Trial Outcomes & Findings for Study to Evaluate the Safety, Tolerability, and Antiviral Activity of Selgantolimod (Formerly GS-9688) in Viremic Adult Participants With Chronic Hepatitis B (CHB) Who Are Not Currently on Treatment (NCT NCT03615066)

NCT ID: NCT03615066

Last Updated: 2022-05-10

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 67 participants
• Primary outcome timeframe: Baseline, Week 24
• Results posted on: 2022-05-10

Participant Flow

Participants were enrolled at study sites in Canada, South Korea, and Taiwan. The first participant was screened on 28 August 2018. The last study visit occurred on 12 April 2021.

96 participants were screened.

Participant milestones

Measure	Selgantolimod 3 mg + TAF Participants with hepatitis B e antigen (HBeAg)-positive chronic hepatitis B (CHB) or HBeAg-negative CHB currently not on oral antiviral (OAV) treatment, received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses along with the tenofovir alafenamide (TAF) 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/early discontinuation (ED). At Week 48, per Principal Investigator's (PI's) discretion, participants can continue in the Treatment Free Follow-Up (TFFU) phase for up to an additional 48 weeks.	Selgantolimod 1.5 mg + TAF Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 1.5 mg (1 x 1.5 mg tablet) and placebo (1 tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.	Placebo + TAF Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, placebo was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.
Main Study STARTED	26	28	13
Main Study COMPLETED	26	27	11
Main Study NOT COMPLETED	0	1	2
Treatment-free Follow-up (TFFU) Phase STARTED	13	12	2
Treatment-free Follow-up (TFFU) Phase COMPLETED	11	11	2
Treatment-free Follow-up (TFFU) Phase NOT COMPLETED	2	1	0

Reasons for withdrawal

Measure	Selgantolimod 3 mg + TAF Participants with hepatitis B e antigen (HBeAg)-positive chronic hepatitis B (CHB) or HBeAg-negative CHB currently not on oral antiviral (OAV) treatment, received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses along with the tenofovir alafenamide (TAF) 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/early discontinuation (ED). At Week 48, per Principal Investigator's (PI's) discretion, participants can continue in the Treatment Free Follow-Up (TFFU) phase for up to an additional 48 weeks.	Selgantolimod 1.5 mg + TAF Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 1.5 mg (1 x 1.5 mg tablet) and placebo (1 tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.	Placebo + TAF Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, placebo was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.
Main Study Withdrew Consent	0	1	1
Main Study Lost to Follow-up	0	0	1
Treatment-free Follow-up (TFFU) Phase Adverse Event	1	0	0
Treatment-free Follow-up (TFFU) Phase Protocol Violation	1	0	0
Treatment-free Follow-up (TFFU) Phase Withdrew Consent	0	1	0

Baseline Characteristics

Study to Evaluate the Safety, Tolerability, and Antiviral Activity of Selgantolimod (Formerly GS-9688) in Viremic Adult Participants With Chronic Hepatitis B (CHB) Who Are Not Currently on Treatment

Baseline characteristics by cohort

Measure	Selgantolimod 3 mg + TAF n=26 Participants Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.	Selgantolimod 1.5 mg + TAF n=28 Participants Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 1.5 mg (1 x 1.5 mg tablet) and placebo (1 tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.	Placebo + TAF n=13 Participants Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, placebo was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.	Total n=67 Participants Total of all reporting groups
Age, Continuous	46 years STANDARD_DEVIATION 10.3 • n=5 Participants	44 years STANDARD_DEVIATION 12.1 • n=7 Participants	46 years STANDARD_DEVIATION 12.0 • n=5 Participants	45 years STANDARD_DEVIATION 11.3 • n=4 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	13 Participants n=7 Participants	4 Participants n=5 Participants	28 Participants n=4 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	15 Participants n=7 Participants	9 Participants n=5 Participants	39 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	26 Participants n=5 Participants	27 Participants n=7 Participants	13 Participants n=5 Participants	66 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	25 Participants n=5 Participants	28 Participants n=7 Participants	13 Participants n=5 Participants	66 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment Canada	12 participants n=5 Participants	15 participants n=7 Participants	6 participants n=5 Participants	33 participants n=4 Participants
Region of Enrollment South Korea	7 participants n=5 Participants	10 participants n=7 Participants	1 participants n=5 Participants	18 participants n=4 Participants
Region of Enrollment Taiwan	7 participants n=5 Participants	3 participants n=7 Participants	6 participants n=5 Participants	16 participants n=4 Participants
HBsAg	3.8 log10 IU/mL STANDARD_DEVIATION 0.86 • n=5 Participants	4.2 log10 IU/mL STANDARD_DEVIATION 0.83 • n=7 Participants	4.0 log10 IU/mL STANDARD_DEVIATION 0.73 • n=5 Participants	4.0 log10 IU/mL STANDARD_DEVIATION 0.82 • n=4 Participants

PRIMARY outcome

Timeframe: Baseline, Week 24

Population: The Full Analysis Set included all randomized participants who took at least 1 dose of the study drug.

Outcome measures

Measure	Selgantolimod 3 mg + TAF n=26 Participants Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.	Selgantolimod 1.5 mg + TAF n=28 Participants Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 1.5 mg (1 x 1.5 mg tablet) and placebo (1 tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.	Placebo + TAF n=13 Participants Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, placebo was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.
Percentage of Participants With ≥ 1 log10 IU/mL Decline in Serum Quantitative Hepatitis B Surface Antigen (qHBsAg) From Baseline at Week 24	0 percentage of participants	0 percentage of participants	0 percentage of participants

PRIMARY outcome

Timeframe: First dose date up to Week 24 plus 30 days

Population: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.

An AE was any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE was any unfavorable and unintended sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the investigational medicinal product. A TEAE was defined as any AE with an onset date on or after the first dose date and no later than 30 days after permanent discontinuation of selgantolimod/placebo; or any AE leading to premature discontinuation of study drugs.

Outcome measures

Measure	Selgantolimod 3 mg + TAF n=26 Participants Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.	Selgantolimod 1.5 mg + TAF n=28 Participants Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 1.5 mg (1 x 1.5 mg tablet) and placebo (1 tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.	Placebo + TAF n=13 Participants Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, placebo was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)	84.6 percentage of participants	60.7 percentage of participants	76.9 percentage of participants

PRIMARY outcome

Timeframe: First dose date up to Week 24 plus 30 days

Population: Participants in the Safety Analysis Set were analyzed.

Treatment-emergent laboratory abnormalities were defined as values that increased at least 1 toxicity grade from baseline at any postbaseline time point, up to and including the date of the last dose of study drug plus 30 days for selgantolimod/placebo at Week 24. If the relevant baseline laboratory value was missing, any abnormality of at least Grade 1 observed within the time frame specified above was considered treatment emergent. Clinical laboratory results were graded according to Gilead Grading Scale for Severity of Adverse Events and Laboratory Abnormalities.

Outcome measures

Measure	Selgantolimod 3 mg + TAF n=26 Participants Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.	Selgantolimod 1.5 mg + TAF n=28 Participants Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 1.5 mg (1 x 1.5 mg tablet) and placebo (1 tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.	Placebo + TAF n=13 Participants Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, placebo was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.
Percentage of Participants With Treatment-Emergent Laboratory Abnormalities	84.6 percentage of participants	92.9 percentage of participants	92.3 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 4

Population: Participants in the Full Analysis Set were analyzed.

Outcome measures

Measure	Selgantolimod 3 mg + TAF n=26 Participants Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.	Selgantolimod 1.5 mg + TAF n=28 Participants Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 1.5 mg (1 x 1.5 mg tablet) and placebo (1 tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.	Placebo + TAF n=13 Participants Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, placebo was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.
Percentage of Participants With ≥ 1 log10 IU/mL Decline in Serum qHBsAg From Baseline at Week 4	0 percentage of participants	0 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 8

Population: Participants in the Full Analysis Set were analyzed.

Outcome measures

Measure	Selgantolimod 3 mg + TAF n=26 Participants Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.	Selgantolimod 1.5 mg + TAF n=28 Participants Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 1.5 mg (1 x 1.5 mg tablet) and placebo (1 tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.	Placebo + TAF n=13 Participants Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, placebo was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.
Percentage of Participants With ≥ 1 log10 IU/mL Decline in Serum qHBsAg From Baseline at Week 8	0 percentage of participants	0 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: Participants in the Full Analysis Set were analyzed.

Outcome measures

Measure	Selgantolimod 3 mg + TAF n=26 Participants Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.	Selgantolimod 1.5 mg + TAF n=28 Participants Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 1.5 mg (1 x 1.5 mg tablet) and placebo (1 tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.	Placebo + TAF n=13 Participants Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, placebo was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.
Percentage of Participants With ≥ 1 log10 IU/mL Decline in Serum qHBsAg From Baseline at Week 12	0 percentage of participants	0 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 48

Population: Participants in the Full Analysis Set were analyzed.

Outcome measures

Measure	Selgantolimod 3 mg + TAF n=26 Participants Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.	Selgantolimod 1.5 mg + TAF n=28 Participants Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 1.5 mg (1 x 1.5 mg tablet) and placebo (1 tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.	Placebo + TAF n=13 Participants Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, placebo was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.
Percentage of Participants With ≥ 1 log10 IU/mL Decline in Serum qHBsAg From Baseline at Week 48	0 percentage of participants	0 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 4

Population: Participants in the Full Analysis Set with available data were analyzed.

Outcome measures

Measure	Selgantolimod 3 mg + TAF n=25 Participants Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.	Selgantolimod 1.5 mg + TAF n=27 Participants Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 1.5 mg (1 x 1.5 mg tablet) and placebo (1 tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.	Placebo + TAF n=13 Participants Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, placebo was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.
Change From Baseline in Serum qHBsAg at Week 4	-0.04 log10 IU/mL Standard Deviation 0.155	-0.01 log10 IU/mL Standard Deviation 0.081	-0.02 log10 IU/mL Standard Deviation 0.065

SECONDARY outcome

Timeframe: Baseline, Week 8

Population: Participants in the Full Analysis Set with available data were analyzed.

Outcome measures

Measure	Selgantolimod 3 mg + TAF n=23 Participants Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.	Selgantolimod 1.5 mg + TAF n=28 Participants Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 1.5 mg (1 x 1.5 mg tablet) and placebo (1 tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.	Placebo + TAF n=12 Participants Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, placebo was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.
Change From Baseline in Serum qHBsAg at Week 8	-0.04 log10 IU/mL Standard Deviation 0.161	-0.05 log10 IU/mL Standard Deviation 0.121	0.00 log10 IU/mL Standard Deviation 0.081

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: Participants in the Full Analysis Set with available data were analyzed.

Outcome measures

Measure	Selgantolimod 3 mg + TAF n=24 Participants Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.	Selgantolimod 1.5 mg + TAF n=27 Participants Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 1.5 mg (1 x 1.5 mg tablet) and placebo (1 tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.	Placebo + TAF n=12 Participants Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, placebo was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.
Change From Baseline in Serum qHBsAg at Week 12	-0.04 log10 IU/mL Standard Deviation 0.163	-0.05 log10 IU/mL Standard Deviation 0.108	0.01 log10 IU/mL Standard Deviation 0.099

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: Participants in the Full Analysis Set with available data were analyzed.

Outcome measures

Measure	Selgantolimod 3 mg + TAF n=24 Participants Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.	Selgantolimod 1.5 mg + TAF n=28 Participants Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 1.5 mg (1 x 1.5 mg tablet) and placebo (1 tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.	Placebo + TAF n=12 Participants Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, placebo was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.
Change From Baseline in Serum qHBsAg at Week 24	-0.08 log10 IU/mL Standard Deviation 0.198	-0.11 log10 IU/mL Standard Deviation 0.174	-0.03 log10 IU/mL Standard Deviation 0.146

SECONDARY outcome

Timeframe: Baseline, Week 48

Population: Participants in the Full Analysis Set with available data were analyzed.

Outcome measures

Measure	Selgantolimod 3 mg + TAF n=24 Participants Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.	Selgantolimod 1.5 mg + TAF n=27 Participants Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 1.5 mg (1 x 1.5 mg tablet) and placebo (1 tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.	Placebo + TAF n=11 Participants Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, placebo was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.
Change From Baseline in Serum qHBsAg at Week 48	-0.12 log10 IU/mL Standard Deviation 0.218	-0.16 log10 IU/mL Standard Deviation 0.235	-0.12 log10 IU/mL Standard Deviation 0.145

SECONDARY outcome

Timeframe: Week 12

Population: Participants in the Full Analysis Set with available data were analyzed.

LLOQ was defined as 20 IU/mL.

Outcome measures

Measure	Selgantolimod 3 mg + TAF n=24 Participants Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.	Selgantolimod 1.5 mg + TAF n=28 Participants Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 1.5 mg (1 x 1.5 mg tablet) and placebo (1 tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.	Placebo + TAF n=12 Participants Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, placebo was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.
Percentage of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) < Lower Limit of Quantification (LLOQ) at Week 12	20.8 percentage of participants	28.6 percentage of participants	25.0 percentage of participants

SECONDARY outcome

Timeframe: Week 24

Population: Participants in the Full Analysis Set with available data were analyzed.

LLOQ was defined as 20 IU/mL.

Outcome measures

Measure	Selgantolimod 3 mg + TAF n=24 Participants Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.	Selgantolimod 1.5 mg + TAF n=28 Participants Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 1.5 mg (1 x 1.5 mg tablet) and placebo (1 tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.	Placebo + TAF n=12 Participants Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, placebo was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.
Percentage of Participants With HBV DNA < LLOQ at Week 24	37.5 percentage of participants	32.1 percentage of participants	33.3 percentage of participants

SECONDARY outcome

Timeframe: Week 48

Population: Participants in the Full Analysis Set with available data were analyzed.

LLOQ was defined as 20 IU/mL.

Outcome measures

Measure	Selgantolimod 3 mg + TAF n=24 Participants Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.	Selgantolimod 1.5 mg + TAF n=27 Participants Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 1.5 mg (1 x 1.5 mg tablet) and placebo (1 tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.	Placebo + TAF n=11 Participants Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, placebo was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.
Percentage of Participants With HBV DNA < LLOQ at Week 48	50.0 percentage of participants	44.4 percentage of participants	45.5 percentage of participants

SECONDARY outcome

Timeframe: Week 12

Population: Participants in the Full Analysis Set with available data were analyzed.

HBsAg loss was defined as qualitative HBsAg changing from positive at baseline to negative at a postbaseline visit.

Outcome measures

Measure	Selgantolimod 3 mg + TAF n=25 Participants Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.	Selgantolimod 1.5 mg + TAF n=28 Participants Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 1.5 mg (1 x 1.5 mg tablet) and placebo (1 tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.	Placebo + TAF n=12 Participants Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, placebo was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.
Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Week 12	0 percentage of participants	0 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: Week 24

Population: Participants in the Full Analysis Set with available data were analyzed.

HBsAg loss was defined as qualitative HBsAg changing from positive at baseline to negative at a postbaseline visit.

Outcome measures

Measure	Selgantolimod 3 mg + TAF n=24 Participants Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.	Selgantolimod 1.5 mg + TAF n=28 Participants Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 1.5 mg (1 x 1.5 mg tablet) and placebo (1 tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.	Placebo + TAF n=12 Participants Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, placebo was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.
Percentage of Participants With HBsAg Loss at Week 24	0 percentage of participants	0 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: Week 48

Population: Participants in the Full Analysis Set with available data were analyzed.

HBsAg loss was defined as qualitative HBsAg changing from positive at baseline to negative at a postbaseline visit.

Outcome measures

Measure	Selgantolimod 3 mg + TAF n=24 Participants Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.	Selgantolimod 1.5 mg + TAF n=27 Participants Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 1.5 mg (1 x 1.5 mg tablet) and placebo (1 tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.	Placebo + TAF n=11 Participants Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, placebo was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.
Percentage of Participants With HBsAg Loss at Week 48	0 percentage of participants	0 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: Week 12

Population: Participants in the Full Analysis Set with available data were analyzed. Analysis was performed only on HBeAg-positive CHB participants.

HBeAg loss was defined as qualitative HBeAg changing from positive at baseline to negative at a postbaseline visit. HBeAg seroconversion was defined as Hepatitis B e antibody (HBeAb) loss and anti-HBe change from negative/missing at baseline to positive at a postbaseline visit.

Outcome measures

Measure	Selgantolimod 3 mg + TAF n=14 Participants Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.	Selgantolimod 1.5 mg + TAF n=17 Participants Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 1.5 mg (1 x 1.5 mg tablet) and placebo (1 tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.	Placebo + TAF n=7 Participants Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, placebo was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.
Percentage of Participants With HBeAg Loss and Seroconversion at Week 12 HBeAg Loss	0 percentage of participants	0 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: Week 24

Population: Participants in the Full Analysis Set were analyzed. Analysis was performed only on HBeAg-positive CHB participants.

HBeAg loss was defined as qualitative HBeAg changing from positive at baseline to negative at a postbaseline visit. HBeAg seroconversion was defined as HBeAb loss and anti-HBe change from negative/missing at baseline to positive at a postbaseline visit.

Outcome measures

Measure	Selgantolimod 3 mg + TAF n=14 Participants Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.	Selgantolimod 1.5 mg + TAF n=18 Participants Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 1.5 mg (1 x 1.5 mg tablet) and placebo (1 tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.	Placebo + TAF n=7 Participants Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, placebo was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.
Percentage of Participants With HBeAg Loss and Seroconversion at Week 24 HBeAg Loss	0 percentage of participants	0 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: Week 48

Population: Participants in the Full Analysis Set with available data were analyzed. Analysis was performed only on HBeAg-positive CHB participants.

HBeAg loss was defined as qualitative HBeAg changing from positive at baseline to negative at a postbaseline visit. HBeAg seroconversion was defined as HBeAb test changing from negative or missing at baseline to positive at a postbaseline visit.

Outcome measures

Measure	Selgantolimod 3 mg + TAF n=14 Participants Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.	Selgantolimod 1.5 mg + TAF n=17 Participants Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 1.5 mg (1 x 1.5 mg tablet) and placebo (1 tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.	Placebo + TAF n=6 Participants Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, placebo was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.
Percentage of Participants With HBeAg Loss and Seroconversion at Week 48 HBeAg Loss	0 percentage of participants	0 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: Baseline up to Week 24

Population: Participants in the Full Analysis Set were analyzed.

Virologic breakthrough was defined as confirmed HBV DNA ≥ 69 IU/mL after having been < 69 IU/mL or confirmed HBV DNA ≥ 1 log10 IU/mL increase from nadir.

Outcome measures

Measure	Selgantolimod 3 mg + TAF n=26 Participants Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.	Selgantolimod 1.5 mg + TAF n=28 Participants Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 1.5 mg (1 x 1.5 mg tablet) and placebo (1 tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.	Placebo + TAF n=13 Participants Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, placebo was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.
Percentage of Participants With Virologic Breakthrough From Baseline up to Week 24	3.8 percentage of participants	7.1 percentage of participants	15.4 percentage of participants

SECONDARY outcome

Timeframe: Baseline up to Week 48

Population: Participants in the Full Analysis Set were analyzed.

Virologic breakthrough was defined as confirmed HBV DNA ≥ 69 IU/mL after having been < 69 IU/mL or confirmed HBV DNA ≥ 1 log10 IU/mL increase from nadir.

Outcome measures

Measure	Selgantolimod 3 mg + TAF n=26 Participants Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.	Selgantolimod 1.5 mg + TAF n=28 Participants Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 1.5 mg (1 x 1.5 mg tablet) and placebo (1 tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.	Placebo + TAF n=13 Participants Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, placebo was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.
Percentage of Participants With Virologic Breakthrough From Baseline up to Week 48	3.8 percentage of participants	10.7 percentage of participants	15.4 percentage of participants

SECONDARY outcome

Timeframe: Baseline up to Week 48

Population: Participants in the Full Analysis Set were analyzed.

Outcome measures

Measure	Selgantolimod 3 mg + TAF n=26 Participants Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.	Selgantolimod 1.5 mg + TAF n=28 Participants Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 1.5 mg (1 x 1.5 mg tablet) and placebo (1 tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.	Placebo + TAF n=13 Participants Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, placebo was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.
Percentage of Participants With Drug Resistance Mutations	0 percentage of participants	0 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose at Day 1 and Week 23

Population: Participants in the PK Substudy Analysis Set (all randomized participants who took at least 1 dose of the study drug, participated in the optional intensive PK substudy, and had at least 1 nonmissing postdose concentration) with available data were analyzed.

AUClast is defined as the concentration of drug from time zero to the last observable concentration.

Outcome measures

Measure	Selgantolimod 3 mg + TAF n=7 Participants Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.	Selgantolimod 1.5 mg + TAF n=8 Participants Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 1.5 mg (1 x 1.5 mg tablet) and placebo (1 tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.	Placebo + TAF Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, placebo was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.
Pharmacokinetic (PK) Parameter: AUClast of Selgantolimod Day 1	1163.0 hr*pg/mL Standard Deviation 833.27	548.0 hr*pg/mL Standard Deviation 393.00	—
Pharmacokinetic (PK) Parameter: AUClast of Selgantolimod Week 23	1441.8 hr*pg/mL Standard Deviation 1601.19	491.2 hr*pg/mL Standard Deviation 489.29	—

SECONDARY outcome

Timeframe: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose at Day 1 and Week 23

Population: Participants in the PK Substudy Analysis Set with available data were analyzed.

AUC0-24 is defined as the concentration of drug over time from time zero to time 24 hours.

Outcome measures

Measure	Selgantolimod 3 mg + TAF n=7 Participants Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.	Selgantolimod 1.5 mg + TAF n=8 Participants Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 1.5 mg (1 x 1.5 mg tablet) and placebo (1 tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.	Placebo + TAF Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, placebo was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.
PK Parameter: AUC0-24 of Selgantolimod Day 1	1162.2 hr*pg/mL Standard Deviation 832.29	547.7 hr*pg/mL Standard Deviation 392.77	—
PK Parameter: AUC0-24 of Selgantolimod Week 23	1440.5 hr*pg/mL Standard Deviation 1598.05	494.4 hr*pg/mL Standard Deviation 485.56	—

SECONDARY outcome

Timeframe: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose at Day 1 and Week 23

Population: Participants in the PK Substudy Analysis Set with available data were analyzed.

AUC0-inf is defined as the concentration of drug over time from time zero to infinity.

Outcome measures

Measure	Selgantolimod 3 mg + TAF n=7 Participants Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.	Selgantolimod 1.5 mg + TAF n=8 Participants Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 1.5 mg (1 x 1.5 mg tablet) and placebo (1 tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.	Placebo + TAF Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, placebo was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.
PK Parameter: AUCinf of Selgantolimod Day 1	1184.2 hr*pg/mL Standard Deviation 843.53	556.4 hr*pg/mL Standard Deviation 394.38	—
PK Parameter: AUCinf of Selgantolimod Week 23	1462.8 hr*pg/mL Standard Deviation 1616.70	503.2 hr*pg/mL Standard Deviation 492.66	—

SECONDARY outcome

Timeframe: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose at Day 1 and Week 23

Population: Participants in the PK Substudy Analysis Set with available data were analyzed.

Cmax is defined as the maximum concentration of drug.

Outcome measures

Measure	Selgantolimod 3 mg + TAF n=7 Participants Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.	Selgantolimod 1.5 mg + TAF n=8 Participants Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 1.5 mg (1 x 1.5 mg tablet) and placebo (1 tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.	Placebo + TAF Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, placebo was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.
PK Parameter: Cmax of Selgantolimod Day 1	373.3 pg/mL Standard Deviation 208.63	307.7 pg/mL Standard Deviation 311.12	—
PK Parameter: Cmax of Selgantolimod Week 23	591.0 pg/mL Standard Deviation 565.11	268.2 pg/mL Standard Deviation 254.16	—

SECONDARY outcome

Timeframe: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose at Day 1 and Week 23

Population: Participants in the PK Substudy Analysis Set with available data were analyzed.

Tmax is defined as the time (observed time point) of Cmax.

Outcome measures

Measure	Selgantolimod 3 mg + TAF n=7 Participants Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.	Selgantolimod 1.5 mg + TAF n=8 Participants Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 1.5 mg (1 x 1.5 mg tablet) and placebo (1 tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.	Placebo + TAF Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, placebo was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.
PK Parameter: Tmax of Selgantolimod Day 1	0.98 hours Interval 0.5 to 4.1	0.53 hours Interval 0.28 to 1.8	—
PK Parameter: Tmax of Selgantolimod Week 23	0.55 hours Interval 0.28 to 1.1	0.50 hours Interval 0.28 to 0.55	—

SECONDARY outcome

Timeframe: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose at Day 1 and Week 23

Population: Participants in the PK Substudy Analysis Set with available data were analyzed.

CL/F is defined as the apparent oral clearance following administration of the drug.

Outcome measures

Measure	Selgantolimod 3 mg + TAF n=7 Participants Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.	Selgantolimod 1.5 mg + TAF n=8 Participants Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 1.5 mg (1 x 1.5 mg tablet) and placebo (1 tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.	Placebo + TAF Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, placebo was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.
PK Parameter: CL/F of Selgantolimod Day 1	4094330.4 mL/hr Standard Deviation 3034917.79	4603039.8 mL/hr Standard Deviation 3733427.89	—
PK Parameter: CL/F of Selgantolimod Week 23	4550308.6 mL/hr Standard Deviation 3858788.24	6223868.1 mL/hr Standard Deviation 5265428.49	—

SECONDARY outcome

Timeframe: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose at Day 1 and Week 23

Population: Participants in the PK Substudy Analysis Set with available data were analyzed.

t1/2 is defined as the estimate of the terminal elimination half-life of the drug.

Outcome measures

Measure	Selgantolimod 3 mg + TAF n=7 Participants Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.	Selgantolimod 1.5 mg + TAF n=8 Participants Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 1.5 mg (1 x 1.5 mg tablet) and placebo (1 tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.	Placebo + TAF Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, placebo was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.
PK Parameter: t1/2 of Selgantolimod Day 1	4.55 hours Interval 4.32 to 4.95	5.13 hours Interval 4.29 to 5.47	—
PK Parameter: t1/2 of Selgantolimod Week 23	4.78 hours Interval 3.95 to 4.95	5.03 hours Interval 4.76 to 5.1	—

Adverse Events

Selgantolimod 3 mg + TAF

Serious events: 1 serious events

Other events: 21 other events

Deaths: 0 deaths

Selgantolimod 1.5 mg + TAF

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Placebo + TAF

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Measure	Selgantolimod 3 mg + TAF n=26 participants at risk Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.	Selgantolimod 1.5 mg + TAF n=28 participants at risk Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 1.5 mg (1 x 1.5 mg tablet) and placebo (1 tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.	Placebo + TAF n=13 participants at risk Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, placebo was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.
Injury, poisoning and procedural complications Limb injury	3.8% 1/26 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.	0.00% 0/28 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.	0.00% 0/13 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.

Other adverse events

Measure	Selgantolimod 3 mg + TAF n=26 participants at risk Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.	Selgantolimod 1.5 mg + TAF n=28 participants at risk Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 1.5 mg (1 x 1.5 mg tablet) and placebo (1 tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.	Placebo + TAF n=13 participants at risk Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, placebo was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.
Cardiac disorders Palpitations	11.5% 3/26 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.	0.00% 0/28 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.	7.7% 1/13 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.
Eye disorders Conjunctival hyperaemia	0.00% 0/26 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.	0.00% 0/28 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.	7.7% 1/13 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.
Eye disorders Dry eye	0.00% 0/26 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.	3.6% 1/28 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.	7.7% 1/13 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.
Eye disorders Eye pruritus	3.8% 1/26 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.	0.00% 0/28 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.	7.7% 1/13 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.
Eye disorders Ocular hyperaemia	0.00% 0/26 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.	0.00% 0/28 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.	7.7% 1/13 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.
Eye disorders Vision blurred	3.8% 1/26 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.	0.00% 0/28 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.	7.7% 1/13 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.
Gastrointestinal disorders Abdominal discomfort	7.7% 2/26 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.	0.00% 0/28 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.	0.00% 0/13 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.
Gastrointestinal disorders Abdominal distension	0.00% 0/26 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.	3.6% 1/28 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.	7.7% 1/13 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.
Gastrointestinal disorders Abdominal pain	7.7% 2/26 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.	3.6% 1/28 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.	0.00% 0/13 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.
Gastrointestinal disorders Abdominal pain upper	3.8% 1/26 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.	10.7% 3/28 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.	0.00% 0/13 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.
Gastrointestinal disorders Diarrhoea	11.5% 3/26 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.	3.6% 1/28 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.	15.4% 2/13 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.
Gastrointestinal disorders Dyspepsia	0.00% 0/26 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.	7.1% 2/28 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.	0.00% 0/13 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.
Gastrointestinal disorders Flatulence	0.00% 0/26 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.	0.00% 0/28 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.	7.7% 1/13 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/26 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.	7.1% 2/28 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.	0.00% 0/13 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.
Gastrointestinal disorders Haemorrhoids	0.00% 0/26 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.	0.00% 0/28 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.	7.7% 1/13 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.
Gastrointestinal disorders Nausea	30.8% 8/26 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.	21.4% 6/28 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.	0.00% 0/13 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.
Gastrointestinal disorders Vomiting	23.1% 6/26 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.	10.7% 3/28 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.	0.00% 0/13 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.
General disorders Chest discomfort	7.7% 2/26 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.	3.6% 1/28 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.	0.00% 0/13 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.
General disorders Chest pain	0.00% 0/26 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.	0.00% 0/28 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.	7.7% 1/13 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.
General disorders Chills	15.4% 4/26 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.	0.00% 0/28 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.	0.00% 0/13 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.
General disorders Fatigue	19.2% 5/26 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.	10.7% 3/28 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.	0.00% 0/13 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.
General disorders Feeling cold	7.7% 2/26 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.	0.00% 0/28 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.	0.00% 0/13 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.
General disorders Malaise	0.00% 0/26 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.	0.00% 0/28 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.	7.7% 1/13 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.
General disorders Pyrexia	7.7% 2/26 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.	3.6% 1/28 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.	7.7% 1/13 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.
Hepatobiliary disorders Hepatic mass	0.00% 0/26 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.	0.00% 0/28 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.	7.7% 1/13 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.
Infections and infestations Eye infection	0.00% 0/26 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.	0.00% 0/28 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.	7.7% 1/13 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.
Infections and infestations Gastroenteritis	0.00% 0/26 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.	0.00% 0/28 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.	7.7% 1/13 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.
Infections and infestations Nasopharyngitis	7.7% 2/26 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.	10.7% 3/28 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.	7.7% 1/13 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.
Infections and infestations Upper respiratory tract infection	7.7% 2/26 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.	3.6% 1/28 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.	23.1% 3/13 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.
Infections and infestations Urinary tract infection	0.00% 0/26 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.	10.7% 3/28 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.	0.00% 0/13 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.
Injury, poisoning and procedural complications Ligament sprain	0.00% 0/26 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.	0.00% 0/28 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.	7.7% 1/13 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.
Investigations Low density lipoprotein increased	0.00% 0/26 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.	0.00% 0/28 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.	7.7% 1/13 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.
Metabolism and nutrition disorders Hyperlipidaemia	0.00% 0/26 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.	0.00% 0/28 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.	7.7% 1/13 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.
Musculoskeletal and connective tissue disorders Arthralgia	7.7% 2/26 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.	0.00% 0/28 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.	0.00% 0/13 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/26 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.	7.1% 2/28 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.	7.7% 1/13 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.
Musculoskeletal and connective tissue disorders Muscle spasms	3.8% 1/26 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.	0.00% 0/28 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.	7.7% 1/13 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.
Musculoskeletal and connective tissue disorders Periarthritis	0.00% 0/26 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.	0.00% 0/28 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.	7.7% 1/13 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.
Nervous system disorders Dizziness	19.2% 5/26 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.	3.6% 1/28 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.	0.00% 0/13 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.
Nervous system disorders Headache	11.5% 3/26 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.	17.9% 5/28 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.	15.4% 2/13 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.
Nervous system disorders Memory impairment	0.00% 0/26 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.	0.00% 0/28 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.	7.7% 1/13 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.
Psychiatric disorders Anxiety	0.00% 0/26 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.	0.00% 0/28 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.	7.7% 1/13 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.
Psychiatric disorders Sleep disorder	0.00% 0/26 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.	0.00% 0/28 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.	7.7% 1/13 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.
Renal and urinary disorders Proteinuria	0.00% 0/26 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.	3.6% 1/28 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.	7.7% 1/13 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.
Respiratory, thoracic and mediastinal disorders Cough	7.7% 2/26 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.	3.6% 1/28 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.	0.00% 0/13 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/26 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.	0.00% 0/28 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.	7.7% 1/13 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/26 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.	3.6% 1/28 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.	7.7% 1/13 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	3.8% 1/26 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.	3.6% 1/28 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.	7.7% 1/13 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/26 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.	7.1% 2/28 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.	0.00% 0/13 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.
Skin and subcutaneous tissue disorders Cold sweat	3.8% 1/26 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.	0.00% 0/28 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.	7.7% 1/13 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/26 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.	3.6% 1/28 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.	7.7% 1/13 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.
Skin and subcutaneous tissue disorders Eczema	7.7% 2/26 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.	0.00% 0/28 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.	0.00% 0/13 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.
Skin and subcutaneous tissue disorders Pruritus	11.5% 3/26 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.	0.00% 0/28 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.	0.00% 0/13 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.
Skin and subcutaneous tissue disorders Psoriasis	0.00% 0/26 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.	0.00% 0/28 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.	7.7% 1/13 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.
Skin and subcutaneous tissue disorders Rash	0.00% 0/26 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.	0.00% 0/28 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.	7.7% 1/13 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.
Surgical and medical procedures Tooth extraction	0.00% 0/26 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.	0.00% 0/28 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.	7.7% 1/13 • All-Cause Mortality: Enrollment up to Week 96 Adverse Events: First dose up to last dose of selgantolimod/placebo (Week 24) plus 30 days; or TAF (Week 48) plus 3 days, whichever came later All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of the study drug.

Additional Information

Gilead Clinical Study Information Center

Gilead Sciences

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

Email: GileadClinicalTrials@gilead.com

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