Trial Outcomes & Findings for A Study of Switching From Entecavir to Tenofovir Disoproxil Fumarate in Subjects With Chronic Hepatitis B (NCT NCT03258710)

Last Updated: 2020-08-04

Results Overview

Blood samples were collected to evaluate the HBsAg reduction from Baseline at Week 48. HBsAg reduction potential was obtained by evaluating log10 observation values minus log10 Baseline values. The HBsAg responder values were\<=-0.25 log10 and non-responder values were \>-0.25 log10 . Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Full analysis set (FAS) Population is defined as population of all participants enrolled in the study, excluding those who meet either of the following criteria: who have not received any dose of study treatment and who have no efficacy data (HBsAg, HBV-DNA, hepatitis B core-related antigen \[HBcrAg\], HBeAg, hepatitis B surface antibody \[HBsAb\],Hepatitis B envelope antibody \[HBeAb\], alanine aminotransferase \[ALT\]) from at least 15 days after the start of study treatment. Data for HBsAg responders have been presented.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

75 participants

Primary outcome timeframe

Baseline (Day 1, Pre-dose) and at Week 48

Results posted on

2020-08-04

Participant Flow

This was a multi-center, single-arm study to assess efficacy and safety of tenofovir disoproxil fumarate (TDF) by switching at Day 1 from entecavir hydrate (ETV) to TDF in chronic hepatitis B envelope antigen (HBeAg)-positive and hepatitis B virus-deoxyribonucleic acid (HBV-DNA) undetectable participants.

A total of 75 participants were enrolled in the study.

Participant milestones

Participant milestones
Measure	Tenofovir Disoproxil Fumarate Participants with on-going ETV treatment were switched to TDF treatment on Day 1. Participants then started with TDF on the day ETV was discontinued, without any overlapping treatment periods. All participants received one tablet of TDF 300 milligram (mg) once daily orally for 96 weeks.
Overall Study STARTED	75
Overall Study COMPLETED	72
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Tenofovir Disoproxil Fumarate Participants with on-going ETV treatment were switched to TDF treatment on Day 1. Participants then started with TDF on the day ETV was discontinued, without any overlapping treatment periods. All participants received one tablet of TDF 300 milligram (mg) once daily orally for 96 weeks.
Overall Study Adverse Event	1
Overall Study Protocol-defined stopping criteria	1
Overall Study Physician Decision	1

Baseline Characteristics

A Study of Switching From Entecavir to Tenofovir Disoproxil Fumarate in Subjects With Chronic Hepatitis B

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tenofovir Disoproxil Fumarate n=75 Participants Participants with on-going ETV treatment were switched to TDF treatment on Day 1. Participants then started with TDF on the day ETV was discontinued, without any overlapping treatment periods. All participants received one tablet of TDF 300 milligram (mg) once daily orally for 96 weeks.
Age, Continuous	48.4 Years STANDARD_DEVIATION 9.35 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants
Sex: Female, Male Male	55 Participants n=5 Participants
Race/Ethnicity, Customized Asian-East Asian Heritage	4 Participants n=5 Participants
Race/Ethnicity, Customized Asian-Japanese Heritage	71 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline (Day 1, Pre-dose) and at Week 48

Population: FAS Population

Outcome measures

Outcome measures
Measure	Tenofovir Disoproxil Fumarate n=74 Participants Participants with on-going ETV treatment were switched to TDF treatment on Day 1. Participants then started with TDF on the day ETV was discontinued, without any overlapping treatment periods. All participants received one tablet of TDF 300 milligram (mg) once daily orally for 96 weeks.
Percentage of Participants Who Achieved 0.25 Logarithm to the Base 10 (Log10) Hepatitis B Surface Antigen (HBsAg) Reduction From the Baseline at Week 48 <= -0.25 log10	4 Percentage of Participants Interval 0.8 to 11.4
Percentage of Participants Who Achieved 0.25 Logarithm to the Base 10 (Log10) Hepatitis B Surface Antigen (HBsAg) Reduction From the Baseline at Week 48 > -0.25 log10	96 Percentage of Participants Interval 88.6 to 99.2

SECONDARY outcome

Timeframe: Baseline (Day 1, Pre-dose) and at Weeks 24 and 96

Population: FAS Population.

Blood samples were collected to evaluate the HBsAg reduction potential from Baseline at Weeks 24 and 96. HBsAg reduction potential was obtained by evaluating log10 observation values minus log10 Baseline values. Data for HBsAg responders have been presented. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.

Outcome measures

Outcome measures
Measure	Tenofovir Disoproxil Fumarate n=74 Participants Participants with on-going ETV treatment were switched to TDF treatment on Day 1. Participants then started with TDF on the day ETV was discontinued, without any overlapping treatment periods. All participants received one tablet of TDF 300 milligram (mg) once daily orally for 96 weeks.
Percentage of Participants Who Achieved 0.25 Log10 HBsAg Reduction From the Baseline at Weeks 24 and 96 Week 24	1 Percentage of Participants Interval 0.0 to 7.3
Percentage of Participants Who Achieved 0.25 Log10 HBsAg Reduction From the Baseline at Weeks 24 and 96 Week 96	12 Percentage of Participants Interval 5.7 to 21.8

SECONDARY outcome

Timeframe: At Weeks 24, 48 and 96

Population: FAS Population.

Blood samples were collected to evaluate the percentage of participants with HBsAg loss at Weeks 24, 48 and 96. A 'Loss' of HBsAg means antigen is negative. HBsAg loss percentage is defined as number of participants with HBsAg loss divided by number of participants with positive HBsAg at Baseline. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.

Outcome measures

Outcome measures
Measure	Tenofovir Disoproxil Fumarate n=74 Participants Participants with on-going ETV treatment were switched to TDF treatment on Day 1. Participants then started with TDF on the day ETV was discontinued, without any overlapping treatment periods. All participants received one tablet of TDF 300 milligram (mg) once daily orally for 96 weeks.
Percentage of Participants Who Achieved HBsAg Loss at Weeks 24, 48 and 96 Week 24	0 Percentage of Participants
Percentage of Participants Who Achieved HBsAg Loss at Weeks 24, 48 and 96 Week 48	0 Percentage of Participants
Percentage of Participants Who Achieved HBsAg Loss at Weeks 24, 48 and 96 Week 96	0 Percentage of Participants

SECONDARY outcome

Timeframe: At Weeks 24, 48 and 96

Population: FAS Population. Only those participants with data available at specified data points were analyzed.

Blood samples were collected to evaluate the percentage of participants who achieved HBsAg/Ab seroconversion at Weeks 24, 48 and 96. Seroconversion of HBsAg means antigen is negative and antibody is positive. HBsAg Seroconversion percentage is defined as number of participants with HBsAg/Ab Seroconversion divided by number of participants with positive HBsAg and Negative HBsAb at Baseline. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.

Outcome measures

Outcome measures
Measure	Tenofovir Disoproxil Fumarate n=73 Participants Participants with on-going ETV treatment were switched to TDF treatment on Day 1. Participants then started with TDF on the day ETV was discontinued, without any overlapping treatment periods. All participants received one tablet of TDF 300 milligram (mg) once daily orally for 96 weeks.
Percentage of Participants Who Achieved HBsAg/Ab Seroconversion at Weeks 24, 48 and 96 Week 24	0 Percentage of Participants
Percentage of Participants Who Achieved HBsAg/Ab Seroconversion at Weeks 24, 48 and 96 Week 48	0 Percentage of Participants
Percentage of Participants Who Achieved HBsAg/Ab Seroconversion at Weeks 24, 48 and 96 Week 96	0 Percentage of Participants

SECONDARY outcome

Timeframe: At Weeks 24, 48 and 96

Population: FAS Population. Only those participants with data available at specified data points were analyzed.

Blood samples were collected to evaluate the percentage of participants with HBeAg loss at Weeks 24, 48 and 96. A 'Loss' of HBeAg means antigen is negative. HBeAg Loss percentage is defined as number of participants with HBeAg loss divided by number of participants with positive HBeAg at Baseline. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.

Outcome measures

Outcome measures
Measure	Tenofovir Disoproxil Fumarate n=69 Participants Participants with on-going ETV treatment were switched to TDF treatment on Day 1. Participants then started with TDF on the day ETV was discontinued, without any overlapping treatment periods. All participants received one tablet of TDF 300 milligram (mg) once daily orally for 96 weeks.
Percentage of Participants Who Achieved HBeAg Loss at Weeks 24, 48 and 96 Week 24	12 Percentage of Participants
Percentage of Participants Who Achieved HBeAg Loss at Weeks 24, 48 and 96 Week 48	12 Percentage of Participants
Percentage of Participants Who Achieved HBeAg Loss at Weeks 24, 48 and 96 Week 96	25 Percentage of Participants

SECONDARY outcome

Timeframe: At Weeks 24, 48 and 96

Population: FAS Population. Only those participants with data available at specified data points were analyzed.

Blood samples were collected to evaluate the percentage of participants who achieved HBeAg/Ab seroconversion at Weeks 24, 48 and 96. Seroconversion of HBeAg means antigen is negative and antibody is positive. HBeAg Seroconversion percentage is defined as number of participants with HBeAg/Ab Seroconversion divided by number of participants with positive HBeAg and Negative HBeAb at Baseline. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.

Outcome measures

Outcome measures
Measure	Tenofovir Disoproxil Fumarate n=53 Participants Participants with on-going ETV treatment were switched to TDF treatment on Day 1. Participants then started with TDF on the day ETV was discontinued, without any overlapping treatment periods. All participants received one tablet of TDF 300 milligram (mg) once daily orally for 96 weeks.
Percentage of Participants Who Achieved HBeAg/Ab Seroconversion at Weeks 24, 48 and 96 Week 24	8 Percentage of Participants
Percentage of Participants Who Achieved HBeAg/Ab Seroconversion at Weeks 24, 48 and 96 Week 48	13 Percentage of Participants
Percentage of Participants Who Achieved HBeAg/Ab Seroconversion at Weeks 24, 48 and 96 Week 96	25 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline (Day 1, Pre-dose) and at Weeks 24, 48 and 96

Population: FAS Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Blood samples were collected to evaluate the HBsAg titer at Weeks 24, 48 and 96. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is calculated as the value at the post-dose visit minus the Baseline value.

Outcome measures

Outcome measures
Measure	Tenofovir Disoproxil Fumarate n=74 Participants Participants with on-going ETV treatment were switched to TDF treatment on Day 1. Participants then started with TDF on the day ETV was discontinued, without any overlapping treatment periods. All participants received one tablet of TDF 300 milligram (mg) once daily orally for 96 weeks.
Change From Baseline Log Values for HBsAg Titer at Weeks 24, 48 and 96 Week 24, n=74	-0.049 Log Kilo International Units per Liter Standard Deviation 0.0913
Change From Baseline Log Values for HBsAg Titer at Weeks 24, 48 and 96 Week 48, n=73	-0.114 Log Kilo International Units per Liter Standard Deviation 0.0837
Change From Baseline Log Values for HBsAg Titer at Weeks 24, 48 and 96 Week 96, n=72	-0.139 Log Kilo International Units per Liter Standard Deviation 0.1207

SECONDARY outcome

Timeframe: Baseline (Day 1, Pre-dose) and at Weeks 24, 48 and 96

Population: FAS Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Blood samples were collected to evaluate the HBcrAg titer at Weeks 24, 48 and 96. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is calculated as the value at the post-dose visit minus the Baseline value.

Outcome measures

Outcome measures
Measure	Tenofovir Disoproxil Fumarate n=74 Participants Participants with on-going ETV treatment were switched to TDF treatment on Day 1. Participants then started with TDF on the day ETV was discontinued, without any overlapping treatment periods. All participants received one tablet of TDF 300 milligram (mg) once daily orally for 96 weeks.
Change From Baseline Log Values for HBcrAg Titer at Weeks 24, 48 and 96 Week 24, n=74	-0.12 Log Kilounits per Liter Standard Deviation 0.232
Change From Baseline Log Values for HBcrAg Titer at Weeks 24, 48 and 96 Week 48, n=73	-0.17 Log Kilounits per Liter Standard Deviation 0.286
Change From Baseline Log Values for HBcrAg Titer at Weeks 24, 48 and 96 Week 96, n=72	-0.30 Log Kilounits per Liter Standard Deviation 0.360

SECONDARY outcome

Timeframe: Up to Week 96

Population: Safety Population.

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, associated with liver injury and impaired liver function or any other situations as per medical or scientific judgement. Safety Population consists of participants who have received at least one dose of study treatment after enrolment.

Outcome measures

Outcome measures
Measure	Tenofovir Disoproxil Fumarate n=75 Participants Participants with on-going ETV treatment were switched to TDF treatment on Day 1. Participants then started with TDF on the day ETV was discontinued, without any overlapping treatment periods. All participants received one tablet of TDF 300 milligram (mg) once daily orally for 96 weeks.
Number of Participants Who Reported Serious Adverse Events (SAEs) and Non-serious Adverse Events (Non-SAEs) Any SAE	2 Participants
Number of Participants Who Reported Serious Adverse Events (SAEs) and Non-serious Adverse Events (Non-SAEs) Any non-SAE	36 Participants

SECONDARY outcome

Timeframe: Baseline (Day 1, Pre-dose) and at Weeks 4, 12, 24, 36, 48, 60, 72, 84 and 96

Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Blood samples were collected for the analysis of clinical chemistry parameter, AFP. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.

Outcome measures

Outcome measures
Measure	Tenofovir Disoproxil Fumarate n=75 Participants Participants with on-going ETV treatment were switched to TDF treatment on Day 1. Participants then started with TDF on the day ETV was discontinued, without any overlapping treatment periods. All participants received one tablet of TDF 300 milligram (mg) once daily orally for 96 weeks.
Absolute Values for Clinical Chemistry Parameter: Alpha-fetoprotein (AFP) Baseline (Day 1), n=75	3.13 Micrograms per liter Standard Deviation 1.474
Absolute Values for Clinical Chemistry Parameter: Alpha-fetoprotein (AFP) Week 4, n=75	3.39 Micrograms per liter Standard Deviation 1.507
Absolute Values for Clinical Chemistry Parameter: Alpha-fetoprotein (AFP) Week 12, n=74	3.46 Micrograms per liter Standard Deviation 1.642
Absolute Values for Clinical Chemistry Parameter: Alpha-fetoprotein (AFP) Week 24, n=74	3.50 Micrograms per liter Standard Deviation 1.597
Absolute Values for Clinical Chemistry Parameter: Alpha-fetoprotein (AFP) Week 36, n=73	3.48 Micrograms per liter Standard Deviation 1.578
Absolute Values for Clinical Chemistry Parameter: Alpha-fetoprotein (AFP) Week 48, n=73	3.55 Micrograms per liter Standard Deviation 1.693
Absolute Values for Clinical Chemistry Parameter: Alpha-fetoprotein (AFP) Week 60, n=73	3.50 Micrograms per liter Standard Deviation 1.683
Absolute Values for Clinical Chemistry Parameter: Alpha-fetoprotein (AFP) Week 72, n=73	3.27 Micrograms per liter Standard Deviation 1.499
Absolute Values for Clinical Chemistry Parameter: Alpha-fetoprotein (AFP) Week 84, n=72	3.10 Micrograms per liter Standard Deviation 1.478
Absolute Values for Clinical Chemistry Parameter: Alpha-fetoprotein (AFP) Week 96, n=72	3.18 Micrograms per liter Standard Deviation 1.537

SECONDARY outcome

Timeframe: Baseline (Day 1, Pre-dose) and at Weeks 4, 12, 24, 36, 48, 60, 72, 84 and 96

Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Blood samples were collected for the analysis of clinical chemistry parameters: albumin and total protein. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.

Outcome measures

Outcome measures
Measure	Tenofovir Disoproxil Fumarate n=75 Participants Participants with on-going ETV treatment were switched to TDF treatment on Day 1. Participants then started with TDF on the day ETV was discontinued, without any overlapping treatment periods. All participants received one tablet of TDF 300 milligram (mg) once daily orally for 96 weeks.
Absolute Values for Clinical Chemistry Parameters: Albumin and Total Protein Total protein, Week 60, n=73	72.8 Grams per liter Standard Deviation 4.08
Absolute Values for Clinical Chemistry Parameters: Albumin and Total Protein Albumin, Baseline (Day 1), n=75	44.7 Grams per liter Standard Deviation 2.60
Absolute Values for Clinical Chemistry Parameters: Albumin and Total Protein Albumin, Week 4, n=75	44.9 Grams per liter Standard Deviation 2.21
Absolute Values for Clinical Chemistry Parameters: Albumin and Total Protein Albumin, Week 12, n=74	45.2 Grams per liter Standard Deviation 2.17
Absolute Values for Clinical Chemistry Parameters: Albumin and Total Protein Albumin, Week 24, n=74	44.5 Grams per liter Standard Deviation 2.18
Absolute Values for Clinical Chemistry Parameters: Albumin and Total Protein Albumin, Week 36, n=73	44.2 Grams per liter Standard Deviation 2.11
Absolute Values for Clinical Chemistry Parameters: Albumin and Total Protein Albumin, Week 48, n=73	44.8 Grams per liter Standard Deviation 2.20
Absolute Values for Clinical Chemistry Parameters: Albumin and Total Protein Albumin, Week 60, n=73	45.1 Grams per liter Standard Deviation 1.88
Absolute Values for Clinical Chemistry Parameters: Albumin and Total Protein Albumin, Week 72, n=73	44.9 Grams per liter Standard Deviation 2.14
Absolute Values for Clinical Chemistry Parameters: Albumin and Total Protein Albumin, Week 84, n=72	44.6 Grams per liter Standard Deviation 2.05
Absolute Values for Clinical Chemistry Parameters: Albumin and Total Protein Albumin, Week 96, n=72	45.4 Grams per liter Standard Deviation 2.26
Absolute Values for Clinical Chemistry Parameters: Albumin and Total Protein Total protein, Baseline (Day 1) n=75	72.4 Grams per liter Standard Deviation 4.28
Absolute Values for Clinical Chemistry Parameters: Albumin and Total Protein Total protein, Week 4, n=75	72.6 Grams per liter Standard Deviation 3.81
Absolute Values for Clinical Chemistry Parameters: Albumin and Total Protein Total protein, Week 12, n=74	73.1 Grams per liter Standard Deviation 3.93
Absolute Values for Clinical Chemistry Parameters: Albumin and Total Protein Total protein, Week 24, n=74	72.0 Grams per liter Standard Deviation 3.86
Absolute Values for Clinical Chemistry Parameters: Albumin and Total Protein Total protein, Week 36, n=73	71.7 Grams per liter Standard Deviation 3.76
Absolute Values for Clinical Chemistry Parameters: Albumin and Total Protein Total protein, Week 48, n=73	72.6 Grams per liter Standard Deviation 4.12
Absolute Values for Clinical Chemistry Parameters: Albumin and Total Protein Total protein, Week 72, n=73	72.4 Grams per liter Standard Deviation 4.32
Absolute Values for Clinical Chemistry Parameters: Albumin and Total Protein Total protein, Week 84, n=72	72.4 Grams per liter Standard Deviation 4.35
Absolute Values for Clinical Chemistry Parameters: Albumin and Total Protein Total protein, Week 96, n=72	73.0 Grams per liter Standard Deviation 4.07

SECONDARY outcome

Timeframe: Baseline (Day 1, Pre-dose) and at Weeks 4, 12, 24, 36, 48, 60, 72, 84 and 96

Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Blood samples were collected for the analysis of clinical chemistry parameters: ALP, ALT, AST, CPK, GGT and LDH. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.

Outcome measures

Outcome measures
Measure	Tenofovir Disoproxil Fumarate n=75 Participants Participants with on-going ETV treatment were switched to TDF treatment on Day 1. Participants then started with TDF on the day ETV was discontinued, without any overlapping treatment periods. All participants received one tablet of TDF 300 milligram (mg) once daily orally for 96 weeks.
Absolute Values for Clinical Chemistry Parameters: Alkaline Phosphate (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatinine Kinase (CPK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) LDH, Week 12, n=74	171.0 International units per liter Standard Deviation 32.19
Absolute Values for Clinical Chemistry Parameters: Alkaline Phosphate (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatinine Kinase (CPK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) LDH, Week 24, n=74	169.4 International units per liter Standard Deviation 28.94
Absolute Values for Clinical Chemistry Parameters: Alkaline Phosphate (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatinine Kinase (CPK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) LDH, Week 36, n=73	170.3 International units per liter Standard Deviation 28.91
Absolute Values for Clinical Chemistry Parameters: Alkaline Phosphate (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatinine Kinase (CPK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) LDH, Week 48, n=73	175.3 International units per liter Standard Deviation 33.33
Absolute Values for Clinical Chemistry Parameters: Alkaline Phosphate (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatinine Kinase (CPK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) LDH, Week 60, n=73	174.4 International units per liter Standard Deviation 33.12
Absolute Values for Clinical Chemistry Parameters: Alkaline Phosphate (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatinine Kinase (CPK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) LDH, Week 72, n=73	174.6 International units per liter Standard Deviation 32.97
Absolute Values for Clinical Chemistry Parameters: Alkaline Phosphate (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatinine Kinase (CPK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) LDH, Week 84, n=72	172.7 International units per liter Standard Deviation 34.58
Absolute Values for Clinical Chemistry Parameters: Alkaline Phosphate (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatinine Kinase (CPK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) LDH, Week 96, n=72	173.2 International units per liter Standard Deviation 34.08
Absolute Values for Clinical Chemistry Parameters: Alkaline Phosphate (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatinine Kinase (CPK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) ALP, Baseline (Day 1), n=75	210.4 International units per liter Standard Deviation 62.87
Absolute Values for Clinical Chemistry Parameters: Alkaline Phosphate (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatinine Kinase (CPK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) ALP, Week 4, n=75	227.6 International units per liter Standard Deviation 70.27
Absolute Values for Clinical Chemistry Parameters: Alkaline Phosphate (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatinine Kinase (CPK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) ALP, Week 12, n=74	243.1 International units per liter Standard Deviation 76.26
Absolute Values for Clinical Chemistry Parameters: Alkaline Phosphate (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatinine Kinase (CPK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) ALP, Week 24, n=74	242.1 International units per liter Standard Deviation 77.76
Absolute Values for Clinical Chemistry Parameters: Alkaline Phosphate (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatinine Kinase (CPK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) ALP, Week 36, n=73	245.3 International units per liter Standard Deviation 75.15
Absolute Values for Clinical Chemistry Parameters: Alkaline Phosphate (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatinine Kinase (CPK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) ALP, Week 48, n=73	249.4 International units per liter Standard Deviation 73.17
Absolute Values for Clinical Chemistry Parameters: Alkaline Phosphate (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatinine Kinase (CPK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) ALP, Week 60, n=73	253.1 International units per liter Standard Deviation 75.62
Absolute Values for Clinical Chemistry Parameters: Alkaline Phosphate (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatinine Kinase (CPK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) ALP, Week 72, n=73	249.2 International units per liter Standard Deviation 72.56
Absolute Values for Clinical Chemistry Parameters: Alkaline Phosphate (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatinine Kinase (CPK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) ALP, Week 84, n=72	237.6 International units per liter Standard Deviation 69.60
Absolute Values for Clinical Chemistry Parameters: Alkaline Phosphate (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatinine Kinase (CPK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) ALP, Week 96, n=72	237.7 International units per liter Standard Deviation 72.92
Absolute Values for Clinical Chemistry Parameters: Alkaline Phosphate (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatinine Kinase (CPK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) ALT, Baseline (Day 1), n=75	23.5 International units per liter Standard Deviation 18.13
Absolute Values for Clinical Chemistry Parameters: Alkaline Phosphate (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatinine Kinase (CPK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) ALT, Week 4, n=75	28.3 International units per liter Standard Deviation 19.82
Absolute Values for Clinical Chemistry Parameters: Alkaline Phosphate (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatinine Kinase (CPK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) ALT, Week 12, n=74	27.9 International units per liter Standard Deviation 16.48
Absolute Values for Clinical Chemistry Parameters: Alkaline Phosphate (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatinine Kinase (CPK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) ALT, Week 24, n=74	27.5 International units per liter Standard Deviation 19.09
Absolute Values for Clinical Chemistry Parameters: Alkaline Phosphate (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatinine Kinase (CPK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) ALT, Week 36, n=73	25.9 International units per liter Standard Deviation 14.70
Absolute Values for Clinical Chemistry Parameters: Alkaline Phosphate (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatinine Kinase (CPK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) ALT, Week 48, n=73	27.0 International units per liter Standard Deviation 13.14
Absolute Values for Clinical Chemistry Parameters: Alkaline Phosphate (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatinine Kinase (CPK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) ALT, Week 60, n=73	26.6 International units per liter Standard Deviation 12.65
Absolute Values for Clinical Chemistry Parameters: Alkaline Phosphate (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatinine Kinase (CPK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) ALT, Week 72, n=73	24.2 International units per liter Standard Deviation 9.16
Absolute Values for Clinical Chemistry Parameters: Alkaline Phosphate (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatinine Kinase (CPK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) ALT, Week 84, n=72	26.3 International units per liter Standard Deviation 20.75
Absolute Values for Clinical Chemistry Parameters: Alkaline Phosphate (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatinine Kinase (CPK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) ALT, Week 96, n=72	26.4 International units per liter Standard Deviation 25.60
Absolute Values for Clinical Chemistry Parameters: Alkaline Phosphate (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatinine Kinase (CPK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) AST, Baseline (Day 1), n=75	22.7 International units per liter Standard Deviation 8.80
Absolute Values for Clinical Chemistry Parameters: Alkaline Phosphate (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatinine Kinase (CPK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) AST, Week 4, n=75	26.1 International units per liter Standard Deviation 8.70
Absolute Values for Clinical Chemistry Parameters: Alkaline Phosphate (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatinine Kinase (CPK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) AST, Week 12, n=74	25.8 International units per liter Standard Deviation 8.34
Absolute Values for Clinical Chemistry Parameters: Alkaline Phosphate (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatinine Kinase (CPK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) AST, Week 24, n=74	25.5 International units per liter Standard Deviation 9.31
Absolute Values for Clinical Chemistry Parameters: Alkaline Phosphate (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatinine Kinase (CPK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) AST, Week 36, n=73	24.6 International units per liter Standard Deviation 7.88
Absolute Values for Clinical Chemistry Parameters: Alkaline Phosphate (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatinine Kinase (CPK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) AST, Week 48, n=73	25.7 International units per liter Standard Deviation 7.58
Absolute Values for Clinical Chemistry Parameters: Alkaline Phosphate (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatinine Kinase (CPK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) AST, Week 60, n=73	25.1 International units per liter Standard Deviation 6.23
Absolute Values for Clinical Chemistry Parameters: Alkaline Phosphate (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatinine Kinase (CPK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) AST, Week 72, n=73	24.1 International units per liter Standard Deviation 5.25
Absolute Values for Clinical Chemistry Parameters: Alkaline Phosphate (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatinine Kinase (CPK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) AST, Week 84, n=72	25.0 International units per liter Standard Deviation 10.38
Absolute Values for Clinical Chemistry Parameters: Alkaline Phosphate (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatinine Kinase (CPK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) AST, Week 96, n=72	24.9 International units per liter Standard Deviation 12.03
Absolute Values for Clinical Chemistry Parameters: Alkaline Phosphate (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatinine Kinase (CPK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) CPK, Baseline (Day 1), n=75	138.9 International units per liter Standard Deviation 100.01
Absolute Values for Clinical Chemistry Parameters: Alkaline Phosphate (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatinine Kinase (CPK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) CPK, Week 4, n=75	151.0 International units per liter Standard Deviation 113.92
Absolute Values for Clinical Chemistry Parameters: Alkaline Phosphate (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatinine Kinase (CPK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) CPK, Week 12, n=74	144.5 International units per liter Standard Deviation 148.47
Absolute Values for Clinical Chemistry Parameters: Alkaline Phosphate (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatinine Kinase (CPK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) CPK, Week 24, n=74	127.9 International units per liter Standard Deviation 56.20
Absolute Values for Clinical Chemistry Parameters: Alkaline Phosphate (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatinine Kinase (CPK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) CPK, Week 36, n=73	131.9 International units per liter Standard Deviation 79.25
Absolute Values for Clinical Chemistry Parameters: Alkaline Phosphate (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatinine Kinase (CPK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) CPK, Week 48, n=73	148.7 International units per liter Standard Deviation 106.89
Absolute Values for Clinical Chemistry Parameters: Alkaline Phosphate (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatinine Kinase (CPK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) CKP, Week 60, n=73	134.1 International units per liter Standard Deviation 65.76
Absolute Values for Clinical Chemistry Parameters: Alkaline Phosphate (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatinine Kinase (CPK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) CKP, Week 72, n=73	143.3 International units per liter Standard Deviation 81.86
Absolute Values for Clinical Chemistry Parameters: Alkaline Phosphate (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatinine Kinase (CPK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) CKP, Week 84, n=72	127.4 International units per liter Standard Deviation 60.37
Absolute Values for Clinical Chemistry Parameters: Alkaline Phosphate (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatinine Kinase (CPK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) CKP, Week 96, n=72	132.3 International units per liter Standard Deviation 67.94
Absolute Values for Clinical Chemistry Parameters: Alkaline Phosphate (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatinine Kinase (CPK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) GGT, Baseline (Day 1), n=75	30.9 International units per liter Standard Deviation 24.23
Absolute Values for Clinical Chemistry Parameters: Alkaline Phosphate (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatinine Kinase (CPK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) GGT, Week 4, n=75	31.6 International units per liter Standard Deviation 27.23
Absolute Values for Clinical Chemistry Parameters: Alkaline Phosphate (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatinine Kinase (CPK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) GGT, Week 12, n=74	31.5 International units per liter Standard Deviation 31.14
Absolute Values for Clinical Chemistry Parameters: Alkaline Phosphate (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatinine Kinase (CPK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) GGT, Week 24, n=74	30.4 International units per liter Standard Deviation 28.57
Absolute Values for Clinical Chemistry Parameters: Alkaline Phosphate (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatinine Kinase (CPK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) GGT, Week 36, n=73	27.6 International units per liter Standard Deviation 24.30
Absolute Values for Clinical Chemistry Parameters: Alkaline Phosphate (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatinine Kinase (CPK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) GGT, Week 48, n=73	27.8 International units per liter Standard Deviation 22.60
Absolute Values for Clinical Chemistry Parameters: Alkaline Phosphate (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatinine Kinase (CPK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) GGT, Week 60, n=73	28.2 International units per liter Standard Deviation 24.67
Absolute Values for Clinical Chemistry Parameters: Alkaline Phosphate (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatinine Kinase (CPK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) GGT, Week 72, n=73	25.6 International units per liter Standard Deviation 16.94
Absolute Values for Clinical Chemistry Parameters: Alkaline Phosphate (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatinine Kinase (CPK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) GGT, Week 84, n=72	27.4 International units per liter Standard Deviation 25.22
Absolute Values for Clinical Chemistry Parameters: Alkaline Phosphate (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatinine Kinase (CPK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) GGT, Week 96, n=72	27.8 International units per liter Standard Deviation 23.75
Absolute Values for Clinical Chemistry Parameters: Alkaline Phosphate (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatinine Kinase (CPK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) LDH, Baseline (Day 1), n=75	165.2 International units per liter Standard Deviation 30.53
Absolute Values for Clinical Chemistry Parameters: Alkaline Phosphate (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatinine Kinase (CPK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) LDH, Week 4, n=75	173.9 International units per liter Standard Deviation 35.23

SECONDARY outcome

Timeframe: Baseline (Day 1, Pre-dose) and at Weeks 4, 12, 24, 36, 48, 60, 72, 84 and 96

Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Blood samples were collected for the analysis of clinical chemistry parameters: amylase and lipase. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.

Outcome measures

Outcome measures
Measure	Tenofovir Disoproxil Fumarate n=75 Participants Participants with on-going ETV treatment were switched to TDF treatment on Day 1. Participants then started with TDF on the day ETV was discontinued, without any overlapping treatment periods. All participants received one tablet of TDF 300 milligram (mg) once daily orally for 96 weeks.
Absolute Values for Clinical Chemistry Parameters: Amylase and Lipase Amylase, Baseline (Day 1), n=75	87.3 Units per liter Standard Deviation 26.00
Absolute Values for Clinical Chemistry Parameters: Amylase and Lipase Amylase, Week 4, n=75	89.5 Units per liter Standard Deviation 24.99
Absolute Values for Clinical Chemistry Parameters: Amylase and Lipase Amylase, Week 12, n=74	88.2 Units per liter Standard Deviation 26.21
Absolute Values for Clinical Chemistry Parameters: Amylase and Lipase Amylase, Week 24, n=74	83.7 Units per liter Standard Deviation 23.30
Absolute Values for Clinical Chemistry Parameters: Amylase and Lipase Amylase, Week 36, n=73	82.3 Units per liter Standard Deviation 24.29
Absolute Values for Clinical Chemistry Parameters: Amylase and Lipase Amylase, Week 48, n=73	84.9 Units per liter Standard Deviation 26.08
Absolute Values for Clinical Chemistry Parameters: Amylase and Lipase Amylase, Week 60, n=73	92.2 Units per liter Standard Deviation 32.20
Absolute Values for Clinical Chemistry Parameters: Amylase and Lipase Amylase, Week 72, n=73	88.8 Units per liter Standard Deviation 27.87
Absolute Values for Clinical Chemistry Parameters: Amylase and Lipase Amylase, Week 84, n=72	84.4 Units per liter Standard Deviation 24.93
Absolute Values for Clinical Chemistry Parameters: Amylase and Lipase Amylase, Week 96, n=72	86.7 Units per liter Standard Deviation 32.31
Absolute Values for Clinical Chemistry Parameters: Amylase and Lipase Lipase, Baseline (Day 1), n=75	40.0 Units per liter Standard Deviation 17.99
Absolute Values for Clinical Chemistry Parameters: Amylase and Lipase Lipase, Week 4, n=75	41.9 Units per liter Standard Deviation 14.27
Absolute Values for Clinical Chemistry Parameters: Amylase and Lipase Lipase, Week 12, n=74	39.1 Units per liter Standard Deviation 13.97
Absolute Values for Clinical Chemistry Parameters: Amylase and Lipase Lipase, Week 24, n=74	36.0 Units per liter Standard Deviation 9.95
Absolute Values for Clinical Chemistry Parameters: Amylase and Lipase Lipase, Week 36, n=73	36.9 Units per liter Standard Deviation 12.64
Absolute Values for Clinical Chemistry Parameters: Amylase and Lipase Lipase, Week 48, n=73	36.2 Units per liter Standard Deviation 12.91
Absolute Values for Clinical Chemistry Parameters: Amylase and Lipase Lipase, Week 60, n=73	39.1 Units per liter Standard Deviation 13.07
Absolute Values for Clinical Chemistry Parameters: Amylase and Lipase Lipase, Week 72, n=73	37.1 Units per liter Standard Deviation 13.72
Absolute Values for Clinical Chemistry Parameters: Amylase and Lipase Lipase, Week 84, n=72	33.5 Units per liter Standard Deviation 11.55
Absolute Values for Clinical Chemistry Parameters: Amylase and Lipase Lipase, Week 96, n=72	34.2 Units per liter Standard Deviation 16.73

SECONDARY outcome

Timeframe: Baseline (Day 1, Pre-dose) and at Weeks 4, 12, 24, 36, 48, 60, 72, 84 and 96

Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Blood samples were collected for the analysis of clinical chemistry parameters: direct bilirubin, total bilirubin, creatinine and uric acid. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.

Outcome measures

Outcome measures
Measure	Tenofovir Disoproxil Fumarate n=75 Participants Participants with on-going ETV treatment were switched to TDF treatment on Day 1. Participants then started with TDF on the day ETV was discontinued, without any overlapping treatment periods. All participants received one tablet of TDF 300 milligram (mg) once daily orally for 96 weeks.
Absolute Values for Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid Uric acid, Week 60, n=73	309.3775 Micromoles per liter Standard Deviation 62.83437
Absolute Values for Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid Direct bilirubin, Baseline (Day 1), n=75	3.899 Micromoles per liter Standard Deviation 2.0574
Absolute Values for Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid Direct bilirubin, Week 4, n=75	3.944 Micromoles per liter Standard Deviation 1.6386
Absolute Values for Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid Direct bilirubin, Week 12, n=74	3.928 Micromoles per liter Standard Deviation 1.5943
Absolute Values for Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid Direct bilirubin, Week 24, n=74	4.021 Micromoles per liter Standard Deviation 1.9493
Absolute Values for Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid Direct bilirubin, Week 36, n=73	3.959 Micromoles per liter Standard Deviation 1.9304
Absolute Values for Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid Direct bilirubin, Week 48, n=73	4.029 Micromoles per liter Standard Deviation 2.1015
Absolute Values for Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid Direct bilirubin, Week 60, n=73	3.607 Micromoles per liter Standard Deviation 1.4409
Absolute Values for Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid Direct bilirubin, Week 72, n=73	3.959 Micromoles per liter Standard Deviation 1.7540
Absolute Values for Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid Direct bilirubin, Week 84, n=72	3.919 Micromoles per liter Standard Deviation 1.7560
Absolute Values for Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid Direct bilirubin, Week 96, n=72	4.418 Micromoles per liter Standard Deviation 1.8765
Absolute Values for Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid Total bilirubin, Baseline (Day 1), n=75	10.693 Micromoles per liter Standard Deviation 5.4663
Absolute Values for Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid Total bilirubin, Week 4, n=75	10.009 Micromoles per liter Standard Deviation 4.1478
Absolute Values for Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid Total bilirubin, Week 12, n=74	9.890 Micromoles per liter Standard Deviation 4.1528
Absolute Values for Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid Total bilirubin, Week 24, n=74	10.584 Micromoles per liter Standard Deviation 5.4641
Absolute Values for Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid Total bilirubin, Week 36, n=73	10.518 Micromoles per liter Standard Deviation 5.2834
Absolute Values for Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid Total bilirubin, Week 48, n=73	10.635 Micromoles per liter Standard Deviation 5.6373
Absolute Values for Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid Total bilirubin, Week 60, n=73	9.557 Micromoles per liter Standard Deviation 3.7684
Absolute Values for Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid Total bilirubin, Week 72, n=73	10.237 Micromoles per liter Standard Deviation 5.0381
Absolute Values for Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid Total bilirubin, Week 84, n=72	10.284 Micromoles per liter Standard Deviation 5.9340
Absolute Values for Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid Total bilirubin, Week 96, n=72	11.329 Micromoles per liter Standard Deviation 4.4037
Absolute Values for Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid Creatinine, Baseline (Day 1), n=75	62.9997 Micromoles per liter Standard Deviation 11.33874
Absolute Values for Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid Creatinine, Week 4, n=75	64.1666 Micromoles per liter Standard Deviation 11.28624
Absolute Values for Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid Creatinine, Week 12, n=74	65.8102 Micromoles per liter Standard Deviation 10.95564
Absolute Values for Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid Creatinine, Week 24, n=74	65.2965 Micromoles per liter Standard Deviation 11.04922
Absolute Values for Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid Creatinine, Week 36, n=73	65.9852 Micromoles per liter Standard Deviation 10.57867
Absolute Values for Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid Creatinine, Week 48, n=73	65.9125 Micromoles per liter Standard Deviation 11.31592
Absolute Values for Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid Creatinine, Week 60, n=73	65.3191 Micromoles per liter Standard Deviation 10.70634
Absolute Values for Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid Creatinine, Week 72, n=73	65.4887 Micromoles per liter Standard Deviation 11.06350
Absolute Values for Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid Creatinine, Week 84, n=72	66.5578 Micromoles per liter Standard Deviation 11.42181
Absolute Values for Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid Creatinine, Week 96, n=72	67.3436 Micromoles per liter Standard Deviation 11.07035
Absolute Values for Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid Uric acid, Baseline (Day 1), n=75	333.0880 Micromoles per liter Standard Deviation 71.24862
Absolute Values for Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid Uric acid, Week 4, n=75	322.9367 Micromoles per liter Standard Deviation 67.10023
Absolute Values for Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid Uric acid, Week 12, n=74	323.3622 Micromoles per liter Standard Deviation 73.51388
Absolute Values for Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid Uric acid, Week 24, n=74	321.3528 Micromoles per liter Standard Deviation 70.76893
Absolute Values for Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid Uric acid, Week 36, n=73	320.9476 Micromoles per liter Standard Deviation 70.10092
Absolute Values for Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid Uric acid, Week 48, n=73	320.8661 Micromoles per liter Standard Deviation 67.21277
Absolute Values for Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid Uric acid, Week 72, n=73	318.0958 Micromoles per liter Standard Deviation 71.99367
Absolute Values for Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid Uric acid, Week 84, n=72	318.0528 Micromoles per liter Standard Deviation 66.72860
Absolute Values for Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid Uric acid, Week 96, n=72	328.0487 Micromoles per liter Standard Deviation 71.10783

SECONDARY outcome

Timeframe: Baseline (Day 1, Pre-dose) and at Weeks 4, 12, 24, 36, 48, 60, 72, 84 and 96

Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Blood samples were collected for the analysis of clinical chemistry parameters: calcium, chloride, glucose, potassium, lactic acid, sodium, phosphorus inorganic and BUN. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.

Outcome measures

Outcome measures
Measure	Tenofovir Disoproxil Fumarate n=75 Participants Participants with on-going ETV treatment were switched to TDF treatment on Day 1. Participants then started with TDF on the day ETV was discontinued, without any overlapping treatment periods. All participants received one tablet of TDF 300 milligram (mg) once daily orally for 96 weeks.
Absolute Values for Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Lactic Acid, Sodium, Phosphorus and Blood Urea Nitrogen (BUN) Chloride, Week 84, n=72	104.9 Millimoles per liter Standard Deviation 2.40
Absolute Values for Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Lactic Acid, Sodium, Phosphorus and Blood Urea Nitrogen (BUN) Lactic acid, Week 84, n=72	1.12526 Millimoles per liter Standard Deviation 0.493101
Absolute Values for Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Lactic Acid, Sodium, Phosphorus and Blood Urea Nitrogen (BUN) Calcium, Baseline (Day 1), n=75	2.290743 Millimoles per liter Standard Deviation 0.0712447
Absolute Values for Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Lactic Acid, Sodium, Phosphorus and Blood Urea Nitrogen (BUN) Calcium, Week 4, n=75	2.272446 Millimoles per liter Standard Deviation 0.0650823
Absolute Values for Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Lactic Acid, Sodium, Phosphorus and Blood Urea Nitrogen (BUN) Calcium, Week 12, n=74	2.265393 Millimoles per liter Standard Deviation 0.0642412
Absolute Values for Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Lactic Acid, Sodium, Phosphorus and Blood Urea Nitrogen (BUN) Calcium, Week 24, n=74	2.251232 Millimoles per liter Standard Deviation 0.0711166
Absolute Values for Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Lactic Acid, Sodium, Phosphorus and Blood Urea Nitrogen (BUN) Calcium, Week 36, n=73	2.257121 Millimoles per liter Standard Deviation 0.0674474
Absolute Values for Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Lactic Acid, Sodium, Phosphorus and Blood Urea Nitrogen (BUN) Calcium, Week 48, n=73	2.297792 Millimoles per liter Standard Deviation 0.0662944
Absolute Values for Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Lactic Acid, Sodium, Phosphorus and Blood Urea Nitrogen (BUN) Calcium, Week 60, n=73	2.316932 Millimoles per liter Standard Deviation 0.0668335
Absolute Values for Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Lactic Acid, Sodium, Phosphorus and Blood Urea Nitrogen (BUN) Calcium, Week 72, n=73	2.297451 Millimoles per liter Standard Deviation 0.0711492
Absolute Values for Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Lactic Acid, Sodium, Phosphorus and Blood Urea Nitrogen (BUN) Calcium, Week 84, n=72	2.289856 Millimoles per liter Standard Deviation 0.0621422
Absolute Values for Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Lactic Acid, Sodium, Phosphorus and Blood Urea Nitrogen (BUN) Calcium, Week 96, n=72	2.306489 Millimoles per liter Standard Deviation 0.0685384
Absolute Values for Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Lactic Acid, Sodium, Phosphorus and Blood Urea Nitrogen (BUN) Chloride, Baseline (Day 1), n=75	103.5 Millimoles per liter Standard Deviation 2.09
Absolute Values for Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Lactic Acid, Sodium, Phosphorus and Blood Urea Nitrogen (BUN) Chloride, Week 4, n=75	103.3 Millimoles per liter Standard Deviation 1.90
Absolute Values for Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Lactic Acid, Sodium, Phosphorus and Blood Urea Nitrogen (BUN) Chloride, Week 12, n=74	103.5 Millimoles per liter Standard Deviation 2.04
Absolute Values for Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Lactic Acid, Sodium, Phosphorus and Blood Urea Nitrogen (BUN) Chloride, Week 24, n=74	103.9 Millimoles per liter Standard Deviation 1.70
Absolute Values for Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Lactic Acid, Sodium, Phosphorus and Blood Urea Nitrogen (BUN) Chloride, Week 36, n=73	104.0 Millimoles per liter Standard Deviation 1.98
Absolute Values for Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Lactic Acid, Sodium, Phosphorus and Blood Urea Nitrogen (BUN) Chloride, Week 48, n=73	103.6 Millimoles per liter Standard Deviation 1.87
Absolute Values for Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Lactic Acid, Sodium, Phosphorus and Blood Urea Nitrogen (BUN) Chloride, Week 60, n=73	103.6 Millimoles per liter Standard Deviation 1.85
Absolute Values for Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Lactic Acid, Sodium, Phosphorus and Blood Urea Nitrogen (BUN) Chloride, Week 72, n=73	104.1 Millimoles per liter Standard Deviation 2.16
Absolute Values for Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Lactic Acid, Sodium, Phosphorus and Blood Urea Nitrogen (BUN) Chloride, Week 96, n=72	104.3 Millimoles per liter Standard Deviation 2.01
Absolute Values for Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Lactic Acid, Sodium, Phosphorus and Blood Urea Nitrogen (BUN) Glucose, Baseline (Day 1), n=75	5.832251 Millimoles per liter Standard Deviation 1.3417805
Absolute Values for Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Lactic Acid, Sodium, Phosphorus and Blood Urea Nitrogen (BUN) Glucose, Week 4, n=75	5.704208 Millimoles per liter Standard Deviation 1.0439295
Absolute Values for Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Lactic Acid, Sodium, Phosphorus and Blood Urea Nitrogen (BUN) Glucose, Week 12, n=74	5.590757 Millimoles per liter Standard Deviation 0.8796367
Absolute Values for Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Lactic Acid, Sodium, Phosphorus and Blood Urea Nitrogen (BUN) Glucose, Week 24, n=74	5.652268 Millimoles per liter Standard Deviation 0.9310549
Absolute Values for Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Lactic Acid, Sodium, Phosphorus and Blood Urea Nitrogen (BUN) Glucose, Week 36, n=73	5.582937 Millimoles per liter Standard Deviation 1.0191927
Absolute Values for Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Lactic Acid, Sodium, Phosphorus and Blood Urea Nitrogen (BUN) Glucose, Week 48, n=73	5.709165 Millimoles per liter Standard Deviation 0.8209347
Absolute Values for Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Lactic Acid, Sodium, Phosphorus and Blood Urea Nitrogen (BUN) Glucose, Week 60, n=73	5.887862 Millimoles per liter Standard Deviation 1.1524669
Absolute Values for Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Lactic Acid, Sodium, Phosphorus and Blood Urea Nitrogen (BUN) Glucose, Week 72, n=73	5.801175 Millimoles per liter Standard Deviation 0.9035958
Absolute Values for Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Lactic Acid, Sodium, Phosphorus and Blood Urea Nitrogen (BUN) Glucose, Week 84, n=72	5.938799 Millimoles per liter Standard Deviation 1.0721973
Absolute Values for Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Lactic Acid, Sodium, Phosphorus and Blood Urea Nitrogen (BUN) Glucose, Week 96, n=72	5.544061 Millimoles per liter Standard Deviation 0.6818280
Absolute Values for Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Lactic Acid, Sodium, Phosphorus and Blood Urea Nitrogen (BUN) Potassium, Baseline (Day 1), n=75	4.07 Millimoles per liter Standard Deviation 0.258
Absolute Values for Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Lactic Acid, Sodium, Phosphorus and Blood Urea Nitrogen (BUN) Potassium, Week 4, n=75	4.07 Millimoles per liter Standard Deviation 0.254
Absolute Values for Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Lactic Acid, Sodium, Phosphorus and Blood Urea Nitrogen (BUN) Potassium, Week 12, n=74	4.04 Millimoles per liter Standard Deviation 0.257
Absolute Values for Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Lactic Acid, Sodium, Phosphorus and Blood Urea Nitrogen (BUN) Potassium, Week 24, n=74	4.03 Millimoles per liter Standard Deviation 0.236
Absolute Values for Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Lactic Acid, Sodium, Phosphorus and Blood Urea Nitrogen (BUN) Potassium, Week 36, n=73	4.02 Millimoles per liter Standard Deviation 0.264
Absolute Values for Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Lactic Acid, Sodium, Phosphorus and Blood Urea Nitrogen (BUN) Potassium, Week 48, n=73	4.05 Millimoles per liter Standard Deviation 0.249
Absolute Values for Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Lactic Acid, Sodium, Phosphorus and Blood Urea Nitrogen (BUN) Potassium, Week 60, n=73	4.09 Millimoles per liter Standard Deviation 0.275
Absolute Values for Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Lactic Acid, Sodium, Phosphorus and Blood Urea Nitrogen (BUN) Potassium, Week 72, n=73	4.10 Millimoles per liter Standard Deviation 0.288
Absolute Values for Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Lactic Acid, Sodium, Phosphorus and Blood Urea Nitrogen (BUN) Potassium, Week 84, n=72	4.03 Millimoles per liter Standard Deviation 0.260
Absolute Values for Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Lactic Acid, Sodium, Phosphorus and Blood Urea Nitrogen (BUN) Potassium, Week 96, n=72	4.05 Millimoles per liter Standard Deviation 0.233
Absolute Values for Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Lactic Acid, Sodium, Phosphorus and Blood Urea Nitrogen (BUN) Lactic acid, Baseline (Day 1), n=75	1.10467 Millimoles per liter Standard Deviation 0.397387
Absolute Values for Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Lactic Acid, Sodium, Phosphorus and Blood Urea Nitrogen (BUN) Lactic acid, Week 4, n=75	1.02342 Millimoles per liter Standard Deviation 0.378255
Absolute Values for Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Lactic Acid, Sodium, Phosphorus and Blood Urea Nitrogen (BUN) Lactic acid, Week 12, n=74	1.07535 Millimoles per liter Standard Deviation 0.464637
Absolute Values for Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Lactic Acid, Sodium, Phosphorus and Blood Urea Nitrogen (BUN) Lactic acid, Week 24, n=74	1.04970 Millimoles per liter Standard Deviation 0.401795
Absolute Values for Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Lactic Acid, Sodium, Phosphorus and Blood Urea Nitrogen (BUN) Lactic acid, Week 36, n=73	1.06089 Millimoles per liter Standard Deviation 0.434265
Absolute Values for Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Lactic Acid, Sodium, Phosphorus and Blood Urea Nitrogen (BUN) Lactic acid, Week 48, n=73	1.02865 Millimoles per liter Standard Deviation 0.413619
Absolute Values for Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Lactic Acid, Sodium, Phosphorus and Blood Urea Nitrogen (BUN) Lactic acid, Week 60, n=73	1.15182 Millimoles per liter Standard Deviation 0.466672
Absolute Values for Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Lactic Acid, Sodium, Phosphorus and Blood Urea Nitrogen (BUN) Lactic acid, Week 72, n=73	1.06332 Millimoles per liter Standard Deviation 0.375955
Absolute Values for Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Lactic Acid, Sodium, Phosphorus and Blood Urea Nitrogen (BUN) Lactic acid, Week 96, n=72	0.93703 Millimoles per liter Standard Deviation 0.400024
Absolute Values for Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Lactic Acid, Sodium, Phosphorus and Blood Urea Nitrogen (BUN) Sodium, Baseline (Day 1), n=75	141.6 Millimoles per liter Standard Deviation 1.64
Absolute Values for Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Lactic Acid, Sodium, Phosphorus and Blood Urea Nitrogen (BUN) Sodium, Week 4, n=75	141.9 Millimoles per liter Standard Deviation 1.61
Absolute Values for Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Lactic Acid, Sodium, Phosphorus and Blood Urea Nitrogen (BUN) Sodium, Week 12, n=74	142.3 Millimoles per liter Standard Deviation 1.45
Absolute Values for Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Lactic Acid, Sodium, Phosphorus and Blood Urea Nitrogen (BUN) Sodium, Week 24, n=74	142.2 Millimoles per liter Standard Deviation 1.32
Absolute Values for Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Lactic Acid, Sodium, Phosphorus and Blood Urea Nitrogen (BUN) Sodium, Week 36, n=73	142.0 Millimoles per liter Standard Deviation 1.52
Absolute Values for Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Lactic Acid, Sodium, Phosphorus and Blood Urea Nitrogen (BUN) Sodium, Week 48, n=73	142.0 Millimoles per liter Standard Deviation 1.45
Absolute Values for Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Lactic Acid, Sodium, Phosphorus and Blood Urea Nitrogen (BUN) Sodium, Week 60, n=73	142.2 Millimoles per liter Standard Deviation 1.55
Absolute Values for Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Lactic Acid, Sodium, Phosphorus and Blood Urea Nitrogen (BUN) Sodium, Week 72, n=73	142.0 Millimoles per liter Standard Deviation 1.26
Absolute Values for Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Lactic Acid, Sodium, Phosphorus and Blood Urea Nitrogen (BUN) Sodium, Week 84, n=72	142.0 Millimoles per liter Standard Deviation 1.74
Absolute Values for Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Lactic Acid, Sodium, Phosphorus and Blood Urea Nitrogen (BUN) Sodium, Week 96, n=72	141.3 Millimoles per liter Standard Deviation 1.43
Absolute Values for Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Lactic Acid, Sodium, Phosphorus and Blood Urea Nitrogen (BUN) Phosphorus inorganic, Baseline (Day 1), n=75	1.072028 Millimoles per liter Standard Deviation 0.1757407
Absolute Values for Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Lactic Acid, Sodium, Phosphorus and Blood Urea Nitrogen (BUN) Phosphorus inorganic, Week 4, n=75	1.031558 Millimoles per liter Standard Deviation 0.1563869
Absolute Values for Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Lactic Acid, Sodium, Phosphorus and Blood Urea Nitrogen (BUN) Phosphorus inorganic, Week 12, n=74	1.061206 Millimoles per liter Standard Deviation 0.1621407
Absolute Values for Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Lactic Acid, Sodium, Phosphorus and Blood Urea Nitrogen (BUN) Phosphorus inorganic, Week 24, n=74	1.052479 Millimoles per liter Standard Deviation 0.1695973
Absolute Values for Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Lactic Acid, Sodium, Phosphorus and Blood Urea Nitrogen (BUN) Phosphorus inorganic, Week 36, n=73	1.061589 Millimoles per liter Standard Deviation 0.1529705
Absolute Values for Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Lactic Acid, Sodium, Phosphorus and Blood Urea Nitrogen (BUN) Phosphorus inorganic, Week 48, n=73	1.073090 Millimoles per liter Standard Deviation 0.1642529
Absolute Values for Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Lactic Acid, Sodium, Phosphorus and Blood Urea Nitrogen (BUN) Phosphorus inorganic, Week 60, n=73	1.071320 Millimoles per liter Standard Deviation 0.1738322
Absolute Values for Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Lactic Acid, Sodium, Phosphorus and Blood Urea Nitrogen (BUN) Phosphorus inorganic, Week 72, n=73	1.082378 Millimoles per liter Standard Deviation 0.1734792
Absolute Values for Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Lactic Acid, Sodium, Phosphorus and Blood Urea Nitrogen (BUN) Phosphorus inorganic, Week 84, n=72	1.070952 Millimoles per liter Standard Deviation 0.1739292
Absolute Values for Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Lactic Acid, Sodium, Phosphorus and Blood Urea Nitrogen (BUN) Phosphorus inorganic, Week 96, n=72	1.095169 Millimoles per liter Standard Deviation 0.1397279
Absolute Values for Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Lactic Acid, Sodium, Phosphorus and Blood Urea Nitrogen (BUN) BUN, Baseline (Day 1), n=75	4.89518 Millimoles per liter Standard Deviation 1.278805
Absolute Values for Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Lactic Acid, Sodium, Phosphorus and Blood Urea Nitrogen (BUN) BUN, Week 4, n=75	4.80712 Millimoles per liter Standard Deviation 1.270529
Absolute Values for Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Lactic Acid, Sodium, Phosphorus and Blood Urea Nitrogen (BUN) BUN, Week 12, n=74	4.86581 Millimoles per liter Standard Deviation 1.389805
Absolute Values for Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Lactic Acid, Sodium, Phosphorus and Blood Urea Nitrogen (BUN) BUN, Week 24, n=74	4.96519 Millimoles per liter Standard Deviation 1.315155
Absolute Values for Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Lactic Acid, Sodium, Phosphorus and Blood Urea Nitrogen (BUN) BUN, Week 36, n=73	4.86449 Millimoles per liter Standard Deviation 1.433234
Absolute Values for Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Lactic Acid, Sodium, Phosphorus and Blood Urea Nitrogen (BUN) BUN, Week 48, n=73	4.71289 Millimoles per liter Standard Deviation 1.240093
Absolute Values for Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Lactic Acid, Sodium, Phosphorus and Blood Urea Nitrogen (BUN) BUN, Week 60, n=73	4.84884 Millimoles per liter Standard Deviation 1.312435
Absolute Values for Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Lactic Acid, Sodium, Phosphorus and Blood Urea Nitrogen (BUN) BUN, Week 72, n=73	4.86889 Millimoles per liter Standard Deviation 1.090615
Absolute Values for Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Lactic Acid, Sodium, Phosphorus and Blood Urea Nitrogen (BUN) BUN, Week 84, n=72	4.70000 Millimoles per liter Standard Deviation 1.441539
Absolute Values for Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Lactic Acid, Sodium, Phosphorus and Blood Urea Nitrogen (BUN) BUN, Week 96, n=72	4.65389 Millimoles per liter Standard Deviation 1.214425

SECONDARY outcome

Timeframe: Baseline (Day 1, Pre-dose) and at Weeks 4, 12, 24, 36, 48, 60, 72, 84 and 96

Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Blood samples were collected for the analysis of clinical chemistry parameter, creatinine clearance. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.

Outcome measures

Outcome measures
Measure	Tenofovir Disoproxil Fumarate n=75 Participants Participants with on-going ETV treatment were switched to TDF treatment on Day 1. Participants then started with TDF on the day ETV was discontinued, without any overlapping treatment periods. All participants received one tablet of TDF 300 milligram (mg) once daily orally for 96 weeks.
Absolute Values for Clinical Chemistry Parameter: Creatinine Clearance Week 36, n=73	105.23 Milliliters per minute Standard Deviation 23.739
Absolute Values for Clinical Chemistry Parameter: Creatinine Clearance Week 48, n=73	105.50 Milliliters per minute Standard Deviation 24.333
Absolute Values for Clinical Chemistry Parameter: Creatinine Clearance Week 60, n=73	107.51 Milliliters per minute Standard Deviation 25.719
Absolute Values for Clinical Chemistry Parameter: Creatinine Clearance Week 72, n=73	106.73 Milliliters per minute Standard Deviation 24.278
Absolute Values for Clinical Chemistry Parameter: Creatinine Clearance Baseline (Day 1), n=75	114.06 Milliliters per minute Standard Deviation 23.849
Absolute Values for Clinical Chemistry Parameter: Creatinine Clearance Week 4, n=75	112.50 Milliliters per minute Standard Deviation 25.283
Absolute Values for Clinical Chemistry Parameter: Creatinine Clearance Week 12, n=74	108.76 Milliliters per minute Standard Deviation 24.634
Absolute Values for Clinical Chemistry Parameter: Creatinine Clearance Week 24, n=74	108.86 Milliliters per minute Standard Deviation 24.963
Absolute Values for Clinical Chemistry Parameter: Creatinine Clearance Week 84, n=72	104.00 Milliliters per minute Standard Deviation 23.511
Absolute Values for Clinical Chemistry Parameter: Creatinine Clearance Week 96, n=72	101.47 Milliliters per minute Standard Deviation 23.705

SECONDARY outcome

Timeframe: Baseline (Day 1, Pre-dose) and at Weeks 4, 12, 24, 36, 48, 60, 72, 84 and 96

Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Blood samples were collected for the analysis of clinical chemistry parameter, GFR. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.

Outcome measures

Outcome measures
Measure	Tenofovir Disoproxil Fumarate n=75 Participants Participants with on-going ETV treatment were switched to TDF treatment on Day 1. Participants then started with TDF on the day ETV was discontinued, without any overlapping treatment periods. All participants received one tablet of TDF 300 milligram (mg) once daily orally for 96 weeks.
Absolute Values for Clinical Chemistry Parameter: Glomerular Filtration Rate (GFR) Baseline (Day 1), n=75	1.46981 Milliliters per second per 1.73*meter^2 Standard Deviation 0.260068
Absolute Values for Clinical Chemistry Parameter: Glomerular Filtration Rate (GFR) Week 4, n=75	1.43825 Milliliters per second per 1.73*meter^2 Standard Deviation 0.260661
Absolute Values for Clinical Chemistry Parameter: Glomerular Filtration Rate (GFR) Week 12, n=74	1.39282 Milliliters per second per 1.73*meter^2 Standard Deviation 0.241198
Absolute Values for Clinical Chemistry Parameter: Glomerular Filtration Rate (GFR) Week 24, n=74	1.40228 Milliliters per second per 1.73*meter^2 Standard Deviation 0.238776
Absolute Values for Clinical Chemistry Parameter: Glomerular Filtration Rate (GFR) Week 36, n=73	1.37971 Milliliters per second per 1.73*meter^2 Standard Deviation 0.235498
Absolute Values for Clinical Chemistry Parameter: Glomerular Filtration Rate (GFR) Week 48, n=73	1.38564 Milliliters per second per 1.73*meter^2 Standard Deviation 0.250919
Absolute Values for Clinical Chemistry Parameter: Glomerular Filtration Rate (GFR) Week 60, n=73	1.39501 Milliliters per second per 1.73*meter^2 Standard Deviation 0.246331
Absolute Values for Clinical Chemistry Parameter: Glomerular Filtration Rate (GFR) Week 72, n=73	1.38998 Milliliters per second per 1.73*meter^2 Standard Deviation 0.243750
Absolute Values for Clinical Chemistry Parameter: Glomerular Filtration Rate (GFR) Week 84, n=72	1.36299 Milliliters per second per 1.73*meter^2 Standard Deviation 0.233140
Absolute Values for Clinical Chemistry Parameter: Glomerular Filtration Rate (GFR) Week 96, n=72	1.34355 Milliliters per second per 1.73*meter^2 Standard Deviation 0.239422

SECONDARY outcome

Timeframe: At Weeks 36, 48, 60, 72, 84 and 96

Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Blood samples were collected for the analysis of hematology parameter: basophils. Mean and standard deviation values for percentage of basophils reported was presented.

Outcome measures

Outcome measures
Measure	Tenofovir Disoproxil Fumarate n=73 Participants Participants with on-going ETV treatment were switched to TDF treatment on Day 1. Participants then started with TDF on the day ETV was discontinued, without any overlapping treatment periods. All participants received one tablet of TDF 300 milligram (mg) once daily orally for 96 weeks.
Percentage of Basophils at Indicated Time Points Week 36, n=32	0.46 Percentage of basophils Standard Deviation 0.240
Percentage of Basophils at Indicated Time Points Week 48, n=73	0.49 Percentage of basophils Standard Deviation 0.303
Percentage of Basophils at Indicated Time Points Week 60, n=73	0.57 Percentage of basophils Standard Deviation 0.453
Percentage of Basophils at Indicated Time Points Week 72, n=73	0.50 Percentage of basophils Standard Deviation 0.319
Percentage of Basophils at Indicated Time Points Week 84, n=72	0.54 Percentage of basophils Standard Deviation 0.305
Percentage of Basophils at Indicated Time Points Week 96, n=72	0.57 Percentage of basophils Standard Deviation 0.376

SECONDARY outcome

Timeframe: At Weeks 36 , 48, 60, 72, 84 and 96

Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Blood samples were collected for the analysis of hematology parameter: eosinophils. Mean and standard deviation values for percentage of eosinophils reported was presented.

Outcome measures

Outcome measures
Measure	Tenofovir Disoproxil Fumarate n=73 Participants Participants with on-going ETV treatment were switched to TDF treatment on Day 1. Participants then started with TDF on the day ETV was discontinued, without any overlapping treatment periods. All participants received one tablet of TDF 300 milligram (mg) once daily orally for 96 weeks.
Percentage of Eosinophils at Indicated Time Points Week 36, n=32	2.44 Percentage of eosinophils Standard Deviation 1.767
Percentage of Eosinophils at Indicated Time Points Week 48, n=73	2.94 Percentage of eosinophils Standard Deviation 2.667
Percentage of Eosinophils at Indicated Time Points Week 60, n=73	2.85 Percentage of eosinophils Standard Deviation 2.298
Percentage of Eosinophils at Indicated Time Points Week 72, n=73	3.09 Percentage of eosinophils Standard Deviation 2.519
Percentage of Eosinophils at Indicated Time Points Week 84, n=72	2.84 Percentage of eosinophils Standard Deviation 2.042
Percentage of Eosinophils at Indicated Time Points Week 96, n=72	2.57 Percentage of eosinophils Standard Deviation 2.145

SECONDARY outcome

Timeframe: At Weeks 36, 48, 60, 72, 84 and 96

Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Blood samples were collected for the analysis of hematology parameter: lymphocytes. Mean and standard deviation values for percentage of lymphocytes reported was presented.

Outcome measures

Outcome measures
Measure	Tenofovir Disoproxil Fumarate n=73 Participants Participants with on-going ETV treatment were switched to TDF treatment on Day 1. Participants then started with TDF on the day ETV was discontinued, without any overlapping treatment periods. All participants received one tablet of TDF 300 milligram (mg) once daily orally for 96 weeks.
Percentage of Lymphocytes at Indicated Time Points Week 36, n=32	33.34 Percentage of lymphocytes Standard Deviation 8.858
Percentage of Lymphocytes at Indicated Time Points Week 48, n=73	32.39 Percentage of lymphocytes Standard Deviation 8.516
Percentage of Lymphocytes at Indicated Time Points Week 60, n=73	32.73 Percentage of lymphocytes Standard Deviation 7.541
Percentage of Lymphocytes at Indicated Time Points Week 72, n=73	32.29 Percentage of lymphocytes Standard Deviation 8.579
Percentage of Lymphocytes at Indicated Time Points Week 84, n=72	31.94 Percentage of lymphocytes Standard Deviation 7.424
Percentage of Lymphocytes at Indicated Time Points Week 96, n=72	32.98 Percentage of lymphocytes Standard Deviation 8.215

SECONDARY outcome

Timeframe: At Weeks 36, 48, 60, 72, 84 and 96

Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Blood samples were collected for the analysis of hematology parameter: monocytes. Mean and standard deviation values for percentage of monocytes reported was presented.

Outcome measures

Outcome measures
Measure	Tenofovir Disoproxil Fumarate n=73 Participants Participants with on-going ETV treatment were switched to TDF treatment on Day 1. Participants then started with TDF on the day ETV was discontinued, without any overlapping treatment periods. All participants received one tablet of TDF 300 milligram (mg) once daily orally for 96 weeks.
Percentage of Monocytes at Indicated Time Points Week 36, n=32	5.30 Percentage of monocytes Standard Deviation 1.492
Percentage of Monocytes at Indicated Time Points Week 48, n=73	5.46 Percentage of monocytes Standard Deviation 1.598
Percentage of Monocytes at Indicated Time Points Week 60, n=73	5.65 Percentage of monocytes Standard Deviation 1.430
Percentage of Monocytes at Indicated Time Points Week 72, n=73	5.67 Percentage of monocytes Standard Deviation 1.814
Percentage of Monocytes at Indicated Time Points Week 84, n=72	5.71 Percentage of monocytes Standard Deviation 1.562
Percentage of Monocytes at Indicated Time Points Week 96, n=72	5.45 Percentage of monocytes Standard Deviation 1.475

SECONDARY outcome

Timeframe: At Weeks 36, 48, 60, 72, 84 and 96

Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Blood samples were collected for the analysis of hematology parameter: total neutrophils. Mean and standard deviation values for percentage of neutrophils reported was presented.

Outcome measures

Outcome measures
Measure	Tenofovir Disoproxil Fumarate n=73 Participants Participants with on-going ETV treatment were switched to TDF treatment on Day 1. Participants then started with TDF on the day ETV was discontinued, without any overlapping treatment periods. All participants received one tablet of TDF 300 milligram (mg) once daily orally for 96 weeks.
Percentage of Total Neutrophils at Indicated Time Points Week 60, n=73	58.20 Percentage of neutrophils Standard Deviation 8.176
Percentage of Total Neutrophils at Indicated Time Points Week 72, n=73	58.45 Percentage of neutrophils Standard Deviation 9.109
Percentage of Total Neutrophils at Indicated Time Points Week 36, n=32	58.46 Percentage of neutrophils Standard Deviation 8.658
Percentage of Total Neutrophils at Indicated Time Points Week 48, n=73	58.72 Percentage of neutrophils Standard Deviation 8.709
Percentage of Total Neutrophils at Indicated Time Points Week 84, n=72	58.97 Percentage of neutrophils Standard Deviation 7.881
Percentage of Total Neutrophils at Indicated Time Points Week 96, n=72	58.43 Percentage of neutrophils Standard Deviation 8.973

SECONDARY outcome

Timeframe: Baseline (Day 1, Pre-dose) and at Weeks 4, 12, 24, 36, 48, 60, 72, 84 and 96

Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Blood samples were collected for the analysis of hematology parameter, hemoglobin. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.

Outcome measures

Outcome measures
Measure	Tenofovir Disoproxil Fumarate n=75 Participants Participants with on-going ETV treatment were switched to TDF treatment on Day 1. Participants then started with TDF on the day ETV was discontinued, without any overlapping treatment periods. All participants received one tablet of TDF 300 milligram (mg) once daily orally for 96 weeks.
Absolute Values for Hematology Parameter: Hemoglobin Baseline (Day 1), n=75	148.2 Grams per liter Standard Deviation 13.13
Absolute Values for Hematology Parameter: Hemoglobin Week 4, n=75	148.9 Grams per liter Standard Deviation 13.40
Absolute Values for Hematology Parameter: Hemoglobin Week 12, n=74	148.4 Grams per liter Standard Deviation 14.41
Absolute Values for Hematology Parameter: Hemoglobin Week 24, n=74	146.3 Grams per liter Standard Deviation 14.28
Absolute Values for Hematology Parameter: Hemoglobin Week 36, n=73	144.1 Grams per liter Standard Deviation 15.58
Absolute Values for Hematology Parameter: Hemoglobin Week 48, n=73	146.5 Grams per liter Standard Deviation 15.81
Absolute Values for Hematology Parameter: Hemoglobin Week 60, n=73	147.1 Grams per liter Standard Deviation 14.93
Absolute Values for Hematology Parameter: Hemoglobin Week 72, n=73	146.4 Grams per liter Standard Deviation 14.95
Absolute Values for Hematology Parameter: Hemoglobin Week 84, n=72	144.6 Grams per liter Standard Deviation 16.01
Absolute Values for Hematology Parameter: Hemoglobin Week 96, n=72	146.4 Grams per liter Standard Deviation 16.07

SECONDARY outcome

Timeframe: Baseline (Day 1, Pre-dose) and at Weeks 4, 12, 24, 36, 48, 60, 72, 84 and 96

Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Blood samples were collected for the analysis of hematology parameter, hematocrit. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.

Outcome measures

Outcome measures
Measure	Tenofovir Disoproxil Fumarate n=75 Participants Participants with on-going ETV treatment were switched to TDF treatment on Day 1. Participants then started with TDF on the day ETV was discontinued, without any overlapping treatment periods. All participants received one tablet of TDF 300 milligram (mg) once daily orally for 96 weeks.
Absolute Values for Hematology Parameter: Hematocrit Baseline (Day 1), n=75	0.4393 Proportion of red blood cells in blood Standard Deviation 0.03331
Absolute Values for Hematology Parameter: Hematocrit Week 4, n=75	0.4441 Proportion of red blood cells in blood Standard Deviation 0.03475
Absolute Values for Hematology Parameter: Hematocrit Week 12, n=74	0.4452 Proportion of red blood cells in blood Standard Deviation 0.03679
Absolute Values for Hematology Parameter: Hematocrit Week 24, n=74	0.4367 Proportion of red blood cells in blood Standard Deviation 0.03550
Absolute Values for Hematology Parameter: Hematocrit Week 36, n=73	0.4283 Proportion of red blood cells in blood Standard Deviation 0.04156
Absolute Values for Hematology Parameter: Hematocrit Week 48, n=73	0.4350 Proportion of red blood cells in blood Standard Deviation 0.03942
Absolute Values for Hematology Parameter: Hematocrit Week 60, n=73	0.4398 Proportion of red blood cells in blood Standard Deviation 0.03940
Absolute Values for Hematology Parameter: Hematocrit Week 72, n=73	0.4391 Proportion of red blood cells in blood Standard Deviation 0.03817
Absolute Values for Hematology Parameter: Hematocrit Week 84, n=72	0.4339 Proportion of red blood cells in blood Standard Deviation 0.04070
Absolute Values for Hematology Parameter: Hematocrit Week 96, n=72	0.4355 Proportion of red blood cells in blood Standard Deviation 0.04159

SECONDARY outcome

Timeframe: Baseline (Day 1, Pre-dose) and at Weeks 4, 12, 24, 36, 48, 60, 72, 84 and 96

Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Blood samples were collected for the analysis of hematology parameters: platelet count and WBC count. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.

Outcome measures

Outcome measures
Measure	Tenofovir Disoproxil Fumarate n=75 Participants Participants with on-going ETV treatment were switched to TDF treatment on Day 1. Participants then started with TDF on the day ETV was discontinued, without any overlapping treatment periods. All participants received one tablet of TDF 300 milligram (mg) once daily orally for 96 weeks.
Absolute Values for Hematology Parameters: Platelet Count and White Blood Cell (WBC) Count Platelet count, Baseline (Day 1), n=75	226.7 Giga cells per liter Standard Deviation 53.40
Absolute Values for Hematology Parameters: Platelet Count and White Blood Cell (WBC) Count Platelet count, Week 4, n=75	227.1 Giga cells per liter Standard Deviation 57.44
Absolute Values for Hematology Parameters: Platelet Count and White Blood Cell (WBC) Count Platelet count, Week 12, n=74	228.9 Giga cells per liter Standard Deviation 57.67
Absolute Values for Hematology Parameters: Platelet Count and White Blood Cell (WBC) Count Platelet count, Week 24, n=74	226.1 Giga cells per liter Standard Deviation 55.46
Absolute Values for Hematology Parameters: Platelet Count and White Blood Cell (WBC) Count Platelet count, Week 36, n=73	231.4 Giga cells per liter Standard Deviation 65.32
Absolute Values for Hematology Parameters: Platelet Count and White Blood Cell (WBC) Count Platelet count, Week 48, n=73	229.9 Giga cells per liter Standard Deviation 57.37
Absolute Values for Hematology Parameters: Platelet Count and White Blood Cell (WBC) Count Platelet count, Week 60, n=73	231.8 Giga cells per liter Standard Deviation 56.11
Absolute Values for Hematology Parameters: Platelet Count and White Blood Cell (WBC) Count Platelet count, Week 72, n=73	224.9 Giga cells per liter Standard Deviation 53.00
Absolute Values for Hematology Parameters: Platelet Count and White Blood Cell (WBC) Count Platelet count, Week 84, n=72	224.8 Giga cells per liter Standard Deviation 57.64
Absolute Values for Hematology Parameters: Platelet Count and White Blood Cell (WBC) Count Platelet count, Week 96, n=72	226.6 Giga cells per liter Standard Deviation 54.72
Absolute Values for Hematology Parameters: Platelet Count and White Blood Cell (WBC) Count WBC count, Baseline (Day 1), n=75	5.18 Giga cells per liter Standard Deviation 1.558
Absolute Values for Hematology Parameters: Platelet Count and White Blood Cell (WBC) Count WBC count, Week 4, n=75	5.21 Giga cells per liter Standard Deviation 1.525
Absolute Values for Hematology Parameters: Platelet Count and White Blood Cell (WBC) Count WBC count, Week 12, n=74	5.30 Giga cells per liter Standard Deviation 1.380
Absolute Values for Hematology Parameters: Platelet Count and White Blood Cell (WBC) Count WBC count, Week 24, n=74	5.06 Giga cells per liter Standard Deviation 1.279
Absolute Values for Hematology Parameters: Platelet Count and White Blood Cell (WBC) Count WBC count, Week 36, n=73	4.99 Giga cells per liter Standard Deviation 1.320
Absolute Values for Hematology Parameters: Platelet Count and White Blood Cell (WBC) Count WBC count, Week 48, n=73	5.16 Giga cells per liter Standard Deviation 1.674
Absolute Values for Hematology Parameters: Platelet Count and White Blood Cell (WBC) Count WBC count, Week 60, n=73	4.84 Giga cells per liter Standard Deviation 1.247
Absolute Values for Hematology Parameters: Platelet Count and White Blood Cell (WBC) Count WBC count, Week 72, n=73	5.00 Giga cells per liter Standard Deviation 1.372
Absolute Values for Hematology Parameters: Platelet Count and White Blood Cell (WBC) Count WBC count, Week 84, n=72	5.00 Giga cells per liter Standard Deviation 1.338
Absolute Values for Hematology Parameters: Platelet Count and White Blood Cell (WBC) Count WBC count, Week 96, n=72	5.08 Giga cells per liter Standard Deviation 1.583

SECONDARY outcome

Timeframe: Baseline (Day 1, Pre-dose) and at Weeks 4, 12, 24, 36, 48, 60, 72, 84 and 96

Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Blood samples were collected for the analysis of hematology parameter, prothrombin time. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.

Outcome measures

Outcome measures
Measure	Tenofovir Disoproxil Fumarate n=75 Participants Participants with on-going ETV treatment were switched to TDF treatment on Day 1. Participants then started with TDF on the day ETV was discontinued, without any overlapping treatment periods. All participants received one tablet of TDF 300 milligram (mg) once daily orally for 96 weeks.
Absolute Values for Hematology Parameter: Prothrombin Time Baseline (Day 1), n=75	11.82 Seconds Standard Deviation 0.632
Absolute Values for Hematology Parameter: Prothrombin Time Week 4, n=75	11.91 Seconds Standard Deviation 0.679
Absolute Values for Hematology Parameter: Prothrombin Time Week 12, n=74	11.95 Seconds Standard Deviation 0.642
Absolute Values for Hematology Parameter: Prothrombin Time Week 24, n=74	11.76 Seconds Standard Deviation 0.627
Absolute Values for Hematology Parameter: Prothrombin Time Week 36, n=73	11.94 Seconds Standard Deviation 0.720
Absolute Values for Hematology Parameter: Prothrombin Time Week 48, n=73	12.71 Seconds Standard Deviation 0.681
Absolute Values for Hematology Parameter: Prothrombin Time Week 60, n=73	12.32 Seconds Standard Deviation 0.613
Absolute Values for Hematology Parameter: Prothrombin Time Week 72, n=73	12.40 Seconds Standard Deviation 0.615
Absolute Values for Hematology Parameter: Prothrombin Time Week 84, n=72	12.58 Seconds Standard Deviation 0.684
Absolute Values for Hematology Parameter: Prothrombin Time Week 96, n=72	12.78 Seconds Standard Deviation 0.766

SECONDARY outcome

Timeframe: Baseline (Day 1, Pre-dose) and at Weeks 4, 12, 24, 36, 48, 60, 72, 84 and 96

Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Blood samples were collected for the analysis of hematology parameter, RBC count. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.

Outcome measures

Outcome measures
Measure	Tenofovir Disoproxil Fumarate n=75 Participants Participants with on-going ETV treatment were switched to TDF treatment on Day 1. Participants then started with TDF on the day ETV was discontinued, without any overlapping treatment periods. All participants received one tablet of TDF 300 milligram (mg) once daily orally for 96 weeks.
Absolute Values for Hematology Parameter: Red Blood Cell (RBC) Count Week 96, n=72	4.777 Trillion cells per liter Standard Deviation 0.4440
Absolute Values for Hematology Parameter: Red Blood Cell (RBC) Count Baseline (Day 1), n=75	4.785 Trillion cells per liter Standard Deviation 0.4087
Absolute Values for Hematology Parameter: Red Blood Cell (RBC) Count Week 4, n=75	4.841 Trillion cells per liter Standard Deviation 0.4154
Absolute Values for Hematology Parameter: Red Blood Cell (RBC) Count Week 12, n=74	4.865 Trillion cells per liter Standard Deviation 0.4358
Absolute Values for Hematology Parameter: Red Blood Cell (RBC) Count Week 24, n=74	4.820 Trillion cells per liter Standard Deviation 0.4061
Absolute Values for Hematology Parameter: Red Blood Cell (RBC) Count Week 36, n=73	4.704 Trillion cells per liter Standard Deviation 0.4473
Absolute Values for Hematology Parameter: Red Blood Cell (RBC) Count Week 48, n=73	4.780 Trillion cells per liter Standard Deviation 0.4026
Absolute Values for Hematology Parameter: Red Blood Cell (RBC) Count Week 60, n=73	4.819 Trillion cells per liter Standard Deviation 0.4288
Absolute Values for Hematology Parameter: Red Blood Cell (RBC) Count Week 72, n=73	4.793 Trillion cells per liter Standard Deviation 0.4058
Absolute Values for Hematology Parameter: Red Blood Cell (RBC) Count Week 84, n=72	4.757 Trillion cells per liter Standard Deviation 0.4314

SECONDARY outcome

Timeframe: Weeks 4, 12, 24, 36 and 48

Population: Safety Population.

Urine samples were collected for analysis of urinalysis data for glucose, protein and urinary sediment by dipstick method. The urine sediments analyzed were amorphous phosphate crystals, amorphous urate crystals, bacteria, calcium oxalate crystals, ammonium magnesium phosphate, renal tubular epithelial cells (RTEC), fungi, hyaline casts, mucous threads, RBCs, spermatozoa, squamous epithelial cells (SEC), transitional epithelial cells (TEC), uric acid crystals (UAC) and WBCs. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters can be read as Trace, 1+, 2+ and 3+, indicating proportional concentrations in the urine sample. Results for RTEC, hyaline casts, RBC, SEC, TEC and WBC can be read as counts per field (some/ every/ whole field). Only abnormal parameters and participants with abnormal data has been reported.

Outcome measures

Outcome measures
Measure	Tenofovir Disoproxil Fumarate n=75 Participants Participants with on-going ETV treatment were switched to TDF treatment on Day 1. Participants then started with TDF on the day ETV was discontinued, without any overlapping treatment periods. All participants received one tablet of TDF 300 milligram (mg) once daily orally for 96 weeks.
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 Bacteria, Week 24, 1+	6 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 Bacteria, Week 48, 2+	1 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 RTEC, Week 36, 0-0.1/Some Field	19 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 Fungi, Week 24, 1+	1 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 Urine glucose, Week 12, 2+	1 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 Urine glucose, Week 48, Trace	1 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 Hyaline casts, Week 4, 0-0.1/Some Field	6 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 Hyaline casts, Week 24, 0-0.1/Some Field	1 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 Hyaline casts, Week 24, 3-5/Whole Field	1 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 Urine protein, Week 4, 1+	1 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 Urine protein, Week 36, 1+	3 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 Urine protein, Week 36, Trace	27 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 RBC, Week 4, 0-0.1/Some Field	35 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 RBC, Week 12, 6-10/Every Field	1 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 RBC, Week 12, 10-20/Every Field	1 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 RBC, Week 24, 0-0.1/Some Field	40 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 RBC, Week 24, 0.2-0.4/Some Field	14 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 RBC, Week 24, 3-5/Every Field	1 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 RBC, Week 24, 10-20/Every Field	1 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 RBC, Week 48, 0-0.1/Some Field	39 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 RBC, Week 48, 0.2-0.4/Some Field	14 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 SEC, Week 4, 3-5/Every Field	2 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 SEC, Week 12, 0.2-0.4/Some Field	9 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 SEC, Week 24, 0-0.1/Some Field	55 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 SEC, Week 48, 6-10/Every Field	1 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 TEC, Week 12, 0-0.1/Some Field	4 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 TEC, Week 24, 0-0.1/Some Field	5 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 UAC, Week 4, 1+	0 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 WBC, Week 24, 1-2/Every Field	5 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 WBC, Week 24, 30-50/Every Field	1 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 WBC, Week 36, 30-50/Every Field	1 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 RTEC, Week 12, 0-0.1/Some Field	25 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 Amorphous phosphate crystals, Week 4, 1+	2 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 Amorphous phosphate crystals, Week 12, 1+	2 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 Amorphous phosphate crystals, Week 24, 1+	3 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 Amorphous phosphate crystals, Week 36, 1+	2 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 Calcium oxalate crystals, Week 12, 1+	9 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 Calcium oxalate crystals, Week 36, 1+	15 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 Amorphous urate crystals, Week 48, 1+	5 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 Bacteria, Week 4, 1+	5 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 Bacteria, Week 12, 1+	11 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 Calcium oxalate crystals, Week 48, 1+	10 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 RTEC, Week 4, 0-0.1/Some Field	23 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 Bacteria, Week 24, 2+	2 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 Bacteria, Week 36, 1+	8 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 Bacteria, Week 48, 1+	11 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 Calcium oxalate crystals, Week 4, 1+	11 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 Amorphous phosphate crystals, Week 48, 1+	2 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 Amorphous urate crystals, Week 4, 1+	3 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 Amorphous urate crystals, Week 12, 1+	6 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 Amorphous urate crystals, Week 24, 1+	8 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 Amorphous urate crystals, Week 36, 1+	5 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 RTEC, Week 4, 0.2-0.4/Some Field	5 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 RTEC, Week 4, 1-2/Every Field	1 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 Calcium oxalate crystals, Week 24, 1+	14 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 RTEC, Week 12, 0.2-0.4/Some Field	4 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 RTEC, Week 24, 1-2/Every Field	1 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 RTEC, Week 24, 0-0.1/Some Field	19 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 RTEC, Week 24, 0.2-0.4/Some Field	2 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 RBC, Week 4, 3-5/Every Field	4 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 RTEC, Week 36, 0.2-0.4/Some Field	2 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 RTEC, Week 36, 1-2/Every Field	1 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 RTEC, Week 48, 0-0.1/Some Field	21 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 RTEC, Week 48, 0.2-0.4/Some Field	5 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 RTEC, Week 48, 1-2/Every Field	3 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 Fungi, Week 4, 1+	0 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 Fungi, Week 12, 1+	0 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 Fungi, Week 36, 1+	0 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 Fungi, Week 48, 1+	0 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 Urine glucose, Week 4, 1+	1 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 Urine glucose, Week 4, Trace	1 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 Urine glucose, Week 12, Trace	1 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 Urine glucose, Week 24, 3+	1 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 Urine glucose, Week 36, Trace	2 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 Urine glucose, Week 48, 1+	1 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 Hyaline casts, Week 12, 0-0.1/Some Field	3 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 Hyaline casts, Week 12, 3-5/Whole Field	2 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 Hyaline casts, Week 24, 1-2/Whole Field	3 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 Hyaline casts, Week 36, 0-0.1/Some Field	1 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 Hyaline casts, Week 36, 0.2-0.4/Some Field	1 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 Hyaline casts, Week 36, 1-2/Every Field	1 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 Hyaline casts, Week 36, 1-2/Whole Field	1 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 Hyaline casts, Week 48, 0-0.1/Some Field	3 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 Hyaline casts, Week 48, 0.2-0.4/Some Field	1 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 Mucus threads, Week 4, 1+	17 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 Mucus threads, Week 12, 1+	21 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 Mucus threads, Week 24, 1+	23 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 Mucus threads, Week 36, 1+	25 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 Mucus threads, Week 48, 1+	22 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 Urine protein, Week 4, 2+	1 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 RBC, Week 4, 6-10/Every Field	3 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 Urine protein, Week 4, Trace	15 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 Urine protein, Week 12, 1+	2 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 Urine protein, Week 12, Trace	24 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 Urine protein, Week 24, 1+	4 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 Urine protein, Week 24, 2+	1 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 Urine protein, Week 24, Trace	28 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 Urine protein, Week 36, 2+	1 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 Urine protein, Week 48, Trace	15 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 Urine glucose, Week 48, 3+	1 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 RBC, Week 12, numerous/Every Field	1 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 RBC, Week 12, 0-0.1/Some Field	33 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 RBC, Week 12, 0.2-0.4/Some Field	23 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 RBC, Week 12, 1-2/Every Field	11 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 RBC, Week 12, 3-5/Every Field	4 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 RBC, Week 24, 1-2/Every Field	14 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 RBC, Week 24, 6-10/Every Field	2 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 RBC, Week 24, 20-30/Every Field	2 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 RBC, Week 36, 0-0.1/Some Field	42 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 RBC, Week 36, 0.2-0.4/Some Field	20 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 RBC, Week 36, 1-2/Every Field	7 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 RBC, Week 36, 3-5/Every Field	1 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 RBC, Week 36, 6-10/Every Field	2 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 RBC, Week 36, 10-20/Every Field	1 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 RBC, Week 48, 1-2/Every Field	14 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 RBC, Week 48, 3-5/Every Field	3 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 RBC, Week 48, 6-10/Every Field	2 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 RBC, Week 48, 10-20/Every Field	1 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 Spermatozoa, Week 4, 1+	1 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 Spermatozoa, Week 12, 1+	0 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 Spermatozoa, Week 24, 1+	2 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 Spermatozoa, Week 36, 1+	3 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 Spermatozoa, Week 48, 1+	0 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 SEC, Week 4, 0-0.1/Some Field	58 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 SEC, Week 4, 0.2-0.4/Some Field	7 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 SEC, Week 4, 1-2/Every Field	7 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 SEC, Week 4, 10-20/Every Field	1 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 SEC, Week 12, 0-0.1/Some Field	54 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 SEC, Week 12, 1-2/Every Field	6 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 SEC, Week 12, 3-5/Every Field	2 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 SEC, Week 12, 6-10/Every Field	1 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 SEC, Week 12, 10-20/Every Field	1 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 SEC, Week 12, 30-50/Every Field	1 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 SEC, Week 24, 0.2-0.4/Some Field	6 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 SEC, Week 24, 1-2/Every Field	8 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 SEC, Week 24, 3-5/Every Field	1 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 SEC, Week 24, 6-10/Every Field	1 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 SEC, Week 24, 10-20/Every Field	2 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 SEC, Week 24, 20-30/Every Field	1 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 SEC, Week 36, 0-0.1/Some Field	59 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 SEC, Week 36, 0.2-0.4/Some Field	4 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 SEC, Week 36, 1-2/Every Field	9 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 SEC, Week 36, 3-5/Every Field	1 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 SEC, Week 48, 0-0.1/Some Field	58 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 SEC, Week 48, 0.2-0.4/Some Field	4 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 SEC, Week 48, 1-2/Every Field	5 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 SEC, Week 48, 3-5/Every Field	5 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 TEC, Week 4, 0-0.1/Some Field	4 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 TEC, Week 24, 0.2-0.4/Some Field	2 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 TEC, Week 36, 0-0.1/Some Field	3 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 TEC, Week 36, 0.2-0.4/Some Field	1 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 TEC, Week 36, 1-2/Every Field	1 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 TEC, Week 48, 0-0.1/Some Field	5 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 UAC, Week 12, 1+	0 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 UAC, Week 24, 1+	0 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 UAC, Week 36, 1+	2 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 UAC, Week 48, 1+	1 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 WBC, Week 4, 0-0.1/Some Field	35 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 WBC, Week 4, 0.2-0.4/Some Field	27 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 WBC, Week 4, 1-2/Every Field	10 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 WBC, Week 4, 3-5/Every Field	1 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 WBC, Week 4, 10-20/Every Field	2 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 WBC, Week 12, 0-0.1/Some Field	37 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 WBC, Week 12, 0.2-0.4/Some Field	22 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 WBC, Week 12, 1-2/Every Field	8 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 WBC, Week 12, 3-5/Every Field	6 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 WBC, Week 12, 6-10/Every Field	1 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 WBC, Week 24, 0-0.1/Some Field	42 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 WBC, Week 24, 0.2-0.4/Some Field	20 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 WBC, Week 24, 3-5/Every Field	3 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 WBC, Week 24, 6-10/Every Field	1 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 WBC, Week 24, 10-20/Every Field	2 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 WBC, Week 36, 0-0.1/Some Field	45 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 WBC, Week 36, 0.2-0.4/Some Field	20 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 WBC, Week 36, 1-2/Every Field	1 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 WBC, Week 36, 3-5/Every Field	4 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 WBC, Week 36, 6-10/Every Field	2 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 WBC, Week 48, 0-0.1/Some Field	43 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 WBC, Week 48, 0.2-0.4/Some Field	14 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 WBC, Week 48, 1-2/Every Field	11 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 WBC, Week 48, 3-5/Every Field	2 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 WBC, Week 48, 6-10/Every Field	2 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 RBC, Week 4, 0.2-0.4/Some Field	20 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 RBC, Week 4, 1-2/Every Field	13 Participants

SECONDARY outcome

Timeframe: Weeks 60, 72, 84 and 96

Population: Safety Population.

Outcome measures

Outcome measures
Measure	Tenofovir Disoproxil Fumarate n=75 Participants Participants with on-going ETV treatment were switched to TDF treatment on Day 1. Participants then started with TDF on the day ETV was discontinued, without any overlapping treatment periods. All participants received one tablet of TDF 300 milligram (mg) once daily orally for 96 weeks.
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 Amorphous phosphate crystals, Week 60, 1+	2 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 Calcium oxalate crystals, Week 60, 1+	14 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 RTEC, Week 84, 3-5/Every Field	1 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 RTEC, Week 96, 0-0.1/Some Field	15 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 RTEC, Week 96, 0.2-0.4/Some Field	2 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 Hyaline casts, Week 72, 0-0.1/Some Field	4 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 Hyaline casts, Week 72, 0.2-0.4/Some Field	1 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 Hyaline casts, Week 84, 0-0.1/Some Field	2 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 Mucus threads, Week 60, 1+	27 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 Urine protein, Week 60, 1+	1 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 Urine protein, Week 60, Trace	11 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 Urine protein, Week 72, 1+	2 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 SEC, Week 60, 10-20/Every Field	2 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 WBC, Week 60, 0.2-0.4/Some Field	19 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 Urine protein, Week 96, Trace	11 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 RBC, Week 60, 0-0.1/Some Field	35 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 RBC, Week 60, 0.2-0.4/Some Field	17 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 RBC, Week 60, 1-2/Every Field	12 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 RBC, Week 60, 3-5/Every Field	5 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 RBC, Week 60, 6-10/Every Field	1 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 RBC, Week 60, 10-20/Every Field	2 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 RBC, Week 60, 30-50/Every Field	1 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 Amorphous phosphate crystals, Week 72, 1+	2 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 Amorphous phosphate crystals, Week 84, 1+	2 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 Amorphous urate crystals, Week 60, 1+	3 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 Amorphous urate crystals, Week 72, 1+	2 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 Amorphous urate crystals, Week 84, 1+	8 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 Amorphous urate crystals, Week 96, 1+	3 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 Bacteria, Week 60, 1+	15 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 Bacteria, Week 72, 1+	7 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 Bacteria, Week 72, 2+	3 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 Bacteria, Week 84, 1+	9 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 Bacteria, Week 84, 2+	2 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 Bacteria, Week 96, 1+	9 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 Bacteria, Week 96, 2+	1 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 Calcium oxalate crystals, Week 72, 1+	12 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 Calcium oxalate crystals, Week 84, 1+	16 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 Calcium oxalate crystals, Week 96, 1+	4 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 RTEC, Week 60, 0-0.1/Some Field	19 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 RTEC, Week 60, 0.2-0.4/Some Field	7 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 RTEC, Week 60, 1-2/Every Field	1 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 RTEC, Week 72, 0-0.1/Some Field	14 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 RTEC, Week 72, 0.2-0.4/Some Field	5 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 RTEC, Week 84, 0-0.1/Some Field	9 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 RTEC, Week 84, 0.2-0.4/Some Field	4 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 RTEC, Week 84, 1-2/Every Field	2 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 RTEC, Week 96, 1-2/Every Field	1 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 Urine glucose, Week 60, 3+	1 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 Urine glucose, Week 72, 1+	1 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 Urine glucose, Week 72, 2+	1 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 Hyaline casts, Week 60, 0-0.1/Some Field	4 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 Hyaline casts, Week 84, 1-2/Whole Field	1 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 Hyaline casts, Week 84, 3-5/Whole Field	1 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 Hyaline casts, Week 96, 0-0.1/Some Field	2 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 Hyaline casts, Week 96, 0.2-0.4/Some Field	1 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 Hyaline casts, Week 96, 3-5/Whole Field	3 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 Mucus threads, Week 72, 1+	15 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 Mucus threads, Week 84, 1+	18 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 Mucus threads, Week 96, 1+	19 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 RBC, Week 72, 0-0.1/Some Field	45 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 Urine protein, Week 72, Trace	14 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 RBC, Week 72, 0.2-0.4/Some Field	11 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 Urine protein, Week 84, 1+	2 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 Urine protein, Week 84, Trace	17 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 Urine protein, Week 96, 1+	3 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 RBC, Week 72, 1-2/Every Field	12 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 RBC, Week 72, 3-5/Every Field	3 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 RBC, Week 72, 30-50/Every Field	2 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 RBC, Week 84, many/Every Field	1 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 RBC, Week 84, 0-0.1/Some Field	40 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 RBC, Week 84, 0.2-0.4/Some Field	9 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 RBC, Week 84, 1-2/Every Field	15 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 RBC, Week 84, 3-5/Every Field	3 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 RBC, Week 84, 6-10/Every Field	2 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 RBC, Week 84, 20-30/Every Field	1 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 RBC, Week 84, 30-50/Every Field	1 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 RBC, Week 96, many/Every Field	1 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 RBC, Week 96, 0-0.1/Some Field	44 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 RBC, Week 96, 0.2-0.4/Some Field	11 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 RBC, Week 96, 1-2/Every Field	11 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 RBC, Week 96, 3-5/Every Field	4 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 RBC, Week 96, 10-20/Every Field	1 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 Spermatozoa, Week 84, 1+	1 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 SEC, Week 60, 0-0.1/Some Field	52 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 SEC, Week 60, 0.2-0.4/Some Field	7 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 SEC, Week 60, 1-2/Every Field	9 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 SEC, Week 60, 3-5/Every Field	2 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 SEC, Week 60, 20-30/Every Field	1 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 SEC, Week 72, 0-0.1/Some Field	55 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 SEC, Week 72, 0.2-0.4/Some Field	6 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 SEC, Week 72, 1-2/Every Field	5 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 SEC, Week 72, 3-5/Every Field	1 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 SEC, Week 72, 6-10/Every Field	2 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 SEC, Week 72, 10-20/Every Field	1 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 SEC, Week 72, 20-30/Every Field	3 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 SEC, Week 84, many/Every Field	1 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 SEC, Week 84, 0-0.1/Some Field	52 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 SEC, Week 84, 0.2-0.4/Some Field	8 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 SEC, Week 84, 1-2/Every Field	5 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 SEC, Week 84, 3-5/Every Field	4 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 SEC, Week 84, 6-10/Every Field	2 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 SEC, Week 96, 0-0.1/Some Field	56 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 SEC, Week 96, 0.2-0.4/Some Field	4 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 SEC, Week 96, 1-2/Every Field	8 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 SEC, Week 96, 3-5/Every Field	1 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 SEC, Week 96, 6-10/Every Field	2 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 SEC, Week 96, 10-20/Every Field	1 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 TEC, Week 60, 0-0.1/Some Field	3 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 TEC, Week 60, 0.2-0.4/Some Field	1 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 TEC, Week 72, 0-0.1/Some Field	7 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 TEC, Week 84, 0-0.1/Some Field	3 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 TEC, Week 96, 0-0.1/Some Field	5 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 UAC, Week 60, 1+	1 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 UAC, Week 72, 1+	1 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 UAC, Week 96, 1+	2 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 WBC, Week 60, 0-0.1/Some Field	38 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 WBC, Week 60, 1-2/Every Field	12 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 WBC, Week 60, 3-5/Every Field	2 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 WBC, Week 60, 6-10/Every Field	1 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 WBC, Week 60, 10-20/Every Field	1 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 WBC, Week 72, 0-0.1/Some Field	39 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 WBC, Week 72, 0.2-0.4/Some Field	19 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 WBC, Week 72, 1-2/Every Field	7 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 WBC, Week 72, 3-5/Every Field	2 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 WBC, Week 72, 6-10/Every Field	5 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 WBC, Week 72, 30-50/Every Field	1 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 WBC, Week 84, many/Every Field	2 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 WBC, Week 84, 0-0.1/Some Field	47 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 WBC, Week 84, 0.2-0.4/Some Field	12 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 WBC, Week 84, 1-2/Every Field	6 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 WBC, Week 84, 10-20/Every Field	3 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 WBC, Week 84, 20-30/Every Field	1 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 WBC, Week 84, 30-50/Every Field	1 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 WBC, Week 96, 0-0.1/Some Field	41 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 WBC, Week 96, 0.2-0.4/Some Field	18 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 WBC, Week 96, 1-2/Every Field	8 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 WBC, Week 96, 6-10/Every Field	4 Participants
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 WBC, Week 96, 20-30/Every Field	1 Participants

SECONDARY outcome

Timeframe: Baseline (Day 1, Pre-dose) and at Weeks 4, 12, 24, 36, 48, 60, 72, 84 and 96

Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Urine samples were collected for analysis of urinalysis data for beta-2-microglobulin. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is calculated as the value at the post-dose visit minus the Baseline value.

Outcome measures

Outcome measures
Measure	Tenofovir Disoproxil Fumarate n=75 Participants Participants with on-going ETV treatment were switched to TDF treatment on Day 1. Participants then started with TDF on the day ETV was discontinued, without any overlapping treatment periods. All participants received one tablet of TDF 300 milligram (mg) once daily orally for 96 weeks.
Change From Baseline Values for Beta-2-microglobulin Week 4, n=75	206.9 Micrograms per liter Standard Deviation 593.69
Change From Baseline Values for Beta-2-microglobulin Week 12, n=74	254.6 Micrograms per liter Standard Deviation 891.36
Change From Baseline Values for Beta-2-microglobulin Week 24, n=74	392.7 Micrograms per liter Standard Deviation 1544.73
Change From Baseline Values for Beta-2-microglobulin Week 36, n=73	261.1 Micrograms per liter Standard Deviation 715.81
Change From Baseline Values for Beta-2-microglobulin Week 48, n=73	206.8 Micrograms per liter Standard Deviation 580.77
Change From Baseline Values for Beta-2-microglobulin Week 60, n=73	309.4 Micrograms per liter Standard Deviation 651.85
Change From Baseline Values for Beta-2-microglobulin Week 72, n=73	235.7 Micrograms per liter Standard Deviation 542.52
Change From Baseline Values for Beta-2-microglobulin Week 84, n=72	271.3 Micrograms per liter Standard Deviation 616.86
Change From Baseline Values for Beta-2-microglobulin Week 96, n=72	196.1 Micrograms per liter Standard Deviation 478.68

SECONDARY outcome

Timeframe: Baseline (Day 1, Pre-dose) and at Weeks 4, 12, 24, 36, 48, 60, 72, 84 and 96

Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Urine samples were collected for analysis of urinalysis data for urine creatinine concentration and urine phosphate. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is calculated as the value at the post-dose visit minus the Baseline value.

Outcome measures

Outcome measures
Measure	Tenofovir Disoproxil Fumarate n=75 Participants Participants with on-going ETV treatment were switched to TDF treatment on Day 1. Participants then started with TDF on the day ETV was discontinued, without any overlapping treatment periods. All participants received one tablet of TDF 300 milligram (mg) once daily orally for 96 weeks.
Change From Baseline Values for Urine Creatinine Concentration and Urine Phosphate Urine phosphate, Week 36, n=73	0.85 Milligrams per deciliter Standard Deviation 36.016
Change From Baseline Values for Urine Creatinine Concentration and Urine Phosphate Urine Creatinine, Week 4, n=75	-5.353 Milligrams per deciliter Standard Deviation 64.9427
Change From Baseline Values for Urine Creatinine Concentration and Urine Phosphate Urine Creatinine, Week 12, n=74	2.047 Milligrams per deciliter Standard Deviation 70.1488
Change From Baseline Values for Urine Creatinine Concentration and Urine Phosphate Urine Creatinine, Week 24, n=74	11.715 Milligrams per deciliter Standard Deviation 78.3996
Change From Baseline Values for Urine Creatinine Concentration and Urine Phosphate Urine Creatinine, Week 36, n=73	15.849 Milligrams per deciliter Standard Deviation 67.4606
Change From Baseline Values for Urine Creatinine Concentration and Urine Phosphate Urine Creatinine, Week 48, n=73	4.674 Milligrams per deciliter Standard Deviation 71.2417
Change From Baseline Values for Urine Creatinine Concentration and Urine Phosphate Urine Creatinine, Week 60, n=73	5.567 Milligrams per deciliter Standard Deviation 58.5998
Change From Baseline Values for Urine Creatinine Concentration and Urine Phosphate Urine Creatinine, Week 72, n=73	-1.378 Milligrams per deciliter Standard Deviation 62.0304
Change From Baseline Values for Urine Creatinine Concentration and Urine Phosphate Urine Creatinine, Week 84, n=72	19.337 Milligrams per deciliter Standard Deviation 73.2844
Change From Baseline Values for Urine Creatinine Concentration and Urine Phosphate Urine Creatinine, Week 96, n=72	10.346 Milligrams per deciliter Standard Deviation 69.2155
Change From Baseline Values for Urine Creatinine Concentration and Urine Phosphate Urine phosphate, Week 4, n=75	-3.87 Milligrams per deciliter Standard Deviation 34.392
Change From Baseline Values for Urine Creatinine Concentration and Urine Phosphate Urine phosphate, Week 12, n=74	-2.08 Milligrams per deciliter Standard Deviation 35.796
Change From Baseline Values for Urine Creatinine Concentration and Urine Phosphate Urine phosphate, Week 24, n=74	2.46 Milligrams per deciliter Standard Deviation 35.994
Change From Baseline Values for Urine Creatinine Concentration and Urine Phosphate Urine phosphate, Week 48, n=73	0.68 Milligrams per deciliter Standard Deviation 36.561
Change From Baseline Values for Urine Creatinine Concentration and Urine Phosphate Urine phosphate, Week 60, n=73	-0.09 Milligrams per deciliter Standard Deviation 37.888
Change From Baseline Values for Urine Creatinine Concentration and Urine Phosphate Urine phosphate, Week 72, n=73	0.85 Milligrams per deciliter Standard Deviation 34.012
Change From Baseline Values for Urine Creatinine Concentration and Urine Phosphate Urine phosphate, Week 84, n=72	5.21 Milligrams per deciliter Standard Deviation 34.599
Change From Baseline Values for Urine Creatinine Concentration and Urine Phosphate Urine phosphate, Week 96, n=72	-0.72 Milligrams per deciliter Standard Deviation 38.732

SECONDARY outcome

Timeframe: Baseline (Day 1, Pre-dose) and at Weeks 4, 12, 24, 36, 48, 60, 72, 84 and 96

Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Blood pressure of participants were measured at indicated time points in supine position after 5 minutes rest. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.

Outcome measures

Outcome measures
Measure	Tenofovir Disoproxil Fumarate n=75 Participants Participants with on-going ETV treatment were switched to TDF treatment on Day 1. Participants then started with TDF on the day ETV was discontinued, without any overlapping treatment periods. All participants received one tablet of TDF 300 milligram (mg) once daily orally for 96 weeks.
Absolute Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) SBP, Baseline (Day 1), n=75	122.5 Millimeters of mercury Standard Deviation 14.15
Absolute Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) SBP, Week 4, n=75	122.9 Millimeters of mercury Standard Deviation 12.91
Absolute Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) SBP, Week 12, n=74	124.9 Millimeters of mercury Standard Deviation 16.28
Absolute Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) SBP, Week 24, n=74	121.9 Millimeters of mercury Standard Deviation 12.33
Absolute Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) SBP, Week 36, n=73	121.5 Millimeters of mercury Standard Deviation 14.81
Absolute Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) SBP, Week 48, n=73	122.5 Millimeters of mercury Standard Deviation 14.76
Absolute Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) SBP, Week 60, n=73	124.7 Millimeters of mercury Standard Deviation 14.68
Absolute Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) SBP, Week 72, n=73	124.2 Millimeters of mercury Standard Deviation 15.36
Absolute Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) SBP, Week 84, n=72	122.1 Millimeters of mercury Standard Deviation 12.86
Absolute Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) SBP, Week 96, n=72	120.8 Millimeters of mercury Standard Deviation 16.07
Absolute Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) DBP, Baseline (Day 1), n=75	76.0 Millimeters of mercury Standard Deviation 11.76
Absolute Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) DBP, Week 4, n=75	75.2 Millimeters of mercury Standard Deviation 11.12
Absolute Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) DBP, Week 12, n=74	78.1 Millimeters of mercury Standard Deviation 10.44
Absolute Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) DBP, Week 24, n=74	75.6 Millimeters of mercury Standard Deviation 10.05
Absolute Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) DBP, Week 36, n=73	75.3 Millimeters of mercury Standard Deviation 10.18
Absolute Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) DBP, Week 48, n=73	77.8 Millimeters of mercury Standard Deviation 11.37
Absolute Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) DBP, Week 60, n=73	78.0 Millimeters of mercury Standard Deviation 11.07
Absolute Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) DBP, Week 72, n=73	77.5 Millimeters of mercury Standard Deviation 10.88
Absolute Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) DBP, Week 84, n=72	76.3 Millimeters of mercury Standard Deviation 10.23
Absolute Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) DBP, Week 96, n=72	76.1 Millimeters of mercury Standard Deviation 10.59

SECONDARY outcome

Timeframe: Baseline (Day 1, Pre-dose) and at Weeks 4, 12, 24, 36, 48, 60, 72, 84 and 96

Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Heart rate of participants were measured at indicated time points in supine position after 5 minutes rest. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.

Outcome measures

Outcome measures
Measure	Tenofovir Disoproxil Fumarate n=75 Participants Participants with on-going ETV treatment were switched to TDF treatment on Day 1. Participants then started with TDF on the day ETV was discontinued, without any overlapping treatment periods. All participants received one tablet of TDF 300 milligram (mg) once daily orally for 96 weeks.
Absolute Values for Heart Rate Baseline (Day 1), n=75	74.7 Beats per minute Standard Deviation 9.14
Absolute Values for Heart Rate Week 4, n=75	75.8 Beats per minute Standard Deviation 10.51
Absolute Values for Heart Rate Week 12, n=74	76.0 Beats per minute Standard Deviation 11.05
Absolute Values for Heart Rate Week 24, n=74	74.8 Beats per minute Standard Deviation 10.17
Absolute Values for Heart Rate Week 36, n=73	74.3 Beats per minute Standard Deviation 9.53
Absolute Values for Heart Rate Week 48, n=73	75.3 Beats per minute Standard Deviation 11.32
Absolute Values for Heart Rate Week 60, n=73	75.8 Beats per minute Standard Deviation 10.32
Absolute Values for Heart Rate Week 72, n=73	74.9 Beats per minute Standard Deviation 11.35
Absolute Values for Heart Rate Week 84, n=72	75.5 Beats per minute Standard Deviation 9.96
Absolute Values for Heart Rate Week 96, n=72	73.1 Beats per minute Standard Deviation 10.49

SECONDARY outcome

Timeframe: Baseline (Day 1, Pre-dose) and at Weeks 4, 12, 24, 36, 48, 60, 72, 84 and 96

Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Temperature of participants were measured at indicated time points in supine position after 5 minutes rest. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.

Outcome measures

Outcome measures
Measure	Tenofovir Disoproxil Fumarate n=75 Participants Participants with on-going ETV treatment were switched to TDF treatment on Day 1. Participants then started with TDF on the day ETV was discontinued, without any overlapping treatment periods. All participants received one tablet of TDF 300 milligram (mg) once daily orally for 96 weeks.
Absolute Values for Temperature Baseline (Day 1), n=75	36.41 degrees Celsius Standard Deviation 0.382
Absolute Values for Temperature Week 4, n=75	36.43 degrees Celsius Standard Deviation 0.385
Absolute Values for Temperature Week 12, n=74	36.40 degrees Celsius Standard Deviation 0.448
Absolute Values for Temperature Week 24, n=74	36.43 degrees Celsius Standard Deviation 0.416
Absolute Values for Temperature Week 36, n=73	36.45 degrees Celsius Standard Deviation 0.360
Absolute Values for Temperature Week 48, n=73	36.41 degrees Celsius Standard Deviation 0.414
Absolute Values for Temperature Week 60, n=73	36.43 degrees Celsius Standard Deviation 0.375
Absolute Values for Temperature Week 72, n=73	36.42 degrees Celsius Standard Deviation 0.357
Absolute Values for Temperature Week 84, n=72	36.46 degrees Celsius Standard Deviation 0.349
Absolute Values for Temperature Week 96, n=72	36.40 degrees Celsius Standard Deviation 0.334

SECONDARY outcome

Timeframe: Up to Week 96

Population: Safety Population.

Twelve-lead ECG was obtained using an ECG machine that automatically calculated the heart rate and measured PR, QRS, QT, and corrected QT (QTc) intervals. Abnormal values with clinically significant and not clinically significant values has been presented. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.

Outcome measures

Outcome measures
Measure	Tenofovir Disoproxil Fumarate n=75 Participants Participants with on-going ETV treatment were switched to TDF treatment on Day 1. Participants then started with TDF on the day ETV was discontinued, without any overlapping treatment periods. All participants received one tablet of TDF 300 milligram (mg) once daily orally for 96 weeks.
Number of Participants With Worst Case Post-Baseline Electrocardiogram (ECG) Values Abnormal-not clinically significant	20 Participants
Number of Participants With Worst Case Post-Baseline Electrocardiogram (ECG) Values Abnormal-clinically significant	1 Participants

SECONDARY outcome

Timeframe: Baseline (Day -1) and at Weeks 24, 48, 72 and 96

Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Bone densitometry was performed on lumbar spine and femur using dual-energy X-ray absorptiometry (DEXA). Bone density percentage was calculated as bone density observation minus bone density Baseline divided by bone density Baseline. Baseline was considered as Day -1. Change from Baseline is calculated as the value at the post-dose visit minus the Baseline value.

Outcome measures

Outcome measures
Measure	Tenofovir Disoproxil Fumarate n=75 Participants Participants with on-going ETV treatment were switched to TDF treatment on Day 1. Participants then started with TDF on the day ETV was discontinued, without any overlapping treatment periods. All participants received one tablet of TDF 300 milligram (mg) once daily orally for 96 weeks.
Change From Baseline Values for Bone Density Femur, Week 48, n=4	-0.0125 Grams per centimeter^2 Standard Deviation 0.01654
Change From Baseline Values for Bone Density Femur, Week 96, n=22	-0.0205 Grams per centimeter^2 Standard Deviation 0.02765
Change From Baseline Values for Bone Density Lumbar vertebra, Week 24, n=1	0.0100 Grams per centimeter^2 Standard Deviation NA NA (Not applicable) indicates standard deviation could not be calculated as a single participant was analyzed.
Change From Baseline Values for Bone Density Lumbar vertebra, Week 48, n=6	-0.0100 Grams per centimeter^2 Standard Deviation 0.04121
Change From Baseline Values for Bone Density Lumbar vertebra, Week 72, n=1	-0.0620 Grams per centimeter^2 Standard Deviation NA NA indicates standard deviation could not be calculated as a single participant was analyzed.
Change From Baseline Values for Bone Density Lumbar vertebra, Week 96, n=72	-0.0193 Grams per centimeter^2 Standard Deviation 0.03539

Adverse Events

Tenofovir Disoproxil Fumarate

Serious events: 2 serious events

Other events: 36 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Tenofovir Disoproxil Fumarate n=75 participants at risk Participants with on-going ETV treatment were switched to TDF treatment on Day 1. Participants then started with TDF on the day ETV was discontinued, without any overlapping treatment periods. All participants received one tablet of TDF 300 milligram (mg) once daily orally for 96 weeks.
Musculoskeletal and connective tissue disorders Osteoarthritis	1.3% 1/75 • SAEs and non-SAEs were collected from the start of the treatment up to Week 96. SAEs and non-SAEs were collected for Safety Population
Infections and infestations Appendicitis	1.3% 1/75 • SAEs and non-SAEs were collected from the start of the treatment up to Week 96. SAEs and non-SAEs were collected for Safety Population

Other adverse events

Other adverse events
Measure	Tenofovir Disoproxil Fumarate n=75 participants at risk Participants with on-going ETV treatment were switched to TDF treatment on Day 1. Participants then started with TDF on the day ETV was discontinued, without any overlapping treatment periods. All participants received one tablet of TDF 300 milligram (mg) once daily orally for 96 weeks.
Investigations Beta 2 microglobulin urine increased	22.7% 17/75 • SAEs and non-SAEs were collected from the start of the treatment up to Week 96. SAEs and non-SAEs were collected for Safety Population
Infections and infestations Nasopharyngitis	25.3% 19/75 • SAEs and non-SAEs were collected from the start of the treatment up to Week 96. SAEs and non-SAEs were collected for Safety Population
Nervous system disorders Headache	5.3% 4/75 • SAEs and non-SAEs were collected from the start of the treatment up to Week 96. SAEs and non-SAEs were collected for Safety Population
Gastrointestinal disorders Dental caries	5.3% 4/75 • SAEs and non-SAEs were collected from the start of the treatment up to Week 96. SAEs and non-SAEs were collected for Safety Population
Musculoskeletal and connective tissue disorders Back pain	5.3% 4/75 • SAEs and non-SAEs were collected from the start of the treatment up to Week 96. SAEs and non-SAEs were collected for Safety Population
Respiratory, thoracic and mediastinal disorders Cough	5.3% 4/75 • SAEs and non-SAEs were collected from the start of the treatment up to Week 96. SAEs and non-SAEs were collected for Safety Population

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER