Table 3.
Ledipasvir/sofosbuvir FDC for genotype 1.
| Study | Population | Regimen | Overall SVR12 | Cirrhotic SVR12 |
|---|---|---|---|---|
| ION-1 | GT1 TN (N = 865) | SOF/LDV, 12 weeks | 99% | 94% |
| (211/214) | (32/34) | |||
| SOF/LDV/RBV, 12 weeks | 97% | 100% | ||
| (211/217) | (33/33) | |||
| SOF/LDV, 24 weeks | 98% | 94% | ||
| (212/217) | (31/33) | |||
| SOF/LDV/RBV, 24 weeks | 99% | 100% | ||
| (215/217) | (36/36) | |||
| ION-2 | GT1 TE (N = 440) | SOF/LDV, 12 weeks | 94% | 86% |
| (102/109) | (19/22) | |||
| SOF/LDV/RBV, 12 weeks | 96% | 82% | ||
| (107/111) | (18/22) | |||
| SOF/LDV, 24 weeks | 99% | 100% | ||
| (108/109) | (22/22) | |||
| SOF/LDV/RBV, 24 weeks | 99% | 100% | ||
| (110/111) | (22/22) | |||
| ION-3 | GT1 TN (N = 647) | SOF/LDV, 8 weeks | 94% | n/a |
| (202/215) | ||||
| SOF/LDV/RBV, 8 weeks | 93% | n/a | ||
| (201/216) | ||||
| SOF/LDV, 12 weeks | 95% | n/a | ||
| (206/216) |
FDC, fixed dose combination tablet; GT, genotype; LDV, ledipasvir; n/a, not applicable; RBV, ribavirin; SOF, sofosbuvir; TE, treatment experienced; TN, treatment naïve.