Hepatitis B, Chronic
Conditions
Brief summary
The purpose of this study is to evaluate the efficacy of a treatment regimen of JNJ-73763989 + pegylated interferon alpha-2a (PegIFN-alpha-2a) + nucleos(t)ide analog (NA).
Detailed description
Hepatitis B virus (HBV) is a small deoxyribonucleic acid virus that specifically infects the human liver. The acute phase of infection is either followed by an immune controlled state or progresses to chronic hepatitis B. The worldwide estimated prevalence of chronic HBV infection is about 292 million people affected. Hepatitis B surface antigen (HBsAg) seroclearance is currently considered to be associated with the most thorough suppression of HBV replication (termed functional cure). With current available NA treatment strategies, rate of HBsAg seroclearance remains very low (around 3 percent \[%\]) even under long-term treatment. Also, with the persistently high global prevalence of HBV-associated mortality, there is a medical need for more effective finite treatment options that lead to sustained HBsAg seroclearance. JNJ-73763989 is a liver-targeted antiviral therapeutic for subcutaneous injection designed to treat chronic HBV infection via a ribonucleic acid interference (RNAi) mechanism. JNJ-56136379 is an orally administered capsid assembly modulator (CAM) that is being developed for the treatment of chronic HBV infection. The aim of the study is to evaluate the efficacy of a treatment regimen of JNJ-73763989 + PegIFN-alpha-2a + NA with or without JNJ-56136379 in participants with hepatitis B e antigen (HBeAg) positive chronic infection. The study will be conducted in 4 phases: a screening phase, an induction phase with flexible duration, a consolidation phase with or without PegIFN-α2a and a follow-up phase. Safety assessments will include Adverse Events (AEs), serious AEs of the study interventions, clinical laboratory tests, Electrocardiograms (ECGs), vital signs, and physical examinations. The study title reflects the original study design and JNJ-56136379 (JNJ-6379) was initially part of the study intervention but was discontinued as per amendment 6 of the study.
Interventions
DRUGJNJ-73763989
JNJ-73763989 injection will be administered subcutaneously.
DRUGPegIFN-alpha-2a
PegIFN-alpha-2a injection will be administered subcutaneously.
DRUGTenofovir disoproxil
Tenofovir disoproxil film-coated tablet will be administered orally.
DRUGTenofovir alafenamide
Tenofovir alafenamide film-coated tablet will be administered orally.
DRUGJNJ-56136379
JNJ-56136379 will be administered orally.
Sponsors
Janssen Research & Development, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Medically stable based on physical examination, medical history, vital signs, laboratory values, and 12-lead Electrocardiogram (ECG) at screening * Currently not treated chronic hepatitis B virus (HBV) infection with alanine transaminase (ALT) less than (\<) 2\* upper limit of normal (ULN) at screening and HBV deoxyribonucleic acid (DNA) greater than or equal to (\>=) 20,000 international units per milliliter (IU/mL) * Body mass index (BMI) between 18.0 and 35.0 kilogram per meter square (kg/m\^2), extremes included * Liver fibrosis stage 0-2 (Metavir) or Fibroscan less than or equal to (\<=) 9 Kilopascal (kPa) at screening
Exclusion criteria
* Evidence of infection with hepatitis A, C, D or E virus infection or evidence of human immunodeficiency, virus type 1 (HIV-1) or HIV-2 infection at screening * History or evidence of clinical signs or symptoms of hepatic decompensation, including but not limited to: portal hypertension, ascites, hepatic encephalopathy, esophageal varices * Evidence of liver disease of non-HBV etiology * Participants with a history of malignancy within 5 years before screening * Participants who had or planned major surgery, (example, requiring general anesthesia) or who have received an organ transplant * Contraindications to the use of PegIFN-α2a
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Functional Cure: Hepatitis B Surface Antigen (HBsAg) Seroclearance at 24 Weeks After Stopping All Study Interventions at the End of Consolidation Phase (CP) and Without Restarting Nucleos(t)Ide Analog (NA) Treatment | At follow-up (FU) phase Week 24 | Percentage of participants with functional cure (defined as percentage of participants with HBsAg seroclearance at 24 weeks after stopping all study interventions at the end of consolidation phase and without restarting NA treatment) were reported. Seroclearance HBsAg was defined as a (quantitative) HBsAg level \<lower limit of quantification (LLOQ; \<0.05 international units per milliliter \[IU/mL\]). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs) | IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2]) | Number of participants with TESAEs were reported. was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the study intervention. Treatment-emergent AEs are all AEs with an onset on or after the first administration of study treatment or any ongoing event that worsened in severity, intensity or frequency after the first administration of study treatment. A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. |
| Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2]) | Clinical laboratory test parameters were Hematology: absolute lymphocyte count, absolute neutrophil count (ANC), hemoglobin, Neutrophils Band Form, Neutrophils segmented, white blood cells (WBC) decreased, ; Chemistry: alanine aminotransferase (ALT) & serum glutamic pyruvic transaminase (SGPT), aspartate aminotransferase(AST)/serum glutamic oxaloacetic transaminase (SGOT), cholesterol (fasting), creatinine Kinase, creatinine, GFR from Creatinine Adjusted for BSA, GFR from Cystatin C Adjusted for BSA, low-density lipoprotein (LDL), triglycerides (fasting); Urinalysis: glycosuria. DAIDS toxicity grades: Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe), Grade 4 (Potentially Life-Threatening). Number of participants with treatment-emergent DAIDS toxicity Grade 3 or 4 were reported in this outcome measure. |
| Number of Participants With Worst Treatment-emergent Abnormality in Electrocardiogram (ECGs) | IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2]) | Number of participants with worst treatment-emergent abnormality in ECG were reported. Treatment-emergent abnormality was defined as the abnormalities that were worsened as compared to the abnormality at baseline; which also included the shift from abnormally high to abnormally low and vice-versa. ECG parameters included heart rate (HR; abnormally low, HR \<45 beats per minute (bpm) and (abnormally high HR\>=120 bpm; PR interval abnormally high \>220 milliseconds (ms): QRS interval abnormally high \>=120 ms; QT corrected (Fridericia QTcF) categories; borderline prolonged QTc interval \<450 to \<=480 ms), prolonged QTc interval \<480 to \<=500 ms) and pathologically prolonged QTc interval \>500 ms). |
| Number of Participants With Worst Treatment-emergent Abnormalities in Vital Signs | IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2]) | Number of participants with worst treatment-emergent abnormalities in vital signs were reported. Treatment-emergent abnormality was defined as the abnormalities that were worsened as compared to the abnormality at baseline; which also included the shift from abnormally high to abnormally low and vice-versa. Abnormalities in vital signs included abnormal pulse rate (PR); abnormally low, \<=45 bpm and abnormally high \>=120 bpm; diastolic blood pressure (DBP) abnormally low \<=50 mmHg, systolic blood pressure (SBP) abnormally low \<=90 mmHg. Additionally, abnormal low SBP and DBP were \<=50 mmHg and \<+90 mmHg. Only those categories in which at least one participant had data were reported. |
| Number of Participants With Clinically Important Abnormalities in Physical Examination | IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2]) | Number of participants with clinically important treatment-emergent abnormalities in physical examination were reported. |
| Percentage of Participants Who Reached HBsAg Less Than (<) 10 (International Units Per Milliliter [IU/mL]) at the End of the Induction Phase (EOI) | At IP Week 36 and EOI; anytime up to IP Week 52 for Cohort 1; up to IP Week 36 for Cohort 2 | Percentage of participants who reached HBsAg \<10 IU/mL at the end induction phase were reported. |
| Time to Achieve First Occurrence of HBsAg <10 IU/mL | From Baseline (Day 1 of IP) up to Follow-up phase Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2]) | Time to achieve first occurrence of HBsAg \<10 IU/mL were reported. Time to HBsAg \<10 IU/mL was defined as the number of days between the date of first study treatment intake and the date of the first occurrence of HBsAg \<10 IU/mL. Kaplan-Meier method was used for the estimation. |
| Percentage of Participants Who Met Nucleos(t)Ide Analog (NA) Treatment Completion Criteria at the End of Consolidation Phase | At CP Week 12 (for Cohort 1 and 2) | Percentage of participants meeting the protocol-defined NA treatment completion criteria at end of consolidation were reported. NA treatment completion criteria at CP Week 12 was defined as HBsAg \<10 IU/mL; HBeAg-negative; HBV DNA \<20 IU/mL, (that is, LLOQ); alanine aminotransferase(ALT) \<3\*ULN. |
| FU Phase: Percentage of Participants With HBsAg Seroclearance 48 Weeks After Stopping All Study Interventions of the Consolidation Phase and Without Restarting NA Treatment During Follow up Phase | FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2]) | Percentage of participants with HBsAg seroclearance 48 weeks after stopping all study interventions at the consolidation phase and without restarting NA treatment during follow up phase were reported. HBsAg seroclearance was defined as (quantitative) HBsAg \< LLOQ (HBsAg 0.05 IU/mL). |
| FU Phase: Percentage of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) <LLOQ 48 Weeks After Stopping All Study Interventions of the Consolidation Phase and Without Restarting NA Treatment During Follow up Phase | FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2]) | Percentage of participants with HBV DNA \<LLOQ (\<20 IU/mL) 48 weeks after stopping all study interventions of the consolidation phase and without restarting NA treatment during follow up phase were reported. |
| FU Phase: Number of Participants With Off-treatment Virologic HBV Flares During Follow up Phase | FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2]) | Number of participants with off-treatment virologic HBV flares were reported. Virologic flare was defined as confirmed HBV DNA \>peak threshold (lowest peak to qualify as virologic flare was HBV DNA \>200 IU/mL) in participants who were off-treatment and had HBV DNA \<LLOQ (\<20 IU/mL) at the last observed time point on all study treatments. The 3 thresholds of virologic flare was 20,000 IU/mL, 2,000 IU/mL and 200 IU/mL. Confirmed means that the criteria was fulfilled at 2 or more consecutive time points or at the last observed time point. Off-treatment was defined as the time period after stopping all study treatments (including NA). |
| FU Phase: Number of Participants With Off-treatment Biochemical HBV Flares During Follow-up Phase | FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2]) | Number of participants with off-treatment biochemical HBV flares were reported. Biochemical flare was defined as first date of 2 consecutive visits with confirmed ALT and/or AST \>=3\*ULN and \>=3\*nadir (lowest value observed up to start of flare). Confirmed means that the criteria was fulfilled at 2 or more consecutive time points or at the last observed time point. Off-treatment was defined as the time period after stopping all study treatments (including NA). |
| FU Phase: Number of Participants With On-treatment Biochemical Flares During Follow-up Phase | FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2]) | Number of participants with on-treatment biochemical HBV flares were reported. Biochemical flare was defined as first date of 2 consecutive visits with confirmed ALT and/or AST \>=3\*ULN and \>=3\*nadir (lowest value observed up to start of flare). Confirmed means that the criteria was fulfilled at 2 or more consecutive time points or at the last observed time point. On-treatment was defined as the time period during which the participant received any of the study drugs. |
| FU Phase: Number of Participants With Off-treatment Clinical Flares During Follow-up Phase | FU phase: FU Week 1 up to FU Week 48(up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2]) | Clinical flares occurred either when a virologic flare (confirmed HBV DNA \>peak threshold) & biochemical flare (ALT and/or AST \>=3\*ULN & \>=3\*nadir \[lowest value observed during off-treatment period up to time point of meeting the flare criteria\]) overlapped in time or when a biochemical flare started within 4 weeks following the end of a virologic flare. The HBV DNA thresholds were: 20,000 IU/mL, 2,000 IU/mL and 200 IU/mL. Confirmed means that criteria was fulfilled at 2 or more consecutive time points or at last observed time point. Off-treatment was defined as time period after stopping all study drugs (including NA). The start date of a clinical flare was minimum start date of virologic flare and biochemical flare. |
| FU Phase: Percentage of Participants Who Required NA Re-treatment During Follow-Up Phase | FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2]) | Percentage of participants who required NA re-treatment during follow-up phase were reported. A responder was defined as a participant who met the criteria for NA re-treatment at any time during follow-up, for those participants who met the NA treatment completion criteria at any time during the study and actually stopped NA treatment. |
| FU Phase: Percentage of Participants Who Achieved Reduction (Sustained) in HBsAg Response (Per Definition 1) at Follow-up Week 48 | At FU Week 48 (Week 112 [Cohort 1]; Week 96 [Cohort 2]) | Percentage of participants with sustained (reduction) HBsAg response (per Definition 1) were reported. Sustained HBsAg response (definition 1) was defined as: For participants with FU Week 48 data: participants who had a \>1 log10 decline from baseline in HBsAg and HBsAg \<000 IU/mL at FU Week 48. For participants without FU Week 48 data: participants who had a HBsAg decline from baseline of \>2 log10 at FU Week 24 or \>1.5 log10 at FU Week 36 (most recent value used) and had HBsAg \<1000 IU/mL at the last available timepoint. |
| Percentage of Participants Who Achieved Reduction (Sustained) in HBsAg Response (Per Definition 2) at Follow-up Week 48 | At FU Week 48 (Week 112 [Cohort 1]; Week 96 [Cohort 2]) | Percentage of participants with sustained (reduction) HBsAg response (per Definition 2) were reported. Sustained HBsAg response (per Definition 2) was defined as: for participants with a \>1 log decline in HBsAg from baseline at last follow-up visit: Among the most recent three visits, the difference between log10 HBsAg at 2 of 3 last visit and 1 of 3 last visit was \<0.2, and the difference between log10 HBsAg at 3 of 3 last visit and 1 of 3 last visit was \<0.2. |
| Percentage of Participants Who Achieved Reduction (Sustained) in HBsAg Response (Per Definition 3) at Follow-up Week 48 | At FU Week 48 (Week 112 [Cohort 1]; Week 96 [Cohort 2]) | Percentage of participants with sustained (reduction) HBsAg response (per definition 3) were reported. Sustained HBsAg response (per Definition 3) was defined as: for participants with a \>1 log decline in HBsAg from baseline at last follow-up visit: Among the most recent three visits, the difference between log10 HBsAg at 2 of 3 last visit and 1 of 3 last visit was \<0.2, and the difference between log10 HBsAg at 3 of 3 last visit and 1 of 3 last visit was \<0.2 and had an HBsAg \<1000 IU/mL at the last available timepoint. |
| Percentage of Participants Who Achieved Reduction (Sustained) in HBsAg Response (Per Definition 4) at Follow-up Week 48 | At FU Week 48 (Week 112 [Cohort 1]; Week 96 [Cohort 2]) | Percentage of participants with sustained (reduction) HBsAg response per Definition 4 were reported. Sustained HBsAg response (per Definition 4) was defined as stable level, decreasing level, and increasing level. Stable level: when HBsAg change from consolidation week 12 to last available follow-up timepoint was within 0.2 log10. Decreasing level: when HBsAg change from consolidation week 12 to last available follow-up timepoint was less than -0.2 log10. Increasing level: when HBsAg change from consolidation week 12 to last available follow-up timepoint was more than 0.2 log10. |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2]) | Number of participants with TEAEs were reported. An adverse event (AE) was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the study intervention. Treatment-emergent AEs are all AEs with an onset on or after the first administration of study treatment or any ongoing event that worsened in severity, intensity or frequency after the first administration of study treatment. |
| Percentage of Participants With HBeAg Seroclearance at Follow-up Week 48 | At FU Week 48 (Week 112 [Cohort 1]; Week 96 [Cohort 2]) | Percentage of participants with HBeAg seroclearance were reported. HBeAg seroclearance was defined as (quantitative) HBeAg levels \<LLOQ (\<0.11 IU/mL). |
| Percentage of Participants With HBsAg Seroconversion | IP Week 24; CP: Week 12, FU phase: Week 48 (Week 112 [Cohort 1]; Week 96 [Cohort 2]) | Seroconversion of HBsAg was defined as having achieved HBsAg seroclearance (defined as quantitative HBsAg \<LLOQ \[\<0.05 IU/mL\]) and appearance of anti-HBs antibodies (defined as a baseline anti-HBs antibodies \[quantitative\] \<LLOQ \[\<5 milli-international units per milliliter (mIU/mL)\] and a post-baseline assessment \>=LLOQ \[\>=5 mIU/mL\]). |
| Time to Achieve First HBeAg Seroclearance | From Baseline (Day 1 of IP) to Follow-up Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2]) | Time to achieve first occurrence of HBeAg seroclearance (HBeAg \<LLOQ \[\<0.11 IU/mL\]) were reported. Time to first occurrence of the HBeAg seroclearance was defined as the number of days between the date of first study intervention intake and the date of the first occurrence of the HBeAg seroclearance. |
| Percentage of Participants With HBeAg Seroconversion | CP: Week 12; FU phase: FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2]) | Percentage of participants with HBeAg seroconversion were reported. Seroconversion of HBeAg was defined as having achieved HBeAg seroclearance (defined as \[quantitative\] HBeAg \<LLOQ \[\<0.11 IU/mL\]) together with appearance of anti-HBe antibodies (defined as a baseline anti-HBe antibodies \[qualitative\] with a negative result and a post-baseline assessment with positive result). |
| Change From Baseline Over Time in HBsAg Levels | Baseline (Day 1 of IP), IP: Week 36; CP: Week 12; FU phase: Week 48 (Week 112 [Cohort 1]; Week 96 [Cohort 2]) | Change from baseline over time in HBsAg levels at specified timepoints were reported |
| Change From Baseline Over Time in HBeAg Levels | Baseline (Day 1 of IP), IP: Week 36; CP: Week 12; FU phase: Week 48 (Week 112 [Cohort 1]; Week 96 [Cohort 2]) | Change from baseline over time in HBsAg levels at specified timepoints were reported. |
| Change From Baseline Over Time in HBV DNA Levels | Baseline (Day 1 of IP), IP: Week 36; CP: Week 12; FU phase: Week 48 (Week 112 [Cohort 1]; Week 96 [Cohort 2]) | Change from baseline over time in HBV DNA Levels at Specified Timepoints were reported. |
| Time to Achieve First HBsAg Seroclearance | From Baseline (Day 1 of IP) to Follow-up Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2]) | Time to achieve first HBsAg seroclearance (defined as quantitative HBsAg \<LLOQ; HBsAg \<0.05 IU/mL) were reported. Time to HBsAg seroclearance was defined as the number of days between the date of first study intervention intake and the date of the first occurrence of HBsAg seroclearance. Kaplan-Meier method was used for the estimation. |
| Time to Achieve First HBV DNA <LLOQ | From Baseline (Day 1 of IP) to Follow-up Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2]) | Time to achieve first occurrence of HBV DNA \< LLOQ (\<20 IU/mL) were reported. Time to first occurrence of the HBV DNA \< LLOQ was defined as the number of days between the date of first study intervention intake and the date of the first occurrence of the HBV DNA \< LLOQ. |
| Percentage of Participants With HBeAg Levels Below Different Cut-offs | IP: Week 36, CP: Week 12; FU phase: Week 48 (Week 112 [Cohort 1]; Week 96 [Cohort 2]) | Percentage of participants with HBeAg levels below different cut-offs were reported. The cut-offs for HBeAg levels were : \<LLOQ (\<0.11 IU/mL), \< 1 IU/mL, \< 10 IU/mL, \<100 IU/mL |
| Percentage of Participants With HBsAg Levels Below Different Cut-offs | IP: Week 36, CP: Week 12; FU phase: Week 48 (Week 112 [Cohort 1]; Week 96 [Cohort 2]) | Percentage of participants with HBsAg levels below different cut-offs were reported. The cut-offs for HBsAg level were: \<LLOQ (\<0.05 IU/mL), \<1 IU/mL, \<10 IU/mL, \<100 IU/mL, \<1000 IU/mL. |
| Percentage of Participants With HBV DNA Levels Below Different Cut-offs | IP: Week 36; CP: Week 12; FU phase: Week 48 (Week 112 [Cohort 1]; Week 96 [Cohort 2]) | Percentage of participants with HBV DNA levels below cut-offs were reported. The cut-offs for HBV DNA were as follows: \<LLOQ (\<20 IU/mL) for target detected and not detected, \< LLOQ for target not detected , and \< LLOQ for target detected, \<60 IU/mL, \<100 IU/mL, \<200 IU/mL, \<1000 IU/mL, \<2000 IU/mL, \<20000 IU/mL. |
| Percentage of Participants With Virologic Breakthrough | IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2]) | Percentage of participants with virologic breakthrough on treatment were reported. Virological breakthrough was defined as confirmed on-treatment HBV DNA increase by \>1 log10 IU/mL from nadir level (lowest level reached during treatment) in participants who did not have on-treatment HBV DNA level \< LLOQ (\<20 IU/mL) or confirmed on-treatment HBV DNA level \>200 IU/mL in participants who had on-treatment HBV DNA level \<LLOQ of the HBV DNA assay. Confirmed HBV DNA increase/level means that the criterion was fulfilled at 2 or more consecutive time points or at the last observed on-treatment time point. |
| Percentage of Participants Who Reached HBV DNA Undetectability After Re-start of NA Treatment During Follow-up | FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2]) | Percentage of participants who reached HBV DNA undetectability after re-start of NA treatment during follow-up were reported. Undetectability of HBV DNA was defined as HBV DNA\<LLOQ that is \<20 IU/mL. |
| Maximum Observed Plasma Concentration (Cmax) of JNJ-73763989 (Molecules: JNJ-73763976 [JNJ3976], JNJ-73763924 [JNJ-3924]) | IP : Predose (0 hour), post dose on 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours on IP Week 24; CP: Predose (0 hour), post dose on 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours on CP Week 8 | Cmax of JNJ-73763989 (molecules: JNJ-73763976 \[JNJ3976\], JNJ-73763924 \[JNJ-3924\]) were reported. Noncompartmental analysis were conducted to analyze Cmax JNJ-73763989 and its molecules |
| Time to Reach the Maximum Observed Plasma Concentration (Tmax) of JNJ-73763989 (Molecules: JNJ-73763976 [JNJ3976], JNJ-73763924 [JNJ-3924]) | IP : Predose (0 hour), post dose on 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours on IP Week 24; CP: Predose (0 hour), post dose on 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours on CP Week 8 | Time to reach the maximum observed plasma concentration (tmax) of JNJ-73763989 (molecules: JNJ-73763976 \[JNJ3976\], JNJ-73763924 \[JNJ-3924\]) were reported. Non-compartmental analysis were conducted to analyze tmax of JNJ-73763989 and its molecules. |
| Plasma Concentration 24 Hours After Administration (C24h) of JNJ-73763989 (Molecules: JNJ-73763976 [JNJ3976], JNJ-73763924 [JNJ-3924]) | IP: 24 hours post dose on Week 24 visit; CP: 24 hours post dose on Week 8 visit | Plasma concentration 24 hours after administration (C24h) of JNJ-73763989 (molecules: JNJ-73763976 \[JNJ3976\], JNJ-73763924 \[JNJ-3924\]) were reported. Non-compartmental analysis were conducted to analyze C24h of JNJ-73763989 and its molecules. |
| Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours [AUC (0- 24 Hours)] of JNJ-73763989 (Molecules: JNJ-73763976 [JNJ3976], JNJ-73763924 [JNJ-3924]) | IP: 24 hours post dose on Week 24 visit; CP: 24 hours post dose on Week 8 visit | Area under the plasma concentration-time curve from time zero to 24hours (AUC0 to 24h) of JNJ-73763989 (molecules:JNJ-73763976 \[JNJ3976\], JNJ-73763924 \[JNJ-3924\]) were reported. Non-compartmental analysis were conducted toanalyze AUC0 to 24h of JNJ-73763989 and its molecules. |
| Percentage of Participants With HBsAg Seroclearance at Follow-up Week 48 | At FU Week 48 (Week 112 [Cohort 1]; Week 96 [Cohort 2]) | Percentage of Participants with HBsAg Seroclearance were reported. HBsAg seroclearance was defined as (quantitative) HBsAg level \<LLOQ (\<0.05 IU/mL). |
Countries
Canada, France, Germany, Japan, Russia, Spain, Taiwan, Turkey (Türkiye), United Kingdom, United States
Participant flow
Recruitment details
Per protocol amendment (PA) 6, all participants stopped JNJ-56136379 (JNJ-6379) treatment and switched to single-arm study design: JNJ-73763989 (JNJ-3989) plus nucleos(t)ide analog (NA; tenofovir disoproxil/tenofovir Alafenamide) plus pegylated interferon alpha-2a (PegIFN-alpha-2a). The Study had of 3 phases: induction phase (IP), consolidation phase (CP) and follow-up (FU) phase.
Pre-assignment details
Response-guided treatment (RGT): Hepatitis B surface antigen (HBsAg) less than (\<) 10 international unit per millilitre (IU/mL). Post PA 5, RGT criterion was removed. Nucleos(t)ide (NA) treatment completion criteria: HBsAg \<10 IU/mL, HB envelop antigen (HBeAg)-negative, and HB virus deoxyribonucleic acid (HBV DNA) \<lower limit of quantification (LLOQ) and alanine aminotransferase (ALT) \<3\*upper limit of normal (ULN).
Participants by arm
| Arm | Count |
|---|---|
| Cohort 1: JNJ-3989 200 mg + JNJ-6379 250 mg+ NA (245/25 mg) + PegIFN-alpha-2a 180 mcg Prior to PA 5, participants enrolled in induction phase (IP) received JNJ-3989 200 milligrams (mg) subcutaneous (SC) injection once every 4 weeks (Q4W) + JNJ-6379 250 mg tablets orally once daily (QD) + NA (TDF 245 mg/TAF 25 mg) tablet orally QD for \>=36 to \<=52 weeks. Participants who met RGT criterion/reached 52 weeks were considered to complete IP and entered 12-week consolidation phase (CP) and randomized to JNJ-3989 + JNJ-6379 + NA or JNJ-3989+JNJ-6379 + NA + PegIFN-alpha-2a 180 micrograms (mcg) SC injection once weekly (QW). Post PA 5, participant who did not reach IP Week 36, started PegINF-alpha-2a at Week 36 for 12 weeks and who passed IP Week 36 and/or were randomized to CP without PegINF-alpha-2a, started pegINF-alpha-2a at their next visit. Per PA 6, JNJ-6379 treatment was stopped. Post CP Week 12, participants entered 48-week FU phase and stopped JNJ-3989+PegIFN-alpha-2a. If NA treatment completion criteria (HBsAg \<10 IU/mL, HBeAg negative, and HBV DNA \<LLOQ and ALT \<3\*ULN). was met at CP Week 12, NA was stopped at FU phase Week 2, if NA treatment completion criteria was not met, NA was continued till end of FU phase. | 27 |
| Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg In IP, participants (enrolled prior to PA 5) received JNJ-3989 200 mg SC injection for Q4W plus NA (tenofovir disoproxil 245 mg/tenofovir alafenamide 25 mg) tablets orally QD for \>=36 to \<=52 weeks. Per PA 5, the end of IP was fixed to Week 36 or to the next planned visit following implementation of PA 5. After completion of IP, all participants entered 12-week CP during which PegINF-alpha-2a 180 mcg SC injection QW was added to their treatment regimen for 12-weeks. After completion of 12-week CP, all participants entered the 48-week FU phase and stopped treatment with JNJ-3989 plus PegIFN-alpha-2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA was continued till the end of FU phase. | 8 |
| Cohort 2: JNJ-3989 200 mg+ NA (245/25 mg)+ PegIFNalpha-2a 180 mcg Participants enrolled as per PA 5 and 6 received JNJ-3989 200 mg SC injection for Q4W plus NA (tenofovir disoproxil 245 mg/tenofovir alafenamide 25 mg) tablet orally QD for 36 weeks in IP. After completion of IP, participants entered 12-week CP and received PegIFN-alpha-2a 180 mcg QW for 12-week. After completion of 12-week CP, all participants entered the 48-week FU phase and stopped treatment with JNJ-3989 plus NA plus PegIFN-alpha-2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met NA was continued till the end of FU phase. | 19 |
| Total | 54 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Follow-up (FU) Phase: FU Week 1 to 48 | Other | 0 | 1 | 0 |
| Follow-up (FU) Phase: FU Week 1 to 48 | Withdrawal by Subject | 0 | 1 | 0 |
| IP:Day 1-Week 36(Post-PA5)/52(Prior-PA5) | Withdrawal by Subject | 1 | 0 | 2 |
Baseline characteristics
| Characteristic | Cohort 2: JNJ-3989 200 mg+ NA (245/25 mg)+ PegIFNalpha-2a 180 mcg | Total | Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Cohort 1: JNJ-3989 200 mg + JNJ-6379 250 mg+ NA (245/25 mg) + PegIFN-alpha-2a 180 mcg |
|---|---|---|---|---|
| Age, Continuous | 33.6 years STANDARD_DEVIATION 11.15 | 33.6 years STANDARD_DEVIATION 10.58 | 27.3 years STANDARD_DEVIATION 9.95 | 35.6 years STANDARD_DEVIATION 9.95 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 18 Participants | 52 Participants | 8 Participants | 26 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 14 Participants | 30 Participants | 3 Participants | 13 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 7 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 1 Participants | 16 Participants | 3 Participants | 12 Participants |
| Region of Enrollment CANADA | 4 Participants | 7 Participants | 0 Participants | 3 Participants |
| Region of Enrollment FRANCE | 2 Participants | 6 Participants | 1 Participants | 3 Participants |
| Region of Enrollment GERMANY | 1 Participants | 2 Participants | 0 Participants | 1 Participants |
| Region of Enrollment JAPAN | 0 Participants | 4 Participants | 0 Participants | 4 Participants |
| Region of Enrollment RUSSIAN FEDERATION | 1 Participants | 10 Participants | 2 Participants | 7 Participants |
| Region of Enrollment SPAIN | 7 Participants | 8 Participants | 0 Participants | 1 Participants |
| Region of Enrollment TAIWAN | 1 Participants | 2 Participants | 0 Participants | 1 Participants |
| Region of Enrollment TURKEY | 0 Participants | 9 Participants | 3 Participants | 6 Participants |
| Region of Enrollment UNITED KINGDOM | 3 Participants | 5 Participants | 1 Participants | 1 Participants |
| Region of Enrollment UNITED STATES | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Sex: Female, Male Female | 8 Participants | 26 Participants | 3 Participants | 15 Participants |
| Sex: Female, Male Male | 11 Participants | 28 Participants | 5 Participants | 12 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 / 27 | 0 / 8 | 0 / 19 | 0 / 25 | 0 / 7 | 0 / 17 | 0 / 26 | 0 / 8 | 0 / 17 |
| other Total, other adverse events | 19 / 27 | 8 / 8 | 15 / 19 | 21 / 25 | 7 / 7 | 13 / 17 | 15 / 26 | 5 / 8 | 11 / 17 |
| serious Total, serious adverse events | 0 / 27 | 0 / 8 | 0 / 19 | 0 / 25 | 0 / 7 | 0 / 17 | 0 / 26 | 0 / 8 | 1 / 17 |
Outcome results
Primary
Percentage of Participants With Functional Cure: Hepatitis B Surface Antigen (HBsAg) Seroclearance at 24 Weeks After Stopping All Study Interventions at the End of Consolidation Phase (CP) and Without Restarting Nucleos(t)Ide Analog (NA) Treatment
Percentage of participants with functional cure (defined as percentage of participants with HBsAg seroclearance at 24 weeks after stopping all study interventions at the end of consolidation phase and without restarting NA treatment) were reported. Seroclearance HBsAg was defined as a (quantitative) HBsAg level \<lower limit of quantification (LLOQ; \<0.05 international units per milliliter \[IU/mL\]).
Time frame: At follow-up (FU) phase Week 24
Population: Per protocol analysis set: all randomized/enrolled participants who received at least 1 dose of CP study intervention and did not had any of the selected major protocol deviations that might affect the assessment of efficacy in terms of the primary endpoint at 24 weeks after stopping all study interventions of the CP.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1: JNJ-3989 200 mg+ JNJ-6379 250 mg+ NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Percentage of Participants With Functional Cure: Hepatitis B Surface Antigen (HBsAg) Seroclearance at 24 Weeks After Stopping All Study Interventions at the End of Consolidation Phase (CP) and Without Restarting Nucleos(t)Ide Analog (NA) Treatment | 0 percentage of participants |
| Cohort 1: JNJ-3989 200 mg+ NA (245/25 mg) + PegIFNalpha-2a 180 mcg | Percentage of Participants With Functional Cure: Hepatitis B Surface Antigen (HBsAg) Seroclearance at 24 Weeks After Stopping All Study Interventions at the End of Consolidation Phase (CP) and Without Restarting Nucleos(t)Ide Analog (NA) Treatment | 0 percentage of participants |
| Cohort 2: JNJ-3989 200 mg+ NA (245/25 mg)+ PegIFNalpha-2a 180 mcg | Percentage of Participants With Functional Cure: Hepatitis B Surface Antigen (HBsAg) Seroclearance at 24 Weeks After Stopping All Study Interventions at the End of Consolidation Phase (CP) and Without Restarting Nucleos(t)Ide Analog (NA) Treatment | 0 percentage of participants |
Secondary
Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours [AUC (0- 24 Hours)] of JNJ-73763989 (Molecules: JNJ-73763976 [JNJ3976], JNJ-73763924 [JNJ-3924])
Area under the plasma concentration-time curve from time zero to 24hours (AUC0 to 24h) of JNJ-73763989 (molecules:JNJ-73763976 \[JNJ3976\], JNJ-73763924 \[JNJ-3924\]) were reported. Non-compartmental analysis were conducted toanalyze AUC0 to 24h of JNJ-73763989 and its molecules.
Time frame: IP: 24 hours post dose on Week 24 visit; CP: 24 hours post dose on Week 8 visit
Population: Pharmacokinetics analysis set (PK): included participants who have received at least 1 dose of any of the study interventions and had at least 1 valid blood sample drawn for PK analysis. Here N (Number of participants analysed) signifies the number of participants that were evaluable for this outcome measure. Data for this endpoint was planned to be collected and analyzed as pooled cohort in induction phase and consolidation phase only.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: JNJ-3989 200 mg+ JNJ-6379 250 mg+ NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours [AUC (0- 24 Hours)] of JNJ-73763989 (Molecules: JNJ-73763976 [JNJ3976], JNJ-73763924 [JNJ-3924]) | JNJ-73763976 | 19109 nanograms*hour per milliliters (ng*h/mL) | Standard Deviation 12482 |
| Cohort 1: JNJ-3989 200 mg+ JNJ-6379 250 mg+ NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours [AUC (0- 24 Hours)] of JNJ-73763989 (Molecules: JNJ-73763976 [JNJ3976], JNJ-73763924 [JNJ-3924]) | JNJ-73763924 | 3089 nanograms*hour per milliliters (ng*h/mL) | Standard Deviation 1964 |
| Cohort 1: JNJ-3989 200 mg+ NA (245/25 mg) + PegIFNalpha-2a 180 mcg | Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours [AUC (0- 24 Hours)] of JNJ-73763989 (Molecules: JNJ-73763976 [JNJ3976], JNJ-73763924 [JNJ-3924]) | JNJ-73763976 | 12219 nanograms*hour per milliliters (ng*h/mL) | Standard Deviation 3499 |
| Cohort 1: JNJ-3989 200 mg+ NA (245/25 mg) + PegIFNalpha-2a 180 mcg | Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours [AUC (0- 24 Hours)] of JNJ-73763989 (Molecules: JNJ-73763976 [JNJ3976], JNJ-73763924 [JNJ-3924]) | JNJ-73763924 | 2117 nanograms*hour per milliliters (ng*h/mL) | Standard Deviation 639 |
Secondary
Change From Baseline Over Time in HBeAg Levels
Change from baseline over time in HBsAg levels at specified timepoints were reported.
Time frame: Baseline (Day 1 of IP), IP: Week 36; CP: Week 12; FU phase: Week 48 (Week 112 [Cohort 1]; Week 96 [Cohort 2])
Population: Treated analysis set included all participants who received at least 1 dose of study treatment within this ISA. Here N (Number of participants analyzed) signifies participants who were evaluable for this outcome measure and n(number analysed) signifies participants evaluable at specified timepoints. Here, n=0, signify that data were not collected and analyzed as that timepoint was not applicable to the respective arm.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: JNJ-3989 200 mg+ JNJ-6379 250 mg+ NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Change From Baseline Over Time in HBeAg Levels | IP: Week 36 | -1.78 log10 IU/mL | Standard Error 0.103 |
| Cohort 1: JNJ-3989 200 mg+ NA (245/25 mg) + PegIFNalpha-2a 180 mcg | Change From Baseline Over Time in HBeAg Levels | IP: Week 36 | -1.77 log10 IU/mL | Standard Error 0.151 |
| Cohort 2: JNJ-3989 200 mg+ NA (245/25 mg)+ PegIFNalpha-2a 180 mcg | Change From Baseline Over Time in HBeAg Levels | IP: Week 36 | -1.49 log10 IU/mL | Standard Error 0.141 |
| CP: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg | Change From Baseline Over Time in HBeAg Levels | CP: Week 12 | -2.14 log10 IU/mL | Standard Error 0.146 |
| CP: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Change From Baseline Over Time in HBeAg Levels | CP: Week 12 | -2.39 log10 IU/mL | Standard Error 0.162 |
| CP: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Change From Baseline Over Time in HBeAg Levels | CP: Week 12 | -2.22 log10 IU/mL | Standard Error 0.234 |
| FU: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg | Change From Baseline Over Time in HBeAg Levels | FU phase: Week 48 | -2.45 log10 IU/mL | Standard Error 0.243 |
| FU: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Change From Baseline Over Time in HBeAg Levels | FU phase: Week 48 | -2.59 log10 IU/mL | Standard Error 0.508 |
| FU: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Change From Baseline Over Time in HBeAg Levels | FU phase: Week 48 | -2.47 log10 IU/mL | Standard Error 0.278 |
Secondary
Change From Baseline Over Time in HBsAg Levels
Change from baseline over time in HBsAg levels at specified timepoints were reported
Time frame: Baseline (Day 1 of IP), IP: Week 36; CP: Week 12; FU phase: Week 48 (Week 112 [Cohort 1]; Week 96 [Cohort 2])
Population: Treated analysis set included all participants who received at least 1 dose of study treatment within this ISA. Here N (Number of participants analyzed) signifies participants who were evaluable for this outcome measure and n(number analysed) signifies participants evaluable at specified timepoints. Here, n=0, signify that data were not collected and analyzed as that timepoint was not applicable to the respective arm.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: JNJ-3989 200 mg+ JNJ-6379 250 mg+ NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Change From Baseline Over Time in HBsAg Levels | IP: Week 36 | -2.78 log10 IU/mL | Standard Error 0.198 |
| Cohort 1: JNJ-3989 200 mg+ NA (245/25 mg) + PegIFNalpha-2a 180 mcg | Change From Baseline Over Time in HBsAg Levels | IP: Week 36 | -3.35 log10 IU/mL | Standard Error 0.417 |
| Cohort 2: JNJ-3989 200 mg+ NA (245/25 mg)+ PegIFNalpha-2a 180 mcg | Change From Baseline Over Time in HBsAg Levels | IP: Week 36 | -2.73 log10 IU/mL | Standard Error 0.15 |
| CP: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg | Change From Baseline Over Time in HBsAg Levels | CP: Week 12 | -3.51 log10 IU/mL | Standard Error 0.275 |
| CP: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Change From Baseline Over Time in HBsAg Levels | CP: Week 12 | -4.17 log10 IU/mL | Standard Error 0.444 |
| CP: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Change From Baseline Over Time in HBsAg Levels | CP: Week 12 | -3.53 log10 IU/mL | Standard Error 0.285 |
| FU: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg | Change From Baseline Over Time in HBsAg Levels | FU phase: Week 48 | -2.41 log10 IU/mL | Standard Error 0.364 |
| FU: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Change From Baseline Over Time in HBsAg Levels | FU phase: Week 48 | -3.14 log10 IU/mL | Standard Error 0.747 |
| FU: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Change From Baseline Over Time in HBsAg Levels | FU phase: Week 48 | -2.82 log10 IU/mL | Standard Error 0.425 |
Secondary
Change From Baseline Over Time in HBV DNA Levels
Change from baseline over time in HBV DNA Levels at Specified Timepoints were reported.
Time frame: Baseline (Day 1 of IP), IP: Week 36; CP: Week 12; FU phase: Week 48 (Week 112 [Cohort 1]; Week 96 [Cohort 2])
Population: Treated analysis set included all participants who received at least 1 dose of study treatment within this ISA. Here N (Number of participants analyzed) signifies participants who were evaluable for this outcome measure and n(number analysed) signifies participants evaluable at specified timepoints. Here, n=0, signify that data were not collected and analyzed as that timepoint was not applicable to the respective arm.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: JNJ-3989 200 mg+ JNJ-6379 250 mg+ NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Change From Baseline Over Time in HBV DNA Levels | IP: Week 36 | -6.36 log10 IU/mL | Standard Error 0.218 |
| Cohort 1: JNJ-3989 200 mg+ NA (245/25 mg) + PegIFNalpha-2a 180 mcg | Change From Baseline Over Time in HBV DNA Levels | IP: Week 36 | -6.08 log10 IU/mL | Standard Error 0.202 |
| Cohort 2: JNJ-3989 200 mg+ NA (245/25 mg)+ PegIFNalpha-2a 180 mcg | Change From Baseline Over Time in HBV DNA Levels | IP: Week 36 | -6.26 log10 IU/mL | Standard Error 0.231 |
| CP: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg | Change From Baseline Over Time in HBV DNA Levels | CP: Week 12 | -6.29 log10 IU/mL | Standard Error 0.205 |
| CP: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Change From Baseline Over Time in HBV DNA Levels | CP: Week 12 | -6.30 log10 IU/mL | Standard Error 0.35 |
| CP: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Change From Baseline Over Time in HBV DNA Levels | CP: Week 12 | -6.07 log10 IU/mL | Standard Error 0.269 |
| FU: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg | Change From Baseline Over Time in HBV DNA Levels | FU phase: Week 48 | -6.79 log10 IU/mL | Standard Error 0.203 |
| FU: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Change From Baseline Over Time in HBV DNA Levels | FU phase: Week 48 | -5.95 log10 IU/mL | Standard Error 0.563 |
| FU: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Change From Baseline Over Time in HBV DNA Levels | FU phase: Week 48 | -6.70 log10 IU/mL | Standard Error 0.257 |
Secondary
FU Phase: Number of Participants With Off-treatment Biochemical HBV Flares During Follow-up Phase
Number of participants with off-treatment biochemical HBV flares were reported. Biochemical flare was defined as first date of 2 consecutive visits with confirmed ALT and/or AST \>=3\*ULN and \>=3\*nadir (lowest value observed up to start of flare). Confirmed means that the criteria was fulfilled at 2 or more consecutive time points or at the last observed time point. Off-treatment was defined as the time period after stopping all study treatments (including NA).
Time frame: FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Population: Treated analysis set included all participants who received at least 1 dose of study treatment within this ISA. Here N (Number of participants analyzed) signifies the number of participants who were evaluable for this outcome measure. Here, N=0 signifies that data were not collected and analyzed for participants who stopped NA at the end of treatment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 2: JNJ-3989 200 mg+ NA (245/25 mg)+ PegIFNalpha-2a 180 mcg | FU Phase: Number of Participants With Off-treatment Biochemical HBV Flares During Follow-up Phase | 0 Participants |
Secondary
FU Phase: Number of Participants With Off-treatment Clinical Flares During Follow-up Phase
Clinical flares occurred either when a virologic flare (confirmed HBV DNA \>peak threshold) & biochemical flare (ALT and/or AST \>=3\*ULN & \>=3\*nadir \[lowest value observed during off-treatment period up to time point of meeting the flare criteria\]) overlapped in time or when a biochemical flare started within 4 weeks following the end of a virologic flare. The HBV DNA thresholds were: 20,000 IU/mL, 2,000 IU/mL and 200 IU/mL. Confirmed means that criteria was fulfilled at 2 or more consecutive time points or at last observed time point. Off-treatment was defined as time period after stopping all study drugs (including NA). The start date of a clinical flare was minimum start date of virologic flare and biochemical flare.
Time frame: FU phase: FU Week 1 up to FU Week 48(up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Population: Treated analysis set included all participants who received at least 1 dose of study treatment within this ISA. Here N (Number of participants analyzed) signifies the number of participants who were evaluable for this outcome measure. Here, N=0 signifies that data were not collected and analyzed for participants who stopped NA at the end of treatment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 2: JNJ-3989 200 mg+ NA (245/25 mg)+ PegIFNalpha-2a 180 mcg | FU Phase: Number of Participants With Off-treatment Clinical Flares During Follow-up Phase | 0 Participants |
Secondary
FU Phase: Number of Participants With Off-treatment Virologic HBV Flares During Follow up Phase
Number of participants with off-treatment virologic HBV flares were reported. Virologic flare was defined as confirmed HBV DNA \>peak threshold (lowest peak to qualify as virologic flare was HBV DNA \>200 IU/mL) in participants who were off-treatment and had HBV DNA \<LLOQ (\<20 IU/mL) at the last observed time point on all study treatments. The 3 thresholds of virologic flare was 20,000 IU/mL, 2,000 IU/mL and 200 IU/mL. Confirmed means that the criteria was fulfilled at 2 or more consecutive time points or at the last observed time point. Off-treatment was defined as the time period after stopping all study treatments (including NA).
Time frame: FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Population: Treated analysis set included all participants who received at least 1 dose of study treatment within this ISA. Here N (Number of participants analyzed) signifies the number of participants who were evaluable for this outcome measure. Here, N=0 signifies that data were not collected and analyzed for participants who stopped NA at the end of treatment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 2: JNJ-3989 200 mg+ NA (245/25 mg)+ PegIFNalpha-2a 180 mcg | FU Phase: Number of Participants With Off-treatment Virologic HBV Flares During Follow up Phase | 0 Participants |
Secondary
FU Phase: Number of Participants With On-treatment Biochemical Flares During Follow-up Phase
Number of participants with on-treatment biochemical HBV flares were reported. Biochemical flare was defined as first date of 2 consecutive visits with confirmed ALT and/or AST \>=3\*ULN and \>=3\*nadir (lowest value observed up to start of flare). Confirmed means that the criteria was fulfilled at 2 or more consecutive time points or at the last observed time point. On-treatment was defined as the time period during which the participant received any of the study drugs.
Time frame: FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Population: Treated analysis set included all participants who received at least 1 dose of study treatment within this ISA.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1: JNJ-3989 200 mg+ JNJ-6379 250 mg+ NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | FU Phase: Number of Participants With On-treatment Biochemical Flares During Follow-up Phase | 2 Participants |
| Cohort 1: JNJ-3989 200 mg+ NA (245/25 mg) + PegIFNalpha-2a 180 mcg | FU Phase: Number of Participants With On-treatment Biochemical Flares During Follow-up Phase | 0 Participants |
| Cohort 2: JNJ-3989 200 mg+ NA (245/25 mg)+ PegIFNalpha-2a 180 mcg | FU Phase: Number of Participants With On-treatment Biochemical Flares During Follow-up Phase | 2 Participants |
Secondary
FU Phase: Percentage of Participants Who Achieved Reduction (Sustained) in HBsAg Response (Per Definition 1) at Follow-up Week 48
Percentage of participants with sustained (reduction) HBsAg response (per Definition 1) were reported. Sustained HBsAg response (definition 1) was defined as: For participants with FU Week 48 data: participants who had a \>1 log10 decline from baseline in HBsAg and HBsAg \<000 IU/mL at FU Week 48. For participants without FU Week 48 data: participants who had a HBsAg decline from baseline of \>2 log10 at FU Week 24 or \>1.5 log10 at FU Week 36 (most recent value used) and had HBsAg \<1000 IU/mL at the last available timepoint.
Time frame: At FU Week 48 (Week 112 [Cohort 1]; Week 96 [Cohort 2])
Population: Treated analysis set included all participants who received at least 1 dose of study treatment within this ISA. Here N (Number of participants analyzed) signifies participants who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1: JNJ-3989 200 mg+ JNJ-6379 250 mg+ NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | FU Phase: Percentage of Participants Who Achieved Reduction (Sustained) in HBsAg Response (Per Definition 1) at Follow-up Week 48 | 53.85 percentage of participants |
| Cohort 1: JNJ-3989 200 mg+ NA (245/25 mg) + PegIFNalpha-2a 180 mcg | FU Phase: Percentage of Participants Who Achieved Reduction (Sustained) in HBsAg Response (Per Definition 1) at Follow-up Week 48 | 57.1 percentage of participants |
| Cohort 2: JNJ-3989 200 mg+ NA (245/25 mg)+ PegIFNalpha-2a 180 mcg | FU Phase: Percentage of Participants Who Achieved Reduction (Sustained) in HBsAg Response (Per Definition 1) at Follow-up Week 48 | 70.6 percentage of participants |
Secondary
FU Phase: Percentage of Participants Who Required NA Re-treatment During Follow-Up Phase
Percentage of participants who required NA re-treatment during follow-up phase were reported. A responder was defined as a participant who met the criteria for NA re-treatment at any time during follow-up, for those participants who met the NA treatment completion criteria at any time during the study and actually stopped NA treatment.
Time frame: FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Population: Treated analysis set included all participants who received at least 1 dose of study treatment within this ISA. Here N (Number of participants analyzed) signifies the number of participants who were evaluable for this outcome measure. Here, N=0 signifies that data were not collected and analyzed for participants who stopped NA at the end of treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 2: JNJ-3989 200 mg+ NA (245/25 mg)+ PegIFNalpha-2a 180 mcg | FU Phase: Percentage of Participants Who Required NA Re-treatment During Follow-Up Phase | 0 percentage of participants |
Secondary
FU Phase: Percentage of Participants With HBsAg Seroclearance 48 Weeks After Stopping All Study Interventions of the Consolidation Phase and Without Restarting NA Treatment During Follow up Phase
Percentage of participants with HBsAg seroclearance 48 weeks after stopping all study interventions at the consolidation phase and without restarting NA treatment during follow up phase were reported. HBsAg seroclearance was defined as (quantitative) HBsAg \< LLOQ (HBsAg 0.05 IU/mL).
Time frame: FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Population: Treated analysis set included all participants who received at least 1 dose of study treatment within this ISA. Here N (Number of participants analyzed) signifies the number of participants that were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1: JNJ-3989 200 mg+ JNJ-6379 250 mg+ NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | FU Phase: Percentage of Participants With HBsAg Seroclearance 48 Weeks After Stopping All Study Interventions of the Consolidation Phase and Without Restarting NA Treatment During Follow up Phase | 11.5 percentage of participants |
| Cohort 1: JNJ-3989 200 mg+ NA (245/25 mg) + PegIFNalpha-2a 180 mcg | FU Phase: Percentage of Participants With HBsAg Seroclearance 48 Weeks After Stopping All Study Interventions of the Consolidation Phase and Without Restarting NA Treatment During Follow up Phase | 16.7 percentage of participants |
| Cohort 2: JNJ-3989 200 mg+ NA (245/25 mg)+ PegIFNalpha-2a 180 mcg | FU Phase: Percentage of Participants With HBsAg Seroclearance 48 Weeks After Stopping All Study Interventions of the Consolidation Phase and Without Restarting NA Treatment During Follow up Phase | 11.8 percentage of participants |
Secondary
FU Phase: Percentage of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) <LLOQ 48 Weeks After Stopping All Study Interventions of the Consolidation Phase and Without Restarting NA Treatment During Follow up Phase
Percentage of participants with HBV DNA \<LLOQ (\<20 IU/mL) 48 weeks after stopping all study interventions of the consolidation phase and without restarting NA treatment during follow up phase were reported.
Time frame: FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Population: Treated analysis set included all participants who received at least 1 dose of study treatment within this ISA. Here N (Number of participants analyzed) signifies the number of participants who were evaluable for this outcome measure. Here, N=0 signifies that data were not collected and analyzed for participants who stopped NA at the end of treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 2: JNJ-3989 200 mg+ NA (245/25 mg)+ PegIFNalpha-2a 180 mcg | FU Phase: Percentage of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) <LLOQ 48 Weeks After Stopping All Study Interventions of the Consolidation Phase and Without Restarting NA Treatment During Follow up Phase | 0 percentage of participants |
Secondary
Maximum Observed Plasma Concentration (Cmax) of JNJ-73763989 (Molecules: JNJ-73763976 [JNJ3976], JNJ-73763924 [JNJ-3924])
Cmax of JNJ-73763989 (molecules: JNJ-73763976 \[JNJ3976\], JNJ-73763924 \[JNJ-3924\]) were reported. Noncompartmental analysis were conducted to analyze Cmax JNJ-73763989 and its molecules
Time frame: IP : Predose (0 hour), post dose on 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours on IP Week 24; CP: Predose (0 hour), post dose on 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours on CP Week 8
Population: Pharmacokinetics analysis set (PK): included participants who had received at least 1 dose of any of the study interventions and had at least 1 valid blood sample drawn for PK analysis. Data for this outcome measure was planned to be collected and analyzed as pooled cohort in induction phase and consolidation phase only.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: JNJ-3989 200 mg+ JNJ-6379 250 mg+ NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Maximum Observed Plasma Concentration (Cmax) of JNJ-73763989 (Molecules: JNJ-73763976 [JNJ3976], JNJ-73763924 [JNJ-3924]) | JNJ-73763924 | 279 nanogram per milliliters (ng/mL) | Standard Deviation 308 |
| Cohort 1: JNJ-3989 200 mg+ JNJ-6379 250 mg+ NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Maximum Observed Plasma Concentration (Cmax) of JNJ-73763989 (Molecules: JNJ-73763976 [JNJ3976], JNJ-73763924 [JNJ-3924]) | JNJ-73763976 | 1376 nanogram per milliliters (ng/mL) | Standard Deviation 1266 |
| Cohort 1: JNJ-3989 200 mg+ NA (245/25 mg) + PegIFNalpha-2a 180 mcg | Maximum Observed Plasma Concentration (Cmax) of JNJ-73763989 (Molecules: JNJ-73763976 [JNJ3976], JNJ-73763924 [JNJ-3924]) | JNJ-73763924 | 135 nanogram per milliliters (ng/mL) | Standard Deviation 39.9 |
| Cohort 1: JNJ-3989 200 mg+ NA (245/25 mg) + PegIFNalpha-2a 180 mcg | Maximum Observed Plasma Concentration (Cmax) of JNJ-73763989 (Molecules: JNJ-73763976 [JNJ3976], JNJ-73763924 [JNJ-3924]) | JNJ-73763976 | 700 nanogram per milliliters (ng/mL) | Standard Deviation 227 |
Secondary
Number of Participants With Clinically Important Abnormalities in Physical Examination
Number of participants with clinically important treatment-emergent abnormalities in physical examination were reported.
Time frame: IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Population: Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1: JNJ-3989 200 mg+ JNJ-6379 250 mg+ NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Number of Participants With Clinically Important Abnormalities in Physical Examination | 0 Participants |
| Cohort 1: JNJ-3989 200 mg+ NA (245/25 mg) + PegIFNalpha-2a 180 mcg | Number of Participants With Clinically Important Abnormalities in Physical Examination | 0 Participants |
| Cohort 2: JNJ-3989 200 mg+ NA (245/25 mg)+ PegIFNalpha-2a 180 mcg | Number of Participants With Clinically Important Abnormalities in Physical Examination | 0 Participants |
| CP: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg | Number of Participants With Clinically Important Abnormalities in Physical Examination | 0 Participants |
| CP: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Number of Participants With Clinically Important Abnormalities in Physical Examination | 0 Participants |
| CP: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Number of Participants With Clinically Important Abnormalities in Physical Examination | 0 Participants |
| FU: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg | Number of Participants With Clinically Important Abnormalities in Physical Examination | 0 Participants |
| FU: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Number of Participants With Clinically Important Abnormalities in Physical Examination | 0 Participants |
| FU: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Number of Participants With Clinically Important Abnormalities in Physical Examination | 0 Participants |
Secondary
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Number of participants with TEAEs were reported. An adverse event (AE) was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the study intervention. Treatment-emergent AEs are all AEs with an onset on or after the first administration of study treatment or any ongoing event that worsened in severity, intensity or frequency after the first administration of study treatment.
Time frame: IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Population: Safety analysis set included all participants who received at least one dose of study intervention. Participants were analyzed according to the study intervention they actually received.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1: JNJ-3989 200 mg+ JNJ-6379 250 mg+ NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | 22 Participants |
| Cohort 1: JNJ-3989 200 mg+ NA (245/25 mg) + PegIFNalpha-2a 180 mcg | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | 8 Participants |
| Cohort 2: JNJ-3989 200 mg+ NA (245/25 mg)+ PegIFNalpha-2a 180 mcg | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | 15 Participants |
| CP: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | 22 Participants |
| CP: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | 7 Participants |
| CP: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | 13 Participants |
| FU: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | 17 Participants |
| FU: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | 5 Participants |
| FU: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | 11 Participants |
Secondary
Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs)
Number of participants with TESAEs were reported. was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the study intervention. Treatment-emergent AEs are all AEs with an onset on or after the first administration of study treatment or any ongoing event that worsened in severity, intensity or frequency after the first administration of study treatment. A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Time frame: IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Population: Safety analysis set included all participants who received at least one dose of study intervention. Participants were analyzed according to the study intervention they actually received.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1: JNJ-3989 200 mg+ JNJ-6379 250 mg+ NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs) | 0 Participants |
| Cohort 1: JNJ-3989 200 mg+ NA (245/25 mg) + PegIFNalpha-2a 180 mcg | Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs) | 0 Participants |
| Cohort 2: JNJ-3989 200 mg+ NA (245/25 mg)+ PegIFNalpha-2a 180 mcg | Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs) | 0 Participants |
| CP: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg | Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs) | 0 Participants |
| CP: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs) | 0 Participants |
| CP: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs) | 0 Participants |
| FU: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg | Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs) | 0 Participants |
| FU: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs) | 0 Participants |
| FU: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs) | 1 Participants |
Secondary
Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests
Clinical laboratory test parameters were Hematology: absolute lymphocyte count, absolute neutrophil count (ANC), hemoglobin, Neutrophils Band Form, Neutrophils segmented, white blood cells (WBC) decreased, ; Chemistry: alanine aminotransferase (ALT) & serum glutamic pyruvic transaminase (SGPT), aspartate aminotransferase(AST)/serum glutamic oxaloacetic transaminase (SGOT), cholesterol (fasting), creatinine Kinase, creatinine, GFR from Creatinine Adjusted for BSA, GFR from Cystatin C Adjusted for BSA, low-density lipoprotein (LDL), triglycerides (fasting); Urinalysis: glycosuria. DAIDS toxicity grades: Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe), Grade 4 (Potentially Life-Threatening). Number of participants with treatment-emergent DAIDS toxicity Grade 3 or 4 were reported in this outcome measure.
Time frame: IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Population: Safety analysis set included all participants who received at least one dose of study intervention. Participants were analyzed according to the study intervention they actually received. Here, n(number analyzed) signifies number of participants analyzed at specified categories.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: JNJ-3989 200 mg+ JNJ-6379 250 mg+ NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Chemistry: AST or SGOT: High: Grade 3 | 0 Participants |
| Cohort 1: JNJ-3989 200 mg+ JNJ-6379 250 mg+ NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Chemistry: Creatinine Kinase : High: Grade 4 | 1 Participants |
| Cohort 1: JNJ-3989 200 mg+ JNJ-6379 250 mg+ NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Chemistry: GFR from Cy C Adjusted for BSA, Low: Grade 4 | 0 Participants |
| Cohort 1: JNJ-3989 200 mg+ JNJ-6379 250 mg+ NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Chemistry: GFR from Cr Adjusted for BSA, Low: Grade 3 | 1 Participants |
| Cohort 1: JNJ-3989 200 mg+ JNJ-6379 250 mg+ NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Chemistry: Triglycerides (Fasting): High: Grade 3 | 0 Participants |
| Cohort 1: JNJ-3989 200 mg+ JNJ-6379 250 mg+ NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Hematology: WBC Decreased: Low: Grade 3 | 0 Participants |
| Cohort 1: JNJ-3989 200 mg+ JNJ-6379 250 mg+ NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Chemistry: LDL (Fasting): High: Grade 3 | 2 Participants |
| Cohort 1: JNJ-3989 200 mg+ JNJ-6379 250 mg+ NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Chemistry: Creatinine Kinase : High: Grade 3 | 0 Participants |
| Cohort 1: JNJ-3989 200 mg+ JNJ-6379 250 mg+ NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Chemistry: ALT or SGPT: High: Grade 3 | 1 Participants |
| Cohort 1: JNJ-3989 200 mg+ JNJ-6379 250 mg+ NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Hematology: Neutrophils Segmented: Low: Grade 3 | 0 Participants |
| Cohort 1: JNJ-3989 200 mg+ JNJ-6379 250 mg+ NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Chemistry: Cholesterol (Fasting): High: Grade 3 | 0 Participants |
| Cohort 1: JNJ-3989 200 mg+ JNJ-6379 250 mg+ NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Hematology: Absolute Neutrophil Count: Grade 3 | 0 Participants |
| Cohort 1: JNJ-3989 200 mg+ JNJ-6379 250 mg+ NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Hematology: Hemoglobin: Low: Grade 3 | 0 Participants |
| Cohort 1: JNJ-3989 200 mg+ JNJ-6379 250 mg+ NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Chemistry: GFR from Cy C Adjusted for BSA, Low: Grade 3 | 1 Participants |
| Cohort 1: JNJ-3989 200 mg+ JNJ-6379 250 mg+ NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Hematology: Absolute Lymphocyte Count: Low: Grade 3 | 0 Participants |
| Cohort 1: JNJ-3989 200 mg+ JNJ-6379 250 mg+ NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Urinalysis: Glycosuria: Grade 3 | 0 Participants |
| Cohort 1: JNJ-3989 200 mg+ NA (245/25 mg) + PegIFNalpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Chemistry: GFR from Cr Adjusted for BSA, Low: Grade 3 | 0 Participants |
| Cohort 1: JNJ-3989 200 mg+ NA (245/25 mg) + PegIFNalpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Chemistry: Cholesterol (Fasting): High: Grade 3 | 0 Participants |
| Cohort 1: JNJ-3989 200 mg+ NA (245/25 mg) + PegIFNalpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Chemistry: GFR from Cy C Adjusted for BSA, Low: Grade 3 | 0 Participants |
| Cohort 1: JNJ-3989 200 mg+ NA (245/25 mg) + PegIFNalpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Hematology: WBC Decreased: Low: Grade 3 | 0 Participants |
| Cohort 1: JNJ-3989 200 mg+ NA (245/25 mg) + PegIFNalpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Chemistry: AST or SGOT: High: Grade 3 | 0 Participants |
| Cohort 1: JNJ-3989 200 mg+ NA (245/25 mg) + PegIFNalpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Chemistry: LDL (Fasting): High: Grade 3 | 0 Participants |
| Cohort 1: JNJ-3989 200 mg+ NA (245/25 mg) + PegIFNalpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Urinalysis: Glycosuria: Grade 3 | 0 Participants |
| Cohort 1: JNJ-3989 200 mg+ NA (245/25 mg) + PegIFNalpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Hematology: Absolute Neutrophil Count: Grade 3 | 0 Participants |
| Cohort 1: JNJ-3989 200 mg+ NA (245/25 mg) + PegIFNalpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Hematology: Absolute Lymphocyte Count: Low: Grade 3 | 0 Participants |
| Cohort 1: JNJ-3989 200 mg+ NA (245/25 mg) + PegIFNalpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Chemistry: ALT or SGPT: High: Grade 3 | 0 Participants |
| Cohort 1: JNJ-3989 200 mg+ NA (245/25 mg) + PegIFNalpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Chemistry: Triglycerides (Fasting): High: Grade 3 | 0 Participants |
| Cohort 1: JNJ-3989 200 mg+ NA (245/25 mg) + PegIFNalpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Hematology: Hemoglobin: Low: Grade 3 | 0 Participants |
| Cohort 1: JNJ-3989 200 mg+ NA (245/25 mg) + PegIFNalpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Hematology: Neutrophils Segmented: Low: Grade 3 | 0 Participants |
| Cohort 1: JNJ-3989 200 mg+ NA (245/25 mg) + PegIFNalpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Chemistry: GFR from Cy C Adjusted for BSA, Low: Grade 4 | 0 Participants |
| Cohort 1: JNJ-3989 200 mg+ NA (245/25 mg) + PegIFNalpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Chemistry: Creatinine Kinase : High: Grade 4 | 0 Participants |
| Cohort 1: JNJ-3989 200 mg+ NA (245/25 mg) + PegIFNalpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Chemistry: Creatinine Kinase : High: Grade 3 | 0 Participants |
| Cohort 2: JNJ-3989 200 mg+ NA (245/25 mg)+ PegIFNalpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Chemistry: GFR from Cr Adjusted for BSA, Low: Grade 3 | 0 Participants |
| Cohort 2: JNJ-3989 200 mg+ NA (245/25 mg)+ PegIFNalpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Hematology: Neutrophils Segmented: Low: Grade 3 | 0 Participants |
| Cohort 2: JNJ-3989 200 mg+ NA (245/25 mg)+ PegIFNalpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Hematology: Absolute Neutrophil Count: Grade 3 | 0 Participants |
| Cohort 2: JNJ-3989 200 mg+ NA (245/25 mg)+ PegIFNalpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Hematology: Absolute Lymphocyte Count: Low: Grade 3 | 0 Participants |
| Cohort 2: JNJ-3989 200 mg+ NA (245/25 mg)+ PegIFNalpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Hematology: Hemoglobin: Low: Grade 3 | 0 Participants |
| Cohort 2: JNJ-3989 200 mg+ NA (245/25 mg)+ PegIFNalpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Chemistry: Triglycerides (Fasting): High: Grade 3 | 1 Participants |
| Cohort 2: JNJ-3989 200 mg+ NA (245/25 mg)+ PegIFNalpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Chemistry: LDL (Fasting): High: Grade 3 | 0 Participants |
| Cohort 2: JNJ-3989 200 mg+ NA (245/25 mg)+ PegIFNalpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Chemistry: Creatinine Kinase : High: Grade 3 | 0 Participants |
| Cohort 2: JNJ-3989 200 mg+ NA (245/25 mg)+ PegIFNalpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Chemistry: GFR from Cy C Adjusted for BSA, Low: Grade 4 | 0 Participants |
| Cohort 2: JNJ-3989 200 mg+ NA (245/25 mg)+ PegIFNalpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Chemistry: GFR from Cy C Adjusted for BSA, Low: Grade 3 | 0 Participants |
| Cohort 2: JNJ-3989 200 mg+ NA (245/25 mg)+ PegIFNalpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Urinalysis: Glycosuria: Grade 3 | 0 Participants |
| Cohort 2: JNJ-3989 200 mg+ NA (245/25 mg)+ PegIFNalpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Chemistry: Creatinine Kinase : High: Grade 4 | 0 Participants |
| Cohort 2: JNJ-3989 200 mg+ NA (245/25 mg)+ PegIFNalpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Chemistry: Cholesterol (Fasting): High: Grade 3 | 0 Participants |
| Cohort 2: JNJ-3989 200 mg+ NA (245/25 mg)+ PegIFNalpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Chemistry: AST or SGOT: High: Grade 3 | 0 Participants |
| Cohort 2: JNJ-3989 200 mg+ NA (245/25 mg)+ PegIFNalpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Chemistry: ALT or SGPT: High: Grade 3 | 0 Participants |
| Cohort 2: JNJ-3989 200 mg+ NA (245/25 mg)+ PegIFNalpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Hematology: WBC Decreased: Low: Grade 3 | 0 Participants |
| CP: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Chemistry: Creatinine Kinase : High: Grade 3 | 0 Participants |
| CP: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Hematology: Hemoglobin: Low: Grade 3 | 1 Participants |
| CP: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Hematology: Neutrophils Band Form: Low: Grade 4 | 3 Participants |
| CP: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Hematology: Neutrophils Segmented: Low: Grade 3 | 2 Participants |
| CP: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Hematology: WBC Decreased: Low: Grade 3 | 3 Participants |
| CP: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Chemistry: AST or SGOT: High: Grade 3 | 0 Participants |
| CP: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Chemistry: Cholesterol (Fasting): High: Grade 3 | 0 Participants |
| CP: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Chemistry: Creatinine Kinase : High: Grade 4 | 0 Participants |
| CP: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Chemistry: GFR from Cy C Adjusted for BSA, Low: Grade 3 | 1 Participants |
| CP: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Hematology: Absolute Lymphocyte Count: Low: Grade 3 | 1 Participants |
| CP: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Hematology: Absolute Neutrophil Count: Grade 3 | 2 Participants |
| CP: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Chemistry: ALT or SGPT: High: Grade 3 | 1 Participants |
| CP: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Chemistry: GFR from Cr Adjusted for BSA, Low: Grade 3 | 0 Participants |
| CP: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Chemistry: GFR from Cy C Adjusted for BSA, Low: Grade 4 | 0 Participants |
| CP: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Chemistry: LDL (Fasting): High: Grade 3 | 1 Participants |
| CP: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Chemistry: Triglycerides (Fasting): High: Grade 3 | 1 Participants |
| CP: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Urinalysis: Glycosuria: Grade 3 | 0 Participants |
| CP: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Chemistry: ALT or SGPT: High: Grade 3 | 0 Participants |
| CP: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Hematology: Neutrophils Segmented: Low: Grade 3 | 0 Participants |
| CP: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Chemistry: GFR from Cy C Adjusted for BSA, Low: Grade 3 | 0 Participants |
| CP: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Chemistry: Creatinine Kinase : High: Grade 4 | 0 Participants |
| CP: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Hematology: Absolute Lymphocyte Count: Low: Grade 3 | 0 Participants |
| CP: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Chemistry: GFR from Cr Adjusted for BSA, Low: Grade 3 | 0 Participants |
| CP: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Chemistry: Cholesterol (Fasting): High: Grade 3 | 0 Participants |
| CP: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Chemistry: AST or SGOT: High: Grade 3 | 0 Participants |
| CP: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Chemistry: Triglycerides (Fasting): High: Grade 3 | 0 Participants |
| CP: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Hematology: WBC Decreased: Low: Grade 3 | 0 Participants |
| CP: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Urinalysis: Glycosuria: Grade 3 | 0 Participants |
| CP: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Chemistry: LDL (Fasting): High: Grade 3 | 0 Participants |
| CP: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Chemistry: GFR from Cy C Adjusted for BSA, Low: Grade 4 | 0 Participants |
| CP: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Hematology: Hemoglobin: Low: Grade 3 | 0 Participants |
| CP: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Chemistry: Creatinine Kinase : High: Grade 3 | 0 Participants |
| CP: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Hematology: Absolute Neutrophil Count: Grade 3 | 0 Participants |
| CP: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Chemistry: GFR from Cy C Adjusted for BSA, Low: Grade 3 | 0 Participants |
| CP: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Hematology: Neutrophils Segmented: Low: Grade 3 | 0 Participants |
| CP: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Hematology: Absolute Lymphocyte Count: Low: Grade 3 | 0 Participants |
| CP: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Hematology: WBC Decreased: Low: Grade 3 | 1 Participants |
| CP: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Urinalysis: Glycosuria: Grade 3 | 0 Participants |
| CP: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Chemistry: Triglycerides (Fasting): High: Grade 3 | 0 Participants |
| CP: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Chemistry: ALT or SGPT: High: Grade 3 | 2 Participants |
| CP: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Chemistry: LDL (Fasting): High: Grade 3 | 1 Participants |
| CP: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Chemistry: AST or SGOT: High: Grade 3 | 1 Participants |
| CP: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Chemistry: GFR from Cr Adjusted for BSA, Low: Grade 3 | 0 Participants |
| CP: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Chemistry: Creatinine Kinase : High: Grade 4 | 1 Participants |
| CP: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Chemistry: GFR from Cy C Adjusted for BSA, Low: Grade 4 | 0 Participants |
| CP: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Chemistry: Cholesterol (Fasting): High: Grade 3 | 2 Participants |
| CP: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Chemistry: Creatinine Kinase : High: Grade 3 | 2 Participants |
| CP: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Hematology: Absolute Neutrophil Count: Grade 3 | 0 Participants |
| CP: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Hematology: Hemoglobin: Low: Grade 3 | 0 Participants |
| FU: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Chemistry: ALT or SGPT: High: Grade 3 | 0 Participants |
| FU: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Chemistry: LDL (Fasting): High: Grade 3 | 0 Participants |
| FU: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Chemistry: Cholesterol (Fasting): High: Grade 3 | 0 Participants |
| FU: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Chemistry: Creatinine Kinase : High: Grade 4 | 0 Participants |
| FU: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Hematology: WBC Decreased: Low: Grade 3 | 1 Participants |
| FU: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Urinalysis: Glycosuria: Grade 3 | 0 Participants |
| FU: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Hematology: Neutrophils Segmented: Low: Grade 3 | 0 Participants |
| FU: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Chemistry: Triglycerides (Fasting): High: Grade 3 | 1 Participants |
| FU: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Chemistry: AST or SGOT: High: Grade 3 | 0 Participants |
| FU: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Hematology: Absolute Neutrophil Count: Grade 3 | 0 Participants |
| FU: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Chemistry: GFR from Cy C Adjusted for BSA, Low: Grade 3 | 1 Participants |
| FU: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Hematology: Absolute Lymphocyte Count: Low: Grade 3 | 0 Participants |
| FU: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Chemistry: Creatinine Kinase : High: Grade 3 | 0 Participants |
| FU: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Hematology: Hemoglobin: Low: Grade 3 | 0 Participants |
| FU: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Hematology: Neutrophils Band Form: Low: Grade 4 | 1 Participants |
| FU: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Chemistry: GFR from Cr Adjusted for BSA, Low: Grade 3 | 0 Participants |
| FU: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Chemistry: GFR from Cy C Adjusted for BSA, Low: Grade 4 | 0 Participants |
| FU: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Chemistry: Cholesterol (Fasting): High: Grade 3 | 0 Participants |
| FU: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Chemistry: GFR from Cy C Adjusted for BSA, Low: Grade 4 | 0 Participants |
| FU: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Chemistry: ALT or SGPT: High: Grade 3 | 0 Participants |
| FU: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Chemistry: Creatinine Kinase : High: Grade 3 | 0 Participants |
| FU: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Hematology: Absolute Neutrophil Count: Grade 3 | 0 Participants |
| FU: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Chemistry: LDL (Fasting): High: Grade 3 | 0 Participants |
| FU: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Hematology: WBC Decreased: Low: Grade 3 | 0 Participants |
| FU: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Chemistry: Creatinine Kinase : High: Grade 4 | 0 Participants |
| FU: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Hematology: Neutrophils Segmented: Low: Grade 3 | 0 Participants |
| FU: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Chemistry: Triglycerides (Fasting): High: Grade 3 | 0 Participants |
| FU: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Hematology: Absolute Lymphocyte Count: Low: Grade 3 | 0 Participants |
| FU: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Urinalysis: Glycosuria: Grade 3 | 1 Participants |
| FU: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Chemistry: AST or SGOT: High: Grade 3 | 0 Participants |
| FU: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Chemistry: GFR from Cy C Adjusted for BSA, Low: Grade 3 | 0 Participants |
| FU: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Chemistry: GFR from Cr Adjusted for BSA, Low: Grade 3 | 0 Participants |
| FU: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Hematology: Hemoglobin: Low: Grade 3 | 1 Participants |
| FU: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Hematology: Absolute Neutrophil Count: Grade 3 | 0 Participants |
| FU: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Chemistry: Creatinine Kinase : High: Grade 3 | 0 Participants |
| FU: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Chemistry: Creatinine Kinase : High: Grade 4 | 0 Participants |
| FU: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Chemistry: Triglycerides (Fasting): High: Grade 3 | 0 Participants |
| FU: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Hematology: Hemoglobin: Low: Grade 3 | 0 Participants |
| FU: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Chemistry: ALT or SGPT: High: Grade 3 | 0 Participants |
| FU: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Chemistry: Cholesterol (Fasting): High: Grade 3 | 0 Participants |
| FU: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Chemistry: GFR from Cy C Adjusted for BSA, Low: Grade 3 | 1 Participants |
| FU: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Chemistry: LDL (Fasting): High: Grade 3 | 0 Participants |
| FU: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Hematology: Neutrophils Band Form: Low: Grade 4 | 1 Participants |
| FU: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Chemistry: GFR from Cy C Adjusted for BSA, Low: Grade 4 | 1 Participants |
| FU: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Hematology: Absolute Lymphocyte Count: Low: Grade 3 | 0 Participants |
| FU: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Chemistry: GFR from Cr Adjusted for BSA, Low: Grade 3 | 0 Participants |
| FU: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Urinalysis: Glycosuria: Grade 3 | 0 Participants |
| FU: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Hematology: Neutrophils Segmented: Low: Grade 3 | 0 Participants |
| FU: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Hematology: WBC Decreased: Low: Grade 3 | 0 Participants |
| FU: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests | Chemistry: AST or SGOT: High: Grade 3 | 1 Participants |
Secondary
Number of Participants With Worst Treatment-emergent Abnormalities in Vital Signs
Number of participants with worst treatment-emergent abnormalities in vital signs were reported. Treatment-emergent abnormality was defined as the abnormalities that were worsened as compared to the abnormality at baseline; which also included the shift from abnormally high to abnormally low and vice-versa. Abnormalities in vital signs included abnormal pulse rate (PR); abnormally low, \<=45 bpm and abnormally high \>=120 bpm; diastolic blood pressure (DBP) abnormally low \<=50 mmHg, systolic blood pressure (SBP) abnormally low \<=90 mmHg. Additionally, abnormal low SBP and DBP were \<=50 mmHg and \<+90 mmHg. Only those categories in which at least one participant had data were reported.
Time frame: IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Population: Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: JNJ-3989 200 mg+ JNJ-6379 250 mg+ NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Number of Participants With Worst Treatment-emergent Abnormalities in Vital Signs | Pulse rate: High | 0 Participants |
| Cohort 1: JNJ-3989 200 mg+ JNJ-6379 250 mg+ NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Number of Participants With Worst Treatment-emergent Abnormalities in Vital Signs | SBP: High | 2 Participants |
| Cohort 1: JNJ-3989 200 mg+ JNJ-6379 250 mg+ NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Number of Participants With Worst Treatment-emergent Abnormalities in Vital Signs | DBP: High: | 3 Participants |
| Cohort 1: JNJ-3989 200 mg+ JNJ-6379 250 mg+ NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Number of Participants With Worst Treatment-emergent Abnormalities in Vital Signs | SBP: Low | 0 Participants |
| Cohort 1: JNJ-3989 200 mg+ NA (245/25 mg) + PegIFNalpha-2a 180 mcg | Number of Participants With Worst Treatment-emergent Abnormalities in Vital Signs | Pulse rate: High | 1 Participants |
| Cohort 1: JNJ-3989 200 mg+ NA (245/25 mg) + PegIFNalpha-2a 180 mcg | Number of Participants With Worst Treatment-emergent Abnormalities in Vital Signs | DBP: High: | 1 Participants |
| Cohort 1: JNJ-3989 200 mg+ NA (245/25 mg) + PegIFNalpha-2a 180 mcg | Number of Participants With Worst Treatment-emergent Abnormalities in Vital Signs | SBP: Low | 1 Participants |
| Cohort 1: JNJ-3989 200 mg+ NA (245/25 mg) + PegIFNalpha-2a 180 mcg | Number of Participants With Worst Treatment-emergent Abnormalities in Vital Signs | SBP: High | 1 Participants |
| Cohort 2: JNJ-3989 200 mg+ NA (245/25 mg)+ PegIFNalpha-2a 180 mcg | Number of Participants With Worst Treatment-emergent Abnormalities in Vital Signs | DBP: High: | 1 Participants |
| Cohort 2: JNJ-3989 200 mg+ NA (245/25 mg)+ PegIFNalpha-2a 180 mcg | Number of Participants With Worst Treatment-emergent Abnormalities in Vital Signs | Pulse rate: High | 0 Participants |
| Cohort 2: JNJ-3989 200 mg+ NA (245/25 mg)+ PegIFNalpha-2a 180 mcg | Number of Participants With Worst Treatment-emergent Abnormalities in Vital Signs | SBP: Low | 0 Participants |
| Cohort 2: JNJ-3989 200 mg+ NA (245/25 mg)+ PegIFNalpha-2a 180 mcg | Number of Participants With Worst Treatment-emergent Abnormalities in Vital Signs | SBP: High | 3 Participants |
| CP: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg | Number of Participants With Worst Treatment-emergent Abnormalities in Vital Signs | Pulse rate: High | 0 Participants |
| CP: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg | Number of Participants With Worst Treatment-emergent Abnormalities in Vital Signs | SBP: High | 1 Participants |
| CP: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg | Number of Participants With Worst Treatment-emergent Abnormalities in Vital Signs | DBP: High: | 1 Participants |
| CP: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg | Number of Participants With Worst Treatment-emergent Abnormalities in Vital Signs | SBP: Low | 1 Participants |
| CP: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Number of Participants With Worst Treatment-emergent Abnormalities in Vital Signs | SBP: High | 0 Participants |
| CP: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Number of Participants With Worst Treatment-emergent Abnormalities in Vital Signs | SBP: Low | 1 Participants |
| CP: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Number of Participants With Worst Treatment-emergent Abnormalities in Vital Signs | DBP: High: | 0 Participants |
| CP: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Number of Participants With Worst Treatment-emergent Abnormalities in Vital Signs | Pulse rate: High | 0 Participants |
| CP: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Number of Participants With Worst Treatment-emergent Abnormalities in Vital Signs | Pulse rate: High | 1 Participants |
| CP: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Number of Participants With Worst Treatment-emergent Abnormalities in Vital Signs | DBP: High: | 1 Participants |
| CP: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Number of Participants With Worst Treatment-emergent Abnormalities in Vital Signs | SBP: High | 0 Participants |
| CP: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Number of Participants With Worst Treatment-emergent Abnormalities in Vital Signs | SBP: Low | 1 Participants |
| FU: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg | Number of Participants With Worst Treatment-emergent Abnormalities in Vital Signs | Pulse rate: High | 0 Participants |
| FU: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg | Number of Participants With Worst Treatment-emergent Abnormalities in Vital Signs | SBP: Low | 1 Participants |
| FU: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg | Number of Participants With Worst Treatment-emergent Abnormalities in Vital Signs | DBP: High: | 1 Participants |
| FU: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg | Number of Participants With Worst Treatment-emergent Abnormalities in Vital Signs | SBP: High | 2 Participants |
| FU: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Number of Participants With Worst Treatment-emergent Abnormalities in Vital Signs | DBP: High: | 1 Participants |
| FU: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Number of Participants With Worst Treatment-emergent Abnormalities in Vital Signs | SBP: High | 1 Participants |
| FU: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Number of Participants With Worst Treatment-emergent Abnormalities in Vital Signs | SBP: Low | 0 Participants |
| FU: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Number of Participants With Worst Treatment-emergent Abnormalities in Vital Signs | Pulse rate: High | 0 Participants |
| FU: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Number of Participants With Worst Treatment-emergent Abnormalities in Vital Signs | SBP: High | 1 Participants |
| FU: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Number of Participants With Worst Treatment-emergent Abnormalities in Vital Signs | DBP: High: | 0 Participants |
| FU: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Number of Participants With Worst Treatment-emergent Abnormalities in Vital Signs | Pulse rate: High | 0 Participants |
| FU: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Number of Participants With Worst Treatment-emergent Abnormalities in Vital Signs | SBP: Low | 0 Participants |
Secondary
Number of Participants With Worst Treatment-emergent Abnormality in Electrocardiogram (ECGs)
Number of participants with worst treatment-emergent abnormality in ECG were reported. Treatment-emergent abnormality was defined as the abnormalities that were worsened as compared to the abnormality at baseline; which also included the shift from abnormally high to abnormally low and vice-versa. ECG parameters included heart rate (HR; abnormally low, HR \<45 beats per minute (bpm) and (abnormally high HR\>=120 bpm; PR interval abnormally high \>220 milliseconds (ms): QRS interval abnormally high \>=120 ms; QT corrected (Fridericia QTcF) categories; borderline prolonged QTc interval \<450 to \<=480 ms), prolonged QTc interval \<480 to \<=500 ms) and pathologically prolonged QTc interval \>500 ms).
Time frame: IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Population: Safety analysis set included all participants who received at least one dose of study intervention. Participants were analyzed according to the study intervention they actually received.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1: JNJ-3989 200 mg+ JNJ-6379 250 mg+ NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Number of Participants With Worst Treatment-emergent Abnormality in Electrocardiogram (ECGs) | 0 Participants |
| Cohort 1: JNJ-3989 200 mg+ NA (245/25 mg) + PegIFNalpha-2a 180 mcg | Number of Participants With Worst Treatment-emergent Abnormality in Electrocardiogram (ECGs) | 0 Participants |
| Cohort 2: JNJ-3989 200 mg+ NA (245/25 mg)+ PegIFNalpha-2a 180 mcg | Number of Participants With Worst Treatment-emergent Abnormality in Electrocardiogram (ECGs) | 0 Participants |
| CP: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg | Number of Participants With Worst Treatment-emergent Abnormality in Electrocardiogram (ECGs) | 0 Participants |
| CP: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Number of Participants With Worst Treatment-emergent Abnormality in Electrocardiogram (ECGs) | 0 Participants |
| CP: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Number of Participants With Worst Treatment-emergent Abnormality in Electrocardiogram (ECGs) | 0 Participants |
| FU: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg | Number of Participants With Worst Treatment-emergent Abnormality in Electrocardiogram (ECGs) | 0 Participants |
| FU: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Number of Participants With Worst Treatment-emergent Abnormality in Electrocardiogram (ECGs) | 0 Participants |
| FU: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Number of Participants With Worst Treatment-emergent Abnormality in Electrocardiogram (ECGs) | 0 Participants |
Secondary
Percentage of Participants Who Achieved Reduction (Sustained) in HBsAg Response (Per Definition 2) at Follow-up Week 48
Percentage of participants with sustained (reduction) HBsAg response (per Definition 2) were reported. Sustained HBsAg response (per Definition 2) was defined as: for participants with a \>1 log decline in HBsAg from baseline at last follow-up visit: Among the most recent three visits, the difference between log10 HBsAg at 2 of 3 last visit and 1 of 3 last visit was \<0.2, and the difference between log10 HBsAg at 3 of 3 last visit and 1 of 3 last visit was \<0.2.
Time frame: At FU Week 48 (Week 112 [Cohort 1]; Week 96 [Cohort 2])
Population: Treated analysis set included all participants who received at least 1 dose of study treatment within this ISA. Here N (Number of participants analyzed) signifies participants who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1: JNJ-3989 200 mg+ JNJ-6379 250 mg+ NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Percentage of Participants Who Achieved Reduction (Sustained) in HBsAg Response (Per Definition 2) at Follow-up Week 48 | 65.4 percentage of participants |
| Cohort 1: JNJ-3989 200 mg+ NA (245/25 mg) + PegIFNalpha-2a 180 mcg | Percentage of Participants Who Achieved Reduction (Sustained) in HBsAg Response (Per Definition 2) at Follow-up Week 48 | 42.9 percentage of participants |
| Cohort 2: JNJ-3989 200 mg+ NA (245/25 mg)+ PegIFNalpha-2a 180 mcg | Percentage of Participants Who Achieved Reduction (Sustained) in HBsAg Response (Per Definition 2) at Follow-up Week 48 | 70.6 percentage of participants |
Secondary
Percentage of Participants Who Achieved Reduction (Sustained) in HBsAg Response (Per Definition 3) at Follow-up Week 48
Percentage of participants with sustained (reduction) HBsAg response (per definition 3) were reported. Sustained HBsAg response (per Definition 3) was defined as: for participants with a \>1 log decline in HBsAg from baseline at last follow-up visit: Among the most recent three visits, the difference between log10 HBsAg at 2 of 3 last visit and 1 of 3 last visit was \<0.2, and the difference between log10 HBsAg at 3 of 3 last visit and 1 of 3 last visit was \<0.2 and had an HBsAg \<1000 IU/mL at the last available timepoint.
Time frame: At FU Week 48 (Week 112 [Cohort 1]; Week 96 [Cohort 2])
Population: Treated analysis set included all participants who received at least 1 dose of study treatment within this ISA. Here N (Number of participants analyzed) signifies participants who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1: JNJ-3989 200 mg+ JNJ-6379 250 mg+ NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Percentage of Participants Who Achieved Reduction (Sustained) in HBsAg Response (Per Definition 3) at Follow-up Week 48 | 42.3 percentage of participants |
| Cohort 1: JNJ-3989 200 mg+ NA (245/25 mg) + PegIFNalpha-2a 180 mcg | Percentage of Participants Who Achieved Reduction (Sustained) in HBsAg Response (Per Definition 3) at Follow-up Week 48 | 28.6 percentage of participants |
| Cohort 2: JNJ-3989 200 mg+ NA (245/25 mg)+ PegIFNalpha-2a 180 mcg | Percentage of Participants Who Achieved Reduction (Sustained) in HBsAg Response (Per Definition 3) at Follow-up Week 48 | 52.9 percentage of participants |
Secondary
Percentage of Participants Who Achieved Reduction (Sustained) in HBsAg Response (Per Definition 4) at Follow-up Week 48
Percentage of participants with sustained (reduction) HBsAg response per Definition 4 were reported. Sustained HBsAg response (per Definition 4) was defined as stable level, decreasing level, and increasing level. Stable level: when HBsAg change from consolidation week 12 to last available follow-up timepoint was within 0.2 log10. Decreasing level: when HBsAg change from consolidation week 12 to last available follow-up timepoint was less than -0.2 log10. Increasing level: when HBsAg change from consolidation week 12 to last available follow-up timepoint was more than 0.2 log10.
Time frame: At FU Week 48 (Week 112 [Cohort 1]; Week 96 [Cohort 2])
Population: Treated analysis set included all participants who received at least 1 dose of study treatment within this ISA. Here N (Number of participants analyzed) signifies the number of participants that were evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1: JNJ-3989 200 mg+ JNJ-6379 250 mg+ NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Percentage of Participants Who Achieved Reduction (Sustained) in HBsAg Response (Per Definition 4) at Follow-up Week 48 | Increased: > +0.2 log10 IU/mL | 76.9 percentage of participants |
| Cohort 1: JNJ-3989 200 mg+ JNJ-6379 250 mg+ NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Percentage of Participants Who Achieved Reduction (Sustained) in HBsAg Response (Per Definition 4) at Follow-up Week 48 | Decreased: <0.2 log10 IU/mL | 19.2 percentage of participants |
| Cohort 1: JNJ-3989 200 mg+ JNJ-6379 250 mg+ NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Percentage of Participants Who Achieved Reduction (Sustained) in HBsAg Response (Per Definition 4) at Follow-up Week 48 | Stable: within +/-0.2 log10 IU/mL | 0 percentage of participants |
| Cohort 1: JNJ-3989 200 mg+ JNJ-6379 250 mg+ NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Percentage of Participants Who Achieved Reduction (Sustained) in HBsAg Response (Per Definition 4) at Follow-up Week 48 | Missing | 3.9 percentage of participants |
| Cohort 1: JNJ-3989 200 mg+ NA (245/25 mg) + PegIFNalpha-2a 180 mcg | Percentage of Participants Who Achieved Reduction (Sustained) in HBsAg Response (Per Definition 4) at Follow-up Week 48 | Missing | 0 percentage of participants |
| Cohort 1: JNJ-3989 200 mg+ NA (245/25 mg) + PegIFNalpha-2a 180 mcg | Percentage of Participants Who Achieved Reduction (Sustained) in HBsAg Response (Per Definition 4) at Follow-up Week 48 | Stable: within +/-0.2 log10 IU/mL | 14.3 percentage of participants |
| Cohort 1: JNJ-3989 200 mg+ NA (245/25 mg) + PegIFNalpha-2a 180 mcg | Percentage of Participants Who Achieved Reduction (Sustained) in HBsAg Response (Per Definition 4) at Follow-up Week 48 | Decreased: <0.2 log10 IU/mL | 14.3 percentage of participants |
| Cohort 1: JNJ-3989 200 mg+ NA (245/25 mg) + PegIFNalpha-2a 180 mcg | Percentage of Participants Who Achieved Reduction (Sustained) in HBsAg Response (Per Definition 4) at Follow-up Week 48 | Increased: > +0.2 log10 IU/mL | 71.4 percentage of participants |
| Cohort 2: JNJ-3989 200 mg+ NA (245/25 mg)+ PegIFNalpha-2a 180 mcg | Percentage of Participants Who Achieved Reduction (Sustained) in HBsAg Response (Per Definition 4) at Follow-up Week 48 | Stable: within +/-0.2 log10 IU/mL | 11.8 percentage of participants |
| Cohort 2: JNJ-3989 200 mg+ NA (245/25 mg)+ PegIFNalpha-2a 180 mcg | Percentage of Participants Who Achieved Reduction (Sustained) in HBsAg Response (Per Definition 4) at Follow-up Week 48 | Increased: > +0.2 log10 IU/mL | 70.6 percentage of participants |
| Cohort 2: JNJ-3989 200 mg+ NA (245/25 mg)+ PegIFNalpha-2a 180 mcg | Percentage of Participants Who Achieved Reduction (Sustained) in HBsAg Response (Per Definition 4) at Follow-up Week 48 | Missing | 0 percentage of participants |
| Cohort 2: JNJ-3989 200 mg+ NA (245/25 mg)+ PegIFNalpha-2a 180 mcg | Percentage of Participants Who Achieved Reduction (Sustained) in HBsAg Response (Per Definition 4) at Follow-up Week 48 | Decreased: <0.2 log10 IU/mL | 17.6 percentage of participants |
Secondary
Percentage of Participants Who Met Nucleos(t)Ide Analog (NA) Treatment Completion Criteria at the End of Consolidation Phase
Percentage of participants meeting the protocol-defined NA treatment completion criteria at end of consolidation were reported. NA treatment completion criteria at CP Week 12 was defined as HBsAg \<10 IU/mL; HBeAg-negative; HBV DNA \<20 IU/mL, (that is, LLOQ); alanine aminotransferase(ALT) \<3\*ULN.
Time frame: At CP Week 12 (for Cohort 1 and 2)
Population: Treated analysis set included all participants who received at least 1 dose of study treatment within this ISA. Here N (Number of participants analyzed) signifies participants who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1: JNJ-3989 200 mg+ JNJ-6379 250 mg+ NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Percentage of Participants Who Met Nucleos(t)Ide Analog (NA) Treatment Completion Criteria at the End of Consolidation Phase | 0 percentage of participants |
| Cohort 1: JNJ-3989 200 mg+ NA (245/25 mg) + PegIFNalpha-2a 180 mcg | Percentage of Participants Who Met Nucleos(t)Ide Analog (NA) Treatment Completion Criteria at the End of Consolidation Phase | 0 percentage of participants |
| Cohort 2: JNJ-3989 200 mg+ NA (245/25 mg)+ PegIFNalpha-2a 180 mcg | Percentage of Participants Who Met Nucleos(t)Ide Analog (NA) Treatment Completion Criteria at the End of Consolidation Phase | 5.9 percentage of participants |
Secondary
Percentage of Participants Who Reached HBsAg Less Than (<) 10 (International Units Per Milliliter [IU/mL]) at the End of the Induction Phase (EOI)
Percentage of participants who reached HBsAg \<10 IU/mL at the end induction phase were reported.
Time frame: At IP Week 36 and EOI; anytime up to IP Week 52 for Cohort 1; up to IP Week 36 for Cohort 2
Population: Treated analysis set included all participants who received at least 1 dose of study treatment within this ISA. Here, n(number analyzed) signifies participants who were evaluable at specified timepoints. Data for this outcome measure were planned to be collected and analyzed for IP only.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1: JNJ-3989 200 mg+ JNJ-6379 250 mg+ NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Percentage of Participants Who Reached HBsAg Less Than (<) 10 (International Units Per Milliliter [IU/mL]) at the End of the Induction Phase (EOI) | IP Week 36 | 0 percentage of participants |
| Cohort 1: JNJ-3989 200 mg+ JNJ-6379 250 mg+ NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Percentage of Participants Who Reached HBsAg Less Than (<) 10 (International Units Per Milliliter [IU/mL]) at the End of the Induction Phase (EOI) | End of Induction phase | 15.4 percentage of participants |
| Cohort 1: JNJ-3989 200 mg+ NA (245/25 mg) + PegIFNalpha-2a 180 mcg | Percentage of Participants Who Reached HBsAg Less Than (<) 10 (International Units Per Milliliter [IU/mL]) at the End of the Induction Phase (EOI) | End of Induction phase | 37.5 percentage of participants |
| Cohort 2: JNJ-3989 200 mg+ NA (245/25 mg)+ PegIFNalpha-2a 180 mcg | Percentage of Participants Who Reached HBsAg Less Than (<) 10 (International Units Per Milliliter [IU/mL]) at the End of the Induction Phase (EOI) | IP Week 36 | 10 percentage of participants |
| Cohort 2: JNJ-3989 200 mg+ NA (245/25 mg)+ PegIFNalpha-2a 180 mcg | Percentage of Participants Who Reached HBsAg Less Than (<) 10 (International Units Per Milliliter [IU/mL]) at the End of the Induction Phase (EOI) | End of Induction phase | 10.5 percentage of participants |
Secondary
Percentage of Participants Who Reached HBV DNA Undetectability After Re-start of NA Treatment During Follow-up
Percentage of participants who reached HBV DNA undetectability after re-start of NA treatment during follow-up were reported. Undetectability of HBV DNA was defined as HBV DNA\<LLOQ that is \<20 IU/mL.
Time frame: FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Population: Treated analysis set included all participants who received at least 1 dose of study treatment within this ISA. Here N=0 signifies that data could not be analyzed due to insufficient number of participants with events.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1: JNJ-3989 200 mg+ JNJ-6379 250 mg+ NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Percentage of Participants Who Reached HBV DNA Undetectability After Re-start of NA Treatment During Follow-up | 0 percentage of participants |
| Cohort 1: JNJ-3989 200 mg+ NA (245/25 mg) + PegIFNalpha-2a 180 mcg | Percentage of Participants Who Reached HBV DNA Undetectability After Re-start of NA Treatment During Follow-up | 0 percentage of participants |
| Cohort 2: JNJ-3989 200 mg+ NA (245/25 mg)+ PegIFNalpha-2a 180 mcg | Percentage of Participants Who Reached HBV DNA Undetectability After Re-start of NA Treatment During Follow-up | 0 percentage of participants |
Secondary
Percentage of Participants With HBeAg Levels Below Different Cut-offs
Percentage of participants with HBeAg levels below different cut-offs were reported. The cut-offs for HBeAg levels were : \<LLOQ (\<0.11 IU/mL), \< 1 IU/mL, \< 10 IU/mL, \<100 IU/mL
Time frame: IP: Week 36, CP: Week 12; FU phase: Week 48 (Week 112 [Cohort 1]; Week 96 [Cohort 2])
Population: Treated analysis set included all participants who received at least 1 dose of study treatment within this ISA.Here N (Number of participants analyzed) signifies participants who were evaluable for this outcome measure and n(number analysed) signifies participants evaluable at specified timepoints. Here, n=0, signify that data were not collected and analyzed as that timepoint was not applicable to the respective arm.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1: JNJ-3989 200 mg+ JNJ-6379 250 mg+ NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBeAg Levels Below Different Cut-offs | IP Week 36: <0.11 IU/mL | 12.5 percentage of participants |
| Cohort 1: JNJ-3989 200 mg+ JNJ-6379 250 mg+ NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBeAg Levels Below Different Cut-offs | IP Week 36: <100 IU/mL | 91.7 percentage of participants |
| Cohort 1: JNJ-3989 200 mg+ JNJ-6379 250 mg+ NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBeAg Levels Below Different Cut-offs | IP Week 36: <10 IU/mL | 54.2 percentage of participants |
| Cohort 1: JNJ-3989 200 mg+ JNJ-6379 250 mg+ NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBeAg Levels Below Different Cut-offs | IP Week 36: <1 IU/mL | 20.8 percentage of participants |
| Cohort 1: JNJ-3989 200 mg+ NA (245/25 mg) + PegIFNalpha-2a 180 mcg | Percentage of Participants With HBeAg Levels Below Different Cut-offs | IP Week 36: <100 IU/mL | 100.0 percentage of participants |
| Cohort 1: JNJ-3989 200 mg+ NA (245/25 mg) + PegIFNalpha-2a 180 mcg | Percentage of Participants With HBeAg Levels Below Different Cut-offs | IP Week 36: <10 IU/mL | 71.4 percentage of participants |
| Cohort 1: JNJ-3989 200 mg+ NA (245/25 mg) + PegIFNalpha-2a 180 mcg | Percentage of Participants With HBeAg Levels Below Different Cut-offs | IP Week 36: <0.11 IU/mL | 0 percentage of participants |
| Cohort 1: JNJ-3989 200 mg+ NA (245/25 mg) + PegIFNalpha-2a 180 mcg | Percentage of Participants With HBeAg Levels Below Different Cut-offs | IP Week 36: <1 IU/mL | 14.3 percentage of participants |
| Cohort 2: JNJ-3989 200 mg+ NA (245/25 mg)+ PegIFNalpha-2a 180 mcg | Percentage of Participants With HBeAg Levels Below Different Cut-offs | IP Week 36: <10 IU/mL | 46.7 percentage of participants |
| Cohort 2: JNJ-3989 200 mg+ NA (245/25 mg)+ PegIFNalpha-2a 180 mcg | Percentage of Participants With HBeAg Levels Below Different Cut-offs | IP Week 36: <0.11 IU/mL | 0 percentage of participants |
| Cohort 2: JNJ-3989 200 mg+ NA (245/25 mg)+ PegIFNalpha-2a 180 mcg | Percentage of Participants With HBeAg Levels Below Different Cut-offs | IP Week 36: <100 IU/mL | 86.7 percentage of participants |
| Cohort 2: JNJ-3989 200 mg+ NA (245/25 mg)+ PegIFNalpha-2a 180 mcg | Percentage of Participants With HBeAg Levels Below Different Cut-offs | IP Week 36: <1 IU/mL | 20.0 percentage of participants |
| CP: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBeAg Levels Below Different Cut-offs | CP Week 12: <0.11 IU/mL | 12.5 percentage of participants |
| CP: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBeAg Levels Below Different Cut-offs | CP Week 12: <10 IU/mL | 75.0 percentage of participants |
| CP: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBeAg Levels Below Different Cut-offs | CP Week 12: <1 IU/mL | 37.5 percentage of participants |
| CP: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBeAg Levels Below Different Cut-offs | CP Week 12: <100 IU/mL | 95.8 percentage of participants |
| CP: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBeAg Levels Below Different Cut-offs | CP Week 12: <0.11 IU/mL | 14.3 percentage of participants |
| CP: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBeAg Levels Below Different Cut-offs | CP Week 12: <1 IU/mL | 14.3 percentage of participants |
| CP: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBeAg Levels Below Different Cut-offs | CP Week 12: <10 IU/mL | 100.0 percentage of participants |
| CP: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBeAg Levels Below Different Cut-offs | CP Week 12: <100 IU/mL | 100.0 percentage of participants |
| CP: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBeAg Levels Below Different Cut-offs | CP Week 12: <100 IU/mL | 94.1 percentage of participants |
| CP: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBeAg Levels Below Different Cut-offs | CP Week 12: <1 IU/mL | 47.1 percentage of participants |
| CP: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBeAg Levels Below Different Cut-offs | CP Week 12: <10 IU/mL | 76.5 percentage of participants |
| CP: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBeAg Levels Below Different Cut-offs | CP Week 12: <0.11 IU/mL | 17.6 percentage of participants |
| FU: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBeAg Levels Below Different Cut-offs | FU Week 48: <1 IU/mL | 44.0 percentage of participants |
| FU: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBeAg Levels Below Different Cut-offs | FU Week 48: <0.11 IU/mL | 28.0 percentage of participants |
| FU: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBeAg Levels Below Different Cut-offs | FU Week 48: <10 IU/mL | 80.0 percentage of participants |
| FU: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBeAg Levels Below Different Cut-offs | FU Week 48: <100IU/mL | 96.0 percentage of participants |
| FU: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBeAg Levels Below Different Cut-offs | FU Week 48: <1 IU/mL | 50.0 percentage of participants |
| FU: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBeAg Levels Below Different Cut-offs | FU Week 48: <10 IU/mL | 83.3 percentage of participants |
| FU: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBeAg Levels Below Different Cut-offs | FU Week 48: <100IU/mL | 100 percentage of participants |
| FU: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBeAg Levels Below Different Cut-offs | FU Week 48: <0.11 IU/mL | 33.3 percentage of participants |
| FU: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBeAg Levels Below Different Cut-offs | FU Week 48: <10 IU/mL | 76.5 percentage of participants |
| FU: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBeAg Levels Below Different Cut-offs | FU Week 48: <1 IU/mL | 52.9 percentage of participants |
| FU: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBeAg Levels Below Different Cut-offs | FU Week 48: <0.11 IU/mL | 17.6 percentage of participants |
| FU: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBeAg Levels Below Different Cut-offs | FU Week 48: <100IU/mL | 100 percentage of participants |
Secondary
Percentage of Participants With HBeAg Seroclearance at Follow-up Week 48
Percentage of participants with HBeAg seroclearance were reported. HBeAg seroclearance was defined as (quantitative) HBeAg levels \<LLOQ (\<0.11 IU/mL).
Time frame: At FU Week 48 (Week 112 [Cohort 1]; Week 96 [Cohort 2])
Population: Treated analysis set included all participants who received at least 1 dose of study treatment within this ISA. Here N (Number of participants analyzed) signifies the number of participants that were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1: JNJ-3989 200 mg+ JNJ-6379 250 mg+ NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBeAg Seroclearance at Follow-up Week 48 | 28.0 percentage of participants |
| Cohort 1: JNJ-3989 200 mg+ NA (245/25 mg) + PegIFNalpha-2a 180 mcg | Percentage of Participants With HBeAg Seroclearance at Follow-up Week 48 | 33.3 percentage of participants |
| Cohort 2: JNJ-3989 200 mg+ NA (245/25 mg)+ PegIFNalpha-2a 180 mcg | Percentage of Participants With HBeAg Seroclearance at Follow-up Week 48 | 17.6 percentage of participants |
Secondary
Percentage of Participants With HBeAg Seroconversion
Percentage of participants with HBeAg seroconversion were reported. Seroconversion of HBeAg was defined as having achieved HBeAg seroclearance (defined as \[quantitative\] HBeAg \<LLOQ \[\<0.11 IU/mL\]) together with appearance of anti-HBe antibodies (defined as a baseline anti-HBe antibodies \[qualitative\] with a negative result and a post-baseline assessment with positive result).
Time frame: CP: Week 12; FU phase: FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Population: Treated analysis set included all participants who received at least 1 dose of study treatment within this ISA. Here N (Number of participants analyzed) signifies participants who were evaluable for this outcome measure and n(number analyzed) signifies participants evaluable at specified timepoints. Data were planned to be collected and analyzed for CP and FU phase only. Here, n=0, signify that data were not collected and analyzed as that timepoint was not applicable to the respective arm.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1: JNJ-3989 200 mg+ JNJ-6379 250 mg+ NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBeAg Seroconversion | CP: Week 12 | 0 percentage of participants |
| Cohort 1: JNJ-3989 200 mg+ NA (245/25 mg) + PegIFNalpha-2a 180 mcg | Percentage of Participants With HBeAg Seroconversion | CP: Week 12 | 16.7 percentage of participants |
| Cohort 2: JNJ-3989 200 mg+ NA (245/25 mg)+ PegIFNalpha-2a 180 mcg | Percentage of Participants With HBeAg Seroconversion | CP: Week 12 | 9.1 percentage of participants |
| CP: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBeAg Seroconversion | FU phase: week 48 | 18.2 percentage of participants |
| CP: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBeAg Seroconversion | FU phase: week 48 | 20.0 percentage of participants |
| CP: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBeAg Seroconversion | FU phase: week 48 | 27.3 percentage of participants |
Secondary
Percentage of Participants With HBsAg Levels Below Different Cut-offs
Percentage of participants with HBsAg levels below different cut-offs were reported. The cut-offs for HBsAg level were: \<LLOQ (\<0.05 IU/mL), \<1 IU/mL, \<10 IU/mL, \<100 IU/mL, \<1000 IU/mL.
Time frame: IP: Week 36, CP: Week 12; FU phase: Week 48 (Week 112 [Cohort 1]; Week 96 [Cohort 2])
Population: Treated analysis set included all participants who received at least 1 dose of study treatment within this ISA.Here N (Number of participants analyzed) signifies participants who were evaluable for this outcome measure and n(number analysed) signifies participants evaluable at specified timepoints. Here, n=0, signify that data were not collected and analyzed as that timepoint was not applicable to the respective arm.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1: JNJ-3989 200 mg+ JNJ-6379 250 mg+ NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBsAg Levels Below Different Cut-offs | IP Week 36: <1000 IU/mL | 88.0 percentage of participants |
| Cohort 1: JNJ-3989 200 mg+ JNJ-6379 250 mg+ NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBsAg Levels Below Different Cut-offs | IP Week 36: <10 IU/mL | 24.0 percentage of participants |
| Cohort 1: JNJ-3989 200 mg+ JNJ-6379 250 mg+ NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBsAg Levels Below Different Cut-offs | IP Week 36: <1 IU/mL | 4.0 percentage of participants |
| Cohort 1: JNJ-3989 200 mg+ JNJ-6379 250 mg+ NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBsAg Levels Below Different Cut-offs | IP Week 36: <0.05 IU/mL | 0 percentage of participants |
| Cohort 1: JNJ-3989 200 mg+ JNJ-6379 250 mg+ NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBsAg Levels Below Different Cut-offs | IP Week 36: <100 IU/mL | 40.0 percentage of participants |
| Cohort 1: JNJ-3989 200 mg+ NA (245/25 mg) + PegIFNalpha-2a 180 mcg | Percentage of Participants With HBsAg Levels Below Different Cut-offs | IP Week 36: <1000 IU/mL | 100.0 percentage of participants |
| Cohort 1: JNJ-3989 200 mg+ NA (245/25 mg) + PegIFNalpha-2a 180 mcg | Percentage of Participants With HBsAg Levels Below Different Cut-offs | IP Week 36: <0.05 IU/mL | 14.3 percentage of participants |
| Cohort 1: JNJ-3989 200 mg+ NA (245/25 mg) + PegIFNalpha-2a 180 mcg | Percentage of Participants With HBsAg Levels Below Different Cut-offs | IP Week 36: <10 IU/mL | 42.9 percentage of participants |
| Cohort 1: JNJ-3989 200 mg+ NA (245/25 mg) + PegIFNalpha-2a 180 mcg | Percentage of Participants With HBsAg Levels Below Different Cut-offs | IP Week 36: <1 IU/mL | 28.6 percentage of participants |
| Cohort 1: JNJ-3989 200 mg+ NA (245/25 mg) + PegIFNalpha-2a 180 mcg | Percentage of Participants With HBsAg Levels Below Different Cut-offs | IP Week 36: <100 IU/mL | 42.9 percentage of participants |
| Cohort 2: JNJ-3989 200 mg+ NA (245/25 mg)+ PegIFNalpha-2a 180 mcg | Percentage of Participants With HBsAg Levels Below Different Cut-offs | IP Week 36: <0.05 IU/mL | 0 percentage of participants |
| Cohort 2: JNJ-3989 200 mg+ NA (245/25 mg)+ PegIFNalpha-2a 180 mcg | Percentage of Participants With HBsAg Levels Below Different Cut-offs | IP Week 36: <1 IU/mL | 0 percentage of participants |
| Cohort 2: JNJ-3989 200 mg+ NA (245/25 mg)+ PegIFNalpha-2a 180 mcg | Percentage of Participants With HBsAg Levels Below Different Cut-offs | IP Week 36: <10 IU/mL | 13.3 percentage of participants |
| Cohort 2: JNJ-3989 200 mg+ NA (245/25 mg)+ PegIFNalpha-2a 180 mcg | Percentage of Participants With HBsAg Levels Below Different Cut-offs | IP Week 36: <100 IU/mL | 66.7 percentage of participants |
| Cohort 2: JNJ-3989 200 mg+ NA (245/25 mg)+ PegIFNalpha-2a 180 mcg | Percentage of Participants With HBsAg Levels Below Different Cut-offs | IP Week 36: <1000 IU/mL | 86.7 percentage of participants |
| CP: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBsAg Levels Below Different Cut-offs | CP Week 12: <100 IU/mL | 60.0 percentage of participants |
| CP: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBsAg Levels Below Different Cut-offs | CP Week 12: <10 IU/mL | 40.0 percentage of participants |
| CP: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBsAg Levels Below Different Cut-offs | CP Week 12: <1000 IU0/mL | 100.0 percentage of participants |
| CP: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBsAg Levels Below Different Cut-offs | CP Week 12: <0.05 IU/mL | 8.0 percentage of participants |
| CP: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBsAg Levels Below Different Cut-offs | CP Week 12: <1 IU/mL | 20.0 percentage of participants |
| CP: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBsAg Levels Below Different Cut-offs | CP Week 12: <100 IU/mL | 71.4 percentage of participants |
| CP: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBsAg Levels Below Different Cut-offs | CP Week 12: <0.05 IU/mL | 42.9 percentage of participants |
| CP: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBsAg Levels Below Different Cut-offs | CP Week 12: <1 IU/mL | 42.9 percentage of participants |
| CP: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBsAg Levels Below Different Cut-offs | CP Week 12: <10 IU/mL | 42.9 percentage of participants |
| CP: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBsAg Levels Below Different Cut-offs | CP Week 12: <1000 IU0/mL | 100.0 percentage of participants |
| CP: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBsAg Levels Below Different Cut-offs | CP Week 12: <0.05 IU/mL | 5.9 percentage of participants |
| CP: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBsAg Levels Below Different Cut-offs | CP Week 12: <1000 IU0/mL | 94.1 percentage of participants |
| CP: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBsAg Levels Below Different Cut-offs | CP Week 12: <1 IU/mL | 23.5 percentage of participants |
| CP: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBsAg Levels Below Different Cut-offs | CP Week 12: <100 IU/mL | 76.5 percentage of participants |
| CP: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBsAg Levels Below Different Cut-offs | CP Week 12: <10 IU/mL | 47.1 percentage of participants |
| FU: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBsAg Levels Below Different Cut-offs | FU Week 48: <1 IU/mL | 11.5 percentage of participants |
| FU: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBsAg Levels Below Different Cut-offs | FU Week 48: <1000 IU/mL | 57.7 percentage of participants |
| FU: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBsAg Levels Below Different Cut-offs | FU Week 48: <0.05 IU/mL | 11.5 percentage of participants |
| FU: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBsAg Levels Below Different Cut-offs | FU Week 48: <10 IU/mL | 19.2 percentage of participants |
| FU: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBsAg Levels Below Different Cut-offs | FU Week 48: <100 IU/mL | 26.9 percentage of participants |
| FU: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBsAg Levels Below Different Cut-offs | FU Week 48: <1 IU/mL | 33.3 percentage of participants |
| FU: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBsAg Levels Below Different Cut-offs | FU Week 48: <10 IU/mL | 50.0 percentage of participants |
| FU: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBsAg Levels Below Different Cut-offs | FU Week 48: <100 IU/mL | 50.0 percentage of participants |
| FU: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBsAg Levels Below Different Cut-offs | FU Week 48: <0.05 IU/mL | 16.7 percentage of participants |
| FU: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBsAg Levels Below Different Cut-offs | FU Week 48: <1000 IU/mL | 66.7 percentage of participants |
| FU: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBsAg Levels Below Different Cut-offs | FU Week 48: <0.05 IU/mL | 11.8 percentage of participants |
| FU: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBsAg Levels Below Different Cut-offs | FU Week 48: <1 IU/mL | 17.6 percentage of participants |
| FU: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBsAg Levels Below Different Cut-offs | FU Week 48: <1000 IU/mL | 76.5 percentage of participants |
| FU: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBsAg Levels Below Different Cut-offs | FU Week 48: <10 IU/mL | 29.4 percentage of participants |
| FU: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBsAg Levels Below Different Cut-offs | FU Week 48: <100 IU/mL | 47.1 percentage of participants |
Secondary
Percentage of Participants With HBsAg Seroclearance at Follow-up Week 48
Percentage of Participants with HBsAg Seroclearance were reported. HBsAg seroclearance was defined as (quantitative) HBsAg level \<LLOQ (\<0.05 IU/mL).
Time frame: At FU Week 48 (Week 112 [Cohort 1]; Week 96 [Cohort 2])
Population: Treated analysis set included all participants who received at least 1 dose of study treatment within this ISA. Here N (Number of participants analyzed) signifies participants who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1: JNJ-3989 200 mg+ JNJ-6379 250 mg+ NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBsAg Seroclearance at Follow-up Week 48 | 11.5 percentage of participants |
| Cohort 1: JNJ-3989 200 mg+ NA (245/25 mg) + PegIFNalpha-2a 180 mcg | Percentage of Participants With HBsAg Seroclearance at Follow-up Week 48 | 16.7 percentage of participants |
| Cohort 2: JNJ-3989 200 mg+ NA (245/25 mg)+ PegIFNalpha-2a 180 mcg | Percentage of Participants With HBsAg Seroclearance at Follow-up Week 48 | 11.8 percentage of participants |
Secondary
Percentage of Participants With HBsAg Seroconversion
Seroconversion of HBsAg was defined as having achieved HBsAg seroclearance (defined as quantitative HBsAg \<LLOQ \[\<0.05 IU/mL\]) and appearance of anti-HBs antibodies (defined as a baseline anti-HBs antibodies \[quantitative\] \<LLOQ \[\<5 milli-international units per milliliter (mIU/mL)\] and a post-baseline assessment \>=LLOQ \[\>=5 mIU/mL\]).
Time frame: IP Week 24; CP: Week 12, FU phase: Week 48 (Week 112 [Cohort 1]; Week 96 [Cohort 2])
Population: Treated analysis set included all participants who received at least 1 dose of study treatment within this ISA. Here N (Number of participants analyzed) signifies participants who were evaluable for this outcome measure and n (number analyzed) signifies participants evaluable at specified timepoints. Also, n=0 signifies that data were not collected and analyzed as that timepoint was not applicable to the respective arm.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1: JNJ-3989 200 mg+ JNJ-6379 250 mg+ NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBsAg Seroconversion | IP: Week 24 | 0 percentage of participants |
| Cohort 1: JNJ-3989 200 mg+ NA (245/25 mg) + PegIFNalpha-2a 180 mcg | Percentage of Participants With HBsAg Seroconversion | IP: Week 24 | 0 percentage of participants |
| Cohort 2: JNJ-3989 200 mg+ NA (245/25 mg)+ PegIFNalpha-2a 180 mcg | Percentage of Participants With HBsAg Seroconversion | IP: Week 24 | 0 percentage of participants |
| CP: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBsAg Seroconversion | CP: Week 12 | 8.3 percentage of participants |
| CP: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBsAg Seroconversion | CP: Week 12 | 33.3 percentage of participants |
| CP: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBsAg Seroconversion | CP: Week 12 | 6.7 percentage of participants |
| FU: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBsAg Seroconversion | FU phase Week 48 | 12.0 percentage of participants |
| FU: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBsAg Seroconversion | FU phase Week 48 | 6.7 percentage of participants |
Secondary
Percentage of Participants With HBV DNA Levels Below Different Cut-offs
Percentage of participants with HBV DNA levels below cut-offs were reported. The cut-offs for HBV DNA were as follows: \<LLOQ (\<20 IU/mL) for target detected and not detected, \< LLOQ for target not detected , and \< LLOQ for target detected, \<60 IU/mL, \<100 IU/mL, \<200 IU/mL, \<1000 IU/mL, \<2000 IU/mL, \<20000 IU/mL.
Time frame: IP: Week 36; CP: Week 12; FU phase: Week 48 (Week 112 [Cohort 1]; Week 96 [Cohort 2])
Population: Treated analysis set included all participants who received at least 1 dose of study treatment within this ISA. Here N (Number of participants analyzed) signifies the number of participants that were evaluable for this outcome measure and n(number of participants analyzed) signifies participants analyzed at specified categories. Here, n=0, signify that data were not collected and analyzed as that timepoint was not applicable to the respective arm.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1: JNJ-3989 200 mg+ JNJ-6379 250 mg+ NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBV DNA Levels Below Different Cut-offs | IP Week 36:<LLOQ target detected and not detected | 52.0 percentage of participants |
| Cohort 1: JNJ-3989 200 mg+ JNJ-6379 250 mg+ NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBV DNA Levels Below Different Cut-offs | IP Week 36:<LLOQ for target not detected | 8.0 percentage of participants |
| Cohort 1: JNJ-3989 200 mg+ JNJ-6379 250 mg+ NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBV DNA Levels Below Different Cut-offs | IP Week 36:<100 IU/mL | 88.0 percentage of participants |
| Cohort 1: JNJ-3989 200 mg+ JNJ-6379 250 mg+ NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBV DNA Levels Below Different Cut-offs | IP Week 36:<2000 IU/mL | 100.0 percentage of participants |
| Cohort 1: JNJ-3989 200 mg+ JNJ-6379 250 mg+ NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBV DNA Levels Below Different Cut-offs | IP Week 36:<200 IU/mL | 92.0 percentage of participants |
| Cohort 1: JNJ-3989 200 mg+ JNJ-6379 250 mg+ NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBV DNA Levels Below Different Cut-offs | IP Week 36:<20000 IU/mL | 100.0 percentage of participants |
| Cohort 1: JNJ-3989 200 mg+ JNJ-6379 250 mg+ NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBV DNA Levels Below Different Cut-offs | IP Week 36:<LLOQ for target detected | 44.0 percentage of participants |
| Cohort 1: JNJ-3989 200 mg+ JNJ-6379 250 mg+ NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBV DNA Levels Below Different Cut-offs | IP Week 36:<1000 IU/mL | 100.0 percentage of participants |
| Cohort 1: JNJ-3989 200 mg+ JNJ-6379 250 mg+ NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBV DNA Levels Below Different Cut-offs | IP Week 36:<60 IU/mL | 72.0 percentage of participants |
| Cohort 1: JNJ-3989 200 mg+ NA (245/25 mg) + PegIFNalpha-2a 180 mcg | Percentage of Participants With HBV DNA Levels Below Different Cut-offs | IP Week 36:<1000 IU/mL | 100.0 percentage of participants |
| Cohort 1: JNJ-3989 200 mg+ NA (245/25 mg) + PegIFNalpha-2a 180 mcg | Percentage of Participants With HBV DNA Levels Below Different Cut-offs | IP Week 36:<20000 IU/mL | 100.0 percentage of participants |
| Cohort 1: JNJ-3989 200 mg+ NA (245/25 mg) + PegIFNalpha-2a 180 mcg | Percentage of Participants With HBV DNA Levels Below Different Cut-offs | IP Week 36:<LLOQ for target not detected | 0 percentage of participants |
| Cohort 1: JNJ-3989 200 mg+ NA (245/25 mg) + PegIFNalpha-2a 180 mcg | Percentage of Participants With HBV DNA Levels Below Different Cut-offs | IP Week 36:<LLOQ for target detected | 28.6 percentage of participants |
| Cohort 1: JNJ-3989 200 mg+ NA (245/25 mg) + PegIFNalpha-2a 180 mcg | Percentage of Participants With HBV DNA Levels Below Different Cut-offs | IP Week 36:<60 IU/mL | 57.1 percentage of participants |
| Cohort 1: JNJ-3989 200 mg+ NA (245/25 mg) + PegIFNalpha-2a 180 mcg | Percentage of Participants With HBV DNA Levels Below Different Cut-offs | IP Week 36:<200 IU/mL | 71.4 percentage of participants |
| Cohort 1: JNJ-3989 200 mg+ NA (245/25 mg) + PegIFNalpha-2a 180 mcg | Percentage of Participants With HBV DNA Levels Below Different Cut-offs | IP Week 36:<2000 IU/mL | 100.0 percentage of participants |
| Cohort 1: JNJ-3989 200 mg+ NA (245/25 mg) + PegIFNalpha-2a 180 mcg | Percentage of Participants With HBV DNA Levels Below Different Cut-offs | IP Week 36:<100 IU/mL | 57.1 percentage of participants |
| Cohort 1: JNJ-3989 200 mg+ NA (245/25 mg) + PegIFNalpha-2a 180 mcg | Percentage of Participants With HBV DNA Levels Below Different Cut-offs | IP Week 36:<LLOQ target detected and not detected | 28.6 percentage of participants |
| Cohort 2: JNJ-3989 200 mg+ NA (245/25 mg)+ PegIFNalpha-2a 180 mcg | Percentage of Participants With HBV DNA Levels Below Different Cut-offs | IP Week 36:<60 IU/mL | 73.3 percentage of participants |
| Cohort 2: JNJ-3989 200 mg+ NA (245/25 mg)+ PegIFNalpha-2a 180 mcg | Percentage of Participants With HBV DNA Levels Below Different Cut-offs | IP Week 36:<100 IU/mL | 80.0 percentage of participants |
| Cohort 2: JNJ-3989 200 mg+ NA (245/25 mg)+ PegIFNalpha-2a 180 mcg | Percentage of Participants With HBV DNA Levels Below Different Cut-offs | IP Week 36:<LLOQ for target not detected | 6.7 percentage of participants |
| Cohort 2: JNJ-3989 200 mg+ NA (245/25 mg)+ PegIFNalpha-2a 180 mcg | Percentage of Participants With HBV DNA Levels Below Different Cut-offs | IP Week 36:<LLOQ for target detected | 33.3 percentage of participants |
| Cohort 2: JNJ-3989 200 mg+ NA (245/25 mg)+ PegIFNalpha-2a 180 mcg | Percentage of Participants With HBV DNA Levels Below Different Cut-offs | IP Week 36:<2000 IU/mL | 100.0 percentage of participants |
| Cohort 2: JNJ-3989 200 mg+ NA (245/25 mg)+ PegIFNalpha-2a 180 mcg | Percentage of Participants With HBV DNA Levels Below Different Cut-offs | IP Week 36:<20000 IU/mL | 100.0 percentage of participants |
| Cohort 2: JNJ-3989 200 mg+ NA (245/25 mg)+ PegIFNalpha-2a 180 mcg | Percentage of Participants With HBV DNA Levels Below Different Cut-offs | IP Week 36:<LLOQ target detected and not detected | 40.0 percentage of participants |
| Cohort 2: JNJ-3989 200 mg+ NA (245/25 mg)+ PegIFNalpha-2a 180 mcg | Percentage of Participants With HBV DNA Levels Below Different Cut-offs | IP Week 36:<1000 IU/mL | 100.0 percentage of participants |
| Cohort 2: JNJ-3989 200 mg+ NA (245/25 mg)+ PegIFNalpha-2a 180 mcg | Percentage of Participants With HBV DNA Levels Below Different Cut-offs | IP Week 36:<200 IU/mL | 86.7 percentage of participants |
| CP: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBV DNA Levels Below Different Cut-offs | CP Week 12:<1000 IU/mL | 100.0 percentage of participants |
| CP: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBV DNA Levels Below Different Cut-offs | CP Week 12:<20000 IU/mL | 100.0 percentage of participants |
| CP: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBV DNA Levels Below Different Cut-offs | CP Week 12:<100 IU/mL | 92.0 percentage of participants |
| CP: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBV DNA Levels Below Different Cut-offs | CP Week 12:<LLOQ for target detected | 32.0 percentage of participants |
| CP: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBV DNA Levels Below Different Cut-offs | CP Week 12:<LLOQ for target not detected | 0 percentage of participants |
| CP: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBV DNA Levels Below Different Cut-offs | CP Week 12:<200 IU/mL | 96.0 percentage of participants |
| CP: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBV DNA Levels Below Different Cut-offs | CP Week 12:<60 IU/mL | 76.0 percentage of participants |
| CP: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBV DNA Levels Below Different Cut-offs | CP Week 12:<LLOQ: target detected and not detected | 32.0 percentage of participants |
| CP: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBV DNA Levels Below Different Cut-offs | CP Week 12:<2000 IU/mL | 100.0 percentage of participants |
| CP: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBV DNA Levels Below Different Cut-offs | CP Week 12:<2000 IU/mL | 100.0 percentage of participants |
| CP: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBV DNA Levels Below Different Cut-offs | CP Week 12:<LLOQ for target not detected | 0 percentage of participants |
| CP: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBV DNA Levels Below Different Cut-offs | CP Week 12:<20000 IU/mL | 100.0 percentage of participants |
| CP: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBV DNA Levels Below Different Cut-offs | CP Week 12:<200 IU/mL | 83.3 percentage of participants |
| CP: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBV DNA Levels Below Different Cut-offs | CP Week 12:<1000 IU/mL | 100.0 percentage of participants |
| CP: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBV DNA Levels Below Different Cut-offs | CP Week 12:<100 IU/mL | 83.3 percentage of participants |
| CP: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBV DNA Levels Below Different Cut-offs | CP Week 12:<LLOQ: target detected and not detected | 33.3 percentage of participants |
| CP: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBV DNA Levels Below Different Cut-offs | CP Week 12:<60 IU/mL | 50.0 percentage of participants |
| CP: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBV DNA Levels Below Different Cut-offs | CP Week 12:<LLOQ for target detected | 33.3 percentage of participants |
| CP: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBV DNA Levels Below Different Cut-offs | CP Week 12:<20000 IU/mL | 100.0 percentage of participants |
| CP: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBV DNA Levels Below Different Cut-offs | CP Week 12:<LLOQ for target not detected | 0 percentage of participants |
| CP: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBV DNA Levels Below Different Cut-offs | CP Week 12:<LLOQ for target detected | 29.4 percentage of participants |
| CP: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBV DNA Levels Below Different Cut-offs | CP Week 12:<200 IU/mL | 82.4 percentage of participants |
| CP: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBV DNA Levels Below Different Cut-offs | CP Week 12:<2000 IU/mL | 100.0 percentage of participants |
| CP: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBV DNA Levels Below Different Cut-offs | CP Week 12:<LLOQ: target detected and not detected | 29.4 percentage of participants |
| CP: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBV DNA Levels Below Different Cut-offs | CP Week 12:<60 IU/mL | 58.8 percentage of participants |
| CP: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBV DNA Levels Below Different Cut-offs | CP Week 12:<100 IU/mL | 64.7 percentage of participants |
| CP: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBV DNA Levels Below Different Cut-offs | CP Week 12:<1000 IU/mL | 94.1 percentage of participants |
| FU: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBV DNA Levels Below Different Cut-offs | FU Week 48:<2000 IU/mL | 100.0 percentage of participants |
| FU: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBV DNA Levels Below Different Cut-offs | FU Week 48:<60 IU/mL | 92.3 percentage of participants |
| FU: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBV DNA Levels Below Different Cut-offs | FU Week 48:<1000 IU/mL | 100.0 percentage of participants |
| FU: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBV DNA Levels Below Different Cut-offs | FU Week 48: <LLOQ for target not detected | 34.6 percentage of participants |
| FU: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBV DNA Levels Below Different Cut-offs | FU Week 48:<LLOQ target detected and not detected | 84.6 percentage of participants |
| FU: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBV DNA Levels Below Different Cut-offs | FU Week 48:<LLOQ for target detected | 50.0 percentage of participants |
| FU: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBV DNA Levels Below Different Cut-offs | FU Week 48:<100 IU/mL | 100.0 percentage of participants |
| FU: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBV DNA Levels Below Different Cut-offs | FU Week 48:<200 IU/mL | 100.0 percentage of participants |
| FU: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBV DNA Levels Below Different Cut-offs | FU Week 48:<20000 IU/mL | 100.0 percentage of participants |
| FU: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBV DNA Levels Below Different Cut-offs | FU Week 48:<200 IU/mL | 83.3 percentage of participants |
| FU: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBV DNA Levels Below Different Cut-offs | FU Week 48:<LLOQ target detected and not detected | 50.0 percentage of participants |
| FU: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBV DNA Levels Below Different Cut-offs | FU Week 48:<20000 IU/mL | 100.0 percentage of participants |
| FU: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBV DNA Levels Below Different Cut-offs | FU Week 48:<LLOQ for target detected | 33.3 percentage of participants |
| FU: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBV DNA Levels Below Different Cut-offs | FU Week 48:<100 IU/mL | 66.7 percentage of participants |
| FU: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBV DNA Levels Below Different Cut-offs | FU Week 48:<60 IU/mL | 50.0 percentage of participants |
| FU: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBV DNA Levels Below Different Cut-offs | FU Week 48:<2000 IU/mL | 83.3 percentage of participants |
| FU: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBV DNA Levels Below Different Cut-offs | FU Week 48: <LLOQ for target not detected | 16.7 percentage of participants |
| FU: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBV DNA Levels Below Different Cut-offs | FU Week 48:<1000 IU/mL | 83.3 percentage of participants |
| FU: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBV DNA Levels Below Different Cut-offs | FU Week 48: <LLOQ for target not detected | 17.6 percentage of participants |
| FU: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBV DNA Levels Below Different Cut-offs | FU Week 48:<LLOQ target detected and not detected | 88.2 percentage of participants |
| FU: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBV DNA Levels Below Different Cut-offs | FU Week 48:<60 IU/mL | 94.1 percentage of participants |
| FU: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBV DNA Levels Below Different Cut-offs | FU Week 48:<LLOQ for target detected | 70.6 percentage of participants |
| FU: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBV DNA Levels Below Different Cut-offs | FU Week 48:<200 IU/mL | 100.0 percentage of participants |
| FU: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBV DNA Levels Below Different Cut-offs | FU Week 48:<20000 IU/mL | 100.0 percentage of participants |
| FU: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBV DNA Levels Below Different Cut-offs | FU Week 48:<1000 IU/mL | 100.0 percentage of participants |
| FU: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBV DNA Levels Below Different Cut-offs | FU Week 48:<100 IU/mL | 100.0 percentage of participants |
| FU: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Percentage of Participants With HBV DNA Levels Below Different Cut-offs | FU Week 48:<2000 IU/mL | 100.0 percentage of participants |
Secondary
Percentage of Participants With Virologic Breakthrough
Percentage of participants with virologic breakthrough on treatment were reported. Virological breakthrough was defined as confirmed on-treatment HBV DNA increase by \>1 log10 IU/mL from nadir level (lowest level reached during treatment) in participants who did not have on-treatment HBV DNA level \< LLOQ (\<20 IU/mL) or confirmed on-treatment HBV DNA level \>200 IU/mL in participants who had on-treatment HBV DNA level \<LLOQ of the HBV DNA assay. Confirmed HBV DNA increase/level means that the criterion was fulfilled at 2 or more consecutive time points or at the last observed on-treatment time point.
Time frame: IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Population: Treated analysis set included all participants who received at least 1 dose of study treatment within this ISA. Here N (Number of participants analyzed) signifies participants who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1: JNJ-3989 200 mg+ JNJ-6379 250 mg+ NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Percentage of Participants With Virologic Breakthrough | 3.7 percentage of participants |
| Cohort 1: JNJ-3989 200 mg+ NA (245/25 mg) + PegIFNalpha-2a 180 mcg | Percentage of Participants With Virologic Breakthrough | 12.5 percentage of participants |
| Cohort 2: JNJ-3989 200 mg+ NA (245/25 mg)+ PegIFNalpha-2a 180 mcg | Percentage of Participants With Virologic Breakthrough | 0 percentage of participants |
| CP: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg | Percentage of Participants With Virologic Breakthrough | 0 percentage of participants |
| CP: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Percentage of Participants With Virologic Breakthrough | 0 percentage of participants |
| CP: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Percentage of Participants With Virologic Breakthrough | 0 percentage of participants |
| FU: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg | Percentage of Participants With Virologic Breakthrough | 0 percentage of participants |
| FU: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Percentage of Participants With Virologic Breakthrough | 50.0 percentage of participants |
| FU: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Percentage of Participants With Virologic Breakthrough | 0 percentage of participants |
Secondary
Plasma Concentration 24 Hours After Administration (C24h) of JNJ-73763989 (Molecules: JNJ-73763976 [JNJ3976], JNJ-73763924 [JNJ-3924])
Plasma concentration 24 hours after administration (C24h) of JNJ-73763989 (molecules: JNJ-73763976 \[JNJ3976\], JNJ-73763924 \[JNJ-3924\]) were reported. Non-compartmental analysis were conducted to analyze C24h of JNJ-73763989 and its molecules.
Time frame: IP: 24 hours post dose on Week 24 visit; CP: 24 hours post dose on Week 8 visit
Population: Pharmacokinetics analysis set (PK): included participants who have received at least 1 dose of any of the study interventions and had at least 1 valid blood sample drawn for PK analysis. Here N (Number of participants analysed) signifies the number of participants that were evaluable for this outcome measure. Data for this endpoint was planned to be collected and analyzed as pooled cohort in induction phase and consolidation phase only.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: JNJ-3989 200 mg+ JNJ-6379 250 mg+ NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Plasma Concentration 24 Hours After Administration (C24h) of JNJ-73763989 (Molecules: JNJ-73763976 [JNJ3976], JNJ-73763924 [JNJ-3924]) | JNJ-73763976 | 315 ng/mL | Standard Deviation 213 |
| Cohort 1: JNJ-3989 200 mg+ JNJ-6379 250 mg+ NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Plasma Concentration 24 Hours After Administration (C24h) of JNJ-73763989 (Molecules: JNJ-73763976 [JNJ3976], JNJ-73763924 [JNJ-3924]) | JNJ-73763924 | 36.9 ng/mL | Standard Deviation 27.9 |
| Cohort 1: JNJ-3989 200 mg+ NA (245/25 mg) + PegIFNalpha-2a 180 mcg | Plasma Concentration 24 Hours After Administration (C24h) of JNJ-73763989 (Molecules: JNJ-73763976 [JNJ3976], JNJ-73763924 [JNJ-3924]) | JNJ-73763976 | 381 ng/mL | Standard Deviation 155 |
| Cohort 1: JNJ-3989 200 mg+ NA (245/25 mg) + PegIFNalpha-2a 180 mcg | Plasma Concentration 24 Hours After Administration (C24h) of JNJ-73763989 (Molecules: JNJ-73763976 [JNJ3976], JNJ-73763924 [JNJ-3924]) | JNJ-73763924 | 54.7 ng/mL | Standard Deviation 25 |
Secondary
Time to Achieve First HBeAg Seroclearance
Time to achieve first occurrence of HBeAg seroclearance (HBeAg \<LLOQ \[\<0.11 IU/mL\]) were reported. Time to first occurrence of the HBeAg seroclearance was defined as the number of days between the date of first study intervention intake and the date of the first occurrence of the HBeAg seroclearance.
Time frame: From Baseline (Day 1 of IP) to Follow-up Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Population: Treated analysis set included all participants who received at least 1 dose of study treatment within this ISA. Here N (Number of participants analyzed) signifies participants who were evaluable for this outcome measure. Per planned analysis, data for this outcome measure was analyzed per pooled cohorts only.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cohort 1: JNJ-3989 200 mg+ JNJ-6379 250 mg+ NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Time to Achieve First HBeAg Seroclearance | 112 weeks |
| Cohort 1: JNJ-3989 200 mg+ NA (245/25 mg) + PegIFNalpha-2a 180 mcg | Time to Achieve First HBeAg Seroclearance | 100.3 weeks |
| Cohort 2: JNJ-3989 200 mg+ NA (245/25 mg)+ PegIFNalpha-2a 180 mcg | Time to Achieve First HBeAg Seroclearance | NA weeks |
Secondary
Time to Achieve First HBsAg Seroclearance
Time to achieve first HBsAg seroclearance (defined as quantitative HBsAg \<LLOQ; HBsAg \<0.05 IU/mL) were reported. Time to HBsAg seroclearance was defined as the number of days between the date of first study intervention intake and the date of the first occurrence of HBsAg seroclearance. Kaplan-Meier method was used for the estimation.
Time frame: From Baseline (Day 1 of IP) to Follow-up Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Population: Treated analysis set included all participants who received at least 1 dose of study treatment within this ISA. Here N (Number of participants analyzed) signifies participants who were evaluable for this endpoint. Per planned analysis, data for this outcome measure was analyzed per pooled cohorts only.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cohort 1: JNJ-3989 200 mg+ JNJ-6379 250 mg+ NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Time to Achieve First HBsAg Seroclearance | NA weeks |
| Cohort 1: JNJ-3989 200 mg+ NA (245/25 mg) + PegIFNalpha-2a 180 mcg | Time to Achieve First HBsAg Seroclearance | NA weeks |
| Cohort 2: JNJ-3989 200 mg+ NA (245/25 mg)+ PegIFNalpha-2a 180 mcg | Time to Achieve First HBsAg Seroclearance | NA weeks |
Secondary
Time to Achieve First HBV DNA <LLOQ
Time to achieve first occurrence of HBV DNA \< LLOQ (\<20 IU/mL) were reported. Time to first occurrence of the HBV DNA \< LLOQ was defined as the number of days between the date of first study intervention intake and the date of the first occurrence of the HBV DNA \< LLOQ.
Time frame: From Baseline (Day 1 of IP) to Follow-up Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Population: Treated analysis set included all participants who received at least 1 dose of study treatment within this ISA. Here N (Number of participants analyzed) signifies participants who were evaluable for this outcome measure. Per planned analysis, data for this outcome measure was analyzed per pooled cohorts only.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cohort 1: JNJ-3989 200 mg+ JNJ-6379 250 mg+ NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Time to Achieve First HBV DNA <LLOQ | 35.9 weeks |
| Cohort 1: JNJ-3989 200 mg+ NA (245/25 mg) + PegIFNalpha-2a 180 mcg | Time to Achieve First HBV DNA <LLOQ | 53.3 weeks |
| Cohort 2: JNJ-3989 200 mg+ NA (245/25 mg)+ PegIFNalpha-2a 180 mcg | Time to Achieve First HBV DNA <LLOQ | 38.1 weeks |
Secondary
Time to Achieve First Occurrence of HBsAg <10 IU/mL
Time to achieve first occurrence of HBsAg \<10 IU/mL were reported. Time to HBsAg \<10 IU/mL was defined as the number of days between the date of first study treatment intake and the date of the first occurrence of HBsAg \<10 IU/mL. Kaplan-Meier method was used for the estimation.
Time frame: From Baseline (Day 1 of IP) up to Follow-up phase Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Population: Treated analysis set included all participants who received at least 1 dose of study treatment within this ISA.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cohort 1: JNJ-3989 200 mg+ JNJ-6379 250 mg+ NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Time to Achieve First Occurrence of HBsAg <10 IU/mL | 48.1 weeks |
| Cohort 1: JNJ-3989 200 mg+ NA (245/25 mg) + PegIFNalpha-2a 180 mcg | Time to Achieve First Occurrence of HBsAg <10 IU/mL | 84.3 weeks |
| Cohort 2: JNJ-3989 200 mg+ NA (245/25 mg)+ PegIFNalpha-2a 180 mcg | Time to Achieve First Occurrence of HBsAg <10 IU/mL | 48.3 weeks |
Secondary
Time to Reach the Maximum Observed Plasma Concentration (Tmax) of JNJ-73763989 (Molecules: JNJ-73763976 [JNJ3976], JNJ-73763924 [JNJ-3924])
Time to reach the maximum observed plasma concentration (tmax) of JNJ-73763989 (molecules: JNJ-73763976 \[JNJ3976\], JNJ-73763924 \[JNJ-3924\]) were reported. Non-compartmental analysis were conducted to analyze tmax of JNJ-73763989 and its molecules.
Time frame: IP : Predose (0 hour), post dose on 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours on IP Week 24; CP: Predose (0 hour), post dose on 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours on CP Week 8
Population: Pharmacokinetics analysis set (PK): included participants who have received at least 1 dose of any of the study interventions and had at least 1 valid blood sample drawn for PK analysis. Data for this endpoint was planned to be collected and analyzed as pooled cohort in induction phase and consolidation phase only.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Cohort 1: JNJ-3989 200 mg+ JNJ-6379 250 mg+ NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Time to Reach the Maximum Observed Plasma Concentration (Tmax) of JNJ-73763989 (Molecules: JNJ-73763976 [JNJ3976], JNJ-73763924 [JNJ-3924]) | JNJ-73763976 | 5.53 hour |
| Cohort 1: JNJ-3989 200 mg+ JNJ-6379 250 mg+ NA (245/25 mg) + PegIFN-alpha-2a 180 mcg | Time to Reach the Maximum Observed Plasma Concentration (Tmax) of JNJ-73763989 (Molecules: JNJ-73763976 [JNJ3976], JNJ-73763924 [JNJ-3924]) | JNJ-73763924 | 4.00 hour |
| Cohort 1: JNJ-3989 200 mg+ NA (245/25 mg) + PegIFNalpha-2a 180 mcg | Time to Reach the Maximum Observed Plasma Concentration (Tmax) of JNJ-73763989 (Molecules: JNJ-73763976 [JNJ3976], JNJ-73763924 [JNJ-3924]) | JNJ-73763976 | 3.99 hour |
| Cohort 1: JNJ-3989 200 mg+ NA (245/25 mg) + PegIFNalpha-2a 180 mcg | Time to Reach the Maximum Observed Plasma Concentration (Tmax) of JNJ-73763989 (Molecules: JNJ-73763976 [JNJ3976], JNJ-73763924 [JNJ-3924]) | JNJ-73763924 | 2.99 hour |