Trial Outcomes & Findings for Tenofovir Disoproxil Fumarate (TDF) 300mg 3 Years RD Therapy Chinese Chronic Hepatitis B (CHN) CHB Multiple Nucleos(t)Ide Analogues (NAs) Failure Points Pts PH4 PMS Study (NCT NCT02195518)
NCT ID: NCT02195518
Last Updated: 2019-11-04
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
213 participants
Primary outcome timeframe
At Week 144
Results posted on
2019-11-04
Participant Flow
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.
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.
Participant milestones
| Measure |
Tenofovir Disoproxil Fumerate 300 mg
Participants received an open-label treatment of Tenofovir Disoproxil Fumarate 300 mg orally once daily for 144-weeks.
|
|---|---|
|
Overall Study
STARTED
|
213
|
|
Overall Study
COMPLETED
|
204
|
|
Overall Study
NOT COMPLETED
|
9
|
Reasons for withdrawal
| Measure |
Tenofovir Disoproxil Fumerate 300 mg
Participants received an open-label treatment of Tenofovir Disoproxil Fumarate 300 mg orally once daily for 144-weeks.
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Protocol Violation
|
4
|
|
Overall Study
Pregnancy
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
Baseline Characteristics
Tenofovir Disoproxil Fumarate (TDF) 300mg 3 Years RD Therapy Chinese Chronic Hepatitis B (CHN) CHB Multiple Nucleos(t)Ide Analogues (NAs) Failure Points Pts PH4 PMS Study
Baseline characteristics by cohort
| Measure |
Tenofovir Disoproxil Fumerate 300 mg
n=213 Participants
Participants received an open-label treatment of Tenofovir Disoproxil Fumarate 300 mg orally once daily for 144-weeks.
|
|---|---|
|
Age, Continuous
|
42.3 Years
STANDARD_DEVIATION 10.29 • n=5 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
186 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
213 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At Week 144Population: mITT Population.
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.
Outcome measures
| Measure |
Tenofovir Disoproxil Fumerate 300 mg
n=213 Participants
Participants received an open-label treatment of Tenofovir Disoproxil Fumarate 300 mg orally once daily for 144-weeks.
|
|---|---|
|
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 outcome
Timeframe: At Weeks 48 and 96Population: mITT Population.
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.
Outcome measures
| Measure |
Tenofovir Disoproxil Fumerate 300 mg
n=213 Participants
Participants received an open-label treatment of Tenofovir Disoproxil Fumarate 300 mg orally once daily for 144-weeks.
|
|---|---|
|
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
|
|
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
|
|
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
|
|
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
|
SECONDARY outcome
Timeframe: At Weeks 48, 96, and 144Population: mITT Population.
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.
Outcome measures
| Measure |
Tenofovir Disoproxil Fumerate 300 mg
n=213 Participants
Participants received an open-label treatment of Tenofovir Disoproxil Fumarate 300 mg orally once daily for 144-weeks.
|
|---|---|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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 outcome
Timeframe: Baseline (Day 0) and at Weeks 48,96, and 144Population: 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).
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.
Outcome measures
| Measure |
Tenofovir Disoproxil Fumerate 300 mg
n=213 Participants
Participants received an open-label treatment of Tenofovir Disoproxil Fumarate 300 mg orally once daily for 144-weeks.
|
|---|---|
|
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
|
|
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 1.50
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
SECONDARY outcome
Timeframe: At Weeks 48, 96 and 144Population: mITT Population. Only those participants with data available at the specified data points were analyzed.
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.
Outcome measures
| Measure |
Tenofovir Disoproxil Fumerate 300 mg
n=190 Participants
Participants received an open-label treatment of Tenofovir Disoproxil Fumarate 300 mg orally once daily for 144-weeks.
|
|---|---|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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 outcome
Timeframe: At Weeks 48,96, and 144Population: mITT Population. Only those participants with data available at the specified data points were analyzed.
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.
Outcome measures
| Measure |
Tenofovir Disoproxil Fumerate 300 mg
n=23 Participants
Participants received an open-label treatment of Tenofovir Disoproxil Fumarate 300 mg orally once daily for 144-weeks.
|
|---|---|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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 outcome
Timeframe: At Weeks 48, 96, and 144Population: mITT Population. Only those participants with data available at the specified data points were analyzed.
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.
Outcome measures
| Measure |
Tenofovir Disoproxil Fumerate 300 mg
n=61 Participants
Participants received an open-label treatment of Tenofovir Disoproxil Fumarate 300 mg orally once daily for 144-weeks.
|
|---|---|
|
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
|
|
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
|
|
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 outcome
Timeframe: At Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120,132, and 144Population: mITT Population.
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.
Outcome measures
| Measure |
Tenofovir Disoproxil Fumerate 300 mg
n=213 Participants
Participants received an open-label treatment of Tenofovir Disoproxil Fumarate 300 mg orally once daily for 144-weeks.
|
|---|---|
|
Percentage of Participants Who Experienced Viral Breakthrough up to Week 144
Week 24
|
0.5 Percentage of Participants
|
|
Percentage of Participants Who Experienced Viral Breakthrough up to Week 144
Week 72
|
0 Percentage of Participants
|
|
Percentage of Participants Who Experienced Viral Breakthrough up to Week 144
Week 84
|
0 Percentage of Participants
|
|
Percentage of Participants Who Experienced Viral Breakthrough up to Week 144
Week 96
|
0 Percentage of Participants
|
|
Percentage of Participants Who Experienced Viral Breakthrough up to Week 144
Week 36
|
0 Percentage of Participants
|
|
Percentage of Participants Who Experienced Viral Breakthrough up to Week 144
Week 48
|
0.5 Percentage of Participants
|
|
Percentage of Participants Who Experienced Viral Breakthrough up to Week 144
Week 60
|
0 Percentage of Participants
|
|
Percentage of Participants Who Experienced Viral Breakthrough up to Week 144
Week 108
|
0.5 Percentage of Participants
|
|
Percentage of Participants Who Experienced Viral Breakthrough up to Week 144
Week 120
|
0 Percentage of Participants
|
|
Percentage of Participants Who Experienced Viral Breakthrough up to Week 144
Week 132
|
0 Percentage of Participants
|
|
Percentage of Participants Who Experienced Viral Breakthrough up to Week 144
Week 144
|
0 Percentage of Participants
|
SECONDARY outcome
Timeframe: Up to Week 144Population: Safety Analysis Population.
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.
Outcome measures
| Measure |
Tenofovir Disoproxil Fumerate 300 mg
n=213 Participants
Participants received an open-label treatment of Tenofovir Disoproxil Fumarate 300 mg orally once daily for 144-weeks.
|
|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs and Non-serious TEAEs
Serious TEAEs
|
20 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs and Non-serious TEAEs
Non-serious TEAEs
|
117 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs and Non-serious TEAEs
Any TEAEs
|
124 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 0) and at Weeks 24, 48, 72, 96, 120 and 144Population: Safety analysis Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Blood samples were collected to 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.
Outcome measures
| Measure |
Tenofovir Disoproxil Fumerate 300 mg
n=208 Participants
Participants received an open-label treatment of Tenofovir Disoproxil Fumarate 300 mg orally once daily for 144-weeks.
|
|---|---|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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 1.470
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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 1.400
|
|
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
|
|
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 0.390
|
|
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
|
|
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 0.490
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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 33.20
|
|
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
|
|
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 outcome
Timeframe: Baseline (Day 0) and at Weeks 24, 48, 72, 96, 120 and 144Population: Safety analysis Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Blood samples were collected to analyze Hb values. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Outcome measures
| Measure |
Tenofovir Disoproxil Fumerate 300 mg
n=208 Participants
Participants received an open-label treatment of Tenofovir Disoproxil Fumarate 300 mg orally once daily for 144-weeks.
|
|---|---|
|
Change From Baseline in Hemoglobin (Hb)
Week 24, n=208
|
2.4 Grams per liter
Standard Deviation 6.53
|
|
Change From Baseline in Hemoglobin (Hb)
Week 48, n=208
|
-0.2 Grams per liter
Standard Deviation 7.04
|
|
Change From Baseline in Hemoglobin (Hb)
Week 72, n=207
|
-0.2 Grams per liter
Standard Deviation 7.68
|
|
Change From Baseline in Hemoglobin (Hb)
Week 96, n=207
|
-1.0 Grams per liter
Standard Deviation 8.67
|
|
Change From Baseline in Hemoglobin (Hb)
Week 120, n=204
|
-1.0 Grams per liter
Standard Deviation 8.86
|
|
Change From Baseline in Hemoglobin (Hb)
Week 144, n=204
|
-0.2 Grams per liter
Standard Deviation 9.24
|
SECONDARY outcome
Timeframe: Baseline (Day 0) and at Weeks 24, 48, 72, 96, 120 and 144Population: Safety analysis Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Blood samples were collected to analyze RBC values. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Outcome measures
| Measure |
Tenofovir Disoproxil Fumerate 300 mg
n=208 Participants
Participants received an open-label treatment of Tenofovir Disoproxil Fumarate 300 mg orally once daily for 144-weeks.
|
|---|---|
|
Change From Baseline in Red Blood Cells (RBC)
Week 48, n=208
|
0.05 Trillion cells per liter
Standard Deviation 0.259
|
|
Change From Baseline in Red Blood Cells (RBC)
Week 72, n=207
|
0.07 Trillion cells per liter
Standard Deviation 0.268
|
|
Change From Baseline in Red Blood Cells (RBC)
Week 24, n=208
|
0.13 Trillion cells per liter
Standard Deviation 0.254
|
|
Change From Baseline in Red Blood Cells (RBC)
Week 96, n=207
|
0.02 Trillion cells per liter
Standard Deviation 0.294
|
|
Change From Baseline in Red Blood Cells (RBC)
Week 120, n=204
|
0.08 Trillion cells per liter
Standard Deviation 0.291
|
|
Change From Baseline in Red Blood Cells (RBC)
Week 144, n=204
|
0.06 Trillion cells per liter
Standard Deviation 0.305
|
SECONDARY outcome
Timeframe: Baseline (Day 0) and at Weeks 12,24,36,48,60,72,84,96,108,120,132,and 144Population: Safety analysis Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Blood samples were collected to 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.
Outcome measures
| Measure |
Tenofovir Disoproxil Fumerate 300 mg
n=209 Participants
Participants received an open-label treatment of Tenofovir Disoproxil Fumarate 300 mg orally once daily for 144-weeks.
|
|---|---|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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 525.680
|
|
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
|
|
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 204.800
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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 45.290
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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 20.760
|
|
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
|
|
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 23.700
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
SECONDARY outcome
Timeframe: Baseline (Day 0) and at Weeks, 12,24,36,48,60,72,84,96,108,120,132,and 144Population: Safety analysis Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Blood samples were collected to 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.
Outcome measures
| Measure |
Tenofovir Disoproxil Fumerate 300 mg
n=209 Participants
Participants received an open-label treatment of Tenofovir Disoproxil Fumarate 300 mg orally once daily for 144-weeks.
|
|---|---|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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 7.480
|
|
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
|
|
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 8.250
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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 8.610
|
SECONDARY outcome
Timeframe: Baseline (Day 0) and at Weeks, 12,24,36,48,60,72,84,96,108,120,132,and 144Population: Safety analysis Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Blood samples were collected to 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.
Outcome measures
| Measure |
Tenofovir Disoproxil Fumerate 300 mg
n=209 Participants
Participants received an open-label treatment of Tenofovir Disoproxil Fumarate 300 mg orally once daily for 144-weeks.
|
|---|---|
|
Change From Baseline in Chemistry Parameters: Albumin, Total Protein
Week 132, albumin, n=205
|
0.51 Grams per liter
Standard Deviation 2.942
|
|
Change From Baseline in Chemistry Parameters: Albumin, Total Protein
Week 144, albumin, n=204
|
0.48 Grams per liter
Standard Deviation 3.171
|
|
Change From Baseline in Chemistry Parameters: Albumin, Total Protein
Week 108, total protein, n=205
|
-0.21 Grams per liter
Standard Deviation 4.855
|
|
Change From Baseline in Chemistry Parameters: Albumin, Total Protein
Week 120, total protein, n=205
|
0.95 Grams per liter
Standard Deviation 5.361
|
|
Change From Baseline in Chemistry Parameters: Albumin, Total Protein
Week 12, albumin, n=209
|
0.22 Grams per liter
Standard Deviation 2.766
|
|
Change From Baseline in Chemistry Parameters: Albumin, Total Protein
Week 24, albumin, n=208
|
0.54 Grams per liter
Standard Deviation 2.722
|
|
Change From Baseline in Chemistry Parameters: Albumin, Total Protein
Week 36, albumin, n=209
|
0.04 Grams per liter
Standard Deviation 2.545
|
|
Change From Baseline in Chemistry Parameters: Albumin, Total Protein
Week 48, albumin, n=208
|
0.24 Grams per liter
Standard Deviation 2.687
|
|
Change From Baseline in Chemistry Parameters: Albumin, Total Protein
Week 60, albumin, n=208
|
0.38 Grams per liter
Standard Deviation 2.757
|
|
Change From Baseline in Chemistry Parameters: Albumin, Total Protein
Week 72, albumin, n=207
|
0.49 Grams per liter
Standard Deviation 2.890
|
|
Change From Baseline in Chemistry Parameters: Albumin, Total Protein
Week 84, albumin, n=207
|
-0.03 Grams per liter
Standard Deviation 3.021
|
|
Change From Baseline in Chemistry Parameters: Albumin, Total Protein
Week 96, albumin, n=207
|
0.13 Grams per liter
Standard Deviation 2.980
|
|
Change From Baseline in Chemistry Parameters: Albumin, Total Protein
Week 108, albumin, n=205
|
-0.56 Grams per liter
Standard Deviation 2.932
|
|
Change From Baseline in Chemistry Parameters: Albumin, Total Protein
Week 120, albumin, n=205
|
0.17 Grams per liter
Standard Deviation 3.272
|
|
Change From Baseline in Chemistry Parameters: Albumin, Total Protein
Week 12, total protein, n=209
|
0.31 Grams per liter
Standard Deviation 4.220
|
|
Change From Baseline in Chemistry Parameters: Albumin, Total Protein
Week 24, total protein, n=207
|
0.92 Grams per liter
Standard Deviation 4.322
|
|
Change From Baseline in Chemistry Parameters: Albumin, Total Protein
Week 36, total protein, n=209
|
-0.30 Grams per liter
Standard Deviation 4.280
|
|
Change From Baseline in Chemistry Parameters: Albumin, Total Protein
Week 48, total protein, n=208
|
-0.53 Grams per liter
Standard Deviation 4.240
|
|
Change From Baseline in Chemistry Parameters: Albumin, Total Protein
Week 60, total protein, n=208
|
-0.32 Grams per liter
Standard Deviation 4.387
|
|
Change From Baseline in Chemistry Parameters: Albumin, Total Protein
Week 72, total protein, n=207
|
-0.26 Grams per liter
Standard Deviation 4.540
|
|
Change From Baseline in Chemistry Parameters: Albumin, Total Protein
Week 84, total protein, n=207
|
-0.57 Grams per liter
Standard Deviation 5.158
|
|
Change From Baseline in Chemistry Parameters: Albumin, Total Protein
Week 96, total protein, n=207
|
-0.44 Grams per liter
Standard Deviation 5.240
|
|
Change From Baseline in Chemistry Parameters: Albumin, Total Protein
Week 132, total protein, n=205
|
1.00 Grams per liter
Standard Deviation 4.494
|
|
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 outcome
Timeframe: Baseline (Day 0) and at Weeks, 12,24,36,48,60,72,84,96,108,120,132,and 144Population: Safety analysis population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Blood samples were collected to 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.
Outcome measures
| Measure |
Tenofovir Disoproxil Fumerate 300 mg
n=209 Participants
Participants received an open-label treatment of Tenofovir Disoproxil Fumarate 300 mg orally once daily for 144-weeks.
|
|---|---|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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 0.1290
|
|
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 0.1370
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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 outcome
Timeframe: Baseline (Day 0) and at Weeks, 12,24,36,48,60,72,84,96,108,120,132,and 144Population: Safety analysis population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Blood samples were collected to 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.
Outcome measures
| Measure |
Tenofovir Disoproxil Fumerate 300 mg
n=209 Participants
Participants received an open-label treatment of Tenofovir Disoproxil Fumarate 300 mg orally once daily for 144-weeks.
|
|---|---|
|
Change From Baseline in Chemistry Parameter: Creatinine Clearance Rate
Week 12, n=208
|
-4.564 Milliliter per minute
Standard Deviation 11.1192
|
|
Change From Baseline in Chemistry Parameter: Creatinine Clearance Rate
Week 24, n=208
|
-2.213 Milliliter per minute
Standard Deviation 11.2288
|
|
Change From Baseline in Chemistry Parameter: Creatinine Clearance Rate
Week 36, n=209
|
-2.311 Milliliter per minute
Standard Deviation 12.4693
|
|
Change From Baseline in Chemistry Parameter: Creatinine Clearance Rate
Week 48, n=208
|
-3.667 Milliliter per minute
Standard Deviation 12.3427
|
|
Change From Baseline in Chemistry Parameter: Creatinine Clearance Rate
Week 60, n=208
|
-2.053 Milliliter per minute
Standard Deviation 13.9768
|
|
Change From Baseline in Chemistry Parameter: Creatinine Clearance Rate
Week 72, n=206
|
-0.519 Milliliter per minute
Standard Deviation 13.1580
|
|
Change From Baseline in Chemistry Parameter: Creatinine Clearance Rate
Week 84, n=207
|
-1.065 Milliliter per minute
Standard Deviation 15.0315
|
|
Change From Baseline in Chemistry Parameter: Creatinine Clearance Rate
Week 96, n=207
|
-2.378 Milliliter per minute
Standard Deviation 13.8827
|
|
Change From Baseline in Chemistry Parameter: Creatinine Clearance Rate
Week 108, n=204
|
-2.512 Milliliter per minute
Standard Deviation 13.4608
|
|
Change From Baseline in Chemistry Parameter: Creatinine Clearance Rate
Week 120, n=203
|
-0.742 Milliliter per minute
Standard Deviation 14.3800
|
|
Change From Baseline in Chemistry Parameter: Creatinine Clearance Rate
Week 132, n=205
|
-1.499 Milliliter per minute
Standard Deviation 13.3816
|
|
Change From Baseline in Chemistry Parameter: Creatinine Clearance Rate
Week 144, n=203
|
-0.821 Milliliter per minute
Standard Deviation 13.8173
|
SECONDARY outcome
Timeframe: Baseline (Day 0) and at Weeks, 12,24,36,48,60,72,84,96,108,120,132,and 144Population: Safety analysis Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Blood samples were collected to 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.
Outcome measures
| Measure |
Tenofovir Disoproxil Fumerate 300 mg
n=209 Participants
Participants received an open-label treatment of Tenofovir Disoproxil Fumarate 300 mg orally once daily for 144-weeks.
|
|---|---|
|
Change From Baseline in Chemistry Parameter: Estimated Glomerular Filtration Rate (eGFR)
Week 132, n=205
|
0.60 Grams per liter
Standard Deviation 8.098
|
|
Change From Baseline in Chemistry Parameter: Estimated Glomerular Filtration Rate (eGFR)
Week 144, n=204
|
0.95 Grams per liter
Standard Deviation 8.313
|
|
Change From Baseline in Chemistry Parameter: Estimated Glomerular Filtration Rate (eGFR)
Week 12, n=209
|
-2.93 Grams per liter
Standard Deviation 7.250
|
|
Change From Baseline in Chemistry Parameter: Estimated Glomerular Filtration Rate (eGFR)
Week 24, n=209
|
-1.11 Grams per liter
Standard Deviation 6.798
|
|
Change From Baseline in Chemistry Parameter: Estimated Glomerular Filtration Rate (eGFR)
Week 36, n=209
|
-0.63 Grams per liter
Standard Deviation 7.558
|
|
Change From Baseline in Chemistry Parameter: Estimated Glomerular Filtration Rate (eGFR)
Week 48, n=208
|
-1.31 Grams per liter
Standard Deviation 7.378
|
|
Change From Baseline in Chemistry Parameter: Estimated Glomerular Filtration Rate (eGFR)
Week 60, n=208
|
-0.12 Grams per liter
Standard Deviation 8.004
|
|
Change From Baseline in Chemistry Parameter: Estimated Glomerular Filtration Rate (eGFR)
Week 72, n=208
|
0.84 Grams per liter
Standard Deviation 7.619
|
|
Change From Baseline in Chemistry Parameter: Estimated Glomerular Filtration Rate (eGFR)
Week 84, n=207
|
0.42 Grams per liter
Standard Deviation 8.731
|
|
Change From Baseline in Chemistry Parameter: Estimated Glomerular Filtration Rate (eGFR)
Week 96, n=207
|
-0.17 Grams per liter
Standard Deviation 8.752
|
|
Change From Baseline in Chemistry Parameter: Estimated Glomerular Filtration Rate (eGFR)
Week 108, n=205
|
0.42 Grams per liter
Standard Deviation 8.379
|
|
Change From Baseline in Chemistry Parameter: Estimated Glomerular Filtration Rate (eGFR)
Week 120, n=205
|
0.77 Grams per liter
Standard Deviation 8.826
|
Adverse Events
Tenofovir Disoproxil Fumerate 300 mg
Serious events: 20 serious events
Other events: 117 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Tenofovir Disoproxil Fumerate 300 mg
n=213 participants at risk
Participants received an open-label treatment of Tenofovir Disoproxil Fumarate 300 mg orally once daily for 144-weeks.
|
|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
1.9%
4/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Testicular seminoma (pure)
|
0.47%
1/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.94%
2/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Hepatobiliary disorders
Bile duct stone
|
0.47%
1/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.47%
1/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.94%
2/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.94%
2/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.47%
1/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.47%
1/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Renal and urinary disorders
Calculus bladder
|
0.47%
1/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.47%
1/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Renal and urinary disorders
Renal cyst
|
0.47%
1/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Gastrointestinal disorders
Anal fistula
|
0.47%
1/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Gastrointestinal disorders
Colitis
|
0.47%
1/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.47%
1/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.47%
1/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Congenital, familial and genetic disorders
Myocardial bridging
|
0.47%
1/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Endocrine disorders
Adrenal cyst
|
0.47%
1/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
General disorders
Sudden cardiac death
|
0.47%
1/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Infections and infestations
Pneumonia
|
0.47%
1/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.47%
1/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Reproductive system and breast disorders
Epididymal cyst
|
0.47%
1/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.94%
2/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
Other adverse events
| Measure |
Tenofovir Disoproxil Fumerate 300 mg
n=213 participants at risk
Participants received an open-label treatment of Tenofovir Disoproxil Fumarate 300 mg orally once daily for 144-weeks.
|
|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
13.1%
28/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Infections and infestations
Urinary tract infection
|
1.9%
4/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Infections and infestations
Influenza
|
0.94%
2/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Infections and infestations
Nasopharyngitis
|
0.94%
2/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Infections and infestations
Pharyngitis
|
0.94%
2/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Infections and infestations
Anal abscess
|
0.47%
1/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Infections and infestations
Chronic tonsillitis
|
0.47%
1/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Infections and infestations
Conjunctivitis
|
0.47%
1/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Infections and infestations
Gingivitis
|
0.47%
1/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Infections and infestations
Helicobacter infection
|
0.47%
1/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Infections and infestations
Lung infection
|
0.47%
1/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Infections and infestations
Papilloma viral infection
|
0.47%
1/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Infections and infestations
Pelvic inflammatory disease
|
0.47%
1/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Investigations
Blood creatine phosphokinase increased
|
5.6%
12/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Investigations
Blood uric acid increased
|
1.4%
3/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Investigations
Weight decreased
|
1.4%
3/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Investigations
Alanine aminotransferase increased
|
0.94%
2/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Investigations
Blood phosphorus decreased
|
0.94%
2/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Investigations
Protein urine present
|
0.94%
2/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Investigations
Transaminases increased
|
0.94%
2/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Investigations
Ultrasound liver abnormal
|
0.94%
2/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Investigations
White blood cells urine positive
|
0.94%
2/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Investigations
Blood creatinine increased
|
0.47%
1/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Investigations
Blood glucose increased
|
0.47%
1/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Investigations
Blood pressure increased
|
0.47%
1/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Investigations
Red blood cell count increased
|
0.47%
1/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Investigations
Urine analysis abnormal
|
0.47%
1/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Gastrointestinal disorders
Diarrhoea
|
1.9%
4/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Gastrointestinal disorders
Chronic gastritis
|
1.4%
3/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Gastrointestinal disorders
Toothache
|
1.4%
3/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Gastrointestinal disorders
Flatulence
|
0.94%
2/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.47%
1/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Gastrointestinal disorders
Abdominal pain
|
0.47%
1/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.47%
1/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Gastrointestinal disorders
Ascites
|
0.47%
1/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Gastrointestinal disorders
Colitis
|
0.47%
1/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Gastrointestinal disorders
Dyspepsia
|
0.47%
1/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.47%
1/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.47%
1/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Gastrointestinal disorders
Gingival pain
|
0.47%
1/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.47%
1/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.47%
1/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Gastrointestinal disorders
Reflux gastritis
|
0.47%
1/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Hepatobiliary disorders
Hepatic steatosis
|
3.3%
7/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Hepatobiliary disorders
Gallbladder polyp
|
1.4%
3/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Hepatobiliary disorders
Hepatic cyst
|
0.94%
2/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.94%
2/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.47%
1/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Hepatobiliary disorders
Hepatic fibrosis
|
0.47%
1/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
3.8%
8/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
1.4%
3/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Hepatobiliary disorders
Steatohepatitis
|
0.94%
2/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.47%
1/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.47%
1/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.47%
1/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.47%
1/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.47%
1/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.94%
2/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Reproductive system and breast disorders
Prostatitis
|
0.94%
2/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Reproductive system and breast disorders
Vaginal inflammation
|
0.94%
2/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Reproductive system and breast disorders
Breast hyperplasia
|
0.47%
1/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Reproductive system and breast disorders
Calculus prostatic
|
0.47%
1/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Reproductive system and breast disorders
Prostatic disorder
|
0.47%
1/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Reproductive system and breast disorders
Prostatomegaly
|
0.47%
1/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Renal and urinary disorders
Nephrolithiasis
|
1.9%
4/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Renal and urinary disorders
Renal cyst
|
0.94%
2/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Renal and urinary disorders
Haematuria
|
0.47%
1/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Renal and urinary disorders
Renal failure
|
0.47%
1/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Renal and urinary disorders
Renal injury
|
0.47%
1/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.94%
2/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Skin and subcutaneous tissue disorders
Achromotrichia acquired
|
0.47%
1/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.47%
1/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.47%
1/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.47%
1/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.47%
1/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.47%
1/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Psychiatric disorders
Insomnia
|
1.9%
4/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Psychiatric disorders
Depression
|
0.94%
2/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Psychiatric disorders
Anxiety
|
0.47%
1/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Psychiatric disorders
Libido decreased
|
0.47%
1/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Psychiatric disorders
Sleep disorder
|
0.47%
1/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
General disorders
Pyrexia
|
1.4%
3/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
General disorders
Asthenia
|
0.47%
1/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
General disorders
Fatigue
|
0.47%
1/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
General disorders
Oedema peripheral
|
0.47%
1/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Blood and lymphatic system disorders
Anaemia
|
0.94%
2/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.94%
2/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Blood and lymphatic system disorders
Splenomegaly
|
0.47%
1/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Nervous system disorders
Headache
|
0.94%
2/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Nervous system disorders
Dizziness
|
0.47%
1/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Nervous system disorders
Hypoaesthesia
|
0.47%
1/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Nervous system disorders
Somnolence
|
0.47%
1/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Vascular disorders
Hypertension
|
1.9%
4/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Vascular disorders
Arteriosclerosis
|
0.47%
1/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Musculoskeletal and connective tissue disorders
Bone formation increased
|
0.47%
1/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
0.47%
1/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.47%
1/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.47%
1/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.47%
1/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.47%
1/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.94%
2/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.47%
1/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.47%
1/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Eye disorders
Dry eye
|
0.94%
2/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Injury, poisoning and procedural complications
Head injury
|
0.47%
1/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.47%
1/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Eye disorders
Visual acuity reduced
|
0.47%
1/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma of liver
|
0.47%
1/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm
|
0.47%
1/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Cardiac disorders
Palpitations
|
0.47%
1/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Congenital, familial and genetic disorders
Hamartoma
|
0.47%
1/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Endocrine disorders
Hypothyroidism
|
0.47%
1/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Immune system disorders
Hypersensitivity
|
0.47%
1/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Infections and infestations
Bacterial infection
|
0.47%
1/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
|
Infections and infestations
Rhinitis
|
0.47%
1/213 • On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER