A Study of JNJ-73763989, JNJ-56136379, Nucleos(t)Ide Analogs, and Pegylated Interferon Alpha-2a in Virologically Suppressed Participants With Chronic Hepatitis B Virus Infection

Percentage of participants with a reduction of at least 2 log10IU/mL in HBsAg levels from baseline to Week 24 were reported. A responder was defined as a participant with reduction of at least 2 log10 IU/mL in HBsAg levels from baseline at Week 24.

Percentage of participants with TEAEs were reported. An adverse event (AE) was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAEs were AEs with onset during the intervention period or follow-up period or that were a consequence of a pre-existing condition that had worsened since baseline.

An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAEs were AEs with onset during the intervention period or follow-up period or that were a consequence of a pre-existing condition that had worsened since baseline. A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

Number of participants with clinically significant abnormalities in vital signs (pulse rate, and blood pressure [systolic and diastolic]) were reported.

Number of participants with clinically significant abnormalities in laboratory findings (including hematology, blood biochemistry, and urinalysis) were reported. Only parameters in which any participant had abnormality are reported below.

Number of participants with clinically significant abnormalities in 12- lead ECGs (heart rate, PR, QRS and QT corrected [QTc]) were reported.

Number of participants with clinically significant abnormalities in physical examination were reported.

Number of participants with abnormalities in Ophthalmic examination were planned to be reported.

Percentage of participants meeting the protocol-defined NA treatment completion criteria at EOSI were reported. NA treatment completion criteria are defined based on laboratory results at Week 24 were; HBsAg <10 IU/mL; HBeAg-negative; HBV DNA <20 IU/mL, that is, lower limit of quantification(LLOQ); alanine aminotransferase(ALT) <3*ULN.

Percentage of participants with HBeAg levels below different cut-offs were reported. The cut-offs for HBeAg levels were as followed:< 100 IU/mL, < 10 IU/mL, < 1 IU/mL, < LLOQ (0.11 IU/mL).

Percentage of participants with HBsAg levels below different cut-offs were reported. The cut-offs for HBsAg level were: <1000 IU/mL, <100 IU/mL, <10 IU/mL, <1 IU/mL, <LLOQ (0.05 IU/mL).

Percentage of participants with HBV DNA levels below cut-offs were reported. The cut-offs for HBV DNA were as follows: <LLOQ (=20 IU/mL) target detected or not detected, < LLOQ target not detected, and < LLOQ target detected, <60 IU/mL, <100 IU/mL, <200 IU/mL, <1000 IU/mL, <2000 IU/mL, <20000 IU/mL.

Percentage of participants with ALT levels below >=3*ULN cut-off were reported.

Percentage of participants with HBeAg seroconversion were reported. Seroconversion of HBeAg is defined as having achieved HBeAg seroclearance (as HBeAg level <LLOQ [0.11 IU/mL]) and appearance of anti-HBe antibodies, defined as baseline anti-HBe antibodies with a negative result and a post-baseline assessment with positive result.

Percentage of participants with HBsAg seroconversion were reported. Seroconversion of HBsAg was defined as having achieved HBsAg seroclearance (defined as HBsAg <LLOQ [0.05 IU/mL]) and appearance of anti-HBs antibodies.

Change from baseline over time in HBsAg levels were reported. The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study agent.

Change from baseline over time in HBeAg levels were reported. The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study agent.

Change from baseline over time in HBV DNA levels were reported. The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study agent.

Time to first occurrence of HBsAg seroclearance were reported in median time. Time to first occurrence of the HBsAg seroclearance was defined as the number of days between the date of first study intervention intake and the date of first occurrence of the HBsAg seroclearance.

Time to first occurrence of HBeAg seroclearance were reported in median time. Time to first occurrence of the HBeAg seroclearance is defined as the number of days between the date of first study intervention intake and the date of the first occurrence of the HBeAg seroclearance.

Time to first occurrence of HBV DNA < LLOQ (20 IU/mL) were reported in median time. Time to first occurrence of the HBV DNA < LLOQ is defined as the number of days between the date of first study intervention intake and the date of the first occurrence of the HBV DNA < LLOQ.

Percentage of Participants with virologic breakthrough were reported. It was defined as confirmed on-treatment (the time period during which the participant received any of the study treatments) HBV DNA increase by >1 log10 IU/mL from nadir or confirmed on-treatment HBV DNA level >200 IU/mL in participants who had HBV DNA level <LLOQ (20 IU/mL) of the HBV DNA assay. Confirmed means that the criteria were fulfilled at 2 or more consecutive time points or at the last observed time point.

Percentage of participants with HBsAg seroclearance at Week 48 (i.e., 24 weeks after completion of all study interventions at Week 24) without re-starting NA treatment were reported. HBsAg seroclearance was defined as [quantitative] HBsAg <LLOQ (0.05 IU/mL).

Percentage of participants with HBV DNA <LLOQ (20 IU/mL) at Week 48 (that is, 24 weeks after completion of all study interventions at Week 24) without re-starting NA treatment were reported.

Percentage of participants with biochemical flares were reported. On-treatment biochemical flare was defined as confirmed ALT and/or AST >=3*ULN and >=3*nadir, while the participant received any of the study interventions. Off-treatment biochemical flare was defined as confirmed ALT and/or AST =3*ULN and =3*nadir, while the participants did not receive any of the study interventions (Off treatment, including NA).

Percentage of participants with virologic flares were reported. Virologic flare was defined as confirmed HBV DNA >peak threshold (lowest peak to qualify as virologic flare was HBV DNA >200 IU/mL) in participants who were off-treatment. Off-treatment was defined as the time period after stopping all study treatments (including NA) and had HBV DNA <LLOQ (20 IU/mL) at the last observed time point on all study interventions.

Number of participants requiring NA re-treatment based on failure in NA treatment completion criteria (HBsAg <10 IU/mL, and HBeAg-negative, and HBV DNA < LLOQ (20 IU/mL), and ALT <3*ULN) were reported.

The maximum observed plasma concentrations (Cmax) of JNJ-73763989 (JNJ-73763976 and JNJ-73763924) were reported.

Plasma concentration 24 hours (C24h) after administration of JNJ-73763989 (JNJ-73763976 and JNJ-73763924) were reported.

Time to reach maximum observed plasma concentration (Cmax) (Tmax) of JNJ-73763989 (JNJ-73763976 and JNJ-73763924) were reported.

Area under the plasma concentration versus time curve from time 0 to 24 hours (AUC[0-24]h) of JNJ-73763989 (JNJ-73763976 and JNJ-73763924) were reported.