A Phase 2 interventional study of Tenofovir Alafenamide and VIR-2218 in Chronic Hepatitis B, sponsored by Gilead Sciences. Completed at 26 sites in 8 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-07-24.
Sponsored by Gilead Sciences · Phase 2, Interventional, and Treatment
The primary objectives of this study are to evaluate the safety and tolerability of study treatment(s) (selgantolimod-containing combination therapies) and to evaluate the efficacy of study treatment(s) as measured by the proportion of participants who achieve functional cure, defined as hepatitis B surface antigen (HBsAg) loss and hepatitis B virus (HBV)deoxyribonucleic acid (DNA) \< lower limit of quantitation (LLOQ) at Follow-up (FU) Week 24 in participants with chronic hepatitis B (CHB).
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Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Nucleos(t)ide(s) (NUC)-suppressed participants with chronic hepatitis B (CHB) will receive tenofovir alafenamide (TAF) 25 mg orally once daily (QD) for 36 weeks and VIR-2218 200 mg subcutaneously (SC) once every 4 weeks (Q4W) for 24 weeks. From Week 12 onwards, participants will receive selgantolimod (SLGN) 3 mg orally once a week (QW) for 24 weeks and nivolumab 0.3 mg/kg intravenously (IV) Q4W for up to 24 weeks (only up to protocol amendment 2, nivolumab was no longer administered post implementation of protocol amendment 2). Participants who are on TAF treatment will continue TAF treatment over the duration of study follow-up. Participants will be followed up for 48 weeks post treatment.
Drug: Tenofovir Alafenamide · Drug: VIR-2218 · Drug: Nivolumab · Drug: Selgantolimod
Viremic participants with CHB will receive VIR-2218, 200 mg SC Q4W for 24 weeks. From Week 12 onwards, participants will receive SLGN 3 mg orally QW for 24 weeks and nivolumab 0.3 mg/kg IV Q4W for up to 24 weeks (only up to protocol amendment 2, nivolumab was no longer administered post implementation of protocol amendment 2). Participants who meet the criteria to initiate NUC treatment will receive TAF 25, mg orally, QD during the study. Participants will be followed up for 48 weeks post treatment.
Drug: Tenofovir Alafenamide · Drug: VIR-2218 · Drug: Nivolumab · Drug: Selgantolimod
Viremic participants with CHB will receive SLGN 3 mg orally QW for 24 weeks and nivolumab 0.3 mg/kg IV Q4W for up to 24 weeks. . Viremic participants who meet the criteria to initiate NUC treatment will receive TAF 25 mg orally QD during the study. Participants will be followed up for 48 weeks post treatment. All treatments were administered up to protocol amendment 2 and after the implementation of protocol amendment 2, the treatments were discontinued for Cohort 2 Group B based on Sponsor decision.
Drug: Tenofovir Alafenamide · Drug: Nivolumab · Drug: Selgantolimod
Administered as film-coated oral tablets
Also known as: TAF, Vemlidy®, GS-7340
Administered as a sub-cutaneous (SC) injection
Administered intravenously
Also known as: Opdivo®
Administered as film-coated oral tablets
Also known as: SLGN, GS-9688
Percentage of Participants Who Achieved Functional Cure
Functional cure was defined as hepatitis B surface antigen (HBsAg) loss and hepatitis B virus (HBV) deoxyribonucleic acid (DNA) less than the lower limit of quantitation (LLOQ) at follow-up Week 24. LLOQ for HBV DNA CAP/CTM 2.0 is 20 IU/mL. LLOQ for HBV DNA Cobas 6800 is 10 IU/mL. The HBsAg loss was defined as HBsAg changing from positive at baseline to negative at any postbaseline visit. Percentages were rounded off.
Time frame: At Follow-up Week 24 (Cohort 1 and Cohort 2A: At Week 60; Cohort 2B: At Week 48)
Percentage of Participants With HBsAg Loss With and Without Anti-HBsAg Seroconversion
HBsAg loss was defined as HBsAg changing from positive at baseline to negative at any postbaseline visit. HBsAg seroconversion was defined as HBsAg loss and HBsAb changes from negative/missing at baseline to positive at a postbaseline visit. Percentages were rounded-off.
Time frame: Up to Follow-up Week 48 (Cohort 1 and Cohort 2A: At Week 84; Cohort 2B: At Week 72)
Percentage of Participants With Hepatitis B e Antigen (HBeAg) Loss With and Without Anti-HBeAg Seroconversion in Participants With CHB Who Are HBeAg-Positive at Baseline
HBeAg loss is defined as HBeAg changing from positive at baseline to negative at any postbaseline visit. HBeAg seroconversion was defined as HBeAb test changing from negative or missing at baseline to positive at a postbaseline visit. Percentages were rounded-off.
Time frame: Up to Follow-up Week 48 (Cohort 1 and Cohort 2A: At Week 84; Cohort 2B: At Week 72)
Percentage of Participants Who Remain Off NUC Treatment During Follow-Up
NUC treatments included for analysis: adefovir dipivoxil, entecavir, telbivudine, tenofovir, tenofovir alafenamide, tenofovir alafenamide fumarate, tenofovir disoproxil fumarate, and lamivudine. Percentages were rounded-off.
Time frame: Cohort 1 and Cohort 2A: From Week 36 up to Week 84 and for Cohort 2B: From Week 24 up to Week 72
Percentage of Participants Experiencing Hepatitis B Virus (HBV) Virologic Breakthrough During Study Treatments
Virologic breakthrough was defined as confirmed HBV DNA ≥ LLOQ after 2 consecutive HBV DNA \< LLOQ in participants who are complying with NUC therapy or confirmed HBV DNA ≥ 1 log10 IU/mL increase from nadir during study treatments. LLOQ for HBV DNA CAP/CTM 2.0 is 20 IU/mL. LLOQ for HBV DNA Cobas 6800 is 10 IU/mL. Percentages were rounded-off.
Time frame: Up to 36 Weeks
Participants were enrolled at study sites in Australia, Denmark, Hong Kong, New Zealand, Singapore, South Korea, Thailand, and the United Kingdom.
| Milestone | Cohort 1: TAF + VIR-2218 + SLGN + Nivolumab | Cohort 2 Group A: VIR-2218 + SLGN + Nivolumab | Cohort 2 Group B: SLGN + Nivolumab |
|---|---|---|---|
| Started | 42 | 40 | 21 |
| Completed | 41 | 36 | 20 |
| Not completed | 1 | 4 | 1 |
| Withdrew: Withdrew consent | 1 | 3 | 0 |
| Withdrew: Enrolled but never treated | 0 | 0 | 1 |
| Withdrew: Investigator's discretion | 0 | 1 | 0 |
Functional cure was defined as hepatitis B surface antigen (HBsAg) loss and hepatitis B virus (HBV) deoxyribonucleic acid (DNA) less than the lower limit of quantitation (LLOQ) at follow-up Week 24. LLOQ for HBV DNA CAP/CTM 2.0 is 20 IU/mL. LLOQ for HBV DNA Cobas 6800 is 10 IU/mL. The HBsAg loss was defined as HBsAg changing from positive at baseline to negative at any postbaseline visit. Percentages were rounded off.
| percentage of participants | Cohort 1: TAF + VIR-2218 + SLGN + Nivolumab | Cohort 2 Group A: VIR-2218 + SLGN + Nivolumab | Cohort 2 Group B: SLGN + Nivolumab |
|---|---|---|---|
| Percentage of Participants Who Achieved Functional Cure | 2.4 (0.1 to 12.6) | 2.5 (0.1 to 13.2) | 0.0 (0.0 to 16.8) |
HBsAg loss was defined as HBsAg changing from positive at baseline to negative at any postbaseline visit. HBsAg seroconversion was defined as HBsAg loss and HBsAb changes from negative/missing at baseline to positive at a postbaseline visit. Percentages were rounded-off.
| percentage of participants | Cohort 1: TAF + VIR-2218 + SLGN + Nivolumab | Cohort 2 Group A: VIR-2218 + SLGN + Nivolumab | Cohort 2 Group B: SLGN + Nivolumab |
|---|---|---|---|
| HBsAg Loss: Week 4 | 0 | 0 | 0 |
| HBsAg Loss and Seroconversion: Week 4 | 0 | 0 | 0 |
| HBsAg Loss: Week 8 | 0 | 0 | 0 |
| HBsAg Loss and Seroconversion: Week 8 | 0 | 0 | 0 |
| HBsAg Loss: Week 12 | 2.4 | 0 | 0 |
| HBsAg Loss and Seroconversion: Week 12 | 0 | 0 | 0 |
| HBsAg Loss: Week 14 | 2.4 | 0 | 0 |
| HBsAg Loss and Seroconversion: Week 14 | 0 | 0 | 0 |
| HBsAg Loss: Week 16 | 0 | 0 | 0 |
| HBsAg Loss and Seroconversion: Week 16 | 0 | 0 | 0 |
| HBsAg Loss: Week 20 | 4.8 | 2.5 | 0 |
| HBsAg Loss and Seroconversion: Week 20 | 0 | 0 | 0 |
| HBsAg Loss: Week 24 | 4.8 | 0 | 0 |
| HBsAg Loss and Seroconversion: Week 24 | 0 | 0 | 0 |
| HBsAg Loss: Week 28 | 4.8 | 0 | — |
| HBsAg Loss and Seroconversion: Week 28 | 0 | 0 | — |
| HBsAg Loss: Week 32 | 4.8 | 0 | — |
| HBsAg Loss and Seroconversion: Week 32 | 0 | 0 | — |
| HBsAg Loss: Week 36 | 4.8 | 0 | — |
| HBsAg Loss and Seroconversion: Week 36 | 0 | 0 | — |
| HBsAg Loss: Follow-up (FU) Week 2 | 4.8 | 0 | 0 |
| HBsAg Loss and Seroconversion: FU Week 2 | 0 | 0 | 0 |
| HBsAg Loss: FU Week 4 | 4.8 | 0 | 0 |
| HBsAg Loss and Seroconversion: FU Week 4 | 0 | 0 | 0 |
| HBsAg Loss: FU Week 8 | 4.8 | 0 | 0 |
| HBsAg Loss and Seroconversion: FU Week 8 | 0 | 0 | 0 |
| HBsAg Loss: FU Week 12 | 7.1 | 0 | 0 |
| HBsAg Loss and Seroconversion: FU Week 12 | 0 | 0 | 0 |
| HBsAg Loss: FU Week 24 | 4.8 | 2.5 | 0 |
| HBsAg Loss and Seroconversion: FU Week 24 | 0 | 0 | 0 |
| HBsAg Loss: FU Week 36 | 7.1 | 2.5 | 0 |
| HBsAg Loss and Seroconversion: FU Week 36 | 2.4 | 0 | 0 |
| HBsAg Loss: FU Week 48 | 7.1 | 2.5 | 0 |
| HBsAg Loss and Seroconversion: FU Week 48 | 0 | 0 | 0 |
HBeAg loss is defined as HBeAg changing from positive at baseline to negative at any postbaseline visit. HBeAg seroconversion was defined as HBeAb test changing from negative or missing at baseline to positive at a postbaseline visit. Percentages were rounded-off.
| percentage of participants | Cohort 1: TAF + VIR-2218 + SLGN + Nivolumab | Cohort 2 Group A: VIR-2218 + SLGN + Nivolumab | Cohort 2 Group B: SLGN + Nivolumab |
|---|---|---|---|
| HBeAg Loss: Week 4 | 5.6 | 0 | 0 |
| HBeAg Loss and Seroconversion: Week 4 | 0 | 0 | 0 |
| HBeAg Loss: Week 8 | 11.1 | 6.3 | 0 |
| HBeAg Loss and Seroconversion: Week 8 | 0 | 0 | 0 |
| HBeAg Loss: Week 12 | 11.1 | 6.3 | 0 |
| HBeAg Loss and Seroconversion: Week 12 | 0 | 0 | 0 |
| HBeAg Loss: Week 14 | 11.1 | 6.3 | 0 |
| HBeAg Loss and Seroconversion: Week 14 | 0 | 0 | 0 |
| HBeAg Loss: Week 16 | 11.1 | 6.3 | 0 |
| HBeAg Loss and Seroconversion: Week 16 | 0 | 0 | 0 |
| HBeAg Loss: Week 20 | 11.1 | 6.3 | 0 |
| HBeAg Loss and Seroconversion: Week 20 | 0 | 0 | 0 |
| HBeAg Loss: Week 24 | 16.7 | 6.3 | 0 |
| HBeAg Loss and Seroconversion: Week 24 | 5.6 | 0 | 0 |
| HBeAg Loss: Week 28 | 16.7 | 6.3 | — |
| HBeAg Loss and Seroconversion: Week 28 | 5.6 | 0 | — |
| HBeAg Loss: Week 32 | 11.1 | 0 | — |
| HBeAg Loss and Seroconversion: Week 32 | 5.6 | 0 | — |
| HBeAg Loss: Week 36 | 11.1 | 0 | — |
| HBeAg Loss and Seroconversion: Week 36 | 5.6 | 0 | — |
| HBeAg Loss: FU Week 2 | 5.6 | 6.3 | 0 |
| HBeAg Loss and Seroconversion: FU Week 2 | 0 | 6.3 | 0 |
| HBeAg Loss: FU Week 4 | 16.7 | 6.3 | 0 |
| HBeAg Loss and Seroconversion: FU Week 4 | 5.6 | 6.3 | 0 |
| HBeAg Loss: FU Week 8 | 11.1 | 6.3 | 0 |
| HBeAg Loss and Seroconversion: FU Week 8 | 0 | 6.3 | 0 |
| HBeAg Loss: FU Week 12 | 16.7 | 6.3 | 0 |
| HBeAg Loss and Seroconversion: FU Week 12 | 5.6 | 6.3 | 0 |
| HBeAg Loss: FU Week 24 | 5.6 | 12.5 | 0 |
| HBeAg Loss and Seroconversion: FU Week 24 | 0 | 12.5 | 0 |
| HBeAg Loss: FU Week 36 | 11.1 | 12.5 | 0 |
| HBeAg Loss and Seroconversion: FU Week 36 | 0 | 6.3 | 0 |
| HBeAg Loss: FU Week 48 | 16.7 | 12.5 | 0 |
| HBeAg Loss and Seroconversion: FU Week 48 | 5.6 | 6.3 | 0 |
NUC treatments included for analysis: adefovir dipivoxil, entecavir, telbivudine, tenofovir, tenofovir alafenamide, tenofovir alafenamide fumarate, tenofovir disoproxil fumarate, and lamivudine. Percentages were rounded-off.
| percentage of participants | Cohort 1: TAF + VIR-2218 + SLGN + Nivolumab | Cohort 2 Group A: VIR-2218 + SLGN + Nivolumab | Cohort 2 Group B: SLGN + Nivolumab |
|---|---|---|---|
| Percentage of Participants Who Remain Off NUC Treatment During Follow-Up | 16.7 | 55.6 | 75.0 |
Virologic breakthrough was defined as confirmed HBV DNA ≥ LLOQ after 2 consecutive HBV DNA \< LLOQ in participants who are complying with NUC therapy or confirmed HBV DNA ≥ 1 log10 IU/mL increase from nadir during study treatments. LLOQ for HBV DNA CAP/CTM 2.0 is 20 IU/mL. LLOQ for HBV DNA Cobas 6800 is 10 IU/mL. Percentages were rounded-off.
| percentage of participants | Cohort 1: TAF + VIR-2218 + SLGN + Nivolumab | Cohort 2 Group A: VIR-2218 + SLGN + Nivolumab | Cohort 2 Group B: SLGN + Nivolumab |
|---|---|---|---|
| Percentage of Participants Experiencing Hepatitis B Virus (HBV) Virologic Breakthrough During Study Treatments | 7.1 | 35.0 | 20.0 |
Collected over All-cause Mortality: Up to 86.4 weeks; Adverse events: Up to 84 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cohort 1: TAF + VIR-2218 + SLGN + Nivolumab | 0/42 (0%) | 2/42 (4.8%) | 34/42 (81%) |
| Cohort 2 Group A: VIR-2218 + SLGN + Nivolumab | 0/40 (0%) | 5/40 (12.5%) | 37/40 (92.5%) |
| Cohort 2 Group B: SLGN + Nivolumab | 0/21 (0%) | 3/20 (15%) | 19/20 (95%) |
| Event | Cohort 1: TAF + VIR-2218 + SLGN + Nivolumab | Cohort 2 Group A: VIR-2218 + SLGN + Nivolumab | Cohort 2 Group B: SLGN + Nivolumab |
|---|---|---|---|
| MalaiseGeneral disorders | 0/42 | 0/40 | 1/20 |
| Alanine aminotransferase increasedInvestigations | 0/42 | 1/40 | 1/20 |
| Type 1 diabetes mellitusMetabolism and nutrition disorders | 0/42 | 0/40 | 1/20 |
| Immune-mediated hepatitisHepatobiliary disorders | 0/42 | 1/40 | 0/20 |
| Chronic hepatitis BInfections and infestations | 0/42 | 1/40 | 0/20 |
| Upper limb fractureInjury, poisoning and procedural complications | 0/42 | 1/40 | 0/20 |
| AdenomyosisReproductive system and breast disorders | 0/42 | 1/40 | 0/20 |
| Covid-19Infections and infestations | 1/42 | 0/40 | 0/20 |
| DehydrationMetabolism and nutrition disorders | 1/42 | 0/40 | 0/20 |
| Event | Cohort 1: TAF + VIR-2218 + SLGN + Nivolumab | Cohort 2 Group A: VIR-2218 + SLGN + Nivolumab | Cohort 2 Group B: SLGN + Nivolumab |
|---|---|---|---|
| NauseaGastrointestinal disorders | 16/42 | 27/40 | 10/20 |
| VomitingGastrointestinal disorders | 8/42 | 15/40 | 9/20 |
| Covid-19Infections and infestations | 16/42 | 10/40 | 4/20 |
| Alanine aminotransferase increasedInvestigations | 2/42 | 11/40 | 4/20 |
| FatigueGeneral disorders | 4/42 | 7/40 | 4/20 |
| HeadacheNervous system disorders | 6/42 | 6/40 | 4/20 |
| DiarrhoeaGastrointestinal disorders | 3/42 | 7/40 | 3/20 |
| ChillsGeneral disorders | 7/42 | 4/40 | 2/20 |
| Injection site painGeneral disorders | 0/42 | 6/40 | 0/20 |
| DizzinessNervous system disorders | 4/42 | 6/40 | 2/20 |
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
| Age, Categorical(Participants) | Cohort 1: TAF + VIR-2218 + SLGN + Nivolumab | Cohort 2 Group A: VIR-2218 + SLGN + Nivolumab | Cohort 2 Group B: SLGN + Nivolumab | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 42 | 40 | 20 | 102 |
| >=65 years | 0 | 0 | 0 | 0 |
| Age, Continuous(years) | Cohort 1: TAF + VIR-2218 + SLGN + Nivolumab | Cohort 2 Group A: VIR-2218 + SLGN + Nivolumab | Cohort 2 Group B: SLGN + Nivolumab | Total |
|---|---|---|---|---|
| Mean | 48 ± 8.1 | 42 ± 7.9 | 44 ± 7.9 | 45 ± 8.5 |
| Sex: Female, Male(Participants) | Cohort 1: TAF + VIR-2218 + SLGN + Nivolumab | Cohort 2 Group A: VIR-2218 + SLGN + Nivolumab | Cohort 2 Group B: SLGN + Nivolumab | Total |
|---|---|---|---|---|
| Female | 16 | 25 | 10 | 51 |
| Male | 26 | 15 | 10 | 51 |
| Ethnicity (NIH/OMB)(Participants) | Cohort 1: TAF + VIR-2218 + SLGN + Nivolumab | Cohort 2 Group A: VIR-2218 + SLGN + Nivolumab | Cohort 2 Group B: SLGN + Nivolumab | Total |
|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 | 0 |
| Not Hispanic or Latino | 40 | 39 | 20 | 99 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | Cohort 1: TAF + VIR-2218 + SLGN + Nivolumab | Cohort 2 Group A: VIR-2218 + SLGN + Nivolumab | Cohort 2 Group B: SLGN + Nivolumab | Total |
|---|---|---|---|---|
| Race — Asian | 41 | 37 | 18 | 96 |
| Race — Black or African American | 1 | 2 | 0 | 3 |
| Race — Other or More Than One Race | 0 | 1 | 2 | 3 |
| Region of Enrollment(participants) | Cohort 1: TAF + VIR-2218 + SLGN + Nivolumab | Cohort 2 Group A: VIR-2218 + SLGN + Nivolumab | Cohort 2 Group B: SLGN + Nivolumab | Total |
|---|---|---|---|---|
| New Zealand | 2 | 1 | 2 | 5 |
| South Korea | 6 | 2 | 1 | 9 |
| Singapore | 2 | 8 | 4 | 14 |
| Hong Kong | 19 | 10 | 7 | 36 |
| Denmark | 1 | 1 | 0 | 2 |
| United Kingdom | 2 | 3 | 0 | 5 |
| Thailand | 8 | 13 | 5 | 26 |
| Australia | 2 | 2 | 1 | 5 |
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