A Phase 2 interventional study of JNJ-73763989 and JNJ-56136379 in Hepatitis B, Chronic, sponsored by Janssen Sciences Ireland UC. Completed at 41 sites in 7 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-02-04.
Sponsored by Janssen Sciences Ireland UC · Phase 2, Interventional, and Treatment
The purpose of this study is to evaluate the efficacy of 48-week study intervention with JNJ-73763989+JNJ-56136379+nucleos(t)ide analog (NA) regimen compared to NA alone assessed by HBsAg levels. This study is part of HepB Wings Platform Trial (PLATFORMPAHPB2001).
Hepatitis B virus (HBV) is a small deoxyribonucleic acid (DNA) virus that infects the liver and can cause either acute or chronic infection. It consists of a so-called nucleocapsid in which viral DNA is packed with hepatitis B core protein (HBc) and membranous envelope containing hepatitis B surface antigen (HBsAg). Chronic HBV infection may lead to serious illnesses like cirrhosis and hepatocellular carcinoma (HCC). Oral treatment with NAs is effective at suppressing viral DNA formation and lowering virus concentration in blood to levels below lower limit of quantification (LLOQ). JNJ-73763989 is a liver-targeted antiviral therapeutic for subcutaneous injection designed to treat chronic HBV infection via ribonucleic acid interference mechanism but rarely lead to functional cure defined as sustained loss of HBs Ag and HBV DNA in serum. JNJ-56136379 is an orally administered capsid assembly modulator that is being developed for treatment of chronic HBV infection. The aim of study is to evaluate efficacy of 48-week study intervention with JNJ-3989+JNJ-6379+NA regimen compared to NA alone, assessed by HBsAg seroclearance at Week 72 (i.e., 24 weeks after completion of all study interventions at Week 48) without restarting NA treatment in HBeAg negative virologically suppressed chronic hepatitis B (CHB) infected participants who received NA treatment for at least 2 years prior to screening. The study will be 2.3 years and will be conducted in 3 phases: a screening phase (4 weeks), a study intervention phase (48 weeks), and a follow-up phase (48 weeks). Safety will be evaluated by AEs including AEs of special interest to any of the study interventions, clinical laboratory tests, ECGs, vital signs, and physical examinations.
2,710 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.
This study's enrollment of 130 is above the median of 100 across 1,887 interventional studies indexed under Hepatitis A.
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Of its 7 completed or terminated interventional studies of FDA-regulated products, 4 (57%) have results posted.
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Exclusion Criteria:
Participants will receive fixed dose of JNJ-73763989 subcutaneous injection once every 4 weeks along with fixed dose of JNJ-56136379 tablet once daily and nucleos(t)ide analog (NA) treatment (either entecavir \[ETV\], tenofovir disoproxil fumarate \[TDF\], or tenofovir alafenamide \[TAF\]) once daily up to 48 weeks.
Drug: JNJ-73763989 · Drug: JNJ-56136379 · Drug: Entecavir (ETV) monohydrate · Drug: Tenofovir disoproxil fumarate (TDF) · Drug: Tenofovir alafenamide (TAF)
Participants will receive matching placebo for JNJ-73763989 subcutaneous injection once every 4 weeks with matching placebo for JNJ-56136379 once daily and NA treatment (either ETV, TDF or TAF) once daily up to 48 weeks.
Drug: Placebo for JNJ-73763989 · Drug: Placebo for JNJ-56136379 · Drug: Entecavir (ETV) monohydrate · Drug: Tenofovir disoproxil fumarate (TDF) · Drug: Tenofovir alafenamide (TAF)
JNJ-73763989 injection will be administered subcutaneously once every 4 weeks up to 48 weeks.
JNJ-56136379 tablets will be administered orally once daily up to 48 weeks.
Matching placebo for JNJ-73763989 will be administered as subcutaneous injection up to 48 weeks.
Matching placebo for JNJ-56136379 tablets will be administered orally up to 48 weeks.
ETV tablet will be administered orally once daily up to 48 weeks as NA treatment.
TDF will be administered orally once daily up to 48 weeks as NA treatment.
TAF will be administered orally once daily up to 48 weeks as NA treatment.
Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Seroclearance at Week 72 Without Restarting NA Treatment
Percentage of participants with HBsAg seroclearance at Week 72 (24 weeks after completion of all study interventions at Week 48) without restarting NA treatment was reported. Seroclearance at Week 72 of the treatment defined as a confirmed loss of HBsAg at Week 72. Loss is defined as a baseline HBsAg with a repeat reactive, confirmed or positive result and a post-baseline assessment with a negative result.
Time frame: Week 72
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
An adverse event (AE) was any untoward medical occurrence in a clinical study participant who was administered a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAE was defined as the AEs occurring after first administration of study intervention (or worsened since then).
Time frame: From screening up to Week 102
Percentage of Participants With Treatment-emergent Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a clinical study participant who was administered a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAE was defined as the AEs occurring after first administration of study intervention (or worsened since then). SAEs included any untoward medical occurrence that resulted in death, were life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the off spring of a study participant.
Time frame: From screening up to 102 weeks
Percentage of Participants With HBsAg Seroclearance at Week 48
Percentage of participants with hepatitis B surface antigen (HBsAg) seroclearance at Week 48 was reported. Seroclearance at Week 48 of the treatment defined as a confirmed loss of HBsAg at Week 48. Loss is defined as a baseline HBsAg with a repeat reactive, confirmed or positive result and a post-baseline assessment with a negative result.
Time frame: Week 48
Percentage of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Less Than (<) Lower Limit of Quantification (LLOQ) at Week 48
Percentage of participants with HBV DNA \<LLOQ (20 international units per milliliters \[IU/mL\]) at Week 48 was reported.
Time frame: Week 48
Percentage of Participants With HBsAg Seroclearance at Week 96 (48 Weeks After Stopping All Study Interventions at Week 48 Without Restarting NA Treatment)
Percentage of participants with HBsAg seroclearance at Week 96 (48 weeks after stopping all study interventions at Week 48 without restarting NA treatment) was reported. Seroclearance at Week 96 of the treatment defined as a confirmed loss of HBsAg at Week 96. Loss is defined as a baseline HBsAg with a repeat reactive, confirmed or positive result and a post-baseline assessment with a negative result. Missing values were imputed by last observation carried forward (LOCF).
Time frame: Week 96
Percentage of Participants With (Sustained) Reduction, Suppression, and/or Seroclearance
Percentage of participants with (sustained) reduction, suppression, and/or seroclearance considering single and multiple markers (such as hepatitis B surface antigen \[HBsAg\] and HBV DNA) (HBsAg \>= lower limit of quantification \[LLOQ\] and HBV DNA\<2000 IU/mL; HBsAg \>= LLOQ and LLOQ \<= HBV DNA \< 2000 IU/mL) off-treatment was reported.
Time frame: Baseline (Day 1) up to Week 96
Percentage of Participants With HBsAg Seroconversion at Week 96
Percentage of participants with HBsAg seroconversion were reported. HBsAg seroconversion was defined as HBsAg seroclearance together with appearance of anti-hepatitis B surface (HBs) or anti-hepatitis e (HBe) antibodies, respectively.
Time frame: Week 96
Change From Baseline in HBsAg Values at Weeks 48, 72, and 96
Change from baseline in HBsAg values was reported.
Time frame: Baseline (Day 1), Weeks 48, 72, and 96
Change From Baseline in HBV DNA Values at Weeks 48, 72, and 96
Change from baseline in HBV DNA values was reported. Participants were considered as virologically suppressed if they were on stable HBV treatment (receiving NA treatment \[ETV, TDF, or TAF)\] for at least 24 months prior to screening and were on the same dose of NA treatment regimen for at least 3 months at the time of screening, and had serum HBV DNA less than (\<)60 IU/mL on 2 sequential measurements at least 6 months and had documented alanine aminotransferase values \<2.0\* upper limit of normal on 2 sequential measurements at least 6 months apart.
Time frame: Baseline (Day 1), Weeks 48, 72, and 96
Time to Achieve First HBsAg Seroclearance
Time to achieve first HBsAg seroclearance was defined as the number of days between the date of first study treatment intake and the date of the first occurrence of HBsAg seroclearance.
Time frame: Baseline (Day 1) up to Week 96
Percentage of Participants With Reduction of More Than (>) 1 log10 IU/mL in HBsAg Levels From Baseline
Percentage of participants with reduction of \>1 log10 in HBsAg Levels IU/mL from baseline was reported.
Time frame: Baseline (Day 1) up to Week 96
Percentage of Participants With HBsAg Levels Less Than (<) 100 IU/mL at Weeks 48, 72, and 96
Percentage of participants with HBsAg Levels \<100 IU/mL at Weeks 48, 72, and 96 was reported.
Time frame: Weeks 48, 72, and 96
Percentage of Participants With HBV DNA Levels Less Than (<) LLOQ From Baseline up to Week 96 (End of Study)
Percentage of Participants with HBV DNA levels \<LLOQ (20 IU/mL) was reported.
Time frame: Baseline (Day 1) up to Week 96
Percentage of Participants With Flares
Percentage of participants with flares (virologic, biochemical and clinical flares) was reported. Biochemical flare was defined as confirmed alanine transaminase flare and/or aspartate aminotransferase flare \>=3\*upper limit of normal and \>=3\*nadir. The start of a confirmed virologic flare was defined as the first date of two consecutive visits with HBV DNA \>200 IU/mL. The end date of the same confirmed virologic flare was defined as the first date when HBV DNA value returns to less than or equal to (\<=)200 IU/mL or the date of NA treatment restart, whichever comes first. Clinical flare was defined as participants with both virologic and biochemical flare.
Time frame: Baseline (Day 1) up to Week 96
Percentage of Participants With Virologic Breakthrough
Percentage of participants with virologic breakthrough defined as confirmed on-treatment HBV DNA increase by more than (\>) 1 log10 IU/mL from nadir level or confirmed on treatment level \>200 IU/mL in participants who had HBV DNA level below \<LLOQ of the HBV DNA assay was reported.
Time frame: Baseline (Day 1) up to Week 48
Percentage of Participants Requiring NA Re-Treatment During Follow-up
Percentage of participants requiring NA re-treatment (either ETV, TDF, or TAF) during follow-up was reported.
Time frame: Baseline (Day 1) up to Week 96
Correlation Coefficient Between On-treatment HBsAg Change From Baseline With On-treatment HBV Blood Markers and Baseline Characteristics
Correlation coefficient between on-treatment HBsAg change from baseline with on-treatment HBV blood markers and baseline characteristics was reported at different timepoints (against age, baseline NA treatment duration, HBsAg value at baseline, HBsAg values at Weeks 24 and 48).
Time frame: Baseline (Day 1) to Week 96
Observed Plasma Concentration at Predose (C[Predose]) of JNJ-73763976 (Molecule of JNJ-73763989)
C(predose) was defined as the observed plasma concentration of JNJ-73763976 (a molecule of JNJ-73763989) at predose of JNJ-73763989. PK sample collection was done based on the availability of the participants at Weeks 4, 8, 12, or 16 and thus collected data were averaged and reported in this outcome measure.
Time frame: Predose at Weeks 4, 8, 12, and 16
Maximum Observed Analyte Concentration (Cmax) of JNJ-73763976 (Molecule of JNJ-73763989)
Cmax was defined as the maximum observed concentration of JNJ-73763976 (molecule of JNJ-73763989). PK sample collection was done based on the availability of the participants at Weeks 4, 8, 12, or 16 and thus collected data were averaged and reported in this outcome measure.
Time frame: Weeks 4, 8, 12, and 16: at Predose, 15 minutes, 30 minutes, 1, 2, 3, 4, 6, 8, 10, and 24 hours postdose
Time to Reach the Maximum Observed Plasma Concentration (Tmax) of JNJ-73763976 (Molecule of JNJ-73763989)
tmax was defined as the time to reach the maximum observed plasma concentration of JNJ-73763976 (molecule of JNJ-73763989). PK sample collection was done based on the availability of the participants at Weeks 4, 8, 12, or 16 and thus collected data were averaged and reported in this outcome measure.
Time frame: Weeks 4, 8, 12, and 16: at Predose, 15 minutes, 30 minutes, 1, 2, 3, 4, 6, 8, 10, and 24 hours postdose
Observed Plasma Concentration at 24 Hour Postdose (C[24h]) of JNJ-73763976 (Molecule of JNJ-73763989)
C(24h) was defined as the observed plasma concentration of JNJ-73763976 (a molecule of JNJ-73763989) at 24 h postdose of JNJ-73763989. PK sample collection was done based on the availability of the participants at Weeks 4, 8, 12, or 16 and thus collected data were averaged and reported in this outcome measure.
Time frame: 24 hours postdose at Weeks 4, 8, 12, and 16
Area Under the Analyte Concentration Versus Time Curve From Time 0 to 24 Hours (AUC[0-24h]) of JNJ-73763976 (Molecule of JNJ-73763989)
AUC(0-24h) was defined as the area under the concentration of JNJ-73763976 (a molecule of JNJ-73763989) versus time curve from time 0 to 24 hours of JNJ-73763989. PK sample collection was done based on the availability of the participants at Weeks 4, 8, 12, or 16 and thus collected data were averaged and reported in this outcome measure.
Time frame: 0 to 24 hours postdose at Weeks 4, 8, 12, and 16
Maximum Observed Analyte Concentration (Cmax) of JNJ-73763976 (Molecule of JNJ-73763989) Dose Normalized to 1 mg (Cmax[Dose Normalized])
Cmax(Dose Normalized) was defined as the maximum observed concentration of JNJ-73763976 (a molecule of JNJ-73763989) dose normalized to 1 mg. PK sample collection was done based on the availability of the participants at Weeks 4, 8, 12, or 16 and thus collected data were averaged and reported in this outcome measure.
Time frame: Weeks 4, 8, 12, and 16: at Predose, 15 minutes, 30 minutes, 1, 2, 3, 4, 6, 8, 10, and 24 hours postdose
Area Under the Analyte Concentration Versus Time Curve From Time 0 to 24 Hours of JNJ-73763976 (Molecule of JNJ-73763989) Dose Normalized to 1 mg (AUC[0-24h], Dose Normalized)
AUC(\[0-24h\], Dose Normalized) was defined as the area under the concentration of JNJ-73763976 (molecule of JNJ-73763989) versus time curve from time 0 to 24 hours of JNJ-73763989 dose normalized to 1 mg. PK sample collection was done based on the availability of the participants at Weeks 4, 8, 12, or 16 and thus collected data were averaged and reported in this outcome measure.
Time frame: 0 to 24 hours post-dose at Weeks 4, 8, 12, and 16
Observed Plasma Concentration at Predose (C[Predose]) of JNJ-73763924 (Molecule of JNJ-73763989)
C(predose) was defined as the observed plasma concentration of JNJ-73763924 (a molecule of JNJ-73763989) at predose of JNJ-73763989. PK sample collection was done based on the availability of the participants at Weeks 4, 8, 12, or 16 and thus collected data were averaged and reported in this outcome measure.
Time frame: Predose at Weeks 4, 8, 12, and 16
Maximum Observed Analyte Concentration (Cmax) of JNJ-73763924 (Molecule of JNJ-73763989)
Cmax was defined as the maximum concentration of JNJ-73763924 (molecule of JNJ-73763989). PK sample collection was done based on the availability of the participants at Weeks 4, 8, 12, or 16 and thus collected data were averaged and reported in this outcome measure.
Time frame: Weeks 4, 8, 12, and 16: at Predose, 15 minutes, 30 minutes, 1, 2, 3, 4, 6, 8, 10, and 24 hours postdose
Time to Reach the Maximum Observed Plasma Concentration (Tmax) of JNJ-73763924 (Molecule of JNJ-73763989)
tmax was defined as the time to reach the maximum observed plasma concentration of JNJ-73763924 (molecule of JNJ-73763989). PK sample collection was done based on the availability of the participants at Weeks 4, 8, 12, or 16 and thus collected data were averaged and reported in this outcome measure.
Time frame: Weeks 4, 8, 12, and 16: at Predose, 15 minutes, 30 minutes, 1, 2, 3, 4, 6, 8, 10, and 24 hours postdose
Observed Plasma Concentration at 24 Hour Postdose (C[24h]) of JNJ-73763924 (Molecule of JNJ-73763989)
C(24h) was defined as the observed plasma concentration of JNJ-73763924 (molecule of JNJ-73763989) at 24 h postdose of JNJ-73763989. PK sample collection was done based on the availability of the participants at Weeks 4, 8, 12, or 16 and thus collected data were averaged and reported in this outcome measure.
Time frame: 24 hours postdose at Weeks 4, 8, 12, and 16
Area Under the Analyte Concentration Versus Time Curve From Time 0 to 24 Hour (AUC[0-24h]) of JNJ-73763924 (Molecule of JNJ-73763989)
AUC(0-24h) was defined as the area under the concentration of JNJ-73763924 (molecule of JNJ-73763989) versus time curve from time 0 to 24 hour of JNJ-73763989. PK sample collection was done based on the availability of the participants at Weeks 4, 8, 12, or 16 and thus collected data were averaged and reported in this outcome measure.
Time frame: 0 to 24 hours postdose at Weeks 4, 8, 12, and 16
Maximum Observed Analyte Concentration (Cmax) of JNJ-73763924 (Molecule of JNJ-73763989) Dose Normalized to 1 mg (Cmax[Dose Normalized])
Cmax(Dose Normalized) was defined as the maximum observed analyte concentration of JNJ-73763924 (molecule of JNJ-73763989) dose normalized to 1 mg. PK sample collection was done based on the availability of the participants at Weeks 4, 8, 12, or 16 and thus collected data were averaged and reported in this outcome measure.
Time frame: Weeks 4, 8, 12, and 16: at Predose, 15 minutes, 30 minutes, 1, 2, 3, 4, 6, 8, 10, and 24 hours postdose
Area Under the Analyte Concentration Versus Time Curve From Time 0 to 24 Hours of JNJ-73763924 (Molecule of JNJ-73763989) Dose Normalized to 1 mg (AUC[0-24h], Dose Normalized)
AUC(\[0-24h\], Dose Normalized) was defined as the area under the analyte concentration JNJ-73763924 (a molecule of JNJ-73763989) versus time curve from time 0 to 24 hours of JNJ-73763989 dose normalized to 1 mg. PK sample collection was done based on the availability of the participants at Weeks 4, 8, 12, or 16 and thus collected data were averaged and reported in this outcome measure.
Time frame: 0 to 24 hours postdose at Weeks 4, 8, 12, and 16
Observed Plasma Concentration at Predose (C[Predose]) of JNJ-56136379
C(predose) was defined as the observed plasma concentration at predose of JNJ-56136379. PK sample collection was done based on the availability of the participants at Weeks 4, 8, 12, or 16 and thus collected data were averaged and reported in this outcome measure.
Time frame: Predose at Weeks 4, 8, 12, and 16
Maximum Observed Analyte Concentration (Cmax) of JNJ-56136379
Cmax was defined as the maximum observed concentration of JNJ-56136379. PK sample collection was done based on the availability of the participants at Weeks 4, 8, 12, or 16 and thus collected data were averaged and reported in this outcome measure.
Time frame: Weeks 4, 8, 12, and 16: at Predose, 15 minutes, 30 minutes, 1, 2, 3, 4, 6, 8, 10, and 24 hours postdose
Time to Reach the Maximum Observed Plasma Concentration (Tmax) of JNJ-56136379
tmax was defined as the time to reach the maximum observed plasma concentration of JNJ-56136379. PK sample collection was done based on the availability of the participants at Weeks 4, 8, 12, or 16 and thus collected data were averaged and reported in this outcome measure.
Time frame: Weeks 4, 8, 12, and 16: at Predose, 15 minutes, 30 minutes, 1, 2, 3, 4, 6, 8, 10, and 24 hours postdose
Observed or Predicted Concentration at the End of a Dosing Interval (Ctau) of JNJ-56136379
Ctau was defined as the observed or predicted concentration at the end of a dosing interval of JNJ-56136379. PK sample collection was done based on the availability of the participants at Weeks 4, 8, 12, or 16 and thus collected data were averaged and reported in this outcome measure.
Time frame: Weeks 4, 8, 12, and 16: at Predose, 15 minutes, 30 minutes, 1, 2, 3, 4, 6, 8, 10, and 24 hours postdose
Area Under the Analyte Concentration Versus Time Curve During a Dosing Interval at Steady State (AUCtau) of JNJ-56136379
AUCtau was defined as the area under the analyte concentration versus time curve during a dosing interval at steady state of JNJ-56136379. PK sample collection was done based on the availability of the participants at Weeks 4, 8, 12, or 16 and thus collected data were averaged and reported in this outcome measure.
Time frame: Weeks 4, 8, 12, and 16: at Predose, 15 minutes, 30 minutes, 1, 2, 3, 4, 6, 8, 10, and 24 hours postdose
| Milestone | Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NA | Arm 2: Nucleos(t)Ide Analog (NA) |
|---|---|---|
| Started | 85 | 45 |
| Completed | 81 | 40 |
| Not completed | 4 | 5 |
| Withdrew: Withdrawal by subject | 4 | 3 |
| Withdrew: Other | 0 | 2 |
Percentage of participants with HBsAg seroclearance at Week 72 (24 weeks after completion of all study interventions at Week 48) without restarting NA treatment was reported. Seroclearance at Week 72 of the treatment defined as a confirmed loss of HBsAg at Week 72. Loss is defined as a baseline HBsAg with a repeat reactive, confirmed or positive result and a post-baseline assessment with a negative result.
| Percentage of participants | Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NA | Arm 2: Nucleos(t)Ide Analog (NA) |
|---|---|---|
| Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Seroclearance at Week 72 Without Restarting NA Treatment | 0.0 | 0.0 |
An adverse event (AE) was any untoward medical occurrence in a clinical study participant who was administered a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAE was defined as the AEs occurring after first administration of study intervention (or worsened since then).
| Percentage of participants | Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NA | Arm 2: Nucleos(t)Ide Analog (NA) |
|---|---|---|
| Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) | 85.9 | 80.0 |
An AE was any untoward medical occurrence in a clinical study participant who was administered a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAE was defined as the AEs occurring after first administration of study intervention (or worsened since then). SAEs included any untoward medical occurrence that resulted in death, were life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the off spring of a study participant.
| Percentage of participants | Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NA | Arm 2: Nucleos(t)Ide Analog (NA) |
|---|---|---|
| Percentage of Participants With Treatment-emergent Serious Adverse Events (SAEs) | 3.5 | 8.9 |
Percentage of participants with hepatitis B surface antigen (HBsAg) seroclearance at Week 48 was reported. Seroclearance at Week 48 of the treatment defined as a confirmed loss of HBsAg at Week 48. Loss is defined as a baseline HBsAg with a repeat reactive, confirmed or positive result and a post-baseline assessment with a negative result.
| Percentage of participants | Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NA | Arm 2: Nucleos(t)Ide Analog (NA) |
|---|---|---|
| Percentage of Participants With HBsAg Seroclearance at Week 48 | 0 | 0 |
Percentage of participants with HBV DNA \<LLOQ (20 international units per milliliters \[IU/mL\]) at Week 48 was reported.
| Percentage of participants | Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NA | Arm 2: Nucleos(t)Ide Analog (NA) |
|---|---|---|
| Percentage of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Less Than (<) Lower Limit of Quantification (LLOQ) at Week 48 | 97.3 | 100 |
Percentage of participants with HBsAg seroclearance at Week 96 (48 weeks after stopping all study interventions at Week 48 without restarting NA treatment) was reported. Seroclearance at Week 96 of the treatment defined as a confirmed loss of HBsAg at Week 96. Loss is defined as a baseline HBsAg with a repeat reactive, confirmed or positive result and a post-baseline assessment with a negative result. Missing values were imputed by last observation carried forward (LOCF).
| Percentage of participants | Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NA | Arm 2: Nucleos(t)Ide Analog (NA) |
|---|---|---|
| Percentage of Participants With HBsAg Seroclearance at Week 96 (48 Weeks After Stopping All Study Interventions at Week 48 Without Restarting NA Treatment) | 0.0 | 0.0 |
Percentage of participants with (sustained) reduction, suppression, and/or seroclearance considering single and multiple markers (such as hepatitis B surface antigen \[HBsAg\] and HBV DNA) (HBsAg \>= lower limit of quantification \[LLOQ\] and HBV DNA\<2000 IU/mL; HBsAg \>= LLOQ and LLOQ \<= HBV DNA \< 2000 IU/mL) off-treatment was reported.
| Percentage of participants | Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NA | Arm 2: Nucleos(t)Ide Analog (NA) |
|---|---|---|
| HBsAg>=LLOQ and HBVDNA<2000 IU/mL | 23.9 | 3.6 |
| HBsAg>=LLOQ and LLOQ<=HBV DNA <2000 IU/mL | 64.8 | 64.3 |
Percentage of participants with HBsAg seroconversion were reported. HBsAg seroconversion was defined as HBsAg seroclearance together with appearance of anti-hepatitis B surface (HBs) or anti-hepatitis e (HBe) antibodies, respectively.
| Percentage of participants | Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NA | Arm 2: Nucleos(t)Ide Analog (NA) |
|---|---|---|
| Percentage of Participants With HBsAg Seroconversion at Week 96 | 0 | 0 |
Change from baseline in HBsAg values was reported.
| log10 IU/mL | Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NA | Arm 2: Nucleos(t)Ide Analog (NA) |
|---|---|---|
| Week 48 | -1.89 ± 0.522 | -0.06 ± 0.082 |
| Week 72 | -1.76 ± 0.658 | -0.25 ± 0.563 |
| Week 96 | -1.46 ± 0.661 | -0.49 ± 0.783 |
Change from baseline in HBV DNA values was reported. Participants were considered as virologically suppressed if they were on stable HBV treatment (receiving NA treatment \[ETV, TDF, or TAF)\] for at least 24 months prior to screening and were on the same dose of NA treatment regimen for at least 3 months at the time of screening, and had serum HBV DNA less than (\<)60 IU/mL on 2 sequential measurements at least 6 months and had documented alanine aminotransferase values \<2.0\* upper limit of normal on 2 sequential measurements at least 6 months apart.
No measurements were reported for this outcome.
Time to achieve first HBsAg seroclearance was defined as the number of days between the date of first study treatment intake and the date of the first occurrence of HBsAg seroclearance.
| Days | Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NA | Arm 2: Nucleos(t)Ide Analog (NA) |
|---|---|---|
| Time to Achieve First HBsAg Seroclearance | NA (NA to NA) | NA (NA to NA) |
Percentage of participants with reduction of \>1 log10 in HBsAg Levels IU/mL from baseline was reported.
| Percentage of participants | Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NA | Arm 2: Nucleos(t)Ide Analog (NA) |
|---|---|---|
| Percentage of Participants With Reduction of More Than (>) 1 log10 IU/mL in HBsAg Levels From Baseline | 81.5 | 12.5 |
Percentage of participants with HBsAg Levels \<100 IU/mL at Weeks 48, 72, and 96 was reported.
| Percentage of participants | Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NA | Arm 2: Nucleos(t)Ide Analog (NA) |
|---|---|---|
| Week 48 | 71.1 | 2.4 |
| Week 72 | 67.1 | 10.3 |
| Week 96 | 46.9 | 15.0 |
Percentage of Participants with HBV DNA levels \<LLOQ (20 IU/mL) was reported.
| Percentage of participants | Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NA | Arm 2: Nucleos(t)Ide Analog (NA) |
|---|---|---|
| Percentage of Participants With HBV DNA Levels Less Than (<) LLOQ From Baseline up to Week 96 (End of Study) | 23.9 | 3.6 |
Percentage of participants with flares (virologic, biochemical and clinical flares) was reported. Biochemical flare was defined as confirmed alanine transaminase flare and/or aspartate aminotransferase flare \>=3\*upper limit of normal and \>=3\*nadir. The start of a confirmed virologic flare was defined as the first date of two consecutive visits with HBV DNA \>200 IU/mL. The end date of the same confirmed virologic flare was defined as the first date when HBV DNA value returns to less than or equal to (\<=)200 IU/mL or the date of NA treatment restart, whichever comes first. Clinical flare was defined as participants with both virologic and biochemical flare.
| Percentage of participants | Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NA | Arm 2: Nucleos(t)Ide Analog (NA) |
|---|---|---|
| Virologic Flare (HBV DNA > 200 - =<2000 IU/mL) | 38.7 | 25.0 |
| Virologic Flare (HBV DNA>2000 - =< 20000 IU/mL) | 24.0 | 30.0 |
| Virologic Flare (HBV DNA >20000 - =<100000 IU/mL) | 8.0 | 10.0 |
| Virologic Flare (HBV DNA >100000 IU/mL) | 2.7 | 27.5 |
| Alanine Transaminase Flare | 3.9 | 19.5 |
| Aspartate Aminotransferase Flare | 1.3 | 14.6 |
| Clinical Flare: HBV DNA > 200 - =<2000IU/mL | 0.0 | 0.0 |
| Clinical Flare: HBV DNA > 2000 - =<20000IU/mL | 1.3 | 0.0 |
| Clinical Flare: HBV DNA > 20000 - =<100000IU/mL | 1.3 | 0.0 |
| Clinical Flare: HBV DNA > 100000 IU/mL | 1.3 | 27.5 |
Percentage of participants with virologic breakthrough defined as confirmed on-treatment HBV DNA increase by more than (\>) 1 log10 IU/mL from nadir level or confirmed on treatment level \>200 IU/mL in participants who had HBV DNA level below \<LLOQ of the HBV DNA assay was reported.
| Percentage of participants | Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NA | Arm 2: Nucleos(t)Ide Analog (NA) |
|---|---|---|
| Percentage of Participants With Virologic Breakthrough | 0.0 | 0.0 |
Percentage of participants requiring NA re-treatment (either ETV, TDF, or TAF) during follow-up was reported.
| Percentage of participants | Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NA | Arm 2: Nucleos(t)Ide Analog (NA) |
|---|---|---|
| Percentage of Participants Requiring NA Re-Treatment During Follow-up | 9.1 | 26.8 |
Correlation coefficient between on-treatment HBsAg change from baseline with on-treatment HBV blood markers and baseline characteristics was reported at different timepoints (against age, baseline NA treatment duration, HBsAg value at baseline, HBsAg values at Weeks 24 and 48).
| correlation coefficient | Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NA | Arm 2: Nucleos(t)Ide Analog (NA) |
|---|---|---|
| Age | 0.2860 | 0.1746 |
| Baseline NA treatment duration | 0.2381 | 0.4324 |
| HBsAg value at baseline | -0.9970 | -0.5923 |
| HBsAg at Week 24 | 0.9983 | 0.7120 |
| HBsAg at Week 48 | 0.9982 | 0.8065 |
C(predose) was defined as the observed plasma concentration of JNJ-73763976 (a molecule of JNJ-73763989) at predose of JNJ-73763989. PK sample collection was done based on the availability of the participants at Weeks 4, 8, 12, or 16 and thus collected data were averaged and reported in this outcome measure.
| nanogram/milliliter (ng/mL) | Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NA |
|---|---|
| Observed Plasma Concentration at Predose (C[Predose]) of JNJ-73763976 (Molecule of JNJ-73763989) | NA ± NA |
Cmax was defined as the maximum observed concentration of JNJ-73763976 (molecule of JNJ-73763989). PK sample collection was done based on the availability of the participants at Weeks 4, 8, 12, or 16 and thus collected data were averaged and reported in this outcome measure.
| ng/mL | Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NA |
|---|---|
| Maximum Observed Analyte Concentration (Cmax) of JNJ-73763976 (Molecule of JNJ-73763989) | 1111 ± 716 |
tmax was defined as the time to reach the maximum observed plasma concentration of JNJ-73763976 (molecule of JNJ-73763989). PK sample collection was done based on the availability of the participants at Weeks 4, 8, 12, or 16 and thus collected data were averaged and reported in this outcome measure.
| Hour | Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NA |
|---|---|
| Time to Reach the Maximum Observed Plasma Concentration (Tmax) of JNJ-73763976 (Molecule of JNJ-73763989) | 6.00 ± 1.00 |
C(24h) was defined as the observed plasma concentration of JNJ-73763976 (a molecule of JNJ-73763989) at 24 h postdose of JNJ-73763989. PK sample collection was done based on the availability of the participants at Weeks 4, 8, 12, or 16 and thus collected data were averaged and reported in this outcome measure.
| ng/mL | Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NA |
|---|---|
| Observed Plasma Concentration at 24 Hour Postdose (C[24h]) of JNJ-73763976 (Molecule of JNJ-73763989) | 275 ± 161 |
AUC(0-24h) was defined as the area under the concentration of JNJ-73763976 (a molecule of JNJ-73763989) versus time curve from time 0 to 24 hours of JNJ-73763989. PK sample collection was done based on the availability of the participants at Weeks 4, 8, 12, or 16 and thus collected data were averaged and reported in this outcome measure.
| nanogram*hour/milliliter (ng*h/mL) | Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NA |
|---|---|
| Area Under the Analyte Concentration Versus Time Curve From Time 0 to 24 Hours (AUC[0-24h]) of JNJ-73763976 (Molecule of JNJ-73763989) | 17833 ± 9670 |
Cmax(Dose Normalized) was defined as the maximum observed concentration of JNJ-73763976 (a molecule of JNJ-73763989) dose normalized to 1 mg. PK sample collection was done based on the availability of the participants at Weeks 4, 8, 12, or 16 and thus collected data were averaged and reported in this outcome measure.
| ng/mL/mg | Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NA |
|---|---|
| Maximum Observed Analyte Concentration (Cmax) of JNJ-73763976 (Molecule of JNJ-73763989) Dose Normalized to 1 mg (Cmax[Dose Normalized]) | 8.34 ± 5.37 |
AUC(\[0-24h\], Dose Normalized) was defined as the area under the concentration of JNJ-73763976 (molecule of JNJ-73763989) versus time curve from time 0 to 24 hours of JNJ-73763989 dose normalized to 1 mg. PK sample collection was done based on the availability of the participants at Weeks 4, 8, 12, or 16 and thus collected data were averaged and reported in this outcome measure.
| ng*h/mL/mg | Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NA |
|---|---|
| Area Under the Analyte Concentration Versus Time Curve From Time 0 to 24 Hours of JNJ-73763976 (Molecule of JNJ-73763989) Dose Normalized to 1 mg (AUC[0-24h], Dose Normalized) | 134 ± 72.5 |
C(predose) was defined as the observed plasma concentration of JNJ-73763924 (a molecule of JNJ-73763989) at predose of JNJ-73763989. PK sample collection was done based on the availability of the participants at Weeks 4, 8, 12, or 16 and thus collected data were averaged and reported in this outcome measure.
| ng/mL | Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NA |
|---|---|
| Observed Plasma Concentration at Predose (C[Predose]) of JNJ-73763924 (Molecule of JNJ-73763989) | NA ± NA |
Cmax was defined as the maximum concentration of JNJ-73763924 (molecule of JNJ-73763989). PK sample collection was done based on the availability of the participants at Weeks 4, 8, 12, or 16 and thus collected data were averaged and reported in this outcome measure.
| ng/mL | Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NA |
|---|---|
| Maximum Observed Analyte Concentration (Cmax) of JNJ-73763924 (Molecule of JNJ-73763989) | 222 ± 142 |
tmax was defined as the time to reach the maximum observed plasma concentration of JNJ-73763924 (molecule of JNJ-73763989). PK sample collection was done based on the availability of the participants at Weeks 4, 8, 12, or 16 and thus collected data were averaged and reported in this outcome measure.
| Hour | Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NA |
|---|---|
| Time to Reach the Maximum Observed Plasma Concentration (Tmax) of JNJ-73763924 (Molecule of JNJ-73763989) | 5.07 ± 1.00 |
C(24h) was defined as the observed plasma concentration of JNJ-73763924 (molecule of JNJ-73763989) at 24 h postdose of JNJ-73763989. PK sample collection was done based on the availability of the participants at Weeks 4, 8, 12, or 16 and thus collected data were averaged and reported in this outcome measure.
| ng/mL | Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NA |
|---|---|
| Observed Plasma Concentration at 24 Hour Postdose (C[24h]) of JNJ-73763924 (Molecule of JNJ-73763989) | 35.0 ± 25.5 |
AUC(0-24h) was defined as the area under the concentration of JNJ-73763924 (molecule of JNJ-73763989) versus time curve from time 0 to 24 hour of JNJ-73763989. PK sample collection was done based on the availability of the participants at Weeks 4, 8, 12, or 16 and thus collected data were averaged and reported in this outcome measure.
| ng*h/mL | Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NA |
|---|---|
| Area Under the Analyte Concentration Versus Time Curve From Time 0 to 24 Hour (AUC[0-24h]) of JNJ-73763924 (Molecule of JNJ-73763989) | 3386 ± 1930 |
Cmax(Dose Normalized) was defined as the maximum observed analyte concentration of JNJ-73763924 (molecule of JNJ-73763989) dose normalized to 1 mg. PK sample collection was done based on the availability of the participants at Weeks 4, 8, 12, or 16 and thus collected data were averaged and reported in this outcome measure.
| nanogram/milliliter/milligram (ng/mL/mg) | Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NA |
|---|---|
| Maximum Observed Analyte Concentration (Cmax) of JNJ-73763924 (Molecule of JNJ-73763989) Dose Normalized to 1 mg (Cmax[Dose Normalized]) | 3.33 ± 2.14 |
AUC(\[0-24h\], Dose Normalized) was defined as the area under the analyte concentration JNJ-73763924 (a molecule of JNJ-73763989) versus time curve from time 0 to 24 hours of JNJ-73763989 dose normalized to 1 mg. PK sample collection was done based on the availability of the participants at Weeks 4, 8, 12, or 16 and thus collected data were averaged and reported in this outcome measure.
| ng*h/mL/mg | Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NA |
|---|---|
| Area Under the Analyte Concentration Versus Time Curve From Time 0 to 24 Hours of JNJ-73763924 (Molecule of JNJ-73763989) Dose Normalized to 1 mg (AUC[0-24h], Dose Normalized) | 50.8 ± 28.9 |
C(predose) was defined as the observed plasma concentration at predose of JNJ-56136379. PK sample collection was done based on the availability of the participants at Weeks 4, 8, 12, or 16 and thus collected data were averaged and reported in this outcome measure.
| ng/mL | Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NA |
|---|---|
| Observed Plasma Concentration at Predose (C[Predose]) of JNJ-56136379 | 10812 ± 2430 |
Cmax was defined as the maximum observed concentration of JNJ-56136379. PK sample collection was done based on the availability of the participants at Weeks 4, 8, 12, or 16 and thus collected data were averaged and reported in this outcome measure.
| ng/mL | Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NA |
|---|---|
| Maximum Observed Analyte Concentration (Cmax) of JNJ-56136379 | 14754 ± 4318 |
tmax was defined as the time to reach the maximum observed plasma concentration of JNJ-56136379. PK sample collection was done based on the availability of the participants at Weeks 4, 8, 12, or 16 and thus collected data were averaged and reported in this outcome measure.
| Hour | Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NA |
|---|---|
| Time to Reach the Maximum Observed Plasma Concentration (Tmax) of JNJ-56136379 | 4.00 ± 0.0 |
Ctau was defined as the observed or predicted concentration at the end of a dosing interval of JNJ-56136379. PK sample collection was done based on the availability of the participants at Weeks 4, 8, 12, or 16 and thus collected data were averaged and reported in this outcome measure.
| ng/mL | Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NA |
|---|---|
| Observed or Predicted Concentration at the End of a Dosing Interval (Ctau) of JNJ-56136379 | 12763 ± 4959 |
AUCtau was defined as the area under the analyte concentration versus time curve during a dosing interval at steady state of JNJ-56136379. PK sample collection was done based on the availability of the participants at Weeks 4, 8, 12, or 16 and thus collected data were averaged and reported in this outcome measure.
| ng*h/mL | Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NA |
|---|---|
| Area Under the Analyte Concentration Versus Time Curve During a Dosing Interval at Steady State (AUCtau) of JNJ-56136379 | 282458 ± 79118 |
Collected over Up to Week 102 (including 6 weeks of screening). Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NA | 0/85 (0%) | 3/85 (3.5%) | 71/85 (83.5%) |
| Arm 2: Nucleos(t)Ide Analog (NA) | 0/45 (0%) | 4/45 (8.9%) | 36/45 (80%) |
| Event | Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NA | Arm 2: Nucleos(t)Ide Analog (NA) |
|---|---|---|
| VertigoEar and labyrinth disorders | 0/85 | 1/45 |
| Subacute Hepatic FailureHepatobiliary disorders | 0/85 | 1/45 |
| Hepatitis B ReactivationInfections and infestations | 0/85 | 1/45 |
| Radius FractureInjury, poisoning and procedural complications | 0/85 | 1/45 |
| Intervertebral Disc DisorderMusculoskeletal and connective tissue disorders | 0/85 | 1/45 |
| Hepatocellular CarcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/85 | 1/45 |
| PyrexiaGeneral disorders | 1/85 | 0/45 |
| Covid-19Infections and infestations | 1/85 | 0/45 |
| Cytomegalovirus Infection ReactivationInfections and infestations | 1/85 | 0/45 |
| CholangiocarcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/85 | 0/45 |
| Event | Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NA | Arm 2: Nucleos(t)Ide Analog (NA) |
|---|---|---|
| Alanine Aminotransferase IncreasedInvestigations | 6/85 | 11/45 |
| HeadacheNervous system disorders | 19/85 | 10/45 |
| Glomerular Filtration Rate DecreasedInvestigations | 18/85 | 4/45 |
| Covid-19Infections and infestations | 17/85 | 4/45 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 9/85 | 9/45 |
| AstheniaGeneral disorders | 12/85 | 4/45 |
| DiarrhoeaGastrointestinal disorders | 3/85 | 6/45 |
| FatigueGeneral disorders | 11/85 | 5/45 |
| HypertensionVascular disorders | 11/85 | 3/45 |
| NasopharyngitisInfections and infestations | 10/85 | 5/45 |
| Age, Continuous(years) | Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NA | Arm 2: Nucleos(t)Ide Analog (NA) | Total |
|---|---|---|---|
| Mean | 45.3 ± 10.1 | 47.4 ± 10.55 | 46 ± 10.27 |
| Sex: Female, Male(Participants) | Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NA | Arm 2: Nucleos(t)Ide Analog (NA) | Total |
|---|---|---|---|
| Female | 27 | 16 | 43 |
| Male | 58 | 29 | 87 |
| Ethnicity (NIH/OMB)(Participants) | Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NA | Arm 2: Nucleos(t)Ide Analog (NA) | Total |
|---|---|---|---|
| Hispanic or Latino | 15 | 3 | 18 |
| Not Hispanic or Latino | 66 | 41 | 107 |
| Unknown or Not Reported | 4 | 1 | 5 |
| Race (NIH/OMB)(Participants) | Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NA | Arm 2: Nucleos(t)Ide Analog (NA) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 17 | 8 | 25 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 7 | 5 | 12 |
| White | 56 | 30 | 86 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 5 | 2 | 7 |
| Region of Enrollment(Participants) | Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NA | Arm 2: Nucleos(t)Ide Analog (NA) | Total |
|---|---|---|---|
| BELGIUM | 7 | 2 | 9 |
| FRANCE | 14 | 7 | 21 |
| GERMANY | 7 | 5 | 12 |
| ITALY | 17 | 5 | 22 |
| POLAND | 13 | 10 | 23 |
| SPAIN | 18 | 7 | 25 |
| UNITED KINGDOM | 9 | 9 | 18 |
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