Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Safety and Efficacy of Switching to Tenofovir Alafenamide (TAF) From Tenofovir Disoproxil Fumarate (TDF) and/or Other Oral Antiviral Treatment (OAV)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03180619
Recruitment Status : Active, not recruiting
First Posted : June 8, 2017
Results First Posted : April 9, 2020
Last Update Posted : April 9, 2020
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Chronic Hepatitis B
Intervention Drug: TAF
Enrollment 124
Recruitment Details Participants were enrolled at study sites in Asia Pacific, North America, and Europe. The first participant was screened on 29 June 2017. The last Week 24 study visit occurred on 27 March 2019.
Pre-assignment Details 147 participants were screened.
Arm/Group Title Part A (Renal Impairment): Moderate or Severe Renal Impairment Part A (Renal Impairment): End Stage Renal Disease Part B: Hepatic Impairment
Hide Arm/Group Description Participants with chronic hepatitis B (CHB) and moderate or severe renal impairment who were virologically suppressed and taking tenofovir disoproxil fumarate (TDF), a TDF-containing anti-hepatitis B virus (HBV) regimen, or other oral antivirals (OAVs), switched to tenofovir alafenamide (TAF) and received TAF 25 mg tablet once daily orally for 96 weeks. Participants with CHB and end stage renal disease who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks. Participants with CHB and moderate or severe hepatic impairment who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.
Period Title: Overall Study
Started 78 15 31
Completed 0 0 0
Not Completed 78 15 31
Reason Not Completed
Withdrew Consent             2             0             1
Death             1             0             0
Still on Study             75             15             30
Arm/Group Title Part A (Renal Impairment): Moderate or Severe Renal Impairment Part A (Renal Impairment): End Stage Renal Disease Part B: Hepatic Impairment Total
Hide Arm/Group Description Participants with CHB and moderate or severe renal impairment who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or other OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks. Participants with CHB and end stage renal disease who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks. Participants with CHB and moderate or severe hepatic impairment who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks. Total of all reporting groups
Overall Number of Baseline Participants 78 15 31 124
Hide Baseline Analysis Population Description
The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 78 participants 15 participants 31 participants 124 participants
66  (10.1) 54  (12.8) 55  (10.8) 61  (11.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 78 participants 15 participants 31 participants 124 participants
Female 21 3 10 34
Male 57 12 21 90
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Ethnicity Number Analyzed 78 participants 15 participants 31 participants 124 participants
Hispanic or Latino 0 0 1 1
Not Hispanic or Latino 77 15 29 121
Not Permitted 1 0 1 2
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race Number Analyzed 78 participants 15 participants 31 participants 124 participants
Asian 59 13 25 97
Black or African American 3 0 1 4
Native Hawaiian or Pacific Islander 0 2 0 2
White 15 0 4 19
Other 1 0 1 2
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
New Zealand Number Analyzed 78 participants 15 participants 31 participants 124 participants
0 2 0 2
Canada Number Analyzed 78 participants 15 participants 31 participants 124 participants
22 0 3 25
South Korea Number Analyzed 78 participants 15 participants 31 participants 124 participants
12 3 5 20
Hong Kong Number Analyzed 78 participants 15 participants 31 participants 124 participants
14 1 2 17
United States Number Analyzed 78 participants 15 participants 31 participants 124 participants
3 0 7 10
Taiwan Number Analyzed 78 participants 15 participants 31 participants 124 participants
13 9 11 33
Italy Number Analyzed 78 participants 15 participants 31 participants 124 participants
13 0 2 15
United Kingdom Number Analyzed 78 participants 15 participants 31 participants 124 participants
1 0 1 2
Alanine Aminotransferase (ALT)  
Mean (Standard Deviation)
Unit of measure:  U/L
Number Analyzed 78 participants 15 participants 31 participants 124 participants
20  (9.6) 14  (5.2) 28  (12.4) 21  (10.8)
ALT Level Based on Central Lab Normal Range   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 78 participants 15 participants 31 participants 124 participants
≤ ULN 75 15 27 117
> ULN - 5xULN 3 0 4 7
> 5xULN 0 0 0 0
[1]
Measure Description: Central laboratory upper limit of normal (ULN) for ALT were as follows: ≤ 43 U/L for males aged 18 to < 69 years and ≤ 35 U/L for males aged ≥ 69 years; ≤ 34 U/L for females aged 18 to < 69 years and ≤ 32 U/L for females aged ≥ 69 years.
ALT Level Based on 2018 American Association for the Study of Liver Diseases (AASLD) Normal Range   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 78 participants 15 participants 31 participants 124 participants
≤ ULN 73 15 21 109
> ULN - 5xULN 5 0 10 15
> 5xULN 0 0 0 0
[1]
Measure Description: The ULN for ALT using the 2018 AASLD normal range was 25 U/L for females and 35 U/L for males.
Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Categories  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 78 participants 15 participants 31 participants 124 participants
< 20 IU/mL 77 14 31 122
≥ 20 IU/mL - < 69 IU/mL 0 1 0 1
≥ 69 IU/mL 1 0 0 1
Estimated Glomerular Filtration Rate by the Cockcroft-Gault Formula (eGFRcg)   [1] 
Mean (Standard Deviation)
Unit of measure:  mL/min
Number Analyzed 78 participants 15 participants 31 participants 124 participants
45.2  (10.90) 7.8  (2.62) 98.8  (34.04) 54.1  (34.24)
[1]
Measure Description: GFR is a measure of the rate at which blood is filtered by the kidney. Cockcroft-Gault is an equation (calculation) used to estimate GFR based on serum creatinine, weight, and gender. eGFRcg = (140 – age in years) * (body weight in kg) * (0.85 if female) divided by 72 * serum creatinine in mg/dL.
Hip Bone Mineral Density (BMD) Status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 77 participants 15 participants 31 participants 123 participants
Normal (T-score ≥ -1.0) 34 3 18 55
Osteopenia (-2.5 ≤ T-score < -1.0) 36 5 12 53
Osteoporosis (T-score < -2.5) 7 7 1 15
[1]
Measure Analysis Population Description: Measure Analysis Population Description: Hip Dual-Energy X-Ray Absorptiometry (DXA) Analysis Set included all participants who were enrolled and received at least 1 dose of study drug and had non-missing baseline hip BMD values.
Spine BMD Status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 78 participants 15 participants 31 participants 124 participants
Normal (T-score ≥ -1.0) 37 5 16 58
Osteopenia (-2.5 ≤ T-score < -1.0) 21 7 9 37
Osteoporosis (T-score < -2.5) 20 3 6 29
[1]
Measure Description: Measure Analysis Population Description: The Spine DXA Analysis Set included all participants who were enrolled and received at least 1 dose of study drug and had non-missing baseline spine BMD values.
Hepatitis s-Antigen (HBsAg) (log10 IU/mL)  
Mean (Standard Deviation)
Unit of measure:  Log10 IU/mL
Number Analyzed 78 participants 15 participants 31 participants 124 participants
2.51  (0.782) 2.72  (1.405) 1.90  (1.169) 2.38  (1.012)
Hepatitis B e Antigen/Antibody (HBeAg/HBeAb) Status  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 78 participants 15 participants 31 participants 124 participants
Positive/Negative 13 3 3 19
Positive/Positive 0 0 0 0
Negative/Negative 15 1 10 26
Negative/Positive 50 11 18 79
FibroTest® Score   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 77 participants 15 participants 31 participants 123 participants
0.53  (0.199) 0.37  (0.199) 0.75  (0.206) 0.57  (0.231)
[1]
Measure Description: The FibroTest® score is used to assess liver fibrosis. Scores range from 0.00 to 1.00, with higher scores indicating a greater degree of fibrosis
[2]
Measure Analysis Population Description: Participants in Safety Analysis Set with available data were analyzed.
Child-Pugh-Turcotte (CPT) Score   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 0 participants 0 participants 31 participants 31 participants
6  (1.7) 6  (1.7)
[1]
Measure Description: CPT scores grade the severity of cirrhosis and are used to determine the need for liver transplantation. Scores can range from 5 to 15, with higher scores indicating a greater severity of disease.
[2]
Measure Analysis Population Description: Participants in the Full Analysis Set only from Part B (Hepatic Impairment) were analyzed.
Model for End-Stage Liver Disease (MELD) Score   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 0 participants 0 participants 31 participants 31 participants
10.7  (3.40) 10.7  (3.40)
[1]
Measure Description: MELD scores are used to assess prognosis and suitability for liver transplantation. Scores can range from 6 to 40, with higher scores indicating greater disease severity.
[2]
Measure Analysis Population Description: Participants in Full Analysis Set with available data were analyzed.
1.Primary Outcome
Title Percentage of Participants Achieving Virologic Response (Plasma Hepatitis B Virus [HBV] Deoxyribonucleic Acid [DNA] < 20 IU/mL) at Week 24
Hide Description The percentage of participants with HBV DNA < 20 IU/mL at Week 24 was determined by the Missing = Failure (M = F) approach.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set included all participants who were enrolled and received at least 1 dose of study drug.
Arm/Group Title Part A (Renal Impairment): Moderate or Severe Renal Impairment Part A (Renal Impairment): End Stage Renal Disease Part B: Hepatic Impairment
Hide Arm/Group Description:
Participants with CHB and moderate or severe renal impairment who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or other OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.
Participants with CHB and end stage renal disease who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.
Participants with CHB and moderate or severe hepatic impairment who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.
Overall Number of Participants Analyzed 78 15 31
Measure Type: Number
Unit of Measure: percentage of participants
97.4 100.0 100.0
2.Primary Outcome
Title Percentage of Participants Who Experienced Graded Treatment-Emergent Adverse Events (AEs) at Week 24
Hide Description

Treatment-emergent AEs were defined as:

  • Any AEs with an onset date on or after the study drug start date and no later than the study drug stop date + 3 days after permanent discontinuation of study drug;
  • Any AEs with onset date on or after the study drug start date for those who have not permanently discontinued study drug;
  • Any AEs leading to premature discontinuation of study drug.

The most severe graded AE from all tests was counted for each participant.

Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug.
Arm/Group Title Part A (Renal Impairment): Moderate or Severe Renal Impairment Part A (Renal Impairment): End Stage Renal Disease Part B: Hepatic Impairment
Hide Arm/Group Description:
Participants with CHB and moderate or severe renal impairment who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or other OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.
Participants with CHB and end stage renal disease who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.
Participants with CHB and moderate or severe hepatic impairment who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.
Overall Number of Participants Analyzed 78 15 31
Measure Type: Number
Unit of Measure: percentage of participants
Any treatment-emergent AEs 53.8 73.3 54.8
Grade 3 and above treatment-emergent AEs 6.4 13.3 6.5
3.Primary Outcome
Title Percentage of Participants Who Experienced Graded Treatment-Emergent Laboratory Abnormalities at Week 24
Hide Description

Graded treatment-emergent laboratory abnormalities were defined as values that increased at least 1 toxicity grade from baseline at any postbaseline visit, up to and including the date of last dose of study drug + 3 days for participants who permanently discontinued study drug or the last available date in the database snapshot for participants who were on treatment at the time of the analysis.

The most severe graded abnormality from all tests was counted for each participant.

Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Safety Analysis Set were analyzed.
Arm/Group Title Part A (Renal Impairment): Moderate or Severe Renal Impairment Part A (Renal Impairment): End Stage Renal Disease Part B: Hepatic Impairment
Hide Arm/Group Description:
Participants with CHB and moderate or severe renal impairment who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or other OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.
Participants with CHB and end stage renal disease who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.
Participants with CHB and moderate or severe hepatic impairment who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.
Overall Number of Participants Analyzed 78 15 31
Measure Type: Number
Unit of Measure: percentage of participants
Any graded laboratory abnormality 96.2 100.0 90.3
Grade 3 and above laboratory abnormality 11.5 46.7 48.4
4.Secondary Outcome
Title Percentage of Participants Who Experienced Graded Treatment-Emergent AEs at Week 48
Hide Description [Not Specified]
Time Frame Week 48
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Percentage of Participants Who Experienced Graded Treatment-Emergent AEs at Week 96
Hide Description [Not Specified]
Time Frame Week 96
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Percentage of Participants Who Experienced Graded Treatment-Emergent Laboratory Abnormalities at Week 48
Hide Description [Not Specified]
Time Frame Week 48
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Percentage of Participants Who Experienced Graded Treatment-Emergent Laboratory Abnormalities at Week 96
Hide Description [Not Specified]
Time Frame Week 96
Outcome Measure Data Not Reported
8.Secondary Outcome
Title Change From Baseline in Estimated Glomerular Filtration Rate by the Cockcroft-Gault Formula (eGFRcg) in Participants With Moderate or Severe Renal Impairment and Hepatically Impaired Participants at Week 24
Hide Description

GFR is a measure of the rate at which blood is filtered by the kidney. Cockcroft-Gault is an equation (calculation) used to estimate GFR based on serum creatinine, weight, and gender. eGFRcg = (140 - age in years) x (body weight in kg) x (0.85 if female) divided by 72 x serum creatinine in mg/dL.

Moderate renal impairment= 30 mL/min ≤ eGFRCG ≤ 59 mL/min Severe renal impairment= 15 mL/min ≤ eGFRCG < 30 mL/min Change from baseline was calculated as the value at Week 24 minus the value at Baseline.

Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Safety Analysis Set with available data were analyzed.
Arm/Group Title Part A (Renal Impairment): Moderate or Severe Renal Impairment Part B: Hepatic Impairment
Hide Arm/Group Description:
Participants with CHB and moderate or severe renal impairment who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or other OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.
Participants with CHB and moderate or severe hepatic impairment who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.
Overall Number of Participants Analyzed 76 31
Median (Inter-Quartile Range)
Unit of Measure: mL/min
0.6
(-3.6 to 3.6)
3.0
(-4.2 to 10.2)
9.Secondary Outcome
Title Change From Baseline in eGFRcg in Participants With Moderate or Severe Renal Impairment and Hepatically Impaired Participants at Week 48
Hide Description [Not Specified]
Time Frame Baseline, Week 48
Outcome Measure Data Not Reported
10.Secondary Outcome
Title Change From Baseline in eGFRcg in Participants With Moderate or Severe Renal Impairment and Hepatically Impaired Participants at Week 96
Hide Description [Not Specified]
Time Frame Baseline, Week 96
Outcome Measure Data Not Reported
11.Secondary Outcome
Title Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 24
Hide Description Percent change = Change from baseline at a postbaseline visit/baseline * 100%.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Hip Dual-Energy X-Ray Absorptiometry (DXA) Analysis Set (all participants who were enrolled and received at least 1 dose of study drug and had non-missing baseline hip BMD values) with available data were analyzed.
Arm/Group Title Part A (Renal Impairment): Moderate or Severe Renal Impairment Part A (Renal Impairment): End Stage Renal Disease Part B: Hepatic Impairment
Hide Arm/Group Description:
Participants with CHB and moderate or severe renal impairment who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or other OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.
Participants with CHB and end stage renal disease who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.
Participants with CHB and moderate or severe hepatic impairment who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.
Overall Number of Participants Analyzed 74 15 31
Mean (Standard Deviation)
Unit of Measure: percent change
0.135  (1.8348) 0.330  (2.1883) 0.322  (2.5105)
12.Secondary Outcome
Title Percent Change From Baseline in Hip BMD at Week 48
Hide Description [Not Specified]
Time Frame Baseline, Week 48
Outcome Measure Data Not Reported
13.Secondary Outcome
Title Percent Change From Baseline in Hip BMD at Week 96
Hide Description [Not Specified]
Time Frame Baseline, Week 96
Outcome Measure Data Not Reported
14.Secondary Outcome
Title Percent Change From Baseline in Spine BMD at Week 24
Hide Description Percent change = Change from baseline at a postbaseline visit/baseline * 100%.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Spine DXA Analysis Set (all participants who were enrolled and received at least 1 dose of study drug and had non-missing baseline spine BMD values) with available data were analyzed.
Arm/Group Title Part A (Renal Impairment): Moderate or Severe Renal Impairment Part A (Renal Impairment): End Stage Renal Disease Part B: Hepatic Impairment
Hide Arm/Group Description:
Participants with CHB and moderate or severe renal impairment who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or other OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.
Participants with CHB and end stage renal disease who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.
Participants with CHB and moderate or severe hepatic impairment who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.
Overall Number of Participants Analyzed 76 15 31
Mean (Standard Deviation)
Unit of Measure: percent change
1.266  (3.4806) 0.689  (3.1405) 1.258  (2.3416)
15.Secondary Outcome
Title Percent Change From Baseline in Spine BMD at Week 48
Hide Description [Not Specified]
Time Frame Baseline, Week 48
Outcome Measure Data Not Reported
16.Secondary Outcome
Title Percent Change From Baseline in Spine BMD at Week 96
Hide Description [Not Specified]
Time Frame Baseline, Week 96
Outcome Measure Data Not Reported
17.Secondary Outcome
Title Percentage of Participants Achieving Virologic Response (Plasma HBV DNA < 20 IU/mL) at Week 48
Hide Description [Not Specified]
Time Frame Weeks 48
Outcome Measure Data Not Reported
18.Secondary Outcome
Title Percentage of Participants Achieving Virologic Response (Plasma HBV DNA < 20 IU/mL) at Week 96
Hide Description [Not Specified]
Time Frame Weeks 96
Outcome Measure Data Not Reported
19.Secondary Outcome
Title Percentage of Participants With Plasma HBV DNA < 20 IU/mL and Target Detected (≥ Lower Limit of Detection [LLOD]) at Week 24
Hide Description The percentage of participants with HBV DNA < 20 IU/mL and target detected (≥ LLOD; i.e. 10 IU/mL) at Week 24 was determined by the M = F approach.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set were analyzed.
Arm/Group Title Part A (Renal Impairment): Moderate or Severe Renal Impairment Part A (Renal Impairment): End Stage Renal Disease Part B: Hepatic Impairment
Hide Arm/Group Description:
Participants with CHB and moderate or severe renal impairment who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or other OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.
Participants with CHB and end stage renal disease who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.
Participants with CHB and moderate or severe hepatic impairment who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.
Overall Number of Participants Analyzed 78 15 31
Measure Type: Number
Unit of Measure: percentage of participants
21.8 40.0 22.6
20.Secondary Outcome
Title Percentage of Participants With Plasma HBV DNA < 20 IU/mL and Target Detected (≥ LLOD) at Week 48
Hide Description [Not Specified]
Time Frame Week 48
Outcome Measure Data Not Reported
21.Secondary Outcome
Title Percentage of Participants With Plasma HBV DNA < 20 IU/mL and Target Detected (≥ LLOD) at Week 96
Hide Description [Not Specified]
Time Frame Week 96
Outcome Measure Data Not Reported
22.Secondary Outcome
Title Percentage of Participants With Plasma HBV DNA < 20 IU/mL and Target Not Detected (< LLOD) at Week 24
Hide Description The percentage of participants with HBV DNA < 20 IU/mL and target not detected (< LLOD; i.e. 10 IU/mL) at Week 24 was determined by the M = F approach.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set were analyzed.
Arm/Group Title Part A (Renal Impairment): Moderate or Severe Renal Impairment Part A (Renal Impairment): End Stage Renal Disease Part B: Hepatic Impairment
Hide Arm/Group Description:
Participants with CHB and moderate or severe renal impairment who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or other OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.
Participants with CHB and end stage renal disease who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.
Participants with CHB and moderate or severe hepatic impairment who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.
Overall Number of Participants Analyzed 78 15 31
Measure Type: Number
Unit of Measure: percentage of participants
75.6 60.0 77.4
23.Secondary Outcome
Title Percentage of Participants With Plasma HBV DNA < 20 IU/mL and Target Not Detected (< LLOD) at Week 48
Hide Description [Not Specified]
Time Frame Weeks 48
Outcome Measure Data Not Reported
24.Secondary Outcome
Title Percentage of Participants With Plasma HBV DNA < 20 IU/mL and Target Not Detected (< LLOD) at Week 96
Hide Description [Not Specified]
Time Frame Weeks 96
Outcome Measure Data Not Reported
25.Secondary Outcome
Title Percentage of Participants With Serological Response: Loss of Hepatitis s-Antigen (HBsAg) in Hepatitis B e-Antigen (HBeAg)-Positive Participants at Week 24
Hide Description HBsAg loss was defined as HBsAg changing from positive at baseline to negative at a postbaseline. The M = F approach was used for this analysis.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
The Serologically Evaluable Full Analysis Set for HBsAg Loss/Seroconversion (all participants who were enrolled and received at least 1 dose of study drug, and with HBsAg positive and HBsAb negative or missing at baseline) with available data were analyzed..
Arm/Group Title Part A (Renal Impairment): Moderate or Severe Renal Impairment Part A (Renal Impairment): End Stage Renal Disease Part B: Hepatic Impairment
Hide Arm/Group Description:
Participants with CHB and moderate or severe renal impairment who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or other OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.
Participants with CHB and end stage renal disease who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.
Participants with CHB and moderate or severe hepatic impairment who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.
Overall Number of Participants Analyzed 78 15 30
Measure Type: Number
Unit of Measure: percentage of participants
0 0 0
26.Secondary Outcome
Title Percentage of Participants With Serological Response: Loss of HBsAg in HBeAg-Positive Participants at Week 48
Hide Description [Not Specified]
Time Frame Week 48
Outcome Measure Data Not Reported
27.Secondary Outcome
Title Percentage of Participants With Serological Response: Loss of HBsAg in HBeAg-Positive Participants at Week 96
Hide Description [Not Specified]
Time Frame Week 96
Outcome Measure Data Not Reported
28.Secondary Outcome
Title Percentage of Participants With Serological Response: Seroconversion to Anti-HBs in HBeAg-Positive Participants at Week 24
Hide Description HBsAg seroconversion was defined as HBsAg loss and HBsAb test changing from negative/missing at baseline to positive at a postbaseline visit. The M = F approach was used for this analysis.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
The Serologically Evaluable Full Analysis Set for HBsAg Loss/Seroconversion were analyzed.
Arm/Group Title Part A (Renal Impairment): Moderate or Severe Renal Impairment Part A (Renal Impairment): End Stage Renal Disease Part B: Hepatic Impairment
Hide Arm/Group Description:
Participants with CHB and moderate or severe renal impairment who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or other OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.
Participants with CHB and end stage renal disease who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.
Participants with CHB and moderate or severe hepatic impairment who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.
Overall Number of Participants Analyzed 78 15 30
Measure Type: Number
Unit of Measure: percentage of participants
0 0 0
29.Secondary Outcome
Title Percentage of Participants With Serological Response: Seroconversion to Anti-HBs in HBeAg-Positive Participants at Week 48
Hide Description [Not Specified]
Time Frame Week 48
Outcome Measure Data Not Reported
30.Secondary Outcome
Title Percentage of Participants With Serological Response: Seroconversion to Anti-HBs in HBeAg-Positive Participants at Week 96
Hide Description [Not Specified]
Time Frame Week 96
Outcome Measure Data Not Reported
31.Secondary Outcome
Title Percentage of Participants With Serological Response: Loss of HBeAg in HBeAg-Positive Participants at Week 24
Hide Description HBeAg loss was defined as HBeAg changing from positive at baseline to negative at a postbaseline. The M = F approach was used for this analysis.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
The Serologically Evaluable Full Analysis Set for HBeAg Loss/Seroconversion included all participants who were enrolled and received at least 1 dose of study drug, and with HBeAg positive and HBeAb negative or missing at baseline.
Arm/Group Title Part A (Renal Impairment): Moderate or Severe Renal Impairment Part A (Renal Impairment): End Stage Renal Disease Part B: Hepatic Impairment
Hide Arm/Group Description:
Participants with CHB and moderate or severe renal impairment who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or other OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.
Participants with CHB and end stage renal disease who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.
Participants with CHB and moderate or severe hepatic impairment who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.
Overall Number of Participants Analyzed 13 3 3
Measure Type: Number
Unit of Measure: percentage of participants
0 0 0
32.Secondary Outcome
Title Percentage of Participants With Serological Response: Loss of HBeAg in HBeAg-Positive Participants at Week 48
Hide Description [Not Specified]
Time Frame Week 48
Outcome Measure Data Not Reported
33.Secondary Outcome
Title Percentage of Participants With Serological Response: Loss of HBeAg in HBeAg-Positive Participants at Week 96
Hide Description [Not Specified]
Time Frame Week 96
Outcome Measure Data Not Reported
34.Secondary Outcome
Title Percentage of Participants With Serological Response: Seroconversion to Anti-HBe in HBeAg-Positive Participants at Week 24
Hide Description HBeAg seroconversion was defined as HBeAg loss and HBeAb test changing from negative/missing at baseline to positive at a postbaseline visit. The M = F approach was used for this analysis.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
The Serologically Evaluable Full Analysis Set for HBeAg Loss/Seroconversion were analyzed.
Arm/Group Title Part A (Renal Impairment): Moderate or Severe Renal Impairment Part A (Renal Impairment): End Stage Renal Disease Part B: Hepatic Impairment
Hide Arm/Group Description:
Participants with CHB and moderate or severe renal impairment who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or other OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.
Participants with CHB and end stage renal disease who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.
Participants with CHB and moderate or severe hepatic impairment who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.
Overall Number of Participants Analyzed 13 3 3
Measure Type: Number
Unit of Measure: percentage of participants
0 0 0
35.Secondary Outcome
Title Percentage of Participants With Serological Response: Seroconversion to Anti-HBe in HBeAg-Positive Participants at Week 48
Hide Description [Not Specified]
Time Frame Week 48
Outcome Measure Data Not Reported
36.Secondary Outcome
Title Percentage of Participants With Serological Response: Seroconversion to Anti-HBe in HBeAg-Positive Participants at Week 96
Hide Description [Not Specified]
Time Frame Week 96
Outcome Measure Data Not Reported
37.Secondary Outcome
Title Percentage of Participants With Normal Alanine Aminotransferase (ALT) at Week 24 by Central Laboratory and the American Association for the Study of Liver Diseases (AASLD) Criteria
Hide Description Central laboratory ULN for ALT were as follows: ≤ 43 U/L for males aged 18 to < 69 years and ≤ 35 U/L for males aged ≥ 69 years; ≤ 34 U/L for females aged 18 to < 69 years and ≤ 32 U/L for females aged ≥ 69 years. The ULN for ALT using the 2018 AASLD normal range was 25 U/L for females and 35 U/L for males. The M = F approach was used for this analysis.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set were analyzed.
Arm/Group Title Part A (Renal Impairment): Moderate or Severe Renal Impairment Part A (Renal Impairment): End Stage Renal Disease Part B: Hepatic Impairment
Hide Arm/Group Description:
Participants with CHB and moderate or severe renal impairment who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or other OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.
Participants with CHB and end stage renal disease who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.
Participants with CHB and moderate or severe hepatic impairment who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.
Overall Number of Participants Analyzed 78 15 31
Measure Type: Number
Unit of Measure: percentage of participants
ALT by central laboratory 92.3 93.3 83.9
ALT by AASLD criteria 87.2 93.3 80.6
38.Secondary Outcome
Title Percentage of Participants With Normal ALT at Week 48 by Central Laboratory and the AASLD Criteria
Hide Description [Not Specified]
Time Frame Week 48
Outcome Measure Data Not Reported
39.Secondary Outcome
Title Percentage of Participants With Normal ALT at Week 96 by Central Laboratory and the AASLD Criteria
Hide Description [Not Specified]
Time Frame Week 96
Outcome Measure Data Not Reported
40.Secondary Outcome
Title Percentage of Participants With Normalized ALT at Week 24 by Central Laboratory and the AASLD Criteria
Hide Description ALT normalization was defined as an ALT value that changed from above the normal range at baseline to within the normal range at the given postbaseline visit. Central laboratory ULN for ALT were as follows: ≤ 43 U/L for males aged 18 to < 69 years and ≤ 35 U/L for males aged ≥ 69 years; ≤ 34 U/L for females aged 18 to < 69 years and ≤ 32 U/L for females aged ≥ 69 years. The ULN for ALT using the 2018 AASLD normal range was 25 U/L for females and 35 U/L for males. The M = F approach was used for this analysis.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with Baseline ALT > ULN were analyzed.
Arm/Group Title Part A (Renal Impairment): Moderate or Severe Renal Impairment Part A (Renal Impairment): End Stage Renal Disease Part B: Hepatic Impairment
Hide Arm/Group Description:
Participants with CHB and moderate or severe renal impairment who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or other OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.
Participants with CHB and end stage renal disease who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.
Participants with CHB and moderate or severe hepatic impairment who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.
Overall Number of Participants Analyzed 5 0 10
Measure Type: Number
Unit of Measure: percentage of participants
Normalized ALT by Central Laboratory Number Analyzed 3 participants 0 participants 4 participants
66.7 50.0
Normalized ALT by AASLD Criteria Number Analyzed 5 participants 0 participants 10 participants
40.0 60.0
41.Secondary Outcome
Title Percentage of Participants With Normalized ALT at Week 48 by Central Laboratory and the AASLD Criteria
Hide Description [Not Specified]
Time Frame Week 48
Outcome Measure Data Not Reported
42.Secondary Outcome
Title Percentage of Participants With Normalized ALT at Week 96 by Central Laboratory and the AASLD Criteria
Hide Description [Not Specified]
Time Frame Week 96
Outcome Measure Data Not Reported
43.Secondary Outcome
Title Change From Baseline in FibroTest® Score at Week 24
Hide Description The FibroTest® score is used to assess liver fibrosis. Scores range from 0.00 to 1.00, with higher scores indicating a greater degree of fibrosis. Change from baseline was calculated as the value at Week 24 minus the value at Baseline.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed.
Arm/Group Title Part A (Renal Impairment): Moderate or Severe Renal Impairment Part A (Renal Impairment): End Stage Renal Disease Part B: Hepatic Impairment
Hide Arm/Group Description:
Participants with CHB and moderate or severe renal impairment who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or other OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.
Participants with CHB and end stage renal disease who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.
Participants with CHB and moderate or severe hepatic impairment who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.
Overall Number of Participants Analyzed 74 15 31
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.01  (0.099) -0.01  (0.064) -0.05  (0.106)
44.Secondary Outcome
Title Change From Baseline in FibroTest® Score at Week 48
Hide Description [Not Specified]
Time Frame Baseline, Week 48
Outcome Measure Data Not Reported
45.Secondary Outcome
Title Change From Baseline in FibroTest® Score at Week 96
Hide Description [Not Specified]
Time Frame Week 96
Outcome Measure Data Not Reported
46.Secondary Outcome
Title Change From Baseline in Child-Pugh-Turcotte (CPT) Score in Hepatically Impaired Participants at Week 24
Hide Description CPT scores grade the severity of cirrhosis and are used to determine the need for liver transplantation. Scores can range from 5 to 15, with higher scores indicating a greater severity of disease.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set only from Part B (Hepatic Impairment) were analyzed.
Arm/Group Title Part B: Hepatic Impairment
Hide Arm/Group Description:
Participants with CHB and moderate or severe hepatic impairment who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.
Overall Number of Participants Analyzed 31
Mean (Standard Deviation)
Unit of Measure: units on a scale
0  (1.1)
47.Secondary Outcome
Title Change From Baseline in CPT Score in Hepatically Impaired Participants at Week 48
Hide Description [Not Specified]
Time Frame Baseline, Week 48
Outcome Measure Data Not Reported
48.Secondary Outcome
Title Change From Baseline in CPT Score in Hepatically Impaired Participants at Week 96
Hide Description [Not Specified]
Time Frame Baseline, Week 96
Outcome Measure Data Not Reported
49.Secondary Outcome
Title Change From Baseline in Model for End-Stage Liver Disease (MELD) Score in Hepatically Impaired Participants at Week 24
Hide Description MELD scores are used to assess prognosis and suitability for liver transplantation. Scores can range from 6 to 40, with higher scores indicating greater disease severity.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set only from Part B (Hepatic Impairment) were analyzed.
Arm/Group Title Part B: Hepatic Impairment
Hide Arm/Group Description:
Participants with CHB and moderate or severe hepatic impairment who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.
Overall Number of Participants Analyzed 31
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.6  (1.94)
50.Secondary Outcome
Title Change From Baseline in MELD Score in Hepatically Impaired Participants at Week 48
Hide Description [Not Specified]
Time Frame Baseline, Week 48
Outcome Measure Data Not Reported
51.Secondary Outcome
Title Change From Baseline in MELD Score in Hepatically Impaired Participants at Week 96
Hide Description [Not Specified]
Time Frame Baseline, Week 96
Outcome Measure Data Not Reported
Time Frame First dose date up to the Week 24 Data Cut
Adverse Event Reporting Description The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug.
 
Arm/Group Title Part A (Renal Impairment): Moderate or Severe Renal Impairment Part A (Renal Impairment): End Stage Renal Disease (Cohort 2) Part B (Hepatic Impairment): Moderate or Severe Hepatic Impair
Hide Arm/Group Description Participants with CHB and moderate or severe renal impairment who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or other OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks. Participants with CHB and end stage renal disease who were virologically suppressed and taking TDF), a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks. Participants with CHB and moderate or severe hepatic impairment who were virologically suppressed and taking TDF), a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.
All-Cause Mortality
Part A (Renal Impairment): Moderate or Severe Renal Impairment Part A (Renal Impairment): End Stage Renal Disease (Cohort 2) Part B (Hepatic Impairment): Moderate or Severe Hepatic Impair
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/78 (1.28%)   0/15 (0.00%)   0/31 (0.00%) 
Hide Serious Adverse Events
Part A (Renal Impairment): Moderate or Severe Renal Impairment Part A (Renal Impairment): End Stage Renal Disease (Cohort 2) Part B (Hepatic Impairment): Moderate or Severe Hepatic Impair
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5/78 (6.41%)   4/15 (26.67%)   5/31 (16.13%) 
Blood and lymphatic system disorders       
Anaemia  1  0/78 (0.00%)  1/15 (6.67%)  0/31 (0.00%) 
Eye disorders       
Cataract  1  1/78 (1.28%)  0/15 (0.00%)  0/31 (0.00%) 
Gastrointestinal disorders       
Abdominal pain  1  0/78 (0.00%)  1/15 (6.67%)  0/31 (0.00%) 
Gingival bleeding  1  0/78 (0.00%)  0/15 (0.00%)  1/31 (3.23%) 
Intestinal obstruction  1  0/78 (0.00%)  1/15 (6.67%)  0/31 (0.00%) 
Hepatobiliary disorders       
Bile duct stone  1  0/78 (0.00%)  0/15 (0.00%)  1/31 (3.23%) 
Infections and infestations       
Bacteraemia  1  0/78 (0.00%)  1/15 (6.67%)  0/31 (0.00%) 
Fungal cystitis  1  0/78 (0.00%)  0/15 (0.00%)  1/31 (3.23%) 
Lower respiratory tract infection  1  0/78 (0.00%)  1/15 (6.67%)  0/31 (0.00%) 
Lower respiratory tract infection viral  1  0/78 (0.00%)  1/15 (6.67%)  0/31 (0.00%) 
Pneumonia  1  1/78 (1.28%)  1/15 (6.67%)  0/31 (0.00%) 
Urinary tract infection  1  0/78 (0.00%)  0/15 (0.00%)  1/31 (3.23%) 
Injury, poisoning and procedural complications       
Arteriovenous fistula thrombosis  1  0/78 (0.00%)  1/15 (6.67%)  0/31 (0.00%) 
Head injury  1  1/78 (1.28%)  0/15 (0.00%)  0/31 (0.00%) 
Shunt occlusion  1  0/78 (0.00%)  1/15 (6.67%)  0/31 (0.00%) 
Investigations       
Carcinoembryonic antigen increased  1  1/78 (1.28%)  0/15 (0.00%)  0/31 (0.00%) 
Nervous system disorders       
Encephalopathy  1  0/78 (0.00%)  0/15 (0.00%)  1/31 (3.23%) 
Hepatic encephalopathy  1  0/78 (0.00%)  0/15 (0.00%)  1/31 (3.23%) 
Subarachnoid haemorrhage  1  1/78 (1.28%)  0/15 (0.00%)  0/31 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Bronchospasm  1  0/78 (0.00%)  1/15 (6.67%)  0/31 (0.00%) 
Dyspnoea  1  0/78 (0.00%)  1/15 (6.67%)  0/31 (0.00%) 
Pleural effusion  1  0/78 (0.00%)  1/15 (6.67%)  0/31 (0.00%) 
Pneumonia aspiration  1  1/78 (1.28%)  0/15 (0.00%)  0/31 (0.00%) 
Respiratory failure  1  1/78 (1.28%)  0/15 (0.00%)  0/31 (0.00%) 
1
Term from vocabulary, MedDRA 21.1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Part A (Renal Impairment): Moderate or Severe Renal Impairment Part A (Renal Impairment): End Stage Renal Disease (Cohort 2) Part B (Hepatic Impairment): Moderate or Severe Hepatic Impair
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   26/78 (33.33%)   10/15 (66.67%)   13/31 (41.94%) 
Blood and lymphatic system disorders       
Anaemia  1  1/78 (1.28%)  1/15 (6.67%)  0/31 (0.00%) 
Ear and labyrinth disorders       
Ear pain  1  0/78 (0.00%)  1/15 (6.67%)  0/31 (0.00%) 
Eye disorders       
Conjunctival haemorrhage  1  0/78 (0.00%)  1/15 (6.67%)  0/31 (0.00%) 
Gastrointestinal disorders       
Abdominal pain  1  1/78 (1.28%)  1/15 (6.67%)  0/31 (0.00%) 
Ascites  1  0/78 (0.00%)  1/15 (6.67%)  1/31 (3.23%) 
Constipation  1  1/78 (1.28%)  1/15 (6.67%)  0/31 (0.00%) 
Diarrhoea  1  1/78 (1.28%)  2/15 (13.33%)  2/31 (6.45%) 
General disorders       
Chest discomfort  1  0/78 (0.00%)  1/15 (6.67%)  0/31 (0.00%) 
Fatigue  1  0/78 (0.00%)  0/15 (0.00%)  2/31 (6.45%) 
Oedema peripheral  1  1/78 (1.28%)  1/15 (6.67%)  1/31 (3.23%) 
Pyrexia  1  0/78 (0.00%)  1/15 (6.67%)  2/31 (6.45%) 
Infections and infestations       
Nasopharyngitis  1  6/78 (7.69%)  0/15 (0.00%)  0/31 (0.00%) 
Upper respiratory tract infection  1  9/78 (11.54%)  2/15 (13.33%)  5/31 (16.13%) 
Injury, poisoning and procedural complications       
Limb injury  1  0/78 (0.00%)  1/15 (6.67%)  0/31 (0.00%) 
Shunt occlusion  1  0/78 (0.00%)  1/15 (6.67%)  0/31 (0.00%) 
Metabolism and nutrition disorders       
Hyperkalaemia  1  1/78 (1.28%)  1/15 (6.67%)  0/31 (0.00%) 
Musculoskeletal and connective tissue disorders       
Arthralgia  1  0/78 (0.00%)  2/15 (13.33%)  3/31 (9.68%) 
Musculoskeletal pain  1  1/78 (1.28%)  2/15 (13.33%)  0/31 (0.00%) 
Nervous system disorders       
Headache  1  1/78 (1.28%)  0/15 (0.00%)  2/31 (6.45%) 
Renal and urinary disorders       
Haematuria  1  1/78 (1.28%)  1/15 (6.67%)  1/31 (3.23%) 
Renal mass  1  0/78 (0.00%)  1/15 (6.67%)  0/31 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Cough  1  3/78 (3.85%)  0/15 (0.00%)  5/31 (16.13%) 
Dyspnoea  1  1/78 (1.28%)  1/15 (6.67%)  0/31 (0.00%) 
Oropharyngeal pain  1  0/78 (0.00%)  0/15 (0.00%)  2/31 (6.45%) 
Pleural effusion  1  0/78 (0.00%)  2/15 (13.33%)  0/31 (0.00%) 
Productive cough  1  0/78 (0.00%)  1/15 (6.67%)  0/31 (0.00%) 
Pulmonary oedema  1  0/78 (0.00%)  1/15 (6.67%)  0/31 (0.00%) 
Rhinorrhoea  1  1/78 (1.28%)  1/15 (6.67%)  0/31 (0.00%) 
Skin and subcutaneous tissue disorders       
Pruritus  1  0/78 (0.00%)  1/15 (6.67%)  1/31 (3.23%) 
Vascular disorders       
Hypertension  1  2/78 (2.56%)  1/15 (6.67%)  0/31 (0.00%) 
Hypotension  1  0/78 (0.00%)  1/15 (6.67%)  0/31 (0.00%) 
Venous occlusion  1  0/78 (0.00%)  1/15 (6.67%)  0/31 (0.00%) 
1
Term from vocabulary, MedDRA 21.1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:

  • The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or
  • The study has been completed at all study sites for at least 2 years
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Gilead Clinical Study Information Center
Organization: Gilead Sciences
Phone: 1-833-445-3230 (GILEAD-0)
EMail: GileadClinicalTrials@gilead.com
Layout table for additonal information
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT03180619    
Other Study ID Numbers: GS-US-320-4035
2016-004625-16 ( EudraCT Number )
First Submitted: June 6, 2017
First Posted: June 8, 2017
Results First Submitted: March 24, 2020
Results First Posted: April 9, 2020
Last Update Posted: April 9, 2020