Trial Outcomes & Findings for A Study Evaluating ABI-H0731-containing Regimens in Chinese Participants With Chronic Hepatitis B Virus Infection (NCT NCT04781647)

NCT ID: NCT04781647

Last Updated: 2023-10-06

Results Overview

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 54 participants
• Primary outcome timeframe: Up to 60 weeks
• Results posted on: 2023-10-06

Participant Flow

Participant milestones

Measure	ABI-H0731 + Entecavir (ETV) Participants with cHBV received ABI-H0731 with ETV for 48 weeks, followed by ETV alone for 12 weeks or until the study was early terminated ABI-H0731: Participants received ABI-H0731 300 mg tablets orally once daily ETV: Participants received ETV 0.5 mg tablets orally once daily	ABI-H0731 + ETV + Pegylated-interferon Alpha (Peg-IFNα) Participants with cHBV received ABI-H0731 with ETV and Peg-IFNα for 24 weeks, followed by ABI-H0731 with ETV for 24 weeks, followed by ETV alone for 12 weeks or until the study was early terminated ABI-H0731: Participants received ABI-H0731 300 mg tablets orally once daily ETV: Participants received ETV 0.5 mg tablets orally once daily Peg-IFNα: Participants received Peg-IFNα with a starting dose of 180 µg solution by subcutaneous injection once weekly	ETV + Peg-IFNα Participants with cHBV received ETV and Peg-IFNα for 24 weeks, followed by ABI-H0731 with ETV for 24 weeks, followed by ETV alone for 12 weeks or until the study was early terminated ETV: Participants received ETV 0.5 mg tablets orally once daily Peg-IFNα: Participants received Peg-IFNα with a starting dose of 180 µg solution by subcutaneous injection once weekly
Overall Study STARTED	20	17	17
Overall Study COMPLETED	6	5	6
Overall Study NOT COMPLETED	14	12	11

Reasons for withdrawal

Measure	ABI-H0731 + Entecavir (ETV) Participants with cHBV received ABI-H0731 with ETV for 48 weeks, followed by ETV alone for 12 weeks or until the study was early terminated ABI-H0731: Participants received ABI-H0731 300 mg tablets orally once daily ETV: Participants received ETV 0.5 mg tablets orally once daily	ABI-H0731 + ETV + Pegylated-interferon Alpha (Peg-IFNα) Participants with cHBV received ABI-H0731 with ETV and Peg-IFNα for 24 weeks, followed by ABI-H0731 with ETV for 24 weeks, followed by ETV alone for 12 weeks or until the study was early terminated ABI-H0731: Participants received ABI-H0731 300 mg tablets orally once daily ETV: Participants received ETV 0.5 mg tablets orally once daily Peg-IFNα: Participants received Peg-IFNα with a starting dose of 180 µg solution by subcutaneous injection once weekly	ETV + Peg-IFNα Participants with cHBV received ETV and Peg-IFNα for 24 weeks, followed by ABI-H0731 with ETV for 24 weeks, followed by ETV alone for 12 weeks or until the study was early terminated ETV: Participants received ETV 0.5 mg tablets orally once daily Peg-IFNα: Participants received Peg-IFNα with a starting dose of 180 µg solution by subcutaneous injection once weekly
Overall Study Study terminated by Sponsor	11	9	9
Overall Study Withdrawal by Subject	1	2	0
Overall Study Adverse Event	0	1	1
Overall Study Protocol Violation	1	0	0
Overall Study Pregnancy	0	0	1
Overall Study Virology rebounded	1	0	0

Baseline Characteristics

Some participants had an unknown number of years positive for HBV so they were not included in the analysis.

Baseline characteristics by cohort

Measure	ABI-H0731 + ETV n=20 Participants Participants with cHBV received ABI-H0731 with ETV for 48 weeks, followed by ETV alone for 12 weeks or until the study was early terminated ABI-H0731: Participants received ABI-H0731 300 mg tablets orally once daily ETV: Participants received ETV 0.5 mg tablets orally once daily	ABI-H0731 + ETV + Peg-IFNα n=17 Participants Participants with cHBV received ABI-H0731 with ETV and Peg-IFNα for 24 weeks, followed by ABI-H0731 with ETV for 24 weeks, followed by ETV alone for 12 weeks or until the study was early terminated ABI-H0731: Participants received ABI-H0731 300 mg tablets orally once daily ETV: Participants received ETV 0.5 mg tablets orally once daily Peg-IFNα: Participants received Peg-IFNα with a starting dose of 180 µg solution by subcutaneous injection once weekly	ETV + Peg-IFNα n=17 Participants Participants with cHBV received ETV and Peg-IFNα for 24 weeks, followed by ABI-H0731 with ETV for 24 weeks, followed by ETV alone for 12 weeks or until the study was early terminated ETV: Participants received ETV 0.5 mg tablets orally once daily Peg-IFNα: Participants received Peg-IFNα with a starting dose of 180 µg solution by subcutaneous injection once weekly	Total n=54 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=20 Participants	0 Participants n=17 Participants	0 Participants n=17 Participants	0 Participants n=54 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=20 Participants	17 Participants n=17 Participants	17 Participants n=17 Participants	54 Participants n=54 Participants
Age, Categorical >=65 years	0 Participants n=20 Participants	0 Participants n=17 Participants	0 Participants n=17 Participants	0 Participants n=54 Participants
Age, Continuous	33 years STANDARD_DEVIATION 6.6 • n=20 Participants	31 years STANDARD_DEVIATION 5.8 • n=17 Participants	34 years STANDARD_DEVIATION 7.8 • n=17 Participants	32 years STANDARD_DEVIATION 6.7 • n=54 Participants
Sex: Female, Male Female	15 Participants n=20 Participants	14 Participants n=17 Participants	10 Participants n=17 Participants	39 Participants n=54 Participants
Sex: Female, Male Male	5 Participants n=20 Participants	3 Participants n=17 Participants	7 Participants n=17 Participants	15 Participants n=54 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=20 Participants	0 Participants n=17 Participants	0 Participants n=17 Participants	0 Participants n=54 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	20 Participants n=20 Participants	17 Participants n=17 Participants	17 Participants n=17 Participants	54 Participants n=54 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=20 Participants	0 Participants n=17 Participants	0 Participants n=17 Participants	0 Participants n=54 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=20 Participants	0 Participants n=17 Participants	0 Participants n=17 Participants	0 Participants n=54 Participants
Race (NIH/OMB) Asian	20 Participants n=20 Participants	17 Participants n=17 Participants	17 Participants n=17 Participants	54 Participants n=54 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=20 Participants	0 Participants n=17 Participants	0 Participants n=17 Participants	0 Participants n=54 Participants
Race (NIH/OMB) Black or African American	0 Participants n=20 Participants	0 Participants n=17 Participants	0 Participants n=17 Participants	0 Participants n=54 Participants
Race (NIH/OMB) White	0 Participants n=20 Participants	0 Participants n=17 Participants	0 Participants n=17 Participants	0 Participants n=54 Participants
Race (NIH/OMB) More than one race	0 Participants n=20 Participants	0 Participants n=17 Participants	0 Participants n=17 Participants	0 Participants n=54 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=20 Participants	0 Participants n=17 Participants	0 Participants n=17 Participants	0 Participants n=54 Participants
Region of Enrollment China	20 participants n=20 Participants	17 participants n=17 Participants	17 participants n=17 Participants	54 participants n=54 Participants
Body Mass Index	22.51 kg/m^2 STANDARD_DEVIATION 2.683 • n=20 Participants	22.90 kg/m^2 STANDARD_DEVIATION 2.407 • n=17 Participants	23.44 kg/m^2 STANDARD_DEVIATION 3.457 • n=17 Participants	22.93 kg/m^2 STANDARD_DEVIATION 2.843 • n=54 Participants
Years positive for HBV	11.3 years STANDARD_DEVIATION 9.23 • n=19 Participants • Some participants had an unknown number of years positive for HBV so they were not included in the analysis.	11.2 years STANDARD_DEVIATION 9.43 • n=15 Participants • Some participants had an unknown number of years positive for HBV so they were not included in the analysis.	11.2 years STANDARD_DEVIATION 8.91 • n=14 Participants • Some participants had an unknown number of years positive for HBV so they were not included in the analysis.	11.3 years STANDARD_DEVIATION 9.00 • n=48 Participants • Some participants had an unknown number of years positive for HBV so they were not included in the analysis.
HBV Genotype Genotype A	0 Participants n=20 Participants	0 Participants n=17 Participants	0 Participants n=17 Participants	0 Participants n=54 Participants
HBV Genotype Genotype B	9 Participants n=20 Participants	8 Participants n=17 Participants	8 Participants n=17 Participants	25 Participants n=54 Participants
HBV Genotype Genotype C	11 Participants n=20 Participants	9 Participants n=17 Participants	9 Participants n=17 Participants	29 Participants n=54 Participants
HBV Genotype Genotype D	0 Participants n=20 Participants	0 Participants n=17 Participants	0 Participants n=17 Participants	0 Participants n=54 Participants
HBV Genotype Other Genotype	0 Participants n=20 Participants	0 Participants n=17 Participants	0 Participants n=17 Participants	0 Participants n=54 Participants
HBV DNA (Log10 IU/mL)	8.2 Log 10 IU/mL STANDARD_DEVIATION 1.02 • n=20 Participants	7.7 Log 10 IU/mL STANDARD_DEVIATION 1.11 • n=17 Participants	8.1 Log 10 IU/mL STANDARD_DEVIATION 0.63 • n=17 Participants	8.0 Log 10 IU/mL STANDARD_DEVIATION 0.96 • n=54 Participants
HBV pgRNA (Log10 U/mL)	6.5 Log10 U/mL STANDARD_DEVIATION 1.33 • n=20 Participants	5.8 Log10 U/mL STANDARD_DEVIATION 1.43 • n=17 Participants	6.5 Log10 U/mL STANDARD_DEVIATION 1.05 • n=17 Participants	6.3 Log10 U/mL STANDARD_DEVIATION 1.30 • n=54 Participants
HBcrAg (Log10 kU/mL)	5.5 Log10 kU/mL STANDARD_DEVIATION .59 • n=20 Participants	5.0 Log10 kU/mL STANDARD_DEVIATION .71 • n=17 Participants	5.4 Log10 kU/mL STANDARD_DEVIATION .46 • n=17 Participants	5.3 Log10 kU/mL STANDARD_DEVIATION .62 • n=54 Participants
HBeAg (Log10 IU/mL)	2.7 Log10 IU/mL STANDARD_DEVIATION .81 • n=20 Participants	2.4 Log10 IU/mL STANDARD_DEVIATION .89 • n=17 Participants	2.7 Log10 IU/mL STANDARD_DEVIATION .64 • n=17 Participants	2.6 Log10 IU/mL STANDARD_DEVIATION .79 • n=54 Participants
HBsAg (Log10 IU/mL)	4.5 Log10 IU/mL STANDARD_DEVIATION .39 • n=20 Participants	4.1 Log10 IU/mL STANDARD_DEVIATION .76 • n=17 Participants	4.3 Log10 IU/mL STANDARD_DEVIATION .53 • n=17 Participants	4.3 Log10 IU/mL STANDARD_DEVIATION .58 • n=54 Participants
ALT (U/L)	149 U/L STANDARD_DEVIATION 65.0 • n=20 Participants	138 U/L STANDARD_DEVIATION 121.2 • n=17 Participants	123 U/L STANDARD_DEVIATION 58.5 • n=17 Participants	137 U/L STANDARD_DEVIATION 84.3 • n=54 Participants

PRIMARY outcome

Timeframe: Up to 60 weeks

Outcome measures

Measure	ABI-H0731 + ETV n=20 Participants Participants with cHBV received ABI-H0731 with ETV for 48 weeks, followed by ETV alone for 12 weeks or until the study was early terminated. ABI-H0731: Participants received ABI-H0731 300 mg tablets orally once daily ETV: Participants received ETV 0.5 mg tablets orally once daily	ABI-H0731 + ETV + Peg-IFNα n=17 Participants Participants with cHBV received ABI-H0731 with ETV and Peg-IFNα for 24 weeks, followed by ABI-H0731 with ETV for 24 weeks, followed by ETV alone for 12 weeks or until the study was early terminated. ABI-H0731: Participants received ABI-H0731 300 mg tablets orally once daily ETV: Participants received ETV 0.5 mg tablets orally once daily Peg-IFNα: Participants received Peg-IFNα with a starting dose of 180 µg solution by subcutaneous injection once weekly	ETV + Peg-IFNα n=17 Participants Participants with cHBV received ETV and Peg-IFNα for 24 weeks, followed by ABI-H0731 with ETV for 24 weeks, followed by ETV alone for 12 weeks or until the study was early terminated. ETV: Participants received ETV 0.5 mg tablets orally once daily Peg-IFNα: Participants received Peg-IFNα with a starting dose of 180 µg solution by subcutaneous injection once weekly
Number of Participants With an Adverse Event	14 Participants	17 Participants	17 Participants

PRIMARY outcome

Timeframe: Up to 60 weeks

Outcome measures

Measure	ABI-H0731 + ETV n=20 Participants Participants with cHBV received ABI-H0731 with ETV for 48 weeks, followed by ETV alone for 12 weeks or until the study was early terminated. ABI-H0731: Participants received ABI-H0731 300 mg tablets orally once daily ETV: Participants received ETV 0.5 mg tablets orally once daily	ABI-H0731 + ETV + Peg-IFNα n=17 Participants Participants with cHBV received ABI-H0731 with ETV and Peg-IFNα for 24 weeks, followed by ABI-H0731 with ETV for 24 weeks, followed by ETV alone for 12 weeks or until the study was early terminated. ABI-H0731: Participants received ABI-H0731 300 mg tablets orally once daily ETV: Participants received ETV 0.5 mg tablets orally once daily Peg-IFNα: Participants received Peg-IFNα with a starting dose of 180 µg solution by subcutaneous injection once weekly	ETV + Peg-IFNα n=17 Participants Participants with cHBV received ETV and Peg-IFNα for 24 weeks, followed by ABI-H0731 with ETV for 24 weeks, followed by ETV alone for 12 weeks or until the study was early terminated. ETV: Participants received ETV 0.5 mg tablets orally once daily Peg-IFNα: Participants received Peg-IFNα with a starting dose of 180 µg solution by subcutaneous injection once weekly
Number of Participants With Premature Discontinuation of Treatment	18 Participants	17 Participants	11 Participants

PRIMARY outcome

Timeframe: Up to 60 weeks

Outcome measures

Measure	ABI-H0731 + ETV n=20 Participants Participants with cHBV received ABI-H0731 with ETV for 48 weeks, followed by ETV alone for 12 weeks or until the study was early terminated. ABI-H0731: Participants received ABI-H0731 300 mg tablets orally once daily ETV: Participants received ETV 0.5 mg tablets orally once daily	ABI-H0731 + ETV + Peg-IFNα n=17 Participants Participants with cHBV received ABI-H0731 with ETV and Peg-IFNα for 24 weeks, followed by ABI-H0731 with ETV for 24 weeks, followed by ETV alone for 12 weeks or until the study was early terminated. ABI-H0731: Participants received ABI-H0731 300 mg tablets orally once daily ETV: Participants received ETV 0.5 mg tablets orally once daily Peg-IFNα: Participants received Peg-IFNα with a starting dose of 180 µg solution by subcutaneous injection once weekly	ETV + Peg-IFNα n=17 Participants Participants with cHBV received ETV and Peg-IFNα for 24 weeks, followed by ABI-H0731 with ETV for 24 weeks, followed by ETV alone for 12 weeks or until the study was early terminated. ETV: Participants received ETV 0.5 mg tablets orally once daily Peg-IFNα: Participants received Peg-IFNα with a starting dose of 180 µg solution by subcutaneous injection once weekly
Number of Participants With a Laboratory Abnormality	19 Participants	16 Participants	17 Participants

SECONDARY outcome

Timeframe: Baseline and at pre-specified time points up to 60 weeks

Population: Due to early termination of the study, not all subjects reached Week 48.

Outcome measures

Measure	ABI-H0731 + ETV n=20 Participants Participants with cHBV received ABI-H0731 with ETV for 48 weeks, followed by ETV alone for 12 weeks or until the study was early terminated. ABI-H0731: Participants received ABI-H0731 300 mg tablets orally once daily ETV: Participants received ETV 0.5 mg tablets orally once daily	ABI-H0731 + ETV + Peg-IFNα n=17 Participants Participants with cHBV received ABI-H0731 with ETV and Peg-IFNα for 24 weeks, followed by ABI-H0731 with ETV for 24 weeks, followed by ETV alone for 12 weeks or until the study was early terminated. ABI-H0731: Participants received ABI-H0731 300 mg tablets orally once daily ETV: Participants received ETV 0.5 mg tablets orally once daily Peg-IFNα: Participants received Peg-IFNα with a starting dose of 180 µg solution by subcutaneous injection once weekly	ETV + Peg-IFNα n=17 Participants Participants with cHBV received ETV and Peg-IFNα for 24 weeks, followed by ABI-H0731 with ETV for 24 weeks, followed by ETV alone for 12 weeks or until the study was early terminated. ETV: Participants received ETV 0.5 mg tablets orally once daily Peg-IFNα: Participants received Peg-IFNα with a starting dose of 180 µg solution by subcutaneous injection once weekly
Mean Change From Baseline in HBV pgRNA Week 1	-1.3 log10 U/mL Standard Deviation .51	-1.5 log10 U/mL Standard Deviation .69	-.5 log10 U/mL Standard Deviation .43
Mean Change From Baseline in HBV pgRNA Week 2	-1.6 log10 U/mL Standard Deviation .58	-1.9 log10 U/mL Standard Deviation .79	-.6 log10 U/mL Standard Deviation .61
Mean Change From Baseline in HBV pgRNA Week 4	-2.0 log10 U/mL Standard Deviation .72	-2.2 log10 U/mL Standard Deviation .74	-.9 log10 U/mL Standard Deviation .70
Mean Change From Baseline in HBV pgRNA Week 6	-2.3 log10 U/mL Standard Deviation .87	-2.6 log10 U/mL Standard Deviation .67	-1.6 log10 U/mL Standard Deviation 1.45
Mean Change From Baseline in HBV pgRNA Week 8	-2.5 log10 U/mL Standard Deviation 1.12	-2.7 log10 U/mL Standard Deviation .95	-2.0 log10 U/mL Standard Deviation 1.75
Mean Change From Baseline in HBV pgRNA Week 12	-2.7 log10 U/mL Standard Deviation 1.15	-3.0 log10 U/mL Standard Deviation 1.17	-2.4 log10 U/mL Standard Deviation 1.72
Mean Change From Baseline in HBV pgRNA Week 16	-2.8 log10 U/mL Standard Deviation 1.28	-2.9 log10 U/mL Standard Deviation 1.34	-2.7 log10 U/mL Standard Deviation 1.68
Mean Change From Baseline in HBV pgRNA Week 20	-2.8 log10 U/mL Standard Deviation 1.38	-3.0 log10 U/mL Standard Deviation 1.35	-2.5 log10 U/mL Standard Deviation 1.61
Mean Change From Baseline in HBV pgRNA Week 24	-2.7 log10 U/mL Standard Deviation 1.55	-3.3 log10 U/mL Standard Deviation 1.41	-2.7 log10 U/mL Standard Deviation 1.67
Mean Change From Baseline in HBV pgRNA Week 28	-2.9 log10 U/mL Standard Deviation 1.66	-3.0 log10 U/mL Standard Deviation 1.3	-3.8 log10 U/mL Standard Deviation 1.63
Mean Change From Baseline in HBV pgRNA Week 32	-3.1 log10 U/mL Standard Deviation 1.52	-3.0 log10 U/mL Standard Deviation .99	-3.2 log10 U/mL Standard Deviation 1.65
Mean Change From Baseline in HBV pgRNA Week 36	-3.3 log10 U/mL Standard Deviation 1.92	-2.9 log10 U/mL Standard Deviation 1.04	-3.8 log10 U/mL Standard Deviation 1.71
Mean Change From Baseline in HBV pgRNA Week 40	-3.1 log10 U/mL Standard Deviation 2.05	-2.5 log10 U/mL Standard Deviation 1.13	-3.3 log10 U/mL Standard Deviation 1.63
Mean Change From Baseline in HBV pgRNA Week 44	-4.0 log10 U/mL Standard Deviation 1.45	-3.3 log10 U/mL Standard Deviation .81	-3.0 log10 U/mL Standard Deviation 2.39
Mean Change From Baseline in HBV pgRNA Week 48	-4.2 log10 U/mL Standard Deviation 1.13	-2.4 log10 U/mL Standard Deviation 1.63	-2.9 log10 U/mL Standard Deviation 1.81

SECONDARY outcome

Timeframe: Baseline and at pre-specified time points up to 60 weeks

Population: Due to early termination of the study, not all subjects reached Week 48.

Outcome measures

Measure	ABI-H0731 + ETV n=20 Participants Participants with cHBV received ABI-H0731 with ETV for 48 weeks, followed by ETV alone for 12 weeks or until the study was early terminated. ABI-H0731: Participants received ABI-H0731 300 mg tablets orally once daily ETV: Participants received ETV 0.5 mg tablets orally once daily	ABI-H0731 + ETV + Peg-IFNα n=17 Participants Participants with cHBV received ABI-H0731 with ETV and Peg-IFNα for 24 weeks, followed by ABI-H0731 with ETV for 24 weeks, followed by ETV alone for 12 weeks or until the study was early terminated. ABI-H0731: Participants received ABI-H0731 300 mg tablets orally once daily ETV: Participants received ETV 0.5 mg tablets orally once daily Peg-IFNα: Participants received Peg-IFNα with a starting dose of 180 µg solution by subcutaneous injection once weekly	ETV + Peg-IFNα n=17 Participants Participants with cHBV received ETV and Peg-IFNα for 24 weeks, followed by ABI-H0731 with ETV for 24 weeks, followed by ETV alone for 12 weeks or until the study was early terminated. ETV: Participants received ETV 0.5 mg tablets orally once daily Peg-IFNα: Participants received Peg-IFNα with a starting dose of 180 µg solution by subcutaneous injection once weekly
Mean Change From Baseline HBV DNA Week 1	-2.1 log10 IU/mL Standard Deviation .64	-2.1 log10 IU/mL Standard Deviation .53	-2.2 log10 IU/mL Standard Deviation .51
Mean Change From Baseline HBV DNA Week 2	-2.5 log10 IU/mL Standard Deviation .76	-2.6 log10 IU/mL Standard Deviation .81	-2.7 log10 IU/mL Standard Deviation .61
Mean Change From Baseline HBV DNA Week 4	-3.2 log10 IU/mL Standard Deviation .92	-2.9 log10 IU/mL Standard Deviation .70	-3.4 log10 IU/mL Standard Deviation .72
Mean Change From Baseline HBV DNA Week 6	-3.6 log10 IU/mL Standard Deviation 1.07	-3.6 log10 IU/mL Standard Deviation .99	-4.0 log10 IU/mL Standard Deviation .94
Mean Change From Baseline HBV DNA Week 8	-4.2 log10 IU/mL Standard Deviation 1.21	-4.1 log10 IU/mL Standard Deviation 1.13	-4.5 log10 IU/mL Standard Deviation .97
Mean Change From Baseline HBV DNA Week 12	-4.9 log10 IU/mL Standard Deviation 1.18	-4.4 log10 IU/mL Standard Deviation 1.00	-5.1 log10 IU/mL Standard Deviation .89
Mean Change From Baseline HBV DNA Week 16	-5.5 log10 IU/mL Standard Deviation 1.06	-5.2 log10 IU/mL Standard Deviation 1.13	-5.6 log10 IU/mL Standard Deviation .74
Mean Change From Baseline HBV DNA Week 20	-5.8 log10 IU/mL Standard Deviation .99	-5.6 log10 IU/mL Standard Deviation 1.05	-6.1 log10 IU/mL Standard Deviation .75
Mean Change From Baseline HBV DNA Week 24	-6.0 log10 IU/mL Standard Deviation .94	-6.0 log10 IU/mL Standard Deviation .92	-6.5 log10 IU/mL Standard Deviation .67
Mean Change From Baseline HBV DNA Week 28	-6.2 log10 IU/mL Standard Deviation .82	-6.3 log10 IU/mL Standard Deviation .87	-6.7 log10 IU/mL Standard Deviation .67
Mean Change From Baseline HBV DNA Week 32	-6.2 log10 IU/mL Standard Deviation .93	-6.2 log10 IU/mL Standard Deviation .94	-6.7 log10 IU/mL Standard Deviation .52
Mean Change From Baseline HBV DNA Week 36	-6.2 log10 IU/mL Standard Deviation 1.05	-6.2 log10 IU/mL Standard Deviation 1.15	-6.9 log10 IU/mL Standard Deviation .5
Mean Change From Baseline HBV DNA Week 40	-6.2 log10 IU/mL Standard Deviation 1.17	-6.0 log10 IU/mL Standard Deviation 1.10	-6.7 log10 IU/mL Standard Deviation .63
Mean Change From Baseline HBV DNA Week 44	-6.5 log10 IU/mL Standard Deviation 1.15	-5.8 log10 IU/mL Standard Deviation 1.4	-6.6 log10 IU/mL Standard Deviation .68
Mean Change From Baseline HBV DNA Week 48	-6.7 log10 IU/mL Standard Deviation 1.27	-5.9 log10 IU/mL Standard Deviation 1.16	-6.8 log10 IU/mL Standard Deviation .75

SECONDARY outcome

Timeframe: Baseline and at pre-specified time points up to 60 weeks

Population: Due to early termination of the study, not all subjects reached Week 48.

Outcome measures

Measure	ABI-H0731 + ETV n=20 Participants Participants with cHBV received ABI-H0731 with ETV for 48 weeks, followed by ETV alone for 12 weeks or until the study was early terminated. ABI-H0731: Participants received ABI-H0731 300 mg tablets orally once daily ETV: Participants received ETV 0.5 mg tablets orally once daily	ABI-H0731 + ETV + Peg-IFNα n=17 Participants Participants with cHBV received ABI-H0731 with ETV and Peg-IFNα for 24 weeks, followed by ABI-H0731 with ETV for 24 weeks, followed by ETV alone for 12 weeks or until the study was early terminated. ABI-H0731: Participants received ABI-H0731 300 mg tablets orally once daily ETV: Participants received ETV 0.5 mg tablets orally once daily Peg-IFNα: Participants received Peg-IFNα with a starting dose of 180 µg solution by subcutaneous injection once weekly	ETV + Peg-IFNα n=17 Participants Participants with cHBV received ETV and Peg-IFNα for 24 weeks, followed by ABI-H0731 with ETV for 24 weeks, followed by ETV alone for 12 weeks or until the study was early terminated. ETV: Participants received ETV 0.5 mg tablets orally once daily Peg-IFNα: Participants received Peg-IFNα with a starting dose of 180 µg solution by subcutaneous injection once weekly
Mean Change From Baseline in HBeAg Week 8	-.6 log10 IU/mL Standard Deviation .59	-.8 log10 IU/mL Standard Deviation .61	-.9 log10 IU/mL Standard Deviation .77
Mean Change From Baseline in HBeAg Week 12	-.8 log10 IU/mL Standard Deviation .66	-.8 log10 IU/mL Standard Deviation .46	-1.1 log10 IU/mL Standard Deviation .74
Mean Change From Baseline in HBeAg Week 16	-1.0 log10 IU/mL Standard Deviation .78	-.9 log10 IU/mL Standard Deviation .50	-1.2 log10 IU/mL Standard Deviation .73
Mean Change From Baseline in HBeAg Week 20	-1.1 log10 IU/mL Standard Deviation .83	-1.1 log10 IU/mL Standard Deviation .68	-1.3 log10 IU/mL Standard Deviation .76
Mean Change From Baseline in HBeAg Week 24	-1.1 log10 IU/mL Standard Deviation .91	-1.2 log10 IU/mL Standard Deviation .73	-1.3 log10 IU/mL Standard Deviation .78
Mean Change From Baseline in HBeAg Week 28	-1.2 log10 IU/mL Standard Deviation .93	-1.2 log10 IU/mL Standard Deviation .71	-1.4 log10 IU/mL Standard Deviation .79
Mean Change From Baseline in HBeAg Week 32	-1.4 log10 IU/mL Standard Deviation .87	-1.2 log10 IU/mL Standard Deviation .70	-1.5 log10 IU/mL Standard Deviation .83
Mean Change From Baseline in HBeAg Week 36	-1.5 log10 IU/mL Standard Deviation .97	-1.1 log10 IU/mL Standard Deviation .61	-1.7 log10 IU/mL Standard Deviation .84
Mean Change From Baseline in HBeAg Week 40	-1.5 log10 IU/mL Standard Deviation .95	-1.2 log10 IU/mL Standard Deviation .65	-1.8 log10 IU/mL Standard Deviation 1.00
Mean Change From Baseline in HBeAg Week 44	-1.8 log10 IU/mL Standard Deviation .83	-1.1 log10 IU/mL Standard Deviation .57	-1.9 log10 IU/mL Standard Deviation 1.07
Mean Change From Baseline in HBeAg Week 48	-1.9 log10 IU/mL Standard Deviation .88	-1.1 log10 IU/mL Standard Deviation .55	-2.1 log10 IU/mL Standard Deviation .96

SECONDARY outcome

Timeframe: Baseline and at pre-specified time points up to 60 weeks

Population: Due to early termination of the study, not all subjects reached Week 48.

Outcome measures

Measure	ABI-H0731 + ETV n=20 Participants Participants with cHBV received ABI-H0731 with ETV for 48 weeks, followed by ETV alone for 12 weeks or until the study was early terminated. ABI-H0731: Participants received ABI-H0731 300 mg tablets orally once daily ETV: Participants received ETV 0.5 mg tablets orally once daily	ABI-H0731 + ETV + Peg-IFNα n=17 Participants Participants with cHBV received ABI-H0731 with ETV and Peg-IFNα for 24 weeks, followed by ABI-H0731 with ETV for 24 weeks, followed by ETV alone for 12 weeks or until the study was early terminated. ABI-H0731: Participants received ABI-H0731 300 mg tablets orally once daily ETV: Participants received ETV 0.5 mg tablets orally once daily Peg-IFNα: Participants received Peg-IFNα with a starting dose of 180 µg solution by subcutaneous injection once weekly	ETV + Peg-IFNα n=17 Participants Participants with cHBV received ETV and Peg-IFNα for 24 weeks, followed by ABI-H0731 with ETV for 24 weeks, followed by ETV alone for 12 weeks or until the study was early terminated. ETV: Participants received ETV 0.5 mg tablets orally once daily Peg-IFNα: Participants received Peg-IFNα with a starting dose of 180 µg solution by subcutaneous injection once weekly
Mean Change From Baseline in HBcrAg Week 4	-.4 log10 kU/mL Standard Deviation .49	-.4 log10 kU/mL Standard Deviation .43	-.3 log10 kU/mL Standard Deviation .36
Mean Change From Baseline in HBcrAg Week 8	-.6 log10 kU/mL Standard Deviation .59	-.8 log10 kU/mL Standard Deviation .57	-.8 log10 kU/mL Standard Deviation .8
Mean Change From Baseline in HBcrAg Week 12	-.9 log10 kU/mL Standard Deviation .68	-.9 log10 kU/mL Standard Deviation .48	-1.1 log10 kU/mL Standard Deviation .85
Mean Change From Baseline in HBcrAg Week 16	-1.0 log10 kU/mL Standard Deviation .68	-1.0 log10 kU/mL Standard Deviation .57	-1.2 log10 kU/mL Standard Deviation .82
Mean Change From Baseline in HBcrAg Week 20	-1.1 log10 kU/mL Standard Deviation .76	-1.2 log10 kU/mL Standard Deviation .66	-1.3 log10 kU/mL Standard Deviation .86
Mean Change From Baseline in HBcrAg Week 24	-1.2 log10 kU/mL Standard Deviation .81	-1.3 log10 kU/mL Standard Deviation .73	-1.4 log10 kU/mL Standard Deviation .88
Mean Change From Baseline in HBcrAg Week 28	-1.2 log10 kU/mL Standard Deviation .86	-1.3 log10 kU/mL Standard Deviation .75	-1.5 log10 kU/mL Standard Deviation .84
Mean Change From Baseline in HBcrAg Week 32	-1.3 log10 kU/mL Standard Deviation .87	-1.2 log10 kU/mL Standard Deviation .65	-1.7 log10 kU/mL Standard Deviation .83
Mean Change From Baseline in HBcrAg Week 36	-1.5 log10 kU/mL Standard Deviation .85	-1.2 log10 kU/mL Standard Deviation .55	-1.9 log10 kU/mL Standard Deviation .83
Mean Change From Baseline in HBcrAg Week 40	-1.6 log10 kU/mL Standard Deviation .97	-1.3 log10 kU/mL Standard Deviation .6	-1.9 log10 kU/mL Standard Deviation .93
Mean Change From Baseline in HBcrAg Week 44	-2.0 log10 kU/mL Standard Deviation .83	-1.3 log10 kU/mL Standard Deviation .55	-2.0 log10 kU/mL Standard Deviation 1.04
Mean Change From Baseline in HBcrAg Week 48	-2.0 log10 kU/mL Standard Deviation .93	-1.2 log10 kU/mL Standard Deviation .59	-2.0 log10 kU/mL Standard Deviation 1.01

SECONDARY outcome

Timeframe: Baseline and at pre-specified time points up to 60 weeks

Population: Due to early termination of the study, not all subjects reached Week 48.

Outcome measures

Measure	ABI-H0731 + ETV n=20 Participants Participants with cHBV received ABI-H0731 with ETV for 48 weeks, followed by ETV alone for 12 weeks or until the study was early terminated. ABI-H0731: Participants received ABI-H0731 300 mg tablets orally once daily ETV: Participants received ETV 0.5 mg tablets orally once daily	ABI-H0731 + ETV + Peg-IFNα n=17 Participants Participants with cHBV received ABI-H0731 with ETV and Peg-IFNα for 24 weeks, followed by ABI-H0731 with ETV for 24 weeks, followed by ETV alone for 12 weeks or until the study was early terminated. ABI-H0731: Participants received ABI-H0731 300 mg tablets orally once daily ETV: Participants received ETV 0.5 mg tablets orally once daily Peg-IFNα: Participants received Peg-IFNα with a starting dose of 180 µg solution by subcutaneous injection once weekly	ETV + Peg-IFNα n=17 Participants Participants with cHBV received ETV and Peg-IFNα for 24 weeks, followed by ABI-H0731 with ETV for 24 weeks, followed by ETV alone for 12 weeks or until the study was early terminated. ETV: Participants received ETV 0.5 mg tablets orally once daily Peg-IFNα: Participants received Peg-IFNα with a starting dose of 180 µg solution by subcutaneous injection once weekly
Mean Change From Baseline in HBsAg Week 4	-.2 log10 IU/mL Standard Deviation .48	-.1 log10 IU/mL Standard Deviation .39	-.2 log10 IU/mL Standard Deviation .25
Mean Change From Baseline in HBsAg Week 8	-.4 log10 IU/mL Standard Deviation .51	-.4 log10 IU/mL Standard Deviation .66	-.5 log10 IU/mL Standard Deviation .64
Mean Change From Baseline in HBsAg Week 12	-.5 log10 IU/mL Standard Deviation .55	-.2 log10 IU/mL Standard Deviation .44	-.5 log10 IU/mL Standard Deviation .65
Mean Change From Baseline in HBsAg Week 16	-.6 log10 IU/mL Standard Deviation .52	-.2 log10 IU/mL Standard Deviation .48	-.6 log10 IU/mL Standard Deviation .59
Mean Change From Baseline in HBsAg Week 20	-.6 log10 IU/mL Standard Deviation .54	-.5 log10 IU/mL Standard Deviation .69	-.7 log10 IU/mL Standard Deviation .66
Mean Change From Baseline in HBsAg Week 24	-.6 log10 IU/mL Standard Deviation .53	-.5 log10 IU/mL Standard Deviation .66	-.7 log10 IU/mL Standard Deviation .7
Mean Change From Baseline in HBsAg Week 28	-.7 log10 IU/mL Standard Deviation .56	-.5 log10 IU/mL Standard Deviation .63	-.7 log10 IU/mL Standard Deviation .71
Mean Change From Baseline in HBsAg Week 32	-.6 log10 IU/mL Standard Deviation .45	-.4 log10 IU/mL Standard Deviation .72	-.8 log10 IU/mL Standard Deviation .79
Mean Change From Baseline in HBsAg Week 36	-.6 log10 IU/mL Standard Deviation .47	-.2 log10 IU/mL Standard Deviation .59	-.9 log10 IU/mL Standard Deviation .81
Mean Change From Baseline in HBsAg Week 40	-.7 log10 IU/mL Standard Deviation .67	-.1 log10 IU/mL Standard Deviation .62	-.9 log10 IU/mL Standard Deviation .80
Mean Change From Baseline in HBsAg Week 44	-1.0 log10 IU/mL Standard Deviation .62	-.1 log10 IU/mL Standard Deviation .70	-1.0 log10 IU/mL Standard Deviation .90
Mean Change From Baseline in HBsAg Week 48	-1.1 log10 IU/mL Standard Deviation .61	-.1 log10 IU/mL Standard Deviation .66	-1.1 log10 IU/mL Standard Deviation .91

SECONDARY outcome

Timeframe: Baseline and at pre-specified time points up to 60 weeks

Population: Due to early termination of the study, data were not collected or analyzed for secondary outcomes.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Predose on Day 1, Week 4, and Week 24 and at pre-specified time points postdose up to Week 24

Population: No ABI-H0731 PK data were collected from the ETV + Peg-IFNα group until Week 24 when they started receiving ABI-H0731.

Outcome measures

Measure	ABI-H0731 + ETV n=20 Participants Participants with cHBV received ABI-H0731 with ETV for 48 weeks, followed by ETV alone for 12 weeks or until the study was early terminated. ABI-H0731: Participants received ABI-H0731 300 mg tablets orally once daily ETV: Participants received ETV 0.5 mg tablets orally once daily	ABI-H0731 + ETV + Peg-IFNα n=17 Participants Participants with cHBV received ABI-H0731 with ETV and Peg-IFNα for 24 weeks, followed by ABI-H0731 with ETV for 24 weeks, followed by ETV alone for 12 weeks or until the study was early terminated. ABI-H0731: Participants received ABI-H0731 300 mg tablets orally once daily ETV: Participants received ETV 0.5 mg tablets orally once daily Peg-IFNα: Participants received Peg-IFNα with a starting dose of 180 µg solution by subcutaneous injection once weekly	ETV + Peg-IFNα n=14 Participants Participants with cHBV received ETV and Peg-IFNα for 24 weeks, followed by ABI-H0731 with ETV for 24 weeks, followed by ETV alone for 12 weeks or until the study was early terminated. ETV: Participants received ETV 0.5 mg tablets orally once daily Peg-IFNα: Participants received Peg-IFNα with a starting dose of 180 µg solution by subcutaneous injection once weekly
Plasma Concentration of ABI-H0731 Week 24, 30 min to 2 hours postdose	2070 ng/mL Standard Deviation 920	1580 ng/mL Standard Deviation 521	374 ng/mL Standard Deviation 331
Plasma Concentration of ABI-H0731 Day 1, Predose	0 ng/mL Standard Deviation 0	0 ng/mL Standard Deviation 0	—
Plasma Concentration of ABI-H0731 Day 1, 2 to 4 hours postdose	852 ng/mL Standard Deviation 552	1240 ng/mL Standard Deviation 550	—
Plasma Concentration of ABI-H0731 Week 2, 30 min to 2 hours postdose	2130 ng/mL Standard Deviation 1190	1700 ng/mL Standard Deviation 802	—
Plasma Concentration of ABI-H0731 Week 4, predose	2070 ng/mL Standard Deviation 802	1390 ng/mL Standard Deviation 636	—
Plasma Concentration of ABI-H0731 Week 8, 30 min to 2 hours postdose	2000 ng/mL Standard Deviation 780	1560 ng/mL Standard Deviation 559	—
Plasma Concentration of ABI-H0731 Week 12, 30 min to 2 hours postdose	1920 ng/mL Standard Deviation 745	1650 ng/mL Standard Deviation 691	—
Plasma Concentration of ABI-H0731 Week 16, 4 to 6 hours postdose	2030 ng/mL Standard Deviation 610	2200 ng/mL Standard Deviation 855	—
Plasma Concentration of ABI-H0731 Week 20, 4 to 6 hours postdose	2210 ng/mL Standard Deviation 702	2090 ng/mL Standard Deviation 735	—
Plasma Concentration of ABI-H0731 Week 24, predose	2020 ng/mL Standard Deviation 951	1730 ng/mL Standard Deviation 661	0 ng/mL Standard Deviation 0

SECONDARY outcome

Timeframe: Pre-specified time points up to 60 weeks

Population: No cases met the criteria for resistance analysis.

Outcome measures

Outcome data not reported

Adverse Events

ABI-H0731 + ETV

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

ABI-H0731 + ETV + Peg-IFNα

Serious events: 1 serious events

Other events: 17 other events

Deaths: 0 deaths

ETV + Peg-IFNα

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

Serious adverse events

Measure	ABI-H0731 + ETV n=20 participants at risk Participants with cHBV received ABI-H0731 with ETV for 48 weeks, followed by ETV alone for 12 weeks or until the study was early terminated ABI-H0731: Participants received ABI-H0731 300 mg tablets orally once daily ETV: Participants received ETV 0.5 mg tablets orally once daily	ABI-H0731 + ETV + Peg-IFNα n=17 participants at risk Participants with cHBV received ABI-H0731 with ETV and Peg-IFNα for 24 weeks, followed by ABI-H0731 with ETV for 24 weeks, followed by ETV alone for 12 weeks or until the study was early terminated ABI-H0731: Participants received ABI-H0731 300 mg tablets orally once daily ETV: Participants received ETV 0.5 mg tablets orally once daily Peg-IFNα: Participants received Peg-IFNα with a starting dose of 180 µg solution by subcutaneous injection once weekly	ETV + Peg-IFNα n=17 participants at risk Participants with cHBV received ETV and Peg-IFNα for 24 weeks, followed by ABI-H0731 with ETV for 24 weeks, followed by ETV alone for 12 weeks or until the study was early terminated ETV: Participants received ETV 0.5 mg tablets orally once daily Peg-IFNα: Participants received Peg-IFNα with a starting dose of 180 µg solution by subcutaneous injection once weekly
Investigations Alanine Aminotransferase Increased	0.00% 0/20 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	5.9% 1/17 • Number of events 1 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	0.00% 0/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.

Other adverse events

Measure	ABI-H0731 + ETV n=20 participants at risk Participants with cHBV received ABI-H0731 with ETV for 48 weeks, followed by ETV alone for 12 weeks or until the study was early terminated ABI-H0731: Participants received ABI-H0731 300 mg tablets orally once daily ETV: Participants received ETV 0.5 mg tablets orally once daily	ABI-H0731 + ETV + Peg-IFNα n=17 participants at risk Participants with cHBV received ABI-H0731 with ETV and Peg-IFNα for 24 weeks, followed by ABI-H0731 with ETV for 24 weeks, followed by ETV alone for 12 weeks or until the study was early terminated ABI-H0731: Participants received ABI-H0731 300 mg tablets orally once daily ETV: Participants received ETV 0.5 mg tablets orally once daily Peg-IFNα: Participants received Peg-IFNα with a starting dose of 180 µg solution by subcutaneous injection once weekly	ETV + Peg-IFNα n=17 participants at risk Participants with cHBV received ETV and Peg-IFNα for 24 weeks, followed by ABI-H0731 with ETV for 24 weeks, followed by ETV alone for 12 weeks or until the study was early terminated ETV: Participants received ETV 0.5 mg tablets orally once daily Peg-IFNα: Participants received Peg-IFNα with a starting dose of 180 µg solution by subcutaneous injection once weekly
Investigations Weight Decreased	5.0% 1/20 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	35.3% 6/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	23.5% 4/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.
Investigations Platelet Count Decreased	5.0% 1/20 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	52.9% 9/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	52.9% 9/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.
General disorders Pyrexia	0.00% 0/20 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	64.7% 11/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	47.1% 8/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.
Metabolism and nutrition disorders Hyperlipidaemia	15.0% 3/20 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	35.3% 6/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	23.5% 4/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.
Investigations White Blood Cell Count Decreased	0.00% 0/20 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	47.1% 8/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	52.9% 9/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.
Investigations Neutrophil Count Decreased	5.0% 1/20 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	35.3% 6/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	47.1% 8/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.
Skin and subcutaneous tissue disorders Rash	5.0% 1/20 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	35.3% 6/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	47.1% 8/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.
Investigations Aspartate Aminotransferase Increased	0.00% 0/20 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	23.5% 4/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	41.2% 7/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.
Investigations Alanine Aminotransferase Increased	5.0% 1/20 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	23.5% 4/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	29.4% 5/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.
Nervous system disorders Dizziness	0.00% 0/20 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	29.4% 5/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	23.5% 4/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.
Infections and infestations Upper Respiratory Tract Infection	10.0% 2/20 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	11.8% 2/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	17.6% 3/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.
General disorders Fatigue	0.00% 0/20 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	5.9% 1/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	29.4% 5/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.
Nervous system disorders Headache	0.00% 0/20 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	23.5% 4/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	11.8% 2/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.
General disorders Injection Site Erythema	0.00% 0/20 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	29.4% 5/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	5.9% 1/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.
Investigations Lymphocyte Count Decreased	0.00% 0/20 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	11.8% 2/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	23.5% 4/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.
Investigations Blood Calcium Decreased	10.0% 2/20 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	11.8% 2/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	5.9% 1/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/20 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	5.9% 1/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	23.5% 4/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/20 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	5.9% 1/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	17.6% 3/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.
Metabolism and nutrition disorders Hyperuricaemia	0.00% 0/20 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	11.8% 2/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	11.8% 2/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.
Gastrointestinal disorders Abdominal Pain	0.00% 0/20 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	11.8% 2/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	5.9% 1/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.
Gastrointestinal disorders Diarrhoea	5.0% 1/20 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	5.9% 1/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	5.9% 1/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.
Investigations Glomerular Filtration Rate Decreased	5.0% 1/20 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	0.00% 0/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	11.8% 2/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.
Gastrointestinal disorders Abdominal Pain Upper	0.00% 0/20 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	5.9% 1/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	5.9% 1/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.
Investigations Activated Partial Thromboplastin Time Prolonged	5.0% 1/20 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	5.9% 1/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	0.00% 0/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.
Investigations Amylase Increased	5.0% 1/20 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	0.00% 0/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	5.9% 1/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/20 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	5.9% 1/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	5.9% 1/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.
Investigations Blood Potassium Increased	5.0% 1/20 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	5.9% 1/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	0.00% 0/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.
Respiratory, thoracic and mediastinal disorders Cough	5.0% 1/20 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	0.00% 0/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	5.9% 1/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.
Metabolism and nutrition disorders Decreased Appetite	0.00% 0/20 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	5.9% 1/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	5.9% 1/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.
Infections and infestations Gingivitis	0.00% 0/20 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	5.9% 1/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	5.9% 1/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.
Hepatobiliary disorders Hepatic Steatosis	0.00% 0/20 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	0.00% 0/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	11.8% 2/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.
Blood and lymphatic system disorders Leukopenia	5.0% 1/20 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	0.00% 0/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	5.9% 1/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.
Infections and infestations Pharyngitis	0.00% 0/20 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	5.9% 1/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	5.9% 1/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/20 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	5.9% 1/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	5.9% 1/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/20 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	5.9% 1/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	5.9% 1/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.
Gastrointestinal disorders Vomiting	0.00% 0/20 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	11.8% 2/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	0.00% 0/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.
Metabolism and nutrition disorders Abnormal Loss of Weight	0.00% 0/20 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	5.9% 1/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	0.00% 0/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.
Blood and lymphatic system disorders Anaemia	0.00% 0/20 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	5.9% 1/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	0.00% 0/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.
Skin and subcutaneous tissue disorders Androgenetic Alopecia	0.00% 0/20 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	5.9% 1/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	0.00% 0/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.
Injury, poisoning and procedural complications Animal Bite	0.00% 0/20 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	0.00% 0/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	5.9% 1/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.
General disorders Asthenia	0.00% 0/20 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	5.9% 1/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	0.00% 0/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.
Investigations Blood Bilirubin Increased	0.00% 0/20 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	0.00% 0/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	5.9% 1/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.
Investigations Blood Cholesterol Increased	5.0% 1/20 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	0.00% 0/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	0.00% 0/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.
Investigations Blood Creatine Phosphokinase Increased	5.0% 1/20 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	0.00% 0/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	0.00% 0/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.
Investigations Blood Phosphorus Decreased	5.0% 1/20 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	0.00% 0/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	0.00% 0/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.
Investigations Blood Thyroid Stimulating Hormone Decreased	0.00% 0/20 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	0.00% 0/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	5.9% 1/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.
Investigations Blood Urine Present	0.00% 0/20 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	0.00% 0/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	5.9% 1/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.
Infections and infestations Bronchitis	0.00% 0/20 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	0.00% 0/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	5.9% 1/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.
General disorders Chills	0.00% 0/20 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	5.9% 1/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	0.00% 0/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.
Injury, poisoning and procedural complications Contusion	0.00% 0/20 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	0.00% 0/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	5.9% 1/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.
Gastrointestinal disorders Dry Mouth	0.00% 0/20 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	5.9% 1/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	0.00% 0/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.
Ear and labyrinth disorders Ear Pain	0.00% 0/20 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	5.9% 1/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	0.00% 0/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.
Gastrointestinal disorders Epigastric Discomfort	0.00% 0/20 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	0.00% 0/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	5.9% 1/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.
Gastrointestinal disorders Functional Gastrointestinal Disorder	0.00% 0/20 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	0.00% 0/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	5.9% 1/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.
Metabolism and nutrition disorders Glucose Tolerance Impaired	5.0% 1/20 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	0.00% 0/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	0.00% 0/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.
Infections and infestations Helicobacter Infection	0.00% 0/20 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	5.9% 1/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	0.00% 0/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.
Hepatobiliary disorders Hepatic Pain	0.00% 0/20 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	5.9% 1/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	0.00% 0/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.
Infections and infestations Hordeolum	0.00% 0/20 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	5.9% 1/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	0.00% 0/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.
General disorders Injection Site Haemorrhage	0.00% 0/20 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	0.00% 0/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	5.9% 1/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.
General disorders Injection Site Pain	0.00% 0/20 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	5.9% 1/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	0.00% 0/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.
General disorders Injection Site Reaction	0.00% 0/20 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	5.9% 1/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	0.00% 0/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.
Psychiatric disorders Insomnia	0.00% 0/20 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	5.9% 1/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	0.00% 0/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.
Injury, poisoning and procedural complications Ligament Sprain	0.00% 0/20 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	0.00% 0/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	5.9% 1/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/20 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	5.9% 1/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	0.00% 0/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.
Blood and lymphatic system disorders Lymphopenia	0.00% 0/20 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	0.00% 0/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	5.9% 1/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.
General disorders Malaise	0.00% 0/20 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	0.00% 0/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	5.9% 1/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.
Investigations Mean Cell Haemoglobin Concentration Increased	0.00% 0/20 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	0.00% 0/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	5.9% 1/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.
Gastrointestinal disorders Mouth Ulceration	0.00% 0/20 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	5.9% 1/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	0.00% 0/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.
Gastrointestinal disorders Nausea	0.00% 0/20 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	5.9% 1/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	0.00% 0/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.
Respiratory, thoracic and mediastinal disorders Oropharyngeal Pain	0.00% 0/20 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	0.00% 0/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	5.9% 1/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.
General disorders Pain	0.00% 0/20 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	5.9% 1/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	0.00% 0/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.
General disorders Pain In Extremity	0.00% 0/20 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	5.9% 1/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	0.00% 0/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.
Infections and infestations Pericoronitis	5.0% 1/20 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	0.00% 0/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	0.00% 0/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.
Skin and subcutaneous tissue disorders Pruritus	5.0% 1/20 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	0.00% 0/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	0.00% 0/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.
Skin and subcutaneous tissue disorders Seborrhoeic Dermatitis	5.0% 1/20 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	0.00% 0/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	0.00% 0/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.
Injury, poisoning and procedural complications Skin Injury	0.00% 0/20 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	0.00% 0/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	5.9% 1/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.
Injury, poisoning and procedural complications Spinal Fracture	5.0% 1/20 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	0.00% 0/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	0.00% 0/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.
Blood and lymphatic system disorders Thrombocytopenic Purpura	5.0% 1/20 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	0.00% 0/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	0.00% 0/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.
Gastrointestinal disorders Toothache	0.00% 0/20 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	5.9% 1/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	0.00% 0/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.
Investigations Urinary Occult Blood Positive	0.00% 0/20 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	5.9% 1/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	0.00% 0/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.
Investigations Urinary Sediment Present	0.00% 0/20 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	0.00% 0/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	5.9% 1/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.
Infections and infestations Urinary Tract Infection	0.00% 0/20 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	5.9% 1/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	0.00% 0/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.
Reproductive system and breast disorders Uterine Haemorrhage	0.00% 0/20 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	0.00% 0/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	5.9% 1/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.
Infections and infestations Vaginal Infection	5.0% 1/20 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	0.00% 0/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	0.00% 0/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.
Infections and infestations Viral Rash	5.0% 1/20 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	0.00% 0/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.	0.00% 0/17 • Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks. Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.

Additional Information

Director of Clinical Operations

Assembly BioSciences Inc.

Phone: 415-366-5172

Email: psalstrand@assemblybio.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60