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Clinical Trial Results:
A Phase 2a, Open-Label Study to Evaluate the Safety and Efficacy of Selgantolimod (SLGN)-Containing Combination Therapies for the Treatment of Chronic Hepatitis B (CHB)

Summary
EudraCT number	2021-000672-11
Trial protocol	DK
Global end of trial date	19 Jul 2024

Results information
Results version number	v1(current)
This version publication date	23 Jul 2025
First version publication date	23 Jul 2025
Other versions

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

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Trial information

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Sponsor protocol code

GS-US-465-4439

ISRCTN number

US NCT number

NCT04891770

WHO universal trial number (UTN)

Sponsor organisation name

Gilead Sciences

Sponsor organisation address

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

Public contact

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

Scientific contact

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

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

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

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

Analysis stage

Final

Date of interim/final analysis

19 Jul 2024

Is this the analysis of the primary completion data?

Yes

Primary completion date

23 Jan 2024

Global end of trial reached?

Yes

Global end of trial date

19 Jul 2024

Was the trial ended prematurely?

Main objective of the trial

The primary objectives of this study were to evaluate the safety and tolerability of study treatment(s) (selgantolimod-containing combination therapies) and to evaluate the efficacy of study treatment(s) as measured by the proportion of participants who achieved functional cure, defined as hepatitis B surface antigen (HBsAg) loss and hepatitis B virus (HBV)deoxyribonucleic acid (DNA) < lower limit of quantitation (LLOQ) at Follow-up (FU) Week 24 in participants with chronic hepatitis B (CHB).

Protection of trial subjects

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

Background therapy

Evidence for comparator

Actual start date of recruitment

14 Aug 2021

Long term follow-up planned

Yes

Long term follow-up rationale

Safety, Efficacy

Long term follow-up duration

11 Months

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

Australia: 5

Country: Number of subjects enrolled

Denmark: 3

Country: Number of subjects enrolled

Hong Kong: 36

Country: Number of subjects enrolled

New Zealand: 5

Country: Number of subjects enrolled

Singapore: 14

Country: Number of subjects enrolled

Korea, Republic of: 9

Country: Number of subjects enrolled

Thailand: 26

Country: Number of subjects enrolled

United Kingdom: 5

Worldwide total number of subjects

103

EEA total number of subjects

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

103

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

Participants were enrolled at study sites in Australia, Denmark, Hong Kong, New Zealand, Singapore, South Korea, Thailand, and the United Kingdom.

Screening details

165 participants were screened.

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Not blinded

Blinding implementation details

In the viremic cohorts, participants were randomized 2:1 into Cohort 2 Groups A and B.

Are arms mutually exclusive

Yes

Cohort 1: TAF + VIR-2218 + SLGN + Nivolumab

Arm description

Nucleos(t)ide(s) (NUC)-suppressed participants with chronic hepatitis B (CHB) received tenofovir alafenamide (TAF) 25 mg orally once daily (QD) for 36 weeks and VIR-2218 200 mg subcutaneously (SC) once every 4 weeks (Q4W) for 24 weeks. From Week 12 onwards, participants also received selgantolimod (SLGN) 3 mg orally once a week (QW) for 24 weeks and nivolumab 0.3 mg/kg intravenously (IV) Q4W for up to 24 weeks (only up to protocol amendment 2, nivolumab was no longer administered post implementation of protocol amendment 2). Participants who were on TAF treatment continued TAF treatment over the duration of study follow-up. Participants were followed up for 48 weeks post treatment.

Arm type

Experimental

Investigational medicinal product name

Tenofovir Alafenamide

Investigational medicinal product code

Other name

TAF, GS-7340, Vemlidy®

Pharmaceutical forms

Film-coated tablet

Routes of administration

Oral use

Dosage and administration details

25 mg administered once daily for 36 weeks

Investigational medicinal product name

Selgantolimod

Investigational medicinal product code

Other name

SLGN, GS-9688

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

3 mg administered once a week for 24 weeks

Investigational medicinal product name

Nivolumab

Investigational medicinal product code

Other name

Opdivo®

Pharmaceutical forms

Concentrate for solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

0.3 mg/kg administered once every 4 weeks for up to 24 weeks

Investigational medicinal product name

VIR-2218

Investigational medicinal product code

Other name

ALN-HBV-02, ALN-81890, AD-81890

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

200 mg administered once every 4 weeks for 24 weeks

Cohort 2 Group A: VIR-2218 + SLGN + Nivolumab

Arm description

Viremic participants with CHB received VIR-2218, 200 mg SC Q4W for 24 weeks. From Week 12 onwards, participants also received SLGN 3 mg orally QW for 24 weeks and nivolumab 0.3 mg/kg IV Q4W for up to 24 weeks (only up to protocol amendment 2, nivolumab was no longer administered post implementation of protocol amendment 2). Participants who met the criteria to initiate NUC treatment received TAF 25 mg orally, QD during the study. Participants were followed up for 48 weeks post treatment.

Arm type

Experimental

Investigational medicinal product name

VIR-2218

Investigational medicinal product code

Other name

ALN-HBV-02, ALN-81890, AD-81890

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

200 mg administered once every 4 weeks for 24 weeks

Investigational medicinal product name

Selgantolimod

Investigational medicinal product code

Other name

SLGN, GS-9688

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

3 mg administered once a week for 24 weeks

Investigational medicinal product name

Nivolumab

Investigational medicinal product code

Other name

Opdivo®

Pharmaceutical forms

Concentrate for solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

0.3 mg/kg administered once every 4 weeks for up to 24 weeks

Cohort 2 Group B: SLGN + Nivolumab

Arm description

Viremic participants with CHB received SLGN 3 mg orally QW for 24 weeks and nivolumab 0.3 mg/kg IV Q4W for up to 24 weeks. Viremic participants who met the criteria to initiate NUC treatment received TAF 25 mg orally QD during the study. Participants were followed up for 48 weeks post treatment. All treatments were administered up to protocol amendment 2 and after the implementation of protocol amendment 2, the treatments were discontinued for Cohort 2 Group B based on Sponsor decision.

Arm type

Experimental

Investigational medicinal product name

Selgantolimod

Investigational medicinal product code

Other name

SLGN, GS-9688

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

3 mg administered once a week for 24 weeks

Investigational medicinal product name

Nivolumab

Investigational medicinal product code

Other name

Opdivo®

Pharmaceutical forms

Concentrate for solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

0.3 mg/kg administered once every 4 weeks for up to 24 weeks

Number of subjects in period 1 ^[1]	Cohort 1: TAF + VIR-2218 + SLGN + Nivolumab	Cohort 2 Group A: VIR-2218 + SLGN + Nivolumab	Cohort 2 Group B: SLGN + Nivolumab
Started	42	40	20
Completed	41	36	20
Not completed	1	4	0
Withdrew consent	1	3	-
Investigator's discretion	-	1	-

Notes
[1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
Justification: One participant was enrolled but did not receive study drug in Cohort 2 Group B: SLGN + Nivolumab.

Baseline characteristics

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Reporting group title

Cohort 1: TAF + VIR-2218 + SLGN + Nivolumab

Reporting group description

Reporting group title

Cohort 2 Group A: VIR-2218 + SLGN + Nivolumab

Reporting group description

Reporting group title

Cohort 2 Group B: SLGN + Nivolumab

Reporting group description

Reporting group values	Cohort 1: TAF + VIR-2218 + SLGN + Nivolumab	Cohort 2 Group A: VIR-2218 + SLGN + Nivolumab	Cohort 2 Group B: SLGN + Nivolumab	Total
Number of subjects	42	40	20	102
Age categorical
Units: Subjects
Age continuous
Units: years
arithmetic mean (standard deviation)	48 ( 8.1 )	42 ( 7.9 )	44 ( 7.9 )	-
Gender categorical
Units: Subjects
Female	16	25	10	51
Male	26	15	10	51
Race
Units: Subjects
Asian	41	37	18	96
Black or African American	1	2	0	3
Other or More Than One Race	0	1	2	3
Ethnicity
Units: Subjects
Hispanic or Latino	0	0	0	0
Not Hispanic or Latino	40	39	20	99
Not Collected	2	1	0	3

End points

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Reporting group title

Cohort 1: TAF + VIR-2218 + SLGN + Nivolumab

Reporting group description

Reporting group title

Cohort 2 Group A: VIR-2218 + SLGN + Nivolumab

Reporting group description

Reporting group title

Cohort 2 Group B: SLGN + Nivolumab

Reporting group description

Primary: Percentage of Participants Who Achieve Functional Cure

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End point title

Percentage of Participants Who Achieve Functional Cure

End point description

Functional cure was defined as hepatitis B surface antigen (HBsAg) loss and hepatitis B virus (HBV) deoxyribonucleic acid (DNA) less than the lower limit of quantitation (LLOQ) at follow-up Week 24. LLOQ for HBV DNA CAP/CTM 2.0 is 20 IU/mL. LLOQ for HBV DNA Cobas 6800 is 10 IU/mL. The HBsAg loss was defined as HBsAg changing from positive at baseline to negative at any postbaseline visit. Percentages were rounded-off. The Full Analysis Set included all enrolled participants in Cohort 1, or all randomized participants in Cohort 2 who received at least 1 dose of study drug.

End point type

Primary

End point timeframe

At Follow-up Week 24 (Cohort 1 and Cohort 2A: At Week 60; Cohort 2B: At Week 48)

End point values	Cohort 1: TAF + VIR-2218 + SLGN + Nivolumab	Cohort 2 Group A: VIR-2218 + SLGN + Nivolumab	Cohort 2 Group B: SLGN + Nivolumab
Number of subjects analysed	42	40	20
Units: percentage of participants
number (confidence interval 95%)	2.4 (0.1 to 12.6)	2.5 (0.1 to 13.2)	0.0 (0.0 to 16.8)

Cohort 2 Group A vs Cohort 2 Group B

Statistical analysis description

For Cohort 2A versus Cohort 2B, the percentage difference and the corresponding 95% confidence interval was calculated using the stratum-adjusted Mantel-Haenszel method, stratified by HBsAg group (> 3 and ≤ 3 log10 IU/mL).

Comparison groups

Cohort 2 Group A: VIR-2218 + SLGN + Nivolumab v Cohort 2 Group B: SLGN + Nivolumab

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

percentage difference

Point estimate

2.5

Confidence interval

level

95%

sides

2-sided

lower limit

-2.3

upper limit

7.3

Secondary: Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss With and Without Anti-HBsAg Seroconversion

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End point title

Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss With and Without Anti-HBsAg Seroconversion

End point description

HBsAg loss was defined as HBsAg changing from positive at baseline to negative at any postbaseline visit. HBsAg seroconversion was defined as HBsAg loss and HBsAb changes from negative/missing at baseline to positive at a postbaseline visit. Percentages were rounded-off. Participants in the Full Analysis Set were analyzed. 9999= In Cohort 2 Group B, participants received study treatment for up to 24 weeks. Thereafter, participants were followed up for 48 weeks. Therefore, data for Weeks 28, 32, and 36 are not reported for this cohort in this outcome measure.

End point type

Secondary

End point timeframe

Up to Follow-up Week 48 (Cohort 1 and Cohort 2A: At Week 84; Cohort 2B: At Week 72)

End point values	Cohort 1: TAF + VIR-2218 + SLGN + Nivolumab	Cohort 2 Group A: VIR-2218 + SLGN + Nivolumab	Cohort 2 Group B: SLGN + Nivolumab
Number of subjects analysed	42	40	20
Units: percentage of participants
number (not applicable)
HBsAg Loss: Week (WK) 4 (n=42,40,20)	0	0	0
HBsAg Loss and Seroconversion: Wk 4 (n=42,40,20)	0	0	0
HBsAg Loss: WK 8 (n=42,40,20)	0	0	0
HBsAg Loss and Seroconversion: Wk 8 (n=42,40,20)	0	0	0
HBsAg Loss: Wk 12 (n=42,40,20)	2.4	0	0
HBsAg Loss and Seroconversion: Wk 12 (n=42,40,20)	0	0	0
HBsAg Loss: Wk 14 (n=42,40,20)	2.4	0	0
HBsAg Loss and Seroconversion: Wk 14 (n=42,40,20)	0	0	0
HBsAg Loss: Wk 16 (n=42,40,20)	0	0	0
HBsAg Loss and Seroconversion: Wk 16 (n=42,40,20)	0	0	0
HBsAg Loss: Wk 20 (n=42,40,20)	4.8	2.5	0
HBsAg Loss and Seroconversion: Wk 20 (n=42,40,20)	0	0	0
HBsAg Loss: Wk 24 (n=42,40,20)	4.8	0	0
HBsAg Loss and Seroconversion: Wk 24 (n=42,40,20)	0	0	0
HBsAg Loss: Wk 28 (n=42,40,0)	4.8	0	9999
HBsAg Loss and Seroconversion: Wk 28 (n=42,40,0)	0	0	9999
HBsAg Loss: Wk 32 (n=42,40,0)	4.8	0	9999
HBsAg Loss and Seroconversion: Wk 32 (n=42,40,0)	0	0	9999
HBsAg Loss: Wk 36 (n=42,40,0)	4.8	0	9999
HBsAg Loss and Seroconversion: Wk 36 (n=42,40,0)	0	0	9999
HBsAg Loss: Follow-up (FU) Wk 2 (n=42,40,20)	4.8	0	0
HBsAg Loss and Seroconversion: FU Wk 2 (n=42,40,20	0	0	0
HBsAg Loss: FU Wk 4 (n=42,40,20)	4.8	0	0
HBsAg Loss and Seroconversion: FU Wk 4 (n=42,40,20	0	0	0
HBsAg Loss: FU Wk 8 (n=42,40,20)	4.8	0	0
HBsAg Loss and Seroconversion: FU Wk 8 (n=42,40,20	0	0	0
HBsAg Loss: FU Wk 12 (n=42,40,20)	7.1	0	0
HBsAg Loss and Seroconversion:FU Wk 12(n=42,40,20)	0	0	0
HBsAg Loss: FU Wk 24 (n=42,40,20)	4.8	2.5	0
HBsAg Loss and Seroconversion:FU Wk 24(n=42,40,20)	0	0	0
HBsAg Loss: FU Wk 36 (n=42,40,20)	7.1	2.5	0
HBsAg Loss and Seroconversion:FU Wk 36(n=42,40,20)	2.4	0	0
HBsAg Loss: FU Wk 48 (n=42,40,20)	7.1	2.5	0
HBsAg Loss and Seroconversion:FU Wk 48(n=42,40,20)	0	0	0

No statistical analyses for this end point

Secondary: Percentage of Participants With Hepatitis B e Antigen (HBeAg) Loss With and Without Anti-HBeAg Seroconversion in Participants With CHB Who Are HBeAg-Positive at Baseline

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End point title

Percentage of Participants With Hepatitis B e Antigen (HBeAg) Loss With and Without Anti-HBeAg Seroconversion in Participants With CHB Who Are HBeAg-Positive at Baseline

End point description

HBeAg loss is defined as HBeAg changing from positive at baseline to negative at any postbaseline visit. HBeAg seroconversion was defined as HBeAb test changing from negative or missing at baseline to positive at a postbaseline visit. Percentages were rounded-off. Participants in the Full Analysis Set with HBeAg positive at Baseline were analyzed. 9999= In Cohort 2 Group B, participants received study treatment for up to 24 weeks. Thereafter, participants were followed up for 48 weeks. Therefore, data for Weeks 28, 32, and 36 are not available for this cohort in this outcome measure.

End point type

Secondary

End point timeframe

Up to Follow-up Week 48 (Cohort 1 and Cohort 2A: At Week 84; Cohort 2B: At Week 72)

End point values	Cohort 1: TAF + VIR-2218 + SLGN + Nivolumab	Cohort 2 Group A: VIR-2218 + SLGN + Nivolumab	Cohort 2 Group B: SLGN + Nivolumab
Number of subjects analysed	18	16	6
Units: percentage of participants
number (not applicable)
HBeAg Loss: Wk 4 (n=18,16,6)	5.6	0	0
HBeAg Loss and Seroconversion: Wk 4 (n=18,16,6)	0	0	0
HBeAg Loss: Wk 8 (n=18,16,6)	11.1	6.3	0
HBeAg Loss and Seroconversion: Wk 8 (n=n=18,16,6)	0	0	0
HBeAg Loss: Wk 12 (n=18,16,6)	11.1	6.3	0
HBeAg Loss and Seroconversion: Wk 12 (n=n=18,16,6)	0	0	0
HBeAg Loss: Wk 14 (n=18,16,6)	11.1	6.3	0
HBeAg Loss and Seroconversion: Wk 14 (n=n=18,16,6)	0	0	0
HBeAg Loss: Wk 16 (n=18,16,6)	11.1	6.3	0
HBeAg Loss and Seroconversion: Wk 16 (n=n=18,16,6	0	0	0
HBeAg Loss: Wk 20 (n=18,16,6)	11.1	6.3	0
HBeAg Loss and Seroconversion: Wk 20 (n=n=18,16,6)	0	0	0
HBeAg Loss: Wk 24 (n=18,16,6)	16.7	6.3	0
HBeAg Loss and Seroconversion: Wk 24 (n=n=18,16,6)	5.6	0	0
HBeAg Loss: Wk 28 (n=18,16,0)	16.7	6.3	9999
HBeAg Loss and Seroconversion: Wk 28 (n=n=18,16,0)	5.6	0	9999
HBeAg Loss: Wk 32 (n=18,16,0)	11.1	0	9999
HBeAg Loss and Seroconversion: Wk 32 (n=n=18,16,0)	5.6	0	9999
HBeAg Loss: Wk 36 (n=18,16,0)	11.1	0	9999
HBeAg Loss and Seroconversion: Wk 36 (n=n=18,16,0)	5.6	0	9999
HBeAg Loss: FU Wk 2 (n=18,16,6)	5.6	6.3	0
HBeAg Loss and Seroconversion: FU Wk 2(n=18,16,6)	0	6.3	0
HBeAg Loss: FU Wk 4 (n=18,16,6)	16.7	6.3	0
HBeAg Loss and Seroconversion: FU Wk 4(n=18,16,6)	5.6	6.3	0
HBeAg Loss: FU Wk 8 (n=18,16,6)	11.1	6.3	0
HBeAg Loss and Seroconversion: FU Wk 8(n=18,16,6	0	6.3	0
HBeAg Loss: FU Wk 12 (n=18,16,6)	16.7	6.3	0
HBeAg Loss and Seroconversion: FU Wk 12(n=18,16,6)	5.6	6.3	0
HBeAg Loss: FU Wk 24 (n=18,16,6)	5.6	12.5	0
HBeAg Loss and Seroconversion: FU Wk 24(n=18,16,6)	0	12.5	0
HBeAg Loss: FU Wk 36 (n=18,16,6)	11.1	12.5	0
HBeAg Loss and Seroconversion: FU Wk 36(n=18,16,6)	0	6.3	0
HBeAg Loss: FU Wk 48 (n=18,16,6)	16.7	12.5	0
HBeAg Loss and Seroconversion: FU Wk 48(n=18,16,6)	5.6	6.3	0

No statistical analyses for this end point

Secondary: Percentage of Participants Who Remain Off NUC Treatment During Follow-Up

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End point title

Percentage of Participants Who Remain Off NUC Treatment During Follow-Up

End point description

NUC treatments included for analysis: adefovir dipivoxil, entecavir, telbivudine, tenofovir, tenofovir alafenamide, tenofovir alafenamide fumarate, tenofovir disoproxil fumarate, and lamivudine. Percentages were rounded-off. The Follow-Up Analysis Set included all participants who have at least 1 follow-up visit, after completing or premature discontinued from the study drugs.

End point type

Secondary

End point timeframe

Cohort 1 and Cohort 2A: From Week 36 up to Week 84 and for Cohort 2B: From Week 24 up to Week 72

End point values	Cohort 1: TAF + VIR-2218 + SLGN + Nivolumab	Cohort 2 Group A: VIR-2218 + SLGN + Nivolumab	Cohort 2 Group B: SLGN + Nivolumab
Number of subjects analysed	42	36	20
Units: percentage of participants
number (not applicable)	16.7	55.6	75.0

No statistical analyses for this end point

Secondary: Percentage of Participants Experiencing Hepatitis B Virus (HBV) Virologic Breakthrough During Study Treatments

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End point title

Percentage of Participants Experiencing Hepatitis B Virus (HBV) Virologic Breakthrough During Study Treatments

End point description

Virologic breakthrough was defined as confirmed HBV DNA ≥ LLOQ after 2 consecutive HBV DNA < LLOQ in participants who are complying with NUC therapy or confirmed HBV DNA ≥ 1 log10 IU/mL increase from nadir during study treatments. LLOQ for HBV DNA CAP/CTM 2.0 is 20 IU/mL. LLOQ for HBV DNA Cobas 6800 is 10 IU/mL. Percentages were rounded-off. Participants in the Full Analysis Set were analyzed.

End point type

Secondary

End point timeframe

Up to 36 Weeks

End point values	Cohort 1: TAF + VIR-2218 + SLGN + Nivolumab	Cohort 2 Group A: VIR-2218 + SLGN + Nivolumab	Cohort 2 Group B: SLGN + Nivolumab
Number of subjects analysed	42	40	20
Units: percentage of participants
number (not applicable)	7.1	35.0	20.0

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

All-cause Mortality: Up to 86.4 weeks; Adverse events: Up to 84 weeks

Adverse event reporting additional description

All-cause Mortality: The All Enrolled Analysis Set included all participants in Cohort 1 who received a study participant identification number in the study after screening, or all participants in Cohort 2 who were randomized in the study. Adverse events: The Safety Analysis Set includes all participants who received at least 1 dose of study drug.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

27.1

Reporting group title

Cohort 1: TAF + VIR-2218 + SLGN + Nivolumab

Reporting group description

NUC -suppressed participants with CHB received TAF 25 mg orally QD for 36 weeks and VIR-2218 200 mg SC Q4W for 24 weeks. From Week 12 onwards, participants also received SLGN 3 mg orally QW for 24 weeks and nivolumab 0.3 mg/kg IV Q4W for up to 24 weeks (only up to protocol amendment 2, nivolumab was no longer administered post implementation of protocol amendment 2). Participants who were on TAF treatment continued TAF treatment over the duration of study follow-up for 48 weeks. Participants were followed up for 48 weeks post treatment.

Reporting group title

Cohort 2 Group B: SLGN + Nivolumab

Reporting group description

Viremic participants with CHB received SLGN 3 mg orally QW for 24 weeks and nivolumab 0.3 mg/kg IV Q4W for up to 24 weeks. Viremic participants who met the criteria to initiate NUC treatment received TAF 25 mg orally QD for up to 36 weeks during the study. Participants were followed up for 48 weeks post treatment. All treatments were administered up to protocol amendment 2 and after the implementation of protocol amendment 2, the treatments were discontinued for Cohort 2 Group B based on Sponsor decision.

Reporting group title

Cohort 2 Group A: VIR-2218 + SLGN + Nivolumab

Reporting group description

Viremic participants with CHB received SLGN 3 mg orally QW for 24 weeks and nivolumab 0.3 mg/kg IV Q4W for up to 24 weeks. Viremic participants who met the criteria to initiate NUC treatment received TAF 25 mg orally QD for up to 36 weeks during the study. Participants were followed up for 48 weeks post treatment. All treatments were administered up to protocol amendment 2 and after the implementation of protocol amendment 2, the treatments were discontinued for Cohort 2 Group B based on Sponsor decision.

Serious adverse events	Cohort 1: TAF + VIR-2218 + SLGN + Nivolumab	Cohort 2 Group B: SLGN + Nivolumab	Cohort 2 Group A: VIR-2218 + SLGN + Nivolumab
Total subjects affected by serious adverse events
subjects affected / exposed	2 / 42 (4.76%)	3 / 20 (15.00%)	5 / 40 (12.50%)
number of deaths (all causes)	0	0	0
number of deaths resulting from adverse events	0	0	0
Investigations
Alanine aminotransferase increased
subjects affected / exposed	0 / 42 (0.00%)	1 / 20 (5.00%)	1 / 40 (2.50%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Injury, poisoning and procedural complications
Upper limb fracture
subjects affected / exposed	0 / 42 (0.00%)	0 / 20 (0.00%)	1 / 40 (2.50%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
General disorders and administration site conditions
Malaise
subjects affected / exposed	0 / 42 (0.00%)	1 / 20 (5.00%)	0 / 40 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Reproductive system and breast disorders
Adenomyosis
subjects affected / exposed	0 / 42 (0.00%)	0 / 20 (0.00%)	1 / 40 (2.50%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hepatobiliary disorders
Immune-mediated hepatitis
subjects affected / exposed	0 / 42 (0.00%)	0 / 20 (0.00%)	1 / 40 (2.50%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Infections and infestations
Chronic hepatitis B
subjects affected / exposed	0 / 42 (0.00%)	0 / 20 (0.00%)	1 / 40 (2.50%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Covid-19
subjects affected / exposed	1 / 42 (2.38%)	0 / 20 (0.00%)	0 / 40 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Metabolism and nutrition disorders
Dehydration
subjects affected / exposed	1 / 42 (2.38%)	0 / 20 (0.00%)	0 / 40 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Type 1 diabetes mellitus
subjects affected / exposed	0 / 42 (0.00%)	1 / 20 (5.00%)	0 / 40 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0

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

Non-serious adverse events	Cohort 1: TAF + VIR-2218 + SLGN + Nivolumab	Cohort 2 Group B: SLGN + Nivolumab	Cohort 2 Group A: VIR-2218 + SLGN + Nivolumab
Total subjects affected by non serious adverse events
subjects affected / exposed	34 / 42 (80.95%)	19 / 20 (95.00%)	37 / 40 (92.50%)
Vascular disorders
Hypertension
subjects affected / exposed	3 / 42 (7.14%)	0 / 20 (0.00%)	0 / 40 (0.00%)
occurrences all number	3	0	0
Surgical and medical procedures
Wisdom teeth removal
subjects affected / exposed	0 / 42 (0.00%)	1 / 20 (5.00%)	0 / 40 (0.00%)
occurrences all number	0	1	0
General disorders and administration site conditions
Chills
subjects affected / exposed	7 / 42 (16.67%)	2 / 20 (10.00%)	4 / 40 (10.00%)
occurrences all number	8	9	12
Fatigue
subjects affected / exposed	4 / 42 (9.52%)	4 / 20 (20.00%)	7 / 40 (17.50%)
occurrences all number	4	5	14
Pyrexia
subjects affected / exposed	4 / 42 (9.52%)	0 / 20 (0.00%)	5 / 40 (12.50%)
occurrences all number	4	0	8
Injection site pain
subjects affected / exposed	0 / 42 (0.00%)	0 / 20 (0.00%)	6 / 40 (15.00%)
occurrences all number	0	0	11
Malaise
subjects affected / exposed	0 / 42 (0.00%)	2 / 20 (10.00%)	1 / 40 (2.50%)
occurrences all number	0	2	2
Injection site reaction
subjects affected / exposed	0 / 42 (0.00%)	0 / 20 (0.00%)	2 / 40 (5.00%)
occurrences all number	0	0	2
Immune system disorders
Seasonal allergy
subjects affected / exposed	0 / 42 (0.00%)	0 / 20 (0.00%)	2 / 40 (5.00%)
occurrences all number	0	0	2
Reproductive system and breast disorders
Menstruation irregular
subjects affected / exposed	0 / 42 (0.00%)	2 / 20 (10.00%)	1 / 40 (2.50%)
occurrences all number	0	2	1
Heavy menstrual bleeding
subjects affected / exposed	0 / 42 (0.00%)	1 / 20 (5.00%)	0 / 40 (0.00%)
occurrences all number	0	1	0
Respiratory, thoracic and mediastinal disorders
Cough
subjects affected / exposed	2 / 42 (4.76%)	0 / 20 (0.00%)	2 / 40 (5.00%)
occurrences all number	2	0	3
Rhinitis allergic
subjects affected / exposed	0 / 42 (0.00%)	1 / 20 (5.00%)	1 / 40 (2.50%)
occurrences all number	0	1	1
Rhinorrhoea
subjects affected / exposed	0 / 42 (0.00%)	1 / 20 (5.00%)	0 / 40 (0.00%)
occurrences all number	0	1	0
Psychiatric disorders
Insomnia
subjects affected / exposed	1 / 42 (2.38%)	0 / 20 (0.00%)	2 / 40 (5.00%)
occurrences all number	1	0	2
Investigations
Alanine aminotransferase increased
subjects affected / exposed	2 / 42 (4.76%)	4 / 20 (20.00%)	11 / 40 (27.50%)
occurrences all number	3	4	11
Aspartate aminotransferase increased
subjects affected / exposed	2 / 42 (4.76%)	1 / 20 (5.00%)	4 / 40 (10.00%)
occurrences all number	2	1	4
Alanine aminotransferase abnormal
subjects affected / exposed	0 / 42 (0.00%)	1 / 20 (5.00%)	0 / 40 (0.00%)
occurrences all number	0	1	0
Injury, poisoning and procedural complications
Eye injury
subjects affected / exposed	0 / 42 (0.00%)	1 / 20 (5.00%)	0 / 40 (0.00%)
occurrences all number	0	1	0
Synovial rupture
subjects affected / exposed	0 / 42 (0.00%)	1 / 20 (5.00%)	0 / 40 (0.00%)
occurrences all number	0	1	0
Cardiac disorders
Palpitations
subjects affected / exposed	1 / 42 (2.38%)	0 / 20 (0.00%)	2 / 40 (5.00%)
occurrences all number	1	0	2
Nervous system disorders
Headache
subjects affected / exposed	6 / 42 (14.29%)	4 / 20 (20.00%)	6 / 40 (15.00%)
occurrences all number	7	12	8
Dizziness
subjects affected / exposed	4 / 42 (9.52%)	2 / 20 (10.00%)	6 / 40 (15.00%)
occurrences all number	6	3	6
Dysgeusia
subjects affected / exposed	0 / 42 (0.00%)	1 / 20 (5.00%)	0 / 40 (0.00%)
occurrences all number	0	1	0
Blood and lymphatic system disorders
Anaemia
subjects affected / exposed	0 / 42 (0.00%)	0 / 20 (0.00%)	3 / 40 (7.50%)
occurrences all number	0	0	3
Eye disorders
Conjunctivitis allergic
subjects affected / exposed	0 / 42 (0.00%)	1 / 20 (5.00%)	1 / 40 (2.50%)
occurrences all number	0	1	1
Vision blurred
subjects affected / exposed	0 / 42 (0.00%)	1 / 20 (5.00%)	1 / 40 (2.50%)
occurrences all number	0	1	1
Dry eye
subjects affected / exposed	0 / 42 (0.00%)	1 / 20 (5.00%)	0 / 40 (0.00%)
occurrences all number	0	1	0
Eye pain
subjects affected / exposed	0 / 42 (0.00%)	1 / 20 (5.00%)	0 / 40 (0.00%)
occurrences all number	0	1	0
Ocular discomfort
subjects affected / exposed	0 / 42 (0.00%)	1 / 20 (5.00%)	0 / 40 (0.00%)
occurrences all number	0	1	0
Optic neuropathy
subjects affected / exposed	0 / 42 (0.00%)	1 / 20 (5.00%)	0 / 40 (0.00%)
occurrences all number	0	1	0
Pseudopapilloedema
subjects affected / exposed	0 / 42 (0.00%)	1 / 20 (5.00%)	0 / 40 (0.00%)
occurrences all number	0	1	0
Gastrointestinal disorders
Nausea
subjects affected / exposed	16 / 42 (38.10%)	10 / 20 (50.00%)	27 / 40 (67.50%)
occurrences all number	62	54	99
Vomiting
subjects affected / exposed	8 / 42 (19.05%)	9 / 20 (45.00%)	15 / 40 (37.50%)
occurrences all number	29	28	29
Diarrhoea
subjects affected / exposed	3 / 42 (7.14%)	3 / 20 (15.00%)	7 / 40 (17.50%)
occurrences all number	3	5	8
Abdominal discomfort
subjects affected / exposed	1 / 42 (2.38%)	1 / 20 (5.00%)	2 / 40 (5.00%)
occurrences all number	1	1	2
Dyspepsia
subjects affected / exposed	3 / 42 (7.14%)	0 / 20 (0.00%)	0 / 40 (0.00%)
occurrences all number	3	0	0
Gastrooesophageal reflux disease
subjects affected / exposed	0 / 42 (0.00%)	1 / 20 (5.00%)	0 / 40 (0.00%)
occurrences all number	0	1	0
Lip ulceration
subjects affected / exposed	0 / 42 (0.00%)	1 / 20 (5.00%)	0 / 40 (0.00%)
occurrences all number	0	1	0
Hepatobiliary disorders
Hypertransaminasaemia
subjects affected / exposed	0 / 42 (0.00%)	2 / 20 (10.00%)	3 / 40 (7.50%)
occurrences all number	0	2	3
Skin and subcutaneous tissue disorders
Skin lesion
subjects affected / exposed	0 / 42 (0.00%)	1 / 20 (5.00%)	0 / 40 (0.00%)
occurrences all number	0	1	0
Psoriasis
subjects affected / exposed	0 / 42 (0.00%)	1 / 20 (5.00%)	0 / 40 (0.00%)
occurrences all number	0	1	0
Rash
subjects affected / exposed	1 / 42 (2.38%)	1 / 20 (5.00%)	1 / 40 (2.50%)
occurrences all number	1	1	1
Rash pruritic
subjects affected / exposed	3 / 42 (7.14%)	0 / 20 (0.00%)	0 / 40 (0.00%)
occurrences all number	3	0	0
Acne
subjects affected / exposed	0 / 42 (0.00%)	0 / 20 (0.00%)	2 / 40 (5.00%)
occurrences all number	0	0	2
Dermatitis
subjects affected / exposed	0 / 42 (0.00%)	0 / 20 (0.00%)	2 / 40 (5.00%)
occurrences all number	0	0	2
Erythema
subjects affected / exposed	0 / 42 (0.00%)	0 / 20 (0.00%)	2 / 40 (5.00%)
occurrences all number	0	0	2
Alopecia
subjects affected / exposed	0 / 42 (0.00%)	1 / 20 (5.00%)	0 / 40 (0.00%)
occurrences all number	0	1	0
Urticaria
subjects affected / exposed	0 / 42 (0.00%)	1 / 20 (5.00%)	0 / 40 (0.00%)
occurrences all number	0	1	0
Renal and urinary disorders
Dysuria
subjects affected / exposed	1 / 42 (2.38%)	1 / 20 (5.00%)	0 / 40 (0.00%)
occurrences all number	1	1	0
Musculoskeletal and connective tissue disorders
Myalgia
subjects affected / exposed	3 / 42 (7.14%)	1 / 20 (5.00%)	1 / 40 (2.50%)
occurrences all number	5	1	1
Infections and infestations
Covid-19
subjects affected / exposed	16 / 42 (38.10%)	4 / 20 (20.00%)	10 / 40 (25.00%)
occurrences all number	17	4	10
Upper respiratory tract infection
subjects affected / exposed	1 / 42 (2.38%)	2 / 20 (10.00%)	1 / 40 (2.50%)
occurrences all number	2	2	1
Anal abscess
subjects affected / exposed	1 / 42 (2.38%)	1 / 20 (5.00%)	0 / 40 (0.00%)
occurrences all number	1	1	0
Hepatitis B
subjects affected / exposed	0 / 42 (0.00%)	0 / 20 (0.00%)	2 / 40 (5.00%)
occurrences all number	0	0	2
Body tinea
subjects affected / exposed	0 / 42 (0.00%)	1 / 20 (5.00%)	0 / 40 (0.00%)
occurrences all number	0	1	0
Cystitis
subjects affected / exposed	0 / 42 (0.00%)	1 / 20 (5.00%)	0 / 40 (0.00%)
occurrences all number	0	1	0
Fungal skin infection
subjects affected / exposed	0 / 42 (0.00%)	1 / 20 (5.00%)	0 / 40 (0.00%)
occurrences all number	0	1	0
Influenza
subjects affected / exposed	0 / 42 (0.00%)	1 / 20 (5.00%)	0 / 40 (0.00%)
occurrences all number	0	1	0
Lower respiratory tract infection
subjects affected / exposed	0 / 42 (0.00%)	1 / 20 (5.00%)	0 / 40 (0.00%)
occurrences all number	0	1	0
Otitis externa
subjects affected / exposed	0 / 42 (0.00%)	1 / 20 (5.00%)	0 / 40 (0.00%)
occurrences all number	0	1	0
Periodontitis
subjects affected / exposed	0 / 42 (0.00%)	1 / 20 (5.00%)	0 / 40 (0.00%)
occurrences all number	0	1	0
Pharyngitis
subjects affected / exposed	0 / 42 (0.00%)	1 / 20 (5.00%)	0 / 40 (0.00%)
occurrences all number	0	1	0
Rhinitis
subjects affected / exposed	0 / 42 (0.00%)	1 / 20 (5.00%)	0 / 40 (0.00%)
occurrences all number	0	1	0
Vulvovaginal candidiasis
subjects affected / exposed	0 / 42 (0.00%)	1 / 20 (5.00%)	0 / 40 (0.00%)
occurrences all number	0	1	0
Metabolism and nutrition disorders
Decreased appetite
subjects affected / exposed	0 / 42 (0.00%)	1 / 20 (5.00%)	1 / 40 (2.50%)
occurrences all number	0	1	1

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Were there any global substantial amendments to the protocol? Yes

20 Apr 2022

28. GSI Grading Scale for Severity of Adverse Events and Laboratory Abnormalities: Text was added to clarify that IRRs will be graded based on Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. 29. Text was added to clarify that management of toxicity considered related to nivolumab must follow the toxicity management guidance as outlined in the local label for nivolumab.

20 Apr 2022

Amendment 1: 1. The ClinicalTrials.gov identifier is available. 2. Text was added to clarify that this study will be conducted in compliance with this protocol and in accordance with the ethical principles that have their origin in the Declaration of Helsinki, and that are consistent with International Council for Harmonisation (ICH) Good Clinical Practice (GCP) and applicable regulatory requirements. 3. Text was added to provide updated information on drug-drug interaction data for SLGN and acid-reducing agents. 4. Text was updated to provide a consistent endpoint irrespective of the different assay limits of detection. 5. Text was updated to clarify the definition of virologic breakthrough. 6. Text was updated to clarify the definition of virologic breakthrough. 7. Study design was updated to adjust the proportion of HBeAg-positive and HBeAg-negative participants per cohort. 8. Text was updated to include alanine aminotransferase (ALT) values for discontinuation criteria and the rationale for allowing discontinuation of study drug at end of treatment (EOT) even if the criteria specified are not met and to specify additional discontinuation criteria. 9. Exclusion criteria were updated to reduce the time from screening for liver biopsy and FibroScan test so that these results could be used for exclusion criteria, and to include details for excluding participants in Cohorts 2 and 3 who fall under the standard of care indication. 10. Nivolumab administration duration was updated. 11. Text was added to clarify that coadministration of antiemetic medication was allowed at the discretion of the investigator and to align with Gilead’s guidance for concomitant medication for COVID-19 vaccines. 12. Text was updated to allow acid-reducing agents. 13. Text was updated to allow for remote drug accountability review.

20 Apr 2022

14. Text was updated to add sparse pharmacokinetics (PK) sampling for nivolumab, and to clarify that sparse PK for SLGN and nivolumab is not required on Day 1 for Cohort 1 and Cohort 2 Group A. 15. Text was added to clarify that participants may be asked to consent to HBeAg testing prior to screening procedures in order to ensure the required minimum of 20% HBeAg-positive participants for each cohort. 16. Screening visit: Text was updated to extend the screening window to 45 days. 17. Baseline/Day 1 Assessments: Text was updated to extend the screening window to 45 days. 18. Criteria were updated to align discontinuation criteria based on Grade 3 or Grade 4 adverse events or laboratory abnormalities. Additional criteria were added to define parameters for permanent discontinuation of study treatment in the event of hepatic disease progression and/or lack of efficacy. 19. Text was added to clarify the process for premature study discontinuation. 20. Assessment of Severity: Text was updated to clarify that grading of infusion-related reaction (IRRs) will be done according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. 21. Text was updated to clarify the definition of hepatotoxicity. 22. ALT Elevation or Flare Management on Treatment and Treatment-Free Follow-up: Text was updated to provide a consistent endpoint irrespective of the different assay limits of detection. 23. Primary Endpoint: Text was updated to provide a consistent endpoint irrespective of the different assay limits of detection. 24. Text was updated to specify plasma vs serum PK. 25. Text was updated to align with Gilead’s template language for case report forms. 26. Text was updated to provide clarification on the preparation of study reports and Gilead publication policies. 27. Study Drug Effects on Pregnancy and Hormonal Contraception was updated for VIR-2218, as per the latest investigator’s brochure.

12 Apr 2023

15. FU Week 2 was removed in order to simplify the FU period for participants. 16. References to Cohort 3 were removed throughout the protocol due to the decision to discontinue this cohort. 17. Incidences of Global Patient Safety have been changed to Patient Safety (PS). 18. Minor changes included to correct typographical errors.

12 Apr 2023

Amendment 2: 1. References to nivolumab were modified throughout the protocol due to Gilead’s decision to discontinue nivolumab dosing across study cohorts. 2. An ongoing study (GS-US-389-5458) assessing the safety, tolerability and efficacy of once-weekly administration of SLGN 3 mg in special populations with chronic hepatitis B virus (CHB) was added. 3. Figure 1 was updated in order to reflect the current changes to study design. 4. A new section to describe the rationale for modifications to the study design was added following the decision to discontinue nivolumab dosing. 5. Benefit/Risk Assessment for nivolumab and Overall Benefit/Risk was updated following discontinuation of nivolumab in this study. 6. Number of viremic chronic hepatitis B (CHB)-infected participants was reduced from 80 to 60 participants to reflect a prior sponsor decision that cohort 3 would not be enrolled. 7. A new subsection for changes to the study design was added. 8. All incidences of ‘Participants who remain on nucleos(t)ide (NUC) treatment into follow-up (FU) period are not required to attend follow up FU Weeks 2 and 8 visits’ have been removed as all participants in Cohort 1 will remain on NUCs throughout the FU period. 9. FU period was updated to outline the procedures following the change to study design. 10. An individual treatment modification criterion (Any on treatment uveitis, confirmed by ophthalmologic evaluation) was moved to individual treatment discontinuation criteria after confirmation that no rechallenge was required following the resolution of the AE. 11. A new section for toxicity management of irAEs observed with nivolumab was added. 12. AE of special interest (eg, uveitis) was added to the safety analysis. 13. FU Week 8 virtual/telephonic visit pregnancy test was changed across all cohorts. 14. The visit windows for FU Weeks 24 through FU Week 48 (for Cohorts 1 and 2) were extended to ± 14 days.

Were there any global interruptions to the trial? No

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

None reported

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Clinical Trial Results:
A Phase 2a, Open-Label Study to Evaluate the Safety and Efficacy of Selgantolimod (SLGN)-Containing Combination Therapies for the Treatment of Chronic Hepatitis B (CHB)

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Primary: Percentage of Participants Who Achieve Functional Cure

Primary: Percentage of Participants Who Achieve Functional Cure

Secondary: Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss With and Without Anti-HBsAg Seroconversion

Secondary: Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss With and Without Anti-HBsAg Seroconversion

Secondary: Percentage of Participants With Hepatitis B e Antigen (HBeAg) Loss With and Without Anti-HBeAg Seroconversion in Participants With CHB Who Are HBeAg-Positive at Baseline

Secondary: Percentage of Participants With Hepatitis B e Antigen (HBeAg) Loss With and Without Anti-HBeAg Seroconversion in Participants With CHB Who Are HBeAg-Positive at Baseline

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Secondary: Percentage of Participants Who Remain Off NUC Treatment During Follow-Up

Secondary: Percentage of Participants Experiencing Hepatitis B Virus (HBV) Virologic Breakthrough During Study Treatments

Secondary: Percentage of Participants Experiencing Hepatitis B Virus (HBV) Virologic Breakthrough During Study Treatments

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Clinical trials

Clinical Trial Results: A Phase 2a, Open-Label Study to Evaluate the Safety and Efficacy of Selgantolimod (SLGN)-Containing Combination Therapies for the Treatment of Chronic Hepatitis B (CHB)

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Primary: Percentage of Participants Who Achieve Functional Cure

Primary: Percentage of Participants Who Achieve Functional Cure

Secondary: Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss With and Without Anti-HBsAg Seroconversion

Secondary: Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss With and Without Anti-HBsAg Seroconversion

Secondary: Percentage of Participants With Hepatitis B e Antigen (HBeAg) Loss With and Without Anti-HBeAg Seroconversion in Participants With CHB Who Are HBeAg-Positive at Baseline

Secondary: Percentage of Participants With Hepatitis B e Antigen (HBeAg) Loss With and Without Anti-HBeAg Seroconversion in Participants With CHB Who Are HBeAg-Positive at Baseline

Secondary: Percentage of Participants Who Remain Off NUC Treatment During Follow-Up

Secondary: Percentage of Participants Who Remain Off NUC Treatment During Follow-Up

Secondary: Percentage of Participants Experiencing Hepatitis B Virus (HBV) Virologic Breakthrough During Study Treatments

Secondary: Percentage of Participants Experiencing Hepatitis B Virus (HBV) Virologic Breakthrough During Study Treatments

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Clinical Trial Results:
A Phase 2a, Open-Label Study to Evaluate the Safety and Efficacy of Selgantolimod (SLGN)-Containing Combination Therapies for the Treatment of Chronic Hepatitis B (CHB)