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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 developed for the treatment of chronic hepatitis C virus (HCV) infection. It has been studied in Phase 2 clinical trials in combination with peginterferon alfa-2a and ribavirin, as well as with GS-9256, for genotype-1 chronic HCV infection.
GS-9190 is being developed by Gilead Sciences, Inc. (NASDAQ: GILD). The company has sponsored Phase 2 clinical trials evaluating the drug in combination with other antiviral agents for the treatment of chronic hepatitis C infection.
GS-9190 is in Phase 2 clinical development. It has completed two Phase 2 trials, one with 252 participants and another with 324 participants. The drug is investigational and has not been approved by regulatory authorities.
GS-9190 has been studied in two completed Phase 2 trials. NCT00743795 evaluated 24 or 48 weeks of GS-9190 with peginterferon alfa-2a and ribavirin in 252 participants with genotype-1 HCV. NCT01225380 studied response-guided duration of therapy with GS-9190, GS-9256, Pegasys, and Copegus in 324 untreated participants.
No, GS-9190 and GS-9256 are different investigational drugs. They were studied together in combination in the clinical trial NCT01225380, which evaluated response-guided duration of therapy with both agents plus Pegasys and Copegus in previously untreated participants with genotype 1 chronic hepatitis C.