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Also known as Tegobuvir (GS-9190), tegobuvir capsule
Tegobuvir · 1 trial · 1 indication
Sustained virologic response (SVR) defined as undetectable hepatitis C virus (HCV) RNA 24 weeks after treatment cessation
| Arm | Type | Description |
|---|---|---|
| Arm 1 | ACTIVE_COMPARATOR | GS-9451 and Tegobuvir (GS-9190) 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 | ACTIVE_COMPARATOR | GS-9451 (active) and Tegobuvir (GS-9190) placebo 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 Tegobuvir (GS-9190) and GS-9451 in combination with Pegasys® and Copegus® for 24 weeks; Pegasys® and Copegus® will be continued for up to 48 weeks total duration |
| Name | Type | Description |
|---|---|---|
| Tegobuvir (GS-9190) | DRUG | Tegobuvir (GS-9190) capsule, 30 mg BID |
| GS-9451 | DRUG | GS-9451 tablet, 200 mg once daily (QD) |
| Pegasys® | BIOLOGICAL | peginterferon alfa-2a (solution for injection) 180 µg/week |
| Copegus® | DRUG | ribavirin tablet (weight based: 1000 mg/day \<75 kg; 1200 mg/day ≥ 75 kg) divided twice daily (BID) |
| Tegobuvir placebo | DRUG | placebo matching Tegobuvir (GS-9190) capsule BID |
| GS-9451 placebo | DRUG | placebo matching GS-9451 tablet QD |
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...
Tegobuvir was studied for the treatment of chronic hepatitis C, specifically genotype 1 infection, in previously untreated patients. It was evaluated as part of a combination regimen rather than as a standalone therapy. Tegobuvir is an investigational small molecule and is not an approved treatment.
Tegobuvir was developed by Gilead Sciences, Inc., which trades on the Nasdaq under the ticker GILD. Gilead sponsored the clinical program evaluating the compound in chronic hepatitis C.
Tegobuvir reached Phase 2 clinical development. One Phase 2 trial has been completed, and no trials are currently active. The drug remains investigational and has not been approved for any indication.
Tegobuvir was evaluated in the completed Phase 2 trial NCT01271790, titled a study of response-guided duration of combination therapy with GS-9451, Pegasys and Copegus with and without Tegobuvir (GS-9190) in previously untreated subjects with genotype 1 chronic hepatitis C. The trial enrolled 245 participants across the United States and several European countries.
Yes, Tegobuvir is also known as GS-9190, and the capsule formulation is referred to as tegobuvir capsule. These names refer to the same investigational compound developed by Gilead Sciences for chronic hepatitis C.
The Phase 2 trial NCT01271790 was a randomized, double-blind, placebo-controlled study. It enrolled 245 adults aged 18 years and older with genotype 1 chronic hepatitis C who had not been previously treated, and it evaluated response-guided duration of combination therapy. The trial has been completed.