Virological response following treatment
| Cohort 1 Treatment-naive | Cohort 2 Ledipasvir/ sofosbuvir or sofosbuvir-experienced | Cohort 3 Interferon-experienced | |||||
| Ledipasvir/ sofosbuvir 8 weeks (n=43) | Ledipasvir/ sofosbuvir+ribavirin 8 weeks (n=42) | Ledipasvir/ sofosbuvir 12 weeks (n=43) | Ledipasvir/ sofosbuvir+ribavirin 12 weeks (n=42) | Ledipasvir/ sofosbuvir+ribavirin 12 weeks (n=11) | Ledipasvir/ sofosbuvir 12 weeks (n=36) | Ledipasvir/ sofosbuvir+ ribavirin 12 weeks (n=38) | |
| Response* | |||||||
| HCV RNA<LLOQ | |||||||
| SVR4 (95% CI) | 41 (95) (84 to 99) | 40 (95) (84 to 99) | 42 (98) (88 to 100) | 41 (98) (87 to 100) | 11 (100) (72 to 100) | 36 (100) (90 to 100) | 38 (100) (91 to 100) |
| SVR12 (95% CI) | 41 (95) (84 to 99) | 38 (90) (77 to 97) | 42 (98) (88 to 100) | 41 (98) (87 to 100) | 11 (100) (72 to 100) | 34 (94) (81 to 99) | 38 (100) (91 to 100) |
| Virological failure | |||||||
| On-treatment virological failure | 0 | 1 (2) | 0 | 0 | 0 | 0 | 0 |
| Post-treatment relapse | 2 (5) | 3 (7) | 1 (2) | 0 | 0 | 1 (3) | 0 |
| Other reason for failure† | 0 | 0 | 0 | 1 (2) | 0 | 1 (3) | 0 |
*All values are n (%) unless stated otherwise.
†Of the two patients with Other reason for failure, one patient from cohort 1 prematurely discontinued study treatment at day 56 due to a serious adverse event and one patient from cohort 3 died prior to study completion at 84 days post-treatment.
HCV, hepatitis C virus; LLOQ, lower limit of quantification; SVRn, sustained virological response at n weeks post-treatment.