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GS-9190 · 2 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| Arm 1 | EXPERIMENTAL | GS-9190 and GS-9256 in combination with Pegasys® and Copegus® for 16 or 24 weeks; Pegasys® and Copegus® may be continued for up to 48 weeks total duration depending on individual response to therapy |
| Arm 2 | EXPERIMENTAL | GS-9256 (active) and placebo matching GS-9190 in combination with Pegasys® and Copegus® for 24 weeks; Pegasys® and Copegus® may be continued for up to 48 weeks total duration depending on individual response to therapy |
| Arm 3 | PLACEBO_COMPARATOR | Placebo matching GS-9190 and placebo matching GS-9256 in combination with Pegasys® and Copegus® for 24 weeks; Pegasys® and Copegus® will be continued for up to 48 weeks total duration |
| 1 | PLACEBO_COMPARATOR | Peginterferon and ribavirin + placebo BID for 48 weeks + 24 weeks treatment-free follow-up (n = 50) |
| 2 | EXPERIMENTAL | Peginterferon and ribavirin + GS 9190 40 mg BID for 48 weeks + 24 weeks treatment-free follow-up (n = 100) |
| 3 | EXPERIMENTAL | Peginterferon and ribavirin + GS 9190 40 mg BID for 48 weeks + 24 weeks treatment-free follow-up. However, subjects who achieve RVR (HCV RNA undetectable at Week 4) and maintain that response through Week 24 will stop all study drugs at Week 24 and be followed for an additional 48 weeks (n = 50). |
| Name | Type | Description |
|---|---|---|
| GS-9190 | DRUG | GS-9190 capsule, 20 mg BID, 16 or 24 weeks |
| GS-9256 | DRUG | GS-9256 capsule, 150 mg BID, 16 or 24 weeks |
| Pegasys® | BIOLOGICAL | peginterferon alfa-2a, (solution for injection) 180 µg/week, up to 48 weeks |
| Copegus® | DRUG | ribavirin 200 mg tablet (weight based: 1000 mg/day \<75 kg; 1200 mg/day \>/= 75 kg) divided twice daily (BID), up to 48 weeks |
| GS-9190 placebo | DRUG | placebo matching GS-9190 capsule BID, 24 weeks |
| GS-9256 placebo | DRUG | placebo matching GS-9256 capsule BID, 24 weeks |
| placebo | DRUG | oral BID |
| Peginterferon Alfa 2a | DRUG | All subjects received a fixed dose of 180 μg PEG via subcutaneous injection on a weekly basis. |
| Ribavirin | DRUG | Ribavirin supplied as 200 mg Copegus® tablets (1000 mg for subjects weighing \< 75 kg and 1200 mg for subjects weighing ≥ 75 kg) were given in a divided daily dose. |
Inclusion Criteria: * Adult subjects 18 to 70 years of age * Chronic HCV infection for at least 6 months prior to Baseline (Day 1) * Liver biopsy results (performed no more than 2 years prior to Screening) indicating the absence of cirrhosis * Monoinfection with HCV genotype 1a or 1b * HCV treatmen...
GS-9190 is an investigational small molecule being studied for the treatment of HCV Infection and Chronic Hepatitis C Infection. It is being developed by Gilead Sciences, Inc. (GILD) and is currently in Phase 2 clinical development.
GS-9190 is a small molecule antiviral agent. Its specific molecular target has not been disclosed in the available information.
GS-9190 is being developed by Gilead Sciences, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol GILD.
GS-9190 is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Two Phase 2 trials have been completed.
GS-9190 has been studied in two completed Phase 2 trials. NCT00743795 evaluated 24 or 48 weeks of GS-9190 in combination with peginterferon alfa 2a and ribavirin in genotype-1 chronic HCV infection. NCT01225380 studied response-guided duration of combination therapy with GS-9190, GS-9256, Pegasys and Copegus in previously untreated subjects with genotype 1 chronic hepatitis C.
No, GS-9190 and GS-9256 are different investigational drugs. In clinical trial NCT01225380, they were studied in combination with each other, along with Pegasys and Copegus, for the treatment of genotype 1 chronic hepatitis C.