Conditions: Chronic HBV Infection
Keywords: Hepatitis B (HBV) Oral antiviral (OAV) GS-4774
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 178
Healthy volunteers: no

Brief summary:
The primary objectives of this study are to evaluate the safety and efficacy of GS-4774 in adults with chronic hepatitis B (CHB) viral infection who have been virally suppressed with an oral antiviral (OAV) medication.

Detailed description:

Arms:
arm 1: Participants will continue their prebaseline OAV regimen alone from baseline to Week 48. arm 2: Participants will continue their prebaseline OAV regimen from baseline to Week 48, and will receive GS-4774 2 yeast units (YU) from baseline to Week 20. arm 3: Participants will continue their prebaseline OAV regimen from baseline to Week 48, and will receive GS-4774 10 YU from baseline to Week 20. arm 4: Participants will continue their prebaseline OAV regimen from baseline to Week 48, and will receive GS-4774 40 YU from baseline to Week 20.

Interventions: intervention 1: GS-4774 intervention 2: OAV Regimen
Intervention descriptions: intervention 1: Administered as a subcutaneous injection every 4 weeks for a total of 6 doses intervention 2: Administered prior to study enrollment (tenofovir disoproxil fumarate, entecavir, adefovir, lamivudine, or telbivudine either as single agents or in combination)

Protocol document: