Hepatitis B, Chronic
Conditions
Brief summary
This is a study designed to evaluate the safety, tolerability and efficacy of New Molecular Entity (NME) combination therapies in Chronic Hepatitis B (CHB) participants with preserved liver function and without significant fibrosis/cirrhosis. The platform design allows comparison of multiple NME combination therapies against a common control, and introduction of additional treatment arms at later study time points. Each arm will consist of a screening phase (up to 8 weeks), treatment phase (up to 48 weeks) and post-treatment follow-up phase (48 weeks). The safety and efficacy will be monitored throughout the study.
Interventions
DRUGNucleos(t)ide (NUC)
Nucleos(t)ide (NUC) will be administered orally
DRUGCpAM (RO7049389)
CpAM (RO7049389) will be administered orally
DRUGTLR7 (RO7020531)
TLR7 (RO7020531) will be administered orally
DRUGsiRNA (RO7445482)
siRNA (RO7445482) will be administered subcutaneously
DRUGPEG-IFN
PEG-IFN will be administered subcutaneously
DRUGPD-L1 LNA (RO7191863)
PD-L1 LNA (RO7191863) will be administered subcutaneously
Sponsors
Hoffmann-La Roche
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 between 18 and 32 kg/m2 inclusive. * Participants with Chronic Hepatitis B (CHB) infection (HBsAg positive for \>=6 months) who are on established NUC (entecavir or tenofovir alafenamide/disoproxil fumarate) monotherapy for \>=12 months, having received the same NUC therapy for \>=3 months prior to screening. * HBV DNA below the lower LLOQ or \< 20 IU/mL for \> 6 months prior to screening and confirmed at screening. * Alanine transaminase (ALT) \<=1.5 x upper limit of normal (ULN) for \> 6 months prior to screening and confirmed at screening. * Female Participants: Eligible to participate if she is not pregnant, not breastfeeding and agrees to remain abstinent (refrain from heterosexual intercourse) or use highly effective contraceptive methods. * Male Participants: During the treatment period and for at least 6 months after the final dose of study treatment, agrees to remain abstinent (refrain from heterosexual intercourse), use contraceptive measures and refrain from donating sperm.
Exclusion criteria
* Pregnant or lactating women. * Co-infection with other pathogens such as Hepatitis A, C, D and E or Human Immunodeficiency Virus (HIV). * History of cirrhosis or current evidence of significant liver fibrosis or cirrhosis or decompensated liver disease. * History of or suspicion of Hepatocellular Carcinoma (HCC). * Thyroid disease poorly controlled on prescribed medications or clinically relevant abnormal thyroid function tests. * Clinically significant disease other than CHB that, in the opinion of the Investigator, makes the participant unsuitable for the study. * Pre-existing cardiac disease that in the opinion of the investigator would increase the risk for the participant to take part in the study. * History of alcohol abuse and/or drug abuse within one year of randomization. * History of having received (in the last 6 months) or currently receiving any systemic antineoplastic (including radiation) or immunosuppressive (including biologic immunosuppressors) or immune modulating treatment. * Currently taking, or have received within 3 months of Day 1, systemic corticosteroids. * Electrocardiogram (ECG) with clinically significant abnormalities. * Previous treatment with an investigational agent for Hepatitis B (HBV) within 6 months prior to screening.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at 24 Weeks Post-End of Treatment (EOT) | Follow-up Week (FUW) 24 | HBsAg loss was defined as quantitative HBsAg \<0.05 international units/milliliters (IU/mL). The percentage of participants with HBsAg loss was calculated as number of participants with HBsAg loss / total number of participants \*100. 95% confidence interval (CI) was calculated using the Clopper-Pearson method. Percentages have been rounded off. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Hepatitis B Early Antigen (HBeAg) Loss in Baseline HBeAg-positive Participants | Weeks 12, 24, 36, and 48; FUW 12, 24, 36, and 48 | HBeAg loss was defined as negative /non-reactive HBeAg level. Percentages have been rounded off. |
| Percentage of Participants With HBeAg Seroconversion in Baseline HBeAg-positive Participants | Weeks 12, 24, 36, and 48; FUW 12, 24, 36, and 48 | HBeAg seroconversion was defined as a negative /non-reactive HBeAg level and a positive anti-HBe antibody. Percentages have been rounded off. |
| Percentage of Participants With HBsAg Loss | Combos 1 and 5: Weeks 24, 36, 48 and FUW 48; Combos 2, 3, 4, 6 and NUC Arm: Week 48 and FUW 48; Combo 7: Week 24; Combo 8: Week 36 | HBsAg loss was defined as quantitative HBsAg \<0.05 IU/mL. The percentage of participants with HBsAg loss was calculated as number of participants with HBsAg loss / total number of participants \*100. 95% CI was calculated using the Clopper-Pearson method. Percentages have been rounded off. |
| Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 12, 24, 36, and 48 | Chronic HBV infection is characterized by high levels of circulating HBV DNA. Therefore, HBV levels are indicative of virological response. At screening participants were on NUC therapy and had circulating HBV DNA levels below the assay LLOQ or below 20 IU/mL for at least 6 months. The emergence of a virological breakthrough (HBV DNA \>100 IU/mL or \>1 log increase from nadir) while on NUC therapy, or the emergence of a virological relapse (\>2,000 IU/mL) in participants taken off NME combination and NUC therapy during follow-up, was monitored through the quantification of HBV DNA in plasma. |
| Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBsAg, Anti-HBs, HBeAg & HBV RNA: Combo 1 to 6 and NUC arm: Weeks 24, 36, 48, FUW 24 and FUW 48; Combo 7: Week 24, FUW 24 & FUW 48; Combo 8: Weeks 24, 36, FUW 24 & FUW 48; HBV DNA: FUW 24 and FUW 48 | The serological markers of HBV infection include viral antigens (HBsAg & HBeAg) and antibody (anti-HBs). Changes in serological markers and efficacy biomarkers (HBV RNA) from baseline are reported. Change from baseline for HBV DNA was assessed in 'ON NUC' participants. |
| Combos 7 and 8: Area Under the Plasma Concentration-time Curve Over the Dosing Interval at Week 1 (AUC1-0-168h) of PD-L1 LNA | Predose on Day 1 and up to 168 hours post dose (Week 1) | The AUC was predicted and summarized by modelling & simulation via the population pharmacokinetics (PopPK) method based on pre and post dose samples. As per planned analysis data was collected and reported in a pooled manner for Combos 7 and 8. |
| Combos 7 and 8: Maximum Plasma Concentration (Cmax) at Week 1 (Cmax1-0-168h) of PD-L1 LNA | Predose on Day 1 and up to 168 hours post dose (Week 1) | The Cmax was predicted and summarized by modelling & simulation via the PopPK method based on pre and post dose samples. As per planned analysis data was collected and reported in a pooled manner for Combos 7 and 8. |
| Combos 7 and 8: AUC Over the Dosing Interval at Week 12 (AUC12-0-168h) of PD-L1 LNA | Predose on Day 1 of Week 12 up to 168 hours post dose (Week 12) | The AUC was predicted and summarized by modelling & simulation via the PopPK method based on pre and post dose samples. As per planned analysis data was collected and reported in a pooled manner for Combos 7 and 8. |
| Combos 7 and 8: Cmax at Week 12 (Cmax12-0-168h) of PD-L1 LNA | Predose on Day 1 of Week 12 up to 168 hours post dose (Week 12) | The Cmax was predicted and summarized by modelling & simulation via the PopPK method based on pre and post dose samples. As per planned analysis data was collected and reported in a pooled manner for Combos 7 and 8. |
| Percentage of Participants With HBsAg Seroconversion | Combos 1 and 5: Weeks 24, 36, 48, FUW 24 and FUW 48; Combos 2, 3, 4, 6 and NUC Arm: Week 48, FUW 24 and FUW 48; Combo 7: Week 24 and FUW 24; Combo 8: Week 36 and FUW 24 | HBsAg seroconversion was defined as a quantitative HBsAg \< 0.05 IU/mL and a positive anti-HBs antibody (defined as per assay reactive threshold anti-HBs ≥10 IU/L). 95% CI was calculated using the Clopper-Pearson method. Percentages have been rounded off. |
| Combos 2, 3, 4, 6, 7 and 8: Cmax Over Days 1-28 of siRNA | Predose on Day 1 and 1-3 and 4-6 hours post dose each day, up to Day 28 | The Cmax was predicted and summarized by modelling & simulation via the PopPK method based on pre and post dose samples. |
| Combos 2, 3, 4, 6, 7 and 8: Area Under the Plasma Concentration Time Curve During the Dosing Interval (AUC Tau) Over Days 29-56 of siRNA | From Day 29 up to Day 56 | The AUC tau was predicted and summarized by modelling & simulation via the PopPK method based on pre and post dose samples. Simulations for the dosing interval between Day 29 and Day 56 was done using population PK modeling informed by sparse PK samples collected on Days 1, 85, 169, 253, and 337 at predose, 1-3 hours, and 4-6 hours post dose. |
| Combos 2, 3, 4, 6, 7 and 8: Cmax Over Days 29-56 of siRNA | From Day 29 up to Day 56 | The Cmax was predicted and summarized by modelling & simulation via the PopPK method based on pre and post dose samples. Simulations for the dosing interval between Day 29 and Day 56 was done using population PK modeling informed by sparse PK samples collected on Days 1, 85, 169, 253, and 337 at predose, 1-3 hours, and 4-6 hours post dose. |
| Combos 1 and 6: AUC of TLR7 | Predose and 1-3 and 4-6 hours post-dose on Days 1, 3, 5 on Weeks 12 and 36 | The AUC was predicted and summarized by modelling & simulation via the PopPK method based on pre and post dose samples. |
| Combos 1 and 6: Cmax of TLR7 | Predose and 1-3 and 4-6 hours post-dose on Days 1, 3, 5 on Weeks 12 and 36 | The Cmax was predicted and summarized by modelling & simulation via the PopPK method based on pre and post dose samples. |
| Number of Participants With Adverse Events (AEs) | From Day 1 up to end of 48 weeks of follow up (up to approximately 1.8 years) | An AE was any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including abnormal laboratory values or abnormal clinical test results), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. |
| Combos 2, 3, 4, 5, 6, 7 and 8: Number of Participants With Anti-siRNA Antibodies | From Day 1 up to end of follow up (up to approximately 4 years) | Treatment-emergent anti drug antibody (ADA) was defined as participants who seroconverted or experienced a boost in preexisting ADA during the study. Participants were considered to be ADA positive if they were ADA negative or had missing data at baseline but develop an ADA response following study drug administration (treatment-induced ADA response), or if they were ADA positive at baseline and the titer of one or more post-baseline samples were greater than the titer of the baseline sample by a scientifically reasonable margin such as at least 4-fold (treatment-enhanced ADA response). |
| Combos 7 and 8: Number of Participants With Anti-PD-L1 Antibodies | From Day 1 for Combo 7 and 8 up to end of follow up (Up to approximately 2 years) | Treatment-emergent ADA was defined as participants who seroconverted or experienced a boost in preexisting ADA during the study. Participants were considered to be ADA positive if they were ADA negative or had missing data at baseline but develop an ADA response following study drug administration (treatment-induced ADA response), or if they were ADA positive at baseline and the titer of one or more post-baseline samples were greater than the titer of the baseline sample by a scientifically reasonable margin such as at least 4-fold (treatment-enhanced ADA response). |
| Combos 2, 3, 4, 6, 7 and 8: Area Under the Plasma Concentration Time Curve (AUC) Over Days 1-28 of siRNA | Predose on Day 1 and 1-3 and 4-6 hours post dose each day, up to Day 28 | The AUC was predicted and summarized by modelling & simulation via the PopPK method based on pre and post dose samples. |
Countries
Bulgaria, Canada, Chile, China, France, Hong Kong, New Zealand, Romania, South Korea, Spain, Taiwan, Thailand, United Kingdom
Participant flow
Recruitment details
A total of 281 participants with chronic hepatitis B (CHB) who had virologic suppression with Nucleos(t)ide (NUC) therapy took part in the study across 13 countries from 05 July 2020 to 19 July 2024.
Pre-assignment details
The study consisted of a screening phase, followed by up to 48 weeks of treatment and up to 48 weeks of post-treatment follow-up. Multiple new combination therapies were compared against a common control. Combos 1, 5, 7 and 8 were prematurely terminated by the Sponsor.
Participants by arm
| Arm | Count |
|---|---|
| NUC Control Arm Participants continued their background NUC therapy for 48 weeks. Thereafter, in line with current CHB treatment guidelines, participants continued NUC treatment during follow-up unless the NUC discontinuation criteria were met. | 36 |
| Combo 1: CpAM + TLR7 Agonist + NUC Participants received CpAM, 600 mg tablets, orally, QD for 48 weeks and TLR7 agonist, 150 mg, orally, QOD during Weeks 1-12 and Weeks 25-36 in addition to their background NUC therapy. After Week 48, participants continued NUC treatment during follow-up unless the NUC discontinuation criteria were met. | 38 |
| Combo 2: siRNA (100 mg) + NUC Participants received siRNA, 100 mg, as a SC injection, Q4W in addition to their background NUC therapy for 48 weeks. After Week 48, participants continued NUC treatment during follow-up unless the NUC discontinuation criteria were met. | 30 |
| Combo 3: siRNA (200 mg) + NUC Participants received siRNA, 200 mg, as a SC injection, Q4W in addition to their background NUC therapy for 48 weeks. After Week 48, participants continued NUC treatment during follow-up unless the NUC discontinuation criteria were met. | 30 |
| Combo 4: siRNA + PEG-IFN + NUC Participants received siRNA, 200 mg, as a SC injection, Q4W and PEG-IFN, 180 µg, as a SC injection, QW in addition to their background NUC therapy for 48 weeks. After Week 48, participants continued NUC treatment during follow-up unless the NUC discontinuation criteria were met. | 30 |
| Combo 5: siRNA + CpAM + NUC Participants received siRNA, 200 mg, as a SC injection, Q4W and CpAM, 600 mg tablets, orally, QD in addition to their background NUC therapy for 48 weeks. After Week 48, participants continued NUC treatment during follow-up unless the NUC discontinuation criteria were met. | 19 |
| Combo 6: siRNA + TLR7 Agonist + NUC Participants received siRNA, 200 mg, as a SC injection, Q4W for 48 weeks and TLR7 agonist, 150 mg tablets, orally, QOD during Weeks 13-24 and Weeks 37-48 in addition to their background NUC therapy. After Week 48, participants continued NUC treatment during follow-up unless the NUC discontinuation criteria were met. | 34 |
| Combo 7: siRNA + PD-L1 LNA + NUC Participants received siRNA, 200 mg, as a SC injection, Q4W up to Week 24 and PD-L1 LNA, 2 mg/kg, as a SC injection, QW during Weeks 13-24 in addition to their background NUC therapy for 24 weeks. After Week 24, participants continued NUC treatment during follow-up unless the NUC discontinuation criteria were met. | 33 |
| Combo 8: siRNA + PD-L1 LNA + NUC Participants received siRNA, 200 mg, as a SC injection, Q4W up to Week 24 and PD-L1 LNA, 2 mg/kg, as a SC injection, QW during Weeks 25-36 in addition to their background NUC therapy for 36 weeks. After Week 36, participants continued NUC treatment during follow-up unless the NUC discontinuation criteria were met. | 31 |
| Total | 281 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 |
|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Overall Study | Arm Terminated By Sponsor | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 17 | 18 |
| Overall Study | Protocol Violation | 1 | 0 | 0 | 0 | 0 | 9 | 0 | 0 | 0 |
| Overall Study | Reason not Specified | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 4 | 1 | 1 | 0 | 3 | 1 | 1 | 1 | 0 |
Baseline characteristics
| Characteristic | Total | Combo 1: CpAM + TLR7 Agonist + NUC | Combo 2: siRNA (100 mg) + NUC | NUC Control Arm | Combo 3: siRNA (200 mg) + NUC | Combo 4: siRNA + PEG-IFN + NUC | Combo 5: siRNA + CpAM + NUC | Combo 6: siRNA + TLR7 Agonist + NUC | Combo 7: siRNA + PD-L1 LNA + NUC | Combo 8: siRNA + PD-L1 LNA + NUC |
|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 4 Participants | 0 Participants | 2 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 277 Participants | 38 Participants | 28 Participants | 36 Participants | 29 Participants | 30 Participants | 19 Participants | 34 Participants | 33 Participants | 30 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 278 Participants | 37 Participants | 30 Participants | 35 Participants | 30 Participants | 30 Participants | 19 Participants | 34 Participants | 33 Participants | 30 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 247 Participants | 34 Participants | 26 Participants | 33 Participants | 29 Participants | 30 Participants | 19 Participants | 32 Participants | 22 Participants | 22 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 3 Participants | 1 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 26 Participants | 3 Participants | 3 Participants | 2 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 9 Participants | 8 Participants |
| Sex: Female, Male Female | 58 Participants | 9 Participants | 1 Participants | 8 Participants | 10 Participants | 5 Participants | 5 Participants | 4 Participants | 10 Participants | 6 Participants |
| Sex: Female, Male Male | 223 Participants | 29 Participants | 29 Participants | 28 Participants | 20 Participants | 25 Participants | 14 Participants | 30 Participants | 23 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 38 | 0 / 30 | 0 / 30 | 0 / 30 | 0 / 19 | 0 / 34 | 0 / 33 | 0 / 31 | 0 / 35 |
| other Total, other adverse events | 33 / 38 | 27 / 30 | 29 / 30 | 29 / 30 | 18 / 19 | 33 / 34 | 23 / 33 | 25 / 31 | 25 / 35 |
| serious Total, serious adverse events | 3 / 38 | 3 / 30 | 4 / 30 | 2 / 30 | 0 / 19 | 2 / 34 | 0 / 33 | 0 / 31 | 1 / 35 |
Outcome results
Primary
Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at 24 Weeks Post-End of Treatment (EOT)
HBsAg loss was defined as quantitative HBsAg \<0.05 international units/milliliters (IU/mL). The percentage of participants with HBsAg loss was calculated as number of participants with HBsAg loss / total number of participants \*100. 95% confidence interval (CI) was calculated using the Clopper-Pearson method. Percentages have been rounded off.
Time frame: Follow-up Week (FUW) 24
Population: Modified Intent to Treat (mITT) population included participants who were randomized and received at least one dose of each drug for their assigned treatment regimen. Overall number analyzed included participants with data available for analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| NUC Control Arm | Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at 24 Weeks Post-End of Treatment (EOT) | 0 percentage of participants |
| Combo 1: CpAM + TLR7 Agonist + NUC | Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at 24 Weeks Post-End of Treatment (EOT) | 0 percentage of participants |
| Combo 2: siRNA (100 mg) + NUC | Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at 24 Weeks Post-End of Treatment (EOT) | 6.7 percentage of participants |
| Combo 3: siRNA (200 mg) + NUC | Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at 24 Weeks Post-End of Treatment (EOT) | 3.3 percentage of participants |
| Combo 4: siRNA + PEG-IFN + NUC | Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at 24 Weeks Post-End of Treatment (EOT) | 23.3 percentage of participants |
| Combo 5: siRNA + CpAM + NUC | Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at 24 Weeks Post-End of Treatment (EOT) | 0 percentage of participants |
| Combo 6: siRNA + TLR7 Agonist + NUC | Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at 24 Weeks Post-End of Treatment (EOT) | 11.8 percentage of participants |
| Combo 7: siRNA + PD-L1 LNA + NUC | Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at 24 Weeks Post-End of Treatment (EOT) | 0 percentage of participants |
| Combo 8: siRNA + PD-L1 LNA + NUC | Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at 24 Weeks Post-End of Treatment (EOT) | 6.7 percentage of participants |
95% CI: [-2.1, 16.4]
95% CI: [-3.1, 10]
95% CI: [9, 39.5]
95% CI: [1.3, 23.3]
95% CI: [0, 0]
95% CI: [-2.2, 15.7]
Secondary
Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time
The serological markers of HBV infection include viral antigens (HBsAg & HBeAg) and antibody (anti-HBs). Changes in serological markers and efficacy biomarkers (HBV RNA) from baseline are reported. Change from baseline for HBV DNA was assessed in 'ON NUC' participants.
Time frame: HBsAg, Anti-HBs, HBeAg & HBV RNA: Combo 1 to 6 and NUC arm: Weeks 24, 36, 48, FUW 24 and FUW 48; Combo 7: Week 24, FUW 24 & FUW 48; Combo 8: Weeks 24, 36, FUW 24 & FUW 48; HBV DNA: FUW 24 and FUW 48
Population: mITT population included participants who were randomized and received at least one dose of each drug for their assigned treatment regimen. Overall number analyzed included participants with data available for analysis. Number analyzed included participants with data available for analysis at that specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NUC Control Arm | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBeAg: Week 24 | -0.08 log10 IU/mL | Standard Deviation 0.1 |
| NUC Control Arm | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBsAg: Week 48 | -0.2 log10 IU/mL | Standard Deviation 0.52 |
| NUC Control Arm | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBsAg: Week 36 | -0.08 log10 IU/mL | Standard Deviation 0.13 |
| NUC Control Arm | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBeAg: FUW 48 | -0.36 log10 IU/mL | Standard Deviation 0.31 |
| NUC Control Arm | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBV RNA: FUW 48 | -0.43 log10 IU/mL | Standard Deviation 0.6 |
| NUC Control Arm | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBeAg: Week 48 | -0.06 log10 IU/mL | Standard Deviation 0.15 |
| NUC Control Arm | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBV RNA: Week 24 | 0.09 log10 IU/mL | Standard Deviation 0.43 |
| NUC Control Arm | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | Anti-HBs: FUW 48 | 0.04 log10 IU/mL | Standard Deviation 0.33 |
| NUC Control Arm | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBV DNA: FUW 48 | NA log10 IU/mL | — |
| NUC Control Arm | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | Anti-HBs: Week 36 | -0.01 log10 IU/mL | Standard Deviation 0.02 |
| NUC Control Arm | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBV RNA: Week 48 | -0.04 log10 IU/mL | Standard Deviation 0.32 |
| NUC Control Arm | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBV RNA: Week 36 | 0.05 log10 IU/mL | Standard Deviation 0.3 |
| NUC Control Arm | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBeAg: FUW 24 | -0.19 log10 IU/mL | Standard Deviation 0.15 |
| NUC Control Arm | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBeAg: Week 36 | -0.08 log10 IU/mL | Standard Deviation 0.14 |
| NUC Control Arm | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | Anti-HBs: Week 24 | -0.01 log10 IU/mL | Standard Deviation 0.04 |
| NUC Control Arm | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBsAg: FUW 48 | -0.25 log10 IU/mL | Standard Deviation 0.43 |
| NUC Control Arm | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | Anti-HBs: FUW 24 | -0.02 log10 IU/mL | Standard Deviation 0.08 |
| NUC Control Arm | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | Anti-HBs: Week 48 | 0 log10 IU/mL | Standard Deviation 0.01 |
| NUC Control Arm | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBsAg: Week 24 | -0.08 log10 IU/mL | Standard Deviation 0.16 |
| NUC Control Arm | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBV RNA: FUW 24 | -0.25 log10 IU/mL | Standard Deviation 0.28 |
| NUC Control Arm | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBsAg: FUW 24 | -0.19 log10 IU/mL | Standard Deviation 0.35 |
| NUC Control Arm | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBV DNA: FUW 24 | NA log10 IU/mL | — |
| Combo 1: CpAM + TLR7 Agonist + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | Anti-HBs: FUW 48 | -0.01 log10 IU/mL | Standard Deviation 0.04 |
| Combo 1: CpAM + TLR7 Agonist + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBeAg: Week 24 | -0.04 log10 IU/mL | Standard Deviation 0.13 |
| Combo 1: CpAM + TLR7 Agonist + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBeAg: Week 36 | -0.05 log10 IU/mL | Standard Deviation 0.04 |
| Combo 1: CpAM + TLR7 Agonist + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBV DNA: FUW 24 | NA log10 IU/mL | — |
| Combo 1: CpAM + TLR7 Agonist + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBsAg: Week 36 | -0.13 log10 IU/mL | Standard Deviation 0.23 |
| Combo 1: CpAM + TLR7 Agonist + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBV RNA: FUW 48 | -0.11 log10 IU/mL | Standard Deviation 0.19 |
| Combo 1: CpAM + TLR7 Agonist + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBsAg: Week 48 | -0.09 log10 IU/mL | Standard Deviation 0.12 |
| Combo 1: CpAM + TLR7 Agonist + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBV RNA: FUW 24 | -0.13 log10 IU/mL | Standard Deviation 0.12 |
| Combo 1: CpAM + TLR7 Agonist + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBsAg: FUW 24 | -0.18 log10 IU/mL | Standard Deviation 0.31 |
| Combo 1: CpAM + TLR7 Agonist + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBV DNA: FUW 48 | NA log10 IU/mL | — |
| Combo 1: CpAM + TLR7 Agonist + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBsAg: FUW 48 | -0.25 log10 IU/mL | Standard Deviation 0.36 |
| Combo 1: CpAM + TLR7 Agonist + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBeAg: Week 48 | -0.06 log10 IU/mL | Standard Deviation 0.06 |
| Combo 1: CpAM + TLR7 Agonist + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBV RNA: Week 48 | -1.66 log10 IU/mL | Standard Deviation 1.4 |
| Combo 1: CpAM + TLR7 Agonist + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBV RNA: Week 36 | -1.66 log10 IU/mL | Standard Deviation 1.4 |
| Combo 1: CpAM + TLR7 Agonist + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | Anti-HBs: Week 24 | -0.01 log10 IU/mL | Standard Deviation 0.08 |
| Combo 1: CpAM + TLR7 Agonist + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBV RNA: Week 24 | -1.19 log10 IU/mL | Standard Deviation 1.19 |
| Combo 1: CpAM + TLR7 Agonist + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | Anti-HBs: Week 36 | -0.02 log10 IU/mL | Standard Deviation 0.09 |
| Combo 1: CpAM + TLR7 Agonist + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | Anti-HBs: Week 48 | -0.04 log10 IU/mL | Standard Deviation 0.11 |
| Combo 1: CpAM + TLR7 Agonist + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBeAg: FUW 48 | -0.22 log10 IU/mL | Standard Deviation 0.11 |
| Combo 1: CpAM + TLR7 Agonist + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | Anti-HBs: FUW 24 | -0.01 log10 IU/mL | Standard Deviation 0.06 |
| Combo 1: CpAM + TLR7 Agonist + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBeAg: FUW 24 | -0.09 log10 IU/mL | Standard Deviation 0.12 |
| Combo 1: CpAM + TLR7 Agonist + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBsAg: Week 24 | -0.11 log10 IU/mL | Standard Deviation 0.26 |
| Combo 2: siRNA (100 mg) + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | Anti-HBs: FUW 24 | 0.05 log10 IU/mL | Standard Deviation 0.31 |
| Combo 2: siRNA (100 mg) + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBV RNA: Week 48 | -0.8 log10 IU/mL | Standard Deviation 0.48 |
| Combo 2: siRNA (100 mg) + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBeAg: Week 48 | -0.48 log10 IU/mL | Standard Deviation 0.18 |
| Combo 2: siRNA (100 mg) + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBsAg: FUW 48 | -0.89 log10 IU/mL | Standard Deviation 0.76 |
| Combo 2: siRNA (100 mg) + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | Anti-HBs: FUW 48 | 0.01 log10 IU/mL | Standard Deviation 0.28 |
| Combo 2: siRNA (100 mg) + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBV RNA: Week 36 | -0.74 log10 IU/mL | Standard Deviation 0.41 |
| Combo 2: siRNA (100 mg) + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBsAg: Week 24 | -1.49 log10 IU/mL | Standard Deviation 0.56 |
| Combo 2: siRNA (100 mg) + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | Anti-HBs: Week 24 | 0.06 log10 IU/mL | Standard Deviation 0.32 |
| Combo 2: siRNA (100 mg) + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBeAg: FUW 24 | -0.02 log10 IU/mL | Standard Deviation 1.37 |
| Combo 2: siRNA (100 mg) + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBeAg: Week 36 | -0.45 log10 IU/mL | Standard Deviation 0.2 |
| Combo 2: siRNA (100 mg) + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBV RNA: Week 24 | -0.7 log10 IU/mL | Standard Deviation 0.34 |
| Combo 2: siRNA (100 mg) + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | Anti-HBs: Week 36 | 0.06 log10 IU/mL | Standard Deviation 0.34 |
| Combo 2: siRNA (100 mg) + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBeAg: Week 24 | -0.39 log10 IU/mL | Standard Deviation 0.16 |
| Combo 2: siRNA (100 mg) + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBeAg: FUW 48 | -0.14 log10 IU/mL | Standard Deviation 1.06 |
| Combo 2: siRNA (100 mg) + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBsAg: Week 36 | -1.52 log10 IU/mL | Standard Deviation 0.67 |
| Combo 2: siRNA (100 mg) + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBV RNA: FUW 48 | -0.6 log10 IU/mL | Standard Deviation 0.48 |
| Combo 2: siRNA (100 mg) + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | Anti-HBs: Week 48 | 0.06 log10 IU/mL | Standard Deviation 0.35 |
| Combo 2: siRNA (100 mg) + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBsAg: Week 48 | -1.58 log10 IU/mL | Standard Deviation 0.63 |
| Combo 2: siRNA (100 mg) + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBV RNA: FUW 24 | -0.68 log10 IU/mL | Standard Deviation 0.49 |
| Combo 2: siRNA (100 mg) + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBV DNA: FUW 48 | NA log10 IU/mL | — |
| Combo 2: siRNA (100 mg) + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBsAg: FUW 24 | -1.19 log10 IU/mL | Standard Deviation 0.76 |
| Combo 2: siRNA (100 mg) + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBV DNA: FUW 24 | NA log10 IU/mL | — |
| Combo 3: siRNA (200 mg) + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | Anti-HBs: Week 48 | 0 log10 IU/mL | Standard Deviation 0 |
| Combo 3: siRNA (200 mg) + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBV RNA: Week 48 | -0.94 log10 IU/mL | Standard Deviation 0.6 |
| Combo 3: siRNA (200 mg) + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | Anti-HBs: Week 36 | 0 log10 IU/mL | Standard Deviation 0 |
| Combo 3: siRNA (200 mg) + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBV DNA: FUW 48 | NA log10 IU/mL | — |
| Combo 3: siRNA (200 mg) + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBsAg: FUW 24 | -1.71 log10 IU/mL | Standard Deviation 0.75 |
| Combo 3: siRNA (200 mg) + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBeAg: FUW 48 | -0.38 log10 IU/mL | Standard Deviation 0.19 |
| Combo 3: siRNA (200 mg) + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBeAg: Week 48 | -0.48 log10 IU/mL | Standard Deviation 0.2 |
| Combo 3: siRNA (200 mg) + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBsAg: Week 48 | -1.93 log10 IU/mL | Standard Deviation 0.6 |
| Combo 3: siRNA (200 mg) + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBV RNA: Week 36 | -0.73 log10 IU/mL | Standard Deviation 0.57 |
| Combo 3: siRNA (200 mg) + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBsAg: Week 36 | -1.93 log10 IU/mL | Standard Deviation 0.47 |
| Combo 3: siRNA (200 mg) + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBsAg: FUW 48 | -1.2 log10 IU/mL | Standard Deviation 0.84 |
| Combo 3: siRNA (200 mg) + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBsAg: Week 24 | -1.78 log10 IU/mL | Standard Deviation 0.59 |
| Combo 3: siRNA (200 mg) + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | Anti-HBs: FUW 24 | 0.01 log10 IU/mL | Standard Deviation 0.05 |
| Combo 3: siRNA (200 mg) + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | Anti-HBs: FUW 48 | 0.02 log10 IU/mL | Standard Deviation 0.12 |
| Combo 3: siRNA (200 mg) + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | Anti-HBs: Week 24 | 0 log10 IU/mL | Standard Deviation 0 |
| Combo 3: siRNA (200 mg) + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBV RNA: FUW 48 | -0.78 log10 IU/mL | Standard Deviation 0.55 |
| Combo 3: siRNA (200 mg) + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBV RNA: FUW 24 | -0.87 log10 IU/mL | Standard Deviation 0.59 |
| Combo 3: siRNA (200 mg) + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBV RNA: Week 24 | -0.95 log10 IU/mL | Standard Deviation 0.6 |
| Combo 3: siRNA (200 mg) + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBeAg: Week 36 | -0.53 log10 IU/mL | Standard Deviation 0.15 |
| Combo 3: siRNA (200 mg) + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBV DNA: FUW 24 | NA log10 IU/mL | — |
| Combo 3: siRNA (200 mg) + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBeAg: Week 24 | -0.4 log10 IU/mL | Standard Deviation 0.21 |
| Combo 3: siRNA (200 mg) + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBeAg: FUW 24 | -0.42 log10 IU/mL | Standard Deviation 0.22 |
| Combo 4: siRNA + PEG-IFN + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBeAg: Week 48 | -0.44 log10 IU/mL | Standard Deviation 0.19 |
| Combo 4: siRNA + PEG-IFN + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBV RNA: Week 48 | -1.43 log10 IU/mL | Standard Deviation 0.95 |
| Combo 4: siRNA + PEG-IFN + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBV DNA: FUW 24 | NA log10 IU/mL | — |
| Combo 4: siRNA + PEG-IFN + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBsAg: Week 24 | -1.89 log10 IU/mL | Standard Deviation 1.05 |
| Combo 4: siRNA + PEG-IFN + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBsAg: Week 36 | -2.14 log10 IU/mL | Standard Deviation 1.27 |
| Combo 4: siRNA + PEG-IFN + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBsAg: Week 48 | -2.22 log10 IU/mL | Standard Deviation 1.16 |
| Combo 4: siRNA + PEG-IFN + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBsAg: FUW 24 | -1.71 log10 IU/mL | Standard Deviation 1.24 |
| Combo 4: siRNA + PEG-IFN + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBsAg: FUW 48 | -1.28 log10 IU/mL | Standard Deviation 1.12 |
| Combo 4: siRNA + PEG-IFN + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | Anti-HBs: Week 24 | 0.03 log10 IU/mL | Standard Deviation 0.2 |
| Combo 4: siRNA + PEG-IFN + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | Anti-HBs: Week 36 | 0.3 log10 IU/mL | Standard Deviation 0.69 |
| Combo 4: siRNA + PEG-IFN + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | Anti-HBs: Week 48 | 0.55 log10 IU/mL | Standard Deviation 0.96 |
| Combo 4: siRNA + PEG-IFN + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | Anti-HBs: FUW 24 | 0.63 log10 IU/mL | Standard Deviation 1.04 |
| Combo 4: siRNA + PEG-IFN + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | Anti-HBs: FUW 48 | 0.41 log10 IU/mL | Standard Deviation 0.93 |
| Combo 4: siRNA + PEG-IFN + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBeAg: Week 24 | -0.37 log10 IU/mL | Standard Deviation 0.19 |
| Combo 4: siRNA + PEG-IFN + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBeAg: Week 36 | -0.43 log10 IU/mL | Standard Deviation 0.2 |
| Combo 4: siRNA + PEG-IFN + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBeAg: FUW 24 | -0.33 log10 IU/mL | Standard Deviation 0.19 |
| Combo 4: siRNA + PEG-IFN + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBeAg: FUW 48 | -0.3 log10 IU/mL | Standard Deviation 0.16 |
| Combo 4: siRNA + PEG-IFN + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBV RNA: Week 24 | -1.43 log10 IU/mL | Standard Deviation 0.89 |
| Combo 4: siRNA + PEG-IFN + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBV RNA: Week 36 | -1.67 log10 IU/mL | Standard Deviation 0.9 |
| Combo 4: siRNA + PEG-IFN + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBV RNA: FUW 24 | -0.64 log10 IU/mL | Standard Deviation 0.82 |
| Combo 4: siRNA + PEG-IFN + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBV RNA: FUW 48 | -0.85 log10 IU/mL | Standard Deviation 0.75 |
| Combo 4: siRNA + PEG-IFN + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBV DNA: FUW 48 | NA log10 IU/mL | — |
| Combo 5: siRNA + CpAM + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | Anti-HBs: FUW 24 | 0.09 log10 IU/mL | Standard Deviation 0.2 |
| Combo 5: siRNA + CpAM + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBsAg: Week 48 | -1.3 log10 IU/mL | Standard Deviation 0.45 |
| Combo 5: siRNA + CpAM + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBsAg: FUW 24 | -1.5 log10 IU/mL | Standard Deviation 0.89 |
| Combo 5: siRNA + CpAM + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBeAg: Week 48 | -0.28 log10 IU/mL | Standard Deviation 0.42 |
| Combo 5: siRNA + CpAM + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBV RNA: Week 48 | -1.32 log10 IU/mL | Standard Deviation 0.68 |
| Combo 5: siRNA + CpAM + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBV RNA: Week 24 | -1.34 log10 IU/mL | Standard Deviation 0.65 |
| Combo 5: siRNA + CpAM + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBeAg: FUW 24 | -0.68 log10 IU/mL | Standard Deviation 0.73 |
| Combo 5: siRNA + CpAM + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | Anti-HBs: Week 24 | 0.06 log10 IU/mL | Standard Deviation 0.13 |
| Combo 5: siRNA + CpAM + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBsAg: FUW 48 | -2.02 log10 IU/mL | — |
| Combo 5: siRNA + CpAM + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBV DNA: FUW 48 | NA log10 IU/mL | — |
| Combo 5: siRNA + CpAM + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | Anti-HBs: FUW 48 | 0 log10 IU/mL | — |
| Combo 5: siRNA + CpAM + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBsAg: Week 36 | -1.51 log10 IU/mL | — |
| Combo 5: siRNA + CpAM + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBV RNA: FUW 24 | -1.04 log10 IU/mL | Standard Deviation 0.63 |
| Combo 5: siRNA + CpAM + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBV DNA: FUW 24 | NA log10 IU/mL | — |
| Combo 5: siRNA + CpAM + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | Anti-HBs: Week 48 | 0.01 log10 IU/mL | Standard Deviation 0.02 |
| Combo 5: siRNA + CpAM + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBeAg: Week 24 | -0.19 log10 IU/mL | Standard Deviation 0.32 |
| Combo 5: siRNA + CpAM + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | Anti-HBs: Week 36 | 0 log10 IU/mL | — |
| Combo 5: siRNA + CpAM + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBsAg: Week 24 | -1.38 log10 IU/mL | Standard Deviation 0.41 |
| Combo 6: siRNA + TLR7 Agonist + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBsAg: FUW 24 | -1.47 log10 IU/mL | Standard Deviation 0.81 |
| Combo 6: siRNA + TLR7 Agonist + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBeAg: Week 48 | -0.69 log10 IU/mL | Standard Deviation 0.44 |
| Combo 6: siRNA + TLR7 Agonist + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | Anti-HBs: FUW 24 | -0.02 log10 IU/mL | Standard Deviation 0.41 |
| Combo 6: siRNA + TLR7 Agonist + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | Anti-HBs: FUW 48 | 0.04 log10 IU/mL | Standard Deviation 0.49 |
| Combo 6: siRNA + TLR7 Agonist + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBeAg: FUW 24 | -0.56 log10 IU/mL | Standard Deviation 0.33 |
| Combo 6: siRNA + TLR7 Agonist + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | Anti-HBs: Week 48 | -0.05 log10 IU/mL | Standard Deviation 0.27 |
| Combo 6: siRNA + TLR7 Agonist + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | Anti-HBs: Week 36 | -0.07 log10 IU/mL | Standard Deviation 0.27 |
| Combo 6: siRNA + TLR7 Agonist + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBeAg: FUW 48 | -0.5 log10 IU/mL | Standard Deviation 0.38 |
| Combo 6: siRNA + TLR7 Agonist + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | Anti-HBs: Week 24 | -0.01 log10 IU/mL | Standard Deviation 0.04 |
| Combo 6: siRNA + TLR7 Agonist + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBV RNA: Week 24 | -0.92 log10 IU/mL | Standard Deviation 0.92 |
| Combo 6: siRNA + TLR7 Agonist + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBsAg: FUW 48 | -1.01 log10 IU/mL | Standard Deviation 0.8 |
| Combo 6: siRNA + TLR7 Agonist + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBV RNA: Week 36 | -0.76 log10 IU/mL | Standard Deviation 0.76 |
| Combo 6: siRNA + TLR7 Agonist + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBV RNA: Week 48 | -0.9 log10 IU/mL | Standard Deviation 0.81 |
| Combo 6: siRNA + TLR7 Agonist + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBsAg: Week 48 | -2.18 log10 IU/mL | Standard Deviation 0.86 |
| Combo 6: siRNA + TLR7 Agonist + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBV DNA: FUW 48 | NA log10 IU/mL | — |
| Combo 6: siRNA + TLR7 Agonist + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBV RNA: FUW 24 | -0.51 log10 IU/mL | Standard Deviation 0.63 |
| Combo 6: siRNA + TLR7 Agonist + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBsAg: Week 36 | -1.71 log10 IU/mL | Standard Deviation 0.69 |
| Combo 6: siRNA + TLR7 Agonist + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBV RNA: FUW 48 | -0.37 log10 IU/mL | Standard Deviation 0.52 |
| Combo 6: siRNA + TLR7 Agonist + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBsAg: Week 24 | -1.74 log10 IU/mL | Standard Deviation 0.62 |
| Combo 6: siRNA + TLR7 Agonist + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBV DNA: FUW 24 | NA log10 IU/mL | — |
| Combo 6: siRNA + TLR7 Agonist + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBeAg: Week 24 | -0.53 log10 IU/mL | Standard Deviation 0.3 |
| Combo 6: siRNA + TLR7 Agonist + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBeAg: Week 36 | -0.65 log10 IU/mL | Standard Deviation 0.44 |
| Combo 7: siRNA + PD-L1 LNA + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBV RNA: Week 24 | -1.17 log10 IU/mL | Standard Deviation 1.26 |
| Combo 7: siRNA + PD-L1 LNA + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | Anti-HBs: FUW 24 | 0.01 log10 IU/mL | Standard Deviation 0.1 |
| Combo 7: siRNA + PD-L1 LNA + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBV DNA: FUW 48 | NA log10 IU/mL | — |
| Combo 7: siRNA + PD-L1 LNA + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBsAg: FUW 48 | -0.91 log10 IU/mL | Standard Deviation 0.69 |
| Combo 7: siRNA + PD-L1 LNA + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBV DNA: FUW 24 | NA log10 IU/mL | — |
| Combo 7: siRNA + PD-L1 LNA + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBeAg: Week 24 | -0.47 log10 IU/mL | Standard Deviation 0.32 |
| Combo 7: siRNA + PD-L1 LNA + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBV RNA: FUW 48 | -0.98 log10 IU/mL | Standard Deviation 0.8 |
| Combo 7: siRNA + PD-L1 LNA + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | Anti-HBs: FUW 48 | 0.09 log10 IU/mL | Standard Deviation 0.26 |
| Combo 7: siRNA + PD-L1 LNA + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBsAg: FUW 24 | -1.3 log10 IU/mL | Standard Deviation 0.7 |
| Combo 7: siRNA + PD-L1 LNA + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBeAg: FUW 24 | -0.4 log10 IU/mL | Standard Deviation 0.37 |
| Combo 7: siRNA + PD-L1 LNA + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBV RNA: FUW 24 | -0.82 log10 IU/mL | Standard Deviation 0.75 |
| Combo 7: siRNA + PD-L1 LNA + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | Anti-HBs: Week 24 | 0.01 log10 IU/mL | Standard Deviation 0.12 |
| Combo 7: siRNA + PD-L1 LNA + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBeAg: FUW 48 | -0.42 log10 IU/mL | Standard Deviation 0.47 |
| Combo 7: siRNA + PD-L1 LNA + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBsAg: Week 24 | -2.12 log10 IU/mL | Standard Deviation 0.73 |
| Combo 8: siRNA + PD-L1 LNA + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBV DNA: FUW 48 | NA log10 IU/mL | — |
| Combo 8: siRNA + PD-L1 LNA + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBV DNA: FUW 24 | NA log10 IU/mL | — |
| Combo 8: siRNA + PD-L1 LNA + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBsAg: Week 36 | -2.08 log10 IU/mL | Standard Deviation 0.63 |
| Combo 8: siRNA + PD-L1 LNA + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | Anti-HBs: Week 24 | -0.03 log10 IU/mL | Standard Deviation 0.1 |
| Combo 8: siRNA + PD-L1 LNA + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBeAg: Week 24 | -0.46 log10 IU/mL | Standard Deviation 0.15 |
| Combo 8: siRNA + PD-L1 LNA + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBeAg: FUW 24 | -0.51 log10 IU/mL | Standard Deviation 0.31 |
| Combo 8: siRNA + PD-L1 LNA + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBV RNA: FUW 24 | -0.81 log10 IU/mL | Standard Deviation 0.55 |
| Combo 8: siRNA + PD-L1 LNA + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBsAg: Week 24 | -1.8 log10 IU/mL | Standard Deviation 0.49 |
| Combo 8: siRNA + PD-L1 LNA + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | Anti-HBs: FUW 24 | -0.06 log10 IU/mL | Standard Deviation 0.2 |
| Combo 8: siRNA + PD-L1 LNA + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBV RNA: FUW 48 | -0.49 log10 IU/mL | Standard Deviation 0.57 |
| Combo 8: siRNA + PD-L1 LNA + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | Anti-HBs: FUW 48 | 0.02 log10 IU/mL | Standard Deviation 0.07 |
| Combo 8: siRNA + PD-L1 LNA + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | Anti-HBs: Week 36 | -0.03 log10 IU/mL | Standard Deviation 0.11 |
| Combo 8: siRNA + PD-L1 LNA + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBV RNA: Week 24 | -0.81 log10 IU/mL | Standard Deviation 0.55 |
| Combo 8: siRNA + PD-L1 LNA + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBeAg: Week 36 | -0.46 log10 IU/mL | Standard Deviation 0.26 |
| Combo 8: siRNA + PD-L1 LNA + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBV RNA: Week 36 | -0.76 log10 IU/mL | Standard Deviation 0.56 |
| Combo 8: siRNA + PD-L1 LNA + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBsAg: FUW 48 | -1.14 log10 IU/mL | Standard Deviation 0.83 |
| Combo 8: siRNA + PD-L1 LNA + NUC | Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time | HBsAg: FUW 24 | -1.46 log10 IU/mL | Standard Deviation 0.74 |
Secondary
Combos 1 and 6: AUC of TLR7
The AUC was predicted and summarized by modelling & simulation via the PopPK method based on pre and post dose samples.
Time frame: Predose and 1-3 and 4-6 hours post-dose on Days 1, 3, 5 on Weeks 12 and 36
Population: PK population included participants who received at least one dose of the TLR7 and had at least one evaluable post-baseline PK sample.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NUC Control Arm | Combos 1 and 6: AUC of TLR7 | 3139 ng*hr/mL | Standard Deviation 938.8 |
| Combo 1: CpAM + TLR7 Agonist + NUC | Combos 1 and 6: AUC of TLR7 | 2813 ng*hr/mL | Standard Deviation 75.33 |
Secondary
Combos 1 and 6: Cmax of TLR7
The Cmax was predicted and summarized by modelling & simulation via the PopPK method based on pre and post dose samples.
Time frame: Predose and 1-3 and 4-6 hours post-dose on Days 1, 3, 5 on Weeks 12 and 36
Population: PK population included participants who received at least one dose of the TLR7 and had at least one evaluable post-baseline PK sample.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NUC Control Arm | Combos 1 and 6: Cmax of TLR7 | 1548 ng/mL | Standard Deviation 419.7 |
| Combo 1: CpAM + TLR7 Agonist + NUC | Combos 1 and 6: Cmax of TLR7 | 1491 ng/mL | Standard Deviation 334.8 |
Secondary
Combos 2, 3, 4, 5, 6, 7 and 8: Number of Participants With Anti-siRNA Antibodies
Treatment-emergent anti drug antibody (ADA) was defined as participants who seroconverted or experienced a boost in preexisting ADA during the study. Participants were considered to be ADA positive if they were ADA negative or had missing data at baseline but develop an ADA response following study drug administration (treatment-induced ADA response), or if they were ADA positive at baseline and the titer of one or more post-baseline samples were greater than the titer of the baseline sample by a scientifically reasonable margin such as at least 4-fold (treatment-enhanced ADA response).
Time frame: From Day 1 up to end of follow up (up to approximately 4 years)
Population: Immunogenicity population included participants who had at least one pre-dose (baseline) or at least one post-dose assessment will be included and analyzed according to the treatment they actually received or were allocated to receive.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| NUC Control Arm | Combos 2, 3, 4, 5, 6, 7 and 8: Number of Participants With Anti-siRNA Antibodies | 3 Participants |
| Combo 1: CpAM + TLR7 Agonist + NUC | Combos 2, 3, 4, 5, 6, 7 and 8: Number of Participants With Anti-siRNA Antibodies | 2 Participants |
| Combo 2: siRNA (100 mg) + NUC | Combos 2, 3, 4, 5, 6, 7 and 8: Number of Participants With Anti-siRNA Antibodies | 12 Participants |
| Combo 3: siRNA (200 mg) + NUC | Combos 2, 3, 4, 5, 6, 7 and 8: Number of Participants With Anti-siRNA Antibodies | 1 Participants |
| Combo 4: siRNA + PEG-IFN + NUC | Combos 2, 3, 4, 5, 6, 7 and 8: Number of Participants With Anti-siRNA Antibodies | 3 Participants |
| Combo 5: siRNA + CpAM + NUC | Combos 2, 3, 4, 5, 6, 7 and 8: Number of Participants With Anti-siRNA Antibodies | 10 Participants |
| Combo 6: siRNA + TLR7 Agonist + NUC | Combos 2, 3, 4, 5, 6, 7 and 8: Number of Participants With Anti-siRNA Antibodies | 14 Participants |
Secondary
Combos 2, 3, 4, 6, 7 and 8: Area Under the Plasma Concentration Time Curve (AUC) Over Days 1-28 of siRNA
The AUC was predicted and summarized by modelling & simulation via the PopPK method based on pre and post dose samples.
Time frame: Predose on Day 1 and 1-3 and 4-6 hours post dose each day, up to Day 28
Population: PK population included participants who received at least one dose of the siRNA and had at least one evaluable post-baseline PK sample.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NUC Control Arm | Combos 2, 3, 4, 6, 7 and 8: Area Under the Plasma Concentration Time Curve (AUC) Over Days 1-28 of siRNA | 4670 hours*nanograms/millilitres (hr*ng/mL) | Standard Deviation 1112 |
| Combo 1: CpAM + TLR7 Agonist + NUC | Combos 2, 3, 4, 6, 7 and 8: Area Under the Plasma Concentration Time Curve (AUC) Over Days 1-28 of siRNA | 11098 hours*nanograms/millilitres (hr*ng/mL) | Standard Deviation 2499 |
| Combo 2: siRNA (100 mg) + NUC | Combos 2, 3, 4, 6, 7 and 8: Area Under the Plasma Concentration Time Curve (AUC) Over Days 1-28 of siRNA | 11073 hours*nanograms/millilitres (hr*ng/mL) | Standard Deviation 2272 |
| Combo 3: siRNA (200 mg) + NUC | Combos 2, 3, 4, 6, 7 and 8: Area Under the Plasma Concentration Time Curve (AUC) Over Days 1-28 of siRNA | 9831 hours*nanograms/millilitres (hr*ng/mL) | Standard Deviation 2215 |
| Combo 4: siRNA + PEG-IFN + NUC | Combos 2, 3, 4, 6, 7 and 8: Area Under the Plasma Concentration Time Curve (AUC) Over Days 1-28 of siRNA | 9780 hours*nanograms/millilitres (hr*ng/mL) | Standard Deviation 1942 |
| Combo 5: siRNA + CpAM + NUC | Combos 2, 3, 4, 6, 7 and 8: Area Under the Plasma Concentration Time Curve (AUC) Over Days 1-28 of siRNA | 9110 hours*nanograms/millilitres (hr*ng/mL) | Standard Deviation 1418 |
Secondary
Combos 2, 3, 4, 6, 7 and 8: Area Under the Plasma Concentration Time Curve During the Dosing Interval (AUC Tau) Over Days 29-56 of siRNA
The AUC tau was predicted and summarized by modelling & simulation via the PopPK method based on pre and post dose samples. Simulations for the dosing interval between Day 29 and Day 56 was done using population PK modeling informed by sparse PK samples collected on Days 1, 85, 169, 253, and 337 at predose, 1-3 hours, and 4-6 hours post dose.
Time frame: From Day 29 up to Day 56
Population: PK population included participants who received at least one dose of the siRNA and had at least one evaluable post-baseline PK sample.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NUC Control Arm | Combos 2, 3, 4, 6, 7 and 8: Area Under the Plasma Concentration Time Curve During the Dosing Interval (AUC Tau) Over Days 29-56 of siRNA | 5401 hr*ng/mL | Standard Deviation 1245 |
| Combo 1: CpAM + TLR7 Agonist + NUC | Combos 2, 3, 4, 6, 7 and 8: Area Under the Plasma Concentration Time Curve During the Dosing Interval (AUC Tau) Over Days 29-56 of siRNA | 12591 hr*ng/mL | Standard Deviation 2659 |
| Combo 2: siRNA (100 mg) + NUC | Combos 2, 3, 4, 6, 7 and 8: Area Under the Plasma Concentration Time Curve During the Dosing Interval (AUC Tau) Over Days 29-56 of siRNA | 12623 hr*ng/mL | Standard Deviation 2428 |
| Combo 3: siRNA (200 mg) + NUC | Combos 2, 3, 4, 6, 7 and 8: Area Under the Plasma Concentration Time Curve During the Dosing Interval (AUC Tau) Over Days 29-56 of siRNA | 11207 hr*ng/mL | Standard Deviation 2371 |
| Combo 4: siRNA + PEG-IFN + NUC | Combos 2, 3, 4, 6, 7 and 8: Area Under the Plasma Concentration Time Curve During the Dosing Interval (AUC Tau) Over Days 29-56 of siRNA | 11216 hr*ng/mL | Standard Deviation 2068 |
| Combo 5: siRNA + CpAM + NUC | Combos 2, 3, 4, 6, 7 and 8: Area Under the Plasma Concentration Time Curve During the Dosing Interval (AUC Tau) Over Days 29-56 of siRNA | 10513 hr*ng/mL | Standard Deviation 1511 |
Secondary
Combos 2, 3, 4, 6, 7 and 8: Cmax Over Days 1-28 of siRNA
The Cmax was predicted and summarized by modelling & simulation via the PopPK method based on pre and post dose samples.
Time frame: Predose on Day 1 and 1-3 and 4-6 hours post dose each day, up to Day 28
Population: PK population included participants who received at least one dose of the siRNA and had at least one evaluable post-baseline PK sample.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NUC Control Arm | Combos 2, 3, 4, 6, 7 and 8: Cmax Over Days 1-28 of siRNA | 190 nanograms/millilitres (ng/mL) | Standard Deviation 116 |
| Combo 1: CpAM + TLR7 Agonist + NUC | Combos 2, 3, 4, 6, 7 and 8: Cmax Over Days 1-28 of siRNA | 463 nanograms/millilitres (ng/mL) | Standard Deviation 203 |
| Combo 2: siRNA (100 mg) + NUC | Combos 2, 3, 4, 6, 7 and 8: Cmax Over Days 1-28 of siRNA | 450 nanograms/millilitres (ng/mL) | Standard Deviation 168 |
| Combo 3: siRNA (200 mg) + NUC | Combos 2, 3, 4, 6, 7 and 8: Cmax Over Days 1-28 of siRNA | 408 nanograms/millilitres (ng/mL) | Standard Deviation 168 |
| Combo 4: siRNA + PEG-IFN + NUC | Combos 2, 3, 4, 6, 7 and 8: Cmax Over Days 1-28 of siRNA | 373 nanograms/millilitres (ng/mL) | Standard Deviation 149 |
| Combo 5: siRNA + CpAM + NUC | Combos 2, 3, 4, 6, 7 and 8: Cmax Over Days 1-28 of siRNA | 311 nanograms/millilitres (ng/mL) | Standard Deviation 97 |
Secondary
Combos 2, 3, 4, 6, 7 and 8: Cmax Over Days 29-56 of siRNA
The Cmax was predicted and summarized by modelling & simulation via the PopPK method based on pre and post dose samples. Simulations for the dosing interval between Day 29 and Day 56 was done using population PK modeling informed by sparse PK samples collected on Days 1, 85, 169, 253, and 337 at predose, 1-3 hours, and 4-6 hours post dose.
Time frame: From Day 29 up to Day 56
Population: PK population included participants who received at least one dose of the siRNA and had at least one evaluable post-baseline PK sample.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NUC Control Arm | Combos 2, 3, 4, 6, 7 and 8: Cmax Over Days 29-56 of siRNA | 192 ng/mL | Standard Deviation 116 |
| Combo 1: CpAM + TLR7 Agonist + NUC | Combos 2, 3, 4, 6, 7 and 8: Cmax Over Days 29-56 of siRNA | 468 ng/mL | Standard Deviation 204 |
| Combo 2: siRNA (100 mg) + NUC | Combos 2, 3, 4, 6, 7 and 8: Cmax Over Days 29-56 of siRNA | 454 ng/mL | Standard Deviation 169 |
| Combo 3: siRNA (200 mg) + NUC | Combos 2, 3, 4, 6, 7 and 8: Cmax Over Days 29-56 of siRNA | 411 ng/mL | Standard Deviation 169 |
| Combo 4: siRNA + PEG-IFN + NUC | Combos 2, 3, 4, 6, 7 and 8: Cmax Over Days 29-56 of siRNA | 376 ng/mL | Standard Deviation 150 |
| Combo 5: siRNA + CpAM + NUC | Combos 2, 3, 4, 6, 7 and 8: Cmax Over Days 29-56 of siRNA | 315 ng/mL | Standard Deviation 98 |
Secondary
Combos 7 and 8: Area Under the Plasma Concentration-time Curve Over the Dosing Interval at Week 1 (AUC1-0-168h) of PD-L1 LNA
The AUC was predicted and summarized by modelling & simulation via the population pharmacokinetics (PopPK) method based on pre and post dose samples. As per planned analysis data was collected and reported in a pooled manner for Combos 7 and 8.
Time frame: Predose on Day 1 and up to 168 hours post dose (Week 1)
Population: PK population included participants who received at least one dose of the PD-L1 LNA and had at least one evaluable post-baseline PK sample.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NUC Control Arm | Combos 7 and 8: Area Under the Plasma Concentration-time Curve Over the Dosing Interval at Week 1 (AUC1-0-168h) of PD-L1 LNA | 1047 hours*nanomoles/liters (hr*nmol/L) | Standard Deviation 273 |
Secondary
Combos 7 and 8: AUC Over the Dosing Interval at Week 12 (AUC12-0-168h) of PD-L1 LNA
The AUC was predicted and summarized by modelling & simulation via the PopPK method based on pre and post dose samples. As per planned analysis data was collected and reported in a pooled manner for Combos 7 and 8.
Time frame: Predose on Day 1 of Week 12 up to 168 hours post dose (Week 12)
Population: PK population included participants who received at least one dose of the PD-L1 LNA and had at least one evaluable post-baseline PK sample.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NUC Control Arm | Combos 7 and 8: AUC Over the Dosing Interval at Week 12 (AUC12-0-168h) of PD-L1 LNA | 1143 hr*nmol/L | Standard Deviation 286 |
Secondary
Combos 7 and 8: Cmax at Week 12 (Cmax12-0-168h) of PD-L1 LNA
The Cmax was predicted and summarized by modelling & simulation via the PopPK method based on pre and post dose samples. As per planned analysis data was collected and reported in a pooled manner for Combos 7 and 8.
Time frame: Predose on Day 1 of Week 12 up to 168 hours post dose (Week 12)
Population: PK population included participants who received at least one dose of the PD-L1 LNA and had at least one evaluable post-baseline PK sample.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NUC Control Arm | Combos 7 and 8: Cmax at Week 12 (Cmax12-0-168h) of PD-L1 LNA | 165 nmol/L | Standard Deviation 60.9 |
Secondary
Combos 7 and 8: Maximum Plasma Concentration (Cmax) at Week 1 (Cmax1-0-168h) of PD-L1 LNA
The Cmax was predicted and summarized by modelling & simulation via the PopPK method based on pre and post dose samples. As per planned analysis data was collected and reported in a pooled manner for Combos 7 and 8.
Time frame: Predose on Day 1 and up to 168 hours post dose (Week 1)
Population: PK population included participants who received at least one dose of the PD-L1 LNA and had at least one evaluable post-baseline PK sample.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NUC Control Arm | Combos 7 and 8: Maximum Plasma Concentration (Cmax) at Week 1 (Cmax1-0-168h) of PD-L1 LNA | 163 nanomoles/liters (nmol/L) | Standard Deviation 60.8 |
Secondary
Combos 7 and 8: Number of Participants With Anti-PD-L1 Antibodies
Treatment-emergent ADA was defined as participants who seroconverted or experienced a boost in preexisting ADA during the study. Participants were considered to be ADA positive if they were ADA negative or had missing data at baseline but develop an ADA response following study drug administration (treatment-induced ADA response), or if they were ADA positive at baseline and the titer of one or more post-baseline samples were greater than the titer of the baseline sample by a scientifically reasonable margin such as at least 4-fold (treatment-enhanced ADA response).
Time frame: From Day 1 for Combo 7 and 8 up to end of follow up (Up to approximately 2 years)
Population: Immunogenicity population included participants who had at least one pre-dose (baseline) or at least one post-dose assessment will be included and analyzed according to the treatment they actually received or were allocated to receive.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| NUC Control Arm | Combos 7 and 8: Number of Participants With Anti-PD-L1 Antibodies | 16 Participants |
| Combo 1: CpAM + TLR7 Agonist + NUC | Combos 7 and 8: Number of Participants With Anti-PD-L1 Antibodies | 15 Participants |
Secondary
Number of Participants With Adverse Events (AEs)
An AE was any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including abnormal laboratory values or abnormal clinical test results), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product.
Time frame: From Day 1 up to end of 48 weeks of follow up (up to approximately 1.8 years)
Population: Safety population included participants randomized to a treatment regimen who received at least one dose of any drug for their assigned treatment regimen, whether prematurely withdrawn from the study or not.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| NUC Control Arm | Number of Participants With Adverse Events (AEs) | 27 Participants |
| Combo 1: CpAM + TLR7 Agonist + NUC | Number of Participants With Adverse Events (AEs) | 34 Participants |
| Combo 2: siRNA (100 mg) + NUC | Number of Participants With Adverse Events (AEs) | 30 Participants |
| Combo 3: siRNA (200 mg) + NUC | Number of Participants With Adverse Events (AEs) | 29 Participants |
| Combo 4: siRNA + PEG-IFN + NUC | Number of Participants With Adverse Events (AEs) | 30 Participants |
| Combo 5: siRNA + CpAM + NUC | Number of Participants With Adverse Events (AEs) | 18 Participants |
| Combo 6: siRNA + TLR7 Agonist + NUC | Number of Participants With Adverse Events (AEs) | 33 Participants |
| Combo 7: siRNA + PD-L1 LNA + NUC | Number of Participants With Adverse Events (AEs) | 26 Participants |
| Combo 8: siRNA + PD-L1 LNA + NUC | Number of Participants With Adverse Events (AEs) | 27 Participants |
Secondary
Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL
Chronic HBV infection is characterized by high levels of circulating HBV DNA. Therefore, HBV levels are indicative of virological response. At screening participants were on NUC therapy and had circulating HBV DNA levels below the assay LLOQ or below 20 IU/mL for at least 6 months. The emergence of a virological breakthrough (HBV DNA \>100 IU/mL or \>1 log increase from nadir) while on NUC therapy, or the emergence of a virological relapse (\>2,000 IU/mL) in participants taken off NME combination and NUC therapy during follow-up, was monitored through the quantification of HBV DNA in plasma.
Time frame: FUW 12, 24, 36, and 48
Population: mITT population included participants who were randomized and received at least one dose of each drug for their assigned treatment regimen. Overall number analyzed included participants with data available for analysis. Number analyzed included participants with data available for analysis at that specified timepoint. Different participants may have contributed data for each timepoint.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| NUC Control Arm | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 24: OFF NUC (≥ 2000 IU/mL) | 1 Participants |
| NUC Control Arm | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 36: ON NUC (≥ 200 - < 2000 IU/mL) | 0 Participants |
| NUC Control Arm | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 12: ON NUC (≥ 2000 IU/mL) | 0 Participants |
| NUC Control Arm | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 24: OFF NUC (≥ 200 - < 2000 IU/mL) | 0 Participants |
| NUC Control Arm | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 12: ON NUC (≥ LLOQ - < 200 IU/mL) | 0 Participants |
| NUC Control Arm | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 24: ON NUC (≥ 2000 IU/mL) | 0 Participants |
| NUC Control Arm | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 12: ON NUC (≥ 200 - < 2000 IU/mL) | 0 Participants |
| NUC Control Arm | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 24: ON NUC (≥ LLOQ - < 200 IU/mL) | 0 Participants |
| NUC Control Arm | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 36: ON NUC (< LLOQ) | 29 Participants |
| NUC Control Arm | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 36: ON NUC (≥ 2000 IU/mL) | 0 Participants |
| NUC Control Arm | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 36: OFF NUC (≥ 2000 IU/mL) | 0 Participants |
| NUC Control Arm | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 36: OFF NUC (≥ 200 - < 2000 IU/mL) | 1 Participants |
| NUC Control Arm | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 48: ON NUC (≥ 2000 IU/mL) | 0 Participants |
| NUC Control Arm | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 36: OFF NUC (≥ LLOQ - < 200 IU/mL) | 0 Participants |
| NUC Control Arm | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 48: ON NUC (< LLOQ) | 30 Participants |
| NUC Control Arm | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 36: ON NUC (≥ LLOQ - < 200 IU/mL) | 0 Participants |
| NUC Control Arm | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 48: ON NUC (≥ 200 - < 2000 IU/mL) | 0 Participants |
| NUC Control Arm | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 12: OFF NUC (≥ 2000 IU/mL) | 0 Participants |
| NUC Control Arm | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 36: OFF NUC (< LLOQ) | 0 Participants |
| NUC Control Arm | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 12: OFF NUC (≥ LLOQ - < 200 IU/mL) | 1 Participants |
| NUC Control Arm | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 12: ON NUC (< LLOQ) | 28 Participants |
| NUC Control Arm | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 24: ON NUC (≥ 200 - < 2000 IU/mL) | 0 Participants |
| NUC Control Arm | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 48: ON NUC (≥ LLOQ - < 200 IU/mL) | 0 Participants |
| NUC Control Arm | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 12: OFF NUC (≥ 200 - < 2000 IU/mL) | 0 Participants |
| NUC Control Arm | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 12: OFF NUC (< LLOQ) | 0 Participants |
| NUC Control Arm | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 24: OFF NUC (≥ LLOQ - < 200 IU/mL) | 1 Participants |
| NUC Control Arm | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 24: ON NUC (< LLOQ) | 27 Participants |
| NUC Control Arm | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 24: OFF NUC (< LLOQ) | 0 Participants |
| Combo 1: CpAM + TLR7 Agonist + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 48: ON NUC (< LLOQ) | 28 Participants |
| Combo 1: CpAM + TLR7 Agonist + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 24: ON NUC (< LLOQ) | 35 Participants |
| Combo 1: CpAM + TLR7 Agonist + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 36: ON NUC (< LLOQ) | 31 Participants |
| Combo 1: CpAM + TLR7 Agonist + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 48: ON NUC (≥ 2000 IU/mL) | 0 Participants |
| Combo 1: CpAM + TLR7 Agonist + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 48: ON NUC (≥ 200 - < 2000 IU/mL) | 0 Participants |
| Combo 1: CpAM + TLR7 Agonist + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 48: ON NUC (≥ LLOQ - < 200 IU/mL) | 0 Participants |
| Combo 1: CpAM + TLR7 Agonist + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 12: ON NUC (≥ 2000 IU/mL) | 0 Participants |
| Combo 1: CpAM + TLR7 Agonist + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 12: ON NUC (≥ 200 - < 2000 IU/mL) | 0 Participants |
| Combo 1: CpAM + TLR7 Agonist + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 12: ON NUC (≥ LLOQ - < 200 IU/mL) | 0 Participants |
| Combo 1: CpAM + TLR7 Agonist + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 24: ON NUC (≥ LLOQ - < 200 IU/mL) | 0 Participants |
| Combo 1: CpAM + TLR7 Agonist + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 12: ON NUC (< LLOQ) | 32 Participants |
| Combo 1: CpAM + TLR7 Agonist + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 24: ON NUC (≥ 2000 IU/mL) | 0 Participants |
| Combo 1: CpAM + TLR7 Agonist + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 24: ON NUC (≥ 200 - < 2000 IU/mL) | 0 Participants |
| Combo 1: CpAM + TLR7 Agonist + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 36: ON NUC (≥ 2000 IU/mL) | 0 Participants |
| Combo 1: CpAM + TLR7 Agonist + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 36: ON NUC (≥ 200 - < 2000 IU/mL) | 0 Participants |
| Combo 1: CpAM + TLR7 Agonist + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 36: ON NUC (≥ LLOQ - < 200 IU/mL) | 0 Participants |
| Combo 2: siRNA (100 mg) + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 12: ON NUC (≥ 2000 IU/mL) | 0 Participants |
| Combo 2: siRNA (100 mg) + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 24: OFF NUC (≥ 2000 IU/mL) | 0 Participants |
| Combo 2: siRNA (100 mg) + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 24: OFF NUC (< LLOQ) | 2 Participants |
| Combo 2: siRNA (100 mg) + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 24: OFF NUC (≥ LLOQ - < 200 IU/mL) | 2 Participants |
| Combo 2: siRNA (100 mg) + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 12: OFF NUC (≥ LLOQ - < 200 IU/mL) | 1 Participants |
| Combo 2: siRNA (100 mg) + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 36: OFF NUC (≥ 200 - < 2000 IU/mL) | 0 Participants |
| Combo 2: siRNA (100 mg) + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 48: ON NUC (≥ LLOQ - < 200 IU/mL) | 0 Participants |
| Combo 2: siRNA (100 mg) + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 36: ON NUC (< LLOQ) | 24 Participants |
| Combo 2: siRNA (100 mg) + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 24: ON NUC (≥ 2000 IU/mL) | 1 Participants |
| Combo 2: siRNA (100 mg) + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 24: OFF NUC (≥ 200 - < 2000 IU/mL) | 0 Participants |
| Combo 2: siRNA (100 mg) + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 12: OFF NUC (< LLOQ) | 3 Participants |
| Combo 2: siRNA (100 mg) + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 48: OFF NUC (≥ 2000 IU/mL) | 0 Participants |
| Combo 2: siRNA (100 mg) + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 48: ON NUC (< LLOQ) | 27 Participants |
| Combo 2: siRNA (100 mg) + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 36: ON NUC (≥ LLOQ - < 200 IU/mL) | 1 Participants |
| Combo 2: siRNA (100 mg) + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 12: OFF NUC (≥ 2000 IU/mL) | 0 Participants |
| Combo 2: siRNA (100 mg) + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 36: OFF NUC (< LLOQ) | 1 Participants |
| Combo 2: siRNA (100 mg) + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 48: OFF NUC (≥ 200 - < 2000 IU/mL) | 1 Participants |
| Combo 2: siRNA (100 mg) + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 48: OFF NUC (≥ LLOQ - < 200 IU/mL) | 1 Participants |
| Combo 2: siRNA (100 mg) + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 48: OFF NUC (< LLOQ) | 0 Participants |
| Combo 2: siRNA (100 mg) + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 36: ON NUC (≥ 2000 IU/mL) | 0 Participants |
| Combo 2: siRNA (100 mg) + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 24: ON NUC (≥ 200 - < 2000 IU/mL) | 0 Participants |
| Combo 2: siRNA (100 mg) + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 48: ON NUC (≥ 200 - < 2000 IU/mL) | 0 Participants |
| Combo 2: siRNA (100 mg) + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 36: OFF NUC (≥ LLOQ - < 200 IU/mL) | 1 Participants |
| Combo 2: siRNA (100 mg) + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 48: ON NUC (≥ 2000 IU/mL) | 0 Participants |
| Combo 2: siRNA (100 mg) + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 24: ON NUC (< LLOQ) | 22 Participants |
| Combo 2: siRNA (100 mg) + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 12: ON NUC (≥ LLOQ - < 200 IU/mL) | 0 Participants |
| Combo 2: siRNA (100 mg) + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 36: OFF NUC (≥ 2000 IU/mL) | 1 Participants |
| Combo 2: siRNA (100 mg) + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 12: ON NUC (≥ 200 - < 2000 IU/mL) | 0 Participants |
| Combo 2: siRNA (100 mg) + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 12: ON NUC (< LLOQ) | 19 Participants |
| Combo 2: siRNA (100 mg) + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 36: ON NUC (≥ 200 - < 2000 IU/mL) | 0 Participants |
| Combo 2: siRNA (100 mg) + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 24: ON NUC (≥ LLOQ - < 200 IU/mL) | 1 Participants |
| Combo 2: siRNA (100 mg) + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 12: OFF NUC (≥ 200 - < 2000 IU/mL) | 1 Participants |
| Combo 3: siRNA (200 mg) + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 48: ON NUC (≥ LLOQ - < 200 IU/mL) | 0 Participants |
| Combo 3: siRNA (200 mg) + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 24: OFF NUC (≥ 200 - < 2000 IU/mL) | 2 Participants |
| Combo 3: siRNA (200 mg) + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 24: ON NUC (≥ LLOQ - < 200 IU/mL) | 0 Participants |
| Combo 3: siRNA (200 mg) + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 24: ON NUC (≥ 2000 IU/mL) | 0 Participants |
| Combo 3: siRNA (200 mg) + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 48: OFF NUC (≥ 200 - < 2000 IU/mL) | 2 Participants |
| Combo 3: siRNA (200 mg) + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 24: ON NUC (< LLOQ) | 24 Participants |
| Combo 3: siRNA (200 mg) + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 24: OFF NUC (≥ 2000 IU/mL) | 0 Participants |
| Combo 3: siRNA (200 mg) + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 36: OFF NUC (< LLOQ) | 3 Participants |
| Combo 3: siRNA (200 mg) + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 36: OFF NUC (≥ LLOQ - < 200 IU/mL) | 0 Participants |
| Combo 3: siRNA (200 mg) + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 24: ON NUC (≥ 200 - < 2000 IU/mL) | 0 Participants |
| Combo 3: siRNA (200 mg) + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 36: OFF NUC (≥ 200 - < 2000 IU/mL) | 2 Participants |
| Combo 3: siRNA (200 mg) + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 36: OFF NUC (≥ 2000 IU/mL) | 0 Participants |
| Combo 3: siRNA (200 mg) + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 36: ON NUC (< LLOQ) | 25 Participants |
| Combo 3: siRNA (200 mg) + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 36: ON NUC (≥ LLOQ - < 200 IU/mL) | 0 Participants |
| Combo 3: siRNA (200 mg) + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 36: ON NUC (≥ 200 - < 2000 IU/mL) | 0 Participants |
| Combo 3: siRNA (200 mg) + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 36: ON NUC (≥ 2000 IU/mL) | 0 Participants |
| Combo 3: siRNA (200 mg) + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 48: OFF NUC (< LLOQ) | 5 Participants |
| Combo 3: siRNA (200 mg) + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 48: OFF NUC (≥ LLOQ - < 200 IU/mL) | 0 Participants |
| Combo 3: siRNA (200 mg) + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 48: ON NUC (< LLOQ) | 23 Participants |
| Combo 3: siRNA (200 mg) + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 48: OFF NUC (≥ 2000 IU/mL) | 0 Participants |
| Combo 3: siRNA (200 mg) + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 12: OFF NUC (< LLOQ) | 4 Participants |
| Combo 3: siRNA (200 mg) + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 12: OFF NUC (≥ LLOQ - < 200 IU/mL) | 1 Participants |
| Combo 3: siRNA (200 mg) + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 12: OFF NUC (≥ 200 - < 2000 IU/mL) | 1 Participants |
| Combo 3: siRNA (200 mg) + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 12: ON NUC (< LLOQ) | 23 Participants |
| Combo 3: siRNA (200 mg) + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 12: ON NUC (≥ LLOQ - < 200 IU/mL) | 0 Participants |
| Combo 3: siRNA (200 mg) + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 12: ON NUC (≥ 200 - < 2000 IU/mL) | 0 Participants |
| Combo 3: siRNA (200 mg) + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 12: ON NUC (≥ 2000 IU/mL) | 0 Participants |
| Combo 3: siRNA (200 mg) + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 24: OFF NUC (< LLOQ) | 3 Participants |
| Combo 3: siRNA (200 mg) + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 24: OFF NUC (≥ LLOQ - < 200 IU/mL) | 0 Participants |
| Combo 3: siRNA (200 mg) + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 48: ON NUC (≥ 200 - < 2000 IU/mL) | 0 Participants |
| Combo 3: siRNA (200 mg) + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 48: ON NUC (≥ 2000 IU/mL) | 0 Participants |
| Combo 3: siRNA (200 mg) + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 12: OFF NUC (≥ 2000 IU/mL) | 0 Participants |
| Combo 4: siRNA + PEG-IFN + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 48: OFF NUC (≥ 200 - < 2000 IU/mL) | 0 Participants |
| Combo 4: siRNA + PEG-IFN + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 24: OFF NUC (≥ 200 - < 2000 IU/mL) | 1 Participants |
| Combo 4: siRNA + PEG-IFN + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 12: ON NUC (≥ 200 - < 2000 IU/mL) | 0 Participants |
| Combo 4: siRNA + PEG-IFN + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 48: OFF NUC (≥ 2000 IU/mL) | 0 Participants |
| Combo 4: siRNA + PEG-IFN + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 12: OFF NUC (< LLOQ) | 4 Participants |
| Combo 4: siRNA + PEG-IFN + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 36: OFF NUC (≥ 200 - < 2000 IU/mL) | 0 Participants |
| Combo 4: siRNA + PEG-IFN + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 12: ON NUC (≥ 2000 IU/mL) | 0 Participants |
| Combo 4: siRNA + PEG-IFN + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 24: ON NUC (≥ LLOQ - < 200 IU/mL) | 0 Participants |
| Combo 4: siRNA + PEG-IFN + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 24: OFF NUC (≥ LLOQ - < 200 IU/mL) | 0 Participants |
| Combo 4: siRNA + PEG-IFN + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 24: OFF NUC (< LLOQ) | 6 Participants |
| Combo 4: siRNA + PEG-IFN + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 48: OFF NUC (< LLOQ) | 3 Participants |
| Combo 4: siRNA + PEG-IFN + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 36: OFF NUC (< LLOQ) | 6 Participants |
| Combo 4: siRNA + PEG-IFN + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 24: ON NUC (≥ 200 - < 2000 IU/mL) | 0 Participants |
| Combo 4: siRNA + PEG-IFN + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 48: OFF NUC (≥ LLOQ - < 200 IU/mL) | 3 Participants |
| Combo 4: siRNA + PEG-IFN + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 12: OFF NUC (≥ 2000 IU/mL) | 0 Participants |
| Combo 4: siRNA + PEG-IFN + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 48: ON NUC (< LLOQ) | 21 Participants |
| Combo 4: siRNA + PEG-IFN + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 48: ON NUC (≥ 2000 IU/mL) | 0 Participants |
| Combo 4: siRNA + PEG-IFN + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 36: ON NUC (≥ 200 - < 2000 IU/mL) | 0 Participants |
| Combo 4: siRNA + PEG-IFN + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 36: OFF NUC (≥ 2000 IU/mL) | 0 Participants |
| Combo 4: siRNA + PEG-IFN + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 24: ON NUC (≥ 2000 IU/mL) | 0 Participants |
| Combo 4: siRNA + PEG-IFN + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 48: ON NUC (≥ 200 - < 2000 IU/mL) | 0 Participants |
| Combo 4: siRNA + PEG-IFN + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 36: ON NUC (≥ 2000 IU/mL) | 0 Participants |
| Combo 4: siRNA + PEG-IFN + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 12: OFF NUC (≥ LLOQ - < 200 IU/mL) | 0 Participants |
| Combo 4: siRNA + PEG-IFN + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 36: ON NUC (< LLOQ) | 21 Participants |
| Combo 4: siRNA + PEG-IFN + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 24: OFF NUC (≥ 2000 IU/mL) | 0 Participants |
| Combo 4: siRNA + PEG-IFN + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 36: OFF NUC (≥ LLOQ - < 200 IU/mL) | 0 Participants |
| Combo 4: siRNA + PEG-IFN + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 12: ON NUC (< LLOQ) | 21 Participants |
| Combo 4: siRNA + PEG-IFN + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 36: ON NUC (≥ LLOQ - < 200 IU/mL) | 0 Participants |
| Combo 4: siRNA + PEG-IFN + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 48: ON NUC (≥ LLOQ - < 200 IU/mL) | 0 Participants |
| Combo 4: siRNA + PEG-IFN + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 24: ON NUC (< LLOQ) | 20 Participants |
| Combo 4: siRNA + PEG-IFN + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 12: OFF NUC (≥ 200 - < 2000 IU/mL) | 1 Participants |
| Combo 4: siRNA + PEG-IFN + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 12: ON NUC (≥ LLOQ - < 200 IU/mL) | 0 Participants |
| Combo 5: siRNA + CpAM + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 36: ON NUC (≥ 200 - < 2000 IU/mL) | 0 Participants |
| Combo 5: siRNA + CpAM + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 48: ON NUC (≥ 200 - < 2000 IU/mL) | 0 Participants |
| Combo 5: siRNA + CpAM + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 36: ON NUC (≥ LLOQ - < 200 IU/mL) | 0 Participants |
| Combo 5: siRNA + CpAM + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 48: ON NUC (≥ LLOQ - < 200 IU/mL) | 0 Participants |
| Combo 5: siRNA + CpAM + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 24: ON NUC (≥ LLOQ - < 200 IU/mL) | 0 Participants |
| Combo 5: siRNA + CpAM + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 12: ON NUC (≥ 200 - < 2000 IU/mL) | 0 Participants |
| Combo 5: siRNA + CpAM + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 24: ON NUC (< LLOQ) | 9 Participants |
| Combo 5: siRNA + CpAM + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 24: ON NUC (≥ 2000 IU/mL) | 0 Participants |
| Combo 5: siRNA + CpAM + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 12: ON NUC (≥ LLOQ - < 200 IU/mL) | 0 Participants |
| Combo 5: siRNA + CpAM + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 48: ON NUC (≥ 2000 IU/mL) | 0 Participants |
| Combo 5: siRNA + CpAM + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 48: ON NUC (< LLOQ) | 1 Participants |
| Combo 5: siRNA + CpAM + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 24: ON NUC (≥ 200 - < 2000 IU/mL) | 0 Participants |
| Combo 5: siRNA + CpAM + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 36: ON NUC (≥ 2000 IU/mL) | 0 Participants |
| Combo 5: siRNA + CpAM + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 12: ON NUC (< LLOQ) | 8 Participants |
| Combo 5: siRNA + CpAM + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 36: ON NUC (< LLOQ) | 1 Participants |
| Combo 5: siRNA + CpAM + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 12: ON NUC (≥ 2000 IU/mL) | 0 Participants |
| Combo 6: siRNA + TLR7 Agonist + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 24: ON NUC (≥ LLOQ - < 200 IU/mL) | 0 Participants |
| Combo 6: siRNA + TLR7 Agonist + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 24: OFF NUC (≥ LLOQ - < 200 IU/mL) | 5 Participants |
| Combo 6: siRNA + TLR7 Agonist + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 12: ON NUC (< LLOQ) | 20 Participants |
| Combo 6: siRNA + TLR7 Agonist + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 12: ON NUC (≥ 2000 IU/mL) | 0 Participants |
| Combo 6: siRNA + TLR7 Agonist + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 36: OFF NUC (≥ 200 - < 2000 IU/mL) | 5 Participants |
| Combo 6: siRNA + TLR7 Agonist + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 24: OFF NUC (≥ 2000 IU/mL) | 0 Participants |
| Combo 6: siRNA + TLR7 Agonist + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 24: OFF NUC (< LLOQ) | 5 Participants |
| Combo 6: siRNA + TLR7 Agonist + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 48: ON NUC (≥ 2000 IU/mL) | 0 Participants |
| Combo 6: siRNA + TLR7 Agonist + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 12: ON NUC (≥ LLOQ - < 200 IU/mL) | 0 Participants |
| Combo 6: siRNA + TLR7 Agonist + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 36: ON NUC (≥ LLOQ - < 200 IU/mL) | 2 Participants |
| Combo 6: siRNA + TLR7 Agonist + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 48: OFF NUC (≥ 2000 IU/mL) | 0 Participants |
| Combo 6: siRNA + TLR7 Agonist + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 36: OFF NUC (≥ LLOQ - < 200 IU/mL) | 3 Participants |
| Combo 6: siRNA + TLR7 Agonist + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 36: OFF NUC (< LLOQ) | 1 Participants |
| Combo 6: siRNA + TLR7 Agonist + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 36: OFF NUC (≥ 2000 IU/mL) | 0 Participants |
| Combo 6: siRNA + TLR7 Agonist + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 12: OFF NUC (≥ LLOQ - < 200 IU/mL) | 2 Participants |
| Combo 6: siRNA + TLR7 Agonist + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 36: ON NUC (< LLOQ) | 22 Participants |
| Combo 6: siRNA + TLR7 Agonist + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 48: OFF NUC (≥ 200 - < 2000 IU/mL) | 2 Participants |
| Combo 6: siRNA + TLR7 Agonist + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 48: OFF NUC (< LLOQ) | 3 Participants |
| Combo 6: siRNA + TLR7 Agonist + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 48: OFF NUC (≥ LLOQ - < 200 IU/mL) | 4 Participants |
| Combo 6: siRNA + TLR7 Agonist + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 24: ON NUC (≥ 200 - < 2000 IU/mL) | 0 Participants |
| Combo 6: siRNA + TLR7 Agonist + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 24: ON NUC (< LLOQ) | 21 Participants |
| Combo 6: siRNA + TLR7 Agonist + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 48: ON NUC (≥ LLOQ - < 200 IU/mL) | 0 Participants |
| Combo 6: siRNA + TLR7 Agonist + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 24: ON NUC (≥ 2000 IU/mL) | 0 Participants |
| Combo 6: siRNA + TLR7 Agonist + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 48: ON NUC (< LLOQ) | 23 Participants |
| Combo 6: siRNA + TLR7 Agonist + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 48: ON NUC (≥ 200 - < 2000 IU/mL) | 0 Participants |
| Combo 6: siRNA + TLR7 Agonist + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 12: OFF NUC (≥ 2000 IU/mL) | 0 Participants |
| Combo 6: siRNA + TLR7 Agonist + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 12: OFF NUC (< LLOQ) | 7 Participants |
| Combo 6: siRNA + TLR7 Agonist + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 24: OFF NUC (≥ 200 - < 2000 IU/mL) | 2 Participants |
| Combo 6: siRNA + TLR7 Agonist + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 12: OFF NUC (≥ 200 - < 2000 IU/mL) | 1 Participants |
| Combo 6: siRNA + TLR7 Agonist + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 12: ON NUC (≥ 200 - < 2000 IU/mL) | 0 Participants |
| Combo 6: siRNA + TLR7 Agonist + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 36: ON NUC (≥ 2000 IU/mL) | 0 Participants |
| Combo 6: siRNA + TLR7 Agonist + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 36: ON NUC (≥ 200 - < 2000 IU/mL) | 0 Participants |
| Combo 7: siRNA + PD-L1 LNA + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 48: ON NUC (≥ 200 - < 2000 IU/mL) | 0 Participants |
| Combo 7: siRNA + PD-L1 LNA + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 36: ON NUC (≥ LLOQ - < 200 IU/mL) | 1 Participants |
| Combo 7: siRNA + PD-L1 LNA + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 36: OFF NUC (≥ LLOQ - < 200 IU/mL) | 0 Participants |
| Combo 7: siRNA + PD-L1 LNA + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 36: ON NUC (≥ 200 - < 2000 IU/mL) | 0 Participants |
| Combo 7: siRNA + PD-L1 LNA + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 36: OFF NUC (< LLOQ) | 5 Participants |
| Combo 7: siRNA + PD-L1 LNA + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 36: ON NUC (≥ 2000 IU/mL) | 0 Participants |
| Combo 7: siRNA + PD-L1 LNA + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 48: OFF NUC (< LLOQ) | 4 Participants |
| Combo 7: siRNA + PD-L1 LNA + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 48: OFF NUC (≥ 2000 IU/mL) | 0 Participants |
| Combo 7: siRNA + PD-L1 LNA + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 24: ON NUC (≥ 2000 IU/mL) | 0 Participants |
| Combo 7: siRNA + PD-L1 LNA + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 48: ON NUC (< LLOQ) | 10 Participants |
| Combo 7: siRNA + PD-L1 LNA + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 12: OFF NUC (< LLOQ) | 2 Participants |
| Combo 7: siRNA + PD-L1 LNA + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 12: OFF NUC (≥ 2000 IU/mL) | 0 Participants |
| Combo 7: siRNA + PD-L1 LNA + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 24: OFF NUC (≥ 2000 IU/mL) | 0 Participants |
| Combo 7: siRNA + PD-L1 LNA + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 12: OFF NUC (≥ LLOQ - < 200 IU/mL) | 1 Participants |
| Combo 7: siRNA + PD-L1 LNA + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 48: ON NUC (≥ 2000 IU/mL) | 0 Participants |
| Combo 7: siRNA + PD-L1 LNA + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 24: ON NUC (< LLOQ) | 24 Participants |
| Combo 7: siRNA + PD-L1 LNA + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 12: ON NUC (< LLOQ) | 30 Participants |
| Combo 7: siRNA + PD-L1 LNA + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 12: ON NUC (≥ LLOQ - < 200 IU/mL) | 0 Participants |
| Combo 7: siRNA + PD-L1 LNA + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 24: OFF NUC (≥ 200 - < 2000 IU/mL) | 1 Participants |
| Combo 7: siRNA + PD-L1 LNA + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 12: ON NUC (≥ 200 - < 2000 IU/mL) | 0 Participants |
| Combo 7: siRNA + PD-L1 LNA + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 24: OFF NUC (≥ LLOQ - < 200 IU/mL) | 2 Participants |
| Combo 7: siRNA + PD-L1 LNA + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 12: OFF NUC (≥ 200 - < 2000 IU/mL) | 0 Participants |
| Combo 7: siRNA + PD-L1 LNA + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 12: ON NUC (≥ 2000 IU/mL) | 0 Participants |
| Combo 7: siRNA + PD-L1 LNA + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 24: OFF NUC (< LLOQ) | 5 Participants |
| Combo 7: siRNA + PD-L1 LNA + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 48: OFF NUC (≥ 200 - < 2000 IU/mL) | 0 Participants |
| Combo 7: siRNA + PD-L1 LNA + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 48: ON NUC (≥ LLOQ - < 200 IU/mL) | 0 Participants |
| Combo 7: siRNA + PD-L1 LNA + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 48: OFF NUC (≥ LLOQ - < 200 IU/mL) | 1 Participants |
| Combo 7: siRNA + PD-L1 LNA + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 36: OFF NUC (≥ 200 - < 2000 IU/mL) | 0 Participants |
| Combo 7: siRNA + PD-L1 LNA + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 24: ON NUC (≥ 200 - < 2000 IU/mL) | 0 Participants |
| Combo 7: siRNA + PD-L1 LNA + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 36: OFF NUC (≥ 2000 IU/mL) | 0 Participants |
| Combo 7: siRNA + PD-L1 LNA + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 36: ON NUC (< LLOQ) | 16 Participants |
| Combo 7: siRNA + PD-L1 LNA + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 24: ON NUC (≥ LLOQ - < 200 IU/mL) | 0 Participants |
| Combo 8: siRNA + PD-L1 LNA + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 12: ON NUC (≥ LLOQ - < 200 IU/mL) | 0 Participants |
| Combo 8: siRNA + PD-L1 LNA + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 12: ON NUC (< LLOQ) | 24 Participants |
| Combo 8: siRNA + PD-L1 LNA + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 48: ON NUC (≥ 2000 IU/mL) | 0 Participants |
| Combo 8: siRNA + PD-L1 LNA + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 24: OFF NUC (≥ 200 - < 2000 IU/mL) | 1 Participants |
| Combo 8: siRNA + PD-L1 LNA + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 48: ON NUC (≥ 200 - < 2000 IU/mL) | 0 Participants |
| Combo 8: siRNA + PD-L1 LNA + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 48: ON NUC (≥ LLOQ - < 200 IU/mL) | 1 Participants |
| Combo 8: siRNA + PD-L1 LNA + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 36: OFF NUC (≥ LLOQ - < 200 IU/mL) | 2 Participants |
| Combo 8: siRNA + PD-L1 LNA + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 12: OFF NUC (≥ LLOQ - < 200 IU/mL) | 1 Participants |
| Combo 8: siRNA + PD-L1 LNA + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 24: OFF NUC (≥ 2000 IU/mL) | 1 Participants |
| Combo 8: siRNA + PD-L1 LNA + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 24: ON NUC (< LLOQ) | 21 Participants |
| Combo 8: siRNA + PD-L1 LNA + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 12: OFF NUC (≥ 2000 IU/mL) | 0 Participants |
| Combo 8: siRNA + PD-L1 LNA + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 24: ON NUC (≥ 200 - < 2000 IU/mL) | 0 Participants |
| Combo 8: siRNA + PD-L1 LNA + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 12: OFF NUC (< LLOQ) | 4 Participants |
| Combo 8: siRNA + PD-L1 LNA + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 36: ON NUC (< LLOQ) | 13 Participants |
| Combo 8: siRNA + PD-L1 LNA + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 36: OFF NUC (≥ 200 - < 2000 IU/mL) | 0 Participants |
| Combo 8: siRNA + PD-L1 LNA + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 24: ON NUC (≥ LLOQ - < 200 IU/mL) | 0 Participants |
| Combo 8: siRNA + PD-L1 LNA + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 24: ON NUC (≥ 2000 IU/mL) | 0 Participants |
| Combo 8: siRNA + PD-L1 LNA + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 48: OFF NUC (≥ LLOQ - < 200 IU/mL) | 1 Participants |
| Combo 8: siRNA + PD-L1 LNA + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 48: OFF NUC (< LLOQ) | 1 Participants |
| Combo 8: siRNA + PD-L1 LNA + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 36: ON NUC (≥ LLOQ - < 200 IU/mL) | 0 Participants |
| Combo 8: siRNA + PD-L1 LNA + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 48: OFF NUC (≥ 2000 IU/mL) | 1 Participants |
| Combo 8: siRNA + PD-L1 LNA + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 36: OFF NUC (≥ 2000 IU/mL) | 1 Participants |
| Combo 8: siRNA + PD-L1 LNA + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 36: ON NUC (≥ 2000 IU/mL) | 0 Participants |
| Combo 8: siRNA + PD-L1 LNA + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 12: OFF NUC (≥ 200 - < 2000 IU/mL) | 0 Participants |
| Combo 8: siRNA + PD-L1 LNA + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 36: OFF NUC (< LLOQ) | 3 Participants |
| Combo 8: siRNA + PD-L1 LNA + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 24: OFF NUC (< LLOQ) | 6 Participants |
| Combo 8: siRNA + PD-L1 LNA + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 12: ON NUC (≥ 2000 IU/mL) | 0 Participants |
| Combo 8: siRNA + PD-L1 LNA + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 24: OFF NUC (≥ LLOQ - < 200 IU/mL) | 1 Participants |
| Combo 8: siRNA + PD-L1 LNA + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 48: ON NUC (< LLOQ) | 7 Participants |
| Combo 8: siRNA + PD-L1 LNA + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 12: ON NUC (≥ 200 - < 2000 IU/mL) | 1 Participants |
| Combo 8: siRNA + PD-L1 LNA + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 48: OFF NUC (≥ 200 - < 2000 IU/mL) | 1 Participants |
| Combo 8: siRNA + PD-L1 LNA + NUC | Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL | FUW 36: ON NUC (≥ 200 - < 2000 IU/mL) | 0 Participants |
Secondary
Percentage of Participants With HBeAg Seroconversion in Baseline HBeAg-positive Participants
HBeAg seroconversion was defined as a negative /non-reactive HBeAg level and a positive anti-HBe antibody. Percentages have been rounded off.
Time frame: Weeks 12, 24, 36, and 48; FUW 12, 24, 36, and 48
Population: mITT population included participants who were randomized and received at least one dose of each drug for their assigned treatment regimen. Overall number analyzed included participants from the mITT population who were positive for HBeAg at baseline. Number analyzed included participants with data available for analysis at that specified timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| NUC Control Arm | Percentage of Participants With HBeAg Seroconversion in Baseline HBeAg-positive Participants | FUW 24 | 14.3 percentage of participants |
| NUC Control Arm | Percentage of Participants With HBeAg Seroconversion in Baseline HBeAg-positive Participants | Week 36 | 0 percentage of participants |
| NUC Control Arm | Percentage of Participants With HBeAg Seroconversion in Baseline HBeAg-positive Participants | FUW 12 | 16.7 percentage of participants |
| NUC Control Arm | Percentage of Participants With HBeAg Seroconversion in Baseline HBeAg-positive Participants | FUW 36 | 12.5 percentage of participants |
| NUC Control Arm | Percentage of Participants With HBeAg Seroconversion in Baseline HBeAg-positive Participants | FUW 48 | 14.3 percentage of participants |
| NUC Control Arm | Percentage of Participants With HBeAg Seroconversion in Baseline HBeAg-positive Participants | Week 12 | 0 percentage of participants |
| NUC Control Arm | Percentage of Participants With HBeAg Seroconversion in Baseline HBeAg-positive Participants | Week 24 | 0 percentage of participants |
| NUC Control Arm | Percentage of Participants With HBeAg Seroconversion in Baseline HBeAg-positive Participants | Week 48 | 0 percentage of participants |
| Combo 1: CpAM + TLR7 Agonist + NUC | Percentage of Participants With HBeAg Seroconversion in Baseline HBeAg-positive Participants | Week 24 | 0 percentage of participants |
| Combo 1: CpAM + TLR7 Agonist + NUC | Percentage of Participants With HBeAg Seroconversion in Baseline HBeAg-positive Participants | FUW 12 | 0 percentage of participants |
| Combo 1: CpAM + TLR7 Agonist + NUC | Percentage of Participants With HBeAg Seroconversion in Baseline HBeAg-positive Participants | FUW 36 | 0 percentage of participants |
| Combo 1: CpAM + TLR7 Agonist + NUC | Percentage of Participants With HBeAg Seroconversion in Baseline HBeAg-positive Participants | Week 12 | 0 percentage of participants |
| Combo 1: CpAM + TLR7 Agonist + NUC | Percentage of Participants With HBeAg Seroconversion in Baseline HBeAg-positive Participants | FUW 24 | 0 percentage of participants |
| Combo 1: CpAM + TLR7 Agonist + NUC | Percentage of Participants With HBeAg Seroconversion in Baseline HBeAg-positive Participants | FUW 48 | 0 percentage of participants |
| Combo 1: CpAM + TLR7 Agonist + NUC | Percentage of Participants With HBeAg Seroconversion in Baseline HBeAg-positive Participants | Week 36 | 0 percentage of participants |
| Combo 1: CpAM + TLR7 Agonist + NUC | Percentage of Participants With HBeAg Seroconversion in Baseline HBeAg-positive Participants | Week 48 | 0 percentage of participants |
| Combo 2: siRNA (100 mg) + NUC | Percentage of Participants With HBeAg Seroconversion in Baseline HBeAg-positive Participants | Week 24 | 0 percentage of participants |
| Combo 2: siRNA (100 mg) + NUC | Percentage of Participants With HBeAg Seroconversion in Baseline HBeAg-positive Participants | FUW 12 | 14.3 percentage of participants |
| Combo 2: siRNA (100 mg) + NUC | Percentage of Participants With HBeAg Seroconversion in Baseline HBeAg-positive Participants | Week 12 | 11.1 percentage of participants |
| Combo 2: siRNA (100 mg) + NUC | Percentage of Participants With HBeAg Seroconversion in Baseline HBeAg-positive Participants | FUW 48 | 11.1 percentage of participants |
| Combo 2: siRNA (100 mg) + NUC | Percentage of Participants With HBeAg Seroconversion in Baseline HBeAg-positive Participants | Week 48 | 11.1 percentage of participants |
| Combo 2: siRNA (100 mg) + NUC | Percentage of Participants With HBeAg Seroconversion in Baseline HBeAg-positive Participants | FUW 36 | 0 percentage of participants |
| Combo 2: siRNA (100 mg) + NUC | Percentage of Participants With HBeAg Seroconversion in Baseline HBeAg-positive Participants | FUW 24 | 0 percentage of participants |
| Combo 2: siRNA (100 mg) + NUC | Percentage of Participants With HBeAg Seroconversion in Baseline HBeAg-positive Participants | Week 36 | 11.1 percentage of participants |
| Combo 3: siRNA (200 mg) + NUC | Percentage of Participants With HBeAg Seroconversion in Baseline HBeAg-positive Participants | FUW 36 | 25 percentage of participants |
| Combo 3: siRNA (200 mg) + NUC | Percentage of Participants With HBeAg Seroconversion in Baseline HBeAg-positive Participants | Week 48 | 12.5 percentage of participants |
| Combo 3: siRNA (200 mg) + NUC | Percentage of Participants With HBeAg Seroconversion in Baseline HBeAg-positive Participants | Week 36 | 0 percentage of participants |
| Combo 3: siRNA (200 mg) + NUC | Percentage of Participants With HBeAg Seroconversion in Baseline HBeAg-positive Participants | FUW 48 | 37.5 percentage of participants |
| Combo 3: siRNA (200 mg) + NUC | Percentage of Participants With HBeAg Seroconversion in Baseline HBeAg-positive Participants | FUW 24 | 25 percentage of participants |
| Combo 3: siRNA (200 mg) + NUC | Percentage of Participants With HBeAg Seroconversion in Baseline HBeAg-positive Participants | Week 12 | 0 percentage of participants |
| Combo 3: siRNA (200 mg) + NUC | Percentage of Participants With HBeAg Seroconversion in Baseline HBeAg-positive Participants | FUW 12 | 12.5 percentage of participants |
| Combo 3: siRNA (200 mg) + NUC | Percentage of Participants With HBeAg Seroconversion in Baseline HBeAg-positive Participants | Week 24 | 12.5 percentage of participants |
| Combo 4: siRNA + PEG-IFN + NUC | Percentage of Participants With HBeAg Seroconversion in Baseline HBeAg-positive Participants | Week 48 | 18.2 percentage of participants |
| Combo 4: siRNA + PEG-IFN + NUC | Percentage of Participants With HBeAg Seroconversion in Baseline HBeAg-positive Participants | FUW 24 | 9.1 percentage of participants |
| Combo 4: siRNA + PEG-IFN + NUC | Percentage of Participants With HBeAg Seroconversion in Baseline HBeAg-positive Participants | Week 12 | 8.3 percentage of participants |
| Combo 4: siRNA + PEG-IFN + NUC | Percentage of Participants With HBeAg Seroconversion in Baseline HBeAg-positive Participants | Week 24 | 8.3 percentage of participants |
| Combo 4: siRNA + PEG-IFN + NUC | Percentage of Participants With HBeAg Seroconversion in Baseline HBeAg-positive Participants | Week 36 | 11.1 percentage of participants |
| Combo 4: siRNA + PEG-IFN + NUC | Percentage of Participants With HBeAg Seroconversion in Baseline HBeAg-positive Participants | FUW 12 | 18.2 percentage of participants |
| Combo 4: siRNA + PEG-IFN + NUC | Percentage of Participants With HBeAg Seroconversion in Baseline HBeAg-positive Participants | FUW 36 | 9.1 percentage of participants |
| Combo 4: siRNA + PEG-IFN + NUC | Percentage of Participants With HBeAg Seroconversion in Baseline HBeAg-positive Participants | FUW 48 | 9.1 percentage of participants |
| Combo 5: siRNA + CpAM + NUC | Percentage of Participants With HBeAg Seroconversion in Baseline HBeAg-positive Participants | Week 48 | 0 percentage of participants |
| Combo 5: siRNA + CpAM + NUC | Percentage of Participants With HBeAg Seroconversion in Baseline HBeAg-positive Participants | FUW 12 | 0 percentage of participants |
| Combo 5: siRNA + CpAM + NUC | Percentage of Participants With HBeAg Seroconversion in Baseline HBeAg-positive Participants | FUW 24 | 33.3 percentage of participants |
| Combo 5: siRNA + CpAM + NUC | Percentage of Participants With HBeAg Seroconversion in Baseline HBeAg-positive Participants | Week 12 | 14.3 percentage of participants |
| Combo 5: siRNA + CpAM + NUC | Percentage of Participants With HBeAg Seroconversion in Baseline HBeAg-positive Participants | Week 24 | 0 percentage of participants |
| Combo 6: siRNA + TLR7 Agonist + NUC | Percentage of Participants With HBeAg Seroconversion in Baseline HBeAg-positive Participants | Week 24 | 0 percentage of participants |
| Combo 6: siRNA + TLR7 Agonist + NUC | Percentage of Participants With HBeAg Seroconversion in Baseline HBeAg-positive Participants | FUW 12 | 11.1 percentage of participants |
| Combo 6: siRNA + TLR7 Agonist + NUC | Percentage of Participants With HBeAg Seroconversion in Baseline HBeAg-positive Participants | Week 36 | 10 percentage of participants |
| Combo 6: siRNA + TLR7 Agonist + NUC | Percentage of Participants With HBeAg Seroconversion in Baseline HBeAg-positive Participants | FUW 24 | 11.1 percentage of participants |
| Combo 6: siRNA + TLR7 Agonist + NUC | Percentage of Participants With HBeAg Seroconversion in Baseline HBeAg-positive Participants | FUW 48 | 33.3 percentage of participants |
| Combo 6: siRNA + TLR7 Agonist + NUC | Percentage of Participants With HBeAg Seroconversion in Baseline HBeAg-positive Participants | FUW 36 | 11.1 percentage of participants |
| Combo 6: siRNA + TLR7 Agonist + NUC | Percentage of Participants With HBeAg Seroconversion in Baseline HBeAg-positive Participants | Week 12 | 0 percentage of participants |
| Combo 6: siRNA + TLR7 Agonist + NUC | Percentage of Participants With HBeAg Seroconversion in Baseline HBeAg-positive Participants | Week 48 | 10 percentage of participants |
| Combo 7: siRNA + PD-L1 LNA + NUC | Percentage of Participants With HBeAg Seroconversion in Baseline HBeAg-positive Participants | Week 12 | 0 percentage of participants |
| Combo 7: siRNA + PD-L1 LNA + NUC | Percentage of Participants With HBeAg Seroconversion in Baseline HBeAg-positive Participants | FUW 12 | 0 percentage of participants |
| Combo 7: siRNA + PD-L1 LNA + NUC | Percentage of Participants With HBeAg Seroconversion in Baseline HBeAg-positive Participants | FUW 24 | 0 percentage of participants |
| Combo 7: siRNA + PD-L1 LNA + NUC | Percentage of Participants With HBeAg Seroconversion in Baseline HBeAg-positive Participants | FUW 36 | 0 percentage of participants |
| Combo 7: siRNA + PD-L1 LNA + NUC | Percentage of Participants With HBeAg Seroconversion in Baseline HBeAg-positive Participants | Week 24 | 0 percentage of participants |
| Combo 7: siRNA + PD-L1 LNA + NUC | Percentage of Participants With HBeAg Seroconversion in Baseline HBeAg-positive Participants | FUW 48 | 0 percentage of participants |
| Combo 8: siRNA + PD-L1 LNA + NUC | Percentage of Participants With HBeAg Seroconversion in Baseline HBeAg-positive Participants | Week 24 | 0 percentage of participants |
| Combo 8: siRNA + PD-L1 LNA + NUC | Percentage of Participants With HBeAg Seroconversion in Baseline HBeAg-positive Participants | Week 12 | 0 percentage of participants |
| Combo 8: siRNA + PD-L1 LNA + NUC | Percentage of Participants With HBeAg Seroconversion in Baseline HBeAg-positive Participants | FUW 12 | 0 percentage of participants |
| Combo 8: siRNA + PD-L1 LNA + NUC | Percentage of Participants With HBeAg Seroconversion in Baseline HBeAg-positive Participants | FUW 36 | 0 percentage of participants |
| Combo 8: siRNA + PD-L1 LNA + NUC | Percentage of Participants With HBeAg Seroconversion in Baseline HBeAg-positive Participants | FUW 24 | 0 percentage of participants |
| Combo 8: siRNA + PD-L1 LNA + NUC | Percentage of Participants With HBeAg Seroconversion in Baseline HBeAg-positive Participants | Week 36 | 0 percentage of participants |
Secondary
Percentage of Participants With HBsAg Loss
HBsAg loss was defined as quantitative HBsAg \<0.05 IU/mL. The percentage of participants with HBsAg loss was calculated as number of participants with HBsAg loss / total number of participants \*100. 95% CI was calculated using the Clopper-Pearson method. Percentages have been rounded off.
Time frame: Combos 1 and 5: Weeks 24, 36, 48 and FUW 48; Combos 2, 3, 4, 6 and NUC Arm: Week 48 and FUW 48; Combo 7: Week 24; Combo 8: Week 36
Population: mITT population included participants who were randomized and received at least one dose of each drug for their assigned treatment regimen. Overall number analyzed included participants with data available for analysis. Number analyzed included participants with data available for analysis at that specified timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| NUC Control Arm | Percentage of Participants With HBsAg Loss | Week 48 | 0 percentage of participants |
| NUC Control Arm | Percentage of Participants With HBsAg Loss | FUW 48 | 2.9 percentage of participants |
| Combo 1: CpAM + TLR7 Agonist + NUC | Percentage of Participants With HBsAg Loss | Week 48 | 0 percentage of participants |
| Combo 1: CpAM + TLR7 Agonist + NUC | Percentage of Participants With HBsAg Loss | FUW 48 | 0 percentage of participants |
| Combo 1: CpAM + TLR7 Agonist + NUC | Percentage of Participants With HBsAg Loss | Week 36 | 0 percentage of participants |
| Combo 1: CpAM + TLR7 Agonist + NUC | Percentage of Participants With HBsAg Loss | Week 24 | 0 percentage of participants |
| Combo 2: siRNA (100 mg) + NUC | Percentage of Participants With HBsAg Loss | Week 48 | 6.7 percentage of participants |
| Combo 2: siRNA (100 mg) + NUC | Percentage of Participants With HBsAg Loss | FUW 48 | 10 percentage of participants |
| Combo 3: siRNA (200 mg) + NUC | Percentage of Participants With HBsAg Loss | Week 48 | 3.3 percentage of participants |
| Combo 3: siRNA (200 mg) + NUC | Percentage of Participants With HBsAg Loss | FUW 48 | 0 percentage of participants |
| Combo 4: siRNA + PEG-IFN + NUC | Percentage of Participants With HBsAg Loss | Week 48 | 30 percentage of participants |
| Combo 4: siRNA + PEG-IFN + NUC | Percentage of Participants With HBsAg Loss | FUW 48 | 16.7 percentage of participants |
| Combo 5: siRNA + CpAM + NUC | Percentage of Participants With HBsAg Loss | Week 36 | 0 percentage of participants |
| Combo 5: siRNA + CpAM + NUC | Percentage of Participants With HBsAg Loss | Week 48 | 0 percentage of participants |
| Combo 5: siRNA + CpAM + NUC | Percentage of Participants With HBsAg Loss | Week 24 | 0 percentage of participants |
| Combo 5: siRNA + CpAM + NUC | Percentage of Participants With HBsAg Loss | FUW 48 | 0 percentage of participants |
| Combo 6: siRNA + TLR7 Agonist + NUC | Percentage of Participants With HBsAg Loss | FUW 48 | 11.8 percentage of participants |
| Combo 6: siRNA + TLR7 Agonist + NUC | Percentage of Participants With HBsAg Loss | Week 48 | 17.6 percentage of participants |
| Combo 7: siRNA + PD-L1 LNA + NUC | Percentage of Participants With HBsAg Loss | Week 24 | 6.1 percentage of participants |
| Combo 8: siRNA + PD-L1 LNA + NUC | Percentage of Participants With HBsAg Loss | Week 36 | 13.3 percentage of participants |
Comparison: Combo 7: Week 2495% CI: [-2, 14.5]
Comparison: Combo 8: Week 3695% CI: [1.2, 25.6]
Comparison: Combo 2: Week 4895% CI: [-2.1, 16.4]
Comparison: Combo 3: Week 4895% CI: [-3.1, 10]
Comparison: Combo 4: Week 4895% CI: [14.7, 47.6]
Comparison: Combo 6: Week 4895% CI: [5.4, 31.4]
Comparison: Combo 2: FUW 4895% CI: [-3.9, 20.1]
Comparison: Combo 3: FUW 4895% CI: [-8.1, 2.7]
Comparison: Combo 4: FUW 4895% CI: [0.4, 28.8]
Comparison: Combo 6: FUW 4895% CI: [-2.5, 21.5]
Secondary
Percentage of Participants With HBsAg Seroconversion
HBsAg seroconversion was defined as a quantitative HBsAg \< 0.05 IU/mL and a positive anti-HBs antibody (defined as per assay reactive threshold anti-HBs ≥10 IU/L). 95% CI was calculated using the Clopper-Pearson method. Percentages have been rounded off.
Time frame: Combos 1 and 5: Weeks 24, 36, 48, FUW 24 and FUW 48; Combos 2, 3, 4, 6 and NUC Arm: Week 48, FUW 24 and FUW 48; Combo 7: Week 24 and FUW 24; Combo 8: Week 36 and FUW 24
Population: mITT population included participants who were randomized and received at least one dose of each drug for their assigned treatment regimen. Overall number analyzed included participants with data available for analysis. Number analyzed included participants with data available for analysis at that specified timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| NUC Control Arm | Percentage of Participants With HBsAg Seroconversion | FUW 48 | 2.9 percentage of participants |
| NUC Control Arm | Percentage of Participants With HBsAg Seroconversion | Week 48 | 0 percentage of participants |
| NUC Control Arm | Percentage of Participants With HBsAg Seroconversion | FUW 24 | 0 percentage of participants |
| Combo 1: CpAM + TLR7 Agonist + NUC | Percentage of Participants With HBsAg Seroconversion | Week 24 | 0 percentage of participants |
| Combo 1: CpAM + TLR7 Agonist + NUC | Percentage of Participants With HBsAg Seroconversion | Week 36 | 0 percentage of participants |
| Combo 1: CpAM + TLR7 Agonist + NUC | Percentage of Participants With HBsAg Seroconversion | Week 48 | 0 percentage of participants |
| Combo 1: CpAM + TLR7 Agonist + NUC | Percentage of Participants With HBsAg Seroconversion | FUW 24 | 0 percentage of participants |
| Combo 1: CpAM + TLR7 Agonist + NUC | Percentage of Participants With HBsAg Seroconversion | FUW 48 | 0 percentage of participants |
| Combo 2: siRNA (100 mg) + NUC | Percentage of Participants With HBsAg Seroconversion | FUW 24 | 3.3 percentage of participants |
| Combo 2: siRNA (100 mg) + NUC | Percentage of Participants With HBsAg Seroconversion | Week 48 | 3.3 percentage of participants |
| Combo 2: siRNA (100 mg) + NUC | Percentage of Participants With HBsAg Seroconversion | FUW 48 | 3.3 percentage of participants |
| Combo 3: siRNA (200 mg) + NUC | Percentage of Participants With HBsAg Seroconversion | FUW 24 | 0 percentage of participants |
| Combo 3: siRNA (200 mg) + NUC | Percentage of Participants With HBsAg Seroconversion | Week 48 | 0 percentage of participants |
| Combo 3: siRNA (200 mg) + NUC | Percentage of Participants With HBsAg Seroconversion | FUW 48 | 0 percentage of participants |
| Combo 4: siRNA + PEG-IFN + NUC | Percentage of Participants With HBsAg Seroconversion | FUW 48 | 16.7 percentage of participants |
| Combo 4: siRNA + PEG-IFN + NUC | Percentage of Participants With HBsAg Seroconversion | Week 48 | 23.3 percentage of participants |
| Combo 4: siRNA + PEG-IFN + NUC | Percentage of Participants With HBsAg Seroconversion | FUW 24 | 20 percentage of participants |
| Combo 5: siRNA + CpAM + NUC | Percentage of Participants With HBsAg Seroconversion | Week 48 | 0 percentage of participants |
| Combo 5: siRNA + CpAM + NUC | Percentage of Participants With HBsAg Seroconversion | FUW 24 | 0 percentage of participants |
| Combo 5: siRNA + CpAM + NUC | Percentage of Participants With HBsAg Seroconversion | Week 24 | 0 percentage of participants |
| Combo 5: siRNA + CpAM + NUC | Percentage of Participants With HBsAg Seroconversion | Week 36 | 0 percentage of participants |
| Combo 5: siRNA + CpAM + NUC | Percentage of Participants With HBsAg Seroconversion | FUW 48 | 0 percentage of participants |
| Combo 6: siRNA + TLR7 Agonist + NUC | Percentage of Participants With HBsAg Seroconversion | Week 48 | 0 percentage of participants |
| Combo 6: siRNA + TLR7 Agonist + NUC | Percentage of Participants With HBsAg Seroconversion | FUW 48 | 5.9 percentage of participants |
| Combo 6: siRNA + TLR7 Agonist + NUC | Percentage of Participants With HBsAg Seroconversion | FUW 24 | 3.1 percentage of participants |
| Combo 7: siRNA + PD-L1 LNA + NUC | Percentage of Participants With HBsAg Seroconversion | FUW 24 | 0 percentage of participants |
| Combo 7: siRNA + PD-L1 LNA + NUC | Percentage of Participants With HBsAg Seroconversion | Week 24 | 0 percentage of participants |
| Combo 8: siRNA + PD-L1 LNA + NUC | Percentage of Participants With HBsAg Seroconversion | Week 36 | 0 percentage of participants |
| Combo 8: siRNA + PD-L1 LNA + NUC | Percentage of Participants With HBsAg Seroconversion | FUW 24 | 0 percentage of participants |
Secondary
Percentage of Participants With Hepatitis B Early Antigen (HBeAg) Loss in Baseline HBeAg-positive Participants
HBeAg loss was defined as negative /non-reactive HBeAg level. Percentages have been rounded off.
Time frame: Weeks 12, 24, 36, and 48; FUW 12, 24, 36, and 48
Population: mITT population included participants who were randomized and received at least one dose of each drug for their assigned treatment regimen. Overall number analyzed included participants from the mITT population who were positive for HBeAg at baseline. Number analyzed included participants with data available for analysis at that specified timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| NUC Control Arm | Percentage of Participants With Hepatitis B Early Antigen (HBeAg) Loss in Baseline HBeAg-positive Participants | FUW 36 | 12.5 percentage of participants |
| NUC Control Arm | Percentage of Participants With Hepatitis B Early Antigen (HBeAg) Loss in Baseline HBeAg-positive Participants | FUW 12 | 16.7 percentage of participants |
| NUC Control Arm | Percentage of Participants With Hepatitis B Early Antigen (HBeAg) Loss in Baseline HBeAg-positive Participants | FUW 24 | 14.3 percentage of participants |
| NUC Control Arm | Percentage of Participants With Hepatitis B Early Antigen (HBeAg) Loss in Baseline HBeAg-positive Participants | Week 48 | 12.5 percentage of participants |
| NUC Control Arm | Percentage of Participants With Hepatitis B Early Antigen (HBeAg) Loss in Baseline HBeAg-positive Participants | Week 36 | 14.3 percentage of participants |
| NUC Control Arm | Percentage of Participants With Hepatitis B Early Antigen (HBeAg) Loss in Baseline HBeAg-positive Participants | Week 24 | 0 percentage of participants |
| NUC Control Arm | Percentage of Participants With Hepatitis B Early Antigen (HBeAg) Loss in Baseline HBeAg-positive Participants | Week 12 | 0 percentage of participants |
| NUC Control Arm | Percentage of Participants With Hepatitis B Early Antigen (HBeAg) Loss in Baseline HBeAg-positive Participants | FUW 48 | 14.3 percentage of participants |
| Combo 1: CpAM + TLR7 Agonist + NUC | Percentage of Participants With Hepatitis B Early Antigen (HBeAg) Loss in Baseline HBeAg-positive Participants | Week 12 | 0 percentage of participants |
| Combo 1: CpAM + TLR7 Agonist + NUC | Percentage of Participants With Hepatitis B Early Antigen (HBeAg) Loss in Baseline HBeAg-positive Participants | FUW 36 | 0 percentage of participants |
| Combo 1: CpAM + TLR7 Agonist + NUC | Percentage of Participants With Hepatitis B Early Antigen (HBeAg) Loss in Baseline HBeAg-positive Participants | FUW 48 | 25 percentage of participants |
| Combo 1: CpAM + TLR7 Agonist + NUC | Percentage of Participants With Hepatitis B Early Antigen (HBeAg) Loss in Baseline HBeAg-positive Participants | Week 24 | 0 percentage of participants |
| Combo 1: CpAM + TLR7 Agonist + NUC | Percentage of Participants With Hepatitis B Early Antigen (HBeAg) Loss in Baseline HBeAg-positive Participants | Week 36 | 0 percentage of participants |
| Combo 1: CpAM + TLR7 Agonist + NUC | Percentage of Participants With Hepatitis B Early Antigen (HBeAg) Loss in Baseline HBeAg-positive Participants | Week 48 | 20 percentage of participants |
| Combo 1: CpAM + TLR7 Agonist + NUC | Percentage of Participants With Hepatitis B Early Antigen (HBeAg) Loss in Baseline HBeAg-positive Participants | FUW 12 | 0 percentage of participants |
| Combo 1: CpAM + TLR7 Agonist + NUC | Percentage of Participants With Hepatitis B Early Antigen (HBeAg) Loss in Baseline HBeAg-positive Participants | FUW 24 | 0 percentage of participants |
| Combo 2: siRNA (100 mg) + NUC | Percentage of Participants With Hepatitis B Early Antigen (HBeAg) Loss in Baseline HBeAg-positive Participants | Week 36 | 44.4 percentage of participants |
| Combo 2: siRNA (100 mg) + NUC | Percentage of Participants With Hepatitis B Early Antigen (HBeAg) Loss in Baseline HBeAg-positive Participants | Week 12 | 22.2 percentage of participants |
| Combo 2: siRNA (100 mg) + NUC | Percentage of Participants With Hepatitis B Early Antigen (HBeAg) Loss in Baseline HBeAg-positive Participants | Week 48 | 44.4 percentage of participants |
| Combo 2: siRNA (100 mg) + NUC | Percentage of Participants With Hepatitis B Early Antigen (HBeAg) Loss in Baseline HBeAg-positive Participants | Week 24 | 37.5 percentage of participants |
| Combo 2: siRNA (100 mg) + NUC | Percentage of Participants With Hepatitis B Early Antigen (HBeAg) Loss in Baseline HBeAg-positive Participants | FUW 48 | 33.3 percentage of participants |
| Combo 2: siRNA (100 mg) + NUC | Percentage of Participants With Hepatitis B Early Antigen (HBeAg) Loss in Baseline HBeAg-positive Participants | FUW 36 | 12.5 percentage of participants |
| Combo 2: siRNA (100 mg) + NUC | Percentage of Participants With Hepatitis B Early Antigen (HBeAg) Loss in Baseline HBeAg-positive Participants | FUW 24 | 12.5 percentage of participants |
| Combo 2: siRNA (100 mg) + NUC | Percentage of Participants With Hepatitis B Early Antigen (HBeAg) Loss in Baseline HBeAg-positive Participants | FUW 12 | 42.9 percentage of participants |
| Combo 3: siRNA (200 mg) + NUC | Percentage of Participants With Hepatitis B Early Antigen (HBeAg) Loss in Baseline HBeAg-positive Participants | Week 36 | 25 percentage of participants |
| Combo 3: siRNA (200 mg) + NUC | Percentage of Participants With Hepatitis B Early Antigen (HBeAg) Loss in Baseline HBeAg-positive Participants | FUW 24 | 50 percentage of participants |
| Combo 3: siRNA (200 mg) + NUC | Percentage of Participants With Hepatitis B Early Antigen (HBeAg) Loss in Baseline HBeAg-positive Participants | Week 48 | 62.5 percentage of participants |
| Combo 3: siRNA (200 mg) + NUC | Percentage of Participants With Hepatitis B Early Antigen (HBeAg) Loss in Baseline HBeAg-positive Participants | FUW 36 | 50 percentage of participants |
| Combo 3: siRNA (200 mg) + NUC | Percentage of Participants With Hepatitis B Early Antigen (HBeAg) Loss in Baseline HBeAg-positive Participants | FUW 48 | 50 percentage of participants |
| Combo 3: siRNA (200 mg) + NUC | Percentage of Participants With Hepatitis B Early Antigen (HBeAg) Loss in Baseline HBeAg-positive Participants | Week 12 | 50 percentage of participants |
| Combo 3: siRNA (200 mg) + NUC | Percentage of Participants With Hepatitis B Early Antigen (HBeAg) Loss in Baseline HBeAg-positive Participants | Week 24 | 50 percentage of participants |
| Combo 3: siRNA (200 mg) + NUC | Percentage of Participants With Hepatitis B Early Antigen (HBeAg) Loss in Baseline HBeAg-positive Participants | FUW 12 | 62.5 percentage of participants |
| Combo 4: siRNA + PEG-IFN + NUC | Percentage of Participants With Hepatitis B Early Antigen (HBeAg) Loss in Baseline HBeAg-positive Participants | FUW 24 | 36.4 percentage of participants |
| Combo 4: siRNA + PEG-IFN + NUC | Percentage of Participants With Hepatitis B Early Antigen (HBeAg) Loss in Baseline HBeAg-positive Participants | FUW 12 | 54.5 percentage of participants |
| Combo 4: siRNA + PEG-IFN + NUC | Percentage of Participants With Hepatitis B Early Antigen (HBeAg) Loss in Baseline HBeAg-positive Participants | Week 48 | 54.5 percentage of participants |
| Combo 4: siRNA + PEG-IFN + NUC | Percentage of Participants With Hepatitis B Early Antigen (HBeAg) Loss in Baseline HBeAg-positive Participants | FUW 48 | 27.3 percentage of participants |
| Combo 4: siRNA + PEG-IFN + NUC | Percentage of Participants With Hepatitis B Early Antigen (HBeAg) Loss in Baseline HBeAg-positive Participants | Week 24 | 41.7 percentage of participants |
| Combo 4: siRNA + PEG-IFN + NUC | Percentage of Participants With Hepatitis B Early Antigen (HBeAg) Loss in Baseline HBeAg-positive Participants | Week 12 | 33.3 percentage of participants |
| Combo 4: siRNA + PEG-IFN + NUC | Percentage of Participants With Hepatitis B Early Antigen (HBeAg) Loss in Baseline HBeAg-positive Participants | FUW 36 | 27.3 percentage of participants |
| Combo 4: siRNA + PEG-IFN + NUC | Percentage of Participants With Hepatitis B Early Antigen (HBeAg) Loss in Baseline HBeAg-positive Participants | Week 36 | 55.6 percentage of participants |
| Combo 5: siRNA + CpAM + NUC | Percentage of Participants With Hepatitis B Early Antigen (HBeAg) Loss in Baseline HBeAg-positive Participants | FUW 12 | 33.3 percentage of participants |
| Combo 5: siRNA + CpAM + NUC | Percentage of Participants With Hepatitis B Early Antigen (HBeAg) Loss in Baseline HBeAg-positive Participants | Week 48 | 50 percentage of participants |
| Combo 5: siRNA + CpAM + NUC | Percentage of Participants With Hepatitis B Early Antigen (HBeAg) Loss in Baseline HBeAg-positive Participants | Week 24 | 50 percentage of participants |
| Combo 5: siRNA + CpAM + NUC | Percentage of Participants With Hepatitis B Early Antigen (HBeAg) Loss in Baseline HBeAg-positive Participants | FUW 24 | 66.7 percentage of participants |
| Combo 5: siRNA + CpAM + NUC | Percentage of Participants With Hepatitis B Early Antigen (HBeAg) Loss in Baseline HBeAg-positive Participants | Week 12 | 28.6 percentage of participants |
| Combo 6: siRNA + TLR7 Agonist + NUC | Percentage of Participants With Hepatitis B Early Antigen (HBeAg) Loss in Baseline HBeAg-positive Participants | Week 36 | 50 percentage of participants |
| Combo 6: siRNA + TLR7 Agonist + NUC | Percentage of Participants With Hepatitis B Early Antigen (HBeAg) Loss in Baseline HBeAg-positive Participants | FUW 12 | 44.4 percentage of participants |
| Combo 6: siRNA + TLR7 Agonist + NUC | Percentage of Participants With Hepatitis B Early Antigen (HBeAg) Loss in Baseline HBeAg-positive Participants | FUW 48 | 44.4 percentage of participants |
| Combo 6: siRNA + TLR7 Agonist + NUC | Percentage of Participants With Hepatitis B Early Antigen (HBeAg) Loss in Baseline HBeAg-positive Participants | Week 48 | 50 percentage of participants |
| Combo 6: siRNA + TLR7 Agonist + NUC | Percentage of Participants With Hepatitis B Early Antigen (HBeAg) Loss in Baseline HBeAg-positive Participants | Week 12 | 30 percentage of participants |
| Combo 6: siRNA + TLR7 Agonist + NUC | Percentage of Participants With Hepatitis B Early Antigen (HBeAg) Loss in Baseline HBeAg-positive Participants | FUW 24 | 44.4 percentage of participants |
| Combo 6: siRNA + TLR7 Agonist + NUC | Percentage of Participants With Hepatitis B Early Antigen (HBeAg) Loss in Baseline HBeAg-positive Participants | Week 24 | 28.6 percentage of participants |
| Combo 6: siRNA + TLR7 Agonist + NUC | Percentage of Participants With Hepatitis B Early Antigen (HBeAg) Loss in Baseline HBeAg-positive Participants | FUW 36 | 33.3 percentage of participants |
| Combo 7: siRNA + PD-L1 LNA + NUC | Percentage of Participants With Hepatitis B Early Antigen (HBeAg) Loss in Baseline HBeAg-positive Participants | Week 12 | 11.1 percentage of participants |
| Combo 7: siRNA + PD-L1 LNA + NUC | Percentage of Participants With Hepatitis B Early Antigen (HBeAg) Loss in Baseline HBeAg-positive Participants | FUW 24 | 11.1 percentage of participants |
| Combo 7: siRNA + PD-L1 LNA + NUC | Percentage of Participants With Hepatitis B Early Antigen (HBeAg) Loss in Baseline HBeAg-positive Participants | FUW 48 | 0 percentage of participants |
| Combo 7: siRNA + PD-L1 LNA + NUC | Percentage of Participants With Hepatitis B Early Antigen (HBeAg) Loss in Baseline HBeAg-positive Participants | FUW 12 | 11.1 percentage of participants |
| Combo 7: siRNA + PD-L1 LNA + NUC | Percentage of Participants With Hepatitis B Early Antigen (HBeAg) Loss in Baseline HBeAg-positive Participants | FUW 36 | 0 percentage of participants |
| Combo 7: siRNA + PD-L1 LNA + NUC | Percentage of Participants With Hepatitis B Early Antigen (HBeAg) Loss in Baseline HBeAg-positive Participants | Week 24 | 11.1 percentage of participants |
| Combo 8: siRNA + PD-L1 LNA + NUC | Percentage of Participants With Hepatitis B Early Antigen (HBeAg) Loss in Baseline HBeAg-positive Participants | Week 36 | 40 percentage of participants |
| Combo 8: siRNA + PD-L1 LNA + NUC | Percentage of Participants With Hepatitis B Early Antigen (HBeAg) Loss in Baseline HBeAg-positive Participants | FUW 12 | 20 percentage of participants |
| Combo 8: siRNA + PD-L1 LNA + NUC | Percentage of Participants With Hepatitis B Early Antigen (HBeAg) Loss in Baseline HBeAg-positive Participants | Week 24 | 40 percentage of participants |
| Combo 8: siRNA + PD-L1 LNA + NUC | Percentage of Participants With Hepatitis B Early Antigen (HBeAg) Loss in Baseline HBeAg-positive Participants | Week 12 | 40 percentage of participants |
| Combo 8: siRNA + PD-L1 LNA + NUC | Percentage of Participants With Hepatitis B Early Antigen (HBeAg) Loss in Baseline HBeAg-positive Participants | FUW 36 | 66.7 percentage of participants |
| Combo 8: siRNA + PD-L1 LNA + NUC | Percentage of Participants With Hepatitis B Early Antigen (HBeAg) Loss in Baseline HBeAg-positive Participants | FUW 24 | 60 percentage of participants |