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Study Comparing Tenofovir Disoproxil Fumarate (TDF), Emtricitabine (FTC)/TDF, and Entecavir (ETV) in the Treatment of Chronic HBV in Subjects With Decompensated Liver Disease.

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ClinicalTrials.gov Identifier: NCT00298363
Recruitment Status : Completed
First Posted : March 2, 2006
Results First Posted : April 25, 2013
Last Update Posted : April 25, 2013
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Chronic Hepatitis B
Interventions Drug: Tenofovir disoproxil fumarate (tenofovir DF; TDF)
Drug: Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF)
Drug: Entecavir (ETV)
Drug: TDF placebo
Drug: FTC/TDF placebo
Drug: ETV placebo
Enrollment 112
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.
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.
Arm/Group Title Tenofovir DF FTC/TDF Entecavir
Hide Arm/Group Description 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). 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. 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.
Period Title: Overall Study
Started 45 45 22
Completed 28 [1] 37 [2] 16 [3]
Not Completed 17 8 6
Reason Not Completed
Lost to Follow-up             0             0             1
Physician Decision             4             1             0
Protocol Violation             1             1             0
Withdrawal by Subject             5             1             3
Adverse Event             5             2             2
Lack of Efficacy             2             3             0
[1]
22 completed while taking DB TDF; 6 completed following switch from DB TDF to OL FTC/TDF.
[2]
34 completed while taking DB FTC/TDF; 3 completed following switch from DB TDF to OL FTC/TDF.
[3]
13 completed while taking DB ETV; 3 completed following switch from DB ETV to OL FTC/TDF.
Arm/Group Title Tenofovir DF FTC/TDF Entecavir Total
Hide Arm/Group Description Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline Total of all reporting groups
Overall Number of Baseline Participants 45 45 22 112
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 45 participants 45 participants 22 participants 112 participants
53  (8.8) 49  (10.1) 52  (12.0) 51  (10.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 45 participants 22 participants 112 participants
Female
8
  17.8%
5
  11.1%
5
  22.7%
18
  16.1%
Male
37
  82.2%
40
  88.9%
17
  77.3%
94
  83.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 45 participants 45 participants 22 participants 112 participants
France 0 0 1 1
United States 10 2 2 14
Taiwan 13 16 9 38
Greece 4 1 1 6
Canada 4 7 1 12
Poland 2 2 2 6
Spain 2 6 2 10
Singapore 1 3 1 5
Turkey 4 6 2 12
Germany 4 1 1 6
Italy 1 1 0 2
Race  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 45 participants 45 participants 22 participants 112 participants
Asian 23 24 13 60
Black 1 1 0 2
Other 2 0 1 3
White 19 20 8 47
Ethnicity  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 45 participants 45 participants 22 participants 112 participants
Hispanic or Latino 2 1 0 3
Not Hispanic or Latino 39 39 21 99
Not Permitted 4 5 1 10
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 45 participants 45 participants 22 participants 112 participants
78.1  (17.02) 74.4  (15.41) 77.3  (16.64) 76.5  (16.26)
Height  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 45 participants 45 participants 22 participants 112 participants
168.3  (7.98) 168.4  (8.47) 167.1  (8.39) 168.1  (8.20)
BMI  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 45 participants 45 participants 22 participants 112 participants
27.6  (5.67) 26.2  (5.07) 27.6  (5.27) 27.0  (5.35)
1.Primary Outcome
Title Percent Probability of Tolerability Failure
Hide Description 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.
Time Frame Baseline to Week 168
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (all randomized subjects who received at least one dose of study drug)
Arm/Group Title Tenofovir DF FTC/TDF TDF or FTC/TDF Entecavir
Hide Arm/Group Description:
Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
Participants in this group include all participants who received TDF or FTC/TDF during the study.
Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
Overall Number of Participants Analyzed 45 45 90 22
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percent probability (KM estimate)
18
(5.8 to 30.6)
4
(0.0 to 10.4)
11
(4.1 to 17.7)
14
(0.0 to 29.5)
2.Primary Outcome
Title 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
Hide Description 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.
Time Frame Baseline to Week 168
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title Tenofovir DF FTC/TDF TDF or FTC/TDF Entecavir
Hide Arm/Group Description:
Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
Participants in this group include all participants who received TDF or FTC/TDF during the study.
Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
Overall Number of Participants Analyzed 45 45 90 22
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percent probability (KM estimate)
15
(3.9 to 25.9)
14
(3.6 to 24.4)
14
(6.8 to 22.0)
10
(0.0 to 22.8)
3.Secondary Outcome
Title Median Time-averaged Change (DAVG) in Plasma Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels at 48 Weeks Relative to Baseline
Hide Description 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.
Time Frame Baseline to 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with HBV DNA measurements at Week 48 were included in this analysis.
Arm/Group Title Tenofovir DF FTC/TDF Entecavir Overall
Hide Arm/Group Description:
Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
Overall Number of Participants Analyzed 36 38 18 92
Median (Inter-Quartile Range)
Unit of Measure: log_10 copies/mL
-2.93
(-3.84 to -2.18)
-3.45
(-4.73 to -2.02)
-3.61
(-4.51 to -1.31)
-3.19
(-4.52 to -2.08)
4.Secondary Outcome
Title Median DAVG in Plasma HBV DNA Levels at 96 Weeks Relative to Baseline
Hide Description 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.
Time Frame Baseline to 96 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set; data collected for participants who underwent liver transplant prior to Week 96 were excluded.
Arm/Group Title Tenofovir DF FTC/TDF Entecavir Overall
Hide Arm/Group Description:
Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
Overall Number of Participants Analyzed 34 35 16 85
Median (Inter-Quartile Range)
Unit of Measure: log_10 copies/mL
-3.06
(-4.17 to -2.18)
-4.06
(-4.97 to -2.38)
-3.32
(-4.82 to -1.26)
-3.40
(-4.81 to -2.14)
5.Secondary Outcome
Title Median DAVG in Plasma HBV DNA Levels at 144 Weeks Relative to Baseline
Hide Description 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.
Time Frame Baseline to 144 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set; data collected for participants who underwent liver transplant prior to Week 144 were excluded.
Arm/Group Title Tenofovir DF FTC/TDF Entecavir Overall
Hide Arm/Group Description:
Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
Participants in this group were randomized to receive FTC 200mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
Overall Number of Participants Analyzed 28 34 15 77
Median (Inter-Quartile Range)
Unit of Measure: log _10 copies/mL
-3.07
(-4.36 to -2.00)
-3.82
(-4.99 to -2.06)
-3.76
(-5.00 to -1.33)
-3.49
(-4.91 to -2.05)
6.Secondary Outcome
Title Median DAVG in Plasma HBV DNA Levels at 168 Weeks Relative to Baseline
Hide Description 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.
Time Frame Baseline to 168 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set; data collected for participants who underwent liver transplant prior to Week 168 were excluded.
Arm/Group Title Tenofovir DF FTC/TDF Entecavir Overall
Hide Arm/Group Description:
Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
Overall Number of Participants Analyzed 26 31 15 72
Median (Inter-Quartile Range)
Unit of Measure: log_10 copies/mL
-3.16
(-4.57 to -1.97)
-4.06
(-5.15 to -2.42)
-3.77
(-5.02 to -1.33)
-3.66
(-4.99 to -2.10)
7.Secondary Outcome
Title Percentage of Participants With Plasma HBV DNA < 400 Copies/mL at Week 48
Hide Description The percentage of participants with plasma HBV DNA < 400 copies/mL at Week 48 was summarized.
Time Frame Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
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]).
Arm/Group Title Tenofovir DF FTC/TDF Entecavir Overall
Hide Arm/Group Description:
Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
Overall Number of Participants Analyzed 44 41 22 107
Measure Type: Number
Unit of Measure: percentage of participants
70.5 87.8 72.7 77.6
8.Secondary Outcome
Title Percentage of Participants With Plasma HBV DNA < 400 Copies/mL at Week 96
Hide Description The percentage of participants with plasma HBV DNA < 400 copies/mL at Week 96 was summarized.
Time Frame Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set; noncompleters/switch = failure
Arm/Group Title Tenofovir DF FTC/TDF Entecavir Overall
Hide Arm/Group Description:
Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
Overall Number of Participants Analyzed 44 39 21 104
Measure Type: Number
Unit of Measure: percentage of participants
59.1 79.5 57.1 66.3
9.Secondary Outcome
Title Percentage of Participants With Plasma HBV DNA < 400 Copies/mL at Week 144
Hide Description The percentage of participants with plasma HBV DNA < 400 copies/mL at Week 144 was summarized.
Time Frame Week 144
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set; noncompleters/switch = failure
Arm/Group Title Tenofovir DF FTC/TDF Entecavir Overall
Hide Arm/Group Description:
Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
Overall Number of Participants Analyzed 44 40 21 105
Measure Type: Number
Unit of Measure: percentage of participants
50.0 77.5 52.4 61.0
10.Secondary Outcome
Title Percentage of Participants With Plasma HBV DNA < 400 Copies/mL at Week 168
Hide Description The percentage of participants with plasma HBV DNA < 400 copies/mL at Week 168 was summarized.
Time Frame Week 168
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set; noncompleters/switch = failure
Arm/Group Title Tenofovir DF FTC/TDF Entecavir Overall
Hide Arm/Group Description:
Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
Overall Number of Participants Analyzed 42 37 21 100
Measure Type: Number
Unit of Measure: percentage of participants
50.0 75.7 52.4 60.0
11.Secondary Outcome
Title Percentage of Participants With Normalized Alanine Aminotransferase (ALT) (for Subjects With Elevated ALT at Baseline) at Week 48
Hide Description 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.
Time Frame Baseline to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Biochemically evaluable analysis set (subjects in full analysis set with abnormal baseline alanine aminotransferase [ALT] values); noncompleters/switch = failure
Arm/Group Title Tenofovir DF FTC/TDF Entecavir Overall
Hide Arm/Group Description:
Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
Overall Number of Participants Analyzed 26 25 17 68
Measure Type: Number
Unit of Measure: percentage of participants
46.2 64.0 41.2 51.5
12.Secondary Outcome
Title Percentage of Participants With Normalized ALT (for Subjects With Elevated ALT at Baseline) at Week 96
Hide Description Normalized ALT is defined as having a baseline ALT value > ULN, and a decrease in ALT value to ≤ ULN at the given time point.
Time Frame Baseline to Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
Biochemically evaluable analysis set; noncompleters/switch = failure
Arm/Group Title Tenofovir DF FTC/TDF Entecavir Overall
Hide Arm/Group Description:
Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
Overall Number of Participants Analyzed 26 24 16 66
Measure Type: Number
Unit of Measure: percentage of participants
50.0 58.3 31.3 48.5
13.Secondary Outcome
Title Percentage of Participants With Normalized ALT (for Subjects With Elevated ALT at Baseline) at Week 144
Hide Description Normalized ALT is defined as having a baseline ALT value > ULN, and a decrease in ALT value to ≤ ULN at the given time point.
Time Frame Baseline to Week 144
Hide Outcome Measure Data
Hide Analysis Population Description
Biochemically evaluable analysis set; noncompleters/switch = failure
Arm/Group Title Tenofovir DF FTC/TDF Entecavir Overall
Hide Arm/Group Description:
Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
Overall Number of Participants Analyzed 26 25 16 67
Measure Type: Number
Unit of Measure: percentage of participants
34.6 64.0 37.5 46.3
14.Secondary Outcome
Title Percentage of Participants With Normalized ALT (for Subjects With Elevated ALT at Baseline) at Week 168
Hide Description Normalized ALT is defined as having a baseline ALT value > ULN, and a decrease in ALT value to ≤ ULN at the given time point.
Time Frame Baseline to Week 168
Hide Outcome Measure Data
Hide Analysis Population Description
Biochemically evaluable analysis set; noncompleters/switch = failure
Arm/Group Title Tenofovir DF FTC/TDF Entecavir Overall
Hide Arm/Group Description:
Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
Overall Number of Participants Analyzed 24 25 16 65
Measure Type: Number
Unit of Measure: percentage of participants
29.2 60.0 37.5 43.1
15.Secondary Outcome
Title Percentage of Participants With an Increase in Child-Pugh Turcotte (CPT) Score of ≥ 2 Points at Weeks 48
Hide Description 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.
Time Frame Baseline to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set; noncompleters/switch = failure
Arm/Group Title Tenofovir DF FTC/TDF Entecavir Overall
Hide Arm/Group Description:
Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
Overall Number of Participants Analyzed 43 38 22 103
Measure Type: Number
Unit of Measure: percentage of participants
0.0 2.6 0.0 1.0
16.Secondary Outcome
Title Percentage of Participants With an Increase in CPT Score of ≥ 2 Points at Week 96
Hide Description 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.
Time Frame Baseline to Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set; noncompleters/switch = failure
Arm/Group Title Tenofovir DF FTC/TDF Entecavir Overall
Hide Arm/Group Description:
Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
Overall Number of Participants Analyzed 43 38 20 101
Measure Type: Number
Unit of Measure: percentage of participants
0.0 0.0 0.0 0.0
17.Secondary Outcome
Title Percentage of Participants With an Increase in CPT Score of ≥ 2 Points at Week 144
Hide Description 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.
Time Frame Baseline to Week 144
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set; noncompleters/switch = failure
Arm/Group Title Tenofovir DF FTC/TDF Entecavir Overall
Hide Arm/Group Description:
Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
Overall Number of Participants Analyzed 43 40 21 104
Measure Type: Number
Unit of Measure: percentage of participants
0.0 2.5 0.0 1.0
18.Secondary Outcome
Title Percentage of Participants With an Increase in CPT Score of ≥ 2 Points at Week 168
Hide Description 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.
Time Frame Baseline to Week 168
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set; noncompleters/switch = failure
Arm/Group Title Tenofovir DF FTC/TDF Entecavir Overall
Hide Arm/Group Description:
Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
Overall Number of Participants Analyzed 41 36 21 98
Measure Type: Number
Unit of Measure: percentage of participants
2.4 0.0 0.0 1.0
19.Secondary Outcome
Title Percentage of Participants With a Decrease in CPT Score of ≥ 2 Points From Baseline at Week 48
Hide Description 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.
Time Frame Baseline to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Tenofovir DF FTC/TDF Entecavir Overall
Hide Arm/Group Description:
Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
Overall Number of Participants Analyzed 27 25 12 64
Measure Type: Number
Unit of Measure: percentage of participants
25.9 48.0 41.7 37.5
20.Secondary Outcome
Title Percentage of Participants With a Decrease in CPT Score of ≥ 2 Points From Baseline at Week 96
Hide Description 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.
Time Frame Baseline to Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
CPT evaluable analysis set; noncompleters/switch = failure
Arm/Group Title Tenofovir DF FTC/TDF Entecavir Overall
Hide Arm/Group Description:
Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
Overall Number of Participants Analyzed 26 25 10 61
Measure Type: Number
Unit of Measure: percentage of participants
23.1 52.0 50.0 39.3
21.Secondary Outcome
Title Percentage of Participants With a Decrease in CPT Score of ≥ 2 Points From Baseline at Week 144
Hide Description 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.
Time Frame Baseline to Week 144
Hide Outcome Measure Data
Hide Analysis Population Description
CPT evaluable analysis set; noncompleters/switch = failure
Arm/Group Title Tenofovir DF FTC/TDF Entecavir Overall
Hide Arm/Group Description:
Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
Overall Number of Participants Analyzed 27 27 11 65
Measure Type: Number
Unit of Measure: percentage of participants
25.9 51.9 45.5 40.0
22.Secondary Outcome
Title Percentage of Participants With a Decrease in CPT Score of ≥ 2 Points From Baseline at Week 168
Hide Description 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.
Time Frame Baseline to Week 168
Hide Outcome Measure Data
Hide Analysis Population Description
CPT evaluable analysis set; noncompleters/switch = failure
Arm/Group Title Tenofovir DF FTC/TDF Entecavir Overall
Hide Arm/Group Description:
Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
Overall Number of Participants Analyzed 25 24 11 60
Measure Type: Number
Unit of Measure: percentage of participants
24.0 45.8 45.5 36.7
23.Secondary Outcome
Title Median Change in Model for End-Stage Liver Disease (MELD) Score From Baseline at Week 48
Hide Description 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.
Time Frame Baseline to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects in the full analysis set with an available score at the visit
Arm/Group Title Tenofovir DF FTC/TDF Entecavir Overall
Hide Arm/Group Description:
Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
Overall Number of Participants Analyzed 35 35 19 89
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
-2.0
(-3.0 to 0.0)
-2.0
(-4.0 to 0.0)
-2.0
(-4.0 to -1.0)
-2.0
(-3.0 to 0.0)
24.Secondary Outcome
Title Median Change in MELD Score From Baseline at Week 96
Hide Description 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.
Time Frame Baseline to Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects in the full analysis set with an available score at the visit
Arm/Group Title Tenofovir DF FTC/TDF Entecavir Overall
Hide Arm/Group Description:
Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
Overall Number of Participants Analyzed 33 33 15 81
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
-2.0
(-3.0 to 1.0)
-3.0
(-4.0 to 0.0)
-3.0
(-4.0 to -1.0)
-2.0
(-4.0 to 0.0)
25.Secondary Outcome
Title Median Change in MELD Score From Baseline at Week 144
Hide Description 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.
Time Frame Baseline to Week 144
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects in the full analysis set with an available score at the visit
Arm/Group Title Tenofovir DF FTC/TDF Entecavir Overall
Hide Arm/Group Description:
Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
Overall Number of Participants Analyzed 28 34 15 77
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
-2.0
(-3.5 to -0.5)
-1.5
(-6.0 to 0.0)
-2.0
(-5.0 to -1.0)
-2.0
(-4.0 to 0.0)
26.Secondary Outcome
Title Median Change in MELD Score From Baseline at Week 168
Hide Description 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.
Time Frame Baseline to Week 168
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects in the full analysis set with an available score at the visit
Arm/Group Title Tenofovir DF FTC/TDF Entecavir Overall
Hide Arm/Group Description:
Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
Overall Number of Participants Analyzed 25 30 15 70
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
-2.0
(-4.0 to -1.0)
-2.0
(-4.0 to 0.0)
-2.0
(-5.0 to 0.0)
-2.0
(-4.0 to 0.0)
27.Secondary Outcome
Title Percentage of Participants With Hepatitis B Early Antigen (HBeAg) Loss and HBeAg Seroconversion at Week 48 (for Participants Who Were HBeAg Positive at Baseline)
Hide Description 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.
Time Frame Baseline to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Serologically evaluable analysis set (subjects in full analysis set with positive hepatitis B early antigen [HBeAg] at baseline); noncompleters/switch = failure
Arm/Group Title Tenofovir DF FTC/TDF Entecavir Overall
Hide Arm/Group Description:
Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
Overall Number of Participants Analyzed 14 15 7 36
Measure Type: Number
Unit of Measure: percentage of participants
HBeAg Loss 21.4 26.7 0.0 19.4
HBeAg Seroconversion 21.4 13.3 0.0 13.9
28.Secondary Outcome
Title Percentage of Participants With HBeAg Loss and HBeAg Seroconversion at Week 96 (for Participants Who Were HBeAg Positive at Baseline)
Hide Description 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.
Time Frame Baseline to Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
Serologically evaluable analysis set; noncompleters/switch = failure
Arm/Group Title Tenofovir DF FTC/TDF Entecavir Overall
Hide Arm/Group Description:
Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
Overall Number of Participants Analyzed 14 15 6 35
Measure Type: Number
Unit of Measure: percentage of participants
HBeAg Loss 14.3 33.3 0.0 20.0
HBeAg Seroconversion 14.3 13.3 0.0 11.4
29.Secondary Outcome
Title Percentage of Participants With HBeAg Loss and HBeAg Seroconversion at Week 144 (for Participants Who Were HBeAg Positive at Baseline)
Hide Description 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.
Time Frame Baseline to Week 144
Hide Outcome Measure Data
Hide Analysis Population Description
Serologically evaluable analysis set; noncompleters/switch = failure
Arm/Group Title Tenofovir DF FTC/TDF Entecavir Overall
Hide Arm/Group Description:
Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
Overall Number of Participants Analyzed 14 15 6 35
Measure Type: Number
Unit of Measure: percentage of participants
HBeAg Loss 14.3 33.3 16.7 22.9
HBeAg Seroconversion 14.3 13.3 0.0 11.4
30.Secondary Outcome
Title Percentage of Participants With HBeAg Loss and HBeAg Seroconversion at Week 168 (for Participants Who Were HBeAg Positive at Baseline)
Hide Description 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.
Time Frame Baseline to Week 168
Hide Outcome Measure Data
Hide Analysis Population Description
Serologically evaluable analysis set; noncompleters/switch = failure
Arm/Group Title Tenofovir DF FTC/TDF Entecavir Overall
Hide Arm/Group Description:
Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
Overall Number of Participants Analyzed 13 14 6 33
Measure Type: Number
Unit of Measure: percentage of participants
HBeAg Loss 23.1 35.7 16.7 27.3
HBeAg Seroconversion 23.1 21.4 0.0 18.2
31.Secondary Outcome
Title Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss and HBsAg Seroconversion at Week 48
Hide Description 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.
Time Frame Baseline to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set; noncompleters/switch = failure
Arm/Group Title Tenofovir DF FTC/TDF Entecavir Overall
Hide Arm/Group Description:
Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
Overall Number of Participants Analyzed 43 41 22 106
Measure Type: Number
Unit of Measure: percentage of participants
HBsAg Loss 0.0 0.0 0.0 0.0
HBsAg Seroconversion 0.0 0.0 0.0 0.0
32.Secondary Outcome
Title Percentage of Participants With HBsAg Loss and HBsAg Seroconversion at Week 96
Hide Description 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.
Time Frame Baseline to Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set; noncompleters/switch = failure
Arm/Group Title Tenofovir DF FTC/TDF Entecavir Overall
Hide Arm/Group Description:
Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
Overall Number of Participants Analyzed 44 39 21 104
Measure Type: Number
Unit of Measure: percentage of participants
HBsAg Loss 0.0 0.0 0.0 0.0
HBsAg Seroconversion 0.0 0.0 0.0 0.0
33.Secondary Outcome
Title Percentage of Participants With HBsAg Loss and HBsAg Seroconversion at Week 144
Hide Description 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.
Time Frame Baseline to Week 144
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set; noncompleters/switch = failure
Arm/Group Title Tenofovir DF FTC/TDF Entecavir Overall
Hide Arm/Group Description:
Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
Overall Number of Participants Analyzed 43 38 21 102
Measure Type: Number
Unit of Measure: percentage of participants
HBsAg Loss 0.0 0.0 0.0 0.0
HBsAg Seroconversion 0.0 0.0 0.0 0.0
34.Secondary Outcome
Title Percentage of Participants With HBsAg Loss and HBsAg Seroconversion at Week 168
Hide Description 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.
Time Frame Baseline to Week 168
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set; noncompleters/switch = failure
Arm/Group Title Tenofovir DF FTC/TDF Entecavir Overall
Hide Arm/Group Description:
Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
Overall Number of Participants Analyzed 41 36 21 98
Measure Type: Number
Unit of Measure: percentage of participants
HBsAg Loss 0.0 0.0 0.0 0.0
HBsAg Seroconversion 0.0 0.0 0.0 0.0
35.Secondary Outcome
Title 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
Hide Description [Not Specified]
Time Frame Baseline to Week 168
Hide Outcome Measure Data
Hide Analysis Population Description
Liver transplantation analysis set
Arm/Group Title Tenofovir DF FTC/TDF Entecavir Overall
Hide Arm/Group Description:
Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
Overall Number of Participants Analyzed 3 7 1 11
Measure Type: Number
Unit of Measure: Days
NA [1]  NA [1]  NA [1]  NA [1] 
[1]
No participant in this category experienced Hepatitis B Recurrence.
36.Other Pre-specified Outcome
Title Percentage of Participants With Only Baseline Adefovir Dipivoxil Resistance (ADV-R) Mutations Achieving HBV DNA < 400 Copies/mL by 168 Weeks
Hide Description ADV resistance mutations are defined as the presence of the rtA181T/V HBV gene mutation and/or the rtN236T HBV gene mutation.
Time Frame Baseline to Week 168
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the full analysis set with ADV resistance mutation at baseline were included in this analysis.
Arm/Group Title Tenofovir DF FTC/TDF Entecavir
Hide Arm/Group Description:
Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
Overall Number of Participants Analyzed 1 1 0
Measure Type: Number
Unit of Measure: percentage of participants
100 100
37.Other Pre-specified Outcome
Title Percentage of Participants With Only Baseline Lamivudine-resistance (LAM-R) Mutations Achieving HBV DNA < 400 Copies/mL by 168 Weeks
Hide Description LAM resistance mutations are defined as the presence of the rtM204V/I HBV gene mutation with or without the rtL180M HBV gene mutation.
Time Frame Baseline to Week 168
Hide Outcome Measure Data
Hide Analysis Population Description
Patients in the full analysis set with LAM resistance mutation at baseline were included in this analysis.
Arm/Group Title Tenofovir DF FTC/TDF Entecavir
Hide Arm/Group Description:
Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
Overall Number of Participants Analyzed 5 8 3
Measure Type: Number
Unit of Measure: percentage of participants
100 100 100
38.Other Pre-specified Outcome
Title Percentage of Participants With Baseline ADV-R + LAM-R Mutations Achieving HBV DNA < 400 Copies/mL by 168 Weeks
Hide Description 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.
Time Frame Baseline to Week 168
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the full analysis set with both ADV and LAM resistance mutations at baseline were included in this analysis.
Arm/Group Title Tenofovir DF FTC/TDF Entecavir
Hide Arm/Group Description:
Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
Overall Number of Participants Analyzed 2 0 0
Measure Type: Number
Unit of Measure: percentage of participants
50
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Double Blind TDF Double Blind FTC/TDF Double Blind ETV Open Label FTC/TDF All TDF
Hide Arm/Group Description Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo 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. Participants in this group received a TDF-containing treatment (all double-blind TDF, FTC/TDF, or open-label FTC/TDF) during the study.
All-Cause Mortality
Double Blind TDF Double Blind FTC/TDF Double Blind ETV Open Label FTC/TDF All TDF
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Double Blind TDF Double Blind FTC/TDF Double Blind ETV Open Label FTC/TDF All TDF
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   21/45 (46.67%)   25/45 (55.56%)   11/22 (50.00%)   4/12 (33.33%)   50/93 (53.76%) 
Blood and lymphatic system disorders           
Thrombocytopenia  1/45 (2.22%)  0/45 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  1/93 (1.08%) 
Ear and labyrinth disorders           
Sudden hearing loss  0/45 (0.00%)  0/45 (0.00%)  0/22 (0.00%)  1/12 (8.33%)  1/93 (1.08%) 
Gastrointestinal disorders           
Ascites  3/45 (6.67%)  3/45 (6.67%)  1/22 (4.55%)  1/12 (8.33%)  7/93 (7.53%) 
Abdominal pain  3/45 (6.67%)  1/45 (2.22%)  1/22 (4.55%)  0/12 (0.00%)  4/93 (4.30%) 
Oesophageal varices haemorrhage  3/45 (6.67%)  1/45 (2.22%)  1/22 (4.55%)  0/12 (0.00%)  4/93 (4.30%) 
Upper gastrointestinal haemorrhage  2/45 (4.44%)  2/45 (4.44%)  1/22 (4.55%)  0/12 (0.00%)  4/93 (4.30%) 
Abdominal distension  1/45 (2.22%)  0/45 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  1/93 (1.08%) 
Abdominal hernia  0/45 (0.00%)  1/45 (2.22%)  0/22 (0.00%)  0/12 (0.00%)  1/93 (1.08%) 
Gastric varices haemorrhage  0/45 (0.00%)  1/45 (2.22%)  0/22 (0.00%)  0/12 (0.00%)  1/93 (1.08%) 
Haematemesis  1/45 (2.22%)  0/45 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  1/93 (1.08%) 
Inguinal hernia  1/45 (2.22%)  0/45 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  1/93 (1.08%) 
Inguinal hernia, obstructive  1/45 (2.22%)  0/45 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  1/93 (1.08%) 
Melaena  1/45 (2.22%)  0/45 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  1/93 (1.08%) 
Nausea  1/45 (2.22%)  0/45 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  1/93 (1.08%) 
Pancreatitis acute  1/45 (2.22%)  0/45 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  1/93 (1.08%) 
Vomiting  1/45 (2.22%)  0/45 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  1/93 (1.08%) 
Gastrointestinal motility disorder  0/45 (0.00%)  0/45 (0.00%)  1/22 (4.55%)  0/12 (0.00%)  0/93 (0.00%) 
Small intestinal obstruction  0/45 (0.00%)  0/45 (0.00%)  1/22 (4.55%)  0/12 (0.00%)  0/93 (0.00%) 
Gastrointestinal haemorrhage  1/45 (2.22%)  1/45 (2.22%)  1/22 (4.55%)  0/12 (0.00%)  2/93 (2.15%) 
General disorders           
Pyrexia  1/45 (2.22%)  1/45 (2.22%)  1/22 (4.55%)  0/12 (0.00%)  2/93 (2.15%) 
Asthenia  1/45 (2.22%)  0/45 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  1/93 (1.08%) 
Generalized oedema  1/45 (2.22%)  0/45 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  1/93 (1.08%) 
Oedema  1/45 (2.22%)  0/45 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  1/93 (1.08%) 
Hepatobiliary disorders           
Hepatic function abnormal  2/45 (4.44%)  5/45 (11.11%)  2/22 (9.09%)  0/12 (0.00%)  7/93 (7.53%) 
Hepatorenal syndrome  1/45 (2.22%)  2/45 (4.44%)  0/22 (0.00%)  0/12 (0.00%)  3/93 (3.23%) 
Chronic hepatic failure  1/45 (2.22%)  1/45 (2.22%)  0/22 (0.00%)  0/12 (0.00%)  2/93 (2.15%) 
Hepatic failure  1/45 (2.22%)  1/45 (2.22%)  0/22 (0.00%)  0/12 (0.00%)  2/93 (2.15%) 
Cholestasis  0/45 (0.00%)  0/45 (0.00%)  0/22 (0.00%)  1/12 (8.33%)  1/93 (1.08%) 
Hepatic cirrhosis  0/45 (0.00%)  1/45 (2.22%)  0/22 (0.00%)  0/12 (0.00%)  1/93 (1.08%) 
Hepatic lesion  0/45 (0.00%)  1/45 (2.22%)  0/22 (0.00%)  0/12 (0.00%)  1/93 (1.08%) 
Hepatitis acute  0/45 (0.00%)  0/45 (0.00%)  0/22 (0.00%)  1/12 (8.33%)  1/93 (1.08%) 
Porcelain gallbladder  0/45 (0.00%)  1/45 (2.22%)  0/22 (0.00%)  0/12 (0.00%)  1/93 (1.08%) 
Immune system disorders           
Contrast media allergy  0/45 (0.00%)  1/45 (2.22%)  0/22 (0.00%)  0/12 (0.00%)  1/93 (1.08%) 
Hypersensitivity  0/45 (0.00%)  1/45 (2.22%)  0/22 (0.00%)  0/12 (0.00%)  1/93 (1.08%) 
Liver transplant rejection  0/45 (0.00%)  1/45 (2.22%)  0/22 (0.00%)  0/12 (0.00%)  1/93 (1.08%) 
Infections and infestations           
Peritonitis bacterial  2/45 (4.44%)  3/45 (6.67%)  0/22 (0.00%)  0/12 (0.00%)  5/93 (5.38%) 
Sepsis  1/45 (2.22%)  3/45 (6.67%)  0/22 (0.00%)  0/12 (0.00%)  4/93 (4.30%) 
Lower respiratory tract infection  0/45 (0.00%)  2/45 (4.44%)  0/22 (0.00%)  0/12 (0.00%)  2/93 (2.15%) 
Osteomyelitis  0/45 (0.00%)  1/45 (2.22%)  1/22 (4.55%)  0/12 (0.00%)  1/93 (1.08%) 
Anal abscess  0/45 (0.00%)  1/45 (2.22%)  0/22 (0.00%)  0/12 (0.00%)  1/93 (1.08%) 
Gastroenteritis viral  0/45 (0.00%)  1/45 (2.22%)  0/22 (0.00%)  0/12 (0.00%)  1/93 (1.08%) 
Laryngitis  0/45 (0.00%)  1/45 (2.22%)  0/22 (0.00%)  0/12 (0.00%)  1/93 (1.08%) 
Pharyngitis  0/45 (0.00%)  1/45 (2.22%)  0/22 (0.00%)  0/12 (0.00%)  1/93 (1.08%) 
Pneumococcal sepsis  0/45 (0.00%)  1/45 (2.22%)  0/22 (0.00%)  0/12 (0.00%)  1/93 (1.08%) 
Pneumonia  0/45 (0.00%)  1/45 (2.22%)  0/22 (0.00%)  0/12 (0.00%)  1/93 (1.08%) 
Pyelonephritis acute  0/45 (0.00%)  0/45 (0.00%)  0/22 (0.00%)  1/12 (8.33%)  1/93 (1.08%) 
Scrotal abscess  0/45 (0.00%)  1/45 (2.22%)  0/22 (0.00%)  0/12 (0.00%)  1/93 (1.08%) 
Subcutaneous abscess  1/45 (2.22%)  0/45 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  1/93 (1.08%) 
Bacteraemia  0/45 (0.00%)  0/45 (0.00%)  1/22 (4.55%)  0/12 (0.00%)  0/93 (0.00%) 
Cellulitis  0/45 (0.00%)  0/45 (0.00%)  1/22 (4.55%)  0/12 (0.00%)  0/93 (0.00%) 
Hepatitis B  0/45 (0.00%)  0/45 (0.00%)  1/22 (4.55%)  0/12 (0.00%)  0/93 (0.00%) 
Necrotising fasciitis  0/45 (0.00%)  0/45 (0.00%)  1/22 (4.55%)  0/12 (0.00%)  0/93 (0.00%) 
Septic shock  0/45 (0.00%)  0/45 (0.00%)  1/22 (4.55%)  0/12 (0.00%)  0/93 (0.00%) 
Wound infection  0/45 (0.00%)  0/45 (0.00%)  1/22 (4.55%)  0/12 (0.00%)  0/93 (0.00%) 
Injury, poisoning and procedural complications           
Allergic transfusion reaction  0/45 (0.00%)  1/45 (2.22%)  0/22 (0.00%)  0/12 (0.00%)  1/93 (1.08%) 
Biliary anastomosis complication  0/45 (0.00%)  0/45 (0.00%)  0/22 (0.00%)  1/12 (8.33%)  1/93 (1.08%) 
Device failure  0/45 (0.00%)  1/45 (2.22%)  0/22 (0.00%)  0/12 (0.00%)  1/93 (1.08%) 
Overdose  0/45 (0.00%)  1/45 (2.22%)  0/22 (0.00%)  0/12 (0.00%)  1/93 (1.08%) 
Post procedural haematoma  0/45 (0.00%)  1/45 (2.22%)  0/22 (0.00%)  0/12 (0.00%)  1/93 (1.08%) 
Thermal burn  1/45 (2.22%)  0/45 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  1/93 (1.08%) 
Traumatic spinal cord compression  0/45 (0.00%)  1/45 (2.22%)  0/22 (0.00%)  0/12 (0.00%)  1/93 (1.08%) 
Multiple fractures  0/45 (0.00%)  0/45 (0.00%)  1/22 (4.55%)  0/12 (0.00%)  0/93 (0.00%) 
Road traffic accident  0/45 (0.00%)  0/45 (0.00%)  1/22 (4.55%)  0/12 (0.00%)  0/93 (0.00%) 
Investigations           
Alanine aminotransferase increased  0/45 (0.00%)  1/45 (2.22%)  0/22 (0.00%)  0/12 (0.00%)  1/93 (1.08%) 
Creatinine renal clearance decreased  1/45 (2.22%)  0/45 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  1/93 (1.08%) 
Metabolism and nutrition disorders           
Diabetic ketoacidosis  0/45 (0.00%)  1/45 (2.22%)  0/22 (0.00%)  0/12 (0.00%)  1/93 (1.08%) 
Fluid overload  1/45 (2.22%)  0/45 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  1/93 (1.08%) 
Hypovolaemia  1/45 (2.22%)  0/45 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  1/93 (1.08%) 
Musculoskeletal and connective tissue disorders           
Intervertebral disc protrusion  0/45 (0.00%)  0/45 (0.00%)  0/22 (0.00%)  1/12 (8.33%)  1/93 (1.08%) 
Musculoskeletal chest pain  1/45 (2.22%)  0/45 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  1/93 (1.08%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Hepatic neoplasm malignant  8/45 (17.78%)  3/45 (6.67%)  2/22 (9.09%)  1/12 (8.33%)  12/93 (12.90%) 
Hodgkin's disease  0/45 (0.00%)  0/45 (0.00%)  1/22 (4.55%)  0/12 (0.00%)  0/93 (0.00%) 
Nervous system disorders           
Hepatic encephalopathy  3/45 (6.67%)  1/45 (2.22%)  2/22 (9.09%)  0/12 (0.00%)  4/93 (4.30%) 
Encephalopathy  1/45 (2.22%)  2/45 (4.44%)  0/22 (0.00%)  0/12 (0.00%)  3/93 (3.23%) 
Cerebral haemorrhage  0/45 (0.00%)  1/45 (2.22%)  0/22 (0.00%)  0/12 (0.00%)  1/93 (1.08%) 
Cerebrospinal fluid rhinorrhoea  1/45 (2.22%)  0/45 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  1/93 (1.08%) 
Depressed level of consciousness  0/45 (0.00%)  1/45 (2.22%)  0/22 (0.00%)  0/12 (0.00%)  1/93 (1.08%) 
Subarachnoid haemorrhage  1/45 (2.22%)  0/45 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  1/93 (1.08%) 
Basal ganglia haemorrhage  0/45 (0.00%)  0/45 (0.00%)  1/22 (4.55%)  0/12 (0.00%)  0/93 (0.00%) 
Cerebral infarction  0/45 (0.00%)  0/45 (0.00%)  1/22 (4.55%)  0/12 (0.00%)  0/93 (0.00%) 
Headache  0/45 (0.00%)  0/45 (0.00%)  1/22 (4.55%)  0/12 (0.00%)  0/93 (0.00%) 
Psychiatric disorders           
Mental status change  2/45 (4.44%)  0/45 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  2/93 (2.15%) 
Schizophreniform disorder  0/45 (0.00%)  1/45 (2.22%)  0/22 (0.00%)  0/12 (0.00%)  1/93 (1.08%) 
Renal and urinary disorders           
Calculus Ureteric  0/45 (0.00%)  0/45 (0.00%)  0/22 (0.00%)  1/12 (8.33%)  1/93 (1.08%) 
Hydronephrosis  0/45 (0.00%)  0/45 (0.00%)  0/22 (0.00%)  1/12 (8.33%)  1/93 (1.08%) 
Nephrolithiasis  0/45 (0.00%)  0/45 (0.00%)  0/22 (0.00%)  1/12 (8.33%)  1/93 (1.08%) 
Renal aneurysm  1/45 (2.22%)  0/45 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  1/93 (1.08%) 
Renal failure  1/45 (2.22%)  0/45 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  1/93 (1.08%) 
Renal failure acute  0/45 (0.00%)  1/45 (2.22%)  0/22 (0.00%)  0/12 (0.00%)  1/93 (1.08%) 
Reproductive system and breast disorders           
Postmenopausal hemorrhage  0/45 (0.00%)  1/45 (2.22%)  0/22 (0.00%)  0/12 (0.00%)  1/93 (1.08%) 
Respiratory, thoracic and mediastinal disorders           
Pleural effusion  0/45 (0.00%)  1/45 (2.22%)  1/22 (4.55%)  0/12 (0.00%)  1/93 (1.08%) 
Chronic obstructive pulmonary disease  0/45 (0.00%)  0/45 (0.00%)  0/22 (0.00%)  1/12 (8.33%)  1/93 (1.08%) 
Hydrothorax  0/45 (0.00%)  1/45 (2.22%)  0/22 (0.00%)  0/12 (0.00%)  1/93 (1.08%) 
Nasal disorder  0/45 (0.00%)  0/45 (0.00%)  0/22 (0.00%)  1/12 (8.33%)  1/93 (1.08%) 
Vascular disorders           
Circulatory collapse  0/45 (0.00%)  1/45 (2.22%)  0/22 (0.00%)  0/12 (0.00%)  1/93 (1.08%) 
Hypotension  1/45 (2.22%)  0/45 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  1/93 (1.08%) 
Aortic dissection  0/45 (0.00%)  0/45 (0.00%)  1/22 (4.55%)  0/12 (0.00%)  0/93 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Double Blind TDF Double Blind FTC/TDF Double Blind ETV Open Label FTC/TDF All TDF
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   41/45 (91.11%)   44/45 (97.78%)   20/22 (90.91%)   9/12 (75.00%)   89/93 (95.70%) 
Blood and lymphatic system disorders           
Anaemia  2/45 (4.44%)  6/45 (13.33%)  2/22 (9.09%)  0/12 (0.00%)  8/93 (8.60%) 
Thrombocytopenia  3/45 (6.67%)  3/45 (6.67%)  2/22 (9.09%)  0/12 (0.00%)  6/93 (6.45%) 
Leukopenia  0/45 (0.00%)  0/45 (0.00%)  2/22 (9.09%)  0/12 (0.00%)  0/93 (0.00%) 
Ear and labyrinth disorders           
Vertigo  2/45 (4.44%)  0/45 (0.00%)  2/22 (9.09%)  1/12 (8.33%)  3/93 (3.23%) 
Sudden hearing loss  0/45 (0.00%)  0/45 (0.00%)  0/22 (0.00%)  1/12 (8.33%)  1/93 (1.08%) 
Gastrointestinal disorders           
Abdominal pain upper  9/45 (20.00%)  7/45 (15.56%)  2/22 (9.09%)  2/12 (16.67%)  18/93 (19.35%) 
Ascites  8/45 (17.78%)  4/45 (8.89%)  6/22 (27.27%)  1/12 (8.33%)  13/93 (13.98%) 
Abdominal pain  6/45 (13.33%)  4/45 (8.89%)  3/22 (13.64%)  1/12 (8.33%)  11/93 (11.83%) 
Nausea  9/45 (20.00%)  3/45 (6.67%)  1/22 (4.55%)  0/12 (0.00%)  12/93 (12.90%) 
Abdominal distension  5/45 (11.11%)  4/45 (8.89%)  2/22 (9.09%)  1/12 (8.33%)  10/93 (10.75%) 
Vomiting  6/45 (13.33%)  2/45 (4.44%)  2/22 (9.09%)  1/12 (8.33%)  9/93 (9.68%) 
Dyspepsia  1/45 (2.22%)  6/45 (13.33%)  1/22 (4.55%)  1/12 (8.33%)  8/93 (8.60%) 
Diarrhoea  4/45 (8.89%)  1/45 (2.22%)  5/22 (22.73%)  1/12 (8.33%)  5/93 (5.38%) 
Constipation  3/45 (6.67%)  3/45 (6.67%)  1/22 (4.55%)  0/12 (0.00%)  6/93 (6.45%) 
Upper gastrointestinal haemorrhage  2/45 (4.44%)  3/45 (6.67%)  1/22 (4.55%)  0/12 (0.00%)  5/93 (5.38%) 
Inguinal hernia  3/45 (6.67%)  2/45 (4.44%)  0/22 (0.00%)  0/12 (0.00%)  5/93 (5.38%) 
Oesophageal varices haemorrhage  3/45 (6.67%)  1/45 (2.22%)  1/22 (4.55%)  0/12 (0.00%)  4/93 (4.30%) 
Duodenal ulcer  0/45 (0.00%)  2/45 (4.44%)  2/22 (9.09%)  0/12 (0.00%)  2/93 (2.15%) 
Gastritis  1/45 (2.22%)  0/45 (0.00%)  0/22 (0.00%)  2/12 (16.67%)  3/93 (3.23%) 
Haemorrhoids  1/45 (2.22%)  1/45 (2.22%)  0/22 (0.00%)  1/12 (8.33%)  3/93 (3.23%) 
Hiatus hernia  0/45 (0.00%)  0/45 (0.00%)  0/22 (0.00%)  1/12 (8.33%)  1/93 (1.08%) 
General disorders           
Oedema peripheral  8/45 (17.78%)  3/45 (6.67%)  5/22 (22.73%)  0/12 (0.00%)  11/93 (11.83%) 
Pyrexia  6/45 (13.33%)  5/45 (11.11%)  4/22 (18.18%)  0/12 (0.00%)  11/93 (11.83%) 
Asthenia  5/45 (11.11%)  2/45 (4.44%)  2/22 (9.09%)  0/12 (0.00%)  7/93 (7.53%) 
Fatigue  2/45 (4.44%)  2/45 (4.44%)  2/22 (9.09%)  0/12 (0.00%)  4/93 (4.30%) 
Chest pain  1/45 (2.22%)  0/45 (0.00%)  1/22 (4.55%)  1/12 (8.33%)  2/93 (2.15%) 
Hepatobiliary disorders           
Hepatic function abnormal  2/45 (4.44%)  5/45 (11.11%)  2/22 (9.09%)  0/12 (0.00%)  7/93 (7.53%) 
Cholelithiasis  2/45 (4.44%)  4/45 (8.89%)  0/22 (0.00%)  0/12 (0.00%)  6/93 (6.45%) 
Jaundice  1/45 (2.22%)  3/45 (6.67%)  1/22 (4.55%)  0/12 (0.00%)  4/93 (4.30%) 
Hepatic steatosis  1/45 (2.22%)  1/45 (2.22%)  0/22 (0.00%)  2/12 (16.67%)  4/93 (4.30%) 
Portal hypertension  2/45 (4.44%)  1/45 (2.22%)  0/22 (0.00%)  1/12 (8.33%)  4/93 (4.30%) 
Hepatomegaly  2/45 (4.44%)  0/45 (0.00%)  0/22 (0.00%)  1/12 (8.33%)  3/93 (3.23%) 
Gallbladder polyp  0/45 (0.00%)  0/45 (0.00%)  2/22 (9.09%)  1/12 (8.33%)  1/93 (1.08%) 
Cholangitis  0/45 (0.00%)  0/45 (0.00%)  0/22 (0.00%)  1/12 (8.33%)  1/93 (1.08%) 
Cholestasis  0/45 (0.00%)  0/45 (0.00%)  0/22 (0.00%)  1/12 (8.33%)  1/93 (1.08%) 
Hepatitis acute  0/45 (0.00%)  0/45 (0.00%)  0/22 (0.00%)  1/12 (8.33%)  1/93 (1.08%) 
Immune system disorders           
Seasonal allergy  1/45 (2.22%)  0/45 (0.00%)  0/22 (0.00%)  1/12 (8.33%)  2/93 (2.15%) 
Infections and infestations           
Nasopharyngitis  5/45 (11.11%)  7/45 (15.56%)  1/22 (4.55%)  0/12 (0.00%)  12/93 (12.90%) 
Upper respiratory tract infection  4/45 (8.89%)  4/45 (8.89%)  2/22 (9.09%)  2/12 (16.67%)  9/93 (9.68%) 
Urinary tract infection  4/45 (8.89%)  2/45 (4.44%)  1/22 (4.55%)  1/12 (8.33%)  7/93 (7.53%) 
Bronchitis  3/45 (6.67%)  1/45 (2.22%)  2/22 (9.09%)  1/12 (8.33%)  5/93 (5.38%) 
Peritonitis bacterial  2/45 (4.44%)  3/45 (6.67%)  0/22 (0.00%)  0/12 (0.00%)  5/93 (5.38%) 
Sepsis  2/45 (4.44%)  3/45 (6.67%)  0/22 (0.00%)  0/12 (0.00%)  5/93 (5.38%) 
Influenza  1/45 (2.22%)  2/45 (4.44%)  0/22 (0.00%)  1/12 (8.33%)  4/93 (4.30%) 
Rhinitis  0/45 (0.00%)  3/45 (6.67%)  0/22 (0.00%)  0/12 (0.00%)  3/93 (3.23%) 
Pyelonephritis acute  0/45 (0.00%)  0/45 (0.00%)  0/22 (0.00%)  1/12 (8.33%)  1/93 (1.08%) 
Wound infection  0/45 (0.00%)  0/45 (0.00%)  2/22 (9.09%)  0/12 (0.00%)  0/93 (0.00%) 
Injury, poisoning and procedural complications           
Biliary anastomosis complication  0/45 (0.00%)  0/45 (0.00%)  0/22 (0.00%)  1/12 (8.33%)  1/93 (1.08%) 
Investigations           
Cardiac murmur  2/45 (4.44%)  1/45 (2.22%)  0/22 (0.00%)  1/12 (8.33%)  4/93 (4.30%) 
Creatinine renal clearance increased  0/45 (0.00%)  0/45 (0.00%)  0/22 (0.00%)  1/12 (8.33%)  1/93 (1.08%) 
Metabolism and nutrition disorders           
Diabetes mellitus  5/45 (11.11%)  2/45 (4.44%)  2/22 (9.09%)  1/12 (8.33%)  8/93 (8.60%) 
Hypokalaemia  0/45 (0.00%)  4/45 (8.89%)  3/22 (13.64%)  0/12 (0.00%)  4/93 (4.30%) 
Hyperglycaemia  3/45 (6.67%)  0/45 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  3/93 (3.23%) 
Iron deficiency  0/45 (0.00%)  0/45 (0.00%)  0/22 (0.00%)  1/12 (8.33%)  1/93 (1.08%) 
Musculoskeletal and connective tissue disorders           
Arthralgia  4/45 (8.89%)  5/45 (11.11%)  2/22 (9.09%)  0/12 (0.00%)  9/93 (9.68%) 
Myalgia  5/45 (11.11%)  3/45 (6.67%)  1/22 (4.55%)  0/12 (0.00%)  8/93 (8.60%) 
Back pain  5/45 (11.11%)  2/45 (4.44%)  0/22 (0.00%)  0/12 (0.00%)  7/93 (7.53%) 
Muscle spasms  3/45 (6.67%)  1/45 (2.22%)  2/22 (9.09%)  0/12 (0.00%)  4/93 (4.30%) 
Musculoskeletal pain  1/45 (2.22%)  3/45 (6.67%)  1/22 (4.55%)  0/12 (0.00%)  4/93 (4.30%) 
Pain in extremity  1/45 (2.22%)  2/45 (4.44%)  1/22 (4.55%)  1/12 (8.33%)  4/93 (4.30%) 
Intervertebral disc protrusion  0/45 (0.00%)  0/45 (0.00%)  0/22 (0.00%)  1/12 (8.33%)  1/93 (1.08%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Hepatic neoplasm malignant  8/45 (17.78%)  3/45 (6.67%)  2/22 (9.09%)  1/12 (8.33%)  12/93 (12.90%) 
Nervous system disorders           
Headache  4/45 (8.89%)  3/45 (6.67%)  5/22 (22.73%)  1/12 (8.33%)  8/93 (8.60%) 
Dizziness  6/45 (13.33%)  3/45 (6.67%)  0/22 (0.00%)  0/12 (0.00%)  9/93 (9.68%) 
Hepatic encephalopathy  5/45 (11.11%)  2/45 (4.44%)  3/22 (13.64%)  0/12 (0.00%)  7/93 (7.53%) 
Encephalopathy  3/45 (6.67%)  3/45 (6.67%)  0/22 (0.00%)  0/12 (0.00%)  6/93 (6.45%) 
Psychiatric disorders           
Insomnia  9/45 (20.00%)  4/45 (8.89%)  4/22 (18.18%)  1/12 (8.33%)  14/93 (15.05%) 
Depression  2/45 (4.44%)  1/45 (2.22%)  1/22 (4.55%)  1/12 (8.33%)  4/93 (4.30%) 
Anxiety  0/45 (0.00%)  1/45 (2.22%)  0/22 (0.00%)  1/12 (8.33%)  2/93 (2.15%) 
Renal and urinary disorders           
Renal failure  2/45 (4.44%)  0/45 (0.00%)  1/22 (4.55%)  1/12 (8.33%)  3/93 (3.23%) 
Hydronephrosis  0/45 (0.00%)  1/45 (2.22%)  1/22 (4.55%)  1/12 (8.33%)  2/93 (2.15%) 
Calculus Ureteric  0/45 (0.00%)  1/45 (2.22%)  0/22 (0.00%)  1/12 (8.33%)  2/93 (2.15%) 
Nephrolithiasis  1/45 (2.22%)  0/45 (0.00%)  0/22 (0.00%)  1/12 (8.33%)  2/93 (2.15%) 
Micturition disorder  0/45 (0.00%)  0/45 (0.00%)  0/22 (0.00%)  1/12 (8.33%)  1/93 (1.08%) 
Reproductive system and breast disorders           
Gynaecomastia  2/45 (4.44%)  3/45 (6.67%)  1/22 (4.55%)  1/12 (8.33%)  6/93 (6.45%) 
Respiratory, thoracic and mediastinal disorders           
Cough  2/45 (4.44%)  4/45 (8.89%)  4/22 (18.18%)  2/12 (16.67%)  8/93 (8.60%) 
Pharyngolaryngeal pain  1/45 (2.22%)  3/45 (6.67%)  0/22 (0.00%)  0/12 (0.00%)  4/93 (4.30%) 
Dyspnoea  1/45 (2.22%)  1/45 (2.22%)  0/22 (0.00%)  1/12 (8.33%)  3/93 (3.23%) 
Chronic obstructrive pulmonary disease  1/45 (2.22%)  0/45 (0.00%)  0/22 (0.00%)  1/12 (8.33%)  1/93 (1.08%) 
Dyspnoea exertional  0/45 (0.00%)  0/45 (0.00%)  0/22 (0.00%)  1/12 (8.33%)  1/93 (1.08%) 
Nasal disorder  0/45 (0.00%)  0/45 (0.00%)  0/22 (0.00%)  1/12 (8.33%)  1/93 (1.08%) 
Skin and subcutaneous tissue disorders           
Pruritis  7/45 (15.56%)  6/45 (13.33%)  2/22 (9.09%)  0/12 (0.00%)  13/93 (13.98%) 
Rash  4/45 (8.89%)  5/45 (11.11%)  1/22 (4.55%)  1/12 (8.33%)  10/93 (10.75%) 
Psoriasis  0/45 (0.00%)  0/45 (0.00%)  0/22 (0.00%)  1/12 (8.33%)  1/93 (1.08%) 
Rash pruritic  0/45 (0.00%)  0/45 (0.00%)  0/22 (0.00%)  1/12 (8.33%)  1/93 (1.08%) 
Scar pain  0/45 (0.00%)  0/45 (0.00%)  0/22 (0.00%)  1/12 (8.33%)  1/93 (1.08%) 
Skin hyperpigmentation  0/45 (0.00%)  0/45 (0.00%)  0/22 (0.00%)  1/12 (8.33%)  1/93 (1.08%) 
Vascular disorders           
Hypertension  1/45 (2.22%)  5/45 (11.11%)  0/22 (0.00%)  1/12 (8.33%)  7/93 (7.53%) 
Hypotension  4/45 (8.89%)  0/45 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  4/93 (4.30%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

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
Results Point of Contact
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Name/Title: Clinical Trial Disclosures
Organization: Gilead Sciences, Inc.
EMail: ClinicalTrialDisclosures@gilead.com
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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT00298363     History of Changes
Other Study ID Numbers: GS-US-174-0108
First Submitted: February 28, 2006
First Posted: March 2, 2006
Results First Submitted: April 10, 2012
Results First Posted: April 25, 2013
Last Update Posted: April 25, 2013