A Study Evaluating ABI-H0731 as Adjunctive Therapy in Par... | NCT03576066

Label	Type	Description	Intervention Names
ABI-H0731 + SOC NUC	Experimental	Virologically suppressed participants will receive ABI-H0731 along with SOC NUC (ETV, TDF or TAF) tablets orally for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to continue open-label ABI-H0731 for up to an additional year if necessary.	Drug: ABI-H0731 Drug: SOC NUC
Placebo + SOC NUC	Active Comparator	Virologically suppressed participants will receive matching placebo tablets and continue their SOC NUC (ETV, TDF or TAF) for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to start treatment on open-label ABI-H0731 for up to a year if necessary.	Drug: SOC NUC Drug: Placebo Oral Tablet

Name	Type	Description	Arm Group Labels	Other Names
ABI-H0731	Drug	Participants will receive ABI-H0731 300 mg tablets orally once daily (QD).	ABI-H0731 + SOC NUC

Measure	Description	Time Frame
Change in Mean log10 Serum HBsAg From Baseline (Day 1) to Week 24 on ABI-H0731 + SOC NUC as Compared to Placebo + SOC NUC		Baseline to Week 24
Change in Mean log10 Serum HBeAg From Baseline (Day 1) to Week 24 on ABI-H0731 + SOC NUC as Compared to Placebo + SOC NUC		Baseline to Week 24

Measure	Description	Time Frame
Number of Participants With One or More Adverse Events		Up to Follow-up (maximum up to Week 36)
Number of Participants With Premature Study Discontinuation		Up to Follow-up (maximum up to Week 36)

Facility	Status	City	State	ZIP	Country	Contacts
Cedars-Sinai Medical Center		Beverly Hills	California	90211	United States
Southern California Research Center

PubMed Identifier	Type	Citation	Retractions
35460726	Derived	Yuen MF, Agarwal K, Ma X, Nguyen TT, Schiff ER, Hann HL, Dieterich DT, Nahass RG, Park JS, Chan S, Han SB, Gane EJ, Bennett M, Alves K, Evanchik M, Yan R, Huang Q, Lopatin U, Colonno R, Ma J, Knox SJ, Stamm LM, Bonacini M, Jacobson IM, Ayoub WS, Weilert F, Ravendhran N, Ramji A, Kwo PY, Elkhashab M, Hassanein T, Bae HS, Lalezari JP, Fung SK, Sulkowski MS. Safety and efficacy of vebicorvir in virologically suppressed patients with chronic hepatitis B virus infection. J Hepatol. 2022 Sep;77(3):642-652. doi: 10.1016/j.jhep.2022.04.005. Epub 2022 Apr 20.

ID	Title	Description
FG000	ABI-H0731 + SOC NUC	Virologically suppressed participants will receive ABI-H0731 along with standard of care (SOC) nucleos(t)ide reverse transcriptase inhibitor (NUC) tablets orally for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to continue open-label ABI-H0731 for up to an additional year if necessary. ABI-H0731: Participants will receive 300 mg QD ABI-H0731 tablets orally. SOC NUC: Participants will continue on their SOC NUC (ETV, TDF or TAF) tablet orally (QD frequency) as per approved package insert.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Nov 9, 2018	Dec 21, 2020

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Change in Mean log10 Serum HBsAg From Baseline (Day 1) to Week 24 on ABI-H0731 + SOC NUC as Compared to Placebo + SOC NUC

Intention-to-treat (ITT) population: all randomized participants. Results were analyzed and reported based on Baseline HBeAg status: positive or negative, for available data at Baseline, Week 24, or both.

Posted

Mean

Standard Deviation

Log10 International Units (IU)/mL

Baseline to Week 24

ID	Title	Description
OG000	HBeAg-positive Participants: ABI-H0731 + SOC NUC	Virologically suppressed participants who are HBeAg positive at Baseline will receive ABI-H0731 along with SOC NUC (ETV, TDF or TAF) tablets orally for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to continue open-label ABI-H0731 for up to an additional year if necessary. ABI-H0731: Participants will receive 300 mg QD ABI-H0731 tablets orally. SOC NUC: Participants will continue on their SOC NUC (ETV, TDF or TAF) tablet orally (QD frequency) as per approved package insert.
OG001	HBeAg-positive Participants: Placebo + SOC NUC	Virologically suppressed participants who are HBeAg positive at Baseline will receive matching placebo tablets and continue their SOC NUC (ETV, TDF or TAF) for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to start treatment on open-label ABI-H0731 for up to a year if necessary. Placebo Oral Tablet: Participants will receive matching QD placebo tablets orally. SOC NUC: Participants will receive SOC NUC (ETV, TDF or TAF) tablet orally as per approved package insert.
OG002	HBeAg-negative Participants: ABI-H0731 + SOC NUC	Virologically suppressed participants who are HBeAg negative at Baseline will receive ABI-H0731 along with SOC NUC (ETV, TDF or TAF) tablets orally for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to continue open-label ABI-H0731 for up to an additional year if necessary. ABI-H0731: Participants will receive 300 mg QD ABI-H0731 tablets orally. SOC NUC: Participants will continue on their SOC NUC (ETV, TDF or TAF) tablet orally (QD frequency) as per approved package insert.
OG003	HBeAg-negative Participants: Placebo + SOC NUC	Virologically suppressed participants who are HBeAg negative at Baseline will receive matching placebo tablets and continue their SOC NUC (ETV, TDF or TAF) for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to start treatment on open-label ABI-H0731 for up to a year if necessary. Placebo Oral Tablet: Participants will receive matching QD placebo tablets orally. SOC NUC: Participants will receive SOC NUC (ETV, TDF or TAF) tablet orally as per approved package insert.

Units	Counts
Participants	OG00029 OG00118 OG00216 OG003

Title	Denominators	Categories
Baseline	ParticipantsOG00029 ParticipantsOG00118 ParticipantsOG00216 ParticipantsOG003

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Least squares (LS) mean difference in HBeAg-positive participants: ABI-H0731 + SOC NUC minus placebo + SOC NUC at Week 24	Repeated measures analysis		0.6855														Other
OG002 OG003	LS mean difference in HBeAg-negative participants: ABI-H0731 + SOC NUC minus placebo + SOC NUC at Week 24

Primary

Change in Mean log10 Serum HBeAg From Baseline (Day 1) to Week 24 on ABI-H0731 + SOC NUC as Compared to Placebo + SOC NUC

ITT population. Results were analyzed and reported only for participants who were HBeAg positive at Baseline and had available data at Baseline, Week 24, or both.

Posted

Mean

Standard Deviation

Log10 International Units (IU)/mL

Baseline to Week 24

ID	Title	Description
OG000	HBeAg-positive Participants: ABI-H0731 + SOC NUC	Virologically suppressed participants who are HBeAg positive at Baseline will receive ABI-H0731 along with SOC NUC (ETV, TDF or TAF) tablets orally for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to continue open-label ABI-H0731 for up to an additional year if necessary. ABI-H0731: Participants will receive 300 mg QD ABI-H0731 tablets orally. SOC NUC: Participants will continue on their SOC NUC (ETV, TDF or TAF) tablet orally (QD frequency) as per approved package insert.
OG001	HBeAg-positive Participants: Placebo + SOC NUC	Virologically suppressed participants who are HBeAg positive at Baseline will receive matching placebo tablets and continue their SOC NUC (ETV, TDF or TAF) for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to start treatment on open-label ABI-H0731 for up to a year if necessary. Placebo Oral Tablet: Participants will receive matching QD placebo tablets orally. SOC NUC: Participants will receive SOC NUC (ETV, TDF or TAF) tablet orally as per approved package insert.

Secondary

Number of Participants With One or More Adverse Events

Safety population: all randomized participants who received any amount of study drug

Posted

Count of Participants

Participants

Up to Follow-up (maximum up to Week 36)

ID	Title	Description
OG000	ABI-H0731 + SOC NUC	Virologically suppressed participants will receive ABI-H0731 along with SOC NUC (ETV, TDF or TAF) tablets orally for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to continue open-label ABI-H0731 for up to an additional year if necessary. ABI-H0731: Participants will receive 300 mg QD ABI-H0731 tablets orally. SOC NUC: Participants will continue on their SOC NUC (ETV, TDF or TAF) tablet orally (QD frequency) as per approved package insert.
OG001	Placebo + SOC NUC	Virologically suppressed participants will receive matching placebo tablets and continue their SOC NUC (ETV, TDF or TAF) for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to start treatment on open-label ABI-H0731 for up to a year if necessary. Placebo Oral Tablet: Participants will receive matching QD placebo tablets orally. SOC NUC: Participants will receive SOC NUC (ETV, TDF or TAF) tablet orally as per approved package insert.

Units

Secondary

Number of Participants With Premature Study Discontinuation

ITT population

Posted

Count of Participants

Participants

Up to Follow-up (maximum up to Week 36)

ID	Title	Description
OG000	ABI-H0731 + SOC NUC	Virologically suppressed participants will receive ABI-H0731 along with SOC NUC (ETV, TDF or TAF) tablets orally for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to continue open-label ABI-H0731 for up to an additional year if necessary. ABI-H0731: Participants will receive 300 mg QD ABI-H0731 tablets orally. SOC NUC: Participants will continue on their SOC NUC (ETV, TDF or TAF) tablet orally (QD frequency) as per approved package insert.
OG001	Placebo + SOC NUC	Virologically suppressed participants will receive matching placebo tablets and continue their SOC NUC (ETV, TDF or TAF) for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to start treatment on open-label ABI-H0731 for up to a year if necessary. Placebo Oral Tablet: Participants will receive matching QD placebo tablets orally. SOC NUC: Participants will receive SOC NUC (ETV, TDF or TAF) tablet orally as per approved package insert.

Units	Counts

Secondary

Number of Participants With One or More Abnormal Safety Laboratory Result

Safety population

Posted

Count of Participants

Participants

Up to Week 36

ID	Title	Description
OG000	ABI-H0731 + SOC NUC	Virologically suppressed participants will receive ABI-H0731 along with SOC NUC (ETV, TDF or TAF) tablets orally for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to continue open-label ABI-H0731 for up to an additional year if necessary. ABI-H0731: Participants will receive 300 mg QD ABI-H0731 tablets orally. SOC NUC: Participants will continue on their SOC NUC (ETV, TDF or TAF) tablet orally (QD frequency) as per approved package insert.
OG001	Placebo + SOC NUC	Virologically suppressed participants will receive matching placebo tablets and continue their SOC NUC (ETV, TDF or TAF) for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to start treatment on open-label ABI-H0731 for up to a year if necessary. Placebo Oral Tablet: Participants will receive matching QD placebo tablets orally. SOC NUC: Participants will receive SOC NUC (ETV, TDF or TAF) tablet orally as per approved package insert.

Units	Counts

Secondary

Number of Participants With a Clinically-significant Electrocardiogram Abnormality

Safety population

Posted

Count of Participants

Participants

Up to Week 24

ID	Title	Description
OG000	ABI-H0731 + SOC NUC	Virologically suppressed participants will receive ABI-H0731 along with SOC NUC (ETV, TDF or TAF) tablets orally for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to continue open-label ABI-H0731 for up to an additional year if necessary. ABI-H0731: Participants will receive 300 mg QD ABI-H0731 tablets orally. SOC NUC: Participants will continue on their SOC NUC (ETV, TDF or TAF) tablet orally (QD frequency) as per approved package insert.
OG001	Placebo + SOC NUC	Virologically suppressed participants will receive matching placebo tablets and continue their SOC NUC (ETV, TDF or TAF) for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to start treatment on open-label ABI-H0731 for up to a year if necessary. Placebo Oral Tablet: Participants will receive matching QD placebo tablets orally. SOC NUC: Participants will receive SOC NUC (ETV, TDF or TAF) tablet orally as per approved package insert.

Units	Counts

Secondary

Number of Participants With a Clinically-significant Change in Vital Signs

Vital signs assessed were body temperature, respiratory rate, and pulse rate

Safety population

Posted

Count of Participants

Participants

Baseline and up to Week 24

ID	Title	Description
OG000	ABI-H0731 + SOC NUC	Virologically suppressed participants will receive ABI-H0731 along with SOC NUC (ETV, TDF or TAF) tablets orally for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to continue open-label ABI-H0731 for up to an additional year if necessary. ABI-H0731: Participants will receive 300 mg QD ABI-H0731 tablets orally. SOC NUC: Participants will continue on their SOC NUC (ETV, TDF or TAF) tablet orally (QD frequency) as per approved package insert.
OG001	Placebo + SOC NUC	Virologically suppressed participants will receive matching placebo tablets and continue their SOC NUC (ETV, TDF or TAF) for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to start treatment on open-label ABI-H0731 for up to a year if necessary. Placebo Oral Tablet: Participants will receive matching QD placebo tablets orally. SOC NUC: Participants will receive SOC NUC (ETV, TDF or TAF) tablet orally as per approved package insert.

Secondary

Number of Participants With Abnormal Alanine Aminotransferase (ALT) at Baseline Who Have Normal ALT at Week 24 on ABI-H0731 + NUC Therapy as Compared With Placebo + NUC Therapy

Abnormal ALT was defined as ≥1.25 x upper limit of normal (34 Units/L for female and 43 Units/L for male participants).

Participants in the ITT population with abnormal ALT at Baseline

Posted

Count of Participants

Participants

Baseline to Week 24

ID	Title	Description
OG000	ABI-H0731 + SOC NUC	Virologically suppressed participants will receive ABI-H0731 along with SOC NUC (ETV, TDF or TAF) tablets orally for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to continue open-label ABI-H0731 for up to an additional year if necessary. ABI-H0731: Participants will receive 300 mg QD ABI-H0731 tablets orally. SOC NUC: Participants will continue on their SOC NUC (ETV, TDF or TAF) tablet orally (QD frequency) as per approved package insert.
OG001	Placebo + SOC NUC	Virologically suppressed participants will receive matching placebo tablets and continue their SOC NUC (ETV, TDF or TAF) for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to start treatment on open-label ABI-H0731 for up to a year if necessary. Placebo Oral Tablet: Participants will receive matching QD placebo tablets orally. SOC NUC: Participants will receive SOC NUC (ETV, TDF or TAF) tablet orally as per approved package insert.

Secondary

Trough Levels of ABI-H0731 on ABI-H0731 + SOC NUC Therapy

Safety population. Results were analyzed and reported only for participants who received ABI-H0731 + SOC NUC and had ABI-H0731 pharmacokinetic data assessments available.

Posted

Mean

Standard Deviation

ng/mL

Before dosing at Baseline (Day 1), Weeks 2, 4, 12, and 24

ID	Title	Description
OG000	ABI-H0731 + SOC NUC	Virologically suppressed participants will receive ABI-H0731 along with SOC NUC (ETV, TDF or TAF) tablets orally for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to continue open-label ABI-H0731 for up to an additional year if necessary. ABI-H0731: Participants will receive 300 mg QD ABI-H0731 tablets orally. SOC NUC: Participants will continue on their SOC NUC (ETV, TDF or TAF) tablet orally (QD frequency) as per approved package insert.

Units	Counts
Participants	OG000

Secondary

Trough Levels of Entecavir (ETV) on ABI-H0731 + SOC NUC Therapy as Compared With Placebo + SOC NUC Therapy

Safety population. Results were analyzed and reported only for participants who received ETV as their SOC NUC and had ETV pharmacokinetic data assessments available.

Posted

Mean

Standard Deviation

ng/mL

Before dosing at Baseline (Day 1), Weeks 2, 4, 12, and 24

ID	Title	Description
OG000	ABI-H0731 + SOC NUC	Virologically suppressed participants will receive ABI-H0731 along with SOC NUC (ETV, TDF or TAF) tablets orally for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to continue open-label ABI-H0731 for up to an additional year if necessary. ABI-H0731: Participants will receive 300 mg QD ABI-H0731 tablets orally. SOC NUC: Participants will continue on their SOC NUC (ETV, TDF or TAF) tablet orally (QD frequency) as per approved package insert.
OG001	Placebo + SOC NUC	Virologically suppressed participants will receive matching placebo tablets and continue their SOC NUC (ETV, TDF or TAF) for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to start treatment on open-label ABI-H0731 for up to a year if necessary. Placebo Oral Tablet: Participants will receive matching QD placebo tablets orally. SOC NUC: Participants will receive SOC NUC (ETV, TDF or TAF) tablet orally as per approved package insert.

Secondary

Trough Levels of Tenofovir Alafenamide (TAF) on ABI-H0731 + SOC NUC Therapy as Compared With Placebo + SOC NUC Therapy

Safety population. Results were analyzed and reported only for participants who received TAF as their SOC NUC and had TAF pharmacokinetic data assessments available.

Posted

Mean

Standard Deviation

ng/mL

Before dosing at Baseline (Day 1), Weeks 2, 4, 12, and 24

ID	Title	Description
OG000	ABI-H0731 + SOC NUC	Virologically suppressed participants will receive ABI-H0731 along with SOC NUC (ETV, TDF or TAF) tablets orally for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to continue open-label ABI-H0731 for up to an additional year if necessary. ABI-H0731: Participants will receive 300 mg QD ABI-H0731 tablets orally. SOC NUC: Participants will continue on their SOC NUC (ETV, TDF or TAF) tablet orally (QD frequency) as per approved package insert.
OG001	Placebo + SOC NUC	Virologically suppressed participants will receive matching placebo tablets and continue their SOC NUC (ETV, TDF or TAF) for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to start treatment on open-label ABI-H0731 for up to a year if necessary. Placebo Oral Tablet: Participants will receive matching QD placebo tablets orally. SOC NUC: Participants will receive SOC NUC (ETV, TDF or TAF) tablet orally as per approved package insert.

Secondary

Trough Levels of Tenofovir Disoproxil Fumarate (TDF) on ABI-H0731 + SOC NUC Therapy as Compared With Placebo + SOC NUC Therapy

Safety population. Results were analyzed and reported only for participants who received TDF as their SOC NUC and had TDF pharmacokinetic data assessments available.

Posted

Mean

Standard Deviation

ng/mL

Before dosing at Baseline (Day 1), Weeks 2, 4, 12, and 24

ID	Title	Description
OG000	ABI-H0731 + SOC NUC	Virologically suppressed participants will receive ABI-H0731 along with SOC NUC (ETV, TDF or TAF) tablets orally for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to continue open-label ABI-H0731 for up to an additional year if necessary. ABI-H0731: Participants will receive 300 mg QD ABI-H0731 tablets orally. SOC NUC: Participants will continue on their SOC NUC (ETV, TDF or TAF) tablet orally (QD frequency) as per approved package insert.
OG001	Placebo + SOC NUC	Virologically suppressed participants will receive matching placebo tablets and continue their SOC NUC (ETV, TDF or TAF) for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to start treatment on open-label ABI-H0731 for up to a year if necessary. Placebo Oral Tablet: Participants will receive matching QD placebo tablets orally. SOC NUC: Participants will receive SOC NUC (ETV, TDF or TAF) tablet orally as per approved package insert.

Secondary

Trough to Peak Ratios of ABI-H0731 on ABI-H0731 + SOC NUC Therapy

Trough to peak ratios were not calculated due to an insufficient number of optional peak exposure samples.

Posted

Baseline, Weeks 2, 4, 12, and 24

ID	Title	Description
OG000	ABI-H0731 + SOC NUC	Virologically suppressed participants will receive ABI-H0731 along with SOC NUC (ETV, TDF or TAF) tablets orally for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to continue open-label ABI-H0731 for up to an additional year if necessary. ABI-H0731: Participants will receive 300 mg QD ABI-H0731 tablets orally. SOC NUC: Participants will continue on their SOC NUC (ETV, TDF or TAF) tablet orally (QD frequency) as per approved package insert.

Units	Counts
Participants	OG000

Secondary

Trough to Peak Ratios of SOC NUC on ABI-H0731 + SOC NUC Therapy as Compared With Placebo + SOC NUC Therapy

Trough to peak ratios were not calculated due to an insufficient number of optional peak exposure samples.

Posted

Baseline, Weeks 2, 4, 12, and 24

ID	Title	Description
OG000	ABI-H0731 + SOC NUC	Virologically suppressed participants will receive ABI-H0731 along with SOC NUC (ETV, TDF or TAF) tablets orally for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to continue open-label ABI-H0731 for up to an additional year if necessary. ABI-H0731: Participants will receive 300 mg QD ABI-H0731 tablets orally. SOC NUC: Participants will continue on their SOC NUC (ETV, TDF or TAF) tablet orally (QD frequency) as per approved package insert.
OG001	Placebo + SOC NUC	Virologically suppressed participants will receive matching placebo tablets and continue their SOC NUC (ETV, TDF or TAF) for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to start treatment on open-label ABI-H0731 for up to a year if necessary. Placebo Oral Tablet: Participants will receive matching QD placebo tablets orally. SOC NUC: Participants will receive SOC NUC (ETV, TDF or TAF) tablet orally as per approved package insert.

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Upper respiratory tract infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0005 events5 affected45 at risk EG0011 events1 affected28 at risk
Nausea	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0004 events4 affected45 at risk EG0010 events0 affected28 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0004 events3 affected45 at risk EG0010 events0 affected28 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected45 at risk EG0012 events2 affected28 at risk
Influenza	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected45 at risk EG0011 events1 affected28 at risk
Nasopharyngitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected45 at risk EG0011 events1 affected28 at risk
Urinary tract infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected45 at risk EG0010 events0 affected28 at risk
Viral infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected45 at risk EG0011 events1 affected28 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected45 at risk EG0011 events1 affected28 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected45 at risk EG0010 events0 affected28 at risk
Rash macular	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected45 at risk EG0010 events0 affected28 at risk
Bacterial vaginosis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected45 at risk EG0010 events0 affected28 at risk
Conjunctivitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected45 at risk EG0010 events0 affected28 at risk
Gastroenteritis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected45 at risk EG0010 events0 affected28 at risk
Onychomycosis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected45 at risk EG0010 events0 affected28 at risk
Oral herpes	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected45 at risk EG0010 events0 affected28 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected45 at risk EG0010 events0 affected28 at risk
Flatulence	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected45 at risk EG0010 events0 affected28 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected45 at risk EG0010 events0 affected28 at risk
Hypoaesthesia oral	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected45 at risk EG0010 events0 affected28 at risk
Tongue ulceration	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected45 at risk EG0010 events0 affected28 at risk
Vomiting	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected45 at risk EG0010 events0 affected28 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected45 at risk EG0010 events0 affected28 at risk
Dermatitis atopic	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected45 at risk EG0010 events0 affected28 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected45 at risk EG0010 events0 affected28 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected45 at risk EG0010 events0 affected28 at risk
Rash pruritic	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected45 at risk EG0010 events0 affected28 at risk
Pyrexia	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected45 at risk EG0012 events1 affected28 at risk
Fatigue	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected45 at risk EG0011 events1 affected28 at risk
Chest discomfort	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected45 at risk EG0011 events1 affected28 at risk
Inflammation	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected45 at risk EG0010 events0 affected28 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected45 at risk EG0010 events0 affected28 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected45 at risk EG0010 events0 affected28 at risk
Skin abrasion	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected45 at risk EG0011 events1 affected28 at risk
Arthropod bite	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected45 at risk EG0011 events1 affected28 at risk
Headache	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected45 at risk EG0010 events0 affected28 at risk
Dizziness	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected45 at risk EG0011 events1 affected28 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected45 at risk EG0010 events0 affected28 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected45 at risk EG0010 events0 affected28 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected45 at risk EG0011 events1 affected28 at risk
Hepatic pain	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected45 at risk EG0010 events0 affected28 at risk
Liver tenderness	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected45 at risk EG0010 events0 affected28 at risk
Palpitations	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected45 at risk EG0010 events0 affected28 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected45 at risk EG0010 events0 affected28 at risk
Seasonal allergy	Immune system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected45 at risk EG0010 events0 affected28 at risk
Libido decreased	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected45 at risk EG0010 events0 affected28 at risk
Dysmenorrhoea	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected45 at risk EG0010 events0 affected28 at risk
Hot flush	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected45 at risk EG0010 events0 affected28 at risk

ID	Term
D019694	Hepatitis B, Chronic
D006509	Hepatitis B

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D018347	Hepadnaviridae Infections
D004266	DNA Virus Infections
D014777	Virus Diseases
D006525	Hepatitis, Viral, Human
D006521	Hepatitis, Chronic
D006505	Hepatitis
D008107	Liver Diseases
D004066	Digestive System Diseases
D002908	Chronic Disease
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
C413685	entecavir
D000068698	Tenofovir
C442442	tenofovir alafenamide

ID	Term
D063065	Organophosphonates
D009943	Organophosphorus Compounds
D009930	Organic Chemicals
D000225	Adenine
D011687	Purines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds

ID	Title	Description
BG000	ABI-H0731 + SOC NUC	Virologically suppressed participants will receive ABI-H0731 along with SOC NUC (ETV, TDF or TAF) tablets orally for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to continue open-label ABI-H0731 for up to an additional year if necessary. ABI-H0731: Participants will receive 300 mg QD ABI-H0731 tablets orally. SOC NUC: Participants will continue on their SOC NUC (ETV, TDF or TAF) tablet orally (QD frequency) as per approved package insert.
BG001	Placebo + SOC NUC	Virologically suppressed participants will receive matching placebo tablets and continue their SOC NUC (ETV, TDF or TAF) for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to start treatment on open-label ABI-H0731 for up to a year if necessary. Placebo Oral Tablet: Participants will receive matching QD placebo tablets orally. SOC NUC: Participants will receive SOC NUC (ETV, TDF or TAF) tablet orally as per approved package insert.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	ABI-H0731 + SOC NUC	Virologically suppressed participants will receive ABI-H0731 along with SOC NUC (ETV, TDF or TAF) tablets orally for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to continue open-label ABI-H0731 for up to an additional year if necessary. ABI-H0731: Participants will receive 300 mg QD ABI-H0731 tablets orally. SOC NUC: Participants will continue on their SOC NUC (ETV, TDF or TAF) tablet orally (QD frequency) as per approved package insert.	0	45	0	45	24	45
EG001	Placebo + SOC NUC	Virologically suppressed participants will receive matching placebo tablets and continue their SOC NUC (ETV, TDF or TAF) for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to start treatment on open-label ABI-H0731 for up to a year if necessary. Placebo Oral Tablet: Participants will receive matching QD placebo tablets orally. SOC NUC: Participants will receive SOC NUC (ETV, TDF or TAF) tablet orally as per approved package insert.	0	28	0	28	8	28