Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study to Evaluate Efficacy and Safety of Switching From TDF to TAF in Adults With Chronic Hepatitis B Who Are Virologically Suppressed

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02979613
Recruitment Status : Completed
First Posted : December 1, 2016
Results First Posted : September 25, 2019
Last Update Posted : September 14, 2020
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Chronic Hepatitis B
Interventions Drug: TAF
Drug: TDF
Drug: TAF Placebo
Drug: TDF Placebo
Enrollment 490
Recruitment Details Participants were enrolled at study sites in North America, Europe, and Asia. The first participant was screened on 29 December 2016. The last study visit occurred on 30 January 2020.
Pre-assignment Details 541 participants were screened.
Arm/Group Title TAF 25 mg TDF 300 mg
Hide Arm/Group Description Participants who were virologically suppressed and taking tenofovir disoproxil fumarate (TDF) 300 mg tablet orally once daily received tenofovir alafenamide (TAF) 25 mg tablet orally once daily, and placebo to match TDF once daily for up to 53 weeks in the double-blind (DB) phase. Participants who completed DB treatment and were willing to enter in the open-label extension (OLE) phase, received TAF 25 mg tablet orally once daily for up to 52 weeks. Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TDF 300 mg tablet orally once daily, and placebo to match TAF once daily for up to 50 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.
Period Title: Double-Blind Phase
Started 245 245
Completed 235 237
Not Completed 10 8
Reason Not Completed
Withdrew Consent             2             4
Pregnancy             2             2
Adverse Event             2             0
Lost to Follow-up             1             1
Protocol Violation             1             1
Randomized but Never Treated             2             0
Period Title: Open-Label Extension (OLE) Phase
Started 235 237
Completed 232 231
Not Completed 3 6
Reason Not Completed
Withdrew Consent             2             4
Adverse Event             1             0
Death             0             1
Investigator's Discretion             0             1
Arm/Group Title TAF 25 mg TDF 300 mg Total
Hide Arm/Group Description Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TAF 25 mg tablet orally once daily, and placebo to match TDF once daily for up to 53 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks. Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TDF 300 mg tablet orally once daily, and placebo to match TAF once daily for up to 50 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks. Total of all reporting groups
Overall Number of Baseline Participants 243 245 488
Hide Baseline Analysis Population Description
The Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 243 participants 245 participants 488 participants
51  (10.5) 51  (10.8) 51  (10.7)
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
< 50 Years Number Analyzed 243 participants 245 participants 488 participants
107 109 216
≥ 50 Years Number Analyzed 243 participants 245 participants 488 participants
136 136 272
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 243 participants 245 participants 488 participants
Female 64 79 143
Male 179 166 345
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 243 participants 245 participants 488 participants
Hispanic or Latino 3 0 3
Not Hispanic or Latino 240 245 485
Unknown or Not Reported 0 0 0
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race Number Analyzed 243 participants 245 participants 488 participants
Asian 195 205 400
Black or African American 9 8 17
Native Hawaiian or Pacific Islander 0 1 1
White 38 31 69
Other 1 0 1
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Canada Number Analyzed 243 participants 245 participants 488 participants
42 47 89
South Korea Number Analyzed 243 participants 245 participants 488 participants
61 77 138
Hong Kong Number Analyzed 243 participants 245 participants 488 participants
15 13 28
United States Number Analyzed 243 participants 245 participants 488 participants
63 64 127
Taiwan Number Analyzed 243 participants 245 participants 488 participants
28 13 41
Italy Number Analyzed 243 participants 245 participants 488 participants
9 12 21
United Kingdom Number Analyzed 243 participants 245 participants 488 participants
6 7 13
Spain Number Analyzed 243 participants 245 participants 488 participants
19 12 31
Alanine Aminotransferase (ALT)  
Mean (Standard Deviation)
Unit of measure:  U/L
Number Analyzed 243 participants 245 participants 488 participants
28  (15.6) 26  (12.0) 27  (13.9)
ALT Level Based on Central Lab Normal Range   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 243 participants 245 participants 488 participants
≤ ULN 211 226 437
> ULN to 5xULN 32 19 51
> 5xULN 0 0 0
[1]
Measure Description: Central laboratory upper limit of normal (ULN) for ALT were as follows: ≤ 43 U/L for males aged 18 to < 69 years and ≤ 35 U/L for males aged ≥ 69 years; ≤ 34 U/L for females aged 18 to < 69 years and ≤ 32 U/L for females aged ≥ 69 years.
ALT Level Based on 2018 American Association for the Study of Liver Diseases (AASLD) Normal Range   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 243 participants 245 participants 488 participants
≤ ULN 191 192 383
> ULN to 5xULN 52 53 105
> 5xULN 0 0 0
[1]
Measure Description: The ULN for ALT using the 2018 AASLD normal range was 25 U/L for females and 35 U/L for males.
Hepatitis B virus (HBV) DNA Category  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 243 participants 245 participants 488 participants
< 20 IU/mL 238 242 480
20 to < 69 IU/mL 2 3 5
≥ 69 IU/mL 3 0 3
Hepatitis B e Antigen/Antibody (HBeAg/HBeAb) Status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 243 participants 245 participants 488 participants
Positive/Negative 78 78 156
Positive/Positive 0 1 1
Negative/Negative 17 28 45
Negative/Positive 148 138 286
[1]
Measure Description: HBeAb status was imputed as negative if missing.
FibroTest® Score   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Scores on a scale
Number Analyzed 241 participants 245 participants 486 participants
0.42  (0.234) 0.41  (0.211) 0.42  (0.223)
[1]
Measure Description: The FibroTest® score is used to assess liver fibrosis. Scores range from 0.00 to 1.00, with higher scores indicating a greater degree of fibrosis.
[2]
Measure Analysis Population Description: Participants in Safety Analysis Set with available data were analyzed.
Estimated Glomerular Filtration Rate by the Cockcroft-Gault Formula (eGFR-CG)  
Mean (Standard Deviation)
Unit of measure:  mL/min
Number Analyzed 243 participants 245 participants 488 participants
95.0  (25.58) 93.8  (25.16) 94.4  (25.35)
Hip Bone Mineral Density (BMD) Status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 241 participants 244 participants 485 participants
Normal (T-score ≥ -1.0) 143 124 267
Osteopenia (-2.5 ≤ T-score < -1.0) 89 116 205
Osteoporosis (T-score < -2.5) 9 4 13
[1]
Measure Analysis Population Description: Hip Dual-Energy X-Ray Absorptiometry (DXA) Analysis Set included all participants who were randomized into the study, received at least 1 dose of study drug, and had nonmissing baseline hip BMD values.
Spine BMD Status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 243 participants 245 participants 488 participants
Normal (T-score ≥ -1.0) 125 120 245
Osteopenia (-2.5 ≤ T-score < -1.0) 90 97 187
Osteoporosis (T-score < -2.5) 28 28 56
[1]
Measure Description: Spine DXA Analysis Set included all participants who were randomized into the study, received at least 1 dose of study drug, and had nonmissing baseline spine BMD values.
1.Primary Outcome
Title Percentage of Participants With Hepatitis B Virus (HBV) DNA Levels ≥ 20 IU/mL at Week 48, as Determined by the Modified United States Food and Drug Administration (US FDA)-Defined Snapshot Algorithm
Hide Description

The percentage of participants with HBV DNA ≥ 20 IU/mL at Week 48 was analyzed using the modified US FDA-defined snapshot algorithm, which included participants who:

  1. Had the last available on-treatment HBV DNA ≥ 20 IU/mL in the Week 48 analysis window (from Day 295 to Day 378, inclusive), or
  2. Did not have on-treatment HBV DNA data available in the Week 48 analysis window and

    • Discontinued study drug prior to or in the Week 48 analysis window due to lack of efficacy, or
    • Discontinued study drug prior to or in the Week 48 analysis window due to reason other than lack of efficacy and had the last available on-treatment HBV DNA ≥ 20 IU/mL
Time Frame Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they were randomized.
Arm/Group Title TAF 25 mg TDF 300 mg
Hide Arm/Group Description:
Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TAF 25 mg tablet orally once daily, and placebo to match TDF once daily for up to 53 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.
Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TDF 300 mg tablet orally once daily, and placebo to match TAF once daily for up to 50 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.
Overall Number of Participants Analyzed 243 245
Measure Type: Number
Unit of Measure: percentage of participants
0.4 0.4
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TAF 25 mg, TDF 300 mg
Comments The null hypothesis was that the TAF group is at least 4% worse than the TDF group with respect to the percentage of participants with HBV DNA ≥ 20 IU/mL at Week 48. The alternative hypothesis was that the TAF group is less than 4% worse than the TDF group with respect to the percentage of participants with HBV DNA ≥ 20 IU/mL at Week 48.
Type of Statistical Test Non-Inferiority
Comments Non-inferiority was assessed using a 95% confidence interval (CI) approach, with a non-inferiority margin of 4%.
Method of Estimation Estimation Parameter Difference in the Percentages
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-1.9 to 2.0
Estimation Comments Difference in the percentages of participants between treatment groups and its 95% CI were calculated based on the stratum-adjusted Mantel-Haenszel (MH) percentage, adjusted by baseline age groups (< 50, ≥ 50 years) and baseline HBeAg status strata.
2.Secondary Outcome
Title Percentage of Participants With HBV DNA Levels ≥ 20 IU/mL at Week 96, as Determined by the Modified US FDA-Defined Snapshot Algorithm
Hide Description

The percentage of participants with HBV DNA ≥ 20 IU/mL at Week 96 was analyzed using the modified US FDA-defined snapshot algorithm, which included participants who:

  1. Had the last available on-treatment HBV DNA ≥ 20 IU/mL in the Week 96 analysis window (from Day 589 to Day 840, inclusive), or
  2. Did not have on-treatment HBV DNA data available in the Week 96 analysis window and

    • Discontinued study drug prior to or in the Week 96 analysis window due to lack of efficacy, or
    • Discontinued study drug prior to or in the Week 96 analysis window due to reason other than lack of efficacy and had the last available on-treatment HBV DNA ≥ 20 IU/mL
Time Frame Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set were analyzed. Participants were analyzed according to the treatment to which they were randomized.
Arm/Group Title TAF 25 mg TDF 300 mg
Hide Arm/Group Description:
Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TAF 25 mg tablet orally once daily, and placebo to match TDF once daily for up to 53 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.
Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TDF 300 mg tablet orally once daily, and placebo to match TAF once daily for up to 50 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.
Overall Number of Participants Analyzed 243 245
Measure Type: Number
Unit of Measure: percentage of participants
0.4 0.4
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TAF 25 mg, TDF 300 mg
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments Non-inferiority was assessed using a 95% confidence interval (CI) approach, with a non-inferiority margin of 4%.
Method of Estimation Estimation Parameter Difference in the Percentages
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-1.9 to 1.9
Estimation Comments Difference in the percentage of participants between treatment groups and its 95% CI were calculated based on the stratum-adjusted MH percentage, adjusted by baseline age groups (< 50, ≥ 50 years) and baseline HBeAg status strata.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection TAF 25 mg, TDF 300 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9953
Comments P-value for the superiority tests compared the percentage of each HBV DNA outcome was from CMH tests stratified by baseline age groups and baseline HBeAg status strata.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Participants With HBV DNA Levels < 20 IU/mL at Week 48
Hide Description The percentage of participants with HBV DNA < 20 IU/mL at Week 48 was analyzed, which included participants who have the last available on-treatment HBV DNA, 20 IU/mL in the Week 48 analysis window. Missing=Failure (M = F) approach was used for analysis.
Time Frame Weeks 48
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set were analyzed. Participants were analyzed according to the treatment to which they were randomized.
Arm/Group Title TAF 25 mg TDF 300 mg
Hide Arm/Group Description:
Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TAF 25 mg tablet orally once daily, and placebo to match TDF once daily for up to 53 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.
Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TDF 300 mg tablet orally once daily, and placebo to match TAF once daily for up to 50 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.
Overall Number of Participants Analyzed 243 245
Measure Type: Number
Unit of Measure: percentage of participants
96.3 96.3
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TAF 25 mg, TDF 300 mg
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments Non-inferiority was assessed using a 95% CI approach, with a non-inferiority margin of 4%.
Method of Estimation Estimation Parameter Difference in the Percentages
Estimated Value -0.0
Confidence Interval (2-Sided) 95%
-3.7 to 3.7
Estimation Comments Difference in the percentage of participants between treatment groups and its 95% CI were calculated based on the stratum-adjusted MH percentage, adjusted by baseline age groups (< 50, ≥ 50 years) and baseline HBeAg status strata.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection TAF 25 mg, TDF 300 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.98
Comments P-value for the superiority tests compared the percentage of each HBV DNA outcome was from CMH tests stratified by baseline age groups and baseline HBeAg status strata.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
4.Secondary Outcome
Title Percentage of Participants With HBV DNA Levels < 20 IU/mL (Target Detected/Not Detected) at Week 48
Hide Description The percentage of participants with HBV DNA < 20 IU/mL at Week 48 was analyzed, which included participants who have the last available on-treatment HBV DNA, 20 IU/mL in the Week 48 analysis window. The method of determining percentage of participants with HBV DNA levels <20 IU/mL (target detected/not detected i.e., lower limit of detection) at Week 48, was handled by M = F, and Missing=Excluded (M = E) approaches.
Time Frame Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set were analyzed. Participants were analyzed according to the treatment to which they were randomized.
Arm/Group Title TAF 25 mg TDF 300 mg
Hide Arm/Group Description:
Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TAF 25 mg tablet orally once daily, and placebo to match TDF once daily for up to 53 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.
Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TDF 300 mg tablet orally once daily, and placebo to match TAF once daily for up to 50 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.
Overall Number of Participants Analyzed 243 245
Measure Type: Number
Unit of Measure: percentage of participants
M = F Approach: < 20 IU/mL Target Not Detected 63.4 62.0
M = F Approach: < 20 IU/mL Target Detected 32.9 34.3
M = E Approach: < 20 IU/mL Target Not Detected 65.5 64.1
M = E Approach: < 20 IU/mL Target Detected 34.0 35.4
5.Secondary Outcome
Title Percentage of Participants With HBV DNA Levels < 20 IU/mL at Week 96
Hide Description The percentage of participants with HBV DNA < 20 IU/mL at Week 96 was analyzed, which included participants who have the last available on-treatment HBV DNA, 20 IU/mL in the Week 96 analysis window. M = F approach was used for analysis.
Time Frame Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set were analyzed. Participants were analyzed according to the treatment to which they were randomized.
Arm/Group Title TAF 25 mg TDF 300 mg
Hide Arm/Group Description:
Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TAF 25 mg tablet orally once daily, and placebo to match TDF once daily for up to 53 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.
Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TDF 300 mg tablet orally once daily, and placebo to match TAF once daily for up to 50 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.
Overall Number of Participants Analyzed 243 245
Measure Type: Number
Unit of Measure: percentage of participants
94.7 93.9
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TAF 25 mg, TDF 300 mg
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments Non-inferiority was assessed using a 95% confidence interval (CI) approach, with a non-inferiority margin of 4%.
Method of Estimation Estimation Parameter Difference in the Percentages
Estimated Value 0.9
Confidence Interval (2-Sided) 95.0%
-3.5 to 5.2
Estimation Comments Difference in the percentages of participants between treatment groups and its 95% CI were calculated based on the stratum-adjusted MH percentage, adjusted by baseline age groups (< 50, ≥ 50 years) and baseline HBeAg status strata.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection TAF 25 mg, TDF 300 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6863
Comments P-value for the superiority tests compared the percentage of each HBV DNA outcome was from CMH tests stratified by baseline age groups and baseline HBeAg status strata.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
6.Secondary Outcome
Title Percentage of Participants With HBV DNA Levels < 20 IU/mL (Target Detected/Not Detected) at Week 96
Hide Description The percentage of participants with HBV DNA < 20 IU/mL at Week 96 was analyzed, which included participants who have the last available on-treatment HBV DNA, 20 IU/mL in the Week 96 analysis window. The method of determining percentage of participants with HBV DNA levels <20 IU/mL (target detected/not detected i.e., lower limit of detection) at Week 96, was handled by Missing=Failure (M = F), and Missing=Excluded (M = E) approaches.
Time Frame Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set were analyzed. Participants were analyzed according to the treatment to which they were randomized.
Arm/Group Title TAF 25 mg TDF 300 mg
Hide Arm/Group Description:
Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TAF 25 mg tablet orally once daily, and placebo to match TDF once daily for up to 53 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.
Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TDF 300 mg tablet orally once daily, and placebo to match TAF once daily for up to 50 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.
Overall Number of Participants Analyzed 243 245
Measure Type: Number
Unit of Measure: percentage of participants
M = F Approach: < 20 IU/mL Target Not Detected 65.8 66.1
M = F Approach: < 20 IU/mL Target Detected 28.8 27.8
M = E Approach: < 20 IU/mL Target Not Detected 69.3 70.1
M = E Approach: < 20 IU/mL Target Detected 30.3 29.4
7.Secondary Outcome
Title Percentage of Participants With Hepatitis B e Antigen (HBeAg) Loss at Week 48
Hide Description HBeAg loss was defined as HBeAg changing from positive at baseline to negative at a postbaseline visit with baseline HBeAb negative or missing. The M = F approach was used for this analysis.
Time Frame Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
The Serologically Evaluable Full Analysis Set for HBeAg loss and seroconversion included all participants who were randomized and received at least 1 dose of study drug and were HBeAg-positive and HBeAb-negative or had a missing value at baseline. Participants were analyzed according to the treatment to which they were randomized.
Arm/Group Title TAF 25 mg TDF 300 mg
Hide Arm/Group Description:
Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TAF 25 mg tablet orally once daily, and placebo to match TDF once daily for up to 53 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.
Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TDF 300 mg tablet orally once daily, and placebo to match TAF once daily for up to 50 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.
Overall Number of Participants Analyzed 78 78
Measure Type: Number
Unit of Measure: percentage of participants
7.7 6.4
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TAF 25 mg, TDF 300 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7258
Comments P-value was from the CMH test, stratified by baseline age groups (< 50, ≥ 50 years).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in the Percentages
Estimated Value 1.4
Confidence Interval (2-Sided) 95%
-7.2 to 10.1
Estimation Comments Difference in the percentage of participants between the treatment groups and its 95% CI were calculated based on the stratum-adjusted MH percentage, adjusted by baseline age groups.
8.Secondary Outcome
Title Percentage of Participants With HBeAg Seroconversion at Week 48
Hide Description HBeAg seroconversion was defined as HBeAg loss and HBeAb changing from negative/missing at baseline to positive at a postbaseline visit. The M = F approach was used for this analysis.
Time Frame Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Serologically Evaluable Full Analysis Set for HBeAg loss and seroconversion were analyzed. Participants were analyzed according to the treatment to which they were randomized.
Arm/Group Title TAF 25 mg TDF 300 mg
Hide Arm/Group Description:
Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TAF 25 mg tablet orally once daily, and placebo to match TDF once daily for up to 53 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.
Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TDF 300 mg tablet orally once daily, and placebo to match TAF once daily for up to 50 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.
Overall Number of Participants Analyzed 78 78
Measure Type: Number
Unit of Measure: percentage of participants
2.6 0.0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TAF 25 mg, TDF 300 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1348
Comments P-value was from the CMH test, stratified by baseline age groups (< 50, ≥ 50 years).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in the Percentages
Estimated Value 2.7
Confidence Interval (2-Sided) 95%
-2.3 to 7.7
Estimation Comments Difference in the percentage of participants between the treatment groups and its 95% CI were calculated based on the stratum-adjusted MH percentage, adjusted by baseline age groups.
9.Secondary Outcome
Title Percentage of Participants With HBeAg Loss at Week 96
Hide Description HBeAg loss was defined as HBeAg changing from positive at baseline to negative at a postbaseline visit with baseline HBeAb negative or missing. The M = F approach was used for this analysis.
Time Frame Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Serologically Evaluable Full Analysis Set for HBeAg loss and seroconversion were analyzed. Participants were analyzed according to the treatment to which they were randomized.
Arm/Group Title TAF 25 mg TDF 300 mg
Hide Arm/Group Description:
Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TAF 25 mg tablet orally once daily, and placebo to match TDF once daily for up to 53 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.
Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TDF 300 mg tablet orally once daily, and placebo to match TAF once daily for up to 50 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.
Overall Number of Participants Analyzed 78 78
Measure Type: Number
Unit of Measure: percentage of participants
17.9 9.0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TAF 25 mg, TDF 300 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1005
Comments P-value was from CMH tests stratified by baseline age groups (< 50, ≥ 50 years).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in the Percentages
Estimated Value 9.0
Confidence Interval (2-Sided) 95%
-2.0 to 20.1
Estimation Comments Difference in the percentages of participants between treatment groups and its 95% CI were calculated based on the stratum-adjusted MH percentage, adjusted by baseline age groups.
10.Secondary Outcome
Title Percentage of Participants With HBeAg Seroconversion at Week 96
Hide Description HBeAg seroconversion was defined as HBeAg loss and HBeAb changing from negative/missing at baseline to positive at a postbaseline visit. The M = F approach was used for this analysis.
Time Frame Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Serologically Evaluable Full Analysis Set for HBeAg loss and seroconversion were analyzed. Participants were analyzed according to the treatment to which they were randomized.
Arm/Group Title TAF 25 mg TDF 300 mg
Hide Arm/Group Description:
Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TAF 25 mg tablet orally once daily, and placebo to match TDF once daily for up to 53 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.
Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TDF 300 mg tablet orally once daily, and placebo to match TAF once daily for up to 50 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.
Overall Number of Participants Analyzed 78 78
Measure Type: Number
Unit of Measure: percentage of participants
5.1 2.6
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TAF 25 mg, TDF 300 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4154
Comments P-value was from CMH tests stratified by baseline age groups (< 50, ≥ 50 years).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in the Percentages
Estimated Value 2.5
Confidence Interval (2-Sided) 95%
-4.5 to 9.5
Estimation Comments Difference in the percentages of participants between treatment groups and its 95% CI were calculated based on the stratum-adjusted MH percentage, adjusted by baseline age groups.
11.Secondary Outcome
Title Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Week 48
Hide Description HBsAg loss was defined as HBsAg changing from positive at baseline to negative at a postbaseline visit with baseline HBsAb negative or missing. The M = F approach was used for this analysis.
Time Frame Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
The Serologically Evaluable Full Analysis Set for HBsAg loss and seroconversion included all participants who were randomized and received at least 1 dose of study drug and were HBsAg-positive and HBsAb-negative or had a missing value at baseline. Participants were analyzed according to the treatment to which they were randomized.
Arm/Group Title TAF 25 mg TDF 300 mg
Hide Arm/Group Description:
Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TAF 25 mg tablet orally once daily, and placebo to match TDF once daily for up to 53 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.
Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TDF 300 mg tablet orally once daily, and placebo to match TAF once daily for up to 50 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.
Overall Number of Participants Analyzed 243 245
Measure Type: Number
Unit of Measure: percentage of participants
0.0 2.0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TAF 25 mg, TDF 300 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0281
Comments P-value was from the CMH test, stratified by baseline age groups (< 50, ≥ 50 years) and baseline HBeAg status strata.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in the Percentages
Estimated Value -2.0
Confidence Interval (2-Sided) 95%
-4.4 to 0.3
Estimation Comments Difference in the percentage of participants between the treatment groups and its 95% CI were calculated based on the stratum-adjusted MH percentage, adjusted by baseline age groups (< 50, ≥ 50 years) and baseline HBeAg status strata.
12.Secondary Outcome
Title Percentage of Participants With HBsAg Seroconversion at Week 48
Hide Description HBsAg seroconversion was defined as HBsAg loss and HBsAb changes from negative/missing at baseline to positive at a postbaseline visit. The M = F approach was used for this analysis.
Time Frame Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Serologically Evaluable Full Analysis Set for HBsAg loss and seroconversion were analyzed. Participants were analyzed according to the treatment to which they were randomized.
Arm/Group Title TAF 25 mg TDF 300 mg
Hide Arm/Group Description:
Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TAF 25 mg tablet orally once daily, and placebo to match TDF once daily for up to 53 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.
Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TDF 300 mg tablet orally once daily, and placebo to match TAF once daily for up to 50 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.
Overall Number of Participants Analyzed 243 245
Measure Type: Number
Unit of Measure: percentage of participants
0.0 0.0
13.Secondary Outcome
Title Percentage of Participants With HBsAg Loss at Week 96
Hide Description HBsAg loss was defined as HBsAg changing from positive at baseline to negative at a postbaseline visit with baseline HBsAb negative or missing. The M = F approach was used for this analysis.
Time Frame Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Serologically Evaluable Full Analysis Set for HBsAg loss and seroconversion were analyzed. Participants were analyzed according to the treatment to which they were randomized.
Arm/Group Title TAF 25 mg TDF 300 mg
Hide Arm/Group Description:
Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TAF 25 mg tablet orally once daily, and placebo to match TDF once daily for up to 53 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.
Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TDF 300 mg tablet orally once daily, and placebo to match TAF once daily for up to 50 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.
Overall Number of Participants Analyzed 243 245
Measure Type: Number
Unit of Measure: percentage of participants
1.6 2.4
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TAF 25 mg, TDF 300 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5373
Comments P-value was from CMH tests stratified by baseline age groups (< 50, ≥ 50 years) and baseline HBeAg status strata.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in the Percentages
Estimated Value -0.8
Confidence Interval (2-Sided) 95%
-3.7 to 2.1
Estimation Comments Difference in the percentages of participants between treatment groups and its 95% CI were calculated based on the stratum-adjusted MH percentage, adjusted by baseline age groups (< 50, ≥ 50 years) and baseline HBeAg status strata.
14.Secondary Outcome
Title Percentage of Participants With HBsAg Seroconversion at Week 96
Hide Description HBsAg seroconversion was defined as HBsAg loss and HBsAb changes from negative/missing at baseline to positive at a postbaseline visit. The M = F approach was used for this analysis.
Time Frame Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Serologically Evaluable Full Analysis Set for HBsAg loss and seroconversion were analyzed. Participants were analyzed according to the treatment to which they were randomized.
Arm/Group Title TAF 25 mg TDF 300 mg
Hide Arm/Group Description:
Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TAF 25 mg tablet orally once daily, and placebo to match TDF once daily for up to 53 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.
Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TDF 300 mg tablet orally once daily, and placebo to match TAF once daily for up to 50 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.
Overall Number of Participants Analyzed 243 245
Measure Type: Number
Unit of Measure: percentage of participants
0.8 0.4
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TAF 25 mg, TDF 300 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5845
Comments P-value was from CMH tests stratified by baseline age groups (< 50, ≥ 50 years) and baseline HBeAg status strata.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in the Percentages
Estimated Value 0.4
Confidence Interval (2-Sided) 95%
-1.7 to 2.5
Estimation Comments Difference in the percentages of participants between treatment groups and its 95% CI were calculated based on the stratum-adjusted MH percentage, adjusted by baseline age groups (< 50, ≥ 50 years) and baseline HBeAg status strata.
15.Secondary Outcome
Title Percentage of Participants With Normal Alanine Aminotransferase (ALT) at Week 48 (by Central Laboratory and the American Association for the Study of Liver Diseases [AASLD] Criteria)
Hide Description Central laboratory ULN for ALT were as follows: ≤ 43 U/L for males aged 18 to < 69 years and ≤ 35 U/L for males aged ≥ 69 years; ≤ 34 U/L for females aged 18 to < 69 years and ≤ 32 U/L for females aged ≥ 69 years. The ULN for ALT using the 2018 AASLD normal range was 25 U/L for females and 35 U/L for males. M = F approach was used for analysis.
Time Frame Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set were analyzed. Participants were analyzed according to the treatment to which they were randomized.
Arm/Group Title TAF 25 mg TDF 300 mg
Hide Arm/Group Description:
Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TAF 25 mg tablet orally once daily, and placebo to match TDF once daily for up to 53 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.
Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TDF 300 mg tablet orally once daily, and placebo to match TAF once daily for up to 50 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.
Overall Number of Participants Analyzed 243 245
Measure Type: Number
Unit of Measure: percentage of participants
Central Laboratory Criteria 89.3 84.9
AASLD Criteria 79.0 75.1
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TAF 25 mg, TDF 300 mg
Comments Central Laboratory Criteria
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1405
Comments P-value was from the CMH test, stratified by baseline age groups (< 50, ≥ 50 years) and baseline HBeAg status strata.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in the Percentages
Estimated Value 4.5
Confidence Interval (2-Sided) 95%
-1.6 to 10.6
Estimation Comments Difference in the percentage of participants between the treatment groups and its 95% CI were calculated based on the stratum-adjusted MH percentage, adjusted by baseline age groups (< 50, ≥ 50 years) and baseline HBeAg status strata.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection TAF 25 mg, TDF 300 mg
Comments AASLD Criteria
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3133
Comments P-value was from the CMH test, stratified by baseline age groups (< 50, ≥ 50 years) and baseline HBeAg status strata.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in the Percentages
Estimated Value 3.8
Confidence Interval (2-Sided) 95%
-3.7 to 11.4
Estimation Comments Difference in the percentage of participants between the treatment groups and its 95% CI were calculated based on the stratum-adjusted MH percentage, adjusted by baseline age groups (< 50, ≥ 50 years) and baseline HBeAg status strata.
16.Secondary Outcome
Title Percentage of Participants With Normalized ALT at Week 48 (by Central Laboratory and AASLD Criteria)
Hide Description ALT normalization was defined as an ALT value that changed from above the normal range at baseline to within the normal range at the given postbaseline visit. Central laboratory ULN for ALT were as follows: ≤ 43 U/L for males aged 18 to < 69 years and ≤ 35 U/L for males aged ≥ 69 years; ≤ 34 U/L for females aged 18 to < 69 years and ≤ 32 U/L for females aged ≥ 69 years. The ULN for ALT using the 2018 AASLD normal range was 25 U/L for females and 35 U/L for males. M = F approach was used for analysis.
Time Frame Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with Baseline ALT > ULN were analyzed. Participants were analyzed according to the treatment to which they were randomized.
Arm/Group Title TAF 25 mg TDF 300 mg
Hide Arm/Group Description:
Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TAF 25 mg tablet orally once daily, and placebo to match TDF once daily for up to 53 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.
Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TDF 300 mg tablet orally once daily, and placebo to match TAF once daily for up to 50 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.
Overall Number of Participants Analyzed 52 53
Measure Type: Number
Unit of Measure: percentage of participants
Central Laboratory Criteria Number Analyzed 32 participants 19 participants
50.0 36.8
AASLD Criteria Number Analyzed 52 participants 53 participants
50.0 26.4
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TAF 25 mg, TDF 300 mg
Comments Central Laboratory criteria
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3381
Comments P-value was from the CMH test, stratified by baseline age groups (< 50, ≥ 50 years) and baseline HBeAg status strata.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in the Percentages
Estimated Value 14.1
Confidence Interval (2-Sided) 95%
-16.4 to 44.6
Estimation Comments Difference in the percentage of participants between the treatment groups and its 95% CI were calculated based on the stratum-adjusted MH percentage, adjusted by baseline age groups (< 50, ≥ 50 years) and baseline HBeAg status strata.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection TAF 25 mg, TDF 300 mg
Comments AASLD Criteria
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0136
Comments P-value was from the CMH test, stratified by baseline age groups (< 50, ≥ 50 years) and baseline HBeAg status strata.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in the Percentages
Estimated Value 23.8
Confidence Interval (2-Sided) 95%
5.3 to 42.3
Estimation Comments Difference in the percentage of participants between the treatment groups and its 95% CI were calculated based on the stratum-adjusted MH percentage, adjusted by baseline age groups (< 50, ≥ 50 years) and baseline HBeAg status strata.
17.Secondary Outcome
Title Percentage of Participants With Normal ALT at Week 96 (by Central Laboratory and the AASLD Criteria)
Hide Description Central laboratory ULN for ALT were as follows: ≤ 43 U/L for males aged 18 to < 69 years and ≤ 35 U/L for males aged ≥ 69 years; ≤ 34 U/L for females aged 18 to < 69 years and ≤ 32 U/L for females aged ≥ 69 years. The ULN for ALT using the 2018 AASLD normal range was 25 U/L for females and 35 U/L for males. M = F approach was used for analysis.
Time Frame Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set were analyzed. Participants were analyzed according to the treatment to which they were randomized.
Arm/Group Title TAF 25 mg TDF 300 mg
Hide Arm/Group Description:
Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TAF 25 mg tablet orally once daily, and placebo to match TDF once daily for up to 53 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.
Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TDF 300 mg tablet orally once daily, and placebo to match TAF once daily for up to 50 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.
Overall Number of Participants Analyzed 243 245
Measure Type: Number
Unit of Measure: percentage of participants
Central Laboratory Criteria 88.5 91.4
AASLD Criteria 80.7 86.5
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TAF 25 mg, TDF 300 mg
Comments Central Laboratory Criteria
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2803
Comments P-value was from CMH tests stratified by baseline age groups (< 50, ≥ 50 years) and baseline HBeAg status strata.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in the Percentages
Estimated Value -2.9
Confidence Interval (2-Sided) 95%
-8.4 to 2.6
Estimation Comments Difference in the percentages of participants between treatment groups and its 95% CI were calculated based on the stratum-adjusted MH percentage, adjusted by baseline age groups (< 50, ≥ 50 years) and baseline HBeAg status strata.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection TAF 25 mg, TDF 300 mg
Comments AASLD Criteria
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0788
Comments P-value was from CMH tests stratified by baseline age groups (< 50, ≥ 50 years) and baseline HBeAg status strata.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in the Percentages
Estimated Value -5.9
Confidence Interval (2-Sided) 95%
-12.6 to 0.7
Estimation Comments Difference in the percentages of participants between treatment groups and its 95% CI were calculated based on the stratum-adjusted MH percentage, adjusted by baseline age groups (< 50, ≥ 50 years) and baseline HBeAg status strata.
18.Secondary Outcome
Title Percentage of Participants With Normalized ALT at Week 96 (by Central Laboratory and AASLD Criteria)
Hide Description ALT normalization was defined as an ALT value that changed from above the normal range at baseline to within the normal range at the given postbaseline visit. Central laboratory ULN for ALT were as follows: ≤ 43 U/L for males aged 18 to < 69 years and ≤ 35 U/L for males aged ≥ 69 years; ≤ 34 U/L for females aged 18 to < 69 years and ≤ 32 U/L for females aged ≥ 69 years. The ULN for ALT using the 2018 AASLD normal range was 25 U/L for females and 35 U/L for males. M = F approach was used for analysis.
Time Frame Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with Baseline ALT > ULN were analyzed. Participants were analyzed according to the treatment to which they were randomized.
Arm/Group Title TAF 25 mg TDF 300 mg
Hide Arm/Group Description:
Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TAF 25 mg tablet orally once daily, and placebo to match TDF once daily for up to 53 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.
Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TDF 300 mg tablet orally once daily, and placebo to match TAF once daily for up to 50 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.
Overall Number of Participants Analyzed 52 53
Measure Type: Number
Unit of Measure: percentage of participants
Central Laboratory Criteria Number Analyzed 32 participants 19 participants
56.3 78.9
AASLD Criteria Number Analyzed 52 participants 53 participants
55.8 73.6
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TAF 25 mg, TDF 300 mg
Comments Central Laboratory Criteria
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0880
Comments P-value was from CMH tests stratified by baseline age groups (< 50, ≥ 50 years) and baseline HBeAg status strata.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in the Percentages
Estimated Value -23.9
Confidence Interval (2-Sided) 95%
-51.2 to 3.4
Estimation Comments Difference in the percentages of participants between treatment groups and its 95% CI were calculated based on the stratum-adjusted MH percentage, adjusted by baseline age groups (< 50, ≥ 50 years) and baseline HBeAg status strata.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection TAF 25 mg, TDF 300 mg
Comments AASLD Criteria
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0510
Comments P-value was from CMH tests stratified by baseline age groups (< 50, ≥ 50 years) and baseline HBeAg status strata.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in the Percentages
Estimated Value -18.6
Confidence Interval (2-Sided) 95.0%
-37.4 to 0.2
Estimation Comments Difference in the percentages of participants between treatment groups and its 95% CI were calculated based on the stratum-adjusted MH percentage, adjusted by baseline age groups (< 50, ≥ 50 years) and baseline HBeAg status strata.
19.Secondary Outcome
Title Change From Baseline in FibroTest® Score at Week 48
Hide Description The FibroTest score is used to assess liver fibrosis. Scores range from 0.00 to 1.00, with higher scores indicating a greater degree of fibrosis. Change from baseline was calculated as the value at Week 48 minus the value at Baseline.
Time Frame Baseline; Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed. Participants were analyzed according to the treatment to which they were randomized.
Arm/Group Title TAF 25 mg TDF 300 mg
Hide Arm/Group Description:
Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TAF 25 mg tablet orally once daily, and placebo to match TDF once daily for up to 53 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.
Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TDF 300 mg tablet orally once daily, and placebo to match TAF once daily for up to 50 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.
Overall Number of Participants Analyzed 234 236
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-0.02  (0.082) -0.01  (0.082)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TAF 25 mg, TDF 300 mg
Comments P-value, difference in least squares mean (LSM), and its 95% CI were derived from analysis of variance (ANOVA) model with baseline age groups (< 50, ≥ 50 years), baseline HBeAg status, and treatment group as fixed effects in the model.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0186
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LSM
Estimated Value -0.02
Confidence Interval (2-Sided) 95%
-0.03 to 0.00
Estimation Comments [Not Specified]
20.Secondary Outcome
Title Change From Baseline in FibroTest® Score at Week 96
Hide Description The FibroTest score is used to assess liver fibrosis. Scores range from 0.00 to 1.00, with higher scores indicating a greater degree of fibrosis. Change from baseline was calculated as the value at Week 96 minus the value at Baseline.
Time Frame Baseline; Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed. Participants were analyzed according to the treatment to which they were randomized.
Arm/Group Title TAF 25 mg TDF 300 mg
Hide Arm/Group Description:
Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TAF 25 mg tablet orally once daily, and placebo to match TDF once daily for up to 53 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.
Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TDF 300 mg tablet orally once daily, and placebo to match TAF once daily for up to 50 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.
Overall Number of Participants Analyzed 231 232
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-0.03  (0.080) -0.03  (0.090)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TAF 25 mg, TDF 300 mg
Comments P-value, difference in LSM, and its 95% CI were from ANOVA with baseline age groups (<50, ≥ 50 years), baseline HBeAg status, and treatment group as fixed effects in the model.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6956
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LSM
Estimated Value 0.00
Confidence Interval (2-Sided) 95%
-0.02 to 0.01
Estimation Comments [Not Specified]
21.Secondary Outcome
Title Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48
Hide Description Percent Change = Change from baseline at a postbaseline visit/baseline * 100%.
Time Frame Baseline; Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Hip DXA Analysis Set (included all participants who were randomized into the study, received at least 1 dose of study drug, and had non-missing baseline hip BMD values) with available data were analysed. Participants were analyzed according to the treatment they actually received.
Arm/Group Title TAF 25 mg TDF 300 mg
Hide Arm/Group Description:
Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TAF 25 mg tablet orally once daily, and placebo to match TDF once daily for up to 53 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.
Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TDF 300 mg tablet orally once daily, and placebo to match TAF once daily for up to 50 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.
Overall Number of Participants Analyzed 225 226
Mean (Standard Deviation)
Unit of Measure: percent change
0.659  (2.0818) -0.507  (1.9051)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TAF 25 mg, TDF 300 mg
Comments P-value, difference in LSM, and its 95% CI were from ANOVA with baseline age groups (<50, ≥ 50 years), baseline HBeAg status, and treatment group as fixed effects in the model.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LSM
Estimated Value 1.167
Confidence Interval (2-Sided) 95%
0.797 to 1.536
Estimation Comments [Not Specified]
22.Secondary Outcome
Title Percent Change From Baseline in Hip BMD at Week 96
Hide Description Percent Change = Change from baseline at a postbaseline visit/baseline * 100%.
Time Frame Baseline; Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Hip DXA Analysis Set with available data were analyzed. Participants were analyzed according to the treatment they actually received.
Arm/Group Title TAF 25 mg TDF 300 mg
Hide Arm/Group Description:
Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TAF 25 mg tablet orally once daily, and placebo to match TDF once daily for up to 53 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.
Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TDF 300 mg tablet orally once daily, and placebo to match TAF once daily for up to 50 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.
Overall Number of Participants Analyzed 227 224
Mean (Standard Deviation)
Unit of Measure: percent change
1.157  (2.8501) 0.180  (2.6813)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TAF 25 mg, TDF 300 mg
Comments P-value, difference in LSM, and its 95% CI were from ANOVA with baseline age groups (<50, ≥ 50 years), baseline HBeAg status, and treatment group as fixed effects in the model.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0002
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LSM
Estimated Value 0.977
Confidence Interval (2-Sided) 95%
0.465 to 1.490
Estimation Comments [Not Specified]
23.Secondary Outcome
Title Percent Change From Baseline in Spine BMD at Week 48
Hide Description Percent Change = Change from baseline at a postbaseline visit/baseline * 100%.
Time Frame Baseline; Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Spine DXA Analysis Set (included all participants who were randomized into the study, received at least 1 dose of study drug, and had non-missing baseline spine BMD values) with available data were analysed. Participants were analyzed according to the treatment they actually received.
Arm/Group Title TAF 25 mg TDF 300 mg
Hide Arm/Group Description:
Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TAF 25 mg tablet orally once daily, and placebo to match TDF once daily for up to 53 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.
Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TDF 300 mg tablet orally once daily, and placebo to match TAF once daily for up to 50 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.
Overall Number of Participants Analyzed 227 229
Mean (Standard Deviation)
Unit of Measure: percent change
1.743  (3.4674) -0.138  (3.1072)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TAF 25 mg, TDF 300 mg
Comments P-value, difference in LSM, and its 95% CI were from ANOVA with baseline age groups (<50, ≥ 50 years), baseline HBeAg status, and treatment group as fixed effects in the model.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LSM
Estimated Value 1.881
Confidence Interval (2-Sided) 95%
1.275 to 2.486
Estimation Comments [Not Specified]
24.Secondary Outcome
Title Percent Change From Baseline in Spine BMD at Week 96
Hide Description Percent Change = Change from baseline at a postbaseline visit/baseline * 100%.
Time Frame Baseline; Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Spine DXA Analysis Set with available data were analyzed. Participants were analyzed according to the treatment they actually received.
Arm/Group Title TAF 25 mg TDF 300 mg
Hide Arm/Group Description:
Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TAF 25 mg tablet orally once daily, and placebo to match TDF once daily for up to 53 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.
Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TDF 300 mg tablet orally once daily, and placebo to match TAF once daily for up to 50 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.
Overall Number of Participants Analyzed 229 227
Mean (Standard Deviation)
Unit of Measure: percent change
2.330  (3.9301) 1.726  (3.8224)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TAF 25 mg, TDF 300 mg
Comments P-value, difference in LSM, and its 95% CI were from ANOVA with baseline age groups (<50, ≥ 50 years), baseline HBeAg status, and treatment group as fixed effects in the model.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0970
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LSM
Estimated Value 0.604
Confidence Interval (2-Sided) 95%
-0.110 to 1.317
Estimation Comments [Not Specified]
25.Secondary Outcome
Title Change From Baseline in Estimated Glomerular Filtration Rate Calculated Using the Cockcroft-Gault Equation (eGFR-CG) at Week 48
Hide Description

Cockcroft-Gault formula is as follows:

  • For men: Glomerular filtration rate (GFR) = (140 - age in years) * body weight in kg / 72 * serum creatinine (mg/dL)
  • For women: GFR = 0.85 * (140 - age in years) * body weight in kg / 72 * serum creatinine (mg/dL).

Change from baseline was calculated as the value at Week 48 minus the value at Baseline.

Time Frame Baseline; Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Safety Analysis Set (included all randomized participants who received at least 1 dose of study drug) with available data were analyzed. Participants were analyzed according to the treatment they actually received.
Arm/Group Title TAF 25 mg TDF 300 mg
Hide Arm/Group Description:
Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TAF 25 mg tablet orally once daily, and placebo to match TDF once daily for up to 53 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.
Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TDF 300 mg tablet orally once daily, and placebo to match TAF once daily for up to 50 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.
Overall Number of Participants Analyzed 234 237
Median (Inter-Quartile Range)
Unit of Measure: mL/min
2.240
(-3.957 to 7.704)
-1.722
(-7.020 to 2.634)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TAF 25 mg, TDF 300 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments P-values were from the 2-sided Wilcoxon rank sum test to compare the 2 treatment groups.
Method Wilcoxon rank sum test
Comments [Not Specified]
26.Secondary Outcome
Title Change From Baseline in eGFR-CG at Week 96
Hide Description

Cockcroft-Gault formula is as follows:

  • For men: Glomerular filtration rate (GFR) = (140 - age in years) * body weight in kg / 72 * serum creatinine (mg/dL)
  • For women: GFR = 0.85 * (140 - age in years) * body weight in kg / 72 * serum creatinine (mg/dL).

Change from baseline was calculated as the value at Week 96 minus the value at Baseline.

Time Frame Baseline; Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Safety Analysis Set with available data were analyzed. Participants were analyzed according to the treatment they actually received.
Arm/Group Title TAF 25 mg TDF 300 mg
Hide Arm/Group Description:
Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TAF 25 mg tablet orally once daily, and placebo to match TDF once daily for up to 53 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.
Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TDF 300 mg tablet orally once daily, and placebo to match TAF once daily for up to 50 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.
Overall Number of Participants Analyzed 232 232
Median (Inter-Quartile Range)
Unit of Measure: mL/min
1.626
(-4.580 to 6.952)
0.544
(-5.227 to 7.678)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TAF 25 mg, TDF 300 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7535
Comments P-values were from the 2-sided Wilcoxon rank sum test to compare the 2 treatment groups.
Method Wilcoxon rank sum test
Comments [Not Specified]
Time Frame All-Cause Mortality: First dose date up to 161 weeks (up to approximately 3 years); Adverse Events: First dose date up to the last dose (maximum: 105 weeks) plus 3 days
Adverse Event Reporting Description The Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
 
Arm/Group Title TAF 25 mg TDF 300 mg OLE TAF 25 mg From TAF 25 mg OLE TAF 25 mg From TDF 300 mg
Hide Arm/Group Description Adverse events reported in this group occurred during the DB phase. Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TAF 25 mg tablet orally once daily, and placebo to match TDF once daily for up to 53 weeks in the DB phase. Adverse events reported in this group occurred during the DB phase. Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TDF 300 mg tablet orally once daily, and placebo to match TAF once daily for up to 50 weeks in the DB phase. Adverse events reported in this group occurred during the OLE phase. Participants who completed TAF treatment in the DB phase and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks. Adverse events reported in this group occurred during the OLE phase. Participants who completed TDF treatment in the DB phase and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.
All-Cause Mortality
TAF 25 mg TDF 300 mg OLE TAF 25 mg From TAF 25 mg OLE TAF 25 mg From TDF 300 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/243 (0.00%)   0/245 (0.00%)   0/235 (0.00%)   1/237 (0.42%) 
Hide Serious Adverse Events
TAF 25 mg TDF 300 mg OLE TAF 25 mg From TAF 25 mg OLE TAF 25 mg From TDF 300 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   11/243 (4.53%)   3/245 (1.22%)   8/235 (3.40%)   5/237 (2.11%) 
Cardiac disorders         
Acute myocardial infarction  1  0/243 (0.00%)  0/245 (0.00%)  0/235 (0.00%)  1/237 (0.42%) 
Angina pectoris  1  1/243 (0.41%)  0/245 (0.00%)  0/235 (0.00%)  0/237 (0.00%) 
Atrial fibrillation  1  0/243 (0.00%)  0/245 (0.00%)  0/235 (0.00%)  1/237 (0.42%) 
Cardiac arrest  1  0/243 (0.00%)  0/245 (0.00%)  0/235 (0.00%)  1/237 (0.42%) 
Gastrointestinal disorders         
Pancreatic mass  1  0/243 (0.00%)  0/245 (0.00%)  1/235 (0.43%)  0/237 (0.00%) 
Pancreatitis  1  1/243 (0.41%)  0/245 (0.00%)  0/235 (0.00%)  0/237 (0.00%) 
Immune system disorders         
Anaphylactic reaction  1  0/243 (0.00%)  0/245 (0.00%)  1/235 (0.43%)  0/237 (0.00%) 
Infections and infestations         
Herpes zoster  1  0/243 (0.00%)  1/245 (0.41%)  0/235 (0.00%)  0/237 (0.00%) 
Necrotising fasciitis  1  0/243 (0.00%)  0/245 (0.00%)  1/235 (0.43%)  0/237 (0.00%) 
Pneumonia necrotising  1  0/243 (0.00%)  0/245 (0.00%)  0/235 (0.00%)  1/237 (0.42%) 
Injury, poisoning and procedural complications         
Muscle rupture  1  1/243 (0.41%)  0/245 (0.00%)  0/235 (0.00%)  0/237 (0.00%) 
Tendon injury  1  1/243 (0.41%)  0/245 (0.00%)  0/235 (0.00%)  0/237 (0.00%) 
Wrist fracture  1  1/243 (0.41%)  0/245 (0.00%)  0/235 (0.00%)  0/237 (0.00%) 
Musculoskeletal and connective tissue disorders         
Back pain  1  0/243 (0.00%)  0/245 (0.00%)  1/235 (0.43%)  0/237 (0.00%) 
Rotator cuff syndrome  1  1/243 (0.41%)  0/245 (0.00%)  0/235 (0.00%)  0/237 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Breast cancer  1  1/243 (0.41%)  0/245 (0.00%)  0/235 (0.00%)  0/237 (0.00%) 
Hepatocellular carcinoma  1  1/243 (0.41%)  1/245 (0.41%)  2/235 (0.85%)  0/237 (0.00%) 
Lipoma  1  1/243 (0.41%)  0/245 (0.00%)  0/235 (0.00%)  0/237 (0.00%) 
Lung squamous cell carcinoma stage II  1  0/243 (0.00%)  0/245 (0.00%)  1/235 (0.43%)  0/237 (0.00%) 
Testicular neoplasm  1  0/243 (0.00%)  0/245 (0.00%)  0/235 (0.00%)  1/237 (0.42%) 
Psychiatric disorders         
Bipolar I disorder  1  1/243 (0.41%)  0/245 (0.00%)  0/235 (0.00%)  0/237 (0.00%) 
Homicidal ideation  1  1/243 (0.41%)  0/245 (0.00%)  0/235 (0.00%)  0/237 (0.00%) 
Suicidal ideation  1  1/243 (0.41%)  0/245 (0.00%)  0/235 (0.00%)  0/237 (0.00%) 
Renal and urinary disorders         
Calculus bladder  1  1/243 (0.41%)  0/245 (0.00%)  0/235 (0.00%)  0/237 (0.00%) 
Reproductive system and breast disorders         
Cervical dysplasia  1  1/243 (0.41%)  0/245 (0.00%)  0/235 (0.00%)  0/237 (0.00%) 
Prostatitis  1  0/243 (0.00%)  0/245 (0.00%)  1/235 (0.43%)  0/237 (0.00%) 
Vascular disorders         
Varicose vein  1  0/243 (0.00%)  1/245 (0.41%)  0/235 (0.00%)  0/237 (0.00%) 
1
Term from vocabulary, MedDRA 22.1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
TAF 25 mg TDF 300 mg OLE TAF 25 mg From TAF 25 mg OLE TAF 25 mg From TDF 300 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   31/243 (12.76%)   28/245 (11.43%)   15/235 (6.38%)   15/237 (6.33%) 
Infections and infestations         
Upper respiratory tract infection  1  18/243 (7.41%)  16/245 (6.53%)  11/235 (4.68%)  12/237 (5.06%) 
Nasopharyngitis  1  13/243 (5.35%)  12/245 (4.90%)  4/235 (1.70%)  3/237 (1.27%) 
1
Term from vocabulary, MedDRA 22.1
Indicates events were collected by systematic assessment
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
Layout table for Results Point of Contact information
Name/Title: Gilead Clinical Study Information Center
Organization: Gilead Sciences
Phone: 1-833-445-3230 (GILEAD-0)
EMail: GileadClinicalTrials@gilead.com
Layout table for additonal information
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02979613    
Other Study ID Numbers: GS-US-320-4018
2016-003632-20 ( EudraCT Number )
First Submitted: November 29, 2016
First Posted: December 1, 2016
Results First Submitted: August 30, 2019
Results First Posted: September 25, 2019
Last Update Posted: September 14, 2020