Chronic Disease, Hepatitis B
Conditions
Keywords
chronic hepatitis B infection
Brief summary
The purpose of this study is to evaluate antiviral activity and efficacy of entecavir (ETV) compared to adefovir in adults with chronic hepatitis B who have not been treated yet with an antiviral medicine.
Interventions
DRUGentecavir
Tablets, Oral, ETV 0.5 mg, once daily, up to 96 weeks
DRUGadefovir
Tablets, Oral, ADV 10 mg, once daily, up to 96 weeks
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Chronic hepatitis B treatment naive * Compensated liver disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Hepatitis B Virus DNA (HBV DNA) by Polymerase Chain Reaction (PCR) Assay at Week 12 | Baseline, Week 12 | Antiviral efficacy, as measured by the mean reduction in serum HBV DNA levels by PCR (log10 copies/mL) at Week 12, adjusted for baseline (Week 12 - baseline). A negative value = improvement. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in HBV DNA by PCR Assay at Week 48 | Baseline, Week 48 | Antiviral efficacy, as measured by the mean reduction in serum HBV DNA levels by PCR (log10 copies/mL) at Week 48, adjusted for baseline (Week 48 - Baseline). A negative value = improvement. |
| Viral Load Undetectable (HBV DNA <300 Copies/mL) | Week 48 | Number of Subjects with HBV DNA \<300 copies/mL by Roche COBAS® Amplicor (limit of quantitation 300 copies/mL) |
| Alanine Aminotransferase (ALT) Normalization | Week 48 | Number of participants with ALT ≤ 1 x upper limit of normal (ULN) |
| HBV DNA Viral Kinetics Estimates of Exponential Decay Model - Efficacy in Blocking Virus Production and de Novo Infections | Week 12 | The biphasic decline of HBV DNA is characterized via a 4-parameter exponential decay model previously published for HBV compounds. The model parameters of interest are the effectiveness of the drug in blocking virus production from infected cells (efficacy, ε) and effectiveness of the study treatment in blocking de novo infection of susceptible cells (η). The model parameters reflect the biphasic pattern that is typically observed after initiation of antiviral therapy. Parameters were estimated for each subject separately and then averaged within each treatment group. |
| HBV DNA Viral Kinetics Estimates of Exponential Decay Model - Viral Clearance Rate and Infected Cell Death Rate | Week 12 | The biphasic decline of HBV DNA is characterized via a 4-parameter exponential decay model previously published for HBV compounds. The model parameters of interest are the clearance rate of the free virus (c), the death rate of productively infected cells (δ), The model parameters reflect the biphasic pattern that is typically observed after initiation of antiviral therapy. Parameters were estimated for each subject separately and then averaged within each treatment group. |
| HBV DNA Viral Kinetics Estimates of Exponential Decay Model - Half-Life of Free Virus | Week 12 | The biphasic decline of HBV DNA is characterized via a 4-parameter exponential decay model previously published for HBV compounds. An important derived parameter is the half-life of free virus (ie, the average amount of time for HBV particles in plasma to be reduced to half the initial level), calculated as 24\*ln(2)/c. The model parameters reflect the biphasic pattern that is typically observed after initiation of antiviral therapy. Parameters were estimated for each subject separately and then averaged within each treatment group. |
| HBV DNA Viral Kinetics - Spline Model | Week 12 | This analysis uses a 3-parameter piece-wise linear model and describes the biphasic decline in HBV DNA (measured by PCR assay) through Week 12. The 3 parameters are the values for the 2 slopes, describing the first and second phase declines, respectively, and the estimated HBV DNA at the knot (at day 10; the time point where the 2 phases join). The biphasic viral decay kinetics for each treatment were obtained using a spline fitting procedure to estimate the 3 parameters for each subject; these estimates were then averaged within each treatment group. |
| Summary of Safety - Most Frequent (> 10%) Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuations Due to AEs, and Deaths | cumulative through the end of on-treatment observation as available at the time of the Week 48 dataset | AE=new untoward medical occurrence or worsening of pre-existing medical condition regardless of causal relationship to treatment. SAE=untoward medical occurrence that is life-threatening, a congenital anomaly/birth defect, or an important medical event, or results in death, inpatient hospitalization/prolongation of hospitalization, or persistent/significant disability. AE grades: mild (1), moderate (2), severe (3), life-threatening (4), death (5). ALT flare= \>2x baseline & \>10x ULN up to end of therapy + 5 days. Hepatic SAE=SAEs consistent with worsening of hepatitis or hepatic decompensation. |
| Summary of Safety - Laboratory Abnormalities Reported as Clinical AEs | Week 48 | Laboratory abnormalities reported as clinical AEs |
Countries
Canada, Hong Kong, Indonesia, Philippines, Singapore, Taiwan, Thailand, United States
Participant flow
Pre-assignment details
132 enrolled; 63 not randomized (59 did not meet study criteria, 3 withdrew consent, 1 lost to follow-up). 1 randomized to adefovir (ADV) received entecavir (ETV) throughout treatment, & is counted in the ADV group for primary efficacy analysis, not included in the secondary efficacy analyses, & counted in the ETV group in safety analyses.
Participants by arm
| Arm | Count |
|---|---|
| Entecavir ETV 0.5 mg once daily (QD) | 35 |
| Adefovir ADV 10 mg QD | 34 |
| Total | 69 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Relocated | 1 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Entecavir | Adefovir | Total |
|---|---|---|---|
| Age Continuous | 38 participants | 28 participants | 31 participants |
| Alanine Aminotransferease (ALT) | 109.4 U/L STANDARD_DEVIATION 81.76 | 176.4 U/L STANDARD_DEVIATION 207.22 | 142.4 U/L STANDARD_DEVIATION 159.12 |
| Hepatitis B virus DNA (HBV DNA) by Polymerase Chain Reaction (PCR) | 10.45 log10 copies/mL STANDARD_DEVIATION 2.125 | 9.89 log10 copies/mL STANDARD_DEVIATION 1.201 | 10.18 log10 copies/mL STANDARD_DEVIATION 1.742 |
| Prior interferon (IFN) No prior IFN | 34 Participants | 33 Participants | 67 Participants |
| Prior interferon (IFN) Prior IFN | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Asian | 31 Participants | 30 Participants | 61 Participants |
| Race/Ethnicity, Customized Black or African American | 3 Participants | 2 Participants | 5 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 1 Participants | 1 Participants | 2 Participants |
| Region of Enrollment East Asia | 26 participants | 21 participants | 47 participants |
| Region of Enrollment North America | 9 participants | 13 participants | 22 participants |
| Sex: Female, Male Female | 13 Participants | 11 Participants | 24 Participants |
| Sex: Female, Male Male | 22 Participants | 23 Participants | 45 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 16 / 33 | 17 / 36 |
| serious Total, serious adverse events | 2 / 33 | 1 / 36 |
Outcome results
Primary
Change From Baseline in Hepatitis B Virus DNA (HBV DNA) by Polymerase Chain Reaction (PCR) Assay at Week 12
Antiviral efficacy, as measured by the mean reduction in serum HBV DNA levels by PCR (log10 copies/mL) at Week 12, adjusted for baseline (Week 12 - baseline). A negative value = improvement.
Time frame: Baseline, Week 12
Population: As-randomized participants who completed 12 weeks of treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Entecavir | Change From Baseline in Hepatitis B Virus DNA (HBV DNA) by Polymerase Chain Reaction (PCR) Assay at Week 12 | -6.23 log10 copies/mL | Standard Error 0.247 |
| Adefovir | Change From Baseline in Hepatitis B Virus DNA (HBV DNA) by Polymerase Chain Reaction (PCR) Assay at Week 12 | -4.52 log10 copies/mL | Standard Error 0.357 |
Secondary
Alanine Aminotransferase (ALT) Normalization
Number of participants with ALT ≤ 1 x upper limit of normal (ULN)
Time frame: Week 48
Population: treated subjects who had both baseline and Week 12 HBV DNA measurements and who received the randomized treatment. 1 participant randomized to ADV actually received ETV and is not counted in secondary efficacy analyses.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Entecavir | Alanine Aminotransferase (ALT) Normalization | 25 participants |
| Adefovir | Alanine Aminotransferase (ALT) Normalization | 20 participants |
Secondary
Change From Baseline in HBV DNA by PCR Assay at Week 48
Antiviral efficacy, as measured by the mean reduction in serum HBV DNA levels by PCR (log10 copies/mL) at Week 48, adjusted for baseline (Week 48 - Baseline). A negative value = improvement.
Time frame: Baseline, Week 48
Population: Treated subjects who had both baseline and Week 12 HBV DNA measurements and who received the randomized treatment. 1 participant randomized to ADV actually received ETV and is not counted in secondary efficacy analyses.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Entecavir | Change From Baseline in HBV DNA by PCR Assay at Week 48 | -7.28 log10 c/mL | Standard Error 0.327 |
| Adefovir | Change From Baseline in HBV DNA by PCR Assay at Week 48 | -5.08 log10 c/mL | Standard Error 0.455 |
Secondary
HBV DNA Viral Kinetics Estimates of Exponential Decay Model - Efficacy in Blocking Virus Production and de Novo Infections
The biphasic decline of HBV DNA is characterized via a 4-parameter exponential decay model previously published for HBV compounds. The model parameters of interest are the effectiveness of the drug in blocking virus production from infected cells (efficacy, ε) and effectiveness of the study treatment in blocking de novo infection of susceptible cells (η). The model parameters reflect the biphasic pattern that is typically observed after initiation of antiviral therapy. Parameters were estimated for each subject separately and then averaged within each treatment group.
Time frame: Week 12
Population: Treated subjects who had both baseline and Week 12 HBV DNA measurements and who received the randomized treatment. 1 participant randomized to ADV actually received ETV and is not counted in secondary efficacy analyses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Entecavir | HBV DNA Viral Kinetics Estimates of Exponential Decay Model - Efficacy in Blocking Virus Production and de Novo Infections | Effectiveness in blocking de novo infections - η | 6.07 percent effective |
| Entecavir | HBV DNA Viral Kinetics Estimates of Exponential Decay Model - Efficacy in Blocking Virus Production and de Novo Infections | Efficacy in blocking virus production - ε | 99.87 percent effective |
| Adefovir | HBV DNA Viral Kinetics Estimates of Exponential Decay Model - Efficacy in Blocking Virus Production and de Novo Infections | Efficacy in blocking virus production - ε | 99.46 percent effective |
| Adefovir | HBV DNA Viral Kinetics Estimates of Exponential Decay Model - Efficacy in Blocking Virus Production and de Novo Infections | Effectiveness in blocking de novo infections - η | 5.87 percent effective |
Secondary
HBV DNA Viral Kinetics Estimates of Exponential Decay Model - Half-Life of Free Virus
The biphasic decline of HBV DNA is characterized via a 4-parameter exponential decay model previously published for HBV compounds. An important derived parameter is the half-life of free virus (ie, the average amount of time for HBV particles in plasma to be reduced to half the initial level), calculated as 24\*ln(2)/c. The model parameters reflect the biphasic pattern that is typically observed after initiation of antiviral therapy. Parameters were estimated for each subject separately and then averaged within each treatment group.
Time frame: Week 12
Population: Treated subjects who had both baseline and Week 12 HBV DNA measurements and who received the randomized treatment. 1 participant randomized to ADV actually received ETV and is not counted in secondary efficacy analyses.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Entecavir | HBV DNA Viral Kinetics Estimates of Exponential Decay Model - Half-Life of Free Virus | 14.52 hours |
| Adefovir | HBV DNA Viral Kinetics Estimates of Exponential Decay Model - Half-Life of Free Virus | 32.46 hours |
Secondary
HBV DNA Viral Kinetics Estimates of Exponential Decay Model - Viral Clearance Rate and Infected Cell Death Rate
The biphasic decline of HBV DNA is characterized via a 4-parameter exponential decay model previously published for HBV compounds. The model parameters of interest are the clearance rate of the free virus (c), the death rate of productively infected cells (δ), The model parameters reflect the biphasic pattern that is typically observed after initiation of antiviral therapy. Parameters were estimated for each subject separately and then averaged within each treatment group.
Time frame: Week 12
Population: Treated subjects who had both baseline and Week 12 HBV DNA measurements and who received the randomized treatment. 1 participant randomized to ADV actually received ETV and is not counted in secondary efficacy analyses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Entecavir | HBV DNA Viral Kinetics Estimates of Exponential Decay Model - Viral Clearance Rate and Infected Cell Death Rate | Infected cell death - δ | 0.08 per day |
| Entecavir | HBV DNA Viral Kinetics Estimates of Exponential Decay Model - Viral Clearance Rate and Infected Cell Death Rate | Viral Clearance - c | 1.70 per day |
| Adefovir | HBV DNA Viral Kinetics Estimates of Exponential Decay Model - Viral Clearance Rate and Infected Cell Death Rate | Infected cell death - δ | 0.04 per day |
| Adefovir | HBV DNA Viral Kinetics Estimates of Exponential Decay Model - Viral Clearance Rate and Infected Cell Death Rate | Viral Clearance - c | 0.91 per day |
Secondary
HBV DNA Viral Kinetics - Spline Model
This analysis uses a 3-parameter piece-wise linear model and describes the biphasic decline in HBV DNA (measured by PCR assay) through Week 12. The 3 parameters are the values for the 2 slopes, describing the first and second phase declines, respectively, and the estimated HBV DNA at the knot (at day 10; the time point where the 2 phases join). The biphasic viral decay kinetics for each treatment were obtained using a spline fitting procedure to estimate the 3 parameters for each subject; these estimates were then averaged within each treatment group.
Time frame: Week 12
Population: Treated subjects who had both baseline and Week 12 HBV DNA measurements and who received the randomized treatment. 1 participant randomized to ADV actually received ETV and is not counted in secondary efficacy analyses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Entecavir | HBV DNA Viral Kinetics - Spline Model | Second slope (second phase of viral decay) | -0.034 log10 copies/mL |
| Entecavir | HBV DNA Viral Kinetics - Spline Model | First slope (first phase of viral decay) | -0.391 log10 copies/mL |
| Adefovir | HBV DNA Viral Kinetics - Spline Model | First slope (first phase of viral decay) | -0.329 log10 copies/mL |
| Adefovir | HBV DNA Viral Kinetics - Spline Model | Second slope (second phase of viral decay) | -0.024 log10 copies/mL |
Secondary
Summary of Safety - Laboratory Abnormalities Reported as Clinical AEs
Laboratory abnormalities reported as clinical AEs
Time frame: Week 48
Population: As-treated population. 1 participant who was randomized to ADV, but treated with ETV was counted in the ETV group.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Entecavir | Summary of Safety - Laboratory Abnormalities Reported as Clinical AEs | ALT increased | 1 Participants |
| Entecavir | Summary of Safety - Laboratory Abnormalities Reported as Clinical AEs | Lipase increased | 1 Participants |
| Entecavir | Summary of Safety - Laboratory Abnormalities Reported as Clinical AEs | Blood phosphorus decreased | 0 Participants |
| Entecavir | Summary of Safety - Laboratory Abnormalities Reported as Clinical AEs | Liver function test abnormal | 0 Participants |
| Entecavir | Summary of Safety - Laboratory Abnormalities Reported as Clinical AEs | Platelet count decreased | 0 Participants |
| Entecavir | Summary of Safety - Laboratory Abnormalities Reported as Clinical AEs | Protein urine present | 0 Participants |
| Adefovir | Summary of Safety - Laboratory Abnormalities Reported as Clinical AEs | Platelet count decreased | 1 Participants |
| Adefovir | Summary of Safety - Laboratory Abnormalities Reported as Clinical AEs | ALT increased | 2 Participants |
| Adefovir | Summary of Safety - Laboratory Abnormalities Reported as Clinical AEs | Liver function test abnormal | 1 Participants |
| Adefovir | Summary of Safety - Laboratory Abnormalities Reported as Clinical AEs | Lipase increased | 2 Participants |
| Adefovir | Summary of Safety - Laboratory Abnormalities Reported as Clinical AEs | Protein urine present | 1 Participants |
| Adefovir | Summary of Safety - Laboratory Abnormalities Reported as Clinical AEs | Blood phosphorus decreased | 1 Participants |
Secondary
Summary of Safety - Most Frequent (> 10%) Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuations Due to AEs, and Deaths
AE=new untoward medical occurrence or worsening of pre-existing medical condition regardless of causal relationship to treatment. SAE=untoward medical occurrence that is life-threatening, a congenital anomaly/birth defect, or an important medical event, or results in death, inpatient hospitalization/prolongation of hospitalization, or persistent/significant disability. AE grades: mild (1), moderate (2), severe (3), life-threatening (4), death (5). ALT flare= \>2x baseline & \>10x ULN up to end of therapy + 5 days. Hepatic SAE=SAEs consistent with worsening of hepatitis or hepatic decompensation.
Time frame: cumulative through the end of on-treatment observation as available at the time of the Week 48 dataset
Population: As-treated population. 1 participant was randomized to ADV, but treated with ETV was counted in the ETV group.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Entecavir | Summary of Safety - Most Frequent (> 10%) Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuations Due to AEs, and Deaths | Malignant neoplasm | 0 Participants |
| Entecavir | Summary of Safety - Most Frequent (> 10%) Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuations Due to AEs, and Deaths | On Treatment: Influenza | 6 Participants |
| Entecavir | Summary of Safety - Most Frequent (> 10%) Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuations Due to AEs, and Deaths | Discontinuation due to AE | 0 Participants |
| Entecavir | Summary of Safety - Most Frequent (> 10%) Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuations Due to AEs, and Deaths | On Treatment: Nasopharyngitis | 4 Participants |
| Entecavir | Summary of Safety - Most Frequent (> 10%) Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuations Due to AEs, and Deaths | On Treatment: Any AE | 28 Participants |
| Entecavir | Summary of Safety - Most Frequent (> 10%) Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuations Due to AEs, and Deaths | On Treatment: Pyrexia | 4 Participants |
| Entecavir | Summary of Safety - Most Frequent (> 10%) Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuations Due to AEs, and Deaths | Serious AE | 1 Participants |
| Entecavir | Summary of Safety - Most Frequent (> 10%) Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuations Due to AEs, and Deaths | On Treatment: Back Pain | 0 Participants |
| Entecavir | Summary of Safety - Most Frequent (> 10%) Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuations Due to AEs, and Deaths | On Treatment: Headache | 9 Participants |
| Entecavir | Summary of Safety - Most Frequent (> 10%) Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuations Due to AEs, and Deaths | On Treatment: Grade 3-4 AEs | 2 Participants |
| Entecavir | Summary of Safety - Most Frequent (> 10%) Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuations Due to AEs, and Deaths | Death | 0 Participants |
| Entecavir | Summary of Safety - Most Frequent (> 10%) Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuations Due to AEs, and Deaths | ALT Flare | 0 Participants |
| Entecavir | Summary of Safety - Most Frequent (> 10%) Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuations Due to AEs, and Deaths | Hepatic SAE | 1 Participants |
| Entecavir | Summary of Safety - Most Frequent (> 10%) Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuations Due to AEs, and Deaths | On Treatment: Upper Respiratory Infection | 8 Participants |
| Adefovir | Summary of Safety - Most Frequent (> 10%) Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuations Due to AEs, and Deaths | Hepatic SAE | 2 Participants |
| Adefovir | Summary of Safety - Most Frequent (> 10%) Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuations Due to AEs, and Deaths | ALT Flare | 1 Participants |
| Adefovir | Summary of Safety - Most Frequent (> 10%) Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuations Due to AEs, and Deaths | Death | 0 Participants |
| Adefovir | Summary of Safety - Most Frequent (> 10%) Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuations Due to AEs, and Deaths | Discontinuation due to AE | 1 Participants |
| Adefovir | Summary of Safety - Most Frequent (> 10%) Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuations Due to AEs, and Deaths | Malignant neoplasm | 0 Participants |
| Adefovir | Summary of Safety - Most Frequent (> 10%) Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuations Due to AEs, and Deaths | On Treatment: Any AE | 27 Participants |
| Adefovir | Summary of Safety - Most Frequent (> 10%) Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuations Due to AEs, and Deaths | On Treatment: Headache | 6 Participants |
| Adefovir | Summary of Safety - Most Frequent (> 10%) Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuations Due to AEs, and Deaths | On Treatment: Upper Respiratory Infection | 8 Participants |
| Adefovir | Summary of Safety - Most Frequent (> 10%) Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuations Due to AEs, and Deaths | On Treatment: Influenza | 4 Participants |
| Adefovir | Summary of Safety - Most Frequent (> 10%) Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuations Due to AEs, and Deaths | On Treatment: Nasopharyngitis | 6 Participants |
| Adefovir | Summary of Safety - Most Frequent (> 10%) Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuations Due to AEs, and Deaths | On Treatment: Pyrexia | 6 Participants |
| Adefovir | Summary of Safety - Most Frequent (> 10%) Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuations Due to AEs, and Deaths | On Treatment: Back Pain | 5 Participants |
| Adefovir | Summary of Safety - Most Frequent (> 10%) Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuations Due to AEs, and Deaths | On Treatment: Grade 3-4 AEs | 5 Participants |
| Adefovir | Summary of Safety - Most Frequent (> 10%) Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuations Due to AEs, and Deaths | Serious AE | 3 Participants |
Secondary
Viral Load Undetectable (HBV DNA <300 Copies/mL)
Number of Subjects with HBV DNA \<300 copies/mL by Roche COBAS® Amplicor (limit of quantitation 300 copies/mL)
Time frame: Week 48
Population: Treated participants who had both baseline and Week 12 HBV DNA measurements and who received the randomized treatment. 1 participant randomized to ADV actually received ETV and is not counted in secondary efficacy analyses.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Entecavir | Viral Load Undetectable (HBV DNA <300 Copies/mL) | 19 Participants |
| Adefovir | Viral Load Undetectable (HBV DNA <300 Copies/mL) | 6 Participants |