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GS-4774 · 2 trials · 2 indications
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.
Frequency of serious adverse events Frequency and severity of common non-serious adverse events Frequency of discontinuations of therapy due to adverse events Common laboratory assessments (chemistry, hematology, urinalysis) Dose Limiting Toxicities
| 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. |
| GS-4774 at 10 yeast units (YU) | EXPERIMENTAL | 10 YU of GS-4774 given either weekly or monthly |
| GS-4774 at 40 YU | EXPERIMENTAL | 40 YU of GS-4774 given either weekly or monthly |
| GS-4774 at 80YU | EXPERIMENTAL | 80 YU of GS-4774 given either weekly or monthly |
| 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 therapeutic being studied for chronic hepatitis B and chronic HBV infection. It was evaluated in a Phase 1 trial in healthy volunteers and a Phase 2 trial in patients with chronic HBV infection. Both trials have been completed.
GS-4774 is being developed by Gilead Sciences, Inc. (NASDAQ: GILD). The company has completed two clinical trials of the drug, including a Phase 2 study in chronic hepatitis B.
GS-4774 has completed Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. Two trials, one Phase 1 and one Phase 2, have been completed with a total enrollment of 178 participants.
GS-4774 has been studied in two completed trials: NCT01779505, a Phase 1 trial in healthy volunteers, and NCT01943799, a Phase 2 trial for chronic HBV infection. Both trials were conducted in the United States, with the Phase 2 trial also including New Zealand.
Yes, GS-4774 is also known as GI-13020. The Phase 1 trial NCT01779505 assessed the safety, tolerability, and immunogenicity of GS-4774 (GI-13020) at various dose levels and regimens in healthy adults.