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

A Multi-centre, One-arm Prospective Study to Evaluate Efficacy and Safety of Switching From Entecavir (ETV) to Tenofovir Disoproxil Fumarate (TDF) in Japanese Chronic Hepatitis B HBeAg-positive and HBV-DNA Undetectable Subjects

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03258710

Enrollment

Registered

2017-08-23

Start date

2017-10-02

Completion date

2019-11-25

Last updated

2020-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis B, Chronic

Keywords

Tenofovir Disoproxil Fumarate, safety, chronic hepatitis B, virological effect

Brief summary

Tenofovir Disoproxil Fumarate is a nucleos(t)ide analogue that inhibits Hepatitis B Virus (HBV) growth, and is marketed in Japan with an indication for inhibition of HBV growth in subjects with chronic hepatitis B associated with HBV growth and abnormal liver function. This study has been planned to evaluate the virological effects and safety of switching from ETV to TDF in chronic hepatitis B (hepatitis B e-antigen \[HBeAg\])-positive and HBV- deoxyribonucleic acid (DNA) undetectable subjects. This study is designed as a multi-center, one-arm, post-marketing clinical study to investigate the HBsAg reduction in subjects who have not achieved the long-term goal, the loss of hepatitis B surface antigen (HBsAg). The study will be conducted in HBeAg-positive and HBV-DNA undetectable subjects treated with ETV. After switching ETV to TDF, TDF will be administered for 96 weeks. Approximately 80 subjects will be screened to achieve 65 evaluable subjects.

Interventions

DRUGTenofovir Disoproxil Fumarate

Tenofovir Disoproxil Fumarate is a nucleos(t)ide analogue that inhibits HBV growth. All subjects will receive one tablet of TDF 300 mg once daily orally for 96 weeks.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

This is a single arm study where on-going ETV treatment is switched to TDF treatment. There is no randomization in this study.

Eligibility

Sex/Gender

ALL

Age

20 Years to 69 Years

Healthy volunteers

Inclusion criteria

* Subjects must be 20 to 69 years of age inclusive, at the time of signing the informed consent * Male and female subjects. A female subject is eligible to participate if she is not pregnant and not breastfeeding, and at least one of the following conditions applies: * Not a woman of childbearing potential (WOCBP), OR * A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 4 days after the last dose of study treatment * Capable of giving signed informed consent form (ICF) * Subjects with chronic hepatitis B (CHB) (excluding hospitalized subjects) * Subjects treated with ETV for at least 2 years prior to initiation of study treatment. * The serum HBV-DNA level at screening is below the limit of quantitation (\< 2.1 Log10 copies/milliliter \[mL\] or \< 20 international unit \[IU\]/mL). * Subjects with serum HBeAg positive at screening * Meet either of the following serum HBsAg levels at screening: * Serum HBsAg 80 \< to \< 800 IU/mL and fluctuation range is equal or more than -0.1 Log10 IU/mL per year * Serum HBsAg \>=800 IU/mL * Meet all of the following criteria at screening: * Creatinine clearance (CLcr) \>=70 mL/minute. CLcr is calculated using the following Cockcroft-Gault formula. Male: CLcr = (body weight in kilogram \[kg\] multiplied by \[140 minus age in years\]) divided by (72 multiplied by serum creatinine \[milligram {mg}/deciliter {dL}\]) Female: CLcr = CLcr (male) multiplied by 0.85 * Hemoglobin \>= 8 gram/dL * WBC \>=1000 per cubic millimeter (mm\^3)

Exclusion criteria

* QTc \> 450 millisecond (msec) or \> 480 msec for subjects with bundle branch block * Received any interferon or Hepatitis B vaccine therapy within 24 weeks prior to initiation of the study treatment. * Received overdose of nonsteroidal anti-inflammatory drugs (NSAIDs) (excluding temporary or topical use) within 7 days prior to initiation of the study treatment. * Received any of the following drugs within 8 weeks prior to initiation of the study treatment (excluding topical products such as ointment and/or cream etc). * Drugs causing renal impairment (examples: aminoglycosides, amphotericin B, vancomycin, foscarnet, cisplatin, pentamidine, tacrolimus, cyclosporine, some contrast mediums \[ionic high-osmolar contrast media, ionic low-osmolar contrast media\] * Competitors of renal excretion (except temporary use, example: probenecid) * Immunosuppressants (examples: azathioprine, cycolphosphamide) or chemotherapeutics (example: etoposide) * Glucocorticoid preparation * Received TDF, Adefovir pivoxil (ADV) or Tenofovir Alafenamide Fumarate (TAF) within 2 years prior to initiation of the study treatment * Participation in another clinical study within 6 months prior to screening, or planned participation in another clinical study simultaneously with this study. * Co-infection with human immunodeficiency virus (HIV) or hepatitis C virus (HCV) * Subjects with serious complication other than compensated CHB (cancer, significant renal, cardiovascular, pulmonary, or neurological disease, uncontrollable diabetes, etc.) * Received or have a plan for solid organ or bone marrow transplantation * Has proximal tubulopathy. * Subjects with decompensated CHB who meet the following: direct bilirubin \> 1.5 times upper limit of normal (ULN), Prothrombin Time (PT) \< 60%, platelets \< 75,000/mm3 and serum albumin \< 3.0 g/dL * Autoimmune hepatitis (Antinuclear titer \> 1:160), excluding CHB * Subjects with or suspected of having hepatocellular carcinoma (HCC) (including both primary and metastatic) from diagnostic imaging at screening, or with serum alpha-fetoprotein (AFP) \> 50 nanogram (ng)/mL at screening * History of HCC (except subjects who underwent resection or received curative treatment by radiofrequency, and with AFP \<=10 ng/mL at screening) * Woman who is pregnant, possibly pregnant, lactating or planning a pregnancy during the study period. * Psychiatry disorder or cognitive disorder that may affect the subject's ability to give informed consent or to follow specified study procedures. * Subjects with a history of alcohol or drug abuse * Subjects whom the investigator (or sub-investigator) considers ineligible for the study. * Subjects with hypersensitivity to study treatments or their components, nucleoside and/or nucleotide analogues. Subjects with drug allergy that, in the investigator's (sub-investigator's) \[or medical monitor's\] opinion, labeled contraindication for participation in the study, or other allergy.

Design outcomes

Primary

Measure	Time frame	Description
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	Baseline (Day 1, Pre-dose) and at Week 48	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.

Secondary

Measure	Time frame	Description
Percentage of Participants Who Achieved HBsAg Loss at Weeks 24, 48 and 96	At Weeks 24, 48 and 96	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.
Percentage of Participants Who Achieved HBsAg/Ab Seroconversion at Weeks 24, 48 and 96	At Weeks 24, 48 and 96	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.
Percentage of Participants Who Achieved HBeAg Loss at Weeks 24, 48 and 96	At Weeks 24, 48 and 96	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.
Percentage of Participants Who Achieved HBeAg/Ab Seroconversion at Weeks 24, 48 and 96	At Weeks 24, 48 and 96	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.
Change From Baseline Log Values for HBsAg Titer at Weeks 24, 48 and 96	Baseline (Day 1, Pre-dose) and at Weeks 24, 48 and 96	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.
Change From Baseline Log Values for HBcrAg Titer at Weeks 24, 48 and 96	Baseline (Day 1, Pre-dose) and at Weeks 24, 48 and 96	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.
Number of Participants Who Reported Serious Adverse Events (SAEs) and Non-serious Adverse Events (Non-SAEs)	Up to Week 96	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.
Absolute Values for Clinical Chemistry Parameter: Alpha-fetoprotein (AFP)	Baseline (Day 1, Pre-dose) and at Weeks 4, 12, 24, 36, 48, 60, 72, 84 and 96	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.
Absolute Values for Clinical Chemistry Parameters: Albumin and Total Protein	Baseline (Day 1, Pre-dose) and at Weeks 4, 12, 24, 36, 48, 60, 72, 84 and 96	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.
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)	Baseline (Day 1, Pre-dose) and at Weeks 4, 12, 24, 36, 48, 60, 72, 84 and 96	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.
Absolute Values for Clinical Chemistry Parameters: Amylase and Lipase	Baseline (Day 1, Pre-dose) and at Weeks 4, 12, 24, 36, 48, 60, 72, 84 and 96	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.
Absolute Values for Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid	Baseline (Day 1, Pre-dose) and at Weeks 4, 12, 24, 36, 48, 60, 72, 84 and 96	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.
Absolute Values for Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Lactic Acid, Sodium, Phosphorus and Blood Urea Nitrogen (BUN)	Baseline (Day 1, Pre-dose) and at Weeks 4, 12, 24, 36, 48, 60, 72, 84 and 96	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.
Absolute Values for Clinical Chemistry Parameter: Creatinine Clearance	Baseline (Day 1, Pre-dose) and at Weeks 4, 12, 24, 36, 48, 60, 72, 84 and 96	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.
Absolute Values for Clinical Chemistry Parameter: Glomerular Filtration Rate (GFR)	Baseline (Day 1, Pre-dose) and at Weeks 4, 12, 24, 36, 48, 60, 72, 84 and 96	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.
Percentage of Basophils at Indicated Time Points	At Weeks 36, 48, 60, 72, 84 and 96	Blood samples were collected for the analysis of hematology parameter: basophils. Mean and standard deviation values for percentage of basophils reported was presented.
Percentage of Eosinophils at Indicated Time Points	At Weeks 36 , 48, 60, 72, 84 and 96	Blood samples were collected for the analysis of hematology parameter: eosinophils. Mean and standard deviation values for percentage of eosinophils reported was presented.
Percentage of Participants Who Achieved 0.25 Log10 HBsAg Reduction From the Baseline at Weeks 24 and 96	Baseline (Day 1, Pre-dose) and at Weeks 24 and 96	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.
Percentage of Monocytes at Indicated Time Points	At Weeks 36, 48, 60, 72, 84 and 96	Blood samples were collected for the analysis of hematology parameter: monocytes. Mean and standard deviation values for percentage of monocytes reported was presented.
Percentage of Total Neutrophils at Indicated Time Points	At Weeks 36, 48, 60, 72, 84 and 96	Blood samples were collected for the analysis of hematology parameter: total neutrophils. Mean and standard deviation values for percentage of neutrophils reported was presented.
Absolute Values for Hematology Parameter: Hemoglobin	Baseline (Day 1, Pre-dose) and at Weeks 4, 12, 24, 36, 48, 60, 72, 84 and 96	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.
Absolute Values for Hematology Parameter: Hematocrit	Baseline (Day 1, Pre-dose) and at Weeks 4, 12, 24, 36, 48, 60, 72, 84 and 96	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.
Absolute Values for Hematology Parameters: Platelet Count and White Blood Cell (WBC) Count	Baseline (Day 1, Pre-dose) and at Weeks 4, 12, 24, 36, 48, 60, 72, 84 and 96	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.
Absolute Values for Hematology Parameter: Prothrombin Time	Baseline (Day 1, Pre-dose) and at Weeks 4, 12, 24, 36, 48, 60, 72, 84 and 96	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.
Absolute Values for Hematology Parameter: Red Blood Cell (RBC) Count	Baseline (Day 1, Pre-dose) and at Weeks 4, 12, 24, 36, 48, 60, 72, 84 and 96	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.
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48	Weeks 4, 12, 24, 36 and 48	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.
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96	Weeks 60, 72, 84 and 96	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.
Change From Baseline Values for Beta-2-microglobulin	Baseline (Day 1, Pre-dose) and at Weeks 4, 12, 24, 36, 48, 60, 72, 84 and 96	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.
Change From Baseline Values for Urine Creatinine Concentration and Urine Phosphate	Baseline (Day 1, Pre-dose) and at Weeks 4, 12, 24, 36, 48, 60, 72, 84 and 96	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.
Absolute Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	Baseline (Day 1, Pre-dose) and at Weeks 4, 12, 24, 36, 48, 60, 72, 84 and 96	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.
Absolute Values for Heart Rate	Baseline (Day 1, Pre-dose) and at Weeks 4, 12, 24, 36, 48, 60, 72, 84 and 96	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.
Absolute Values for Temperature	Baseline (Day 1, Pre-dose) and at Weeks 4, 12, 24, 36, 48, 60, 72, 84 and 96	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.
Number of Participants With Worst Case Post-Baseline Electrocardiogram (ECG) Values	Up to Week 96	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.
Change From Baseline Values for Bone Density	Baseline (Day -1) and at Weeks 24, 48, 72 and 96	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.
Percentage of Lymphocytes at Indicated Time Points	At Weeks 36, 48, 60, 72, 84 and 96	Blood samples were collected for the analysis of hematology parameter: lymphocytes. Mean and standard deviation values for percentage of lymphocytes reported was presented.

Countries

Japan

Participant flow

Recruitment details

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.

Pre-assignment details

A total of 75 participants were enrolled in the study.

Participants by arm

Arm	Count
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.	75
Total	75

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Adverse Event	1
Overall Study	Physician Decision	1
Overall Study	Protocol-defined stopping criteria	1

Baseline characteristics

Characteristic	Tenofovir Disoproxil Fumarate
Age, Continuous	48.4 Years STANDARD_DEVIATION 9.35
Race/Ethnicity, Customized Asian-East Asian Heritage	4 Participants
Race/Ethnicity, Customized Asian-Japanese Heritage	71 Participants
Sex: Female, Male Female	20 Participants
Sex: Female, Male Male	55 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 75
other Total, other adverse events	36 / 75
serious Total, serious adverse events	2 / 75

Outcome results

Primary

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

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.

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

Population: FAS Population

Arm	Measure	Group	Value (NUMBER)
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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

Secondary

Absolute Values for Clinical Chemistry Parameter: Alpha-fetoprotein (AFP)

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.

Time frame: 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).

Arm	Measure	Group	Value (MEAN)	Dispersion
Tenofovir Disoproxil Fumarate	Absolute Values for Clinical Chemistry Parameter: Alpha-fetoprotein (AFP)	Week 48, n=73	3.55 Micrograms per liter	Standard Deviation 1.693
Tenofovir Disoproxil Fumarate	Absolute Values for Clinical Chemistry Parameter: Alpha-fetoprotein (AFP)	Baseline (Day 1), n=75	3.13 Micrograms per liter	Standard Deviation 1.474
Tenofovir Disoproxil Fumarate	Absolute Values for Clinical Chemistry Parameter: Alpha-fetoprotein (AFP)	Week 4, n=75	3.39 Micrograms per liter	Standard Deviation 1.507
Tenofovir Disoproxil Fumarate	Absolute Values for Clinical Chemistry Parameter: Alpha-fetoprotein (AFP)	Week 12, n=74	3.46 Micrograms per liter	Standard Deviation 1.642
Tenofovir Disoproxil Fumarate	Absolute Values for Clinical Chemistry Parameter: Alpha-fetoprotein (AFP)	Week 24, n=74	3.50 Micrograms per liter	Standard Deviation 1.597
Tenofovir Disoproxil Fumarate	Absolute Values for Clinical Chemistry Parameter: Alpha-fetoprotein (AFP)	Week 36, n=73	3.48 Micrograms per liter	Standard Deviation 1.578
Tenofovir Disoproxil Fumarate	Absolute Values for Clinical Chemistry Parameter: Alpha-fetoprotein (AFP)	Week 60, n=73	3.50 Micrograms per liter	Standard Deviation 1.683
Tenofovir Disoproxil Fumarate	Absolute Values for Clinical Chemistry Parameter: Alpha-fetoprotein (AFP)	Week 72, n=73	3.27 Micrograms per liter	Standard Deviation 1.499
Tenofovir Disoproxil Fumarate	Absolute Values for Clinical Chemistry Parameter: Alpha-fetoprotein (AFP)	Week 84, n=72	3.10 Micrograms per liter	Standard Deviation 1.478
Tenofovir Disoproxil Fumarate	Absolute Values for Clinical Chemistry Parameter: Alpha-fetoprotein (AFP)	Week 96, n=72	3.18 Micrograms per liter	Standard Deviation 1.537

Secondary

Absolute Values for Clinical Chemistry Parameter: Creatinine Clearance

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.

Time frame: 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).

Arm	Measure	Group	Value (MEAN)	Dispersion
Tenofovir Disoproxil Fumarate	Absolute Values for Clinical Chemistry Parameter: Creatinine Clearance	Baseline (Day 1), n=75	114.06 Milliliters per minute	Standard Deviation 23.849
Tenofovir Disoproxil Fumarate	Absolute Values for Clinical Chemistry Parameter: Creatinine Clearance	Week 4, n=75	112.50 Milliliters per minute	Standard Deviation 25.283
Tenofovir Disoproxil Fumarate	Absolute Values for Clinical Chemistry Parameter: Creatinine Clearance	Week 12, n=74	108.76 Milliliters per minute	Standard Deviation 24.634
Tenofovir Disoproxil Fumarate	Absolute Values for Clinical Chemistry Parameter: Creatinine Clearance	Week 24, n=74	108.86 Milliliters per minute	Standard Deviation 24.963
Tenofovir Disoproxil Fumarate	Absolute Values for Clinical Chemistry Parameter: Creatinine Clearance	Week 36, n=73	105.23 Milliliters per minute	Standard Deviation 23.739
Tenofovir Disoproxil Fumarate	Absolute Values for Clinical Chemistry Parameter: Creatinine Clearance	Week 48, n=73	105.50 Milliliters per minute	Standard Deviation 24.333
Tenofovir Disoproxil Fumarate	Absolute Values for Clinical Chemistry Parameter: Creatinine Clearance	Week 60, n=73	107.51 Milliliters per minute	Standard Deviation 25.719
Tenofovir Disoproxil Fumarate	Absolute Values for Clinical Chemistry Parameter: Creatinine Clearance	Week 72, n=73	106.73 Milliliters per minute	Standard Deviation 24.278
Tenofovir Disoproxil Fumarate	Absolute Values for Clinical Chemistry Parameter: Creatinine Clearance	Week 84, n=72	104.00 Milliliters per minute	Standard Deviation 23.511
Tenofovir Disoproxil Fumarate	Absolute Values for Clinical Chemistry Parameter: Creatinine Clearance	Week 96, n=72	101.47 Milliliters per minute	Standard Deviation 23.705

Secondary

Absolute Values for Clinical Chemistry Parameter: Glomerular Filtration Rate (GFR)

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.

Time frame: 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).

Arm	Measure	Group	Value (MEAN)	Dispersion
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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 0.24375
Tenofovir Disoproxil Fumarate	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 0.23314
Tenofovir Disoproxil Fumarate	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

Absolute Values for Clinical Chemistry Parameters: Albumin and Total Protein

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.

Time frame: 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).

Arm	Measure	Group	Value (MEAN)	Dispersion
Tenofovir Disoproxil Fumarate	Absolute Values for Clinical Chemistry Parameters: Albumin and Total Protein	Albumin, Baseline (Day 1), n=75	44.7 Grams per liter	Standard Deviation 2.6
Tenofovir Disoproxil Fumarate	Absolute Values for Clinical Chemistry Parameters: Albumin and Total Protein	Albumin, Week 4, n=75	44.9 Grams per liter	Standard Deviation 2.21
Tenofovir Disoproxil Fumarate	Absolute Values for Clinical Chemistry Parameters: Albumin and Total Protein	Albumin, Week 12, n=74	45.2 Grams per liter	Standard Deviation 2.17
Tenofovir Disoproxil Fumarate	Absolute Values for Clinical Chemistry Parameters: Albumin and Total Protein	Albumin, Week 24, n=74	44.5 Grams per liter	Standard Deviation 2.18
Tenofovir Disoproxil Fumarate	Absolute Values for Clinical Chemistry Parameters: Albumin and Total Protein	Albumin, Week 36, n=73	44.2 Grams per liter	Standard Deviation 2.11
Tenofovir Disoproxil Fumarate	Absolute Values for Clinical Chemistry Parameters: Albumin and Total Protein	Albumin, Week 48, n=73	44.8 Grams per liter	Standard Deviation 2.2
Tenofovir Disoproxil Fumarate	Absolute Values for Clinical Chemistry Parameters: Albumin and Total Protein	Albumin, Week 60, n=73	45.1 Grams per liter	Standard Deviation 1.88
Tenofovir Disoproxil Fumarate	Absolute Values for Clinical Chemistry Parameters: Albumin and Total Protein	Albumin, Week 72, n=73	44.9 Grams per liter	Standard Deviation 2.14
Tenofovir Disoproxil Fumarate	Absolute Values for Clinical Chemistry Parameters: Albumin and Total Protein	Albumin, Week 84, n=72	44.6 Grams per liter	Standard Deviation 2.05
Tenofovir Disoproxil Fumarate	Absolute Values for Clinical Chemistry Parameters: Albumin and Total Protein	Albumin, Week 96, n=72	45.4 Grams per liter	Standard Deviation 2.26
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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

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)

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.

Time frame: 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).

Arm	Measure	Group	Value (MEAN)	Dispersion
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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 69.6
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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 14.7
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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 25.6
Tenofovir Disoproxil Fumarate	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 8.8
Tenofovir Disoproxil Fumarate	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 8.7
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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 56.2
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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 24.3
Tenofovir Disoproxil Fumarate	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 22.6
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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

Secondary

Absolute Values for Clinical Chemistry Parameters: Amylase and Lipase

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.

Time frame: 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).

Arm	Measure	Group	Value (MEAN)	Dispersion
Tenofovir Disoproxil Fumarate	Absolute Values for Clinical Chemistry Parameters: Amylase and Lipase	Amylase, Baseline (Day 1), n=75	87.3 Units per liter	Standard Deviation 26
Tenofovir Disoproxil Fumarate	Absolute Values for Clinical Chemistry Parameters: Amylase and Lipase	Amylase, Week 4, n=75	89.5 Units per liter	Standard Deviation 24.99
Tenofovir Disoproxil Fumarate	Absolute Values for Clinical Chemistry Parameters: Amylase and Lipase	Amylase, Week 12, n=74	88.2 Units per liter	Standard Deviation 26.21
Tenofovir Disoproxil Fumarate	Absolute Values for Clinical Chemistry Parameters: Amylase and Lipase	Amylase, Week 24, n=74	83.7 Units per liter	Standard Deviation 23.3
Tenofovir Disoproxil Fumarate	Absolute Values for Clinical Chemistry Parameters: Amylase and Lipase	Amylase, Week 36, n=73	82.3 Units per liter	Standard Deviation 24.29
Tenofovir Disoproxil Fumarate	Absolute Values for Clinical Chemistry Parameters: Amylase and Lipase	Amylase, Week 48, n=73	84.9 Units per liter	Standard Deviation 26.08
Tenofovir Disoproxil Fumarate	Absolute Values for Clinical Chemistry Parameters: Amylase and Lipase	Amylase, Week 60, n=73	92.2 Units per liter	Standard Deviation 32.2
Tenofovir Disoproxil Fumarate	Absolute Values for Clinical Chemistry Parameters: Amylase and Lipase	Amylase, Week 72, n=73	88.8 Units per liter	Standard Deviation 27.87
Tenofovir Disoproxil Fumarate	Absolute Values for Clinical Chemistry Parameters: Amylase and Lipase	Amylase, Week 84, n=72	84.4 Units per liter	Standard Deviation 24.93
Tenofovir Disoproxil Fumarate	Absolute Values for Clinical Chemistry Parameters: Amylase and Lipase	Amylase, Week 96, n=72	86.7 Units per liter	Standard Deviation 32.31
Tenofovir Disoproxil Fumarate	Absolute Values for Clinical Chemistry Parameters: Amylase and Lipase	Lipase, Baseline (Day 1), n=75	40.0 Units per liter	Standard Deviation 17.99
Tenofovir Disoproxil Fumarate	Absolute Values for Clinical Chemistry Parameters: Amylase and Lipase	Lipase, Week 4, n=75	41.9 Units per liter	Standard Deviation 14.27
Tenofovir Disoproxil Fumarate	Absolute Values for Clinical Chemistry Parameters: Amylase and Lipase	Lipase, Week 12, n=74	39.1 Units per liter	Standard Deviation 13.97
Tenofovir Disoproxil Fumarate	Absolute Values for Clinical Chemistry Parameters: Amylase and Lipase	Lipase, Week 24, n=74	36.0 Units per liter	Standard Deviation 9.95
Tenofovir Disoproxil Fumarate	Absolute Values for Clinical Chemistry Parameters: Amylase and Lipase	Lipase, Week 36, n=73	36.9 Units per liter	Standard Deviation 12.64
Tenofovir Disoproxil Fumarate	Absolute Values for Clinical Chemistry Parameters: Amylase and Lipase	Lipase, Week 48, n=73	36.2 Units per liter	Standard Deviation 12.91
Tenofovir Disoproxil Fumarate	Absolute Values for Clinical Chemistry Parameters: Amylase and Lipase	Lipase, Week 60, n=73	39.1 Units per liter	Standard Deviation 13.07
Tenofovir Disoproxil Fumarate	Absolute Values for Clinical Chemistry Parameters: Amylase and Lipase	Lipase, Week 72, n=73	37.1 Units per liter	Standard Deviation 13.72
Tenofovir Disoproxil Fumarate	Absolute Values for Clinical Chemistry Parameters: Amylase and Lipase	Lipase, Week 84, n=72	33.5 Units per liter	Standard Deviation 11.55
Tenofovir Disoproxil Fumarate	Absolute Values for Clinical Chemistry Parameters: Amylase and Lipase	Lipase, Week 96, n=72	34.2 Units per liter	Standard Deviation 16.73

Secondary

Absolute Values for Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Lactic Acid, Sodium, Phosphorus and Blood Urea Nitrogen (BUN)

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.

Time frame: 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).

Arm	Measure	Group	Value (MEAN)	Dispersion
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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 0.681828
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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 0.26
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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 1.9
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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 1.7
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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 2.4
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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

Secondary

Absolute Values for Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid

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.

Time frame: 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).

Arm	Measure	Group	Value (MEAN)	Dispersion
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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 1.754
Tenofovir Disoproxil Fumarate	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 1.756
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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 5.934
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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 11.0635
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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 66.7286
Tenofovir Disoproxil Fumarate	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

Absolute Values for Heart Rate

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.

Time frame: 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).

Arm	Measure	Group	Value (MEAN)	Dispersion
Tenofovir Disoproxil Fumarate	Absolute Values for Heart Rate	Baseline (Day 1), n=75	74.7 Beats per minute	Standard Deviation 9.14
Tenofovir Disoproxil Fumarate	Absolute Values for Heart Rate	Week 4, n=75	75.8 Beats per minute	Standard Deviation 10.51
Tenofovir Disoproxil Fumarate	Absolute Values for Heart Rate	Week 12, n=74	76.0 Beats per minute	Standard Deviation 11.05
Tenofovir Disoproxil Fumarate	Absolute Values for Heart Rate	Week 24, n=74	74.8 Beats per minute	Standard Deviation 10.17
Tenofovir Disoproxil Fumarate	Absolute Values for Heart Rate	Week 36, n=73	74.3 Beats per minute	Standard Deviation 9.53
Tenofovir Disoproxil Fumarate	Absolute Values for Heart Rate	Week 48, n=73	75.3 Beats per minute	Standard Deviation 11.32
Tenofovir Disoproxil Fumarate	Absolute Values for Heart Rate	Week 60, n=73	75.8 Beats per minute	Standard Deviation 10.32
Tenofovir Disoproxil Fumarate	Absolute Values for Heart Rate	Week 72, n=73	74.9 Beats per minute	Standard Deviation 11.35
Tenofovir Disoproxil Fumarate	Absolute Values for Heart Rate	Week 84, n=72	75.5 Beats per minute	Standard Deviation 9.96
Tenofovir Disoproxil Fumarate	Absolute Values for Heart Rate	Week 96, n=72	73.1 Beats per minute	Standard Deviation 10.49

Secondary

Absolute Values for Hematology Parameter: Hematocrit

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.

Time frame: 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).

Arm	Measure	Group	Value (MEAN)	Dispersion
Tenofovir Disoproxil Fumarate	Absolute Values for Hematology Parameter: Hematocrit	Baseline (Day 1), n=75	0.4393 Proportion of red blood cells in blood	Standard Deviation 0.03331
Tenofovir Disoproxil Fumarate	Absolute Values for Hematology Parameter: Hematocrit	Week 4, n=75	0.4441 Proportion of red blood cells in blood	Standard Deviation 0.03475
Tenofovir Disoproxil Fumarate	Absolute Values for Hematology Parameter: Hematocrit	Week 12, n=74	0.4452 Proportion of red blood cells in blood	Standard Deviation 0.03679
Tenofovir Disoproxil Fumarate	Absolute Values for Hematology Parameter: Hematocrit	Week 24, n=74	0.4367 Proportion of red blood cells in blood	Standard Deviation 0.0355
Tenofovir Disoproxil Fumarate	Absolute Values for Hematology Parameter: Hematocrit	Week 36, n=73	0.4283 Proportion of red blood cells in blood	Standard Deviation 0.04156
Tenofovir Disoproxil Fumarate	Absolute Values for Hematology Parameter: Hematocrit	Week 48, n=73	0.4350 Proportion of red blood cells in blood	Standard Deviation 0.03942
Tenofovir Disoproxil Fumarate	Absolute Values for Hematology Parameter: Hematocrit	Week 60, n=73	0.4398 Proportion of red blood cells in blood	Standard Deviation 0.0394
Tenofovir Disoproxil Fumarate	Absolute Values for Hematology Parameter: Hematocrit	Week 72, n=73	0.4391 Proportion of red blood cells in blood	Standard Deviation 0.03817
Tenofovir Disoproxil Fumarate	Absolute Values for Hematology Parameter: Hematocrit	Week 84, n=72	0.4339 Proportion of red blood cells in blood	Standard Deviation 0.0407
Tenofovir Disoproxil Fumarate	Absolute Values for Hematology Parameter: Hematocrit	Week 96, n=72	0.4355 Proportion of red blood cells in blood	Standard Deviation 0.04159

Secondary

Absolute Values for Hematology Parameter: Hemoglobin

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.

Time frame: 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).

Arm	Measure	Group	Value (MEAN)	Dispersion
Tenofovir Disoproxil Fumarate	Absolute Values for Hematology Parameter: Hemoglobin	Baseline (Day 1), n=75	148.2 Grams per liter	Standard Deviation 13.13
Tenofovir Disoproxil Fumarate	Absolute Values for Hematology Parameter: Hemoglobin	Week 4, n=75	148.9 Grams per liter	Standard Deviation 13.4
Tenofovir Disoproxil Fumarate	Absolute Values for Hematology Parameter: Hemoglobin	Week 12, n=74	148.4 Grams per liter	Standard Deviation 14.41
Tenofovir Disoproxil Fumarate	Absolute Values for Hematology Parameter: Hemoglobin	Week 24, n=74	146.3 Grams per liter	Standard Deviation 14.28
Tenofovir Disoproxil Fumarate	Absolute Values for Hematology Parameter: Hemoglobin	Week 36, n=73	144.1 Grams per liter	Standard Deviation 15.58
Tenofovir Disoproxil Fumarate	Absolute Values for Hematology Parameter: Hemoglobin	Week 48, n=73	146.5 Grams per liter	Standard Deviation 15.81
Tenofovir Disoproxil Fumarate	Absolute Values for Hematology Parameter: Hemoglobin	Week 60, n=73	147.1 Grams per liter	Standard Deviation 14.93
Tenofovir Disoproxil Fumarate	Absolute Values for Hematology Parameter: Hemoglobin	Week 72, n=73	146.4 Grams per liter	Standard Deviation 14.95
Tenofovir Disoproxil Fumarate	Absolute Values for Hematology Parameter: Hemoglobin	Week 84, n=72	144.6 Grams per liter	Standard Deviation 16.01
Tenofovir Disoproxil Fumarate	Absolute Values for Hematology Parameter: Hemoglobin	Week 96, n=72	146.4 Grams per liter	Standard Deviation 16.07

Secondary

Absolute Values for Hematology Parameter: Prothrombin Time

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.

Time frame: 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).

Arm	Measure	Group	Value (MEAN)	Dispersion
Tenofovir Disoproxil Fumarate	Absolute Values for Hematology Parameter: Prothrombin Time	Baseline (Day 1), n=75	11.82 Seconds	Standard Deviation 0.632
Tenofovir Disoproxil Fumarate	Absolute Values for Hematology Parameter: Prothrombin Time	Week 4, n=75	11.91 Seconds	Standard Deviation 0.679
Tenofovir Disoproxil Fumarate	Absolute Values for Hematology Parameter: Prothrombin Time	Week 12, n=74	11.95 Seconds	Standard Deviation 0.642
Tenofovir Disoproxil Fumarate	Absolute Values for Hematology Parameter: Prothrombin Time	Week 24, n=74	11.76 Seconds	Standard Deviation 0.627
Tenofovir Disoproxil Fumarate	Absolute Values for Hematology Parameter: Prothrombin Time	Week 36, n=73	11.94 Seconds	Standard Deviation 0.72
Tenofovir Disoproxil Fumarate	Absolute Values for Hematology Parameter: Prothrombin Time	Week 48, n=73	12.71 Seconds	Standard Deviation 0.681
Tenofovir Disoproxil Fumarate	Absolute Values for Hematology Parameter: Prothrombin Time	Week 60, n=73	12.32 Seconds	Standard Deviation 0.613
Tenofovir Disoproxil Fumarate	Absolute Values for Hematology Parameter: Prothrombin Time	Week 72, n=73	12.40 Seconds	Standard Deviation 0.615
Tenofovir Disoproxil Fumarate	Absolute Values for Hematology Parameter: Prothrombin Time	Week 84, n=72	12.58 Seconds	Standard Deviation 0.684
Tenofovir Disoproxil Fumarate	Absolute Values for Hematology Parameter: Prothrombin Time	Week 96, n=72	12.78 Seconds	Standard Deviation 0.766

Secondary

Absolute Values for Hematology Parameter: Red Blood Cell (RBC) Count

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.

Time frame: 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).

Arm	Measure	Group	Value (MEAN)	Dispersion
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	Absolute Values for Hematology Parameter: Red Blood Cell (RBC) Count	Week 4, n=75	4.841 Trillion cells per liter	Standard Deviation 0.4154
Tenofovir Disoproxil Fumarate	Absolute Values for Hematology Parameter: Red Blood Cell (RBC) Count	Week 12, n=74	4.865 Trillion cells per liter	Standard Deviation 0.4358
Tenofovir Disoproxil Fumarate	Absolute Values for Hematology Parameter: Red Blood Cell (RBC) Count	Week 24, n=74	4.820 Trillion cells per liter	Standard Deviation 0.4061
Tenofovir Disoproxil Fumarate	Absolute Values for Hematology Parameter: Red Blood Cell (RBC) Count	Week 36, n=73	4.704 Trillion cells per liter	Standard Deviation 0.4473
Tenofovir Disoproxil Fumarate	Absolute Values for Hematology Parameter: Red Blood Cell (RBC) Count	Week 48, n=73	4.780 Trillion cells per liter	Standard Deviation 0.4026
Tenofovir Disoproxil Fumarate	Absolute Values for Hematology Parameter: Red Blood Cell (RBC) Count	Week 60, n=73	4.819 Trillion cells per liter	Standard Deviation 0.4288
Tenofovir Disoproxil Fumarate	Absolute Values for Hematology Parameter: Red Blood Cell (RBC) Count	Week 72, n=73	4.793 Trillion cells per liter	Standard Deviation 0.4058
Tenofovir Disoproxil Fumarate	Absolute Values for Hematology Parameter: Red Blood Cell (RBC) Count	Week 84, n=72	4.757 Trillion cells per liter	Standard Deviation 0.4314
Tenofovir Disoproxil Fumarate	Absolute Values for Hematology Parameter: Red Blood Cell (RBC) Count	Week 96, n=72	4.777 Trillion cells per liter	Standard Deviation 0.444

Secondary

Absolute Values for Hematology Parameters: Platelet Count and White Blood Cell (WBC) Count

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.

Time frame: 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).

Arm	Measure	Group	Value (MEAN)	Dispersion
Tenofovir Disoproxil Fumarate	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 53.4
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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 1.38
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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 1.32
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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

Absolute Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)

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.

Time frame: 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).

Arm	Measure	Group	Value (MEAN)	Dispersion
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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

Absolute Values for Temperature

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.

Time frame: 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).

Arm	Measure	Group	Value (MEAN)	Dispersion
Tenofovir Disoproxil Fumarate	Absolute Values for Temperature	Baseline (Day 1), n=75	36.41 degrees Celsius	Standard Deviation 0.382
Tenofovir Disoproxil Fumarate	Absolute Values for Temperature	Week 4, n=75	36.43 degrees Celsius	Standard Deviation 0.385
Tenofovir Disoproxil Fumarate	Absolute Values for Temperature	Week 12, n=74	36.40 degrees Celsius	Standard Deviation 0.448
Tenofovir Disoproxil Fumarate	Absolute Values for Temperature	Week 24, n=74	36.43 degrees Celsius	Standard Deviation 0.416
Tenofovir Disoproxil Fumarate	Absolute Values for Temperature	Week 36, n=73	36.45 degrees Celsius	Standard Deviation 0.36
Tenofovir Disoproxil Fumarate	Absolute Values for Temperature	Week 48, n=73	36.41 degrees Celsius	Standard Deviation 0.414
Tenofovir Disoproxil Fumarate	Absolute Values for Temperature	Week 60, n=73	36.43 degrees Celsius	Standard Deviation 0.375
Tenofovir Disoproxil Fumarate	Absolute Values for Temperature	Week 72, n=73	36.42 degrees Celsius	Standard Deviation 0.357
Tenofovir Disoproxil Fumarate	Absolute Values for Temperature	Week 84, n=72	36.46 degrees Celsius	Standard Deviation 0.349
Tenofovir Disoproxil Fumarate	Absolute Values for Temperature	Week 96, n=72	36.40 degrees Celsius	Standard Deviation 0.334

Secondary

Change From Baseline Log Values for HBcrAg Titer at Weeks 24, 48 and 96

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.

Time frame: 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).

Arm	Measure	Group	Value (MEAN)	Dispersion
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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 0.36

Secondary

Change From Baseline Log Values for HBsAg Titer at Weeks 24, 48 and 96

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.

Time frame: 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).

Arm	Measure	Group	Value (MEAN)	Dispersion
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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

Change From Baseline Values for Beta-2-microglobulin

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.

Time frame: 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).

Arm	Measure	Group	Value (MEAN)	Dispersion
Tenofovir Disoproxil Fumarate	Change From Baseline Values for Beta-2-microglobulin	Week 4, n=75	206.9 Micrograms per liter	Standard Deviation 593.69
Tenofovir Disoproxil Fumarate	Change From Baseline Values for Beta-2-microglobulin	Week 12, n=74	254.6 Micrograms per liter	Standard Deviation 891.36
Tenofovir Disoproxil Fumarate	Change From Baseline Values for Beta-2-microglobulin	Week 24, n=74	392.7 Micrograms per liter	Standard Deviation 1544.73
Tenofovir Disoproxil Fumarate	Change From Baseline Values for Beta-2-microglobulin	Week 36, n=73	261.1 Micrograms per liter	Standard Deviation 715.81
Tenofovir Disoproxil Fumarate	Change From Baseline Values for Beta-2-microglobulin	Week 48, n=73	206.8 Micrograms per liter	Standard Deviation 580.77
Tenofovir Disoproxil Fumarate	Change From Baseline Values for Beta-2-microglobulin	Week 60, n=73	309.4 Micrograms per liter	Standard Deviation 651.85
Tenofovir Disoproxil Fumarate	Change From Baseline Values for Beta-2-microglobulin	Week 72, n=73	235.7 Micrograms per liter	Standard Deviation 542.52
Tenofovir Disoproxil Fumarate	Change From Baseline Values for Beta-2-microglobulin	Week 84, n=72	271.3 Micrograms per liter	Standard Deviation 616.86
Tenofovir Disoproxil Fumarate	Change From Baseline Values for Beta-2-microglobulin	Week 96, n=72	196.1 Micrograms per liter	Standard Deviation 478.68

Secondary

Change From Baseline Values for Bone Density

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.

Time frame: 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).

Arm	Measure	Group	Value (MEAN)	Dispersion
Tenofovir Disoproxil Fumarate	Change From Baseline Values for Bone Density	Lumbar vertebra, Week 96, n=72	-0.0193 Grams per centimeter^2	Standard Deviation 0.03539
Tenofovir Disoproxil Fumarate	Change From Baseline Values for Bone Density	Lumbar vertebra, Week 48, n=6	-0.0100 Grams per centimeter^2	Standard Deviation 0.04121
Tenofovir Disoproxil Fumarate	Change From Baseline Values for Bone Density	Lumbar vertebra, Week 72, n=1	-0.0620 Grams per centimeter^2	—
Tenofovir Disoproxil Fumarate	Change From Baseline Values for Bone Density	Femur, Week 48, n=4	-0.0125 Grams per centimeter^2	Standard Deviation 0.01654
Tenofovir Disoproxil Fumarate	Change From Baseline Values for Bone Density	Femur, Week 96, n=22	-0.0205 Grams per centimeter^2	Standard Deviation 0.02765
Tenofovir Disoproxil Fumarate	Change From Baseline Values for Bone Density	Lumbar vertebra, Week 24, n=1	0.0100 Grams per centimeter^2	—
Unknown	Change From Baseline Values for Bone Density	Femur, Week 72, n=0	— Grams per centimeter^2	—
Unknown	Change From Baseline Values for Bone Density	Femur, Week 24, n=0	— Grams per centimeter^2	—

Secondary

Change From Baseline Values for Urine Creatinine Concentration and Urine Phosphate

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.

Time frame: 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).

Arm	Measure	Group	Value (MEAN)	Dispersion
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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

Number of Participants Who Reported Serious Adverse Events (SAEs) and Non-serious Adverse Events (Non-SAEs)

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.

Time frame: Up to Week 96

Population: Safety Population.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Tenofovir Disoproxil Fumarate	Number of Participants Who Reported Serious Adverse Events (SAEs) and Non-serious Adverse Events (Non-SAEs)	Any SAE	2 Participants
Tenofovir Disoproxil Fumarate	Number of Participants Who Reported Serious Adverse Events (SAEs) and Non-serious Adverse Events (Non-SAEs)	Any non-SAE	36 Participants

Secondary

Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48

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.

Time frame: Weeks 4, 12, 24, 36 and 48

Population: Safety Population.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48	Urine glucose, Week 48, 1+	1 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48	Urine glucose, Week 48, 3+	1 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48	Urine glucose, Week 48, Trace	1 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48	Amorphous phosphate crystals, Week 4, 1+	2 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48	Amorphous phosphate crystals, Week 12, 1+	2 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48	Amorphous phosphate crystals, Week 24, 1+	3 Participants
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48	Amorphous phosphate crystals, Week 36, 1+	2 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48	Amorphous phosphate crystals, Week 48, 1+	2 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48	Amorphous urate crystals, Week 4, 1+	3 Participants
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48	Amorphous urate crystals, Week 12, 1+	6 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48	Amorphous urate crystals, Week 24, 1+	8 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48	Amorphous urate crystals, Week 36, 1+	5 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48	Amorphous urate crystals, Week 48, 1+	5 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48	Bacteria, Week 4, 1+	5 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48	Bacteria, Week 12, 1+	11 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48	Bacteria, Week 24, 1+	6 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48	Bacteria, Week 24, 2+	2 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48	Bacteria, Week 36, 1+	8 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48	Bacteria, Week 48, 1+	11 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48	Bacteria, Week 48, 2+	1 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48	Calcium oxalate crystals, Week 4, 1+	11 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48	Calcium oxalate crystals, Week 12, 1+	9 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48	Calcium oxalate crystals, Week 24, 1+	14 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48	Calcium oxalate crystals, Week 36, 1+	15 Participants
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48	Calcium oxalate crystals, Week 48, 1+	10 Participants
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48	RTEC, Week 4, 1-2/Every Field	1 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48	RTEC, Week 24, 1-2/Every Field	1 Participants
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48	RTEC, Week 36, 1-2/Every Field	1 Participants
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48	RTEC, Week 48, 1-2/Every Field	3 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48	Fungi, Week 4, 1+	0 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48	Fungi, Week 12, 1+	0 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48	Fungi, Week 24, 1+	1 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48	Fungi, Week 36, 1+	0 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48	Fungi, Week 48, 1+	0 Participants
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48	Urine glucose, Week 4, 1+	1 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48	Urine glucose, Week 4, Trace	1 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48	Urine glucose, Week 12, 2+	1 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48	Urine glucose, Week 12, Trace	1 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48	Urine glucose, Week 24, 3+	1 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48	Urine glucose, Week 36, Trace	2 Participants
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48	Mucus threads, Week 4, 1+	17 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48	Mucus threads, Week 12, 1+	21 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48	Mucus threads, Week 24, 1+	23 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48	Mucus threads, Week 36, 1+	25 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48	Mucus threads, Week 48, 1+	22 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48	Urine protein, Week 4, 1+	1 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48	Urine protein, Week 4, 2+	1 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48	Urine protein, Week 4, Trace	15 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48	Urine protein, Week 12, 1+	2 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48	Urine protein, Week 12, Trace	24 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48	Urine protein, Week 24, 1+	4 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48	Urine protein, Week 24, 2+	1 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48	Urine protein, Week 24, Trace	28 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48	Urine protein, Week 36, 1+	3 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48	Urine protein, Week 36, 2+	1 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48	Urine protein, Week 36, Trace	27 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48	Urine protein, Week 48, Trace	15 Participants
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48	RBC, Week 4, 1-2/Every Field	13 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48	RBC, Week 4, 3-5/Every Field	4 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48	RBC, Week 4, 6-10/Every Field	3 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48	RBC, Week 12, numerous/Every Field	1 Participants
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48	RBC, Week 12, 1-2/Every Field	11 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48	RBC, Week 12, 3-5/Every Field	4 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48	RBC, Week 12, 6-10/Every Field	1 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48	RBC, Week 12, 10-20/Every Field	1 Participants
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48	RBC, Week 24, 1-2/Every Field	14 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48	RBC, Week 24, 3-5/Every Field	1 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48	RBC, Week 24, 6-10/Every Field	2 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48	RBC, Week 24, 10-20/Every Field	1 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48	RBC, Week 24, 20-30/Every Field	2 Participants
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48	RBC, Week 36, 1-2/Every Field	7 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48	RBC, Week 36, 3-5/Every Field	1 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48	RBC, Week 36, 6-10/Every Field	2 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48	RBC, Week 36, 10-20/Every Field	1 Participants
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48	RBC, Week 48, 1-2/Every Field	14 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48	RBC, Week 48, 3-5/Every Field	3 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48	RBC, Week 48, 6-10/Every Field	2 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48	RBC, Week 48, 10-20/Every Field	1 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48	Spermatozoa, Week 4, 1+	1 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48	Spermatozoa, Week 12, 1+	0 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48	Spermatozoa, Week 24, 1+	2 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48	Spermatozoa, Week 36, 1+	3 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48	Spermatozoa, Week 48, 1+	0 Participants
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48	SEC, Week 4, 1-2/Every Field	7 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48	SEC, Week 4, 3-5/Every Field	2 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48	SEC, Week 4, 10-20/Every Field	1 Participants
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48	SEC, Week 12, 1-2/Every Field	6 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48	SEC, Week 12, 3-5/Every Field	2 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48	SEC, Week 12, 6-10/Every Field	1 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48	SEC, Week 12, 10-20/Every Field	1 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48	SEC, Week 12, 30-50/Every Field	1 Participants
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48	SEC, Week 24, 1-2/Every Field	8 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48	SEC, Week 24, 3-5/Every Field	1 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48	SEC, Week 24, 6-10/Every Field	1 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48	SEC, Week 24, 10-20/Every Field	2 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48	SEC, Week 24, 20-30/Every Field	1 Participants
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48	SEC, Week 36, 1-2/Every Field	9 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48	SEC, Week 36, 3-5/Every Field	1 Participants
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48	SEC, Week 48, 1-2/Every Field	5 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48	SEC, Week 48, 3-5/Every Field	5 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48	SEC, Week 48, 6-10/Every Field	1 Participants
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48	TEC, Week 36, 1-2/Every Field	1 Participants
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48	UAC, Week 4, 1+	0 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48	UAC, Week 12, 1+	0 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48	UAC, Week 24, 1+	0 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48	UAC, Week 36, 1+	2 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48	UAC, Week 48, 1+	1 Participants
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48	WBC, Week 4, 1-2/Every Field	10 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48	WBC, Week 4, 3-5/Every Field	1 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48	WBC, Week 4, 10-20/Every Field	2 Participants
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48	WBC, Week 12, 1-2/Every Field	8 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48	WBC, Week 12, 3-5/Every Field	6 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48	WBC, Week 12, 6-10/Every Field	1 Participants
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48	WBC, Week 24, 1-2/Every Field	5 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48	WBC, Week 24, 3-5/Every Field	3 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48	WBC, Week 24, 6-10/Every Field	1 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48	WBC, Week 24, 10-20/Every Field	2 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48	WBC, Week 24, 30-50/Every Field	1 Participants
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48	WBC, Week 36, 1-2/Every Field	1 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48	WBC, Week 36, 3-5/Every Field	4 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48	WBC, Week 36, 6-10/Every Field	2 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48	WBC, Week 36, 30-50/Every Field	1 Participants
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48	WBC, Week 48, 1-2/Every Field	11 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48	WBC, Week 48, 3-5/Every Field	2 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48	WBC, Week 48, 6-10/Every Field	2 Participants

Secondary

Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96

Time frame: Weeks 60, 72, 84 and 96

Population: Safety Population.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96	Urine protein, Week 96, 1+	3 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96	Urine protein, Week 96, Trace	11 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96	RBC, Week 60, 0-0.1/Some Field	35 Participants
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96	RBC, Week 60, 1-2/Every Field	12 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96	RBC, Week 60, 3-5/Every Field	5 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96	RBC, Week 60, 6-10/Every Field	1 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96	RBC, Week 60, 10-20/Every Field	2 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96	RBC, Week 60, 30-50/Every Field	1 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96	RBC, Week 72, 0-0.1/Some Field	45 Participants
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96	RBC, Week 72, 1-2/Every Field	12 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96	RBC, Week 72, 3-5/Every Field	3 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96	RBC, Week 72, 30-50/Every Field	2 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96	RBC, Week 84, many/Every Field	1 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96	RBC, Week 84, 0-0.1/Some Field	40 Participants
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96	RBC, Week 84, 1-2/Every Field	15 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96	RBC, Week 84, 3-5/Every Field	3 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96	RBC, Week 84, 6-10/Every Field	2 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96	RBC, Week 84, 20-30/Every Field	1 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96	RBC, Week 84, 30-50/Every Field	1 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96	RBC, Week 96, many/Every Field	1 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96	RBC, Week 96, 0-0.1/Some Field	44 Participants
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96	RBC, Week 96, 1-2/Every Field	11 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96	RBC, Week 96, 3-5/Every Field	4 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96	RBC, Week 96, 10-20/Every Field	1 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96	Spermatozoa, Week 84, 1+	1 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96	SEC, Week 60, 0-0.1/Some Field	52 Participants
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96	SEC, Week 60, 1-2/Every Field	9 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96	SEC, Week 60, 3-5/Every Field	2 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96	SEC, Week 60, 10-20/Every Field	2 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96	SEC, Week 60, 20-30/Every Field	1 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96	SEC, Week 72, 0-0.1/Some Field	55 Participants
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96	SEC, Week 72, 1-2/Every Field	5 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96	SEC, Week 72, 3-5/Every Field	1 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96	SEC, Week 72, 6-10/Every Field	2 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96	SEC, Week 72, 10-20/Every Field	1 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96	SEC, Week 72, 20-30/Every Field	3 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96	SEC, Week 84, many/Every Field	1 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96	SEC, Week 84, 0-0.1/Some Field	52 Participants
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96	SEC, Week 84, 1-2/Every Field	5 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96	SEC, Week 84, 3-5/Every Field	4 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96	SEC, Week 84, 6-10/Every Field	2 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96	SEC, Week 96, 0-0.1/Some Field	56 Participants
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96	SEC, Week 96, 1-2/Every Field	8 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96	SEC, Week 96, 3-5/Every Field	1 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96	SEC, Week 96, 6-10/Every Field	2 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96	SEC, Week 96, 10-20/Every Field	1 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96	TEC, Week 60, 0-0.1/Some Field	3 Participants
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96	TEC, Week 72, 0-0.1/Some Field	7 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96	TEC, Week 84, 0-0.1/Some Field	3 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96	TEC, Week 96, 0-0.1/Some Field	5 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96	UAC, Week 60, 1+	1 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96	UAC, Week 72, 1+	1 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96	UAC, Week 96, 1+	2 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96	WBC, Week 60, 0-0.1/Some Field	38 Participants
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96	WBC, Week 60, 1-2/Every Field	12 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96	WBC, Week 60, 3-5/Every Field	2 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96	WBC, Week 60, 6-10/Every Field	1 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96	WBC, Week 60, 10-20/Every Field	1 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96	WBC, Week 72, 0-0.1/Some Field	39 Participants
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96	WBC, Week 72, 1-2/Every Field	7 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96	WBC, Week 72, 3-5/Every Field	2 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96	WBC, Week 72, 6-10/Every Field	5 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96	WBC, Week 72, 30-50/Every Field	1 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96	WBC, Week 84, many/Every Field	2 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96	WBC, Week 84, 0-0.1/Some Field	47 Participants
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96	WBC, Week 84, 1-2/Every Field	6 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96	WBC, Week 84, 10-20/Every Field	3 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96	WBC, Week 84, 20-30/Every Field	1 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96	WBC, Week 84, 30-50/Every Field	1 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96	WBC, Week 96, 0-0.1/Some Field	41 Participants
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96	WBC, Week 96, 1-2/Every Field	8 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96	WBC, Week 96, 6-10/Every Field	4 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96	WBC, Week 96, 20-30/Every Field	1 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96	Amorphous phosphate crystals, Week 60, 1+	2 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96	Amorphous phosphate crystals, Week 72, 1+	2 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96	Amorphous phosphate crystals, Week 84, 1+	2 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96	Amorphous urate crystals, Week 60, 1+	3 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96	Amorphous urate crystals, Week 72, 1+	2 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96	Amorphous urate crystals, Week 84, 1+	8 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96	Amorphous urate crystals, Week 96, 1+	3 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96	Bacteria, Week 60, 1+	15 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96	Bacteria, Week 72, 1+	7 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96	Bacteria, Week 72, 2+	3 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96	Bacteria, Week 84, 1+	9 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96	Bacteria, Week 84, 2+	2 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96	Bacteria, Week 96, 1+	9 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96	Bacteria, Week 96, 2+	1 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96	Calcium oxalate crystals, Week 60, 1+	14 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96	Calcium oxalate crystals, Week 72, 1+	12 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96	Calcium oxalate crystals, Week 84, 1+	16 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96	Calcium oxalate crystals, Week 96, 1+	4 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96	RTEC, Week 60, 0-0.1/Some Field	19 Participants
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96	RTEC, Week 60, 1-2/Every Field	1 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96	RTEC, Week 72, 0-0.1/Some Field	14 Participants
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96	RTEC, Week 84, 0-0.1/Some Field	9 Participants
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96	RTEC, Week 84, 1-2/Every Field	2 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96	RTEC, Week 84, 3-5/Every Field	1 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96	RTEC, Week 96, 0-0.1/Some Field	15 Participants
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96	RTEC, Week 96, 1-2/Every Field	1 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96	Urine glucose, Week 60, 3+	1 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96	Urine glucose, Week 72, 1+	1 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96	Urine glucose, Week 72, 2+	1 Participants
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96	Hyaline casts, Week 84, 1-2/Whole Field	1 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96	Hyaline casts, Week 84, 3-5/Whole Field	1 Participants
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	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
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96	Hyaline casts, Week 96, 3-5/Whole Field	3 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96	Mucus threads, Week 60, 1+	27 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96	Mucus threads, Week 72, 1+	15 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96	Mucus threads, Week 84, 1+	18 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96	Mucus threads, Week 96, 1+	19 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96	Urine protein, Week 60, 1+	1 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96	Urine protein, Week 60, Trace	11 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96	Urine protein, Week 72, 1+	2 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96	Urine protein, Week 72, Trace	14 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96	Urine protein, Week 84, 1+	2 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96	Urine protein, Week 84, Trace	17 Participants

Secondary

Number of Participants With Worst Case Post-Baseline Electrocardiogram (ECG) Values

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.

Time frame: Up to Week 96

Population: Safety Population.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Tenofovir Disoproxil Fumarate	Number of Participants With Worst Case Post-Baseline Electrocardiogram (ECG) Values	Abnormal-not clinically significant	20 Participants
Tenofovir Disoproxil Fumarate	Number of Participants With Worst Case Post-Baseline Electrocardiogram (ECG) Values	Abnormal-clinically significant	1 Participants

Secondary

Percentage of Basophils at Indicated Time Points

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

Time frame: 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).

Arm	Measure	Group	Value (MEAN)	Dispersion
Tenofovir Disoproxil Fumarate	Percentage of Basophils at Indicated Time Points	Week 36, n=32	0.46 Percentage of basophils	Standard Deviation 0.24
Tenofovir Disoproxil Fumarate	Percentage of Basophils at Indicated Time Points	Week 48, n=73	0.49 Percentage of basophils	Standard Deviation 0.303
Tenofovir Disoproxil Fumarate	Percentage of Basophils at Indicated Time Points	Week 60, n=73	0.57 Percentage of basophils	Standard Deviation 0.453
Tenofovir Disoproxil Fumarate	Percentage of Basophils at Indicated Time Points	Week 72, n=73	0.50 Percentage of basophils	Standard Deviation 0.319
Tenofovir Disoproxil Fumarate	Percentage of Basophils at Indicated Time Points	Week 84, n=72	0.54 Percentage of basophils	Standard Deviation 0.305
Tenofovir Disoproxil Fumarate	Percentage of Basophils at Indicated Time Points	Week 96, n=72	0.57 Percentage of basophils	Standard Deviation 0.376

Secondary

Percentage of Eosinophils at Indicated Time Points

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

Time frame: 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).

Arm	Measure	Group	Value (MEAN)	Dispersion
Tenofovir Disoproxil Fumarate	Percentage of Eosinophils at Indicated Time Points	Week 36, n=32	2.44 Percentage of eosinophils	Standard Deviation 1.767
Tenofovir Disoproxil Fumarate	Percentage of Eosinophils at Indicated Time Points	Week 48, n=73	2.94 Percentage of eosinophils	Standard Deviation 2.667
Tenofovir Disoproxil Fumarate	Percentage of Eosinophils at Indicated Time Points	Week 60, n=73	2.85 Percentage of eosinophils	Standard Deviation 2.298
Tenofovir Disoproxil Fumarate	Percentage of Eosinophils at Indicated Time Points	Week 72, n=73	3.09 Percentage of eosinophils	Standard Deviation 2.519
Tenofovir Disoproxil Fumarate	Percentage of Eosinophils at Indicated Time Points	Week 84, n=72	2.84 Percentage of eosinophils	Standard Deviation 2.042
Tenofovir Disoproxil Fumarate	Percentage of Eosinophils at Indicated Time Points	Week 96, n=72	2.57 Percentage of eosinophils	Standard Deviation 2.145

Secondary

Percentage of Lymphocytes at Indicated Time Points

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

Time frame: 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).

Arm	Measure	Group	Value (MEAN)	Dispersion
Tenofovir Disoproxil Fumarate	Percentage of Lymphocytes at Indicated Time Points	Week 36, n=32	33.34 Percentage of lymphocytes	Standard Deviation 8.858
Tenofovir Disoproxil Fumarate	Percentage of Lymphocytes at Indicated Time Points	Week 48, n=73	32.39 Percentage of lymphocytes	Standard Deviation 8.516
Tenofovir Disoproxil Fumarate	Percentage of Lymphocytes at Indicated Time Points	Week 60, n=73	32.73 Percentage of lymphocytes	Standard Deviation 7.541
Tenofovir Disoproxil Fumarate	Percentage of Lymphocytes at Indicated Time Points	Week 72, n=73	32.29 Percentage of lymphocytes	Standard Deviation 8.579
Tenofovir Disoproxil Fumarate	Percentage of Lymphocytes at Indicated Time Points	Week 84, n=72	31.94 Percentage of lymphocytes	Standard Deviation 7.424
Tenofovir Disoproxil Fumarate	Percentage of Lymphocytes at Indicated Time Points	Week 96, n=72	32.98 Percentage of lymphocytes	Standard Deviation 8.215

Secondary

Percentage of Monocytes at Indicated Time Points

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

Time frame: 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).

Arm	Measure	Group	Value (MEAN)	Dispersion
Tenofovir Disoproxil Fumarate	Percentage of Monocytes at Indicated Time Points	Week 36, n=32	5.30 Percentage of monocytes	Standard Deviation 1.492
Tenofovir Disoproxil Fumarate	Percentage of Monocytes at Indicated Time Points	Week 48, n=73	5.46 Percentage of monocytes	Standard Deviation 1.598
Tenofovir Disoproxil Fumarate	Percentage of Monocytes at Indicated Time Points	Week 60, n=73	5.65 Percentage of monocytes	Standard Deviation 1.43
Tenofovir Disoproxil Fumarate	Percentage of Monocytes at Indicated Time Points	Week 72, n=73	5.67 Percentage of monocytes	Standard Deviation 1.814
Tenofovir Disoproxil Fumarate	Percentage of Monocytes at Indicated Time Points	Week 84, n=72	5.71 Percentage of monocytes	Standard Deviation 1.562
Tenofovir Disoproxil Fumarate	Percentage of Monocytes at Indicated Time Points	Week 96, n=72	5.45 Percentage of monocytes	Standard Deviation 1.475

Secondary

Percentage of Participants Who Achieved 0.25 Log10 HBsAg Reduction From the Baseline at Weeks 24 and 96

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.

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

Population: FAS Population.

Arm	Measure	Group	Value (NUMBER)
Tenofovir Disoproxil Fumarate	Percentage of Participants Who Achieved 0.25 Log10 HBsAg Reduction From the Baseline at Weeks 24 and 96	Week 24	1 Percentage of Participants
Tenofovir Disoproxil Fumarate	Percentage of Participants Who Achieved 0.25 Log10 HBsAg Reduction From the Baseline at Weeks 24 and 96	Week 96	12 Percentage of Participants

Secondary

Percentage of Participants Who Achieved HBeAg/Ab Seroconversion at Weeks 24, 48 and 96

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.

Time frame: At Weeks 24, 48 and 96

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

Arm	Measure	Group	Value (NUMBER)
Tenofovir Disoproxil Fumarate	Percentage of Participants Who Achieved HBeAg/Ab Seroconversion at Weeks 24, 48 and 96	Week 24	8 Percentage of Participants
Tenofovir Disoproxil Fumarate	Percentage of Participants Who Achieved HBeAg/Ab Seroconversion at Weeks 24, 48 and 96	Week 48	13 Percentage of Participants
Tenofovir Disoproxil Fumarate	Percentage of Participants Who Achieved HBeAg/Ab Seroconversion at Weeks 24, 48 and 96	Week 96	25 Percentage of Participants

Secondary

Percentage of Participants Who Achieved HBeAg Loss at Weeks 24, 48 and 96

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.

Time frame: At Weeks 24, 48 and 96

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

Arm	Measure	Group	Value (NUMBER)
Tenofovir Disoproxil Fumarate	Percentage of Participants Who Achieved HBeAg Loss at Weeks 24, 48 and 96	Week 24	12 Percentage of Participants
Tenofovir Disoproxil Fumarate	Percentage of Participants Who Achieved HBeAg Loss at Weeks 24, 48 and 96	Week 48	12 Percentage of Participants
Tenofovir Disoproxil Fumarate	Percentage of Participants Who Achieved HBeAg Loss at Weeks 24, 48 and 96	Week 96	25 Percentage of Participants

Secondary

Percentage of Participants Who Achieved HBsAg/Ab Seroconversion at Weeks 24, 48 and 96

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.

Time frame: At Weeks 24, 48 and 96

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

Arm	Measure	Group	Value (NUMBER)
Tenofovir Disoproxil Fumarate	Percentage of Participants Who Achieved HBsAg/Ab Seroconversion at Weeks 24, 48 and 96	Week 24	0 Percentage of Participants
Tenofovir Disoproxil Fumarate	Percentage of Participants Who Achieved HBsAg/Ab Seroconversion at Weeks 24, 48 and 96	Week 48	0 Percentage of Participants
Tenofovir Disoproxil Fumarate	Percentage of Participants Who Achieved HBsAg/Ab Seroconversion at Weeks 24, 48 and 96	Week 96	0 Percentage of Participants

Secondary

Percentage of Participants Who Achieved HBsAg Loss at Weeks 24, 48 and 96

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.

Time frame: At Weeks 24, 48 and 96

Population: FAS Population.

Arm	Measure	Group	Value (NUMBER)
Tenofovir Disoproxil Fumarate	Percentage of Participants Who Achieved HBsAg Loss at Weeks 24, 48 and 96	Week 24	0 Percentage of Participants
Tenofovir Disoproxil Fumarate	Percentage of Participants Who Achieved HBsAg Loss at Weeks 24, 48 and 96	Week 48	0 Percentage of Participants
Tenofovir Disoproxil Fumarate	Percentage of Participants Who Achieved HBsAg Loss at Weeks 24, 48 and 96	Week 96	0 Percentage of Participants

Secondary

Percentage of Total Neutrophils at Indicated Time Points

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

Time frame: 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).

Arm	Measure	Group	Value (MEAN)	Dispersion
Tenofovir Disoproxil Fumarate	Percentage of Total Neutrophils at Indicated Time Points	Week 36, n=32	58.46 Percentage of neutrophils	Standard Deviation 8.658
Tenofovir Disoproxil Fumarate	Percentage of Total Neutrophils at Indicated Time Points	Week 48, n=73	58.72 Percentage of neutrophils	Standard Deviation 8.709
Tenofovir Disoproxil Fumarate	Percentage of Total Neutrophils at Indicated Time Points	Week 60, n=73	58.20 Percentage of neutrophils	Standard Deviation 8.176
Tenofovir Disoproxil Fumarate	Percentage of Total Neutrophils at Indicated Time Points	Week 72, n=73	58.45 Percentage of neutrophils	Standard Deviation 9.109
Tenofovir Disoproxil Fumarate	Percentage of Total Neutrophils at Indicated Time Points	Week 84, n=72	58.97 Percentage of neutrophils	Standard Deviation 7.881
Tenofovir Disoproxil Fumarate	Percentage of Total Neutrophils at Indicated Time Points	Week 96, n=72	58.43 Percentage of neutrophils	Standard Deviation 8.973

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026

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

Conditions

Keywords

Brief summary

Related papers

Interventions

Sponsors

Study design

Intervention model description

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Recruitment details

Pre-assignment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

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

Absolute Values for Clinical Chemistry Parameter: Alpha-fetoprotein (AFP)

Absolute Values for Clinical Chemistry Parameter: Creatinine Clearance

Absolute Values for Clinical Chemistry Parameter: Glomerular Filtration Rate (GFR)

Absolute Values for Clinical Chemistry Parameters: Albumin and Total Protein

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)

Absolute Values for Clinical Chemistry Parameters: Amylase and Lipase

Absolute Values for Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Lactic Acid, Sodium, Phosphorus and Blood Urea Nitrogen (BUN)

Absolute Values for Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid

Absolute Values for Heart Rate

Absolute Values for Hematology Parameter: Hematocrit

Absolute Values for Hematology Parameter: Hemoglobin

Absolute Values for Hematology Parameter: Prothrombin Time

Absolute Values for Hematology Parameter: Red Blood Cell (RBC) Count

Absolute Values for Hematology Parameters: Platelet Count and White Blood Cell (WBC) Count

Absolute Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)

Absolute Values for Temperature

Change From Baseline Log Values for HBcrAg Titer at Weeks 24, 48 and 96

Change From Baseline Log Values for HBsAg Titer at Weeks 24, 48 and 96

Change From Baseline Values for Beta-2-microglobulin

Change From Baseline Values for Bone Density

Change From Baseline Values for Urine Creatinine Concentration and Urine Phosphate

Number of Participants Who Reported Serious Adverse Events (SAEs) and Non-serious Adverse Events (Non-SAEs)

Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48

Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96

Number of Participants With Worst Case Post-Baseline Electrocardiogram (ECG) Values

Percentage of Basophils at Indicated Time Points

Percentage of Eosinophils at Indicated Time Points

Percentage of Lymphocytes at Indicated Time Points

Percentage of Monocytes at Indicated Time Points

Percentage of Participants Who Achieved 0.25 Log10 HBsAg Reduction From the Baseline at Weeks 24 and 96

Percentage of Participants Who Achieved HBeAg/Ab Seroconversion at Weeks 24, 48 and 96

Percentage of Participants Who Achieved HBeAg Loss at Weeks 24, 48 and 96

Percentage of Participants Who Achieved HBsAg/Ab Seroconversion at Weeks 24, 48 and 96

Percentage of Participants Who Achieved HBsAg Loss at Weeks 24, 48 and 96

Percentage of Total Neutrophils at Indicated Time Points