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

A Phase 2, Randomized, Open-Label, Active-Controlled Study to Evaluate the Safety and Antiviral Activity of GS-9992 Plus Tenofovir Alafenamide (TAF) for 12 Weeks in Chronic Hepatitis B (CHB) Subjects

The primary objectives of this study are to evaluate the safety and tolerability of the 12 week treatment regimens of inarigivir soproxil 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).

Key Inclusion Criteria:

• Groups 1-3 and 5:

  • Individuals not taking any prescribed hepatitis B virus (HBV) NUC treatment

• Group 4:

  • HBV deoxyribonucleic acid (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 hepatitis C virus (HCV), human immunodeficiency virus (HIV), or hepatitis D virus (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.