Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 is an investigational small molecule being studied for the treatment of chronic hepatitis C. It was evaluated in a Phase 2 clinical trial in previously untreated patients with genotype 1 chronic hepatitis C, in combination with other antiviral therapies.
Tegobuvir is being developed by Gilead Sciences, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol GILD. The company sponsored the Phase 2 clinical trial of the drug.
Tegobuvir is in Phase 2 clinical development. It has completed one Phase 2 trial, and there are no active trials currently ongoing. The drug is investigational and has not been approved by regulatory authorities.
Tegobuvir has been studied in one completed Phase 2 clinical trial, identified as NCT01271790. This trial enrolled 245 participants and evaluated response-guided duration of combination therapy with GS-9451, Pegasys, and Copegus, with or without Tegobuvir, in previously untreated patients with genotype 1 chronic hepatitis C.
Yes, Tegobuvir is also known as GS-9190. The clinical trial NCT01271790 refers to the drug as both Tegobuvir and GS-9190 in its title, confirming that these names refer to the same investigational compound.