Hepatitis B
Conditions
Keywords
Chronic Hepatitis B, GSK3228836, Pegylated interferon, Nucleos(t)ide analogue, Sustained virologic response
Brief summary
This study is intended to evaluate if 12 or 24 weeks of treatment with GSK3228836 followed by up to 24 weeks of pegylated interferon (PegIFN) can increase the rate of hepatitis B virus surface antigen (HBsAg) loss in participants on stable nucleos(t)ide analogue (NA) therapy, and whether virologic response can be sustained once PegIFN treatment is discontinued. Participants will be randomized to receive GSK3228836 for 12 or 24 weeks followed by up to 24 weeks of PegIFN.
Interventions
DRUGGSK3228836
Participants will be administered GSK3228836.
DRUGPegIFN
Participants will be administered PegIFN.
DRUGNA therapy
Participants will continue to receive their NA therapy for the duration of the study.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants will be randomised in a ratio of 1:1 to one of two treatment arms: 24 weeks GSK3228836 followed by up to 24 weeks PegIFN, or 12 weeks GSK3228836 followed by up to 24 weeks PegIFN.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 18 to 75 years of age at the time of signing the informed consent. * Participants who are eligible to be treated with PegIFN. * Documented chronic HBV infection \>=6 months prior to screening and currently receiving stable NA therapy except telbivudine, defined as no changes to their NA regimen from at least 6 months prior to screening and with no planned changes to the stable regimen over the duration of the study. * Plasma or serum HBsAg concentration \>100 International Units per milliliter (IU/mL). * Plasma or serum HBV DNA concentration \<90 IU/mL. * ALT \<=2 times ULN. * A male participant is eligible to participate if they agree to the following during the intervention period and for at least 90 days after the last dose of study treatment: a) Refrain from donating sperm; b) Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent or agree to use contraception/barrier: Agree to use a male condom (and should also be advised of the benefit for a female partner to use a highly effective method of contraception as a condom may break or leak) when having sexual intercourse with a woman of childbearing potential who is not currently pregnant. * A female participant is eligible to participate: a) If she is not pregnant or breastfeeding; b) at least one of the following conditions applies: Is not a woman of childbearing potential (WOCBP) or is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of \<1 percent per year), preferably with low user dependency during the intervention period and for at least 90 days after the last dose of study treatment. * A WOCBP must have both a negative highly sensitive pregnancy test within 24 hours before the first dose of study intervention. If a urine test cannot be confirmed as negative, a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive. * Capable of giving signed informed consent.
Exclusion criteria
* Clinically significant abnormalities, aside from chronic HBV infection in medical history or physical examination. * Co-infection with: Current or past history of Hepatitis C virus (HCV); Human immunodeficiency virus (HIV); Hepatitis D virus (HDV). * History of or suspected liver cirrhosis and/or evidence of cirrhosis as determined by both: Aspartate aminotransferase (AST)-Platelet Index (APRI) \>2 and FibroSure/FibroTest result \>0.7. If only one parameter (APRI or FibroSure/FibroTest) result is positive, a discussion with the Medical Monitor is required before inclusion in study is permitted. Regardless of APRI of Fibrosure/FibroTest score, if the participant meets one of the following criteria, they will be excluded from the study: a) Liver biopsy (i.e., Metavir Score F4); b) Liver stiffness \>12 kilopascals (kPa). * Diagnosed or suspected hepatocellular carcinoma as evidenced by the following: Alpha- fetoprotein concentration \>=200 nanogram per milliliter (ng/mL); If the screening alpha fetoprotein concentration is \>=50 ng/mL and \<200 ng/mL, the absence of liver mass must be documented by imaging within 6 months before randomization. * History of malignancy within the past 5 years with the exception of specific cancers that are cured by surgical resection (e.g., skin cancer). Participants under evaluation for possible malignancy are not eligible. * History of vasculitis or presence of symptoms and signs of potential vasculitis (e.g., vasculitic rash, skin ulceration, repeated blood detected in urine without identified cause) or history/presence of other diseases that may be associated with vasculitis condition (e.g., systemic lupus erythematosus, rheumatoid arthritis, relapsing polychondritis, mononeuritis multiplex). * History of extrahepatic disorders possibly related to HBV immune conditions (e.g., nephrotic syndrome, any type of glomerulonephritis, polyarteritis nodosa, cryoglobulinemia, uncontrolled hypertension). * Poorly controlled thyroid dysfunction or abnormal thyroid stimulating hormone (TSH) levels * Positive (or borderline positive) anti-neutrophil cytoplasmic antibody (ANCA) at screening. Participants that meet these criteria may be considered for inclusion in the study following: a) Analysis of myeloperoxidase (MPO)-ANCA \[perinuclear ANCA (pANCA)\] and PR3-ANCA \[classical ANCA (cANCA)\]; b) A discussion with the Medical Monitor to review participant's complete medical history to ensure no past history or current manifestations of a vasculitic/inflammatory/auto-immune condition. * Low complement 3 (C3) at screening and evidence of past history or current manifestations of vasculitic/inflammatory/auto-immune conditions. All participants with low C3 at screening should have their medical history discussed with the Medical Monitor prior to enrolment. * History of alcohol or drug abuse/dependence. Current alcohol use as judged by investigator to potentially interfere with participant compliance; History of or current drug abuse/dependence as judged by the investigator to potentially interfere with participant compliance. Refers to illicit drugs and substances with abuse potential. Medications that are used by the participant as directed, whether over-the-counter or through prescription, are acceptable and would not meet the
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Arm 1 - Percentage of Participants Achieving Sustained Virologic Response (SVR) for 24 Weeks After End of Treatment | Up to 24 weeks off treatment (Study Weeks 48 to 72) | Sustained virologic response is defined as undetectable levels of Hepatitis B surface antigen (HBsAg) and Hepatitis-B virus deoxy-ribonucleic acid (HBV DNA) on treatment. The SVR was a composite endpoint defined as HBsAg and HBV DNA levels were less than (\<) Lower limit of quantitation (LLOQ) at the planned end of sequential treatment of GSK3228836 and PegIFN treatment which is sustained for 24 weeks post-GSK3228836 and PegIFN treatment in the absence of any rescue medication. Percentage values are rounded-off. |
| Treatment Arm 2 - Percentage of Participants Achieving Sustained Virologic Response (SVR) for 24 Weeks After End of Treatment | Up to 24 weeks off treatment (Study Weeks 36 to 60) | Sustained virologic response is defined as undetectable levels of Hepatitis B surface antigen (HBsAg) and Hepatitis-B virus deoxy-ribonucleic acid (HBV DNA) on treatment. The SVR was a composite endpoint defined as HBsAg and HBV DNA levels were less than (\<) Lower limit of quantitation (LLOQ) at the planned end of sequential treatment of GSK3228836 and PegIFN treatment which is sustained for 24 weeks post-GSK3228836 and PegIFN treatment in the absence of any rescue medication. Percentage values are rounded-off. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Arm 1: Percentage of Participants Achieving HBsAg and HBV DNA < Lower Limit of Quantitation (LLOQ) | End of treatment (up to 48 weeks) and up to 24 weeks off treatment follow-up (Study Weeks 48 to 72) | Percentage of participants achieving HBsAg and HBV DNA \<LLOQ were reported. Percentage values are rounded-off. |
| Treatment Arm 2: Percentage of Participants Achieving HBsAg and HBV DNA < Lower Limit of Quantitation (LLOQ) | End of treatment (up to 36 weeks), up to 24 weeks off treatment follow-up (Study Weeks 36 to 60) and up to 36 weeks off treatment follow-up (Study Weeks 36 to 72) | Percentage of participants achieving HBsAg and HBV DNA \<LLOQ were reported. Percentage values are rounded-off. |
| Treatment Arm 1: Actual Values of ALT | At baseline, end of treatment (up to 48 weeks), and up to 24 weeks off treatment follow-up (Study Weeks 48 to 72) | Blood samples were collected to assess ALT mean values. |
| Treatment Arm 1: Percentage of Participants With Categorical Changes From Baseline in HBsAg Values | Baseline, End of treatment (up to 48 weeks), and up to 24 weeks off treatment follow-up (Study Weeks 48 to 72) | Participants who achieved a decline in HBsAg values from baseline were reported. Participants were categorized in the following categorical HBsAg decline of \<0.5, greater than or equal to (\>=) 0.5, \>=1, \>=1.5, and \>=3 log10 international units per milliliter (IU/mL). The 'HBsAg \< LLOQ' category is derived based on Absolute/raw HBsAg result. The HBsAg decline categories are based on change from baseline values. Percentage values are rounded-off. |
| Treatment Arm 2: Percentage of Participants With Categorical Changes From Baseline in HBsAg Values | Baseline, End of treatment (up to 36 weeks), up to 24 weeks off treatment follow-up (Study Weeks 36 to 60) and up to 36 weeks off treatment follow-up (Study Weeks 36 to 72) | Participants who achieved a decline in HBsAg values from baseline were reported. Participants were categorized in the following categorical HBsAg decline of \<0.5, greater than or equal to (\>=) 0.5, \>=1, \>=1.5, and \>=3 log10 international units per milliliter (IU/mL). The 'HBsAg \< LLOQ' category is derived based on Absolute/raw HBsAg result. The HBsAg decline categories are based on change from baseline values. Percentage values are rounded-off. |
| Treatment Arm 1: Number of Participants With Alanine Aminotransferase (ALT) Normalization | At baseline, end of treatment (up to 48 weeks) and up to 24 weeks off treatment follow-up (Study Weeks 48 to 72) | The ALT normalization (ALT \<=upper limit of normal \[ULN\]) over time in absence of rescue medication in participants with baseline ALT\>ULN and ALT data at that visit. Participants who achieved ALT normalization were reported. |
| Treatment Arm 2: Number of Participants With Alanine Aminotransferase (ALT) Normalization | At baseline, End of treatment (up to 36 weeks), up to 24 weeks off treatment follow-up (Study Weeks 36 to 60), and up to 36 weeks off treatment follow-up (Study Weeks 36 to 72) | The ALT normalization (ALT \<=upper limit of normal \[ULN\]) over time in absence of rescue medication in participants with baseline ALT\>ULN and ALT data at that visit. Participants who achieved ALT normalization were reported. |
| Treatment Arm 1: Number of Participants With HBe Antibody (Anti-HBeAg) Levels | At baseline, end of treatment (up to 48 weeks), and up to 24 weeks off treatment follow-up (Study Weeks 48 to 72) | Blood samples were collected to assess HBe antibody levels and results reported are for baseline HBeAg positive participants. |
| Treatment Arm 2: Number of Participants With HBe Antibody (Anti-HBeAg) Levels | At baseline, End of treatment (up to 36 weeks), up to 24 weeks off treatment follow-up (Study Weeks 36 to 60), and up to 36 weeks off treatment follow-up (Study Weeks 36 to 72) | Blood samples were collected to assess HBe antibody levels and results reported are for baseline HBeAg positive participants. |
| Treatment Arm 1: Mean Change From Baseline in HBe Antibody Levels | At baseline, end of treatment (up to 48 weeks), and up to 24 weeks off treatment follow-up (Study Weeks 48 to 72) | Blood samples were collected to assess HBe antibody levels and results reported are for baseline HBeAg positive participants. Change from Baseline was defined as value at the indicated time point minus Baseline value. Baseline was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. |
| Treatment Arm 2: Mean Change From Baseline in HBe Antibody Levels | At baseline, End of treatment (up to 36 weeks), up to 24 weeks off treatment follow-up (Study Weeks 36 to 60), and up to 36 weeks off treatment follow-up (Study Weeks 36 to 72) | Blood samples were collected to assess HBe antibody levels and results reported are for baseline HBeAg positive participants. Change from Baseline was defined as value at the indicated time point minus Baseline value. Baseline was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. |
| Treatment Arm 1: Actual Values of HBsAg Levels | At baseline, end of treatment (up to 48 weeks), and up to 24 weeks off treatment follow-up (Study Weeks 48 to 72) | Blood samples were collected from participants to assess HBsAg at indicated time points. |
| Treatment Arm 2: Actual Values of HBsAg Levels | At baseline, end of treatment (up to 36 weeks), up to 24 weeks off treatment follow-up (Study Weeks 36 to 60), and up to 36 weeks off treatment follow-up (Study Weeks 36 to 72) | Blood samples were collected from participants to assess HBsAg at indicated time points. |
| Treatment Arm 1: Mean Change From Baseline in HBsAg Levels | At baseline, end of treatment (up to 48 weeks), and up to 24 weeks off treatment follow-up (Study Weeks 48 to 72) | Blood samples were collected to assess HBsAg change from baselines levels. Change from Baseline was defined as value at the indicated time point minus Baseline value. Baseline was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. |
| Treatment Arm 2: Actual Values of ALT | At baseline, end of treatment (up to 36 weeks), up to 24 weeks off treatment follow-up (Study Weeks 36 to 60), and up to 36 weeks off treatment follow-up (Study Weeks 36 to 72) | Blood samples were collected to assess ALT mean values. |
| Treatment Arm 2: Mean Change From Baseline in HBsAg Levels | At baseline, end of treatment (up to 36 weeks), up to 24 weeks off treatment follow-up (Study Weeks 36 to 60), and up to 36 weeks off treatment follow-up (Study Weeks 36 to 72) | Blood samples were collected to assess HBsAg change from baselines levels. Change from Baseline was defined as value at the indicated time point minus Baseline value. Baseline was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. |
| Treatment Arm 1: Actual Values of HBV DNA Levels | At baseline, end of treatment (up to 48 weeks), and up to 24 weeks off treatment follow-up (Study Weeks 48 to 72) | Blood samples were collected to assess HBV DNA levels. |
| Treatment Arm 2: Actual Values of HBV DNA Levels | At baseline, end of treatment (up to 36 weeks), up to 24 weeks off treatment follow-up (Study Weeks 36 to 60), and up to 36 weeks off treatment follow-up (Study Weeks 36 to 72) | Blood samples were collected to assess HBV DNA levels. |
| Treatment Arm 1: Mean Change From Baseline in HBV DNA Levels | At baseline, end of treatment (up to 48 weeks), and up to 24 weeks off treatment follow-up (Study Weeks 48 to 72) | Blood samples were collected to assess HBV DNA levels. Change from Baseline was defined as value at the indicated time point minus Baseline value. Baseline was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. |
| Treatment Arm 2: Mean Change From Baseline in HBV DNA Levels | At baseline, end of treatment (up to 36 weeks), up to 24 weeks off treatment follow-up (Study Weeks 36 to 60), and up to 36 weeks off treatment follow-up (Study Weeks 36 to 72) | Blood samples were collected to assess HBV DNA levels. Change from Baseline was defined as value at the indicated time point minus Baseline value. Baseline was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. |
| Treatment Arm 1: Actual Values of Hepatitis B Virus E-antigen (HBeAg) Levels | At baseline, end of treatment (up to 48 weeks), and up to 24 weeks off treatment follow-up (Study Weeks 48 to 72) | Blood samples were collected to assess HBeAg levels. |
| Treatment Arm 2: Actual Values of Hepatitis B Virus E-antigen (HBeAg) Levels | At baseline, end of treatment (up to 36 weeks), up to 24 weeks off treatment follow-up (Study Weeks 36 to 60), and up to 36 weeks off treatment follow-up (Study Weeks 36 to 72) | Blood samples were collected to assess HBeAg levels. |
| Treatment Arm 1: Mean Change From Baseline in HBeAg Levels | At baseline, end of treatment (up to 48 weeks), and up to 24 weeks off treatment follow-up (Study Weeks 48 to 72) | Blood samples were collected to assess HBeAg levels. Change from Baseline was defined as value at the indicated time point minus Baseline value. Baseline was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. |
| Treatment Arm 2: Mean Change From Baseline in HBeAg Levels | At baseline, end of treatment (up to 36 weeks), up to 24 weeks off treatment follow-up (Study Weeks 36 to 60), and up to 36 weeks off treatment follow-up (Study Weeks 36 to 72) | Blood samples were collected to assess HBeAg levels. Change from Baseline was defined as value at the indicated time point minus Baseline value. Baseline was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. |
| Treatment Arm 1: Actual Values of HBs Antibody Levels | At baseline, end of treatment (up to 48 weeks), and up to 24 weeks off treatment follow-up (Study Weeks 48 to 72) | Blood samples were collected to assess HBs antibody levels. |
| Treatment Arm 2: Actual Values of HBs Antibody Levels | At baseline, end of treatment (up to 36 weeks), up to 24 weeks off treatment follow-up (Study Weeks 36 to 60), and up to 36 weeks off treatment follow-up (Study Weeks 36 to 72) | Blood samples were collected to assess HBs antibody levels. |
| Treatment Arm 1: Mean Change From Baseline in HBs Antibody Levels | At baseline, end of treatment (up to 48 weeks), and up to 24 weeks off treatment follow-up (Study Weeks 48 to 72) | Blood samples were collected to assess HBs antibody levels over time. Change from Baseline was defined as value at the indicated time point minus Baseline value. Baseline was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. |
| Treatment Arm 2: Mean Change From Baseline in HBs Antibody Levels | At baseline, end of treatment (up to 36 weeks), up to 24 weeks off treatment follow-up (Study Weeks 36 to 60), and up to 36 weeks off treatment follow-up (Study Weeks 36 to 72) | Blood samples were collected to assess HBs antibody levels over time. Change from Baseline was defined as value at the indicated time point minus Baseline value. Baseline was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. |
| Treatment Arm 1: Change From Baseline in ALT | At baseline, end of treatment (up to 48 weeks), and up to 24 weeks off treatment follow-up (Study Weeks 48 to 72) | Blood samples were collected to assess ALT values. Change from Baseline was defined as value at the indicated time point minus Baseline value. Baseline was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. |
| Treatment Arm 2: Change From Baseline in ALT | At baseline, end of treatment (up to 36 weeks), up to 24 weeks off treatment follow-up (Study Weeks 36 to 60), and up to 36 weeks off treatment follow-up (Study Weeks 36 to 72) | Blood samples were collected to assess ALT values. Change from Baseline was defined as value at the indicated time point minus Baseline value. Baseline was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. |
| Treatment Arm 1 - Median Time to ALT Normalization in Absence of Rescue Medication for 24 Weeks After End of Treatment | Up to 24 weeks off treatment (Study Week 48 to72) | Time to ALT normalization in absence of rescue medication were measured in participants having Baseline ALT\>ULN. |
| Treatment Arm 2 - Median Time to ALT Normalization in Absence of Rescue Medication for 24 Weeks After End of Treatment | Up to 24 weeks off treatment (Study Weeks 36 to 60) | Time to ALT normalization in absence of rescue medication were measured in participants having Baseline ALT\>ULN. |
| Percentage of Participants Achieving Sustained Virologic Response (SVR) for 24 Weeks Off Treatment for Comparison of Efficacy Between Different Treatment Durations | Up to 24 weeks off treatment (Treatment Arm 1: Study Weeks 48 to 72 and Treatment Arm 2: Study Weeks 36 to 60) | Sustained virologic response is defined as undetectable levels of HBsAg and Hepatitis-B virus deoxy-ribonucleic acid (HBV DNA) on treatment. The SVR was a composite endpoint defined as Hepatitis B surface antigen (HBsAg) and Hepatitis B virus (HBV) Deoxyribonucleic acid (DNA) levels were less than (\<) Lower limit of quantitation (LLOQ) at the planned end of GSK3228836 treatment which is sustained for 24 weeks post-GSK3228836 treatment in the absence of rescue medication. The point estimate for the difference in SVR and its respective credible interval (CI) were evaluated at 24 weeks off of planned treatment for both arms. The comparison of efficacy is between treatment durations and timepoint corresponds to Week 72 in Arm 1 and Week 60 in Arm 2. 95% CI here refers as credible interval. Percentage values are rounded-off. |
Countries
Canada, China, Italy, Japan, Poland, Russia, South Africa, South Korea, Spain, United Kingdom, United States
Participant flow
Recruitment details
A total of 108 participants were enrolled in this study.
Pre-assignment details
Participants who were on stable nucleos(t)ide analogue (NA) therapy randomized (1:1) into one of 2 parallel treatment arms. Treatment arm 1: 300 mg/week GSK3228836 for 24 weeks + PegIFN 180 mcg/week for 24 weeks; on-treatment until Week 48 and off-treatment from Weeks 48 to 72. Treatment arm 2: 300 mg/week GSK3228836 for 12 weeks + 180 mcg/week PegIFN for 24 weeks, on-treatment until Week 36 and off-treatment follow-up from Weeks 36 to Week 60 and 72.
Participants by arm
| Arm | Count |
|---|---|
| GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) Participants on stable NA therapy received 300mg/week GSK3228836 for 24 weeks (plus a loading dose on Day 4 and 11), followed by PegIFN 180 microgram per week (mcg/week) up to 24 weeks. | 55 |
| GSK3228836 300 mg (12 Weeks) + PegIFN 180 mcg (24 Weeks) Participants on stable NA therapy received 300mg/week GSK3228836 for 12 weeks (plus a loading dose on Day 4 and 11), followed by PegIFN 180 mcg/week up to 24 weeks. | 53 |
| Total | 108 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 0 |
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Physician Decision | 0 | 1 |
| Overall Study | Withdrawal by Subject | 3 | 2 |
Baseline characteristics
| Characteristic | GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | GSK3228836 300 mg (12 Weeks) + PegIFN 180 mcg (24 Weeks) | Total |
|---|---|---|---|
| Age, Continuous | 45.5 YEARS STANDARD_DEVIATION 10.73 | 45.5 YEARS STANDARD_DEVIATION 9.35 | 45.5 YEARS STANDARD_DEVIATION 10.03 |
| Race/Ethnicity, Customized ASIAN | 30 Participants | 26 Participants | 56 Participants |
| Race/Ethnicity, Customized BLACK OR AFRICAN AMERICAN | 3 Participants | 3 Participants | 6 Participants |
| Race/Ethnicity, Customized WHITE | 22 Participants | 24 Participants | 46 Participants |
| Sex: Female, Male Female | 11 Participants | 20 Participants | 31 Participants |
| Sex: Female, Male Male | 44 Participants | 33 Participants | 77 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 55 | 0 / 53 |
| other Total, other adverse events | 52 / 55 | 50 / 53 |
| serious Total, serious adverse events | 6 / 55 | 2 / 53 |
Outcome results
Primary
Treatment Arm 1 - Percentage of Participants Achieving Sustained Virologic Response (SVR) for 24 Weeks After End of Treatment
Sustained virologic response is defined as undetectable levels of Hepatitis B surface antigen (HBsAg) and Hepatitis-B virus deoxy-ribonucleic acid (HBV DNA) on treatment. The SVR was a composite endpoint defined as HBsAg and HBV DNA levels were less than (\<) Lower limit of quantitation (LLOQ) at the planned end of sequential treatment of GSK3228836 and PegIFN treatment which is sustained for 24 weeks post-GSK3228836 and PegIFN treatment in the absence of any rescue medication. Percentage values are rounded-off.
Time frame: Up to 24 weeks off treatment (Study Weeks 48 to 72)
Population: Intent to Treat (ITT) Set that included all randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | Treatment Arm 1 - Percentage of Participants Achieving Sustained Virologic Response (SVR) for 24 Weeks After End of Treatment | 9 Percentage of Participants |
Primary
Treatment Arm 2 - Percentage of Participants Achieving Sustained Virologic Response (SVR) for 24 Weeks After End of Treatment
Sustained virologic response is defined as undetectable levels of Hepatitis B surface antigen (HBsAg) and Hepatitis-B virus deoxy-ribonucleic acid (HBV DNA) on treatment. The SVR was a composite endpoint defined as HBsAg and HBV DNA levels were less than (\<) Lower limit of quantitation (LLOQ) at the planned end of sequential treatment of GSK3228836 and PegIFN treatment which is sustained for 24 weeks post-GSK3228836 and PegIFN treatment in the absence of any rescue medication. Percentage values are rounded-off.
Time frame: Up to 24 weeks off treatment (Study Weeks 36 to 60)
Population: Intent to Treat (ITT) Set that included all randomized participants. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | Treatment Arm 2 - Percentage of Participants Achieving Sustained Virologic Response (SVR) for 24 Weeks After End of Treatment | 15 Percentage of Participants |
Secondary
Percentage of Participants Achieving Sustained Virologic Response (SVR) for 24 Weeks Off Treatment for Comparison of Efficacy Between Different Treatment Durations
Sustained virologic response is defined as undetectable levels of HBsAg and Hepatitis-B virus deoxy-ribonucleic acid (HBV DNA) on treatment. The SVR was a composite endpoint defined as Hepatitis B surface antigen (HBsAg) and Hepatitis B virus (HBV) Deoxyribonucleic acid (DNA) levels were less than (\<) Lower limit of quantitation (LLOQ) at the planned end of GSK3228836 treatment which is sustained for 24 weeks post-GSK3228836 treatment in the absence of rescue medication. The point estimate for the difference in SVR and its respective credible interval (CI) were evaluated at 24 weeks off of planned treatment for both arms. The comparison of efficacy is between treatment durations and timepoint corresponds to Week 72 in Arm 1 and Week 60 in Arm 2. 95% CI here refers as credible interval. Percentage values are rounded-off.
Time frame: Up to 24 weeks off treatment (Treatment Arm 1: Study Weeks 48 to 72 and Treatment Arm 2: Study Weeks 36 to 60)
Population: Intent to Treat (ITT) Set that included all randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | Percentage of Participants Achieving Sustained Virologic Response (SVR) for 24 Weeks Off Treatment for Comparison of Efficacy Between Different Treatment Durations | 9 Percentage of participants |
| GSK3228836 300 mg (12 Weeks) + PegIFN 180 mcg (24 Weeks) | Percentage of Participants Achieving Sustained Virologic Response (SVR) for 24 Weeks Off Treatment for Comparison of Efficacy Between Different Treatment Durations | 15 Percentage of participants |
95% CI: [-29, 11]
Secondary
Treatment Arm 1: Actual Values of ALT
Blood samples were collected to assess ALT mean values.
Time frame: At baseline, end of treatment (up to 48 weeks), and up to 24 weeks off treatment follow-up (Study Weeks 48 to 72)
Population: Intent to Treat (ITT) Set that included all randomized participants. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | Treatment Arm 1: Actual Values of ALT | At Baseline | 22.7 International Units Per Liter (IU/L) | Standard Deviation 13.97 |
| GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | Treatment Arm 1: Actual Values of ALT | End of Treatment (up to 48 weeks) | 53.1 International Units Per Liter (IU/L) | Standard Deviation 60.61 |
| GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | Treatment Arm 1: Actual Values of ALT | Up to 24 weeks off treatment follow-up (Study Weeks 48 to 72) | 19.2 International Units Per Liter (IU/L) | Standard Deviation 9.77 |
Secondary
Treatment Arm 1: Actual Values of HBsAg Levels
Blood samples were collected from participants to assess HBsAg at indicated time points.
Time frame: At baseline, end of treatment (up to 48 weeks), and up to 24 weeks off treatment follow-up (Study Weeks 48 to 72)
Population: Intent to Treat (ITT) Set that included all randomized participants. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | Treatment Arm 1: Actual Values of HBsAg Levels | At Baseline | 3.34 Log10 IU/mL | Standard Deviation 0.555 |
| GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | Treatment Arm 1: Actual Values of HBsAg Levels | End of Treatment (up to 48 weeks) | 1.52 Log10 IU/mL | Standard Deviation 2.071 |
| GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | Treatment Arm 1: Actual Values of HBsAg Levels | Up to 24 weeks off treatment follow-up (Study Weeks 48 to 72) | 1.72 Log10 IU/mL | Standard Deviation 2.043 |
Secondary
Treatment Arm 1: Actual Values of HBs Antibody Levels
Blood samples were collected to assess HBs antibody levels.
Time frame: At baseline, end of treatment (up to 48 weeks), and up to 24 weeks off treatment follow-up (Study Weeks 48 to 72)
Population: Intent to Treat (ITT) Set that included all randomized participants. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | Treatment Arm 1: Actual Values of HBs Antibody Levels | At Baseline | 0.62 Log10 IU/L | Standard Deviation 0.271 |
| GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | Treatment Arm 1: Actual Values of HBs Antibody Levels | End of Treatment (up to 48 weeks) | 1.06 Log10 IU/L | Standard Deviation 0.903 |
| GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | Treatment Arm 1: Actual Values of HBs Antibody Levels | Up to 24 weeks off treatment follow-up (Study Weeks 48 to 72) | 0.82 Log10 IU/L | Standard Deviation 0.718 |
Secondary
Treatment Arm 1: Actual Values of HBV DNA Levels
Blood samples were collected to assess HBV DNA levels.
Time frame: At baseline, end of treatment (up to 48 weeks), and up to 24 weeks off treatment follow-up (Study Weeks 48 to 72)
Population: Intent to Treat (ITT) Set that included all randomized participants. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | Treatment Arm 1: Actual Values of HBV DNA Levels | At Baseline | 0.64 Log10 IU/mL | Standard Deviation 0.796 |
| GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | Treatment Arm 1: Actual Values of HBV DNA Levels | End of Treatment (up to 48 weeks) | 0.97 Log10 IU/mL | Standard Deviation 0.629 |
| GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | Treatment Arm 1: Actual Values of HBV DNA Levels | Up to 24 weeks off treatment follow-up (Study Weeks 48 to 72) | 0.17 Log10 IU/mL | Standard Deviation 0.438 |
Secondary
Treatment Arm 1: Actual Values of Hepatitis B Virus E-antigen (HBeAg) Levels
Blood samples were collected to assess HBeAg levels.
Time frame: At baseline, end of treatment (up to 48 weeks), and up to 24 weeks off treatment follow-up (Study Weeks 48 to 72)
Population: Intent to Treat (ITT) Set that included all randomized participants. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | Treatment Arm 1: Actual Values of Hepatitis B Virus E-antigen (HBeAg) Levels | At Baseline | 14.221 Log10 IU/mL | Standard Deviation 69.3438 |
| GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | Treatment Arm 1: Actual Values of Hepatitis B Virus E-antigen (HBeAg) Levels | End of Treatment (up to 48 weeks) | 0.250 Log10 IU/mL | Standard Deviation 0.4193 |
| GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | Treatment Arm 1: Actual Values of Hepatitis B Virus E-antigen (HBeAg) Levels | Up to 24 weeks off treatment follow-up (Study Weeks 48 to 72) | 1.197 Log10 IU/mL | Standard Deviation 2.4945 |
Secondary
Treatment Arm 1: Change From Baseline in ALT
Blood samples were collected to assess ALT values. Change from Baseline was defined as value at the indicated time point minus Baseline value. Baseline was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: At baseline, end of treatment (up to 48 weeks), and up to 24 weeks off treatment follow-up (Study Weeks 48 to 72)
Population: Intent to Treat (ITT) Set that included all randomized participants. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | Treatment Arm 1: Change From Baseline in ALT | End of Treatment (up to 48 weeks) | 27.6 IU/L | Standard Deviation 56.05 |
| GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | Treatment Arm 1: Change From Baseline in ALT | Up to 24 weeks off treatment follow-up (Study Weeks 48 to 72) | -3.8 IU/L | Standard Deviation 9.86 |
Secondary
Treatment Arm 1: Mean Change From Baseline in HBeAg Levels
Blood samples were collected to assess HBeAg levels. Change from Baseline was defined as value at the indicated time point minus Baseline value. Baseline was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: At baseline, end of treatment (up to 48 weeks), and up to 24 weeks off treatment follow-up (Study Weeks 48 to 72)
Population: Intent to Treat (ITT) Set that included all randomized participants. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | Treatment Arm 1: Mean Change From Baseline in HBeAg Levels | End of Treatment (up to 48 weeks) | -21.774 Log10 IU/mL | Standard Deviation 65.4276 |
| GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | Treatment Arm 1: Mean Change From Baseline in HBeAg Levels | Up to 24 weeks off treatment follow-up (Study Weeks 48 to 72) | -19.482 Log10 IU/mL | Standard Deviation 55.1948 |
Secondary
Treatment Arm 1: Mean Change From Baseline in HBe Antibody Levels
Blood samples were collected to assess HBe antibody levels and results reported are for baseline HBeAg positive participants. Change from Baseline was defined as value at the indicated time point minus Baseline value. Baseline was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: At baseline, end of treatment (up to 48 weeks), and up to 24 weeks off treatment follow-up (Study Weeks 48 to 72)
Population: Intent to Treat (ITT) Set that included all randomized participants. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | Treatment Arm 1: Mean Change From Baseline in HBe Antibody Levels | End of Treatment (up to 48 weeks) | -1.04 Log10 IU/mL | Standard Deviation 1.133 |
| GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | Treatment Arm 1: Mean Change From Baseline in HBe Antibody Levels | Up to 24 weeks off treatment follow-up (Study Weeks 48 to 72) | -0.81 Log10 IU/mL | Standard Deviation 1.044 |
Secondary
Treatment Arm 1: Mean Change From Baseline in HBsAg Levels
Blood samples were collected to assess HBsAg change from baselines levels. Change from Baseline was defined as value at the indicated time point minus Baseline value. Baseline was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: At baseline, end of treatment (up to 48 weeks), and up to 24 weeks off treatment follow-up (Study Weeks 48 to 72)
Population: Intent to Treat (ITT) Set that included all randomized participants. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | Treatment Arm 1: Mean Change From Baseline in HBsAg Levels | End of Treatment (up to 48 weeks) | -1.76 Log10 IU/mL | Standard Deviation 1.726 |
| GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | Treatment Arm 1: Mean Change From Baseline in HBsAg Levels | Up to 24 weeks off treatment follow-up (Study Weeks 48 to 72) | -1.58 Log10 IU/mL | Standard Deviation 1.722 |
Secondary
Treatment Arm 1: Mean Change From Baseline in HBs Antibody Levels
Blood samples were collected to assess HBs antibody levels over time. Change from Baseline was defined as value at the indicated time point minus Baseline value. Baseline was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: At baseline, end of treatment (up to 48 weeks), and up to 24 weeks off treatment follow-up (Study Weeks 48 to 72)
Population: Intent to Treat (ITT) Set that included all randomized participants. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | Treatment Arm 1: Mean Change From Baseline in HBs Antibody Levels | End of treatment (up to 48 weeks) | 0.42 Log10 IU/L | Standard Deviation 0.934 |
| GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | Treatment Arm 1: Mean Change From Baseline in HBs Antibody Levels | Up to 24 weeks off treatment follow-up (Study Weeks 48 to 72) | 0.18 Log10 IU/L | Standard Deviation 0.757 |
Secondary
Treatment Arm 1: Mean Change From Baseline in HBV DNA Levels
Blood samples were collected to assess HBV DNA levels. Change from Baseline was defined as value at the indicated time point minus Baseline value. Baseline was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: At baseline, end of treatment (up to 48 weeks), and up to 24 weeks off treatment follow-up (Study Weeks 48 to 72)
Population: Intent to Treat (ITT) Set that included all randomized participants. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | Treatment Arm 1: Mean Change From Baseline in HBV DNA Levels | End of treatment (up to 48 weeks) | 0.40 Log10 IU/mL | Standard Deviation 0.945 |
| GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | Treatment Arm 1: Mean Change From Baseline in HBV DNA Levels | Up to 24 weeks off treatment follow-up (Study Weeks 48 to 72) | -0.39 Log10 IU/mL | Standard Deviation 0.727 |
Secondary
Treatment Arm 1 - Median Time to ALT Normalization in Absence of Rescue Medication for 24 Weeks After End of Treatment
Time to ALT normalization in absence of rescue medication were measured in participants having Baseline ALT\>ULN.
Time frame: Up to 24 weeks off treatment (Study Week 48 to72)
Population: Intent to Treat (ITT) Set that included all randomized participants. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | Treatment Arm 1 - Median Time to ALT Normalization in Absence of Rescue Medication for 24 Weeks After End of Treatment | NA Weeks |
Secondary
Treatment Arm 1: Number of Participants With Alanine Aminotransferase (ALT) Normalization
The ALT normalization (ALT \<=upper limit of normal \[ULN\]) over time in absence of rescue medication in participants with baseline ALT\>ULN and ALT data at that visit. Participants who achieved ALT normalization were reported.
Time frame: At baseline, end of treatment (up to 48 weeks) and up to 24 weeks off treatment follow-up (Study Weeks 48 to 72)
Population: Intent to Treat (ITT) Set that included all randomized participants. The n represents the number of participants with baseline ALT \> ULN and ALT data at that visit. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | Treatment Arm 1: Number of Participants With Alanine Aminotransferase (ALT) Normalization | ALT>ULN, At Baseline | 4 Participants |
| GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | Treatment Arm 1: Number of Participants With Alanine Aminotransferase (ALT) Normalization | ALT normalization, End of Treatment (up to 48 weeks) | 0 Participants |
| GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | Treatment Arm 1: Number of Participants With Alanine Aminotransferase (ALT) Normalization | ALT normalization, Up to 24 weeks off treatment follow-up (Study Weeks 48 to 72) | 2 Participants |
Secondary
Treatment Arm 1: Number of Participants With HBe Antibody (Anti-HBeAg) Levels
Blood samples were collected to assess HBe antibody levels and results reported are for baseline HBeAg positive participants.
Time frame: At baseline, end of treatment (up to 48 weeks), and up to 24 weeks off treatment follow-up (Study Weeks 48 to 72)
Population: Intent to Treat (ITT) Set that included all randomized participants. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | Treatment Arm 1: Number of Participants With HBe Antibody (Anti-HBeAg) Levels | At Baseline | 2 Participants |
| GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | Treatment Arm 1: Number of Participants With HBe Antibody (Anti-HBeAg) Levels | End of Treatment (up to 48 weeks) | 5 Participants |
| GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | Treatment Arm 1: Number of Participants With HBe Antibody (Anti-HBeAg) Levels | Up to 24 weeks off treatment follow-up (Study Weeks 48 to 72) | 4 Participants |
Secondary
Treatment Arm 1: Percentage of Participants Achieving HBsAg and HBV DNA < Lower Limit of Quantitation (LLOQ)
Percentage of participants achieving HBsAg and HBV DNA \<LLOQ were reported. Percentage values are rounded-off.
Time frame: End of treatment (up to 48 weeks) and up to 24 weeks off treatment follow-up (Study Weeks 48 to 72)
Population: Intent to Treat (ITT) Set that included all randomized participants. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | Treatment Arm 1: Percentage of Participants Achieving HBsAg and HBV DNA < Lower Limit of Quantitation (LLOQ) | End of treatment (up to 48 weeks) | 15 Percentage of Participants |
| GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | Treatment Arm 1: Percentage of Participants Achieving HBsAg and HBV DNA < Lower Limit of Quantitation (LLOQ) | Up to 24 weeks off treatment follow-up (Study Weeks 48 to 72) | 13 Percentage of Participants |
Secondary
Treatment Arm 1: Percentage of Participants With Categorical Changes From Baseline in HBsAg Values
Participants who achieved a decline in HBsAg values from baseline were reported. Participants were categorized in the following categorical HBsAg decline of \<0.5, greater than or equal to (\>=) 0.5, \>=1, \>=1.5, and \>=3 log10 international units per milliliter (IU/mL). The 'HBsAg \< LLOQ' category is derived based on Absolute/raw HBsAg result. The HBsAg decline categories are based on change from baseline values. Percentage values are rounded-off.
Time frame: Baseline, End of treatment (up to 48 weeks), and up to 24 weeks off treatment follow-up (Study Weeks 48 to 72)
Population: Intent to Treat (ITT) Set that included all randomized participants. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | Treatment Arm 1: Percentage of Participants With Categorical Changes From Baseline in HBsAg Values | HBsAg <LLOQ - End of Treatment (up to 48 weeks) | 18 Percentage of Participants |
| GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | Treatment Arm 1: Percentage of Participants With Categorical Changes From Baseline in HBsAg Values | HBsAg<LLOQ - Up to 24 weeks off treatment follow-up (Study Weeks 48 to 72) | 13 Percentage of Participants |
| GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | Treatment Arm 1: Percentage of Participants With Categorical Changes From Baseline in HBsAg Values | HBsAg decline <0.5 - End of Treatment (up to 48 weeks) | 24 Percentage of Participants |
| GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | Treatment Arm 1: Percentage of Participants With Categorical Changes From Baseline in HBsAg Values | HBsAg decline <0.5- Up to 24 weeks off treatment follow-up (Study Weeks 48 to 72) | 45 Percentage of Participants |
| GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | Treatment Arm 1: Percentage of Participants With Categorical Changes From Baseline in HBsAg Values | HBsAg decline >=0.5 - End of Treatment (up to 48 weeks) | 42 Percentage of Participants |
| GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | Treatment Arm 1: Percentage of Participants With Categorical Changes From Baseline in HBsAg Values | HBsAg decline >=0.5 - Up to 24 weeks off treatment follow-up (Study Weeks 48 to 72) | 44 Percentage of Participants |
| GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | Treatment Arm 1: Percentage of Participants With Categorical Changes From Baseline in HBsAg Values | HBsAg decline >=1 - End of Treatment (up to 48 weeks) | 33 Percentage of Participants |
| GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | Treatment Arm 1: Percentage of Participants With Categorical Changes From Baseline in HBsAg Values | HBsAg decline >=1- Up to 24 weeks off treatment follow-up (Study Weeks 48 to 72) | 36 Percentage of Participants |
| GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | Treatment Arm 1: Percentage of Participants With Categorical Changes From Baseline in HBsAg Values | HBsAg decline >=1.5 - End of Treatment (up to 48 weeks) | 27 Percentage of Participants |
| GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | Treatment Arm 1: Percentage of Participants With Categorical Changes From Baseline in HBsAg Values | HBsAg decline >=1.5 - Up to 24 weeks off treatment follow-up (Study Weeks 48 to 72) | 36 Percentage of Participants |
| GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | Treatment Arm 1: Percentage of Participants With Categorical Changes From Baseline in HBsAg Values | HBsAg decline >=3 - End of Treatment (up to 48 weeks) | 20 Percentage of Participants |
| GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | Treatment Arm 1: Percentage of Participants With Categorical Changes From Baseline in HBsAg Values | HBsAg decline >=3 - Up to 24 weeks off treatment follow-up (Study Weeks 48 to 72) | 27 Percentage of Participants |
Secondary
Treatment Arm 2: Actual Values of ALT
Blood samples were collected to assess ALT mean values.
Time frame: At baseline, end of treatment (up to 36 weeks), up to 24 weeks off treatment follow-up (Study Weeks 36 to 60), and up to 36 weeks off treatment follow-up (Study Weeks 36 to 72)
Population: Intent to Treat (ITT) Set that included all randomized participants. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | Treatment Arm 2: Actual Values of ALT | At Baseline | 26.9 IU/L | Standard Deviation 19.16 |
| GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | Treatment Arm 2: Actual Values of ALT | End of Treatment (up to 36 weeks) | 55.3 IU/L | Standard Deviation 46.6 |
| GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | Treatment Arm 2: Actual Values of ALT | Up to 24 weeks off treatment follow-up (Study Weeks 36 to 60) | 22.1 IU/L | Standard Deviation 13.3 |
| GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | Treatment Arm 2: Actual Values of ALT | Up to 36 weeks off treatment follow-up (Study Weeks 36 to 72) | 23.5 IU/L | Standard Deviation 15.61 |
Secondary
Treatment Arm 2: Actual Values of HBsAg Levels
Blood samples were collected from participants to assess HBsAg at indicated time points.
Time frame: At baseline, end of treatment (up to 36 weeks), up to 24 weeks off treatment follow-up (Study Weeks 36 to 60), and up to 36 weeks off treatment follow-up (Study Weeks 36 to 72)
Population: Intent to Treat (ITT) Set that included all randomized participants. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | Treatment Arm 2: Actual Values of HBsAg Levels | At Baseline | 3.32 Log10 IU/mL | Standard Deviation 0.622 |
| GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | Treatment Arm 2: Actual Values of HBsAg Levels | End of Treatment (up to 36 weeks) | 1.70 Log10 IU/mL | Standard Deviation 1.896 |
| GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | Treatment Arm 2: Actual Values of HBsAg Levels | Up to 24 weeks off treatment follow-up (Study Weeks 36 to 60) | 2.12 Log10 IU/mL | Standard Deviation 1.827 |
| GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | Treatment Arm 2: Actual Values of HBsAg Levels | Up to 36 weeks off treatment follow-up (Study Weeks 36 to 72) | 2.12 Log10 IU/mL | Standard Deviation 1.83 |
Secondary
Treatment Arm 2: Actual Values of HBs Antibody Levels
Blood samples were collected to assess HBs antibody levels.
Time frame: At baseline, end of treatment (up to 36 weeks), up to 24 weeks off treatment follow-up (Study Weeks 36 to 60), and up to 36 weeks off treatment follow-up (Study Weeks 36 to 72)
Population: Intent to Treat (ITT) Set that included all randomized participants. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | Treatment Arm 2: Actual Values of HBs Antibody Levels | End of Treatment (up to 36 weeks) | 0.87 Log10 IU/L | Standard Deviation 0.491 |
| GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | Treatment Arm 2: Actual Values of HBs Antibody Levels | At Baseline | 0.69 Log10 IU/L | Standard Deviation 0.204 |
| GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | Treatment Arm 2: Actual Values of HBs Antibody Levels | Up to 24 weeks off treatment follow-up (study week 36 to week 60) | 0.80 Log10 IU/L | Standard Deviation 0.521 |
| GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | Treatment Arm 2: Actual Values of HBs Antibody Levels | Up to 36 weeks off treatment follow-up (study week 36 to week 72) | 0.76 Log10 IU/L | Standard Deviation 0.481 |
Secondary
Treatment Arm 2: Actual Values of HBV DNA Levels
Blood samples were collected to assess HBV DNA levels.
Time frame: At baseline, end of treatment (up to 36 weeks), up to 24 weeks off treatment follow-up (Study Weeks 36 to 60), and up to 36 weeks off treatment follow-up (Study Weeks 36 to 72)
Population: Intent to Treat (ITT) Set that included all randomized participants. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | Treatment Arm 2: Actual Values of HBV DNA Levels | At Baseline | 0.57 Log10 IU/mL | Standard Deviation 0.687 |
| GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | Treatment Arm 2: Actual Values of HBV DNA Levels | End of treatment (up to 36 weeks) | 0.70 Log10 IU/mL | Standard Deviation 0.7 |
| GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | Treatment Arm 2: Actual Values of HBV DNA Levels | Up to 24 weeks off treatment follow-up (Study Weeks 36 to 60) | 0.34 Log10 IU/mL | Standard Deviation 0.579 |
| GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | Treatment Arm 2: Actual Values of HBV DNA Levels | Up to 36 weeks off treatment follow-up (Study Weeks 36 to 72) | 0.35 Log10 IU/mL | Standard Deviation 0.587 |
Secondary
Treatment Arm 2: Actual Values of Hepatitis B Virus E-antigen (HBeAg) Levels
Blood samples were collected to assess HBeAg levels.
Time frame: At baseline, end of treatment (up to 36 weeks), up to 24 weeks off treatment follow-up (Study Weeks 36 to 60), and up to 36 weeks off treatment follow-up (Study Weeks 36 to 72)
Population: Intent to Treat (ITT) Set that included all randomized participants. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | Treatment Arm 2: Actual Values of Hepatitis B Virus E-antigen (HBeAg) Levels | At Baseline | 8.510 Log10 IU/mL | Standard Deviation 42.1588 |
| GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | Treatment Arm 2: Actual Values of Hepatitis B Virus E-antigen (HBeAg) Levels | End of Treatment (up to 36 weeks) | 3.008 Log10 IU/mL | Standard Deviation 6.2682 |
| GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | Treatment Arm 2: Actual Values of Hepatitis B Virus E-antigen (HBeAg) Levels | Up to 24 weeks off treatment follow-up (Study Weeks 36 to 60) | 3.410 Log10 IU/mL | Standard Deviation 6.0421 |
| GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | Treatment Arm 2: Actual Values of Hepatitis B Virus E-antigen (HBeAg) Levels | Up to 36 weeks off treatment follow-up (Study Weeks 36 to 72) | 2.797 Log10 IU/mL | Standard Deviation 4.8973 |
Secondary
Treatment Arm 2: Change From Baseline in ALT
Blood samples were collected to assess ALT values. Change from Baseline was defined as value at the indicated time point minus Baseline value. Baseline was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: At baseline, end of treatment (up to 36 weeks), up to 24 weeks off treatment follow-up (Study Weeks 36 to 60), and up to 36 weeks off treatment follow-up (Study Weeks 36 to 72)
Population: Intent to Treat (ITT) Set that included all randomized participants. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | Treatment Arm 2: Change From Baseline in ALT | End of treatment (up to 36 weeks) | 27.8 IU/L | Standard Deviation 40.55 |
| GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | Treatment Arm 2: Change From Baseline in ALT | Up to 24 weeks off treatment follow-up (Study Weeks 36 to 60) | -4.3 IU/L | Standard Deviation 17.5 |
| GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | Treatment Arm 2: Change From Baseline in ALT | Up to 36 weeks off treatment follow-up (Study Weeks 36 to 72) | -3.1 IU/L | Standard Deviation 18.65 |
Secondary
Treatment Arm 2: Mean Change From Baseline in HBeAg Levels
Blood samples were collected to assess HBeAg levels. Change from Baseline was defined as value at the indicated time point minus Baseline value. Baseline was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: At baseline, end of treatment (up to 36 weeks), up to 24 weeks off treatment follow-up (Study Weeks 36 to 60), and up to 36 weeks off treatment follow-up (Study Weeks 36 to 72)
Population: Intent to Treat (ITT) Set that included all randomized participants. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | Treatment Arm 2: Mean Change From Baseline in HBeAg Levels | End of Treatment (up to 36 weeks) | -5.270 Log10 IU/mL | Standard Deviation 8.8942 |
| GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | Treatment Arm 2: Mean Change From Baseline in HBeAg Levels | Up to 24 weeks off treatment follow-up (Study Weeks 36 to 60) | -26.384 Log10 IU/mL | Standard Deviation 80.2108 |
| GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | Treatment Arm 2: Mean Change From Baseline in HBeAg Levels | Up to 36 weeks off treatment follow-up (Study Weeks 36 to 72) | -26.345 Log10 IU/mL | Standard Deviation 77.2836 |
Secondary
Treatment Arm 2: Mean Change From Baseline in HBe Antibody Levels
Blood samples were collected to assess HBe antibody levels and results reported are for baseline HBeAg positive participants. Change from Baseline was defined as value at the indicated time point minus Baseline value. Baseline was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: At baseline, End of treatment (up to 36 weeks), up to 24 weeks off treatment follow-up (Study Weeks 36 to 60), and up to 36 weeks off treatment follow-up (Study Weeks 36 to 72)
Population: Intent to Treat (ITT) Set that included all randomized participants. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | Treatment Arm 2: Mean Change From Baseline in HBe Antibody Levels | End of Treatment (up to 36 weeks) | -0.52 Log10 IU/mL | Standard Deviation 0.598 |
| GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | Treatment Arm 2: Mean Change From Baseline in HBe Antibody Levels | Up to 24 weeks off treatment follow-up (Study Weeks 36 to 60) | -0.58 Log10 IU/mL | Standard Deviation 0.766 |
| GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | Treatment Arm 2: Mean Change From Baseline in HBe Antibody Levels | Up to 36 weeks off treatment follow-up (Study Weeks 36 to 72) | -0.65 Log10 IU/mL | Standard Deviation 0.787 |
Secondary
Treatment Arm 2: Mean Change From Baseline in HBsAg Levels
Blood samples were collected to assess HBsAg change from baselines levels. Change from Baseline was defined as value at the indicated time point minus Baseline value. Baseline was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: At baseline, end of treatment (up to 36 weeks), up to 24 weeks off treatment follow-up (Study Weeks 36 to 60), and up to 36 weeks off treatment follow-up (Study Weeks 36 to 72)
Population: Intent to Treat (ITT) Set that included all randomized participants. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | Treatment Arm 2: Mean Change From Baseline in HBsAg Levels | End of Treatment (up to 36 weeks) | -1.54 Log10 IU/mL | Standard Deviation 1.567 |
| GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | Treatment Arm 2: Mean Change From Baseline in HBsAg Levels | Up to 24 weeks off treatment follow-up (Study Weeks 36 to 60) | -1.20 Log10 IU/mL | Standard Deviation 1.458 |
| GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | Treatment Arm 2: Mean Change From Baseline in HBsAg Levels | Up to 36 weeks off treatment follow-up (Study Weeks 36 to 72) | -1.20 Log10 IU/mL | Standard Deviation 1.46 |
Secondary
Treatment Arm 2: Mean Change From Baseline in HBs Antibody Levels
Blood samples were collected to assess HBs antibody levels over time. Change from Baseline was defined as value at the indicated time point minus Baseline value. Baseline was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: At baseline, end of treatment (up to 36 weeks), up to 24 weeks off treatment follow-up (Study Weeks 36 to 60), and up to 36 weeks off treatment follow-up (Study Weeks 36 to 72)
Population: Intent to Treat (ITT) Set that included all randomized participants. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | Treatment Arm 2: Mean Change From Baseline in HBs Antibody Levels | End of Treatment (up to 36 weeks) | 0.18 Log10 IU/L | Standard Deviation 0.45 |
| GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | Treatment Arm 2: Mean Change From Baseline in HBs Antibody Levels | Up to 24 weeks off treatment follow-up (Study Weeks 36 to 60) | 0.09 Log10 IU/L | Standard Deviation 0.487 |
| GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | Treatment Arm 2: Mean Change From Baseline in HBs Antibody Levels | Up to 36 weeks off treatment follow-up (Study Weeks 36 to 72) | 0.05 Log10 IU/L | Standard Deviation 0.453 |
Secondary
Treatment Arm 2: Mean Change From Baseline in HBV DNA Levels
Blood samples were collected to assess HBV DNA levels. Change from Baseline was defined as value at the indicated time point minus Baseline value. Baseline was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: At baseline, end of treatment (up to 36 weeks), up to 24 weeks off treatment follow-up (Study Weeks 36 to 60), and up to 36 weeks off treatment follow-up (Study Weeks 36 to 72)
Population: Intent to Treat (ITT) Set that included all randomized participants. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | Treatment Arm 2: Mean Change From Baseline in HBV DNA Levels | End of Treatment (up to 36 weeks) | 0.21 Log10 IU/mL | Standard Deviation 0.925 |
| GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | Treatment Arm 2: Mean Change From Baseline in HBV DNA Levels | Up to 24 weeks off treatment follow-up (Study Weeks 36 to 60) | -0.21 Log10 IU/mL | Standard Deviation 0.876 |
| GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | Treatment Arm 2: Mean Change From Baseline in HBV DNA Levels | Up to 36 weeks off treatment follow-up (Study Weeks 36 to 72) | -0.22 Log10 IU/mL | Standard Deviation 0.754 |
Secondary
Treatment Arm 2 - Median Time to ALT Normalization in Absence of Rescue Medication for 24 Weeks After End of Treatment
Time to ALT normalization in absence of rescue medication were measured in participants having Baseline ALT\>ULN.
Time frame: Up to 24 weeks off treatment (Study Weeks 36 to 60)
Population: Intent to Treat (ITT) Set that included all randomized participants. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | Treatment Arm 2 - Median Time to ALT Normalization in Absence of Rescue Medication for 24 Weeks After End of Treatment | 4.1 Weeks |
Secondary
Treatment Arm 2: Number of Participants With Alanine Aminotransferase (ALT) Normalization
The ALT normalization (ALT \<=upper limit of normal \[ULN\]) over time in absence of rescue medication in participants with baseline ALT\>ULN and ALT data at that visit. Participants who achieved ALT normalization were reported.
Time frame: At baseline, End of treatment (up to 36 weeks), up to 24 weeks off treatment follow-up (Study Weeks 36 to 60), and up to 36 weeks off treatment follow-up (Study Weeks 36 to 72)
Population: Intent to Treat (ITT) Set that included all randomized participants. The n represents the number of participants with baseline ALT \> ULN and ALT data at that visit. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | Treatment Arm 2: Number of Participants With Alanine Aminotransferase (ALT) Normalization | ALT>ULN, At Baseline | 10 Participants |
| GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | Treatment Arm 2: Number of Participants With Alanine Aminotransferase (ALT) Normalization | ALT normalization, End of Treatment (up to 36 weeks) | 1 Participants |
| GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | Treatment Arm 2: Number of Participants With Alanine Aminotransferase (ALT) Normalization | ALT normalization, Up to 24 weeks off treatment follow-up (Study Weeks 36 to 60) | 5 Participants |
| GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | Treatment Arm 2: Number of Participants With Alanine Aminotransferase (ALT) Normalization | ALT normalization, Up to 36 weeks off treatment follow-up (Study Weeks 36 to 72) | 6 Participants |
Secondary
Treatment Arm 2: Number of Participants With HBe Antibody (Anti-HBeAg) Levels
Blood samples were collected to assess HBe antibody levels and results reported are for baseline HBeAg positive participants.
Time frame: At baseline, End of treatment (up to 36 weeks), up to 24 weeks off treatment follow-up (Study Weeks 36 to 60), and up to 36 weeks off treatment follow-up (Study Weeks 36 to 72)
Population: Intent to Treat (ITT) Set that included all randomized participants. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | Treatment Arm 2: Number of Participants With HBe Antibody (Anti-HBeAg) Levels | At Baseline | 1 Participants |
| GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | Treatment Arm 2: Number of Participants With HBe Antibody (Anti-HBeAg) Levels | End of Treatment (up to 36 weeks) | 1 Participants |
| GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | Treatment Arm 2: Number of Participants With HBe Antibody (Anti-HBeAg) Levels | Up to 24 weeks off treatment follow-up (Study Weeks 36 to 60) | 1 Participants |
| GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | Treatment Arm 2: Number of Participants With HBe Antibody (Anti-HBeAg) Levels | Up to 36 weeks off treatment follow-up (Study Weeks 36 to 72) | 0 Participants |
Secondary
Treatment Arm 2: Percentage of Participants Achieving HBsAg and HBV DNA < Lower Limit of Quantitation (LLOQ)
Percentage of participants achieving HBsAg and HBV DNA \<LLOQ were reported. Percentage values are rounded-off.
Time frame: End of treatment (up to 36 weeks), up to 24 weeks off treatment follow-up (Study Weeks 36 to 60) and up to 36 weeks off treatment follow-up (Study Weeks 36 to 72)
Population: Intent to Treat (ITT) Set that included all randomized participants. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | Treatment Arm 2: Percentage of Participants Achieving HBsAg and HBV DNA < Lower Limit of Quantitation (LLOQ) | End of treatment (up to 36 weeks) | 15 Percentage of Participants |
| GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | Treatment Arm 2: Percentage of Participants Achieving HBsAg and HBV DNA < Lower Limit of Quantitation (LLOQ) | Up to 24 weeks off treatment follow-up (Study Weeks 36 to 60) | 17 Percentage of Participants |
| GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | Treatment Arm 2: Percentage of Participants Achieving HBsAg and HBV DNA < Lower Limit of Quantitation (LLOQ) | Up to 36 weeks off treatment follow-up (Study Weeks 36 to 72) | 15 Percentage of Participants |
Secondary
Treatment Arm 2: Percentage of Participants With Categorical Changes From Baseline in HBsAg Values
Participants who achieved a decline in HBsAg values from baseline were reported. Participants were categorized in the following categorical HBsAg decline of \<0.5, greater than or equal to (\>=) 0.5, \>=1, \>=1.5, and \>=3 log10 international units per milliliter (IU/mL). The 'HBsAg \< LLOQ' category is derived based on Absolute/raw HBsAg result. The HBsAg decline categories are based on change from baseline values. Percentage values are rounded-off.
Time frame: Baseline, End of treatment (up to 36 weeks), up to 24 weeks off treatment follow-up (Study Weeks 36 to 60) and up to 36 weeks off treatment follow-up (Study Weeks 36 to 72)
Population: Intent to Treat (ITT) Set that included all randomized participants. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | Treatment Arm 2: Percentage of Participants With Categorical Changes From Baseline in HBsAg Values | HBsAg <LLOQ - End of Treatment (up to 36 weeks) | 15 Percentage of Participants |
| GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | Treatment Arm 2: Percentage of Participants With Categorical Changes From Baseline in HBsAg Values | HBsAg<LLOQ - Up to 24 weeks off treatment follow-up (Study Weeks 36 to 60) | 17 Percentage of Participants |
| GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | Treatment Arm 2: Percentage of Participants With Categorical Changes From Baseline in HBsAg Values | HBsAg <LLOQ - Up to 36 weeks off treatment follow-up (Study Weeks 36 to 72) | 15 Percentage of Participants |
| GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | Treatment Arm 2: Percentage of Participants With Categorical Changes From Baseline in HBsAg Values | HBsAg decline <0.5 - End of Treatment (up to 36 weeks) | 26 Percentage of Participants |
| GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | Treatment Arm 2: Percentage of Participants With Categorical Changes From Baseline in HBsAg Values | HBsAg decline <0.5 - Up to 24 weeks off treatment follow-up (Study Weeks 36 to 60) | 42 Percentage of Participants |
| GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | Treatment Arm 2: Percentage of Participants With Categorical Changes From Baseline in HBsAg Values | HBsAg decline <0.5 - Up to 36 weeks off treatment follow-up (Study Weeks 36 to 72) | 43 Percentage of Participants |
| GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | Treatment Arm 2: Percentage of Participants With Categorical Changes From Baseline in HBsAg Values | HBsAg decline >=0.5 - End of Treatment (up to 36 weeks) | 42 Percentage of Participants |
| GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | Treatment Arm 2: Percentage of Participants With Categorical Changes From Baseline in HBsAg Values | HBsAg decline >=0.5 - Up to 24 weeks off treatment follow-up (Study Weeks 36 to 60) | 51 Percentage of Participants |
| GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | Treatment Arm 2: Percentage of Participants With Categorical Changes From Baseline in HBsAg Values | HBsAg decline >=0.5 - Up to 36 weeks off treatment follow-up (Study Weeks 36 to 72) | 47 Percentage of Participants |
| GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | Treatment Arm 2: Percentage of Participants With Categorical Changes From Baseline in HBsAg Values | HBsAg decline >=1 - End of Treatment (up to 36 weeks) | 34 Percentage of Participants |
| GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | Treatment Arm 2: Percentage of Participants With Categorical Changes From Baseline in HBsAg Values | HBsAg decline >=1 - Up to 24 weeks off treatment follow-up (Study Weeks 36 to 60) | 34 Percentage of Participants |
| GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | Treatment Arm 2: Percentage of Participants With Categorical Changes From Baseline in HBsAg Values | HBsAg decline >=1 - Up to 36 weeks off treatment follow-up (Study Weeks 36 to 72) | 32 Percentage of Participants |
| GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | Treatment Arm 2: Percentage of Participants With Categorical Changes From Baseline in HBsAg Values | HBsAg decline >=1.5 - End of Treatment (up to 36 weeks) | 28 Percentage of Participants |
| GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | Treatment Arm 2: Percentage of Participants With Categorical Changes From Baseline in HBsAg Values | HBsAg decline >=1.5 - Up to 24 weeks off treatment follow-up (Study Weeks 36 to 60) | 23 Percentage of Participants |
| GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | Treatment Arm 2: Percentage of Participants With Categorical Changes From Baseline in HBsAg Values | HBsAg decline >=1.5-up to 36 weeks off treatment follow-up (Study Weeks 36 to 72) | 19 Percentage of Participants |
| GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | Treatment Arm 2: Percentage of Participants With Categorical Changes From Baseline in HBsAg Values | HBsAg decline >=3 - End of Treatment (up to 36 weeks) | 15 Percentage of Participants |
| GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | Treatment Arm 2: Percentage of Participants With Categorical Changes From Baseline in HBsAg Values | HBsAg decline >=3 - Up to 24 weeks off treatment follow-up (Study Weeks 36 to 60) | 17 Percentage of Participants |
| GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | Treatment Arm 2: Percentage of Participants With Categorical Changes From Baseline in HBsAg Values | HBsAg decline >=3 - Up to 36 weeks off treatment follow-up (Study Weeks 36 to 72) | 17 Percentage of Participants |