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)

Gilead Sciences

Status and phase: Terminated; Phase 2

Conditions: Chronic Hepatitis B

Treatments: Drug: Inarigivir Soproxil; Drug: TAF

Study type: Interventional

Funder types: Industry

Identifiers

NCT03434353

GS-US-464-4437

Details and patient eligibility

About

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).

Enrollment: 123 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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123 participants in 5 patient groups

Group 1: Inarigivir Soproxil 50 mg + TAF

Experimental group

Description:

Viremic participants will be administered inarigivir soproxil 50 mg (2 x 25 mg capsules) once daily orally 1 hour before or 1 hour after a meal plus TAF 25 mg tablet once daily orally with food for 12 weeks followed by TAF 25 mg tablet once daily orally with food for 36 weeks.

Treatment:

Drug: TAF

Drug: Inarigivir Soproxil

Group 2: TAF

Experimental group

Description:

Viremic participants will be administered TAF 25 mg tablet once daily orally with food for 48 weeks.

Treatment:

Drug: TAF

Group 3: Inarigivir Soproxil 200 mg + TAF

Experimental group

Description:

Viremic participants will be administered inarigivir soproxil 200 mg (2 x 100 mg tablets) once daily orally 1 hour before or 1 hour after a meal plus TAF 25 mg tablet once daily orally with food for 12 weeks followed by TAF 25 mg tablet once daily orally with food for 36 weeks

Treatment:

Drug: TAF

Drug: Inarigivir Soproxil

Group 4: Inarigivir Soproxil 100 mg + commercially available NUCs

Experimental group

Description:

Virally suppressed participants receiving commercially available nucleoside/nucleotide (NUC) will be administered inarigivir soproxil 100 mg tablet once daily orally 1 hour before or 1 hour after a meal for 12 weeks. Participants will continue commercially available NUCs for 48 weeks.

Treatment:

Drug: Inarigivir Soproxil

Group 5: Inarigivir Soproxil 400 mg + TAF

Experimental group

Description:

Viremic participants will be administered inarigivir soproxil 400 mg (2 x 200 mg tablets) once daily orally 1 hour before or 1 hour after a meal plus TAF 25 mg tablet once daily orally with food for 12 weeks followed TAF 25 mg tablet once daily orally with food for 36 weeks.

Treatment:

Drug: TAF

Drug: Inarigivir Soproxil