Trial Outcomes & Findings for Study to Evaluate the Safety and Efficacy of Selgantolimod (SLGN)-Containing Combination Therapies for the Treatment of Chronic Hepatitis B (CHB) (NCT NCT04891770)

Last Updated: 2025-07-24

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

103 participants

Primary outcome timeframe

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

Results posted on

2025-07-24

Participant Flow

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

165 participants were screened.

Participant milestones

Participant milestones
Measure	Cohort 1: TAF + VIR-2218 + SLGN + Nivolumab 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.	Cohort 2 Group A: VIR-2218 + SLGN + Nivolumab 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.	Cohort 2 Group B: SLGN + Nivolumab 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.
Overall Study STARTED	42	40	21
Overall Study COMPLETED	41	36	20
Overall Study NOT COMPLETED	1	4	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort 1: TAF + VIR-2218 + SLGN + Nivolumab 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.	Cohort 2 Group A: VIR-2218 + SLGN + Nivolumab 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.	Cohort 2 Group B: SLGN + Nivolumab 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.
Overall Study Withdrew consent	1	3	0
Overall Study Enrolled but never treated	0	0	1
Overall Study Investigator's discretion	0	1	0

Baseline Characteristics

For Ethnicity, data was not collected for 2 participants in the Cohort 1: TAF + VIR-2218 + SLGN + Nivolumab group and for 1 participant in the Cohort 2 Group A: VIR-2218+ SLGN + Nivolumab group.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1: TAF + VIR-2218 + SLGN + Nivolumab n=42 Participants 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. Participants were followed up for 48 weeks post treatment.	Cohort 2 Group A: VIR-2218 + SLGN + Nivolumab n=40 Participants 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.	Cohort 2 Group B: SLGN + Nivolumab n=20 Participants 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.	Total n=102 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=42 Participants	0 Participants n=40 Participants	0 Participants n=20 Participants	0 Participants n=102 Participants
Age, Categorical Between 18 and 65 years	42 Participants n=42 Participants	40 Participants n=40 Participants	20 Participants n=20 Participants	102 Participants n=102 Participants
Age, Categorical >=65 years	0 Participants n=42 Participants	0 Participants n=40 Participants	0 Participants n=20 Participants	0 Participants n=102 Participants
Age, Continuous	48 years STANDARD_DEVIATION 8.1 • n=42 Participants	42 years STANDARD_DEVIATION 7.9 • n=40 Participants	44 years STANDARD_DEVIATION 7.9 • n=20 Participants	45 years STANDARD_DEVIATION 8.5 • n=102 Participants
Sex: Female, Male Female	16 Participants n=42 Participants	25 Participants n=40 Participants	10 Participants n=20 Participants	51 Participants n=102 Participants
Sex: Female, Male Male	26 Participants n=42 Participants	15 Participants n=40 Participants	10 Participants n=20 Participants	51 Participants n=102 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=40 Participants • For Ethnicity, data was not collected for 2 participants in the Cohort 1: TAF + VIR-2218 + SLGN + Nivolumab group and for 1 participant in the Cohort 2 Group A: VIR-2218+ SLGN + Nivolumab group.	0 Participants n=39 Participants • For Ethnicity, data was not collected for 2 participants in the Cohort 1: TAF + VIR-2218 + SLGN + Nivolumab group and for 1 participant in the Cohort 2 Group A: VIR-2218+ SLGN + Nivolumab group.	0 Participants n=20 Participants • For Ethnicity, data was not collected for 2 participants in the Cohort 1: TAF + VIR-2218 + SLGN + Nivolumab group and for 1 participant in the Cohort 2 Group A: VIR-2218+ SLGN + Nivolumab group.	0 Participants n=99 Participants • For Ethnicity, data was not collected for 2 participants in the Cohort 1: TAF + VIR-2218 + SLGN + Nivolumab group and for 1 participant in the Cohort 2 Group A: VIR-2218+ SLGN + Nivolumab group.
Ethnicity (NIH/OMB) Not Hispanic or Latino	40 Participants n=40 Participants • For Ethnicity, data was not collected for 2 participants in the Cohort 1: TAF + VIR-2218 + SLGN + Nivolumab group and for 1 participant in the Cohort 2 Group A: VIR-2218+ SLGN + Nivolumab group.	39 Participants n=39 Participants • For Ethnicity, data was not collected for 2 participants in the Cohort 1: TAF + VIR-2218 + SLGN + Nivolumab group and for 1 participant in the Cohort 2 Group A: VIR-2218+ SLGN + Nivolumab group.	20 Participants n=20 Participants • For Ethnicity, data was not collected for 2 participants in the Cohort 1: TAF + VIR-2218 + SLGN + Nivolumab group and for 1 participant in the Cohort 2 Group A: VIR-2218+ SLGN + Nivolumab group.	99 Participants n=99 Participants • For Ethnicity, data was not collected for 2 participants in the Cohort 1: TAF + VIR-2218 + SLGN + Nivolumab group and for 1 participant in the Cohort 2 Group A: VIR-2218+ SLGN + Nivolumab group.
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=40 Participants • For Ethnicity, data was not collected for 2 participants in the Cohort 1: TAF + VIR-2218 + SLGN + Nivolumab group and for 1 participant in the Cohort 2 Group A: VIR-2218+ SLGN + Nivolumab group.	0 Participants n=39 Participants • For Ethnicity, data was not collected for 2 participants in the Cohort 1: TAF + VIR-2218 + SLGN + Nivolumab group and for 1 participant in the Cohort 2 Group A: VIR-2218+ SLGN + Nivolumab group.	0 Participants n=20 Participants • For Ethnicity, data was not collected for 2 participants in the Cohort 1: TAF + VIR-2218 + SLGN + Nivolumab group and for 1 participant in the Cohort 2 Group A: VIR-2218+ SLGN + Nivolumab group.	0 Participants n=99 Participants • For Ethnicity, data was not collected for 2 participants in the Cohort 1: TAF + VIR-2218 + SLGN + Nivolumab group and for 1 participant in the Cohort 2 Group A: VIR-2218+ SLGN + Nivolumab group.
Race/Ethnicity, Customized Race · Asian	41 Participants n=42 Participants	37 Participants n=40 Participants	18 Participants n=20 Participants	96 Participants n=102 Participants
Race/Ethnicity, Customized Race · Black or African American	1 Participants n=42 Participants	2 Participants n=40 Participants	0 Participants n=20 Participants	3 Participants n=102 Participants
Race/Ethnicity, Customized Race · Other or More Than One Race	0 Participants n=42 Participants	1 Participants n=40 Participants	2 Participants n=20 Participants	3 Participants n=102 Participants
Region of Enrollment New Zealand	2 participants n=42 Participants	1 participants n=40 Participants	2 participants n=20 Participants	5 participants n=102 Participants
Region of Enrollment South Korea	6 participants n=42 Participants	2 participants n=40 Participants	1 participants n=20 Participants	9 participants n=102 Participants
Region of Enrollment Singapore	2 participants n=42 Participants	8 participants n=40 Participants	4 participants n=20 Participants	14 participants n=102 Participants
Region of Enrollment Hong Kong	19 participants n=42 Participants	10 participants n=40 Participants	7 participants n=20 Participants	36 participants n=102 Participants
Region of Enrollment Denmark	1 participants n=42 Participants	1 participants n=40 Participants	0 participants n=20 Participants	2 participants n=102 Participants
Region of Enrollment United Kingdom	2 participants n=42 Participants	3 participants n=40 Participants	0 participants n=20 Participants	5 participants n=102 Participants
Region of Enrollment Thailand	8 participants n=42 Participants	13 participants n=40 Participants	5 participants n=20 Participants	26 participants n=102 Participants
Region of Enrollment Australia	2 participants n=42 Participants	2 participants n=40 Participants	1 participants n=20 Participants	5 participants n=102 Participants

PRIMARY outcome

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

Population: 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.

Outcome measures

Outcome measures
Measure	Cohort 1: TAF + VIR-2218 + SLGN + Nivolumab n=42 Participants 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. Participants were followed up for 48 weeks post treatment.	Cohort 2 Group A: VIR-2218 + SLGN + Nivolumab n=40 Participants 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.	Cohort 2 Group B: SLGN + Nivolumab n=20 Participants 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.
Percentage of Participants Who Achieved Functional Cure	2.4 percentage of participants Interval 0.1 to 12.6	2.5 percentage of participants Interval 0.1 to 13.2	0.0 percentage of participants Interval 0.0 to 16.8

SECONDARY outcome

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

Population: Participants in the Full Analysis Set were analyzed. 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.

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.

Outcome measures

Outcome measures
Measure	Cohort 1: TAF + VIR-2218 + SLGN + Nivolumab n=42 Participants 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. Participants were followed up for 48 weeks post treatment.	Cohort 2 Group A: VIR-2218 + SLGN + Nivolumab n=40 Participants 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.	Cohort 2 Group B: SLGN + Nivolumab n=20 Participants 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.
Percentage of Participants With HBsAg Loss With and Without Anti-HBsAg Seroconversion HBsAg Loss: Week 4	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With HBsAg Loss With and Without Anti-HBsAg Seroconversion HBsAg Loss and Seroconversion: Week 8	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With HBsAg Loss With and Without Anti-HBsAg Seroconversion HBsAg Loss and Seroconversion: Week 12	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With HBsAg Loss With and Without Anti-HBsAg Seroconversion HBsAg Loss and Seroconversion: Week 32	0 percentage of participants	0 percentage of participants	—
Percentage of Participants With HBsAg Loss With and Without Anti-HBsAg Seroconversion HBsAg Loss and Seroconversion: FU Week 48	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With HBsAg Loss With and Without Anti-HBsAg Seroconversion HBsAg Loss and Seroconversion: Week 4	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With HBsAg Loss With and Without Anti-HBsAg Seroconversion HBsAg Loss: Week 8	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With HBsAg Loss With and Without Anti-HBsAg Seroconversion HBsAg Loss: Week 12	2.4 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With HBsAg Loss With and Without Anti-HBsAg Seroconversion HBsAg Loss: Week 14	2.4 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With HBsAg Loss With and Without Anti-HBsAg Seroconversion HBsAg Loss and Seroconversion: Week 14	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With HBsAg Loss With and Without Anti-HBsAg Seroconversion HBsAg Loss: Week 16	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With HBsAg Loss With and Without Anti-HBsAg Seroconversion HBsAg Loss and Seroconversion: Week 16	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With HBsAg Loss With and Without Anti-HBsAg Seroconversion HBsAg Loss: Week 20	4.8 percentage of participants	2.5 percentage of participants	0 percentage of participants
Percentage of Participants With HBsAg Loss With and Without Anti-HBsAg Seroconversion HBsAg Loss and Seroconversion: Week 20	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With HBsAg Loss With and Without Anti-HBsAg Seroconversion HBsAg Loss: Week 24	4.8 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With HBsAg Loss With and Without Anti-HBsAg Seroconversion HBsAg Loss and Seroconversion: Week 24	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With HBsAg Loss With and Without Anti-HBsAg Seroconversion HBsAg Loss: Week 28	4.8 percentage of participants	0 percentage of participants	—
Percentage of Participants With HBsAg Loss With and Without Anti-HBsAg Seroconversion HBsAg Loss and Seroconversion: Week 28	0 percentage of participants	0 percentage of participants	—
Percentage of Participants With HBsAg Loss With and Without Anti-HBsAg Seroconversion HBsAg Loss: Week 32	4.8 percentage of participants	0 percentage of participants	—
Percentage of Participants With HBsAg Loss With and Without Anti-HBsAg Seroconversion HBsAg Loss: Week 36	4.8 percentage of participants	0 percentage of participants	—
Percentage of Participants With HBsAg Loss With and Without Anti-HBsAg Seroconversion HBsAg Loss and Seroconversion: Week 36	0 percentage of participants	0 percentage of participants	—
Percentage of Participants With HBsAg Loss With and Without Anti-HBsAg Seroconversion HBsAg Loss: Follow-up (FU) Week 2	4.8 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With HBsAg Loss With and Without Anti-HBsAg Seroconversion HBsAg Loss and Seroconversion: FU Week 2	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With HBsAg Loss With and Without Anti-HBsAg Seroconversion HBsAg Loss: FU Week 4	4.8 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With HBsAg Loss With and Without Anti-HBsAg Seroconversion HBsAg Loss and Seroconversion: FU Week 4	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With HBsAg Loss With and Without Anti-HBsAg Seroconversion HBsAg Loss: FU Week 8	4.8 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With HBsAg Loss With and Without Anti-HBsAg Seroconversion HBsAg Loss and Seroconversion: FU Week 8	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With HBsAg Loss With and Without Anti-HBsAg Seroconversion HBsAg Loss: FU Week 12	7.1 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With HBsAg Loss With and Without Anti-HBsAg Seroconversion HBsAg Loss and Seroconversion: FU Week 12	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With HBsAg Loss With and Without Anti-HBsAg Seroconversion HBsAg Loss: FU Week 24	4.8 percentage of participants	2.5 percentage of participants	0 percentage of participants
Percentage of Participants With HBsAg Loss With and Without Anti-HBsAg Seroconversion HBsAg Loss and Seroconversion: FU Week 24	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With HBsAg Loss With and Without Anti-HBsAg Seroconversion HBsAg Loss: FU Week 36	7.1 percentage of participants	2.5 percentage of participants	0 percentage of participants
Percentage of Participants With HBsAg Loss With and Without Anti-HBsAg Seroconversion HBsAg Loss and Seroconversion: FU Week 36	2.4 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With HBsAg Loss With and Without Anti-HBsAg Seroconversion HBsAg Loss: FU Week 48	7.1 percentage of participants	2.5 percentage of participants	0 percentage of participants

SECONDARY outcome

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

Population: Participants in the Full Analysis Set with HBeAg positive at Baseline were analyzed. 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.

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.

Outcome measures

Outcome measures
Measure	Cohort 1: TAF + VIR-2218 + SLGN + Nivolumab n=18 Participants 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. Participants were followed up for 48 weeks post treatment.	Cohort 2 Group A: VIR-2218 + SLGN + Nivolumab n=16 Participants 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.	Cohort 2 Group B: SLGN + Nivolumab n=6 Participants 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.
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 HBeAg Loss: Week 12	11.1 percentage of participants	6.3 percentage of participants	0 percentage of participants
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 HBeAg Loss and Seroconversion: Week 14	0 percentage of participants	0 percentage of participants	0 percentage of participants
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 HBeAg Loss: Week 16	11.1 percentage of participants	6.3 percentage of participants	0 percentage of participants
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 HBeAg Loss and Seroconversion: Week 16	0 percentage of participants	0 percentage of participants	0 percentage of participants
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 HBeAg Loss and Seroconversion: Week 24	5.6 percentage of participants	0 percentage of participants	0 percentage of participants
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 HBeAg Loss: FU Week 36	11.1 percentage of participants	12.5 percentage of participants	0 percentage of participants
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 HBeAg Loss: FU Week 2	5.6 percentage of participants	6.3 percentage of participants	0 percentage of participants
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 HBeAg Loss and Seroconversion: FU Week 2	0 percentage of participants	6.3 percentage of participants	0 percentage of participants
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 HBeAg Loss: FU Week 4	16.7 percentage of participants	6.3 percentage of participants	0 percentage of participants
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 HBeAg Loss and Seroconversion: FU Week 4	5.6 percentage of participants	6.3 percentage of participants	0 percentage of participants
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 HBeAg Loss: FU Week 8	11.1 percentage of participants	6.3 percentage of participants	0 percentage of participants
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 HBeAg Loss: Week 4	5.6 percentage of participants	0 percentage of participants	0 percentage of participants
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 HBeAg Loss and Seroconversion: Week 4	0 percentage of participants	0 percentage of participants	0 percentage of participants
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 HBeAg Loss: Week 8	11.1 percentage of participants	6.3 percentage of participants	0 percentage of participants
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 HBeAg Loss and Seroconversion: Week 8	0 percentage of participants	0 percentage of participants	0 percentage of participants
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 HBeAg Loss and Seroconversion: Week 12	0 percentage of participants	0 percentage of participants	0 percentage of participants
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 HBeAg Loss: Week 14	11.1 percentage of participants	6.3 percentage of participants	0 percentage of participants
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 HBeAg Loss: Week 20	11.1 percentage of participants	6.3 percentage of participants	0 percentage of participants
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 HBeAg Loss and Seroconversion: Week 20	0 percentage of participants	0 percentage of participants	0 percentage of participants
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 HBeAg Loss: Week 24	16.7 percentage of participants	6.3 percentage of participants	0 percentage of participants
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 HBeAg Loss: Week 28	16.7 percentage of participants	6.3 percentage of participants	—
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 HBeAg Loss and Seroconversion: Week 28	5.6 percentage of participants	0 percentage of participants	—
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 HBeAg Loss: Week 32	11.1 percentage of participants	0 percentage of participants	—
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 HBeAg Loss and Seroconversion: Week 32	5.6 percentage of participants	0 percentage of participants	—
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 HBeAg Loss: Week 36	11.1 percentage of participants	0 percentage of participants	—
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 HBeAg Loss and Seroconversion: Week 36	5.6 percentage of participants	0 percentage of participants	—
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 HBeAg Loss and Seroconversion: FU Week 8	0 percentage of participants	6.3 percentage of participants	0 percentage of participants
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 HBeAg Loss: FU Week 12	16.7 percentage of participants	6.3 percentage of participants	0 percentage of participants
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 HBeAg Loss and Seroconversion: FU Week 12	5.6 percentage of participants	6.3 percentage of participants	0 percentage of participants
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 HBeAg Loss: FU Week 24	5.6 percentage of participants	12.5 percentage of participants	0 percentage of participants
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 HBeAg Loss and Seroconversion: FU Week 24	0 percentage of participants	12.5 percentage of participants	0 percentage of participants
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 HBeAg Loss and Seroconversion: FU Week 36	0 percentage of participants	6.3 percentage of participants	0 percentage of participants
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 HBeAg Loss: FU Week 48	16.7 percentage of participants	12.5 percentage of participants	0 percentage of participants
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 HBeAg Loss and Seroconversion: FU Week 48	5.6 percentage of participants	6.3 percentage of participants	0 percentage of participants

SECONDARY outcome

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

Population: 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.

NUC treatments included for analysis: adefovir dipivoxil, entecavir, telbivudine, tenofovir, tenofovir alafenamide, tenofovir alafenamide fumarate, tenofovir disoproxil fumarate, and lamivudine. Percentages were rounded-off.

Outcome measures

Outcome measures
Measure	Cohort 1: TAF + VIR-2218 + SLGN + Nivolumab n=42 Participants 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. Participants were followed up for 48 weeks post treatment.	Cohort 2 Group A: VIR-2218 + SLGN + Nivolumab n=36 Participants 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.	Cohort 2 Group B: SLGN + Nivolumab n=20 Participants 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.
Percentage of Participants Who Remain Off NUC Treatment During Follow-Up	16.7 percentage of participants	55.6 percentage of participants	75.0 percentage of participants

SECONDARY outcome

Timeframe: Up to 36 Weeks

Population: Participants in the Full Analysis Set were analyzed.

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.

Outcome measures

Outcome measures
Measure	Cohort 1: TAF + VIR-2218 + SLGN + Nivolumab n=42 Participants 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. Participants were followed up for 48 weeks post treatment.	Cohort 2 Group A: VIR-2218 + SLGN + Nivolumab n=40 Participants 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.	Cohort 2 Group B: SLGN + Nivolumab n=20 Participants 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.
Percentage of Participants Experiencing Hepatitis B Virus (HBV) Virologic Breakthrough During Study Treatments	7.1 percentage of participants	35.0 percentage of participants	20.0 percentage of participants

Adverse Events

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

Serious events: 2 serious events

Other events: 34 other events

Deaths: 0 deaths

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

Serious events: 5 serious events

Other events: 37 other events

Deaths: 0 deaths

Cohort 2 Group B: SLGN + Nivolumab

Serious events: 3 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Cohort 1: TAF + VIR-2218 + SLGN + Nivolumab n=42 participants at risk 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.	Cohort 2 Group A: VIR-2218 + SLGN + Nivolumab n=40 participants at risk 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, for up to 36 weeks during the study. Participants were followed up for 48 weeks post treatment.	Cohort 2 Group B: SLGN + Nivolumab n=20 participants at risk 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.
General disorders Malaise	0.00% 0/42 • All-cause Mortality: Up to 86.4 weeks; Adverse events: Up to 84 weeks 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.	0.00% 0/40 • All-cause Mortality: Up to 86.4 weeks; Adverse events: Up to 84 weeks 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.	5.0% 1/20 • All-cause Mortality: Up to 86.4 weeks; Adverse events: Up to 84 weeks 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.
Hepatobiliary disorders Immune-mediated hepatitis	0.00% 0/42 • All-cause Mortality: Up to 86.4 weeks; Adverse events: Up to 84 weeks 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.	2.5% 1/40 • All-cause Mortality: Up to 86.4 weeks; Adverse events: Up to 84 weeks 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.	0.00% 0/20 • All-cause Mortality: Up to 86.4 weeks; Adverse events: Up to 84 weeks 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.
Infections and infestations Chronic hepatitis B	0.00% 0/42 • All-cause Mortality: Up to 86.4 weeks; Adverse events: Up to 84 weeks 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.	2.5% 1/40 • All-cause Mortality: Up to 86.4 weeks; Adverse events: Up to 84 weeks 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.	0.00% 0/20 • All-cause Mortality: Up to 86.4 weeks; Adverse events: Up to 84 weeks 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.
Infections and infestations Covid-19	2.4% 1/42 • All-cause Mortality: Up to 86.4 weeks; Adverse events: Up to 84 weeks 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.	0.00% 0/40 • All-cause Mortality: Up to 86.4 weeks; Adverse events: Up to 84 weeks 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.	0.00% 0/20 • All-cause Mortality: Up to 86.4 weeks; Adverse events: Up to 84 weeks 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.
Injury, poisoning and procedural complications Upper limb fracture	0.00% 0/42 • All-cause Mortality: Up to 86.4 weeks; Adverse events: Up to 84 weeks 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.	2.5% 1/40 • All-cause Mortality: Up to 86.4 weeks; Adverse events: Up to 84 weeks 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.	0.00% 0/20 • All-cause Mortality: Up to 86.4 weeks; Adverse events: Up to 84 weeks 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.
Investigations Alanine aminotransferase increased	0.00% 0/42 • All-cause Mortality: Up to 86.4 weeks; Adverse events: Up to 84 weeks 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.	2.5% 1/40 • All-cause Mortality: Up to 86.4 weeks; Adverse events: Up to 84 weeks 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.	5.0% 1/20 • All-cause Mortality: Up to 86.4 weeks; Adverse events: Up to 84 weeks 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.
Metabolism and nutrition disorders Dehydration	2.4% 1/42 • All-cause Mortality: Up to 86.4 weeks; Adverse events: Up to 84 weeks 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.	0.00% 0/40 • All-cause Mortality: Up to 86.4 weeks; Adverse events: Up to 84 weeks 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.	0.00% 0/20 • All-cause Mortality: Up to 86.4 weeks; Adverse events: Up to 84 weeks 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.
Metabolism and nutrition disorders Type 1 diabetes mellitus	0.00% 0/42 • All-cause Mortality: Up to 86.4 weeks; Adverse events: Up to 84 weeks 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.	0.00% 0/40 • All-cause Mortality: Up to 86.4 weeks; Adverse events: Up to 84 weeks 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.	5.0% 1/20 • All-cause Mortality: Up to 86.4 weeks; Adverse events: Up to 84 weeks 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.
Reproductive system and breast disorders Adenomyosis	0.00% 0/42 • All-cause Mortality: Up to 86.4 weeks; Adverse events: Up to 84 weeks 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.	2.5% 1/40 • All-cause Mortality: Up to 86.4 weeks; Adverse events: Up to 84 weeks 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.	0.00% 0/20 • All-cause Mortality: Up to 86.4 weeks; Adverse events: Up to 84 weeks 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.

Other adverse events

Additional Information

Gilead Clinical Study Information Center

Gilead Sciences

Phone: 1-833-445-3230 (GILEAD-0)

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or The study has been completed at all study sites for at least 2 years
Publication restrictions are in place

Restriction type: OTHER