An Efficacy and Safety Study of a Combination of JNJ-73763989, Nucleos(t)Ide Analogs (NA), and a Programmed Cell Death Protein Receptor-1 (PD-1) Inhibitor in Chronic Hepatitis B Participants

An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily had a causal relationship with the pharmaceutical/biological agent under study. Any AE occurring at or after the initial administration of study intervention was considered to be treatment emergent. AEs of interest were significant AEs that are judged to be of special interest because of clinical importance, known class effects or based on nonclinical signals.

Number of participants with TEAEs by severity were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that did not necessarily had a causal relationship with the pharmaceutical/biological agent under study. Any AE occurring at or after the initial administration of study intervention was considered to be treatment emergent. Severity of AE were graded by using Division of Acquired Immunodeficiency Syndrome (DAIDS) grading scale that ranges from Grade 1 to Grade 5. Grade 1 indicates a mild event, Grade 2 indicates a moderate event, Grade 3 indicates a severe event, Grade 4 indicated a potentially life-threatening event, Grade 5 indicated death.

Number of participants with immune related TEAEs were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that did not necessarily have a causal relationship with the pharmaceutical/ biological agent under study. Any AE occurring at or after the initial administration of study intervention was considered to be treatment emergent. Immune-related AEs (irAEs) were alanine aminotransferase/alanine aminotransferase (ALT/AST) elevations including immune-related hepatic AEs, infusion-related reaction (IRRs) and other irAEs (including gastrointestinal AEs, neurological AEs, pulmonary AEs, renal AEs, endocrinopathies, rash, uveitis and visual complaints, lipase/amylase elevations, and infection), hematological abnormalities and injection site reactions.

Number of participants with abnormalities in vital signs measurements (including pulse rate: abnormally low: less than or equal to [<=] 45 beats per minute [bpm], abnormally high: greater than or equal to [>=] 120 bpm; diastolic blood pressure [BP]: abnormally low: <=50 millimeters of mercury [mmHg], mild: >90 to <100 mmHg, moderate: >=100 to <110 mmHg, and severe: >=110 mmHg; systolic BP: abnormally low: <=90 mmHg, mild: >140 to <160 mmHg, moderate: >=160 to <180 mmHg, and severe: >=180 mmHg) were reported.

Number of participants with abnormalities in 12-lead ECGs: heart rate (abnormally low: <45 beats per minute [bpm], abnormally high: greater than or equal [>=] 120 bpm), PR interval (abnormally high: greater than [>] 220 millisecond [msec]), QRS interval (abnormally high: >=120 msec), QTc interval Fridericia (Borderline prolonged QT: 450< QTc <=480 msec; Prolonged QT: 480 < QTc <=500; Pathologically prolonged QT: QTc >500) were reported.

Number of participants with abnormalities in physical examinations were reported.

Percentage of participants with abnormalities in hematology parameters (including basophils/Leukocytes high, erythrocytes mean corpuscular volume high, erythrocytes high and low, lymphocytes/leukocytes high and low, monocytes/leukocytes high and low, neutrophils, segmented+band form high and low, reticulocytes/erythrocytes high and low, basophils/leukocytes, eosinophils/leukocytes high, erythrocyte mean corpuscular hemoglobin low, reticulocytes/erythrocytes high and low, lymphocytes atypical/leukocytes high, lymphocytes atypical high, hematocrit high, monocytes low and high) were reported. Abnormalities with at least 1 participant is included. Low and high categorization depend on investigator's discretion.

Number of participants with abnormalities in clinical chemistry parameters (including C reactive protein high, cystatin C low and high, gamma glutamyl transferase low, high density lipoprotein [HDL] cholesterol low and high, indirect bilirubin high, lactate dehydrogenase high, protein high, thyrotropin low and high, free thyroxine high, free triiodothyronine low and high, and urea nitrogen high) were reported. Abnormalities with at least 1 participant is included. Low and high categorization depend on investigator's discretion.

Number of participants with abnormalities in clinical laboratory parameters (including specific gravity high and urine hyaline casts high) were reported. Abnormalities with at least 1 participant is included. Low and high categorization depend on investigator's discretion.

Change from baseline in HBsAg levels were reported. International units per milliliters=IU/mL. End of Study Intervention (EOSI) was the last post-baseline visit in study intervention period. End of study (EOS) was the last visit in the study.

Percentage of participants with change in HBsAg levels below/above different cut-offs (<0.05 IU/mL, <1 U/mL, <10 IU/mL, <100 IU/mL , <1000 IU/mL) over time were reported. EOSI was the last post-baseline visit in study intervention period. EOS was the last visit in the study.

Percentage of participants with HBsAg seroclearance were reported. Seroclearance of HBsAg was defined as a HBsAg level <lower limit of quantification (LLOQ) (0.05 IU/mL).

Percentage of participants with HBsAg seroconversion were reported. Seroconversion of HBsAg was defined as having achieved HBsAg seroclearance and appearance of anti-HBs antibodies (baseline anti-HBs antibodies <LLOQ and a post-baseline assessment >=LLOQ).

Time to achieve HBsAg seroclearance was reported. Seroclearance of HBsAg was defined as a (quantitative) HBsAg level <LLOQ (0.05 IU/mL).

Time to achieve HBsAg seroconversion were reported. Seroconversion of HBsAg was defined as having achieved HBsAg seroclearance and appearance of anti-HBs antibodies (baseline anti-HBs antibodies <LLOQ and a post-baseline assessment >=LLOQ).

HBV DNA levels over time were reported. EOSI was the last post-baseline visit in study intervention period. EOS was the last visit in the study.

Percentage of participants with HBV DNA level below/above different cut-offs over time were reported. HBV DNA cut offs: <LLOQ target detected (TD): that is, traces of HBV DNA were detected/found but were too low to be quantified; <LLOQ target not detected (TND): that is, no traces of HBV DNA were detected/found. EOSI was the last post-baseline visit in study intervention period. EOS was the last visit in the study. The LLOQ for HBV DNA was 20 IU/mL. As indicated in the data table, the sum of percentage values of each sub-categories within the specific timepoints "IP: Week 2" and "FU Phase: Week 4", shows a slight deviation from 100% due to rounding.

Percentage of participants with HBeAg level below/above different cut-offs over time were reported. HBeAg cut-offs: <LLOQ (0.11 IU/mL). EOSI was the last post-baseline visit in study intervention period. EOS was the last visit in the study.

Percentage of participants with virologic breakthrough (confirmed on-treatment HBV DNA increase by >1 log10 IU/mL from nadir in participants who did not have on-treatment HBV DNA level below LLOQ or a confirmed on-treatment HBV DNA level >200 IU/mL in participants who had on-treatment HBV DNA level below LLOQ) were reported.