Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01435226 | GS-5885, GS-9451, Tegobuvir and Ribovirin in Treatment-Experienced Subjects With Chronic Genotype 1a Or 1b Hepatitis C Virus (HCV) Infection | PHASE2 | COMPLETED | 170 | — | — | Sep 1, 2011 | Jul 1, 2013 | Dec 17, 2013 | 51 | United States, Germany |
| NCT01356160 | GS-5885 Alone or in Combination With GS-9451 With Peginterferon Alfa 2a and Ribavirin in Treatment Chronic Genotype 1 Hepatitis C Virus | PHASE2 | COMPLETED | 351 | — | — | Jul 1, 2011 | Jun 1, 2013 | Feb 3, 2014 | 23 | United States, Australia +1 |
| NCT01371578 | Oral Antivirals (GS-5885, Tegobuvir, and/or GS-9451) With Peginterferon Alfa 2a and Ribavirin in Treatment Experienced Subjects With Chronic Genotype 1 Hepatitis C Virus Infection | PHASE2 | COMPLETED | 163 | — | — | Jul 1, 2011 | Mar 1, 2013 | Feb 11, 2014 | 55 | United States, Puerto Rico |
| NCT01353248 | GS 5885 Administered Concomitantly With GS-9451, Tegobuvir and Ribavirin (RBV) in Chronic Genotype 1 Hepatitis C Virus (HCV) Infection | PHASE2 | COMPLETED | 141 | — | — | May 1, 2011 | Mar 1, 2013 | Dec 20, 2013 | 43 | United States, Puerto Rico |
To evaluate safety and tolerability of combination therapy with GS-5885, GS-9451, tegobuvir and ribavirin or GS-5885, GS-9451 and tegobuvir or GS-5885, GS-9451 and ribavirin. Safety will be assessed during the study through the reporting of adverse events, clinical laboratory tests, physical examinations, vital signs and 12-lead ECGs at various time points during the study.
To evaluate the antiviral efficacy as measured by sustained virologic response (SVR, defined as HCV RNA \< lower limit of quantitation \[LLoQ\] 24 weeks post-treatment) of combination therapy with GS-5885, GS-9451, tegobuvir and RBV compared with GS-5885, GS-9451 and tegobuvir or GS-5885, GS-9451 and RBV in treatment-experienced subjects with chronic genotype 1a or 1b HCV infection
To evaluate the antiviral efficacy as measured by sustained virologic response (SVR, defined as plasma HCV RNA \< Lower Limit of Quantification (LLoQ) at 24 weeks post-treatment) of response guided therapy (RGT) with GS-5885 + GS-9451 + PEG/RBV, or GS-5885 + PEG/RBV.
To evaluate antiviral efficacy as measured by sustained virologic response (SVR, defined as HCV RNA \< Lower Limit of Quantification (LLoQ) 24 weeks post-treatment) of response guided therapy (RGT) with GS-9451 + GS-5885, with peginterferon alfa-2a (PEG) and ribavirin (RBV) in treatment-experienced subjects.
| Arm | Type | Description |
|---|---|---|
| Arm 1 | ACTIVE_COMPARATOR | GS-5885 90 mg QD + GS-9451 200 mg QD + tegobuvir 30 mg BID + RBV BID |
| Arm 2 | ACTIVE_COMPARATOR | GS-5885 90 mg QD + GS-9451 200 mg QD + tegobuvir 30 mg BID + RBV placebo BID |
| Arm 3 | ACTIVE_COMPARATOR | GS-5885 90 mg QD + GS-9451 200 mg QD + tegobuvir placebo BID + RBV BID |
| Name | Type | Description |
|---|---|---|
| GS-5885 | DRUG | Drug: GS-5885 tablet GS-5885 tablet, 90 mg, QD |
| GS-9451 | DRUG | Drug: GS-9451 tablet GS-9451 tablet, 200 mg QD |
| tegobuvir | DRUG | tegobuvir 30 mg BID |
| placebo to match tegobuvir | DRUG | tegobuvir placebo BID |
| placebo to match RBV | DRUG | Ribovirin placebo BID |
| Ribavirin | DRUG | Ribavirin (Copegus®) BID (1000 mg for subjects weighing \< 75 kg and 1200 mg for subjects weighing ≥ 75 kg) divided BID |
| peginterferon alfa-2a | BIOLOGICAL | (solution for injection) 180 µg/week |
| ribavirin tablet | DRUG | ribavirin tablet (weight based: 1000 mg/day \<75 kg; 1200 mg/day ≥ 75 kg) divided twice daily (BID) |
| GS-9451 Placebo | DRUG | Placebo to match GS-9451 QD |
| GS-5885 tablet | DRUG | 30 mg active tablet |
| GS-9451 tablet | DRUG | two active 100 mg tablets |
Inclusion Criteria: * Age ≥18 years with chronic HCV infection * Liver biopsy results ≤ 3 years prior to screening indicating the absence of cirrhosis. Alternatively, a non-invasive procedure conducted within 6 months of screening is permitted in countries where allowed * Monoinfection with HCV gen...