Hepatitis B, Chronic
Conditions
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
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Seroclearance at Week 72 Without Restarting NA Treatment | Week 72 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Treatment-emergent Serious Adverse Events (SAEs) | From screening up to 102 weeks | 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 With HBsAg Seroclearance at Week 48 | 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. |
| Percentage of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Less Than (<) Lower Limit of Quantification (LLOQ) at Week 48 | Week 48 | Percentage 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 96 | 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 With (Sustained) Reduction, Suppression, and/or Seroclearance | Baseline (Day 1) up to Week 96 | 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 With HBsAg Seroconversion at Week 96 | 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. |
| Change From Baseline in HBsAg Values at Weeks 48, 72, and 96 | Baseline (Day 1), Weeks 48, 72, and 96 | Change from baseline in HBsAg values was reported. |
| Change From Baseline in HBV DNA Values at Weeks 48, 72, and 96 | Baseline (Day 1), 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 to Achieve First HBsAg Seroclearance | Baseline (Day 1) up to Week 96 | 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. |
| Percentage of Participants With Reduction of More Than (>) 1 log10 IU/mL in HBsAg Levels From Baseline | Baseline (Day 1) up to Week 96 | Percentage 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 96 | Weeks 48, 72, and 96 | Percentage 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 96 | Percentage of Participants with HBV DNA levels \<LLOQ (20 IU/mL) was reported. |
| Percentage of Participants With Flares | Baseline (Day 1) up to Week 96 | 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 With Virologic Breakthrough | Baseline (Day 1) up to Week 48 | 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 Requiring NA Re-Treatment During Follow-up | Baseline (Day 1) up to Week 96 | Percentage 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 Characteristics | Baseline (Day 1) to Week 96 | 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). |
| Observed Plasma Concentration at Predose (C[Predose]) of JNJ-73763976 (Molecule of JNJ-73763989) | Predose at Weeks 4, 8, 12, and 16 | 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. |
| Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) | From screening up to Week 102 | 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 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 postdose | 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. |
| 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 16 | 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. |
| 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 16 | 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. |
| 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 postdose | 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. |
| 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 16 | 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. |
| Observed Plasma Concentration at Predose (C[Predose]) of JNJ-73763924 (Molecule of JNJ-73763989) | Predose at Weeks 4, 8, 12, and 16 | 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. |
| 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 postdose | 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 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 postdose | 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. |
| 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 16 | 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. |
| 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 16 | 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. |
| 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 postdose | 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. |
| 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 16 | 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. |
| Observed Plasma Concentration at Predose (C[Predose]) of JNJ-56136379 | Predose at Weeks 4, 8, 12, and 16 | 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. |
| Maximum Observed Analyte Concentration (Cmax) of JNJ-56136379 | Weeks 4, 8, 12, and 16: at Predose, 15 minutes, 30 minutes, 1, 2, 3, 4, 6, 8, 10, and 24 hours postdose | 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 to Reach the Maximum Observed Plasma Concentration (Tmax) of JNJ-56136379 | Weeks 4, 8, 12, and 16: at Predose, 15 minutes, 30 minutes, 1, 2, 3, 4, 6, 8, 10, and 24 hours postdose | 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. |
| Observed or Predicted Concentration at the End of a Dosing Interval (Ctau) of JNJ-56136379 | Weeks 4, 8, 12, and 16: at Predose, 15 minutes, 30 minutes, 1, 2, 3, 4, 6, 8, 10, and 24 hours postdose | 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. |
| Area Under the Analyte Concentration Versus Time Curve During a Dosing Interval at Steady State (AUCtau) of JNJ-56136379 | Weeks 4, 8, 12, and 16: at Predose, 15 minutes, 30 minutes, 1, 2, 3, 4, 6, 8, 10, and 24 hours postdose | 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. |
| 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 postdose | 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. |
Countries
Belgium, France, Germany, Italy, Poland, Spain, United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 |
| Total | 130 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Other | 0 | 2 |
| Overall Study | Withdrawal by Subject | 4 | 3 |
Baseline characteristics
| Characteristic | Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NA | Total | Arm 2: Nucleos(t)Ide Analog (NA) |
|---|---|---|---|
| Age, Continuous | 45.3 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 Participants | 18 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 66 Participants | 107 Participants | 41 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 4 Participants | 5 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 17 Participants | 25 Participants | 8 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants | 12 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants | 7 Participants | 2 Participants |
| Race (NIH/OMB) White | 56 Participants | 86 Participants | 30 Participants |
| Region of Enrollment BELGIUM | 7 Participants | 9 Participants | 2 Participants |
| Region of Enrollment FRANCE | 14 Participants | 21 Participants | 7 Participants |
| Region of Enrollment GERMANY | 7 Participants | 12 Participants | 5 Participants |
| Region of Enrollment ITALY | 17 Participants | 22 Participants | 5 Participants |
| Region of Enrollment POLAND | 13 Participants | 23 Participants | 10 Participants |
| Region of Enrollment SPAIN | 18 Participants | 25 Participants | 7 Participants |
| Region of Enrollment UNITED KINGDOM | 9 Participants | 18 Participants | 9 Participants |
| Sex: Female, Male Female | 27 Participants | 43 Participants | 16 Participants |
| Sex: Female, Male Male | 58 Participants | 87 Participants | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 85 | 0 / 45 |
| other Total, other adverse events | 71 / 85 | 36 / 45 |
| serious Total, serious adverse events | 3 / 85 | 4 / 45 |
Outcome results
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NA | Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Seroclearance at Week 72 Without Restarting NA Treatment | 0.0 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 Treatment | 0.0 Percentage of participants |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 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 ng*h/mL | Standard Deviation 79118 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 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 ng*h/mL | Standard Deviation 1930 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 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 nanogram*hour/milliliter (ng*h/mL) | Standard Deviation 9670 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 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 ng*h/mL/mg | Standard Deviation 28.9 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 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 ng*h/mL/mg | Standard Deviation 72.5 |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NA | Change From Baseline in HBsAg Values at Weeks 48, 72, and 96 | Week 72 | -1.76 log10 IU/mL | Standard Deviation 0.658 |
| Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NA | Change From Baseline in HBsAg Values at Weeks 48, 72, and 96 | Week 96 | -1.46 log10 IU/mL | Standard Deviation 0.661 |
| Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NA | Change From Baseline in HBsAg Values at Weeks 48, 72, and 96 | Week 48 | -1.89 log10 IU/mL | Standard Deviation 0.522 |
| Arm 2: Nucleos(t)Ide Analog (NA) | Change From Baseline in HBsAg Values at Weeks 48, 72, and 96 | Week 48 | -0.06 log10 IU/mL | Standard Deviation 0.082 |
| Arm 2: Nucleos(t)Ide Analog (NA) | Change From Baseline in HBsAg Values at Weeks 48, 72, and 96 | Week 72 | -0.25 log10 IU/mL | Standard Deviation 0.563 |
| Arm 2: Nucleos(t)Ide Analog (NA) | Change From Baseline in HBsAg Values at Weeks 48, 72, and 96 | Week 96 | -0.49 log10 IU/mL | Standard Deviation 0.783 |
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.
| Arm | Measure | Group | Value |
|---|---|---|---|
| Unknown | Change From Baseline in HBV DNA Values at Weeks 48, 72, and 96 | Week 48 | — |
| Unknown | Change From Baseline in HBV DNA Values at Weeks 48, 72, and 96 | Week 72 | — |
| Unknown | Change From Baseline in HBV DNA Values at Weeks 48, 72, and 96 | 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
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NA | Correlation Coefficient Between On-treatment HBsAg Change From Baseline With On-treatment HBV Blood Markers and Baseline Characteristics | Baseline NA treatment duration | 0.2381 correlation coefficient |
| Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NA | Correlation Coefficient Between On-treatment HBsAg Change From Baseline With On-treatment HBV Blood Markers and Baseline Characteristics | HBsAg at Week 24 | 0.9983 correlation coefficient |
| Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NA | Correlation Coefficient Between On-treatment HBsAg Change From Baseline With On-treatment HBV Blood Markers and Baseline Characteristics | HBsAg value at baseline | -0.9970 correlation coefficient |
| Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NA | Correlation Coefficient Between On-treatment HBsAg Change From Baseline With On-treatment HBV Blood Markers and Baseline Characteristics | HBsAg at Week 48 | 0.9982 correlation coefficient |
| Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NA | Correlation Coefficient Between On-treatment HBsAg Change From Baseline With On-treatment HBV Blood Markers and Baseline Characteristics | Age | 0.2860 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 Characteristics | HBsAg at Week 48 | 0.8065 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 Characteristics | Age | 0.1746 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 Characteristics | Baseline NA treatment duration | 0.4324 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 Characteristics | HBsAg 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 Characteristics | HBsAg at Week 24 | 0.7120 correlation coefficient |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NA | Maximum Observed Analyte Concentration (Cmax) of JNJ-56136379 | 14754 ng/mL | Standard Deviation 4318 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 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 ng/mL | Standard Deviation 142 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 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 nanogram/milliliter/milligram (ng/mL/mg) | Standard Deviation 2.14 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 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 ng/mL | Standard Deviation 716 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 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 ng/mL/mg | Standard Deviation 5.37 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 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 ng/mL | Standard Deviation 4959 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 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 ng/mL | Standard Deviation 25.5 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 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 ng/mL | Standard Deviation 161 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NA | Observed Plasma Concentration at Predose (C[Predose]) of JNJ-56136379 | 10812 ng/mL | Standard Deviation 2430 |
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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| 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 ng/mL |
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).
| Arm | Measure | Value (MEAN) |
|---|---|---|
| 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 nanogram/milliliter (ng/mL) |
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NA | Percentage of Participants Requiring NA Re-Treatment During Follow-up | 9.1 Percentage of participants |
| Arm 2: Nucleos(t)Ide Analog (NA) | Percentage of Participants Requiring NA Re-Treatment During Follow-up | 26.8 Percentage of participants |
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NA | Percentage of Participants With Flares | Clinical Flare: HBV DNA > 2000 - =<20000IU/mL | 1.3 Percentage of participants |
| Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NA | Percentage of Participants With Flares | Alanine Transaminase Flare | 3.9 Percentage of participants |
| Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NA | Percentage of Participants With Flares | Virologic Flare (HBV DNA>2000 - =< 20000 IU/mL) | 24.0 Percentage of participants |
| Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NA | Percentage of Participants With Flares | Aspartate Aminotransferase Flare | 1.3 Percentage of participants |
| Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NA | Percentage of Participants With Flares | Clinical Flare: HBV DNA > 100000 IU/mL | 1.3 Percentage of participants |
| Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NA | Percentage of Participants With Flares | Clinical Flare: HBV DNA > 200 - =<2000IU/mL | 0.0 Percentage of participants |
| Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NA | Percentage of Participants With Flares | Virologic Flare (HBV DNA >20000 - =<100000 IU/mL) | 8.0 Percentage of participants |
| Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NA | Percentage of Participants With Flares | Clinical Flare: HBV DNA > 20000 - =<100000IU/mL | 1.3 Percentage of participants |
| Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NA | Percentage of Participants With Flares | Virologic Flare (HBV DNA >100000 IU/mL) | 2.7 Percentage of participants |
| Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NA | Percentage of Participants With Flares | Virologic Flare (HBV DNA > 200 - =<2000 IU/mL) | 38.7 Percentage of participants |
| Arm 2: Nucleos(t)Ide Analog (NA) | Percentage of Participants With Flares | Clinical Flare: HBV DNA > 100000 IU/mL | 27.5 Percentage of participants |
| Arm 2: Nucleos(t)Ide Analog (NA) | Percentage of Participants With Flares | Virologic Flare (HBV DNA > 200 - =<2000 IU/mL) | 25.0 Percentage of participants |
| Arm 2: Nucleos(t)Ide Analog (NA) | Percentage of Participants With Flares | Virologic Flare (HBV DNA>2000 - =< 20000 IU/mL) | 30.0 Percentage of participants |
| Arm 2: Nucleos(t)Ide Analog (NA) | Percentage of Participants With Flares | Clinical Flare: HBV DNA > 2000 - =<20000IU/mL | 0.0 Percentage of participants |
| Arm 2: Nucleos(t)Ide Analog (NA) | Percentage of Participants With Flares | Virologic Flare (HBV DNA >20000 - =<100000 IU/mL) | 10.0 Percentage of participants |
| Arm 2: Nucleos(t)Ide Analog (NA) | Percentage of Participants With Flares | Virologic Flare (HBV DNA >100000 IU/mL) | 27.5 Percentage of participants |
| Arm 2: Nucleos(t)Ide Analog (NA) | Percentage of Participants With Flares | Alanine Transaminase Flare | 19.5 Percentage of participants |
| Arm 2: Nucleos(t)Ide Analog (NA) | Percentage of Participants With Flares | Aspartate Aminotransferase Flare | 14.6 Percentage of participants |
| Arm 2: Nucleos(t)Ide Analog (NA) | Percentage of Participants With Flares | Clinical Flare: HBV DNA > 200 - =<2000IU/mL | 0.0 Percentage of participants |
| Arm 2: Nucleos(t)Ide Analog (NA) | Percentage of Participants With Flares | Clinical Flare: HBV DNA > 20000 - =<100000IU/mL | 0.0 Percentage of participants |
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NA | Percentage of Participants With HBsAg Levels Less Than (<) 100 IU/mL at Weeks 48, 72, and 96 | Week 48 | 71.1 Percentage of participants |
| Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NA | Percentage of Participants With HBsAg Levels Less Than (<) 100 IU/mL at Weeks 48, 72, and 96 | Week 72 | 67.1 Percentage of participants |
| Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NA | Percentage of Participants With HBsAg Levels Less Than (<) 100 IU/mL at Weeks 48, 72, and 96 | Week 96 | 46.9 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 96 | Week 48 | 2.4 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 96 | Week 96 | 15.0 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 96 | Week 72 | 10.3 Percentage of participants |
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NA | Percentage of Participants With HBsAg Seroclearance at Week 48 | 0 Percentage of participants |
| Arm 2: Nucleos(t)Ide Analog (NA) | Percentage of Participants With HBsAg Seroclearance at Week 48 | 0 Percentage of participants |
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+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 |
| 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 |
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NA | Percentage of Participants With HBsAg Seroconversion at Week 96 | 0 Percentage of participants |
| Arm 2: Nucleos(t)Ide Analog (NA) | Percentage of Participants With HBsAg Seroconversion at Week 96 | 0 Percentage of participants |
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NA | Percentage 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 |
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NA | Percentage of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Less Than (<) Lower Limit of Quantification (LLOQ) at Week 48 | 97.3 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 48 | 100 Percentage of participants |
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NA | Percentage of Participants With Reduction of More Than (>) 1 log10 IU/mL in HBsAg Levels From Baseline | 81.5 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 Baseline | 12.5 Percentage of participants |
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NA | Percentage of Participants With (Sustained) Reduction, Suppression, and/or Seroclearance | HBsAg>=LLOQ and HBVDNA<2000 IU/mL | 23.9 Percentage of participants |
| Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NA | Percentage of Participants With (Sustained) Reduction, Suppression, and/or Seroclearance | HBsAg>=LLOQ and LLOQ<=HBV DNA <2000 IU/mL | 64.8 Percentage of participants |
| Arm 2: Nucleos(t)Ide Analog (NA) | Percentage of Participants With (Sustained) Reduction, Suppression, and/or Seroclearance | HBsAg>=LLOQ and HBVDNA<2000 IU/mL | 3.6 Percentage of participants |
| Arm 2: Nucleos(t)Ide Analog (NA) | Percentage of Participants With (Sustained) Reduction, Suppression, and/or Seroclearance | HBsAg>=LLOQ and LLOQ<=HBV DNA <2000 IU/mL | 64.3 Percentage of participants |
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NA | Percentage 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 |
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NA | Percentage 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 |
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NA | Percentage of Participants With Virologic Breakthrough | 0.0 Percentage of participants |
| Arm 2: Nucleos(t)Ide Analog (NA) | Percentage of Participants With Virologic Breakthrough | 0.0 Percentage of participants |
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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NA | Time to Achieve First HBsAg Seroclearance | NA Days |
| Arm 2: Nucleos(t)Ide Analog (NA) | Time to Achieve First HBsAg Seroclearance | NA Days |
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.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| 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 Hour | Full Range 0 |
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.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| 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 Hour | Full Range 1 |
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.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| 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 Hour | Full Range 1 |