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Clinical Trial Results:
A Phase 2, Open-label Study to Evaluate the Safety and Efficacy of Switching to Tenofovir Alafenamide (TAF) from Tenofovir Disoproxil Fumarate (TDF) and/or Other Oral Antiviral Treatment (OAV) in Virologically Suppressed Chronic Hepatitis B Subjects with Renal and/or Hepatic Impairment

Summary
EudraCT number	2016-004625-16
Trial protocol	GB FR IT
Global end of trial date	04 Sep 2020

Results information
Results version number	v1(current)
This version publication date	15 Sep 2021
First version publication date	15 Sep 2021
Other versions

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

GS-US-320-4035

ISRCTN number

US NCT number

NCT03180619

WHO universal trial number (UTN)

Sponsor organisation name

Gilead Sciences

Sponsor organisation address

333 Lakeside Drive, Foster City, CA, United States, 94404

Public contact

Gilead Clinical Study Information Center, Gilead Sciences, GileadClinicalTrials@gilead.com

Scientific contact

Gilead Clinical Study Information Center, Gilead Sciences, GileadClinicalTrials@gilead.com

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

04 Sep 2020

Is this the analysis of the primary completion data?

Yes

Primary completion date

27 Mar 2019

Global end of trial reached?

Yes

Global end of trial date

04 Sep 2020

Was the trial ended prematurely?

Main objective of the trial

The primary objective of this study was to evaluate the safety and tolerability and virologic response of tenofovir alafenamide (TAF) in virologically suppressed chronic hepatitis B participants with renal and/or hepatic impairment.

Protection of trial subjects

The protocol and consent/assent forms were submitted by each investigator to a duly constituted Independent Ethics Committee (IEC) or Institutional Review Board (IRB) for review and approval before study initiation. All revisions to the consent/assent forms (if applicable) after initial IEC/IRB approval were submitted by the investigator to the IEC/IRB for review and approval before implementation in accordance with regulatory requirements. This study was conducted in accordance with recognized international scientific and ethical standards, including but not limited to the International Conference on Harmonization guideline for Good Clinical Practice (ICH GCP) and the original principles embodied in the Declaration of Helsinki.

Background therapy

Evidence for comparator

Actual start date of recruitment

29 Jun 2017

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

United Kingdom: 2

Country: Number of subjects enrolled

Taiwan: 33

Country: Number of subjects enrolled

Canada: 25

Country: Number of subjects enrolled

Korea, Republic of: 20

Country: Number of subjects enrolled

Hong Kong: 17

Country: Number of subjects enrolled

Italy: 15

Country: Number of subjects enrolled

United States: 10

Country: Number of subjects enrolled

New Zealand: 2

Worldwide total number of subjects

124

EEA total number of subjects

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

From 65 to 84 years

85 years and over

Subject disposition

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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 study visit occurred on 04 September 2020.

Screening details

147 participants were screened.

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Non-randomised - controlled

Blinding used

Not blinded

Are arms mutually exclusive

Yes

Part A (Renal Impairment): Moderate or Severe Renal Impairment

Arm description

Participants with chronic hepatitis B (CHB) and moderate or severe renal impairment who were virologically suppressed and took 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.

Arm type

Experimental

Investigational medicinal product name

Tenofovir Alafenamide

Investigational medicinal product code

Other name

Vemlidy®

Pharmaceutical forms

Film-coated tablet

Routes of administration

Oral use

Dosage and administration details

25 mg administered once daily

Part A (Renal Impairment): End Stage Renal Disease

Arm description

Participants with CHB and end stage renal disease who were virologically suppressed and took TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.

Arm type

Experimental

Investigational medicinal product name

Tenofovir Alafenamide

Investigational medicinal product code

Other name

Vemlidy®

Pharmaceutical forms

Film-coated tablet

Routes of administration

Oral use

Dosage and administration details

25 mg administered once daily

Part B: Hepatic Impairment

Arm description

Participants with CHB and moderate or severe hepatic impairment who were virologically suppressed and took TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.

Arm type

Experimental

Investigational medicinal product name

Tenofovir Alafenamide

Investigational medicinal product code

Other name

Vemlidy®

Pharmaceutical forms

Film-coated tablet

Routes of administration

Oral use

Dosage and administration details

25 mg administered once daily

Number of subjects in period 1	Part A (Renal Impairment): Moderate or Severe Renal Impairment	Part A (Renal Impairment): End Stage Renal Disease	Part B: Hepatic Impairment
Started	78	15	31
Completed	67	14	25
Not completed	11	1	6
Death	2	1	2
Adverse event	2	-	1
Withdrew consent	5	-	2
Investigator's discretion	2	-	1

Baseline characteristics

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Reporting group title

Part A (Renal Impairment): Moderate or Severe Renal Impairment

Reporting group description

Reporting group title

Part A (Renal Impairment): End Stage Renal Disease

Reporting group description

Reporting group title

Part B: Hepatic Impairment

Reporting group description

Reporting group values	Part A (Renal Impairment): Moderate or Severe Renal Impairment	Part A (Renal Impairment): End Stage Renal Disease	Part B: Hepatic Impairment	Total
Number of subjects	78	15	31	124
Age categorical
Units: Subjects
Age continuous
Units: years
arithmetic mean (standard deviation)	66 ( 10.1 )	54 ( 12.8 )	55 ( 10.8 )	-
Gender categorical
Units: Subjects
Female	21	3	10	34
Male	57	12	21	90
Race
Units: Subjects
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
Ethnicity
Units: Subjects
Hispanic or Latino	0	0	1	1
Not Hispanic or Latino	78	15	30	123
ALT Level Based on Central Lab Normal Range
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.
Units: Subjects
<= ULN	75	15	27	117
> ULN - 5xULN	3	0	4	7
> 5xULN	0	0	0	0
ALT Level Based on 2018 American Association for the Study of Liver Diseases (AASLD) Normal Range
The ULN for ALT using the 2018 AASLD normal range was 25 U/L for females and 35 U/L for males.
Units: Subjects
<= ULN	73	15	21	109
> ULN - 5xULN	5	0	10	15
> 5xULN	0	0	0	0
Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Categories
Units: Subjects
< 20 IU/mL	77	14	31	122
>= 20 IU/mL - < 69 IU/mL	0	1	0	1
>= 69 IU/mL	1	0	0	1
Hepatitis B e Antigen/Antibody (HBeAg/HBeAb) Status
Units: Subjects
Positive/Negative	13	3	3	19
Positive/Positive	0	0	0	0
Negative/Negative	15	1	10	26
Negative/Positive	50	11	18	79
Alanine Aminotransferase (ALT)
Units: U/L
arithmetic mean (standard deviation)	20 ( 9.6 )	14 ( 5.2 )	28 ( 12.4 )	-
Estimated Glomerular Filtration Rate by the Cockcroft-Gault Formula (eGFRcg)
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.
Units: mL/min
arithmetic mean (standard deviation)	45.5 ( 10.89 )	7.8 ( 2.63 )	98.8 ( 33.94 )	-
Hepatitis s-Antigen (HBsAg)
Units: log10 IU/mL
arithmetic mean (standard deviation)	2.51 ( 0.782 )	2.72 ( 1.405 )	1.90 ( 1.169 )	-
FibroTest® Score
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.
Units: units on a scale
arithmetic mean (standard deviation)	0.53 ( 0.199 )	0.37 ( 0.199 )	0.75 ( 0.206 )	-

End points

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Reporting group title

Part A (Renal Impairment): Moderate or Severe Renal Impairment

Reporting group description

Reporting group title

Part A (Renal Impairment): End Stage Renal Disease

Reporting group description

Reporting group title

Part B: Hepatic Impairment

Reporting group description

Primary: Percentage of Participants Achieving Virologic Response (Plasma Hepatitis B Virus [HBV] Deoxyribonucleic Acid [DNA] < 20 IU/mL) at Week 24

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End point title

Percentage of Participants Achieving Virologic Response (Plasma Hepatitis B Virus [HBV] Deoxyribonucleic Acid [DNA] < 20 IU/mL) at Week 24 ^[1]

End point description

The percentage of participants with HBV DNA < 20 IU/mL at Week 24 was determined by the Missing = Failure (M = F) approach. The Full Analysis Set included all participants who were enrolled and received at least 1 dose of study drug.

End point type

Primary

End point timeframe

Week 24

Notes
[1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical comparison was planned or performed since this is a single treatment design.

End point values	Part A (Renal Impairment): Moderate or Severe Renal Impairment	Part A (Renal Impairment): End Stage Renal Disease	Part B: Hepatic Impairment
Number of subjects analysed	78	15	31
Units: percentage of participants
number (not applicable)	97.4	100.0	100.0

No statistical analyses for this end point

Primary: Percentage of Participants Who Experienced Graded Treatment-Emergent Adverse Events (AEs) at Week 24

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End point title

Percentage of Participants Who Experienced Graded Treatment-Emergent Adverse Events (AEs) at Week 24 ^[2]

End point 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. The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug.

End point type

Primary

End point timeframe

Week 24

Notes
[2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical comparison was planned or performed.

End point values	Part A (Renal Impairment): Moderate or Severe Renal Impairment	Part A (Renal Impairment): End Stage Renal Disease	Part B: Hepatic Impairment
Number of subjects analysed	78	15	31
Units: percentage of participants
number (not applicable)
Any treatment-emergent AEs	53.8	73.3	54.8
Grade 3 and above treatment-emergent AEs	6.4	13.3	6.5

No statistical analyses for this end point

Primary: Percentage of Participants Who Experienced Graded Treatment-Emergent Laboratory Abnormalities at Week 24

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End point title

Percentage of Participants Who Experienced Graded Treatment-Emergent Laboratory Abnormalities at Week 24 ^[3]

End point 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. Participants in the Safety Analysis Set were analyzed.

End point type

Primary

End point timeframe

Week 24

Notes
[3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical comparison was planned or performed.

End point values	Part A (Renal Impairment): Moderate or Severe Renal Impairment	Part A (Renal Impairment): End Stage Renal Disease	Part B: Hepatic Impairment
Number of subjects analysed	78	15	31
Units: percentage of participants
number (not applicable)
Any Graded Laboratory Abnormality	96.2	100.0	90.3
Grade 3 and Above Laboratory Abnormality	11.5	46.7	48.4

No statistical analyses for this end point

Secondary: Percentage of Participants Who Experienced Graded Treatment-Emergent AEs at Week 48

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End point title

Percentage of Participants Who Experienced Graded Treatment-Emergent AEs at Week 48

End point 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. Participants in the Safety Analysis Set were analyzed.

End point type

Secondary

End point timeframe

Week 48

End point values	Part A (Renal Impairment): Moderate or Severe Renal Impairment	Part A (Renal Impairment): End Stage Renal Disease	Part B: Hepatic Impairment
Number of subjects analysed	78	15	31
Units: percentage of participants
number (not applicable)
Any Treatment-emergent AE	71.8	86.7	71.0
Grade 3 and Above Treatment-emergent AEs	15.4	20.0	12.9

No statistical analyses for this end point

Secondary: Percentage of Participants Who Experienced Graded Treatment-Emergent AEs at Week 96

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End point title

Percentage of Participants Who Experienced Graded Treatment-Emergent AEs at Week 96

End point description

End point type

Secondary

End point timeframe

Week 96

End point values	Part A (Renal Impairment): Moderate or Severe Renal Impairment	Part A (Renal Impairment): End Stage Renal Disease	Part B: Hepatic Impairment
Number of subjects analysed	78	15	31
Units: percentage of participants
number (not applicable)
Any Treatment-emergent AEs	74.4	100.0	77.4
Grade 3 and Above Treatment-emergent AEs	17.9	26.7	25.8

No statistical analyses for this end point

Secondary: Percentage of Participants Who Experienced Graded Treatment-Emergent Laboratory Abnormalities at Week 48

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End point title

Percentage of Participants Who Experienced Graded Treatment-Emergent Laboratory Abnormalities at Week 48

End point description

End point type

Secondary

End point timeframe

Week 48

End point values	Part A (Renal Impairment): Moderate or Severe Renal Impairment	Part A (Renal Impairment): End Stage Renal Disease	Part B: Hepatic Impairment
Number of subjects analysed	78	15	31
Units: percentage of participants
number (not applicable)
Any Graded Laboratory Abnormality	96.2	100.0	90.3
Grade 3	12.8	40.0	41.9
Grade 4	0	26.7	9.7

No statistical analyses for this end point

Secondary: Percentage of Participants Who Experienced Graded Treatment-Emergent Laboratory Abnormalities at Week 96

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End point title

Percentage of Participants Who Experienced Graded Treatment-Emergent Laboratory Abnormalities at Week 96

End point description

Graded treatment-emergent laboratory abnormalities were defined as values that increased at least 1 toxicity grade from baseline at any post-baseline 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. Participants in the Safety Analysis Set were analyzed.

End point type

Secondary

End point timeframe

Week 96

End point values	Part A (Renal Impairment): Moderate or Severe Renal Impairment	Part A (Renal Impairment): End Stage Renal Disease	Part B: Hepatic Impairment
Number of subjects analysed	78	15	31
Units: percentage of participants
number (not applicable)
Any Graded Laboratory Abnormality	96.2	100.0	100.0
Grade 3	15.4	46.7	41.9
Grade 4	1.3	26.7	12.9

No statistical analyses for this end point

Secondary: 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

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End point 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 ^[4]

End point 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. Participants in the Safety Analysis Set with available data were analyzed.

End point type

Secondary

End point timeframe

Baseline, Week 24

Notes
[4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint was analyzed only for participants with moderate or severe renal impairment and hepatic impairment. Only descriptive analysis was planned.

End point values	Part A (Renal Impairment): Moderate or Severe Renal Impairment	Part B: Hepatic Impairment
Number of subjects analysed	77	31
Units: mL/min
median (inter-quartile range (Q1-Q3))	-0.4 (-3.9 to 4.5)	1.9 (-5.6 to 12.2)

No statistical analyses for this end point

Secondary: Change From Baseline in eGFRcg in Participants With Moderate or Severe Renal Impairment and Hepatically Impaired Participants at Week 48

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End point title

Change From Baseline in eGFRcg in Participants With Moderate or Severe Renal Impairment and Hepatically Impaired Participants at Week 48 ^[5]

End point 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 48 minus the value at Baseline. Participants in the Safety Analysis Set with available data were analyzed.

End point type

Secondary

End point timeframe

Baseline, Week 48

Notes
[5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint was analyzed only for participants with moderate or severe renal impairment and hepatic impairment. Only descriptive analysis was planned.

End point values	Part A (Renal Impairment): Moderate or Severe Renal Impairment	Part B: Hepatic Impairment
Number of subjects analysed	73	31
Units: mL/min
median (inter-quartile range (Q1-Q3))	-0.5 (-4.1 to 3.0)	1.2 (-13.5 to 6.5)

No statistical analyses for this end point

Secondary: Change From Baseline in eGFRcg in Participants With Moderate or Severe Renal Impairment and Hepatically Impaired Participants at Week 96

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End point title

Change From Baseline in eGFRcg in Participants With Moderate or Severe Renal Impairment and Hepatically Impaired Participants at Week 96 ^[6]

End point 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 96 minus the value at Baseline. Participants in the Safety Analysis Set with available data were analyzed.

End point type

Secondary

End point timeframe

Baseline, Week 96

Notes
[6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint was analyzed only for participants with moderate or severe renal impairment and hepatic impairment. Only descriptive analysis was planned.

End point values	Part A (Renal Impairment): Moderate or Severe Renal Impairment	Part B: Hepatic Impairment
Number of subjects analysed	66	25
Units: mL/min
median (inter-quartile range (Q1-Q3))	1.0 (-2.8 to 4.5)	-2.4 (-11.4 to 10.7)

No statistical analyses for this end point

Secondary: Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 24

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End point title

Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 24

End point description

Percent change = Change from baseline at a postbaseline visit/baseline * 100%. 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.

End point type

Secondary

End point timeframe

Baseline, Week 24

End point values	Part A (Renal Impairment): Moderate or Severe Renal Impairment	Part A (Renal Impairment): End Stage Renal Disease	Part B: Hepatic Impairment
Number of subjects analysed	74	15	31
Units: percent change
arithmetic mean (standard deviation)	0.135 ( 1.8348 )	0.322 ( 2.1835 )	0.322 ( 2.5105 )

No statistical analyses for this end point

Secondary: Percent Change From Baseline in Hip BMD at Week 48

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End point title

Percent Change From Baseline in Hip BMD at Week 48

End point description

Percent change = Change from baseline at a postbaseline visit/baseline * 100%. Participants in Hip DXA Analysis Set with available data were analyzed.

End point type

Secondary

End point timeframe

Baseline, Week 48

End point values	Part A (Renal Impairment): Moderate or Severe Renal Impairment	Part A (Renal Impairment): End Stage Renal Disease	Part B: Hepatic Impairment
Number of subjects analysed	72	14	31
Units: percent change
arithmetic mean (standard deviation)	0.565 ( 2.6160 )	-1.075 ( 3.6355 )	-0.221 ( 3.0158 )

No statistical analyses for this end point

Secondary: Percent Change From Baseline in Hip BMD at Week 96

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End point title

Percent Change From Baseline in Hip BMD at Week 96

End point description

Percent change = Change from baseline at a postbaseline visit/baseline * 100%. Participants in Hip DXA Analysis Set with available data were analyzed.

End point type

Secondary

End point timeframe

Baseline, Week 96

End point values	Part A (Renal Impairment): Moderate or Severe Renal Impairment	Part A (Renal Impairment): End Stage Renal Disease	Part B: Hepatic Impairment
Number of subjects analysed	59	13	24
Units: percent change
arithmetic mean (standard deviation)	0.425 ( 2.8381 )	-0.834 ( 4.7171 )	0.277 ( 3.2549 )

No statistical analyses for this end point

Secondary: Percent Change From Baseline in Spine BMD at Week 24

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End point title

Percent Change From Baseline in Spine BMD at Week 24

End point description

Percent change = Change from baseline at a postbaseline visit/baseline * 100%. 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.

End point type

Secondary

End point timeframe

Baseline, Week 24

End point values	Part A (Renal Impairment): Moderate or Severe Renal Impairment	Part A (Renal Impairment): End Stage Renal Disease	Part B: Hepatic Impairment
Number of subjects analysed	76	15	31
Units: percent change
arithmetic mean (standard deviation)	1.229 ( 3.4252 )	0.683 ( 3.1307 )	1.258 ( 2.3416 )

No statistical analyses for this end point

Secondary: Percent Change From Baseline in Spine BMD at Week 48

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End point title

Percent Change From Baseline in Spine BMD at Week 48

End point description

Percent change = Change from baseline at a postbaseline visit/baseline * 100%. Participants in the Spine DXA Analysis Set with available data were analyzed.

End point type

Secondary

End point timeframe

Baseline, Week 48

End point values	Part A (Renal Impairment): Moderate or Severe Renal Impairment	Part A (Renal Impairment): End Stage Renal Disease	Part B: Hepatic Impairment
Number of subjects analysed	73	14	31
Units: percent change
arithmetic mean (standard deviation)	1.516 ( 3.7486 )	0.016 ( 4.1636 )	0.535 ( 3.4386 )

No statistical analyses for this end point

Secondary: Percent Change From Baseline in Spine BMD at Week 96

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End point title

Percent Change From Baseline in Spine BMD at Week 96

End point description

Percent change = Change from baseline at a postbaseline visit/baseline * 100%. Participants in the Spine DXA Analysis Set with available data were analyzed.

End point type

Secondary

End point timeframe

Baseline, Week 96

End point values	Part A (Renal Impairment): Moderate or Severe Renal Impairment	Part A (Renal Impairment): End Stage Renal Disease	Part B: Hepatic Impairment
Number of subjects analysed	61	13	23
Units: percent change
arithmetic mean (standard deviation)	1.293 ( 4.4136 )	-0.283 ( 4.5327 )	-0.249 ( 3.9127 )

No statistical analyses for this end point

Secondary: Percentage of Participants Achieving Virologic Response (Plasma HBV DNA < 20 IU/mL) at Week 48

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End point title

Percentage of Participants Achieving Virologic Response (Plasma HBV DNA < 20 IU/mL) at Week 48

End point description

The percentage of participants with HBV DNA < 20 IU/mL at Week 48 was determined by the Missing = Failure (M = F) approach. Participants in the Full Analysis Set were analyzed.

End point type

Secondary

End point timeframe

Weeks 48

End point values	Part A (Renal Impairment): Moderate or Severe Renal Impairment	Part A (Renal Impairment): End Stage Renal Disease	Part B: Hepatic Impairment
Number of subjects analysed	78	15	31
Units: percentage of participants
number (not applicable)	92.3	93.3	100.0

No statistical analyses for this end point

Secondary: Percentage of Participants Achieving Virologic Response (Plasma HBV DNA < 20 IU/mL) at Week 96

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End point title

Percentage of Participants Achieving Virologic Response (Plasma HBV DNA < 20 IU/mL) at Week 96

End point description

The percentage of participants with HBV DNA < 20 IU/mL at Week 48 was determined by the Missing = Failure (M = F) approach. Participants in the Full Analysis Set were analyzed.

End point type

Secondary

End point timeframe

Weeks 96

End point values	Part A (Renal Impairment): Moderate or Severe Renal Impairment	Part A (Renal Impairment): End Stage Renal Disease	Part B: Hepatic Impairment
Number of subjects analysed	78	15	31
Units: percentage of participants
number (not applicable)	83.3	86.7	77.4

No statistical analyses for this end point

Secondary: Percentage of Participants With Plasma HBV DNA < 20 IU/mL and Target Detected (≥ Lower Limit of Detection [LLOD]) at Week 24

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End point title

Percentage of Participants With Plasma HBV DNA < 20 IU/mL and Target Detected (≥ Lower Limit of Detection [LLOD]) at Week 24

End point 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. Participants in the Full Analysis Set were analyzed.

End point type

Secondary

End point timeframe

Week 24

End point values	Part A (Renal Impairment): Moderate or Severe Renal Impairment	Part A (Renal Impairment): End Stage Renal Disease	Part B: Hepatic Impairment
Number of subjects analysed	78	15	31
Units: percentage of participants
number (not applicable)	21.8	40.0	22.6

No statistical analyses for this end point

Secondary: Percentage of Participants With Plasma HBV DNA < 20 IU/mL and Target Detected (≥ LLOD) at Week 48

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End point title

Percentage of Participants With Plasma HBV DNA < 20 IU/mL and Target Detected (≥ LLOD) at Week 48

End point description

The percentage of participants with HBV DNA < 20 IU/mL and target detected (≥ LLOD; i.e. 10 IU/mL) at Week 48 was determined by the M = F approach. Participants in the Full Analysis Set were analyzed.

End point type

Secondary

End point timeframe

Week 48

End point values	Part A (Renal Impairment): Moderate or Severe Renal Impairment	Part A (Renal Impairment): End Stage Renal Disease	Part B: Hepatic Impairment
Number of subjects analysed	78	15	31
Units: percentage of participants
number (not applicable)	26.9	26.7	25.8

No statistical analyses for this end point

Secondary: Percentage of Participants With Plasma HBV DNA < 20 IU/mL and Target Detected (≥ LLOD) at Week 96

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End point title

Percentage of Participants With Plasma HBV DNA < 20 IU/mL and Target Detected (≥ LLOD) at Week 96

End point description

The percentage of participants with HBV DNA < 20 IU/mL and target detected (≥ LLOD; i.e. 10 IU/mL) at Week 96 was determined by the M = F approach. Participants in the Full Analysis Set were analyzed.

End point type

Secondary

End point timeframe

Week 96

End point values	Part A (Renal Impairment): Moderate or Severe Renal Impairment	Part A (Renal Impairment): End Stage Renal Disease	Part B: Hepatic Impairment
Number of subjects analysed	78	15	31
Units: percentage of participants
number (not applicable)	14.1	20.0	0

No statistical analyses for this end point

Secondary: Percentage of Participants With Plasma HBV DNA < 20 IU/mL and Target Not Detected (< LLOD) at Week 24

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End point title

Percentage of Participants With Plasma HBV DNA < 20 IU/mL and Target Not Detected (< LLOD) at Week 24

End point 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. Participants in the Full Analysis Set were analyzed.

End point type

Secondary

End point timeframe

Week 24

End point values	Part A (Renal Impairment): Moderate or Severe Renal Impairment	Part A (Renal Impairment): End Stage Renal Disease	Part B: Hepatic Impairment
Number of subjects analysed	78	15	31
Units: percentage of participants
number (not applicable)	75.6	60.0	77.4

No statistical analyses for this end point

Secondary: Percentage of Participants With Plasma HBV DNA < 20 IU/mL and Target Not Detected (< LLOD) at Week 48

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End point title

Percentage of Participants With Plasma HBV DNA < 20 IU/mL and Target Not Detected (< LLOD) at Week 48

End point description

The percentage of participants with HBV DNA < 20 IU/mL and target not detected (< LLOD; i.e. 10 IU/mL) at Week 48 was determined by the M = F approach. Participants in the Full Analysis Set were analyzed.

End point type

Secondary

End point timeframe

Weeks 48

End point values	Part A (Renal Impairment): Moderate or Severe Renal Impairment	Part A (Renal Impairment): End Stage Renal Disease	Part B: Hepatic Impairment
Number of subjects analysed	78	15	31
Units: percentage of participants
number (not applicable)	65.4	66.7	74.2

No statistical analyses for this end point

Secondary: Percentage of Participants With Plasma HBV DNA < 20 IU/mL and Target Not Detected (< LLOD) at Week 96

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End point title

Percentage of Participants With Plasma HBV DNA < 20 IU/mL and Target Not Detected (< LLOD) at Week 96

End point description

The percentage of participants with HBV DNA < 20 IU/mL and target not detected (< LLOD; i.e. 10 IU/mL) at Week 96 was determined by the M = F approach. Participants in the Full Analysis Set were analyzed.

End point type

Secondary

End point timeframe

Weeks 96

End point values	Part A (Renal Impairment): Moderate or Severe Renal Impairment	Part A (Renal Impairment): End Stage Renal Disease	Part B: Hepatic Impairment
Number of subjects analysed	78	15	31
Units: percentage of participants
number (not applicable)	69.2	66.7	77.4

No statistical analyses for this end point

Secondary: Percentage of Participants With Serological Response: Loss of Hepatitis B s-Antigen (HBsAg) at Week 24

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End point title

Percentage of Participants With Serological Response: Loss of Hepatitis B s-Antigen (HBsAg) at Week 24

End point 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. Participants in 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.

End point type

Secondary

End point timeframe

Week 24

End point values	Part A (Renal Impairment): Moderate or Severe Renal Impairment	Part A (Renal Impairment): End Stage Renal Disease	Part B: Hepatic Impairment
Number of subjects analysed	78	15	31
Units: percentage of participants
number (not applicable)	0	0	0

No statistical analyses for this end point

Secondary: Percentage of Participants With Serological Response: Loss of HBsAg at Week 48

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End point title

Percentage of Participants With Serological Response: Loss of HBsAg at Week 48

End point description

End point type

Secondary

End point timeframe

Week 48

End point values	Part A (Renal Impairment): Moderate or Severe Renal Impairment	Part A (Renal Impairment): End Stage Renal Disease	Part B: Hepatic Impairment
Number of subjects analysed	78	15	30
Units: percentage of participants
number (not applicable)	0	6.7	3.3

No statistical analyses for this end point

Secondary: Percentage of Participants With Serological Response: Loss of HBsAg at Week 96

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End point title

Percentage of Participants With Serological Response: Loss of HBsAg at Week 96

End point description

End point type

Secondary

End point timeframe

Week 96

End point values	Part A (Renal Impairment): Moderate or Severe Renal Impairment	Part A (Renal Impairment): End Stage Renal Disease	Part B: Hepatic Impairment
Number of subjects analysed	78	15	30
Units: percentage of participants
number (not applicable)	0	0	6.7

No statistical analyses for this end point

Secondary: Percentage of Participants With Serological Response: Seroconversion to Anti-HBs at Week 24

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End point title

Percentage of Participants With Serological Response: Seroconversion to Anti-HBs at Week 24

End point 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. Participants in the Serologically Evaluable Full Analysis Set for HBsAg Loss/Seroconversion were analyzed.

End point type

Secondary

End point timeframe

Week 24

End point values	Part A (Renal Impairment): Moderate or Severe Renal Impairment	Part A (Renal Impairment): End Stage Renal Disease	Part B: Hepatic Impairment
Number of subjects analysed	78	15	30
Units: percentage of participants
number (not applicable)	0	0	0

No statistical analyses for this end point

Secondary: Percentage of Participants With Serological Response: Seroconversion to Anti-HBs at Week 48

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End point title

Percentage of Participants With Serological Response: Seroconversion to Anti-HBs at Week 48

End point description

End point type

Secondary

End point timeframe

Week 48

End point values	Part A (Renal Impairment): Moderate or Severe Renal Impairment	Part A (Renal Impairment): End Stage Renal Disease	Part B: Hepatic Impairment
Number of subjects analysed	78	15	30
Units: percentage of participants
number (not applicable)	0	0	0

No statistical analyses for this end point

Secondary: Percentage of Participants With Serological Response: Seroconversion to Anti-HBs at Week 96

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End point title

Percentage of Participants With Serological Response: Seroconversion to Anti-HBs at Week 96

End point description

End point type

Secondary

End point timeframe

Week 96

End point values	Part A (Renal Impairment): Moderate or Severe Renal Impairment	Part A (Renal Impairment): End Stage Renal Disease	Part B: Hepatic Impairment
Number of subjects analysed	78	15	30
Units: percentage of participants
number (not applicable)	0	0	0

No statistical analyses for this end point

Secondary: Percentage of Participants With Serological Response: Loss of HBeAg in HBeAg-Positive Participants at Week 24

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End point title

Percentage of Participants With Serological Response: Loss of HBeAg in HBeAg-Positive Participants at Week 24

End point 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. 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.

End point type

Secondary

End point timeframe

Week 24

End point values	Part A (Renal Impairment): Moderate or Severe Renal Impairment	Part A (Renal Impairment): End Stage Renal Disease	Part B: Hepatic Impairment
Number of subjects analysed	13	3	3
Units: percentage of participants
number (not applicable)	0	0	0

No statistical analyses for this end point

Secondary: Percentage of Participants With Serological Response: Loss of HBeAg in HBeAg-Positive Participants at Week 48

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End point title

Percentage of Participants With Serological Response: Loss of HBeAg in HBeAg-Positive Participants at Week 48

End point 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. Participants in the Serologically Evaluable Full Analysis Set were analyzed.

End point type

Secondary

End point timeframe

Week 48

End point values	Part A (Renal Impairment): Moderate or Severe Renal Impairment	Part A (Renal Impairment): End Stage Renal Disease	Part B: Hepatic Impairment
Number of subjects analysed	13	3	3
Units: percentage of participants
number (not applicable)	0	0	0

No statistical analyses for this end point

Secondary: Percentage of Participants With Serological Response: Loss of HBeAg in HBeAg-Positive Participants at Week 96

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End point title

Percentage of Participants With Serological Response: Loss of HBeAg in HBeAg-Positive Participants at Week 96

End point description

End point type

Secondary

End point timeframe

Week 96

End point values	Part A (Renal Impairment): Moderate or Severe Renal Impairment	Part A (Renal Impairment): End Stage Renal Disease	Part B: Hepatic Impairment
Number of subjects analysed	13	3	3
Units: percentage of participants
number (not applicable)	0	33.3	0

No statistical analyses for this end point

Secondary: Percentage of Participants With Serological Response: Seroconversion to Anti-HBe in HBeAg-Positive Participants at Week 24

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End point title

Percentage of Participants With Serological Response: Seroconversion to Anti-HBe in HBeAg-Positive Participants at Week 24

End point 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. Participants in the Serologically Evaluable Full Analysis Set for HBeAg Loss/Seroconversion were analyzed.

End point type

Secondary

End point timeframe

Week 24

End point values	Part A (Renal Impairment): Moderate or Severe Renal Impairment	Part A (Renal Impairment): End Stage Renal Disease	Part B: Hepatic Impairment
Number of subjects analysed	13	3	3
Units: percentage of participants
number (not applicable)	0	0	0

No statistical analyses for this end point

Secondary: Percentage of Participants With Serological Response: Seroconversion to Anti-HBe in HBeAg-Positive Participants at Week 48

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End point title

Percentage of Participants With Serological Response: Seroconversion to Anti-HBe in HBeAg-Positive Participants at Week 48

End point description

End point type

Secondary

End point timeframe

Week 48

End point values	Part A (Renal Impairment): Moderate or Severe Renal Impairment	Part A (Renal Impairment): End Stage Renal Disease	Part B: Hepatic Impairment
Number of subjects analysed	13	3	3
Units: percentage of participants
number (not applicable)	0	0	0

No statistical analyses for this end point

Secondary: Percentage of Participants With Serological Response: Seroconversion to Anti-HBe in HBeAg-Positive Participants at Week 96

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End point title

Percentage of Participants With Serological Response: Seroconversion to Anti-HBe in HBeAg-Positive Participants at Week 96

End point description

End point type

Secondary

End point timeframe

Week 96

End point values	Part A (Renal Impairment): Moderate or Severe Renal Impairment	Part A (Renal Impairment): End Stage Renal Disease	Part B: Hepatic Impairment
Number of subjects analysed	13	3	3
Units: percentage of participants
number (not applicable)	0	33.3	0

No statistical analyses for this end point

Secondary: 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

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End point 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

End point 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. Participants in the Full Analysis Set were analyzed.

End point type

Secondary

End point timeframe

Week 24

End point values	Part A (Renal Impairment): Moderate or Severe Renal Impairment	Part A (Renal Impairment): End Stage Renal Disease	Part B: Hepatic Impairment
Number of subjects analysed	78	15	31
Units: percentage of participants
number (not applicable)
ALT by central laboratory	92.3	93.3	83.9
ALT by AASLD criteria	87.2	93.3	80.6

No statistical analyses for this end point

Secondary: Percentage of Participants With Normal ALT at Week 48 by Central Laboratory and the AASLD Criteria

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End point title

Percentage of Participants With Normal ALT at Week 48 by Central Laboratory and the AASLD Criteria

End point description

End point type

Secondary

End point timeframe

Week 48

End point values	Part A (Renal Impairment): Moderate or Severe Renal Impairment	Part A (Renal Impairment): End Stage Renal Disease	Part B: Hepatic Impairment
Number of subjects analysed	78	15	31
Units: percentage of participants
number (not applicable)
ALT by central laboratory	89.7	86.7	90.3
ALT by AASLD criteria	87.2	80.0	80.6

No statistical analyses for this end point

Secondary: Percentage of Participants With Normal ALT at Week 96 by Central Laboratory and the AASLD Criteria

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End point title

Percentage of Participants With Normal ALT at Week 96 by Central Laboratory and the AASLD Criteria

End point description

End point type

Secondary

End point timeframe

Week 96

End point values	Part A (Renal Impairment): Moderate or Severe Renal Impairment	Part A (Renal Impairment): End Stage Renal Disease	Part B: Hepatic Impairment
Number of subjects analysed	78	15	31
Units: percentage of participants
number (not applicable)
ALT by central laboratory	82.1	86.7	71.0
ALT by AASLD criteria	74.4	86.7	58.1

No statistical analyses for this end point

Secondary: Percentage of Participants With Normalized ALT at Week 24 by Central Laboratory and the AASLD Criteria

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End point title

Percentage of Participants With Normalized ALT at Week 24 by Central Laboratory and the AASLD Criteria

End point 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. Participants in the Full Analysis Set with Baseline ALT > ULN were analyzed.

End point type

Secondary

End point timeframe

Week 24

End point values	Part A (Renal Impairment): Moderate or Severe Renal Impairment	Part A (Renal Impairment): End Stage Renal Disease	Part B: Hepatic Impairment
Number of subjects analysed	5	0 ^[7]	10
Units: percentage of participants
number (not applicable)
Normalized ALT by Central Laboratory (n=3, 0, 4))	66.7		50.0
Normalized ALT by AASLD Criteria (n=5, 0, 10)	40.0		60.0

Notes
[7] - Number of participants analyzed were 0.

No statistical analyses for this end point

Secondary: Percentage of Participants With Normalized ALT at Week 48 by Central Laboratory and the AASLD Criteria

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End point title

Percentage of Participants With Normalized ALT at Week 48 by Central Laboratory and the AASLD Criteria

End point description

End point type

Secondary

End point timeframe

Week 48

End point values	Part A (Renal Impairment): Moderate or Severe Renal Impairment	Part A (Renal Impairment): End Stage Renal Disease	Part B: Hepatic Impairment
Number of subjects analysed	5	0 ^[8]	10
Units: percentage of participants
number (not applicable)
Normalized ALT by Central Laboratory (n=3, 0, 4)	33.3		75
Normalized ALT by AASLD Criteria (n=5, 0, 10)	60		60

Notes
[8] - Number of participants analyzed were 0 at a given time point.

No statistical analyses for this end point

Secondary: Percentage of Participants With Normalized ALT at Week 96 by Central Laboratory and the AASLD Criteria

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End point title

Percentage of Participants With Normalized ALT at Week 96 by Central Laboratory and the AASLD Criteria

End point description

End point type

Secondary

End point timeframe

Week 96

End point values	Part A (Renal Impairment): Moderate or Severe Renal Impairment	Part A (Renal Impairment): End Stage Renal Disease	Part B: Hepatic Impairment
Number of subjects analysed	5	0 ^[9]	10
Units: percentage of participants
number (not applicable)
Normalized ALT by Central Laboratory (n=3, 0, 4)	33.3		50
Normalized ALT by AASLD Criteria (n=5, 0, 10)	20		50

Notes
[9] - Number of participants analyzed were 0 at given time point.

No statistical analyses for this end point

Secondary: Change From Baseline in FibroTest® Score at Week 24

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End point title

Change From Baseline in FibroTest® Score at Week 24

End point 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. Participants in the Full Analysis Set with available data were analyzed.

End point type

Secondary

End point timeframe

Baseline, Week 24

End point values	Part A (Renal Impairment): Moderate or Severe Renal Impairment	Part A (Renal Impairment): End Stage Renal Disease	Part B: Hepatic Impairment
Number of subjects analysed	74	15	31
Units: units on a scale
arithmetic mean (standard deviation)	-0.01 ( 0.099 )	-0.01 ( 0.064 )	-0.05 ( 0.106 )

No statistical analyses for this end point

Secondary: Change From Baseline in FibroTest® Score at Week 48

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End point title

Change From Baseline in FibroTest® Score at Week 48

End point 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 48 minus the value at Baseline. Participants in the Full Analysis Set with available data were analyzed.

End point type

Secondary

End point timeframe

Baseline, Week 48

End point values	Part A (Renal Impairment): Moderate or Severe Renal Impairment	Part A (Renal Impairment): End Stage Renal Disease	Part B: Hepatic Impairment
Number of subjects analysed	73	14	31
Units: units on a scale
arithmetic mean (standard deviation)	-0.03 ( 0.102 )	-0.01 ( 0.071 )	-0.03 ( 0.102 )

No statistical analyses for this end point

Secondary: Change From Baseline in FibroTest® Score at Week 96

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End point title

Change From Baseline in FibroTest® Score at Week 96

End point 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 96 minus the value at Baseline. Participants in the Full Analysis Set with available data were analyzed.

End point type

Secondary

End point timeframe

Week 96

End point values	Part A (Renal Impairment): Moderate or Severe Renal Impairment	Part A (Renal Impairment): End Stage Renal Disease	Part B: Hepatic Impairment
Number of subjects analysed	65	13	26
Units: units on a scale
arithmetic mean (standard deviation)	-0.01 ( 0.114 )	0.03 ( 0.107 )	-0.02 ( 0.118 )

No statistical analyses for this end point

Secondary: Change From Baseline in Child-Pugh-Turcotte (CPT) Score in Hepatically Impaired Participants at Week 24

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End point title

Change From Baseline in Child-Pugh-Turcotte (CPT) Score in Hepatically Impaired Participants at Week 24 ^[10]

End point 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. Participants in the Full Analysis Set only from Part B (Hepatic Impairment) were analyzed.

End point type

Secondary

End point timeframe

Baseline, Week 24

Notes
[10] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint was analyzed only for participants with hepatic impairment. Only descriptive analysis was planned.

End point values	Part B: Hepatic Impairment
Number of subjects analysed	31
Units: units on a scale
arithmetic mean (standard deviation)	0 ( 1.1 )

No statistical analyses for this end point

Secondary: Change From Baseline in CPT Score in Hepatically Impaired Participants at Week 48

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End point title

Change From Baseline in CPT Score in Hepatically Impaired Participants at Week 48 ^[11]

End point description

End point type

Secondary

End point timeframe

Baseline, Week 48

Notes
[11] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint was analyzed only for participants with hepatic impairment. Only descriptive analysis was planned.

End point values	Part B: Hepatic Impairment
Number of subjects analysed	31
Units: units on a scale
arithmetic mean (standard deviation)	0 ( 1.1 )

No statistical analyses for this end point

Secondary: Change From Baseline in CPT Score in Hepatically Impaired Participants at Week 96

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End point title

Change From Baseline in CPT Score in Hepatically Impaired Participants at Week 96 ^[12]

End point description

End point type

Secondary

End point timeframe

Baseline, Week 96

Notes
[12] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint was analyzed only for participants with hepatic impairment. Only descriptive analysis was planned.

End point values	Part B: Hepatic Impairment
Number of subjects analysed	25
Units: units on a scale
arithmetic mean (standard deviation)	0 ( 1.2 )

No statistical analyses for this end point

Secondary: Change From Baseline in Model for End-Stage Liver Disease (MELD) Score in Hepatically Impaired Participants at Week 24

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End point title

Change From Baseline in Model for End-Stage Liver Disease (MELD) Score in Hepatically Impaired Participants at Week 24 ^[13]

End point 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. Participants in the Full Analysis Set only from Part B (Hepatic Impairment) were analyzed.

End point type

Secondary

End point timeframe

Baseline, Week 24

Notes
[13] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint was analyzed only for participants with hepatic impairment. Only descriptive analysis was planned.

End point values	Part B: Hepatic Impairment
Number of subjects analysed	31
Units: units on a scale
arithmetic mean (standard deviation)	-0.6 ( 1.94 )

No statistical analyses for this end point

Secondary: Change From Baseline in MELD Score in Hepatically Impaired Participants at Week 48

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End point title

Change From Baseline in MELD Score in Hepatically Impaired Participants at Week 48 ^[14]

End point description

End point type

Secondary

End point timeframe

Baseline, Week 48

Notes
[14] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint was analyzed only for participants with hepatic impairment. Only descriptive analysis was planned.

End point values	Part B: Hepatic Impairment
Number of subjects analysed	30
Units: units on a scale
arithmetic mean (standard deviation)	0.1 ( 2.35 )

No statistical analyses for this end point

Secondary: Change From Baseline in MELD Score in Hepatically Impaired Participants at Week 96

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End point title

Change From Baseline in MELD Score in Hepatically Impaired Participants at Week 96 ^[15]

End point description

End point type

Secondary

End point timeframe

Baseline, Week 96

Notes
[15] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint was analyzed only for participants with hepatic impairment. Only descriptive analysis was planned.

End point values	Part B: Hepatic Impairment
Number of subjects analysed	25
Units: units on a scale
arithmetic mean (standard deviation)	-1.0 ( 1.61 )

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

Adverse Events: From the first dose date up to last dose date (maximum: 108 .1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days

Adverse event reporting additional description

Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

Reporting group title

Part A (Renal Impairment): Moderate or Severe Renal Impairment

Reporting group description

Reporting group title

Part A (Renal Impairment): End Stage Renal Disease

Reporting group description

Participants with CHB and end stage renal disease who were virologically suppressed and took TDF, a TDF containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.

Reporting group title

Part B: Hepatic Impairment

Reporting group description

Serious adverse events	Part A (Renal Impairment): Moderate or Severe Renal Impairment	Part A (Renal Impairment): End Stage Renal Disease	Part B: Hepatic Impairment
Total subjects affected by serious adverse events
subjects affected / exposed	12 / 78 (15.38%)	8 / 15 (53.33%)	10 / 31 (32.26%)
number of deaths (all causes)	2	1	2
number of deaths resulting from adverse events	0	1	2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
subjects affected / exposed	0 / 78 (0.00%)	1 / 15 (6.67%)	1 / 31 (3.23%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Bladder cancer
subjects affected / exposed	1 / 78 (1.28%)	0 / 15 (0.00%)	0 / 31 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Lung neoplasm malignant
subjects affected / exposed	1 / 78 (1.28%)	0 / 15 (0.00%)	0 / 31 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Ovarian cancer
subjects affected / exposed	0 / 78 (0.00%)	1 / 15 (6.67%)	0 / 31 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Rectal cancer
subjects affected / exposed	1 / 78 (1.28%)	0 / 15 (0.00%)	0 / 31 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
General disorders and administration site conditions
Catheter site discharge
subjects affected / exposed	0 / 78 (0.00%)	1 / 15 (6.67%)	0 / 31 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Pleural effusion
subjects affected / exposed	0 / 78 (0.00%)	2 / 15 (13.33%)	0 / 31 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pneumonia aspiration
subjects affected / exposed	1 / 78 (1.28%)	0 / 15 (0.00%)	1 / 31 (3.23%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 1
Bronchospasm
subjects affected / exposed	0 / 78 (0.00%)	1 / 15 (6.67%)	0 / 31 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Dyspnoea
subjects affected / exposed	0 / 78 (0.00%)	1 / 15 (6.67%)	0 / 31 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Haemothorax
subjects affected / exposed	0 / 78 (0.00%)	1 / 15 (6.67%)	0 / 31 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0
Respiratory failure
subjects affected / exposed	1 / 78 (1.28%)	0 / 15 (0.00%)	0 / 31 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Investigations
Carcinoembryonic antigen increased
subjects affected / exposed	1 / 78 (1.28%)	0 / 15 (0.00%)	0 / 31 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Model for end stage liver disease score ~ increased
subjects affected / exposed	0 / 78 (0.00%)	0 / 15 (0.00%)	1 / 31 (3.23%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Injury, poisoning and procedural complications
Arteriovenous fistula site complication
subjects affected / exposed	0 / 78 (0.00%)	1 / 15 (6.67%)	0 / 31 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Arteriovenous fistula thrombosis
subjects affected / exposed	0 / 78 (0.00%)	1 / 15 (6.67%)	0 / 31 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Drain site complication
subjects affected / exposed	0 / 78 (0.00%)	0 / 15 (0.00%)	1 / 31 (3.23%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Head injury
subjects affected / exposed	1 / 78 (1.28%)	0 / 15 (0.00%)	0 / 31 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Shunt occlusion
subjects affected / exposed	0 / 78 (0.00%)	1 / 15 (6.67%)	0 / 31 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Subdural haematoma
subjects affected / exposed	0 / 78 (0.00%)	0 / 15 (0.00%)	1 / 31 (3.23%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cardiac disorders
Atrial flutter
subjects affected / exposed	0 / 78 (0.00%)	0 / 15 (0.00%)	1 / 31 (3.23%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Atrioventricular block complete
subjects affected / exposed	1 / 78 (1.28%)	0 / 15 (0.00%)	0 / 31 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Nervous system disorders
Ischaemic stroke
subjects affected / exposed	2 / 78 (2.56%)	0 / 15 (0.00%)	1 / 31 (3.23%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hepatic encephalopathy
subjects affected / exposed	0 / 78 (0.00%)	0 / 15 (0.00%)	2 / 31 (6.45%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Subarachnoid haemorrhage
subjects affected / exposed	1 / 78 (1.28%)	0 / 15 (0.00%)	1 / 31 (3.23%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Encephalopathy
subjects affected / exposed	0 / 78 (0.00%)	0 / 15 (0.00%)	1 / 31 (3.23%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Blood and lymphatic system disorders
Anaemia
subjects affected / exposed	0 / 78 (0.00%)	1 / 15 (6.67%)	0 / 31 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 20	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Thrombocytopenia
subjects affected / exposed	0 / 78 (0.00%)	1 / 15 (6.67%)	0 / 31 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0
Ear and labyrinth disorders
Deafness neurosensory
subjects affected / exposed	0 / 78 (0.00%)	1 / 15 (6.67%)	0 / 31 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Eye disorders
Cataract
subjects affected / exposed	2 / 78 (2.56%)	0 / 15 (0.00%)	0 / 31 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gastrointestinal disorders
Abdominal pain
subjects affected / exposed	0 / 78 (0.00%)	1 / 15 (6.67%)	0 / 31 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Ascites
subjects affected / exposed	0 / 78 (0.00%)	0 / 15 (0.00%)	1 / 31 (3.23%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Colitis
subjects affected / exposed	0 / 78 (0.00%)	1 / 15 (6.67%)	0 / 31 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Duodenal ulcer haemorrhage
subjects affected / exposed	0 / 78 (0.00%)	0 / 15 (0.00%)	1 / 31 (3.23%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gingival bleeding
subjects affected / exposed	0 / 78 (0.00%)	0 / 15 (0.00%)	1 / 31 (3.23%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Intestinal obstruction
subjects affected / exposed	0 / 78 (0.00%)	1 / 15 (6.67%)	0 / 31 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Upper gastrointestinal haemorrhage
subjects affected / exposed	0 / 78 (0.00%)	0 / 15 (0.00%)	1 / 31 (3.23%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hepatobiliary disorders
Bile duct stone
subjects affected / exposed	0 / 78 (0.00%)	0 / 15 (0.00%)	1 / 31 (3.23%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hepatic failure
subjects affected / exposed	0 / 78 (0.00%)	0 / 15 (0.00%)	1 / 31 (3.23%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hepatorenal syndrome
subjects affected / exposed	0 / 78 (0.00%)	0 / 15 (0.00%)	1 / 31 (3.23%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 1
Endocrine disorders
Adrenal mass
subjects affected / exposed	0 / 78 (0.00%)	0 / 15 (0.00%)	1 / 31 (3.23%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
Back pain
subjects affected / exposed	1 / 78 (1.28%)	0 / 15 (0.00%)	0 / 31 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Focal myositis
subjects affected / exposed	0 / 78 (0.00%)	1 / 15 (6.67%)	0 / 31 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Infections and infestations
Pneumonia
subjects affected / exposed	2 / 78 (2.56%)	1 / 15 (6.67%)	0 / 31 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Sepsis
subjects affected / exposed	0 / 78 (0.00%)	1 / 15 (6.67%)	1 / 31 (3.23%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0
Bacteraemia
subjects affected / exposed	0 / 78 (0.00%)	1 / 15 (6.67%)	0 / 31 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Fungal cystitis
subjects affected / exposed	0 / 78 (0.00%)	0 / 15 (0.00%)	1 / 31 (3.23%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Lower respiratory tract infection
subjects affected / exposed	0 / 78 (0.00%)	1 / 15 (6.67%)	0 / 31 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Lower respiratory tract infection viral
subjects affected / exposed	0 / 78 (0.00%)	1 / 15 (6.67%)	0 / 31 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Peritonitis bacterial
subjects affected / exposed	0 / 78 (0.00%)	0 / 15 (0.00%)	1 / 31 (3.23%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Urinary tract infection
subjects affected / exposed	0 / 78 (0.00%)	0 / 15 (0.00%)	1 / 31 (3.23%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Metabolism and nutrition disorders
Hyperkalaemia
subjects affected / exposed	1 / 78 (1.28%)	0 / 15 (0.00%)	0 / 31 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	Part A (Renal Impairment): Moderate or Severe Renal Impairment	Part A (Renal Impairment): End Stage Renal Disease	Part B: Hepatic Impairment
Total subjects affected by non serious adverse events
subjects affected / exposed	34 / 78 (43.59%)	15 / 15 (100.00%)	23 / 31 (74.19%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
subjects affected / exposed	1 / 78 (1.28%)	1 / 15 (6.67%)	0 / 31 (0.00%)
occurrences all number	1	1	0
Ovarian cancer stage I
subjects affected / exposed	0 / 78 (0.00%)	1 / 15 (6.67%)	0 / 31 (0.00%)
occurrences all number	0	1	0
Vascular disorders
Hypertension
subjects affected / exposed	2 / 78 (2.56%)	4 / 15 (26.67%)	1 / 31 (3.23%)
occurrences all number	2	4	1
Hypotension
subjects affected / exposed	0 / 78 (0.00%)	2 / 15 (13.33%)	0 / 31 (0.00%)
occurrences all number	0	2	0
Thrombosis
subjects affected / exposed	0 / 78 (0.00%)	1 / 15 (6.67%)	0 / 31 (0.00%)
occurrences all number	0	1	0
Venous occlusion
subjects affected / exposed	0 / 78 (0.00%)	1 / 15 (6.67%)	0 / 31 (0.00%)
occurrences all number	0	1	0
General disorders and administration site conditions
Pyrexia
subjects affected / exposed	0 / 78 (0.00%)	3 / 15 (20.00%)	5 / 31 (16.13%)
occurrences all number	0	4	6
Oedema peripheral
subjects affected / exposed	1 / 78 (1.28%)	1 / 15 (6.67%)	2 / 31 (6.45%)
occurrences all number	1	1	2
Fatigue
subjects affected / exposed	0 / 78 (0.00%)	0 / 15 (0.00%)	2 / 31 (6.45%)
occurrences all number	0	0	2
Chest discomfort
subjects affected / exposed	0 / 78 (0.00%)	1 / 15 (6.67%)	0 / 31 (0.00%)
occurrences all number	0	1	0
Pain
subjects affected / exposed	0 / 78 (0.00%)	1 / 15 (6.67%)	0 / 31 (0.00%)
occurrences all number	0	1	0
Respiratory, thoracic and mediastinal disorders
Cough
subjects affected / exposed	4 / 78 (5.13%)	0 / 15 (0.00%)	6 / 31 (19.35%)
occurrences all number	4	0	6
Pleural effusion
subjects affected / exposed	0 / 78 (0.00%)	3 / 15 (20.00%)	2 / 31 (6.45%)
occurrences all number	0	4	2
Oropharyngeal pain
subjects affected / exposed	1 / 78 (1.28%)	0 / 15 (0.00%)	3 / 31 (9.68%)
occurrences all number	1	0	3
Dyspnoea
subjects affected / exposed	1 / 78 (1.28%)	2 / 15 (13.33%)	0 / 31 (0.00%)
occurrences all number	1	2	0
Productive cough
subjects affected / exposed	0 / 78 (0.00%)	2 / 15 (13.33%)	1 / 31 (3.23%)
occurrences all number	0	4	1
Rhinorrhoea
subjects affected / exposed	1 / 78 (1.28%)	2 / 15 (13.33%)	0 / 31 (0.00%)
occurrences all number	1	4	0
Haemoptysis
subjects affected / exposed	0 / 78 (0.00%)	1 / 15 (6.67%)	1 / 31 (3.23%)
occurrences all number	0	1	1
Nasal congestion
subjects affected / exposed	0 / 78 (0.00%)	1 / 15 (6.67%)	0 / 31 (0.00%)
occurrences all number	0	1	0
Nasal obstruction
subjects affected / exposed	0 / 78 (0.00%)	1 / 15 (6.67%)	0 / 31 (0.00%)
occurrences all number	0	1	0
Pulmonary oedema
subjects affected / exposed	0 / 78 (0.00%)	1 / 15 (6.67%)	0 / 31 (0.00%)
occurrences all number	0	1	0
Psychiatric disorders
Insomnia
subjects affected / exposed	4 / 78 (5.13%)	1 / 15 (6.67%)	2 / 31 (6.45%)
occurrences all number	4	1	2
Investigations
Bone density decreased
subjects affected / exposed	1 / 78 (1.28%)	0 / 15 (0.00%)	5 / 31 (16.13%)
occurrences all number	1	0	5
Blood creatinine increased
subjects affected / exposed	1 / 78 (1.28%)	0 / 15 (0.00%)	2 / 31 (6.45%)
occurrences all number	1	0	2
Blood bilirubin increased
subjects affected / exposed	0 / 78 (0.00%)	0 / 15 (0.00%)	2 / 31 (6.45%)
occurrences all number	0	0	2
Injury, poisoning and procedural complications
Ligament sprain
subjects affected / exposed	1 / 78 (1.28%)	1 / 15 (6.67%)	0 / 31 (0.00%)
occurrences all number	1	1	0
Arteriovenous fistula site complication
subjects affected / exposed	0 / 78 (0.00%)	1 / 15 (6.67%)	0 / 31 (0.00%)
occurrences all number	0	1	0
Incision site pain
subjects affected / exposed	0 / 78 (0.00%)	1 / 15 (6.67%)	0 / 31 (0.00%)
occurrences all number	0	1	0
Limb injury
subjects affected / exposed	0 / 78 (0.00%)	1 / 15 (6.67%)	0 / 31 (0.00%)
occurrences all number	0	1	0
Procedural pain
subjects affected / exposed	0 / 78 (0.00%)	1 / 15 (6.67%)	0 / 31 (0.00%)
occurrences all number	0	1	0
Shunt occlusion
subjects affected / exposed	0 / 78 (0.00%)	1 / 15 (6.67%)	0 / 31 (0.00%)
occurrences all number	0	1	0
Vascular pseudoaneurysm
subjects affected / exposed	0 / 78 (0.00%)	1 / 15 (6.67%)	0 / 31 (0.00%)
occurrences all number	0	1	0
Nervous system disorders
Dizziness
subjects affected / exposed	3 / 78 (3.85%)	1 / 15 (6.67%)	0 / 31 (0.00%)
occurrences all number	3	1	0
Headache
subjects affected / exposed	2 / 78 (2.56%)	0 / 15 (0.00%)	2 / 31 (6.45%)
occurrences all number	2	0	2
Cognitive disorder
subjects affected / exposed	1 / 78 (1.28%)	1 / 15 (6.67%)	0 / 31 (0.00%)
occurrences all number	1	1	0
Amnesia
subjects affected / exposed	0 / 78 (0.00%)	1 / 15 (6.67%)	0 / 31 (0.00%)
occurrences all number	0	1	0
Carotid arteriosclerosis
subjects affected / exposed	0 / 78 (0.00%)	1 / 15 (6.67%)	0 / 31 (0.00%)
occurrences all number	0	1	0
Cerebral atrophy
subjects affected / exposed	0 / 78 (0.00%)	1 / 15 (6.67%)	0 / 31 (0.00%)
occurrences all number	0	1	0
Cerebrovascular accident
subjects affected / exposed	0 / 78 (0.00%)	1 / 15 (6.67%)	0 / 31 (0.00%)
occurrences all number	0	1	0
Dementia
subjects affected / exposed	0 / 78 (0.00%)	1 / 15 (6.67%)	0 / 31 (0.00%)
occurrences all number	0	1	0
Dyskinesia
subjects affected / exposed	0 / 78 (0.00%)	1 / 15 (6.67%)	0 / 31 (0.00%)
occurrences all number	0	1	0
Hydrocephalus
subjects affected / exposed	0 / 78 (0.00%)	1 / 15 (6.67%)	0 / 31 (0.00%)
occurrences all number	0	1	0
Vascular encephalopathy
subjects affected / exposed	0 / 78 (0.00%)	1 / 15 (6.67%)	0 / 31 (0.00%)
occurrences all number	0	1	0
Blood and lymphatic system disorders
Anaemia
subjects affected / exposed	2 / 78 (2.56%)	3 / 15 (20.00%)	1 / 31 (3.23%)
occurrences all number	2	3	1
Thrombocytopenia
subjects affected / exposed	0 / 78 (0.00%)	1 / 15 (6.67%)	1 / 31 (3.23%)
occurrences all number	0	1	1
Blood loss anaemia
subjects affected / exposed	0 / 78 (0.00%)	1 / 15 (6.67%)	0 / 31 (0.00%)
occurrences all number	0	1	0
Coagulopathy
subjects affected / exposed	0 / 78 (0.00%)	1 / 15 (6.67%)	0 / 31 (0.00%)
occurrences all number	0	1	0
Thrombotic thrombocytopenic purpura
subjects affected / exposed	0 / 78 (0.00%)	1 / 15 (6.67%)	0 / 31 (0.00%)
occurrences all number	0	1	0
Ear and labyrinth disorders
Vertigo
subjects affected / exposed	1 / 78 (1.28%)	1 / 15 (6.67%)	0 / 31 (0.00%)
occurrences all number	1	1	0
Deafness neurosensory
subjects affected / exposed	0 / 78 (0.00%)	1 / 15 (6.67%)	0 / 31 (0.00%)
occurrences all number	0	1	0
Ear haemorrhage
subjects affected / exposed	0 / 78 (0.00%)	1 / 15 (6.67%)	0 / 31 (0.00%)
occurrences all number	0	1	0
Ear pain
subjects affected / exposed	0 / 78 (0.00%)	1 / 15 (6.67%)	0 / 31 (0.00%)
occurrences all number	0	1	0
Eye disorders
Cataract
subjects affected / exposed	1 / 78 (1.28%)	1 / 15 (6.67%)	1 / 31 (3.23%)
occurrences all number	1	1	1
Conjunctival haemorrhage
subjects affected / exposed	0 / 78 (0.00%)	1 / 15 (6.67%)	1 / 31 (3.23%)
occurrences all number	0	1	1
Cataract nuclear
subjects affected / exposed	0 / 78 (0.00%)	1 / 15 (6.67%)	0 / 31 (0.00%)
occurrences all number	0	1	0
Iridocyclitis
subjects affected / exposed	0 / 78 (0.00%)	1 / 15 (6.67%)	0 / 31 (0.00%)
occurrences all number	0	1	0
Gastrointestinal disorders
Diarrhoea
subjects affected / exposed	3 / 78 (3.85%)	3 / 15 (20.00%)	6 / 31 (19.35%)
occurrences all number	3	4	7
Constipation
subjects affected / exposed	2 / 78 (2.56%)	4 / 15 (26.67%)	3 / 31 (9.68%)
occurrences all number	2	4	4
Ascites
subjects affected / exposed	0 / 78 (0.00%)	2 / 15 (13.33%)	4 / 31 (12.90%)
occurrences all number	0	2	5
Abdominal pain
subjects affected / exposed	2 / 78 (2.56%)	1 / 15 (6.67%)	2 / 31 (6.45%)
occurrences all number	2	1	2
Toothache
subjects affected / exposed	3 / 78 (3.85%)	1 / 15 (6.67%)	0 / 31 (0.00%)
occurrences all number	3	2	0
Dental caries
subjects affected / exposed	0 / 78 (0.00%)	1 / 15 (6.67%)	2 / 31 (6.45%)
occurrences all number	0	1	2
Haemorrhoids
subjects affected / exposed	2 / 78 (2.56%)	1 / 15 (6.67%)	0 / 31 (0.00%)
occurrences all number	2	1	0
Nausea
subjects affected / exposed	1 / 78 (1.28%)	1 / 15 (6.67%)	1 / 31 (3.23%)
occurrences all number	1	1	1
Vomiting
subjects affected / exposed	0 / 78 (0.00%)	1 / 15 (6.67%)	2 / 31 (6.45%)
occurrences all number	0	1	2
Abdominal pain lower
subjects affected / exposed	1 / 78 (1.28%)	1 / 15 (6.67%)	0 / 31 (0.00%)
occurrences all number	1	1	0
Flatulence
subjects affected / exposed	0 / 78 (0.00%)	0 / 15 (0.00%)	2 / 31 (6.45%)
occurrences all number	0	0	2
Portal hypertensive gastropathy
subjects affected / exposed	0 / 78 (0.00%)	0 / 15 (0.00%)	2 / 31 (6.45%)
occurrences all number	0	0	2
Mouth ulceration
subjects affected / exposed	0 / 78 (0.00%)	1 / 15 (6.67%)	0 / 31 (0.00%)
occurrences all number	0	1	0
Peptic ulcer
subjects affected / exposed	0 / 78 (0.00%)	1 / 15 (6.67%)	0 / 31 (0.00%)
occurrences all number	0	1	0
Stomatitis
subjects affected / exposed	0 / 78 (0.00%)	1 / 15 (6.67%)	0 / 31 (0.00%)
occurrences all number	0	1	0
Hepatobiliary disorders
Jaundice
subjects affected / exposed	0 / 78 (0.00%)	1 / 15 (6.67%)	0 / 31 (0.00%)
occurrences all number	0	1	0
Skin and subcutaneous tissue disorders
Pruritus
subjects affected / exposed	3 / 78 (3.85%)	2 / 15 (13.33%)	1 / 31 (3.23%)
occurrences all number	3	3	1
Dermatitis
subjects affected / exposed	1 / 78 (1.28%)	1 / 15 (6.67%)	0 / 31 (0.00%)
occurrences all number	1	1	0
Skin lesion
subjects affected / exposed	0 / 78 (0.00%)	1 / 15 (6.67%)	0 / 31 (0.00%)
occurrences all number	0	1	0
Renal and urinary disorders
Haematuria
subjects affected / exposed	3 / 78 (3.85%)	1 / 15 (6.67%)	1 / 31 (3.23%)
occurrences all number	3	1	1
Chronic kidney disease
subjects affected / exposed	0 / 78 (0.00%)	0 / 15 (0.00%)	2 / 31 (6.45%)
occurrences all number	0	0	2
Renal mass
subjects affected / exposed	0 / 78 (0.00%)	1 / 15 (6.67%)	0 / 31 (0.00%)
occurrences all number	0	1	0
Musculoskeletal and connective tissue disorders
Arthralgia
subjects affected / exposed	0 / 78 (0.00%)	2 / 15 (13.33%)	3 / 31 (9.68%)
occurrences all number	0	3	3
Musculoskeletal pain
subjects affected / exposed	1 / 78 (1.28%)	3 / 15 (20.00%)	1 / 31 (3.23%)
occurrences all number	1	6	1
Back pain
subjects affected / exposed	2 / 78 (2.56%)	1 / 15 (6.67%)	0 / 31 (0.00%)
occurrences all number	2	1	0
Bone loss
subjects affected / exposed	0 / 78 (0.00%)	1 / 15 (6.67%)	0 / 31 (0.00%)
occurrences all number	0	1	0
Groin pain
subjects affected / exposed	0 / 78 (0.00%)	1 / 15 (6.67%)	0 / 31 (0.00%)
occurrences all number	0	1	0
Infections and infestations
Upper respiratory tract infection
subjects affected / exposed	11 / 78 (14.10%)	3 / 15 (20.00%)	6 / 31 (19.35%)
occurrences all number	25	8	22
Nasopharyngitis
subjects affected / exposed	6 / 78 (7.69%)	0 / 15 (0.00%)	0 / 31 (0.00%)
occurrences all number	14	0	0
Pneumonia
subjects affected / exposed	2 / 78 (2.56%)	1 / 15 (6.67%)	1 / 31 (3.23%)
occurrences all number	2	1	1
Urinary tract infection
subjects affected / exposed	3 / 78 (3.85%)	1 / 15 (6.67%)	0 / 31 (0.00%)
occurrences all number	3	1	0
Conjunctivitis
subjects affected / exposed	0 / 78 (0.00%)	1 / 15 (6.67%)	2 / 31 (6.45%)
occurrences all number	0	1	2
Cellulitis
subjects affected / exposed	0 / 78 (0.00%)	1 / 15 (6.67%)	0 / 31 (0.00%)
occurrences all number	0	1	0
Endophthalmitis
subjects affected / exposed	0 / 78 (0.00%)	1 / 15 (6.67%)	0 / 31 (0.00%)
occurrences all number	0	1	0
Hordeolum
subjects affected / exposed	0 / 78 (0.00%)	1 / 15 (6.67%)	0 / 31 (0.00%)
occurrences all number	0	1	0
Skin infection
subjects affected / exposed	0 / 78 (0.00%)	1 / 15 (6.67%)	0 / 31 (0.00%)
occurrences all number	0	1	0
Metabolism and nutrition disorders
Hyperkalaemia
subjects affected / exposed	1 / 78 (1.28%)	2 / 15 (13.33%)	0 / 31 (0.00%)
occurrences all number	1	2	0
Hyperlipidaemia
subjects affected / exposed	1 / 78 (1.28%)	0 / 15 (0.00%)	2 / 31 (6.45%)
occurrences all number	1	0	2
Hypokalaemia
subjects affected / exposed	0 / 78 (0.00%)	1 / 15 (6.67%)	1 / 31 (3.23%)
occurrences all number	0	1	1
Metabolic acidosis
subjects affected / exposed	0 / 78 (0.00%)	1 / 15 (6.67%)	0 / 31 (0.00%)
occurrences all number	0	1	0
Vitamin B12 deficiency
subjects affected / exposed	0 / 78 (0.00%)	1 / 15 (6.67%)	0 / 31 (0.00%)
occurrences all number	0	1	0

More information

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Were there any global substantial amendments to the protocol? Yes

23 May 2017

1. Clarified that imaging for HCC must have been performed within 6 months of screening. 2. Total bilirubin > 2.5 × ULN was included as a biochemical abnormality. 3. Clarified that for subjects who had sequence analysis for HBV resistance mutations, phenotypic analysis would also be performed. 4. Clarified that for subjects receiving hemodialysis, study drug would not be administered until after any postdialysis samples had been collected. 5. Clarified in-clinic dosing requirements at Weeks 4, 8, and 12.

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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Clinical trials

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Percentage of Participants Achieving Virologic Response (Plasma Hepatitis B Virus [HBV] Deoxyribonucleic Acid [DNA] < 20 IU/mL) at Week 24

Primary: Percentage of Participants Achieving Virologic Response (Plasma Hepatitis B Virus [HBV] Deoxyribonucleic Acid [DNA] < 20 IU/mL) at Week 24

Primary: Percentage of Participants Who Experienced Graded Treatment-Emergent Adverse Events (AEs) at Week 24

Primary: Percentage of Participants Who Experienced Graded Treatment-Emergent Adverse Events (AEs) at Week 24

Primary: Percentage of Participants Who Experienced Graded Treatment-Emergent Laboratory Abnormalities at Week 24

Primary: Percentage of Participants Who Experienced Graded Treatment-Emergent Laboratory Abnormalities at Week 24

Secondary: Percentage of Participants Who Experienced Graded Treatment-Emergent AEs at Week 48

Secondary: Percentage of Participants Who Experienced Graded Treatment-Emergent AEs at Week 48

Secondary: Percentage of Participants Who Experienced Graded Treatment-Emergent AEs at Week 96

Secondary: Percentage of Participants Who Experienced Graded Treatment-Emergent AEs at Week 96

Secondary: Percentage of Participants Who Experienced Graded Treatment-Emergent Laboratory Abnormalities at Week 48

Secondary: Percentage of Participants Who Experienced Graded Treatment-Emergent Laboratory Abnormalities at Week 48

Secondary: Percentage of Participants Who Experienced Graded Treatment-Emergent Laboratory Abnormalities at Week 96

Secondary: Percentage of Participants Who Experienced Graded Treatment-Emergent Laboratory Abnormalities at Week 96

Secondary: 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

Secondary: 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

Secondary: Change From Baseline in eGFRcg in Participants With Moderate or Severe Renal Impairment and Hepatically Impaired Participants at Week 48

Secondary: Change From Baseline in eGFRcg in Participants With Moderate or Severe Renal Impairment and Hepatically Impaired Participants at Week 48

Secondary: Change From Baseline in eGFRcg in Participants With Moderate or Severe Renal Impairment and Hepatically Impaired Participants at Week 96

Secondary: Change From Baseline in eGFRcg in Participants With Moderate or Severe Renal Impairment and Hepatically Impaired Participants at Week 96

Secondary: Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 24

Secondary: Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 24

Secondary: Percent Change From Baseline in Hip BMD at Week 48

Secondary: Percent Change From Baseline in Hip BMD at Week 48

Secondary: Percent Change From Baseline in Hip BMD at Week 96

Secondary: Percent Change From Baseline in Hip BMD at Week 96

Secondary: Percent Change From Baseline in Spine BMD at Week 24

Secondary: Percent Change From Baseline in Spine BMD at Week 24

Secondary: Percent Change From Baseline in Spine BMD at Week 48

Secondary: Percent Change From Baseline in Spine BMD at Week 48

Secondary: Percent Change From Baseline in Spine BMD at Week 96

Secondary: Percent Change From Baseline in Spine BMD at Week 96

Secondary: Percentage of Participants Achieving Virologic Response (Plasma HBV DNA < 20 IU/mL) at Week 48

Secondary: Percentage of Participants Achieving Virologic Response (Plasma HBV DNA < 20 IU/mL) at Week 48

Secondary: Percentage of Participants Achieving Virologic Response (Plasma HBV DNA < 20 IU/mL) at Week 96

Secondary: Percentage of Participants Achieving Virologic Response (Plasma HBV DNA < 20 IU/mL) at Week 96

Secondary: Percentage of Participants With Plasma HBV DNA < 20 IU/mL and Target Detected (≥ Lower Limit of Detection [LLOD]) at Week 24

Secondary: Percentage of Participants With Plasma HBV DNA < 20 IU/mL and Target Detected (≥ Lower Limit of Detection [LLOD]) at Week 24

Secondary: Percentage of Participants With Plasma HBV DNA < 20 IU/mL and Target Detected (≥ LLOD) at Week 48

Secondary: Percentage of Participants With Plasma HBV DNA < 20 IU/mL and Target Detected (≥ LLOD) at Week 48

Secondary: Percentage of Participants With Plasma HBV DNA < 20 IU/mL and Target Detected (≥ LLOD) at Week 96

Secondary: Percentage of Participants With Plasma HBV DNA < 20 IU/mL and Target Detected (≥ LLOD) at Week 96

Secondary: Percentage of Participants With Plasma HBV DNA < 20 IU/mL and Target Not Detected (< LLOD) at Week 24

Secondary: Percentage of Participants With Plasma HBV DNA < 20 IU/mL and Target Not Detected (< LLOD) at Week 24

Secondary: Percentage of Participants With Plasma HBV DNA < 20 IU/mL and Target Not Detected (< LLOD) at Week 48

Secondary: Percentage of Participants With Plasma HBV DNA < 20 IU/mL and Target Not Detected (< LLOD) at Week 48

Secondary: Percentage of Participants With Plasma HBV DNA < 20 IU/mL and Target Not Detected (< LLOD) at Week 96

Secondary: Percentage of Participants With Plasma HBV DNA < 20 IU/mL and Target Not Detected (< LLOD) at Week 96

Secondary: Percentage of Participants With Serological Response: Loss of Hepatitis B s-Antigen (HBsAg) at Week 24

Secondary: Percentage of Participants With Serological Response: Loss of Hepatitis B s-Antigen (HBsAg) at Week 24

Secondary: Percentage of Participants With Serological Response: Loss of HBsAg at Week 48

Secondary: Percentage of Participants With Serological Response: Loss of HBsAg at Week 48

Secondary: Percentage of Participants With Serological Response: Loss of HBsAg at Week 96

Secondary: Percentage of Participants With Serological Response: Loss of HBsAg at Week 96

Secondary: Percentage of Participants With Serological Response: Seroconversion to Anti-HBs at Week 24

Secondary: Percentage of Participants With Serological Response: Seroconversion to Anti-HBs at Week 24

Secondary: Percentage of Participants With Serological Response: Seroconversion to Anti-HBs at Week 48

Secondary: Percentage of Participants With Serological Response: Seroconversion to Anti-HBs at Week 48

Secondary: Percentage of Participants With Serological Response: Seroconversion to Anti-HBs at Week 96

Secondary: Percentage of Participants With Serological Response: Seroconversion to Anti-HBs at Week 96

Secondary: Percentage of Participants With Serological Response: Loss of HBeAg in HBeAg-Positive Participants at Week 24

Secondary: Percentage of Participants With Serological Response: Loss of HBeAg in HBeAg-Positive Participants at Week 24

Secondary: Percentage of Participants With Serological Response: Loss of HBeAg in HBeAg-Positive Participants at Week 48

Secondary: Percentage of Participants With Serological Response: Loss of HBeAg in HBeAg-Positive Participants at Week 48

Secondary: Percentage of Participants With Serological Response: Loss of HBeAg in HBeAg-Positive Participants at Week 96

Secondary: Percentage of Participants With Serological Response: Loss of HBeAg in HBeAg-Positive Participants at Week 96

Secondary: Percentage of Participants With Serological Response: Seroconversion to Anti-HBe in HBeAg-Positive Participants at Week 24

Secondary: Percentage of Participants With Serological Response: Seroconversion to Anti-HBe in HBeAg-Positive Participants at Week 24

Secondary: Percentage of Participants With Serological Response: Seroconversion to Anti-HBe in HBeAg-Positive Participants at Week 48

Secondary: Percentage of Participants With Serological Response: Seroconversion to Anti-HBe in HBeAg-Positive Participants at Week 48

Secondary: Percentage of Participants With Serological Response: Seroconversion to Anti-HBe in HBeAg-Positive Participants at Week 96