Phase 2
Completed N=192
Study to Evaluate the Safety, Tolerability, and Efficacy of Vesatolimod in Combination With Tenofovir Disoproxil Fumarate (TDF) in Adults With Chronic Hepatitis B (CHB) Infection Who Are Currently Not Being Treated
Source: ClinicalTrials.gov NCT02579382 ↗Enrolled (actual)
192
Serious AEs
3.8%
Results posted
May 2020
Primary outcomePrimary: Mean Change (Measured in log10 IU/mL) in Hepatitis B Surface Antigen (HBsAg) From Baseline at Week 24 — -0.163; -0.056; -0.146; -0.036 log10 IU/mL — p=0.227
Summary
The primary objectives of this study are to evaluate the safety, tolerability, and efficacy of vesatolimod (formerly GS-9620) in adults with chronic hepatitis B (CHB) infection who are currently not being treated.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change (Measured in log10 IU/mL) in Hepatitis B Surface Antigen (HBsAg) From Baseline at Week 24 |
-0.163; -0.056; -0.146; -0.036 | 0.227 |
| SECONDARY Percentage of Participants With HBeAg Loss and Seroconversion at Week 24 |
0; 0; 0; 0 | — |
| SECONDARY Percentage of Participants With HBeAg Loss and Seroconversion at Week 48 |
0; 5.0; 4.3; 4.8 | — |
| SECONDARY Percentage of Participants With HBsAg Loss and Seroconversion at Week 24 |
0; 0; 0; 0 | — |
| SECONDARY Percentage of Participants With HBsAg Loss and Seroconversion at Week 48 |
0; 0; 0; 0 | — |
| SECONDARY Mean Change (Measured in log10 IU/mL) in HBsAg From Baseline at Week 12 |
-0.087; -0.041; -0.138; -0.020 | — |
| SECONDARY Mean Change (Measured in log10 IU/mL) in HBsAg From Baseline at Week 48 |
-0.338; -0.079; -0.197; -0.088 | — |
| SECONDARY Percentage of Participants With a ≥ 0.5 log10 IU/mL Decline in Serum HBsAg Titers From Baseline at Week 12 |
7.1; 3.8; 10.7; 1.8 | — |
| SECONDARY Percentage of Participants With a ≥ 0.5 log10 IU/mL Decline in Serum HBsAg Titers From Baseline at Week 24 |
10.7; 3.8; 10.7; 3.6 | — |
| SECONDARY Percentage of Participants With a ≥ 0.5 log10 IU/mL Decline in Serum HBsAg Titers From Baseline at Week 48 |
17.9; 5.7; 16.1; 14.5 | — |
| SECONDARY Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantitation (LLOQ) at Week 24 |
53.6; 58.5; 59.3; 63.0 | — |
| SECONDARY Percentage of Participants With HBV DNA < LLOQ at Week 48 |
64.3; 62.3; 75.9; 75.5 | — |
| SECONDARY Percentage of Participants Experiencing Virologic Breakthrough |
0; 0; 1.8; 0; 0; 3.8 | — |
| SECONDARY Number of Participants With Sequence Changes From Baseline Within the HBV Polymerase/Reverse Transcriptase (Pol/RT) |
2; 4; 2; 2 | — |
| SECONDARY Pharmacokinetic (PK) Parameter: AUClast of Vesatolimod |
5252.3; 7170.6; 28537.2 | — |
| SECONDARY PK Parameter: AUCinf of Vesatolimod |
7277.3; 10239.0; 34534.8 | — |
| SECONDARY PK Parameter: %AUCexp of Vesatolimod |
31.1; 28.6; 19.3 | — |
| SECONDARY PK Parameter: Cmax of Vesatolimod |
667.8; 850.4; 4957.5 | — |
| SECONDARY PK Parameter: Clast of Vesatolimod |
92.8; 119.0; 328.0 | — |
| SECONDARY PK Parameter: Tmax of Vesatolimod |
1.00; 2.00; 3.00 | — |
| SECONDARY PK Parameter: Tlast of Vesatolimod |
24.00; 24.00; 24.00 | — |
| SECONDARY PK Parameter: T1/2 of Vesatolimod |
10.79; 14.12; 13.32 | — |
| SECONDARY PK Parameter: CL/F of Vesatolimod |
273.9; 262.3; 156.2 | — |
Eligibility Criteria
Key Inclusion Criteria
- Adult males or females between the ages of 18-65
- Chronic hepatitis B virus (HBV) infection
- HBV deoxyribonucleic acid (DNA ) ≥ 2000 IU/mL at screening
Key Exclusion Criteria
- Extensive bridging fibrosis or cirrhosis
- Received oral antiviral treatment for HBV or prolonged therapy with immune-modulators or biologics within 3 months of screening
- Co-infection with hepatitis C virus (HCV), human immunodeficiency virus (HIV) or hepatitis D virus (HDV)
- Chronic liver disease other than HBV
- Lactating or pregnant females or those that wish to become pregnant during the course of the study
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT02579382). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.