Phase 3 Study of GSK548470 in Patients With Compensated Chronic Hepatitis B With Poor Response to Other Drugs

A Multi-center, Open-label Study of GSK548470 (Tenofovir Disoproxil Fumarate) in Patients With Compensated Chronic Hepatitis B With Poor Response to Other Drugs

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01475851

Enrollment

Registered

2011-11-21

Start date

2011-12-31

Completion date

2014-10-31

Last updated

2015-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis B, Chronic

Keywords

Tenofovir disoproxil fumarate, compensated chronic hepatitis B

Brief summary

The purpose of this study is to evaluate the efficacy and safety of once-daily treatment with GSK548470 300 mg in Japanese patients with compensated chronic hepatitis B with poor response to other drugs.

Detailed description

This is a multicenter, open-label study in Japanese patients with compensated chronic hepatitis B with poor response to other drugs in order to evaluate the efficacy and safety of GSK548470 administered at a dose of 300 mg once daily. The target sample size is set at 32 subjects. The primary objective is to evaluate the efficacy and safety of once-daily treatment with GSK548470 300 mg in subjects with compensated chronic hepatitis B with poor response to other drugs. The secondary objective is to evaluate the long-term efficacy and safety of once-daily treatment with GSK548470 300 mg.To evaluate the efficacy and safety of GSK548470 in the study, subjects receiving a combination of lamivudine (LAM) and adefovir pivoxil (ADV) will be switched to a combination of LAM and GSK548470, while subjects on entecavir hydrate (ETV) with or without ADV will be switched to a combination of ETV and GSK548470.

Interventions

DRUGGSK548470 300 mg tablet

Blue tablets containing 300 mg of tenofovir disoproxil fumarate

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

16 Years to 69 Years

Healthy volunteers

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 \<480msec with Bundle Branch Block * Chronic HBV infection, defined as positive serum HBsAg for at least 6 month * Subjects currently treated with LAM/ADV, ETV or ETV/ADV for greater than 24 weeks * Chronic hepatitis B ; HBV NDA \>= 4 log10 copies/mL, Chronic hepatitis B with cirrhosis ; HBV NDA \>= 3 log10 copies/mL * Serum ALT \<= 10 × ULN * Creatinine clearance \>= 70 mL/min * Haemoglobin \>= 8 g/dL * WBC \>= 1,000 /mm3

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 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
Number of Participants With HBV DNA Level < 2.1 log10 Copies/mL at Week 24	Week 24	The number of participants with serum hepatitis B virus deoxyribonucleic acid (HBV DNA) level \< the lower limit of quantitation (2.1 log10 copies/millilitres\[copies/mL\]) (i.e., the rate of suppression) at Week 24 was summarized. Statistical analysis was not provided for the number of participants achieving HBV DNA \<2.1 log10 copies/mL (at Week 24). Missing values observed during the treatment period was imputed by the last observation carried forward (LOCF) method.

Secondary

Measure	Time frame	Description
Number of Participants With Serum HBV DNA < 2.1 log10 Copies/mL at Week 48 and Week 96	Week 48 and Week 96	The number of participants with serum HBV DNA level \< the lower limit of quantitation (2.1 log10 copies/mL) (i.e., the rate of suppression) at 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 hepatitis Be antigen (HBeAg)/hepatitis B e 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 change of detectable antibody to HBeAg from negative to positive. The LOCF method was applied for missing values.
Mean Change From Baseline in Serum HBV DNA Level at Week 24, Week 48 and Week 96	Baseline and Week 24, Week 48 and Week 96	The mean change from Baseline in the hepatitis B virus deoxyribonucleic acid (HBV DNA) level at Week 24, Week 48 and Week 96 were assessed (HBV DNA values below the lower limit of quantitation \[i.e. 2.1 log10 copies/mL\] for the assay were set to the lower limit minus 0.1 \[i.e. 2.0 log10 copies/mL\]). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Last Observation Carried Forward (LOCF) method was applied for missing values.
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 hepatitis B surface antigen (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 was defined as change of detectable antibody to HBsAg from negative to positive. The LOCF method was applied for missing values.
Number of Participants With Virological Breakthrough and Resistance-related Mutations	Screening, Week 24, Week 48, Week 96 and Virological Breakthrough	The number of participants who harbored resistance-related mutations and developed virological breakthrough was summarized. Virological breakthrough defined as HBV DNA level increase \>=1 log10 copies/mL above the treatment nadir were analyzed through end of treatment. Subjects who achieved the HBV-DNA values below lower limit of quantification (LLQ) (\< 2.1 log10 copies/mL) in quantitative analysis at Week 96 were also considered negative in drug-resistance without implementation of genotypic analysis. Lamivudine (LAM), adefovir pivoxil (ADV), and entecavir hydrate (ETV) resistance-related mutations were analyzed at Screening (i.e. Baseline), Week 24, Week 48 and Week 96 in participants with HBV DNA level above the lower limit of detection. Virologic breakthrough was defined as 1.0 log10 or greater increases in serum HBV DNA levels from on-treatment nadir. 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 hepatitis B surface antigen (HBsAg) category (HBsAg \<80, 80 to 800, 800 to 8000, 8000 to 80000, \>=80000) (kilo international unit per liter \[KIU/L\]) by study visit was summarized.
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 log10, 3.0 to 4.0 log10, 4.0 to 5.0 log10, 5.0 to 6.0 log10, \>=6.0 log10) (kilo units per liter \[KU/L\]) by study visit was summarized. 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.

Countries

Japan

Participant flow

Pre-assignment details

A total of 34 participants (13 participants in the Lamivudine \[LAM\]/ Tenofovir disoproxil fumarate \[TDF\] group and 21 participants in the Entecavir \[ETV\]/TDF group) were enrolled in the study

Participants by arm

Arm	Count
LAM 100 mg/TDF 300 mg Participants received a single, Open-Label (OL) Lamivudine (LAM) 100 milligram (mg) tablet once daily (OD) and a single, OL tenofovir disoproxil fumarate (TDF) 300 mg tablet OD for 96 weeks.	13
ETV 0.5 mg/TDF 300 mg Participants received a single, OL entecavir (ETV) 0.5 mg tablet OD and a single, OL TDF 300 mg tablet OD for 96 weeks.	21
Total	34

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Protocol defined stopping criteria	1	0

Baseline characteristics

Characteristic	LAM 100 mg/TDF 300 mg	ETV 0.5 mg/TDF 300 mg	Total
Age, Continuous	52.1 Years STANDARD_DEVIATION 7.57	50.3 Years STANDARD_DEVIATION 9.18	51.0 Years STANDARD_DEVIATION 8.52
Race/Ethnicity, Customized Asian-Japanese Heritage	13 Participants	21 Participants	34 Participants
Sex: Female, Male Female	5 Participants	4 Participants	9 Participants
Sex: Female, Male Male	8 Participants	17 Participants	25 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	12 / 13	17 / 21
serious Total, serious adverse events	1 / 13	2 / 21

Outcome results

Primary

Number of Participants With HBV DNA Level < 2.1 log10 Copies/mL at Week 24

The number of participants with serum hepatitis B virus deoxyribonucleic acid (HBV DNA) level \< the lower limit of quantitation (2.1 log10 copies/millilitres\[copies/mL\]) (i.e., the rate of suppression) at Week 24 was summarized. Statistical analysis was not provided for the number of participants achieving HBV DNA \<2.1 log10 copies/mL (at Week 24). Missing values observed during the treatment period was imputed by the last observation carried forward (LOCF) method.

Time frame: Week 24

Population: Full Analysis Set (FAS) Population: all participants who received at least one dose of investigational product (IP) and had at least one efficacy assessment after the start of study treatment.

Arm	Measure	Value (NUMBER)
LAM 100 mg/TDF 300 mg	Number of Participants With HBV DNA Level < 2.1 log10 Copies/mL at Week 24	8 participants
ETV 0.5 mg/TDF 300 mg	Number of Participants With HBV DNA Level < 2.1 log10 Copies/mL at Week 24	12 participants

Secondary

Mean Change From Baseline in Serum HBV DNA Level at Week 24, Week 48 and Week 96

The mean change from Baseline in the hepatitis B virus deoxyribonucleic acid (HBV DNA) level at Week 24, Week 48 and Week 96 were assessed (HBV DNA values below the lower limit of quantitation \[i.e. 2.1 log10 copies/mL\] for the assay were set to the lower limit minus 0.1 \[i.e. 2.0 log10 copies/mL\]). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Last Observation Carried Forward (LOCF) method was applied for missing values.

Time frame: Baseline and Week 24, Week 48 and Week 96

Population: FAS Population

Arm	Measure	Group	Value (MEAN)
LAM 100 mg/TDF 300 mg	Mean Change From Baseline in Serum HBV DNA Level at Week 24, Week 48 and Week 96	Week 24	-2.72 log10 copies/mL
LAM 100 mg/TDF 300 mg	Mean Change From Baseline in Serum HBV DNA Level at Week 24, Week 48 and Week 96	Week 48	-2.88 log10 copies/mL
LAM 100 mg/TDF 300 mg	Mean Change From Baseline in Serum HBV DNA Level at Week 24, Week 48 and Week 96	Week 96	-3.02 log10 copies/mL
ETV 0.5 mg/TDF 300 mg	Mean Change From Baseline in Serum HBV DNA Level at Week 24, Week 48 and Week 96	Week 24	-3.33 log10 copies/mL
ETV 0.5 mg/TDF 300 mg	Mean Change From Baseline in Serum HBV DNA Level at Week 24, Week 48 and Week 96	Week 48	-3.50 log10 copies/mL
ETV 0.5 mg/TDF 300 mg	Mean Change From Baseline in Serum HBV DNA Level at Week 24, Week 48 and Week 96	Week 96	-3.50 log10 copies/mL

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 log10, 3.0 to 4.0 log10, 4.0 to 5.0 log10, 5.0 to 6.0 log10, \>=6.0 log10) (kilo units 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)
LAM 100 mg/TDF 300 mg	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	0 Participants
LAM 100 mg/TDF 300 mg	Number of Participants Achieving Each Indicated HBcrAg Category at Baseline,Week 24, Week 48 and Week 96	HBcrAg >=6.0 Log KU/L, Baseline	12 Participants
LAM 100 mg/TDF 300 mg	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	1 Participants
LAM 100 mg/TDF 300 mg	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	1 Participants
LAM 100 mg/TDF 300 mg	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	0 Participants
LAM 100 mg/TDF 300 mg	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	0 Participants
LAM 100 mg/TDF 300 mg	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	2 Participants
LAM 100 mg/TDF 300 mg	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	0 Participants
LAM 100 mg/TDF 300 mg	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	10 Participants
LAM 100 mg/TDF 300 mg	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	0 Participants
LAM 100 mg/TDF 300 mg	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	0 Participants
LAM 100 mg/TDF 300 mg	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	0 Participants
LAM 100 mg/TDF 300 mg	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	1 Participants
LAM 100 mg/TDF 300 mg	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	1 Participants
LAM 100 mg/TDF 300 mg	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	0 Participants
LAM 100 mg/TDF 300 mg	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	1 Participants
LAM 100 mg/TDF 300 mg	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	3 Participants
LAM 100 mg/TDF 300 mg	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	11 Participants
LAM 100 mg/TDF 300 mg	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	9 Participants
LAM 100 mg/TDF 300 mg	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/TDF 300 mg	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	17 Participants
ETV 0.5 mg/TDF 300 mg	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	1 Participants
ETV 0.5 mg/TDF 300 mg	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/TDF 300 mg	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	1 Participants
ETV 0.5 mg/TDF 300 mg	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	0 Participants
ETV 0.5 mg/TDF 300 mg	Number of Participants Achieving Each Indicated HBcrAg Category at Baseline,Week 24, Week 48 and Week 96	HBcrAg >=6.0 Log KU/L, Baseline	19 Participants
ETV 0.5 mg/TDF 300 mg	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	0 Participants
ETV 0.5 mg/TDF 300 mg	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	1 Participants
ETV 0.5 mg/TDF 300 mg	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	1 Participants
ETV 0.5 mg/TDF 300 mg	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	18 Participants
ETV 0.5 mg/TDF 300 mg	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	0 Participants
ETV 0.5 mg/TDF 300 mg	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	1 Participants
ETV 0.5 mg/TDF 300 mg	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	1 Participants
ETV 0.5 mg/TDF 300 mg	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	1 Participants
ETV 0.5 mg/TDF 300 mg	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	18 Participants
ETV 0.5 mg/TDF 300 mg	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	0 Participants
ETV 0.5 mg/TDF 300 mg	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	1 Participants
ETV 0.5 mg/TDF 300 mg	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	1 Participants
ETV 0.5 mg/TDF 300 mg	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	2 Participants
ETV 0.5 mg/TDF 300 mg	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	1 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 hepatitis B surface antigen (HBsAg) category (HBsAg \<80, 80 to 800, 800 to 8000, 8000 to 80000, \>=80000) (kilo international unit per liter \[KIU/L\]) by study visit was summarized.

Time frame: Baseline, Week 24, Week 48 and Week 96

Population: FAS Population

Arm	Measure	Group	Value (NUMBER)
LAM 100 mg/TDF 300 mg	Number of Participants Achieving Each Indicated HBsAg Category at Baseline, Week 24, Week 48 and Week 96	HBsAg <80 KIU/L, Week 48	0 participants
LAM 100 mg/TDF 300 mg	Number of Participants Achieving Each Indicated HBsAg Category at Baseline, Week 24, Week 48 and Week 96	HBsAg >=80,000 KIU/L, Baseline	0 participants
LAM 100 mg/TDF 300 mg	Number of Participants Achieving Each Indicated HBsAg Category at Baseline, Week 24, Week 48 and Week 96	HBsAg 80-800 KIU/L, Week 48	3 participants
LAM 100 mg/TDF 300 mg	Number of Participants Achieving Each Indicated HBsAg Category at Baseline, Week 24, Week 48 and Week 96	HBsAg <80 KIU/L, Baseline	0 participants
LAM 100 mg/TDF 300 mg	Number of Participants Achieving Each Indicated HBsAg Category at Baseline, Week 24, Week 48 and Week 96	HBsAg 800-8000 KIU/L, Week 48	5 participants
LAM 100 mg/TDF 300 mg	Number of Participants Achieving Each Indicated HBsAg Category at Baseline, Week 24, Week 48 and Week 96	HBsAg <80 KIU/L, Week 24	0 participants
LAM 100 mg/TDF 300 mg	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	5 participants
LAM 100 mg/TDF 300 mg	Number of Participants Achieving Each Indicated HBsAg Category at Baseline, Week 24, Week 48 and Week 96	HBsAg 800-8000 KIU/L, Baseline	6 participants
LAM 100 mg/TDF 300 mg	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
LAM 100 mg/TDF 300 mg	Number of Participants Achieving Each Indicated HBsAg Category at Baseline, Week 24, Week 48 and Week 96	HBsAg 800-8000 KIU/L, Week 24	5 participants
LAM 100 mg/TDF 300 mg	Number of Participants Achieving Each Indicated HBsAg Category at Baseline, Week 24, Week 48 and Week 96	HBsAg <80 KIU/L, Week 96	0 participants
LAM 100 mg/TDF 300 mg	Number of Participants Achieving Each Indicated HBsAg Category at Baseline, Week 24, Week 48 and Week 96	HBsAg 80-800 KIU/L, Week 24	3 participants
LAM 100 mg/TDF 300 mg	Number of Participants Achieving Each Indicated HBsAg Category at Baseline, Week 24, Week 48 and Week 96	HBsAg 80-800 KIU/L, Week 96	4 participants
LAM 100 mg/TDF 300 mg	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	5 participants
LAM 100 mg/TDF 300 mg	Number of Participants Achieving Each Indicated HBsAg Category at Baseline, Week 24, Week 48 and Week 96	HBsAg 800-8000 KIU/L, Week 96	6 participants
LAM 100 mg/TDF 300 mg	Number of Participants Achieving Each Indicated HBsAg Category at Baseline, Week 24, Week 48 and Week 96	HBsAg 8000-80,000 KIU/L, Baseline	6 participants
LAM 100 mg/TDF 300 mg	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	3 participants
LAM 100 mg/TDF 300 mg	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
LAM 100 mg/TDF 300 mg	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
LAM 100 mg/TDF 300 mg	Number of Participants Achieving Each Indicated HBsAg Category at Baseline, Week 24, Week 48 and Week 96	HBsAg 80-800 KIU/L, Baseline	1 participants
ETV 0.5 mg/TDF 300 mg	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/TDF 300 mg	Number of Participants Achieving Each Indicated HBsAg Category at Baseline, Week 24, Week 48 and Week 96	HBsAg <80 KIU/L, Baseline	0 participants
ETV 0.5 mg/TDF 300 mg	Number of Participants Achieving Each Indicated HBsAg Category at Baseline, Week 24, Week 48 and Week 96	HBsAg 80-800 KIU/L, Baseline	0 participants
ETV 0.5 mg/TDF 300 mg	Number of Participants Achieving Each Indicated HBsAg Category at Baseline, Week 24, Week 48 and Week 96	HBsAg 800-8000 KIU/L, Baseline	12 participants
ETV 0.5 mg/TDF 300 mg	Number of Participants Achieving Each Indicated HBsAg Category at Baseline, Week 24, Week 48 and Week 96	HBsAg 8000-80,000 KIU/L, Baseline	8 participants
ETV 0.5 mg/TDF 300 mg	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/TDF 300 mg	Number of Participants Achieving Each Indicated HBsAg Category at Baseline, Week 24, Week 48 and Week 96	HBsAg 80-800 KIU/L, Week 24	0 participants
ETV 0.5 mg/TDF 300 mg	Number of Participants Achieving Each Indicated HBsAg Category at Baseline, Week 24, Week 48 and Week 96	HBsAg 800-8000 KIU/L, Week 24	15 participants
ETV 0.5 mg/TDF 300 mg	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	6 participants
ETV 0.5 mg/TDF 300 mg	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/TDF 300 mg	Number of Participants Achieving Each Indicated HBsAg Category at Baseline, Week 24, Week 48 and Week 96	HBsAg <80 KIU/L, Week 48	0 participants
ETV 0.5 mg/TDF 300 mg	Number of Participants Achieving Each Indicated HBsAg Category at Baseline, Week 24, Week 48 and Week 96	HBsAg 80-800 KIU/L, Week 48	1 participants
ETV 0.5 mg/TDF 300 mg	Number of Participants Achieving Each Indicated HBsAg Category at Baseline, Week 24, Week 48 and Week 96	HBsAg 800-8000 KIU/L, Week 48	14 participants
ETV 0.5 mg/TDF 300 mg	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	6 participants
ETV 0.5 mg/TDF 300 mg	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
ETV 0.5 mg/TDF 300 mg	Number of Participants Achieving Each Indicated HBsAg Category at Baseline, Week 24, Week 48 and Week 96	HBsAg <80 KIU/L, Week 96	0 participants
ETV 0.5 mg/TDF 300 mg	Number of Participants Achieving Each Indicated HBsAg Category at Baseline, Week 24, Week 48 and Week 96	HBsAg 80-800 KIU/L, Week 96	3 participants
ETV 0.5 mg/TDF 300 mg	Number of Participants Achieving Each Indicated HBsAg Category at Baseline, Week 24, Week 48 and Week 96	HBsAg 800-8000 KIU/L, Week 96	13 participants
ETV 0.5 mg/TDF 300 mg	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	5 participants
ETV 0.5 mg/TDF 300 mg	Number of Participants Achieving Each Indicated HBsAg Category at Baseline, Week 24, Week 48 and Week 96	HBsAg <80 KIU/L, Week 24	0 participants

Secondary

Number of Participants Achieving HBsAg/HBsAb Seroconversion at Week 24, Week 48 and Week 96

The number of participants with hepatitis B surface antigen (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 was defined as change of detectable antibody to HBsAg from negative to positive. The LOCF method was applied for missing values.