Hepatitis B
Conditions
Keywords
tenofovir disoproxil fumarate, chronic hepatitis B, adefovir dipivoxil
Brief summary
This is a multi-centre, double blind, double dummy, randomised, controlled study to evaluate the efficacy and safety of TDF 300mg QD versus ADV 10mg QD in Chinese subjects with CHB. This study is designed to demonstrate the superiority of TDF 300mg QD over ADV 10mg QD in treating Chinese subjects with CHB (hepatitis B e antigen \[HBeAg\] positive subjects and HBeAg negative subjects). It will also provide long-term efficacy and safety data (up to 240 weeks) for TDF 300 mg administered once daily.
Detailed description
This is a multi-centre, double-blind, double-dummy, randomised, controlled study to evaluate the efficacy and safety of TDF 300mg QD versus ADV 10mg QD in Chinese subjects with CHB. Four hundred and ninety-four subjects with CHB (200 HBeAg positive subjects and 294 HBeAg negative subjects) will be randomised (1:1ratio) to either TDF 300mg QD or ADV 10mg QD treatment arms. The primary endpoint is the proportion of subjects with blood hepatitis B virus (HBV) deoxyribonucleic acid (DNA) \<400copies/mL (Roche COBAS Taqman HBV test) at Week 48 in HBeAg positive subjects with CHB and HBeAg negative subjects with CHB. This is a two-part study. The first treatment period (baseline to Week 48) will investigate the effects of TDF and ADV on safety and efficacy endpoints; dosing will be double-blind. This period will be followed by 192 weeks in which all subjects will receive open-label TDF (Week 49 to Week 240). Subjects will undergo regular safety and efficacy assessments every 4 weeks for the first 12 weeks followed by every 12 weeks for a total of up to 5 years.
Interventions
DRUGTenofovir disoproxil fumarate (TDF) tablets
white, almond-shaped, film-coated tablets containing 300mg of TDF
DRUGAdefovir dipivoxil (ADV) tablets
white to off-white, round, biconvex tablets containing 10mg of ADV
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 69 Years
Healthy volunteers
No
Inclusion criteria
* HBeAg positive/negative CHB with blood HBVDNA≥10\^5 copies/mL and elevated ALT * Nucleoside and nucleotide naïve CHB subjects. Previous lamivudine treatment is allowed in less than 10% of the total study population
Exclusion criteria
* subjects with hepatocellular carcinoma (HCC) potential or decompensated liver disease * subjects with acute liver disease due to other causes * subjects with medication history of immunosuppressive therapy, immunomodulatory therapy, systemic cytotoxic agents, chronic antiviral agents including Chinese herbal medicines known to have activity against HBV (e.g., lamivudine, hepatitis B immunoglobulin (HBIg)) within the previous 6 months prior to randomisation into this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) <400 Copies/Milliliter (mL) at Week 48 | Week 48 | The number of participants with Hepatitis B Virus (HBV) deoxyribonucleic acid (DNA) \<400 copies/milliliter (mL) at Week 48 in the hepatitis B e antigen (HBeAg)-positive and HBeAg-negative population was assessed. HBeAg is a viral protein that is secreted by hepatitis B-infected cells. It is associated with chronic hepatitis B infections and is used as a marker of active viral disease and a participant's degree of infectiousness. A positive result indicates that the participant has high levels of virus in the blood and greater infectiousness. Usually, a negative result indicates that the participant has lower levels of virus in the blood and is less infectious. A non-completers equal failures approach is used for the analysis in ITT population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participants With HBV DNA <400 Copies/mL at Weeks 96, 144, 192, and 240 | Weeks 96, 144, 192, and 240 | The number of participants with HBV DNA \<400 copies/mL in the hepatitis B e antigen (HBeAg)-positive and HBeAg-negative population was assessed. HBeAg is a viral protein that is secreted by hepatitis B-infected cells. It is associated with chronic hepatitis B infections and is used as a marker of active viral disease and a participant's degree of infectiousness. A positive result indicates that the participant has high levels of virus in the blood and greater infectiousness. Usually, a negative result indicates that the participant has lower levels of virus in the blood and is less infectious. Week 96, 144, 192, and 240 data are not yet available, as this report includes data up to and including Week 48. A non-completers equal failures approach is used for the analysis in ITT population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. |
| Change From Baseline of Log 10 Copies/mL HBV DNA at Weeks 48, 96, 144, 192 and 240 | Baseline, Weeks 48, 96, 144, 192 and 240 | Change from Baseline of log 10 copies/mL HBV DNA at Weeks 48, 96, 144, 192 and 240 in the HBeAg-positive and HBeAg-negative population was assessed. HBeAg is a viral protein that is secreted by hepatitis B-infected cells. It is associated with chronic hepatitis B infections and is used as a marker of active viral disease and a participant's degree of infectiousness. A positive result indicates that the participant has high levels of virus in the blood and greater infectiousness. Usually a negative result indicates that the participant has lower levels of virus in the blood and less infectious. Values at Day 0 were considered as Baseline values. Change from Baseline was calculated as post Baseline values minus Baseline values. A non-completers equal failures approach is used for the analysis in ITT population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. |
| Number of Participants With Alanine Aminotransferase (ALT) Normalization at Weeks 48, 96, 144, 192 and 240 in Participants Who Had Abnormal ALT at Baseline | Baseline; Weeks 48, 96, 144, 192 and 240 | Participants who had abnormal ALT at Baseline and had normalized ALT at Weeks 48, 96, 144, 192 and 240 were assessed. This report includes data up to and including Weeks 48, 96, 144, 192 and 240. An increased level of ALT is referred to as abnormal ALT (the normal range is 0 to 48 units per liter \[U/L\]). Values at Day 0 were considered as Baseline values. A non-completers equal failures approach is used for the analysis in ITT population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. |
| Number of Participants With Histological Improvement at Weeks 48 and 240 Who Had a Baseline Knodell Necroinflammatory Score (KNS) >=2. | Baseline; Week 48 and Week 240 | Histological improvement is defined as a reduction of \>=2 points in the KNS with no increase in fibrosis at Week 48 and Week 240 in participants with Baseline KNS \>=2 which was derived from the American Association for the Study of Liver Diseases Practice Guidelines for Management of Chronic Hepatitis B (2009) and the European Association for the Study of the Liver Clinical Practice Guidelines Management of chronic hepatitis B virus infection (2012). The Knodell scale consists of 5 domains: periportal +/- bridging necrosis (scored from best to worst: 0, 1, 3, 4, 5, 6, or 10); intralobular degeneration and focal necrosis (0 to 4); portal inflammation (0 to 4); and fibrosis (0 to 4). The necroinflammatory score (ranging from 0 \[best\] to 14 \[worst\]) is the combined score for necrosis (0 to 10) plus inflammation (0 to 4; the participant is scored for only one inflammatory condition). Liver biopsy slides within 6 months prior to randomization could be accepted as Baseline evaluation. |
| Number of HBeAg-positive Participants Achieving HBeAg Loss and HBeAg Seroconversion at Weeks 24, 48, 96, 144, 192 and 240. | Weeks 24, 48, 96, 144, 192 and 240 | HBeAg loss is defined as a negative HBeAg result for those participants who were HBeAg positive at Baseline. Seroconversion to anti-HBe is defined as HBeAg loss and a positive anti-HBe result. This report includes data up to and including Weeks 24, 48, 96, 144, 192 and 240. |
| Number of Participants Achieving Durable HBsAg Loss From Weeks 24 to Week 48 | Week 24 to Week 48 | Durable HBsAg loss is defined as the loss of HBsAg and no detectable HBV DNA and ALT normalization at any three consecutive visits at least 12 Weeks apart. This report includes data up to and including Week 48. A non-completers equal failures approach was used for the analysis in ITT population. |
| Number of HBeAg-positive Participants Achieving Hepatitis B Surface Antigen (HBsAg) Loss and HBsAg Seroconversion at Weeks 24, 48, 96, 144, 192 and 240 | Weeks 24, 48, 96, 144, 192 and 240 | HBsAg loss is defined as negative HBsAg results for those participants with who were HBsAg positive at Baseline. Seroconversion to anti-HBs is defined as HBsAg loss and a positive anti-HBs result. This report includes data up to and including Week 240. |
| Number of HBeAg-negative Participants Achieving HBsAg Loss and HBsAg Seroconversion at Weeks 24, 48, 96, 144, 192, 240 | Weeks 24, 48, 96, 144, 192 and 240 | HBsAg loss is defined as a negative HBsAg result for those participants with who were HBsAg positive at Baseline. Seroconversion to anti-HBs is defined as HBsAg loss and a positive anti-HBs result. This report includes data up to and including Week 240. |
| Number of Participants Achieving Durable HBsAg Loss From Weeks 96 to Week 240 | Week 96 to Week 240 | Durable HBsAg loss is defined as the loss of HBsAg and no detectable HBV DNA and ALT normalization at any three consecutive visits at least 12 Weeks apart from Week 96 to 240. This report includes data up to and including Week 240. A non-completers equal failures approach was used for the analysis in ITT population. |
| Number of Participants With Virological Breakthrough at Weeks 48, 96, 144, 192 and 240 | Weeks 48, 96, 144, 192 and 240 | The number of HBeAg-positive and HBeAg-negative participants who had virological breakthrough at Weeks 48, 96, 144, 192 and 240 were assessed. Virological breakthrough is defined by \>= one log increase in HBV DNA from NADIR (as determined by two sequential HBV DNA measurements at least one month apart or last on treatment measurement). A non-completers equal failures approach was used for the analysis in ITT population. |
| Number of Participants With Any Serious Adverse Event (SAE) and Any Non-serious Adverse Event (AE) | Up to Week 240 treatment period and 24 weeks follow-up visit off treatment | An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is Grade 4 (life threatening or disabling). Participants with any non-serious AEs and SAEs has been reported. |
| Number of Participants With the Indicated Grade 3 and Grade 4 Treatment-emergent (TE) Laboratory Abnormalities (LAs) | Up to Week 240 | TE grade 3 or grade 4 LAs are defined as values that increase by \>=1 grade from Baseline (Day 0) to Grade 3 (severe) or 4 (potentially life threatening) at any post-Baseline value. The Gilead Grading Scale for Severity of Adverse Events and Laboratory Abnormalities, version 21, September 2011 was referred for grading. Laboratory parameters assessed included Sodium for hyponatremia and hypernatremia; Potassium for hypokalemia and hyperkalemia; glucose for hypoglycemia and hyperglycemia non-fasting; Phosphate for hypophosphatemia; alanine aminotransferase/aspartate aminotransferase, bilirubin, creatinine kinase, hemoglobin, platelets, neutrophils, lymphocytes, prothrombin time and amylase. |
| Number of Participants With the Indicated Treatment-emergent Laboratory Abnormalities for Serum Creatinine and Serum Phosphorus | Up to Week 240 | The Gilead Grading Scale for Severity of Adverse Events and Laboratory Abnormalities, version 21, September 2011 was referred for grading. Serum creatinine: Grade 1, \> 133 to 177 micromoles per Liter (µmoles/Liter), Grade 2, \>177 to 265 µmoles/Liter, Grade 3, \>265 to 530 µmoles/Liter, Grade 4, \>530 µmoles/Liter. Serum phosphorus: Grade 2, 0.63 to \<0.80 millimoles per Liter (mmoles/L), Grade 3, 0.31 to \<0.63 mmoles/L, Grade 4, \<0.31 mmoles/L. The normal range for serum phosphorus was 0.8 to 1.45 mmoles/L; the upper limit for a Grade 2 abnormality is 0.80 mmoles/L. Therefore, no Grade 1 abnormalities could be attributed, as values were contained within the normal range. NA indicates the value was not available for the indicated time point. |
| Number of Participants in the Indicated Category for Renal Laboratory Abnormalities | Up to Week 240 | The Gilead Grading Scale for Severity of Adverse Events and Laboratory Abnormalities, version 21, September 2011 was used for grading. Confirmed is defined as two consecutive visits. mg=milligrams. dL=deciliter, G= Grade. |
Countries
China
Participant flow
Recruitment details
This was a 2 sequential treatment period study. In first period (double-blinded),participants received tenofovir disoproxil fumarate (TDF) 300 milligram (mg) once daily (QD) or adefovir dipivoxil (ADV) 10 mg QD for 48 Weeks. In second period (open-label single treatment), participants received TDF 300 mg QD for additional 192 Weeks.
Pre-assignment details
969 participants were screened, 512 were randomized and 509 were treated with at least one dose of study medication in the double-blind treatment period. Participants who received at least one dose of study medication continued in open-label period.
Participants by arm
| Arm | Count |
|---|---|
| TDF-TDF In first treatment period, participants self-administered TDF 300 mg tablets plus matching ADV placebo at the same time QD for 48 Weeks. In second treatment, participants self-administered TDF 300 mg QD for additional 192 Weeks. | 257 |
| ADV-TDF In first treatment period, participants self-administered ADV 10 mg tablets plus matching TDF placebo at the same time QD for 48 Weeks. In second treatment, participants self-administered TDF 300 mg QD for additional 192 Weeks. | 252 |
| Total | 509 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 |
| Overall Study | Lost to Follow-up | 14 | 12 |
| Overall Study | Participant reached stopping critera | 2 | 0 |
| Overall Study | Participant refused return to hospital | 1 | 0 |
| Overall Study | Participant stopped medication | 1 | 1 |
| Overall Study | Pregnancy | 2 | 1 |
| Overall Study | Protocol Violation | 2 | 3 |
| Overall Study | Withdrawal by Subject | 5 | 9 |
Baseline characteristics
| Characteristic | TDF-TDF | ADV-TDF | Total |
|---|---|---|---|
| Age, Continuous | 36.1 Years STANDARD_DEVIATION 10.48 | 36.4 Years STANDARD_DEVIATION 10.43 | 36.3 Years STANDARD_DEVIATION 10.44 |
| Race/Ethnicity, Customized Asian - East Asian Heritage | 257 participants | 252 participants | 509 participants |
| Sex: Female, Male Female | 43 Participants | 42 Participants | 85 Participants |
| Sex: Female, Male Male | 214 Participants | 210 Participants | 424 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 257 | 0 / 252 |
| other Total, other adverse events | 140 / 257 | 121 / 252 |
| serious Total, serious adverse events | 12 / 257 | 20 / 252 |
Outcome results
Primary
Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) <400 Copies/Milliliter (mL) at Week 48
The number of participants with Hepatitis B Virus (HBV) deoxyribonucleic acid (DNA) \<400 copies/milliliter (mL) at Week 48 in the hepatitis B e antigen (HBeAg)-positive and HBeAg-negative population was assessed. HBeAg is a viral protein that is secreted by hepatitis B-infected cells. It is associated with chronic hepatitis B infections and is used as a marker of active viral disease and a participant's degree of infectiousness. A positive result indicates that the participant has high levels of virus in the blood and greater infectiousness. Usually, a negative result indicates that the participant has lower levels of virus in the blood and is less infectious. A non-completers equal failures approach is used for the analysis in ITT population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Time frame: Week 48
Population: Intent-to-Treat (ITT) Population: All randomized participants who received at least one dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TDF 300 mg | Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) <400 Copies/Milliliter (mL) at Week 48 | HBeAg-positive, n=103, 99 | 79 Participants |
| TDF 300 mg | Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) <400 Copies/Milliliter (mL) at Week 48 | HBeAg-negative, n=154, 153 | 149 Participants |
| ADV 10 mg | Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) <400 Copies/Milliliter (mL) at Week 48 | HBeAg-positive, n=103, 99 | 18 Participants |
| ADV 10 mg | Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) <400 Copies/Milliliter (mL) at Week 48 | HBeAg-negative, n=154, 153 | 109 Participants |
p-value: <0.000197.5% CI: [45.8, 71.3]Roche COBAS Taqman HBV test
p-value: <0.000197.5% CI: [16.7, 34.3]Roche COBAS Taqman HBV test
Secondary
Change From Baseline of Log 10 Copies/mL HBV DNA at Weeks 48, 96, 144, 192 and 240
Change from Baseline of log 10 copies/mL HBV DNA at Weeks 48, 96, 144, 192 and 240 in the HBeAg-positive and HBeAg-negative population was assessed. HBeAg is a viral protein that is secreted by hepatitis B-infected cells. It is associated with chronic hepatitis B infections and is used as a marker of active viral disease and a participant's degree of infectiousness. A positive result indicates that the participant has high levels of virus in the blood and greater infectiousness. Usually a negative result indicates that the participant has lower levels of virus in the blood and less infectious. Values at Day 0 were considered as Baseline values. Change from Baseline was calculated as post Baseline values minus Baseline values. A non-completers equal failures approach is used for the analysis in ITT population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Time frame: Baseline, Weeks 48, 96, 144, 192 and 240
Population: ITT Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TDF 300 mg | Change From Baseline of Log 10 Copies/mL HBV DNA at Weeks 48, 96, 144, 192 and 240 | Week 48,HBeAg-positive, n=102, 97 | -6.4 log10 copies/mL | Standard Deviation 0.86 |
| TDF 300 mg | Change From Baseline of Log 10 Copies/mL HBV DNA at Weeks 48, 96, 144, 192 and 240 | Week 48,HBeAg-negative, n=151, 148 | -4.9 log10 copies/mL | Standard Deviation 1.16 |
| TDF 300 mg | Change From Baseline of Log 10 Copies/mL HBV DNA at Weeks 48, 96, 144, 192 and 240 | Week 96, HBeAg-positive, n=101, 97 | -6.5 log10 copies/mL | Standard Deviation 0.86 |
| TDF 300 mg | Change From Baseline of Log 10 Copies/mL HBV DNA at Weeks 48, 96, 144, 192 and 240 | Week 96, HBeAg-negative, n=147,148 | -4.9 log10 copies/mL | Standard Deviation 1.26 |
| TDF 300 mg | Change From Baseline of Log 10 Copies/mL HBV DNA at Weeks 48, 96, 144, 192 and 240 | Week 144, HBeAg-postive, n=100, 96 | -6.6 log10 copies/mL | Standard Deviation 0.86 |
| TDF 300 mg | Change From Baseline of Log 10 Copies/mL HBV DNA at Weeks 48, 96, 144, 192 and 240 | Week 144, HBeAg-negative, n=145, 146 | -4.9 log10 copies/mL | Standard Deviation 1.16 |
| TDF 300 mg | Change From Baseline of Log 10 Copies/mL HBV DNA at Weeks 48, 96, 144, 192 and 240 | Week 192, HBeAg-positive, n=97,93 | -6.6 log10 copies/mL | Standard Deviation 0.86 |
| TDF 300 mg | Change From Baseline of Log 10 Copies/mL HBV DNA at Weeks 48, 96, 144, 192 and 240 | Week 192, HBeAg-negative, n=145,145 | -4.9 log10 copies/mL | Standard Deviation 1.17 |
| TDF 300 mg | Change From Baseline of Log 10 Copies/mL HBV DNA at Weeks 48, 96, 144, 192 and 240 | Week 240, HBeAg-positive, n=91,90 | -6.6 log10 copies/mL | Standard Deviation 1.01 |
| TDF 300 mg | Change From Baseline of Log 10 Copies/mL HBV DNA at Weeks 48, 96, 144, 192 and 240 | Week 240, HBeAg-negative, n=138,138 | -4.9 log10 copies/mL | Standard Deviation 1.16 |
| ADV 10 mg | Change From Baseline of Log 10 Copies/mL HBV DNA at Weeks 48, 96, 144, 192 and 240 | Week 192, HBeAg-negative, n=145,145 | -4.8 log10 copies/mL | Standard Deviation 1.14 |
| ADV 10 mg | Change From Baseline of Log 10 Copies/mL HBV DNA at Weeks 48, 96, 144, 192 and 240 | Week 48,HBeAg-positive, n=102, 97 | -4.4 log10 copies/mL | Standard Deviation 1.69 |
| ADV 10 mg | Change From Baseline of Log 10 Copies/mL HBV DNA at Weeks 48, 96, 144, 192 and 240 | Week 144, HBeAg-negative, n=145, 146 | -4.9 log10 copies/mL | Standard Deviation 1.09 |
| ADV 10 mg | Change From Baseline of Log 10 Copies/mL HBV DNA at Weeks 48, 96, 144, 192 and 240 | Week 48,HBeAg-negative, n=151, 148 | -4.3 log10 copies/mL | Standard Deviation 1.31 |
| ADV 10 mg | Change From Baseline of Log 10 Copies/mL HBV DNA at Weeks 48, 96, 144, 192 and 240 | Week 240, HBeAg-negative, n=138,138 | -4.9 log10 copies/mL | Standard Deviation 1.07 |
| ADV 10 mg | Change From Baseline of Log 10 Copies/mL HBV DNA at Weeks 48, 96, 144, 192 and 240 | Week 96, HBeAg-positive, n=101, 97 | -6.5 log10 copies/mL | Standard Deviation 0.81 |
| ADV 10 mg | Change From Baseline of Log 10 Copies/mL HBV DNA at Weeks 48, 96, 144, 192 and 240 | Week 192, HBeAg-positive, n=97,93 | -6.6 log10 copies/mL | Standard Deviation 0.81 |
| ADV 10 mg | Change From Baseline of Log 10 Copies/mL HBV DNA at Weeks 48, 96, 144, 192 and 240 | Week 96, HBeAg-negative, n=147,148 | -4.8 log10 copies/mL | Standard Deviation 1.17 |
| ADV 10 mg | Change From Baseline of Log 10 Copies/mL HBV DNA at Weeks 48, 96, 144, 192 and 240 | Week 240, HBeAg-positive, n=91,90 | -6.5 log10 copies/mL | Standard Deviation 0.79 |
| ADV 10 mg | Change From Baseline of Log 10 Copies/mL HBV DNA at Weeks 48, 96, 144, 192 and 240 | Week 144, HBeAg-postive, n=100, 96 | -6.5 log10 copies/mL | Standard Deviation 0.8 |
Secondary
Number of HBeAg-negative Participants Achieving HBsAg Loss and HBsAg Seroconversion at Weeks 24, 48, 96, 144, 192, 240
HBsAg loss is defined as a negative HBsAg result for those participants with who were HBsAg positive at Baseline. Seroconversion to anti-HBs is defined as HBsAg loss and a positive anti-HBs result. This report includes data up to and including Week 240.
Time frame: Weeks 24, 48, 96, 144, 192 and 240
Population: ITT Population. Only those participants with data available at specific time point were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TDF 300 mg | Number of HBeAg-negative Participants Achieving HBsAg Loss and HBsAg Seroconversion at Weeks 24, 48, 96, 144, 192, 240 | Week 24, HBsAg loss | 0 Participants |
| TDF 300 mg | Number of HBeAg-negative Participants Achieving HBsAg Loss and HBsAg Seroconversion at Weeks 24, 48, 96, 144, 192, 240 | Week 24, HBsAg seroconversion | 0 Participants |
| TDF 300 mg | Number of HBeAg-negative Participants Achieving HBsAg Loss and HBsAg Seroconversion at Weeks 24, 48, 96, 144, 192, 240 | Week 48, HBsAg loss | 0 Participants |
| TDF 300 mg | Number of HBeAg-negative Participants Achieving HBsAg Loss and HBsAg Seroconversion at Weeks 24, 48, 96, 144, 192, 240 | Week 48, HBsAg seroconversion | 0 Participants |
| TDF 300 mg | Number of HBeAg-negative Participants Achieving HBsAg Loss and HBsAg Seroconversion at Weeks 24, 48, 96, 144, 192, 240 | Week 96, HBsAg loss | 0 Participants |
| TDF 300 mg | Number of HBeAg-negative Participants Achieving HBsAg Loss and HBsAg Seroconversion at Weeks 24, 48, 96, 144, 192, 240 | Week 96, HBsAg seroconversion | 0 Participants |
| TDF 300 mg | Number of HBeAg-negative Participants Achieving HBsAg Loss and HBsAg Seroconversion at Weeks 24, 48, 96, 144, 192, 240 | Week 144, HBsAg loss | 0 Participants |
| TDF 300 mg | Number of HBeAg-negative Participants Achieving HBsAg Loss and HBsAg Seroconversion at Weeks 24, 48, 96, 144, 192, 240 | Week 144, HBsAg seroconversion | 0 Participants |
| TDF 300 mg | Number of HBeAg-negative Participants Achieving HBsAg Loss and HBsAg Seroconversion at Weeks 24, 48, 96, 144, 192, 240 | Week 192, HBsAg loss | 0 Participants |
| TDF 300 mg | Number of HBeAg-negative Participants Achieving HBsAg Loss and HBsAg Seroconversion at Weeks 24, 48, 96, 144, 192, 240 | Week 192, HBsAg seroconversion | 0 Participants |
| TDF 300 mg | Number of HBeAg-negative Participants Achieving HBsAg Loss and HBsAg Seroconversion at Weeks 24, 48, 96, 144, 192, 240 | Week 240, HBsAg loss | 0 Participants |
| TDF 300 mg | Number of HBeAg-negative Participants Achieving HBsAg Loss and HBsAg Seroconversion at Weeks 24, 48, 96, 144, 192, 240 | Week 240, HBsAg seroconversion | 0 Participants |
| ADV 10 mg | Number of HBeAg-negative Participants Achieving HBsAg Loss and HBsAg Seroconversion at Weeks 24, 48, 96, 144, 192, 240 | Week 240, HBsAg loss | 0 Participants |
| ADV 10 mg | Number of HBeAg-negative Participants Achieving HBsAg Loss and HBsAg Seroconversion at Weeks 24, 48, 96, 144, 192, 240 | Week 24, HBsAg loss | 0 Participants |
| ADV 10 mg | Number of HBeAg-negative Participants Achieving HBsAg Loss and HBsAg Seroconversion at Weeks 24, 48, 96, 144, 192, 240 | Week 144, HBsAg loss | 1 Participants |
| ADV 10 mg | Number of HBeAg-negative Participants Achieving HBsAg Loss and HBsAg Seroconversion at Weeks 24, 48, 96, 144, 192, 240 | Week 24, HBsAg seroconversion | 0 Participants |
| ADV 10 mg | Number of HBeAg-negative Participants Achieving HBsAg Loss and HBsAg Seroconversion at Weeks 24, 48, 96, 144, 192, 240 | Week 192, HBsAg seroconversion | 0 Participants |
| ADV 10 mg | Number of HBeAg-negative Participants Achieving HBsAg Loss and HBsAg Seroconversion at Weeks 24, 48, 96, 144, 192, 240 | Week 48, HBsAg loss | 0 Participants |
| ADV 10 mg | Number of HBeAg-negative Participants Achieving HBsAg Loss and HBsAg Seroconversion at Weeks 24, 48, 96, 144, 192, 240 | Week 144, HBsAg seroconversion | 1 Participants |
| ADV 10 mg | Number of HBeAg-negative Participants Achieving HBsAg Loss and HBsAg Seroconversion at Weeks 24, 48, 96, 144, 192, 240 | Week 48, HBsAg seroconversion | 0 Participants |
| ADV 10 mg | Number of HBeAg-negative Participants Achieving HBsAg Loss and HBsAg Seroconversion at Weeks 24, 48, 96, 144, 192, 240 | Week 240, HBsAg seroconversion | 0 Participants |
| ADV 10 mg | Number of HBeAg-negative Participants Achieving HBsAg Loss and HBsAg Seroconversion at Weeks 24, 48, 96, 144, 192, 240 | Week 96, HBsAg loss | 0 Participants |
| ADV 10 mg | Number of HBeAg-negative Participants Achieving HBsAg Loss and HBsAg Seroconversion at Weeks 24, 48, 96, 144, 192, 240 | Week 192, HBsAg loss | 0 Participants |
| ADV 10 mg | Number of HBeAg-negative Participants Achieving HBsAg Loss and HBsAg Seroconversion at Weeks 24, 48, 96, 144, 192, 240 | Week 96, HBsAg seroconversion | 0 Participants |
Secondary
Number of HBeAg-positive Participants Achieving HBeAg Loss and HBeAg Seroconversion at Weeks 24, 48, 96, 144, 192 and 240.
HBeAg loss is defined as a negative HBeAg result for those participants who were HBeAg positive at Baseline. Seroconversion to anti-HBe is defined as HBeAg loss and a positive anti-HBe result. This report includes data up to and including Weeks 24, 48, 96, 144, 192 and 240.
Time frame: Weeks 24, 48, 96, 144, 192 and 240
Population: ITT Population. Only those participants with data available at specific time point were analyzed
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TDF 300 mg | Number of HBeAg-positive Participants Achieving HBeAg Loss and HBeAg Seroconversion at Weeks 24, 48, 96, 144, 192 and 240. | Week 144, HBeAg loss | 37 Participants |
| TDF 300 mg | Number of HBeAg-positive Participants Achieving HBeAg Loss and HBeAg Seroconversion at Weeks 24, 48, 96, 144, 192 and 240. | Week 24, HBeAg loss | 15 Participants |
| TDF 300 mg | Number of HBeAg-positive Participants Achieving HBeAg Loss and HBeAg Seroconversion at Weeks 24, 48, 96, 144, 192 and 240. | Week 24, HBeAg seroconversion | 14 Participants |
| TDF 300 mg | Number of HBeAg-positive Participants Achieving HBeAg Loss and HBeAg Seroconversion at Weeks 24, 48, 96, 144, 192 and 240. | Week 48, HBeAg loss | 18 Participants |
| TDF 300 mg | Number of HBeAg-positive Participants Achieving HBeAg Loss and HBeAg Seroconversion at Weeks 24, 48, 96, 144, 192 and 240. | Week 48, HBeAg seroconversion | 16 Participants |
| TDF 300 mg | Number of HBeAg-positive Participants Achieving HBeAg Loss and HBeAg Seroconversion at Weeks 24, 48, 96, 144, 192 and 240. | Week 96, HBeAg loss | 37 Participants |
| TDF 300 mg | Number of HBeAg-positive Participants Achieving HBeAg Loss and HBeAg Seroconversion at Weeks 24, 48, 96, 144, 192 and 240. | Week 96, HBeAg seroconversion | 32 Participants |
| TDF 300 mg | Number of HBeAg-positive Participants Achieving HBeAg Loss and HBeAg Seroconversion at Weeks 24, 48, 96, 144, 192 and 240. | Week 144, HBeAg seroconversion | 33 Participants |
| TDF 300 mg | Number of HBeAg-positive Participants Achieving HBeAg Loss and HBeAg Seroconversion at Weeks 24, 48, 96, 144, 192 and 240. | Week 192, HBeAg loss | 43 Participants |
| TDF 300 mg | Number of HBeAg-positive Participants Achieving HBeAg Loss and HBeAg Seroconversion at Weeks 24, 48, 96, 144, 192 and 240. | Week 192, HBeAg seroconversion | 33 Participants |
| TDF 300 mg | Number of HBeAg-positive Participants Achieving HBeAg Loss and HBeAg Seroconversion at Weeks 24, 48, 96, 144, 192 and 240. | Week 240, HBeAg loss | 43 Participants |
| TDF 300 mg | Number of HBeAg-positive Participants Achieving HBeAg Loss and HBeAg Seroconversion at Weeks 24, 48, 96, 144, 192 and 240. | Week 240, HBeAg seroconversion | 33 Participants |
| ADV 10 mg | Number of HBeAg-positive Participants Achieving HBeAg Loss and HBeAg Seroconversion at Weeks 24, 48, 96, 144, 192 and 240. | Week 240, HBeAg loss | 36 Participants |
| ADV 10 mg | Number of HBeAg-positive Participants Achieving HBeAg Loss and HBeAg Seroconversion at Weeks 24, 48, 96, 144, 192 and 240. | Week 144, HBeAg loss | 24 Participants |
| ADV 10 mg | Number of HBeAg-positive Participants Achieving HBeAg Loss and HBeAg Seroconversion at Weeks 24, 48, 96, 144, 192 and 240. | Week 96, HBeAg seroconversion | 18 Participants |
| ADV 10 mg | Number of HBeAg-positive Participants Achieving HBeAg Loss and HBeAg Seroconversion at Weeks 24, 48, 96, 144, 192 and 240. | Week 24, HBeAg loss | 4 Participants |
| ADV 10 mg | Number of HBeAg-positive Participants Achieving HBeAg Loss and HBeAg Seroconversion at Weeks 24, 48, 96, 144, 192 and 240. | Week 192, HBeAg seroconversion | 24 Participants |
| ADV 10 mg | Number of HBeAg-positive Participants Achieving HBeAg Loss and HBeAg Seroconversion at Weeks 24, 48, 96, 144, 192 and 240. | Week 24, HBeAg seroconversion | 4 Participants |
| ADV 10 mg | Number of HBeAg-positive Participants Achieving HBeAg Loss and HBeAg Seroconversion at Weeks 24, 48, 96, 144, 192 and 240. | Week 144, HBeAg seroconversion | 20 Participants |
| ADV 10 mg | Number of HBeAg-positive Participants Achieving HBeAg Loss and HBeAg Seroconversion at Weeks 24, 48, 96, 144, 192 and 240. | Week 48, HBeAg loss | 10 Participants |
| ADV 10 mg | Number of HBeAg-positive Participants Achieving HBeAg Loss and HBeAg Seroconversion at Weeks 24, 48, 96, 144, 192 and 240. | Week 240, HBeAg seroconversion | 28 Participants |
| ADV 10 mg | Number of HBeAg-positive Participants Achieving HBeAg Loss and HBeAg Seroconversion at Weeks 24, 48, 96, 144, 192 and 240. | Week 48, HBeAg seroconversion | 9 Participants |
| ADV 10 mg | Number of HBeAg-positive Participants Achieving HBeAg Loss and HBeAg Seroconversion at Weeks 24, 48, 96, 144, 192 and 240. | Week 192, HBeAg loss | 31 Participants |
| ADV 10 mg | Number of HBeAg-positive Participants Achieving HBeAg Loss and HBeAg Seroconversion at Weeks 24, 48, 96, 144, 192 and 240. | Week 96, HBeAg loss | 21 Participants |
Secondary
Number of HBeAg-positive Participants Achieving Hepatitis B Surface Antigen (HBsAg) Loss and HBsAg Seroconversion at Weeks 24, 48, 96, 144, 192 and 240
HBsAg loss is defined as negative HBsAg results for those participants with who were HBsAg positive at Baseline. Seroconversion to anti-HBs is defined as HBsAg loss and a positive anti-HBs result. This report includes data up to and including Week 240.
Time frame: Weeks 24, 48, 96, 144, 192 and 240
Population: ITT Population. Only those participants with data available at specific time point were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TDF 300 mg | Number of HBeAg-positive Participants Achieving Hepatitis B Surface Antigen (HBsAg) Loss and HBsAg Seroconversion at Weeks 24, 48, 96, 144, 192 and 240 | Week 24, HBsAg loss | 0 Participants |
| TDF 300 mg | Number of HBeAg-positive Participants Achieving Hepatitis B Surface Antigen (HBsAg) Loss and HBsAg Seroconversion at Weeks 24, 48, 96, 144, 192 and 240 | Week 24, HBsAg seroconversion | 0 Participants |
| TDF 300 mg | Number of HBeAg-positive Participants Achieving Hepatitis B Surface Antigen (HBsAg) Loss and HBsAg Seroconversion at Weeks 24, 48, 96, 144, 192 and 240 | Week 48, HBsAg loss | 0 Participants |
| TDF 300 mg | Number of HBeAg-positive Participants Achieving Hepatitis B Surface Antigen (HBsAg) Loss and HBsAg Seroconversion at Weeks 24, 48, 96, 144, 192 and 240 | Week 48, HBsAg seroconversion | 0 Participants |
| TDF 300 mg | Number of HBeAg-positive Participants Achieving Hepatitis B Surface Antigen (HBsAg) Loss and HBsAg Seroconversion at Weeks 24, 48, 96, 144, 192 and 240 | Week 96, HBsAg loss | 0 Participants |
| TDF 300 mg | Number of HBeAg-positive Participants Achieving Hepatitis B Surface Antigen (HBsAg) Loss and HBsAg Seroconversion at Weeks 24, 48, 96, 144, 192 and 240 | Week 96, HBsAg seroconversion | 0 Participants |
| TDF 300 mg | Number of HBeAg-positive Participants Achieving Hepatitis B Surface Antigen (HBsAg) Loss and HBsAg Seroconversion at Weeks 24, 48, 96, 144, 192 and 240 | Week 144, HBsAg loss | 1 Participants |
| TDF 300 mg | Number of HBeAg-positive Participants Achieving Hepatitis B Surface Antigen (HBsAg) Loss and HBsAg Seroconversion at Weeks 24, 48, 96, 144, 192 and 240 | Week 144, HBaAg seroconversion | 0 Participants |
| TDF 300 mg | Number of HBeAg-positive Participants Achieving Hepatitis B Surface Antigen (HBsAg) Loss and HBsAg Seroconversion at Weeks 24, 48, 96, 144, 192 and 240 | Week 192, HBsAg, loss | 1 Participants |
| TDF 300 mg | Number of HBeAg-positive Participants Achieving Hepatitis B Surface Antigen (HBsAg) Loss and HBsAg Seroconversion at Weeks 24, 48, 96, 144, 192 and 240 | Week 192, HBsAg, seroconversion | 0 Participants |
| TDF 300 mg | Number of HBeAg-positive Participants Achieving Hepatitis B Surface Antigen (HBsAg) Loss and HBsAg Seroconversion at Weeks 24, 48, 96, 144, 192 and 240 | Week 240, HBsAg loss | 1 Participants |
| TDF 300 mg | Number of HBeAg-positive Participants Achieving Hepatitis B Surface Antigen (HBsAg) Loss and HBsAg Seroconversion at Weeks 24, 48, 96, 144, 192 and 240 | Week 240 HBsAg seroconversion | 0 Participants |
| ADV 10 mg | Number of HBeAg-positive Participants Achieving Hepatitis B Surface Antigen (HBsAg) Loss and HBsAg Seroconversion at Weeks 24, 48, 96, 144, 192 and 240 | Week 240, HBsAg loss | 0 Participants |
| ADV 10 mg | Number of HBeAg-positive Participants Achieving Hepatitis B Surface Antigen (HBsAg) Loss and HBsAg Seroconversion at Weeks 24, 48, 96, 144, 192 and 240 | Week 24, HBsAg loss | 0 Participants |
| ADV 10 mg | Number of HBeAg-positive Participants Achieving Hepatitis B Surface Antigen (HBsAg) Loss and HBsAg Seroconversion at Weeks 24, 48, 96, 144, 192 and 240 | Week 144, HBsAg loss | 0 Participants |
| ADV 10 mg | Number of HBeAg-positive Participants Achieving Hepatitis B Surface Antigen (HBsAg) Loss and HBsAg Seroconversion at Weeks 24, 48, 96, 144, 192 and 240 | Week 24, HBsAg seroconversion | 0 Participants |
| ADV 10 mg | Number of HBeAg-positive Participants Achieving Hepatitis B Surface Antigen (HBsAg) Loss and HBsAg Seroconversion at Weeks 24, 48, 96, 144, 192 and 240 | Week 192, HBsAg, seroconversion | 0 Participants |
| ADV 10 mg | Number of HBeAg-positive Participants Achieving Hepatitis B Surface Antigen (HBsAg) Loss and HBsAg Seroconversion at Weeks 24, 48, 96, 144, 192 and 240 | Week 48, HBsAg loss | 0 Participants |
| ADV 10 mg | Number of HBeAg-positive Participants Achieving Hepatitis B Surface Antigen (HBsAg) Loss and HBsAg Seroconversion at Weeks 24, 48, 96, 144, 192 and 240 | Week 144, HBaAg seroconversion | 0 Participants |
| ADV 10 mg | Number of HBeAg-positive Participants Achieving Hepatitis B Surface Antigen (HBsAg) Loss and HBsAg Seroconversion at Weeks 24, 48, 96, 144, 192 and 240 | Week 48, HBsAg seroconversion | 0 Participants |
| ADV 10 mg | Number of HBeAg-positive Participants Achieving Hepatitis B Surface Antigen (HBsAg) Loss and HBsAg Seroconversion at Weeks 24, 48, 96, 144, 192 and 240 | Week 240 HBsAg seroconversion | 0 Participants |
| ADV 10 mg | Number of HBeAg-positive Participants Achieving Hepatitis B Surface Antigen (HBsAg) Loss and HBsAg Seroconversion at Weeks 24, 48, 96, 144, 192 and 240 | Week 96, HBsAg loss | 0 Participants |
| ADV 10 mg | Number of HBeAg-positive Participants Achieving Hepatitis B Surface Antigen (HBsAg) Loss and HBsAg Seroconversion at Weeks 24, 48, 96, 144, 192 and 240 | Week 192, HBsAg, loss | 0 Participants |
| ADV 10 mg | Number of HBeAg-positive Participants Achieving Hepatitis B Surface Antigen (HBsAg) Loss and HBsAg Seroconversion at Weeks 24, 48, 96, 144, 192 and 240 | Week 96, HBsAg seroconversion | 0 Participants |
Secondary
Number of Participants Achieving Durable HBsAg Loss From Weeks 24 to Week 48
Durable HBsAg loss is defined as the loss of HBsAg and no detectable HBV DNA and ALT normalization at any three consecutive visits at least 12 Weeks apart. This report includes data up to and including Week 48. A non-completers equal failures approach was used for the analysis in ITT population.
Time frame: Week 24 to Week 48
Population: ITT Population. Only those participants available at the indicated time points were assessed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TDF 300 mg | Number of Participants Achieving Durable HBsAg Loss From Weeks 24 to Week 48 | HBeAg-positive, n =100, 97 | 0 Participants |
| TDF 300 mg | Number of Participants Achieving Durable HBsAg Loss From Weeks 24 to Week 48 | HBeAg-negative, n=150, 147 | 0 Participants |
| ADV 10 mg | Number of Participants Achieving Durable HBsAg Loss From Weeks 24 to Week 48 | HBeAg-positive, n =100, 97 | 0 Participants |
| ADV 10 mg | Number of Participants Achieving Durable HBsAg Loss From Weeks 24 to Week 48 | HBeAg-negative, n=150, 147 | 0 Participants |
Secondary
Number of Participants Achieving Durable HBsAg Loss From Weeks 96 to Week 240
Durable HBsAg loss is defined as the loss of HBsAg and no detectable HBV DNA and ALT normalization at any three consecutive visits at least 12 Weeks apart from Week 96 to 240. This report includes data up to and including Week 240. A non-completers equal failures approach was used for the analysis in ITT population.
Time frame: Week 96 to Week 240
Population: ITT Population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TDF 300 mg | Number of Participants Achieving Durable HBsAg Loss From Weeks 96 to Week 240 | HBeAg-positive, n= 88, 90 | 1 Participants |
| TDF 300 mg | Number of Participants Achieving Durable HBsAg Loss From Weeks 96 to Week 240 | HBeAg-negative, n = 132, 137 | 0 Participants |
| ADV 10 mg | Number of Participants Achieving Durable HBsAg Loss From Weeks 96 to Week 240 | HBeAg-positive, n= 88, 90 | 0 Participants |
| ADV 10 mg | Number of Participants Achieving Durable HBsAg Loss From Weeks 96 to Week 240 | HBeAg-negative, n = 132, 137 | 1 Participants |
Secondary
Number of Participants in the Indicated Category for Renal Laboratory Abnormalities
The Gilead Grading Scale for Severity of Adverse Events and Laboratory Abnormalities, version 21, September 2011 was used for grading. Confirmed is defined as two consecutive visits. mg=milligrams. dL=deciliter, G= Grade.
Time frame: Up to Week 240
Population: Safety Analysis Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TDF 300 mg | Number of Participants in the Indicated Category for Renal Laboratory Abnormalities | Creatinine increase of 0.5 mg/dL above Baseline | 1 Participants |
| TDF 300 mg | Number of Participants in the Indicated Category for Renal Laboratory Abnormalities | Confirmed creatinine >=2.0 mg/dL | 0 Participants |
| TDF 300 mg | Number of Participants in the Indicated Category for Renal Laboratory Abnormalities | Confirmed clearance <50 milliliters/minute | 0 Participants |
| TDF 300 mg | Number of Participants in the Indicated Category for Renal Laboratory Abnormalities | Confirmed phosphorus G 3/4 abnormality, <2.0 mg/dL | 3 Participants |
| ADV 10 mg | Number of Participants in the Indicated Category for Renal Laboratory Abnormalities | Confirmed phosphorus G 3/4 abnormality, <2.0 mg/dL | 0 Participants |
| ADV 10 mg | Number of Participants in the Indicated Category for Renal Laboratory Abnormalities | Creatinine increase of 0.5 mg/dL above Baseline | 0 Participants |
| ADV 10 mg | Number of Participants in the Indicated Category for Renal Laboratory Abnormalities | Confirmed clearance <50 milliliters/minute | 0 Participants |
| ADV 10 mg | Number of Participants in the Indicated Category for Renal Laboratory Abnormalities | Confirmed creatinine >=2.0 mg/dL | 0 Participants |
Secondary
Number of Participants With Alanine Aminotransferase (ALT) Normalization at Weeks 48, 96, 144, 192 and 240 in Participants Who Had Abnormal ALT at Baseline
Participants who had abnormal ALT at Baseline and had normalized ALT at Weeks 48, 96, 144, 192 and 240 were assessed. This report includes data up to and including Weeks 48, 96, 144, 192 and 240. An increased level of ALT is referred to as abnormal ALT (the normal range is 0 to 48 units per liter \[U/L\]). Values at Day 0 were considered as Baseline values. A non-completers equal failures approach is used for the analysis in ITT population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Time frame: Baseline; Weeks 48, 96, 144, 192 and 240
Population: ITT Population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TDF 300 mg | Number of Participants With Alanine Aminotransferase (ALT) Normalization at Weeks 48, 96, 144, 192 and 240 in Participants Who Had Abnormal ALT at Baseline | Week 48, HBeAg-positive, n=102, 97 | 88 Participants |
| TDF 300 mg | Number of Participants With Alanine Aminotransferase (ALT) Normalization at Weeks 48, 96, 144, 192 and 240 in Participants Who Had Abnormal ALT at Baseline | Week 48, HBeAg-negative, n=136, 132 | 120 Participants |
| TDF 300 mg | Number of Participants With Alanine Aminotransferase (ALT) Normalization at Weeks 48, 96, 144, 192 and 240 in Participants Who Had Abnormal ALT at Baseline | Week 96, HBeAg-positive, n=102, 97 | 93 Participants |
| TDF 300 mg | Number of Participants With Alanine Aminotransferase (ALT) Normalization at Weeks 48, 96, 144, 192 and 240 in Participants Who Had Abnormal ALT at Baseline | Week 96, HBeAg-negative, n=136,132 | 126 Participants |
| TDF 300 mg | Number of Participants With Alanine Aminotransferase (ALT) Normalization at Weeks 48, 96, 144, 192 and 240 in Participants Who Had Abnormal ALT at Baseline | Week 144, HBeAg-positive, n=102, 97 | 92 Participants |
| TDF 300 mg | Number of Participants With Alanine Aminotransferase (ALT) Normalization at Weeks 48, 96, 144, 192 and 240 in Participants Who Had Abnormal ALT at Baseline | Week 144, HBeAg-negative, n=136, 132 | 123 Participants |
| TDF 300 mg | Number of Participants With Alanine Aminotransferase (ALT) Normalization at Weeks 48, 96, 144, 192 and 240 in Participants Who Had Abnormal ALT at Baseline | Week 192, HBeAg-positive, n=102, 97 | 89 Participants |
| TDF 300 mg | Number of Participants With Alanine Aminotransferase (ALT) Normalization at Weeks 48, 96, 144, 192 and 240 in Participants Who Had Abnormal ALT at Baseline | Week 192, HBeAg-negative, n=136,132 | 125 Participants |
| TDF 300 mg | Number of Participants With Alanine Aminotransferase (ALT) Normalization at Weeks 48, 96, 144, 192 and 240 in Participants Who Had Abnormal ALT at Baseline | Week 240, HBeAg-positive, n=102, 97 | 82 Participants |
| TDF 300 mg | Number of Participants With Alanine Aminotransferase (ALT) Normalization at Weeks 48, 96, 144, 192 and 240 in Participants Who Had Abnormal ALT at Baseline | Week 240, HBeAg-negative, n=136,132 | 119 Participants |
| ADV 10 mg | Number of Participants With Alanine Aminotransferase (ALT) Normalization at Weeks 48, 96, 144, 192 and 240 in Participants Who Had Abnormal ALT at Baseline | Week 192, HBeAg-negative, n=136,132 | 118 Participants |
| ADV 10 mg | Number of Participants With Alanine Aminotransferase (ALT) Normalization at Weeks 48, 96, 144, 192 and 240 in Participants Who Had Abnormal ALT at Baseline | Week 48, HBeAg-positive, n=102, 97 | 83 Participants |
| ADV 10 mg | Number of Participants With Alanine Aminotransferase (ALT) Normalization at Weeks 48, 96, 144, 192 and 240 in Participants Who Had Abnormal ALT at Baseline | Week 144, HBeAg-negative, n=136, 132 | 119 Participants |
| ADV 10 mg | Number of Participants With Alanine Aminotransferase (ALT) Normalization at Weeks 48, 96, 144, 192 and 240 in Participants Who Had Abnormal ALT at Baseline | Week 48, HBeAg-negative, n=136, 132 | 116 Participants |
| ADV 10 mg | Number of Participants With Alanine Aminotransferase (ALT) Normalization at Weeks 48, 96, 144, 192 and 240 in Participants Who Had Abnormal ALT at Baseline | Week 240, HBeAg-negative, n=136,132 | 111 Participants |
| ADV 10 mg | Number of Participants With Alanine Aminotransferase (ALT) Normalization at Weeks 48, 96, 144, 192 and 240 in Participants Who Had Abnormal ALT at Baseline | Week 96, HBeAg-positive, n=102, 97 | 88 Participants |
| ADV 10 mg | Number of Participants With Alanine Aminotransferase (ALT) Normalization at Weeks 48, 96, 144, 192 and 240 in Participants Who Had Abnormal ALT at Baseline | Week 192, HBeAg-positive, n=102, 97 | 79 Participants |
| ADV 10 mg | Number of Participants With Alanine Aminotransferase (ALT) Normalization at Weeks 48, 96, 144, 192 and 240 in Participants Who Had Abnormal ALT at Baseline | Week 96, HBeAg-negative, n=136,132 | 118 Participants |
| ADV 10 mg | Number of Participants With Alanine Aminotransferase (ALT) Normalization at Weeks 48, 96, 144, 192 and 240 in Participants Who Had Abnormal ALT at Baseline | Week 240, HBeAg-positive, n=102, 97 | 80 Participants |
| ADV 10 mg | Number of Participants With Alanine Aminotransferase (ALT) Normalization at Weeks 48, 96, 144, 192 and 240 in Participants Who Had Abnormal ALT at Baseline | Week 144, HBeAg-positive, n=102, 97 | 87 Participants |
Secondary
Number of Participants With Any Serious Adverse Event (SAE) and Any Non-serious Adverse Event (AE)
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is Grade 4 (life threatening or disabling). Participants with any non-serious AEs and SAEs has been reported.
Time frame: Up to Week 240 treatment period and 24 weeks follow-up visit off treatment
Population: Safety Analysis Population: All participants who received at least one dose of study medication and had at least one post-Baseline safety assessment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TDF 300 mg | Number of Participants With Any Serious Adverse Event (SAE) and Any Non-serious Adverse Event (AE) | Non-serious AE | 140 Participants |
| TDF 300 mg | Number of Participants With Any Serious Adverse Event (SAE) and Any Non-serious Adverse Event (AE) | SAE | 12 Participants |
| ADV 10 mg | Number of Participants With Any Serious Adverse Event (SAE) and Any Non-serious Adverse Event (AE) | Non-serious AE | 121 Participants |
| ADV 10 mg | Number of Participants With Any Serious Adverse Event (SAE) and Any Non-serious Adverse Event (AE) | SAE | 20 Participants |
Secondary
Number of Participants With Histological Improvement at Weeks 48 and 240 Who Had a Baseline Knodell Necroinflammatory Score (KNS) >=2.
Histological improvement is defined as a reduction of \>=2 points in the KNS with no increase in fibrosis at Week 48 and Week 240 in participants with Baseline KNS \>=2 which was derived from the American Association for the Study of Liver Diseases Practice Guidelines for Management of Chronic Hepatitis B (2009) and the European Association for the Study of the Liver Clinical Practice Guidelines Management of chronic hepatitis B virus infection (2012). The Knodell scale consists of 5 domains: periportal +/- bridging necrosis (scored from best to worst: 0, 1, 3, 4, 5, 6, or 10); intralobular degeneration and focal necrosis (0 to 4); portal inflammation (0 to 4); and fibrosis (0 to 4). The necroinflammatory score (ranging from 0 \[best\] to 14 \[worst\]) is the combined score for necrosis (0 to 10) plus inflammation (0 to 4; the participant is scored for only one inflammatory condition). Liver biopsy slides within 6 months prior to randomization could be accepted as Baseline evaluation.
Time frame: Baseline; Week 48 and Week 240
Population: ITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TDF 300 mg | Number of Participants With Histological Improvement at Weeks 48 and 240 Who Had a Baseline Knodell Necroinflammatory Score (KNS) >=2. | Week 48, HBeAg-positive, n=38, 49 | 31 Participants |
| TDF 300 mg | Number of Participants With Histological Improvement at Weeks 48 and 240 Who Had a Baseline Knodell Necroinflammatory Score (KNS) >=2. | Week 48, HBeAg-negative, n=45, 50 | 32 Participants |
| TDF 300 mg | Number of Participants With Histological Improvement at Weeks 48 and 240 Who Had a Baseline Knodell Necroinflammatory Score (KNS) >=2. | Week 240, HBeAg-positive, n=38, 49 | 5 Participants |
| TDF 300 mg | Number of Participants With Histological Improvement at Weeks 48 and 240 Who Had a Baseline Knodell Necroinflammatory Score (KNS) >=2. | Week 240, HBeAg-negative, n=45, 50 | 8 Participants |
| ADV 10 mg | Number of Participants With Histological Improvement at Weeks 48 and 240 Who Had a Baseline Knodell Necroinflammatory Score (KNS) >=2. | Week 240, HBeAg-negative, n=45, 50 | 4 Participants |
| ADV 10 mg | Number of Participants With Histological Improvement at Weeks 48 and 240 Who Had a Baseline Knodell Necroinflammatory Score (KNS) >=2. | Week 48, HBeAg-positive, n=38, 49 | 39 Participants |
| ADV 10 mg | Number of Participants With Histological Improvement at Weeks 48 and 240 Who Had a Baseline Knodell Necroinflammatory Score (KNS) >=2. | Week 240, HBeAg-positive, n=38, 49 | 2 Participants |
| ADV 10 mg | Number of Participants With Histological Improvement at Weeks 48 and 240 Who Had a Baseline Knodell Necroinflammatory Score (KNS) >=2. | Week 48, HBeAg-negative, n=45, 50 | 34 Participants |
Secondary
Number of Participants With the Indicated Grade 3 and Grade 4 Treatment-emergent (TE) Laboratory Abnormalities (LAs)
TE grade 3 or grade 4 LAs are defined as values that increase by \>=1 grade from Baseline (Day 0) to Grade 3 (severe) or 4 (potentially life threatening) at any post-Baseline value. The Gilead Grading Scale for Severity of Adverse Events and Laboratory Abnormalities, version 21, September 2011 was referred for grading. Laboratory parameters assessed included Sodium for hyponatremia and hypernatremia; Potassium for hypokalemia and hyperkalemia; glucose for hypoglycemia and hyperglycemia non-fasting; Phosphate for hypophosphatemia; alanine aminotransferase/aspartate aminotransferase, bilirubin, creatinine kinase, hemoglobin, platelets, neutrophils, lymphocytes, prothrombin time and amylase.
Time frame: Up to Week 240
Population: Safety Analysis Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TDF 300 mg | Number of Participants With the Indicated Grade 3 and Grade 4 Treatment-emergent (TE) Laboratory Abnormalities (LAs) | Sodium | 2 participants |
| TDF 300 mg | Number of Participants With the Indicated Grade 3 and Grade 4 Treatment-emergent (TE) Laboratory Abnormalities (LAs) | Phosphate | 2 participants |
| TDF 300 mg | Number of Participants With the Indicated Grade 3 and Grade 4 Treatment-emergent (TE) Laboratory Abnormalities (LAs) | Alanine aminotransferase | 19 participants |
| TDF 300 mg | Number of Participants With the Indicated Grade 3 and Grade 4 Treatment-emergent (TE) Laboratory Abnormalities (LAs) | Aspartate aminotransferase | 10 participants |
| TDF 300 mg | Number of Participants With the Indicated Grade 3 and Grade 4 Treatment-emergent (TE) Laboratory Abnormalities (LAs) | Bilirubin | 1 participants |
| TDF 300 mg | Number of Participants With the Indicated Grade 3 and Grade 4 Treatment-emergent (TE) Laboratory Abnormalities (LAs) | Creatine kinase | 6 participants |
| TDF 300 mg | Number of Participants With the Indicated Grade 3 and Grade 4 Treatment-emergent (TE) Laboratory Abnormalities (LAs) | Hemoglobin | 4 participants |
| TDF 300 mg | Number of Participants With the Indicated Grade 3 and Grade 4 Treatment-emergent (TE) Laboratory Abnormalities (LAs) | Platelets | 4 participants |
| TDF 300 mg | Number of Participants With the Indicated Grade 3 and Grade 4 Treatment-emergent (TE) Laboratory Abnormalities (LAs) | Neutrophils | 6 participants |
| TDF 300 mg | Number of Participants With the Indicated Grade 3 and Grade 4 Treatment-emergent (TE) Laboratory Abnormalities (LAs) | Prothrombin time | 10 participants |
| TDF 300 mg | Number of Participants With the Indicated Grade 3 and Grade 4 Treatment-emergent (TE) Laboratory Abnormalities (LAs) | Potassium | 1 participants |
| TDF 300 mg | Number of Participants With the Indicated Grade 3 and Grade 4 Treatment-emergent (TE) Laboratory Abnormalities (LAs) | Glucose | 1 participants |
| TDF 300 mg | Number of Participants With the Indicated Grade 3 and Grade 4 Treatment-emergent (TE) Laboratory Abnormalities (LAs) | Lymphocytes | 2 participants |
| TDF 300 mg | Number of Participants With the Indicated Grade 3 and Grade 4 Treatment-emergent (TE) Laboratory Abnormalities (LAs) | Amylase | 1 participants |
| ADV 10 mg | Number of Participants With the Indicated Grade 3 and Grade 4 Treatment-emergent (TE) Laboratory Abnormalities (LAs) | Potassium | 0 participants |
| ADV 10 mg | Number of Participants With the Indicated Grade 3 and Grade 4 Treatment-emergent (TE) Laboratory Abnormalities (LAs) | Sodium | 0 participants |
| ADV 10 mg | Number of Participants With the Indicated Grade 3 and Grade 4 Treatment-emergent (TE) Laboratory Abnormalities (LAs) | Platelets | 3 participants |
| ADV 10 mg | Number of Participants With the Indicated Grade 3 and Grade 4 Treatment-emergent (TE) Laboratory Abnormalities (LAs) | Phosphate | 3 participants |
| ADV 10 mg | Number of Participants With the Indicated Grade 3 and Grade 4 Treatment-emergent (TE) Laboratory Abnormalities (LAs) | Lymphocytes | 3 participants |
| ADV 10 mg | Number of Participants With the Indicated Grade 3 and Grade 4 Treatment-emergent (TE) Laboratory Abnormalities (LAs) | Alanine aminotransferase | 14 participants |
| ADV 10 mg | Number of Participants With the Indicated Grade 3 and Grade 4 Treatment-emergent (TE) Laboratory Abnormalities (LAs) | Neutrophils | 4 participants |
| ADV 10 mg | Number of Participants With the Indicated Grade 3 and Grade 4 Treatment-emergent (TE) Laboratory Abnormalities (LAs) | Aspartate aminotransferase | 6 participants |
| ADV 10 mg | Number of Participants With the Indicated Grade 3 and Grade 4 Treatment-emergent (TE) Laboratory Abnormalities (LAs) | Glucose | 2 participants |
| ADV 10 mg | Number of Participants With the Indicated Grade 3 and Grade 4 Treatment-emergent (TE) Laboratory Abnormalities (LAs) | Bilirubin | 1 participants |
| ADV 10 mg | Number of Participants With the Indicated Grade 3 and Grade 4 Treatment-emergent (TE) Laboratory Abnormalities (LAs) | Prothrombin time | 17 participants |
| ADV 10 mg | Number of Participants With the Indicated Grade 3 and Grade 4 Treatment-emergent (TE) Laboratory Abnormalities (LAs) | Creatine kinase | 4 participants |
| ADV 10 mg | Number of Participants With the Indicated Grade 3 and Grade 4 Treatment-emergent (TE) Laboratory Abnormalities (LAs) | Amylase | 2 participants |
| ADV 10 mg | Number of Participants With the Indicated Grade 3 and Grade 4 Treatment-emergent (TE) Laboratory Abnormalities (LAs) | Hemoglobin | 5 participants |
Secondary
Number of Participants With the Indicated Treatment-emergent Laboratory Abnormalities for Serum Creatinine and Serum Phosphorus
The Gilead Grading Scale for Severity of Adverse Events and Laboratory Abnormalities, version 21, September 2011 was referred for grading. Serum creatinine: Grade 1, \> 133 to 177 micromoles per Liter (µmoles/Liter), Grade 2, \>177 to 265 µmoles/Liter, Grade 3, \>265 to 530 µmoles/Liter, Grade 4, \>530 µmoles/Liter. Serum phosphorus: Grade 2, 0.63 to \<0.80 millimoles per Liter (mmoles/L), Grade 3, 0.31 to \<0.63 mmoles/L, Grade 4, \<0.31 mmoles/L. The normal range for serum phosphorus was 0.8 to 1.45 mmoles/L; the upper limit for a Grade 2 abnormality is 0.80 mmoles/L. Therefore, no Grade 1 abnormalities could be attributed, as values were contained within the normal range. NA indicates the value was not available for the indicated time point.
Time frame: Up to Week 240
Population: Safety Analysis Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TDF 300 mg | Number of Participants With the Indicated Treatment-emergent Laboratory Abnormalities for Serum Creatinine and Serum Phosphorus | Serum creatinine, Grade 1 | 0 Participants |
| TDF 300 mg | Number of Participants With the Indicated Treatment-emergent Laboratory Abnormalities for Serum Creatinine and Serum Phosphorus | Serum creatinine, Grade 2 | 0 Participants |
| TDF 300 mg | Number of Participants With the Indicated Treatment-emergent Laboratory Abnormalities for Serum Creatinine and Serum Phosphorus | Serum creatinine, Grade 3 | 0 Participants |
| TDF 300 mg | Number of Participants With the Indicated Treatment-emergent Laboratory Abnormalities for Serum Creatinine and Serum Phosphorus | Serum creatinine, Grade 4 | 0 Participants |
| TDF 300 mg | Number of Participants With the Indicated Treatment-emergent Laboratory Abnormalities for Serum Creatinine and Serum Phosphorus | Serum phosphorus, Grade 1 | NA Participants |
| TDF 300 mg | Number of Participants With the Indicated Treatment-emergent Laboratory Abnormalities for Serum Creatinine and Serum Phosphorus | Serum phosphorus, Grade 2 | 42 Participants |
| TDF 300 mg | Number of Participants With the Indicated Treatment-emergent Laboratory Abnormalities for Serum Creatinine and Serum Phosphorus | Serum phosphorus, Grade 3 | 2 Participants |
| TDF 300 mg | Number of Participants With the Indicated Treatment-emergent Laboratory Abnormalities for Serum Creatinine and Serum Phosphorus | Serum phosphorus, Grade 4 | 0 Participants |
| ADV 10 mg | Number of Participants With the Indicated Treatment-emergent Laboratory Abnormalities for Serum Creatinine and Serum Phosphorus | Serum phosphorus, Grade 4 | 0 Participants |
| ADV 10 mg | Number of Participants With the Indicated Treatment-emergent Laboratory Abnormalities for Serum Creatinine and Serum Phosphorus | Serum creatinine, Grade 1 | 1 Participants |
| ADV 10 mg | Number of Participants With the Indicated Treatment-emergent Laboratory Abnormalities for Serum Creatinine and Serum Phosphorus | Serum phosphorus, Grade 1 | NA Participants |
| ADV 10 mg | Number of Participants With the Indicated Treatment-emergent Laboratory Abnormalities for Serum Creatinine and Serum Phosphorus | Serum creatinine, Grade 2 | 0 Participants |
| ADV 10 mg | Number of Participants With the Indicated Treatment-emergent Laboratory Abnormalities for Serum Creatinine and Serum Phosphorus | Serum phosphorus, Grade 3 | 3 Participants |
| ADV 10 mg | Number of Participants With the Indicated Treatment-emergent Laboratory Abnormalities for Serum Creatinine and Serum Phosphorus | Serum creatinine, Grade 3 | 0 Participants |
| ADV 10 mg | Number of Participants With the Indicated Treatment-emergent Laboratory Abnormalities for Serum Creatinine and Serum Phosphorus | Serum phosphorus, Grade 2 | 55 Participants |
| ADV 10 mg | Number of Participants With the Indicated Treatment-emergent Laboratory Abnormalities for Serum Creatinine and Serum Phosphorus | Serum creatinine, Grade 4 | 0 Participants |
Secondary
Number of Participants With Virological Breakthrough at Weeks 48, 96, 144, 192 and 240
The number of HBeAg-positive and HBeAg-negative participants who had virological breakthrough at Weeks 48, 96, 144, 192 and 240 were assessed. Virological breakthrough is defined by \>= one log increase in HBV DNA from NADIR (as determined by two sequential HBV DNA measurements at least one month apart or last on treatment measurement). A non-completers equal failures approach was used for the analysis in ITT population.
Time frame: Weeks 48, 96, 144, 192 and 240
Population: ITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TDF 300 mg | Number of Participants With Virological Breakthrough at Weeks 48, 96, 144, 192 and 240 | Week 192, HBeAg-negative, n=154, 153 | 3 Participants |
| TDF 300 mg | Number of Participants With Virological Breakthrough at Weeks 48, 96, 144, 192 and 240 | Week 48,HBeAg-Positive, n=103, 99 | 0 Participants |
| TDF 300 mg | Number of Participants With Virological Breakthrough at Weeks 48, 96, 144, 192 and 240 | Week 48, HBeAg-Negative, n=154, 153 | 0 Participants |
| TDF 300 mg | Number of Participants With Virological Breakthrough at Weeks 48, 96, 144, 192 and 240 | Week 96, HBeAg-positive, n=103, 99 | 0 Participants |
| TDF 300 mg | Number of Participants With Virological Breakthrough at Weeks 48, 96, 144, 192 and 240 | Week 96, HBeAg-negative, n=154, 153 | 2 Participants |
| TDF 300 mg | Number of Participants With Virological Breakthrough at Weeks 48, 96, 144, 192 and 240 | Week 144, HBeAg-positive, n=103, 99 | 0 Participants |
| TDF 300 mg | Number of Participants With Virological Breakthrough at Weeks 48, 96, 144, 192 and 240 | Week 144, HBeAg-negative, n=154, 153 | 3 Participants |
| TDF 300 mg | Number of Participants With Virological Breakthrough at Weeks 48, 96, 144, 192 and 240 | Week 192, HBeAg-positive, n=103, 99 | 0 Participants |
| TDF 300 mg | Number of Participants With Virological Breakthrough at Weeks 48, 96, 144, 192 and 240 | Week 240, HBeAg-positive, n=103, 99 | 4 Participants |
| TDF 300 mg | Number of Participants With Virological Breakthrough at Weeks 48, 96, 144, 192 and 240 | Week 240, HBeAg-negative, n=154, 153 | 3 Participants |
| ADV 10 mg | Number of Participants With Virological Breakthrough at Weeks 48, 96, 144, 192 and 240 | Week 192, HBeAg-positive, n=103, 99 | 7 Participants |
| ADV 10 mg | Number of Participants With Virological Breakthrough at Weeks 48, 96, 144, 192 and 240 | Week 192, HBeAg-negative, n=154, 153 | 5 Participants |
| ADV 10 mg | Number of Participants With Virological Breakthrough at Weeks 48, 96, 144, 192 and 240 | Week 144, HBeAg-positive, n=103, 99 | 7 Participants |
| ADV 10 mg | Number of Participants With Virological Breakthrough at Weeks 48, 96, 144, 192 and 240 | Week 48,HBeAg-Positive, n=103, 99 | 4 Participants |
| ADV 10 mg | Number of Participants With Virological Breakthrough at Weeks 48, 96, 144, 192 and 240 | Week 240, HBeAg-negative, n=154, 153 | 8 Participants |
| ADV 10 mg | Number of Participants With Virological Breakthrough at Weeks 48, 96, 144, 192 and 240 | Week 48, HBeAg-Negative, n=154, 153 | 2 Participants |
| ADV 10 mg | Number of Participants With Virological Breakthrough at Weeks 48, 96, 144, 192 and 240 | Week 144, HBeAg-negative, n=154, 153 | 4 Participants |
| ADV 10 mg | Number of Participants With Virological Breakthrough at Weeks 48, 96, 144, 192 and 240 | Week 96, HBeAg-positive, n=103, 99 | 4 Participants |
| ADV 10 mg | Number of Participants With Virological Breakthrough at Weeks 48, 96, 144, 192 and 240 | Week 240, HBeAg-positive, n=103, 99 | 11 Participants |
| ADV 10 mg | Number of Participants With Virological Breakthrough at Weeks 48, 96, 144, 192 and 240 | Week 96, HBeAg-negative, n=154, 153 | 3 Participants |
Secondary
Participants With HBV DNA <400 Copies/mL at Weeks 96, 144, 192, and 240
The number of participants with HBV DNA \<400 copies/mL in the hepatitis B e antigen (HBeAg)-positive and HBeAg-negative population was assessed. HBeAg is a viral protein that is secreted by hepatitis B-infected cells. It is associated with chronic hepatitis B infections and is used as a marker of active viral disease and a participant's degree of infectiousness. A positive result indicates that the participant has high levels of virus in the blood and greater infectiousness. Usually, a negative result indicates that the participant has lower levels of virus in the blood and is less infectious. Week 96, 144, 192, and 240 data are not yet available, as this report includes data up to and including Week 48. A non-completers equal failures approach is used for the analysis in ITT population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Time frame: Weeks 96, 144, 192, and 240
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TDF 300 mg | Participants With HBV DNA <400 Copies/mL at Weeks 96, 144, 192, and 240 | Week 96, HBeAg-negative, n=154, 153 | 144 Participants |
| TDF 300 mg | Participants With HBV DNA <400 Copies/mL at Weeks 96, 144, 192, and 240 | Week 192,HBeAg-negative, n=154,153 | 144 Participants |
| TDF 300 mg | Participants With HBV DNA <400 Copies/mL at Weeks 96, 144, 192, and 240 | Week 144, HBeAg-negative, n=154,153 | 144 Participants |
| TDF 300 mg | Participants With HBV DNA <400 Copies/mL at Weeks 96, 144, 192, and 240 | Week 240, HBeAg-positive, n=103,99 | 87 Participants |
| TDF 300 mg | Participants With HBV DNA <400 Copies/mL at Weeks 96, 144, 192, and 240 | Week 144, HBeAg-positive, n=103, 99 | 97 Participants |
| TDF 300 mg | Participants With HBV DNA <400 Copies/mL at Weeks 96, 144, 192, and 240 | Week 240, HBeAg-negative, n=154,153 | 138 Participants |
| TDF 300 mg | Participants With HBV DNA <400 Copies/mL at Weeks 96, 144, 192, and 240 | Week 192, HBeAg-positive, n=103,99 | 94 Participants |
| TDF 300 mg | Participants With HBV DNA <400 Copies/mL at Weeks 96, 144, 192, and 240 | Week 96, HBeAg-positive, n=103, 99 | 95 Participants |
| ADV 10 mg | Participants With HBV DNA <400 Copies/mL at Weeks 96, 144, 192, and 240 | Week 192, HBeAg-positive, n=103,99 | 93 Participants |
| ADV 10 mg | Participants With HBV DNA <400 Copies/mL at Weeks 96, 144, 192, and 240 | Week 96, HBeAg-negative, n=154, 153 | 143 Participants |
| ADV 10 mg | Participants With HBV DNA <400 Copies/mL at Weeks 96, 144, 192, and 240 | Week 144, HBeAg-positive, n=103, 99 | 95 Participants |
| ADV 10 mg | Participants With HBV DNA <400 Copies/mL at Weeks 96, 144, 192, and 240 | Week 144, HBeAg-negative, n=154,153 | 145 Participants |
| ADV 10 mg | Participants With HBV DNA <400 Copies/mL at Weeks 96, 144, 192, and 240 | Week 96, HBeAg-positive, n=103, 99 | 92 Participants |
| ADV 10 mg | Participants With HBV DNA <400 Copies/mL at Weeks 96, 144, 192, and 240 | Week 192,HBeAg-negative, n=154,153 | 141 Participants |
| ADV 10 mg | Participants With HBV DNA <400 Copies/mL at Weeks 96, 144, 192, and 240 | Week 240, HBeAg-positive, n=103,99 | 87 Participants |
| ADV 10 mg | Participants With HBV DNA <400 Copies/mL at Weeks 96, 144, 192, and 240 | Week 240, HBeAg-negative, n=154,153 | 137 Participants |