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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02378935 | Safety and Efficacy of Voxilaprevir Plus Sofosbuvir/Velpatasvir Fixed Dose Combination in Adults With Chronic Genotype 1 HCV Infection | PHASE2 | COMPLETED | 205 | — | — | Feb 17, 2015 | Apr 12, 2016 | Mar 6, 2020 | 34 | United States, New Zealand +1 |
| NCT02378961 | Safety and Efficacy of Voxilaprevir Plus Sofosbuvir/Velpatasvir Fixed Dose Combination in Adults With Chronic Non-Genotype 1 HCV Infection | PHASE2 | COMPLETED | 128 | — | — | Feb 16, 2015 | Jan 26, 2016 | Mar 3, 2020 | 34 | United States, New Zealand +1 |
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study treatment.
| Arm | Type | Description |
|---|---|---|
| VOX+SOF/VEL 6 wk, TN, without cirrhosis | EXPERIMENTAL | VOX + SOF/VEL for 6 weeks (treatment naive (TN), without cirrhosis) |
| VOX+SOF/VEL 8 wk, TN, without cirrhosis | EXPERIMENTAL | VOX + SOF/VEL for 8 weeks (treatment naive, without cirrhosis) |
| VOX+SOF/VEL 6 wk, TN, with cirrhosis | EXPERIMENTAL | VOX + SOF/VEL for 6 weeks (treatment naive, with cirrhosis) |
| VOX+SOF/VEL 8 wk, TN, with cirrhosis | EXPERIMENTAL | VOX + SOF/VEL for 8 weeks (treatment naive, with cirrhosis) |
| VOX+SOF/VEL+RBV 8 wk, TN, with cirrhosis | EXPERIMENTAL | VOX + SOF/VEL+RBV for 8 weeks (treatment naive, with cirrhosis) |
| VOX+SOF/VEL 8 wk, DAA-E, without cirrhosis | EXPERIMENTAL | VOX + SOF/VEL for 8 weeks (direct-acting antiviral experienced (DAA-E), without cirrhosis) |
| VOX+SOF/VEL 12 wk, DAA-E, without cirrhosis | EXPERIMENTAL | VOX + SOF/VEL for 12 weeks (direct-acting antiviral experienced, without cirrhosis) |
| VOX+SOF/VEL 8 wk, DAA-E, with cirrhosis | EXPERIMENTAL | GS-9857 + SOF/VEL for 8 weeks (direct-acting antiviral experienced, with cirrhosis) |
| VOX+SOF/VEL 12 wk, DAA-E, with cirrhosis | EXPERIMENTAL | GS-9857 + SOF/VEL for 12 weeks (direct-acting antiviral experienced, with cirrhosis) |
| VOX+SOF/VEL 12 wk (GS-US-338-1121) | EXPERIMENTAL | VOX + SOF/VEL for 12 weeks (participants who were previously enrolled in GS-US-338-1121 phase 1b study) |
| GS-9857+SOF/VEL 6 wk, TN, with cirrhosis | EXPERIMENTAL | GS-9857 + SOF/VEL for 6 weeks (treatment naive, with cirrhosis) |
| VOX+SOF/VEL 8 wk,TE, without cirrhosis | EXPERIMENTAL | GS-9857 + SOF/VEL for 8 weeks (treatment experienced (TE), without cirrhosis) |
| VOX+SOF/VEL 12 wk, TE, without cirrhosis | EXPERIMENTAL | VOX + SOF/VEL for 12 weeks (treatment experienced, without cirrhosis) |
| GS-9857+SOF/VEL 8 wk, TE, with cirrhosis | EXPERIMENTAL | GS-9857 + SOF/VEL for 8 weeks (treatment experienced, with cirrhosis) |
| VOX+SOF/VEL 12 wk, TE, with cirrhosis | EXPERIMENTAL | VOX + SOF/VEL for 12 weeks (treatment experienced, without cirrhosis) |
| Name | Type | Description |
|---|---|---|
| VOX | DRUG | 100 mg tablet(s) administered orally once daily with food |
| SOF/VEL | DRUG | 400/100 mg FDC tablet administered orally once daily with food |
| RBV | DRUG | Tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) |
Key Inclusion Criteria: * Individuals with chronic HCV infection * HCV RNA ≥10\^4 IU/mL at screening * HCV genotype 1 * Cirrhosis determination; a liver biopsy may be required * Screening laboratory values within defined thresholds * Use of two contraception methods if female of childbearing potent...