Table 3.
Major GLE/PIB clinical trials SVR results by category
| Study | Arm | SVR by ITT (%) |
|---|---|---|
| (a) Dosing and RBV use | ||
| SURVEYOR-I, part 1 | GLE 200 mg/PIB 40 mg | 97 |
| SURVEYOR-I, part 1 | GLE 200 mg/PIB 120 mg | 100 |
| SURVEYOR-II, part 1 | GLE 300 mg/PIB 120 mg | 97 |
| SURVEYOR-II, part 1 | GLE 200 mg/PIB 120 mg | 93 |
| SURVEYOR-II, part 1 | GLE 200 mg/PIB 120 mg + RBV | 97 |
| SURVEYOR-II, part 1 | GLE 200 mg/PIB 40 mg | 90 |
| SURVEYOR-II, part 1 | GLE 300 mg/PIB 120 mg | 96 |
| SURVEYOR-II, part 1 | GLE 200 mg/PIB 120 mg | 100 |
| SURVEYOR-II, part 1 | GLE 200 mg/PIB 120 mg + RBV | 100 |
| (b) Duration of therapy | ||
| SURVEYOR-I, part 2 | 8 weeks of GLE/PIB | 97 |
| SURVEYOR-I, part 2 | 12 weeks of GLE/PIB | 100 |
| SURVEYOR-II, part 2 | 8 weeks of GLE/PIB | 98 |
| SURVEYOR-II, part 2 | 8 weeks of GLE/PIB | 97 |
| SURVEYOR-II, part 2 | 12 weeks of GLE/PIB | 92 |
| SURVEYOR-II, part 4 | 8 weeks of GLE/PIB | 97 |
| ENDURANCE-I | 8 weeks of GLE/PIB | 99 |
| ENDURANCE-I | 12 weeks of GLE/PIB | 100 |
| ENDURANCE-III | 12 weeks of GLE/PIB | 95 |
| ENDURANCE-III | 8 weeks of GLE/PIB | 95 |
| EXPEDITION-II | 8 weeks of GLE/PIB | 99 |
| (c) HIV co-infection | ||
| ENDURANCE-I | No cirrhosis | 100 |
| EXPEDITION-II | No cirrhosis | 99 |
| EXPEDITION-II | Compensated cirrhosis | 88 |
| (d) Cirrhosis | ||
| EXPEDITION-I | GT 1, 2, 4, 5, 6 | 99 |
| EXPEDITION-II | GT 1, 2, 3, 4, 6 | 88 |
| SURVEYOR-I and II, part 2 | GT 1 | 96 |
| SURVEYOR-I and II, part 2 | GT 3 without RBV | 96 |
| SURVEYOR-I and II, part 2 | GT 3 with RBV | 100 |
| SURVEYOR-II, part 3 | GT 3, treatment naïve | 98 |
| SURVEYOR-II, part 3 | GT 3, treatment experience | 96 |
| (e) Renal disease | ||
| EXPEDITION-IV | GT 1, 2, 3, 4, 5, 6 | 98 |
| CERTAIN-I | GT 1, 2 | 100 |
| (f) Organ transplantation | ||
| MAGELLAN-II | GT 1, 2, 3, 4, 6 | 98 |
| (g) DAA failure | ||
| MAGELLAN-I, part 1 | GLE/PIB with RBV | 95 |
| MAGELLAN-I, part 1 | GLE/PIB without RBV | 86 |
| MAGELLAN-I, part 2 | No cirrhosis | 89 |
| MAGELLAN-I, part 2 | Compensated cirrhosis | 91 |
| CERTAIN-I | N/A | 94 |
SVR sustained virologic response, ITT intention-to-treat, GLE glecaprevir, PIB pibrentasvir, GT genotype, RBV ribavirin, DAA direct-acting antiviral