Study Comparing Tenofovir Disoproxil Fumarate (TDF), Emtricitabine (FTC)/TDF, and Entecavir (ETV) in the Treatment of Chronic HBV in Subjects With Decompensated Liver Disease.
Official Title
A Phase 2, Double-Blind, Multi-center, Randomized Study Comparing Tenofovir Disoproxil Fumarate, Emtricitabine Plus Tenofovir Disoproxil Fumarate, and Entecavir in the Treatment of Chronic Hepatitis B Subjects With Decompensated Liver Disease and in the Prevention of Hepatitis B Recurrence Post-Transplantation
Acronym
Not provided
Organization
Gilead SciencesINDUSTRY
Status Module
Record Verification Date
Apr 2013
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Apr 2006
Primary Completion Date
Apr 2011Actual
Completion Date
Apr 2011Actual
First Submitted Date
Feb 28, 2006
First Submission Date that Met QC Criteria
Feb 28, 2006
First Posted Date
Mar 2, 2006Estimated
Results Waived
Not provided
Results First Submitted Date
Apr 10, 2012
Results First Submitted that Met QC Criteria
Apr 19, 2013
Results First Posted Date
Apr 25, 2013Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Apr 19, 2013
Last Update Posted Date
Apr 25, 2013Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Gilead SciencesINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This study was designed to evaluate and compare the safety and tolerability of tenofovir disoproxil fumarate (TDF), emtricitabine (FTC)/TDF, and entecavir (ETV) in the treatment of hepatitis B patients with decompensated liver disease. Safety was assessed by evaluating adverse events (AEs) and laboratory abnormalities. Efficacy was assessed by evaluating reductions in Child-Pugh-Turcotte (CPT) and Model for End Stage Liver Disease (MELD) scores, reductions in hepatitis B virus (HBV) deoxyribonucleic acid (DNA), changes in liver enzymes, development of drug-resistant mutations, and generation of antibody to virus.
A maximum randomized treatment duration of 168 weeks was planned. Since subjects with decompensated liver disease were enrolled into this study, it was necessary to provide early intervention strategies if profound viral suppression was not expeditiously achieved. For this reason, subjects with a decrease in plasma HBV DNA from baseline of < 2 log_10 copies/mL and plasma HBV DNA > 10,000 copies/mL (or plasma HBV DNA > 1,000 copies/mL for subjects who entered the study with HBV DNA < 10,000 copies/mL) at Week 8 had the option to start open-label FTC/TDF and continue in the study. Subjects with a virologic breakthrough or who had plasma HBV DNA levels remaining > 400 copies/mL (confirmed) at or after 24 weeks of treatment could have been unblinded at the investigator's discretion for selection of alternative anti-HBV therapy that may have included open-label FTC/TDF. If study drug was permanently discontinued, immediate initiation of another anti-HBV regimen was strongly recommended.
Detailed Description
Not provided
Conditions Module
Conditions
Chronic Hepatitis B
Keywords
Hepatitis; Hepatitis B virus; Tenofovir
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
112Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Tenofovir DF
Experimental
TDF 300 mg + FTC/TDF placebo + ETV placebo once daily (QD)
ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo QD
Drug: Entecavir (ETV)
Drug: TDF placebo
Drug: FTC/TDF placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Tenofovir disoproxil fumarate (tenofovir DF; TDF)
Drug
300-mg tablet QD
Tenofovir DF
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percent Probability of Tolerability Failure
Tolerability failure was defined as permanent discontinuation of study drug due to a treatment-emergent adverse event (AE), including any subject who temporarily discontinued study drug due to an AE and did not restart. Results are expressed as proportions of participants who experience tolerability failure using the Kaplan-Meier (KM) method of estimation.
Baseline to Week 168
Percent Probability of a Confirmed Increase in Serum Creatinine of ≥ 0.5 mg/dL From Baseline or a Confirmed Serum Phosphorus Level < 2.0 mg/dL
Results are expressed as proportions of participants who experience a confirmed increase in serum creatinine of ≥ 0.5 mg/dL from baseline or a confirmed serum phosphorus level < 2.0 mg/dL using the KM method of estimation.
Baseline to Week 168
Secondary Outcomes
Measure
Description
Time Frame
Median Time-averaged Change (DAVG) in Plasma Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels at 48 Weeks Relative to Baseline
Change from baseline was evaluated by subtracting baseline HBV DNA log_10 copies/mL from Week 48 HBV DNA log_10 copies/mL. DAVG is defined as the area of the trapezoid under the response-time curve divided by time to the last available evaluation of the patient minus the baseline value.
Other Outcomes
Measure
Description
Time Frame
Percentage of Participants With Only Baseline Adefovir Dipivoxil Resistance (ADV-R) Mutations Achieving HBV DNA < 400 Copies/mL by 168 Weeks
ADV resistance mutations are defined as the presence of the rtA181T/V HBV gene mutation and/or the rtN236T HBV gene mutation.
Baseline to Week 168
Percentage of Participants With Only Baseline Lamivudine-resistance (LAM-R) Mutations Achieving HBV DNA < 400 Copies/mL by 168 Weeks
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
A participant was required to meet all of the following inclusion criteria to be eligible for participation in the study:
Chronic Hepatitis B infection
18 through 69 years of age, inclusive
HBV DNA ≥ 1000 copies/mL
Decompensated liver disease with all of the following:
CPT score of 7-12 (inclusive) OR history of CPT score ≥ 7 and any CPT at screen ≤ 12
Serum alanine aminotransferase (ALT) < 10 x the upper limit of the normal range (ULN)
Hemoglobin ≥ 7.5 g/dL
Total white blood cell (WBC) count ≥ 1,500/mm^3
Platelet count ≥ 30,000/mm^3
Alpha-fetoprotein ≤ 20 ng/mL and ultrasound or other imaging with no evidence of hepatocellular carcinoma (HCC), or alpha-fetoprotein of 21-50 ng/mL and computed tomography (CT)/magnetic resonance imaging (MRI) scan with no evidence of HCC, within 6 months of screening
Calculated creatinine clearance ≥ 50 mL/min
Negative human immunodeficiency virus (HIV), hepatitis C virus (HCV), and hepatitis D virus (HDV) serologies
Less than 24 months of total prior adefovir dipivoxil exposure
Willing and able to provide written informed consent
Exclusion Criteria:
A participant who met any of the following exclusion criteria could not be enrolled in the study:
Pregnant women, women who were breastfeeding or who believed they may have wished to become pregnant during the course of the study
Males and females of reproductive potential who were unwilling to use an effective method of contraception during the study
Prior use of TDF or ETV
History of variceal bleeding, hepatorenal syndrome, Grade 3 or 4 hepatic encephalopathy, or spontaneous bacterial peritonitis within 60 days of screening
Grade 2 hepatic encephalopathy at screening
History of solid organ or bone marrow transplant
Current use of hepatotoxic drugs, nephrotoxic drugs, or drugs that interfere with renal tubular secretion
Current therapy with immunomodulators (eg, corticosteroids, interleukin-2, etc.) or investigational drugs
Diagnosis of proximal tubulopathy
Use of investigational agent within 30 days prior to screening
Known hypersensitivity to TDF, FTC, ETV, or formulation excipients of any of the study drug products
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
69 Years
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
John Flaherty, PharmD
Gilead Sciences
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Pfleger Liver Institute
Los Angeles
California
90095
United States
California Pacific Medical Center Research Institute
Liaw YF, Sheen IS, Lee CM, Akarca US, Papatheodoridis GV, Suet-Hing Wong F, Chang TT, Horban A, Wang C, Kwan P, Buti M, Prieto M, Berg T, Kitrinos K, Peschell K, Mondou E, Frederick D, Rousseau F, Schiff ER. Tenofovir disoproxil fumarate (TDF), emtricitabine/TDF, and entecavir in patients with decompensated chronic hepatitis B liver disease. Hepatology. 2011 Jan;53(1):62-72. doi: 10.1002/hep.23952. Epub 2010 Oct 27.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
196 participants screened; 112 randomized and treated (full analysis set; randomized analysis set). Subjects without adequate decrease in HBV DNA at Week 8 could start open-label FTC/TDF. Subjects with virologic breakthrough or HBV DNA levels > 400 copies/mL at ≥ 24 weeks could have received other therapy that may have included open-label FTC/TDF.
Recruitment Details
Of the 112 participants randomized, 43 were in Taiwan or Singapore, 43 were in Europe (Turkey, Spain, Germany, Greece, Poland, Italy, or France), and 26 were in the US or Canada. The first participant was screened on 04 April 2006, and the last participant was randomized on 03 January 2008. Last participant observation date was 12 April 2011.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Tenofovir DF
Participants in this group were randomized to receive double-blind (DB) TDF 300 mg + FTC)/TDF placebo + ETV placebo at baseline, and may have been unblinded (due to either lack of adequate decrease of HBV DNA or virologic breakthrough) and switched to open-label (OL) FTC/TDF (this study enrolled participants with decompensated liver disease, and early intervention strategies were provided if profound viral suppression was not achieved quickly).
Median DAVG in Plasma HBV DNA Levels at 96 Weeks Relative to Baseline
Change from baseline was evaluated by subtracting baseline HBV DNA log_10 copies/mL from Week 96 HBV DNA log_10 copies/mL. DAVG is defined as the area of the trapezoid under the response-time curve divided by time to the last available evaluation of the patient minus the baseline value.
Baseline to 96 weeks
Median DAVG in Plasma HBV DNA Levels at 144 Weeks Relative to Baseline
Change from baseline was evaluated by subtracting baseline HBV DNA log_10 copies/mL from Week 144 HBV DNA log_10 copies/mL. DAVG is defined as the area of the trapezoid under the response-time curve divided by time to the last available evaluation of the patient minus the baseline value.
Baseline to 144 weeks
Median DAVG in Plasma HBV DNA Levels at 168 Weeks Relative to Baseline
Change from baseline was evaluated by subtracting baseline HBV DNA log_10 copies/mL from Week 168 HBV DNA log_10 copies/mL. DAVG is defined as the area of the trapezoid under the response-time curve divided by time to the last available evaluation of the patient minus the baseline value.
Baseline to 168 weeks
Percentage of Participants With Plasma HBV DNA < 400 Copies/mL at Week 48
The percentage of participants with plasma HBV DNA < 400 copies/mL at Week 48 was summarized.
Week 48
Percentage of Participants With Plasma HBV DNA < 400 Copies/mL at Week 96
The percentage of participants with plasma HBV DNA < 400 copies/mL at Week 96 was summarized.
Week 96
Percentage of Participants With Plasma HBV DNA < 400 Copies/mL at Week 144
The percentage of participants with plasma HBV DNA < 400 copies/mL at Week 144 was summarized.
Week 144
Percentage of Participants With Plasma HBV DNA < 400 Copies/mL at Week 168
The percentage of participants with plasma HBV DNA < 400 copies/mL at Week 168 was summarized.
Week 168
Percentage of Participants With Normalized Alanine Aminotransferase (ALT) (for Subjects With Elevated ALT at Baseline) at Week 48
Normalized ALT is defined as having a baseline ALT value > the upper limit of the normal range (ULN), and a decrease in ALT value to ≤ ULN at the given time point.
Baseline to Week 48
Percentage of Participants With Normalized ALT (for Subjects With Elevated ALT at Baseline) at Week 96
Normalized ALT is defined as having a baseline ALT value > ULN, and a decrease in ALT value to ≤ ULN at the given time point.
Baseline to Week 96
Percentage of Participants With Normalized ALT (for Subjects With Elevated ALT at Baseline) at Week 144
Normalized ALT is defined as having a baseline ALT value > ULN, and a decrease in ALT value to ≤ ULN at the given time point.
Baseline to Week 144
Percentage of Participants With Normalized ALT (for Subjects With Elevated ALT at Baseline) at Week 168
Normalized ALT is defined as having a baseline ALT value > ULN, and a decrease in ALT value to ≤ ULN at the given time point.
Baseline to Week 168
Percentage of Participants With an Increase in Child-Pugh Turcotte (CPT) Score of ≥ 2 Points at Weeks 48
CPT scores, widely used to grade the severity of cirrhosis and to determine the need for liver transplantation, are calculated based on a combination of laboratory values and clinical features. CPT scores can range from 5 to 15, with higher scores indicating a greater severity of disease.
Baseline to Week 48
Percentage of Participants With an Increase in CPT Score of ≥ 2 Points at Week 96
CPT scores, widely used to grade the severity of cirrhosis and to determine the need for liver transplantation, are calculated based on a combination of laboratory values and clinical features. CPT scores can range from 5 to 15, with higher scores indicating a greater severity of disease.
Baseline to Week 96
Percentage of Participants With an Increase in CPT Score of ≥ 2 Points at Week 144
CPT scores, widely used to grade the severity of cirrhosis and to determine the need for liver transplantation, are calculated based on a combination of laboratory values and clinical features. CPT scores can range from 5 to 15, with higher scores indicating a greater severity of disease.
Baseline to Week 144
Percentage of Participants With an Increase in CPT Score of ≥ 2 Points at Week 168
CPT scores, widely used to grade the severity of cirrhosis and to determine the need for liver transplantation, are calculated based on a combination of laboratory values and clinical features. CPT scores can range from 5 to 15, with higher scores indicating a greater severity of disease.
Baseline to Week 168
Percentage of Participants With a Decrease in CPT Score of ≥ 2 Points From Baseline at Week 48
CPT scores, widely used to grade the severity of cirrhosis and to determine the need for liver transplantation, are calculated based on a combination of laboratory values and clinical features. CPT scores can range from 5 to 15, with higher scores indicating a greater severity of disease.
Baseline to Week 48
Percentage of Participants With a Decrease in CPT Score of ≥ 2 Points From Baseline at Week 96
CPT scores, widely used to grade the severity of cirrhosis and to determine the need for liver transplantation, are calculated based on a combination of laboratory values and clinical features. CPT scores can range from 5 to 15, with higher scores indicating a greater severity of disease.
Baseline to Week 96
Percentage of Participants With a Decrease in CPT Score of ≥ 2 Points From Baseline at Week 144
CPT scores, widely used to grade the severity of cirrhosis and to determine the need for liver transplantation, are calculated based on a combination of laboratory values and clinical features. CPT scores can range from 5 to 15, with higher scores indicating a greater severity of disease.
Baseline to Week 144
Percentage of Participants With a Decrease in CPT Score of ≥ 2 Points From Baseline at Week 168
CPT scores, widely used to grade the severity of cirrhosis and to determine the need for liver transplantation, are calculated based on a combination of laboratory values and clinical features. CPT scores can range from 5 to 15, with higher scores indicating a greater severity of disease.
Baseline to Week 168
Median Change in Model for End-Stage Liver Disease (MELD) Score From Baseline at Week 48
MELD scores, used to assess prognosis and suitability for transplant, are calculated based on laboratory values only and can range from 6 to 40, with higher scores indicating greater disease severity.
Baseline to Week 48
Median Change in MELD Score From Baseline at Week 96
MELD scores, used to assess prognosis and suitability for transplant, are calculated based on laboratory values only and can range from 6 to 40, with higher scores indicating greater disease severity.
Baseline to Week 96
Median Change in MELD Score From Baseline at Week 144
MELD scores, used to assess prognosis and suitability for transplant, are calculated based on laboratory values only and can range from 6 to 40, with higher scores indicating greater disease severity.
Baseline to Week 144
Median Change in MELD Score From Baseline at Week 168
MELD scores, used to assess prognosis and suitability for transplant, are calculated based on laboratory values only and can range from 6 to 40, with higher scores indicating greater disease severity.
Baseline to Week 168
Percentage of Participants With Hepatitis B Early Antigen (HBeAg) Loss and HBeAg Seroconversion at Week 48 (for Participants Who Were HBeAg Positive at Baseline)
Loss of HBeAg was defined as change of detectable HBeAg from positive to negative. HBeAg seroconversion was defined as change of detectable antibody to HBeAg from negative to positive.
Baseline to Week 48
Percentage of Participants With HBeAg Loss and HBeAg Seroconversion at Week 96 (for Participants Who Were HBeAg Positive at Baseline)
Loss of HBeAg was defined as change of detectable HBeAg from positive to negative. HBeAg seroconversion was defined as change of detectable antibody to HBeAg from negative to positive.
Baseline to Week 96
Percentage of Participants With HBeAg Loss and HBeAg Seroconversion at Week 144 (for Participants Who Were HBeAg Positive at Baseline)
Loss of HBeAg was defined as change of detectable HBeAg from positive to negative. HBeAg seroconversion was defined as change of detectable antibody to HBeAg from negative to positive.
Baseline to Week 144
Percentage of Participants With HBeAg Loss and HBeAg Seroconversion at Week 168 (for Participants Who Were HBeAg Positive at Baseline)
Loss of HBeAg was defined as change of detectable HBeAg from positive to negative. HBeAg seroconversion was defined as change of detectable antibody to HBeAg from negative to positive.
Baseline to Week 168
Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss and HBsAg Seroconversion at Week 48
Loss of HBsAg was defined as change of detectable HBsAg from positive to negative. HBsAg seroconversion was defined as change of detectable antibody to HBsAg from negative to positive.
Baseline to Week 48
Percentage of Participants With HBsAg Loss and HBsAg Seroconversion at Week 96
Loss of HBsAg was defined as change of detectable HBsAg from positive to negative. HBsAg seroconversion was defined as change of detectable antibody to HBsAg from negative to positive.
Baseline to Week 96
Percentage of Participants With HBsAg Loss and HBsAg Seroconversion at Week 144
Loss of HBsAg was defined as change of detectable HBsAg from positive to negative. HBsAg seroconversion was defined as change of detectable antibody to HBsAg from negative to positive.
Baseline to Week 144
Percentage of Participants With HBsAg Loss and HBsAg Seroconversion at Week 168
Loss of HBsAg was defined as change of detectable HBsAg from positive to negative. HBsAg seroconversion was defined as change of detectable antibody to HBsAg from negative to positive.
Baseline to Week 168
In the Subset of Participants Undergoing Liver Transplantation, Time to Recurrence of Hepatitis B, Defined as 2 Consecutive Plasma HBV DNA Concentrations ≥ 400 Copies/mL or 2 Consecutive HBsAg(+) Results
Baseline to Week 168
LAM resistance mutations are defined as the presence of the rtM204V/I HBV gene mutation with or without the rtL180M HBV gene mutation.
Baseline to Week 168
Percentage of Participants With Baseline ADV-R + LAM-R Mutations Achieving HBV DNA < 400 Copies/mL by 168 Weeks
ADV resistance mutation + LAM resistance mutations are defined as the presence of the rtA181T/V HBV gene mutation and/or the rtN236T HBV gene mutation, and the rtM204V/I HBV gene mutation with or without the rtL180M HBV gene mutation.
Baseline to Week 168
San Francisco
California
94115
United States
University of Miami, Center for Liver Diseases
Miami
Florida
33136
United States
Rush Presbyterian - St. Luke's Medical Center
Chicago
Illinois
60612
United States
Henry Ford Hospital and Health System
Detroit
Michigan
48202
United States
Mt. Sinai School of Medicine/ Mt. Sinai Medical Center
New York
New York
10029
United States
Columbia Presbyterian Medical Center
New York
New York
10032
United States
Metropolitan Research
Fairfax
Virginia
22031
United States
Virginia Mason Medical Center
Seattle
Washington
98104
United States
Heritage Medical Research Clinic
Calgary
Alberta
T2N4N1
Canada
Vancouver General Hospital
Vancouver
British Columbia
V5Z1H2
Canada
The Gordon & Leslie Diamond Centre
Vancouver
British Columbia
V5Z3M9
Canada
Toronto General Hospital
Toronto
Ontario
M5G 2C4
Canada
Hopital Conception
Marseille
13005
France
Medizinische Klinik mit Schwerpunkt Hepatologie und Gastroenterologie
Berlin
13353
Germany
Universitat Heidelberg
Heidelberg
69120
Germany
Johannes Gutenberg-Universitat
Mainz
55131
Germany
General Hospital of Athens "Ippokratio"
Athens
11527
Greece
Universita de Padova
Padova
35128
Italy
Policlinico Universitario
Udine
33100
Italy
Wojewodzki Szpital Specjalistyczny im Dluskeigo
Bialystok
15-540
Poland
Wojewodzki Szpital Obserwacy
Bydgoszcz
85-030
Poland
Wojewodzki Szpital Zakazny
Warsaw
01-201
Poland
National University Hospital Dept. of Gastroenterology & Hepatology
Singapore
119074
Singapore
Singapore General Hospital
Singapore
169608
Singapore
Tan Tock Seng Hospital
Singapore
308433
Singapore
Changi General Hospital
Singapore
529889
Singapore
Hospital General Universitari Vall d'Hebron
Barcelona
08035
Spain
Hospital Clinic i Provincial de Barcelona (HCPB)
Barcelona
08036
Spain
Hospital Universitario de Bellvitge
Barcelona
08907
Spain
Hospital General Universitario Gregorio Maranon
Madrid
28007
Spain
Hospital Universitario y Politecnico la Fe
Valencia
46026
Spain
Chang Gung Memorial Hospital - Kaohsiung
Kaoshiung Hsien
833
Taiwan
National Cheng Kung University Hospital
Tainan
70428
Taiwan
Cathay General Hospital
Taipei
10650
Taiwan
Chang-Gung Memorial Hospital
Taipei
114
Taiwan
Marmara Universitesi School of Medicine
Istanbul
34899
Turkey (Türkiye)
Ege Universitesi Tip Fakultesi Hastanesi
Izmir
35100
Turkey (Türkiye)
FG001
FTC/TDF
Participants in this group were randomized to receive DB FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline, and may have been unblinded (due to either lack of adequate decrease of HBV DNA or virologic breakthrough) and switched to OL FTC/TDF.
FG002
Entecavir
Participants in this group were randomized to receive DB ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline, and may have been unblinded (due to either lack of adequate decrease of HBV DNA or virologic breakthrough) and switched to OL FTC/TDF.
FG00045 subjects
FG00145 subjects
FG00222 subjects
COMPLETED
FG00028 subjects22 completed while taking DB TDF; 6 completed following switch from DB TDF to OL FTC/TDF.
FG00137 subjects34 completed while taking DB FTC/TDF; 3 completed following switch from DB TDF to OL FTC/TDF.
FG00216 subjects13 completed while taking DB ETV; 3 completed following switch from DB ETV to OL FTC/TDF.
NOT COMPLETED
FG00017 subjects
FG0018 subjects
FG0026 subjects
Type
Comment
Reasons
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0021 subjects
Physician Decision
FG0004 subjects
FG0011 subjects
FG0020 subjects
Protocol Violation
FG0001 subjects
FG0011 subjects
FG0020 subjects
Withdrawal by Subject
FG0005 subjects
FG0011 subjects
FG0023 subjects
Adverse Event
FG0005 subjects
FG0012 subjects
FG0022 subjects
Lack of Efficacy
FG0002 subjects
FG0013 subjects
FG0020 subjects
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Tenofovir DF
Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
BG001
FTC/TDF
Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
BG002
Entecavir
Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
BG003
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00045
BG00145
BG00222
BG003112
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00053± 8.8
BG00149± 10.1
BG00252± 12.0
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0008
BG0015
BG002
Region of Enrollment
Number
participants
Title
Denominators
Categories
France
Title
Measurements
BG0000
BG0010
BG002
Race
Number
participants
Title
Denominators
Categories
Asian
Title
Measurements
BG00023
BG00124
BG002
Ethnicity
Number
participants
Title
Denominators
Categories
Hispanic or Latino
Title
Measurements
BG0002
BG0011
BG002
Weight
Mean
Standard Deviation
kg
Title
Denominators
Categories
Title
Measurements
BG00078.1± 17.02
BG00174.4± 15.41
BG002
Height
Mean
Standard Deviation
cm
Title
Denominators
Categories
Title
Measurements
BG000168.3± 7.98
BG001168.4± 8.47
BG002
BMI
Mean
Standard Deviation
kg/m^2
Title
Denominators
Categories
Title
Measurements
BG00027.6± 5.67
BG00126.2± 5.07
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Percent Probability of Tolerability Failure
Tolerability failure was defined as permanent discontinuation of study drug due to a treatment-emergent adverse event (AE), including any subject who temporarily discontinued study drug due to an AE and did not restart. Results are expressed as proportions of participants who experience tolerability failure using the Kaplan-Meier (KM) method of estimation.
Full analysis set (all randomized subjects who received at least one dose of study drug)
Posted
Number
95% Confidence Interval
percent probability (KM estimate)
Baseline to Week 168
ID
Title
Description
OG000
Tenofovir DF
Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
OG001
FTC/TDF
Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
OG002
TDF or FTC/TDF
Participants in this group include all participants who received TDF or FTC/TDF during the study.
OG003
Entecavir
Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
Units
Counts
Participants
OG00045
OG00145
OG00290
OG003
Title
Denominators
Categories
Title
Measurements
OG00018(5.8 to 30.6)
OG0014(0.0 to 10.4)
OG00211(4.1 to 17.7)
OG003
Secondary
Median Time-averaged Change (DAVG) in Plasma Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels at 48 Weeks Relative to Baseline
Change from baseline was evaluated by subtracting baseline HBV DNA log_10 copies/mL from Week 48 HBV DNA log_10 copies/mL. DAVG is defined as the area of the trapezoid under the response-time curve divided by time to the last available evaluation of the patient minus the baseline value.
Participants with HBV DNA measurements at Week 48 were included in this analysis.
Posted
Median
Inter-Quartile Range
log_10 copies/mL
Baseline to 48 weeks
ID
Title
Description
OG000
Tenofovir DF
Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
OG001
FTC/TDF
Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
OG002
Entecavir
Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
OG003
Overall
Secondary
Median DAVG in Plasma HBV DNA Levels at 96 Weeks Relative to Baseline
Change from baseline was evaluated by subtracting baseline HBV DNA log_10 copies/mL from Week 96 HBV DNA log_10 copies/mL. DAVG is defined as the area of the trapezoid under the response-time curve divided by time to the last available evaluation of the patient minus the baseline value.
Full analysis set; data collected for participants who underwent liver transplant prior to Week 96 were excluded.
Posted
Median
Inter-Quartile Range
log_10 copies/mL
Baseline to 96 weeks
ID
Title
Description
OG000
Tenofovir DF
Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
OG001
FTC/TDF
Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
OG002
Entecavir
Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
OG003
Overall
Secondary
Median DAVG in Plasma HBV DNA Levels at 144 Weeks Relative to Baseline
Change from baseline was evaluated by subtracting baseline HBV DNA log_10 copies/mL from Week 144 HBV DNA log_10 copies/mL. DAVG is defined as the area of the trapezoid under the response-time curve divided by time to the last available evaluation of the patient minus the baseline value.
Full analysis set; data collected for participants who underwent liver transplant prior to Week 144 were excluded.
Posted
Median
Inter-Quartile Range
log _10 copies/mL
Baseline to 144 weeks
ID
Title
Description
OG000
Tenofovir DF
Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
OG001
FTC/TDF
Participants in this group were randomized to receive FTC 200mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
OG002
Entecavir
Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
OG003
Overall
Secondary
Median DAVG in Plasma HBV DNA Levels at 168 Weeks Relative to Baseline
Change from baseline was evaluated by subtracting baseline HBV DNA log_10 copies/mL from Week 168 HBV DNA log_10 copies/mL. DAVG is defined as the area of the trapezoid under the response-time curve divided by time to the last available evaluation of the patient minus the baseline value.
Full analysis set; data collected for participants who underwent liver transplant prior to Week 168 were excluded.
Posted
Median
Inter-Quartile Range
log_10 copies/mL
Baseline to 168 weeks
ID
Title
Description
OG000
Tenofovir DF
Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
OG001
FTC/TDF
Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
OG002
Entecavir
Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
OG003
Overall
Secondary
Percentage of Participants With Plasma HBV DNA < 400 Copies/mL at Week 48
The percentage of participants with plasma HBV DNA < 400 copies/mL at Week 48 was summarized.
Full analysis set; noncompleters/switch = failure analysis (participants who did not complete treatment or changed from double-blind to open-label treatment up to the time point were considered as failing to meet efficacy response criteria [defined as not achieving viral suppression of < 400 copies/mL]).
Posted
Number
percentage of participants
Week 48
ID
Title
Description
OG000
Tenofovir DF
Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
OG001
FTC/TDF
Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
OG002
Entecavir
Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
OG003
Overall
Secondary
Percentage of Participants With Plasma HBV DNA < 400 Copies/mL at Week 96
The percentage of participants with plasma HBV DNA < 400 copies/mL at Week 96 was summarized.
Full analysis set; noncompleters/switch = failure
Posted
Number
percentage of participants
Week 96
ID
Title
Description
OG000
Tenofovir DF
Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
OG001
FTC/TDF
Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
OG002
Entecavir
Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
OG003
Overall
Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
Secondary
Percentage of Participants With Plasma HBV DNA < 400 Copies/mL at Week 144
The percentage of participants with plasma HBV DNA < 400 copies/mL at Week 144 was summarized.
Full analysis set; noncompleters/switch = failure
Posted
Number
percentage of participants
Week 144
ID
Title
Description
OG000
Tenofovir DF
Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
OG001
FTC/TDF
Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
OG002
Entecavir
Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
OG003
Overall
Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
Secondary
Percentage of Participants With Plasma HBV DNA < 400 Copies/mL at Week 168
The percentage of participants with plasma HBV DNA < 400 copies/mL at Week 168 was summarized.
Full analysis set; noncompleters/switch = failure
Posted
Number
percentage of participants
Week 168
ID
Title
Description
OG000
Tenofovir DF
Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
OG001
FTC/TDF
Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
OG002
Entecavir
Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
OG003
Overall
Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
Secondary
Percentage of Participants With Normalized Alanine Aminotransferase (ALT) (for Subjects With Elevated ALT at Baseline) at Week 48
Normalized ALT is defined as having a baseline ALT value > the upper limit of the normal range (ULN), and a decrease in ALT value to ≤ ULN at the given time point.
Biochemically evaluable analysis set (subjects in full analysis set with abnormal baseline alanine aminotransferase [ALT] values); noncompleters/switch = failure
Posted
Number
percentage of participants
Baseline to Week 48
ID
Title
Description
OG000
Tenofovir DF
Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
OG001
FTC/TDF
Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
OG002
Entecavir
Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
OG003
Overall
Secondary
Percentage of Participants With Normalized ALT (for Subjects With Elevated ALT at Baseline) at Week 96
Normalized ALT is defined as having a baseline ALT value > ULN, and a decrease in ALT value to ≤ ULN at the given time point.
Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
OG001
FTC/TDF
Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
OG002
Entecavir
Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
OG003
Overall
Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
Secondary
Percentage of Participants With an Increase in Child-Pugh Turcotte (CPT) Score of ≥ 2 Points at Weeks 48
CPT scores, widely used to grade the severity of cirrhosis and to determine the need for liver transplantation, are calculated based on a combination of laboratory values and clinical features. CPT scores can range from 5 to 15, with higher scores indicating a greater severity of disease.
Full analysis set; noncompleters/switch = failure
Posted
Number
percentage of participants
Baseline to Week 48
ID
Title
Description
OG000
Tenofovir DF
Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
OG001
FTC/TDF
Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
OG002
Entecavir
Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
OG003
Overall
Secondary
Percentage of Participants With an Increase in CPT Score of ≥ 2 Points at Week 96
CPT scores, widely used to grade the severity of cirrhosis and to determine the need for liver transplantation, are calculated based on a combination of laboratory values and clinical features. CPT scores can range from 5 to 15, with higher scores indicating a greater severity of disease.
Full analysis set; noncompleters/switch = failure
Posted
Number
percentage of participants
Baseline to Week 96
ID
Title
Description
OG000
Tenofovir DF
Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
OG001
FTC/TDF
Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
OG002
Entecavir
Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
OG003
Overall
Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
Secondary
Percentage of Participants With an Increase in CPT Score of ≥ 2 Points at Week 144
CPT scores, widely used to grade the severity of cirrhosis and to determine the need for liver transplantation, are calculated based on a combination of laboratory values and clinical features. CPT scores can range from 5 to 15, with higher scores indicating a greater severity of disease.
Full analysis set; noncompleters/switch = failure
Posted
Number
percentage of participants
Baseline to Week 144
ID
Title
Description
OG000
Tenofovir DF
Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
OG001
FTC/TDF
Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
OG002
Entecavir
Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
OG003
Overall
Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
Secondary
Percentage of Participants With an Increase in CPT Score of ≥ 2 Points at Week 168
CPT scores, widely used to grade the severity of cirrhosis and to determine the need for liver transplantation, are calculated based on a combination of laboratory values and clinical features. CPT scores can range from 5 to 15, with higher scores indicating a greater severity of disease.
Full analysis set; noncompleters/switch = failure
Posted
Number
percentage of participants
Baseline to Week 168
ID
Title
Description
OG000
Tenofovir DF
Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
OG001
FTC/TDF
Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
OG002
Entecavir
Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
OG003
Overall
Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
Secondary
Percentage of Participants With a Decrease in CPT Score of ≥ 2 Points From Baseline at Week 48
CPT scores, widely used to grade the severity of cirrhosis and to determine the need for liver transplantation, are calculated based on a combination of laboratory values and clinical features. CPT scores can range from 5 to 15, with higher scores indicating a greater severity of disease.
CPT evaluable analysis set (subjects with CPT scores ≥ 7 at baseline; because the minimum CPT score was 5, only these subjects were evaluable for analyses of ≥ 2-point decrease in CPT score); noncompleters/switch = failure
Posted
Number
percentage of participants
Baseline to Week 48
ID
Title
Description
OG000
Tenofovir DF
Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
OG001
FTC/TDF
Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
OG002
Entecavir
Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
OG003
Secondary
Percentage of Participants With a Decrease in CPT Score of ≥ 2 Points From Baseline at Week 96
CPT scores, widely used to grade the severity of cirrhosis and to determine the need for liver transplantation, are calculated based on a combination of laboratory values and clinical features. CPT scores can range from 5 to 15, with higher scores indicating a greater severity of disease.
Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
OG001
FTC/TDF
Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
OG002
Entecavir
Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
OG003
Overall
Secondary
Percentage of Participants With a Decrease in CPT Score of ≥ 2 Points From Baseline at Week 144
CPT scores, widely used to grade the severity of cirrhosis and to determine the need for liver transplantation, are calculated based on a combination of laboratory values and clinical features. CPT scores can range from 5 to 15, with higher scores indicating a greater severity of disease.
Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
OG001
FTC/TDF
Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
OG002
Entecavir
Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
OG003
Overall
Secondary
Percentage of Participants With a Decrease in CPT Score of ≥ 2 Points From Baseline at Week 168
CPT scores, widely used to grade the severity of cirrhosis and to determine the need for liver transplantation, are calculated based on a combination of laboratory values and clinical features. CPT scores can range from 5 to 15, with higher scores indicating a greater severity of disease.
Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
OG001
FTC/TDF
Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
OG002
Entecavir
Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
OG003
Overall
Secondary
Median Change in Model for End-Stage Liver Disease (MELD) Score From Baseline at Week 48
MELD scores, used to assess prognosis and suitability for transplant, are calculated based on laboratory values only and can range from 6 to 40, with higher scores indicating greater disease severity.
Subjects in the full analysis set with an available score at the visit
Posted
Median
Inter-Quartile Range
units on a scale
Baseline to Week 48
ID
Title
Description
OG000
Tenofovir DF
Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
OG001
FTC/TDF
Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
OG002
Entecavir
Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
OG003
Overall
Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
Secondary
Median Change in MELD Score From Baseline at Week 96
MELD scores, used to assess prognosis and suitability for transplant, are calculated based on laboratory values only and can range from 6 to 40, with higher scores indicating greater disease severity.
Subjects in the full analysis set with an available score at the visit
Posted
Median
Inter-Quartile Range
units on a scale
Baseline to Week 96
ID
Title
Description
OG000
Tenofovir DF
Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
OG001
FTC/TDF
Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
OG002
Entecavir
Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
OG003
Overall
Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
Secondary
Median Change in MELD Score From Baseline at Week 144
MELD scores, used to assess prognosis and suitability for transplant, are calculated based on laboratory values only and can range from 6 to 40, with higher scores indicating greater disease severity.
Subjects in the full analysis set with an available score at the visit
Posted
Median
Inter-Quartile Range
units on a scale
Baseline to Week 144
ID
Title
Description
OG000
Tenofovir DF
Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
OG001
FTC/TDF
Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
OG002
Entecavir
Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
OG003
Overall
Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
Secondary
Median Change in MELD Score From Baseline at Week 168
MELD scores, used to assess prognosis and suitability for transplant, are calculated based on laboratory values only and can range from 6 to 40, with higher scores indicating greater disease severity.
Subjects in the full analysis set with an available score at the visit
Posted
Median
Inter-Quartile Range
units on a scale
Baseline to Week 168
ID
Title
Description
OG000
Tenofovir DF
Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
OG001
FTC/TDF
Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
OG002
Entecavir
Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
OG003
Overall
Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
Secondary
Percentage of Participants With Hepatitis B Early Antigen (HBeAg) Loss and HBeAg Seroconversion at Week 48 (for Participants Who Were HBeAg Positive at Baseline)
Loss of HBeAg was defined as change of detectable HBeAg from positive to negative. HBeAg seroconversion was defined as change of detectable antibody to HBeAg from negative to positive.
Serologically evaluable analysis set (subjects in full analysis set with positive hepatitis B early antigen [HBeAg] at baseline); noncompleters/switch = failure
Posted
Number
percentage of participants
Baseline to Week 48
ID
Title
Description
OG000
Tenofovir DF
Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
OG001
FTC/TDF
Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
OG002
Entecavir
Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
OG003
Overall
Secondary
Percentage of Participants With HBeAg Loss and HBeAg Seroconversion at Week 96 (for Participants Who Were HBeAg Positive at Baseline)
Loss of HBeAg was defined as change of detectable HBeAg from positive to negative. HBeAg seroconversion was defined as change of detectable antibody to HBeAg from negative to positive.
Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
OG001
FTC/TDF
Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
OG002
Entecavir
Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
OG003
Overall
Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
Secondary
Percentage of Participants With HBeAg Loss and HBeAg Seroconversion at Week 144 (for Participants Who Were HBeAg Positive at Baseline)
Loss of HBeAg was defined as change of detectable HBeAg from positive to negative. HBeAg seroconversion was defined as change of detectable antibody to HBeAg from negative to positive.
Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
OG001
FTC/TDF
Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
OG002
Entecavir
Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
OG003
Overall
Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
Secondary
Percentage of Participants With HBeAg Loss and HBeAg Seroconversion at Week 168 (for Participants Who Were HBeAg Positive at Baseline)
Loss of HBeAg was defined as change of detectable HBeAg from positive to negative. HBeAg seroconversion was defined as change of detectable antibody to HBeAg from negative to positive.
Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
OG001
FTC/TDF
Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
OG002
Entecavir
Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
OG003
Overall
Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
Secondary
Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss and HBsAg Seroconversion at Week 48
Loss of HBsAg was defined as change of detectable HBsAg from positive to negative. HBsAg seroconversion was defined as change of detectable antibody to HBsAg from negative to positive.
Full analysis set; noncompleters/switch = failure
Posted
Number
percentage of participants
Baseline to Week 48
ID
Title
Description
OG000
Tenofovir DF
Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
OG001
FTC/TDF
Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
OG002
Entecavir
Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
OG003
Overall
Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
Other Pre-specified
Percentage of Participants With Only Baseline Adefovir Dipivoxil Resistance (ADV-R) Mutations Achieving HBV DNA < 400 Copies/mL by 168 Weeks
ADV resistance mutations are defined as the presence of the rtA181T/V HBV gene mutation and/or the rtN236T HBV gene mutation.
Participants in the full analysis set with ADV resistance mutation at baseline were included in this analysis.
Posted
Number
percentage of participants
Baseline to Week 168
ID
Title
Description
OG000
Tenofovir DF
Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
OG001
FTC/TDF
Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
OG002
Entecavir
Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
Units
Counts
Other Pre-specified
Percentage of Participants With Only Baseline Lamivudine-resistance (LAM-R) Mutations Achieving HBV DNA < 400 Copies/mL by 168 Weeks
LAM resistance mutations are defined as the presence of the rtM204V/I HBV gene mutation with or without the rtL180M HBV gene mutation.
Patients in the full analysis set with LAM resistance mutation at baseline were included in this analysis.
Posted
Number
percentage of participants
Baseline to Week 168
ID
Title
Description
OG000
Tenofovir DF
Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
OG001
FTC/TDF
Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
OG002
Entecavir
Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
Units
Counts
Other Pre-specified
Percentage of Participants With Baseline ADV-R + LAM-R Mutations Achieving HBV DNA < 400 Copies/mL by 168 Weeks
ADV resistance mutation + LAM resistance mutations are defined as the presence of the rtA181T/V HBV gene mutation and/or the rtN236T HBV gene mutation, and the rtM204V/I HBV gene mutation with or without the rtL180M HBV gene mutation.
Participants in the full analysis set with both ADV and LAM resistance mutations at baseline were included in this analysis.
Posted
Number
percentage of participants
Baseline to Week 168
ID
Title
Description
OG000
Tenofovir DF
Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
OG001
FTC/TDF
Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
OG002
Entecavir
Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
Primary
Percent Probability of a Confirmed Increase in Serum Creatinine of ≥ 0.5 mg/dL From Baseline or a Confirmed Serum Phosphorus Level < 2.0 mg/dL
Results are expressed as proportions of participants who experience a confirmed increase in serum creatinine of ≥ 0.5 mg/dL from baseline or a confirmed serum phosphorus level < 2.0 mg/dL using the KM method of estimation.
Full analysis set
Posted
Number
95% Confidence Interval
percent probability (KM estimate)
Baseline to Week 168
ID
Title
Description
OG000
Tenofovir DF
Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
OG001
FTC/TDF
Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
OG002
TDF or FTC/TDF
Participants in this group include all participants who received TDF or FTC/TDF during the study.
OG003
Entecavir
Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
Secondary
Percentage of Participants With HBsAg Loss and HBsAg Seroconversion at Week 96
Loss of HBsAg was defined as change of detectable HBsAg from positive to negative. HBsAg seroconversion was defined as change of detectable antibody to HBsAg from negative to positive.
Full analysis set; noncompleters/switch = failure
Posted
Number
percentage of participants
Baseline to Week 96
ID
Title
Description
OG000
Tenofovir DF
Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
OG001
FTC/TDF
Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
OG002
Entecavir
Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
OG003
Overall
Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
Secondary
Percentage of Participants With HBsAg Loss and HBsAg Seroconversion at Week 144
Loss of HBsAg was defined as change of detectable HBsAg from positive to negative. HBsAg seroconversion was defined as change of detectable antibody to HBsAg from negative to positive.
Full analysis set; noncompleters/switch = failure
Posted
Number
percentage of participants
Baseline to Week 144
ID
Title
Description
OG000
Tenofovir DF
Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
OG001
FTC/TDF
Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
OG002
Entecavir
Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
OG003
Overall
Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
Secondary
Percentage of Participants With HBsAg Loss and HBsAg Seroconversion at Week 168
Loss of HBsAg was defined as change of detectable HBsAg from positive to negative. HBsAg seroconversion was defined as change of detectable antibody to HBsAg from negative to positive.
Full analysis set; noncompleters/switch = failure
Posted
Number
percentage of participants
Baseline to Week 168
ID
Title
Description
OG000
Tenofovir DF
Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
OG001
FTC/TDF
Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
OG002
Entecavir
Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
OG003
Overall
Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
Secondary
In the Subset of Participants Undergoing Liver Transplantation, Time to Recurrence of Hepatitis B, Defined as 2 Consecutive Plasma HBV DNA Concentrations ≥ 400 Copies/mL or 2 Consecutive HBsAg(+) Results
Liver transplantation analysis set
Posted
Number
Days
Baseline to Week 168
ID
Title
Description
OG000
Tenofovir DF
Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
OG001
FTC/TDF
Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
OG002
Entecavir
Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
OG003
Overall
Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
Time Frame
Not provided
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Double Blind TDF
Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo
21
45
41
45
EG001
Double Blind FTC/TDF
Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo
25
45
44
45
EG002
Double Blind ETV
Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo
11
22
20
22
EG003
Open Label FTC/TDF
Participants in this group were randomized to receive TDF, FTC/TDF, or ETV at the beginning of the study, but switched to open label FTC/TDF during the study.
4
12
9
12
EG004
All TDF
Participants in this group received a TDF-containing treatment (all double-blind TDF, FTC/TDF, or open-label FTC/TDF) during the study.
50
93
89
93
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Ascites
Gastrointestinal disorders
EG0003 affected45 at risk
EG0013 affected45 at risk
EG0021 affected22 at risk
EG0031 affected12 at risk
EG0047 affected93 at risk
Abdominal pain
Gastrointestinal disorders
EG0003 affected45 at risk
EG0011 affected45 at risk
EG0021 affected22 at risk
EG003
Oesophageal varices haemorrhage
Gastrointestinal disorders
EG0003 affected45 at risk
EG0011 affected45 at risk
EG0021 affected22 at risk
EG003
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
EG0002 affected45 at risk
EG0012 affected45 at risk
EG0021 affected22 at risk
EG003
Abdominal distension
Gastrointestinal disorders
EG0001 affected45 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Abdominal hernia
Gastrointestinal disorders
EG0000 affected45 at risk
EG0011 affected45 at risk
EG0020 affected22 at risk
EG003
Gastric varices haemorrhage
Gastrointestinal disorders
EG0000 affected45 at risk
EG0011 affected45 at risk
EG0020 affected22 at risk
EG003
Haematemesis
Gastrointestinal disorders
EG0001 affected45 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Inguinal hernia
Gastrointestinal disorders
EG0001 affected45 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Inguinal hernia, obstructive
Gastrointestinal disorders
EG0001 affected45 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Melaena
Gastrointestinal disorders
EG0001 affected45 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Nausea
Gastrointestinal disorders
EG0001 affected45 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Pancreatitis acute
Gastrointestinal disorders
EG0001 affected45 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Vomiting
Gastrointestinal disorders
EG0001 affected45 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Gastrointestinal motility disorder
Gastrointestinal disorders
EG0000 affected45 at risk
EG0010 affected45 at risk
EG0021 affected22 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
EG0000 affected45 at risk
EG0010 affected45 at risk
EG0021 affected22 at risk
EG003
Hepatic function abnormal
Hepatobiliary disorders
EG0002 affected45 at risk
EG0015 affected45 at risk
EG0022 affected22 at risk
EG003
Hepatorenal syndrome
Hepatobiliary disorders
EG0001 affected45 at risk
EG0012 affected45 at risk
EG0020 affected22 at risk
EG003
Chronic hepatic failure
Hepatobiliary disorders
EG0001 affected45 at risk
EG0011 affected45 at risk
EG0020 affected22 at risk
EG003
Hepatic failure
Hepatobiliary disorders
EG0001 affected45 at risk
EG0011 affected45 at risk
EG0020 affected22 at risk
EG003
Cholestasis
Hepatobiliary disorders
EG0000 affected45 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Hepatic cirrhosis
Hepatobiliary disorders
EG0000 affected45 at risk
EG0011 affected45 at risk
EG0020 affected22 at risk
EG003
Hepatic lesion
Hepatobiliary disorders
EG0000 affected45 at risk
EG0011 affected45 at risk
EG0020 affected22 at risk
EG003
Hepatitis acute
Hepatobiliary disorders
EG0000 affected45 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Porcelain gallbladder
Hepatobiliary disorders
EG0000 affected45 at risk
EG0011 affected45 at risk
EG0020 affected22 at risk
EG003
Peritonitis bacterial
Infections and infestations
EG0002 affected45 at risk
EG0013 affected45 at risk
EG0020 affected22 at risk
EG003
Sepsis
Infections and infestations
EG0001 affected45 at risk
EG0013 affected45 at risk
EG0020 affected22 at risk
EG003
Lower respiratory tract infection
Infections and infestations
EG0000 affected45 at risk
EG0012 affected45 at risk
EG0020 affected22 at risk
EG003
Osteomyelitis
Infections and infestations
EG0000 affected45 at risk
EG0011 affected45 at risk
EG0021 affected22 at risk
EG003
Anal abscess
Infections and infestations
EG0000 affected45 at risk
EG0011 affected45 at risk
EG0020 affected22 at risk
EG003
Gastroenteritis viral
Infections and infestations
EG0000 affected45 at risk
EG0011 affected45 at risk
EG0020 affected22 at risk
EG003
Laryngitis
Infections and infestations
EG0000 affected45 at risk
EG0011 affected45 at risk
EG0020 affected22 at risk
EG003
Pharyngitis
Infections and infestations
EG0000 affected45 at risk
EG0011 affected45 at risk
EG0020 affected22 at risk
EG003
Pneumococcal sepsis
Infections and infestations
EG0000 affected45 at risk
EG0011 affected45 at risk
EG0020 affected22 at risk
EG003
Pneumonia
Infections and infestations
EG0000 affected45 at risk
EG0011 affected45 at risk
EG0020 affected22 at risk
EG003
Pyelonephritis acute
Infections and infestations
EG0000 affected45 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Scrotal abscess
Infections and infestations
EG0000 affected45 at risk
EG0011 affected45 at risk
EG0020 affected22 at risk
EG003
Subcutaneous abscess
Infections and infestations
EG0001 affected45 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Bacteraemia
Infections and infestations
EG0000 affected45 at risk
EG0010 affected45 at risk
EG0021 affected22 at risk
EG003
Cellulitis
Infections and infestations
EG0000 affected45 at risk
EG0010 affected45 at risk
EG0021 affected22 at risk
EG003
Hepatitis B
Infections and infestations
EG0000 affected45 at risk
EG0010 affected45 at risk
EG0021 affected22 at risk
EG003
Necrotising fasciitis
Infections and infestations
EG0000 affected45 at risk
EG0010 affected45 at risk
EG0021 affected22 at risk
EG003
Septic shock
Infections and infestations
EG0000 affected45 at risk
EG0010 affected45 at risk
EG0021 affected22 at risk
EG003
Wound infection
Infections and infestations
EG0000 affected45 at risk
EG0010 affected45 at risk
EG0021 affected22 at risk
EG003
Hepatic neoplasm malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
EG0008 affected45 at risk
EG0013 affected45 at risk
EG0022 affected22 at risk
EG003
Hodgkin's disease
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
EG0000 affected45 at risk
EG0010 affected45 at risk
EG0021 affected22 at risk
EG003
Hepatic encephalopathy
Nervous system disorders
EG0003 affected45 at risk
EG0011 affected45 at risk
EG0022 affected22 at risk
EG003
Encephalopathy
Nervous system disorders
EG0001 affected45 at risk
EG0012 affected45 at risk
EG0020 affected22 at risk
EG003
Cerebral haemorrhage
Nervous system disorders
EG0000 affected45 at risk
EG0011 affected45 at risk
EG0020 affected22 at risk
EG003
Cerebrospinal fluid rhinorrhoea
Nervous system disorders
EG0001 affected45 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Depressed level of consciousness
Nervous system disorders
EG0000 affected45 at risk
EG0011 affected45 at risk
EG0020 affected22 at risk
EG003
Subarachnoid haemorrhage
Nervous system disorders
EG0001 affected45 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Basal ganglia haemorrhage
Nervous system disorders
EG0000 affected45 at risk
EG0010 affected45 at risk
EG0021 affected22 at risk
EG003
Cerebral infarction
Nervous system disorders
EG0000 affected45 at risk
EG0010 affected45 at risk
EG0021 affected22 at risk
EG003
Headache
Nervous system disorders
EG0000 affected45 at risk
EG0010 affected45 at risk
EG0021 affected22 at risk
EG003
Allergic transfusion reaction
Injury, poisoning and procedural complications
EG0000 affected45 at risk
EG0011 affected45 at risk
EG0020 affected22 at risk
EG003
Biliary anastomosis complication
Injury, poisoning and procedural complications
EG0000 affected45 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Device failure
Injury, poisoning and procedural complications
EG0000 affected45 at risk
EG0011 affected45 at risk
EG0020 affected22 at risk
EG003
Overdose
Injury, poisoning and procedural complications
EG0000 affected45 at risk
EG0011 affected45 at risk
EG0020 affected22 at risk
EG003
Post procedural haematoma
Injury, poisoning and procedural complications
EG0000 affected45 at risk
EG0011 affected45 at risk
EG0020 affected22 at risk
EG003
Thermal burn
Injury, poisoning and procedural complications
EG0001 affected45 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Traumatic spinal cord compression
Injury, poisoning and procedural complications
EG0000 affected45 at risk
EG0011 affected45 at risk
EG0020 affected22 at risk
EG003
Multiple fractures
Injury, poisoning and procedural complications
EG0000 affected45 at risk
EG0010 affected45 at risk
EG0021 affected22 at risk
EG003
Road traffic accident
Injury, poisoning and procedural complications
EG0000 affected45 at risk
EG0010 affected45 at risk
EG0021 affected22 at risk
EG003
Pyrexia
General disorders
EG0001 affected45 at risk
EG0011 affected45 at risk
EG0021 affected22 at risk
EG003
Asthenia
General disorders
EG0001 affected45 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Generalized oedema
General disorders
EG0001 affected45 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Oedema
General disorders
EG0001 affected45 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Calculus Ureteric
Renal and urinary disorders
EG0000 affected45 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Hydronephrosis
Renal and urinary disorders
EG0000 affected45 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
EG0000 affected45 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Renal aneurysm
Renal and urinary disorders
EG0001 affected45 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Renal failure
Renal and urinary disorders
EG0001 affected45 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Renal failure acute
Renal and urinary disorders
EG0000 affected45 at risk
EG0011 affected45 at risk
EG0020 affected22 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
EG0000 affected45 at risk
EG0011 affected45 at risk
EG0021 affected22 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
EG0000 affected45 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Hydrothorax
Respiratory, thoracic and mediastinal disorders
EG0000 affected45 at risk
EG0011 affected45 at risk
EG0020 affected22 at risk
EG003
Nasal disorder
Respiratory, thoracic and mediastinal disorders
EG0000 affected45 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Contrast media allergy
Immune system disorders
EG0000 affected45 at risk
EG0011 affected45 at risk
EG0020 affected22 at risk
EG003
Hypersensitivity
Immune system disorders
EG0000 affected45 at risk
EG0011 affected45 at risk
EG0020 affected22 at risk
EG003
Liver transplant rejection
Immune system disorders
EG0000 affected45 at risk
EG0011 affected45 at risk
EG0020 affected22 at risk
EG003
Mental status change
Psychiatric disorders
EG0002 affected45 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Schizophreniform disorder
Psychiatric disorders
EG0000 affected45 at risk
EG0011 affected45 at risk
EG0020 affected22 at risk
EG003
Circulatory collapse
Vascular disorders
EG0000 affected45 at risk
EG0011 affected45 at risk
EG0020 affected22 at risk
EG003
Hypotension
Vascular disorders
EG0001 affected45 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Aortic dissection
Vascular disorders
EG0000 affected45 at risk
EG0010 affected45 at risk
EG0021 affected22 at risk
EG003
Alanine aminotransferase increased
Investigations
EG0000 affected45 at risk
EG0011 affected45 at risk
EG0020 affected22 at risk
EG003
Creatinine renal clearance decreased
Investigations
EG0001 affected45 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Diabetic ketoacidosis
Metabolism and nutrition disorders
EG0000 affected45 at risk
EG0011 affected45 at risk
EG0020 affected22 at risk
EG003
Fluid overload
Metabolism and nutrition disorders
EG0001 affected45 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Hypovolaemia
Metabolism and nutrition disorders
EG0001 affected45 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
EG0000 affected45 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
EG0001 affected45 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
EG0001 affected45 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Sudden hearing loss
Ear and labyrinth disorders
EG0000 affected45 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Postmenopausal hemorrhage
Reproductive system and breast disorders
EG0000 affected45 at risk
EG0011 affected45 at risk
EG0020 affected22 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
EG0001 affected45 at risk
EG0011 affected45 at risk
EG0021 affected22 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abdominal pain upper
Gastrointestinal disorders
EG0009 affected45 at risk
EG0017 affected45 at risk
EG0022 affected22 at risk
EG0032 affected12 at risk
EG00418 affected93 at risk
Ascites
Gastrointestinal disorders
EG0008 affected45 at risk
EG0014 affected45 at risk
EG0026 affected22 at risk
EG003
Abdominal pain
Gastrointestinal disorders
EG0006 affected45 at risk
EG0014 affected45 at risk
EG0023 affected22 at risk
EG003
Nausea
Gastrointestinal disorders
EG0009 affected45 at risk
EG0013 affected45 at risk
EG0021 affected22 at risk
EG003
Abdominal distension
Gastrointestinal disorders
EG0005 affected45 at risk
EG0014 affected45 at risk
EG0022 affected22 at risk
EG003
Vomiting
Gastrointestinal disorders
EG0006 affected45 at risk
EG0012 affected45 at risk
EG0022 affected22 at risk
EG003
Dyspepsia
Gastrointestinal disorders
EG0001 affected45 at risk
EG0016 affected45 at risk
EG0021 affected22 at risk
EG003
Diarrhoea
Gastrointestinal disorders
EG0004 affected45 at risk
EG0011 affected45 at risk
EG0025 affected22 at risk
EG003
Constipation
Gastrointestinal disorders
EG0003 affected45 at risk
EG0013 affected45 at risk
EG0021 affected22 at risk
EG003
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
EG0002 affected45 at risk
EG0013 affected45 at risk
EG0021 affected22 at risk
EG003
Inguinal hernia
Gastrointestinal disorders
EG0003 affected45 at risk
EG0012 affected45 at risk
EG0020 affected22 at risk
EG003
Oesophageal varices haemorrhage
Gastrointestinal disorders
EG0003 affected45 at risk
EG0011 affected45 at risk
EG0021 affected22 at risk
EG003
Duodenal ulcer
Gastrointestinal disorders
EG0000 affected45 at risk
EG0012 affected45 at risk
EG0022 affected22 at risk
EG003
Gastritis
Gastrointestinal disorders
EG0001 affected45 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
EG0001 affected45 at risk
EG0011 affected45 at risk
EG0020 affected22 at risk
EG003
Hiatus hernia
Gastrointestinal disorders
EG0000 affected45 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Nasopharyngitis
Infections and infestations
EG0005 affected45 at risk
EG0017 affected45 at risk
EG0021 affected22 at risk
EG003
Upper respiratory tract infection
Infections and infestations
EG0004 affected45 at risk
EG0014 affected45 at risk
EG0022 affected22 at risk
EG003
Urinary tract infection
Infections and infestations
EG0004 affected45 at risk
EG0012 affected45 at risk
EG0021 affected22 at risk
EG003
Bronchitis
Infections and infestations
EG0003 affected45 at risk
EG0011 affected45 at risk
EG0022 affected22 at risk
EG003
Peritonitis bacterial
Infections and infestations
EG0002 affected45 at risk
EG0013 affected45 at risk
EG0020 affected22 at risk
EG003
Sepsis
Infections and infestations
EG0002 affected45 at risk
EG0013 affected45 at risk
EG0020 affected22 at risk
EG003
Influenza
Infections and infestations
EG0001 affected45 at risk
EG0012 affected45 at risk
EG0020 affected22 at risk
EG003
Rhinitis
Infections and infestations
EG0000 affected45 at risk
EG0013 affected45 at risk
EG0020 affected22 at risk
EG003
Pyelonephritis acute
Infections and infestations
EG0000 affected45 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Wound infection
Infections and infestations
EG0000 affected45 at risk
EG0010 affected45 at risk
EG0022 affected22 at risk
EG003
Hepatic function abnormal
Hepatobiliary disorders
EG0002 affected45 at risk
EG0015 affected45 at risk
EG0022 affected22 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
EG0002 affected45 at risk
EG0014 affected45 at risk
EG0020 affected22 at risk
EG003
Jaundice
Hepatobiliary disorders
EG0001 affected45 at risk
EG0013 affected45 at risk
EG0021 affected22 at risk
EG003
Hepatic steatosis
Hepatobiliary disorders
EG0001 affected45 at risk
EG0011 affected45 at risk
EG0020 affected22 at risk
EG003
Portal hypertension
Hepatobiliary disorders
EG0002 affected45 at risk
EG0011 affected45 at risk
EG0020 affected22 at risk
EG003
Hepatomegaly
Hepatobiliary disorders
EG0002 affected45 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Gallbladder polyp
Hepatobiliary disorders
EG0000 affected45 at risk
EG0010 affected45 at risk
EG0022 affected22 at risk
EG003
Cholangitis
Hepatobiliary disorders
EG0000 affected45 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Cholestasis
Hepatobiliary disorders
EG0000 affected45 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Hepatitis acute
Hepatobiliary disorders
EG0000 affected45 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Oedema peripheral
General disorders
EG0008 affected45 at risk
EG0013 affected45 at risk
EG0025 affected22 at risk
EG003
Pyrexia
General disorders
EG0006 affected45 at risk
EG0015 affected45 at risk
EG0024 affected22 at risk
EG003
Asthenia
General disorders
EG0005 affected45 at risk
EG0012 affected45 at risk
EG0022 affected22 at risk
EG003
Fatigue
General disorders
EG0002 affected45 at risk
EG0012 affected45 at risk
EG0022 affected22 at risk
EG003
Chest pain
General disorders
EG0001 affected45 at risk
EG0010 affected45 at risk
EG0021 affected22 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
EG0004 affected45 at risk
EG0015 affected45 at risk
EG0022 affected22 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
EG0005 affected45 at risk
EG0013 affected45 at risk
EG0021 affected22 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
EG0005 affected45 at risk
EG0012 affected45 at risk
EG0020 affected22 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
EG0003 affected45 at risk
EG0011 affected45 at risk
EG0022 affected22 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
EG0001 affected45 at risk
EG0013 affected45 at risk
EG0021 affected22 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
EG0001 affected45 at risk
EG0012 affected45 at risk
EG0021 affected22 at risk
EG003
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
EG0000 affected45 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Headache
Nervous system disorders
EG0004 affected45 at risk
EG0013 affected45 at risk
EG0025 affected22 at risk
EG003
Dizziness
Nervous system disorders
EG0006 affected45 at risk
EG0013 affected45 at risk
EG0020 affected22 at risk
EG003
Hepatic encephalopathy
Nervous system disorders
EG0005 affected45 at risk
EG0012 affected45 at risk
EG0023 affected22 at risk
EG003
Encephalopathy
Nervous system disorders
EG0003 affected45 at risk
EG0013 affected45 at risk
EG0020 affected22 at risk
EG003
Pruritis
Skin and subcutaneous tissue disorders
EG0007 affected45 at risk
EG0016 affected45 at risk
EG0022 affected22 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
EG0004 affected45 at risk
EG0015 affected45 at risk
EG0021 affected22 at risk
EG003
Psoriasis
Skin and subcutaneous tissue disorders
EG0000 affected45 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Rash pruritic
Skin and subcutaneous tissue disorders
EG0000 affected45 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Scar pain
Skin and subcutaneous tissue disorders
EG0000 affected45 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Skin hyperpigmentation
Skin and subcutaneous tissue disorders
EG0000 affected45 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Biliary anastomosis complication
Injury, poisoning and procedural complications
EG0000 affected45 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Diabetes mellitus
Metabolism and nutrition disorders
EG0005 affected45 at risk
EG0012 affected45 at risk
EG0022 affected22 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
EG0000 affected45 at risk
EG0014 affected45 at risk
EG0023 affected22 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
EG0003 affected45 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Iron deficiency
Metabolism and nutrition disorders
EG0000 affected45 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Insomnia
Psychiatric disorders
EG0009 affected45 at risk
EG0014 affected45 at risk
EG0024 affected22 at risk
EG003
Depression
Psychiatric disorders
EG0002 affected45 at risk
EG0011 affected45 at risk
EG0021 affected22 at risk
EG003
Anxiety
Psychiatric disorders
EG0000 affected45 at risk
EG0011 affected45 at risk
EG0020 affected22 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
EG0002 affected45 at risk
EG0014 affected45 at risk
EG0024 affected22 at risk
EG003
Pharyngolaryngeal pain
Respiratory, thoracic and mediastinal disorders
EG0001 affected45 at risk
EG0013 affected45 at risk
EG0020 affected22 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
EG0001 affected45 at risk
EG0011 affected45 at risk
EG0020 affected22 at risk
EG003
Chronic obstructrive pulmonary disease
Respiratory, thoracic and mediastinal disorders
EG0001 affected45 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
EG0000 affected45 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Nasal disorder
Respiratory, thoracic and mediastinal disorders
EG0000 affected45 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Anaemia
Blood and lymphatic system disorders
EG0002 affected45 at risk
EG0016 affected45 at risk
EG0022 affected22 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
EG0003 affected45 at risk
EG0013 affected45 at risk
EG0022 affected22 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
EG0000 affected45 at risk
EG0010 affected45 at risk
EG0022 affected22 at risk
EG003
Cardiac murmur
Investigations
EG0002 affected45 at risk
EG0011 affected45 at risk
EG0020 affected22 at risk
EG003
Hepatic neoplasm malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
EG0008 affected45 at risk
EG0013 affected45 at risk
EG0022 affected22 at risk
EG003
Renal failure
Renal and urinary disorders
EG0002 affected45 at risk
EG0010 affected45 at risk
EG0021 affected22 at risk
EG003
Hydronephrosis
Renal and urinary disorders
EG0000 affected45 at risk
EG0011 affected45 at risk
EG0021 affected22 at risk
EG003
Calculus Ureteric
Renal and urinary disorders
EG0000 affected45 at risk
EG0011 affected45 at risk
EG0020 affected22 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
EG0001 affected45 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Micturition disorder
Renal and urinary disorders
EG0000 affected45 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Hypertension
Vascular disorders
EG0001 affected45 at risk
EG0015 affected45 at risk
EG0020 affected22 at risk
EG003
Hypotension
Vascular disorders
EG0004 affected45 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Gynaecomastia
Reproductive system and breast disorders
EG0002 affected45 at risk
EG0013 affected45 at risk
EG0021 affected22 at risk
EG003
Vertigo
Ear and labyrinth disorders
EG0002 affected45 at risk
EG0010 affected45 at risk
EG0022 affected22 at risk
EG003
Sudden hearing loss
Ear and labyrinth disorders
EG0000 affected45 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Seasonal allergy
Immune system disorders
EG0001 affected45 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Creatinine renal clearance increased
Investigations
EG0000 affected45 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:
The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or
The study has been completed at all study sites for at least 2 years
Point of Contact
Title
Organization
Phone
Extension
Email
Clinical Trial Disclosures
Gilead Sciences, Inc.
ClinicalTrialDisclosures@gilead.com
ID
Term
D019694
Hepatitis B, Chronic
D006505
Hepatitis
D006509
Hepatitis B
Ancestor Terms
ID
Term
D000086982
Blood-Borne Infections
D003141
Communicable Diseases
D007239
Infections
D018347
Hepadnaviridae Infections
D004266
DNA Virus Infections
D014777
Virus Diseases
D006525
Hepatitis, Viral, Human
D006521
Hepatitis, Chronic
D008107
Liver Diseases
D004066
Digestive System Diseases
D002908
Chronic Disease
D020969
Disease Attributes
D010335
Pathologic Processes
D013568
Pathological Conditions, Signs and Symptoms
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
D000068698
Tenofovir
D000068679
Emtricitabine
D000069480
Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
C413685
entecavir
Ancestor Terms
ID
Term
D063065
Organophosphonates
D009943
Organophosphorus Compounds
D009930
Organic Chemicals
D000225
Adenine
D011687
Purines
D006574
Heterocyclic Compounds, 2-Ring
D000072471
Heterocyclic Compounds, Fused-Ring
D006571
Heterocyclic Compounds
D003841
Deoxycytidine
D003562
Cytidine
D011741
Pyrimidine Nucleosides
D011743
Pyrimidines
D006573
Heterocyclic Compounds, 1-Ring
D003853
Deoxyribonucleosides
D009705
Nucleosides
D009706
Nucleic Acids, Nucleotides, and Nucleosides
D004338
Drug Combinations
D004364
Pharmaceutical Preparations
Browse Leaves
Not provided
Browse Branches
Not provided
51
± 10.0
5
BG00318
Male
BG00037
BG00140
BG00217
BG00394
1
BG0031
United States
Title
Measurements
BG00010
BG0012
BG0022
BG00314
Taiwan
Title
Measurements
BG00013
BG00116
BG0029
BG00338
Greece
Title
Measurements
BG0004
BG0011
BG0021
BG0036
Canada
Title
Measurements
BG0004
BG0017
BG0021
BG00312
Poland
Title
Measurements
BG0002
BG0012
BG0022
BG0036
Spain
Title
Measurements
BG0002
BG0016
BG0022
BG00310
Singapore
Title
Measurements
BG0001
BG0013
BG0021
BG0035
Turkey
Title
Measurements
BG0004
BG0016
BG0022
BG00312
Germany
Title
Measurements
BG0004
BG0011
BG0021
BG0036
Italy
Title
Measurements
BG0001
BG0011
BG0020
BG0032
13
BG00360
Black
Title
Measurements
BG0001
BG0011
BG0020
BG0032
Other
Title
Measurements
BG0002
BG0010
BG0021
BG0033
White
Title
Measurements
BG00019
BG00120
BG0028
BG00347
0
BG0033
Not Hispanic or Latino
Title
Measurements
BG00039
BG00139
BG00221
BG00399
Not Permitted
Title
Measurements
BG0004
BG0015
BG0021
BG00310
77.3
± 16.64
BG00376.5± 16.26
167.1
± 8.39
BG003168.1± 8.20
27.6
± 5.27
BG00327.0± 5.35
22
14
(0.0 to 29.5)
Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
Units
Counts
Participants
OG00036
OG00138
OG00218
OG00392
Title
Denominators
Categories
Title
Measurements
OG000-2.93(-3.84 to -2.18)
OG001-3.45(-4.73 to -2.02)
OG002-3.61(-4.51 to -1.31)
OG003-3.19(-4.52 to -2.08)
Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
Units
Counts
Participants
OG00034
OG00135
OG00216
OG00385
Title
Denominators
Categories
Title
Measurements
OG000-3.06(-4.17 to -2.18)
OG001-4.06(-4.97 to -2.38)
OG002-3.32(-4.82 to -1.26)
OG003-3.40(-4.81 to -2.14)
Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
Units
Counts
Participants
OG00028
OG00134
OG00215
OG00377
Title
Denominators
Categories
Title
Measurements
OG000-3.07(-4.36 to -2.00)
OG001-3.82(-4.99 to -2.06)
OG002-3.76(-5.00 to -1.33)
OG003-3.49(-4.91 to -2.05)
Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
Units
Counts
Participants
OG00026
OG00131
OG00215
OG00372
Title
Denominators
Categories
Title
Measurements
OG000-3.16(-4.57 to -1.97)
OG001-4.06(-5.15 to -2.42)
OG002-3.77(-5.02 to -1.33)
OG003-3.66(-4.99 to -2.10)
Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
Units
Counts
Participants
OG00044
OG00141
OG00222
OG003107
Title
Denominators
Categories
Title
Measurements
OG00070.5
OG00187.8
OG00272.7
OG00377.6
Units
Counts
Participants
OG00044
OG00139
OG00221
OG003104
Title
Denominators
Categories
Title
Measurements
OG00059.1
OG00179.5
OG00257.1
OG00366.3
Units
Counts
Participants
OG00044
OG00140
OG00221
OG003105
Title
Denominators
Categories
Title
Measurements
OG00050.0
OG00177.5
OG00252.4
OG00361.0
Units
Counts
Participants
OG00042
OG00137
OG00221
OG003100
Title
Denominators
Categories
Title
Measurements
OG00050.0
OG00175.7
OG00252.4
OG00360.0
Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
Units
Counts
Participants
OG00026
OG00125
OG00217
OG00368
Title
Denominators
Categories
Title
Measurements
OG00046.2
OG00164.0
OG00241.2
OG00351.5
Units
Counts
Participants
OG00026
OG00124
OG00216
OG00366
Title
Denominators
Categories
Title
Measurements
OG00050.0
OG00158.3
OG00231.3
OG00348.5
Units
Counts
Participants
OG00026
OG00125
OG00216
OG00367
Title
Denominators
Categories
Title
Measurements
OG00034.6
OG00164.0
OG00237.5
OG00346.3
Units
Counts
Participants
OG00024
OG00125
OG00216
OG00365
Title
Denominators
Categories
Title
Measurements
OG00029.2
OG00160.0
OG00237.5
OG00343.1
Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
Units
Counts
Participants
OG00043
OG00138
OG00222
OG003103
Title
Denominators
Categories
Title
Measurements
OG0000.0
OG0012.6
OG0020.0
OG0031.0
Units
Counts
Participants
OG00043
OG00138
OG00220
OG003101
Title
Denominators
Categories
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG0030.0
Units
Counts
Participants
OG00043
OG00140
OG00221
OG003104
Title
Denominators
Categories
Title
Measurements
OG0000.0
OG0012.5
OG0020.0
OG0031.0
Units
Counts
Participants
OG00041
OG00136
OG00221
OG00398
Title
Denominators
Categories
Title
Measurements
OG0002.4
OG0010.0
OG0020.0
OG0031.0
Overall
Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
Units
Counts
Participants
OG00027
OG00125
OG00212
OG00364
Title
Denominators
Categories
Title
Measurements
OG00025.9
OG00148.0
OG00241.7
OG00337.5
Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
Units
Counts
Participants
OG00026
OG00125
OG00210
OG00361
Title
Denominators
Categories
Title
Measurements
OG00023.1
OG00152.0
OG00250.0
OG00339.3
Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
Units
Counts
Participants
OG00027
OG00127
OG00211
OG00365
Title
Denominators
Categories
Title
Measurements
OG00025.9
OG00151.9
OG00245.5
OG00340.0
Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
Units
Counts
Participants
OG00025
OG00124
OG00211
OG00360
Title
Denominators
Categories
Title
Measurements
OG00024.0
OG00145.8
OG00245.5
OG00336.7
Units
Counts
Participants
OG00035
OG00135
OG00219
OG00389
Title
Denominators
Categories
Title
Measurements
OG000-2.0(-3.0 to 0.0)
OG001-2.0(-4.0 to 0.0)
OG002-2.0(-4.0 to -1.0)
OG003-2.0(-3.0 to 0.0)
Units
Counts
Participants
OG00033
OG00133
OG00215
OG00381
Title
Denominators
Categories
Title
Measurements
OG000-2.0(-3.0 to 1.0)
OG001-3.0(-4.0 to 0.0)
OG002-3.0(-4.0 to -1.0)
OG003-2.0(-4.0 to 0.0)
Units
Counts
Participants
OG00028
OG00134
OG00215
OG00377
Title
Denominators
Categories
Title
Measurements
OG000-2.0(-3.5 to -0.5)
OG001-1.5(-6.0 to 0.0)
OG002-2.0(-5.0 to -1.0)
OG003-2.0(-4.0 to 0.0)
Units
Counts
Participants
OG00025
OG00130
OG00215
OG00370
Title
Denominators
Categories
Title
Measurements
OG000-2.0(-4.0 to -1.0)
OG001-2.0(-4.0 to 0.0)
OG002-2.0(-5.0 to 0.0)
OG003-2.0(-4.0 to 0.0)
Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
Units
Counts
Participants
OG00014
OG00115
OG0027
OG00336
Title
Denominators
Categories
HBeAg Loss
Title
Measurements
OG00021.4
OG00126.7
OG0020.0
OG00319.4
HBeAg Seroconversion
Title
Measurements
OG00021.4
OG00113.3
OG0020.0
OG003
Units
Counts
Participants
OG00014
OG00115
OG0026
OG00335
Title
Denominators
Categories
HBeAg Loss
Title
Measurements
OG00014.3
OG00133.3
OG0020.0
OG00320.0
HBeAg Seroconversion
Title
Measurements
OG00014.3
OG00113.3
OG0020.0
OG003
Units
Counts
Participants
OG00014
OG00115
OG0026
OG00335
Title
Denominators
Categories
HBeAg Loss
Title
Measurements
OG00014.3
OG00133.3
OG00216.7
OG00322.9
HBeAg Seroconversion
Title
Measurements
OG00014.3
OG00113.3
OG0020.0
OG003
Units
Counts
Participants
OG00013
OG00114
OG0026
OG00333
Title
Denominators
Categories
HBeAg Loss
Title
Measurements
OG00023.1
OG00135.7
OG00216.7
OG00327.3
HBeAg Seroconversion
Title
Measurements
OG00023.1
OG00121.4
OG0020.0
OG003
Units
Counts
Participants
OG00043
OG00141
OG00222
OG003106
Title
Denominators
Categories
HBsAg Loss
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG0030.0
HBsAg Seroconversion
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG003
Participants
OG0001
OG0011
OG0020
Title
Denominators
Categories
Title
Measurements
OG000100
OG001100
Participants
OG0005
OG0018
OG0023
Title
Denominators
Categories
Title
Measurements
OG000100
OG001100
OG002100
Units
Counts
Participants
OG0002
OG0010
OG0020
Title
Denominators
Categories
Title
Measurements
OG00050
Units
Counts
Participants
OG00045
OG00145
OG00290
OG00322
Title
Denominators
Categories
Title
Measurements
OG00015(3.9 to 25.9)
OG00114(3.6 to 24.4)
OG00214(6.8 to 22.0)
OG00310(0.0 to 22.8)
Units
Counts
Participants
OG00044
OG00139
OG00221
OG003104
Title
Denominators
Categories
HBsAg Loss
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG0030.0
HBsAg Seroconversion
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG003
Units
Counts
Participants
OG00043
OG00138
OG00221
OG003102
Title
Denominators
Categories
HBsAg Loss
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG0030.0
HBsAg Seroconversion
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG003
Units
Counts
Participants
OG00041
OG00136
OG00221
OG00398
Title
Denominators
Categories
HBsAg Loss
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG0030.0
HBsAg Seroconversion
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG003
Units
Counts
Participants
OG0003
OG0017
OG0021
OG00311
Title
Denominators
Categories
Title
Measurements
OG000NANo participant in this category experienced Hepatitis B Recurrence.
OG001NANo participant in this category experienced Hepatitis B Recurrence.
OG002NANo participant in this category experienced Hepatitis B Recurrence.
OG003NANo participant in this category experienced Hepatitis B Recurrence.