg-IFNα | Mean Change From Baseline in HBeAg | Week 48 | -1.1 log10 IU/mL | Standard Deviation 0.55 |
| ETV + Peg-IFNα | Mean Change From Baseline in HBeAg | Week 44 | -1.9 log10 IU/mL | Standard Deviation 1.07 |
| ETV + Peg-IFNα | Mean Change From Baseline in HBeAg | Week 36 | -1.7 log10 IU/mL | Standard Deviation 0.84 |
| ETV + Peg-IFNα | Mean Change From Baseline in HBeAg | Week 16 | -1.2 log10 IU/mL | Standard Deviation 0.73 |
| ETV + Peg-IFNα | Mean Change From Baseline in HBeAg | Week 8 | -.9 log10 IU/mL | Standard Deviation 0.77 |
| ETV + Peg-IFNα | Mean Change From Baseline in HBeAg | Week 40 | -1.8 log10 IU/mL | Standard Deviation 1 |
| ETV + Peg-IFNα | Mean Change From Baseline in HBeAg | Week 12 | -1.1 log10 IU/mL | Standard Deviation 0.74 |
| ETV + Peg-IFNα | Mean Change From Baseline in HBeAg | Week 28 | -1.4 log10 IU/mL | Standard Deviation 0.79 |
| ETV + Peg-IFNα | Mean Change From Baseline in HBeAg | Week 24 | -1.3 log10 IU/mL | Standard Deviation 0.78 |
| ETV + Peg-IFNα | Mean Change From Baseline in HBeAg | Week 48 | -2.1 log10 IU/mL | Standard Deviation 0.96 |
| ETV + Peg-IFNα | Mean Change From Baseline in HBeAg | Week 32 | -1.5 log10 IU/mL | Standard Deviation 0.83 |
| ETV + Peg-IFNα | Mean Change From Baseline in HBeAg | Week 20 | -1.3 log10 IU/mL | Standard Deviation 0.76 |
Secondary
Mean Change From Baseline in HBsAg
Time frame: Baseline and at pre-specified time points up to 60 weeks
Population: Due to early termination of the study, not all subjects reached Week 48.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABI-H0731 + ETV | Mean Change From Baseline in HBsAg | Week 4 | -.2 log10 IU/mL | Standard Deviation 0.48 |
| ABI-H0731 + ETV | Mean Change From Baseline in HBsAg | Week 16 | -.6 log10 IU/mL | Standard Deviation 0.52 |
| ABI-H0731 + ETV | Mean Change From Baseline in HBsAg | Week 40 | -.7 log10 IU/mL | Standard Deviation 0.67 |
| ABI-H0731 + ETV | Mean Change From Baseline in HBsAg | Week 36 | -.6 log10 IU/mL | Standard Deviation 0.47 |
| ABI-H0731 + ETV | Mean Change From Baseline in HBsAg | Week 20 | -.6 log10 IU/mL | Standard Deviation 0.54 |
| ABI-H0731 + ETV | Mean Change From Baseline in HBsAg | Week 48 | -1.1 log10 IU/mL | Standard Deviation 0.61 |
| ABI-H0731 + ETV | Mean Change From Baseline in HBsAg | Week 44 | -1.0 log10 IU/mL | Standard Deviation 0.62 |
| ABI-H0731 + ETV | Mean Change From Baseline in HBsAg | Week 24 | -.6 log10 IU/mL | Standard Deviation 0.53 |
| ABI-H0731 + ETV | Mean Change From Baseline in HBsAg | Week 32 | -.6 log10 IU/mL | Standard Deviation 0.45 |
| ABI-H0731 + ETV | Mean Change From Baseline in HBsAg | Week 8 | -.4 log10 IU/mL | Standard Deviation 0.51 |
| ABI-H0731 + ETV | Mean Change From Baseline in HBsAg | Week 28 | -.7 log10 IU/mL | Standard Deviation 0.56 |
| ABI-H0731 + ETV | Mean Change From Baseline in HBsAg | Week 12 | -.5 log10 IU/mL | Standard Deviation 0.55 |
| ABI-H0731 + ETV + Peg-IFNα | Mean Change From Baseline in HBsAg | Week 28 | -.5 log10 IU/mL | Standard Deviation 0.63 |
| ABI-H0731 + ETV + Peg-IFNα | Mean Change From Baseline in HBsAg | Week 32 | -.4 log10 IU/mL | Standard Deviation 0.72 |
| ABI-H0731 + ETV + Peg-IFNα | Mean Change From Baseline in HBsAg | Week 44 | -.1 log10 IU/mL | Standard Deviation 0.7 |
| ABI-H0731 + ETV + Peg-IFNα | Mean Change From Baseline in HBsAg | Week 36 | -.2 log10 IU/mL | Standard Deviation 0.59 |
| ABI-H0731 + ETV + Peg-IFNα | Mean Change From Baseline in HBsAg | Week 12 | -.2 log10 IU/mL | Standard Deviation 0.44 |
| ABI-H0731 + ETV + Peg-IFNα | Mean Change From Baseline in HBsAg | Week 48 | -.1 log10 IU/mL | Standard Deviation 0.66 |
| ABI-H0731 + ETV + Peg-IFNα | Mean Change From Baseline in HBsAg | Week 40 | -.1 log10 IU/mL | Standard Deviation 0.62 |
| ABI-H0731 + ETV + Peg-IFNα | Mean Change From Baseline in HBsAg | Week 16 | -.2 log10 IU/mL | Standard Deviation 0.48 |
| ABI-H0731 + ETV + Peg-IFNα | Mean Change From Baseline in HBsAg | Week 4 | -.1 log10 IU/mL | Standard Deviation 0.39 |
| ABI-H0731 + ETV + Peg-IFNα | Mean Change From Baseline in HBsAg | Week 20 | -.5 log10 IU/mL | Standard Deviation 0.69 |
| ABI-H0731 + ETV + Peg-IFNα | Mean Change From Baseline in HBsAg | Week 24 | -.5 log10 IU/mL | Standard Deviation 0.66 |
| ABI-H0731 + ETV + Peg-IFNα | Mean Change From Baseline in HBsAg | Week 8 | -.4 log10 IU/mL | Standard Deviation 0.66 |
| ETV + Peg-IFNα | Mean Change From Baseline in HBsAg | Week 48 | -1.1 log10 IU/mL | Standard Deviation 0.91 |
| ETV + Peg-IFNα | Mean Change From Baseline in HBsAg | Week 40 | -.9 log10 IU/mL | Standard Deviation 0.8 |
| ETV + Peg-IFNα | Mean Change From Baseline in HBsAg | Week 4 | -.2 log10 IU/mL | Standard Deviation 0.25 |
| ETV + Peg-IFNα | Mean Change From Baseline in HBsAg | Week 8 | -.5 log10 IU/mL | Standard Deviation 0.64 |
| ETV + Peg-IFNα | Mean Change From Baseline in HBsAg | Week 12 | -.5 log10 IU/mL | Standard Deviation 0.65 |
| ETV + Peg-IFNα | Mean Change From Baseline in HBsAg | Week 16 | -.6 log10 IU/mL | Standard Deviation 0.59 |
| ETV + Peg-IFNα | Mean Change From Baseline in HBsAg | Week 20 | -.7 log10 IU/mL | Standard Deviation 0.66 |
| ETV + Peg-IFNα | Mean Change From Baseline in HBsAg | Week 24 | -.7 log10 IU/mL | Standard Deviation 0.7 |
| ETV + Peg-IFNα | Mean Change From Baseline in HBsAg | Week 28 | -.7 log10 IU/mL | Standard Deviation 0.71 |
| ETV + Peg-IFNα | Mean Change From Baseline in HBsAg | Week 32 | -.8 log10 IU/mL | Standard Deviation 0.79 |
| ETV + Peg-IFNα | Mean Change From Baseline in HBsAg | Week 36 | -.9 log10 IU/mL | Standard Deviation 0.81 |
| ETV + Peg-IFNα | Mean Change From Baseline in HBsAg | Week 44 | -1.0 log10 IU/mL | Standard Deviation 0.9 |
Secondary
Mean Change From Baseline in HBV pgRNA
Time frame: Baseline and at pre-specified time points up to 60 weeks
Population: Due to early termination of the study, not all subjects reached Week 48.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABI-H0731 + ETV | Mean Change From Baseline in HBV pgRNA | Week 12 | -2.7 log10 U/mL | Standard Deviation 1.15 |
| ABI-H0731 + ETV | Mean Change From Baseline in HBV pgRNA | Week 4 | -2.0 log10 U/mL | Standard Deviation 0.72 |
| ABI-H0731 + ETV | Mean Change From Baseline in HBV pgRNA | Week 28 | -2.9 log10 U/mL | Standard Deviation 1.66 |
| ABI-H0731 + ETV | Mean Change From Baseline in HBV pgRNA | Week 16 | -2.8 log10 U/mL | Standard Deviation 1.28 |
| ABI-H0731 + ETV | Mean Change From Baseline in HBV pgRNA | Week 2 | -1.6 log10 U/mL | Standard Deviation 0.58 |
| ABI-H0731 + ETV | Mean Change From Baseline in HBV pgRNA | Week 36 | -3.3 log10 U/mL | Standard Deviation 1.92 |
| ABI-H0731 + ETV | Mean Change From Baseline in HBV pgRNA | Week 20 | -2.8 log10 U/mL | Standard Deviation 1.38 |
| ABI-H0731 + ETV | Mean Change From Baseline in HBV pgRNA | Week 40 | -3.1 log10 U/mL | Standard Deviation 2.05 |
| ABI-H0731 + ETV | Mean Change From Baseline in HBV pgRNA | Week 24 | -2.7 log10 U/mL | Standard Deviation 1.55 |
| ABI-H0731 + ETV | Mean Change From Baseline in HBV pgRNA | Week 6 | -2.3 log10 U/mL | Standard Deviation 0.87 |
| ABI-H0731 + ETV | Mean Change From Baseline in HBV pgRNA | Week 48 | -4.2 log10 U/mL | Standard Deviation 1.13 |
| ABI-H0731 + ETV | Mean Change From Baseline in HBV pgRNA | Week 1 | -1.3 log10 U/mL | Standard Deviation 0.51 |
| ABI-H0731 + ETV | Mean Change From Baseline in HBV pgRNA | Week 8 | -2.5 log10 U/mL | Standard Deviation 1.12 |
| ABI-H0731 + ETV | Mean Change From Baseline in HBV pgRNA | Week 44 | -4.0 log10 U/mL | Standard Deviation 1.45 |
| ABI-H0731 + ETV | Mean Change From Baseline in HBV pgRNA | Week 32 | -3.1 log10 U/mL | Standard Deviation 1.52 |
| ABI-H0731 + ETV + Peg-IFNα | Mean Change From Baseline in HBV pgRNA | Week 36 | -2.9 log10 U/mL | Standard Deviation 1.04 |
| ABI-H0731 + ETV + Peg-IFNα | Mean Change From Baseline in HBV pgRNA | Week 1 | -1.5 log10 U/mL | Standard Deviation 0.69 |
| ABI-H0731 + ETV + Peg-IFNα | Mean Change From Baseline in HBV pgRNA | Week 2 | -1.9 log10 U/mL | Standard Deviation 0.79 |
| ABI-H0731 + ETV + Peg-IFNα | Mean Change From Baseline in HBV pgRNA | Week 4 | -2.2 log10 U/mL | Standard Deviation 0.74 |
| ABI-H0731 + ETV + Peg-IFNα | Mean Change From Baseline in HBV pgRNA | Week 6 | -2.6 log10 U/mL | Standard Deviation 0.67 |
| ABI-H0731 + ETV + Peg-IFNα | Mean Change From Baseline in HBV pgRNA | Week 8 | -2.7 log10 U/mL | Standard Deviation 0.95 |
| ABI-H0731 + ETV + Peg-IFNα | Mean Change From Baseline in HBV pgRNA | Week 12 | -3.0 log10 U/mL | Standard Deviation 1.17 |
| ABI-H0731 + ETV + Peg-IFNα | Mean Change From Baseline in HBV pgRNA | Week 16 | -2.9 log10 U/mL | Standard Deviation 1.34 |
| ABI-H0731 + ETV + Peg-IFNα | Mean Change From Baseline in HBV pgRNA | Week 20 | -3.0 log10 U/mL | Standard Deviation 1.35 |
| ABI-H0731 + ETV + Peg-IFNα | Mean Change From Baseline in HBV pgRNA | Week 24 | -3.3 log10 U/mL | Standard Deviation 1.41 |
| ABI-H0731 + ETV + Peg-IFNα | Mean Change From Baseline in HBV pgRNA | Week 28 | -3.0 log10 U/mL | Standard Deviation 1.3 |
| ABI-H0731 + ETV + Peg-IFNα | Mean Change From Baseline in HBV pgRNA | Week 32 | -3.0 log10 U/mL | Standard Deviation 0.99 |
| ABI-H0731 + ETV + Peg-IFNα | Mean Change From Baseline in HBV pgRNA | Week 40 | -2.5 log10 U/mL | Standard Deviation 1.13 |
| ABI-H0731 + ETV + Peg-IFNα | Mean Change From Baseline in HBV pgRNA | Week 44 | -3.3 log10 U/mL | Standard Deviation 0.81 |
| ABI-H0731 + ETV + Peg-IFNα | Mean Change From Baseline in HBV pgRNA | Week 48 | -2.4 log10 U/mL | Standard Deviation 1.63 |
| ETV + Peg-IFNα | Mean Change From Baseline in HBV pgRNA | Week 48 | -2.9 log10 U/mL | Standard Deviation 1.81 |
| ETV + Peg-IFNα | Mean Change From Baseline in HBV pgRNA | Week 28 | -3.8 log10 U/mL | Standard Deviation 1.63 |
| ETV + Peg-IFNα | Mean Change From Baseline in HBV pgRNA | Week 8 | -2.0 log10 U/mL | Standard Deviation 1.75 |
| ETV + Peg-IFNα | Mean Change From Baseline in HBV pgRNA | Week 44 | -3.0 log10 U/mL | Standard Deviation 2.39 |
| ETV + Peg-IFNα | Mean Change From Baseline in HBV pgRNA | Week 6 | -1.6 log10 U/mL | Standard Deviation 1.45 |
| ETV + Peg-IFNα | Mean Change From Baseline in HBV pgRNA | Week 36 | -3.8 log10 U/mL | Standard Deviation 1.71 |
| ETV + Peg-IFNα | Mean Change From Baseline in HBV pgRNA | Week 4 | -.9 log10 U/mL | Standard Deviation 0.7 |
| ETV + Peg-IFNα | Mean Change From Baseline in HBV pgRNA | Week 1 | -.5 log10 U/mL | Standard Deviation 0.43 |
| ETV + Peg-IFNα | Mean Change From Baseline in HBV pgRNA | Week 40 | -3.3 log10 U/mL | Standard Deviation 1.63 |
| ETV + Peg-IFNα | Mean Change From Baseline in HBV pgRNA | Week 20 | -2.5 log10 U/mL | Standard Deviation 1.61 |
| ETV + Peg-IFNα | Mean Change From Baseline in HBV pgRNA | Week 32 | -3.2 log10 U/mL | Standard Deviation 1.65 |
| ETV + Peg-IFNα | Mean Change From Baseline in HBV pgRNA | Week 16 | -2.7 log10 U/mL | Standard Deviation 1.68 |
| ETV + Peg-IFNα | Mean Change From Baseline in HBV pgRNA | Week 2 | -.6 log10 U/mL | Standard Deviation 0.61 |
| ETV + Peg-IFNα | Mean Change From Baseline in HBV pgRNA | Week 24 | -2.7 log10 U/mL | Standard Deviation 1.67 |
| ETV + Peg-IFNα | Mean Change From Baseline in HBV pgRNA | Week 12 | -2.4 log10 U/mL | Standard Deviation 1.72 |
Secondary
Number of Participants With Normalized Alanine Aminotransferase (ALT)
Time frame: Baseline and at pre-specified time points up to 60 weeks
Population: Due to early termination of the study, data were not collected or analyzed for secondary outcomes.
Secondary
Plasma Concentration of ABI-H0731
Time frame: Predose on Day 1, Week 4, and Week 24 and at pre-specified time points postdose up to Week 24
Population: No ABI-H0731 PK data were collected from the ETV + Peg-IFNα group until Week 24 when they started receiving ABI-H0731.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABI-H0731 + ETV | Plasma Concentration of ABI-H0731 | Week 12, 30 min to 2 hours postdose | 1920 ng/mL | Standard Deviation 745 |
| ABI-H0731 + ETV | Plasma Concentration of ABI-H0731 | Day 1, Predose | 0 ng/mL | Standard Deviation 0 |
| ABI-H0731 + ETV | Plasma Concentration of ABI-H0731 | Week 16, 4 to 6 hours postdose | 2030 ng/mL | Standard Deviation 610 |
| ABI-H0731 + ETV | Plasma Concentration of ABI-H0731 | Week 4, predose | 2070 ng/mL | Standard Deviation 802 |
| ABI-H0731 + ETV | Plasma Concentration of ABI-H0731 | Week 20, 4 to 6 hours postdose | 2210 ng/mL | Standard Deviation 702 |
| ABI-H0731 + ETV | Plasma Concentration of ABI-H0731 | Week 2, 30 min to 2 hours postdose | 2130 ng/mL | Standard Deviation 1190 |
| ABI-H0731 + ETV | Plasma Concentration of ABI-H0731 | Week 24, predose | 2020 ng/mL | Standard Deviation 951 |
| ABI-H0731 + ETV | Plasma Concentration of ABI-H0731 | Week 8, 30 min to 2 hours postdose | 2000 ng/mL | Standard Deviation 780 |
| ABI-H0731 + ETV | Plasma Concentration of ABI-H0731 | Week 24, 30 min to 2 hours postdose | 2070 ng/mL | Standard Deviation 920 |
| ABI-H0731 + ETV | Plasma Concentration of ABI-H0731 | Day 1, 2 to 4 hours postdose | 852 ng/mL | Standard Deviation 552 |
| ABI-H0731 + ETV + Peg-IFNα | Plasma Concentration of ABI-H0731 | Week 12, 30 min to 2 hours postdose | 1650 ng/mL | Standard Deviation 691 |
| ABI-H0731 + ETV + Peg-IFNα | Plasma Concentration of ABI-H0731 | Day 1, Predose | 0 ng/mL | Standard Deviation 0 |
| ABI-H0731 + ETV + Peg-IFNα | Plasma Concentration of ABI-H0731 | Day 1, 2 to 4 hours postdose | 1240 ng/mL | Standard Deviation 550 |
| ABI-H0731 + ETV + Peg-IFNα | Plasma Concentration of ABI-H0731 | Week 2, 30 min to 2 hours postdose | 1700 ng/mL | Standard Deviation 802 |
| ABI-H0731 + ETV + Peg-IFNα | Plasma Concentration of ABI-H0731 | Week 4, predose | 1390 ng/mL | Standard Deviation 636 |
| ABI-H0731 + ETV + Peg-IFNα | Plasma Concentration of ABI-H0731 | Week 8, 30 min to 2 hours postdose | 1560 ng/mL | Standard Deviation 559 |
| ABI-H0731 + ETV + Peg-IFNα | Plasma Concentration of ABI-H0731 | Week 16, 4 to 6 hours postdose | 2200 ng/mL | Standard Deviation 855 |
| ABI-H0731 + ETV + Peg-IFNα | Plasma Concentration of ABI-H0731 | Week 20, 4 to 6 hours postdose | 2090 ng/mL | Standard Deviation 735 |
| ABI-H0731 + ETV + Peg-IFNα | Plasma Concentration of ABI-H0731 | Week 24, predose | 1730 ng/mL | Standard Deviation 661 |
| ABI-H0731 + ETV + Peg-IFNα | Plasma Concentration of ABI-H0731 | Week 24, 30 min to 2 hours postdose | 1580 ng/mL | Standard Deviation 521 |
| ETV + Peg-IFNα | Plasma Concentration of ABI-H0731 | Week 24, 30 min to 2 hours postdose | 374 ng/mL | Standard Deviation 331 |
| ETV + Peg-IFNα | Plasma Concentration of ABI-H0731 | Week 24, predose | 0 ng/mL | Standard Deviation 0 |