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Efficacy & Safety of Tenofovir Disoproxil Fumarate (TDF) Plus Peginterferon α-2a (Peg-IFN) Versus TDF or Peg-IFN Monotherapy in Chronic Hepatitis B

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ClinicalTrials.gov Identifier: NCT01277601
Recruitment Status : Completed
First Posted : January 17, 2011
Results First Posted : September 9, 2015
Last Update Posted : August 26, 2016
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Chronic Hepatitis B
Interventions Drug: TDF
Drug: Peg-IFN
Enrollment 751
Recruitment Details Participants were enrolled at study sites in North America, Europe, Asia, and Australia. The first participant was screened on 12 April 2011. The last study visit occurred on 17 July 2015.
Pre-assignment Details 1597 participants were screened.
Arm/Group Title TDF+Peg-IFN 48 Weeks TDF 48 Weeks + Peg-IFN 16 Weeks TDF 120 Weeks Peg-IFN 48 Weeks
Hide Arm/Group Description Tenofovir disoproxil fumarate (TDF) 300 mg tablet once daily plus peginterferon α-2a (Peg-IFN) 180 µg subcutaneous (s.c.) injection once weekly for 48 weeks TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 16 weeks followed by TDF 300 mg tablet once daily for an additional 32 weeks TDF 300 mg tablet once daily for 120 weeks Peg-IFN 180 µg s.c. injection once weekly for 48 weeks
Period Title: Overall Study
Started 188 187 190 186
Completed 151 139 163 150
Not Completed 37 48 27 36
Reason Not Completed
Adverse Event             5             3             0             7
Withdrawal by Subject             18             21             8             17
Lost to Follow-up             7             9             4             2
Physician Decision             3             5             1             6
Pregnancy             2             2             4             1
Noncompliance with Study Drug             1             3             2             0
Subject Never Dosed with Study Drug             1             2             3             1
Protocol Violation             0             2             5             0
Subject Terminated from Study by Sponsor             0             1             0             2
Arm/Group Title TDF+Peg-IFN 48 Weeks TDF 48 Weeks + Peg-IFN 16 Week TDF 120 Weeks Peg-IFN 48 Weeks Total
Hide Arm/Group Description TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 48 weeks TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 16 weeks followed by TDF 300 mg tablet once daily for an additional 32 weeks TDF 300 mg tablet once daily for 120 weeks Peg-IFN 180 µg s.c. injection once weekly for 48 weeks Total of all reporting groups
Overall Number of Baseline Participants 186 184 185 185 740
Hide Baseline Analysis Population Description
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received. 11 participants were never dosed are not included in the Safety Analysis Set due to the following reasons for discontinuation: 7 = Subject Never Dosed with Study Drug; 4 = Withdrawal by Subject.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 186 participants 184 participants 185 participants 185 participants 740 participants
38  (10.7) 37  (9.9) 36  (10.8) 38  (10.5) 37  (10.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 186 participants 184 participants 185 participants 185 participants 740 participants
Female
59
  31.7%
65
  35.3%
64
  34.6%
66
  35.7%
254
  34.3%
Male
127
  68.3%
119
  64.7%
121
  65.4%
119
  64.3%
486
  65.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 186 participants 184 participants 185 participants 185 participants 740 participants
Hispanic or Latino
4
   2.2%
4
   2.2%
3
   1.6%
7
   3.8%
18
   2.4%
Not Hispanic or Latino
182
  97.8%
179
  97.3%
181
  97.8%
177
  95.7%
719
  97.2%
Unknown or Not Reported
0
   0.0%
1
   0.5%
1
   0.5%
1
   0.5%
3
   0.4%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 186 participants 184 participants 185 participants 185 participants 740 participants
Asian 142 134 141 137 554
Black or African American 5 3 4 6 18
Native Hawaiian or Other Pacific Islander 2 0 0 1 3
White 36 45 39 41 161
Other 1 2 1 0 4
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 186 participants 184 participants 185 participants 185 participants 740 participants
Romania 12 15 13 9 49
Singapore 7 5 7 8 27
Hong Kong 25 24 27 21 97
United States 19 17 23 26 85
United Kingdom 2 3 1 4 10
Portugal 0 3 0 0 3
India 10 5 9 6 30
Spain 3 3 3 5 14
Greece 0 3 2 4 9
Canada 19 14 14 11 58
Netherlands 2 1 0 1 4
Turkey 5 6 6 7 24
Taiwan 20 15 12 19 66
Korea, Republic of 34 38 38 35 145
Poland 4 7 6 5 22
Italy 2 1 4 4 11
Australia 10 14 15 14 53
France 6 3 1 3 13
Germany 6 7 4 3 20
Hepatitis B Surface Antigen (HBsAg)  
Mean (Standard Deviation)
Unit of measure:  Log 10 IU/mL
Number Analyzed 186 participants 184 participants 185 participants 185 participants 740 participants
3.88  (0.840) 3.84  (0.849) 3.89  (0.812) 3.76  (0.844) 3.84  (0.836)
Hepatitis B e Antigen (HBeAg) Status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 186 participants 184 participants 185 participants 185 participants 740 participants
Reactive 108 105 109 106 428
Nonreactive 78 79 76 79 312
Hepatitis B Virus (HBV) DNA  
Mean (Standard Deviation)
Unit of measure:  Log 10 IU/mL
Number Analyzed 186 participants 184 participants 185 participants 185 participants 740 participants
7.06  (1.542) 7.13  (1.505) 7.02  (1.550) 6.94  (1.619) 7.04  (1.553)
HBV Genotype  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 186 participants 184 participants 185 participants 185 participants 740 participants
Genotype A 17 16 14 14 61
Genotype B 50 51 49 53 203
Genotype C 78 79 78 79 314
Genotype D 39 36 41 38 154
Genotype E-H 2 2 3 1 8
Alanine Aminotransferase (ALT)  
Mean (Standard Deviation)
Unit of measure:  U/L
Number Analyzed 186 participants 184 participants 185 participants 185 participants 740 participants
121.2  (180.82) 112.2  (94.44) 100.9  (67.65) 106.6  (91.51) 110.3  (116.94)
1.Primary Outcome
Title Percentage of Participants With HBsAg Loss at Week 72 Following Treatment With 48 Weeks of TDF Plus Peg-IFN Combination Versus Peg-IFN Alone for 48 Weeks or TDF Alone
Hide Description

Loss of HBsAg was defined as change of detectable HBsAg from positive to negative. Proportions are based on a Kaplan-Meier estimate.

The analysis visit window for Week 72 comprised Week 70 through Week 78, so results up to Week 78 are included in this analysis.

Time Frame Baseline; Week 72
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants in the TDF+Peg-IFN 48 Weeks, TDF 120 Weeks, and Peg-IFN 48 Weeks groups were analyzed by randomized treatment.
Arm/Group Title TDF+Peg-IFN 48 Weeks TDF 120 Weeks Peg-IFN 48 Weeks
Hide Arm/Group Description:
TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 48 weeks
TDF 300 mg tablet once daily for 120 weeks
Peg-IFN 180 µg s.c. injection once weekly for 48 weeks
Overall Number of Participants Analyzed 186 185 185
Measure Type: Number
Unit of Measure: percentage of participants
9.05 0.00 2.84
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TDF+Peg-IFN 48 Weeks, TDF 120 Weeks
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments Raw p-values comparing treatments were based on a log-rank test stratified by HBeAg status and viral genotype.
Method Log Rank
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection TDF+Peg-IFN 48 Weeks, Peg-IFN 48 Weeks
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments Raw p-values comparing treatments were based on a log-rank test stratified by HBeAg status and viral genotype.
Method Log Rank
Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants With HBsAg Loss at Week 72 Following Treatment With TDF (48 Weeks) Plus Peg-IFN (16 Weeks) Combination Versus Peg-IFN Alone for 48 Weeks or TDF Alone
Hide Description

Loss of HBsAg was defined as change of detectable HBsAg from positive to negative. Proportions are based on a Kaplan-Meier estimate.

The analysis visit window for Week 72 comprised Week 70 through Week 78, so results up to Week 78 are included in this analysis.

Time Frame Baseline; Week 72
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set. Participants in the TDF 48 week + Peg-IFN 16 Weeks, TDF 120 Weeks, and Peg-IFN 48 Weeks groups were analyzed.
Arm/Group Title TDF 48 Weeks + Peg-IFN 16 Weeks TDF 120 Weeks Peg-IFN 48 Weeks
Hide Arm/Group Description:
TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 16 weeks followed by TDF 300 mg tablet once daily for an additional 32 weeks
TDF 300 mg tablet once daily for 120 weeks
Peg-IFN 180 µg s.c. injection once weekly for 48 weeks
Overall Number of Participants Analyzed 184 185 185
Measure Type: Number
Unit of Measure: percentage of participants
2.83 0.00 2.84
3.Secondary Outcome
Title Percentage of Participants With HBsAg Loss at Weeks 96 and 120
Hide Description

Loss of HBsAg was defined as change of detectable HBsAg from positive to negative. Proportions are based on a Kaplan-Meier estimate.

The analysis visit window for Week 96 comprised study Week 90 through Week 102, so results up to Week 102 are included in this analysis. The analysis visit window for Week 120 comprised study Week 114 through Week 126, so results up to Week 126 are included in this analysis.

Time Frame Baseline; Weeks 96 and 120
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title TDF+Peg-IFN 48 Weeks TDF 48 Weeks + Peg-IFN 16 Weeks TDF 120 Week Peg-IFN 48 Weeks
Hide Arm/Group Description:
TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 48 weeks
TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 16 weeks followed by TDF 300 mg tablet once daily for an additional 32 weeks
TDF 300 mg tablet once daily for 120 weeks
Peg-IFN 180 µg s.c. injection once weekly for 48 weeks
Overall Number of Participants Analyzed 186 184 185 185
Measure Type: Number
Unit of Measure: percentage of participants
Week 96 9.69 3.49 0.00 2.84
Week 120 10.36 3.49 0.00 3.51
4.Secondary Outcome
Title Percentage of Participants With HBsAg Seroconversion at Weeks 72, 96, and 120
Hide Description

HBsAg seroconversion was defined as change of detectable antibody to HBsAg from negative to positive. Proportions are based on a Kaplan-Meier estimate.

The analysis visit window for Week 72 comprised Week 70 through Week 78, so results up to Week 78 are included in this analysis. The analysis visit window for Week 96 comprised Week 90 through Week 102, so results up to Week 102 are included in this analysis. The analysis visit window for Week 120 comprised Week 114 through Week 120.

Time Frame Baseline; Weeks 72, 96, and 120
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title TDF+Peg-IFN 48 Weeks TDF 48 Weeks + Peg-IFN 16 Weeks TDF 120 Weeks Peg-IFN 48 Weeks
Hide Arm/Group Description:
TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 48 weeks
TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 16 weeks followed by TDF 300 mg tablet once daily for an additional 32 weeks
TDF 300 mg tablet once daily for 120 weeks
Peg-IFN 180 µg s.c. injection once weekly for 48 weeks
Overall Number of Participants Analyzed 186 184 185 185
Measure Type: Number
Unit of Measure: percentage of participants
Week 72 8.05 0.56 0.00 2.87
Week 96 8.05 0.56 0.00 2.87
Week 120 10.08 0.56 0.00 2.87
5.Secondary Outcome
Title Percentage of Participants With HBeAg Loss and Seroconversion at Week 72
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. Percentages were based on the number of subjects with non-missing HBeAg results or missing HBeAg results imputed as failures at each visit.

For the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups, data are presented in the "Not Retreated" column for participants who had not entered the retreatment phase by Week 72, and in the "Retreated" column for participants who did enter the retreatment phase by Week 72.

Time Frame Baseline; Week 72
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set who were HBeAg reactive or indeterminate at baseline were analyzed. The missing = failure method was used in which participants on study with missing data were considered to have failed to achieve the outcome.
Arm/Group Title TDF+Peg-IFN 48 Week (Not Retreated) TDF+Peg-IFN 48 Weeks (Retreated) TDF 48 Weeks + Peg-IFN 16 Week (Not Retreated) TDF 48 Weeks + Peg-IFN 16 Weeks (Retreated) TDF 120 Weeks Peg-IFN 48 Weeks (Not Retreated) Peg-IFN 48 Weeks (Retreated)
Hide Arm/Group Description:
TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 48 weeks in the initial treatment phase
Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 16 weeks followed by TDF 300 mg tablet once daily for an additional 32 weeks in the initial treatment phase
Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
TDF 300 mg tablet once daily for 120 weeks. Participants in this group were not eligible to enter the retreatment phase.
Peg-IFN 180 µg s.c. injection once weekly for 48 weeks in the initial treatment phase
Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
Overall Number of Participants Analyzed 76 32 61 44 109 64 42
Measure Type: Number
Unit of Measure: percentage of participants
HBeAg Loss 35.5 15.6 32.8 15.9 14.7 32.8 14.3
HBeAg Seroconversion 28.9 15.6 31.1 13.6 12.8 31.3 14.3
6.Secondary Outcome
Title Percentage of Participants With HBeAg Loss and Seroconversion at Week 96
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. Percentages were based on the number of subjects with non-missing HBeAg results or missing HBeAg results imputed as failures at each visit.

For the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups, data are presented in the "Not Retreated" column for participants who had not entered the retreatment phase by Week 96, and in the "Retreated" column for participants who did enter the retreatment phase by Week 96.

Time Frame Baseline; Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set who were HBeAg reactive or indeterminate at baseline were analyzed. The missing = failure method was used in which participants on study with missing data were considered to have failed to achieve the outcome.
Arm/Group Title TDF+Peg-IFN 48 Week (Not Retreated) TDF+Peg-IFN 48 Weeks (Retreated) TDF 48 Weeks + Peg-IFN 16 Week (Not Retreated) TDF 48 Weeks + Peg-IFN 16 Weeks (Retreated) TDF 120 Weeks Peg-IFN 48 Weeks (Not Retreated) Peg-IFN 48 Weeks (Retreated)
Hide Arm/Group Description:
TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 48 weeks in the initial treatment phase
Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 16 weeks followed by TDF 300 mg tablet once daily for an additional 32 weeks in the initial treatment phase
Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
TDF 300 mg tablet once daily for 120 weeks. Participants in this group were not eligible to enter the retreatment phase.
Peg-IFN 180 µg s.c. injection once weekly for 48 weeks in the initial treatment phase
Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
Overall Number of Participants Analyzed 44 64 44 61 109 37 69
Measure Type: Number
Unit of Measure: percentage of participants
HBeAg Loss 43.2 20.3 45.5 14.8 18.3 37.8 14.5
HBeAg Seroconversion 36.4 18.8 43.2 13.1 16.5 29.7 13.0
7.Secondary Outcome
Title Percentage of Participants With HBeAg Loss and Seroconversion at Week 120
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. Percentages were based on the number of subjects with non-missing HBeAg results or missing HBeAg results imputed as failures at each visit.

For the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups, data are presented in the "Not Retreated" column for participants who had not entered the retreatment phase by Week 120, and in the "Retreated" column for participants who did enter the retreatment phase by Week 120.

Time Frame Baseline; Week 120
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set who were HBeAg reactive or indeterminate at baseline were analyzed. The missing = failure method was used in which participants on study with missing data were considered to have failed to achieve the outcome.
Arm/Group Title TDF+Peg-IFN 48 Week (Not Retreated) TDF+Peg-IFN 48 Weeks (Retreated) TDF 48 Weeks + Peg-IFN 16 Week (Not Retreated) TDF 48 Weeks + Peg-IFN 16 Weeks (Retreated) TDF 120 Weeks Peg-IFN 48 Weeks (Not Retreated) Peg-IFN 48 Weeks (Retreated)
Hide Arm/Group Description:
TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 48 weeks in the initial treatment phase
Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 16 weeks followed by TDF 300 mg tablet once daily for an additional 32 weeks in the initial treatment phase
Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
TDF 300 mg tablet once daily for 120 weeks. Participants in this group were not eligible to enter the retreatment phase.
Peg-IFN 180 µg s.c. injection once weekly for 48 weeks in the initial treatment phase
Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
Overall Number of Participants Analyzed 44 64 40 65 109 36 70
Measure Type: Number
Unit of Measure: percentage of participants
HBeAg Loss 38.6 25.0 37.5 23.1 20.2 33.3 18.6
HBeAg Seroconversion 29.5 21.9 35.0 15.4 15.6 25.0 17.1
8.Secondary Outcome
Title Percentage of Participants With Virological Response (HBV DNA < 117 IU/mL) at Week 72
Hide Description For the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups, data are presented in the "Not Retreated" column for participants who had not entered the retreatment phase by Week 72, and in the "Retreated" column for participants who did enter the retreatment phase by Week 72.
Time Frame Week 72
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set. The missing = failure method was used in which participants on study with missing data were considered to have failed to achieve the endpoint.
Arm/Group Title TDF+Peg-IFN 48 Weeks (Not Retreated) TDF+Peg-IFN 48 Weeks (Retreated) TDF 48 Weeks + Peg-IFN 16 Weeks (Not Retreated) TDF 48 Weeks + Peg-IFN 16 Weeks (Retreated) TDF 120 Weeks Peg-IFN 48 Weeks (Not Retreated) Peg-IFN 48 Weeks (Retreated)
Hide Arm/Group Description:
TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 48 weeks in the initial treatment phase
Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 16 weeks followed by TDF 300 mg tablet once daily for an additional 32 weeks in the initial treatment phase
Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
TDF 300 mg tablet once daily for 120 weeks. Participants in this group were not eligible to enter the retreatment phase.
Peg-IFN 180 µg s.c. injection once weekly for 48 weeks in the initial treatment phase
Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
Overall Number of Participants Analyzed 144 42 131 53 185 128 57
Measure Type: Number
Unit of Measure: percentage of participants
15.3 26.2 14.5 15.1 84.9 11.7 40.4
9.Secondary Outcome
Title Percentage of Participants With Virological Response (HBV DNA < 117 IU/mL) at Week 96
Hide Description For the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups, data are presented in the "Not Retreated" column for participants who had not entered the retreatment phase by Week 96, and in the "Retreated" column for participants who did enter the retreatment phase by Week 96.
Time Frame Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set. The missing = failure method was used in which participants on study with missing data were considered to have failed to achieve the endpoint.
Arm/Group Title TDF+Peg-IFN 48 Weeks (Not Retreated) TDF+Peg-IFN 48 Weeks (Retreated) TDF 48 Weeks + Peg-IFN 16 Weeks (Not Retreated) TDF 48 Weeks + Peg-IFN 16 Weeks (Retreated) TDF 120 Weeks Peg-IFN 48 Weeks (Not Retreated) Peg-IFN 48 Weeks (Retreated)
Hide Arm/Group Description:
TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 48 weeks in the initial treatment phase
Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 16 weeks followed by TDF 300 mg tablet once daily for an additional 32 weeks in the initial treatment phase
Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
TDF 300 mg tablet once daily for 120 weeks. Participants in this group were not eligible to enter the retreatment phase.
Peg-IFN 180 µg s.c. injection once weekly for 48 weeks in the initial treatment phase
Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
Overall Number of Participants Analyzed 83 103 83 101 185 72 113
Measure Type: Number
Unit of Measure: percentage of participants
21.7 68.0 15.7 80.2 83.8 13.9 70.8
10.Secondary Outcome
Title Percentage of Participants With Virological Response (HBV DNA < 117 IU/mL) at Week 120
Hide Description For the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups, data are presented in the "Not Retreated" column for participants who had not entered the retreatment phase by Week 120, and in the "Retreated" column for participants who did enter the retreatment phase by Week 120.
Time Frame Week 120
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set. The missing = failure method was used in which participants on study with missing data were considered to have failed to achieve the endpoint.
Arm/Group Title TDF+Peg-IFN 48 Weeks (Not Retreated) TDF+Peg-IFN 48 Weeks (Retreated) TDF 48 Weeks + Peg-IFN 16 Weeks (Not Retreated) TDF 48 Weeks + Peg-IFN 16 Weeks (Retreated) TDF 120 Weeks Peg-IFN 48 Weeks (Not Retreated) Peg-IFN 48 Weeks (Retreated)
Hide Arm/Group Description:
TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 48 weeks in the initial treatment phase
Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 16 weeks followed by TDF 300 mg tablet once daily for an additional 32 weeks in the initial treatment phase
Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
TDF 300 mg tablet once daily for 120 weeks. Participants in this group were not eligible to enter the retreatment phase.
Peg-IFN 180 µg s.c. injection once weekly for 48 weeks in the initial treatment phase
Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
Overall Number of Participants Analyzed 74 112 69 115 185 68 117
Measure Type: Number
Unit of Measure: percentage of participants
32.4 81.3 18.8 83.5 82.2 13.2 82.1
11.Secondary Outcome
Title Percentage of Participants With Normal ALT at Week 72
Hide Description

Normal ALT was ≤ 30 U/L for males and ≤ 19 U/L for females (based on the American Association for the Study of Liver Diseases (AASLD) 2008 guidelines), and ≤ 41 U/L for males and ≤ 31 U/L for females (based on central laboratory upper limit of the normal range (ULN) for ALT).

For the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups, data are presented in the "Not Retreated" column for participants who had not entered the retreatment phase by Week 72, and in the "Retreated" column for participants who did enter the retreatment phase by Week 72.

Time Frame Week 72
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set. The missing = failure method was used in which participants on study with missing data were considered to have failed to achieve the endpoint.
Arm/Group Title TDF+Peg-IFN 48 Weeks (Not Retreated) TDF+Peg-IFN 48 Weeks (Retreated) TDF 48 Weeks + Peg-IFN 16 Weeks (Not Retreated) TDF 48 Weeks + Peg-IFN 16 Weeks (Retreated) TDF 120 Weeks Peg-IFN 48 Week (Not Retreated) Peg-IFN 48 Weeks (Retreated)
Hide Arm/Group Description:
TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 48 weeks in the initial treatment phase
Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 16 weeks followed by TDF 300 mg tablet once daily for an additional 32 weeks in the initial treatment phase
Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
TDF 300 mg tablet once daily for 120 weeks. Participants in this group were not eligible to enter the retreatment phase.
Peg-IFN 180 µg s.c. injection once weekly for 48 weeks in the initial treatment phase
Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
Overall Number of Participants Analyzed 126 60 118 66 185 120 65
Measure Type: Number
Unit of Measure: percentage of participants
AASLD Criteria 42.1 18.3 40.7 18.2 47.6 35.0 9.2
Central Laboratory Criteria 59.5 40.0 57.6 34.8 72.4 57.5 33.8
12.Secondary Outcome
Title Percentage of Participants With Normal ALT at Week 96
Hide Description

Normal ALT was ≤ 30 U/L for males and ≤ 19 U/L for females (based on the American Association for the Study of Liver Diseases (AASLD) 2008 guidelines), and ≤ 41 U/L for males and ≤ 31 U/L for females (based on central laboratory upper limit of the normal range (ULN) for ALT).

For the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups, data are presented in the "Not Retreated" column for participants who had not entered the retreatment phase by Week 96, and in the "Retreated" column for participants who did enter the retreatment phase by Week 96.

Time Frame Week 96
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Hide Analysis Population Description
Full Analysis Set. The missing = failure method was used in which participants on study with missing data were considered to have failed to achieve the endpoint.
Arm/Group Title TDF+Peg-IFN 48 Weeks (Not Retreated) TDF+Peg-IFN 48 Weeks (Retreated) TDF 48 Weeks + Peg-IFN 16 Weeks (Not Retreated) TDF 48 Weeks + Peg-IFN 16 Weeks (Retreated) TDF 120 Weeks Peg-IFN 48 Week (Not Retreated) Peg-IFN 48 Weeks (Retreated)
Hide Arm/Group Description:
TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 48 weeks in the initial treatment phase
Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 16 weeks followed by TDF 300 mg tablet once daily for an additional 32 weeks in the initial treatment phase
Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
TDF 300 mg tablet once daily for 120 weeks. Participants in this group were not eligible to enter the retreatment phase.
Peg-IFN 180 µg s.c. injection once weekly for 48 weeks in the initial treatment phase
Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
Overall Number of Participants Analyzed 81 105 82 102 185 72 113
Measure Type: Number
Unit of Measure: percentage of participants
AASLD Criteria 43.2 42.9 34.1 46.1 48.1 34.7 39.8
Central Laboratory Criteria 55.6 71.4 52.4 73.5 73.0 47.2 68.1
13.Secondary Outcome
Title Percentage of Participants With Normal ALT at Week 120
Hide Description

Normal ALT was ≤ 30 U/L for males and ≤ 19 U/L for females (based on the American Association for the Study of Liver Diseases (AASLD) 2008 guidelines), and ≤ 41 U/L for males and ≤ 31 U/L for females (based on central laboratory upper limit of the normal range (ULN) for ALT).

For the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups, data are presented in the "Not Retreated" column for participants who had not entered the retreatment phase by Week 120, and in the "Retreated" column for participants who did enter the retreatment phase by Week 120.

Time Frame Week 120
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set. The missing = failure method was used in which participants on study with missing data were considered to have failed to achieve the endpoint.
Arm/Group Title TDF+Peg-IFN 48 Weeks (Not Retreated) TDF+Peg-IFN 48 Weeks (Retreated) TDF 48 Weeks + Peg-IFN 16 Weeks (Not Retreated) TDF 48 Weeks + Peg-IFN 16 Weeks (Retreated) TDF 120 Weeks Peg-IFN 48 Week (Not Retreated) Peg-IFN 48 Weeks (Retreated)
Hide Arm/Group Description:
TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 48 weeks in the initial treatment phase
Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 16 weeks followed by TDF 300 mg tablet once daily for an additional 32 weeks in the initial treatment phase
Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
TDF 300 mg tablet once daily for 120 weeks. Participants in this group were not eligible to enter the retreatment phase.
Peg-IFN 180 µg s.c. injection once weekly for 48 weeks in the initial treatment phase
Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
Overall Number of Participants Analyzed 74 112 69 115 185 68 117
Measure Type: Number
Unit of Measure: percentage of participants
AASLD Criteria 39.2 54.5 30.4 48.7 48.6 30.9 47.0
Central Laboratory Criteria 44.6 72.3 40.6 78.3 73.0 41.2 73.5
14.Secondary Outcome
Title Percentage of Participants Who Required Retreatment
Hide Description Participants in the TDF 120 week group were not eligible to enter the retreatment phase and are not presented.
Time Frame Up to 120 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set. Participants in the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups were analyzed.
Arm/Group Title TDF+Peg-IFN 48 Weeks TDF 48 Weeks + Peg-IFN 16 Weeks Peg-IFN 48 Weeks
Hide Arm/Group Description:
TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 48 weeks
TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 16 weeks followed by TDF 300 mg tablet once daily for an additional 32 weeks
Peg-IFN 180 µg s.c. injection once weekly for 48 weeks
Overall Number of Participants Analyzed 186 184 185
Measure Type: Number
Unit of Measure: percentage of participants
60.2 62.5 63.2
Time Frame Up to 120 weeks plus 30 days
Adverse Event Reporting Description Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.
 
Arm/Group Title TDF+Peg-IFN 48 Weeks (Not Retreated) TDF+Peg-IFN 48 Weeks (Retreated) TDF 48 Week + Peg-IFN 16 Weeks (Not Retreated) TDF 48 Weeks + Peg-IFN 16 Weeks (Retreated) TDF 120 Weeks Peg-IFN 48 Weeks (Not Retreated) Peg-IFN 48 Weeks (Retreated)
Hide Arm/Group Description

Adverse events in this reporting group are those occurring in participants who were not retreated or before retreatment through last non-retreatment dose plus 30 days.

TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 48 weeks

Adverse events in this reporting group are those occurring after TDF retreatment through last TDF retreatment dose plus 30 days.

TDF 300 mg tablet once daily up to Week 120

Adverse events in this reporting group are those occurring in participants who were not retreated or before retreatment through last non-retreatment dose plus 30 days.

TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 16 weeks followed by TDF 300 mg tablet once daily for an additional 32 weeks

Adverse events in this reporting group are those occurring after TDF retreatment through last TDF retreatment dose plus 30 days.

TDF 300 mg tablet once daily up to Week 120

Adverse events in this reporting group are those occurring during the initial treatment phase (up to 120 weeks plus 30 days).

TDF 300 mg tablet once daily for up to 120 weeks

Adverse events in this reporting group are those occurring in participants who were not retreated or before retreatment through last non-retreatment dose plus 30 days.

Peg-IFN 180 µg s.c. injection once weekly for 48 weeks

Adverse events in this reporting group are those occurring during the retreatment phase (from start of retreatment up to Week 120 plus 30 days).

TDF 300 mg tablet once daily up to Week 120

All-Cause Mortality
TDF+Peg-IFN 48 Weeks (Not Retreated) TDF+Peg-IFN 48 Weeks (Retreated) TDF 48 Week + Peg-IFN 16 Weeks (Not Retreated) TDF 48 Weeks + Peg-IFN 16 Weeks (Retreated) TDF 120 Weeks Peg-IFN 48 Weeks (Not Retreated) Peg-IFN 48 Weeks (Retreated)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
TDF+Peg-IFN 48 Weeks (Not Retreated) TDF+Peg-IFN 48 Weeks (Retreated) TDF 48 Week + Peg-IFN 16 Weeks (Not Retreated) TDF 48 Weeks + Peg-IFN 16 Weeks (Retreated) TDF 120 Weeks Peg-IFN 48 Weeks (Not Retreated) Peg-IFN 48 Weeks (Retreated)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   21/186 (11.29%)   7/112 (6.25%)   18/184 (9.78%)   3/115 (2.61%)   13/185 (7.03%)   18/185 (9.73%)   6/117 (5.13%) 
Blood and lymphatic system disorders               
Thrombocytopenia  1  1/186 (0.54%)  0/112 (0.00%)  0/184 (0.00%)  0/115 (0.00%)  0/185 (0.00%)  0/185 (0.00%)  0/117 (0.00%) 
Cardiac disorders               
Atrial septal defect acquired  1  0/186 (0.00%)  0/112 (0.00%)  1/184 (0.54%)  0/115 (0.00%)  0/185 (0.00%)  0/185 (0.00%)  0/117 (0.00%) 
Endocrine disorders               
Hyperthyroidism  1  0/186 (0.00%)  0/112 (0.00%)  0/184 (0.00%)  0/115 (0.00%)  1/185 (0.54%)  0/185 (0.00%)  0/117 (0.00%) 
Gastrointestinal disorders               
Abdominal pain  1  1/186 (0.54%)  0/112 (0.00%)  0/184 (0.00%)  0/115 (0.00%)  0/185 (0.00%)  0/185 (0.00%)  0/117 (0.00%) 
Haematemesis  1  0/186 (0.00%)  0/112 (0.00%)  1/184 (0.54%)  0/115 (0.00%)  0/185 (0.00%)  0/185 (0.00%)  0/117 (0.00%) 
Haemorrhoids  1  1/186 (0.54%)  0/112 (0.00%)  1/184 (0.54%)  0/115 (0.00%)  0/185 (0.00%)  0/185 (0.00%)  0/117 (0.00%) 
Intestinal obstruction  1  0/186 (0.00%)  0/112 (0.00%)  0/184 (0.00%)  0/115 (0.00%)  1/185 (0.54%)  0/185 (0.00%)  0/117 (0.00%) 
Pancreatitis acute  1  0/186 (0.00%)  0/112 (0.00%)  0/184 (0.00%)  0/115 (0.00%)  1/185 (0.54%)  0/185 (0.00%)  0/117 (0.00%) 
Rectal haemorrhage  1  0/186 (0.00%)  0/112 (0.00%)  1/184 (0.54%)  0/115 (0.00%)  0/185 (0.00%)  0/185 (0.00%)  0/117 (0.00%) 
Hepatobiliary disorders               
Cholangitis  1  0/186 (0.00%)  0/112 (0.00%)  0/184 (0.00%)  0/115 (0.00%)  1/185 (0.54%)  0/185 (0.00%)  0/117 (0.00%) 
Cholangitis acute  1  1/186 (0.54%)  0/112 (0.00%)  0/184 (0.00%)  0/115 (0.00%)  0/185 (0.00%)  0/185 (0.00%)  0/117 (0.00%) 
Cholecystitis chronic  1  0/186 (0.00%)  0/112 (0.00%)  0/184 (0.00%)  0/115 (0.00%)  2/185 (1.08%)  0/185 (0.00%)  0/117 (0.00%) 
Hepatitis  1  3/186 (1.61%)  2/112 (1.79%)  4/184 (2.17%)  0/115 (0.00%)  1/185 (0.54%)  7/185 (3.78%)  1/117 (0.85%) 
Infections and infestations               
Anal abscess  1  0/186 (0.00%)  0/112 (0.00%)  0/184 (0.00%)  0/115 (0.00%)  0/185 (0.00%)  1/185 (0.54%)  0/117 (0.00%) 
Appendicitis  1  1/186 (0.54%)  0/112 (0.00%)  0/184 (0.00%)  0/115 (0.00%)  1/185 (0.54%)  1/185 (0.54%)  0/117 (0.00%) 
Cellulitis  1  1/186 (0.54%)  0/112 (0.00%)  0/184 (0.00%)  0/115 (0.00%)  0/185 (0.00%)  0/185 (0.00%)  0/117 (0.00%) 
Gastroenteritis  1  1/186 (0.54%)  0/112 (0.00%)  0/184 (0.00%)  0/115 (0.00%)  0/185 (0.00%)  0/185 (0.00%)  0/117 (0.00%) 
Gastroenteritis viral  1  0/186 (0.00%)  0/112 (0.00%)  0/184 (0.00%)  0/115 (0.00%)  1/185 (0.54%)  0/185 (0.00%)  0/117 (0.00%) 
Psoas abscess  1  0/186 (0.00%)  0/112 (0.00%)  0/184 (0.00%)  0/115 (0.00%)  0/185 (0.00%)  1/185 (0.54%)  0/117 (0.00%) 
Sinusitis  1  1/186 (0.54%)  0/112 (0.00%)  0/184 (0.00%)  0/115 (0.00%)  0/185 (0.00%)  0/185 (0.00%)  0/117 (0.00%) 
Injury, poisoning and procedural complications               
Contusion  1  0/186 (0.00%)  0/112 (0.00%)  0/184 (0.00%)  0/115 (0.00%)  1/185 (0.54%)  0/185 (0.00%)  0/117 (0.00%) 
Investigations               
Alanine aminotransferase abnormal  1  1/186 (0.54%)  0/112 (0.00%)  0/184 (0.00%)  0/115 (0.00%)  0/185 (0.00%)  0/185 (0.00%)  0/117 (0.00%) 
Alanine aminotransferase increased  1  6/186 (3.23%)  3/112 (2.68%)  8/184 (4.35%)  2/115 (1.74%)  1/185 (0.54%)  7/185 (3.78%)  2/117 (1.71%) 
Amylase increased  1  0/186 (0.00%)  0/112 (0.00%)  0/184 (0.00%)  0/115 (0.00%)  0/185 (0.00%)  0/185 (0.00%)  1/117 (0.85%) 
Aspartate aminotransferase increased  1  1/186 (0.54%)  2/112 (1.79%)  1/184 (0.54%)  0/115 (0.00%)  0/185 (0.00%)  2/185 (1.08%)  1/117 (0.85%) 
Lipase increased  1  0/186 (0.00%)  0/112 (0.00%)  0/184 (0.00%)  0/115 (0.00%)  0/185 (0.00%)  0/185 (0.00%)  1/117 (0.85%) 
Transaminases increased  1  0/186 (0.00%)  0/112 (0.00%)  1/184 (0.54%)  0/115 (0.00%)  0/185 (0.00%)  0/185 (0.00%)  1/117 (0.85%) 
Metabolism and nutrition disorders               
Cholesterosis  1  0/186 (0.00%)  0/112 (0.00%)  0/184 (0.00%)  0/115 (0.00%)  0/185 (0.00%)  0/185 (0.00%)  1/117 (0.85%) 
Musculoskeletal and connective tissue disorders               
Exostosis  1  0/186 (0.00%)  0/112 (0.00%)  0/184 (0.00%)  0/115 (0.00%)  1/185 (0.54%)  0/185 (0.00%)  0/117 (0.00%) 
Rotator cuff syndrome  1  0/186 (0.00%)  1/112 (0.89%)  0/184 (0.00%)  0/115 (0.00%)  0/185 (0.00%)  0/185 (0.00%)  0/117 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)               
Adenocarcinoma of the cervix  1  0/186 (0.00%)  0/112 (0.00%)  0/184 (0.00%)  0/115 (0.00%)  1/185 (0.54%)  0/185 (0.00%)  0/117 (0.00%) 
B-cell lymphoma  1  0/186 (0.00%)  0/112 (0.00%)  0/184 (0.00%)  0/115 (0.00%)  1/185 (0.54%)  0/185 (0.00%)  0/117 (0.00%) 
Benign neoplasm of bladder  1  0/186 (0.00%)  0/112 (0.00%)  0/184 (0.00%)  0/115 (0.00%)  1/185 (0.54%)  0/185 (0.00%)  0/117 (0.00%) 
Brain cancer metastatic  1  0/186 (0.00%)  0/112 (0.00%)  1/184 (0.54%)  0/115 (0.00%)  0/185 (0.00%)  0/185 (0.00%)  0/117 (0.00%) 
Breast cancer  1  0/186 (0.00%)  0/112 (0.00%)  0/184 (0.00%)  0/115 (0.00%)  0/185 (0.00%)  0/185 (0.00%)  1/117 (0.85%) 
Cholangiocarcinoma  1  0/186 (0.00%)  1/112 (0.89%)  0/184 (0.00%)  0/115 (0.00%)  0/185 (0.00%)  0/185 (0.00%)  0/117 (0.00%) 
Gallbladder neoplasm  1  0/186 (0.00%)  0/112 (0.00%)  1/184 (0.54%)  0/115 (0.00%)  0/185 (0.00%)  0/185 (0.00%)  0/117 (0.00%) 
Haemangioma  1  0/186 (0.00%)  0/112 (0.00%)  0/184 (0.00%)  0/115 (0.00%)  0/185 (0.00%)  0/185 (0.00%)  1/117 (0.85%) 
Hepatocellular carcinoma  1  0/186 (0.00%)  0/112 (0.00%)  1/184 (0.54%)  0/115 (0.00%)  0/185 (0.00%)  0/185 (0.00%)  1/117 (0.85%) 
Lung neoplasm malignant  1  0/186 (0.00%)  0/112 (0.00%)  1/184 (0.54%)  0/115 (0.00%)  0/185 (0.00%)  0/185 (0.00%)  0/117 (0.00%) 
Mixed hepatocellular cholangiocarcinoma  1  0/186 (0.00%)  1/112 (0.89%)  0/184 (0.00%)  0/115 (0.00%)  0/185 (0.00%)  0/185 (0.00%)  0/117 (0.00%) 
Nervous system disorders               
Hepatic encephalopathy  1  0/186 (0.00%)  0/112 (0.00%)  0/184 (0.00%)  1/115 (0.87%)  0/185 (0.00%)  0/185 (0.00%)  0/117 (0.00%) 
Myelopathy  1  1/186 (0.54%)  0/112 (0.00%)  0/184 (0.00%)  0/115 (0.00%)  0/185 (0.00%)  0/185 (0.00%)  0/117 (0.00%) 
Neuropathy peripheral  1  1/186 (0.54%)  0/112 (0.00%)  0/184 (0.00%)  0/115 (0.00%)  0/185 (0.00%)  0/185 (0.00%)  0/117 (0.00%) 
Pregnancy, puerperium and perinatal conditions               
Abortion spontaneous  1  1/186 (0.54%)  0/112 (0.00%)  0/184 (0.00%)  0/115 (0.00%)  0/185 (0.00%)  0/185 (0.00%)  0/117 (0.00%) 
Psychiatric disorders               
Anxiety  1  1/186 (0.54%)  0/112 (0.00%)  0/184 (0.00%)  0/115 (0.00%)  0/185 (0.00%)  0/185 (0.00%)  0/117 (0.00%) 
Depression  1  1/186 (0.54%)  0/112 (0.00%)  0/184 (0.00%)  0/115 (0.00%)  0/185 (0.00%)  0/185 (0.00%)  0/117 (0.00%) 
Reproductive system and breast disorders               
Prostatitis  1  0/186 (0.00%)  0/112 (0.00%)  0/184 (0.00%)  0/115 (0.00%)  0/185 (0.00%)  1/185 (0.54%)  0/117 (0.00%) 
Respiratory, thoracic and mediastinal disorders               
Haemoptysis  1  1/186 (0.54%)  0/112 (0.00%)  0/184 (0.00%)  0/115 (0.00%)  0/185 (0.00%)  0/185 (0.00%)  0/117 (0.00%) 
Skin and subcutaneous tissue disorders               
Rash  1  0/186 (0.00%)  0/112 (0.00%)  0/184 (0.00%)  0/115 (0.00%)  0/185 (0.00%)  1/185 (0.54%)  0/117 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
TDF+Peg-IFN 48 Weeks (Not Retreated) TDF+Peg-IFN 48 Weeks (Retreated) TDF 48 Week + Peg-IFN 16 Weeks (Not Retreated) TDF 48 Weeks + Peg-IFN 16 Weeks (Retreated) TDF 120 Weeks Peg-IFN 48 Weeks (Not Retreated) Peg-IFN 48 Weeks (Retreated)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   147/186 (79.03%)   26/112 (23.21%)   142/184 (77.17%)   31/115 (26.96%)   89/185 (48.11%)   152/185 (82.16%)   33/117 (28.21%) 
Blood and lymphatic system disorders               
Neutropenia  1  15/186 (8.06%)  0/112 (0.00%)  11/184 (5.98%)  1/115 (0.87%)  0/185 (0.00%)  15/185 (8.11%)  0/117 (0.00%) 
Gastrointestinal disorders               
Abdominal pain  1  7/186 (3.76%)  1/112 (0.89%)  6/184 (3.26%)  1/115 (0.87%)  6/185 (3.24%)  10/185 (5.41%)  1/117 (0.85%) 
Abdominal pain upper  1  11/186 (5.91%)  2/112 (1.79%)  7/184 (3.80%)  0/115 (0.00%)  7/185 (3.78%)  6/185 (3.24%)  6/117 (5.13%) 
Diarrhoea  1  13/186 (6.99%)  2/112 (1.79%)  10/184 (5.43%)  0/115 (0.00%)  11/185 (5.95%)  19/185 (10.27%)  4/117 (3.42%) 
Dyspepsia  1  9/186 (4.84%)  1/112 (0.89%)  6/184 (3.26%)  1/115 (0.87%)  15/185 (8.11%)  9/185 (4.86%)  1/117 (0.85%) 
Nausea  1  26/186 (13.98%)  0/112 (0.00%)  24/184 (13.04%)  3/115 (2.61%)  11/185 (5.95%)  13/185 (7.03%)  6/117 (5.13%) 
General disorders               
Asthenia  1  20/186 (10.75%)  0/112 (0.00%)  9/184 (4.89%)  1/115 (0.87%)  4/185 (2.16%)  12/185 (6.49%)  1/117 (0.85%) 
Chills  1  5/186 (2.69%)  0/112 (0.00%)  13/184 (7.07%)  0/115 (0.00%)  3/185 (1.62%)  11/185 (5.95%)  1/117 (0.85%) 
Fatigue  1  40/186 (21.51%)  2/112 (1.79%)  33/184 (17.93%)  4/115 (3.48%)  21/185 (11.35%)  41/185 (22.16%)  6/117 (5.13%) 
Influenza like illness  1  19/186 (10.22%)  0/112 (0.00%)  17/184 (9.24%)  0/115 (0.00%)  10/185 (5.41%)  17/185 (9.19%)  2/117 (1.71%) 
Injection site erythema  1  12/186 (6.45%)  0/112 (0.00%)  11/184 (5.98%)  0/115 (0.00%)  0/185 (0.00%)  10/185 (5.41%)  0/117 (0.00%) 
Malaise  1  20/186 (10.75%)  0/112 (0.00%)  12/184 (6.52%)  1/115 (0.87%)  2/185 (1.08%)  7/185 (3.78%)  3/117 (2.56%) 
Pain  1  8/186 (4.30%)  0/112 (0.00%)  5/184 (2.72%)  0/115 (0.00%)  0/185 (0.00%)  11/185 (5.95%)  2/117 (1.71%) 
Pyrexia  1  39/186 (20.97%)  1/112 (0.89%)  36/184 (19.57%)  1/115 (0.87%)  8/185 (4.32%)  43/185 (23.24%)  2/117 (1.71%) 
Infections and infestations               
Nasopharyngitis  1  5/186 (2.69%)  3/112 (2.68%)  16/184 (8.70%)  3/115 (2.61%)  20/185 (10.81%)  6/185 (3.24%)  3/117 (2.56%) 
Upper respiratory tract infection  1  10/186 (5.38%)  3/112 (2.68%)  9/184 (4.89%)  9/115 (7.83%)  16/185 (8.65%)  10/185 (5.41%)  5/117 (4.27%) 
Metabolism and nutrition disorders               
Decreased appetite  1  23/186 (12.37%)  0/112 (0.00%)  36/184 (19.57%)  2/115 (1.74%)  2/185 (1.08%)  18/185 (9.73%)  0/117 (0.00%) 
Musculoskeletal and connective tissue disorders               
Arthralgia  1  9/186 (4.84%)  3/112 (2.68%)  11/184 (5.98%)  3/115 (2.61%)  4/185 (2.16%)  9/185 (4.86%)  2/117 (1.71%) 
Back pain  1  16/186 (8.60%)  3/112 (2.68%)  11/184 (5.98%)  3/115 (2.61%)  11/185 (5.95%)  10/185 (5.41%)  3/117 (2.56%) 
Musculoskeletal pain  1  5/186 (2.69%)  2/112 (1.79%)  2/184 (1.09%)  1/115 (0.87%)  10/185 (5.41%)  8/185 (4.32%)  1/117 (0.85%) 
Myalgia  1  29/186 (15.59%)  0/112 (0.00%)  36/184 (19.57%)  1/115 (0.87%)  2/185 (1.08%)  35/185 (18.92%)  1/117 (0.85%) 
Nervous system disorders               
Dizziness  1  20/186 (10.75%)  0/112 (0.00%)  18/184 (9.78%)  1/115 (0.87%)  9/185 (4.86%)  17/185 (9.19%)  4/117 (3.42%) 
Headache  1  54/186 (29.03%)  3/112 (2.68%)  37/184 (20.11%)  3/115 (2.61%)  16/185 (8.65%)  52/185 (28.11%)  4/117 (3.42%) 
Psychiatric disorders               
Insomnia  1  19/186 (10.22%)  3/112 (2.68%)  14/184 (7.61%)  1/115 (0.87%)  6/185 (3.24%)  18/185 (9.73%)  2/117 (1.71%) 
Irritability  1  11/186 (5.91%)  1/112 (0.89%)  2/184 (1.09%)  0/115 (0.00%)  0/185 (0.00%)  11/185 (5.95%)  0/117 (0.00%) 
Respiratory, thoracic and mediastinal disorders               
Cough  1  11/186 (5.91%)  3/112 (2.68%)  9/184 (4.89%)  3/115 (2.61%)  12/185 (6.49%)  16/185 (8.65%)  3/117 (2.56%) 
Oropharyngeal pain  1  10/186 (5.38%)  3/112 (2.68%)  5/184 (2.72%)  0/115 (0.00%)  9/185 (4.86%)  11/185 (5.95%)  2/117 (1.71%) 
Skin and subcutaneous tissue disorders               
Alopecia  1  46/186 (24.73%)  0/112 (0.00%)  32/184 (17.39%)  1/115 (0.87%)  2/185 (1.08%)  45/185 (24.32%)  1/117 (0.85%) 
Pruritus  1  14/186 (7.53%)  0/112 (0.00%)  14/184 (7.61%)  2/115 (1.74%)  4/185 (2.16%)  21/185 (11.35%)  0/117 (0.00%) 
Rash  1  20/186 (10.75%)  1/112 (0.89%)  17/184 (9.24%)  1/115 (0.87%)  1/185 (0.54%)  9/185 (4.86%)  2/117 (1.71%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.0
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
Name/Title: Clinical Trial Disclosures
Organization: Gilead Sciences
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01277601     History of Changes
Other Study ID Numbers: GS-US-174-0149
2010-024586-45 ( EudraCT Number )
First Submitted: January 13, 2011
First Posted: January 17, 2011
Results First Submitted: August 10, 2015
Results First Posted: September 9, 2015
Last Update Posted: August 26, 2016