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A Study of JNJ 73763989+JNJ 56136379+Nucleos(t)Ide Analog (NA) Regimen Compared to NA Alone in e Antigen Negative Virologically Suppressed Participants With Chronic Hepatitis B Virus Infection

A Randomized, Double Blind, Placebo-controlled Phase 2b Study to Evaluate Efficacy, Pharmacokinetics, and Safety of 48-week Study Intervention With JNJ 73763989+JNJ 56136379+Nucleos(t)Ide Analog (NA) Regimen Compared to NA Alone in e Antigen Negative Virologically Suppressed Participants With Chronic Hepatitis B Virus Infection

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04129554
Enrollment
130
Registered
2019-10-17
Start date
2019-11-06
Completion date
2022-06-09
Last updated
2025-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis B, Chronic

Brief summary

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).

Detailed description

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.

Interventions

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.

Sponsors

Janssen Sciences Ireland UC
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Medically stable based on physical examination, medical history, vital signs, electrocardiogram (ECG) at screening * Chronic hepatitis B virus (HBV) infection with documentation at least 6 months prior to screening * Hepatitis B e (antigen) (HBeAg)-negative on stable nucleotide analogue (NA) treatment for at least 24 months prior to screening * Hepatitis B surface antigen (HBsAg) greater than (\>) 100 International Units per Milliliter (IU/mL) at screening * Body mass index (BMI) between 18.0 and 35 kilogram per meter square (kg/m\^2), extremes included * Highly effective contraceptive measures in place for female participants of childbearing potential or male participants with female partners of childbearing potential * Liver fibrosis stage 0-2 (Metavir) or Fibroscan less than (\<) 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/symptoms of hepatic decompensation including but not limited to: portal hypertension, ascites, hepatic encephalopathy, esophageal varices or any laboratory abnormalities indicating a reduced liver function as defined in the protocol * Evidence of liver disease of non-HBV etiology * History or signs of cirrhosis or portal hypertension (nodules, no smooth liver contour, no normal portal vein, spleen size ≥12 cm) or signs of hepatocellular carcinoma (HCC) * Significant laboratory abnormalities as defined in the protocol at screening * Participants with a history of malignancy within 5 years before screening * Abnormal sinus rhythm or ECG parameters at screening as defined in the protocol * History of or current cardiac arrhythmia or history or clinical evidence of significant or unstable cardiac disease * Participants with any current or previous illness for which, in the opinion of the investigator and/or sponsor, participation would not be in the best interest of the participant * History of or current clinically significant skin disease or drug rash * Known allergies, hypersensitivity, or intolerance to JNJ-73763989 and JNJ-56136379 or their excipients or to placebo content * Contraindications to the use of entecavir (ETV), tenofovir disoproxil fumarate (TDF), or tenofovir alafenamide (TAF) per local prescribing information * Participants who have taken any therapies disallowed per protocol

Design outcomes

Primary

MeasureTime frameDescription
Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Seroclearance at Week 72 Without Restarting NA TreatmentWeek 72Percentage 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.

Secondary

MeasureTime frameDescription
Percentage of Participants With Treatment-emergent Serious Adverse Events (SAEs)From screening up to 102 weeksAn 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 With HBsAg Seroclearance at Week 48Week 48Percentage 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 With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Less Than (<) Lower Limit of Quantification (LLOQ) at Week 48Week 48Percentage of participants with HBV DNA \<LLOQ (20 international units per milliliters \[IU/mL\]) at Week 48 was reported.
Percentage of Participants With HBsAg Seroclearance at Week 96 (48 Weeks After Stopping All Study Interventions at Week 48 Without Restarting NA Treatment)Week 96Percentage 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 With (Sustained) Reduction, Suppression, and/or SeroclearanceBaseline (Day 1) up to Week 96Percentage 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 With HBsAg Seroconversion at Week 96Week 96Percentage 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.
Change From Baseline in HBsAg Values at Weeks 48, 72, and 96Baseline (Day 1), Weeks 48, 72, and 96Change from baseline in HBsAg values was reported.
Change From Baseline in HBV DNA Values at Weeks 48, 72, and 96Baseline (Day 1), Weeks 48, 72, and 96Change 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 to Achieve First HBsAg SeroclearanceBaseline (Day 1) up to Week 96Time 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.
Percentage of Participants With Reduction of More Than (>) 1 log10 IU/mL in HBsAg Levels From BaselineBaseline (Day 1) up to Week 96Percentage of participants with reduction of \>1 log10 in HBsAg Levels IU/mL from baseline was reported.
Percentage of Participants With HBsAg Levels Less Than (<) 100 IU/mL at Weeks 48, 72, and 96Weeks 48, 72, and 96Percentage of participants with HBsAg Levels \<100 IU/mL at Weeks 48, 72, and 96 was reported.
Percentage of Participants With HBV DNA Levels Less Than (<) LLOQ From Baseline up to Week 96 (End of Study)Baseline (Day 1) up to Week 96Percentage of Participants with HBV DNA levels \<LLOQ (20 IU/mL) was reported.
Percentage of Participants With FlaresBaseline (Day 1) up to Week 96Percentage 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 With Virologic BreakthroughBaseline (Day 1) up to Week 48Percentage 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 Requiring NA Re-Treatment During Follow-upBaseline (Day 1) up to Week 96Percentage of participants requiring NA re-treatment (either ETV, TDF, or TAF) during follow-up was reported.
Correlation Coefficient Between On-treatment HBsAg Change From Baseline With On-treatment HBV Blood Markers and Baseline CharacteristicsBaseline (Day 1) to Week 96Correlation 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).
Observed Plasma Concentration at Predose (C[Predose]) of JNJ-73763976 (Molecule of JNJ-73763989)Predose at Weeks 4, 8, 12, and 16C(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.
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)From screening up to Week 102An 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 to Reach the Maximum Observed Plasma Concentration (Tmax) of JNJ-73763976 (Molecule of JNJ-73763989)Weeks 4, 8, 12, and 16: at Predose, 15 minutes, 30 minutes, 1, 2, 3, 4, 6, 8, 10, and 24 hours postdosetmax 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.
Observed Plasma Concentration at 24 Hour Postdose (C[24h]) of JNJ-73763976 (Molecule of JNJ-73763989)24 hours postdose at Weeks 4, 8, 12, and 16C(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.
Area Under the Analyte Concentration Versus Time Curve From Time 0 to 24 Hours (AUC[0-24h]) of JNJ-73763976 (Molecule of JNJ-73763989)0 to 24 hours postdose at Weeks 4, 8, 12, and 16AUC(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.
Maximum Observed Analyte Concentration (Cmax) of JNJ-73763976 (Molecule of JNJ-73763989) Dose Normalized to 1 mg (Cmax[Dose Normalized])Weeks 4, 8, 12, and 16: at Predose, 15 minutes, 30 minutes, 1, 2, 3, 4, 6, 8, 10, and 24 hours postdoseCmax(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.
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)0 to 24 hours post-dose at Weeks 4, 8, 12, and 16AUC(\[0-24h\], 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.
Observed Plasma Concentration at Predose (C[Predose]) of JNJ-73763924 (Molecule of JNJ-73763989)Predose at Weeks 4, 8, 12, and 16C(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.
Maximum Observed Analyte Concentration (Cmax) of JNJ-73763924 (Molecule of JNJ-73763989)Weeks 4, 8, 12, and 16: at Predose, 15 minutes, 30 minutes, 1, 2, 3, 4, 6, 8, 10, and 24 hours postdoseCmax 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 to Reach the Maximum Observed Plasma Concentration (Tmax) of JNJ-73763924 (Molecule of JNJ-73763989)Weeks 4, 8, 12, and 16: at Predose, 15 minutes, 30 minutes, 1, 2, 3, 4, 6, 8, 10, and 24 hours postdosetmax 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.
Observed Plasma Concentration at 24 Hour Postdose (C[24h]) of JNJ-73763924 (Molecule of JNJ-73763989)24 hours postdose at Weeks 4, 8, 12, and 16C(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.
Area Under the Analyte Concentration Versus Time Curve From Time 0 to 24 Hour (AUC[0-24h]) of JNJ-73763924 (Molecule of JNJ-73763989)0 to 24 hours postdose at Weeks 4, 8, 12, and 16AUC(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.
Maximum Observed Analyte Concentration (Cmax) of JNJ-73763924 (Molecule of JNJ-73763989) Dose Normalized to 1 mg (Cmax[Dose Normalized])Weeks 4, 8, 12, and 16: at Predose, 15 minutes, 30 minutes, 1, 2, 3, 4, 6, 8, 10, and 24 hours postdoseCmax(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.
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)0 to 24 hours postdose at Weeks 4, 8, 12, and 16AUC(\[0-24h\], 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.
Observed Plasma Concentration at Predose (C[Predose]) of JNJ-56136379Predose at Weeks 4, 8, 12, and 16C(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.
Maximum Observed Analyte Concentration (Cmax) of JNJ-56136379Weeks 4, 8, 12, and 16: at Predose, 15 minutes, 30 minutes, 1, 2, 3, 4, 6, 8, 10, and 24 hours postdoseCmax 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 to Reach the Maximum Observed Plasma Concentration (Tmax) of JNJ-56136379Weeks 4, 8, 12, and 16: at Predose, 15 minutes, 30 minutes, 1, 2, 3, 4, 6, 8, 10, and 24 hours postdosetmax 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.
Observed or Predicted Concentration at the End of a Dosing Interval (Ctau) of JNJ-56136379Weeks 4, 8, 12, and 16: at Predose, 15 minutes, 30 minutes, 1, 2, 3, 4, 6, 8, 10, and 24 hours postdoseCtau 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.
Area Under the Analyte Concentration Versus Time Curve During a Dosing Interval at Steady State (AUCtau) of JNJ-56136379Weeks 4, 8, 12, and 16: at Predose, 15 minutes, 30 minutes, 1, 2, 3, 4, 6, 8, 10, and 24 hours postdoseAUCtau 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.
Maximum Observed Analyte Concentration (Cmax) of JNJ-73763976 (Molecule of JNJ-73763989)Weeks 4, 8, 12, and 16: at Predose, 15 minutes, 30 minutes, 1, 2, 3, 4, 6, 8, 10, and 24 hours postdoseCmax 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.

Countries

Belgium, France, Germany, Italy, Poland, Spain, United Kingdom

Participant flow

Participants by arm

ArmCount
Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NA
Participants received JNJ-73763989 200 mg subcutaneous (SC) injection, once every 4 weeks (q4w), along with JNJ-56136379 250 mg tablet once daily (qd) and NA treatment orally (either entecavir \[ETV\], tenofovir disoproxil fumarate \[TDF\] or tenofovir alafenamide \[TAF\]) qd up to 48 weeks.
85
Arm 2: Nucleos(t)Ide Analog (NA)
Participants received matching placebo for JNJ-73763989 by SC injection q4w, along with matching placebo for JNJ-56136379 qd and NA treatment orally (either ETV, TDF or TAF) qd up to 48 weeks.
45
Total130

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyOther02
Overall StudyWithdrawal by Subject43

Baseline characteristics

CharacteristicArm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NATotalArm 2: Nucleos(t)Ide Analog (NA)
Age, Continuous45.3 years
STANDARD_DEVIATION 10.1
46 years
STANDARD_DEVIATION 10.27
47.4 years
STANDARD_DEVIATION 10.55
Ethnicity (NIH/OMB)
Hispanic or Latino
15 Participants18 Participants3 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
66 Participants107 Participants41 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
4 Participants5 Participants1 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
17 Participants25 Participants8 Participants
Race (NIH/OMB)
Black or African American
7 Participants12 Participants5 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
5 Participants7 Participants2 Participants
Race (NIH/OMB)
White
56 Participants86 Participants30 Participants
Region of Enrollment
BELGIUM
7 Participants9 Participants2 Participants
Region of Enrollment
FRANCE
14 Participants21 Participants7 Participants
Region of Enrollment
GERMANY
7 Participants12 Participants5 Participants
Region of Enrollment
ITALY
17 Participants22 Participants5 Participants
Region of Enrollment
POLAND
13 Participants23 Participants10 Participants
Region of Enrollment
SPAIN
18 Participants25 Participants7 Participants
Region of Enrollment
UNITED KINGDOM
9 Participants18 Participants9 Participants
Sex: Female, Male
Female
27 Participants43 Participants16 Participants
Sex: Female, Male
Male
58 Participants87 Participants29 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 850 / 45
other
Total, other adverse events
71 / 8536 / 45
serious
Total, serious adverse events
3 / 854 / 45

Outcome results

Primary

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

Population: Modified intent-to-treat (mITT) included all participants who were randomized in the study and received at least one dose of study intervention excluding those participants impacted by the pandemic. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure.

ArmMeasureValue (NUMBER)
Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NAPercentage of Participants With Hepatitis B Surface Antigen (HBsAg) Seroclearance at Week 72 Without Restarting NA Treatment0.0 Percentage of participants
Arm 2: Nucleos(t)Ide Analog (NA)Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Seroclearance at Week 72 Without Restarting NA Treatment0.0 Percentage of participants
Secondary

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

Population: PK analysis set included participants who have received at least 1 dose of any of the study interventions and have at least 1 valid blood sample drawn for PK analysis. Here, 'N' (number analyzed) signifies number of participants analyzed for this outcome measure. NA was TDF.

ArmMeasureValue (MEAN)Dispersion
Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NAArea Under the Analyte Concentration Versus Time Curve During a Dosing Interval at Steady State (AUCtau) of JNJ-56136379282458 ng*h/mLStandard Deviation 79118
Secondary

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

Population: PK analysis set 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. Here, 'N' (number analyzed) signifies number of participants analyzed for this outcome measure. NA was TDF.

ArmMeasureValue (MEAN)Dispersion
Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NAArea Under the Analyte Concentration Versus Time Curve From Time 0 to 24 Hour (AUC[0-24h]) of JNJ-73763924 (Molecule of JNJ-73763989)3386 ng*h/mLStandard Deviation 1930
Secondary

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

Population: PK analysis set 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. Here, 'N' (number analyzed) signifies number of participants analyzed for this outcome measure. NA was TDF.

ArmMeasureValue (MEAN)Dispersion
Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NAArea Under the Analyte Concentration Versus Time Curve From Time 0 to 24 Hours (AUC[0-24h]) of JNJ-73763976 (Molecule of JNJ-73763989)17833 nanogram*hour/milliliter (ng*h/mL)Standard Deviation 9670
Secondary

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

Population: PK analysis set 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. Here, 'N' (number analyzed) signifies number of participants analyzed for this outcome measure. NA was TDF.

ArmMeasureValue (MEAN)Dispersion
Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NAArea 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 ng*h/mL/mgStandard Deviation 28.9
Secondary

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

Population: PK analysis set 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. Here, 'N' (number analyzed) signifies number of participants analyzed for this outcome measure. NA was TDF.

ArmMeasureValue (MEAN)Dispersion
Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NAArea 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 ng*h/mL/mgStandard Deviation 72.5
Secondary

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

Population: mITT included all participants who were randomized in the study and received at least one dose of study intervention excluding those participants impacted by the pandemic. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure and 'n' (number evaluable) signifies number of participants analyzed at each specified timepoints.

ArmMeasureGroupValue (MEAN)Dispersion
Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NAChange From Baseline in HBsAg Values at Weeks 48, 72, and 96Week 72-1.76 log10 IU/mLStandard Deviation 0.658
Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NAChange From Baseline in HBsAg Values at Weeks 48, 72, and 96Week 96-1.46 log10 IU/mLStandard Deviation 0.661
Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NAChange From Baseline in HBsAg Values at Weeks 48, 72, and 96Week 48-1.89 log10 IU/mLStandard Deviation 0.522
Arm 2: Nucleos(t)Ide Analog (NA)Change From Baseline in HBsAg Values at Weeks 48, 72, and 96Week 48-0.06 log10 IU/mLStandard Deviation 0.082
Arm 2: Nucleos(t)Ide Analog (NA)Change From Baseline in HBsAg Values at Weeks 48, 72, and 96Week 72-0.25 log10 IU/mLStandard Deviation 0.563
Arm 2: Nucleos(t)Ide Analog (NA)Change From Baseline in HBsAg Values at Weeks 48, 72, and 96Week 96-0.49 log10 IU/mLStandard Deviation 0.783
Secondary

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

Population: mITT included as all participants who were randomized in the study and received at least one dose of study intervention excluding those participants impacted by the pandemic. Here, 'N' (number of participants analyzed) signifies that no participants were available for change from baseline HBV DNA analysis because all participants were virologically suppressed, thereby planned data collection and analysis was not performed and thus, no data was reported for this outcome measure.

ArmMeasureGroupValue
UnknownChange From Baseline in HBV DNA Values at Weeks 48, 72, and 96Week 48
UnknownChange From Baseline in HBV DNA Values at Weeks 48, 72, and 96Week 72
UnknownChange From Baseline in HBV DNA Values at Weeks 48, 72, and 96Week 96
Secondary

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

Population: mITT included all participants who were randomized in the study and received at least one dose of study intervention excluding those participants impacted by the pandemic. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure.

ArmMeasureGroupValue (NUMBER)
Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NACorrelation Coefficient Between On-treatment HBsAg Change From Baseline With On-treatment HBV Blood Markers and Baseline CharacteristicsBaseline NA treatment duration0.2381 correlation coefficient
Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NACorrelation Coefficient Between On-treatment HBsAg Change From Baseline With On-treatment HBV Blood Markers and Baseline CharacteristicsHBsAg at Week 240.9983 correlation coefficient
Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NACorrelation Coefficient Between On-treatment HBsAg Change From Baseline With On-treatment HBV Blood Markers and Baseline CharacteristicsHBsAg value at baseline-0.9970 correlation coefficient
Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NACorrelation Coefficient Between On-treatment HBsAg Change From Baseline With On-treatment HBV Blood Markers and Baseline CharacteristicsHBsAg at Week 480.9982 correlation coefficient
Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NACorrelation Coefficient Between On-treatment HBsAg Change From Baseline With On-treatment HBV Blood Markers and Baseline CharacteristicsAge0.2860 correlation coefficient
Arm 2: Nucleos(t)Ide Analog (NA)Correlation Coefficient Between On-treatment HBsAg Change From Baseline With On-treatment HBV Blood Markers and Baseline CharacteristicsHBsAg at Week 480.8065 correlation coefficient
Arm 2: Nucleos(t)Ide Analog (NA)Correlation Coefficient Between On-treatment HBsAg Change From Baseline With On-treatment HBV Blood Markers and Baseline CharacteristicsAge0.1746 correlation coefficient
Arm 2: Nucleos(t)Ide Analog (NA)Correlation Coefficient Between On-treatment HBsAg Change From Baseline With On-treatment HBV Blood Markers and Baseline CharacteristicsBaseline NA treatment duration0.4324 correlation coefficient
Arm 2: Nucleos(t)Ide Analog (NA)Correlation Coefficient Between On-treatment HBsAg Change From Baseline With On-treatment HBV Blood Markers and Baseline CharacteristicsHBsAg value at baseline-0.5923 correlation coefficient
Arm 2: Nucleos(t)Ide Analog (NA)Correlation Coefficient Between On-treatment HBsAg Change From Baseline With On-treatment HBV Blood Markers and Baseline CharacteristicsHBsAg at Week 240.7120 correlation coefficient
Secondary

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

Population: PK analysis set 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. Here, 'N' (number analyzed) signifies number of participants analyzed for this outcome measure. NA was TDF.

ArmMeasureValue (MEAN)Dispersion
Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NAMaximum Observed Analyte Concentration (Cmax) of JNJ-5613637914754 ng/mLStandard Deviation 4318
Secondary

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

Population: PK analysis set 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. Here, 'N' (number analyzed) signifies number of participants analyzed for this outcome measure. NA was TDF.

ArmMeasureValue (MEAN)Dispersion
Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NAMaximum Observed Analyte Concentration (Cmax) of JNJ-73763924 (Molecule of JNJ-73763989)222 ng/mLStandard Deviation 142
Secondary

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

Population: PK analysis set 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. Here, 'N' (number analyzed) signifies number of participants analyzed for this outcome measure. NA was TDF.

ArmMeasureValue (MEAN)Dispersion
Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NAMaximum Observed Analyte Concentration (Cmax) of JNJ-73763924 (Molecule of JNJ-73763989) Dose Normalized to 1 mg (Cmax[Dose Normalized])3.33 nanogram/milliliter/milligram (ng/mL/mg)Standard Deviation 2.14
Secondary

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

Population: PK analysis set 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. NA was TDF. Here, 'N' (number analyzed) signifies number of participants analyzed for this outcome measure.

ArmMeasureValue (MEAN)Dispersion
Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NAMaximum Observed Analyte Concentration (Cmax) of JNJ-73763976 (Molecule of JNJ-73763989)1111 ng/mLStandard Deviation 716
Secondary

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

Population: PK analysis set 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. Here, 'N' (number analyzed) signifies number of participants analyzed for this outcome measure. NA was TDF.

ArmMeasureValue (MEAN)Dispersion
Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NAMaximum Observed Analyte Concentration (Cmax) of JNJ-73763976 (Molecule of JNJ-73763989) Dose Normalized to 1 mg (Cmax[Dose Normalized])8.34 ng/mL/mgStandard Deviation 5.37
Secondary

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

Population: PK analysis set 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. Here, 'N' (number analyzed) signifies number of participants analyzed for this outcome measure. NA was TDF.

ArmMeasureValue (MEAN)Dispersion
Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NAObserved or Predicted Concentration at the End of a Dosing Interval (Ctau) of JNJ-5613637912763 ng/mLStandard Deviation 4959
Secondary

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

Population: PK analysis set 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. Here, 'N' (number analyzed) signifies number of participants analyzed for this outcome measure. NA was TDF.

ArmMeasureValue (MEAN)Dispersion
Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NAObserved Plasma Concentration at 24 Hour Postdose (C[24h]) of JNJ-73763924 (Molecule of JNJ-73763989)35.0 ng/mLStandard Deviation 25.5
Secondary

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

Population: PK analysis set 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. Here, 'N' (number analyzed) signifies number of participants analyzed for this outcome measure. NA was TDF.

ArmMeasureValue (MEAN)Dispersion
Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NAObserved Plasma Concentration at 24 Hour Postdose (C[24h]) of JNJ-73763976 (Molecule of JNJ-73763989)275 ng/mLStandard Deviation 161
Secondary

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

Population: PK analysis set was defined as 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. Here, 'N' (number analyzed) signifies number of participants analyzed at each specified outcome measure. NA was TDF.

ArmMeasureValue (MEAN)Dispersion
Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NAObserved Plasma Concentration at Predose (C[Predose]) of JNJ-5613637910812 ng/mLStandard Deviation 2430
Secondary

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

Population: PK analysis set was defined as 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. Here, 'N' (number analyzed) signifies number of participants analyzed at each specified outcome measure. NA was TDF.

ArmMeasureValue (MEAN)
Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NAObserved Plasma Concentration at Predose (C[Predose]) of JNJ-73763924 (Molecule of JNJ-73763989)NA ng/mL
Secondary

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

Population: Pharmacokinetic (PK) analysis set included all 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. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure. NA (nucleos\[t\]ide analog) was tenofovir disoproxil fumarate (TDF).

ArmMeasureValue (MEAN)
Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NAObserved Plasma Concentration at Predose (C[Predose]) of JNJ-73763976 (Molecule of JNJ-73763989)NA nanogram/milliliter (ng/mL)
Secondary

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

Population: mITT included all participants who were randomized in the study and received at least one dose of study intervention excluding those participants impacted by the pandemic. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure.

ArmMeasureValue (NUMBER)
Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NAPercentage of Participants Requiring NA Re-Treatment During Follow-up9.1 Percentage of participants
Arm 2: Nucleos(t)Ide Analog (NA)Percentage of Participants Requiring NA Re-Treatment During Follow-up26.8 Percentage of participants
Secondary

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

Population: mITT included all participants who were randomized in the study and received at least one dose of study intervention excluding those participants impacted by the pandemic. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure.

ArmMeasureGroupValue (NUMBER)
Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NAPercentage of Participants With FlaresClinical Flare: HBV DNA > 2000 - =<20000IU/mL1.3 Percentage of participants
Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NAPercentage of Participants With FlaresAlanine Transaminase Flare3.9 Percentage of participants
Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NAPercentage of Participants With FlaresVirologic Flare (HBV DNA>2000 - =< 20000 IU/mL)24.0 Percentage of participants
Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NAPercentage of Participants With FlaresAspartate Aminotransferase Flare1.3 Percentage of participants
Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NAPercentage of Participants With FlaresClinical Flare: HBV DNA > 100000 IU/mL1.3 Percentage of participants
Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NAPercentage of Participants With FlaresClinical Flare: HBV DNA > 200 - =<2000IU/mL0.0 Percentage of participants
Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NAPercentage of Participants With FlaresVirologic Flare (HBV DNA >20000 - =<100000 IU/mL)8.0 Percentage of participants
Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NAPercentage of Participants With FlaresClinical Flare: HBV DNA > 20000 - =<100000IU/mL1.3 Percentage of participants
Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NAPercentage of Participants With FlaresVirologic Flare (HBV DNA >100000 IU/mL)2.7 Percentage of participants
Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NAPercentage of Participants With FlaresVirologic Flare (HBV DNA > 200 - =<2000 IU/mL)38.7 Percentage of participants
Arm 2: Nucleos(t)Ide Analog (NA)Percentage of Participants With FlaresClinical Flare: HBV DNA > 100000 IU/mL27.5 Percentage of participants
Arm 2: Nucleos(t)Ide Analog (NA)Percentage of Participants With FlaresVirologic Flare (HBV DNA > 200 - =<2000 IU/mL)25.0 Percentage of participants
Arm 2: Nucleos(t)Ide Analog (NA)Percentage of Participants With FlaresVirologic Flare (HBV DNA>2000 - =< 20000 IU/mL)30.0 Percentage of participants
Arm 2: Nucleos(t)Ide Analog (NA)Percentage of Participants With FlaresClinical Flare: HBV DNA > 2000 - =<20000IU/mL0.0 Percentage of participants
Arm 2: Nucleos(t)Ide Analog (NA)Percentage of Participants With FlaresVirologic Flare (HBV DNA >20000 - =<100000 IU/mL)10.0 Percentage of participants
Arm 2: Nucleos(t)Ide Analog (NA)Percentage of Participants With FlaresVirologic Flare (HBV DNA >100000 IU/mL)27.5 Percentage of participants
Arm 2: Nucleos(t)Ide Analog (NA)Percentage of Participants With FlaresAlanine Transaminase Flare19.5 Percentage of participants
Arm 2: Nucleos(t)Ide Analog (NA)Percentage of Participants With FlaresAspartate Aminotransferase Flare14.6 Percentage of participants
Arm 2: Nucleos(t)Ide Analog (NA)Percentage of Participants With FlaresClinical Flare: HBV DNA > 200 - =<2000IU/mL0.0 Percentage of participants
Arm 2: Nucleos(t)Ide Analog (NA)Percentage of Participants With FlaresClinical Flare: HBV DNA > 20000 - =<100000IU/mL0.0 Percentage of participants
Secondary

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

Population: mITT included all participants who were randomized in the study and received at least one dose of study intervention excluding those participants impacted by the pandemic. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure.

ArmMeasureGroupValue (NUMBER)
Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NAPercentage of Participants With HBsAg Levels Less Than (<) 100 IU/mL at Weeks 48, 72, and 96Week 4871.1 Percentage of participants
Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NAPercentage of Participants With HBsAg Levels Less Than (<) 100 IU/mL at Weeks 48, 72, and 96Week 7267.1 Percentage of participants
Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NAPercentage of Participants With HBsAg Levels Less Than (<) 100 IU/mL at Weeks 48, 72, and 96Week 9646.9 Percentage of participants
Arm 2: Nucleos(t)Ide Analog (NA)Percentage of Participants With HBsAg Levels Less Than (<) 100 IU/mL at Weeks 48, 72, and 96Week 482.4 Percentage of participants
Arm 2: Nucleos(t)Ide Analog (NA)Percentage of Participants With HBsAg Levels Less Than (<) 100 IU/mL at Weeks 48, 72, and 96Week 9615.0 Percentage of participants
Arm 2: Nucleos(t)Ide Analog (NA)Percentage of Participants With HBsAg Levels Less Than (<) 100 IU/mL at Weeks 48, 72, and 96Week 7210.3 Percentage of participants
Secondary

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

Population: mITT included all participants who were randomized in the study and received at least one dose of study intervention excluding those participants impacted by the pandemic. Here, 'N' (number of subjects analyzed) signifies participants who were evaluable for this outcome measure.

ArmMeasureValue (NUMBER)
Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NAPercentage of Participants With HBsAg Seroclearance at Week 480 Percentage of participants
Arm 2: Nucleos(t)Ide Analog (NA)Percentage of Participants With HBsAg Seroclearance at Week 480 Percentage of participants
Secondary

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

Population: mITT included all participants who were randomized in the study and received at least one dose of study intervention excluding those participants impacted by the pandemic.

ArmMeasureValue (NUMBER)
Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NAPercentage of Participants With HBsAg Seroclearance at Week 96 (48 Weeks After Stopping All Study Interventions at Week 48 Without Restarting NA Treatment)0.0 Percentage of participants
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 Percentage of participants
Secondary

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

Population: mITT included all participants who were randomized in the study and received at least one dose of study intervention excluding those participants impacted by the pandemic. Here, 'N' (number of subjects analyzed) signifies participants who were evaluable for this outcome measure.

ArmMeasureValue (NUMBER)
Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NAPercentage of Participants With HBsAg Seroconversion at Week 960 Percentage of participants
Arm 2: Nucleos(t)Ide Analog (NA)Percentage of Participants With HBsAg Seroconversion at Week 960 Percentage of participants
Secondary

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

Population: mITT included as all participants who were randomized in the study and received at least one dose of study intervention excluding those participants impacted by the pandemic. Here, 'N' (number of participants analyzed) included participants with blood marker data.

ArmMeasureValue (NUMBER)
Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NAPercentage of Participants With HBV DNA Levels Less Than (<) LLOQ From Baseline up to Week 96 (End of Study)23.9 Percentage of participants
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)3.6 Percentage of participants
Secondary

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

Population: mITT included all participants who were randomized in the study and received at least one dose of study intervention excluding those participants impacted by the pandemic. Here, 'N' (number of subjects analyzed) signifies participants who were evaluable for this outcome measure.

ArmMeasureValue (NUMBER)
Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NAPercentage of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Less Than (<) Lower Limit of Quantification (LLOQ) at Week 4897.3 Percentage of participants
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 48100 Percentage of participants
Secondary

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

Population: mITT included as all participants who were randomized in the study and received at least one dose of study intervention excluding those participants impacted by the pandemic. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure

ArmMeasureValue (NUMBER)
Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NAPercentage of Participants With Reduction of More Than (>) 1 log10 IU/mL in HBsAg Levels From Baseline81.5 Percentage of participants
Arm 2: Nucleos(t)Ide Analog (NA)Percentage of Participants With Reduction of More Than (>) 1 log10 IU/mL in HBsAg Levels From Baseline12.5 Percentage of participants
Secondary

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

Population: mITT included all participants, who were randomized in the study and received at least one dose of study intervention excluding those participants impacted by the pandemic. Here, 'N' (number of participants analyzed) included participants with blood marker data.

ArmMeasureGroupValue (NUMBER)
Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NAPercentage of Participants With (Sustained) Reduction, Suppression, and/or SeroclearanceHBsAg>=LLOQ and HBVDNA<2000 IU/mL23.9 Percentage of participants
Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NAPercentage of Participants With (Sustained) Reduction, Suppression, and/or SeroclearanceHBsAg>=LLOQ and LLOQ<=HBV DNA <2000 IU/mL64.8 Percentage of participants
Arm 2: Nucleos(t)Ide Analog (NA)Percentage of Participants With (Sustained) Reduction, Suppression, and/or SeroclearanceHBsAg>=LLOQ and HBVDNA<2000 IU/mL3.6 Percentage of participants
Arm 2: Nucleos(t)Ide Analog (NA)Percentage of Participants With (Sustained) Reduction, Suppression, and/or SeroclearanceHBsAg>=LLOQ and LLOQ<=HBV DNA <2000 IU/mL64.3 Percentage of participants
Secondary

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

Population: Safety analysis set included all randomized participants who received at least 1 dose of study drug.

ArmMeasureValue (NUMBER)
Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NAPercentage of Participants With Treatment-emergent Adverse Events (TEAEs)85.9 Percentage of participants
Arm 2: Nucleos(t)Ide Analog (NA)Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)80.0 Percentage of participants
Secondary

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

Population: Safety analysis set included all randomized participants who received at least 1 dose of study drug.

ArmMeasureValue (NUMBER)
Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NAPercentage of Participants With Treatment-emergent Serious Adverse Events (SAEs)3.5 Percentage of participants
Arm 2: Nucleos(t)Ide Analog (NA)Percentage of Participants With Treatment-emergent Serious Adverse Events (SAEs)8.9 Percentage of participants
Secondary

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

Population: mITT included all participants who were randomized in the study and received at least one dose of study intervention excluding those participants impacted by the pandemic.

ArmMeasureValue (NUMBER)
Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NAPercentage of Participants With Virologic Breakthrough0.0 Percentage of participants
Arm 2: Nucleos(t)Ide Analog (NA)Percentage of Participants With Virologic Breakthrough0.0 Percentage of participants
Secondary

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

Population: mITT included all participants who were randomized in the study and received at least one dose of study intervention excluding those participants impacted by the pandemic. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure.

ArmMeasureValue (MEDIAN)
Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NATime to Achieve First HBsAg SeroclearanceNA Days
Arm 2: Nucleos(t)Ide Analog (NA)Time to Achieve First HBsAg SeroclearanceNA Days
Secondary

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

Population: PK analysis set 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. Here, 'N' (number analyzed) signifies number of participants analyzed for this outcome measure. NA was TDF.

ArmMeasureValue (MEDIAN)Dispersion
Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NATime to Reach the Maximum Observed Plasma Concentration (Tmax) of JNJ-561363794.00 HourFull Range 0
Secondary

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

Population: PK analysis set 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. Here, 'N' (number analyzed) signifies number of participants analyzed for this outcome measure. NA was TDF.

ArmMeasureValue (MEDIAN)Dispersion
Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NATime to Reach the Maximum Observed Plasma Concentration (Tmax) of JNJ-73763924 (Molecule of JNJ-73763989)5.07 HourFull Range 1
Secondary

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

Population: PK analysis set 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. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure. NA was TDF.

ArmMeasureValue (MEDIAN)Dispersion
Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NATime to Reach the Maximum Observed Plasma Concentration (Tmax) of JNJ-73763976 (Molecule of JNJ-73763989)6.00 HourFull Range 1

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026