Hepatitis B, Chronic
Conditions
Keywords
Chronic Hepatitis B, Tenofovir disoproxil fumarate, Failure of multiple NAs treatment
Brief summary
This is a phase IV, single-arm, open-label, multi-centre study to assess the efficacy of TDF in Chronic hepatitis B (CHB) subjects following failure of multiple Nucleos(t)ide analogues (NAs). The study will enrol 200 CHB subjects following failure of multiple NAs. Subjects will be assessed for eligibility at a screening visit, with eligible subjects returning for a baseline assessment after approximately 4 weeks (Screening phase). In the treatment phase all enrolled subjects will receive open label TDF at a dose of 300 milligrams (mg) orally once daily. All the eligible study subjects will undergo safety and efficacy assessments every 12 weeks for a total of 14 visits. Tenofovir disoproxil fumarate, the oral pro-drug of tenofovir (TFV), is a nucleotide analogue that inhibits viral polymerases by direct binding and after incorporation into deoxyribonucleic acid (DNA), by termination of the DNA) chain. TDF is a highly potent treatment in treatment-naïve and lamivudine (LAM) resistant CHB patients. The purpose of our study is to evaluate the efficacy of TDF treatment in Chinese CHB patients following failure of multiple NAs. In addition, the study will also explore the relationship of baseline factors and early HBV DNA suppression to long-term virological response. The efficacy of TDF in multi-drug resistant patients will be analysed separately. The data generated by this study could then be used to optimize the clinical application of TDF and provide new evidence for management of the HBV infections following failure of multiple NAs. The result of this study will help Chinese physicians better manage the CHB patients following failure of multiple NAs.
Interventions
DRUGTenofovir disoproxil fumarate
Tenofovir disoproxil fumarate tablets supplied will be white, almond-shaped, film-coated tablets containing 300 mg of TDF. Each tablet contains the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, pregelatinised starch, croscarmellose sodium, and magnesium stearate.
Sponsors
GlaxoSmithKline
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Aged between 18-65years (inclusive). Male or female; 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 serum pregnancy test at baseline, 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 or cervical/vault caps) with a vaginal spermicidal agent (foam/gel/film /cream/suppository). * The ability to understand and sign a written informed consent prior to any study-related procedure and comply with the requirements of the study. * Positive HBsAg for more than 6 months, and anti-HBs negative. * Serum HBV DNA level \>=200 IU/mL at study screening (Use central lab results). * Experienced multiple NAs treatment failure which is defined as HBV DNA greater than 200 IU/mL after at least two NAs treatment (at least 6 months continuous treatment for each NA(s), total duration is no less than 12 months). In addition, subjects judged by the treating physician to have adhered to previous NA therapy. * 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 but a history of rising serum alpha-fetoprotein and serum alpha-fetoprotein \>20 nanogram (ng) per mL at screening. * Clinical signs of decompensated liver disease at baseline. These may include but are not limited to:Total serum bilirubin \>1.5 x Upper limit of the normal range (ULN), International Normalized Ratio \>1.3, Serum albumin \<32grams per Liter (g/L), History of clinical hepatic decompensation (e.g., ascites, variceal bleeding, or encephalopathy). * Creatinine clearance less than 70 milliliter per minutes (mL/min). * Alanine aminotransferase \>10 times ULN at screening or history of acute exacerbation leading to transient decompensation. * Haemoglobin \<8 grams per deciliter (g/dL), absolute neutrophil count \<1.0 x 10\^9 per Liter, platelets \<75 x 10\^9 per Liter. * 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 RNA is undetectable are considered to be not eligible for enrolment. * Evidence of active liver disease due to autoimmune hepatitis (antinuclear antibody titre \>1:160) * 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 breast. * Use of immunosuppressive therapy, immunomodulatory therapy \[including Pegylated interferon (PEG-IFN) and short-acting interferon or thymosin alpha\], systemic cytotoxic agents within the previous 6 months prior to screening. * Planned for liver transplantation or previous liver transplantation. * Receipt of TDF within 6 months prior to screening. * 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. * History of hypersensitivity to nucleoside and/or nucleotide analogues and/or any component of study medication. * Inability to comply with study requirements as determined by the study Investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Serum Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) <20 International Unit Per Milliliter (IU/mL) at Week 144 | At Week 144 | HBV DNA level were analyzed using the sensitive HBV test in central laboratory using Roche cobas Taqman HBV test from the blood samples collected at Week 144. A 95 percent confidence interval (CI) was constructed by normal approximation and continuity correction method. Percentage of participants with serum HBV DNA \<20 IU/mL at Week 144 have been presented. The Modified Intent-to-treat (mITT) Population was defined as all recruited participants who received at least one dose of study medication. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants in the Subgroup With Confirmed Multi-drug Resistance Mutations at Baseline With Serum HBV DNA <20 IU/mL and Serum HBV DNA <69 IU/mL at Weeks 48, 96 and 144 | At Weeks 48, 96, and 144 | Serum samples were collected and analyzed for HBV DNA levels at indicated time points. Resistance surveillance of the HBV polymerase gene were performed by direct sequencing for all participants at Baseline. Day 0 was considered as Baseline. Percentage of participants in the subgroup with confirmed multi-drug resistance mutations at Baseline with serum HBV DNA \<20 IU/mL and serum HBV DNA \<69 IU/mL at Weeks 48, 96 and 144 have been presented. |
| Change From Baseline in Logarithm to the Base 10 (Log 10) Reduction in Serum HBV DNA at Week 48, 96 and 144 | Baseline (Day 0) and at Weeks 48,96, and 144 | Log10 reduction in serum HBV DNA was analyzed by patterns of mutation. The patterns of mutation were summarized by 2 categories. Category 1 included wild-type, LAM-R (Lamivudine-resistant), ADV-R (Adefovir-resistant) and ETV-R (Entecavir-resistant). Category 2 included Wild type, ADV-R single mutation, ADV-R double mutation and other mutation. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. |
| Percentage of Hepatitis B e Antigen (HBeAg) Positive Participants Achieving HBeAg Loss, HBeAg Seroconversion or Hepatitis B s Antigen (HBsAg) Loss and HBsAg Seroconversion at Weeks 48, 96, and 144 | At Weeks 48, 96 and 144 | Serological response was assessed at Weeks 48, 96 and 144 in participants with Positive HBeAg at Baseline (Day 0). It was presented as HBeAg Loss, HBeAg Seroconversion, HBsAg Loss and HBsAg Seroconversion. HBeAg Loss was defined as HBeAg changed to be negative. HBeAg seroconversion was defined as HBeAg changed to negative and HBeAb was positive. 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 HBeAg Negative Participants Achieving HBsAg Loss and HBsAg Seroconversion at Weeks 48, 96, and 144 | At Weeks 48,96, and 144 | Serological response was assessed at Weeks 48, 96 and 144 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 With Alanine Aminotransferase (ALT) Normalization at Weeks 48, 96, and 144 in Participants Who Had Abnormal ALT at Baseline | At Weeks 48, 96, and 144 | Blood samples were collected for evaluation of ALT at indicated time points. ALT normalization was defined as measurement less than or equal to the upper limit of the normal range. Normal range for ALT is 7 to 56 International Units per liter. Percentage of participants with ALT normalization at Weeks 48, 96, and 144 in Participants who had abnormal ALT at Baseline (Day 0) have been presented. |
| Percentage of Participants Who Experienced Viral Breakthrough up to Week 144 | At Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120,132, and 144 | Viral breakthrough was defined as 1 log increase in HBV DNA from nadir determined by two sequential HBV DNA measurements. Percentage of participants who experienced viral breakthrough at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132 and 144 have been presented. |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs and Non-serious TEAEs | Up to Week 144 | An adverse event was 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 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 associated with liver injury and impaired liver function. The Safety analysis (SA) Population was defined as all participants who received at least one dose of study medication and have at least one post Baseline safety assessment. |
| Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets | Baseline (Day 0) and at Weeks 24, 48, 72, 96, 120 and 144 | Blood samples were collected to analyze the hematology parameters: WBC, basophils, eosinophils, 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. |
| Percentage of Participants With Serum HBV DNA <20 IU/mL and Serum HBV DNA <69 IU/mL at Weeks 48 and 96 | At Weeks 48 and 96 | HBV DNA level were analyzed using the sensitive HBV test in central laboratory using Roche cobas Taqman HBV test from the blood samples collected at Weeks 48 and 96. Virological response was assessed by proportion of participants with serum serum HBV \<20 IU/mL and \<69 IU/mL at Weeks 48 and 96. Percentage of participants with serum HBV DNA \<20 IU/mL and \<69 IU/mL at Weeks 48 and 96 have been presented. |
| Change From Baseline in Red Blood Cells (RBC) | Baseline (Day 0) and at Weeks 24, 48, 72, 96, 120 and 144 | 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: ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH) | Baseline (Day 0) and at Weeks 12,24,36,48,60,72,84,96,108,120,132,and 144 | 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 Billirubin, Direct Bilirubin, Serum Creatinine | Baseline (Day 0) and at Weeks, 12,24,36,48,60,72,84,96,108,120,132,and 144 | 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, Total Protein | Baseline (Day 0) and at Weeks, 12,24,36,48,60,72,84,96,108,120,132,and 144 | 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, Chloridian, Phosphorus, Calcium and Fasting Blood Glucose. | Baseline (Day 0) and at Weeks, 12,24,36,48,60,72,84,96,108,120,132,and 144 | Blood samples were collected to analyze the chemistry parameters: BUN, potassium, sodium, chloridian, 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 Parameter: Creatinine Clearance Rate | Baseline (Day 0) and at Weeks, 12,24,36,48,60,72,84,96,108,120,132,and 144 | Blood samples were collected to analyze the chemistry parameter: 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 Parameter: Estimated Glomerular Filtration Rate (eGFR) | Baseline (Day 0) and at Weeks, 12,24,36,48,60,72,84,96,108,120,132,and 144 | Blood samples were collected to analyze the chemistry parameter: eGFR. 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 Weeks 24, 48, 72, 96, 120 and 144 | 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. |
Countries
China
Participant flow
Recruitment details
This study was conducted to evaluate the efficacy and safety of Tenofovir Disoproxil Fumarate treatment in Chinese chronic hepatitis B (CHB) participants following failure of multiple Nucleos(t)ide analogues(NAs) at different centers in China.
Pre-assignment details
A total of 281 participants were screened; of these 68 were screen failures. A total of 213 participants entered the treatment phase of the study.
Participants by arm
| Arm | Count |
|---|---|
| Tenofovir Disoproxil Fumerate 300 mg Participants received an open-label treatment of Tenofovir Disoproxil Fumarate 300 mg orally once daily for 144-weeks. | 213 |
| Total | 213 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Pregnancy | 2 |
| Overall Study | Protocol Violation | 4 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Tenofovir Disoproxil Fumerate 300 mg |
|---|---|
| Age, Continuous | 42.3 Years STANDARD_DEVIATION 10.29 |
| Race/Ethnicity, Customized Asian | 213 Participants |
| Sex: Female, Male Female | 27 Participants |
| Sex: Female, Male Male | 186 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 213 |
| other Total, other adverse events | 117 / 213 |
| serious Total, serious adverse events | 20 / 213 |
Outcome results
Primary
Percentage of Participants With Serum Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) <20 International Unit Per Milliliter (IU/mL) at Week 144
HBV DNA level were analyzed using the sensitive HBV test in central laboratory using Roche cobas Taqman HBV test from the blood samples collected at Week 144. A 95 percent confidence interval (CI) was constructed by normal approximation and continuity correction method. Percentage of participants with serum HBV DNA \<20 IU/mL at Week 144 have been presented. The Modified Intent-to-treat (mITT) Population was defined as all recruited participants who received at least one dose of study medication.
Time frame: At Week 144
Population: mITT Population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tenofovir Disoproxil Fumerate 300 mg | Percentage of Participants With Serum Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) <20 International Unit Per Milliliter (IU/mL) at Week 144 | 77.0 Percentage of Participants |
Secondary
Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridian, Phosphorus, Calcium and Fasting Blood Glucose.
Blood samples were collected to analyze the chemistry parameters: BUN, potassium, sodium, chloridian, 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 Weeks, 12,24,36,48,60,72,84,96,108,120,132,and 144
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 Fumerate 300 mg | Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridian, Phosphorus, Calcium and Fasting Blood Glucose. | Week 12, BUN, n=209 | -0.020 Millimoles per liter | Standard Deviation 1.0496 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridian, Phosphorus, Calcium and Fasting Blood Glucose. | Week 24, BUN, n=208 | 0.069 Millimoles per liter | Standard Deviation 1.0725 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridian, Phosphorus, Calcium and Fasting Blood Glucose. | Week 36, BUN, n=209 | 0.081 Millimoles per liter | Standard Deviation 1.0921 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridian, Phosphorus, Calcium and Fasting Blood Glucose. | Week 48, BUN, n=208 | 0.075 Millimoles per liter | Standard Deviation 1.0907 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridian, Phosphorus, Calcium and Fasting Blood Glucose. | Week 60, BUN, n=208 | 0.078 Millimoles per liter | Standard Deviation 1.0372 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridian, Phosphorus, Calcium and Fasting Blood Glucose. | Week 72, BUN, n=206 | 0.119 Millimoles per liter | Standard Deviation 1.1114 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridian, Phosphorus, Calcium and Fasting Blood Glucose. | Week 84, BUN, n=207 | 0.164 Millimoles per liter | Standard Deviation 1.0819 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridian, Phosphorus, Calcium and Fasting Blood Glucose. | Week 96, BUN, n=207 | 0.100 Millimoles per liter | Standard Deviation 1.0482 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridian, Phosphorus, Calcium and Fasting Blood Glucose. | Week 108, BUN, n=204 | 0.051 Millimoles per liter | Standard Deviation 1.1279 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridian, Phosphorus, Calcium and Fasting Blood Glucose. | Week 120, BUN, n=205 | 0.110 Millimoles per liter | Standard Deviation 1.1672 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridian, Phosphorus, Calcium and Fasting Blood Glucose. | Week 132, BUN, n=205 | 0.090 Millimoles per liter | Standard Deviation 1.1443 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridian, Phosphorus, Calcium and Fasting Blood Glucose. | Week 144, BUN, n=203 | 0.193 Millimoles per liter | Standard Deviation 1.2236 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridian, Phosphorus, Calcium and Fasting Blood Glucose. | Week 12, Potassium, n=209 | -0.029 Millimoles per liter | Standard Deviation 0.3391 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridian, Phosphorus, Calcium and Fasting Blood Glucose. | Week 24, Potassium, n=208 | 0.028 Millimoles per liter | Standard Deviation 0.3659 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridian, Phosphorus, Calcium and Fasting Blood Glucose. | Week 36, Potassium, n=209 | 0.073 Millimoles per liter | Standard Deviation 0.3681 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridian, Phosphorus, Calcium and Fasting Blood Glucose. | Week 48, Potassium, n=208 | 0.016 Millimoles per liter | Standard Deviation 0.3206 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridian, Phosphorus, Calcium and Fasting Blood Glucose. | Week 60, Potassium, n=208 | 0.014 Millimoles per liter | Standard Deviation 0.3622 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridian, Phosphorus, Calcium and Fasting Blood Glucose. | Week 72, Potassium, n=206 | -0.032 Millimoles per liter | Standard Deviation 0.3402 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridian, Phosphorus, Calcium and Fasting Blood Glucose. | Week 84, Potassium, n=206 | 0.022 Millimoles per liter | Standard Deviation 0.3617 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridian, Phosphorus, Calcium and Fasting Blood Glucose. | Week 96, Potassium, n=206 | -0.019 Millimoles per liter | Standard Deviation 0.3357 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridian, Phosphorus, Calcium and Fasting Blood Glucose. | Week 108, Potassium, n=204 | -0.023 Millimoles per liter | Standard Deviation 0.3326 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridian, Phosphorus, Calcium and Fasting Blood Glucose. | Week 120, Potassium, n=204 | -0.002 Millimoles per liter | Standard Deviation 0.3221 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridian, Phosphorus, Calcium and Fasting Blood Glucose. | Week 132, Potassium, n=204 | 0.001 Millimoles per liter | Standard Deviation 0.3531 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridian, Phosphorus, Calcium and Fasting Blood Glucose. | Week 144, Potassium, n=204 | -0.000 Millimoles per liter | Standard Deviation 0.3851 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridian, Phosphorus, Calcium and Fasting Blood Glucose. | Week 12, Sodium, n=209 | 0.31 Millimoles per liter | Standard Deviation 2.227 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridian, Phosphorus, Calcium and Fasting Blood Glucose. | Week 24, Sodium, n=208 | 0.52 Millimoles per liter | Standard Deviation 2.514 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridian, Phosphorus, Calcium and Fasting Blood Glucose. | Week 36, Sodium, n=209 | 0.23 Millimoles per liter | Standard Deviation 2.437 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridian, Phosphorus, Calcium and Fasting Blood Glucose. | Week 48, Sodium, n=208 | 0.40 Millimoles per liter | Standard Deviation 2.781 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridian, Phosphorus, Calcium and Fasting Blood Glucose. | Week 60, Sodium, n=208 | 0.59 Millimoles per liter | Standard Deviation 2.569 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridian, Phosphorus, Calcium and Fasting Blood Glucose. | Week 72, Sodium, n=206 | 0.47 Millimoles per liter | Standard Deviation 2.631 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridian, Phosphorus, Calcium and Fasting Blood Glucose. | Week 84, Sodium, n=207 | 0.54 Millimoles per liter | Standard Deviation 2.689 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridian, Phosphorus, Calcium and Fasting Blood Glucose. | Week 96, Sodium, n=206 | 0.44 Millimoles per liter | Standard Deviation 2.388 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridian, Phosphorus, Calcium and Fasting Blood Glucose. | Week 108, Sodium, n=204 | 0.05 Millimoles per liter | Standard Deviation 2.352 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridian, Phosphorus, Calcium and Fasting Blood Glucose. | Week 120, Sodium, n=204 | 0.03 Millimoles per liter | Standard Deviation 3.332 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridian, Phosphorus, Calcium and Fasting Blood Glucose. | Week 132, Sodium, n=204 | 0.35 Millimoles per liter | Standard Deviation 2.672 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridian, Phosphorus, Calcium and Fasting Blood Glucose. | Week 144, Sodium, n=204 | 0.13 Millimoles per liter | Standard Deviation 2.642 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridian, Phosphorus, Calcium and Fasting Blood Glucose. | Week 12, Chloridion n=209 | -0.23 Millimoles per liter | Standard Deviation 3.271 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridian, Phosphorus, Calcium and Fasting Blood Glucose. | Week 24, Chloridion, n=208 | -0.32 Millimoles per liter | Standard Deviation 3.834 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridian, Phosphorus, Calcium and Fasting Blood Glucose. | Week 36, Chloridion, n=209 | -0.50 Millimoles per liter | Standard Deviation 3.453 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridian, Phosphorus, Calcium and Fasting Blood Glucose. | Week 48, Chloridion, n=208 | -0.31 Millimoles per liter | Standard Deviation 3.601 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridian, Phosphorus, Calcium and Fasting Blood Glucose. | Week 60, Chloridion, n=208 | -0.37 Millimoles per liter | Standard Deviation 3.305 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridian, Phosphorus, Calcium and Fasting Blood Glucose. | Week 72, Chloridion, n=206 | -0.30 Millimoles per liter | Standard Deviation 3.388 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridian, Phosphorus, Calcium and Fasting Blood Glucose. | Week 84, Chloridion, n=207 | -0.38 Millimoles per liter | Standard Deviation 3.519 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridian, Phosphorus, Calcium and Fasting Blood Glucose. | Week 96, Chloridion, n=206 | 0.04 Millimoles per liter | Standard Deviation 3.418 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridian, Phosphorus, Calcium and Fasting Blood Glucose. | Week 108, Chloridion, n=204 | -0.27 Millimoles per liter | Standard Deviation 3.587 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridian, Phosphorus, Calcium and Fasting Blood Glucose. | Week 120, Chloridion, n=204 | -0.17 Millimoles per liter | Standard Deviation 4.309 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridian, Phosphorus, Calcium and Fasting Blood Glucose. | Week 132, Chloridion, n=204 | -0.14 Millimoles per liter | Standard Deviation 3.717 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridian, Phosphorus, Calcium and Fasting Blood Glucose. | Week 144, Chloridion, n=204 | -0.28 Millimoles per liter | Standard Deviation 3.855 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridian, Phosphorus, Calcium and Fasting Blood Glucose. | Week 12, Phosphorus, n=209 | -0.018 Millimoles per liter | Standard Deviation 0.1607 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridian, Phosphorus, Calcium and Fasting Blood Glucose. | Week 24, Phosphorus, n=208 | -0.001 Millimoles per liter | Standard Deviation 0.1662 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridian, Phosphorus, Calcium and Fasting Blood Glucose. | Week 36, Phosphorus, n=209 | -0.001 Millimoles per liter | Standard Deviation 0.1779 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridian, Phosphorus, Calcium and Fasting Blood Glucose. | Week 48, Phosphorus, n=208 | -0.008 Millimoles per liter | Standard Deviation 0.1634 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridian, Phosphorus, Calcium and Fasting Blood Glucose. | Week 60, Phosphorus, n=208 | 0.004 Millimoles per liter | Standard Deviation 0.1685 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridian, Phosphorus, Calcium and Fasting Blood Glucose. | Week 72, Phosphorus, n=207 | -0.011 Millimoles per liter | Standard Deviation 0.1713 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridian, Phosphorus, Calcium and Fasting Blood Glucose. | Week 84, Phosphorus, n=207 | -0.023 Millimoles per liter | Standard Deviation 0.1736 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridian, Phosphorus, Calcium and Fasting Blood Glucose. | Week 96, Phosphorus, n=206 | -0.019 Millimoles per liter | Standard Deviation 0.1669 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridian, Phosphorus, Calcium and Fasting Blood Glucose. | Week 108, Phosphorus, n=201 | -0.008 Millimoles per liter | Standard Deviation 0.1779 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridian, Phosphorus, Calcium and Fasting Blood Glucose. | Week 120, Phosphorus, n=203 | -0.015 Millimoles per liter | Standard Deviation 0.1687 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridian, Phosphorus, Calcium and Fasting Blood Glucose. | Week 132, Phosphorus, n=204 | 0.002 Millimoles per liter | Standard Deviation 0.1757 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridian, Phosphorus, Calcium and Fasting Blood Glucose. | Week 144, Phosphorus, n=204 | -0.016 Millimoles per liter | Standard Deviation 0.1692 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridian, Phosphorus, Calcium and Fasting Blood Glucose. | Week 12, Calcium, n=209 | -0.005 Millimoles per liter | Standard Deviation 0.1172 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridian, Phosphorus, Calcium and Fasting Blood Glucose. | Week 24, Calcium, n=208 | -0.027 Millimoles per liter | Standard Deviation 0.1289 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridian, Phosphorus, Calcium and Fasting Blood Glucose. | Week 36, Calcium, n=209 | -0.030 Millimoles per liter | Standard Deviation 0.1432 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridian, Phosphorus, Calcium and Fasting Blood Glucose. | Week 48, Calcium, n=208 | -0.041 Millimoles per liter | Standard Deviation 0.1375 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridian, Phosphorus, Calcium and Fasting Blood Glucose. | Week 60, Calcium, n=208 | -0.038 Millimoles per liter | Standard Deviation 0.1365 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridian, Phosphorus, Calcium and Fasting Blood Glucose. | Week 72, Calcium, n=207 | -0.061 Millimoles per liter | Standard Deviation 0.1296 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridian, Phosphorus, Calcium and Fasting Blood Glucose. | Week 84, Calcium, n=207 | -0.060 Millimoles per liter | Standard Deviation 0.1321 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridian, Phosphorus, Calcium and Fasting Blood Glucose. | Week 96, Calcium, n=206 | -0.051 Millimoles per liter | Standard Deviation 0.1198 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridian, Phosphorus, Calcium and Fasting Blood Glucose. | Week 108, Calcium, n=204 | -0.062 Millimoles per liter | Standard Deviation 0.129 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridian, Phosphorus, Calcium and Fasting Blood Glucose. | Week 120, Calcium, n=204 | -0.051 Millimoles per liter | Standard Deviation 0.137 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridian, Phosphorus, Calcium and Fasting Blood Glucose. | Week 132, Calcium, n=204 | -0.052 Millimoles per liter | Standard Deviation 0.1235 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridian, Phosphorus, Calcium and Fasting Blood Glucose. | Week 144, Calcium, n=204 | -0.050 Millimoles per liter | Standard Deviation 0.1393 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridian, Phosphorus, Calcium and Fasting Blood Glucose. | Week 12, Fasting blood glucose, n=205 | -0.088 Millimoles per liter | Standard Deviation 1.0006 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridian, Phosphorus, Calcium and Fasting Blood Glucose. | Week 24, fasting blood glucose, n=208 | -0.087 Millimoles per liter | Standard Deviation 0.8926 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridian, Phosphorus, Calcium and Fasting Blood Glucose. | Week 36, fasting blood glucose, n=208 | -0.150 Millimoles per liter | Standard Deviation 0.9535 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridian, Phosphorus, Calcium and Fasting Blood Glucose. | Week 48, fasting blood glucose, n=208 | -0.234 Millimoles per liter | Standard Deviation 0.8378 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridian, Phosphorus, Calcium and Fasting Blood Glucose. | Week 60, fasting blood glucose, n=208 | -0.206 Millimoles per liter | Standard Deviation 0.8658 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridian, Phosphorus, Calcium and Fasting Blood Glucose. | Week 72, fasting blood glucose, n=202 | -0.187 Millimoles per liter | Standard Deviation 0.8626 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridian, Phosphorus, Calcium and Fasting Blood Glucose. | Week 84, fasting blood glucose, n=207 | -0.143 Millimoles per liter | Standard Deviation 1.0564 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridian, Phosphorus, Calcium and Fasting Blood Glucose. | Week 96, fasting blood glucose, n=206 | -0.132 Millimoles per liter | Standard Deviation 1.1423 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridian, Phosphorus, Calcium and Fasting Blood Glucose. | Week 108, fasting blood glucose, n=200 | -0.230 Millimoles per liter | Standard Deviation 0.9042 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridian, Phosphorus, Calcium and Fasting Blood Glucose. | Week 120, fasting blood glucose, n=204 | -0.180 Millimoles per liter | Standard Deviation 0.9873 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridian, Phosphorus, Calcium and Fasting Blood Glucose. | Week 132, fasting blood glucose, n=204 | -0.151 Millimoles per liter | Standard Deviation 0.9312 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridian, Phosphorus, Calcium and Fasting Blood Glucose. | Week 144, fasting blood glucose, n=204 | -0.070 Millimoles per liter | Standard Deviation 1.0163 |
Secondary
Change From Baseline in Chemistry Parameter: Creatinine Clearance Rate
Blood samples were collected to analyze the chemistry parameter: 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 Weeks, 12,24,36,48,60,72,84,96,108,120,132,and 144
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 Fumerate 300 mg | Change From Baseline in Chemistry Parameter: Creatinine Clearance Rate | Week 36, n=209 | -2.311 Milliliter per minute | Standard Deviation 12.4693 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameter: Creatinine Clearance Rate | Week 12, n=208 | -4.564 Milliliter per minute | Standard Deviation 11.1192 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameter: Creatinine Clearance Rate | Week 24, n=208 | -2.213 Milliliter per minute | Standard Deviation 11.2288 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameter: Creatinine Clearance Rate | Week 48, n=208 | -3.667 Milliliter per minute | Standard Deviation 12.3427 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameter: Creatinine Clearance Rate | Week 60, n=208 | -2.053 Milliliter per minute | Standard Deviation 13.9768 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameter: Creatinine Clearance Rate | Week 72, n=206 | -0.519 Milliliter per minute | Standard Deviation 13.158 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameter: Creatinine Clearance Rate | Week 84, n=207 | -1.065 Milliliter per minute | Standard Deviation 15.0315 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameter: Creatinine Clearance Rate | Week 96, n=207 | -2.378 Milliliter per minute | Standard Deviation 13.8827 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameter: Creatinine Clearance Rate | Week 108, n=204 | -2.512 Milliliter per minute | Standard Deviation 13.4608 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameter: Creatinine Clearance Rate | Week 120, n=203 | -0.742 Milliliter per minute | Standard Deviation 14.38 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameter: Creatinine Clearance Rate | Week 132, n=205 | -1.499 Milliliter per minute | Standard Deviation 13.3816 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameter: Creatinine Clearance Rate | Week 144, n=203 | -0.821 Milliliter per minute | Standard Deviation 13.8173 |
Secondary
Change From Baseline in Chemistry Parameter: Estimated Glomerular Filtration Rate (eGFR)
Blood samples were collected to analyze the chemistry parameter: 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 Weeks, 12,24,36,48,60,72,84,96,108,120,132,and 144
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 Fumerate 300 mg | Change From Baseline in Chemistry Parameter: Estimated Glomerular Filtration Rate (eGFR) | Week 12, n=209 | -2.93 Grams per liter | Standard Deviation 7.25 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameter: Estimated Glomerular Filtration Rate (eGFR) | Week 24, n=209 | -1.11 Grams per liter | Standard Deviation 6.798 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameter: Estimated Glomerular Filtration Rate (eGFR) | Week 36, n=209 | -0.63 Grams per liter | Standard Deviation 7.558 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameter: Estimated Glomerular Filtration Rate (eGFR) | Week 48, n=208 | -1.31 Grams per liter | Standard Deviation 7.378 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameter: Estimated Glomerular Filtration Rate (eGFR) | Week 60, n=208 | -0.12 Grams per liter | Standard Deviation 8.004 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameter: Estimated Glomerular Filtration Rate (eGFR) | Week 72, n=208 | 0.84 Grams per liter | Standard Deviation 7.619 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameter: Estimated Glomerular Filtration Rate (eGFR) | Week 84, n=207 | 0.42 Grams per liter | Standard Deviation 8.731 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameter: Estimated Glomerular Filtration Rate (eGFR) | Week 96, n=207 | -0.17 Grams per liter | Standard Deviation 8.752 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameter: Estimated Glomerular Filtration Rate (eGFR) | Week 108, n=205 | 0.42 Grams per liter | Standard Deviation 8.379 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameter: Estimated Glomerular Filtration Rate (eGFR) | Week 120, n=205 | 0.77 Grams per liter | Standard Deviation 8.826 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameter: Estimated Glomerular Filtration Rate (eGFR) | Week 132, n=205 | 0.60 Grams per liter | Standard Deviation 8.098 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameter: Estimated Glomerular Filtration Rate (eGFR) | Week 144, n=204 | 0.95 Grams per liter | Standard Deviation 8.313 |
Secondary
Change From Baseline in Chemistry Parameters: Albumin, 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 Weeks, 12,24,36,48,60,72,84,96,108,120,132,and 144
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 Fumerate 300 mg | Change From Baseline in Chemistry Parameters: Albumin, Total Protein | Week 12, albumin, n=209 | 0.22 Grams per liter | Standard Deviation 2.766 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameters: Albumin, Total Protein | Week 24, albumin, n=208 | 0.54 Grams per liter | Standard Deviation 2.722 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameters: Albumin, Total Protein | Week 36, albumin, n=209 | 0.04 Grams per liter | Standard Deviation 2.545 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameters: Albumin, Total Protein | Week 48, albumin, n=208 | 0.24 Grams per liter | Standard Deviation 2.687 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameters: Albumin, Total Protein | Week 60, albumin, n=208 | 0.38 Grams per liter | Standard Deviation 2.757 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameters: Albumin, Total Protein | Week 72, albumin, n=207 | 0.49 Grams per liter | Standard Deviation 2.89 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameters: Albumin, Total Protein | Week 84, albumin, n=207 | -0.03 Grams per liter | Standard Deviation 3.021 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameters: Albumin, Total Protein | Week 96, albumin, n=207 | 0.13 Grams per liter | Standard Deviation 2.98 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameters: Albumin, Total Protein | Week 108, albumin, n=205 | -0.56 Grams per liter | Standard Deviation 2.932 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameters: Albumin, Total Protein | Week 120, albumin, n=205 | 0.17 Grams per liter | Standard Deviation 3.272 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameters: Albumin, Total Protein | Week 132, albumin, n=205 | 0.51 Grams per liter | Standard Deviation 2.942 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameters: Albumin, Total Protein | Week 144, albumin, n=204 | 0.48 Grams per liter | Standard Deviation 3.171 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameters: Albumin, Total Protein | Week 12, total protein, n=209 | 0.31 Grams per liter | Standard Deviation 4.22 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameters: Albumin, Total Protein | Week 24, total protein, n=207 | 0.92 Grams per liter | Standard Deviation 4.322 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameters: Albumin, Total Protein | Week 36, total protein, n=209 | -0.30 Grams per liter | Standard Deviation 4.28 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameters: Albumin, Total Protein | Week 48, total protein, n=208 | -0.53 Grams per liter | Standard Deviation 4.24 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameters: Albumin, Total Protein | Week 60, total protein, n=208 | -0.32 Grams per liter | Standard Deviation 4.387 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameters: Albumin, Total Protein | Week 72, total protein, n=207 | -0.26 Grams per liter | Standard Deviation 4.54 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameters: Albumin, Total Protein | Week 84, total protein, n=207 | -0.57 Grams per liter | Standard Deviation 5.158 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameters: Albumin, Total Protein | Week 96, total protein, n=207 | -0.44 Grams per liter | Standard Deviation 5.24 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameters: Albumin, Total Protein | Week 108, total protein, n=205 | -0.21 Grams per liter | Standard Deviation 4.855 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameters: Albumin, Total Protein | Week 120, total protein, n=205 | 0.95 Grams per liter | Standard Deviation 5.361 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameters: Albumin, Total Protein | Week 132, total protein, n=205 | 1.00 Grams per liter | Standard Deviation 4.494 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameters: Albumin, Total Protein | Week 144, total protein, n=204 | 0.94 Grams per liter | Standard Deviation 4.794 |
Secondary
Change From Baseline in Chemistry Parameters: 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 Weeks 12,24,36,48,60,72,84,96,108,120,132,and 144
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 Fumerate 300 mg | Change From Baseline in Chemistry Parameters: ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH) | Week 12, ALT, n=209 | 1.66 International units per liter | Standard Deviation 54.582 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameters: ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH) | Week 24, ALT, n=208 | -2.80 International units per liter | Standard Deviation 51.195 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameters: ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH) | Week 36, ALT, n=209 | -4.57 International units per liter | Standard Deviation 51.811 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameters: ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH) | Week 48, ALT, n=208 | -7.07 International units per liter | Standard Deviation 50.986 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameters: ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH) | Week 60, ALT, n=208 | -9.20 International units per liter | Standard Deviation 50.312 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameters: ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH) | Week 72, ALT, n=207 | -8.12 International units per liter | Standard Deviation 51.538 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameters: ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH) | Week 84, ALT, n=207 | -10.53 International units per liter | Standard Deviation 51.781 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameters: ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH) | Week 96, ALT, n=207 | -9.13 International units per liter | Standard Deviation 54.323 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameters: ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH) | Week 108, ALT, n=205 | -11.25 International units per liter | Standard Deviation 52.277 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameters: ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH) | Week 120, ALT, n=205 | -11.95 International units per liter | Standard Deviation 51.584 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameters: ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH) | Week 132, ALT, n=205 | -11.56 International units per liter | Standard Deviation 51.594 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameters: ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH) | Week 144, ALT, n=204 | -10.97 International units per liter | Standard Deviation 53.326 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameters: ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH) | Week 12, AST, n=209 | -1.68 International units per liter | Standard Deviation 44.258 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameters: ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH) | Week 24, AST, n=208 | -3.20 International units per liter | Standard Deviation 44.506 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameters: ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH) | Week 36, AST, n=209 | -2.93 International units per liter | Standard Deviation 45.755 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameters: ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH) | Week 48, AST, n=205 | -4.23 International units per liter | Standard Deviation 45.393 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameters: ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH) | Week 60, AST, n=208 | -4.68 International units per liter | Standard Deviation 44.969 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameters: ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH) | Week 72, AST, n=207 | -4.43 International units per liter | Standard Deviation 44.901 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameters: ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH) | Week 84, AST, n=207 | -5.56 International units per liter | Standard Deviation 45.435 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameters: ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH) | Week 96, AST, n=207 | -4.37 International units per liter | Standard Deviation 46.008 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameters: ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH) | Week 108, AST, n=205 | -5.81 International units per liter | Standard Deviation 45.818 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameters: ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH) | Week 120, AST, n=205 | -5.67 International units per liter | Standard Deviation 45.645 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameters: ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH) | Week 132, AST, n=205 | -6.05 International units per liter | Standard Deviation 45.29 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameters: ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH) | Week 144, AST, n=204 | -5.85 International units per liter | Standard Deviation 46.176 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameters: ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH) | Week 12, ALP, n=208 | 4.46 International units per liter | Standard Deviation 11.718 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameters: ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH) | Week 24, ALP, n=208 | 7.22 International units per liter | Standard Deviation 13.819 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameters: ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH) | Week 36, ALP, n=209 | 6.27 International units per liter | Standard Deviation 12.609 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameters: ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH) | Week 48, ALP, n=208 | 8.24 International units per liter | Standard Deviation 12.225 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameters: ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH) | Week 60, ALP, n=208 | 8.75 International units per liter | Standard Deviation 14.321 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameters: ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH) | Week 72, ALP, n=207 | 10.06 International units per liter | Standard Deviation 16.259 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameters: ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH) | Week 84, ALP, n=207 | 7.32 International units per liter | Standard Deviation 14.478 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameters: ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH) | Week 96, ALP, n=207 | 8.73 International units per liter | Standard Deviation 13.854 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameters: ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH) | Week 108, ALP, n=205 | 7.62 International units per liter | Standard Deviation 15.102 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameters: ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH) | Week 120, ALP, n=205 | 7.54 International units per liter | Standard Deviation 17.844 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameters: ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH) | Week 132, ALP, n=205 | 7.36 International units per liter | Standard Deviation 15.802 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameters: ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH) | Week 144, ALP, n=205 | 7.14 International units per liter | Standard Deviation 15.099 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameters: ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH) | Week 12, GGT, n=208 | -1.83 International units per liter | Standard Deviation 18.966 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameters: ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH) | Week 24, GGT, n=208 | -1.83 International units per liter | Standard Deviation 19.853 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameters: ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH) | Week 36, GGT, n=209 | -2.25 International units per liter | Standard Deviation 20.205 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameters: ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH) | Week 48, GGT, n=207 | -1.90 International units per liter | Standard Deviation 20.76 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameters: ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH) | Week 60, GGT, n=208 | -1.25 International units per liter | Standard Deviation 22.512 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameters: ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH) | Week 72, GGT, n=207 | -1.45 International units per liter | Standard Deviation 23.7 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameters: ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH) | Week 84, GGT, n=207 | -2.10 International units per liter | Standard Deviation 21.532 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameters: ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH) | Week 96, GGT, n=207 | -2.50 International units per liter | Standard Deviation 21.436 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameters: ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH) | Week 108, GGT, n=205 | -1.62 International units per liter | Standard Deviation 22.053 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameters: ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH) | Week 120, GGT, n=205 | -1.61 International units per liter | Standard Deviation 22.872 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameters: ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH) | Week 132, GGT, n=205 | -1.80 International units per liter | Standard Deviation 21.897 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameters: ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH) | Week 144, GGT, n=203 | -0.76 International units per liter | Standard Deviation 25.363 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameters: ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH) | Week 12, CK, n=206 | 10.84 International units per liter | Standard Deviation 525.68 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameters: ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH) | Week 24, CK, n=198 | -9.28 International units per liter | Standard Deviation 108.221 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameters: ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH) | Week 36, CK, n=201 | 13.87 International units per liter | Standard Deviation 315.156 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameters: ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH) | Week 48 CK, n=206 | -21.58 International units per liter | Standard Deviation 202.083 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameters: ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH) | Week 60, CK, n=205 | -22.26 International units per liter | Standard Deviation 207.666 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameters: ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH) | Week 72, CK, n=206 | -13.45 International units per liter | Standard Deviation 209.963 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameters: ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH) | Week 84, CK, n=207 | -17.40 International units per liter | Standard Deviation 204.8 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameters: ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH) | Week 96, CK, n=207 | 26.58 International units per liter | Standard Deviation 415.775 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameters: ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH) | Week 108, CK, n=199 | -20.58 International units per liter | Standard Deviation 211.398 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameters: ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH) | Week 120, CK, n=203 | 0.59 International units per liter | Standard Deviation 261.655 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameters: ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH) | Week 132, CK, n=204 | -19.34 International units per liter | Standard Deviation 214.775 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameters: ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH) | Week 144, CK, n=204 | -7.17 International units per liter | Standard Deviation 270.074 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameters: ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH) | Week 12, LDH, n=209 | 1.66 International units per liter | Standard Deviation 54.582 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameters: ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH) | Week 24, LDH, n=208 | -2.80 International units per liter | Standard Deviation 51.195 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameters: ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH) | Week 36, LDH, n=209 | -4.57 International units per liter | Standard Deviation 51.811 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameters: ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH) | Week 48, LDH, n=208 | -7.07 International units per liter | Standard Deviation 50.986 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameters: ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH) | Week 60, LDH, n=208 | -9.20 International units per liter | Standard Deviation 50.312 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameters: ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH) | Week 72, LDH, n=207 | -8.12 International units per liter | Standard Deviation 51.538 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameters: ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH) | Week 84, LDH, n=207 | -10.53 International units per liter | Standard Deviation 51.781 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameters: ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH) | Week 96, LDH, n=207 | -9.13 International units per liter | Standard Deviation 54.323 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameters: ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH) | Week 108, LDH, n=205 | -11.25 International units per liter | Standard Deviation 52.277 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameters: ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH) | Week 120, LDH, n=205 | -11.95 International units per liter | Standard Deviation 51.584 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameters: ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH) | Week 132, LDH, n=205 | -11.56 International units per liter | Standard Deviation 51.594 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameters: ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH) | Week 144, LDH, n=204 | -10.97 International units per liter | Standard Deviation 53.326 |
Secondary
Change From Baseline in Chemistry Parameters: Total Billirubin, 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 Weeks, 12,24,36,48,60,72,84,96,108,120,132,and 144
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 Fumerate 300 mg | Change From Baseline in Chemistry Parameters: Total Billirubin, Direct Bilirubin, Serum Creatinine | Week 48, total bilirubin, n=207 | -0.167 Micromoles per liter | Standard Deviation 4.8371 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameters: Total Billirubin, Direct Bilirubin, Serum Creatinine | Week 60, total bilirubin, n=208 | -0.334 Micromoles per liter | Standard Deviation 4.9175 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameters: Total Billirubin, Direct Bilirubin, Serum Creatinine | Week 12, total bilirubin, n=209 | -0.506 Micromoles per liter | Standard Deviation 4.8201 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameters: Total Billirubin, Direct Bilirubin, Serum Creatinine | Week 24, total bilirubin, n=208 | -0.755 Micromoles per liter | Standard Deviation 5.0494 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameters: Total Billirubin, Direct Bilirubin, Serum Creatinine | Week 36, total bilirubin, n=209 | -0.878 Micromoles per liter | Standard Deviation 5.0063 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameters: Total Billirubin, Direct Bilirubin, Serum Creatinine | Week 72, total bilirubin, n=207 | -1.209 Micromoles per liter | Standard Deviation 5.1706 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameters: Total Billirubin, Direct Bilirubin, Serum Creatinine | Week 84, total bilirubin, n=207 | -1.112 Micromoles per liter | Standard Deviation 5.0813 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameters: Total Billirubin, Direct Bilirubin, Serum Creatinine | Week 96, total bilirubin, n=207 | -0.780 Micromoles per liter | Standard Deviation 5.1218 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameters: Total Billirubin, Direct Bilirubin, Serum Creatinine | Week 108, total bilirubin, n=205 | -0.795 Micromoles per liter | Standard Deviation 5.7857 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameters: Total Billirubin, Direct Bilirubin, Serum Creatinine | Week 120, total bilirubin, n=205 | -1.021 Micromoles per liter | Standard Deviation 5.3998 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameters: Total Billirubin, Direct Bilirubin, Serum Creatinine | Week 132, total bilirubin, n=205 | -1.471 Micromoles per liter | Standard Deviation 4.8998 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameters: Total Billirubin, Direct Bilirubin, Serum Creatinine | Week 144, total bilirubin, n=204 | -0.869 Micromoles per liter | Standard Deviation 5.4163 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameters: Total Billirubin, Direct Bilirubin, Serum Creatinine | Week 12, direct bilirubin, n=209 | -0.181 Micromoles per liter | Standard Deviation 2.6421 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameters: Total Billirubin, Direct Bilirubin, Serum Creatinine | Week 24, direct bilirubin, n=208 | -0.360 Micromoles per liter | Standard Deviation 2.2236 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameters: Total Billirubin, Direct Bilirubin, Serum Creatinine | Week 36, direct bilirubin, n=208 | -0.541 Micromoles per liter | Standard Deviation 3.2564 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameters: Total Billirubin, Direct Bilirubin, Serum Creatinine | Week 48, direct bilirubin, n=207 | -0.085 Micromoles per liter | Standard Deviation 3.0478 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameters: Total Billirubin, Direct Bilirubin, Serum Creatinine | Week 60, direct bilirubin, n=208 | -0.111 Micromoles per liter | Standard Deviation 3.1364 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameters: Total Billirubin, Direct Bilirubin, Serum Creatinine | Week 72, direct bilirubin, n=207 | -0.654 Micromoles per liter | Standard Deviation 3.7846 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameters: Total Billirubin, Direct Bilirubin, Serum Creatinine | Week 84, direct bilirubin, n=207 | -0.797 Micromoles per liter | Standard Deviation 3.6592 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameters: Total Billirubin, Direct Bilirubin, Serum Creatinine | Week 96, direct bilirubin, n=207 | -0.711 Micromoles per liter | Standard Deviation 3.3849 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameters: Total Billirubin, Direct Bilirubin, Serum Creatinine | Week 108, direct bilirubin, n=205 | -0.632 Micromoles per liter | Standard Deviation 3.4657 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameters: Total Billirubin, Direct Bilirubin, Serum Creatinine | Week 120, direct bilirubin, n=205 | -0.802 Micromoles per liter | Standard Deviation 3.6175 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameters: Total Billirubin, Direct Bilirubin, Serum Creatinine | Week 132, direct bilirubin, n=205 | -0.805 Micromoles per liter | Standard Deviation 3.1588 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameters: Total Billirubin, Direct Bilirubin, Serum Creatinine | Week 144, direct bilirubin, n=204 | -0.573 Micromoles per liter | Standard Deviation 2.8964 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameters: Total Billirubin, Direct Bilirubin, Serum Creatinine | Week 12, serum creatinine, n=209 | 2.94 Micromoles per liter | Standard Deviation 7.089 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameters: Total Billirubin, Direct Bilirubin, Serum Creatinine | Week 24, serum creatinine, n=208 | 1.16 Micromoles per liter | Standard Deviation 6.934 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameters: Total Billirubin, Direct Bilirubin, Serum Creatinine | Week 36, serum creatinine, n=209 | 0.67 Micromoles per liter | Standard Deviation 7.743 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameters: Total Billirubin, Direct Bilirubin, Serum Creatinine | Week 48, serum creatinine, n=208 | 1.43 Micromoles per liter | Standard Deviation 7.48 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameters: Total Billirubin, Direct Bilirubin, Serum Creatinine | Week 60, serum creatinine, n=208 | 0.25 Micromoles per liter | Standard Deviation 8.181 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameters: Total Billirubin, Direct Bilirubin, Serum Creatinine | Week 72, serum creatinine, n=206 | -1.00 Micromoles per liter | Standard Deviation 7.583 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameters: Total Billirubin, Direct Bilirubin, Serum Creatinine | Week 84, serum creatinine, n=207 | -0.65 Micromoles per liter | Standard Deviation 9.075 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameters: Total Billirubin, Direct Bilirubin, Serum Creatinine | Week 96, serum creatinine, n=207 | 0.22 Micromoles per liter | Standard Deviation 9.013 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameters: Total Billirubin, Direct Bilirubin, Serum Creatinine | Week 108, serum creatinine, n=204 | -0.28 Micromoles per liter | Standard Deviation 8.511 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameters: Total Billirubin, Direct Bilirubin, Serum Creatinine | Week 120, serum creatinine, n=205 | -1.22 Micromoles per liter | Standard Deviation 8.844 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameters: Total Billirubin, Direct Bilirubin, Serum Creatinine | Week 132, serum creatinine, n=205 | -0.81 Micromoles per liter | Standard Deviation 8.25 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Chemistry Parameters: Total Billirubin, Direct Bilirubin, Serum Creatinine | Week 144, serum creatinine, n=203 | -1.28 Micromoles per liter | Standard Deviation 8.61 |
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: WBC, basophils, eosinophils, 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 Weeks 24, 48, 72, 96, 120 and 144
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 Fumerate 300 mg | Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets | Week 24, WBC, n=208 | 0.19 Billion cells per liter | Standard Deviation 1.409 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets | Week 48, WBC, n=208 | 0.15 Billion cells per liter | Standard Deviation 1.47 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets | Week 72, WBC, n=207 | 0.13 Billion cells per liter | Standard Deviation 1.553 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets | Week 96, WBC, n=207 | 0.07 Billion cells per liter | Standard Deviation 1.504 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets | Week 120, WBC, n=204 | 0.10 Billion cells per liter | Standard Deviation 1.566 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets | Week 144, WBC, n=204 | 0.12 Billion cells per liter | Standard Deviation 1.484 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets | Week 24, Neutrophils, n=208 | 0.15 Billion cells per liter | Standard Deviation 1.322 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets | Week 48, Neutrophils, n=208 | 0.09 Billion cells per liter | Standard Deviation 1.419 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets | Week 72, Neutrophils, n=207 | 0.10 Billion cells per liter | Standard Deviation 1.388 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets | Week 96, Neutrophils, n=207 | 0.05 Billion cells per liter | Standard Deviation 1.414 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets | Week 120, Neutrophils, n=204 | 0.14 Billion cells per liter | Standard Deviation 1.4 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets | Week 144, Neutrophils, n=204 | 0.12 Billion cells per liter | Standard Deviation 1.293 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets | Week 24, Lymphocytes, n=208 | 0.02 Billion cells per liter | Standard Deviation 0.39 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets | Week 48, Lymphocytes, n=208 | 0.05 Billion cells per liter | Standard Deviation 0.396 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets | Week 72, Lymphocytes, n=207 | 0.02 Billion cells per liter | Standard Deviation 0.49 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets | Week 96, Lymphocytes, n=207 | 0.02 Billion cells per liter | Standard Deviation 0.439 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets | Week 120, Lymphocytes, n=204 | -0.05 Billion cells per liter | Standard Deviation 0.459 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets | Week 144, Lymphocyte, n=204 | 0.00 Billion cells per liter | Standard Deviation 0.443 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets | Week 24, Monocytes, n=208 | -0.001 Billion cells per liter | Standard Deviation 0.1069 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets | Week 48, Monocytes, n=208 | 0.004 Billion cells per liter | Standard Deviation 0.1163 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets | Week 72, Monocytes, n=207 | -0.010 Billion cells per liter | Standard Deviation 0.1177 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets | Week 96, Monocytes, n=207 | -0.009 Billion cells per liter | Standard Deviation 0.1123 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets | Week 120, Monocytes, n=204 | -0.006 Billion cells per liter | Standard Deviation 0.1209 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets | Week 144, Monocytes, n=204 | -0.008 Billion cells per liter | Standard Deviation 0.1285 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets | Week 24, Eosinophils, n=208 | 0.02 Billion cells per liter | Standard Deviation 0.153 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets | Week 48, Eosinophils, n=208 | -0.00 Billion cells per liter | Standard Deviation 0.079 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets | Week 72, Eosinophils, n=207 | 0.02 Billion cells per liter | Standard Deviation 0.225 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets | Week 96, Eosinophils, n=207 | -0.00 Billion cells per liter | Standard Deviation 0.076 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets | Week 120, Eosinophils, n=204 | 0.00 Billion cells per liter | Standard Deviation 0.092 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets | Week 144, Eosinophils, n=204 | 0.00 Billion cells per liter | Standard Deviation 0.097 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets | Week 24, Basophils, n=208 | 0.00 Billion cells per liter | Standard Deviation 0.027 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets | Week 48, Basophils, n=208 | 0.00 Billion cells per liter | Standard Deviation 0.023 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets | Week 72, Basophils, n=207 | -0.00 Billion cells per liter | Standard Deviation 0.025 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets | Week 96, Basophils, n=207 | -0.00 Billion cells per liter | Standard Deviation 0.024 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets | Week 120, Basophils, n=203 | 0.00 Billion cells per liter | Standard Deviation 0.025 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets | Week 144, Basophils, n=203 | 0.00 Billion cells per liter | Standard Deviation 0.025 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets | Week 24, Platelets, n=208 | 3.5 Billion cells per liter | Standard Deviation 27.07 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets | Week 48, Platelets, n=208 | 2.5 Billion cells per liter | Standard Deviation 29.38 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets | Week 72, Platelets, n=207 | 1.9 Billion cells per liter | Standard Deviation 33.74 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets | Week 96, Platelets, n=207 | 3.9 Billion cells per liter | Standard Deviation 33.2 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets | Week 120, Platelets, n=204 | 7.2 Billion cells per liter | Standard Deviation 33.48 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets | Week 144, Platelets, n=204 | 9.3 Billion cells per liter | Standard Deviation 34.74 |
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 Weeks 24, 48, 72, 96, 120 and 144
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 Fumerate 300 mg | Change From Baseline in Hemoglobin (Hb) | Week 24, n=208 | 2.4 Grams per liter | Standard Deviation 6.53 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Hemoglobin (Hb) | Week 48, n=208 | -0.2 Grams per liter | Standard Deviation 7.04 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Hemoglobin (Hb) | Week 72, n=207 | -0.2 Grams per liter | Standard Deviation 7.68 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Hemoglobin (Hb) | Week 96, n=207 | -1.0 Grams per liter | Standard Deviation 8.67 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Hemoglobin (Hb) | Week 120, n=204 | -1.0 Grams per liter | Standard Deviation 8.86 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Hemoglobin (Hb) | Week 144, n=204 | -0.2 Grams per liter | Standard Deviation 9.24 |
Secondary
Change From Baseline in Logarithm to the Base 10 (Log 10) Reduction in Serum HBV DNA at Week 48, 96 and 144
Log10 reduction in serum HBV DNA was analyzed by patterns of mutation. The patterns of mutation were summarized by 2 categories. Category 1 included wild-type, LAM-R (Lamivudine-resistant), ADV-R (Adefovir-resistant) and ETV-R (Entecavir-resistant). Category 2 included Wild type, ADV-R single mutation, ADV-R double mutation and other mutation. 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 Weeks 48,96, and 144
Population: mITT Population. All the participants in the study were analyzed (213 Participants) but only the 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 Fumerate 300 mg | Change From Baseline in Logarithm to the Base 10 (Log 10) Reduction in Serum HBV DNA at Week 48, 96 and 144 | Category 1, Week 48, Wild type, n=57 | -2.2 Log 10 (IU/mL) | Standard Deviation 1.63 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Logarithm to the Base 10 (Log 10) Reduction in Serum HBV DNA at Week 48, 96 and 144 | Category 1,Week 96, Wild type, n=57 | -2.3 Log 10 (IU/mL) | Standard Deviation 1.61 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Logarithm to the Base 10 (Log 10) Reduction in Serum HBV DNA at Week 48, 96 and 144 | Category 1,Week 144, Wild type, n=56 | -2.4 Log 10 (IU/mL) | Standard Deviation 1.54 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Logarithm to the Base 10 (Log 10) Reduction in Serum HBV DNA at Week 48, 96 and 144 | Category 1,Week 48, ADV-R, n=38 | -3.0 Log 10 (IU/mL) | Standard Deviation 1.58 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Logarithm to the Base 10 (Log 10) Reduction in Serum HBV DNA at Week 48, 96 and 144 | Category 1, Week 96, ADV-R, n=38 | -3.3 Log 10 (IU/mL) | Standard Deviation 1.53 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Logarithm to the Base 10 (Log 10) Reduction in Serum HBV DNA at Week 48, 96 and 144 | Category 1, Week 144, ADV-R, n=38 | -3.5 Log 10 (IU/mL) | Standard Deviation 1.55 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Logarithm to the Base 10 (Log 10) Reduction in Serum HBV DNA at Week 48, 96 and 144 | Category 1, Week 48, ETV-R, n=32 | -3.2 Log 10 (IU/mL) | Standard Deviation 1.49 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Logarithm to the Base 10 (Log 10) Reduction in Serum HBV DNA at Week 48, 96 and 144 | Category 1, Week 96, ETV-R, n=32 | -3.4 Log 10 (IU/mL) | Standard Deviation 1.49 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Logarithm to the Base 10 (Log 10) Reduction in Serum HBV DNA at Week 48, 96 and 144 | Category 1, Week 144, ETV-R, n=31 | -3.6 Log 10 (IU/mL) | Standard Deviation 1.47 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Logarithm to the Base 10 (Log 10) Reduction in Serum HBV DNA at Week 48, 96 and 144 | Category 1, Week 48, LAM-R, n=93 | -3.1 Log 10 (IU/mL) | Standard Deviation 1.5 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Logarithm to the Base 10 (Log 10) Reduction in Serum HBV DNA at Week 48, 96 and 144 | Category 1, Week 96, LAM-R, n=92 | -3.3 Log 10 (IU/mL) | Standard Deviation 1.59 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Logarithm to the Base 10 (Log 10) Reduction in Serum HBV DNA at Week 48, 96 and 144 | Category 1, Week 144,LAM-R, n=91 | -3.2 Log 10 (IU/mL) | Standard Deviation 1.75 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Logarithm to the Base 10 (Log 10) Reduction in Serum HBV DNA at Week 48, 96 and 144 | Category 2, Week 48, Wild type, n=57 | -2.2 Log 10 (IU/mL) | Standard Deviation 1.63 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Logarithm to the Base 10 (Log 10) Reduction in Serum HBV DNA at Week 48, 96 and 144 | Category 2,Week 96, Wild type, n=57 | -2.3 Log 10 (IU/mL) | Standard Deviation 1.61 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Logarithm to the Base 10 (Log 10) Reduction in Serum HBV DNA at Week 48, 96 and 144 | Category 2 Week 144, Wild type, n=56 | -2.4 Log 10 (IU/mL) | Standard Deviation 1.54 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Logarithm to the Base 10 (Log 10) Reduction in Serum HBV DNA at Week 48, 96 and 144 | Category 2, Week 48, ADV-R single mutation, n=28 | -2.9 Log 10 (IU/mL) | Standard Deviation 1.69 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Logarithm to the Base 10 (Log 10) Reduction in Serum HBV DNA at Week 48, 96 and 144 | Category 2, Week 96, ADV-R, single mutation, n=28 | -3.3 Log 10 (IU/mL) | Standard Deviation 1.65 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Logarithm to the Base 10 (Log 10) Reduction in Serum HBV DNA at Week 48, 96 and 144 | Category 2, Week 144, ADV-R single mutation, n=28 | -3.5 Log 10 (IU/mL) | Standard Deviation 1.64 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Logarithm to the Base 10 (Log 10) Reduction in Serum HBV DNA at Week 48, 96 and 144 | Category 2, Week 48,ADV-R double mutation, n=10 | -3.2 Log 10 (IU/mL) | Standard Deviation 1.26 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Logarithm to the Base 10 (Log 10) Reduction in Serum HBV DNA at Week 48, 96 and 144 | Category 2, Week 96, ADV-R double mutation, n=10 | -3.3 Log 10 (IU/mL) | Standard Deviation 1.22 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Logarithm to the Base 10 (Log 10) Reduction in Serum HBV DNA at Week 48, 96 and 144 | Category 1, Week 144, ADV-R double mutation, n=10 | -3.5 Log 10 (IU/mL) | Standard Deviation 1.36 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Logarithm to the Base 10 (Log 10) Reduction in Serum HBV DNA at Week 48, 96 and 144 | Category 2, Week 48, other mutation, n=113 | -3.1 Log 10 (IU/mL) | Standard Deviation 1.48 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Logarithm to the Base 10 (Log 10) Reduction in Serum HBV DNA at Week 48, 96 and 144 | Category 2, Week 96, other mutation, n=112 | -3.2 Log 10 (IU/mL) | Standard Deviation 1.53 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Logarithm to the Base 10 (Log 10) Reduction in Serum HBV DNA at Week 48, 96 and 144 | Category 2, Week 144, other mutation, n=110 | -3.2 Log 10 (IU/mL) | Standard Deviation 1.67 |
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 Weeks 24, 48, 72, 96, 120 and 144
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 Fumerate 300 mg | Change From Baseline in Red Blood Cells (RBC) | Week 24, n=208 | 0.13 Trillion cells per liter | Standard Deviation 0.254 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Red Blood Cells (RBC) | Week 48, n=208 | 0.05 Trillion cells per liter | Standard Deviation 0.259 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Red Blood Cells (RBC) | Week 72, n=207 | 0.07 Trillion cells per liter | Standard Deviation 0.268 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Red Blood Cells (RBC) | Week 96, n=207 | 0.02 Trillion cells per liter | Standard Deviation 0.294 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Red Blood Cells (RBC) | Week 120, n=204 | 0.08 Trillion cells per liter | Standard Deviation 0.291 |
| Tenofovir Disoproxil Fumerate 300 mg | Change From Baseline in Red Blood Cells (RBC) | Week 144, n=204 | 0.06 Trillion cells per liter | Standard Deviation 0.305 |
Secondary
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs and Non-serious TEAEs
An adverse event was 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 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 associated with liver injury and impaired liver function. The Safety analysis (SA) Population was defined as all participants who received at least one dose of study medication and have at least one post Baseline safety assessment.
Time frame: Up to Week 144
Population: Safety Analysis Population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tenofovir Disoproxil Fumerate 300 mg | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs and Non-serious TEAEs | Any TEAEs | 124 Participants |
| Tenofovir Disoproxil Fumerate 300 mg | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs and Non-serious TEAEs | Serious TEAEs | 20 Participants |
| Tenofovir Disoproxil Fumerate 300 mg | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs and Non-serious TEAEs | Non-serious TEAEs | 117 Participants |
Secondary
Percentage of HBeAg Negative Participants Achieving HBsAg Loss and HBsAg Seroconversion at Weeks 48, 96, and 144
Serological response was assessed at Weeks 48, 96 and 144 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: At Weeks 48,96, and 144
Population: mITT Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tenofovir Disoproxil Fumerate 300 mg | Percentage of HBeAg Negative Participants Achieving HBsAg Loss and HBsAg Seroconversion at Weeks 48, 96, and 144 | Week 48, HBsAg loss | 0 Percentage of Participants |
| Tenofovir Disoproxil Fumerate 300 mg | Percentage of HBeAg Negative Participants Achieving HBsAg Loss and HBsAg Seroconversion at Weeks 48, 96, and 144 | Week 48, HBsAg seroconversion | 0 Percentage of Participants |
| Tenofovir Disoproxil Fumerate 300 mg | Percentage of HBeAg Negative Participants Achieving HBsAg Loss and HBsAg Seroconversion at Weeks 48, 96, and 144 | Week 96, HBsAg loss | 0 Percentage of Participants |
| Tenofovir Disoproxil Fumerate 300 mg | Percentage of HBeAg Negative Participants Achieving HBsAg Loss and HBsAg Seroconversion at Weeks 48, 96, and 144 | Week 96, HBsAg seroconversion | 0 Percentage of Participants |
| Tenofovir Disoproxil Fumerate 300 mg | Percentage of HBeAg Negative Participants Achieving HBsAg Loss and HBsAg Seroconversion at Weeks 48, 96, and 144 | Week 144, HBsAg loss | 0 Percentage of Participants |
| Tenofovir Disoproxil Fumerate 300 mg | Percentage of HBeAg Negative Participants Achieving HBsAg Loss and HBsAg Seroconversion at Weeks 48, 96, and 144 | Week 144, HBsAg seroconversion | 0 Percentage of Participants |
Secondary
Percentage of Hepatitis B e Antigen (HBeAg) Positive Participants Achieving HBeAg Loss, HBeAg Seroconversion or Hepatitis B s Antigen (HBsAg) Loss and HBsAg Seroconversion at Weeks 48, 96, and 144
Serological response was assessed at Weeks 48, 96 and 144 in participants with Positive HBeAg at Baseline (Day 0). It was presented as HBeAg Loss, HBeAg Seroconversion, HBsAg Loss and HBsAg Seroconversion. HBeAg Loss was defined as HBeAg changed to be negative. HBeAg seroconversion was defined as HBeAg changed to negative and HBeAb was positive. 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: At Weeks 48, 96 and 144
Population: mITT Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tenofovir Disoproxil Fumerate 300 mg | Percentage of Hepatitis B e Antigen (HBeAg) Positive Participants Achieving HBeAg Loss, HBeAg Seroconversion or Hepatitis B s Antigen (HBsAg) Loss and HBsAg Seroconversion at Weeks 48, 96, and 144 | Week 96, HBsAg loss | 0.5 Percentage of Participants |
| Tenofovir Disoproxil Fumerate 300 mg | Percentage of Hepatitis B e Antigen (HBeAg) Positive Participants Achieving HBeAg Loss, HBeAg Seroconversion or Hepatitis B s Antigen (HBsAg) Loss and HBsAg Seroconversion at Weeks 48, 96, and 144 | Week 96, HBsAg seroconversion | 0.5 Percentage of Participants |
| Tenofovir Disoproxil Fumerate 300 mg | Percentage of Hepatitis B e Antigen (HBeAg) Positive Participants Achieving HBeAg Loss, HBeAg Seroconversion or Hepatitis B s Antigen (HBsAg) Loss and HBsAg Seroconversion at Weeks 48, 96, and 144 | Week 48, HBeAg loss | 5.3 Percentage of Participants |
| Tenofovir Disoproxil Fumerate 300 mg | Percentage of Hepatitis B e Antigen (HBeAg) Positive Participants Achieving HBeAg Loss, HBeAg Seroconversion or Hepatitis B s Antigen (HBsAg) Loss and HBsAg Seroconversion at Weeks 48, 96, and 144 | Week 48, HBeAg seroconversion | 2.6 Percentage of Participants |
| Tenofovir Disoproxil Fumerate 300 mg | Percentage of Hepatitis B e Antigen (HBeAg) Positive Participants Achieving HBeAg Loss, HBeAg Seroconversion or Hepatitis B s Antigen (HBsAg) Loss and HBsAg Seroconversion at Weeks 48, 96, and 144 | Week 48, HBsAg loss | 0.5 Percentage of Participants |
| Tenofovir Disoproxil Fumerate 300 mg | Percentage of Hepatitis B e Antigen (HBeAg) Positive Participants Achieving HBeAg Loss, HBeAg Seroconversion or Hepatitis B s Antigen (HBsAg) Loss and HBsAg Seroconversion at Weeks 48, 96, and 144 | Week 48, HBsAg seroconversion | 0 Percentage of Participants |
| Tenofovir Disoproxil Fumerate 300 mg | Percentage of Hepatitis B e Antigen (HBeAg) Positive Participants Achieving HBeAg Loss, HBeAg Seroconversion or Hepatitis B s Antigen (HBsAg) Loss and HBsAg Seroconversion at Weeks 48, 96, and 144 | Week 96, HBeAg loss | 10.0 Percentage of Participants |
| Tenofovir Disoproxil Fumerate 300 mg | Percentage of Hepatitis B e Antigen (HBeAg) Positive Participants Achieving HBeAg Loss, HBeAg Seroconversion or Hepatitis B s Antigen (HBsAg) Loss and HBsAg Seroconversion at Weeks 48, 96, and 144 | Week 96, HBeAg seroconversion | 2.6 Percentage of Participants |
| Tenofovir Disoproxil Fumerate 300 mg | Percentage of Hepatitis B e Antigen (HBeAg) Positive Participants Achieving HBeAg Loss, HBeAg Seroconversion or Hepatitis B s Antigen (HBsAg) Loss and HBsAg Seroconversion at Weeks 48, 96, and 144 | Week 144, HBeAg loss | 15.3 Percentage of Participants |
| Tenofovir Disoproxil Fumerate 300 mg | Percentage of Hepatitis B e Antigen (HBeAg) Positive Participants Achieving HBeAg Loss, HBeAg Seroconversion or Hepatitis B s Antigen (HBsAg) Loss and HBsAg Seroconversion at Weeks 48, 96, and 144 | Week 144, HBeAg seroconversion | 4.7 Percentage of Participants |
| Tenofovir Disoproxil Fumerate 300 mg | Percentage of Hepatitis B e Antigen (HBeAg) Positive Participants Achieving HBeAg Loss, HBeAg Seroconversion or Hepatitis B s Antigen (HBsAg) Loss and HBsAg Seroconversion at Weeks 48, 96, and 144 | Week 144, HBsAg loss | 1.1 Percentage of Participants |
| Tenofovir Disoproxil Fumerate 300 mg | Percentage of Hepatitis B e Antigen (HBeAg) Positive Participants Achieving HBeAg Loss, HBeAg Seroconversion or Hepatitis B s Antigen (HBsAg) Loss and HBsAg Seroconversion at Weeks 48, 96, and 144 | Week 144, HBsAg seroconversion | 0.5 Percentage of Participants |
Secondary
Percentage of Participants in the Subgroup With Confirmed Multi-drug Resistance Mutations at Baseline With Serum HBV DNA <20 IU/mL and Serum HBV DNA <69 IU/mL at Weeks 48, 96 and 144
Serum samples were collected and analyzed for HBV DNA levels at indicated time points. Resistance surveillance of the HBV polymerase gene were performed by direct sequencing for all participants at Baseline. Day 0 was considered as Baseline. Percentage of participants in the subgroup with confirmed multi-drug resistance mutations at Baseline with serum HBV DNA \<20 IU/mL and serum HBV DNA \<69 IU/mL at Weeks 48, 96 and 144 have been presented.
Time frame: At Weeks 48, 96, and 144
Population: mITT Population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tenofovir Disoproxil Fumerate 300 mg | Percentage of Participants in the Subgroup With Confirmed Multi-drug Resistance Mutations at Baseline With Serum HBV DNA <20 IU/mL and Serum HBV DNA <69 IU/mL at Weeks 48, 96 and 144 | Week 48, HBV DNA <20 IU/mL | 34.2 Percentage of Participants |
| Tenofovir Disoproxil Fumerate 300 mg | Percentage of Participants in the Subgroup With Confirmed Multi-drug Resistance Mutations at Baseline With Serum HBV DNA <20 IU/mL and Serum HBV DNA <69 IU/mL at Weeks 48, 96 and 144 | Week 48, HBV DNA <69 IU/mL | 60.5 Percentage of Participants |
| Tenofovir Disoproxil Fumerate 300 mg | Percentage of Participants in the Subgroup With Confirmed Multi-drug Resistance Mutations at Baseline With Serum HBV DNA <20 IU/mL and Serum HBV DNA <69 IU/mL at Weeks 48, 96 and 144 | Week 96, HBV DNA <20 IU/mL | 55.3 Percentage of Participants |
| Tenofovir Disoproxil Fumerate 300 mg | Percentage of Participants in the Subgroup With Confirmed Multi-drug Resistance Mutations at Baseline With Serum HBV DNA <20 IU/mL and Serum HBV DNA <69 IU/mL at Weeks 48, 96 and 144 | Week 96, HBV DNA <69 IU/mL | 76.3 Percentage of Participants |
| Tenofovir Disoproxil Fumerate 300 mg | Percentage of Participants in the Subgroup With Confirmed Multi-drug Resistance Mutations at Baseline With Serum HBV DNA <20 IU/mL and Serum HBV DNA <69 IU/mL at Weeks 48, 96 and 144 | Week 144, HBV DNA <20 IU/mL | 65.8 Percentage of Participants |
| Tenofovir Disoproxil Fumerate 300 mg | Percentage of Participants in the Subgroup With Confirmed Multi-drug Resistance Mutations at Baseline With Serum HBV DNA <20 IU/mL and Serum HBV DNA <69 IU/mL at Weeks 48, 96 and 144 | Week 144, HBV DNA <69 IU/mL | 84.2 Percentage of Participants |
Secondary
Percentage of Participants Who Experienced Viral Breakthrough up to Week 144
Viral breakthrough was defined as 1 log increase in HBV DNA from nadir determined by two sequential HBV DNA measurements. Percentage of participants who experienced viral breakthrough at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132 and 144 have been presented.
Time frame: At Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120,132, and 144
Population: mITT Population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tenofovir Disoproxil Fumerate 300 mg | Percentage of Participants Who Experienced Viral Breakthrough up to Week 144 | Week 24 | 0.5 Percentage of Participants |
| Tenofovir Disoproxil Fumerate 300 mg | Percentage of Participants Who Experienced Viral Breakthrough up to Week 144 | Week 36 | 0 Percentage of Participants |
| Tenofovir Disoproxil Fumerate 300 mg | Percentage of Participants Who Experienced Viral Breakthrough up to Week 144 | Week 48 | 0.5 Percentage of Participants |
| Tenofovir Disoproxil Fumerate 300 mg | Percentage of Participants Who Experienced Viral Breakthrough up to Week 144 | Week 60 | 0 Percentage of Participants |
| Tenofovir Disoproxil Fumerate 300 mg | Percentage of Participants Who Experienced Viral Breakthrough up to Week 144 | Week 72 | 0 Percentage of Participants |
| Tenofovir Disoproxil Fumerate 300 mg | Percentage of Participants Who Experienced Viral Breakthrough up to Week 144 | Week 84 | 0 Percentage of Participants |
| Tenofovir Disoproxil Fumerate 300 mg | Percentage of Participants Who Experienced Viral Breakthrough up to Week 144 | Week 96 | 0 Percentage of Participants |
| Tenofovir Disoproxil Fumerate 300 mg | Percentage of Participants Who Experienced Viral Breakthrough up to Week 144 | Week 108 | 0.5 Percentage of Participants |
| Tenofovir Disoproxil Fumerate 300 mg | Percentage of Participants Who Experienced Viral Breakthrough up to Week 144 | Week 120 | 0 Percentage of Participants |
| Tenofovir Disoproxil Fumerate 300 mg | Percentage of Participants Who Experienced Viral Breakthrough up to Week 144 | Week 132 | 0 Percentage of Participants |
| Tenofovir Disoproxil Fumerate 300 mg | Percentage of Participants Who Experienced Viral Breakthrough up to Week 144 | Week 144 | 0 Percentage of Participants |
Secondary
Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Weeks 48, 96, and 144 in Participants Who Had Abnormal ALT at Baseline
Blood samples were collected for evaluation of ALT at indicated time points. ALT normalization was defined as measurement less than or equal to the upper limit of the normal range. Normal range for ALT is 7 to 56 International Units per liter. Percentage of participants with ALT normalization at Weeks 48, 96, and 144 in Participants who had abnormal ALT at Baseline (Day 0) have been presented.
Time frame: At Weeks 48, 96, and 144
Population: mITT Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tenofovir Disoproxil Fumerate 300 mg | Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Weeks 48, 96, and 144 in Participants Who Had Abnormal ALT at Baseline | Week 48 | 52.5 Percentage of Participants |
| Tenofovir Disoproxil Fumerate 300 mg | Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Weeks 48, 96, and 144 in Participants Who Had Abnormal ALT at Baseline | Week 96 | 60.7 Percentage of Participants |
| Tenofovir Disoproxil Fumerate 300 mg | Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Weeks 48, 96, and 144 in Participants Who Had Abnormal ALT at Baseline | Week 144 | 68.3 Percentage of Participants |
Secondary
Percentage of Participants With Serum HBV DNA <20 IU/mL and Serum HBV DNA <69 IU/mL at Weeks 48 and 96
HBV DNA level were analyzed using the sensitive HBV test in central laboratory using Roche cobas Taqman HBV test from the blood samples collected at Weeks 48 and 96. Virological response was assessed by proportion of participants with serum serum HBV \<20 IU/mL and \<69 IU/mL at Weeks 48 and 96. Percentage of participants with serum HBV DNA \<20 IU/mL and \<69 IU/mL at Weeks 48 and 96 have been presented.
Time frame: At Weeks 48 and 96
Population: mITT Population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tenofovir Disoproxil Fumerate 300 mg | Percentage of Participants With Serum HBV DNA <20 IU/mL and Serum HBV DNA <69 IU/mL at Weeks 48 and 96 | Week 96, HBV DNA <69 IU/mL | 84.0 Percentage of Participants |
| Tenofovir Disoproxil Fumerate 300 mg | Percentage of Participants With Serum HBV DNA <20 IU/mL and Serum HBV DNA <69 IU/mL at Weeks 48 and 96 | Week 48, HBV DNA <20 IU/mL | 46.9 Percentage of Participants |
| Tenofovir Disoproxil Fumerate 300 mg | Percentage of Participants With Serum HBV DNA <20 IU/mL and Serum HBV DNA <69 IU/mL at Weeks 48 and 96 | Week 48, HBV DNA <69 IU/mL | 76.5 Percentage of Participants |
| Tenofovir Disoproxil Fumerate 300 mg | Percentage of Participants With Serum HBV DNA <20 IU/mL and Serum HBV DNA <69 IU/mL at Weeks 48 and 96 | Week 96, HBV DNA <20 IU/mL | 61.0 Percentage of Participants |