Hepatitis B
Conditions
Keywords
hepatitis B, hepatitis B Virus (HBV), chronic hepatitis B, telbivudine, peginterferon
Brief summary
To evaluate the combination of telbivudine 600 mg orally (PO) once daily and peginterferon alpha-2a 180 ug subcutaneous (sq) injection weekly for antiviral efficacy in comparison to peginterferon alpha-2a monotherapy.
Interventions
600 mg orally once daily for 104 weeks.
180 μg subcutaneous injection once a week for 52 weeks.
Sponsors
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Documented Chronic hepatitis B (CHB) defined by all of the following: * Clinical history compatible with CHB * Detectable serum Hepatitis B Surface Antigen (HBsAg) at the Screening visit and at least 6 months prior * HBeAg-positive at the Screening visit * Hepatitis B 'e' Antibody (HBeAb)-negative at the Screening visit * History of evidence of chronic liver inflammation, * Elevated serum Alanine aminotransferase (ALT) level (1.3 - 10 x upper limit of normal (ULN)) at the Screening visit * Serum HBV DNA level ≥ 6 log10 copies/mL, * Chronic liver inflammation on previous liver biopsy within the previous 24 months.
Exclusion criteria
* Co-infection with Hepatitis C Virus (HCV), Hepatitis D Virus (HDV), or Human Immunodeficiency Virus (HIV). * Has any of the following drug therapy: * Previously been treated in a trial with telbivudine * Received nucleoside or nucleotide therapy whether approved or investigational * Received any immunomodulatory treatment in the 12 months before Screening for this study. * Has a medical condition that required prolonged or frequent use of systemic acyclovir or famciclovir. * Has a medical condition that requires frequent or prolonged use of systemic corticosteroids although inhaled or intra-articular corticosteroids are allowed. * Has a medical condition requiring the chronic or prolonged use of potentially hepatotoxic drugs or nephrotoxic drugs. * Is currently abusing alcohol or illicit drugs or has a history of alcohol abuse illicit substance abuse within the preceding two years. * Uses other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer. * Is currently receiving methadone. * Patient has any of the following: * History of or clinical signs/symptoms of hepatic decompensation such as ascites, esophageal variceal bleeding, hepatic encephalopathy, or spontaneous bacterial peritonitis. * History of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin. Patients with previous findings suggestive of possible HCC should have the disease ruled out prior to entrance into the study. * One or more additional known primary or secondary causes of liver disease other than hepatitis B, including steatohepatitis. * History of clinical and laboratory evidence of chronic pancreatitis, or demonstrates a clinical and laboratory course consistent with current pancreatitis. * Has laboratory values during screening visit not within normal limits. * Is pregnant or breastfeeding. * Is a women of child-bearing potential that is unwilling to practice birth control.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Achieved HBV DNA Non-detectability With Peginterferon Alpha-2a Plus Telbivudine Combination Therapy Versus Peginterferon Alpha-2a Monotherapy | At week 52 | The original primary efficacy variable was the percentage of patients achieving HBV DNA non-detectability utilizing polymerase chain reaction (PCR) (threshold for detection 300 copies/mL); however, this analysis was not performed due to premature study termination. |
| Percentage of Participants With HBV DNA Non-detectability and Alanine Aminotransferase (ALT) Normalization at Week 12 and Week 24 in Participants With HBeAg-positive Chronic Hepatitis B (CHB) | Weeks 12 and 24 | The percentage of participants who achieved HBV DNA non-detectability using the COBAS Amplicor HBV Monitor assay utilizing polymerase chain reaction (PCR) (threshold for detection 300 copies/mL) and Alanine aminotransferase (ALT) normalization defined as ALT within normal limits on two successive visits for a patient with an elevated ALT (\>1.0 x upper limit normal) at baseline summarized at Weeks 12 and 24. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Hepatitis B 'e' Antigen (HBeAg) Loss and HBeAg Seroconversion | Weeks 18, 24, 48, 52 and Treatment completion (TC) | HBeAg loss is defined as the loss of detectable serum HBeAg in a patient who was HBeAg positive at baseline. HBeAg seroconversion is defined as HBeAg loss with detectable Hepatitis B 'e' antibody (HBeAb). The efficacy was assessed for 18 weeks, 24 weeks, 48 weeks, 52 weeks and on treatment completion (TC). |
| Change From Baseline in HBV DNA Concentration | Weeks 12 and 24 | The change from baseline in HBV DNA concentration at Weeks 12 and 24 was analyzed using an analysis of covariance (ANCOVA) model with baseline HBV DNA concentration (log10 copies/ml) as a covariate, treatment and country as factors. |
| Percentage of Participants Who Achieved HBV DNA Non-detectability With Peginterferon Alpha-2a Plus Telbivudine Combination Therapy Versus Telbivudine Monotherapy | Week 52 | Antiviral efficacy was assessed by percentage of patients achieving HBV DNA non-detectability assay utilizing polymerase chain reaction (PCR) (threshold for detection 300 copies/mL); however, this analysis was not performed due to premature study termination. |
| Percentage of Participants Who Achieved HBV DNA Non-detectability With Telbivudine Monotherapy Versus Peginterferon Alpha-2a Monotherapy | Week 52 | Antiviral efficacy was assessed by percentage of patients achieving HBV DNA non-detectability assay utilizing polymerase chain reaction (PCR) (threshold for detection 300 copies/mL); however, this analysis was not performed due to premature study termination. |
| Percentage of Participants Who Experienced Virologic Breakthrough at Weeks 48 and 52 | Weeks 48 and 52 | The percentage of participants with Virologic breakthrough at Week 48 and 52 by treatment. For the subgroup of patients on treatment who achieve HBV DNA \>= 1 log10 copies/mL reduction from baseline on 2 consecutive visits, Virologic Breakthrough is defined as HBV DNA \>= 1 log10 copies/mL from nadir on two consecutive visits. |
Countries
United States
Participant flow
Recruitment details
This is a randomized, open-label, controlled, multi-center two-year study enrolling male and female subjects starting December 2006 and ending February 2009.
Participants by arm
| Arm | Count |
|---|---|
| LdT + PEG-INF Telbivudine (LdT) 600 mg orally once a day for 104 weeks in combination with peg interferon (PEG-INF) alpha-2a 180 μg subcutaneous injection once a week for 52 weeks. | 50 |
| LdT Monotherapy Telbivudine (LdT) monotherapy: 600 mg orally once daily for 104 weeks. | 55 |
| PEG-INF Monotherapy Peg interferon (PEG- INF) alpha-2a monotherapy: 180 μg subcutaneous injection once a week for 52 weeks. | 54 |
| Total | 159 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Abnormal laboratory value(s) | 1 | 0 | 0 |
| Overall Study | Administrative problems | 21 | 17 | 14 |
| Overall Study | Adverse Event | 8 | 3 | 3 |
| Overall Study | Lack of Efficacy | 0 | 0 | 3 |
| Overall Study | Lost to Follow-up | 1 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 1 | 2 |
Baseline characteristics
| Characteristic | LdT + PEG-INF | LdT Monotherapy | PEG-INF Monotherapy | Total |
|---|---|---|---|---|
| Age Continuous | 35.6 years STANDARD_DEVIATION 10 | 35.0 years STANDARD_DEVIATION 11.48 | 33.8 years STANDARD_DEVIATION 9.47 | 34.7 years STANDARD_DEVIATION 10.33 |
| Sex: Female, Male Female | 16 Participants | 15 Participants | 20 Participants | 51 Participants |
| Sex: Female, Male Male | 34 Participants | 40 Participants | 34 Participants | 108 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 38 / 50 | 35 / 54 | 47 / 54 |
| serious Total, serious adverse events | 11 / 50 | 2 / 54 | 2 / 54 |
Outcome results
Primary
Percentage of Participants Who Achieved HBV DNA Non-detectability With Peginterferon Alpha-2a Plus Telbivudine Combination Therapy Versus Peginterferon Alpha-2a Monotherapy
The original primary efficacy variable was the percentage of patients achieving HBV DNA non-detectability utilizing polymerase chain reaction (PCR) (threshold for detection 300 copies/mL); however, this analysis was not performed due to premature study termination.
Time frame: At week 52
Population: The analysis was planned on intention to treat (ITT) population. Due to premature study termination, the analysis was not performed.
Primary
Percentage of Participants With HBV DNA Non-detectability and Alanine Aminotransferase (ALT) Normalization at Week 12 and Week 24 in Participants With HBeAg-positive Chronic Hepatitis B (CHB)
The percentage of participants who achieved HBV DNA non-detectability using the COBAS Amplicor HBV Monitor assay utilizing polymerase chain reaction (PCR) (threshold for detection 300 copies/mL) and Alanine aminotransferase (ALT) normalization defined as ALT within normal limits on two successive visits for a patient with an elevated ALT (\>1.0 x upper limit normal) at baseline summarized at Weeks 12 and 24.
Time frame: Weeks 12 and 24
Population: Intent to Treat (ITT) population. The study was terminated and some participants did not complete all visits. n in each of the categories represents the number of participants in each arm with non-missing efficacy endpoint observations for the respective week.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| LdT + PEG-INF | Percentage of Participants With HBV DNA Non-detectability and Alanine Aminotransferase (ALT) Normalization at Week 12 and Week 24 in Participants With HBeAg-positive Chronic Hepatitis B (CHB) | HBV DNA non-detectability Week 12 (n=37,52,50) | 13.5 Percentage of participants |
| LdT + PEG-INF | Percentage of Participants With HBV DNA Non-detectability and Alanine Aminotransferase (ALT) Normalization at Week 12 and Week 24 in Participants With HBeAg-positive Chronic Hepatitis B (CHB) | ALT normalization Week 12 (n=37,52,50) | 13.5 Percentage of participants |
| LdT + PEG-INF | Percentage of Participants With HBV DNA Non-detectability and Alanine Aminotransferase (ALT) Normalization at Week 12 and Week 24 in Participants With HBeAg-positive Chronic Hepatitis B (CHB) | HBV DNA non-detectability Week 24 (n=17,48,42) | 70.6 Percentage of participants |
| LdT + PEG-INF | Percentage of Participants With HBV DNA Non-detectability and Alanine Aminotransferase (ALT) Normalization at Week 12 and Week 24 in Participants With HBeAg-positive Chronic Hepatitis B (CHB) | ALT normalization Week 24 (n=17,48,41) | 11.8 Percentage of participants |
| PEG-INF Monotherapy | Percentage of Participants With HBV DNA Non-detectability and Alanine Aminotransferase (ALT) Normalization at Week 12 and Week 24 in Participants With HBeAg-positive Chronic Hepatitis B (CHB) | ALT normalization Week 24 (n=17,48,41) | 54.2 Percentage of participants |
| PEG-INF Monotherapy | Percentage of Participants With HBV DNA Non-detectability and Alanine Aminotransferase (ALT) Normalization at Week 12 and Week 24 in Participants With HBeAg-positive Chronic Hepatitis B (CHB) | HBV DNA non-detectability Week 12 (n=37,52,50) | 9.6 Percentage of participants |
| PEG-INF Monotherapy | Percentage of Participants With HBV DNA Non-detectability and Alanine Aminotransferase (ALT) Normalization at Week 12 and Week 24 in Participants With HBeAg-positive Chronic Hepatitis B (CHB) | HBV DNA non-detectability Week 24 (n=17,48,42) | 35.4 Percentage of participants |
| PEG-INF Monotherapy | Percentage of Participants With HBV DNA Non-detectability and Alanine Aminotransferase (ALT) Normalization at Week 12 and Week 24 in Participants With HBeAg-positive Chronic Hepatitis B (CHB) | ALT normalization Week 12 (n=37,52,50) | 28.8 Percentage of participants |
| PEG-INF Monotherapy | Percentage of Participants With HBV DNA Non-detectability and Alanine Aminotransferase (ALT) Normalization at Week 12 and Week 24 in Participants With HBeAg-positive Chronic Hepatitis B (CHB) | ALT normalization Week 24 (n=17,48,41) | 31.7 Percentage of participants |
| PEG-INF Monotherapy | Percentage of Participants With HBV DNA Non-detectability and Alanine Aminotransferase (ALT) Normalization at Week 12 and Week 24 in Participants With HBeAg-positive Chronic Hepatitis B (CHB) | ALT normalization Week 12 (n=37,52,50) | 20.0 Percentage of participants |
| PEG-INF Monotherapy | Percentage of Participants With HBV DNA Non-detectability and Alanine Aminotransferase (ALT) Normalization at Week 12 and Week 24 in Participants With HBeAg-positive Chronic Hepatitis B (CHB) | HBV DNA non-detectability Week 24 (n=17,48,42) | 7.1 Percentage of participants |
| PEG-INF Monotherapy | Percentage of Participants With HBV DNA Non-detectability and Alanine Aminotransferase (ALT) Normalization at Week 12 and Week 24 in Participants With HBeAg-positive Chronic Hepatitis B (CHB) | HBV DNA non-detectability Week 12 (n=37,52,50) | 0.0 Percentage of participants |
Secondary
Change From Baseline in HBV DNA Concentration
The change from baseline in HBV DNA concentration at Weeks 12 and 24 was analyzed using an analysis of covariance (ANCOVA) model with baseline HBV DNA concentration (log10 copies/ml) as a covariate, treatment and country as factors.
Time frame: Weeks 12 and 24
Population: Intent to Treat (ITT) population. n= the number of patients who have both baseline and post baseline observation for the respective week
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| LdT + PEG-INF | Change From Baseline in HBV DNA Concentration | Week 12 (n= 37, 52, 50) | -6.0569 log 10 copies/ml | Standard Error 0.3124 |
| LdT + PEG-INF | Change From Baseline in HBV DNA Concentration | Week 24 (n= 17, 48, 42) | -6.9187 log 10 copies/ml | Standard Error 0.5462 |
| PEG-INF Monotherapy | Change From Baseline in HBV DNA Concentration | Week 12 (n= 37, 52, 50) | -5.1658 log 10 copies/ml | Standard Error 0.2717 |
| PEG-INF Monotherapy | Change From Baseline in HBV DNA Concentration | Week 24 (n= 17, 48, 42) | -5.9633 log 10 copies/ml | Standard Error 0.3523 |
| PEG-INF Monotherapy | Change From Baseline in HBV DNA Concentration | Week 12 (n= 37, 52, 50) | -1.8991 log 10 copies/ml | Standard Error 0.2607 |
| PEG-INF Monotherapy | Change From Baseline in HBV DNA Concentration | Week 24 (n= 17, 48, 42) | -2.4513 log 10 copies/ml | Standard Error 0.3485 |
Secondary
Percentage of Participants Who Achieved HBV DNA Non-detectability With Peginterferon Alpha-2a Plus Telbivudine Combination Therapy Versus Telbivudine Monotherapy
Antiviral efficacy was assessed by percentage of patients achieving HBV DNA non-detectability assay utilizing polymerase chain reaction (PCR) (threshold for detection 300 copies/mL); however, this analysis was not performed due to premature study termination.
Time frame: Week 52
Population: The analysis was planned on intent to treat (ITT) population. Due to premature study termination, the analysis was not performed.
Secondary
Percentage of Participants Who Achieved HBV DNA Non-detectability With Telbivudine Monotherapy Versus Peginterferon Alpha-2a Monotherapy
Antiviral efficacy was assessed by percentage of patients achieving HBV DNA non-detectability assay utilizing polymerase chain reaction (PCR) (threshold for detection 300 copies/mL); however, this analysis was not performed due to premature study termination.
Time frame: Week 52
Population: The analysis was planned on intent to treat (ITT) population. Due to premature study termination, the analysis was not performed.
Secondary
Percentage of Participants Who Experienced Virologic Breakthrough at Weeks 48 and 52
The percentage of participants with Virologic breakthrough at Week 48 and 52 by treatment. For the subgroup of patients on treatment who achieve HBV DNA \>= 1 log10 copies/mL reduction from baseline on 2 consecutive visits, Virologic Breakthrough is defined as HBV DNA \>= 1 log10 copies/mL from nadir on two consecutive visits.
Time frame: Weeks 48 and 52
Population: Intent to treat (ITT) population. As most patients did not reach Week 48 and Week 52, the LOCF was used.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| LdT + PEG-INF | Percentage of Participants Who Experienced Virologic Breakthrough at Weeks 48 and 52 | Virologic breakthrough Week 48 | 0.0 Percentage of participants |
| LdT + PEG-INF | Percentage of Participants Who Experienced Virologic Breakthrough at Weeks 48 and 52 | Virologic breakthrough Week 52 | 0.0 Percentage of participants |
| PEG-INF Monotherapy | Percentage of Participants Who Experienced Virologic Breakthrough at Weeks 48 and 52 | Virologic breakthrough Week 48 | 5.7 Percentage of participants |
| PEG-INF Monotherapy | Percentage of Participants Who Experienced Virologic Breakthrough at Weeks 48 and 52 | Virologic breakthrough Week 52 | 7.5 Percentage of participants |
| PEG-INF Monotherapy | Percentage of Participants Who Experienced Virologic Breakthrough at Weeks 48 and 52 | Virologic breakthrough Week 48 | 7.5 Percentage of participants |
| PEG-INF Monotherapy | Percentage of Participants Who Experienced Virologic Breakthrough at Weeks 48 and 52 | Virologic breakthrough Week 52 | 9.4 Percentage of participants |
Secondary
Percentage of Participants With Hepatitis B 'e' Antigen (HBeAg) Loss and HBeAg Seroconversion
HBeAg loss is defined as the loss of detectable serum HBeAg in a patient who was HBeAg positive at baseline. HBeAg seroconversion is defined as HBeAg loss with detectable Hepatitis B 'e' antibody (HBeAb). The efficacy was assessed for 18 weeks, 24 weeks, 48 weeks, 52 weeks and on treatment completion (TC).
Time frame: Weeks 18, 24, 48, 52 and Treatment completion (TC)
Population: Intent to Treat (ITT) population. The study was terminated and some participants did not complete all visits. n in each of the categories represents the number of participants in each arm with non-missing efficacy endpoint observations for the respective week and on treatment completion (TC).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| LdT + PEG-INF | Percentage of Participants With Hepatitis B 'e' Antigen (HBeAg) Loss and HBeAg Seroconversion | HBeAg loss Week 18 (n=28,51,45) | 17.9 Percentage of participants |
| LdT + PEG-INF | Percentage of Participants With Hepatitis B 'e' Antigen (HBeAg) Loss and HBeAg Seroconversion | HBeAg seroconversion Week 18 (n=28,51,45) | 17.9 Percentage of participants |
| LdT + PEG-INF | Percentage of Participants With Hepatitis B 'e' Antigen (HBeAg) Loss and HBeAg Seroconversion | HBeAg loss Week 24 (n=17,48,42) | 17.6 Percentage of participants |
| LdT + PEG-INF | Percentage of Participants With Hepatitis B 'e' Antigen (HBeAg) Loss and HBeAg Seroconversion | HBeAg seroconversion Week 24 (n=17,48,42) | 7.6 Percentage of participants |
| LdT + PEG-INF | Percentage of Participants With Hepatitis B 'e' Antigen (HBeAg) Loss and HBeAg Seroconversion | HBeAg loss Week 48 (n=0,19,12) | NA Percentage of participants |
| LdT + PEG-INF | Percentage of Participants With Hepatitis B 'e' Antigen (HBeAg) Loss and HBeAg Seroconversion | HBeAg seroconversion Week 48 (n=0,19,12) | NA Percentage of participants |
| LdT + PEG-INF | Percentage of Participants With Hepatitis B 'e' Antigen (HBeAg) Loss and HBeAg Seroconversion | HBeAg loss Week 52 (n=0,10,6) | NA Percentage of participants |
| LdT + PEG-INF | Percentage of Participants With Hepatitis B 'e' Antigen (HBeAg) Loss and HBeAg Seroconversion | HBeAg seroconversion Week 52 (n=0,10,6) | NA Percentage of participants |
| LdT + PEG-INF | Percentage of Participants With Hepatitis B 'e' Antigen (HBeAg) Loss and HBeAg Seroconversion | HBeAg loss TC (n=14,24,9) | 7.1 Percentage of participants |
| LdT + PEG-INF | Percentage of Participants With Hepatitis B 'e' Antigen (HBeAg) Loss and HBeAg Seroconversion | HBeAg seroconversion TC (n=14,24,9) | 7.1 Percentage of participants |
| PEG-INF Monotherapy | Percentage of Participants With Hepatitis B 'e' Antigen (HBeAg) Loss and HBeAg Seroconversion | HBeAg loss TC (n=14,24,9) | 29.2 Percentage of participants |
| PEG-INF Monotherapy | Percentage of Participants With Hepatitis B 'e' Antigen (HBeAg) Loss and HBeAg Seroconversion | HBeAg loss Week 18 (n=28,51,45) | 7.8 Percentage of participants |
| PEG-INF Monotherapy | Percentage of Participants With Hepatitis B 'e' Antigen (HBeAg) Loss and HBeAg Seroconversion | HBeAg seroconversion Week 48 (n=0,19,12) | 36.8 Percentage of participants |
| PEG-INF Monotherapy | Percentage of Participants With Hepatitis B 'e' Antigen (HBeAg) Loss and HBeAg Seroconversion | HBeAg loss Week 48 (n=0,19,12) | 36.8 Percentage of participants |
| PEG-INF Monotherapy | Percentage of Participants With Hepatitis B 'e' Antigen (HBeAg) Loss and HBeAg Seroconversion | HBeAg seroconversion Week 18 (n=28,51,45) | 7.8 Percentage of participants |
| PEG-INF Monotherapy | Percentage of Participants With Hepatitis B 'e' Antigen (HBeAg) Loss and HBeAg Seroconversion | HBeAg seroconversion TC (n=14,24,9) | 25.0 Percentage of participants |
| PEG-INF Monotherapy | Percentage of Participants With Hepatitis B 'e' Antigen (HBeAg) Loss and HBeAg Seroconversion | HBeAg seroconversion Week 52 (n=0,10,6) | 50.0 Percentage of participants |
| PEG-INF Monotherapy | Percentage of Participants With Hepatitis B 'e' Antigen (HBeAg) Loss and HBeAg Seroconversion | HBeAg loss Week 24 (n=17,48,42) | 6.3 Percentage of participants |
| PEG-INF Monotherapy | Percentage of Participants With Hepatitis B 'e' Antigen (HBeAg) Loss and HBeAg Seroconversion | HBeAg loss Week 52 (n=0,10,6) | 50.0 Percentage of participants |
| PEG-INF Monotherapy | Percentage of Participants With Hepatitis B 'e' Antigen (HBeAg) Loss and HBeAg Seroconversion | HBeAg seroconversion Week 24 (n=17,48,42) | 4.2 Percentage of participants |
| PEG-INF Monotherapy | Percentage of Participants With Hepatitis B 'e' Antigen (HBeAg) Loss and HBeAg Seroconversion | HBeAg seroconversion Week 52 (n=0,10,6) | 16.7 Percentage of participants |
| PEG-INF Monotherapy | Percentage of Participants With Hepatitis B 'e' Antigen (HBeAg) Loss and HBeAg Seroconversion | HBeAg seroconversion Week 24 (n=17,48,42) | 11.9 Percentage of participants |
| PEG-INF Monotherapy | Percentage of Participants With Hepatitis B 'e' Antigen (HBeAg) Loss and HBeAg Seroconversion | HBeAg loss Week 48 (n=0,19,12) | 25.0 Percentage of participants |
| PEG-INF Monotherapy | Percentage of Participants With Hepatitis B 'e' Antigen (HBeAg) Loss and HBeAg Seroconversion | HBeAg seroconversion Week 48 (n=0,19,12) | 25.0 Percentage of participants |
| PEG-INF Monotherapy | Percentage of Participants With Hepatitis B 'e' Antigen (HBeAg) Loss and HBeAg Seroconversion | HBeAg loss TC (n=14,24,9) | 33.3 Percentage of participants |
| PEG-INF Monotherapy | Percentage of Participants With Hepatitis B 'e' Antigen (HBeAg) Loss and HBeAg Seroconversion | HBeAg loss Week 52 (n=0,10,6) | 16.7 Percentage of participants |
| PEG-INF Monotherapy | Percentage of Participants With Hepatitis B 'e' Antigen (HBeAg) Loss and HBeAg Seroconversion | HBeAg loss Week 18 (n=28,51,45) | 8.9 Percentage of participants |
| PEG-INF Monotherapy | Percentage of Participants With Hepatitis B 'e' Antigen (HBeAg) Loss and HBeAg Seroconversion | HBeAg seroconversion TC (n=14,24,9) | 33.3 Percentage of participants |
| PEG-INF Monotherapy | Percentage of Participants With Hepatitis B 'e' Antigen (HBeAg) Loss and HBeAg Seroconversion | HBeAg seroconversion Week 18 (n=28,51,45) | 8.9 Percentage of participants |
| PEG-INF Monotherapy | Percentage of Participants With Hepatitis B 'e' Antigen (HBeAg) Loss and HBeAg Seroconversion | HBeAg loss Week 24 (n=17,48,42) | 11.9 Percentage of participants |