Primary-outcome results across pivotal trials
Per-arm reported values from Phase 2/3 and Phase 3 trials with results posted to ClinicalTrials.gov.
| Trial | Indication | Primary endpoint | Arm | Value |
|---|---|---|---|---|
| NCT02692703 | Hepatitis C | Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) 12 weeks after the last dose of study drug (up to 24 weeks) | Glecaprevir/Pibrentasvir | 98 percentage of participants |
| NCT02939989 MAGELLAN-3 | Hepatitis C | Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) 12 weeks after the last actual dose of study drug, Week 24 or Week 28 depending on the treatment regimen. | Glecaprevir/Pibrentasvir + SOF + RBV for 12 Weeks | 100 percentage of participants |
| Glecaprevir/Pibrentasvir + SOF + RBV for 16 Weeks | 96.4 percentage of participants | |||
| Total | 97.0 percentage of participants | |||
| NCT02966795 ENDURANCE-5 6 | Hepatitis C | Percentage of Participants With Sustained Virologic Response 12 Weeks Post Treatment (SVR12) 12 weeks after last dose of study drug (week 20 or 24 depending on the treatment regimen) | Genotype 5-infected | 95.7 percentage of participants |
| Genotype 6-infected | 98.4 percentage of participants | |||
| NCT03067129 DORA | Hepatitis C | Percentage of Participants With Sustained Virologic Response 12 Weeks Post Treatment (SVR12) 12 weeks after last dose of study drug (Week 20, 24, or 28 depending on treatment duration) | Cohort 1: Adult Formulation GLE/PIB; 12 to < 18 Years | 100 percentage of participants |
| Cohort 2: Pediatric Formulation GLE + PIB; 9 to < 12 Years | 93.1 percentage of participants | |||
| Cohort 3: Pediatric Formulation GLE + PIB; 6 to < 9 Years | 100 percentage of participants | |||
| Cohort 4: Pediatric Formulation GLE + PIB; 3 to < 6 Years | 95.8 percentage of participants | |||
| Cohorts 2-4: Pediatric Formulation GLE + PIB; 3 to < 12 Years | 96.3 percentage of participants | |||
| Total | 97.6 percentage of participants | |||
| NCT03067129 DORA | Hepatitis C | Steady-state Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours Postdose (AUC0-24) of Glecaprevir Week 2 from predose to 24 hours post-dose | Cohort 1: Adult Formulation GLE/PIB; 12 to < 18 Years | 4790 ng*h/mL |
| Cohort 2: Pediatric Formulation GLE + PIB; 9 to < 12 Years | 7870 ng*h/mL | |||
| Cohort 3: Pediatric Formulation GLE + PIB; 6 to < 9 Years | 6860 ng*h/mL | |||
| Cohort 4: Pediatric Formulation GLE + PIB; 3 to < 6 Years | 7520 ng*h/mL | |||
| NCT03067129 DORA | Hepatitis C | Steady-state AUC0-24 of Pibrentasvir Week 2 from predose to 24 hours post-dose | Cohort 1: Adult Formulation GLE/PIB; 12 to < 18 Years | 1380 ng*h/mL |
| Cohort 2: Pediatric Formulation GLE + PIB; 9 to < 12 Years | 2200 ng*h/mL | |||
| Cohort 3: Pediatric Formulation GLE + PIB; 6 to < 9 Years | 1640 ng*h/mL | |||
| Cohort 4: Pediatric Formulation GLE + PIB; 3 to < 6 Years | 1790 ng*h/mL | |||
| NCT03069365 EXPEDITION-5 | Hepatitis C | Percentage of Participants Achieving Sustained Virologic Response 12 Weeks Post Dosing (SVR12) 12 weeks after the last actual dose of study drug | GLE/PIB for 8, 12, or 16 Weeks | 97.0 percentage of participants |
| NCT03089944 EXPEDITION-8 | Hepatitis C | Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) in Hepatitis C Virus (HCV) Genotype (GT) 1,2,4,5 and 6-infected Participants in the Per Protocol (PP) Population 12 weeks after last dose of study drug | Glecaprevir (GLE)/Pibrentasvir (PIB) for 8 Weeks | 100 percentage of participants |
| NCT03089944 EXPEDITION-8 | Hepatitis C | Percentage of Participants With SVR12 in HCV GT 1,2,4,5 and 6-infected Participants in the Intent-To-Treat (ITT) Population 12 weeks after last dose of study drug | Glecaprevir (GLE)/Pibrentasvir (PIB) for 8 Weeks | 98.2 percentage of participants |
| NCT03092375 | Hepatitis C | Comparison of Cirrhotic Participants Achieving SVR 12 After G/P Plus RBV for 12 Wks vs. G/P for 16 Wks Up to 28 weeks | Arm C: G/P 300 mg/120 mg QD + RBV 12 Wks | 18 Participants |
| Arm C: G/P 300 mg/120 mg QD + RBV 12 Wks | 3 Participants | |||
| Arm D: G/P 300 mg/120 mg QD for 16 Wks | 28 Participants | |||
| Arm D: G/P 300 mg/120 mg QD for 16 Wks | 1 Participants | |||
| NCT03092375 | Hepatitis C | SVR After G/P 12 Wks (Arm A) vs. G/P Given for 16 Weeks (Arm B) to Non-cirrhotic Treatment-experienced GT1 HCV Participants Up to 28 weeks | Arm A: G/P 300 mg/120 mg QD for 12 Wks | 70 Participants |
| Arm A: G/P 300 mg/120 mg QD for 12 Wks | 8 Participants | |||
| Arm B: G/P 300 mg/120 mg QD for 16 Wks | 46 Participants | |||
| Arm B: G/P 300 mg/120 mg QD for 16 Wks | 3 Participants | |||
| NCT03092375 | Hepatitis C | Tolerability of G/P +/-RBV Up to 16 weeks | Arm A: G/P 300 mg/120 mg QD for 12 Wks | 0 Participants |
| Arm B: G/P 300 mg/120 mg QD for 16 Wks | 0 Participants | |||
| Arm C: G/P 300 mg/120 mg QD + RBV 12 Wks | 0 Participants | |||
| Arm D: G/P 300 mg/120 mg QD for 16 Wks | 0 Participants | |||
| NCT03117569 SMART-C | Hepatitis C, Chronic | Undetectable HCV RNA (ITT Population) 12 weeks post end of treatment (SVR12) | Simplified Monitoring Schedule | 233 Participants |
| Standard Monitoring Schedule | 121 Participants | |||
| NCT03212521 | Hepatitis C | Percentage of Participants in the Modified Intention-to-Treat Population With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) 12 weeks after the last actual dose of study drug, Week 20 | Glecaprevir/Pibrentasvir | 100.0 percentage of participants |
| NCT03219216 | Hepatitis C | Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) 12 weeks after last dose of study drug (week 20 or 24 depending on treatment regimen) | All Participants | 98.0 percentage of participants |
| NCT03222583 VOYAGE-1 | Hepatitis C | Percentage of HCV GT1-Infected Participants in Arm A Who Achieved SVR12 12 weeks after last actual dose of study drug, Week 20 or Week 28 depending on the treatment regimen | Arm A: Glecaprevir/Pibrentasvir | 99.4 percentage of participants |
| NCT03222583 VOYAGE-1 | Hepatitis C | Percentage of HCV GT1 - GT6-Infected Participants in Arm A Who Achieved Sustained Virologic Response 12 Weeks Post Treatment (SVR12) 12 weeks after the last actual dose of study drug, Week 20 or Week 28 depending on the treatment regimen. | Arm A: Glecaprevir/Pibrentasvir | 97.2 percentage of participants |
| NCT03222583 VOYAGE-1 | Hepatitis C | Percentage of HCV GT2-Infected Participants in Arm A Who Achieved SVR12 12 weeks after the last dose of study drug, Week 20 or Week 28 depending on the treatment regimen. | Arm A: Glecaprevir/Pibrentasvir | 97.8 percentage of participants |
| NCT03235349 VOYAGE-2 | Hepatitis C | Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) 12 weeks after the last actual dose of study drug, Week 24 or Week 28 depending on the treatment regimen. | Glecaprevir/Pibrentasvir | 99.4 percentage of participants |
| NCT03801707 | Hepatitis C | Elevation in Liver Enzyme >5 Times the Upper Limits, Development of Acute Cholestatic Hepatitis , or Intolerance to Direct Acting Antiviral Therapies 12 weeks | Intervention Group | 2 Participants |
| Intervention Group | 0 Participants | |||
| Intervention Group | 0 Participants | |||
| Intervention Group | 28 Participants | |||
| NCT03801707 | Hepatitis C | Proportion of Patients With Undetectable Hepatitis C Virus (HCV) Polymerase Chain Reaction (PCR) at 12 Weeks After Completion of HCV Treatment 12 weeks | Intervention Group | 28 Participants |
| NCT04903626 | Hepatitis C | Percentage of Participants Achieving Sustained Virologic Response 12 Weeks Post-treatment (SVR12) in the Intention-to-Treat (ITT) Population 12 weeks after last dose of study treatment (Week 20) | Glecaprevir/Pibrentasvir | 96.2 percentage of participants |