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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03092375 | Multi-Center, Randomized, Open-Label Study of G/P +/- RBV for NS5A + SOF Previously Treated GT1 HCV Subjects | PHASE3 | COMPLETED | 177 | — | — | Apr 20, 2017 | Feb 6, 2020 | Feb 26, 2020 | 31 | United States |
Number of non-cirrhotic treatment-experienced HCV genotype 1 with a NS5Ai inhibitor + SOF +/-RBV participants with undetectable HCV RNA (HCV RNA \<Lower Limit of Quantification -LLOQ) 12 weeks after completing G/P 300 mg/100 mg daily for 12 weeks (Arm A) vs. 16 weeks of G/P 300 mg/100 mg daily (Arm B)
Number of cirrhotic participants who are treatment experienced with a NS5A inhibitor + SOF +/RBV with undetectable HCV RNA 12 weeks after completing G/P plus RBV for 12 wks vs. G/P for 16 Wks
Number of subjects who discontinued G/P due to adverse events
| Arm | Type | Description |
|---|---|---|
| Arm A: G/P 300 mg/120 mg QD for 12 Wks | EXPERIMENTAL | Non-cirrhotic subjects will take Glecaprevir/Pibrentasvir (G/P) 300mg/120mg (3 Glecaprevir/Pibrentasvir (G/P) 100mg/40mg Tablets once-daily by mouth) for 12 weeks. |
| Arm B: G/P 300 mg/120 mg QD for 16 Wks | EXPERIMENTAL | Non-cirrhotic subjects will take Glecaprevir/Pibrentasvir (G/P) 300mg/120mg once-daily by mouth for 16 weeks (G/P 300 mg/120 mg QD for 16 Wks) |
| Arm C: G/P 300 mg/120 mg QD + RBV 12 Wks | EXPERIMENTAL | Cirrhotic subjects will take Glecaprevir/Pibrentasvir (G/P) 300mg/120mg once daily plus Ribavirin 200Mg Tablet (2-3 tablets) twice a day for 12 weeks (G/P 300 mg/120 mg QD + RBV 12 Wks) |
| Arm D: G/P 300 mg/120 mg QD for 16 Wks | EXPERIMENTAL | Cirrhotic subjects will take Glecaprevir/Pibrentasvir (G/P) 300mg/120mg once daily for 16 weeks (G/P 300 mg/120mg QD for 16 Wks) |
| Name | Type | Description |
|---|---|---|
| Glecaprevir/Pibrentasvir (G/P) 300mg/120mg | DRUG | daily |
| Ribavirin 200Mg Tablet | DRUG | Weight-based 1000-1200 mg |
Inclusion Criteria: 1. Male or female at least 18 years of age at time of screening. 2. A history of previous treatment with an NS5A-inhibitor plus sofosbuvir therapy ± RBV for chronic HCV genotype 1 infection. 3. Treatment must have been completed at least 1 month prior to Screening Visit. 4. Scre...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Atea Pharmaceuticals, Inc. | AVIR | 2 | PHASE3 | Bemnifosbuvir-Ruzasvir, Sofosbuvir-Velpatasvir |
| Abbott Laboratories | ABT | 2 | — | Undisclosed |
| AbbVie, Inc. | ABBV | 1 | — | Undisclosed |