Hepatitis B, Chronic
Conditions
Keywords
Tenofovir Disoproxil Fumarate, Chronic Hepatitis B
Brief summary
The purpose of this study is to evaluate the efficacy and safety of GSK548470 administered once daily at a dose level of 300 mg to Japanese patients with compensated chronic hepatitis B untreated with any nucleic acid analogue. In efficacy, the non-inferiority of GSK548470 to ETV will be verified using the antiviral effect as the index.
Detailed description
This study is a multicenter, randomized, active comparator-controlled, double-blind, parallel-group comparison study in Japanese patients with compensated chronic hepatitis B untreated with any nucleic acid analogue and its subsequent open-label study. Efficacy and safety will be compared between once-daily dosing of GSK548470 300 mg and once-daily dosing of ETV 0.5 mg, and subsequently the efficacy and safety of GSK548470 administered long term will be investigated. A total of 165 subjects will be assigned to the GSK548470 group or the ETV group at a ratio of 2:1. The subjects will be assigned by stratified randomization in terms of HBe antigen and serum HBV-DNA level. The primary purpose is to verify the non-inferiority of GSK548470 to ETV using as an index the change amount of HBV-DNA level at Week 24 from the baseline level. The secondary purpose is to investigate the efficacy and safety of GSK548470 300 mg administered once daily for a long term.
Interventions
Blue tablets, each tablet containing 300 mg of tenofovir disoproxil fumarate
DRUGETV 0.5 mg capsule
Brown capsules, each capsule containing 0.53 mg of entecavir hydrate
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
16 Years to 69 Years
Healthy volunteers
No
Inclusion criteria
* The ability to understand and sign a written informed consent form * 16 to 69 years of age at the time of informed consent * Females of childbearing potential must have a negative pregnancy test and agree to avoidance of pregnancy * Subject must show QTc \< 450 millisecond (msec) or \< 480 msec with Bundle Branch Block * Chronic HBV infection, defined as positive serum HBsAg for at least 6 month, or negative serum IgM-HBc antibody * HBeAg positive; HBV-DNA \>= 6 log10 copies/mL, HBeAg negative; HBV-DNA \>= 5 log10 copies/mL * Serum ALT \>= 31 U/L and \<= 10 × ULN * Creatinine clearance \>= 70 mL/min * Haemoglobin \>= 8 g/dL * WBC \>= 1,000 /mm3 * Nucleic acid analogue naïve, i.e., no prior therapy for over 6 months in the past * No mutation that shows resistance in LAM, ETV and/or TDF at screening
Exclusion criteria
* Decompensated liver disease * Co-infection with HIV or HCV * Autoimmune hepatitis rather than chronic hepatitis B * Subject with serious complication * Received or have a plan for solid organ or bone marrow transplantation * Has proximal tubulopathy * History of hypersensitivity to nucleoside and/or nucleotide analogues * Evidence of hepatocellular carcinoma by diagnostic imaging at screening and/or serum α-fetoprotein \> 50 ng/mL at screening * History of HCC * Received any nucleoside, nucleotide, interferon or HB vaccine therapy within 24 weeks prior to initiation * Received overdose NSAIDs, excluding temporary or topical use, within 7 days prior to initiation * Received drugs for injection containing glycyrrhizin as the main component within 4 weeks prior to initiation * Received drugs causing renal impairment, competitors of renal excretion, immunosuppressants, chemotherapeutics and/or corticosteroids within 8 weeks prior to initiation * Participation in another clinical study within 6 months of study entry or planned participation in another clinical study after entry to this study * Woman who is pregnant, lactating, possibly pregnant or planning a pregnancy during the study period * Psychiatry disorder or cognitive disorder that may affect the subject ability to give informed consent or to follow specified study procedures * History of alcohol or drug abuse * Any condition or situation that may interfere with the subject's participation in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Serum HBV DNA Level at Week 24 | Baseline and Week 24 | The mean change from Baseline in the hepatitis B virus deoxyribonucleic acid (HBV DNA) level at Week 24 was assessed (lower limit of quantitation : 2.1 log 10 copies/mL). The mean values were adjusted by Baseline HBV DNA levels. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Serum HBV DNA < 2.1 log10 Copies/mL at Week 24, Week 48 and Week 96 | Week 24, Week 48 and Week 96 | The number of participants with serum HBV DNA level less than the lower limit of quantitation (i.e. 2.1 log10 copies/mL) at Week 24, Week 48 and Week 96 were summarized. The LOCF method was applied for missing values. |
| Number of Participants With Alanine Aminotransferase (ALT) Normalization at Week 24, Week 48 and Week 96 | Week 24, Week 48 and Week 96 | The number of participants with alanine aminotransferase (ALT) normalization at Week 24, Week 48 and Week 96 were summarized. ALT normalization is defined as when an ALT value exceeds the upper limit of normal range (ULN) at Baseline and within the normal range at the end of treatment. The LOCF method was applied for missing values. |
| Number of Participants With HBeAg Loss at Week 24, Week 48 and Week 96 | Week 24, Week 48 and Week 96 | The number of participants achieving hepatitis Be antigen (HBeAg) loss at Week 24, Week 48 and Week 96 in positive HBeAg participants at Baseline were summarized. Loss of HBeAg is defined as the change of detectable HBeAg from positive to negative. The LOCF method was applied for missing values. |
| Number of Participants With HBeAg/HBeAb Seroconversion at Week 24, Week 48 and Week 96 | Week 24, Week 48 and Week 96 | The number of participants achieving HBeAg/hepatitis Be antibody (HBeAb) seroconversion at Week 24, Week 48 and Week 96 in positive HBeAg and negative HBeAb participants at Baseline were summarized. Seroconversion to HBeAg is defined as the change of detectable antibody to HBeAg from negative to positive. The LOCF method was applied for missing values. |
| Number of Participants Achieving HBsAg Loss at Week 24, Week 48 and Week 96 | Week 24, Week 48 and Week 96 | The number of participants with hepatitis B surface antigen (HBsAg) loss at Week 24, Week 48 and Week 96 in positive HBsAg participants at Baseline were summarized. Loss of HBsAg is defined as change of detectable HBsAg from positive to negative. The LOCF method was applied for missing values. |
| Mean Change From Baseline in Serum HBV DNA Level at Week 48 and Week 96 | Baseline, Week 48 and Week 96 | The mean change from Baseline in the HBV DNA level at Week 48 and Week 96 were assessed (lower limit of quantitation : 2.1 log10 copies/mL). The mean values were adjusted by Baseline HBV DNA levels. Change from Baseline was calculated as the post-baseline value minus the Baseline value. The LOCF method was applied for missing values. |
| Number of Participants Achieving Each Indicated HBsAg Category at Baseline, Week 24, Week 48 and Week 96 | Baseline, Week 24, Week 48 and Week 96 | The number of participants achieving each indicated HBsAg category (HBsAg \<80, 80 to 800, 800 to 8000, 8000 to 80000, and \>=80000) (kilo international unit per liter \[KIU/L\]) by study visit was summarized. The LOCF method was applied for missing values. |
| Number of Participants Achieving Each Indicated HBcrAg Category at Baseline, Week 24, Week 48 and Week 96 | Baseline, Week 24, Week 48 and Week 96 | The number of participants achieving each indicated hepatitis B core-related antigen (HBcrAg) category (HBcrAg \<3.0, 3.0 to 4.0, 4.0 to 5.0, 5.0 to 6.0, and \>=6.0) (Log kilo unit per liter \[KU/L\]) by study visit was summarized. The LOCF method was applied for missing values. |
| Number of Participants With Virological Breakthrough Through End of the Study | From Baseline to throughout study | The number of participants who experienced virological breakthrough was summarized. Virological breakthrough is defined as serum HBV DNA level increase \>=1 log10 copies/mL above the treatment nadir. Virological breakthrough values were presented from Baseline to through out the study. Baseline is defined as the value at Week 0 visit. |
| Number of Participants With Resistance Related Mutations at Week 24, Week 48, Week 96 and Virological Breakthrough (Baseline to Throughout the Study) | Screening, Week 24, Week 48, Week 96 and Virological Breakthrough (Baseline to throughout the study) | The development of drug resistance-related (RA) mutations was analyzed to look for resistance to Lamivudine (LAM), Adefovir dipivoxil (ADV), and/or ETV in a case where a virologic breakthrough has been observed after starting the study treatment (serum HBV DNA level has increased from the nadir by at least 1 log10 copies/mL) or where the serum HBV DNA level is not less than the HBV DNA detection limit (2.1 log10 copies/mL) at Week 24, Week 48 and Week 96. Virologic breakthrough was defined as 1.0 log10 or greater increases in serum HBV-DNA levels from on-treatment nadir. Participants who achieved the HBV-DNA values below lower limit of quantification (LLQ) (\< 2.1 log10 copies/mL) in quantitative analysis at entire the study were also considered Negative in drug-resistance without implementation of genotypic analysis. Resistance mutation values were presented from Baseline to throughout the study. Baseline is defined as the value at Week 0 visit. |
| Number of Participants Achieving HBsAg/HBsAb Seroconversion at Week 24, Week 48 and Week 96 | Week 24, Week 48 and Week 96 | The number of participants with HBsAg/hepatitis B surface antibody (HBsAb) seroconversion at Week 24, Week 48 and Week 96 in positive HBsAg and negative HBsAb participants at Baseline were summarized. HBsAg seroconversion .is defined as change of detectable antibody to HBsAg from negative to positive. The LOCF method was applied for missing values. |
Countries
Japan
Participant flow
Pre-assignment details
A total of 166 participants (110 participants in the Tenofovir Disoproxil Fumarate \[GSK548470, TDF\] group and 56 participants in the Entecavir Hydrate \[ETV\] group) were enrolled in the study.
Participants by arm
| Arm | Count |
|---|---|
| TDF 300 mg OD Participants received TDF 300 mg tablet OD and ETV placebo capsule OD for 96 weeks. | 109 |
| ETV 0.5 mg OD Participants received ETV 0.5 mg capsule OD and TDF placebo tablet OD for 48 weeks. | 56 |
| Total | 165 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Physician Decision | 1 | 0 |
| Overall Study | Study closed/terminated | 3 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 0 |
Baseline characteristics
| Characteristic | TDF 300 mg OD | ETV 0.5 mg OD | Total |
|---|---|---|---|
| Age, Continuous | 45.4 Years STANDARD_DEVIATION 9.23 | 46.1 Years STANDARD_DEVIATION 9.68 | 45.6 Years STANDARD_DEVIATION 9.36 |
| Race/Ethnicity, Customized Asian - Japanese Heritage | 109 Participants | 56 Participants | 165 Participants |
| Sex: Female, Male Female | 41 Participants | 16 Participants | 57 Participants |
| Sex: Female, Male Male | 68 Participants | 40 Participants | 108 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 83 / 109 | 40 / 56 |
| serious Total, serious adverse events | 7 / 109 | 2 / 56 |
Outcome results
Primary
Mean Change From Baseline in Serum HBV DNA Level at Week 24
The mean change from Baseline in the hepatitis B virus deoxyribonucleic acid (HBV DNA) level at Week 24 was assessed (lower limit of quantitation : 2.1 log 10 copies/mL). The mean values were adjusted by Baseline HBV DNA levels. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Time frame: Baseline and Week 24
Population: Per Protocol Set (PPS) Population: all participants who received at least 1 dose of investigational product (IP) and had at least one efficacy assessment after the treatment initiation, and with no major protocol violations. Missing values observed during the treatment period were imputed by the last observation carried forward (LOCF) method.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| TDF 300 mg OD | Mean Change From Baseline in Serum HBV DNA Level at Week 24 | -4.63 log10 copies/milliliter (copies/mL) | Standard Error 0.044 |
| ETV 0.5 mg OD | Mean Change From Baseline in Serum HBV DNA Level at Week 24 | -4.50 log10 copies/milliliter (copies/mL) | Standard Error 0.063 |
p-value: <0.000195% CI: [-0.28, 0.02]ANCOVA
Secondary
Mean Change From Baseline in Serum HBV DNA Level at Week 48 and Week 96
The mean change from Baseline in the HBV DNA level at Week 48 and Week 96 were assessed (lower limit of quantitation : 2.1 log10 copies/mL). The mean values were adjusted by Baseline HBV DNA levels. Change from Baseline was calculated as the post-baseline value minus the Baseline value. The LOCF method was applied for missing values.
Time frame: Baseline, Week 48 and Week 96
Population: Full Analysis Set (FAS) Population: all participants who entered into the study, received at least one dose of investigational product, and have at least one efficacy assessment after the treatment initiation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TDF 300 mg OD | Mean Change From Baseline in Serum HBV DNA Level at Week 48 and Week 96 | Week 48 | -4.86 log10 copies/mL | Standard Deviation 1.353 |
| TDF 300 mg OD | Mean Change From Baseline in Serum HBV DNA Level at Week 48 and Week 96 | Week 96 | -4.96 log10 copies/mL | Standard Deviation 1.445 |
| ETV 0.5 mg OD | Mean Change From Baseline in Serum HBV DNA Level at Week 48 and Week 96 | Week 48 | -4.85 log10 copies/mL | Standard Deviation 0.916 |
| ETV 0.5 mg OD | Mean Change From Baseline in Serum HBV DNA Level at Week 48 and Week 96 | Week 96 | NA log10 copies/mL | — |
95% CI: [-0.4, 0.39]
Secondary
Number of Participants Achieving Each Indicated HBcrAg Category at Baseline, Week 24, Week 48 and Week 96
The number of participants achieving each indicated hepatitis B core-related antigen (HBcrAg) category (HBcrAg \<3.0, 3.0 to 4.0, 4.0 to 5.0, 5.0 to 6.0, and \>=6.0) (Log kilo unit per liter \[KU/L\]) by study visit was summarized. The LOCF method was applied for missing values.
Time frame: Baseline, Week 24, Week 48 and Week 96
Population: FAS Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TDF 300 mg OD | Number of Participants Achieving Each Indicated HBcrAg Category at Baseline, Week 24, Week 48 and Week 96 | HBcrAg 4.0-5.0 Log KU/L, Baseline | 19 Participants |
| TDF 300 mg OD | Number of Participants Achieving Each Indicated HBcrAg Category at Baseline, Week 24, Week 48 and Week 96 | HBcrAg <3.0 Log KU/L, Week 48 | 24 Participants |
| TDF 300 mg OD | Number of Participants Achieving Each Indicated HBcrAg Category at Baseline, Week 24, Week 48 and Week 96 | HBcrAg <3.0 Log KU/L, Week 24 | 21 Participants |
| TDF 300 mg OD | Number of Participants Achieving Each Indicated HBcrAg Category at Baseline, Week 24, Week 48 and Week 96 | HBcrAg 3.0-4.0 Log KU/L, Week 48 | 16 Participants |
| TDF 300 mg OD | Number of Participants Achieving Each Indicated HBcrAg Category at Baseline, Week 24, Week 48 and Week 96 | HBcrAg 3.0-4.0 Log KU/L, Baseline | 13 Participants |
| TDF 300 mg OD | Number of Participants Achieving Each Indicated HBcrAg Category at Baseline, Week 24, Week 48 and Week 96 | HBcrAg 4.0-5.0 Log KU/L, Week 48 | 18 Participants |
| TDF 300 mg OD | Number of Participants Achieving Each Indicated HBcrAg Category at Baseline, Week 24, Week 48 and Week 96 | HBcrAg 3.0-4.0 Log KU/L, Week 24 | 16 Participants |
| TDF 300 mg OD | Number of Participants Achieving Each Indicated HBcrAg Category at Baseline, Week 24, Week 48 and Week 96 | HBcrAg 5.0-6.0 Log KU/L, Week 48 | 23 Participants |
| TDF 300 mg OD | Number of Participants Achieving Each Indicated HBcrAg Category at Baseline, Week 24, Week 48 and Week 96 | HBcrAg 5.0-6.0 Log KU/L, Baseline | 19 Participants |
| TDF 300 mg OD | Number of Participants Achieving Each Indicated HBcrAg Category at Baseline, Week 24, Week 48 and Week 96 | HBcrAg >=6.0 Log KU/L, Week 48 | 28 Participants |
| TDF 300 mg OD | Number of Participants Achieving Each Indicated HBcrAg Category at Baseline, Week 24, Week 48 and Week 96 | HBcrAg 4.0-5.0 Log KU/L, Week 24 | 18 Participants |
| TDF 300 mg OD | Number of Participants Achieving Each Indicated HBcrAg Category at Baseline, Week 24, Week 48 and Week 96 | HBcrAg <3.0 Log KU/L, Week 96 | 24 Participants |
| TDF 300 mg OD | Number of Participants Achieving Each Indicated HBcrAg Category at Baseline, Week 24, Week 48 and Week 96 | HBcrAg <3.0 Log KU/L, Baseline | 7 Participants |
| TDF 300 mg OD | Number of Participants Achieving Each Indicated HBcrAg Category at Baseline, Week 24, Week 48 and Week 96 | HBcrAg 5.0-6.0 Log KU/L, Week 24 | 17 Participants |
| TDF 300 mg OD | Number of Participants Achieving Each Indicated HBcrAg Category at Baseline, Week 24, Week 48 and Week 96 | HBcrAg 4.0-5.0 Log KU/L, Week 96 | 22 Participants |
| TDF 300 mg OD | Number of Participants Achieving Each Indicated HBcrAg Category at Baseline, Week 24, Week 48 and Week 96 | HBcrAg >=6.0 Log KU/L, Baseline | 51 Participants |
| TDF 300 mg OD | Number of Participants Achieving Each Indicated HBcrAg Category at Baseline, Week 24, Week 48 and Week 96 | HBcrAg 5.0-6.0 Log KU/L, Week 96 | 23 Participants |
| TDF 300 mg OD | Number of Participants Achieving Each Indicated HBcrAg Category at Baseline, Week 24, Week 48 and Week 96 | HBcrAg >=6.0 Log KU/L, Week 24 | 37 Participants |
| TDF 300 mg OD | Number of Participants Achieving Each Indicated HBcrAg Category at Baseline, Week 24, Week 48 and Week 96 | HBcrAg >=6.0 Log KU/L, Week 96 | 22 Participants |
| TDF 300 mg OD | Number of Participants Achieving Each Indicated HBcrAg Category at Baseline, Week 24, Week 48 and Week 96 | HBcrAg 3.0-4.0 Log KU/L, Week 96 | 18 Participants |
| ETV 0.5 mg OD | Number of Participants Achieving Each Indicated HBcrAg Category at Baseline, Week 24, Week 48 and Week 96 | HBcrAg >=6.0 Log KU/L, Week 96 | NA Participants |
| ETV 0.5 mg OD | Number of Participants Achieving Each Indicated HBcrAg Category at Baseline, Week 24, Week 48 and Week 96 | HBcrAg <3.0 Log KU/L, Baseline | 0 Participants |
| ETV 0.5 mg OD | Number of Participants Achieving Each Indicated HBcrAg Category at Baseline, Week 24, Week 48 and Week 96 | HBcrAg 3.0-4.0 Log KU/L, Baseline | 6 Participants |
| ETV 0.5 mg OD | Number of Participants Achieving Each Indicated HBcrAg Category at Baseline, Week 24, Week 48 and Week 96 | HBcrAg 4.0-5.0 Log KU/L, Baseline | 11 Participants |
| ETV 0.5 mg OD | Number of Participants Achieving Each Indicated HBcrAg Category at Baseline, Week 24, Week 48 and Week 96 | HBcrAg 5.0-6.0 Log KU/L, Baseline | 9 Participants |
| ETV 0.5 mg OD | Number of Participants Achieving Each Indicated HBcrAg Category at Baseline, Week 24, Week 48 and Week 96 | HBcrAg >=6.0 Log KU/L, Baseline | 30 Participants |
| ETV 0.5 mg OD | Number of Participants Achieving Each Indicated HBcrAg Category at Baseline, Week 24, Week 48 and Week 96 | HBcrAg <3.0 Log KU/L, Week 24 | 10 Participants |
| ETV 0.5 mg OD | Number of Participants Achieving Each Indicated HBcrAg Category at Baseline, Week 24, Week 48 and Week 96 | HBcrAg 3.0-4.0 Log KU/L, Week 24 | 8 Participants |
| ETV 0.5 mg OD | Number of Participants Achieving Each Indicated HBcrAg Category at Baseline, Week 24, Week 48 and Week 96 | HBcrAg 4.0-5.0 Log KU/L, Week 24 | 8 Participants |
| ETV 0.5 mg OD | Number of Participants Achieving Each Indicated HBcrAg Category at Baseline, Week 24, Week 48 and Week 96 | HBcrAg 5.0-6.0 Log KU/L, Week 24 | 7 Participants |
| ETV 0.5 mg OD | Number of Participants Achieving Each Indicated HBcrAg Category at Baseline, Week 24, Week 48 and Week 96 | HBcrAg >=6.0 Log KU/L, Week 24 | 23 Participants |
| ETV 0.5 mg OD | Number of Participants Achieving Each Indicated HBcrAg Category at Baseline, Week 24, Week 48 and Week 96 | HBcrAg <3.0 Log KU/L, Week 48 | 12 Participants |
| ETV 0.5 mg OD | Number of Participants Achieving Each Indicated HBcrAg Category at Baseline, Week 24, Week 48 and Week 96 | HBcrAg 3.0-4.0 Log KU/L, Week 48 | 6 Participants |
| ETV 0.5 mg OD | Number of Participants Achieving Each Indicated HBcrAg Category at Baseline, Week 24, Week 48 and Week 96 | HBcrAg 4.0-5.0 Log KU/L, Week 48 | 9 Participants |
| ETV 0.5 mg OD | Number of Participants Achieving Each Indicated HBcrAg Category at Baseline, Week 24, Week 48 and Week 96 | HBcrAg 5.0-6.0 Log KU/L, Week 48 | 10 Participants |
| ETV 0.5 mg OD | Number of Participants Achieving Each Indicated HBcrAg Category at Baseline, Week 24, Week 48 and Week 96 | HBcrAg >=6.0 Log KU/L, Week 48 | 19 Participants |
| ETV 0.5 mg OD | Number of Participants Achieving Each Indicated HBcrAg Category at Baseline, Week 24, Week 48 and Week 96 | HBcrAg <3.0 Log KU/L, Week 96 | NA Participants |
| ETV 0.5 mg OD | Number of Participants Achieving Each Indicated HBcrAg Category at Baseline, Week 24, Week 48 and Week 96 | HBcrAg 3.0-4.0 Log KU/L, Week 96 | NA Participants |
| ETV 0.5 mg OD | Number of Participants Achieving Each Indicated HBcrAg Category at Baseline, Week 24, Week 48 and Week 96 | HBcrAg 4.0-5.0 Log KU/L, Week 96 | NA Participants |
| ETV 0.5 mg OD | Number of Participants Achieving Each Indicated HBcrAg Category at Baseline, Week 24, Week 48 and Week 96 | HBcrAg 5.0-6.0 Log KU/L, Week 96 | NA Participants |
Secondary
Number of Participants Achieving Each Indicated HBsAg Category at Baseline, Week 24, Week 48 and Week 96
The number of participants achieving each indicated HBsAg category (HBsAg \<80, 80 to 800, 800 to 8000, 8000 to 80000, and \>=80000) (kilo international unit per liter \[KIU/L\]) by study visit was summarized. The LOCF method was applied for missing values.
Time frame: Baseline, Week 24, Week 48 and Week 96
Population: FAS Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TDF 300 mg OD | Number of Participants Achieving Each Indicated HBsAg Category at Baseline, Week 24, Week 48 and Week 96 | HBsAg <80 KIU/L, Baseline | 2 Participants |
| TDF 300 mg OD | Number of Participants Achieving Each Indicated HBsAg Category at Baseline, Week 24, Week 48 and Week 96 | HBsAg 80-800 KIU/L, Baseline | 15 Participants |
| TDF 300 mg OD | Number of Participants Achieving Each Indicated HBsAg Category at Baseline, Week 24, Week 48 and Week 96 | HBsAg 800-8000 KIU/L, Baseline | 58 Participants |
| TDF 300 mg OD | Number of Participants Achieving Each Indicated HBsAg Category at Baseline, Week 24, Week 48 and Week 96 | HBsAg 8000-80,000 KIU/L, Baseline | 31 Participants |
| TDF 300 mg OD | Number of Participants Achieving Each Indicated HBsAg Category at Baseline, Week 24, Week 48 and Week 96 | HBsAg >=80,000 KIU/L, Baseline | 3 Participants |
| TDF 300 mg OD | Number of Participants Achieving Each Indicated HBsAg Category at Baseline, Week 24, Week 48 and Week 96 | HBsAg <80 KIU/L, Week 24 | 3 Participants |
| TDF 300 mg OD | Number of Participants Achieving Each Indicated HBsAg Category at Baseline, Week 24, Week 48 and Week 96 | HBsAg 80-800 KIU/L, Week 24 | 17 Participants |
| TDF 300 mg OD | Number of Participants Achieving Each Indicated HBsAg Category at Baseline, Week 24, Week 48 and Week 96 | HBsAg 800-8000 KIU/L, Week 24 | 63 Participants |
| TDF 300 mg OD | Number of Participants Achieving Each Indicated HBsAg Category at Baseline, Week 24, Week 48 and Week 96 | HBsAg 8000-80,000 KIU/L, Week 24 | 26 Participants |
| TDF 300 mg OD | Number of Participants Achieving Each Indicated HBsAg Category at Baseline, Week 24, Week 48 and Week 96 | HBsAg >=80,000 KIU/L, Week 24 | 0 Participants |
| TDF 300 mg OD | Number of Participants Achieving Each Indicated HBsAg Category at Baseline, Week 24, Week 48 and Week 96 | HBsAg <80 KIU/L, Week 48 | 5 Participants |
| TDF 300 mg OD | Number of Participants Achieving Each Indicated HBsAg Category at Baseline, Week 24, Week 48 and Week 96 | HBsAg 80-800 KIU/L, Week 48 | 19 Participants |
| TDF 300 mg OD | Number of Participants Achieving Each Indicated HBsAg Category at Baseline, Week 24, Week 48 and Week 96 | HBsAg 800-8000 KIU/L, Week 48 | 60 Participants |
| TDF 300 mg OD | Number of Participants Achieving Each Indicated HBsAg Category at Baseline, Week 24, Week 48 and Week 96 | HBsAg 8000-80,000 KIU/L, Week 48 | 25 Participants |
| TDF 300 mg OD | Number of Participants Achieving Each Indicated HBsAg Category at Baseline, Week 24, Week 48 and Week 96 | HBsAg >=80,000 KIU/L, Week 48 | 0 Participants |
| TDF 300 mg OD | Number of Participants Achieving Each Indicated HBsAg Category at Baseline, Week 24, Week 48 and Week 96 | HBsAg <80 KIU/L, Week 96 | 5 Participants |
| TDF 300 mg OD | Number of Participants Achieving Each Indicated HBsAg Category at Baseline, Week 24, Week 48 and Week 96 | HBsAg 80-800 KIU/L, Week 96 | 23 Participants |
| TDF 300 mg OD | Number of Participants Achieving Each Indicated HBsAg Category at Baseline, Week 24, Week 48 and Week 96 | HBsAg 800-8000 KIU/L, Week 96 | 60 Participants |
| TDF 300 mg OD | Number of Participants Achieving Each Indicated HBsAg Category at Baseline, Week 24, Week 48 and Week 96 | HBsAg 8000-80,000 KIU/L, Week 96 | 21 Participants |
| TDF 300 mg OD | Number of Participants Achieving Each Indicated HBsAg Category at Baseline, Week 24, Week 48 and Week 96 | HBsAg >=80,000 KIU/L, Week 96 | 0 Participants |
| ETV 0.5 mg OD | Number of Participants Achieving Each Indicated HBsAg Category at Baseline, Week 24, Week 48 and Week 96 | HBsAg 800-8000 KIU/L, Week 96 | NA Participants |
| ETV 0.5 mg OD | Number of Participants Achieving Each Indicated HBsAg Category at Baseline, Week 24, Week 48 and Week 96 | HBsAg <80 KIU/L, Baseline | 2 Participants |
| ETV 0.5 mg OD | Number of Participants Achieving Each Indicated HBsAg Category at Baseline, Week 24, Week 48 and Week 96 | HBsAg <80 KIU/L, Week 48 | 1 Participants |
| ETV 0.5 mg OD | Number of Participants Achieving Each Indicated HBsAg Category at Baseline, Week 24, Week 48 and Week 96 | HBsAg 80-800 KIU/L, Baseline | 10 Participants |
| ETV 0.5 mg OD | Number of Participants Achieving Each Indicated HBsAg Category at Baseline, Week 24, Week 48 and Week 96 | HBsAg <80 KIU/L, Week 96 | NA Participants |
| ETV 0.5 mg OD | Number of Participants Achieving Each Indicated HBsAg Category at Baseline, Week 24, Week 48 and Week 96 | HBsAg 800-8000 KIU/L, Baseline | 33 Participants |
| ETV 0.5 mg OD | Number of Participants Achieving Each Indicated HBsAg Category at Baseline, Week 24, Week 48 and Week 96 | HBsAg 80-800 KIU/L, Week 48 | 9 Participants |
| ETV 0.5 mg OD | Number of Participants Achieving Each Indicated HBsAg Category at Baseline, Week 24, Week 48 and Week 96 | HBsAg 8000-80,000 KIU/L, Baseline | 10 Participants |
| ETV 0.5 mg OD | Number of Participants Achieving Each Indicated HBsAg Category at Baseline, Week 24, Week 48 and Week 96 | HBsAg >=80,000 KIU/L, Week 96 | NA Participants |
| ETV 0.5 mg OD | Number of Participants Achieving Each Indicated HBsAg Category at Baseline, Week 24, Week 48 and Week 96 | HBsAg >=80,000 KIU/L, Baseline | 1 Participants |
| ETV 0.5 mg OD | Number of Participants Achieving Each Indicated HBsAg Category at Baseline, Week 24, Week 48 and Week 96 | HBsAg 800-8000 KIU/L, Week 48 | 39 Participants |
| ETV 0.5 mg OD | Number of Participants Achieving Each Indicated HBsAg Category at Baseline, Week 24, Week 48 and Week 96 | HBsAg <80 KIU/L, Week 24 | 1 Participants |
| ETV 0.5 mg OD | Number of Participants Achieving Each Indicated HBsAg Category at Baseline, Week 24, Week 48 and Week 96 | HBsAg 80-800 KIU/L, Week 96 | NA Participants |
| ETV 0.5 mg OD | Number of Participants Achieving Each Indicated HBsAg Category at Baseline, Week 24, Week 48 and Week 96 | HBsAg 80-800 KIU/L, Week 24 | 10 Participants |
| ETV 0.5 mg OD | Number of Participants Achieving Each Indicated HBsAg Category at Baseline, Week 24, Week 48 and Week 96 | HBsAg 8000-80,000 KIU/L, Week 48 | 7 Participants |
| ETV 0.5 mg OD | Number of Participants Achieving Each Indicated HBsAg Category at Baseline, Week 24, Week 48 and Week 96 | HBsAg >=80,000 KIU/L, Week 24 | 0 Participants |
| ETV 0.5 mg OD | Number of Participants Achieving Each Indicated HBsAg Category at Baseline, Week 24, Week 48 and Week 96 | HBsAg 800-8000 KIU/L, Week 24 | 36 Participants |
| ETV 0.5 mg OD | Number of Participants Achieving Each Indicated HBsAg Category at Baseline, Week 24, Week 48 and Week 96 | HBsAg 8000-80,000 KIU/L, Week 96 | NA Participants |
| ETV 0.5 mg OD | Number of Participants Achieving Each Indicated HBsAg Category at Baseline, Week 24, Week 48 and Week 96 | HBsAg 8000-80,000 KIU/L, Week 24 | 9 Participants |
| ETV 0.5 mg OD | Number of Participants Achieving Each Indicated HBsAg Category at Baseline, Week 24, Week 48 and Week 96 | HBsAg >=80,000 KIU/L, Week 48 | 0 Participants |
Secondary
Number of Participants Achieving HBsAg/HBsAb Seroconversion at Week 24, Week 48 and Week 96
The number of participants with HBsAg/hepatitis B surface antibody (HBsAb) seroconversion at Week 24, Week 48 and Week 96 in positive HBsAg and negative HBsAb participants at Baseline were summarized. HBsAg seroconversion .is defined as change of detectable antibody to HBsAg from negative to positive. The LOCF method was applied for missing values.
Time frame: Week 24, Week 48 and Week 96
Population: FAS Population. Only participants with positive HBsAg and negative HBsAb at Baseline were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TDF 300 mg OD | Number of Participants Achieving HBsAg/HBsAb Seroconversion at Week 24, Week 48 and Week 96 | Week 24 | 0 Participants |
| TDF 300 mg OD | Number of Participants Achieving HBsAg/HBsAb Seroconversion at Week 24, Week 48 and Week 96 | Week 48 | 0 Participants |
| TDF 300 mg OD | Number of Participants Achieving HBsAg/HBsAb Seroconversion at Week 24, Week 48 and Week 96 | Week 96 | 1 Participants |
| ETV 0.5 mg OD | Number of Participants Achieving HBsAg/HBsAb Seroconversion at Week 24, Week 48 and Week 96 | Week 24 | 0 Participants |
| ETV 0.5 mg OD | Number of Participants Achieving HBsAg/HBsAb Seroconversion at Week 24, Week 48 and Week 96 | Week 48 | 0 Participants |
| ETV 0.5 mg OD | Number of Participants Achieving HBsAg/HBsAb Seroconversion at Week 24, Week 48 and Week 96 | Week 96 | NA Participants |
Secondary
Number of Participants Achieving HBsAg Loss at Week 24, Week 48 and Week 96
The number of participants with hepatitis B surface antigen (HBsAg) loss at Week 24, Week 48 and Week 96 in positive HBsAg participants at Baseline were summarized. Loss of HBsAg is defined as change of detectable HBsAg from positive to negative. The LOCF method was applied for missing values.
Time frame: Week 24, Week 48 and Week 96
Population: FAS Population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TDF 300 mg OD | Number of Participants Achieving HBsAg Loss at Week 24, Week 48 and Week 96 | Week 24 | 0 Participants |
| TDF 300 mg OD | Number of Participants Achieving HBsAg Loss at Week 24, Week 48 and Week 96 | Week 48 | 0 Participants |
| TDF 300 mg OD | Number of Participants Achieving HBsAg Loss at Week 24, Week 48 and Week 96 | Week 96 | 1 Participants |
| ETV 0.5 mg OD | Number of Participants Achieving HBsAg Loss at Week 24, Week 48 and Week 96 | Week 24 | 0 Participants |
| ETV 0.5 mg OD | Number of Participants Achieving HBsAg Loss at Week 24, Week 48 and Week 96 | Week 48 | 0 Participants |
| ETV 0.5 mg OD | Number of Participants Achieving HBsAg Loss at Week 24, Week 48 and Week 96 | Week 96 | NA Participants |
Secondary
Number of Participants With Alanine Aminotransferase (ALT) Normalization at Week 24, Week 48 and Week 96
The number of participants with alanine aminotransferase (ALT) normalization at Week 24, Week 48 and Week 96 were summarized. ALT normalization is defined as when an ALT value exceeds the upper limit of normal range (ULN) at Baseline and within the normal range at the end of treatment. The LOCF method was applied for missing values.
Time frame: Week 24, Week 48 and Week 96
Population: Biochemically Evaluable Population (BEP): all participants who received at least one dose of IP and with an abnormal ALT at Baseline. The population for the analysis of ALT normalization was all participants with an ALT value \> ULN at Baseline.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TDF 300 mg OD | Number of Participants With Alanine Aminotransferase (ALT) Normalization at Week 24, Week 48 and Week 96 | Week 24 | 58 Participants |
| TDF 300 mg OD | Number of Participants With Alanine Aminotransferase (ALT) Normalization at Week 24, Week 48 and Week 96 | Week 48 | 62 Participants |
| TDF 300 mg OD | Number of Participants With Alanine Aminotransferase (ALT) Normalization at Week 24, Week 48 and Week 96 | Week 96 | 74 Participants |
| ETV 0.5 mg OD | Number of Participants With Alanine Aminotransferase (ALT) Normalization at Week 24, Week 48 and Week 96 | Week 24 | 35 Participants |
| ETV 0.5 mg OD | Number of Participants With Alanine Aminotransferase (ALT) Normalization at Week 24, Week 48 and Week 96 | Week 48 | 35 Participants |
| ETV 0.5 mg OD | Number of Participants With Alanine Aminotransferase (ALT) Normalization at Week 24, Week 48 and Week 96 | Week 96 | NA Participants |
Secondary
Number of Participants With HBeAg/HBeAb Seroconversion at Week 24, Week 48 and Week 96
The number of participants achieving HBeAg/hepatitis Be antibody (HBeAb) seroconversion at Week 24, Week 48 and Week 96 in positive HBeAg and negative HBeAb participants at Baseline were summarized. Seroconversion to HBeAg is defined as the change of detectable antibody to HBeAg from negative to positive. The LOCF method was applied for missing values.
Time frame: Week 24, Week 48 and Week 96
Population: FAS Population. Only participants with positive HBeAg and negative HBeAb at Baseline were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TDF 300 mg OD | Number of Participants With HBeAg/HBeAb Seroconversion at Week 24, Week 48 and Week 96 | Week 48 | 4 Participants |
| TDF 300 mg OD | Number of Participants With HBeAg/HBeAb Seroconversion at Week 24, Week 48 and Week 96 | Week 24 | 0 Participants |
| TDF 300 mg OD | Number of Participants With HBeAg/HBeAb Seroconversion at Week 24, Week 48 and Week 96 | Week 96 | 5 Participants |
| ETV 0.5 mg OD | Number of Participants With HBeAg/HBeAb Seroconversion at Week 24, Week 48 and Week 96 | Week 24 | 1 Participants |
| ETV 0.5 mg OD | Number of Participants With HBeAg/HBeAb Seroconversion at Week 24, Week 48 and Week 96 | Week 48 | 2 Participants |
| ETV 0.5 mg OD | Number of Participants With HBeAg/HBeAb Seroconversion at Week 24, Week 48 and Week 96 | Week 96 | NA Participants |
Secondary
Number of Participants With HBeAg Loss at Week 24, Week 48 and Week 96
The number of participants achieving hepatitis Be antigen (HBeAg) loss at Week 24, Week 48 and Week 96 in positive HBeAg participants at Baseline were summarized. Loss of HBeAg is defined as the change of detectable HBeAg from positive to negative. The LOCF method was applied for missing values.
Time frame: Week 24, Week 48 and Week 96
Population: FAS Population. Only participants with positive HBeAg at Baseline were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TDF 300 mg OD | Number of Participants With HBeAg Loss at Week 24, Week 48 and Week 96 | Week 24 | 3 Participants |
| TDF 300 mg OD | Number of Participants With HBeAg Loss at Week 24, Week 48 and Week 96 | Week 48 | 9 Participants |
| TDF 300 mg OD | Number of Participants With HBeAg Loss at Week 24, Week 48 and Week 96 | Week 96 | 13 Participants |
| ETV 0.5 mg OD | Number of Participants With HBeAg Loss at Week 24, Week 48 and Week 96 | Week 24 | 2 Participants |
| ETV 0.5 mg OD | Number of Participants With HBeAg Loss at Week 24, Week 48 and Week 96 | Week 48 | 3 Participants |
| ETV 0.5 mg OD | Number of Participants With HBeAg Loss at Week 24, Week 48 and Week 96 | Week 96 | NA Participants |
Secondary
Number of Participants With Resistance Related Mutations at Week 24, Week 48, Week 96 and Virological Breakthrough (Baseline to Throughout the Study)
The development of drug resistance-related (RA) mutations was analyzed to look for resistance to Lamivudine (LAM), Adefovir dipivoxil (ADV), and/or ETV in a case where a virologic breakthrough has been observed after starting the study treatment (serum HBV DNA level has increased from the nadir by at least 1 log10 copies/mL) or where the serum HBV DNA level is not less than the HBV DNA detection limit (2.1 log10 copies/mL) at Week 24, Week 48 and Week 96. Virologic breakthrough was defined as 1.0 log10 or greater increases in serum HBV-DNA levels from on-treatment nadir. Participants who achieved the HBV-DNA values below lower limit of quantification (LLQ) (\< 2.1 log10 copies/mL) in quantitative analysis at entire the study were also considered Negative in drug-resistance without implementation of genotypic analysis. Resistance mutation values were presented from Baseline to throughout the study. Baseline is defined as the value at Week 0 visit.
Time frame: Screening, Week 24, Week 48, Week 96 and Virological Breakthrough (Baseline to throughout the study)
Population: FAS Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TDF 300 mg OD | Number of Participants With Resistance Related Mutations at Week 24, Week 48, Week 96 and Virological Breakthrough (Baseline to Throughout the Study) | ADV RA mutations, Week 24, n=49, 34 | 0 Participants |
| TDF 300 mg OD | Number of Participants With Resistance Related Mutations at Week 24, Week 48, Week 96 and Virological Breakthrough (Baseline to Throughout the Study) | ETV RA mutations, Week 48, n=23, 19 | 0 Participants |
| TDF 300 mg OD | Number of Participants With Resistance Related Mutations at Week 24, Week 48, Week 96 and Virological Breakthrough (Baseline to Throughout the Study) | ADV RA mutations, Screening, n=109, 56 | 0 Participants |
| TDF 300 mg OD | Number of Participants With Resistance Related Mutations at Week 24, Week 48, Week 96 and Virological Breakthrough (Baseline to Throughout the Study) | LAM RA mutations, Week 96, n=11, 0 | 0 Participants |
| TDF 300 mg OD | Number of Participants With Resistance Related Mutations at Week 24, Week 48, Week 96 and Virological Breakthrough (Baseline to Throughout the Study) | ETV RA mutations, Week 24, n=49, 34 | 0 Participants |
| TDF 300 mg OD | Number of Participants With Resistance Related Mutations at Week 24, Week 48, Week 96 and Virological Breakthrough (Baseline to Throughout the Study) | ADV RA mutations, Week 96, n=11, 0 | 0 Participants |
| TDF 300 mg OD | Number of Participants With Resistance Related Mutations at Week 24, Week 48, Week 96 and Virological Breakthrough (Baseline to Throughout the Study) | LAM RA mutations, Week 24, n=49, 34 | 0 Participants |
| TDF 300 mg OD | Number of Participants With Resistance Related Mutations at Week 24, Week 48, Week 96 and Virological Breakthrough (Baseline to Throughout the Study) | ETV RA mutations, Week 96, n=11, 0 | 0 Participants |
| TDF 300 mg OD | Number of Participants With Resistance Related Mutations at Week 24, Week 48, Week 96 and Virological Breakthrough (Baseline to Throughout the Study) | LAM RA mutations, Week 48, n=23, 19 | 0 Participants |
| TDF 300 mg OD | Number of Participants With Resistance Related Mutations at Week 24, Week 48, Week 96 and Virological Breakthrough (Baseline to Throughout the Study) | LAM RA mutations, Virologic Breakthrough, n=2, 2 | 0 Participants |
| TDF 300 mg OD | Number of Participants With Resistance Related Mutations at Week 24, Week 48, Week 96 and Virological Breakthrough (Baseline to Throughout the Study) | ETV RA mutations, Screening, n=109, 56 | 0 Participants |
| TDF 300 mg OD | Number of Participants With Resistance Related Mutations at Week 24, Week 48, Week 96 and Virological Breakthrough (Baseline to Throughout the Study) | ADV RA mutations, Virologic Breakthrough, n=2, 2 | 0 Participants |
| TDF 300 mg OD | Number of Participants With Resistance Related Mutations at Week 24, Week 48, Week 96 and Virological Breakthrough (Baseline to Throughout the Study) | ADV RA mutations, Week 48, n=23, 19 | 0 Participants |
| TDF 300 mg OD | Number of Participants With Resistance Related Mutations at Week 24, Week 48, Week 96 and Virological Breakthrough (Baseline to Throughout the Study) | ETV RA mutations, Virologic Breakthrough, n=2, 2 | 0 Participants |
| TDF 300 mg OD | Number of Participants With Resistance Related Mutations at Week 24, Week 48, Week 96 and Virological Breakthrough (Baseline to Throughout the Study) | LAM RA mutations, Screening, n=109, 56 | 0 Participants |
| ETV 0.5 mg OD | Number of Participants With Resistance Related Mutations at Week 24, Week 48, Week 96 and Virological Breakthrough (Baseline to Throughout the Study) | ETV RA mutations, Virologic Breakthrough, n=2, 2 | 0 Participants |
| ETV 0.5 mg OD | Number of Participants With Resistance Related Mutations at Week 24, Week 48, Week 96 and Virological Breakthrough (Baseline to Throughout the Study) | LAM RA mutations, Screening, n=109, 56 | 0 Participants |
| ETV 0.5 mg OD | Number of Participants With Resistance Related Mutations at Week 24, Week 48, Week 96 and Virological Breakthrough (Baseline to Throughout the Study) | ADV RA mutations, Screening, n=109, 56 | 0 Participants |
| ETV 0.5 mg OD | Number of Participants With Resistance Related Mutations at Week 24, Week 48, Week 96 and Virological Breakthrough (Baseline to Throughout the Study) | ETV RA mutations, Screening, n=109, 56 | 0 Participants |
| ETV 0.5 mg OD | Number of Participants With Resistance Related Mutations at Week 24, Week 48, Week 96 and Virological Breakthrough (Baseline to Throughout the Study) | LAM RA mutations, Week 24, n=49, 34 | 0 Participants |
| ETV 0.5 mg OD | Number of Participants With Resistance Related Mutations at Week 24, Week 48, Week 96 and Virological Breakthrough (Baseline to Throughout the Study) | ADV RA mutations, Week 24, n=49, 34 | 0 Participants |
| ETV 0.5 mg OD | Number of Participants With Resistance Related Mutations at Week 24, Week 48, Week 96 and Virological Breakthrough (Baseline to Throughout the Study) | ETV RA mutations, Week 24, n=49, 34 | 0 Participants |
| ETV 0.5 mg OD | Number of Participants With Resistance Related Mutations at Week 24, Week 48, Week 96 and Virological Breakthrough (Baseline to Throughout the Study) | LAM RA mutations, Week 48, n=23, 19 | 0 Participants |
| ETV 0.5 mg OD | Number of Participants With Resistance Related Mutations at Week 24, Week 48, Week 96 and Virological Breakthrough (Baseline to Throughout the Study) | ADV RA mutations, Week 48, n=23, 19 | 0 Participants |
| ETV 0.5 mg OD | Number of Participants With Resistance Related Mutations at Week 24, Week 48, Week 96 and Virological Breakthrough (Baseline to Throughout the Study) | ETV RA mutations, Week 48, n=23, 19 | 0 Participants |
| ETV 0.5 mg OD | Number of Participants With Resistance Related Mutations at Week 24, Week 48, Week 96 and Virological Breakthrough (Baseline to Throughout the Study) | LAM RA mutations, Week 96, n=11, 0 | NA Participants |
| ETV 0.5 mg OD | Number of Participants With Resistance Related Mutations at Week 24, Week 48, Week 96 and Virological Breakthrough (Baseline to Throughout the Study) | ADV RA mutations, Week 96, n=11, 0 | NA Participants |
| ETV 0.5 mg OD | Number of Participants With Resistance Related Mutations at Week 24, Week 48, Week 96 and Virological Breakthrough (Baseline to Throughout the Study) | ETV RA mutations, Week 96, n=11, 0 | NA Participants |
| ETV 0.5 mg OD | Number of Participants With Resistance Related Mutations at Week 24, Week 48, Week 96 and Virological Breakthrough (Baseline to Throughout the Study) | LAM RA mutations, Virologic Breakthrough, n=2, 2 | 0 Participants |
| ETV 0.5 mg OD | Number of Participants With Resistance Related Mutations at Week 24, Week 48, Week 96 and Virological Breakthrough (Baseline to Throughout the Study) | ADV RA mutations, Virologic Breakthrough, n=2, 2 | 0 Participants |
Secondary
Number of Participants With Serum HBV DNA < 2.1 log10 Copies/mL at Week 24, Week 48 and Week 96
The number of participants with serum HBV DNA level less than the lower limit of quantitation (i.e. 2.1 log10 copies/mL) at Week 24, Week 48 and Week 96 were summarized. The LOCF method was applied for missing values.
Time frame: Week 24, Week 48 and Week 96
Population: FAS Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TDF 300 mg OD | Number of Participants With Serum HBV DNA < 2.1 log10 Copies/mL at Week 24, Week 48 and Week 96 | Week 24 | 59 Participants |
| TDF 300 mg OD | Number of Participants With Serum HBV DNA < 2.1 log10 Copies/mL at Week 24, Week 48 and Week 96 | Week 48 | 84 Participants |
| TDF 300 mg OD | Number of Participants With Serum HBV DNA < 2.1 log10 Copies/mL at Week 24, Week 48 and Week 96 | Week 96 | 97 Participants |
| ETV 0.5 mg OD | Number of Participants With Serum HBV DNA < 2.1 log10 Copies/mL at Week 24, Week 48 and Week 96 | Week 24 | 22 Participants |
| ETV 0.5 mg OD | Number of Participants With Serum HBV DNA < 2.1 log10 Copies/mL at Week 24, Week 48 and Week 96 | Week 48 | 37 Participants |
| ETV 0.5 mg OD | Number of Participants With Serum HBV DNA < 2.1 log10 Copies/mL at Week 24, Week 48 and Week 96 | Week 96 | NA Participants |
Secondary
Number of Participants With Virological Breakthrough Through End of the Study
The number of participants who experienced virological breakthrough was summarized. Virological breakthrough is defined as serum HBV DNA level increase \>=1 log10 copies/mL above the treatment nadir. Virological breakthrough values were presented from Baseline to through out the study. Baseline is defined as the value at Week 0 visit.
Time frame: From Baseline to throughout study
Population: FAS Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TDF 300 mg OD | Number of Participants With Virological Breakthrough Through End of the Study | 2 Participants |
| ETV 0.5 mg OD | Number of Participants With Virological Breakthrough Through End of the Study | 2 Participants |