Study to Evaluate the Antiviral Activity of Inarigivir Soproxil (GS-9992) Plus Tenofovir Alafenamide (TAF) for 12 Weeks in Adults With Chronic Hepatitis B (CHB)

• Status: Completed
• Trial end date: 2021-01-26
• Target enrollment: 0
• Participant gender: All

Summary

The primary objectives of this study are to evaluate the safety and tolerability of the 12 week treatment regimens of inarigivir soproxil (GS-9992) plus tenofovir alafenamide (TAF) or commercially available nucleoside/nucleotide (NUC) in adults with chronic hepatitis B (CHB), to evaluate the antiviral activity of 12 weeks of inarigivir soproxil plus TAF versus TAF alone in viremic CHB participants (Groups 1-3, 5), and to evaluate the antiviral activity of 12 weeks of inarigivir soproxil with commercially available NUC(s) in virally suppressed CHB participants (Group 4).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gilead Sciences
• Collaborators: F-star Therapeutics, Inc.; Spring Bank Pharmaceuticals, Inc.
• Treatments: Antiviral Agents; Tenofovir

Criteria

Key Inclusion Criteria:

• All Groups:

• Aged 18 to 70 years of age, inclusive, based on the date of screening visit.

• Chronic hepatitis B infection

• Groups 1-3 and 5:

• Individuals not taking any prescribed HBV NUC treatment

• Group 4:

• HBV DNA ≤ 20 IU/mL at Screening by Central Lab.

• Have been on a commercially available HBV NUC treatment(s)

Key Exclusion Criteria:

• Co-infection with HCV, HIV, or HDV.

• Extensive bridging fibrosis or cirrhosis

• Evidence of hepatocellular carcinoma on imaging

• Any history of, or current evidence of, clinical hepatic decompensation (e.g., ascites, encephalopathy or variceal hemorrhage).

• Chronic liver disease of a non-HBV etiology

• Current alcohol or substance abuse

Note: Other protocol defined Inclusion/Exclusion criteria may apply.