Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GS-4774 · 1 trial · 1 indication
The change from baseline to Week 24 in HBsAg was analyzed using a mixed effect model for repeated measures (MMRM). The model included included treatment, HBsAg baseline level (≤ 1000 IU/mL or \> 1000 IU/mL), HBeAg baseline status (positive or negative), visit, and treatment-by-visit interaction as fixed effects and visit as a repeated measure.
| Arm | Type | Description |
|---|---|---|
| OAV Alone | EXPERIMENTAL | Participants will continue their prebaseline OAV regimen alone from baseline to Week 48. |
| OAV + GS-4774 2 YU | EXPERIMENTAL | 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. |
| OAV + GS-4774 10 YU | EXPERIMENTAL | Participants will continue their prebaseline OAV regimen from baseline to Week 48, and will receive GS-4774 10 YU from baseline to Week 20. |
| OAV + GS-4774 40 YU | EXPERIMENTAL | Participants will continue their prebaseline OAV regimen from baseline to Week 48, and will receive GS-4774 40 YU from baseline to Week 20. |
| Name | Type | Description |
|---|---|---|
| GS-4774 | BIOLOGICAL | Administered as a subcutaneous injection every 4 weeks for a total of 6 doses |
| OAV Regimen | DRUG | Administered prior to study enrollment (tenofovir disoproxil fumarate, entecavir, adefovir, lamivudine, or telbivudine either as single agents or in combination) |
Key Inclusion Criteria: * Ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures * Currently taking an approved HBV oral antiviral medication * Documented evidence of chronic HBV infection (eg, HBsAg positive for more than 6 mo...
GS-4774 is an investigational therapy being studied for the treatment of chronic hepatitis B virus (HBV) infection. It was evaluated in a Phase 2 clinical trial in adults with chronic HBV. It is not approved for any indication and remains in clinical development.
GS-4774 is being developed by Gilead Sciences, Inc., which trades on the Nasdaq under the ticker GILD. Gilead sponsored the Phase 2 study of GS-4774 in chronic hepatitis B.
GS-4774 is in Phase 2 development. One Phase 2 trial has been completed, and no trials are currently active. The drug is investigational and has not been approved by the FDA for any indication.
GS-4774 was evaluated in the Phase 2 trial NCT01943799, titled Safety and Efficacy of GS-4774 for the Treatment of Chronic Hepatitis B. The completed study enrolled 178 adults with chronic HBV infection across the United States and New Zealand.
The Phase 2 trial NCT01943799 was a randomized, controlled study of GS-4774 in 178 adults aged 18 years and older with chronic hepatitis B. It enrolled participants in the United States and New Zealand and has been completed.