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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)

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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)

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

Trial documents
2

Trial contacts and locations

13

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Data sourced from clinicaltrials.gov

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