Efficacy and Safety Study of Tenofovir Disoproxil Fumarate (TDF) in Chinese Chronic Hepatitis B (CHB) Subjects With Advanced Fibrosis & Compensated Cirrhosis

A Prospective, Multi-center, Cohort Study to Evaluate the Efficacy and Safety of Tenofovir Disoproxil Fumarate (TDF) Therapy in Chinese Chronic Hepatitis B (CHB) Subjects With Advanced Fibrosis & Compensated Cirrhosis

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02224456

Enrollment

197

Registered

2014-08-25

Start date

2015-03-25

Completion date

2020-12-04

Last updated

2022-02-14

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, hepatocellular carcinoma, chronic hepatitis B, Cirrhosis

Brief summary

Chronic Hepatitis B infection (CHB) is known as the most frequently identified cause of liver disease that predisposes patients to the development of hepatocellular carcinoma (HCC). Active hepatitis B virus (HBV) replication is the key driver of liver injury and disease progression. Majority of Chinese patients are infected with genotype B and C HBV, which is different from Caucasian counterparts. This prospective multi-center cohort open-label study is designed to investigate the long-term effect of TDF on prevention of HCC and disease progression as well as to evaluate the efficacy and safety of long-term TDF in Chinese CHB subjects with advanced liver diseases. The study will enrol 240 subjects.

Interventions

DRUGTenofovir disoproxil fumarate

White, almond-shaped, film-coated tablet containing 300 mg of TDF, debossed with GILEAD and 4331 on one side of the tablet.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Inclusion criteria

* Age 18-60 years(inclusive); * Presence of HBsAg in serum at screening and for at least 6 months before screening assessment; * Serum HBV DNA\>=2000 IU/mL if HBeAg positive at screening (with or without ALT elevation); or serum HBV DNA\>=200IU/mL if HBeAg negative at screening (with or without ALT elevation); * Clinically diagnosed as advanced fibrosis or compensated cirrhosis defined as both of following : liver stiffness measure (LSM) \>12.4 kiloPascals (kpa) (ALT\> Upper limit of normal \[ULN\]) or LSM\>9.0 kpa (ALT\<=ULN); One of following: Liver biopsy showing advanced fibrosis or cirrhosis (Ishak score \>=4, within the previous 6 months before screening and provided that no treatment likely to improve liver histology has been taken since). The slides must be available for review by an independent histopathologist; Endoscopy-proven gastroesophageal or gastric varices, non-cirrhotic portal hypertension excluded; Abdominal ultrasound or CT found changes indicating cirrhosis, irregular liver surface or nodularity, with/without splenomegaly (depth of spleen\>4.0cm or spleen length\>13cm); Blood platelets \<100 x10\^9/L (and other causes of thrombocytopenia excluded); * Ability to give written informed consent; * A female is eligible to enter and participate in this study if she is of: non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is post-menopausal), or Child-bearing potential, has a negative urine pregnancy test at screening, and agrees to one of the following methods for avoidance of pregnancy during the period of the study and until 30 days after last dose of study medication: Oral contraceptive, either combined or progestogen alone; Injectable progestogen; Implants of levonorgestrel; Oestrogenic vaginal ring; Percutaneous contraceptive patches; Intrauterine device (IUD) or intrauterine system (IUS) showing that the expected failure rate is less than 1% per year as stated in the IUD or IUS product label; Has a male partner who is sterilised; Double barrier method: condom and an occlusive cap (diaphragm orcervical/vault caps) with a vaginal spermicidal agent (foam/gel/film /cream/suppository). * Agreement not to participate in any other investigational trials or to undertake other HBV systemic antiviral or interferon (IFN) regimens during participation in this study.

Exclusion criteria

* Hepatocellular carcinoma as evidenced by one of the following: Suspicious foci on ultrasound or radiological examination; Normal ultrasound serum alpha-fetoprotein \>50 nanograms (ng)/mL at screening. * Serum ALT \>10 times ULN at screening or history of acute exacerbation leading to transient decompensation; * Documented co-infection with hepatitis A (HAV), hepatitis C (HCV), hepatitis delta virus (HDV), hepatitis E virus (HEV) or human immunodeficiency virus (HIV). For HCV co-infection, subjects who are anti-HCV positive and in whom HCV ribonucleic acid (RNA) is undetectable are considered to be not eligible for enrolment. * Evidence of active liver disease due to autoimmune hepatitis (antinuclear antibody (ANA) titre \>1:160). * Decompensated liver disease as indicated by any of the following: serum bilirubin \>1.5 xULN prothrombin time activity \<60% or International normalized ratio (INR)\>1.5; serum albumin \<32 grams per liter (g/L); history of previous clinical hepatic decompensation (e.g., ascites, variceal bleeding, or encephalopathy); * Planned for liver transplantation or previous liver transplantation; * Creatinine clearance less than 70 mL/minute (min); * Haemoglobin \<10 g/deciliter (dL), white blood cell (WBC) count \<1.5 x 10\^9/liter (L), platelets \<=50 x 10\^9/L; * Any serious or active medical or psychiatric illnesses other than hepatitis B which, in the opinion of the Investigator, would interfere with subject treatment, assessment or compliance with the protocol. This would include any uncontrolled clinically significant renal, cardiac, pulmonary, vascular, neurogenic, digestive, metabolic (diabetes, thyroid disorders, adrenal disease), immunodeficiency disorders, pathological fractures or cancer; * Active alcohol or drug abuse or history of alcohol or drug abuse considered by the Investigator to be sufficient to hinder compliance with treatment, participation in the study or interpretation of results; * A female who is breastfeeding or plan to breastfeed; * Use of immunosuppressive therapy, immunomodulatory therapy (including IFN or thymosin alpha), systemic cytotoxic agents, chronic antiviral agents including Chinese herbal medicines known to have activity against HBV (e.g., lamivudine (LAM), adefovir, entecavir (ETV), telbivudine (LdT) or hepatitis B immunoglobulin (HBIg)) within the previous 6 months prior to screening into this study; * Have ever received TDF or any medicinal products containing the above mentioned antiviral agents or any investigative anti-HBV treatments (e.g., emtricitabine (FTC), (2R,4R)-4-(2,6-Diaminopurin-9-yl)-1,3-dioxolan-2-yl\]methanol (DAPD) and 1-(2-fluoro-5-methyl-beta, Larabinofuranosyl) uracil (L-FMAU)); * History of hypersensitivity to nucleoside and/or nucleotide analogues and/or any component of study medication; * Therapy with nephrotoxic drugs (e.g., aminoglycosides, amphotercin B, vancomycin, cidofovir, foscarnet, cis-platinum, pentamidine etc.) or competitors of renal excretion (e.g., probenecid) within 2 months prior to study screening or the expectation that subject will receive any of these during the course of the study; * Inability to comply with study requirements as determined by the study Investigator

Design outcomes

Primary

Measure	Time frame	Description
Incidence Rate of Newly Diagnosed Hepatocellular Carcinoma (HCC) at Week 240	Week 240	The newly diagnosed HCC was defined as HCC cases from Week 24 to Week 240 and the participants were required to meet one of the following criteria: without HCC before Week 24; a histological diagnosis of HCC (i.e. by biopsy or at post-mortem); participants with nodules \>2 centimeter (cm), identification of typical HCC characteristics (hyper-vascular in the arterial phase with washout in the portal venous or delayed phases) by 4-phase multi-detector computed tomography (CT) scan or dynamic contrast-enhanced magnetic resonance imaging (MRI); participants with nodules \>1 cm, identification of typical HCC characteristics by both techniques (4-phase multi-detector CT and dynamic contrast-enhanced MRI).
Percentage of Participants With Disease Progression at Week 240	Week 240	Disease progression was defined as the first occurrence of any one of the following criteria: 1) an increase in Childs-Pugh score of 2 or more points from Baseline; 2) an increase in Childs-Pugh score of 2 or more points, solely based on laboratory parameters (i.e. bilirubin, prothrombin time and/or albumin) confirmed between two consecutive visits at least one month apart; 3) spontaneous bacterial peritonitis (with proven sepsis); 4) renal insufficiency; 5) bleeding gastric/esophageal varices; 6) hepatocellular carcinoma; 7)liver-related death.

Secondary

Measure	Time frame	Description
Percentage of Participants With Disease Progression at Week 48, Week 96, Week 144, Week 192 and Week 240	Week 48, Week 96, Week 144, Week 192 and Week 240	Disease progression was defined as the first occurrence of any one of the following criteria: 1) an increase in Childs-Pugh score of 2 or more points from Baseline; 2) an increase in Childs-Pugh score of 2 or more points, solely based on laboratory parameters (i.e. bilirubin, prothrombin time and/or albumin) confirmed between two consecutive visits at least one month apart; 3) spontaneous bacterial peritonitis (with proven sepsis); 4) renal insufficiency; 5) bleeding gastric/oesophageal varices; 6) hepatocellular carcinoma; 7) liver-related death. The cumulative percentage of participants with disease progression has been presented along with 95% CI (Wald method).
Mean Change From Baseline in Liver Stiffness Measure at Week 48, Week 96, Week 144, Week 192 and Week 240	Baseline (Day 0), Week 48, Week 96, Week 144, Week 192 and Week 240	Liver stiffness measure was obtained by a non-invasive transient elastography using FibroScan. Baseline is defined as the last assessment (Day 0) before administration of the study drug. Change from Baseline is defined as post-dose visit value minus Baseline value
Percentage of Participants With Serum Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) <20 International Units Per Milliliter (IU/mL) at Weeks 48, 96, 144, 192 and 240	Week 48, Week 96, Week 144, Week 192 and Week 240	Serum samples were collected for the analysis of HBV DNA levels using Roche Cobas Taqman HBV test. Confidence interval was calculated by normal approximation and continuity correction method.
Change From Baseline in Logarithm to the Base 10 (Log 10) Serum HBV DNA	Baseline (Day 0) and Week 48, Week 96, Week 144, Week 192 and Week 240	Serum samples were collected for the analysis of HBV DNA levels. Baseline is defined as the last assessment (Day 0) before administration of the study drug. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Week 48, Week 96, Week 144, Week 192 and Week 240 in Participants Who Had Abnormal ALT at Baseline	Week 48, Week 96, Week 144, Week 192 and Week 240	Blood samples were collected for evaluation of ALT at indicated time points. ALT normalization is defined as ALT outside the normal range at Baseline and within the normal range at Week 48, Week 96, Week 144, Week 192 and Week 240. Normal range of ALT is 7 to 56 International Units per liter. Percentage of participants with ALT normalization at Weeks 48, 96, 144, 192 and 240 in participants who had abnormal ALT at Baseline (Day 0) have been presented. Confidence interval was calculated using normal approximation and continuity correction method.
Percentage of Hepatitis B e Antigen (HBeAg) Positive Participants Achieving HBeAg Loss, HBeAg Seroconversion at Week 48, Week 96, Week 144, Week 192 and Week 240.	Week 48, Week 96, Week 144, Week 192 and Week 240	Serological response was assessed at Week 48, Week 96, Week 144, Week 192 and Week 240 in participants with Positive HBeAg at Baseline (Day 0). It was presented as HBeAg Loss and HBeAg Seroconversion. HBeAg Loss was defined as HBeAg changed to be negative. HBeAg seroconversion was defined as HBeAg changed to negative and HBeAb was positive. Confidence interval was calculated using normal approximation and continuity correction method.
Percentage of HBeAg Negative Participants Achieving HBsAg Loss and HBsAg Seroconversion at Week 48, Week 96, Week 144, Week 192 and Week 240	Week 48, Week 96, Week 144, Week 192 and Week 240	Serological response was assessed at Week 48, Week 96, Week 144, Week 192 and Week 240 in participants with negative HBeAg at Baseline (Day 0). HBsAg Loss was defined as HBsAg changed to be negative. HBsAg seroconversion was defined as HBsAg changed to negative and HBsAb was positive.
Percentage of Participants Who Experienced Viral Breakthrough	Week 48, Week 96, Week 144, Week 192 and Week 240	Viral breakthrough was defined as \>=1 log10 increase in HBV DNA from nadir determined by two sequential HBV DNA measurements. Percentage of Participants who experienced viral breakthrough at Week 48, Week 96, Week 144, Week 192 and Week 240 is presented.
Percentage of Participants With Histological Improvement at Week 216	Week 216	The Knodell scoring system, also called the Histologic Activity Index (HAI), classifies liver biopsy specimens according to scores into 4 categories of histologic features: (I) Periportal or periseptal interface hepatitis (piecemeal necrosis) (scores from 0, 1, 2, 3, 4 or 10); (II) Confluent necrosis (scores from 0, 1, 3, 4, 5, 6 or 10); (III) Focal (spotty) lytic necrosis, apoptosis and focal inflammation (scores from 0, 1, 2, 3, 4 or 10); (IV) Portal inflammation (scores from 0, 1, 2, 3, 4 or 10). Histological improvement is considered as a reduction of two or more points in the Knodell necroinflammatory score with no increase in fibrosis.
Percentage of Participants With Cirrhosis Reversal at Week 216	Week 216	Cirrhosis reversal was defined as a reduction of one or more points in the Ishak score with no evidence of cirrhosis. The Ishak liver fibrosis score ranges from 0 indicating no fibrosis to 6 indicating cirrhosis.
Number of Participants With Newly Diagnosed Hepatocellular Carcinoma (HCC) at Week 48, Week 96, Week 144 and Week 192	Week 48, Week 96, Week 144 and Week 192	The newly diagnosed HCC was defined as HCC cases from Week 24 to Week 240 and the participants were required to meet one of the following criteria: without HCC before Week 24; a histological diagnosis of HCC (i.e. by biopsy or at post-mortem); participants with nodules \>2 centimeter (cm), identification of typical HCC characteristics (hyper-vascular in the arterial phase with washout in the portal venous or delayed phases) by 4-phase multi-detector computed tomography (CT) scan or dynamic contrast-enhanced magnetic resonance imaging (MRI); participants with nodules \>1 cm, identification of typical HCC characteristics by both techniques (4-phase multi-detector CT and dynamic contrast-enhanced MRI).
Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets	Baseline (Day 0) and at Week 48, Week 96, Week 144, Week 192 and Week 240	Blood samples were collected to analyze the hematology parameters: basophils, eosinophils, WBC, lymphocytes, monocytes, neutrophils and platelets. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Change From Baseline in Hemoglobin (Hb)	Baseline (Day 0) and at Week 48, Week 96, Week 144, Week 192 and Week 240	Blood samples were collected to analyze Hb values. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Change From Baseline in Red Blood Cells (RBC)	Baseline (Day 0) and at Week 48, Week 96, Week 144, Week 192 and Week 240	Blood samples were collected to analyze RBC values. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Change From Baseline in Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH)	Baseline (Day 0) and at Week 48, Week 96, Week 144, Week 192 and Week 240	Blood samples were collected to analyze the chemistry parameters: ALT, ALP, AST, GGT, CK, LDH. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Change From Baseline in Chemistry Parameters: Total Bilirubin, Direct Bilirubin, Serum Creatinine	Baseline (Day 0) and at Week 48, Week 96, Week 144, Week 192 and Week 240	Blood samples were collected to analyze the chemistry parameters: total billirubin,direct bilirubin and serum creatinine. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Change From Baseline in Chemistry Parameters: Albumin and Total Protein	Baseline (Day 0) and at Week 48, Week 96, Week 144, Week 192 and Week 240	Blood samples were collected to analyze the chemistry parameters: albumin and total protein. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridion, Phosphorus, Calcium and Fasting Blood Glucose	Baseline (Day 0) and at Week 48, Week 96, Week 144, Week 192 and Week 240	Blood samples were collected to analyze the chemistry parameters: BUN, potassium, sodium, chloridion, phosphorus,calcium and fasting blood glucose. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Change From Baseline in Chemistry Parameters: Creatinine Clearance Rate	Baseline (Day 0) and at Week 48, Week 96, Week 144, Week 192 and Week 240	Blood samples were collected to analyze the chemistry parameters: creatinine clearance rate. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Change From Baseline in Chemistry Parameters: Estimated Glomerular Filtration Rate (eGFR)	Baseline (Day 0) and at Week 48, Week 96, Week 144, Week 192 and Week 240	Blood samples were collected to analyze the chemistry parameters: eGFR. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs and Non-serious TEAEs	Up to Week 240	An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. TEAE is defined as AE that occurred on or after the first dose date of study drug. SAE is any untoward medical occurrence that results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability or incapacity, is a congenital anomaly/birth defect and other situations according to medical or scientific judgement or events possible drug-induced liver injury with hyperbilirubinemia.
Percentage of Participants With Newly Diagnosed Hepatocellular Carcinoma (HCC) at Week 48, Week 96, Week 144, Week 192 and Week 240	Week 48, Week 96, Week 144, Week 192 and Week 240	The newly diagnosed HCC was defined as HCC cases from Week 24 to Week 240 and the participants were required to meet one of the following criteria: without HCC before Week 24; a histological diagnosis of HCC (i.e. by biopsy or at post-mortem); participants with nodules \>2 centimeter (cm), identification of typical HCC characteristics (hyper-vascular in the arterial phase with washout in the portal venous or delayed phases) by 4-phase multi-detector computed tomography (CT) scan or dynamic contrast-enhanced magnetic resonance imaging (MRI); participants with nodules \>1 cm, identification of typical HCC characteristics by both techniques (4-phase multi-detector CT and dynamic contrast-enhanced MRI).The cumulative percentage of participants with newly diagnosed Hepatocellular Carcinoma has been presented along with 95% confidence interval (CI) (Wald method).

Countries

China

Participant flow

Recruitment details

This study was conducted to evaluate the efficacy and safety of 300 milligram (mg) Tenofovir Disoproxil Fumarate (TDF) therapy in Chinese chronic hepatitis B (CHB) participants with advanced fibrosis and compensated cirrhosis

Pre-assignment details

A total of 266 participants were screened, of which 197 entered the study.

Participants by arm

Arm	Count
Tenofovir Disoproxil Fumarate 300 mg Participants received Tenofovir Disoproxil Fumarate 300 mg tablet once daily (QD) orally for 240 weeks.	195
Total	195

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Death	2
Overall Study	Lack of Efficacy	1
Overall Study	Lost to Follow-up	15
Overall Study	Physician Decision	3
Overall Study	Pregnancy	4
Overall Study	Protocol Violation	1
Overall Study	Treatment Interruptions of ≥28 days	1
Overall Study	Withdrawal by Subject	9

Baseline characteristics

Characteristic	Tenofovir Disoproxil Fumarate 300 mg
Age, Continuous	42.3 Years STANDARD_DEVIATION 9.8
Race/Ethnicity, Customized Asian	195 Participants
Sex: Female, Male Female	47 Participants
Sex: Female, Male Male	148 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	2 / 195
other Total, other adverse events	129 / 195
serious Total, serious adverse events	34 / 195

Outcome results

Primary

Incidence Rate of Newly Diagnosed Hepatocellular Carcinoma (HCC) at Week 240

The newly diagnosed HCC was defined as HCC cases from Week 24 to Week 240 and the participants were required to meet one of the following criteria: without HCC before Week 24; a histological diagnosis of HCC (i.e. by biopsy or at post-mortem); participants with nodules \>2 centimeter (cm), identification of typical HCC characteristics (hyper-vascular in the arterial phase with washout in the portal venous or delayed phases) by 4-phase multi-detector computed tomography (CT) scan or dynamic contrast-enhanced magnetic resonance imaging (MRI); participants with nodules \>1 cm, identification of typical HCC characteristics by both techniques (4-phase multi-detector CT and dynamic contrast-enhanced MRI).

Time frame: Week 240

Population: Modified Intent-to-treat (mITT) Population consisted of all recruited participants who received at least one dose of study medication.

Arm	Measure	Value (NUMBER)
Tenofovir Disoproxil Fumarate 300 mg	Incidence Rate of Newly Diagnosed Hepatocellular Carcinoma (HCC) at Week 240	6.045 Events per person-year

Primary

Percentage of Participants With Disease Progression at Week 240

Disease progression was defined as the first occurrence of any one of the following criteria: 1) an increase in Childs-Pugh score of 2 or more points from Baseline; 2) an increase in Childs-Pugh score of 2 or more points, solely based on laboratory parameters (i.e. bilirubin, prothrombin time and/or albumin) confirmed between two consecutive visits at least one month apart; 3) spontaneous bacterial peritonitis (with proven sepsis); 4) renal insufficiency; 5) bleeding gastric/esophageal varices; 6) hepatocellular carcinoma; 7)liver-related death.

Time frame: Week 240

Population: mITT Population

Arm	Measure	Value (NUMBER)
Tenofovir Disoproxil Fumarate 300 mg	Percentage of Participants With Disease Progression at Week 240	7.2 Percentage of participants

Secondary

Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridion, Phosphorus, Calcium and Fasting Blood Glucose

Blood samples were collected to analyze the chemistry parameters: BUN, potassium, sodium, chloridion, phosphorus,calcium and fasting blood glucose. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.

Time frame: Baseline (Day 0) and at Week 48, Week 96, Week 144, Week 192 and Week 240

Population: Safety analysis 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 300 mg	Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridion, Phosphorus, Calcium and Fasting Blood Glucose	Week 48, BUN, n=191	-0.046 Millimoles per liter	Standard Deviation 1.1067
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridion, Phosphorus, Calcium and Fasting Blood Glucose	Week 96, BUN, n=188	0.000 Millimoles per liter	Standard Deviation 1.1875
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridion, Phosphorus, Calcium and Fasting Blood Glucose	Week 144, BUN, n=184	0.037 Millimoles per liter	Standard Deviation 1.0892
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridion, Phosphorus, Calcium and Fasting Blood Glucose	Week 192, BUN, n=178	0.143 Millimoles per liter	Standard Deviation 1.1234
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridion, Phosphorus, Calcium and Fasting Blood Glucose	Week 240, BUN, n=155	0.131 Millimoles per liter	Standard Deviation 1.1358
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridion, Phosphorus, Calcium and Fasting Blood Glucose	Week 48, Potassium, n=191	-0.001 Millimoles per liter	Standard Deviation 0.3703
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridion, Phosphorus, Calcium and Fasting Blood Glucose	Week 144, Potassium, n=184	-0.039 Millimoles per liter	Standard Deviation 0.3871
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridion, Phosphorus, Calcium and Fasting Blood Glucose	Week 192, Potassium, n=178	0.015 Millimoles per liter	Standard Deviation 0.4223
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridion, Phosphorus, Calcium and Fasting Blood Glucose	Week 48, Sodium, n=191	0.21 Millimoles per liter	Standard Deviation 3.495
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridion, Phosphorus, Calcium and Fasting Blood Glucose	Week 96, Sodium, n=186	-0.02 Millimoles per liter	Standard Deviation 3.121
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridion, Phosphorus, Calcium and Fasting Blood Glucose	Week 144, Sodium, n=184	0.35 Millimoles per liter	Standard Deviation 2.73
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridion, Phosphorus, Calcium and Fasting Blood Glucose	Week 192, Sodium, n=178	0.38 Millimoles per liter	Standard Deviation 2.998
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridion, Phosphorus, Calcium and Fasting Blood Glucose	Week 48, Chloridion, n=191	-0.13 Millimoles per liter	Standard Deviation 3.6
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridion, Phosphorus, Calcium and Fasting Blood Glucose	Week 96, Chloridion, n=186	0.40 Millimoles per liter	Standard Deviation 3.535
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridion, Phosphorus, Calcium and Fasting Blood Glucose	Week 144, Chloridion, n=183	0.35 Millimoles per liter	Standard Deviation 3.492
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridion, Phosphorus, Calcium and Fasting Blood Glucose	Week 192, Chloridion, n=178	0.77 Millimoles per liter	Standard Deviation 3.142
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridion, Phosphorus, Calcium and Fasting Blood Glucose	Week 240, Chloridion, n=158	0.49 Millimoles per liter	Standard Deviation 3.364
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridion, Phosphorus, Calcium and Fasting Blood Glucose	Week 48, Phosphorus, n=190	-0.044 Millimoles per liter	Standard Deviation 0.1724
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridion, Phosphorus, Calcium and Fasting Blood Glucose	Week 96, Phosphorus, n=187	-0.038 Millimoles per liter	Standard Deviation 0.1632
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridion, Phosphorus, Calcium and Fasting Blood Glucose	Week 144, Phosphorus, n=184	-0.037 Millimoles per liter	Standard Deviation 0.1955
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridion, Phosphorus, Calcium and Fasting Blood Glucose	Week 192, Phosphorus, n=175	-0.059 Millimoles per liter	Standard Deviation 0.1876
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridion, Phosphorus, Calcium and Fasting Blood Glucose	Week 240, Phosphorus, n=159	-0.042 Millimoles per liter	Standard Deviation 0.2009
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridion, Phosphorus, Calcium and Fasting Blood Glucose	Week 48, Calcium, n=190	-0.023 Millimoles per liter	Standard Deviation 0.1513
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridion, Phosphorus, Calcium and Fasting Blood Glucose	Week 144, Fasting Blood Glucose, n=185	-0.094 Millimoles per liter	Standard Deviation 0.8979
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridion, Phosphorus, Calcium and Fasting Blood Glucose	Week 192, Fasting Blood Glucose, n=177	-0.052 Millimoles per liter	Standard Deviation 0.7548
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridion, Phosphorus, Calcium and Fasting Blood Glucose	Week 240, Fasting Blood Glucose, n=158	0.052 Millimoles per liter	Standard Deviation 1.2197
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridion, Phosphorus, Calcium and Fasting Blood Glucose	Week 96, Potassium, n=186	0.002 Millimoles per liter	Standard Deviation 0.323
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridion, Phosphorus, Calcium and Fasting Blood Glucose	Week 240, Potassium, n=158	-0.013 Millimoles per liter	Standard Deviation 0.3946
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridion, Phosphorus, Calcium and Fasting Blood Glucose	Week 240, Sodium, n=158	-0.13 Millimoles per liter	Standard Deviation 2.707
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridion, Phosphorus, Calcium and Fasting Blood Glucose	Week 96, Calcium, n=187	-0.006 Millimoles per liter	Standard Deviation 0.1652
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridion, Phosphorus, Calcium and Fasting Blood Glucose	Week 144, Calcium, n=184	-0.022 Millimoles per liter	Standard Deviation 0.1605
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridion, Phosphorus, Calcium and Fasting Blood Glucose	Week 192, Calcium, n=178	-0.004 Millimoles per liter	Standard Deviation 0.147
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridion, Phosphorus, Calcium and Fasting Blood Glucose	Week 240, Calcium, n=158	-0.006 Millimoles per liter	Standard Deviation 0.1558
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridion, Phosphorus, Calcium and Fasting Blood Glucose	Week 48, Fasting Blood Glucose, n=191	-0.162 Millimoles per liter	Standard Deviation 0.7154
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridion, Phosphorus, Calcium and Fasting Blood Glucose	Week 96, Fasting Blood Glucose, n=188	-0.109 Millimoles per liter	Standard Deviation 0.7139

Secondary

Change From Baseline in Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH)

Blood samples were collected to analyze the chemistry parameters: ALT, ALP, AST, GGT, CK, LDH. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.

Time frame: Baseline (Day 0) and at Week 48, Week 96, Week 144, Week 192 and Week 240

Population: Safety analysis 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 300 mg	Change From Baseline in Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH)	Week 144, ALT, n=185	-28.99 Units per liter	Standard Deviation 56.983
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH)	Week 192, ALT, n=178	-31.79 Units per liter	Standard Deviation 57.955
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH)	Week 48, ALT, n=190	-23.98 Units per liter	Standard Deviation 59.452
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH)	Week 96, ALT, n=187	-28.99 Units per liter	Standard Deviation 56.983
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH)	Week 240, ALT, n=158	-32.02 Units per liter	Standard Deviation 63.157
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH)	Week 48, AST, n=191	-14.69 Units per liter	Standard Deviation 36.674
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH)	Week 96, AST, n=188	-17.97 Units per liter	Standard Deviation 36.057
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH)	Week 144, AST, n=184	-18.10 Units per liter	Standard Deviation 36.809
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH)	Week 192, AST, n=178	-19.82 Units per liter	Standard Deviation 36.312
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH)	Week 240, AST, n=158	-20.24 Units per liter	Standard Deviation 43.908
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH)	Week 48, ALP, n=190	10.18 Units per liter	Standard Deviation 20.288
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH)	Week 96, ALP, n=188	2.60 Units per liter	Standard Deviation 28.233
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH)	Week 144, ALP, n=185	-2.20 Units per liter	Standard Deviation 26.555
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH)	Week 192, ALP, n=177	-0.94 Units per liter	Standard Deviation 31.604
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH)	Week 240, ALP, n=158	-4.68 Units per liter	Standard Deviation 27.596
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH)	Week 48, GGT, n=190	-17.88 Units per liter	Standard Deviation 32.753
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH)	Week 96, GGT, n=188	-22.20 Units per liter	Standard Deviation 34.866
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH)	Week 144, GGT, n=185	-24.69 Units per liter	Standard Deviation 39.764
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH)	Week 192, GGT, n=175	-24.07 Units per liter	Standard Deviation 38.609
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH)	Week 240, GGT, n=152	-27.26 Units per liter	Standard Deviation 42.932
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH)	Week 48 CK, n=188	10.51 Units per liter	Standard Deviation 103.515
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH)	Week 96, CK, n=185	16.77 Units per liter	Standard Deviation 141.961
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH)	Week 144, CK, n=182	5.96 Units per liter	Standard Deviation 101.897
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH)	Week 192, CK, n=173	13.72 Units per liter	Standard Deviation 106.986
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH)	Week 240, CK, n=156	2.79 Units per liter	Standard Deviation 105.349
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH)	Week 48, LDH, n=187	-10.62 Units per liter	Standard Deviation 52.851
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH)	Week 96, LDH, n=185	-10.21 Units per liter	Standard Deviation 48.112
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH)	Week 144, LDH, n=180	3.34 Units per liter	Standard Deviation 73.047
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH)	Week 192, LDH, n=172	-18.45 Units per liter	Standard Deviation 87.931
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH)	Week 240, LDH, n=155	25.79 Units per liter	Standard Deviation 87.464

Secondary

Change From Baseline in Chemistry Parameters: Albumin and Total Protein

Blood samples were collected to analyze the chemistry parameters: albumin and total protein. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.

Time frame: Baseline (Day 0) and at Week 48, Week 96, Week 144, Week 192 and Week 240

Population: Safety analysis 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 300 mg	Change From Baseline in Chemistry Parameters: Albumin and Total Protein	Week 192, albumin, n=175	1.65 Grams per liter	Standard Deviation 3.78
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Chemistry Parameters: Albumin and Total Protein	Week 240, albumin, n=158	1.81 Grams per liter	Standard Deviation 3.79
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Chemistry Parameters: Albumin and Total Protein	Week 48, total protein, n=191	-1.01 Grams per liter	Standard Deviation 5.273
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Chemistry Parameters: Albumin and Total Protein	Week 96, total protein, n=188	-0.21 Grams per liter	Standard Deviation 5.397
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Chemistry Parameters: Albumin and Total Protein	Week 240, total protein, n=158	-1.61 Grams per liter	Standard Deviation 5.829
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Chemistry Parameters: Albumin and Total Protein	Week 48, albumin, n=191	1.06 Grams per liter	Standard Deviation 3.063
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Chemistry Parameters: Albumin and Total Protein	Week 96, albumin, n=188	1.23 Grams per liter	Standard Deviation 3.313
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Chemistry Parameters: Albumin and Total Protein	Week 144, albumin, n=185	1.86 Grams per liter	Standard Deviation 3.675
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Chemistry Parameters: Albumin and Total Protein	Week 144, total protein, n=185	0.27 Grams per liter	Standard Deviation 5.065
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Chemistry Parameters: Albumin and Total Protein	Week 192, total protein, n=175	-0.94 Grams per liter	Standard Deviation 5.175

Secondary

Change From Baseline in Chemistry Parameters: Creatinine Clearance Rate

Blood samples were collected to analyze the chemistry parameters: creatinine clearance rate. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.

Time frame: Baseline (Day 0) and at Week 48, Week 96, Week 144, Week 192 and Week 240

Population: Safety analysis 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 300 mg	Change From Baseline in Chemistry Parameters: Creatinine Clearance Rate	Week 48, n=190	-3.064 Milliliter per minute (mL/min)	Standard Deviation 11.5995
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Chemistry Parameters: Creatinine Clearance Rate	Week 96, n=188	-4.214 Milliliter per minute (mL/min)	Standard Deviation 12.7883
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Chemistry Parameters: Creatinine Clearance Rate	Week 144, n=184	-4.324 Milliliter per minute (mL/min)	Standard Deviation 15.3937
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Chemistry Parameters: Creatinine Clearance Rate	Week 192, n=177	-6.599 Milliliter per minute (mL/min)	Standard Deviation 13.8858
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Chemistry Parameters: Creatinine Clearance Rate	Week 240, n=155	-6.658 Milliliter per minute (mL/min)	Standard Deviation 16.5351

Secondary

Change From Baseline in Chemistry Parameters: Estimated Glomerular Filtration Rate (eGFR)

Blood samples were collected to analyze the chemistry parameters: eGFR. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.

Time frame: Baseline (Day 0) and at Week 48, Week 96, Week 144, Week 192 and Week 240

Population: Safety analysis 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 300 mg	Change From Baseline in Chemistry Parameters: Estimated Glomerular Filtration Rate (eGFR)	Week 48, n=191	-0.86 mL/minute per 1.73 square meter	Standard Deviation 6.581
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Chemistry Parameters: Estimated Glomerular Filtration Rate (eGFR)	Week 96, n=188	-0.87 mL/minute per 1.73 square meter	Standard Deviation 7.078
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Chemistry Parameters: Estimated Glomerular Filtration Rate (eGFR)	Week 144, n=185	-0.68 mL/minute per 1.73 square meter	Standard Deviation 8.368
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Chemistry Parameters: Estimated Glomerular Filtration Rate (eGFR)	Week 192, n=180	-1.06 mL/minute per 1.73 square meter	Standard Deviation 8.442
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Chemistry Parameters: Estimated Glomerular Filtration Rate (eGFR)	Week 240, n=161	-1.42 mL/minute per 1.73 square meter	Standard Deviation 9.609

Secondary

Change From Baseline in Chemistry Parameters: Total Bilirubin, Direct Bilirubin, Serum Creatinine

Blood samples were collected to analyze the chemistry parameters: total billirubin,direct bilirubin and serum creatinine. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.

Time frame: Baseline (Day 0) and at Week 48, Week 96, Week 144, Week 192 and Week 240

Population: Safety analysis 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 300 mg	Change From Baseline in Chemistry Parameters: Total Bilirubin, Direct Bilirubin, Serum Creatinine	Week 240, total bilirubin, n=158	-1.772 Micromoles per liter	Standard Deviation 6.9786
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Chemistry Parameters: Total Bilirubin, Direct Bilirubin, Serum Creatinine	Week 48, direct bilirubin, n=191	-0.296 Micromoles per liter	Standard Deviation 3.1229
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Chemistry Parameters: Total Bilirubin, Direct Bilirubin, Serum Creatinine	Week 96, direct bilirubin, n=188	-0.462 Micromoles per liter	Standard Deviation 3.1875
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Chemistry Parameters: Total Bilirubin, Direct Bilirubin, Serum Creatinine	Week 48, total bilirubin, n=191	-1.485 Micromoles per liter	Standard Deviation 7.1347
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Chemistry Parameters: Total Bilirubin, Direct Bilirubin, Serum Creatinine	Week 96, total bilirubin, n=188	-1.823 Micromoles per liter	Standard Deviation 6.7167
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Chemistry Parameters: Total Bilirubin, Direct Bilirubin, Serum Creatinine	Week 144, total bilirubin, n=185	-2.665 Micromoles per liter	Standard Deviation 7.1281
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Chemistry Parameters: Total Bilirubin, Direct Bilirubin, Serum Creatinine	Week 192, total bilirubin, n=177	-2.791 Micromoles per liter	Standard Deviation 6.923
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Chemistry Parameters: Total Bilirubin, Direct Bilirubin, Serum Creatinine	Week 144, direct bilirubin, n=185	-0.713 Micromoles per liter	Standard Deviation 3.4898
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Chemistry Parameters: Total Bilirubin, Direct Bilirubin, Serum Creatinine	Week 192, direct bilirubin, n=178	-0.780 Micromoles per liter	Standard Deviation 3.5942
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Chemistry Parameters: Total Bilirubin, Direct Bilirubin, Serum Creatinine	Week 240, direct bilirubin, n=157	-0.599 Micromoles per liter	Standard Deviation 3.5608
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Chemistry Parameters: Total Bilirubin, Direct Bilirubin, Serum Creatinine	Week 48, serum creatinine, n=191	1.03 Micromoles per liter	Standard Deviation 7.02
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Chemistry Parameters: Total Bilirubin, Direct Bilirubin, Serum Creatinine	Week 96, serum creatinine, n=188	1.10 Micromoles per liter	Standard Deviation 7.597
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Chemistry Parameters: Total Bilirubin, Direct Bilirubin, Serum Creatinine	Week 144, serum creatinine, n=184	0.76 Micromoles per liter	Standard Deviation 9.122
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Chemistry Parameters: Total Bilirubin, Direct Bilirubin, Serum Creatinine	Week 192, serum creatinine, n=178	1.37 Micromoles per liter	Standard Deviation 8.591
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Chemistry Parameters: Total Bilirubin, Direct Bilirubin, Serum Creatinine	Week 240, serum creatinine, n=159	1.35 Micromoles per liter	Standard Deviation 9.879

Secondary

Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets

Blood samples were collected to analyze the hematology parameters: basophils, eosinophils, WBC, lymphocytes, monocytes, neutrophils and platelets. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.

Time frame: Baseline (Day 0) and at Week 48, Week 96, Week 144, Week 192 and Week 240

Population: Safety analysis 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 300 mg	Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets	Week 48, WBC, n=191	0.02 10^9 cells per liter	Standard Deviation 1.264
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets	Week 144, Eosinophils, n=185	-0.04 10^9 cells per liter	Standard Deviation 0.237
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets	Week 48, Platelets, n=191	7.8 10^9 cells per liter	Standard Deviation 31.45
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets	Week 96, WBC, n=188	0.09 10^9 cells per liter	Standard Deviation 1.38
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets	Week 144, WBC, n=185	-0.12 10^9 cells per liter	Standard Deviation 1.378
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets	Week 192, WBC, n=179	0.12 10^9 cells per liter	Standard Deviation 1.412
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets	Week 240, WBC, n=160	0.06 10^9 cells per liter	Standard Deviation 1.434
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets	Week 48, Neutrophils, n=191	0.08 10^9 cells per liter	Standard Deviation 1.051
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets	Week 96, Neutrophils, n=188	0.21 10^9 cells per liter	Standard Deviation 1.184
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets	Week 144, Neutrophils, n=185	0.07 10^9 cells per liter	Standard Deviation 1.162
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets	Week 192, Neutrophils, n=179	0.26 10^9 cells per liter	Standard Deviation 1.197
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets	Week 240, Neutrophils, n=160	0.28 10^9 cells per liter	Standard Deviation 1.194
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets	Week 48, Lymphocytes, n=191	0.00 10^9 cells per liter	Standard Deviation 0.438
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets	Week 96, Lymphocytes, n=188	-0.06 10^9 cells per liter	Standard Deviation 0.511
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets	Week 144, Lymphocytes, n=185	-0.13 10^9 cells per liter	Standard Deviation 0.422
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets	Week 192, Lymphocytes, n=179	-0.10 10^9 cells per liter	Standard Deviation 0.442
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets	Week 240, Lymphocytes, n=160	-0.15 10^9 cells per liter	Standard Deviation 0.483
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets	Week 48, Monocytes, n=191	-0.032 10^9 cells per liter	Standard Deviation 0.1056
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets	Week 96, Monocytes, n=188	-0.033 10^9 cells per liter	Standard Deviation 0.1113
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets	Week 144, Monocytes, n=185	-0.035 10^9 cells per liter	Standard Deviation 0.1244
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets	Week 192, Monocytes, n=179	-0.025 10^9 cells per liter	Standard Deviation 0.1162
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets	Week 240, Monocytes, n=160	-0.005 10^9 cells per liter	Standard Deviation 0.1664
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets	Week 48, Eosinophils, n=191	-0.02 10^9 cells per liter	Standard Deviation 0.114
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets	Week 96, Eosinophils, n=188	-0.02 10^9 cells per liter	Standard Deviation 0.164
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets	Week 192, Eosinophils, n=179	-0.03 10^9 cells per liter	Standard Deviation 0.248
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets	Week 240, Eosinophils, n=160	-0.03 10^9 cells per liter	Standard Deviation 0.251
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets	Week 48, Basophils, n=191	0.00 10^9 cells per liter	Standard Deviation 0.017
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets	Week 96, Basophils, n=188	0.00 10^9 cells per liter	Standard Deviation 0.019
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets	Week 144, Basophils, n=184	0.01 10^9 cells per liter	Standard Deviation 0.025
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets	Week 192, Basophils, n=179	0.01 10^9 cells per liter	Standard Deviation 0.021
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets	Week 240, Basophils, n=160	0.01 10^9 cells per liter	Standard Deviation 0.033
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets	Week 96, Platelets, n=188	14.1 10^9 cells per liter	Standard Deviation 32.46
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets	Week 144, Platelets, n=185	20.6 10^9 cells per liter	Standard Deviation 42.02
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets	Week 192, Platelets, n=179	25.7 10^9 cells per liter	Standard Deviation 42.56
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets	Week 240, Platelets, n=160	26.6 10^9 cells per liter	Standard Deviation 38.39

Secondary

Change From Baseline in Hemoglobin (Hb)

Blood samples were collected to analyze Hb values. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.

Time frame: Baseline (Day 0) and at Week 48, Week 96, Week 144, Week 192 and Week 240

Population: Safety analysis 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 300 mg	Change From Baseline in Hemoglobin (Hb)	Week 48, n=191	-0.6 Grams per liter	Standard Deviation 10.12
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Hemoglobin (Hb)	Week 96, n=188	0.2 Grams per liter	Standard Deviation 11.63
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Hemoglobin (Hb)	Week 144, n=185	0.9 Grams per liter	Standard Deviation 11.26
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Hemoglobin (Hb)	Week 192, n=179	-0.3 Grams per liter	Standard Deviation 12.61
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Hemoglobin (Hb)	Week 240, n=160	1.2 Grams per liter	Standard Deviation 12.71

Secondary

Change From Baseline in Logarithm to the Base 10 (Log 10) Serum HBV DNA

Serum samples were collected for the analysis of HBV DNA levels. Baseline is defined as the last assessment (Day 0) before administration of the study drug. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.

Time frame: Baseline (Day 0) and Week 48, Week 96, Week 144, Week 192 and Week 240

Population: mITT 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 300 mg	Change From Baseline in Logarithm to the Base 10 (Log 10) Serum HBV DNA	Week 48, n=191	-4.2 Log 10 (IU/mL)	Standard Deviation 1.4
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Logarithm to the Base 10 (Log 10) Serum HBV DNA	Week 96, n=188	-4.3 Log 10 (IU/mL)	Standard Deviation 1.44
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Logarithm to the Base 10 (Log 10) Serum HBV DNA	Week 144, n=185	-4.3 Log 10 (IU/mL)	Standard Deviation 1.48
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Logarithm to the Base 10 (Log 10) Serum HBV DNA	Week 192, n=174	-4.2 Log 10 (IU/mL)	Standard Deviation 1.5
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Logarithm to the Base 10 (Log 10) Serum HBV DNA	Week 240, n=160	-4.3 Log 10 (IU/mL)	Standard Deviation 1.46

Secondary

Change From Baseline in Red Blood Cells (RBC)

Blood samples were collected to analyze RBC values. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.

Time frame: Baseline (Day 0) and at Week 48, Week 96, Week 144, Week 192 and Week 240

Population: Safety analysis 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 300 mg	Change From Baseline in Red Blood Cells (RBC)	Week 48, n=191	0.11 Trillion cells per liter	Standard Deviation 0.306
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Red Blood Cells (RBC)	Week 96, n=188	0.13 Trillion cells per liter	Standard Deviation 0.344
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Red Blood Cells (RBC)	Week 144, n=185	0.15 Trillion cells per liter	Standard Deviation 0.34
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Red Blood Cells (RBC)	Week 192, n=179	0.10 Trillion cells per liter	Standard Deviation 0.363
Tenofovir Disoproxil Fumarate 300 mg	Change From Baseline in Red Blood Cells (RBC)	Week 240, n=160	0.12 Trillion cells per liter	Standard Deviation 0.341

Secondary

Mean Change From Baseline in Liver Stiffness Measure at Week 48, Week 96, Week 144, Week 192 and Week 240

Liver stiffness measure was obtained by a non-invasive transient elastography using FibroScan. Baseline is defined as the last assessment (Day 0) before administration of the study drug. Change from Baseline is defined as post-dose visit value minus Baseline value

Time frame: Baseline (Day 0), Week 48, Week 96, Week 144, Week 192 and Week 240

Population: mITT 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 300 mg	Mean Change From Baseline in Liver Stiffness Measure at Week 48, Week 96, Week 144, Week 192 and Week 240	Week 48, n=182	-3.3 Kilopascals	Standard Deviation 4.84
Tenofovir Disoproxil Fumarate 300 mg	Mean Change From Baseline in Liver Stiffness Measure at Week 48, Week 96, Week 144, Week 192 and Week 240	Week 96, n= 176	-4.7 Kilopascals	Standard Deviation 5.6
Tenofovir Disoproxil Fumarate 300 mg	Mean Change From Baseline in Liver Stiffness Measure at Week 48, Week 96, Week 144, Week 192 and Week 240	Week 144, n= 175	-5.1 Kilopascals	Standard Deviation 5.85
Tenofovir Disoproxil Fumarate 300 mg	Mean Change From Baseline in Liver Stiffness Measure at Week 48, Week 96, Week 144, Week 192 and Week 240	Week 192, n=167	-5.1 Kilopascals	Standard Deviation 7.82
Tenofovir Disoproxil Fumarate 300 mg	Mean Change From Baseline in Liver Stiffness Measure at Week 48, Week 96, Week 144, Week 192 and Week 240	Week 240, n= 131	-6.2 Kilopascals	Standard Deviation 5.55

Secondary

Number of Participants With Newly Diagnosed Hepatocellular Carcinoma (HCC) at Week 48, Week 96, Week 144 and Week 192

Time frame: Week 48, Week 96, Week 144 and Week 192

Population: mITT Population

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Tenofovir Disoproxil Fumarate 300 mg	Number of Participants With Newly Diagnosed Hepatocellular Carcinoma (HCC) at Week 48, Week 96, Week 144 and Week 192	Week 48	0 Participants
Tenofovir Disoproxil Fumarate 300 mg	Number of Participants With Newly Diagnosed Hepatocellular Carcinoma (HCC) at Week 48, Week 96, Week 144 and Week 192	Week 96	0 Participants
Tenofovir Disoproxil Fumarate 300 mg	Number of Participants With Newly Diagnosed Hepatocellular Carcinoma (HCC) at Week 48, Week 96, Week 144 and Week 192	Week 144	4 Participants
Tenofovir Disoproxil Fumarate 300 mg	Number of Participants With Newly Diagnosed Hepatocellular Carcinoma (HCC) at Week 48, Week 96, Week 144 and Week 192	Week 192	9 Participants

Secondary

Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs and Non-serious TEAEs

An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. TEAE is defined as AE that occurred on or after the first dose date of study drug. SAE is any untoward medical occurrence that results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability or incapacity, is a congenital anomaly/birth defect and other situations according to medical or scientific judgement or events possible drug-induced liver injury with hyperbilirubinemia.

Time frame: Up to Week 240

Population: Safety Analysis Population was defined as all participants who received at least one dose of study medication and have at least one post Baseline safety assessment.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Tenofovir Disoproxil Fumarate 300 mg	Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs and Non-serious TEAEs	Any TEAEs	139 Participants
Tenofovir Disoproxil Fumarate 300 mg	Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs and Non-serious TEAEs	Serious TEAE	34 Participants
Tenofovir Disoproxil Fumarate 300 mg	Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs and Non-serious TEAEs	Non-serious TEAE	129 Participants

Secondary

Percentage of HBeAg Negative Participants Achieving HBsAg Loss and HBsAg Seroconversion at Week 48, Week 96, Week 144, Week 192 and Week 240

Serological response was assessed at Week 48, Week 96, Week 144, Week 192 and Week 240 in participants with negative HBeAg at Baseline (Day 0). HBsAg Loss was defined as HBsAg changed to be negative. HBsAg seroconversion was defined as HBsAg changed to negative and HBsAb was positive.

Time frame: Week 48, Week 96, Week 144, Week 192 and Week 240

Population: mITT 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 (NUMBER)
Tenofovir Disoproxil Fumarate 300 mg	Percentage of HBeAg Negative Participants Achieving HBsAg Loss and HBsAg Seroconversion at Week 48, Week 96, Week 144, Week 192 and Week 240	Week 48, HBsAg Loss, n=97	1.0 Percentage of Participants
Tenofovir Disoproxil Fumarate 300 mg	Percentage of HBeAg Negative Participants Achieving HBsAg Loss and HBsAg Seroconversion at Week 48, Week 96, Week 144, Week 192 and Week 240	Week 48, HBsAg Seroconversion, n=97	1.0 Percentage of Participants
Tenofovir Disoproxil Fumarate 300 mg	Percentage of HBeAg Negative Participants Achieving HBsAg Loss and HBsAg Seroconversion at Week 48, Week 96, Week 144, Week 192 and Week 240	Week 96, HBsAg , n=93	0 Percentage of Participants
Tenofovir Disoproxil Fumarate 300 mg	Percentage of HBeAg Negative Participants Achieving HBsAg Loss and HBsAg Seroconversion at Week 48, Week 96, Week 144, Week 192 and Week 240	Week 96, HBsAg Seroconversion, n=93	0 Percentage of Participants
Tenofovir Disoproxil Fumarate 300 mg	Percentage of HBeAg Negative Participants Achieving HBsAg Loss and HBsAg Seroconversion at Week 48, Week 96, Week 144, Week 192 and Week 240	Week 144, HBsAg Loss, n=93	3.2 Percentage of Participants
Tenofovir Disoproxil Fumarate 300 mg	Percentage of HBeAg Negative Participants Achieving HBsAg Loss and HBsAg Seroconversion at Week 48, Week 96, Week 144, Week 192 and Week 240	Week 144, HBsAg Seroconversion, n=93	0 Percentage of Participants
Tenofovir Disoproxil Fumarate 300 mg	Percentage of HBeAg Negative Participants Achieving HBsAg Loss and HBsAg Seroconversion at Week 48, Week 96, Week 144, Week 192 and Week 240	Week 192, HBsAg Loss, n=89	4.5 Percentage of Participants
Tenofovir Disoproxil Fumarate 300 mg	Percentage of HBeAg Negative Participants Achieving HBsAg Loss and HBsAg Seroconversion at Week 48, Week 96, Week 144, Week 192 and Week 240	Week 192, HBsAg Seroconversion, n=89	2.2 Percentage of Participants
Tenofovir Disoproxil Fumarate 300 mg	Percentage of HBeAg Negative Participants Achieving HBsAg Loss and HBsAg Seroconversion at Week 48, Week 96, Week 144, Week 192 and Week 240	Week 240, HBsAg Loss, n=77	5.2 Percentage of Participants
Tenofovir Disoproxil Fumarate 300 mg	Percentage of HBeAg Negative Participants Achieving HBsAg Loss and HBsAg Seroconversion at Week 48, Week 96, Week 144, Week 192 and Week 240	Week 240, HBsAg Seroconversion, n=77	1.3 Percentage of Participants

Secondary

Percentage of Hepatitis B e Antigen (HBeAg) Positive Participants Achieving HBeAg Loss, HBeAg Seroconversion at Week 48, Week 96, Week 144, Week 192 and Week 240.

Serological response was assessed at Week 48, Week 96, Week 144, Week 192 and Week 240 in participants with Positive HBeAg at Baseline (Day 0). It was presented as HBeAg Loss and HBeAg Seroconversion. HBeAg Loss was defined as HBeAg changed to be negative. HBeAg seroconversion was defined as HBeAg changed to negative and HBeAb was positive. Confidence interval was calculated using normal approximation and continuity correction method.

Time frame: Week 48, Week 96, Week 144, Week 192 and Week 240

Population: mITT 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 (NUMBER)
Tenofovir Disoproxil Fumarate 300 mg	Percentage of Hepatitis B e Antigen (HBeAg) Positive Participants Achieving HBeAg Loss, HBeAg Seroconversion at Week 48, Week 96, Week 144, Week 192 and Week 240.	Week 48, HBeAg Loss, n=94	18.1 Percentage of participants
Tenofovir Disoproxil Fumarate 300 mg	Percentage of Hepatitis B e Antigen (HBeAg) Positive Participants Achieving HBeAg Loss, HBeAg Seroconversion at Week 48, Week 96, Week 144, Week 192 and Week 240.	Week 48, HBeAg Seroconversion, n=94	9.6 Percentage of participants
Tenofovir Disoproxil Fumarate 300 mg	Percentage of Hepatitis B e Antigen (HBeAg) Positive Participants Achieving HBeAg Loss, HBeAg Seroconversion at Week 48, Week 96, Week 144, Week 192 and Week 240.	Week 96, HBeAg , n=94	33.0 Percentage of participants
Tenofovir Disoproxil Fumarate 300 mg	Percentage of Hepatitis B e Antigen (HBeAg) Positive Participants Achieving HBeAg Loss, HBeAg Seroconversion at Week 48, Week 96, Week 144, Week 192 and Week 240.	Week 96, HBeAg Seroconversion, n=94	14.9 Percentage of participants
Tenofovir Disoproxil Fumarate 300 mg	Percentage of Hepatitis B e Antigen (HBeAg) Positive Participants Achieving HBeAg Loss, HBeAg Seroconversion at Week 48, Week 96, Week 144, Week 192 and Week 240.	Week 144, HBeAg Loss, n=90	35.6 Percentage of participants
Tenofovir Disoproxil Fumarate 300 mg	Percentage of Hepatitis B e Antigen (HBeAg) Positive Participants Achieving HBeAg Loss, HBeAg Seroconversion at Week 48, Week 96, Week 144, Week 192 and Week 240.	Week 144, HBeAg Seroconversion, n=90	14.4 Percentage of participants
Tenofovir Disoproxil Fumarate 300 mg	Percentage of Hepatitis B e Antigen (HBeAg) Positive Participants Achieving HBeAg Loss, HBeAg Seroconversion at Week 48, Week 96, Week 144, Week 192 and Week 240.	Week 192, HBeAg Loss, n=90	47.8 Percentage of participants
Tenofovir Disoproxil Fumarate 300 mg	Percentage of Hepatitis B e Antigen (HBeAg) Positive Participants Achieving HBeAg Loss, HBeAg Seroconversion at Week 48, Week 96, Week 144, Week 192 and Week 240.	Week 192, HBeAg Seroconversion, n=90	16.7 Percentage of participants
Tenofovir Disoproxil Fumarate 300 mg	Percentage of Hepatitis B e Antigen (HBeAg) Positive Participants Achieving HBeAg Loss, HBeAg Seroconversion at Week 48, Week 96, Week 144, Week 192 and Week 240.	Week 240, HBeAg Loss, n=82	51.2 Percentage of participants
Tenofovir Disoproxil Fumarate 300 mg	Percentage of Hepatitis B e Antigen (HBeAg) Positive Participants Achieving HBeAg Loss, HBeAg Seroconversion at Week 48, Week 96, Week 144, Week 192 and Week 240.	Week 240, HBeAg Seroconversion, n=82	23.2 Percentage of participants

Secondary

Percentage of Participants Who Experienced Viral Breakthrough

Viral breakthrough was defined as \>=1 log10 increase in HBV DNA from nadir determined by two sequential HBV DNA measurements. Percentage of Participants who experienced viral breakthrough at Week 48, Week 96, Week 144, Week 192 and Week 240 is presented.

Time frame: Week 48, Week 96, Week 144, Week 192 and Week 240

Population: mITT 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 (NUMBER)
Tenofovir Disoproxil Fumarate 300 mg	Percentage of Participants Who Experienced Viral Breakthrough	Week 48, n=195	0 Percentage of Participants
Tenofovir Disoproxil Fumarate 300 mg	Percentage of Participants Who Experienced Viral Breakthrough	Week 96, n=195	0 Percentage of Participants
Tenofovir Disoproxil Fumarate 300 mg	Percentage of Participants Who Experienced Viral Breakthrough	Week 144, n=185	0.5 Percentage of Participants
Tenofovir Disoproxil Fumarate 300 mg	Percentage of Participants Who Experienced Viral Breakthrough	Week 192, n=180	1.1 Percentage of Participants
Tenofovir Disoproxil Fumarate 300 mg	Percentage of Participants Who Experienced Viral Breakthrough	Week 240, n=161	0.6 Percentage of Participants

Secondary

Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Week 48, Week 96, Week 144, Week 192 and Week 240 in Participants Who Had Abnormal ALT at Baseline

Blood samples were collected for evaluation of ALT at indicated time points. ALT normalization is defined as ALT outside the normal range at Baseline and within the normal range at Week 48, Week 96, Week 144, Week 192 and Week 240. Normal range of ALT is 7 to 56 International Units per liter. Percentage of participants with ALT normalization at Weeks 48, 96, 144, 192 and 240 in participants who had abnormal ALT at Baseline (Day 0) have been presented. Confidence interval was calculated using normal approximation and continuity correction method.

Time frame: Week 48, Week 96, Week 144, Week 192 and Week 240

Population: mITT 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 (NUMBER)
Tenofovir Disoproxil Fumarate 300 mg	Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Week 48, Week 96, Week 144, Week 192 and Week 240 in Participants Who Had Abnormal ALT at Baseline	Week 48, n=97	63.9 Percentage of participants
Tenofovir Disoproxil Fumarate 300 mg	Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Week 48, Week 96, Week 144, Week 192 and Week 240 in Participants Who Had Abnormal ALT at Baseline	Week 96, n= 97	66.0 Percentage of participants
Tenofovir Disoproxil Fumarate 300 mg	Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Week 48, Week 96, Week 144, Week 192 and Week 240 in Participants Who Had Abnormal ALT at Baseline	Week 144, n=96	70.8 Percentage of participants
Tenofovir Disoproxil Fumarate 300 mg	Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Week 48, Week 96, Week 144, Week 192 and Week 240 in Participants Who Had Abnormal ALT at Baseline	Week 192, n=93	82.8 Percentage of participants
Tenofovir Disoproxil Fumarate 300 mg	Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Week 48, Week 96, Week 144, Week 192 and Week 240 in Participants Who Had Abnormal ALT at Baseline	Week 240, n=87	82.8 Percentage of participants

Secondary

Percentage of Participants With Cirrhosis Reversal at Week 216

Cirrhosis reversal was defined as a reduction of one or more points in the Ishak score with no evidence of cirrhosis. The Ishak liver fibrosis score ranges from 0 indicating no fibrosis to 6 indicating cirrhosis.

Time frame: Week 216

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

Arm	Measure	Value (NUMBER)
Tenofovir Disoproxil Fumarate 300 mg	Percentage of Participants With Cirrhosis Reversal at Week 216	41.9 Percentage of participants

Secondary

Percentage of Participants With Disease Progression at Week 48, Week 96, Week 144, Week 192 and Week 240

Disease progression was defined as the first occurrence of any one of the following criteria: 1) an increase in Childs-Pugh score of 2 or more points from Baseline; 2) an increase in Childs-Pugh score of 2 or more points, solely based on laboratory parameters (i.e. bilirubin, prothrombin time and/or albumin) confirmed between two consecutive visits at least one month apart; 3) spontaneous bacterial peritonitis (with proven sepsis); 4) renal insufficiency; 5) bleeding gastric/oesophageal varices; 6) hepatocellular carcinoma; 7) liver-related death. The cumulative percentage of participants with disease progression has been presented along with 95% CI (Wald method).

Time frame: Week 48, Week 96, Week 144, Week 192 and Week 240

Population: mITT Population

Arm	Measure	Group	Value (NUMBER)
Tenofovir Disoproxil Fumarate 300 mg	Percentage of Participants With Disease Progression at Week 48, Week 96, Week 144, Week 192 and Week 240	Week 48	2.1 Percentage of participants
Tenofovir Disoproxil Fumarate 300 mg	Percentage of Participants With Disease Progression at Week 48, Week 96, Week 144, Week 192 and Week 240	Week 96	2.6 Percentage of participants
Tenofovir Disoproxil Fumarate 300 mg	Percentage of Participants With Disease Progression at Week 48, Week 96, Week 144, Week 192 and Week 240	Week 144	4.1 Percentage of participants
Tenofovir Disoproxil Fumarate 300 mg	Percentage of Participants With Disease Progression at Week 48, Week 96, Week 144, Week 192 and Week 240	Week 192	7.2 Percentage of participants
Tenofovir Disoproxil Fumarate 300 mg	Percentage of Participants With Disease Progression at Week 48, Week 96, Week 144, Week 192 and Week 240	Week 240	7.2 Percentage of participants

Secondary

Percentage of Participants With Histological Improvement at Week 216

The Knodell scoring system, also called the Histologic Activity Index (HAI), classifies liver biopsy specimens according to scores into 4 categories of histologic features: (I) Periportal or periseptal interface hepatitis (piecemeal necrosis) (scores from 0, 1, 2, 3, 4 or 10); (II) Confluent necrosis (scores from 0, 1, 3, 4, 5, 6 or 10); (III) Focal (spotty) lytic necrosis, apoptosis and focal inflammation (scores from 0, 1, 2, 3, 4 or 10); (IV) Portal inflammation (scores from 0, 1, 2, 3, 4 or 10). Histological improvement is considered as a reduction of two or more points in the Knodell necroinflammatory score with no increase in fibrosis.

Time frame: Week 216

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

Arm	Measure	Value (NUMBER)
Tenofovir Disoproxil Fumarate 300 mg	Percentage of Participants With Histological Improvement at Week 216	45.2 Percentage of participants

Secondary

Percentage of Participants With Newly Diagnosed Hepatocellular Carcinoma (HCC) at Week 48, Week 96, Week 144, Week 192 and Week 240

Time frame: Week 48, Week 96, Week 144, Week 192 and Week 240

Population: mITT Population

Arm	Measure	Group	Value (NUMBER)
Tenofovir Disoproxil Fumarate 300 mg	Percentage of Participants With Newly Diagnosed Hepatocellular Carcinoma (HCC) at Week 48, Week 96, Week 144, Week 192 and Week 240	Week 48	0 Percentage of participants
Tenofovir Disoproxil Fumarate 300 mg	Percentage of Participants With Newly Diagnosed Hepatocellular Carcinoma (HCC) at Week 48, Week 96, Week 144, Week 192 and Week 240	Week 96	0 Percentage of participants
Tenofovir Disoproxil Fumarate 300 mg	Percentage of Participants With Newly Diagnosed Hepatocellular Carcinoma (HCC) at Week 48, Week 96, Week 144, Week 192 and Week 240	Week 144	2.1 Percentage of participants
Tenofovir Disoproxil Fumarate 300 mg	Percentage of Participants With Newly Diagnosed Hepatocellular Carcinoma (HCC) at Week 48, Week 96, Week 144, Week 192 and Week 240	Week 192	4.6 Percentage of participants
Tenofovir Disoproxil Fumarate 300 mg	Percentage of Participants With Newly Diagnosed Hepatocellular Carcinoma (HCC) at Week 48, Week 96, Week 144, Week 192 and Week 240	Week 240	5.6 Percentage of participants

Secondary

Percentage of Participants With Serum Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) <20 International Units Per Milliliter (IU/mL) at Weeks 48, 96, 144, 192 and 240

Serum samples were collected for the analysis of HBV DNA levels using Roche Cobas Taqman HBV test. Confidence interval was calculated by normal approximation and continuity correction method.

Time frame: Week 48, Week 96, Week 144, Week 192 and Week 240

Population: mITT 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 (NUMBER)
Tenofovir Disoproxil Fumarate 300 mg	Percentage of Participants With Serum Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) <20 International Units Per Milliliter (IU/mL) at Weeks 48, 96, 144, 192 and 240	Week 48, n=191	81.2 Percentage of participants
Tenofovir Disoproxil Fumarate 300 mg	Percentage of Participants With Serum Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) <20 International Units Per Milliliter (IU/mL) at Weeks 48, 96, 144, 192 and 240	Week 96, n=188	88.8 Percentage of participants
Tenofovir Disoproxil Fumarate 300 mg	Percentage of Participants With Serum Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) <20 International Units Per Milliliter (IU/mL) at Weeks 48, 96, 144, 192 and 240	Week 144, n=185	94.1 Percentage of participants
Tenofovir Disoproxil Fumarate 300 mg	Percentage of Participants With Serum Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) <20 International Units Per Milliliter (IU/mL) at Weeks 48, 96, 144, 192 and 240	Week 192, n=174	97.7 Percentage of participants
Tenofovir Disoproxil Fumarate 300 mg	Percentage of Participants With Serum Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) <20 International Units Per Milliliter (IU/mL) at Weeks 48, 96, 144, 192 and 240	Week 240, n=160	99.4 Percentage of participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026

Efficacy and Safety Study of Tenofovir Disoproxil Fumarate (TDF) in Chinese Chronic Hepatitis B (CHB) Subjects With Advanced Fibrosis & Compensated Cirrhosis

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Participant flow

Recruitment details

Pre-assignment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Incidence Rate of Newly Diagnosed Hepatocellular Carcinoma (HCC) at Week 240

Percentage of Participants With Disease Progression at Week 240

Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridion, Phosphorus, Calcium and Fasting Blood Glucose

Change From Baseline in Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH)

Change From Baseline in Chemistry Parameters: Albumin and Total Protein

Change From Baseline in Chemistry Parameters: Creatinine Clearance Rate

Change From Baseline in Chemistry Parameters: Estimated Glomerular Filtration Rate (eGFR)

Change From Baseline in Chemistry Parameters: Total Bilirubin, Direct Bilirubin, Serum Creatinine

Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets

Change From Baseline in Hemoglobin (Hb)

Change From Baseline in Logarithm to the Base 10 (Log 10) Serum HBV DNA

Change From Baseline in Red Blood Cells (RBC)

Mean Change From Baseline in Liver Stiffness Measure at Week 48, Week 96, Week 144, Week 192 and Week 240

Number of Participants With Newly Diagnosed Hepatocellular Carcinoma (HCC) at Week 48, Week 96, Week 144 and Week 192

Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs and Non-serious TEAEs

Percentage of HBeAg Negative Participants Achieving HBsAg Loss and HBsAg Seroconversion at Week 48, Week 96, Week 144, Week 192 and Week 240

Percentage of Hepatitis B e Antigen (HBeAg) Positive Participants Achieving HBeAg Loss, HBeAg Seroconversion at Week 48, Week 96, Week 144, Week 192 and Week 240.

Percentage of Participants Who Experienced Viral Breakthrough

Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Week 48, Week 96, Week 144, Week 192 and Week 240 in Participants Who Had Abnormal ALT at Baseline

Percentage of Participants With Cirrhosis Reversal at Week 216

Percentage of Participants With Disease Progression at Week 48, Week 96, Week 144, Week 192 and Week 240

Percentage of Participants With Histological Improvement at Week 216

Percentage of Participants With Newly Diagnosed Hepatocellular Carcinoma (HCC) at Week 48, Week 96, Week 144, Week 192 and Week 240

Percentage of Participants With Serum Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) <20 International Units Per Milliliter (IU/mL) at Weeks 48, 96, 144, 192 and 240