Adults 18 to 65, any sex, with Chronic Hepatitis B. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change From Baseline in Serum Hepatitis B Surface Antigen (HBsAg) Level at Week 24Primary· Baseline to Week 24
A mixed effect model for repeated measures (MMRM) was used to analyze HBsAg change from baseline, which included treatment, baseline HBsAg level (\> 5000 IU/mL or ≤ 5000 IU/mL), HBeAg baseline status (positive or negative), visit and treatment-by-visit interaction as fixed effect and visit as repeated measurement.
Group
Value
95% CI
Vesatolimod 1 mg 4 Weeks (Cohort A)
-0.011
-0.054 – 0.031
Vesatolimod 2 mg 4 Weeks (Cohort A)
0.033
-0.012 – 0.079
Vesatolimod 4 mg 4 Weeks (Cohort A)
-0.018
-0.062 – 0.026
Placebo 4 Weeks (Cohort A)
-0.035
-0.109 – 0.040
Vesatolimod 1 mg 8 Weeks (Cohort B)
-0.081
-0.145 – -0.016
Vesatolimod 2 mg 8 Weeks (Cohort B)
-0.081
-0.147 – -0.014
Vesatolimod 4 mg 8 Weeks (Cohort B)
-0.082
-0.148 – -0.015
Placebo 8 Weeks (Cohort B)
-0.163
-0.281 – -0.045
Vesatolimod 1 mg 12 Weeks (Cohort C)
-0.015
-0.057 – 0.027
Vesatolimod 2 mg 12 Weeks (Cohort C)
0.000
-0.041 – 0.042
Vesatolimod 4 mg 12 Weeks (Cohort C)
0.000
-0.046 – 0.047
Placebo 12 Weeks (Cohort C)
0.001
-0.057 – 0.058
Composite Endpoint Measuring the Percentage of Participants With Hepatitis B Envelope Antigen (HBeAg) Loss and Seroconversion at Week 24Secondary· Week 24
HBeAg loss was defined as qualitative HBeAg result changing from positive at baseline to negative at any postbaseline visit within the targeted time window.
HBeAg seroconversion was defined as qualitative hepatitis B envelope antibody (HBeAb) result changing from negative at baseline to positive at any postbaseline visit within the targeted time window.
Participants who had missing information were assumed to have no HBeAg loss and no HBeAg seroconversion.
Group
Value
95% CI
Vesatolimod 1 mg 4 Weeks (Cohort A)
0.0
Vesatolimod 2 mg 4 Weeks (Cohort A)
0.0
Vesatolimod 4 mg 4 Weeks (Cohort A)
0.0
Placebo 4 Weeks (Cohort A)
0.0
Vesatolimod 1 mg 8 Weeks (Cohort B)
20.0
Vesatolimod 2 mg 8 Weeks (Cohort B)
0.0
Vesatolimod 4 mg 8 Weeks (Cohort B)
0.0
Vesatolimod 1 mg 12 Weeks (Cohort C)
0.0
Vesatolimod 2 mg 12 Weeks (Cohort C)
0.0
Vesatolimod 4 mg 12 Weeks (Cohort C)
0.0
Placebo 12 Weeks (Cohort C)
0.0
Composite Endpoint Measuring the Percentage of Participants With Hepatitis B Envelope Antigen (HBeAg) Loss and Seroconversion at Week 48Secondary· Week 48
HBeAg loss was defined as qualitative HBeAg result changing from positive at baseline to negative at any postbaseline visit within the targeted time window.
HBeAg seroconversion was defined as qualitative hepatitis B envelope antibody (HBeAb) result changing from negative at baseline to positive at any postbaseline visit within the targeted time window.
Participants who had missing information were assumed to have no HBeAg loss and no HBeAg seroconversion.
Only participants who were HBeAg+ at baseline were included.
Group
Value
95% CI
Vesatolimod 1 mg 4 Weeks (Cohort A)
0.0
Vesatolimod 2 mg 4 Weeks (Cohort A)
0.0
Vesatolimod 4 mg 4 Weeks (Cohort A)
0.0
Placebo 4 Weeks (Cohort A)
0.0
Vesatolimod 1 mg 8 Weeks (Cohort B)
20.0
Vesatolimod 2 mg 8 Weeks (Cohort B)
0.0
Vesatolimod 4 mg 8 Weeks (Cohort B)
0.0
Vesatolimod 1 mg 12 Weeks (Cohort C)
33.3
Vesatolimod 2 mg 12 Weeks (Cohort C)
0.0
Vesatolimod 4 mg 12 Weeks (Cohort C)
0.0
Placebo 12 Weeks (Cohort C)
0.0
Composite Endpoint Measuring the Percentage of Participants With HBsAg Loss and Seroconversion at Week 24Secondary· Week 24
HBsAg loss was defined as qualitative HBsAg result changing from positive at baseline to negative at any postbaseline visit within the targeted time window.
HBsAg seroconversion was defined as qualitative hepatitis B surface antibody (HBsAb) result changing from negative at baseline to positive at any postbaseline visit within the targeted time window.
Participants who had missing information were assumed to have no HBsAg loss and no HBsAg seroconversion.
Group
Value
95% CI
Vesatolimod 1 mg 4 Weeks (Cohort A)
0
Vesatolimod 2 mg 4 Weeks (Cohort A)
0
Vesatolimod 4 mg 4 Weeks (Cohort A)
0
Placebo 4 Weeks (Cohort A)
0
Vesatolimod 1 mg 8 Weeks (Cohort B)
0
Vesatolimod 2 mg 8 Weeks (Cohort B)
0
Vesatolimod 4 mg 8 Weeks (Cohort B)
0
Placebo 8 Weeks (Cohort B)
0
Vesatolimod 1 mg 12 Weeks (Cohort C)
0
Vesatolimod 2 mg 12 Weeks (Cohort C)
0
Vesatolimod 4 mg 12 Weeks (Cohort C)
0
Placebo 12 Weeks (Cohort C)
0
Composite Endpoint Measuring the Percentage of Participants With HBsAg Loss and Seroconversion at Week 48Secondary· Week 48
HBsAg loss was defined as qualitative HBsAg result changing from positive at baseline to negative at any postbaseline visit within the targeted time window.
HBsAg seroconversion was defined as qualitative hepatitis B surface antibody (HBsAb) result changing from negative at baseline to positive at any postbaseline visit within the targeted time window.
Participants who had missing information were assumed to have no HBsAg loss and no HBsAg seroconversion.
Group
Value
95% CI
Vesatolimod 1 mg 4 Weeks (Cohort A)
0.0
Vesatolimod 2 mg 4 Weeks (Cohort A)
0.0
Vesatolimod 4 mg 4 Weeks (Cohort A)
0.0
Placebo 4 Weeks (Cohort A)
0.0
Vesatolimod 1 mg 8 Weeks (Cohort B)
0.0
Vesatolimod 2 mg 8 Weeks (Cohort B)
0.0
Vesatolimod 4 mg 8 Weeks (Cohort B)
0.0
Placebo 8 Weeks (Cohort B)
0.0
Vesatolimod 1 mg 12 Weeks (Cohort C)
0.0
Vesatolimod 2 mg 12 Weeks (Cohort C)
0.0
Vesatolimod 4 mg 12 Weeks (Cohort C)
0.0
Placebo 12 Weeks (Cohort C)
0.0
Change From Baseline in Serum HBsAg Level at Week 4Secondary· Baseline; Week 4
Group
Value
95% CI
Vesatolimod 1 mg 4 Weeks (Cohort A)
-0.009
± 0.0505
Vesatolimod 2 mg 4 Weeks (Cohort A)
0.025
± 0.0514
Vesatolimod 4 mg 4 Weeks (Cohort A)
-0.008
± 0.0516
Placebo 4 Weeks (Cohort A)
-0.017
± 0.0600
Vesatolimod 1 mg 8 Weeks (Cohort B)
-0.003
± 0.0574
Vesatolimod 2 mg 8 Weeks (Cohort B)
0.014
± 0.0794
Vesatolimod 4 mg 8 Weeks (Cohort B)
-0.001
± 0.0436
Placebo 8 Weeks (Cohort B)
0.046
± 0.0648
Vesatolimod 1 mg 12 Weeks (Cohort C)
-0.034
± 0.0375
Vesatolimod 2 mg 12 Weeks (Cohort C)
-0.023
± 0.0529
Vesatolimod 4 mg 12 Weeks (Cohort C)
-0.001
± 0.0627
Placebo 12 Weeks (Cohort C)
-0.041
± 0.0955
Change From Baseline in Serum HBsAg Level at Week 8Secondary· Baseline; Week 8
Group
Value
95% CI
Vesatolimod 1 mg 4 Weeks (Cohort A)
-0.029
± 0.0666
Vesatolimod 2 mg 4 Weeks (Cohort A)
0.002
± 0.0544
Vesatolimod 4 mg 4 Weeks (Cohort A)
-0.035
± 0.0649
Placebo 4 Weeks (Cohort A)
-0.013
± 0.0440
Vesatolimod 1 mg 8 Weeks (Cohort B)
0.000
± 0.0442
Vesatolimod 2 mg 8 Weeks (Cohort B)
0.006
± 0.0772
Vesatolimod 4 mg 8 Weeks (Cohort B)
0.020
± 0.0596
Placebo 8 Weeks (Cohort B)
0.006
± 0.0600
Vesatolimod 1 mg 12 Weeks (Cohort C)
-0.021
± 0.0376
Vesatolimod 2 mg 12 Weeks (Cohort C)
-0.033
± 0.0487
Vesatolimod 4 mg 12 Weeks (Cohort C)
-0.013
± 0.0426
Placebo 12 Weeks (Cohort C)
-0.019
± 0.0483
Change From Baseline in Serum HBsAg Level at Week 12Secondary· Baseline; Week 12
Group
Value
95% CI
Vesatolimod 1 mg 4 Weeks (Cohort A)
-0.050
± 0.0755
Vesatolimod 2 mg 4 Weeks (Cohort A)
0.017
± 0.0646
Vesatolimod 4 mg 4 Weeks (Cohort A)
-0.004
± 0.0546
Placebo 4 Weeks (Cohort A)
-0.023
± 0.0623
Vesatolimod 1 mg 8 Weeks (Cohort B)
-0.031
± 0.0817
Vesatolimod 2 mg 8 Weeks (Cohort B)
-0.005
± 0.0843
Vesatolimod 4 mg 8 Weeks (Cohort B)
-0.021
± 0.0716
Placebo 8 Weeks (Cohort B)
-0.020
± 0.0666
Vesatolimod 1 mg 12 Weeks (Cohort C)
-0.023
± 0.0545
Vesatolimod 2 mg 12 Weeks (Cohort C)
-0.034
± 0.0549
Vesatolimod 4 mg 12 Weeks (Cohort C)
-0.010
± 0.0621
Placebo 12 Weeks (Cohort C)
-0.024
± 0.0661
Change From Baseline in Serum HBsAg Level at Week 48Secondary· Baseline; Week 48
Group
Value
95% CI
Vesatolimod 1 mg 4 Weeks (Cohort A)
-0.048
± 0.1054
Vesatolimod 2 mg 4 Weeks (Cohort A)
-0.055
± 0.1400
Vesatolimod 4 mg 4 Weeks (Cohort A)
-0.071
± 0.0857
Placebo 4 Weeks (Cohort A)
-0.067
± 0.0831
Vesatolimod 1 mg 8 Weeks (Cohort B)
-0.035
± 0.0923
Vesatolimod 2 mg 8 Weeks (Cohort B)
-0.024
± 0.0679
Vesatolimod 4 mg 8 Weeks (Cohort B)
-0.114
± 0.2169
Placebo 8 Weeks (Cohort B)
-0.324
± 0.6811
Vesatolimod 1 mg 12 Weeks (Cohort C)
-0.083
± 0.0858
Vesatolimod 2 mg 12 Weeks (Cohort C)
-0.071
± 0.1076
Vesatolimod 4 mg 12 Weeks (Cohort C)
-0.054
± 0.0715
Placebo 12 Weeks (Cohort C)
-0.063
± 0.1011
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Vesatolimod 1 mg 4 Weeks (Cohort A)
Serious: 0/16 (0%)
Deaths: 0/16
Vesatolimod 2 mg 4 Weeks (Cohort A)
Serious: 1/15 (7%)
Deaths: 0/15
Vesatolimod 4 mg 4 Weeks (Cohort A)
Serious: 1/16 (6%)
Deaths: 0/16
Placebo 4 Weeks (Cohort A)
Serious: 0/5 (0%)
Deaths: 0/5
Vesatolimod 1 mg 8 Weeks (Cohort B)
Serious: 0/18 (0%)
Deaths: 0/18
Vesatolimod 2 mg 8 Weeks (Cohort B)
Serious: 0/17 (0%)
Deaths: 0/17
Vesatolimod 4 mg 8 Weeks (Cohort B)
Serious: 0/17 (0%)
Deaths: 0/17
Placebo 8 Weeks (Cohort B)
Serious: 0/5 (0%)
Deaths: 0/5
Vesatolimod 1 mg 12 Weeks (Cohort C)
Serious: 0/16 (0%)
Deaths: 0/16
Vesatolimod 2 mg 12 Weeks (Cohort C)
Serious: 1/17 (6%)
Deaths: 0/17
Vesatolimod 4 mg 12 Weeks (Cohort C)
Serious: 1/14 (7%)
Deaths: 0/14
Placebo 12 Weeks (Cohort C)
Serious: 0/6 (0%)
Deaths: 0/6
Serious adverse events (8 terms)
Reaction
System
Vesatolimod 1 mg 4 Weeks (…
Vesatolimod 2 mg 4 Weeks (…
Vesatolimod 4 mg 4 Weeks (…
Placebo 4 Weeks (Cohort A)
Vesatolimod 1 mg 8 Weeks (…
Vesatolimod 2 mg 8 Weeks (…
Vesatolimod 4 mg 8 Weeks (…
Placebo 8 Weeks (Cohort B)
Vesatolimod 1 mg 12 Weeks …
Vesatolimod 2 mg 12 Weeks …
Vesatolimod 4 mg 12 Weeks …
Placebo 12 Weeks (Cohort C)
Cataract
Eye disorders
—
—
—
—
—
—
—
—
—
—
—
—
Chills
General disorders
—
—
—
—
—
—
—
—
—
—
—
—
Pyrexia
General disorders
—
—
—
—
—
—
—
—
—
—
—
—
Cholecystitis
Hepatobiliary disorders
—
—
—
—
—
—
—
—
—
—
—
—
Headache
Nervous system disorders
—
—
—
—
—
—
—
—
—
—
—
—
Tremor
Nervous system disorders
—
—
—
—
—
—
—
—
—
—
—
—
Hot flush
Vascular disorders
—
—
—
—
—
—
—
—
—
—
—
—
Hypotension
Vascular disorders
—
—
—
—
—
—
—
—
—
—
—
—
Other adverse events (120 terms — click to expand)
The primary objectives of this study are to evaluate the safety, tolerability, and efficacy of vesatolimod in participants with chronic hepatitis B (CHB) infection currently being treated with oral antivirals (OAV).
Participants will be randomized in 3 sequential cohorts (Cohorts A, B, and C). Within each cohort, participants will be randomized in a 1:3:3:3 ratio to placebo or one of the doses of vesatolimod (1, 2, or 4 mg).
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT05458102 — Drug-Drug Interaction Study of Vesatolimod in Adults With HIV-1 Who Have Very Low or Undetectable Virus Levels
· Phase 1
· terminated
NCT05281510 — Study of VRC07-523LS, CAP256V2LS, and Vesatolimod, in Early Antiretroviral-treated HIV-1 Clade C-infected Women
· Phase 2
· completed
NCT03060447 — Study to Evaluate the Safety and Efficacy of Vesatolimod in Antiretroviral Treated Human Immunodeficiency Virus (HIV-1)
· Phase 1
· completed
NCT02579382 — Study to Evaluate the Safety, Tolerability, and Efficacy of Vesatolimod in Combination With Tenofovir Disoproxil Fumarat
· Phase 2
· completed
NCT02858401 — Safety and Biological Activity of Vesatolimod in HIV-1 Infected, Virologically Suppressed Adults
· Phase 1
· completed
NCT04843852 — TLR-9 Adjuvanted Vaccination for Chronic Hepatitis B
· Phase 1
· recruiting
NCT07135349 — A Phase II Clinical Study of BW-20507 in Combination With PEG-IFNα for the Treatment of Hepatitis B
· Phase 2
· active not recruiting
NCT07307586 — A Small Sample Prospective Clinical Study of Azvudine Tablets to Promote Clinical Cure in Patients With Chronic Hepatiti
· Phase 3
· recruiting
NCT07246889 — Study of AHB-137 in Participants With Chronic Hepatitis B (CHB) Treated With Nucleos(t)Ide Analogues (NAs)(AUSHINE)
· Phase 3
· active not recruiting
Other Gilead Sciences trials
Trials by the same sponsor.
NCT07115368 — Study of GS-1219 in Participants With HIV-1
· Phase 1
· terminated
NCT06784973 — Study of Obeldesivir to Treat Children With Respiratory Syncytial Virus (RSV) Infection
· Phase 2
· terminated
NCT06683482 — A Qualitative Study on Advanced Breast Cancer Patients and Their Caregivers in Spain
· completed
NCT06613685 — Study of Oral Weekly GS-1720 and GS-4182 Compared With Biktarvy in People With HIV-1 Who Have Not Been Treated
· Phase 2, PHASE3
· terminated
NCT06585150 — Study of Obeldesivir to Treat Nonhospitalized Adults With Acute Respiratory Syncytial Virus (RSV) Infection
· Phase 2
· terminated
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Gilead Sciences
Last refreshed: 14 October 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02166047.